CN116801789A

CN116801789A - Blood collection devices, systems and methods

Info

Publication number: CN116801789A
Application number: CN202180089317.5A
Authority: CN
Inventors: K•J•库克
Original assignee: Avia Vascular Co
Current assignee: Avia Vascular Co
Priority date: 2020-11-26
Filing date: 2021-11-26
Publication date: 2023-09-22

Abstract

The pathway system may include: a connector for coupling with a catheter assembly having a catheter tube positionable in a blood vessel of a patient; a reinforcing member fixedly secured to the connector; and a sleeve movable relative to the reinforcement member from a retracted position in which at least a portion of the sleeve is within the reinforcement member to an advanced position. The sleeve may include a polymeric tube and a support tube surrounding a portion of the polymeric tube. As the sleeve transitions from the retracted position to the advanced position, the support tube defines a distal edge within the reinforcement member when the distal tip of the polymeric tube is initially positioned distally and externally of the reinforcement member.

Description

Blood collection devices, systems, and methods

Cross Reference to Related Applications

U.S. provisional patent application Ser. No. 63/118,679, U.S. provisional patent application Ser. No. 63/225,992, and U.S. provisional patent application Ser. No. 2021/256,625, entitled BLOOD COLLECTION device, system and method (BLOOD COLLECTION DEVICES, SYSTEMS, AND METHOD) filed on month 11, 26 of 2020, and U.S. provisional patent application Ser. No. 63/118,679, U.S. provisional patent application Ser. No. 2021/37/256,625, entitled BLOOD COLLECTION device, system and method (BLOOD COLLECTION DEVICES, SYSTEMS, AND METHOD) filed on month 10, 2021.

Technical Field

Certain embodiments described herein relate generally to devices, systems, and methods for blood collection, and further embodiments relate particularly to devices, systems, and methods for facilitating blood collection via a previously placed catheter (such as, for example, a peripheral intravenous catheter).

Background

Known devices, systems, and methods for drawing blood, including using previously placed catheters to draw blood, have a number of disadvantages. Embodiments disclosed herein correct, ameliorate or avoid one or more of these disadvantages. Other or further uses and methods are also disclosed.

Drawings

The written disclosure herein describes non-limiting and non-exhaustive illustrative embodiments. Reference is made to certain such illustrative embodiments depicted in the accompanying drawings, in which:

fig. 1A is a schematic cross-sectional view of a proximal portion of one embodiment of a base catheter system (base catheter system) placed within a patient;

FIG. 1B is a schematic cross-sectional view of the distal end of the base catheter system of FIG. 1A within a patient's vessel;

FIG. 2 is a perspective view of one embodiment of an access system configured to couple with one embodiment of a base catheter system, the access system shown in an undeployed or retracted state;

FIG. 3 is a side elevational view of the access system of FIG. 2 in an undeployed or retracted state;

FIG. 4 is another side elevational view of the access system of FIG. 2 in a fully deployed or advanced state;

FIG. 5 is a cross-sectional view through the longitudinal axis of the access system of FIG. 2, wherein the access system is in a fully deployed or advanced state;

FIG. 6 is a side elevation view of one embodiment of a sleeve compatible with the access system of FIG. 2;

FIG. 7 is a side elevational view of the distal portion of the access system of FIG. 2 in an undeployed or retracted state;

FIG. 8 is a cross-sectional view of a distal portion of another embodiment of an access system shown in an undeployed or retracted state;

FIG. 9 is a cross-sectional view of a distal portion of another embodiment of an access system shown in an undeployed or retracted state;

FIG. 10 is a cross-sectional view of a distal portion of another embodiment of an access system shown in an undeployed or retracted state;

FIG. 11 is a cross-sectional view of a distal portion of another embodiment of an access system shown in an undeployed or retracted state;

fig. 12 is a perspective view of one embodiment of a closed intravenous catheter system in a fully assembled state, which may be referred to as an insertion configuration;

Fig. 13 is a perspective view of the closed intravenous catheter system of fig. 12 in a state in which the penetrating instrument has been removed from the hub and catheter tube, which may be referred to as a pathway configuration;

FIG. 14 is a cross-sectional view of a portion of the closure catheter system of FIG. 12 in a pathway configuration;

FIG. 15 is a perspective view of another embodiment of an access system configured to couple with an embodiment of a base catheter system, the access system shown in an undeployed or retracted state;

FIG. 16 is a cross-sectional view of the access system of FIG. 15 in an undeployed or retracted state;

FIG. 17A is a perspective view of one embodiment of a housing compatible with the access system of FIG. 15;

FIG. 17B is a cross-sectional view of the housing of FIG. 17A;

FIG. 17C is another cross-sectional view of the housing of FIG. 17A;

FIG. 18A is a perspective view of one embodiment of a coupling member compatible with the access system of FIG. 15;

FIG. 18B is a cross-sectional view of the coupling member of FIG. 18A;

FIG. 19A is a perspective view of one embodiment of a follower (follower) compatible with the access system of FIG. 15;

FIG. 19B is another perspective view of the follower of FIG. 19A;

FIG. 19C is a cross-sectional view of the follower of FIG. 19A;

FIG. 20 is a cross-sectional view of one embodiment of a connector compatible with the access system of FIG. 15;

FIG. 21 is a partially exploded elevational view of one embodiment of a sleeve showing a tie layer separate from the two component parts of the sleeve for connecting the two component parts together;

FIG. 22 is an enlarged cross-sectional view of the sleeve with the tie layer on the two-part portion of the sleeve;

FIG. 23A is a cross-sectional view of a generally proximal portion of the access system of FIG. 15 in a retracted state;

FIG. 23B is a cross-sectional view of the distal portion of the access system of FIG. 15 in a retracted state;

FIG. 24 is an exploded perspective view of one embodiment of a base catheter assembly including one embodiment of an open intravenous catheter assembly and one embodiment of an extension set coupleable to the open intravenous catheter assembly;

FIG. 25 is a cross-sectional view of the base catheter assembly of FIG. 24 in an assembled state;

FIG. 26 is a side elevational view of the access system of FIG. 15 in a retracted state coupled with the assembled base catheter assembly of FIG. 25;

FIG. 27 is a cross-sectional view of the distal portion of the access system of FIG. 15 in a retracted state coupled with the assembled base catheter assembly of FIG. 25;

FIG. 28 is a cross-sectional view of the access system of FIG. 15 in a fully deployed state while coupled with the assembled base catheter assembly of FIG. 25;

FIG. 29A is a cross-sectional view of a generally intermediate portion of the access system in the configuration depicted in FIG. 28;

FIG. 29B is a cross-sectional view of the generally distal portion of the access system of FIG. 15 and the proximal portion of the assembled base catheter assembly of FIG. 25 in the configuration depicted in FIG. 28;

FIG. 29C is a cross-sectional view of the distal end of the assembled base catheter assembly of FIG. 25 and the access system of FIG. 15 in the configuration depicted in FIG. 28;

FIG. 30 is a perspective view of another embodiment of an access system configured to couple with an embodiment of a base catheter system, wherein the access system is shown in a retracted or undeployed state;

FIG. 31 is a cross-sectional view of the access system of FIG. 30;

FIG. 32A is a perspective view of one embodiment of a coupling member compatible with the access system of FIG. 30;

FIG. 32B is a cross-sectional view of the coupling member of FIG. 32A;

FIG. 33 is a cross-sectional view of the distal end of the access system of FIG. 30 advanced toward one embodiment of a closed intravenous catheter system coupled thereto (such as the closed intravenous catheter system of FIG. 12) in a retracted state or an undeployed state;

FIG. 34 is a cross-sectional view of the distal end of the access system of FIG. 30 coupled to a closed intravenous catheter system in a retracted or undeployed state;

FIG. 35 is a perspective view of another embodiment of an access system configured to couple with an embodiment of a base catheter system, wherein the access system is shown in a retracted or undeployed state;

FIG. 36 is a cross-sectional view of the access system of FIG. 35 in a retracted state;

FIG. 37A is a perspective view of one embodiment of a housing compatible with the access system of FIG. 35;

FIG. 37B is a perspective cross-sectional view of the housing of FIG. 37A;

FIG. 38A is a perspective view of one embodiment of a follower compatible with the access system of FIG. 35, the follower including a selective engagement feature;

FIG. 38B is a cross-sectional view of the follower of FIG. 38A;

FIG. 39A is a perspective view of one embodiment of a reinforced pipe assembly including a reinforced pipe and a catch (catch);

FIG. 39B is a cross-sectional view of the reinforcement tube assembly of FIG. 39A;

FIG. 40 is a cross-sectional view of the distal end of the access system of FIG. 35 in the retracted state of FIGS. 35 and 36;

FIG. 41 is a cross-sectional view of the distal region of the access system of FIG. 35 in a retracted state;

FIG. 42 is a cross-sectional view of an intermediate region of the access system of FIG. 35 in a retracted state;

FIG. 43 is a cross-sectional view of a generally proximal portion of the access system of FIG. 35 in a retracted state;

FIG. 44 is a cross-sectional view of the access system of FIG. 35 coupled with one embodiment of a base catheter assembly (such as the base catheter assembly of FIG. 24) when the access system of FIG. 35 is in a retracted state;

FIG. 45 is a cross-sectional view of a generally intermediate region of the access system of FIG. 35 in the retracted configuration depicted in FIG. 44;

FIG. 46 is a cross-sectional view of the distal portion of the access system and the proximal portion of the catheter assembly when the access system of FIG. 35 is in the retracted configuration depicted in FIG. 44;

FIG. 47 is a cross-sectional view of the access system of FIG. 35 coupled with a base catheter assembly while in a partially deployed state or in other words at an intermediate stage of deployment;

FIG. 48 is a cross-sectional view of an intermediate region of the access system of FIG. 35 in the intermediate deployment configuration depicted in FIG. 47;

FIG. 49 is a cross-sectional view of the distal end of the access system and the proximal portion of the base catheter assembly when the access system of FIG. 35 is in the intermediate deployment configuration depicted in FIG. 47;

FIG. 50 is a cross-sectional view of the access system of FIG. 35 coupled with a base catheter assembly in a fully deployed state;

FIG. 51 is a cross-sectional view of an intermediate region of the access system of FIG. 35 in the fully deployed state depicted in FIG. 50;

FIG. 52 is a cross-sectional view of a generally distal portion of the access system and a proximal portion of the base catheter assembly when the access system of FIG. 35 is in the fully deployed state depicted in FIG. 50;

FIG. 53 is a cross-sectional view of the distal end of the access system and base catheter assembly of FIG. 35 when the access system is in the fully deployed state depicted in FIG. 50;

FIG. 54 is a perspective view of another embodiment of an access system in a retracted state;

FIG. 55 is a cross-sectional view of the access system of FIG. 54 in a retracted state;

FIG. 56A is an enlarged cross-sectional view of the distal region of the access system of FIG. 54 in a retracted state;

FIG. 56B is an enlarged cross-sectional view of the proximal region of the access system of FIG. 54 in a retracted state;

FIG. 57 is a perspective view of another embodiment of an access system in a retracted state;

FIG. 58 is a cross-sectional view of the pathway system of FIG. 57;

FIG. 59 is an enlarged cross-sectional view of the access system of FIG. 57 taken along line of sight (view line) 59 of FIG. 58, showing one embodiment of a sealing member at the proximal end of the stiffening tube;

FIG. 60 is a cross-sectional view of another embodiment of a seal member compatible with the access system of FIG. 57;

FIG. 61 is a perspective view of another embodiment of an access system in a retracted state;

FIG. 62 is a cross-sectional view of the access system of FIG. 61 in a retracted state;

FIG. 63 is a perspective cross-sectional view of another embodiment of an access system; and

fig. 64 is a cross-sectional view of a generally distal portion of the access system of fig. 63.

Detailed Description

Embodiments of the present disclosure generally relate to devices, systems, and methods for blood collection (also known as blood drawing, blood aspiration, phlebotomy procedures, etc.). Blood collection may be accomplished via an access system that includes a tube or cannula that is inserted into a previously placed catheter, such as a catheter tube of a previously placed catheter, such as, for example, a previously placed Peripheral Intravenous (PIV) catheter. In certain embodiments, the access system may provide a desired venipuncture (venipuncture) alternative.

In one environment, fluids, particularly blood, are routinely drawn from patients in many hospitals, clinics and laboratories. One of the most common ways to withdraw blood is venipuncture, a method that involves inserting a needle through the skin into a subcutaneous vein to provide access to the patient's blood. In some cases, the frequency of blood draw may be as high as once every six hours. Furthermore, each time the needle is inserted into the skin, the patient may experience multiple attempts and the more frequent the withdrawal, the more difficult it is to find the location of the next withdrawal. Each attempt may be painful and boring. Difficult venous access (Difficult intravenous access, DIVA) is a common problem affecting many patients. However, other options for withdrawing blood and other fluids are limited and often may be even more painful than venipuncture. Some of these options include the use of peripherally inserted central catheter (peripherally inserted central catheters, PICC line), central catheter, repeated peripheral venipuncture, and groin sticks (groin sticks).

In some cases, blood may be drawn via a peripheral intravenous catheter at the time of insertion. However, in many cases, over time, a clot or fibrin sheath may form at the tip of the intravenous catheter, and thus it is generally undesirable to withdraw blood from the peripheral intravenous catheter at any significant time after placement, as previously designed. In various circumstances, obstructions formed at the distal tip may completely occlude the distal tip, thereby completely preventing blood from being withdrawn through the catheter. In other cases, the obstruction may only partially obstruct the distal tip, but may affect fluid flow through the catheter such that hemolysis is promoted and/or otherwise the quality of blood drawn through the catheter is reduced and/or the speed of drawing is reduced.

In some cases, intravenous catheters may lack sufficient rigidity to remain fully open (patent) during blood drawing. For example, in some cases, the catheter is formed of a material that softens over time while within the patient's vasculature. Although blood may be drawn when the catheter is initially placed, after initial placement, blood drawing becomes increasingly difficult as the catheter softens and eventually fails. When negative pressure is applied to the proximal end of the catheter in an attempt to draw blood, the lumen of the catheter may collapse, thereby inhibiting or preventing blood drawing.

In some cases, even if blood can be drawn through a softened catheter, the quality of the drawn blood may deteriorate as the catheter softens relative to the quality of the blood drawn immediately after placement of the catheter. Without being bound by theory, this reduction in mass may be due to the lumen defined by the catheter becoming more tortuous or otherwise changing shape as the catheter softens. For example, upon initial placement, the catheter may have relatively few curves (curves) and/or regions of the catheter extending through the skin, and the vessel wall may define a rounded cross-sectional profile. Over time, the softened or softened catheter may become compliant so that the cross-sectional profile conforming to the tortuous anatomy through which it passes and/or at the insertion region may flatten or otherwise change shape. Blood drawn through these altered regions may, for example, be more prone to hemolysis.

In yet other or further cases, during an attempted blood draw, the opening at the catheter tip may aspirate a feature of the vascular anatomy, such as a valve or a vessel wall, thereby preventing blood from being drawn through the opening.

For one or more of the foregoing reasons, and/or for other possible reasons, it may be desirable to provide a tubing or cannula that passes through a previously placed catheter (e.g., a PIV catheter) to achieve high quality blood draw through the catheter. The terms "tubing" and "casing" are used interchangeably herein. In some cases, the cannula may have sufficient rigidity to provide or maintain an open cavity through which blood may readily pass. In other or further cases, the cannula may be easily inserted into and/or through the blood vessel through a tortuous path. In other or further cases, the distal end of the cannula may be placed distally relative to the tip of a previously placed catheter, which may, for example, avoid interference from a clot or fibrin sheath; may allow access to areas outside of anatomical features that would otherwise be occluded, such as by moving past one or more venous valves and/or away from the vessel wall; may allow movement to areas of increased blood flow; and/or may be moved away from the area where venipuncture and catheterization caused vascular trauma, any or all of which may result in significant improvement in blood draw, such as, for example, by establishing blood flow and/or by reducing hemolysis of the sampled blood.

Certain embodiments disclosed herein may correct, ameliorate or avoid one or more of the limitations or disadvantages of known systems in which catheters are inserted through previously placed catheters for blood collection. One or more of these and/or other advantages will be apparent in light of this disclosure.

For example, in some cases, a catheter is introduced into a patient, and a cannula is then introduced into the patient through the catheter. The catheter may be referred to herein as a placement catheter, a pre-deployment catheter, an anchoring catheter, or a base catheter. In some cases, the cannula may also be referred to as a tube, a fluid channel, a fluid extraction member, or the like. In many cases, the cannula will have different characteristics than the catheter placed. For example, in some cases, at least a portion of the cannula may be harder or more rigid than the placement catheter. In some cases, the cannula may define an open lumen or channel through which blood may pass from the blood vessel and out of the patient through the cannula into any suitable blood collection device. In some cases, the cannula may be reinforced to avoid buckling or kinking, thereby facilitating access to and extension through the tortuous path of the lumen defined by the catheter. In some cases, the cannula may straighten or otherwise reduce the tortuosity of the path through the pre-set catheter system. In some cases, the cannula may be advanced through the distal end of the deployment catheter.

Fig. 1A and 1B depict one embodiment of a base catheter system 100, such as, for example, a Peripheral Intravenous (PIV) catheter system. The base catheter system 100 may also be referred to herein as a placement catheter system, a pre-deployment catheter system, an anchoring catheter system, or the like. Base catheter system 100 includes a catheter tube 104 and a catheter hub 106, catheter hub 106 being fixedly secured to a proximal end of catheter tube 104. The base catheter system 100 may be inserted into the patient P in any suitable manner such that at least the distal end of the catheter 104 extends into a vessel V (e.g., vein) of the patient (fig. 1B) and such that a proximal portion of the base catheter system 100 (including the catheter hub 106) is accessible (accessable) outside of the patient. The catheter tube 104 may define a lumen 108, for example, infusions (infusions) may be delivered into the blood vessel V through the lumen 108. Catheter hub 106 may be of any suitable variety. In some embodiments, catheter hub 106 is a female luer connector.

Although not shown in fig. 1A, in many embodiments, the proximal portion of the base catheter system 100 that remains external to the patient P may be secured to the patient's skin after placement of the catheter tube 104. A variety of dressing options are possible, including adhesive tapes or adhesive dressings specifically designed for such securement. As discussed further below, certain embodiments may be used with the base catheter system 100 when securing the base catheter system 100 to a patient using tape or adhesive dressing (e.g., standard or known dressing), and in further cases, may be used with the base catheter system 100 without the use of any special equipment (e.g., wedge-shaped support members), which may be coupled with the base catheter system 100 to position the proximal ends of the catheter hub 106 and the tube 104 at an angle (such as, for example, an acute angle, similar to that shown in fig. 1A) relative to the skin surface.

In some embodiments, the base catheter system 100 may be an open catheter system, such as an open intravenous catheter system (e.g., an open PIV catheter system). The term "open/open" in this context is used in its ordinary sense in the relevant art and includes catheter systems in which the connector 106 may not provide a barrier (e.g., a fluid-tight seal) between the lumen 108 and the environment outside the catheter hub 106. For example, in the illustrated embodiment, catheter hub 106 defines an open proximal end that is exposed to the environment. In some embodiments, a sealing member, such as any suitable valve flap (valve), septum, or needleless connector, may be attached to catheter hub 106. In other or further embodiments, an extension set (see, e.g., fig. 24 and 25) may be coupled to catheter hub 106. In certain embodiments (such as the embodiment depicted in fig. 24), the extension set may include a connector at its proximal end, a connector at its distal end for coupling with catheter hub 106, and a side port therebetween having an extension tube and any suitable connector at the proximal end of the extension tube. In some cases, the proximal connector may include or couple a valve flap, a septum, or a needleless connector.

As discussed further below, in other embodiments, the base catheter system 100 may instead be a "closed" catheter system, such as a closed intravenous catheter system (e.g., a closed PIV catheter system). An illustrative example of such a closed intravenous catheter system is depicted and further discussed below with reference to fig. 12-14. The term "closed" in this context is used in its ordinary sense in the relevant art and includes such systems: catheter tube 104 is attached to a distal port of catheter hub 106, catheter hub 106 further comprising a proximal port from which a introducer needle (introducer needle) may be withdrawn and sealed or plugged and an integral side port in fluid communication with catheter tube 104 via which fluid delivery and/or removal via catheter tube 104 is effected. One illustrative example of a closed PIV catheter system is NEXIVA ^TM Closed IV catheter system available from Becton Dickinson.

Referring to fig. 2-5, in some embodiments, the access system 200 may be configured to couple with the base catheter system 100. The pathway system 200 may also or alternatively be referred to as a pathway assembly. The illustrated access system 200 may be particularly suitable for use in connection with an open-base catheter system 100 such as the illustrative system 100 depicted in fig. 1 and 2 and/or for use in pushing a conduit into an open-base catheter system 100. In other or further cases, the access system 200 may be configured to couple with an expansion set (e.g., such as the expansion set depicted in fig. 24) of the open-base catheter system 100, and may advance tubing through the expansion set and ultimately into the catheter tube 104. The access system 200 may also be referred to as a fluid channel (channel) system, a fluid extraction system, a blood removal system, a follow-on cannula system, a secondary catheter system, a supplemental catheter system, and the like.

The base catheter system 100, such as its catheter tube 104, may be inserted into a patient's blood vessel in any suitable manner, including in a manner known in the art. In some cases, no portion of the access system 200 is coupled to the base catheter system 100 prior to insertion of the base catheter system 100 into a patient. For example, the access system 200 may be coupled with the base catheter system 100 after the base catheter system 100 is placed within the patient. Specifically, after placement of the base catheter system 100, one or more portions of the access system 200 may be coupled to the base catheter system 100 at any suitable time. In some cases, a suitable time may be no less than 30 minutes, 1 hour, 6 hours, 12 hours, 18 hours, 1 day, 2 days, or 3 days after initial placement of the base catheter system 100.

The access system 200 includes a connector 202 and a cannula 204. The sleeve 204 may also be referred to as a conduit. The cannula 204 may define a continuous fluid path through which blood may be withdrawn from the vasculature of the patient. The sleeve 204 is configured to move relative to the connector 202 between a retracted or undeployed state (fig. 2 and 3) and an advanced or deployed state (fig. 4 and 5). In particular, a user may grasp the cannula 204, e.g., the proximal end of the cannula 204, to distally advance (e.g., translate forward) the cannula 204 from the retracted state to the advanced state relative to the connector 202. Likewise, a user may grasp the cannula 204, e.g., the proximal end of the cannula 204, to proximally retract (e.g., translate rearward) the cannula 204 from the advanced state to the retracted state relative to the connector 202. For example, in some cases, a user may grasp the connector 229 at the proximal end of the cannula 204 to advance and/or retract the cannula 204.

The connector 202 may include a coupling interface 210, which may be at a distal end of the connector 202. In the illustrated embodiment, coupling hub 210 includes a threaded male luer 211, such as may be readily coupled with a female luer of catheter hub 106 described above. Any other suitable coupling interface 210 is contemplated.

The connector 202 may be longitudinally elongated so as to be substantially tubular in shape. For example, in some embodiments, the distal end of the connector 202 may include a connection region 203 at its distal end defining a coupling interface 210, and may further include a housing, barrel, tube, or sheath 205 extending proximally from the connection region 203. Sheath 205 may define an extension channel 212 (fig. 5), which may also be referred to as an interior chamber, lumen, or interior space, within which a portion of cannula 204 may be located. For example, in various embodiments, at least some portion of the cannula 204 may be positioned within or inside the sheath 205 when the cannula 204 is in the retracted state, the deployed state, and throughout the transition between the retracted state and the deployed state.

Referring to fig. 5 and 6, in various embodiments, sleeve 204 may be a multi-part component or a multi-part component. For example, in the illustrated embodiment, the cannula 204 is a three-stage element that defines a continuous or uninterrupted flow path or fluid path 220 for drawing blood. In the illustrated embodiment, each segment is defined by a separate piece, and each piece is formed of one or more materials that are different from the materials of one or more of the other two pieces. In other embodiments, two or more of the plurality of segments (e.g., proximal and medial segments) may be integrally formed from a unitary piece of material. In yet other or further embodiments, each segment may include one or more components or constituent elements. In some of these embodiments, two or all three segments may have at least one component that differs from each of the remaining segments in some manner, such as, for example, by physical characteristics, quantity, presence or absence, etc. The fluid path 220 may include a cavity 221. In some embodiments, the diameter of the cavity 221 may vary along the length of the cannula 204. For example, in the illustrated embodiment, the lumen 221 defines a larger inner diameter in its proximal region than the distal region of the cannula 204. In other embodiments, the cavity 221 may define a substantially constant inner diameter along substantially the entire length of the cannula 204.

In some embodiments, cannula 204 may include proximal section 222; a middle section, middle section or inner section 224; and distal segment 226, as identified in fig. 6. In some embodiments, the material and/or material properties of at least one of the segments may vary relative to the material and/or material properties of one or more of the remaining segments.

In certain embodiments, the proximal section 222 may be rigid or semi-rigid. The proximal section 222 may be made of transparent plastic, for example, which may allow visualization of fluid flow. The rigidity of the proximal section 222 may allow the cannula 204 to be pushed distally relative to the connector 202. In some embodiments, the proximal section 222 may include a connector 229 at its proximal end. The connector 229 may be of any suitable variety. For example, in the illustrated embodiment, the proximal section 222 includes a connector 229, the connector 229 being a female luer connector (i.e., conforming to ISO standards), which may be connected to any suitable fluid source and/or fluid collection device. For example, the connector 229 may be configured to couple with a syringe, which may be used for infusion or blood collection. Connector 229 may be used in connection with a blood drawing device such as a syringe or vacuum blood collection tube (e.g., available from Becton Dickinson A tube) and/or a device connection therefor. For example, in some embodiments, connector 229 may include or may be configured to be associated with +.>A single use holder (holder) connection, via which blood can be drawn to one or more +.>In the tube. In other embodiments, the connector 229 may be integrally formed with the fluid source and/or the fluid collection apparatus.

In some embodiments, a valve flap or vent fitting may be removably attached to or incorporated into the proximal section 222. A vent fitting (such as, for example, vent fitting 819 depicted in fig. 12) may allow blood to flow from the vasculature through the cannula 204, for example, when air within the cannula lumen 221 is vented into the environment, and the vent fitting may act as a liquid-tight barrier for the blood. In some embodiments, the proximal section 222 may allow for visualization of the initial passage of blood through the lumen 221, or in other words, may provide for blood flashback (flashback) visualization. For example, when the proximal section 222 comprises a tube of transparent or translucent material, the proximal section 222 may allow for potential visualization of blood flashback. In various embodiments, proximal section 222 may comprise or be formed from a polycarbonate, polyurethane, and/or polypropylene tube. Any other or further suitable material is contemplated.

In some embodiments, the proximal section 222 may be flexible in a transverse direction relative to the longitudinal axis of the proximal section 222, but may be sufficiently rigid in the longitudinal direction to transmit distal forces along the cannula 204. For example, in some embodiments, the proximal section 222 may be flexible enough to bend up to about 90, 120, 150, or 180 degrees, e.g., without plastic deformation, but may straighten and advance distally to advance the cannula 204 distally relative to the connector 202. In some cases, the proximal section 222 may be packaged in a curved state, which may allow for a reduction in the overall packaged length of the pre-packaged access system 200. The user may remove the access system 200 from the package and manually straighten the proximal section 222 or allow the proximal section 222 to resiliently straighten into a relaxed state, which may be substantially linear. In other words, in some embodiments, the proximal section 222 may be elastically deformable and may naturally straighten into a substantially straight configuration upon removal from the package. The user may advance the straightened proximal section 222 through the proximal end of the sheath 203 to distally advance the cannula 204 relative to the connector 202.

In other embodiments, the proximal section 222 may be relatively rigid. The proximal segment 222 may have a linear configuration, as depicted in fig. 6, and may be relatively resistant to lateral deformation from the linear shape. For example, the proximal segment 222 may be preformed, packaged, and used in a rectilinear shape, and in further embodiments may be substantially resistant to deformation from the rectilinear shape.

In certain embodiments, the inner section 224 of the sleeve 204 may be hard or rigid to avoid bending or kinking. Medial section 224 may transfer distal forces from proximal section 222 to distal section 226. In various embodiments, the inner section 224 may comprise or be formed of a metal, such as, for example, stainless steel. For example, in some embodiments, the medial section 224 consists essentially of a metal tube, such as a hypotube, coupled to the distal section 226. In other embodiments, the inner section comprises a metal tube, such as a hypotube, that surrounds a portion of a polymer tube that extends through a lumen of the metal tube. Other or further suitable materials and/or configurations are also contemplated.

Proximal segment 222 and medial segment 224 may be joined together in any suitable manner. For example, in various embodiments, the proximal section 222 may be overmolded (over molded) on the proximal end of the medial section 224. In other embodiments, the proximal segment 222 and the medial segment 224 may be press fit, friction fit, attached, or otherwise joined together, and may be fluid tight such that leakage from the cavity 221 does not occur at the interface between the two segments.

The distal section 226 may be relatively soft or flexible so as to be easily advanced through the pre-catheter 104. For example, the distal segment 226 may be substantially softer and/or more flexible (e.g., may deflect laterally more easily) than the medial segment 224. For example, the distal segment 226 may be sufficiently soft or flexible to prevent or inhibit damage to the catheter tube 104 and/or, in some embodiments, the vessel V (e.g., if the distal segment 226 extends past the distal end of the catheter tube 104 and contacts the vessel V). However, in various embodiments, the distal segment 226 may be sufficiently rigid to advance through the catheter tube 104. In some embodiments, the distal segment 226 may be made more straight as the distal segment 226 is advanced through the catheter tube 104.

In some embodiments, the distal tip 227 of the distal segment 226 includes one or more features that render the distal tip 227 atraumatic or substantially atraumatic relative to one or more of the pre-catheter tube 104 and the patient's vasculature. For example, in some embodiments, the distal section 226 comprises a polymeric material (e.g., polyimide) tube. In some embodiments, the distal tip 227 of the tube is laser ablated to smooth and round the tip so that the distal tip 227 is less prone to scoring, scraping, cutting and/or puncturing the inner surface of the catheter tube 104 and/or the vessel in which the catheter tube 104 is located as the distal tip 227 extends from the catheter tube 104. In other or further embodiments, distal tip 227 may comprise a softer material (e.g., a lower durometer material) attached to the distal end of the polymer tube. For example, in some embodiments, a silicone layer may be positioned at the distal tip 227 in any suitable manner.

During blood drawing, when cannula 204 is in the advanced state, distal segment 226 may be fully positioned within catheter tube 104 such that distal tip 227 is recessed (recessed) proximally or substantially flush with the distal tip of catheter tube 104, or distal segment 226 may extend slightly beyond the distal tip of catheter tube 104. When a portion of the catheter system 100 (i.e., at least a portion of the catheter tube 104) is positioned within the vasculature, the distal segment 226 may conform to the tortuous path of the vasculature and/or defined by the pre-set catheter system 100. The distal segment 226 may prevent damage thereto, for example, during advancement through the catheter tube 104. For example, if the catheter tube 104 is sharply bent or kinked, the distal segment 226 may avoid puncturing or scoring the interior of the catheter tube 104 at the bending or kinking site during distal advancement of the distal segment 226 through the catheter tube 104.

In various embodiments, distal segment 226 may include or be formed from: polyimide, polyether block amide, silicone, polyamide, nylon, PEEK and/or polyurethane. In other or further embodiments, the distal section may comprise a siliconized polyurethane, such as one or more materials described in U.S. patent application publication No. 2019/0153147 to Muse et al, the entire contents of which are hereby incorporated by reference herein. Any other or further suitable material is contemplated.

In some embodiments, the distal segment 226 may have sufficient rigidity to at least partially straighten the catheter tube 104 as the distal segment 226 is advanced through the catheter tube 104 of the system 100. For example, in some embodiments, the distal section 226 may have a hardness that is greater than the hardness of the catheter tube 104. In some instances, straightening via the distal segment may facilitate drawing blood and/or allow laminar or substantially laminar blood flow through cannula 204. In other words, the distal segment 226 may provide a straight or straightened flow path relative to the flow path defined by the pre-catheter system 100 prior to use of the system 200. For example, in some instances, when the system 200 is deployed within the pre-catheter system 100, the fluid path 220 through the deployed system 200 may be substantially straight or rectilinear, or may be gently sloped or gently curved (e.g., without sharp turns or kinks) along at least the length of the distal segment 226. The distal section 226, or at least a distal portion thereof, may be sized to slide or otherwise advance through the lumen 108 of the catheter tube 104.

In other embodiments, the distal section 226 may be relatively softer than embodiments that may achieve significant straightening of the pre-set catheter tube. In various embodiments, the distal section may achieve a lesser amount, a minimal amount, or even substantially no straightening of the pre-catheter tube 104. Nonetheless, the relatively soft distal section 226 is still able to follow a tortuous path through the catheter system 100 while maintaining patency through the lumen 221. In some embodiments, the lateral support provided to the distal segment 226 by the reinforcement members included in the connector 202 and/or the strength and kink resistance provided by the medial segment 224 may assist in advancing the distal segment 226 into the catheter tube 104, as discussed further below.

Distal segment 226 may be coupled to medial segment 224 in any suitable manner. For example, in some embodiments, the medial and distal sections 224, 226 are attached via a length of thin-walled heat-shrinkable tubing (see, e.g., fig. 21 and 22). Such an attachment mechanism may be particularly useful, for example, when the inner section 224 comprises a metal (e.g., stainless steel) tube and the distal section 226 comprises a polymer tube that abuts the metal tube. Any other or further suitable attachment is contemplated.

In some embodiments, only the distal section 226 is introduced into and through the pre-catheter tube 104. In other words, when the access system 200 is in the fully deployed state, the distal end of the inner section 224 remains proximal to the proximal end of the catheter tube 104 and at least a portion of the distal section 226 extends into and/or through the catheter tube 104. As previously described, in at least some embodiments, the distal end of the distal segment 226 can extend distally past the distal tip of the catheter tube 104 when the access system 200 is in the fully deployed state.

In other embodiments, the distal segment 226 may be relatively short and may act as a substantially atraumatic tip of the medial segment 224, and at least a portion of the medial segment 224 may be introduced into the catheter tube 104. In some embodiments, the inner section 224 may provide a straightened path through at least a proximal portion of the catheter tube 104. For example, the distal segment 226 may include any of the tip features discussed previously and may help prevent trauma to the catheter and vessel, and the inner segment 224 may straighten at least a portion of the catheter tube 104 as the inner segment 224 is advanced through the at least a portion of the catheter tube 104 of the system 100. Such straightening may facilitate drawing blood and/or achieve laminar or substantially laminar blood flow through cannula 204. In other words, in various embodiments, the inner section 224, either alone or in combination with the distal section 226, may provide a straight or straightened flow path relative to the flow path defined by the pre-set catheter system 100 prior to use of the system 200. For example, when the system 200 is deployed within the pre-catheter system 100, the fluid path 220 through the deployed system 200 may be substantially straight or rectilinear, or may be gently sloped or gently curved (e.g., without sharp turns or kinks) along at least the length of the medial section 224. The inner section 224, or at least a distal portion thereof, may be sized to slide or otherwise advance through at least a portion of the lumen 108 of the catheter tube 104.

In other embodiments, as discussed further below, the inner section 224 may not extend into the catheter tube 104. For example, in some embodiments, the inner section 224 has an outer diameter that is greater than the inner diameter of the catheter tube 104 and may be prevented from entering the proximal end of the catheter tube 104.

Referring to fig. 7, in some embodiments, the connector 202 includes a reinforcement member 230, which may also or alternatively be referred to herein as a reinforcement member. In the illustrated embodiment, the reinforcement member 230 includes a tubular member, such as a needle element or reinforcement sleeve 232. The reinforcement sleeve 232 may also or alternatively be referred to herein as a reinforcement tube. In some embodiments, the reinforcement sleeve 232 may be formed from a metallic hypotube. The reinforcement members 230 can provide external or lateral support to the distal segment 226 to prevent buckling and/or kinking of the distal segment 226 during forward advancement of the cannula 204. For example, in various embodiments, the distal tip 227 of the distal segment 226 may encounter resistance as the distal segment 226 is advanced distally into the catheter tube 104. In particular, during such distal advancement, the proximal end of the distal segment 226 may be provided with a distally directed force by the relatively stiff or reinforced (e.g., axially or longitudinally reinforced) inner segment 224, while a force resisting distal advancement of the distal segment 226 may tend to act in a generally opposite direction (e.g., generally proximally) at the distal end of the distal segment 226. These generally oppositely directed forces may tend to compress the distal segment 226, causing the distal segment 226 to buckle, arch, bend, kink, or laterally displace. The reinforcement members 230 may resist these lateral forces, thereby preventing buckling or kinking and facilitating insertion of the distal segment 226 through the catheter tube 104.

The inner diameter of the reinforcement sleeve 232 may be such that the outer diameter of one of the distal segment 226 and at least the distal portion of the inner segment 224 may fit therein. Such a fit may desirably be relatively tight such that there is a minimal gap between the inner surface of the reinforcement member 230 and the outer surface of each of the distal segment 226 and the inner segment 224. In various embodiments, the inner diameter (e.g., the maximum lateral dimension of the inner circumference, and/or inner profile) of the reinforcement member 230 can be no more than 5%, 10%, 15%, 20%, 25%, or 30% greater than the outer diameter (e.g., the maximum lateral dimension of the outer circumference, and/or outer profile) of at least one of the distal segment 226 and the inner segment 224. In certain embodiments, the cannula 204 may be said to slide through the reinforcement cannula 232 during advancement and retraction (e.g., transitioning between a retracted state and an advanced state).

In the illustrated embodiment, the reinforcement sleeve 232 completely covers or encloses the distal section 226 in a fully retracted state, which may also be referred to as a set, ready, initial, pre-deployed, or proximal state, position, orientation, or configuration. The deployed state may also or alternatively be referred to as an advanced, active, or distal state, position, orientation, or configuration. In some embodiments, as shown, the proximal tip of the distal segment 226 and the distal tip of the medial segment 224 may be located within the reinforcement sleeve 232 when in the retracted state.

In other words, in some embodiments, the medial section 224 may terminate in a distal terminal end 250, and the distal terminal end 250 may correspond to the distal-most tip of the medial section 224. In the illustrated embodiment, the medial section 224 comprises a tubular member having a substantially flat or planar laterally oriented face at the distal terminal end 250. This lateral face abuts a substantially flat or planar laterally oriented face at the proximal tip of the tubular member of the distal segment 226. As previously discussed, in some embodiments, a heat shrink tube may extend over these abutment surfaces, which may interconnect or assist in the interconnection of the inner and distal tubular members. In other words, in some embodiments, the medial and distal segments 224, 226 are joined at an interface 252, in the illustrated embodiment, the interface 252 includes abutting surfaces of the medial and distal tubes or tubular members. Heat shrink tubing (see, e.g., feature 1080 in fig. 21 and 22) may extend over these abutment surfaces at interface 252, or in other words, over interface 252.

With continued reference to fig. 7, when the cannula 204 is in the retracted, initial, or set position, the distal terminal end 250 and/or the interface 252 may be located within the reinforcement member 230. This may ensure that the full length of distal segment 226 is enhanced when distal tip 227 begins to encounter resistance to distal advancement of cannula 204. For example, as shown in fig. 7, in the illustrated embodiment, when the cannula 204 is in the retracted position, the distal tip 227 of the distal section 226 of the cannula 204 is substantially flush with or slightly recessed relative to the distal tip of the stiffening tube 232, while the proximal tip of the distal section 226 is located at the interface 252, the interface 252 likewise being located within the stiffening tube 232. Thus, once the cannula 204 begins to advance distally, the distal tip 227 of the cannula 204 advances distally past the distal tip of the stiffening tube 232, and in some cases may be susceptible to resistance, such as by kinking, bending, curving, or otherwise contacting the portion of the pre-set catheter 104 through which resistance is created. In this case, by positioning distal terminal end 250 of inner section 224, or in other words, by positioning interface 252 of inner section 224 and distal section 226 within reinforcement member 230, it can be ensured that distal tip 227 is laterally supported by reinforcement member 230 once exposed when cannula 204 is in the fully retracted position. Likewise, when distal segment 226 is pushed distally out of reinforcement member 230, the overall length of any portion of distal segment 226 that remains within reinforcement member 230 may be reinforced. In certain embodiments, to achieve lateral support of distal segment 226 as just described, the length of reinforcement member 230 and/or the length of distal segment 226 within reinforcement member 230 when in the set position may be greater than the distance between the distal tip of reinforcement member 230 and the location where distal segment 226 initially encounters a force resisting distal advancement when distal segment 226 is deployed from the set position.

In other embodiments, when cannula 204 is in the fully retracted position, distal tip 227 of distal segment 226 may be recessed proximally within reinforcement member 230 a more significant distance (e.g., a length approximately equal to the outer diameter of distal segment 226 or approximately two, three, four, or more times the outer diameter of distal segment 226). In some embodiments, the interface 252 may be located proximal to the proximal end of the reinforcement member 230 when the cannula 204 is in the fully retracted position, while in other embodiments, the interface 252 may be located within the reinforcement member 230 when the cannula 204 is in the fully retracted position. In any case, in various embodiments, when distal tip 227 is first positioned distally and externally of reinforcement member 230, interface 252 may be desirably positioned within reinforcement member 230. For example, when cannula 204 is in the fully retracted position, interface 252 may be positioned proximal to the proximal tip of reinforcement member 230 a distance less than or equal to the distance that distal tip 227 is recessed relative to the distal tip of reinforcement member 230. Thus, as cannula 204 is advanced distally, interface 252 may enter the proximal end of reinforcement member 230 at the same time or before distal tip 227 exits the distal end of reinforcement member 230 distally.

In certain embodiments, the inner section 224 is sufficiently rigid to independently avoid buckling and/or kinking as the distal section 226 is advanced through the reinforcement sleeve 232 and into and through the pre-catheter tube 104. For example, the unsupported length of the medial section 224 relative to the reinforcement sleeve 232 (e.g., the portion of the medial section 224 outside the reinforcement sleeve 232) may be self-supporting, intrinsically supporting, or otherwise sufficiently rigid to avoid buckling and/or kinking that would otherwise occur if the medial section 224 were instead formed of only the same material and geometry as the distal section 226-e.g., if the medial section 224 and distal section 226 were formed of a continuous tube of a single material of uniform construction (e.g., uniform hardness, thickness, and diameter) -and the medial section 224 was not reinforced, or in other words, if the medial section 224 was formed of only a continuous extension of the soft and/or flexible distal section 22 6. Although the inner side segment 224 may be "unsupported," such as without reinforcing structures or support structures on its exterior, the inner side segment 224 may still be self-supporting. For example, the portion of the medial section 224 positioned proximal of the reinforcement member 230 may not be reinforced or supported by the reinforcement member 230, but may still be inherently supported-e.g., due to its inherent rigidity.

For example, to transition the cannula 204 from the retracted position to the advanced or deployed position, a distally directed force is applied to the proximal section 222 of the cannula 204, or more generally, to the proximal end of the cannula 204. These distally directed forces tend to push the inner and distal sections 224, 226 distally. When distal segment 226 encounters resistance to its distal advancement, these resistance or opposing forces are transmitted proximally through cannula 204. Thus, during such propulsion and resistance events, the inner section 224 encounters opposing forces at its proximal and distal ends. These opposing forces or compressive forces may tend to bend, kink, or otherwise laterally deflect, for example, medial section 224 at a medial region that is external to and unsupported by reinforcement member 230. However, the inner section 224 may be configured to withstand deflection from an opposing force or compressive force. For example, as previously discussed, in some embodiments, the medial section 224 is formed from a rigid material such as stainless steel that has sufficient intrinsic strength to resist compressive forces without bending (or an insignificant amount of bending) and/or without buckling or kinking. In other words, the inner side segment 224 may be self-reinforcing, internally reinforcing, or intrinsically reinforcing such that the entire length of the inner side segment 224, whether or not within the reinforcing member 230, may be referred to as being reinforced.

In other or further embodiments, the inner section 224 may include a separate reinforcing member or support member, such as a support tube, as discussed further below (see, e.g., fig. 56A, 56B, and 59 and the accompanying text). For example, in some embodiments, the distal segment 226 and the medial segment 224 may comprise a continuous polymeric tube of uniform characteristics and dimensions that spans the full length of each of the distal segment 226 and the medial segment 224. The inner section 224 may additionally include a reinforcing or support tube surrounding the polymeric tube. The inner surface of the support tube may be only slightly larger, and/or closely conform to the outer surface of the polymeric tube. For example, in various embodiments, the inner diameter (e.g., the largest lateral dimension of the inner perimeter, inner circumference, and/or inner profile) of the support tube may be no more than 5%, 10%, 15%, 20%, 25%, or 30% greater than the outer diameter (e.g., the largest lateral dimension of the outer perimeter, outer circumference, and/or outer profile) of the inner polymer tube. As discussed further below, the support tube may be fixedly secured to and/or relative to the polymeric tube.

The support tube may have a distal end positioned within the reinforcement member 230 when the sleeve 204 is in the retracted state. The support tube may slide within the reinforcement member 230 as the cannula 204 is advanced distally. The support tube may generally maintain a straight profile of the portion of the polymeric tube therein when compressive forces are generated at opposite ends of the inner polymeric tube during distal advancement thereof. In other words, the relatively stiff support tube resists deflection, bending, buckling, or kinking of the inner polymer tube. As with the embodiments discussed in the previous paragraph, the inboard segment 224 may be said to be subject to deflection from an opposing force or compressive force. For example, the support tube may be formed of a rigid material, such as stainless steel, that has sufficient strength to counteract deflection of the inner polymer tube when it encounters compressive forces that tend to cause the polymer tube to deflect, bend, buckle, or kink. The support tube, in turn, may prevent bending (or allow a insignificant amount of bending), buckling, or kinking of the inner polymer tube. In other words, the inner side segment 224 may be self-reinforcing or inherently reinforcing such that the entire length of the inner side segment 224, whether or not within the reinforcing member 230, may be referred to as being reinforced.

In view of the foregoing discussion, at least a portion of the distal segment 226 can be reinforced when the cannula 204 is in the retracted state or set position, which can be provided by the reinforcing member 230 of the connector 202. Further, when the cannula 204 is in the retracted state or set position, at least a portion of the inner section 224 may be reinforced, which may be inherently provided, such as by a relatively stiff or rigid tube of material integrally constituting the inner section 224 or such as by a relatively stiff or rigid tube of material supporting a length of polymeric tubing within the relatively stiff tube in the region of the inner section 224. In a further example, at least a distal end of the inner section 224 may be externally reinforced by the reinforcing member 230 when the cannula 204 is in the retracted state. Thus, more generally, the length of sleeve 204 within connector 202, such as within connection region 203 and sheath 205, may be enhanced. In various embodiments, the enhanced length of sleeve 204 may be no less than 50%, 60%, 70%, 80%, or 90% of the total length of connector 202 when in the retracted state. In other or further embodiments, the enhanced length of sleeve 204 when in the retracted state may be no less than 50%, 60%, 70%, 80%, or 90% of the total length of sheath 205. In yet other or further embodiments, the enhanced length of the cannula 204 when in the retracted state may be no less than 50%, 60%, 70%, 80%, or 90% of the length of the inner lumen 212 of the sheath 205. In yet other or further embodiments, the reinforced length of sleeve 204 when in the retracted state may be no less than 50%, 60%, 70%, 80%, or 90% of the distance between the proximal end of reinforcing member 230 and the proximal end of inner lumen 212 of sheath 205.

Furthermore, in view of the foregoing discussion, a majority of the length of the cannula 204 may be enhanced throughout the movement of the cannula 204 from the retracted position to the fully deployed position. The length of the reinforcement may vary throughout at least a portion of the deployment event, such as when the amount of distal segment 226 exiting from the distal end of reinforcement member 230 increases. In various embodiments, the enhanced length of cannula 204 varies throughout at least a portion of the entire deployment event in which cannula 204 moves from the retracted state to the fully deployed state, and the minimum enhanced length of cannula 204 throughout the entire fully deployed event may be no less than 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, or 75% of the total length of cannula 204. The overall length of cannula 204 may be defined as, for example, the distance between distal tip 227 of cannula 204 and the proximal tip of connector 229 (see fig. 6). In many embodiments, a minimum enhanced length may be achieved when cannula 204 is in a fully deployed state.

With continued reference to fig. 7, the reinforcement sleeve 232 may be formed of any suitable material. For example, the reinforcement sleeve 232 may include or be formed from: stainless steel and/or rigid plastic. In some embodiments, the reinforcement sleeve 232 may be formed from a metallic hypotube. The reinforcement sleeve 232 may be attached to the connector 202 in any suitable manner, such as, for example, via a press fit, adhesive, or overmolding. For example, in the illustrated embodiment, the connector 230 includes a polymeric material overmolded onto the reinforcement sleeve 232.

In other embodiments, the reinforcement sleeve 232 is omitted. For example, the reinforcement member 230 may instead be formed as a channel or lumen extending through, for example, the distal end of the connector 202. In some embodiments, the distal end of the connector 202 may be molded or otherwise formed from another material (e.g., a polymeric material) than that shown in fig. 7, through which the channels or lumens forming the reinforcement member 230 extend. For example, in some embodiments, at least a portion of the distal end of the connector 202 including the connection interface 210 may extend longitudinally in a proximal direction to define an elongated reinforcement member 230. The alternative reinforcement member may, for example, have the same length as the reinforcement tube 232 depicted in fig. 7, but may instead be formed of another polymeric material, having a lumen extending therethrough.

Referring again to fig. 5 and 6, in some embodiments, the system 200 may include a friction or resistance element 240 that may resist, adjust, mitigate, adjust, or otherwise passively respond to relative movement of the connector 202 and the sleeve 204. In the illustrated embodiment, the resistance element 240 includes an O-ring 242, the O-ring 242 being received within an annular channel 244 defined by the proximal section 222. The O-ring 242 may slide along the inner surface of the connector 202. Any other suitable resistance mechanism such as serrations, ratchets, or other interfaces between the proximal section 222 and the connector 202 are contemplated. In other or further embodiments, the resistance element 240 may include a friction grease (friction grease) in addition to or in lieu of other resistance elements that regulate the relative movement of the connector 202 and the sleeve 204.

As previously discussed, in various embodiments, the connector 202 may be configured to couple with an open conduit system and/or a closed conduit system. In some embodiments, connector 202 may be directly attached to a catheter hub of an open catheter system, while in other embodiments, the open catheter system may include an expansion set attached to the catheter hub, and connector 202 may be attached to a port of the expansion set.

Referring again to fig. 7, in some embodiments, the reinforcement member 230 includes a protrusion or extension 213 extending distally from a surface 217 (e.g., a distally facing surface) of the connector 202. The surface 217 may also be referred to as a bottom surface or a recessed, inner or inner surface of the connection region 203 of the connector 202. While surface 217 is the integral exterior of connector 202, the interior surfaces and interior surface descriptors result from the recessed relationship of surface 217 relative to adjacent portions of connector 202, such as relative to threaded skirt 215 and the central male luer. In the illustrated embodiment, the extension 213 includes a central male luer formed of a polymeric material and the distal portion of the stiffening tube 232 is located within the central male luer. In other words, the extension 213 includes a distal end of the reinforcement tube 232 surrounded by other material (e.g., polymeric material) that extends distally from the recessed surface 217. In some embodiments, the extension 213 may be coupled directly with an open hub (e.g., catheter hub 106 in fig. 1) to engage the hub (e.g., via a luer) such as in a fluid-tight seal. The extension 213 may be configured to open or otherwise break a flap, septum, or the like of an expansion set of a (device) hub or coupled to the catheter hub 106, which may allow fluid communication between the catheter tube 104 and the cannula 204. In the illustrated embodiment, the extension 213 extends distally from the bottom surface 217 of the connection interface 211. The connection hub 211 also includes a threaded skirt 215 that may conform to the ISO standard of a luer fitting. The skirt 215 may include a distal edge 219, which may correspond to the distal-most or distal-most tip of the connector 202. In the illustrated embodiment, the extension 213 extends distally beyond the distal edge 219 of the connector 202.

The coupling interface 210 of the connector 202 may be of any suitable kind. For example, the coupling interface 210 may include threads 225, such as for luer lock connections (interfacing). Similar threads 525, 625 are depicted in fig. 10 and 11. In other embodiments, the coupling interface 210 may utilize a friction fit or other mechanical engagement (e.g., a snap fit). Illustrative examples of friction fit interfaces are identified in fig. 8 and 9 as features 328 and 428, respectively. As discussed further below, an illustrative snap-fit coupling interface is depicted, for example, in fig. 32A.

In various embodiments, the reinforcement member 230 and/or the reinforcement sleeve 232 may be flush with the inner surface, recessed surface, bottom surface, or distal-facing surface 217 of the connector 202. For example, in the embodiment depicted in fig. 8, the distal end of the reinforcement sleeve 332 is surrounded or encapsulated (encaged) by the material forming the connector 302.

In other embodiments, such as previously discussed, the reinforcement member 230 and/or the reinforcement sleeve 232 may extend distally from a distally facing surface of the connector 202, such as from an inner surface, recessed surface, bottom surface, or distally facing surface 217 of the coupling interface 210. In this manner, when the connector 202 is coupled to the pre-set catheter system, the reinforcing member 230 and/or the reinforcing sleeve 232 may puncture or otherwise break the flaps, stops, etc. of the pre-set catheter system. For example, the catheter hub of the pre-set catheter system may include a septum or valve flap that may be pierced, compressed, or otherwise opened by the reinforcement member 230. For example, as previously discussed, the extension 213 of the embodiment depicted in fig. 7, including the distal end of the reinforcing sleeve 232 therein, may be configured to open or break a flap member (valve member) of the pre-set catheter system-e.g., in some cases, may break a flap associated with catheter hub 106 (see fig. 1), and/or may break a flap associated with an extension set (see, e.g., fig. 24) coupled with catheter hub 106.

Referring to fig. 9 and 11, the distal ends of the reinforcement members 430, 630 defining the protrusions 413, 613 may be formed solely by the distal ends of the reinforcement sleeves 432, 632 extending distally from the bottom, inner, recessed or distal-facing surfaces 417, 617, respectively. In some cases, when the respective connector 402, 602 of each reinforcement sleeve 432, 632 is coupled with the pre-set catheter system, each reinforcement sleeve 432, 632 may be inserted through a valve flap (whether directly coupled to the catheter hub or to the hub of the expansion set). In other cases, as discussed below, the reinforcement sleeve 432, 632 can be sized such that when the associated connector 402, 602 is attached to the pre-set catheter system, the distal tip of the reinforcement sleeve 432, 632 is instead positioned at, near, or slightly recessed proximally from the proximal surface of the valve flap member. As discussed further below, in some such embodiments, the respective sleeve 404, 604 can be advanced distally to pierce the valve flap member while being reinforced by the distal extension of the reinforcement sleeve 432, 632.

Referring again to fig. 5-7, in some embodiments, sleeve 204 may be formed from less than three distinct pieces or less than three separate segments. For example, in some embodiments, the cannula 204 may include a distal section 226, such as previously disclosed, coupled to a rigid tube that extends proximally to a connector 229 (e.g., a luer connector) at the proximal end of the cannula 204. In other words, the medial section 224 may extend proximally to replace an elongated portion of the proximal section 222. In some cases, the rigid tube is a metal tube, such as stainless steel. In a further instance, as previously discussed, the rigid tube abuts the polymer tube forming the distal section 226. For example, the polymer tube of the distal section 226 and the stainless steel tube of the inner section 224 may abut at an interface and be connected to each other via a heat-shrinkable tubing.

In other cases where the proximal section 222 is replaced with an elongated medial section 226, the polymeric tube may extend continuously along both the distal section 226 and the medial section 224. The rigid tube of the inner section 224 may surround the portion of the polymeric tube extending proximally from the distal section 226. In other words, in some embodiments, a single polymer tube (e.g., polyimide tube) may extend continuously from the distal tip 217 of the cannula 204 to the proximal connector 229. A second tube, such as the support tube described previously, may encase a portion of the (shaping) polymer tube and extend proximally from the interface 252 all the way to the proximal connector 229. Stated another way, the cannula 204 can include (1) a distal section 226 formed from only a polymer tube extending distally from the hub 252 to the distal tip 217 of the cannula 204, and (2) an inner section 224 formed from a continuous proximal extension of the polymer tube and a second rigid support tube encasing or surrounding the proximal extension of the polymer tube, each of the continuous proximal extensions of the polymer tube and support tube extending proximally from the hub 252 and terminating in a proximal connector 229.

In still other embodiments, the rigid tube of the medial section 224 may extend proximally through the interior of the proximal section 222. In other words, the proximal section 222 may include a larger diameter piece (e.g., a plastic piece) that surrounds a proximal portion of the medial section 224. In some embodiments, a rigid sleeve (e.g., which may be metallic) of the inner section 224 may extend proximally to the connector 229.

The proximal section 222 is described herein as being part of the cannula 204. The elongate molding forming the proximal section 222 shown may alternatively be described as an elongate proximal connector 229 (e.g., an elongate luer connector) extending distally. That is, the proximal segment 222 may be considered a distal extension of the connector 229.

Fig. 8 depicts a distal portion of another embodiment of an access system 300, which may be similar to other access systems disclosed herein such as, for example, access system 200. Thus, features of pathway system 300 are denoted with reference numerals similar to those of pathway system 200, with the leading digit "2" replaced with "3". Accordingly, the foregoing related disclosure regarding similar identifying features may not be repeated hereinafter. Furthermore, specific features of the access system 300 may not be shown or identified by reference numerals in the figures or specifically discussed in the written description below. However, these features may obviously be the same or substantially the same as other embodiments and/or features described in relation to these embodiments. Accordingly, the relevant descriptions of these features are equally applicable to the features of the access system 300. Any suitable combination of features described with respect to the pathway system 200 and variations thereof may be used with the pathway system 300 and vice versa. Similarly, the access system 300 may be applicable to the base catheter system 100 and other pre-set catheters and catheter systems described herein. That is, to simplify the present discussion, the disclosure regarding the various access systems 300 may be suitably applied to other access systems described herein. This mode of disclosure applies equally to other embodiments depicted in the various figures and described herein, wherein the leading numbers may be further varied.

As previously mentioned, the access system 300 includes a connection interface 310 having a friction fit arrangement rather than threads. The distal end of the reinforcing tube 332 is flush with the inner surface 317 of the connection interface 310.

In the illustrated embodiment, the sleeve 304 is shown in a retracted orientation. In this orientation, the distal tip 327 of the sleeve 304 is slightly recessed from the distal tip of the reinforcement tube 332.

Fig. 9 depicts another embodiment of an access system 400, the access system 400 including a connector 402 having a connection interface 410, the connection interface 410 also having a friction fit arrangement. The extension 413 is defined by a distal end of the reinforcement tube 432 that extends distally from the inner or recessed surface 417 of the connection interface 410. In the illustrated embodiment, the distal tip of the reinforcement tube 432 is recessed proximally relative to the distal edge 419 of the connector 402.

In the illustrated embodiment, the distal tip 427 of the sleeve is substantially flush with the distal tip of the stiffening tube 432 when the movable sleeve 404 is in the retracted position. In this retracted orientation, the distal tip 427 of the cannula 404 is spaced distally from the inner or recessed surface 417 and proximally from the distal edge 419 of the connector 402.

As previously discussed, fig. 10 and 11 depict additional embodiments of pathway systems 500, 600 that are similar to pathway systems 300, 400, respectively. The access system 500, 600 has a connector 502, 602, the connector 502, 602 having a connection interface 510, 610 including threads 525, 625. The access system 500, 600 includes a reinforcement member 530, 630, the reinforcement member 530, 630 including a reinforcement tube 532, 632.

In some embodiments, the access system 300, 400, 500, 600 may be particularly suitable for coupling with a closed intravenous catheter system. As discussed further below, in some embodiments, the reinforcement tubes 332, 432, 532, 632 may be spaced from the outer membrane or cover of the closed IV catheter system. In other embodiments, the reinforcement tubes 332, 432, 532, 632 may be sized to extend through the outer membrane or cover of the closed IV catheter, but their distal tips may be (1) located at or proximally spaced from the proximal surface of the valve flap (or plunger or inner membrane), (2) not extend through the valve flap, and/or (3) not contact the valve flap, as discussed further below.

Fig. 12 is a perspective view of one embodiment of a closed conduit system 700, the closed conduit system 700 may also be referred to herein as a closed base conduit system 700. Any suitable closed catheter system such as, for example, closed intravenous catheter systems are also contemplated. For example, the closed base catheter system 700 may includeAny NEXIVA obtained from Becton Dickinson ^TM Series of catheters (e.g. DIFFUSICS ^TM Series). Some such closed catheter systems may have an expansion kit 802 integrated therein. For example, in the illustrated embodiment, the hub 806 of the extension set 802 includes a side port 813 with an extension tube 817, a connector 818, and a removable vent fitting 819, similar to an extension set arrangement that may be used with an open intravenous catheter assembly (e.g., an extension set such as depicted and described with respect to fig. 24). Hub 806 may also be referred to as a catheter hub.

The closed catheter system 700 may include a removable needle assembly 721, the needle assembly 721 including a needle 720 connected to a needle hub 722. Needle assembly 721 may be coupled to catheter hub 806 and used during insertion of catheter tube 704 into a patient's vasculature and may be later removed from catheter hub 806. During assembly of the closed catheter system 700, the needle 720 and its two-part hub 722 may be inserted into the catheter hub 806 and catheter tube 704, and may be packaged in such a pre-assembled configuration, such as the pre-assembled configuration depicted in fig. 12.

In fig. 12, catheter system 700 is shown in an inserted configuration. A needle 720 extends from the distal tip of the catheter 704 to allow insertion of the catheter tube 704 into the vasculature of a patient.

Fig. 13 is a perspective view of the closed catheter system 700 in an disassembled state, such as may be achieved after the catheter tube 704 has been inserted into a patient's blood vessel. Needle assembly 721 is shown removed from hub 806 and catheter tube 704. The configuration shown may be referred to as a pathway configuration. For example, once the catheter tube 704 is positioned within the vasculature of the patient in any suitable manner, including that currently employed, and once the needle assembly 721 has been removed, access to the vasculature may be achieved via the catheter tube 704 placed. For example, the vent fitting 819 may be removed at any suitable stage and if the integrated extension set 802 is to enable delivery of fluid to and/or removal of fluid from the vasculature via the catheter tube 704, a fluid source or fluid container may be coupled with the connector 818.

The needle 720 may be fixedly attached to the needle hub 722. In the illustrated embodiment, needle hub 722 is a two-part hub that provides a protective capability for the distal tip of needle 720 to avoid needle sticks as needle 720 is withdrawn from catheter hub 806 after catheter tube 704 is introduced into a patient's blood vessel.

Fig. 14 is a cross-sectional view of catheter hub 806 and catheter tube 704 of closed catheter system 700 in an operational state, wherein needle 720 has been completely removed from catheter tube 704 and catheter hub 806. Catheter hub 806 may include a distal port 807 in fluid communication with catheter tube 704, a proximal port 809 described below, and a side port 813 of integrated extension set 802, with extension tube 817 and connector 818 (fig. 12) coupled to side port 813. Each of distal port 807 and side port 813 are in continuous fluid communication with inner chamber 810.

Certain embodiments of the access systems (e.g., access systems 300, 400, 500, 600) or portions thereof disclosed herein, such as any suitable access system or portion thereof, may be used with the closed catheter system 700 in the operational state depicted in fig. 14 (where the needle assembly 721 has been removed), i.e., the access state. In some embodiments, the access systems (e.g., 300, 400, 500, 600) may not include their own expansion sets (e.g., such as the expansion sets depicted in fig. 24) because catheter hub 806 of closed base catheter system 700 already includes an expansion set integrated therein. In some embodiments, the distal connection interface of the access systems 300, 400, 500, 600, such as depicted in fig. 8-11, may be particularly suitable for connection with the closed catheter system 700. For example, a friction fit or snap fit connector may be well connected with certain embodiments of the proximal port 809.

With continued reference to fig. 14, the proximal port 809 may include a plurality of components coupled thereto or coupled thereto. Specifically, proximal port 809 may include: an outer septum or cap, or proximal septum or cap 851; an inner septum or cap, or distal septum or plunger 852; and a holder (holder) 853. In various embodiments, the diaphragms 851, 852 may be formed of any suitable elastic material. The retainer 853 may be formed of a relatively rigid polymeric material and may be coupled to a polymeric housing with catheter hub 806 formed to retain the diaphragms 851, 852 within the proximal port 809.

In a typical or standard use of the closed catheter system 700, when the closed catheter system 700 is in the insertion configuration, the needle 720 (fig. 12 and 13) extends through the retainer 853 and septum 851, 852 of the proximal port 809, through the catheter hub 806, and through the catheter tube 704. Needle 720 may be more generally referred to as a piercing member or piercing instrument. For example, in other embodiments, the needle 720 may be replaced with any other suitable piercing member or piercing element, such as, for example, a trocar. The proximal port 809 may also be referred to as an instrument port.

After placement of the catheter tube 704 within the patient's blood vessel, the needle 720 is completely removed, thereby placing the closed catheter system 700 in the access state depicted in fig. 14. When the needle 720 is removed from the inner septum, distal septum, or plunger 852, the plunger 852 self seals to close the proximal end of the inner chamber 810 and prevent fluid communication between the inner chamber 810 and the proximal port 809. In typical or standard use, the proximal port 809 is no longer used, and all further fluid communication with the inner chamber 810 and/or catheter 704 is achieved via the integrated expansion suite 802, or in other words, via the side port 813. The plunger 852 is not used for any further access events and desirably remains sealed for the remainder of the closed catheter system 700.

As previously discussed, and as discussed further below, certain embodiments of the access system can connect with the proximal port 809 in an atypical manner by coupling with the proximal port 809 and passing a cannula (e.g., 304, 404, 504, 604) through the plunger 852 and into the catheter tube 704. Through this process, the cannula (e.g., 304, 404, 504, 604) may achieve fluid communication with the inner chamber 810 and/or the catheter tube 704 as it passes through the plunger 852. Further, as the cannula (e.g., 304, 404, 504, 604) extends through the plunger 852, fluid can pass through the cannula and thus can pass through the plunger 852 and, more generally, through the proximal port 809. Further, in some cases, multiple access events through the plunger 852 are possible in this manner. After removal of the cannula (e.g., 304, 404, 504, 604), the plunger 852 may again self-seal. Thus, because fluid communication between (1) the interior chamber 810 of the catheter tube 704 and/or catheter hub 806 and (2) the exterior of the closed catheter system 700 via the proximal port 809 can be selectively achieved using the distal septum or plunger 852, the distal septum or plunger 852 may additionally or alternatively be referred to herein as a flap or flap member 852. Further, the distal diaphragm, plunger, flap, or flap member 852 may also or alternatively be referred to as a seal or seal member.

In view of the foregoing, the diaphragms 851, 852 and the retainer 853 may be described in additional or alternative terms. For example, proximal port 809 may be referred to as including a flap assembly 850, flap assembly 850 may allow selective fluid communication between inner chamber 810 and proximal port 809. In some cases, the flap assembly 850 is configured to fluidly seal against the needle 720 when the needle 120 is fully inserted therethrough, such as in the insertion configuration depicted in fig. 12, and is configured to self-seal to prevent fluid from exiting the inner chamber 810 and passing through the proximal port 809 when the needle 720 is removed from the proximal port 809, thereby achieving the access configuration depicted in fig. 13.

With continued reference to fig. 14, the valve flap assembly 850 of the proximal port 809 can include a proximal diaphragm 851, a distal diaphragm 852, and a retaining member or retainer 853. The retainer 853 may comprise a generally tubular element that engages the body of the catheter hub 806 to retain the proximal septum 851 and the distal septum 852 within the proximal port 809. That is, the retainer 853 may cooperate with the housing portion of the hub 806 to retain the diaphragms 851, 852 in place within the proximal port 809. Although the illustrated flap assembly 850 includes a plurality of diaphragms 851, 852, only the distal diaphragm 852 can provide the valving (valve) functionality of the flap assembly 850 discussed above and further discussed below.

In some embodiments, the proximal septum 851 (also or alternatively referred to as a cap) includes an opening 854, which opening 854 may be centered with respect to the port 809. The opening 854 may be a permanent opening. When the closed catheter system 700 is in the inserted state depicted in fig. 12, the needle 720 can extend through the opening 854 of the proximal septum 851. The opening 854 may be preformed and/or may be large enough so that the opening 854 does not self-seal when the needle 720 is removed therefrom.

The retainer 853 can include an opening 855 that can be larger than the opening 854 of the proximal septum 851. The opening 855 may be concentric with the opening 854.

As previously described, the valve flap 852 may be self-sealing such that upon removal of the needle 720 therefrom, the sealable area 856, which may also or alternatively be referred to as a "closable opening" (opposite the permanent opening 854 of the proximal septum 851), is self-sealing to prevent fluid communication between the chamber 810 and the port 809. In some embodiments, the fluid-tight seal formed by closable opening or sealable region 856 is strong enough to withstand high pressures, such as may be achieved when performing a power injection via side port 813 to pass fluid through inner chamber 810 and distal port 807.

In certain embodiments, when an access system (e.g., either of the access systems 400, 600) is coupled with the proximal port 809 of the closed catheter system 700, the reinforcement members of the access system (e.g., reinforcement members 430, 630 of the access systems 400, 600, respectively) can extend through the openings 855, 854 of the retainer 853 and the proximal diaphragm 851, respectively, and the distal tips of the reinforcement members (e.g., distal tips of the reinforcement tubes 432, 632) can be positioned at or recessed proximally from the proximal surface of the distal diaphragm or valve flap 852. One such illustrative coupling event and coupling configuration is depicted in fig. 33 and 34, respectively, as will be discussed further below. The distal tips of the reinforcement members (e.g., 430, 630) can be fixed in this position relative to the valve flap 852. The reinforcement members (e.g., 430, 630) can thereby align the movable/deployable sleeve (e.g., 404, 604) of the access system with the valve flap 852. In other words, the longitudinal axis of the reinforcing tube (e.g., 432, 632) can be centered and collinear with a line extending through the sealable region 856 of the valve flap 852 that corresponds to a seal trace (which may also be referred to as a needle trace) through the sealable region 856 from which the needle 720 has been previously removed. The reinforcement member (e.g., reinforcement tube) does not contact the valve flap 852 or extend into or through the valve flap 852. Instead, the cannula (e.g., 404, 604) of the access system extends out of the reinforcement member (e.g., reinforcement tube 432, 632) and then through the sealable region 856 of the valve flap 852.

In still other embodiments, when an access system (e.g., either of the access systems 300, 500) is coupled with the proximal port 809 of the closed catheter system 700, the reinforcement member (e.g., 330, 530) of the access system (e.g., 300, 500) may remain outside of the openings 855, 854 of the retainer 853 and proximal septum 851, recessed from the openings 855, 854, or otherwise not extend through the openings 855, 854. The distal tips of the reinforcement members (e.g., distal tips of the reinforcement tubes 332, 532) can be recessed proximally from the proximal surface of the distal diaphragm or flap 852. Indeed, the distal tips of the reinforcement members (e.g., distal tips of the reinforcement tubes 332, 532) can be sufficiently recessed from the valve flap 852 to also recess at or proximally from the proximal surface of the cap or proximal diaphragm 851. The distal tips of the reinforcement members (e.g., 330, 530) can be fixed in this position relative to the valve flap 852. The reinforcement member (e.g., 330, 530) can align a movable/deployable sleeve (e.g., sleeve 304, 504) of the access system with a longitudinal axis of the valve flap 852. In other words, the longitudinal axis of the reinforcing tube (e.g., 332, 532) can be centered and collinear with a line passing through the sealable region 856 of the valve flap 852 that corresponds to a seal channel from which the needle 720 has been previously removed (e.g., a needle channel passing through the seal region 856), as previously described. The imaginary extension line of the line in the proximal direction may extend through the openings 855, 854 of the retainer 853 and proximal septum 851, respectively, and be aligned with the longitudinal axis of the reinforcement tube. The reinforcement member (e.g., 330, 530), or in some embodiments, the reinforcement tube (e.g., 332, 532), does not contact the valve flap 852 or does not extend into or through the valve flap 852. Instead, the cannula (e.g., 304, 504) of the access system extends out of the reinforcement member (e.g., 330, 530), then through the proximal septum 851, and then through the sealable region 856 of the valve flap 852 along a substantially straight path.

In certain embodiments, the distal end of a deployable cannula (e.g., any of the cannulas 304, 404, 504, 604 of the access systems 300, 400, 500, 600) can successfully extend through the valve flap 852 without damaging or kinking the cannula (e.g., 304, 404, 504, 604) and without damaging the valve flap 852. In some cases, by avoiding contact of the reinforcement tube with the valve flap 852, or by not embedding the reinforcement tube within the valve flap 852, the material of the valve flap 852 remains in a more relaxed state, or in other words, in a less compressed or less stressed state, or may be in a completely uncompressed or unstressed state, during an insertion event or deployment event, which may facilitate insertion of a movable cannula (e.g., 304, 404, 504, 604) therethrough. Further, as previously described, in some cases, coupling the access system (e.g., 300, 400, 500, 600) with the proximal port 809 can center the reinforcement member (e.g., 330, 430, 530, 630) relative to the valve flap 852, thereby aligning the cannula (e.g., 304, 404, 504, 604) with the valve flap 852 such that the cannula (e.g., 304, 404, 504 604) can be inserted along the same path through the valve flap 852 or through the same portion of the valve flap 852 from which the needle 720 had been previously removed (e.g., the needle tract through the sealable area 856), which can facilitate or enable insertion of the cannula (e.g., 304, 404, 504, 604) through the valve flap 852. In certain embodiments, the enhanced features as described elsewhere herein may enable such insertion of only the sleeve (e.g., 304, 404, 504, 604) through the valve flap 852. In some cases, if the sleeve is not reinforced in its more proximal region, the sleeve may bend or kink when in contact with the valve flap 852, which may prevent the sleeve from being inserted through the valve flap 852.

In some cases, it may be advantageous not to insert a reinforcing tube (e.g., reinforcing tube 432, 632 of the access system 400, 600) or any portion thereof into the valve flap 852 in order to thereafter advance the cannula (e.g., 404, 604) through the reinforcing tube, thereby enabling the cannula to pass through the valve flap. As previously described, maintaining the reinforcing tube (e.g., 432, 632) outside of the valve flap 852 (or recessed proximally from the proximal surface of the valve flap 852) prior to and during insertion of the sleeve (e.g., 404, 604) through the valve flap 852 may maintain the valve flap 852 in a relatively relaxed or uncompressed state, which may facilitate distal movement of the sleeve (e.g., 404, 604) through the valve flap 852. In other or further cases, damage to the valve flap 852 may be avoided, such as the distal tip of the reinforcement tube (e.g., 432, 632) puncturing (ringing) the valve flap 852 and/or the valve flap 852 being permanently stretched or deformed by the relatively larger outer diameter of the reinforcement tube (e.g., 432, 632).

In other words, as can be appreciated by the present disclosure, in some cases, it may be advantageous to advance a sleeve through the valve flap 852 without first inserting or passing a separate support member or reinforcement member through the valve flap 852 (e.g., a larger diameter reinforcement member that may stretch or deform the valve flap 852 and/or various reinforcement members that may undesirably puncture a portion of the valve flap 852 when passing through the valve flap 852). That is, it may be advantageous to have the cannula advance through the valve flap 852 independently, alone, or not advance the cannula through the valve flap 852 by a separate member (e.g., a reinforcing member or support member) that has been previously advanced into or through the valve flap and still be positioned in or through the valve flap so as to define an open channel (e.g., corresponding to an internal cavity of the support member) through at least a portion of the valve flap for subsequent passage of the cannula.

In some cases, after the access system (e.g., 300, 400, 500, 600) has been used with and removed from the closed conduit system 700, the valve flap 852 can remain sealed during subsequent use of the integrated extension kit 802. In other words, the use of the access system (e.g., 300, 400, 500, 600) in combination with the closed conduit system 700 may not adversely affect the operation of the valve flap 852 or may preserve the effective or normal operation of the valve flap 852. In other words, the use of the access system in combination with the closed catheter system 700 may allow the inner septum 852 to again block or seal the proximal port 809 when the access system is removed. For example, in some instances, after removal of the deployable cannula (e.g., 304, 404, 504, 604) from the catheter tube 704 of the closed catheter system 700 and from the distal flap 852 after use of the access system (e.g., 300, 400, 500, 600), the integrated extension kit 802 of the closed catheter system 700 may be used to access the vasculature of a patient (e.g., for infusion or aspiration events) via the placed catheter tube 704 in the same manner as may be done prior to use of the access system (e.g., 300, 400, 500, 600) with the closed catheter system 700. In some cases, the valve flap 852 is still strong enough and fluid tight to allow for power injection through the side port 813 using the closed conduit system 700 after removal of the access system (e.g., 300, 400, 500, 600). In certain embodiments, the use of the access system (e.g., 300, 400, 500, 600) with the closed conduit system 700 does not adversely affect the valve flap 852 such that the valve flap 852 of the closed conduit system 700 continues to operate in its original manner after 1, 2, 3, 4, 5, 10, 15, 20, or 25 or more cycles of coupling and decoupling of one or more access components (e.g., 300, 400, 500, 600) with the closed conduit system 700. For example, after one or more coupling/decoupling events, the valve flap 852 can continue to maintain a fluid-tight seal during power injection through the closed conduit system 700.

Fig. 15 is a perspective view of another embodiment of an access system 1000 configured to couple with an embodiment of a base catheter system. For example, in some embodiments, the access system 1000 is configured to couple with an open-base catheter system directly (e.g., by being directly attached to a catheter hub) and/or indirectly (e.g., by being directly attached to a proximal port of an extension set attached to a catheter hub), as discussed further below. The access system 1000 is shown in a fully retracted state or an undeployed state.

In the illustrated embodiment, the access system 1000 includes a connector 1002 and a cannula 1004, the cannula 1004 being selectively advanced and retracted relative to the connector 1002. As with other embodiments described herein, the cannula 1004 may include a connector 1029 at its proximal end. In the illustrated embodiment, the connector 1029 is a female luer fitting.

The connector 1002 may include a connection interface 1010 and a reinforcing member 1030. In the illustrated embodiment, the reinforcing member 1030 includes a distal protrusion 1013, the distal protrusion 1013 extending a substantial distance past the distal face of the connection interface 1010. In some cases, the distal protrusion 1013 may be narrower and more elongated than the luer.

Referring to fig. 16, in some embodiments, the access system 1000 includes an internal stop, hub, or follower 1060 to which the proximal section 1022 of the cannula 1004 is attached. The follower 1060 may be sized to prevent the cannula 1004 from being fully retracted from the sheath 1005. In other words, the proximal end of the sheath 1005 and the follower 1060 may cooperate to define a proximal movement of the cannula 1004. Follower 1060 may have a larger radial dimension than opening 1061 at the proximal end of sheath 1005. In various embodiments, the follower 1060 may be fixedly secured to one or more components of the cannula 1004 (e.g., the proximal segment 1022 and/or the medial segment 1024) and may be movable in response to movement of the cannula 1004. In other words, the follower 1060 may move in unison with the cannula 1004 and in response to a force applied to the cannula 1004. Specifically, the follower 1060 is not directly accessible to the user, but instead moves only in response to a force applied by the user to the proximal section 1022 of the cannula 1004 outside of the sheath 1005.

In certain embodiments, the follower 1060 may constrain, inhibit, or prevent rotational movement of the sleeve 1004 relative to the sheath 1005 about a longitudinal axis that may be common to these components. In other words, the follower 1060 may cooperate with the sheath 1005 to rotationally lock the sleeve 1004 relative to the sheath 1005, preventing relative rotation of the components about a central longitudinal axis about which the components are concentrically arranged. For example, in the illustrated embodiment, the follower 1060 includes a protrusion 1062 that fits within a longitudinal groove 1064 defined by the sheath 1005. In other embodiments, the groove/protrusion interface may be reversed. For example, in some embodiments, the follower 1060 defines a groove that receives a longitudinal protrusion extending inwardly from the sheath 1005. The protrusions 1062 and grooves 1064 may be referred to as a rotational alignment mechanism 1065 or a rotational lock. Any suitable rotational alignment mechanism is contemplated.

Other embodiments may allow free rotation between the cannula 1004 and the sheath 1005. For example, some embodiments may lack a rotational alignment mechanism. For example, in some embodiments, the inner surface of the sheath 1005 and the outer surface of the follower 1060 may each be substantially cylindrical to readily allow relative rotation.

Fig. 17A is a perspective view of the housing 1005, and fig. 17B and 17C are separate sectional views of the housing 1005. The grooves 1064, which may also be referred to as internal tracks, are visible in each view. Referring to fig. 17A, in some embodiments, the housing 1005 includes one or more gripping features 1068. The gripping features 1068 may include one or more of grooves, coverings, coatings, and/or other surface features to enhance the grippability, ergonomics, and/or manipulation of the housing 1005. The gripping features 1068 of the illustrated embodiment include grooves and a layer of high friction material. The gripping feature 1068 also includes a pair of diametrically opposed raised wings 1069 at the distal end of the housing 1005. In some cases, wings 1069 may assist in manipulation of housing 1005 to rotate housing 1005 for coupling with access system 1000 with a connector with a catheter hub or an extension set hub.

Fig. 18A and 18B depict one embodiment of a coupling member 1070, the coupling member 1070 may be attached to the distal end of the housing 1005 and may form the distal end of the connector 1002. Coupling member 1070 may include any suitable connection interface 1010, such as those previously discussed. In the illustrated embodiment, the connection interface 1010 includes internal threads, such as may be used, for example, to couple with a threaded luer.

The coupling member 1070 may define a reinforcing member 1030. As with other embodiments previously discussed, the reinforcing member 1030 may include a distal protrusion 1013 extending distally from the bottom, inner, or recessed surface 1017 of the connection interface 1010. In the illustrated embodiment, the distal protrusion 1013 is formed from two different components. Specifically, the outer layer of distal extension 1013 is formed from a polymeric material and constitutes an extension of the continuously cast or molded polymeric material, with a majority of reinforcing member 1030 being formed from the polymeric material. The distal extension 1030 further includes at least one distal end of an internally located stiffening tube 1032, such as the stiffening tube previously described. The reinforcing tube 1032 is embedded within the coupling member 1070. In some embodiments, the polymer portion of the coupling member 1070 is overmolded onto the reinforcing tube 1032.

The reinforcing member 1030 may also include an elongated proximal extension 1031 of polymeric material. As shown in fig. 16, when the coupling member 1070 is secured to the sheath 1005, the proximal extension 1031 may extend proximally into the inner lumen of the sheath 1005. Lumen 1033 may extend continuously through proximal extension 1031 and through reinforcing tube 1032. In some embodiments, the inner diameter of the lumen 1033 is substantially constant along the entire length of the stiffening member 1030, or in other words, along the entire length of the lumen 1033 extending from the proximal tip of the proximal extension 1031 to the distal tip of the stiffening tube 1032.

In other embodiments, the proximal extension 1031 may be omitted and the reinforcing tube 1032 may extend proximally, similar to an arrangement such as depicted in fig. 7.

Fig. 19A and 19B are perspective views of the follower 1060, and fig. 19C is a sectional view of the follower 1060. A longitudinally extending protrusion 1062 is shown in each view. The follower 1060 defines a proximal cavity 1071, the proximal cavity 1071 being sized to receive a distal end of the proximal section 1022 of the cannula 1004 therein. In some embodiments, the distal end of the proximal section 122 is attached to a follower 1060 (see fig. 23A). The follower 1060 may also define a distal cavity 1072, the distal cavity 1072 being enlarged relative to the outer diameter of the inner side section 1024 of the cannula 1004 such that the inner side section 1024 may easily pass through the distal cavity 1072 (see fig. 23A). Follower 1060 may include an opening 1073 through a sidewall 1074, the sidewall 1074 separating proximal cavity 1071 from distal cavity 1072.

Referring to fig. 19A, 19B and 23A simultaneously, the opening 1073 may be sized to allow the inner section 1024 of the sleeve 1004 to pass therethrough. The proximal end of the tube forming at least a portion of the inner side section 1024 may extend through the opening 1073 and be embedded into the distal end of at least a portion of the tube forming the proximal section 1022 of the sleeve 1004, as shown in fig. 23A. In some embodiments, the tubes may be attached to one another. In some illustrative manufacturing processes, the tubes of the sleeve 1004 may be attached to one another and then passed distally through the opening 1073, at which point the distal end of the proximal tube may be attached to the follower 1060 within the cavity 1071.

Fig. 20 is a cross-sectional view of one embodiment of a connector 1029. In the illustrated embodiment, connector 1029 includes a female luer 1074. The connector 1029 also defines a cavity 1076, the cavity 1076 being sized to receive a proximal end of the proximal section 1022 of the cannula 1004 therein (see, e.g., fig. 16).

FIG. 21 is a partially exploded elevation view of cannula 1004 showing connection layer 1080 separated from distal tube 1081 and inner tube 1082. In the illustrated embodiment, the distal tube 1081 is included in the distal section 1026 of the cannula 1004, while the medial tube 1082 is included in the medial section 1024 of the cannula 1004. Distal tube 1081 may be any suitable material for distal segment 1026, such as those previously described. For example, in some embodiments, distal tube 1081 is formed from polyimide. Inner tube 1082 may likewise be formed from any suitable material for inner section 1024. For example, in some embodiments, the inner tube 1082 comprises a stainless steel tube.

The tie layer 1080 may be used to join the tubes 1081, 1082 together. For example, as previously discussed, in some embodiments, the connection layer 1080 may comprise a thin-walled tube of heat-shrinkable material that advances over at least the proximal end of the distal tube 1081 and the distal end of the inner tube 1082. The heat shrink tubing may then be heated to securely attach the ends of the tubing 1081, 1082 together. As with other embodiments discussed herein, in various embodiments, the distal tube 1081 comprises a polymeric material and the inner tube 1082 comprises a metallic material. The connection layer 1080 may comprise any suitable material. For example, in various embodiments, the connection layer 1080 comprises a heat-shrinkable polyethylene terephthalate (PET) tube.

Fig. 22 is an enlarged cross-sectional view of sleeve 1004 with tie layers 1080 positioned over tubes 1081, 1082. In the illustrated embodiment, the immediately adjacent ends of the tubes 1081, 1082 abut each other. Specifically, in the illustrated embodiment, each tube 1081, 1082 end has a substantially flat or planar surface that is transverse to the longitudinal axis of the sleeve 1004. These lateral surfaces abut each other to provide a continuous contacting surface. In some cases, abutment along a plane perpendicular to a longitudinal axis passing through the tubes 1081, 1082 may inhibit bending of the joint of the tubes 1081, 1082. For example, by maintaining intimate contact at the abutment surfaces, the tubes 1081, 1082 may be less prone to bending or kinking at the junction than, for example, where space is provided between adjacent tube ends. Consistent with other disclosure herein, the tubes 1081, 1082 may be said to abut one another at the interface 1052 of the sleeve 1004. The distal end of inner tube 1082 represents distal terminal end 1050 of inner member 1024.

In the illustrated embodiment, the inner diameters of the tubes 1081, 1082 are substantially the same such that the lumen 1021 of the cannula 1004 is substantially smooth at the transition from the distal tube 1081 to the inner tube 1082. In some cases, the smooth transition may inhibit or prevent hemolysis of the blood as it passes through interface 1052.

In some embodiments, the distal tip of the connection layer 1080 may be proximally spaced from the distal tip of the cannula 1004. Such an arrangement may allow the distal tip of the connection layer to contact the inner surface of the catheter tube 104 at the distal tip of the catheter tube 104 to define proximal movement of the sleeve 1004 relative to the catheter tube 104. This may be a way to effectively limit the amount by which the sleeve 1004 can extend past the distal end of the catheter tube 104. In some cases, contact between the distal end of the connection layer 1080 and the narrowed inner surface of the catheter tube 104 at the distal tip of the catheter tube 104 may provide tactile feedback to the user regarding the position of the cannula 1004 relative to the catheter tube 104, and in particular alert the user that the cannula 1004 has been fully deployed.

Fig. 23A is a cross-sectional view of a generally proximal portion of the access system 1000 when the access system 1000 is in a retracted state, or in other words, when the cannula 1004 of the access system 1000 is in a retracted state. As shown, the follower 1060 may be substantially at the proximal end of the sheath 1005 when the cannula 1004 is in the retracted state.

Fig. 23B is a cross-sectional view of the distal portion of the access system 1000 in a retracted state. In this state, similar to the previous embodiments, the interface 1052 of the sleeve 1004 may be positioned within the reinforcing member 1030. In other words, when the cannula 1004 is in the retracted state, the entire proximal end of the distal section 1026 of the cannula 1004, including the proximal tip of the distal section 1026, and the distal terminal end 1050 of the inner section 1024 can both be positioned within the reinforcing member 1030. In the illustrated embodiment, in this operational state, the interface 1052 is located within the proximal extension 1031 of the stiffening member 1030.

In the illustrated embodiment, distal tube 1081 has a distal tip that is slightly recessed relative to the distal tip of reinforcing tube 1032 of reinforcing member 1030. In the illustrated embodiment, the entire distal tube 1081 is located within the reinforcing member 1030. The distal end of the distal tube 1081 is within the stiffening tube 1032 of the stiffening member 1030, while the proximal end of the distal tube 1081 is within the proximal extension 1031 of the stiffening member 1030. As with other embodiments discussed herein, the reinforcement member 1030 may prevent the distal tube 1081 from bending or kinking during an insertion event due to the reinforcement provided by the relatively tight fit between the inner diameter of the reinforcement member 1030 and the outer diameter of the distal tube 1081.

Fig. 24 is an exploded perspective view of one embodiment of a base catheter assembly 1100, this embodiment of the base catheter assembly 1100 including one embodiment of an open intravenous catheter assembly 1101 and one embodiment of an expansion kit 1150 that is coupleable to the open intravenous catheter assembly 1101. Catheter assembly 1101 includes catheter hub 1106 and catheter tube 1104, which may be similar to catheter hub 106 and catheter tube 104 described previously.

Extension kit 1150 includes extension hub 1180. Extension hub 1180 includes a distal port 1181, a side port 1182, and a proximal port 1183. Distal port 1181 may include any suitable type of connector 1151 configured to couple with catheter hub 1106. In the illustrated embodiment, connector 1151 comprises a rotatable luer lock connector for selective engagement of male luer fitting 1171 with catheter hub 1106. The side port 1182 includes an extension tube 1157 coupled thereto. A connector 1158 is attached to an opposite end of the extension tube 1157. The proximal port 1183 may include a connector 1162 and any suitable connection interface of the access system (e.g., 200, 300, 400, 500, 600, 1000) may be attached to the connector 1162. In some embodiments, a flap 1184, which may also or alternatively be referred to as a septum, seal, or the like, may be included within the proximal port 1183. In some cases, extension 1013 of access system 1000 can extend through valve flap 1184, and cannula 1004 can be deployed, advanced, or extended distally from the distal end of extension 1013 to a position distal of valve flap 1184.

Each of the distal port 1181, the side port 1182, and the proximal port 1183 may be in fluid communication with an interior chamber 1173 (see fig. 25) defined by the expansion hub 1180. As described, in some embodiments, the proximal port 1183 may allow selective fluid communication with the interior chamber 1173 via the valve flap 1184.

Fig. 25 is a cross-sectional view of base catheter assembly 1100 in an assembled state. The cut-away view is taken such that the side port 1182 is not shown. The male luer fitting 1171 may be inserted into and fluidly sealed to the female luer fitting of catheter hub 1106. The male luer 1171 may have an elongated cavity 1172 within its interior, the cavity 1172 corresponding to the distal end of the interior cavity 1173. Lumen 1172 may be a necked down section or a narrowed section of inner chamber 1173. Generally, when the access system 1000 is coupled with the expansion set 1150, rather than directly with the catheter hub 1106 of the catheter assembly 1101, the cannula 1004 travels a greater distance before entering the catheter tube 1104. In other words, when the access system 1000 is directly coupled to the catheter hub 1106, the catheter hub 1106 provides a first unsupported length between the distal tip of the access system 1000 and the proximal end of the catheter tube 1104, and when the access system 1000 is directly coupled to the expansion hub 1180, the catheter hub 1106 and the expansion hub 1180 provide a second unsupported length between the distal tip of the access system 1000 and the proximal end of the catheter tube 1104 when coupled together, and the second unsupported length is substantially greater than the first unsupported length.

Fig. 26 is a side elevation view of access system 1000 in a retracted state, with access system 1000 coupled with an assembled base catheter assembly 1100, base catheter assembly 1100 including an expansion kit 1150 having a side port 1182. Fig. 27 is a cross-sectional view of a distal portion of the access system 1000 in a retracted state while coupled with the assembled base catheter assembly 1100. As with fig. 25, the cross-sectional view is taken such that the side port 1182 of the extension set 1150 is not shown.

With the connector 1002 of the access system 1000 coupled with the connector 1162 of the expansion sleeve 1150, the distal protrusion 1013 of the reinforcement member 1030 extends into the inner chamber 1173 of the expansion sleeve 1180. In the illustrated embodiment, the distal tip of the distal protrusion 1013 is located within the proximal end of the narrowed lumen 1172 of the male luer 1171. The distal tip of protrusion 1013 is proximally spaced from the proximal tip 1107 or proximal edge of catheter hub 1106. Thus, as previously discussed, to access the proximal end of catheter tube 1104, cannula 1004 travels a greater distance through expansion hub 1180 and catheter hub 1106 than is required when access system 1000 is directly coupled to catheter hub 1106. In some embodiments, distal protrusion 1013 may be longer and/or narrower for access assemblies intended for use with the extension set than those intended for use directly with catheter hub 1106. Further, in the illustrated embodiment, the distal end of the distal protrusion 1013 is advanced into the narrowed lumen 1172 of the male luer 1171. Accordingly, in some embodiments, distal protrusion 1013 may be longer and/or narrower than a standard male luer fitting.

Fig. 28 is a cross-sectional view of the access system 1000 in a fully deployed state while coupled with the assembled base catheter assembly 1100. Fig. 29A-29C are close-up cross-sectional views of various portions of the access system 1000 and base catheter assembly 1100 in this operational configuration. Specifically, fig. 29A depicts a generally intermediate portion of the access system 1000, fig. 29B depicts a generally distal portion of the access system 1000 and a proximal portion of the base catheter assembly 1100, and fig. 29C depicts a distal end of the access system 1000 and the base catheter assembly 1100.

As shown in fig. 29A, in some embodiments, the proximal extension 1031 of the reinforcing member 1030 can define a distal movement of the cannula 1004. As previously discussed, the proximal section 1022 of the sleeve 1004 may be fixedly secured to the follower 1060. The distal cavity 1072 of the follower 1060 may have an inner diameter large enough to receive the proximal end of the proximal extension 1031 of the reinforcement member 1030 therein. As the cannula 1004 is advanced distally, the distal cavity 1072 of the follower 1060 advances over the proximal end of the proximal extension 1031 until contact is made between the sidewall 1074 of the follower 1060 and the proximal extension 1031. Such contact may prevent further distal advancement of the cannula 1004.

Referring to fig. 29B, in the illustrated embodiment, the distal section 1026 extends into and through the catheter tube 1104 when the cannula 1004 is in the fully deployed position. Specifically, as shown in fig. 29C, in the illustrated embodiment, the distal section 1026 of the sleeve 1004 extends a substantial distance beyond the distal tip 1109 of the catheter tube 1104. In various embodiments, the distal segment 1026 may extend distally beyond the distal tip of the catheter tube 1104 a distance no less than 3, 5, 10, or 15 times greater than the outer diameter of the distal segment 1026.

Referring again to fig. 29B, when the cannula 1004 is in the fully deployed position, the interface 1052 where the distal segment 1026 and the inner segment 1024 meet can be positioned proximally relative to the proximal tip 1107 of the catheter tube 1104. In other words, the distal terminal end 1050 of the inner section 1024 may remain outside the catheter tube 1104 while being distal to the reinforcing member 1030. In some instances, the inherent support or self-reinforcing properties of the medial section 1024 may inhibit kinking or buckling of the cannula in the elongated, generally unsupported region of the interior chamber 1173 of the expansion hub 1180 and the interior chamber of the catheter hub 1106 as the cannula 1004 is advanced distally.

In other embodiments, the inner section 1024 is accessible and further accessible through at least a proximal portion of the catheter tube 1104. For example, as previously described, in some embodiments, the distal segment 1026 and the medial segment 1024 can have substantially the same outer diameter dimension such that the medial segment 1024 can easily follow the distal segment 1026 into the catheter tube 1104.

The relative lengths of, for example, the reinforcement member 1030 (e.g., the proximal extension 1031 thereof) and the cannula 1004, particularly the overall length of the reinforcement member 1030 and the length of the portion of the cannula 1004 that is inserted through the expansion sleeve 1150 and through the catheter tube 1104, can be adjusted to ensure that the distal tip of the cannula 1004 reaches a desired position relative to the distal tip of the catheter tube 1104 when the cannula 1004 is in the fully deployed state. For example, as previously discussed, in various embodiments, when the cannula 1004 is in the fully deployed state, the distal tip of the cannula 1004 may desirably extend distally beyond the distal tip of the catheter tube 1104, may be substantially flush with the distal tip of the catheter tube 1104, or may be slightly proximally recessed relative to the distal tip of the catheter tube 1104.

The relative lengths of, for example, the reinforcement member 1030 (e.g., the proximal extension 1031 thereof) and the inner side segment 1024 can be adjusted to ensure that the distal tip of the inner side segment 1024 reaches a desired position relative to the proximal end of the catheter tube 1104 when the cannula 1004 is in the fully deployed state. For example, as previously discussed, in various embodiments, when the cannula 1004 is in the fully deployed state, the distal tip or distal terminal end 1050 of the inner side segment 1024 may remain proximally recessed, may be substantially flush with the proximal end of the catheter tube 1104, or may enter the proximal end of the catheter tube 1104.

In other embodiments, the inner section 1024 may include an outer tube or support tube (e.g., such as support tube 1495 depicted in fig. 56A and 56B and described below). In some embodiments, at least an outer diameter of the support tube may be greater than an opening at the proximal end of the catheter tube 1104 (e.g., which corresponds to an inner diameter of the catheter tube 1104). The distal tip of the support tube, which corresponds to the distal terminus 1050 of the inner section 1024, may prevent the inner section 1024 from entering the catheter tube 1104. In some embodiments, the use of a larger diameter support tube as just described may advantageously serve to primarily resist entry of the support tube into the catheter tube 1104. In other embodiments, this may act as a failsafe to ensure that the distal tip of the support tube does not enter the catheter 1104, such as, for example, if other dimensions of the access assembly 1000 are also selected to prevent the support tube from entering the catheter tube 1104. For example, in some embodiments, it may be desirable to avoid access to the distal tip of the support tube, which, if allowed, would otherwise potentially deform, scratch, destroy and/or damage the catheter tube 1104 in some arrangements. In other embodiments, the support tube may be sufficiently narrow to enter the catheter tube 1104.

With continued reference to fig. 29B, as previously discussed, when the expansion sleeve 1150 is present, there may be a substantial distance between the distal tip of the stiffening member 1030 and the proximal end of the catheter tube 1104. In some instances, the self-reinforcing medial section 1024 may be sufficiently strong and/or rigid to avoid bending, kinking, or buckling within the unfilled portion of the inner chamber 1173 of the expansion hub 1180 and the unfilled cavity of the immediately adjacent catheter hub 1106 as the cannula 1004 is advanced distally through the enlarged cavity region (i.e., enlarged as compared to the constriction provided by the reinforcing member 1030). In other or further cases, the self-reinforcing inner section 1024 can maintain the distal section 1026 aligned with the longitudinal axis of the catheter tube 1104 as the cannula 1004 is advanced distally. In other or further cases, the self-reinforcing medial section 1024 may reduce the unsupported length of the cannula 1004 within the expansion hub 1180 and further, in some cases and/or later in deployment, within the catheter hub 1106 when the cannula 1004 is advanced distally to a fully deployed state.

In some cases, the cannula 1004 may not be moved to a fully deployed state. For example, in some cases, the cannula 1104 may be advanced only from the initial or retracted position to the partially advanced position. Such a partially deployed state, partially advanced state, or intermediate state may be sufficient to achieve a desired position of the distal tip of the cannula 1004 beyond or within the distal end of the catheter tube 1104. For example, in some embodiments, the access system 1000 may be used with a variety of different base catheter systems that may have catheter tubes 1104 of varying lengths, and the user may deploy the cannula 1004 in different amounts depending on the length of the catheter tube present.

Fig. 30 is a perspective view of another embodiment of an access system 1200 configured to couple with an embodiment of a base catheter system, wherein the access system 1200 is shown in a retracted state or undeployed state. The access system 1200 may be particularly suited for use with closed intravenous catheter systems such as, for example, NEXIVA ^TM A closed catheter system is used in combination. The implementation of the pathway system 1200 may be similar to the implementations of pathway systems 300, 400, 500, 600 described above, for example. Accordingly, the relevant disclosure regarding the various pathway systems 300, 400, 500, 600, 1200 may be interchangeably applied.

For example, the access system 1200 may include any suitable kind of cannula 1204, including those disclosed elsewhere herein. In some embodiments, the sleeve 1204 may be of any of the types discussed above, such as, for example, with respect to the sleeves 204, 1004, or below, such as, for example, with respect to the sleeve 1404.

In the illustrated embodiment, the access system 1200 includes a connector 1202, the connector 1202 being configured to couple with a proximal port 809 of an embodiment of the closed intravenous catheter system 700 (see, e.g., fig. 14 and 34). For example, the distal end of the connector 1202 may include a snap arrangement or a snap fit arrangement. In the illustrated embodiment, the connector end 1202 includes a pair of opposing arms or flaps 1280 having inward protrusions 1281 to securely snap over the proximal port 809 as shown in fig. 32A (see also fig. 33 and 34).

Fig. 31 is a cross-sectional view of the access system 1200 in a retracted state. Fig. 32A is a perspective view of one embodiment of a coupling member 1270 compatible with an access system 1200. Fig. 32B is a cross-sectional view of the coupling member 1270. The coupling member 1270 includes a reinforcement tube 1232, with the reinforcement tube 1232 extending or protruding distally relative to a bottom surface, inner surface, recessed surface, or distal-facing surface 1217 of the connector 1202 in a manner such as previously discussed.

In other embodiments, the proximal extension 1231 may instead be defined only by a proximal extension of the reinforcement tube 1232, similar to an arrangement such as depicted in fig. 7. In other words, the reinforcement tube 1232 can define both the distal extension 1213 and the proximal extension 1231.

Fig. 33 is a cross-sectional view of the distal end of the access system 1200 being advanced toward one embodiment of the closed intravenous catheter system 700 for coupling thereto in a retracted state or undeployed state. Fig. 34 is a cross-sectional view of the distal end of the access system 1200 coupled to the closed intravenous catheter system 700 in a retracted state or undeployed state. In the illustrated embodiment, the distal tip of the reinforcement tube 1232 is advanced through the proximal septum 851, but is proximally spaced from the valve flap 852 when the access system 1200 and the closed catheter system 700 are coupled together. Advancement of the cannula portion of the access system 1200 through the reinforcement tube 1232, the valve flap 852, and ultimately through the catheter tube 704 may be performed in a manner such as that previously discussed.

For example, in the illustrated embodiment, the reinforcement tube 1232 is advanced distally through the opening 855 of the retainer 853 and then through the opening 854 of the proximal septum 851. These openings 855, 854 are aligned or collinear with the sealable area 856 (and more particularly, the substantially linear needle tract through the sealable area 856). In the illustrated embodiment, once the access system 1200 is fully coupled to the proximal port 809 of the closed intravenous catheter system 700, the distal tip of the reinforcement tube 1232 is positioned inside the proximal septum 851, as shown in fig. 34. After such coupling, the cannula 1204 can be advanced distally and the distal tip of the cannula 1204 can emerge from the reinforcement tube 1232 to move substantially linearly through the distal end of the proximal septum 851, then through the valve flap 852 (including through the sealable region 856 of the valve flap 856), then through the hub 806, and then into and through the catheter tube 704. As discussed elsewhere, the inherent support provided by the support member 1230 and/or the inner side segment of the sleeve 1204 can assist in the successful insertion of the sleeve 1204 through the valve flap 852 without kinking or buckling of the distal segment of the sleeve 1204.

In some cases, once the distal tip of the cannula 1204 passes through the sealable region 856 of the valve flap 852, the valve flap 852 can support the cannula 1204 as the cannula 1204 is advanced further distally through the hub 806 and the catheter tube 704. For example, the flap 852 can provide lateral support that inhibits lateral deflection of the sleeve 1204 in the contact area between the sealable area 856 and the sleeve 1204.

With continued reference to fig. 34, as previously described, in various embodiments, the sleeve 1204 may be similar to any of the disclosed varieties of sleeve 204, 1004, or 1404 (described below). For example, in some embodiments, the cannula 1204 includes distal and medial sections similar to the distal and medial sections 226, 224 and/or 1026, 1024, respectively, discussed above, and/or any of the types of distal and medial sections 1426, 1424, respectively, discussed below. Although only the distal section is shown in fig. 34, the presence and structure of the inner section may be understood from other figures and disclosure herein.

In some embodiments, the inner section of the sleeve 1204 includes two adjoining tubes joined by a heat shrink tubing (see, e.g., fig. 22). The inner tube may be rigid and may be formed of metal-for example, the inner tube may comprise a stainless steel hypotube. In other embodiments, the medial section of the cannula 1204 includes a flexible central tube that extends continuously along the distal and medial sections, but is surrounded by a rigid tube along the length of the medial section (see, e.g., fig. 56A and 56B). The rigid tube may be formed of metal, such as stainless steel hypotubes. In either case, the inner section may have substantial radial strength to resist radial compression that might otherwise constrict or close the lumen through the tube. For example, in various embodiments, due to the presence of the rigid tube in the inner section, the inner section may have a greater ability to maintain the fluid path extending through the center of the inner section in an open state even under radial forces or stresses on the inner section that would tend to constrict or close the fluid path if not impeded.

In certain embodiments of the access system 1200, the inner section of the cannula 1204 extends completely through the valve flap 852 of the closed intravenous catheter system 700 when the cannula 1204 is in the deployed state. For example, in some embodiments, a rigid tube forming the medial section or a support sleeve surrounding the flexible inner tube along the length of the medial section passes through the valve flap 852 near the end of advancing the sleeve 1204 through the catheter tube 704. Due to the inherent rigidity of the rigid tube of the inner segment, the inner segment may prevent inward stress provided to the sleeve 1204 by the valve flap 852, caused by expansion due to collapse of the inner segment by the sealable opening 856. For example, in some embodiments that include a flexible center tube within a rigid tube, the rigid tube can resist the compressive force from the valve flaps 852 to maintain the inner tube in an open state. In other words, after the cannula 1204 is finally advanced, or when the user is ready to aspirate or draw blood through the cannula 1204, the inner side segment of the cannula 1204 may extend through the entire sealable area 856 of the valve flap 852 to prevent the valve flap 852 from collapsing the flow path through the cannula 1204.

In various embodiments, the outside diameter of the inner section of the cannula 1204 is equal to or only slightly larger than the outside diameter of the distal section. For example, in various embodiments, the outer diameter of the inner section is no more than 5%, 10%, or 15% greater than the outer diameter of the distal section. In some embodiments, when the cannula 1204 is advanced distally, an inside segment having a diameter equal to or only slightly greater than the outer diameter of the distal segment can easily follow the distal segment through the valve flap 852 and/or can pass through the valve flap 852 without damaging it. In other or further embodiments, by following the distal segment into and through the valve flap 852, the inner segment can easily pass through the valve flap 852 and/or can pass through the valve flap 852 without damaging the valve flap 852.

Reference is now made to fig. 35-53, which relate to another embodiment of an access system 1300 that may be used, inter alia, with an open-base catheter system. For example, in certain instances, the access system 1300 may be particularly suitable for use with an open-base catheter system including an expansion kit coupled with a catheter assembly, such as the open-base catheter system 1100 depicted in fig. 24 and 25. As previously discussed with respect to fig. 24-27 and 29B, catheter system 1100 may include a large interior region in which the cannula is unsupported as the cannula is advanced distally therethrough when positioned therein. This relatively large inner diameter(s) region corresponds to the inner cavity of the connected hub 1180, 1106 (see fig. 25). Referring to fig. 36, an embodiment of an access system 1300 may include a reinforcement member 1330, the reinforcement member 1330 including a movable reinforcement sleeve 1332. The reinforcement sleeve 1332 is movable relative to the connector 1302 to be advanced distally into this unsupported region of the catheter system 1100 and to provide lateral support or reinforcement to the sleeve 1304 as it is advanced distally through the hubs 1180, 1160 into the catheter tube 1104 of the catheter system 1100.

The sleeve 1304 may be of any suitable construction, including those discussed elsewhere herein. For example, in some embodiments, the cannula 1304 includes at least a distal section and a medial section formed in a manner such as described elsewhere. The medial section may be inherently reinforced to resist or prevent kinking or buckling thereat as the cannula 1304 is advanced distally.

Fig. 35 is a perspective view of access system 1300 in a retracted or undeployed state. As described, in some embodiments, the access system 1300 may be particularly suitable for use with an open intravenous catheter system, and may be further suitable for use with an extension set coupled with such an open intravenous catheter system. The removable stiffening tube 1332 may be said to support the cannula 1304 along at least a portion of the length of an expansion set (such as expansion set 1150) and/or through a length of a catheter hub (such as catheter hub 1106) to which the expansion set is coupled. Fig. 36 is a cross-sectional view of the access system 1300 in a retracted state.

Fig. 37A is a perspective view of one embodiment of a connector 1302 that includes a housing 1305 compatible with the access system 1300. Fig. 37B is a perspective cross-sectional view of the housing of fig. 37A. The housing 1305 may define a proximal chamber 1390 and a distal chamber 1391. The distal chamber 1391 may have a larger inner diameter than the proximal chamber 1390. As discussed below, the proximal chamber 1390 may be narrower to define a constrained region, while the distal chamber 1391 may be relatively larger to define an expanded region. In the illustrated embodiment, the proximal chamber 1390 includes a track 1364, similar to the anti-rotation track 1064 discussed previously.

The housing 1305 may include distal protrusions 1313 similar to like numbered elements above. As discussed further below, the distal protrusion or extension 1313 may cooperate with the reinforcing member 1330 or support the reinforcing member 1330 (see fig. 36). Distal extension 1313 may be fixed relative to connector 1302. For example, the distal extension 1313 may be integrally formed with at least the distal tube of the housing 1305. The distal extension 1313 may define an inner diameter slightly larger than the outer diameter of the stiffening tube 1332. The stiffening tube 1332 may be sized to slide through the distal extension 1313. Distal extension 1313 may be considered a component of reinforcement member 1330. For example, the reinforcement member 1330 may include both a distal extension 1313 and a reinforcement sleeve 1332. In various embodiments, at least a portion of the reinforcing member 1330 is fixed relative to the housing 1305. In various embodiments, at least a portion of the reinforcing member 1330 is movable relative to the connector housing 1305.

Fig. 38A is a perspective view of one embodiment of a follower 1360 compatible with the pathway system 1300. The follower 1360 may include selective engagement features that may engage or disengage the reinforcement sleeve 1332. Fig. 38B is a cross-sectional view of the follower 1360. The follower 1360 includes a selective engagement feature by which the follower 1360 can selectively engage and selectively disengage the reinforcement sleeve 1332. Specifically, the follower 1360 includes a plurality of engagement arms 1392, the distal ends of the engagement arms 1392 being configured to engage with a catch 1393 attached to the reinforcement sleeve 1332 (see fig. 42). Specifically, the engagement arms 1392 may each include an engagement protrusion 1394, the engagement protrusions 1394 being configured to engage with the jaws 1393 in a manner such as described below. In the illustrated embodiment, each engagement projection 1394 includes an engagement surface 1395. The engagement surface 1395 may be a sloped or angled surface. Each engagement surface 1395 may be angled away from the central longitudinal axis of follower 1360 in a proximal-to-distal direction.

The follower 1360 may include an anti-rotation protrusion 1362, which may be similar to the protrusion 1062 discussed above. The anti-rotation protrusions 1362 may be configured to engage with the rails 1364 of the housing 1305 in a manner such as previously described. The follower 1360 may also include a proximal cavity 1371 and an opening 1373, which may be similar to the proximal cavity 1071 and the opening 1073 described above.

Fig. 39A is a perspective view of one embodiment of a reinforcement shuttle 1335 that includes a reinforcement tube 1332 and a catch 1393. Fig. 39B is a cross-sectional view of the reinforcement shuttle 1335.

The pawl 1393 may be fixedly secured to the proximal end of the stiffening tube 1332. The pawl 1393 can define a recess 1337, the recess 1337 being sized to receive the engagement protrusion 1394 of the engagement arm 1392. In the illustrated embodiment, the recess 1337 is formed as an annular depression (depression) having a cross-sectional profile complementary to the profile of each engagement protrusion 1394. The recess 1337 may include an engagement surface 1339, the engagement surface 1339 being configured to contact an engagement surface 1395 of the engagement protrusion 1394. The engagement surface 1339 may be a sloped or angled surface. Specifically, the engagement surface 1339 may be angled away from the central longitudinal axis of the reinforcing shuttle 1335 in a proximal-to-distal direction. The angled engagement surfaces 1339, 1395 of the pawl 1393 and arm 1392 may be referred to as angled interfaces.

Fig. 40 is a cross-sectional view of the distal end of the access system 1300 in a retracted state. In the illustrated embodiment, when in this operational state, the distal tip of the sleeve 1304 is recessed relative to the distal tip of the reinforcement sleeve 1332, and the distal tip of the reinforcement sleeve 1332 is recessed relative to the distal tip of the distal extension 1313.

Fig. 41 is a cross-sectional view of a larger distal region of the access system 1300 in a retracted state. As shown, both distal extension 1313 and reinforcement shuttle 1335 including reinforcement sleeve 1332 may be components of reinforcement member 1300. These components cooperate to strengthen the cannula 1304 when the cannula 1304 is advanced from the retracted position, such as in a manner discussed below.

Fig. 42 is a cross-sectional view of a middle region of the access system 1300 in a retracted state. As can be seen in this view, the cannula 1304 can include a distal section 1326 and an inner section 1324, which can be similar to similarly named and numbered features discussed elsewhere herein. For example, in some embodiments, the distal section 1326 can be formed from a polymeric tube (e.g., polyimide). In some embodiments, the medial section 1324 includes a proximal extension of the polymeric tube, and further includes a rigid tubular support member (e.g., a metallic construction) surrounding the polymeric tube. In other embodiments, the inner section 1324 comprises a rigid tube (e.g., formed of metal) including a distal tip that abuts a distal tip of the polymeric tube; the adjoining ends of the tubes may be joined in any suitable manner, such as via a superimposed heat shrink tube. Other suitable arrangements are contemplated. The distal section 1326 and the medial section 1324 may meet at an interface 1352, the interface 1352 being located within the stiffening tube 1332 in the retracted state shown in the access system 1300.

In the retracted state shown (also depicted in fig. 45), the pawl 1393 and the distal end of the arm 1392 of the follower 1360 coupled to the pawl 1393 may be located within the proximal chamber 1390 of the housing 1305. The narrow inner side wall of the housing 1305 defining the proximal chamber 1390 may constrain the arms 1392, thereby maintaining the arms 1392 in a coupled state with the jaws 1393. Specifically, the proximal chamber 1390 may be sized to hold the angled faces 1395, 1339 of the arm 1392 and pawl 1335, respectively, in engagement with each other. As discussed further below, this engagement of the angled surfaces may allow the arms 1392 of the follower 1360 to push the dogs 1393 distally as the sleeve 1304 attached to the follower 1360 is advanced distally.

In some embodiments, the arms 1392 may be resiliently biased outwardly or away from the central longitudinal axis to spring outwardly when no longer constrained within the proximal chamber 1390. In other embodiments, arm 1392 may lack a bias. The arm 1392 may be flexible enough to be pushed outward by the interaction of the angled faces 1395, 1339 when distal advancement of the reinforcement shuttle 1335 is inhibited and when the arm 1392 is not constrained within the proximal chamber 1390, as discussed further below.

Fig. 43 is a cross-sectional view of a generally proximal portion of the access system 1300 in a retracted state. The follower 1360 may be located at the proximal end of the housing 1305. Anti-rotation protrusions 1362 may be located within rails 1364 of housing 1305. Further details of the sleeve 1304 are shown, and the sleeve 1304 may be similar to other sleeves previously discussed.

Fig. 44 is a cross-sectional view of an access system 1300 coupled with one embodiment of a base catheter assembly 1100 while the access system 1300 is in a retracted state. The base catheter assembly 1100 includes an open intravenous catheter 1101 and a docking kit 1150 coupled thereto in a manner such as that described previously with respect to fig. 24 and 25.

Fig. 45 is a cross-sectional view of a generally middle region of the access system 1300 in the coupled and retracted configuration depicted in fig. 44. Fig. 46 is a cross-sectional view of the distal portion of the access system 1300 in the coupled and retracted state, further depicting the proximal portion of the catheter assembly 1100. As shown in fig. 46, distal extension 1313 may extend a substantial distance within hub 1180. However, as previously discussed, within the hubs 1180, 1106, a larger diameter region extends between the distal tip of the distal extension 1313 and the proximal tip of the catheter tube 1104. This is the area bridged by the stiffening tube 1332 when the access system 1300 is deployed, as discussed further below.

Fig. 47 is a cross-sectional view of an access system 1300 coupled to a base catheter assembly 1100 in a partially deployed state, or in other words, in an intermediate stage or state of deployment. The cannula 1304 has been advanced distally a first distance, which in turn causes the follower 1360 to be advanced distally the same distance through the housing 1305.

Fig. 48 is a cross-sectional view of a middle region of an access system 1300 in a partially deployed state. When advanced to the orientation shown, the arm 1392 is already in and still in a low profile state, as constrained by the proximal chamber 1390. This maintains contact between the angled surfaces 1395, 1339. The sloped surface 1395 pushes against the sloped surface 1339, distally advancing the reinforcement shuttle 1335 in concert with distally advancing the follower 1360 and the sleeve 1304.

As shown, the distal end of the arm 1392 has been advanced distally past the end of the proximal chamber 1390 of the housing 1305 and has entered the enlarged cavity of the distal chamber 1391. In the illustrated embodiment, the arms 1392 are not resiliently biased outwardly and therefore do not automatically expand to an expanded state when no longer constrained in the low profile orientation. In the constrained state, a majority of the proximal length of the arms 1392 remains positioned within the proximal chamber 1390 such that the distal tips of the arms 1392 remain generally in a low profile state, even in the enlarged distal chamber 1391, unless and until they are pushed outwardly. In other words, the distal end of the arm 1392 is at a position within the distal chamber 1391 where the arm 1392 can be allowed to push radially or laterally outward to an expanded profile.

Fig. 49 is a cross-sectional view of the distal end of the access system 1300 and the proximal portion of the base catheter assembly 1100 when the access system 1300 is in a partially deployed state. At this point, the distal tip of the stiffening tube 1332 has been in contact with the proximal tip 1107 of the catheter tube 1104. Such contact may prevent further distal advancement of the stiffening tube 1332. In the illustrated configuration, the distal end of the sleeve 1304 remains within the reinforcement tube 1332 until there is relative movement between the follower 1360 and the reinforcement shuttle 1335 (fig. 48).

Fig. 50 is a cross-sectional view of an access system 1300 coupled to a base catheter assembly 1100 in a fully deployed state. Fig. 51 is a cross-sectional view of the middle region of the access system 1300 in a fully deployed state. Upon reaching this state, the reinforcement shuttle 1335 remains in the same configuration depicted in fig. 47-49. That is, the distal tip of the stiffening tube 1330 still abuts the proximal tip 1107 of the catheter tube 1104 (fig. 49). Note that in other embodiments, stiffening tube 1330 may additionally or alternatively be sized to abut the inner surface of catheter hub 1106 (fig. 49). As the cannula 1304 is advanced distally relative to the orientation shown in fig. 47-49, the follower 1360 moves distally in unison with the cannula 1304 to which it is attached. The reinforcement tube 1104 and the catch 1393 attached thereto remain in a fixed position relative to the housing 1305 due to interference between the reinforcement sleeve 1332 and the catheter tube 1104. The angled or sloped surface 1395 of the arm 1392 presses against the angled or sloped surface 1339 of the fixed pawl 1393. Angled surface 1395 interacts with angled surface 1339 to push the distal end of boom 1392 outward. The distal chamber 1391 of the housing 1305 provides sufficient clearance to allow the deflected end of the arm 1392 to pass over the catch 1393 and resiliently return to the straightened state shown in fig. 51. As the cannula 1304 is advanced further distally, the follower 1360 moves in unison with the cannula 1304 and the arms 1392 of the follower 1360 pass over or past the outer surface of the dogs 1393 or are located alongside the outer surface of the dogs 1393.

In various embodiments, various parameters may be adjusted to allow the arm 1392 to disengage from the jaw 1393 and move distally relative to the jaw 1393 in a manner such as just described. For example, in some embodiments, the stiffness of the arms 1392 may be selected to ensure that disengagement occurs only when the distal movement of the reinforcement tube 1332 experiences a threshold level of resistance. The relative orientation of the proximal and distal chambers 1390, 1391 of the housing 1305 may also or alternatively be adjusted. In various embodiments, the access system 1300 may be configured for use with a variety of different base catheter systems (with and/or without an extension set) that define a variety of different lengths through which the reinforcement tube 1332 passes before encountering resistance to advancement. Certain embodiments may allow the arm 1392 to remain engaged with the jaw 1393 until resistance is encountered at any of these various lengths and thereafter disengaged from the jaw 1393.

Fig. 52 is a cross-sectional view of a generally distal portion of the access system 1300 and a proximal portion of the base catheter assembly 1100 when the access system is in a fully deployed state. As shown, the distal tip of the reinforcement sleeve 1332 remains engaged with and secured by the proximal tip 1107 of the catheter tube 1104 throughout the distal advancement of the sleeve 1304 past the intermediate position depicted in fig. 47-49. The cannula 1304 passes through a fixed reinforcement cannula 1332 and is thereby reinforced in the event of encountering resistance to distal movement of the cannula 1304, such as at bends or kinks in the catheter tube 1304.

Fig. 53 is a cross-sectional view of the access system 1300 and the distal end of the base catheter assembly 1100 when the access system 1300 is in a fully deployed state. In the illustrated embodiment, the cannula 1304 extends through the distal tip of the catheter tube 1104.

Fig. 54 is a perspective view of another embodiment of an access system 1400, and fig. 55 is a cross-sectional view of the access system 1400. The access system 1400 is shown in both figures in a retracted state. The access system 1400 includes a removable sterile cap 1494 coupled to the connector 1402. Cap 1494 may be included in packaged access system 1400 for removal prior to use. The connector 1402 shown includes a snap-fit arrangement, such as previously disclosed, for example, with respect to the access system 1200.

The access system 1400 may be similar in many respects to the access system 1200 and may be particularly suited for use with a closed intravenous catheter system. As discussed above, the sleeve 1204 of the embodiment of the access system 1200 shown in fig. 30-34 includes two adjoining tubes joined by a heat shrink tubing. However, other cannula configurations are disclosed with respect to the access system 1200, including a cannula comprising a continuous polymer tube and a support tube surrounding at least a middle region of the polymer tube. The cannula 1204 of the access system 1400 is the latter configuration.

Referring to fig. 56A and 56B, the cannula 1404 can include a proximal segment 1422, an inner segment 1424, and a distal segment 1426. Sleeve 1404 includes a central tube 1496 defining a distal section 1426. The center tube 1496 extends continuously through the inner section 1424. The proximal end of the center tube 1496 is located in a portion of the proximal section 1422. The proximal section 1422 also includes a proximal tube 1422 of any suitable form, such as described previously herein. The center tube 1496 may be coupled to the proximal tube 1422 in any suitable manner, such as by a press fit, an adhesive, or the like. At least the proximal tube 1422 can be fixedly secured to the follower 1460.

The center tube 1496 may be formed of any suitable material, such as the materials disclosed with respect to other embodiments (e.g., polymeric materials). The center tube 1496 may be flexible. Embodiments of the center tube 1496 may be laterally flexible while having sufficient columnar or axial strength or rigidity to navigate through the catheter tube or through tortuous paths and/or having sufficient radial strength to remain open while within such tortuous paths. The inboard segment 1424 may also include a support tube 1495 surrounding, encircling, wrapping, covering, overlaying, etc., the middle portion of the center tube 1496. As previously discussed, the support tube 1495 may be relatively rigid. In some embodiments, the support tube 1495 may be metallic, such as a stainless steel hypotube. In some embodiments, the support tube 1495 is fixedly secured to at least the proximal end of the center tube 1496. In some embodiments, the support tube 1495 is attached or otherwise secured to the center tube 1496 only at the proximal end of the support tube 1495. In other embodiments, the support tube 1495 may be attached or otherwise secured to the center tube 1496 along substantially the entire length of the support tube 1495. Other arrangements are contemplated.

The inner diameter of the support tube 1495 may be only slightly, barely, minutely or minimally larger than; approximately equal to; conformal or substantially conformal; and/or substantially inhibit, limit, and/or prevent lateral movement of the outer diameter of the center tube 1496. The support tube 1495 may be in a fixed longitudinal relationship with the center tube 1496 to move in unison therewith while preventing lateral movement of the center tube 1496 within the lumen of the support tube 1495 that would otherwise bend, kink and/or buckle the center tube 1496. In various embodiments, the inner diameter of the support tube 1495 is no more than 5%, 10%, 15%, 20%, 25%, or 30% greater than the outer diameter of the center tube 1496.

Referring to fig. 56A, the distal tip or distal edge of the support tube 1495 may correspond to the distal tip 1450 of the medial section 1424. Although the center tube 1496 may extend continuously through the distal terminal 1450, the medial and distal segments 1424, 1426 may still be referred to as meeting at an interface 1452 at the distal terminal 1450 of the medial segment 1424.

As with other embodiments disclosed herein, in some embodiments, the interface 1452 can be located within the stiffening tube 1432 when the cannula 1404 is in a retracted state, as shown in fig. 56A. As the cannula is advanced distally, the support tube 1495 moves in concert with its surrounding center tube 1496 (in tangent with) and slides distally within the reinforcement tube 1432.

In some instances, the access system 1400 may be particularly suited for use with closed conduit systems. Access system 1400 can be coupled and used with closed catheter system 700 in a manner such as described above with respect to access system 1200 in fig. 33 and 34.

Fig. 57 and 58 depict another embodiment of an access system 1500. In some embodiments, the access system 1500 may be particularly suited for use with an open catheter system (whether with an expansion kit or not). The pathway system 1500 may include a sleeve 1504, the sleeve 1504 being substantially identical to the sleeve 1404 just discussed with respect to the pathway system 1400. Specifically, the sleeve 1404 may include a central tube and a support member surrounding the central tube. Other arrangements of the sleeve 1504, including those discussed elsewhere herein, are also contemplated.

The access system 1500 may also include a sealing member 1600 coupled to the reinforcement tube 1532 and the cannula 1504. The open conduit system may not include a sealing member or flap that is capable of sealing the sleeve 1504 during use. The sealing member 1600 may prevent blood that may pass proximally through the annular space between the reinforcement tube 1532 and the cannula 1504 from exiting the proximal end of the reinforcement tube 1532 and entering the housing of the access system 1500.

Fig. 59 provides a more detailed view of the interior of the access assembly 1500 including the sealing member 1600. The sealing member 1600 may be securely fixed to the proximal end of the reinforcement tube 1532. The proximal end of the sealing member may include a proximal opening 1602, through which proximal opening 1602 a support tube 1595 of the sleeve 1504 passes. The sealing member 1600 may form a static seal with the reinforcement tube 1532 and may form a dynamic seal with the support tube 1595. In other words, the sealing member 1600 may be in a fixed relationship relative to the reinforcement tube 1532, but may allow the support tube 1595 to move relative thereto while the sealing member 1600 maintains a fluid tight seal with each of the reinforcement tube 1532 and the support tube 1595. The sealing member 1600 may prevent blood from flowing out of the support tube 1595 and through the proximal opening 1602.

Fig. 60 depicts another embodiment of a sealing member 1700 that is similar in many respects to sealing member 1600. The sealing member 1700 includes a proximal opening 1702 and a strain-relief region 1704 at a proximal end of the sealing member 1700. In particular, the distal end of the inner cavity 1706 defined by the sealing member 1700 may have a reduced diameter D1, at which diameter D1 the sealing member 1700 tightly grips and forms a static, fluid-tight seal with the reinforcement member 1532. The proximal end of the inner lumen 1704 may have an undercut or enlarged region defining an enlarged diameter D2. In the enlarged proximal region, the sealing member 1700 may be recessed from or spaced apart from the outer surface of the reinforcement member 1532 when the access system 1500 is fully assembled. This may in some cases allow the support tube 1595 to move more rapidly (reader) through the proximal end of the sealing member 1700 as the support tube 1595 is moved through the proximal opening 1702, thereby maintaining a firm, dynamic, fluid-tight seal between the sealing member 1700 and the support tube 1595. The enlarged diameter may allow the proximal end of the sealing member 1700 to bend more rapidly.

Fig. 61 is a perspective view of another embodiment of an access system 1800 in a retracted state. Fig. 62 is a cross-sectional view of access system 1800 in a retracted state. The access system 1800 includes tabs 1898 that extend through longitudinal rails 1899 in the housing element. The tab 1898 is attached to the inner coupler 1861, and the inner coupler 1861 may be similar in overall configuration to the follower previously described, but may differ significantly in its connection with the externally positioned tab 1898. The internal coupler 1861 may alternatively be referred to as a follower, although it differs from other followers described herein in at least one important aspect. While the other followers move only in response to force applied to the sleeve, the internal coupler 1861 may additionally move in response to force applied to the tab 1898. In any event, the internal coupler 1861 does not cause or otherwise result in movement of the cannula 1804 to which it is attached. Movement of the internal coupler 1861 is entirely passive and is responsive to movement of the sleeve 1804 or movement of the tab 1898. The internal coupler 1861 may be connected with a portion of the sleeve 1804 such that the sleeve 1804 may move in response to movement of the tab 1898. The tabs 1898 may be used to move the inner coupler 1861 forward and backward along a designated track 1898, thereby advancing and retracting the cannula 1804.

Fig. 63 is a perspective cutaway view of another embodiment of an access system 1900 that includes a deployable cannula 1904. FIG. 64 is a cross-sectional view of a generally distal portion of an access system 1900. The cannula 1904 includes a unitary central tube 1996 (e.g., formed of a polymeric material) without any support tubes attached thereto. The central tube 1996 is attached at its proximal end to the proximal side 1923. Access system 1900 includes a reinforcement member 1930 at its distal end defined by a connection member 1970.

Methods of using embodiments of the pathway system are discussed above. Certain methods may include placing a base catheter system in the vasculature of a patient. Other or further methods may include coupling the access system with a pre-set base catheter system. In certain embodiments, the base catheter system may be placed in one or more of the dorsiflexion, forearm, or antecubital fossa positions of the patient's hand. The various embodiments disclosed herein can be used with pre-set base catheter systems that have been placed in any of these areas. For example, the access system may include a supported sleeve that can be used with a base catheter tube that may define a significantly tortuous path.

In some cases, the base catheter system may be placed on the patient in a general manner that does not involve the use of specially spaced or oriented devices. For example, some embodiments of the access system may be used with a base catheter system that has been taped down to the patient's skin or secured to the patient's skin with a standard flat dressing. There may be no spacer element such as a wedge shaped device configured to provide an entry angle to the access system. That is, the access system may be used to traverse tortuous areas defined by the base catheter system that is taped or otherwise secured directly to the skin of the patient.

Examples

This paragraph recites 322 illustrative examples of systems, kits (kits) and methods corresponding to the various embodiments of the foregoing written description and/or illustrative figures. In these examples, the term "embodiment X to embodiment Y" refers to embodiment X to embodiment Y and thus includes the endpoints of the stated example ranges.

Embodiment 1. Pathway system, comprising:

a connector configured to couple with a catheter assembly, the catheter assembly including a catheter tube configured to be positioned in a blood vessel of a patient;

a reinforcing member coupled with the connector; and

a cannula movable relative to the reinforcing member from a retracted position with at least a portion of the cannula within the reinforcing member to an advanced position, the cannula comprising:

a first section at the distal end of the cannula defining a distal tip of the cannula; and

a second section relatively stiffer than and extending proximally from the first section, the second section including a distal terminal end configured to be within the reinforcement member when the distal tip of the cannula is first positioned distally and externally of the reinforcement member as the cannula transitions from the retracted position to the advanced position,

wherein when the connector and catheter assembly are in the coupled state, at least a portion of the first section of the cannula is configured to be advanced through at least a portion of the catheter tube as the cannula transitions from the retracted position to the advanced position.

Embodiment 2. The access system of embodiment 1, wherein the catheter assembly is configured to be pre-positioned in the patient such that the catheter tube is positioned in the patient's blood vessel prior to coupling the connector of the access system with the catheter assembly.

Embodiment 3. The access system of embodiment 1 or embodiment 2, wherein advancement of the cannula to the advanced position enables direct fluid communication between the cannula and the blood vessel when the catheter tube of the catheter assembly is positioned in the blood vessel of the patient and when the connector of the access system and the catheter assembly are in the coupled state.

Embodiment 4. The access system of any of embodiments 1-3, wherein the distal tip of the cannula extends distally past the distal tip of the catheter tube when the cannula is in the advanced position.

Embodiment 5. The access system of any of embodiments 1-3, wherein the distal tip of the cannula is positioned within the catheter tube at or near the distal tip of the catheter tube when the cannula is in the advanced position.

Embodiment 6. The access system of any of embodiments 1-5, wherein the at least a portion of the cannula is positioned beyond and distal to the distal tip of the reinforcement member when the cannula is in the advanced position.

Embodiment 7. The pathway system of any one of embodiments 1-6, wherein the second section of the cannula is relatively stiffer than the first section of the cannula.

Embodiment 8. The pathway system of any one of embodiments 1-7, wherein the second section of the cannula comprises a flexible tube and/or a polymeric tube and a support member that is stiffer than and surrounds at least a portion of the flexible tube and/or polymeric tube.

Embodiment 9. The access system of embodiment 8, wherein at least the distal end of the support member is surrounded by the reinforcement member when the cannula is in the retracted position.

Embodiment 10. The access system of embodiment 8 or embodiment 9, wherein at least a middle portion of the flexible tube and/or the polymer tube extending continuously along at least a portion of each of the first and second sections is surrounded by one or more of the reinforcing member and the support member along the entire length of the middle portion when the sleeve is in the retracted position.

Embodiment 11. The access system of any of embodiments 8-10, wherein the support member is advanced distally through the reinforcement member throughout movement of the cannula from the retracted position to the advanced position.

Embodiment 12. The access system of any one of embodiments 8-11, wherein the distal terminal end comprises a distal tip of the support member.

Embodiment 13. The access system of any of embodiments 8-12, wherein the flexible tube and/or the polymer tube fits tightly within the support member.

Embodiment 14. The access system of any of embodiments 8-13, wherein the support member is fixed relative to the flexible tube and/or the polymer tube.

Embodiment 15. The access system of embodiment 14, wherein the support member is attached to the flexible tube and/or the polymer tube.

Embodiment 16. The access system of any of embodiments 8-15, wherein the flexible tube and/or the polymer tube extends through the entire length of the support member.

Embodiment 17. The pathway system of any one of embodiments 8-16, wherein the support member extends along the entire length of the second segment.

Embodiment 18. The access system of any of embodiments 8-17, wherein the cannula further comprises a third segment extending proximally from the second segment.

Embodiment 19. The access system of embodiment 18, wherein the third segment comprises a proximal tube having an outer diameter greater than an outer diameter of the flexible tube and/or the polymer tube.

Embodiment 20. The access system of embodiment 18 or embodiment 19, wherein the flexible tube and/or the polymer tube is fixedly secured to the proximal tube.

Embodiment 21. The pathway system of any one of embodiments 18-20, further comprising a follower attached to each of the second and third segments.

Embodiment 22. The pathway system of any one of embodiments 8-20, wherein the first segment comprises a portion of a flexible tube and/or a polymer tube.

Embodiment 23. The access system of embodiment 22, wherein the first segment is exclusively formed from flexible tubing and/or polymeric tubing.

Embodiment 24. The pathway system of embodiment 22, wherein the flexible tube and/or the polymer tube is formed from a unitary piece of material that extends continuously from the first segment to the second segment.

Embodiment 25. The access system of any of embodiments 8-24, wherein the flexible tube and/or the polymer tube is formed from polyimide.

Embodiment 26. The access system of any of embodiments 8-25, wherein the support member comprises a support tube surrounding an outer surface of the flexible tube and/or the polymer tube.

Embodiment 27. The pathway system of embodiment 26, wherein the support tube comprises a metallic material.

Example 28. The access system of example 27, wherein the support tube is formed of stainless steel.

Embodiment 29 the access system of any of embodiments 8-28, wherein the support member is sized to slide through at least a portion of the reinforcement member as the sleeve transitions from the retracted position to the advanced position.

Embodiment 30 the access system of any of embodiments 8-29, further comprising a sealing member coupled to each of the reinforcing member and the support member to form a fluid-tight seal to prevent fluid from flowing into or out of a space between the reinforcing member and the support member.

Embodiment 31. The access system of embodiment 30, wherein the sealing member is fixedly secured to the reinforcing member and the support member is movable relative to the sealing member.

Embodiment 32. The access system of embodiment 30 or embodiment 31, wherein the sealing member is attached to the proximal end of the reinforcement member.

Embodiment 33 the access system of any of embodiments 30-32, wherein the sealing member surrounds a proximal tip of the reinforcement member.

Embodiment 34. The pathway system of any one of embodiments 8-33, wherein the reinforcement member defines a cavity that defines an inner diameter that is no more than 20% greater than an outer diameter of the support member.

Embodiment 35 the access system of any of embodiments 8-34, wherein the support member prevents kinking of the flexible tube and/or the polymeric tube by preventing lateral movement of the flexible tube and/or the polymeric tube within the support member when the first segment encounters a force that urges the distal tip of the impedance cannula distally.

Embodiment 36. The pathway system of any one of embodiments 1-7, wherein the first segment comprises a first tube comprising a first end face, the second segment comprises a second tube comprising a second end face, and the first end face and the second end face abut one another at an interface located at a distal terminal end of the second segment.

Embodiment 37. The pathway system of embodiment 36, wherein each of the first end face and the second end face is oriented transversely relative to the longitudinal axis of the sleeve.

Embodiment 38 the access system of embodiment 36 or embodiment 37, wherein the second tube is stiffer than the first tube.

Embodiment 39. The pathway system of embodiment 38, wherein the second tube is formed of a metallic material.

Embodiment 40. The pathway system of embodiment 39, wherein the second tube is formed of stainless steel.

Embodiment 41. The pathway system of any one of embodiments 36-40, wherein the first tube is formed from a polymeric material.

Embodiment 42 the pathway system of any one of embodiments 36-41, further comprising a connection layer extending over the interface and at least a portion of each of the first tube and the second tube of the first section and the second section, respectively, to attach the first tube and the second tube together or to enhance attachment between the first tube and the second tube.

Embodiment 43. The pathway system of embodiment 42, wherein the outer diameter of the first tube and the outer diameter of the second tube are substantially the same at least in the region of the cannula comprising the interface.

Embodiment 44. The access system of embodiment 42 or embodiment 43, wherein the outer diameter of the connection layer is substantially constant along a transition region comprising the proximal end of the first segment, the interface, and the distal end of the second segment.

Embodiment 45 the pathway system of any one of embodiments 42-44, wherein the connection layer comprises a tubular member defining a thickness that is not less than one fifth of the thickness of the first tube.

Embodiment 46 the pathway system of any one of embodiments 42-45, wherein the connection layer comprises a tube formed from a heat-shrinkable material.

Embodiment 47. The pathway system of any one of embodiments 42-46, wherein the hardness of the connection layer is less than the hardness of the first segment.

Embodiment 48 the access system of any of embodiments 42-47, wherein the distal tip of the connection layer is proximally spaced from the distal tip of the cannula, and wherein the distal tip of the connection layer is configured to contact an inner surface of the catheter tube to define proximal movement of the cannula relative to the catheter tube.

Embodiment 49 the access system of any of embodiments 42-48, wherein the distal tip of the connection layer is proximally spaced from the distal tip of the cannula, and wherein the distal tip of the connection layer is configured to contact an inner surface of the catheter tube to provide tactile feedback to a user regarding the position of the cannula relative to the catheter tube.

Embodiment 50. The access system of any of embodiments 1-49, wherein the reinforcement member prevents kinking of the first segment by preventing the first segment from moving laterally inside the reinforcement member when the first segment encounters a force that urges the distal tip of the impedance sheath distally.

Embodiment 51. The pathway system of any one of embodiments 1-50, wherein the inner diameter of the first segment is not greater than the inner diameter of the second segment.

Embodiment 52. The pathway system of any one of embodiments 1-50, wherein the inner diameter of the first section and the inner diameter of the second section are substantially the same at least in the region of the sleeve comprising the terminal end.

Embodiment 53. The pathway system of any one of embodiments 1-52, wherein the reinforcement member defines a cavity that defines an inner diameter that is no more than 20% greater than an outer diameter of the first section of the cannula.

Embodiment 54 the access system of embodiment 53, wherein the inner diameter of the lumen is constant along a tubular region extending along at least a portion of the entire length of the reinforcement member.

Embodiment 55 the access system of embodiment 54, wherein the tubular region extends to a distal tip of the reinforcement member.

Embodiment 56 the access system of embodiment 54 or embodiment 55, wherein the tubular region extends along at least a majority of the entire length of the reinforcement member.

Embodiment 57. The pathway system of any one of embodiments 1-56, wherein the reinforcement member comprises a stainless steel tube.

Embodiment 58 the access system of embodiment 57, wherein the reinforcement member further comprises a polymeric material overmolded onto the stainless steel tube.

Embodiment 59. The pathway system of any one of embodiments 1-56, wherein the connector and the reinforcement member are formed from a unitary piece of material.

Example 60. The pathway system of example 59, wherein the monolithic piece of material is polymeric.

Embodiment 61. The pathway system of any one of embodiments 1-60, wherein the first segment is shorter than the reinforcement member.

Embodiment 62. The pathway system of any one of embodiments 1-60, wherein the first segment is longer than the reinforcement member.

Embodiment 63 the access system of any of embodiments 1-62, wherein the distal tip of the cannula is positioned within the stiffening member when the cannula is in the retracted position such that the distal tip of the cannula is positioned distally and outward of the stiffening member only after the cannula has been moved from the retracted position.

Embodiment 64 the access system of any of embodiments 1-62, wherein the distal tip of the cannula is initially positioned distally and externally of the reinforcement member when the cannula is in the retracted position.

Embodiment 65 the access system of any of embodiments 1-64, wherein the distal terminus of the second section of the cannula is within the reinforcing member when the cannula is in the retracted position.

Embodiment 66. The access system of any of embodiments 1-65, wherein the distal terminus of the second section of the cannula is distal to the distal edge of the reinforcement member when the cannula is in the advanced position.

Embodiment 67. The access system of any of embodiments 1-66, wherein the catheter assembly comprises an expansion kit comprising a hub, wherein the distal terminus of the second section of the cannula is positioned within the hub when the cannula is in the advanced position.

Embodiment 68 the access system of any of embodiments 1-66, wherein the catheter assembly comprises a catheter hub coupled to the catheter tube, wherein the distal terminus of the second section of the cannula is positioned within the catheter hub when the cannula is in the advanced position.

Embodiment 69 the access system of any one of embodiments 1-65, wherein the distal terminus of the second section of the cannula is within the reinforcement member when the cannula is in the advanced position.

Embodiment 70. The access system of any of embodiments 1-65, wherein the distal terminus of the second section of the cannula is within the reinforcement member throughout movement of the cannula from the retracted position to the advanced position.

Embodiment 71 the access system of any of embodiments 1-70, further comprising a sheath coupled to the connector, wherein the cannula extends through at least a portion of the sheath, the cannula being movable relative to the sheath from a retracted position to an advanced position.

Embodiment 72. The access system of embodiment 71, wherein at least a portion of the sheath and at least a portion of the connector are integrally formed from a unitary piece of material.

Embodiment 73 the access system of embodiment 71 or embodiment 72, wherein at least some portion of the cannula is positioned within the sheath when the cannula is in each of the retracted position and the advanced position.

Embodiment 74 the access system of any of embodiments 71-73, wherein at least some portion of the cannula is positioned within the sheath throughout movement of the cannula from the retracted position to the advanced position.

Embodiment 75 the access system of any of embodiments 71-74, wherein the sheath comprises a tube having a proximal end and a distal end, and wherein the cannula extends at least through the proximal end of the sheath when in the retracted position and at least through the distal end of the sheath when in the advanced position.

Embodiment 76 the access system of any of embodiments 71-75, further comprising a follower fixedly attached to the cannula and positioned within the sheath, wherein the follower moves in unison with the cannula as the cannula moves from the retracted position to the advanced position.

Embodiment 77 the access system of embodiment 76, wherein the follower cooperates with the sheath to define proximal movement of the cannula relative to the sheath.

Embodiment 78. The access system of embodiment 76 or embodiment 77, wherein the follower and the sheath comprise a rotational alignment mechanism by which the rotational orientation of the cannula relative to the sheath is maintained.

Embodiment 79. The pathway system of embodiment 78, wherein the rotational alignment mechanism comprises a protrusion positioned within a groove, wherein the sheath defines one of the protrusion and the groove, and the follower defines the other of the protrusion and the groove.

Embodiment 80. The pathway system of any one of embodiment 76 to embodiment 79, wherein:

the reinforcement member includes a reinforcement tube movable relative to the connector;

when the cannula is in the retracted position, the follower is coupled to the stiffening tube such that the follower and the stiffening tube move distally in concert with the cannula throughout movement of the cannula from the retracted position to an intermediate position proximal of the advanced position; and is also provided with

The follower is configured to decouple from the stiffening tube as the cannula moves distally through the intermediate position.

Embodiment 81 the access system of embodiment 80 wherein when the follower is uncoupled from the stiffening tube, the follower and sleeve are allowed to move distally relative to the stiffening tube while the stiffening tube remains fixed relative to the connector.

Embodiment 82 the access system of embodiment 80 or embodiment 81, further comprising a pawl fixedly attached to the stiffening tube, wherein the follower comprises a plurality of arms that grasp the pawl throughout movement of the cannula from the retracted position to the intermediate position and release the pawl as the cannula moves distally past the intermediate position.

Embodiment 83. The pathway system of embodiment 82, wherein:

the sheath includes a first chamber defining a first diameter and a second chamber positioned distal to the first chamber, the second chamber defining a second diameter that is greater than the first diameter;

the first chamber of the sheath is sized to at least inhibit outward deflection of the distal ends of the plurality of arms when positioned in the first chamber such that the arms engage the jaws when in the first chamber; and is also provided with

The second chamber of the sheath is sized to allow the distal ends of the plurality of arms to flex outwardly to disengage from the jaws and move distally past the jaws.

Embodiment 84 the access system of embodiment 83, wherein the proximal end of the second chamber is proximal of the intermediate position.

Embodiment 85 the pathway system of embodiment 83 or embodiment 84, wherein the plurality of arms are biased outwardly such that distal ends of the plurality of arms automatically flex outwardly and disengage from the jaws when advanced through the second lumen of the sheath.

Embodiment 86 the access system of embodiment 83 or embodiment 84, wherein the plurality of arms and the jaws include sloped interfaces that flex distal ends of the plurality of arms outward and disengage from the jaws as the cannula is advanced toward the advanced position when positioned in the second lumen of the sheath and when the stiffening tube encounters increased resistance to distal movement.

Embodiment 87 the access system of any of embodiments 71-86, further comprising an actuator attached to the cannula, wherein at least a portion of the actuator is accessible from outside the sheath to be manipulated to move the cannula between the advanced position and the retracted position.

Embodiment 88 the access system of embodiment 87, wherein the sheath comprises a longitudinally extending rail, and wherein a portion of the actuator extends through the rail.

Embodiment 89 the pathway system of any one of embodiments 71-88, wherein the cannula is moved from the retracted position to the advanced position by direct contact with the cannula.

Embodiment 90 the access system of any of embodiments 1-89, wherein the connector comprises a threaded region configured to mate with a complementary portion of the catheter assembly to securely couple the connector with the catheter assembly.

Embodiment 91 the pathway system of any one of embodiments 1-89, wherein the connector comprises at least two tabs configured to mate with a portion of the catheter assembly to securely snap the connector onto the catheter assembly.

Embodiment 92 the access system of any of embodiments 1-91, wherein the cannula comprises another connector at its proximal end for connecting the cannula with the fluid transfer device.

Embodiment 93 the access system of embodiment 92, wherein the fluid transfer device comprises a blood collection unit.

Embodiment 94 the access system of embodiment 92 or embodiment 93, wherein the other connector comprises a luer fitting.

Embodiment 95 the access system of any of embodiments 1-94, wherein the cannula is further movable from an advanced position to a retracted position.

Embodiment 96 the access system of any one of embodiments 1-95, wherein the length of the cannula extends through the reinforcing member when the cannula is in the advanced position.

Embodiment 97 the access system of embodiment 96, wherein the second section of the cannula defines at least a portion of a length of the cannula extending through the reinforcing member when the cannula is in the advanced position.

Embodiment 98. The pathway system of any one of embodiments 1-97, wherein:

The catheter assembly includes a septum; and is also provided with

The distal tip of the reinforcing member is configured to be positioned proximal to the septum when the connector is attached to the catheter assembly.

Embodiment 99. The pathway system of any one of embodiments 1-97, wherein:

the catheter assembly includes a septum;

the reinforcement member includes a protrusion extending distally from a surface of the connector; and is also provided with

At least a portion of the extension of the reinforcing member is configured to extend through the septum of the catheter assembly when the connector is attached to the catheter assembly.

Embodiment 100. The access system of embodiment 99, wherein the septum includes an opening, the opening being in an unsealed state prior to insertion of the projection of the reinforcing member through the septum.

Embodiment 101. The access system of embodiment 100, wherein the extension of the reinforcement member is configured to be inserted through the opening of the septum.

Embodiment 102 the access system of any one of embodiments 99-101, wherein the projection extends distally past the distal end of the connector.

Embodiment 103 the access system of any one of embodiments 99-101, wherein the protrusion is recessed proximally relative to the distal end of the connector.

Embodiment 104 the access system of any of embodiments 99-104, wherein the catheter assembly further comprises a valve flap positioned distal to the septum.

Embodiment 105. The pathway system of embodiment 104, wherein no portion of the reinforcement member extends through the valve flap when the connector is coupled with the catheter assembly.

Embodiment 106. The access system of embodiment 104 or embodiment 105, wherein the distal tip of the reinforcement member is at or proximally spaced from the proximal surface of the flap when the connector is coupled with the catheter assembly.

Embodiment 107 the pathway system of any one of embodiments 104-106, wherein a portion of the reinforcement member extends through the septum when the connector is coupled with the catheter assembly.

Embodiment 108 the access system of any of embodiments 104-107, wherein, when the connector is coupled with the catheter assembly, the reinforcement member aims the cannula at the sealable opening of the flap such that the distal tip of the cannula is advanced through the sealable opening of the flap as the cannula moves from the retracted position to the advanced position.

Embodiment 109. The access system of embodiment 108, wherein the sealable opening is substantially centered with respect to the valve flap, and wherein the reinforcement member is substantially centered to align with the sealable opening when the connector is coupled with the conduit assembly.

Embodiment 110. The pathway system of any of embodiments 104-109, wherein at least a portion of the second section of the cannula extends through the valve flap when the cannula is in the advanced position.

Embodiment 111 the access system of embodiment 110, wherein the distal terminus of the second segment of the cannula is distal to the valve flap when the cannula is in the advanced position.

Embodiment 112 the access system of any of embodiments 99-111, wherein the catheter assembly further comprises a removable piercing member extending through the septum and through the catheter tube to assist in positioning the catheter tube in the blood vessel of the patient, and wherein the piercing member is configured to be removed from the catheter assembly prior to coupling the connector of the access system with the catheter assembly.

Embodiment 113 the access system of embodiment 112, wherein the removable piercing member further extends through the valve flap when extending through the septum and through the catheter tube.

Embodiment 114. The access system of any of embodiments 1-97, wherein the catheter assembly is a closed intravenous catheter system.

Embodiment 115 the access system of embodiment 114, wherein the closed intravenous catheter system comprises an integral side port through which fluid may be transferred to or from the catheter tube.

Embodiment 116. The access system of any of embodiments 1-97, wherein the catheter assembly is an open intravenous catheter system.

Embodiment 117 the access system of any of embodiments 1-116, wherein the entire reinforcement member is external to the catheter tube when the connector is coupled to the catheter assembly.

Embodiment 118 the access system of embodiment 117, wherein the entire reinforcing member remains external to the catheter tube throughout movement of the cannula from the retracted position to the advanced position.

Embodiment 119 the access system of any one of embodiments 1-118, wherein the distal tip of the reinforcement member is proximal to the proximal tip of the catheter tube when the connector is coupled with the catheter assembly.

Embodiment 120 the access system of embodiment 119, wherein the distal tip of the stiffening member remains proximal to the proximal tip of the catheter tube throughout movement of the cannula from the retracted position to the advanced position.

Embodiment 121. The access system of embodiment 1, wherein the reinforcement member is fixed relative to the connector.

Embodiment 122 the pathway system of embodiment 1, wherein the reinforcement member comprises a first metallic hypotube, and wherein the second segment comprises a second metallic hypotube sized to translate within the first metallic hypotube.

Embodiment 123 the pathway system of embodiment 122, wherein each of the first segment and the second segment is at least partially defined by a unitary polymer tube, and wherein the second metallic hypotube surrounds a portion of the polymer tube.

Embodiment 124 the access system of embodiment 122 or embodiment 123, wherein the distal tip of the second metallic hypotube defines a distal terminus of the second segment.

Embodiment 125 the pathway system of any one of embodiments 1-124, further comprising a catheter assembly.

Embodiment 126. Kit comprising:

the pathway system of any one of embodiments 1-125; and

instructions for using the kit, the instructions comprising the following instructions:

coupling the connector to the catheter assembly when the catheter tube of the catheter assembly is positioned in the blood vessel of the patient; and advancing the cannula from the retracted position to the advanced position.

Example 127. The kit of example 126, wherein the instructions for using the kit further comprise the following instructions:

coupling a fluid transfer device to the cannula; and

blood is withdrawn from the vessel through the cannula and into the fluid transfer device.

Embodiment 128. The method of using the pathway system of any of embodiments 1-125, the method comprising:

coupling the connector to the catheter assembly when the catheter tube of the catheter assembly is positioned in the blood vessel of the patient; and

the cannula is advanced from the retracted position to the advanced position.

Embodiment 129. An access system comprising:

a reinforcing member coupled with the connector; and

a flexible tube and/or a polymeric tube defining a distal tip; and

a support tube that is stiffer than and surrounds a portion of the flexible tube and/or polymeric tube, the support tube defining a distal edge configured to be within the reinforcement member when the distal tip of the flexible tube and/or polymeric tube is first positioned distally and externally of the reinforcement member as the cannula transitions from the retracted position to the advanced position,

wherein when the connector and catheter assembly are in the coupled state, at least a portion of the flexible tube and/or the polymeric tube is configured to be advanced through at least a portion of the catheter tube as the cannula transitions from the retracted position to the advanced position. Flexible tubing and/or polymeric tubing means that in some embodiments, the cannula comprises flexible tubing (whether polymeric or not), while in other or further embodiments, the cannula comprises polymeric tubing that may have properties such as described in this disclosure.

Embodiment 130. An access system comprising:

a reinforcing member coupled with the connector; and

a flexible tube and/or a polymeric tube defining a distal tip; and

a support tube surrounding a portion of the flexible tube and/or polymer tube, the support tube being in a fixed relationship with the flexible tube and/or polymer tube to move in unison with the flexible tube and/or polymer tube as the sleeve transitions from the retracted position to the advanced position,

wherein when the connector and catheter assembly are in the coupled state, at least a portion of the flexible tube and/or the polymer tube is configured to be advanced through at least a portion of the catheter tube as the cannula transitions from the retracted position to the advanced position.

Embodiment 131. An access system comprising:

a reinforcing member coupled with the connector; and

a flexible tube and/or a polymeric tube defining a distal tip; and

a support tube surrounding a portion of the flexible tube and/or the polymeric tube, the support tube defining a distal edge proximally spaced from a distal tip of the flexible tube and/or the polymeric tube,

Embodiment 132 the access system of any one of embodiments 129-131, wherein at least some portion of the support tube is positioned within the reinforcement member at each stage of the overall movement of the sleeve from the retracted position to the advanced position.

Embodiment 133 the pathway system of any one of embodiments 129-132, wherein the flexible tube and/or the polymer tube comprises polyimide.

The access system of any of embodiments 134-129, wherein the distal edge of the support tube is configured to extend distally past the distal tip of the reinforcement member when the cannula is in the advanced position.

Embodiment 135 the access system of any of embodiments 129-134, wherein when the cannula is in the retracted position, the distal tip of the flexible tube and/or the polymer tube is positioned within the reinforcement member such that the distal tip of the flexible tube and/or the polymer tube is positioned distally and outside of the reinforcement member only first after the cannula has been moved from the retracted position.

Embodiment 136 the access system of any of embodiments 129-134, wherein the distal tip of the flexible tube and/or the polymer tube is positioned first distally and externally of the reinforcement member when the cannula is in the retracted position.

The access system of any of embodiments 137, 129-136, wherein the distal edge of the support tube is within the reinforcement member when the cannula is in the retracted position.

The access system of any of embodiments 138, 129-137, wherein the distal edge of the support tube is distal to the distal edge of the reinforcement member when the cannula is in the advanced position.

Embodiment 139 the access system of any of embodiments 129-138, wherein the catheter assembly comprises an expansion sleeve comprising a hub, wherein the distal edge of the support tube is positioned within the hub when the cannula is in the advanced position.

Embodiment 140 the access system of any of embodiments 129-138, wherein the catheter assembly comprises a catheter hub coupled to the catheter tube, wherein the distal edge of the support tube is positioned within the catheter hub when the cannula is in the advanced position.

Embodiment 141 the access system of any of embodiments 129-137, wherein the distal edge of the support tube is within the reinforcement member when the cannula is in the advanced position.

Embodiment 142 the access system of embodiment 129 or embodiment 141, wherein the distal edge of the support tube is within the reinforcement member throughout movement of the cannula from the retracted position to the advanced position.

Embodiment 143 the access system of any of embodiment 129-142, further comprising a sheath coupled to the connector, wherein the cannula extends through at least a portion of the sheath, the cannula being movable relative to the sheath from the retracted position to the advanced position.

Embodiment 144 the access system of embodiment 143, wherein at least a portion of the sheath and at least a portion of the connector are integrally formed from a unitary piece of material.

Embodiment 145 the access system of embodiment 143 or embodiment 144, wherein at least some portion of the cannula is positioned within the sheath when the cannula is in each of the retracted position and the advanced position.

Embodiment 146 the access system of any of embodiments 143-145, wherein at least some portion of the cannula is positioned within the sheath throughout movement of the cannula from the retracted position to the advanced position.

Embodiment 147, the access system of any of embodiments 143-146, wherein the sheath comprises a tube having a proximal end and a distal end, and wherein the cannula extends at least through the proximal end of the sheath when in the retracted position and at least through the distal end of the sheath when in the advanced position.

Embodiment 148 the access system of any of embodiments 143-147, further comprising a follower fixedly attached to the cannula and positioned within the sheath, wherein the follower moves in unison with the cannula as the cannula moves from the retracted position to the advanced position.

Embodiment 149. The access system of embodiment 148, wherein the follower cooperates with the sheath to define proximal movement of the cannula relative to the sheath.

Embodiment 150. The access system of embodiment 148 or embodiment 149, wherein the follower and the sheath comprise a rotational alignment mechanism by which the rotational orientation of the cannula relative to the sheath is maintained.

Embodiment 151. The pathway system of embodiment 150, wherein the rotational alignment mechanism comprises a protrusion positioned within a groove, wherein the sheath defines one of the protrusion and the groove, and the follower defines the other of the protrusion and the groove.

Embodiment 152 the pathway system of any one of embodiment 129-151, wherein:

the catheter assembly includes a septum; and is also provided with

Embodiment 153 the pathway system of any one of embodiment 129-151, wherein:

the catheter assembly includes a septum;

Embodiment 154 the access system of embodiment 153, wherein the septum includes a sealable area that provides a fluid-tight seal prior to insertion of the extension of the reinforcing member through the sealable area.

Embodiment 155 the access system of embodiment 153, wherein the septum includes an opening, the opening being in an unsealed state prior to insertion of the projection of the reinforcing member through the septum.

Embodiment 156 the access system of embodiment 155, wherein the extension of the reinforcement member is configured to be inserted through an opening of the septum.

Embodiment 157 the access system of any of embodiments 153-156, wherein the projection extends distally past the distal end of the connector.

Embodiment 158 the access system of any of embodiments 153-156, wherein the protrusion is recessed proximally relative to the distal end of the connector.

Embodiment 159 the access system of any one of embodiments 153-158, wherein the catheter assembly further comprises a flap positioned distal to the septum.

Embodiment 160. The pathway system of embodiment 159, wherein no portion of the reinforcement member extends through the valve flap when the connector is coupled with the catheter assembly.

Embodiment 161. The access system of embodiment 159 or embodiment 160, wherein the distal tip of the reinforcement member is at or proximally spaced from the proximal surface of the flap when the connector is coupled with the catheter assembly.

The access system of any of embodiments 162-159, wherein a portion of the reinforcing member extends through the septum when the connector is coupled with the catheter assembly.

The access system of any of embodiments 163-159, wherein, when the connector is coupled with the catheter assembly, the reinforcement member aims the cannula at the sealable opening of the flap such that the distal tip of the flexible tube and/or the polymer tube is advanced through the sealable opening of the flap as the cannula moves from the retracted position to the advanced position.

The access system of embodiment 164, wherein the sealable opening is substantially centered with respect to the valve flap, and wherein the reinforcement member is substantially centered to align with the sealable opening when the connector is coupled with the conduit assembly.

Embodiment 165, the access system of any of embodiments 153-164, wherein the catheter assembly further comprises a removable piercing member extending through the septum and through the catheter tube to assist in positioning the catheter tube in the blood vessel of the patient, and wherein the piercing member is configured to be removed from the catheter assembly prior to coupling the connector of the access system with the catheter assembly.

Embodiment 166 the access system of any of embodiments 159-165, wherein the removable piercing member further extends through the valve flap when extending through the septum and through the catheter tube.

Embodiment 167. The access system of any of embodiments 129-166, wherein the catheter assembly is a closed intravenous catheter system.

Embodiment 168 the access system of embodiment 167, wherein the closed intravenous catheter system comprises an integral side port through which fluid can be transferred to or from the catheter tube.

Embodiment 169 the access system of any of embodiments 129-166, wherein the catheter assembly is an open intravenous catheter system.

Embodiment 170 the access system of any one of embodiments 129-169, further comprising a sealing member coupled to each of the reinforcing member and the support tube to form a fluid-tight seal to prevent fluid from flowing into or out of a space between the reinforcing member and the support tube.

Embodiment 171 the access system of embodiment 170, wherein the sealing member is fixedly secured to the reinforcing member and the support tube is movable relative to the sealing member.

Embodiment 172 the access system of embodiment 170 or embodiment 171, wherein the sealing member is attached to the proximal end of the reinforcing member.

Embodiment 173 the access system of any of embodiments 170-172, wherein the sealing member surrounds a proximal tip of the reinforcement member.

Embodiment 174 the pathway system of any of embodiments 129-173, further comprising a catheter assembly.

Example 175. Kit, comprising:

the pathway system of any one of embodiments 129-174; and

Example 176. The kit of example 175, wherein the instructions for using the kit further comprise the following instructions:

coupling a fluid transfer device to the cannula; and

Embodiment 177. The method of using the pathway system of any one of embodiments 129-174, the method comprising:

the cannula is advanced from the retracted position to the advanced position.

Embodiment 178, an access system comprising:

a connector configured to couple with a closed intravenous catheter system comprising a valve flap and a catheter tube configured to be positioned in a blood vessel of a patient;

a reinforcing member coupled with the connector such that when the connector is coupled with the closed intravenous catheter system, a distal tip of the reinforcing member is at or proximally spaced from a proximal surface of the valve flap; and

a sleeve movable relative to the reinforcing member from a retracted position to an advanced position,

wherein, when the connector and the closed intravenous catheter system are in the coupled state, at least a portion of the cannula is configured to advance through the valve flap and through at least a portion of the catheter tube as the cannula transitions from the retracted position to the advanced position.

Embodiment 179. Pathway system comprising:

a reinforcing member coupled with the connector such that no portion of the reinforcing member is in contact with the valve flap when the connector is coupled with the closed intravenous catheter system; and

Embodiment 180. An access system comprising:

a reinforcing member coupled with the connector such that no portion of the reinforcing member extends through the valve flap when the connector is coupled with the closed intravenous catheter system; and

Embodiment 181 the access system of any of embodiments 178-180, wherein the closed intravenous catheter system is configured to be pre-set in a patient such that the catheter tube is positioned in a blood vessel of the patient prior to coupling the connector of the access system with the closed intravenous catheter system.

Embodiment 182 the access system of any of embodiments 178-181, wherein advancement of the cannula to the advanced position enables direct fluid communication between the cannula and the blood vessel when the catheter tube of the closed intravenous catheter system is positioned in the blood vessel of the patient and when the connector of the access system and the closed intravenous catheter system are in the coupled state.

The access system of any of embodiments 178-182, wherein the distal tip of the cannula extends distally past the distal tip of the catheter tube when the cannula is in the advanced position.

The access system of any of embodiments 178-182, wherein the distal tip of the cannula is positioned within the catheter tube at or near the distal tip of the catheter tube when the cannula is in the advanced position.

The access system of any of embodiments 178-184, wherein at least a portion of the cannula is positioned beyond and distal of the distal tip of the reinforcement member when the cannula is in the advanced position.

The access system of any of embodiments 186, 178-185, wherein the cannula includes a first segment at a distal end thereof and a second segment extending proximally from the first segment and being relatively stiffer than the first segment.

Embodiment 187 the access system of embodiment 186, wherein the second section of the sleeve comprises a flexible tube and/or a polymeric tube and a support member surrounding at least a portion of the flexible tube and/or polymeric tube.

Embodiment 188. The access system of embodiment 187, wherein the support member is in a fixed relationship relative to the flexible tube and/or the polymer tube so as to move in unison therewith.

Embodiment 189 the access system of embodiment 187 or embodiment 188, wherein at least the distal end of the support member is surrounded by the reinforcement member when the sleeve is in the retracted position.

Embodiment 190 the pathway system of any one of embodiments 187-189, wherein at least a middle portion of the flexible tube and/or the polymer tube extending continuously along at least a portion of each of the first and second segments is surrounded by one or more of the reinforcing member and the support member along the entire length of the middle portion.

Embodiment 191 the access system of any of embodiments 187-190, wherein the support member is advanced distally through the reinforcement member throughout movement of the cannula from the retracted position to the advanced position.

Embodiment 192 the access system of any one of embodiments 187-191, wherein the distal tip of the support member corresponds to a distal terminus of the second segment.

Embodiment 193 the access system of any of embodiments 187-192, wherein the flexible tube and/or the polymer tube fits tightly within the support member.

Embodiment 194 the pathway system of any of embodiments 187-193, wherein the support member is fixedly secured to the flexible tube and/or the polymer tube.

Embodiment 195. The access system of embodiment 194, wherein the support member is attached to the flexible tube and/or the polymer tube.

Embodiment 196 the pathway system of any one of embodiments 187-195, wherein the flexible tube and/or the polymer tube extends through the entire length of the support member.

The pathway system of any one of embodiments 197-196, wherein the support member extends along the entire length of the second segment.

Embodiment 198 the pathway system of any one of embodiment 187-197, wherein:

The cannula further includes a third section extending proximally from the second section;

the third section comprises a proximal tube having an outer diameter greater than the outer diameter of the flexible tube and/or the polymeric tube; and is also provided with

The flexible tube and/or the polymer tube is firmly fixed to the proximal tube.

Embodiment 199 the pathway system of any one of embodiments 187-198, wherein the first segment comprises a portion of a flexible tube and/or a polymer tube.

Embodiment 200 the access system of embodiment 199, wherein the first section is exclusively formed from flexible tubing and/or polymeric tubing.

Embodiment 201. The pathway system of embodiment 199, wherein the flexible tube and/or the polymer tube is formed from a unitary piece of material that extends continuously from the first segment to the second segment.

Embodiment 202. The pathway system of any one of embodiments 187-201, wherein the flexible tube and/or the polymer tube is formed of polyimide.

Embodiment 203 the pathway system of any one of embodiments 187-202, wherein the support member comprises a support tube surrounding an outer surface of the flexible tube and/or the polymer tube.

Embodiment 204. The pathway system of embodiment 203, wherein the support tube is formed of stainless steel.

Embodiment 205 the access system of any of embodiments 187-204, wherein the support member is sized to slide through at least a portion of the reinforcement member as the sleeve transitions from the retracted position to the advanced position.

Embodiment 206 the pathway system of any one of embodiments 187-205, wherein the reinforcement member defines a cavity that defines an inner diameter that is no more than 20% greater than an outer diameter of the support member.

Embodiment 207 the access system of any one of embodiments 187-206, wherein the support member prevents kinking of the flexible tube and/or the polymeric tube by preventing lateral movement of the flexible tube and/or the polymeric tube within the support member when the first segment encounters a force that urges the distal tip of the impedance sleeve distally.

Embodiment 208 the pathway system of embodiment 186, wherein the first segment comprises a first tube comprising a first end face, the second segment comprises a second tube comprising a second end face, and the first end face and the second end face abut one another at an interface located at a distal terminal end of the second segment.

Embodiment 209 the pathway system of embodiment 208, wherein each of the first end face and the second end face is oriented transverse to the longitudinal axis of the sleeve.

Embodiment 210 the pathway system of embodiment 208 or embodiment 209, wherein the second tube is formed of stainless steel.

Embodiment 211 the pathway system of any one of embodiments 208-210, wherein the first tube is formed from a polymeric material.

Embodiment 212 the pathway system of any one of embodiments 208-211, further comprising a connection layer extending over at least a portion of the interface and each of the first and second tubes of the first and second segments, respectively, to attach the first and second tubes together or to enhance attachment between the first and second tubes.

Embodiment 213 the pathway system of embodiment 212, wherein the outer diameter of the first tube and the outer diameter of the second tube are substantially the same at least in the region of the sleeve comprising the interface.

Embodiment 214. The access system of embodiment 212 or embodiment 213, wherein an outer diameter of the connection layer is substantially constant along a transition region comprising a proximal end of the first segment, the interface, and a distal end of the second segment.

Embodiment 215 the pathway system of any one of embodiments 212-214, wherein the connection layer comprises a tubular member defining a thickness that is not less than 1/20 of a thickness of the first tube.

Embodiment 216 the pathway system of any one of embodiments 212-215, wherein the connection layer comprises a tube formed from a heat-shrinkable material.

Embodiment 217. The pathway system of any of embodiments 212-216, wherein the hardness of the connection layer is less than the hardness of the first segment.

Embodiment 218 the access system of any one of embodiments 212-217, wherein the distal tip of the connection layer is proximally spaced from the distal tip of the cannula, and wherein the distal tip of the connection layer is configured to contact an inner surface of the catheter tube to define proximal movement of the cannula relative to the catheter tube.

The access system of any of embodiments 219, 212-218, wherein the distal tip of the connection layer is proximally spaced from the distal tip of the cannula, and wherein the distal tip of the connection layer is configured to contact an inner surface of the catheter tube to provide tactile feedback to a user regarding the position of the cannula relative to the catheter tube.

The access system of any of embodiments 178-219, wherein the reinforcement member prevents kinking of the cannula by preventing lateral movement of the cannula within the reinforcement member when the cannula encounters a force resisting distal advancement of the distal tip of the cannula by an amount that would otherwise be sufficient to kink the cannula.

Embodiment 221 the access system of any of embodiments 178-220, wherein the reinforcement member defines a lumen that defines an inner diameter that is no more than 20% greater than an outer diameter of the distal portion of the cannula.

Embodiment 222. The access system of embodiment 221, wherein the inner diameter of the lumen is constant along a tubular region extending along at least a majority of the entire length of the reinforcement member.

Embodiment 223 the access system of any of embodiments 178-222, wherein the distal tip of the cannula is positioned within the reinforcement member when the cannula is in the retracted position such that the distal tip of the cannula is positioned distally and outward of the reinforcement member only after the cannula has been moved from the retracted position.

The access system of any of embodiments 178-222, wherein the distal tip of the cannula is initially positioned distally and externally of the reinforcing member when the cannula is in the retracted position.

Embodiment 225 the access system of any one of embodiments 178-224, wherein the cannula includes a first distal segment that is relatively softer than a second segment proximally adjacent the first segment, and wherein the second segment includes a distal terminal end that is within the reinforcing member when the cannula is in the retracted position.

The access system of any of embodiments 178-225, wherein the distal terminus of the second section of the cannula is within the reinforcing member when the cannula is in the advanced position.

Embodiment 227 the access system of embodiment 225 or embodiment 226, wherein the distal terminus of the second section of the cannula is within the reinforcing member throughout movement of the cannula from the retracted position to the advanced position.

The access system of any of embodiments 228-178, wherein the distal terminus of the second section of the cannula is distal to the distal tip of the reinforcing member when the cannula is in the advanced position.

The access system of any of embodiments 229, 178-227, further comprising a sheath coupled to the connector, wherein the cannula extends through at least a portion of the sheath, the cannula being movable relative to the sheath from a retracted position to an advanced position.

Embodiment 230 the access system of embodiment 229, wherein at least a portion of the sheath and at least a portion of the connector are integrally formed from a unitary piece of material.

Embodiment 231 the access system of embodiment 229 or embodiment 230, wherein at least some portion of the cannula is positioned within the sheath when the cannula is in each of the retracted position and the advanced position.

Embodiment 232 the access system of any of embodiments 229-231, wherein at least some portion of the cannula is positioned within the sheath throughout movement of the cannula from the retracted position to the advanced position.

Embodiment 233 the access system of any of embodiments 229-232, wherein the sheath comprises a tube having a proximal end and a distal end, and wherein the cannula extends at least through the proximal end of the sheath when in the retracted position and at least through the distal end of the sheath when in the advanced position.

The access system of any of embodiments 234, 229-233, further comprising a follower fixedly attached to the cannula and positioned within the sheath, wherein the follower moves in unison with the cannula as the cannula moves from the retracted position to the advanced position.

Embodiment 235 the access system of embodiment 234, wherein the follower cooperates with the sheath to define proximal movement of the cannula relative to the sheath.

Embodiment 236 the access system of embodiment 234 or embodiment 235, wherein the follower and sheath comprise a rotational alignment mechanism by which the rotational orientation of the cannula relative to the sheath is maintained.

The pathway system of embodiment 237, wherein the rotational alignment mechanism comprises a protrusion positioned within a groove, wherein the sheath defines one of the protrusion and the groove and the follower defines the other of the protrusion and the groove.

The access system of any of embodiments 238, 229-237, further comprising an actuator attached to the cannula, wherein at least a portion of the actuator is accessible from outside the sheath to be manipulated to move the cannula between the advanced and retracted positions.

Embodiment 239 the access system of embodiment 238, wherein the sheath comprises a longitudinally extending rail, and wherein a portion of the actuator extends through the rail.

Embodiment 240 the pathway system of any one of embodiments 229-239, wherein the cannula lacks an actuator.

Embodiment 241 the pathway system of any one of embodiments 229-240, wherein the cannula is moved from the retracted position to the advanced position by direct contact with the cannula.

Embodiment 242 the access system of any of embodiments 178-241, wherein the connector comprises a snap-fit arrangement configured to snap over a hub of the closed intravenous catheter system to securely couple the connector to the closed intravenous catheter system.

Embodiment 243 the access system of embodiment 242, wherein the snap-fit arrangement comprises two or more flexible tabs configured to selectively attach to a hub of the closed intravenous catheter system.

Embodiment 244 the pathway system of any one of embodiments 178-243, wherein:

the closed intravenous catheter system further comprises a septum spaced from the valve flap; and is also provided with

The distal tip of the reinforcing member is configured to be positioned proximal to the septum when the connector is attached to the closed intravenous catheter system.

Embodiment 245 the pathway system of any one of embodiments 178-243, wherein:

The closed intravenous catheter system includes a septum spaced from the valve flap;

At least a portion of the extension of the reinforcing member is configured to extend through the septum of the closed intravenous catheter system when the connector is attached to the closed intravenous catheter system.

Embodiment 246 the access system of embodiment 245, wherein the septum includes an opening, the opening being in an unsealed state prior to insertion of the projection of the reinforcing member through the septum.

Embodiment 247 the access system of embodiment 246, wherein the projection of the reinforcing member is configured to be inserted through an opening of the septum.

Embodiment 248 the access system of any of embodiments 245 to 247, wherein the projection extends distally past the distal end of the connector.

The access system of any of embodiments 249, 245-247, wherein the projection is recessed proximally relative to the distal end of the connector.

Embodiment 250 the access system of any of embodiments 178-249, wherein, when the connector is coupled with the closed intravenous catheter system, the reinforcement member aims the cannula at the sealable opening of the valve flap such that the distal tip of the cannula is advanced through the sealable opening of the valve flap as the cannula moves from the retracted position to the advanced position.

Embodiment 251. The access system of embodiment 250, wherein the sealable opening is substantially centered with respect to the valve flap, and wherein the reinforcement member is substantially centered to align with the sealable opening when the connector is coupled with the closed intravenous catheter system.

Embodiment 252 the access system of any of embodiments 178-251, wherein the closed intravenous catheter system further comprises a removable piercing member extending through the valve flap and through the catheter tube to assist in positioning the catheter tube in the blood vessel of the patient, and wherein the piercing member is configured to be removed from the closed intravenous catheter system prior to coupling the connector of the access system with the closed intravenous catheter system.

The access system of any of embodiments 253, 178-252, wherein the closed intravenous catheter system comprises an integral side port through which fluid can be transferred to or from the catheter tube.

Embodiment 254 the access system of embodiment 253, wherein the side port includes an extension tube and another connector coupled to a proximal end of the extension tube.

Embodiment 255 the access system of embodiment 254, wherein no portion of the cannula passes through the extension cannula as the cannula moves between the retracted position and the advanced position.

Embodiment 256, the access system of any of embodiments 178-255, wherein the closed intravenous catheter system comprises a hub defining a cavity, and wherein the valve flap is positioned within the cavity.

Example 257 the access system of example 256, further comprising a septum positioned at the proximal end of the cavity and spaced from the valve flap.

Embodiment 258 the access system of embodiment 257, wherein the septum defines a permanent opening and the valve flap defines a sealable opening aligned with a longitudinal axis extending through the catheter tube.

Embodiment 259 the access system of embodiment 258, wherein the closed intravenous catheter system further comprises a piercing member extending through the opening of the septum and the valve flap and further extending through the catheter tube, and wherein the piercing member is configured to be removed from the catheter tube, the valve flap, and the septum prior to coupling the connector with the closed intravenous line.

Embodiment 260. The access system of embodiment 258 or embodiment 259, wherein the distal tip of the cannula is advanced substantially straight through the septum, the valve flap, and into the catheter tube as the cannula moves from the retracted position to the advanced position.

Embodiment 261 the access system of any one of embodiments 257-260, wherein the reinforcement member extends through the septum when the connector is coupled with the closed intravenous catheter system.

Embodiment 262 the access system of any of embodiments 178-261, wherein the cannula includes a first segment at a distal end thereof and a second segment extending proximally from the first segment, wherein the second segment is stiffer than the first segment.

Embodiment 263 the pathway system of embodiment 262, wherein at least a portion of the second segment extends through the valve flap when the cannula is in the advanced position.

Embodiment 264. The access system of embodiment 262 or embodiment 263, wherein the second section comprises a rigid tube surrounding a flexible tube.

Embodiment 265. The access system of embodiment 264, wherein the rigid tube is formed from a metallic material, and wherein the flexible tube is formed from a polymeric material.

Embodiment 266 the access system of any of embodiments 178-265 further comprising a closed intravenous catheter system.

Example 267. Kit, comprising:

the pathway system of any one of embodiments 178-266; and

coupling the connector to the closed intravenous catheter system when the catheter tube of the closed intravenous catheter system is positioned in a blood vessel of the patient; and

the cannula is advanced from the retracted position to the advanced position.

Example 268. The kit of example 267, wherein the instructions for using the kit further comprise the following instructions:

coupling a fluid transfer device to the cannula; and

Embodiment 269. The method of using the pathway system of any of embodiments 178-266, the method comprising:

the cannula is advanced from the retracted position to the advanced position.

Embodiment 270. An access system comprising:

a connector configured to couple with an instrument port of a catheter assembly configured to transition from an insertion configuration to a pathway configuration, the catheter assembly comprising:

a hub comprising an instrument port, an access port, and a lumen, the instrument port configured to allow a penetrating instrument to extend therethrough when the catheter assembly is in the inserted configuration;

a catheter tube coupled to the hub, the catheter tube defining a first lumen in fluid communication with the lumen, the first lumen configured to receive at least a portion of a piercing instrument therein when the catheter assembly is in an insertion configuration, the catheter tube configured for insertion into a blood vessel of a patient;

An extension tube coupled to the access port of the hub, the extension tube defining a second lumen in fluid communication with the lumen; and

a valve flap coupled to the hub, the valve flap configured to be in an open state when the penetrating instrument extends therethrough when the catheter assembly is in the inserted configuration, the valve flap further configured to transition to a closed state when the penetrating instrument is removed from the sealing member to prevent fluid communication between the cavity and the instrument port;

a cannula coupled to the connector and configured to move relative to the connector from a retracted position to an advanced position, the cannula being sized to extend through at least a portion of the catheter tube when in the advanced position to provide a blood passageway within the blood vessel when the catheter tube is within the blood vessel; and

a reinforcing member sized to allow a portion of the cannula to be advanced therethrough as the cannula is advanced from the retracted position to the advanced position, wherein the reinforcing member satisfies one or more of the following conditions when the connector is coupled with the instrument port of the catheter assembly:

the distal tip of the reinforcement member is positioned proximal of the valve flap and not embedded in the valve flap;

the distal tip of the reinforcement member is proximally spaced from the proximal face of the valve flap;

No part of the reinforcing member is in contact with the valve flap; or (b)

No part of the reinforcement member extends through the valve flap.

Embodiment 271. The access system of embodiment 270, wherein the cannula comprises a polymer tube and a rigid support member surrounding a portion of the polymer tube, and wherein the support member is sized such that at least a portion of the support member passes through the reinforcement member as the cannula is moved to the advanced position.

Embodiment 272 the access system of embodiment 270 or embodiment 271, further comprising a catheter assembly.

Embodiment 273 the access system of any of embodiments 270 to 272, wherein the catheter assembly further comprises a piercing instrument.

Embodiment 274. The access system of any of embodiments 270-273, wherein the penetrating instrument comprises a needle.

Embodiment 275. An access system comprising:

a cannula movable relative to the connector from a retracted position to an intermediate position and from the intermediate position to an advanced position, the cannula including a distal tip; and

a stiffening tube surrounding at least the distal tip of the cannula and releasably connected with the cannula for movement in tandem with the cannula throughout movement of the cannula from the retracted position to the intermediate position, the stiffening tube and cannula being configured to be separated from one another at the intermediate position to permit distal advancement of the cannula through the stiffening tube as the cannula transitions from the intermediate position to the advanced position.

Embodiment 276 the access system of embodiment 275, wherein when the connector and catheter assembly are in the coupled state, at least the distal tip of the cannula is configured to be advanced through at least a portion of the catheter tube as the cannula is moved to the advanced position.

Embodiment 277 the pathway system of embodiment 275 or embodiment 276, wherein the stiffening tube becomes substantially stationary relative to the connector as the sleeve passes through the intermediate position.

Embodiment 278. The access system of embodiment 277, wherein the stiffening tube remains substantially stationary relative to the connector as the cannula transitions from the intermediate position to the advanced position.

Embodiment 279 the access system of any one of embodiments 275-278, further comprising an arm attached to the cannula and a pawl attached to the stiffening tube, wherein the arm engages the pawl throughout movement of the cannula from the retracted position to the intermediate position and the arm disengages the pawl as the cannula moves distally past the intermediate position.

Embodiment 280 the access system of embodiment 279, further comprising a sheath comprising a first chamber and a second chamber, the first chamber defining a first diameter, the second chamber being positioned distally of the first chamber and defining a second diameter that is greater than the first diameter,

Wherein the first chamber of the sheath is sized to at least inhibit the distal end of the arm from flexing outwardly when positioned in the first chamber such that the arm engages the pawl when positioned in the first chamber, and

wherein the second chamber of the sheath is sized to allow the distal ends of the arms to flex outwardly to disengage the jaws and move distally past the jaws.

Embodiment 281 the access system of embodiment 280, wherein the proximal end of the second chamber is proximal of the intermediate position.

Embodiment 282. The pathway system of embodiment 280 or embodiment 281, wherein the arms are biased outwardly such that the distal ends of the arms automatically flex outwardly and disengage the jaws when advanced through the second lumen of the sheath.

Embodiment 283 the pathway system of embodiment 280 or embodiment 281, wherein the arms and jaws comprise sloped interfaces that flex the distal ends of the arms outward and away from the jaws as the cannula is advanced toward the advanced position when positioned in the second lumen of the sheath and when the stiffening tube encounters increased resistance to distal movement.

Embodiment 284. An access system comprising:

a connector configured to couple with a catheter assembly including a catheter tube predisposed into a blood vessel of a patient; and

A cannula movable relative to the connector from a retracted state to a deployed state, the cannula including at least a distal portion configured to be advanced through at least a portion of the catheter tube as the cannula transitions from the retracted state to the advanced state, the cannula comprising:

a first section at the distal end of the cannula;

a second section attached to the first section at an interface, the first section being relatively softer than the second section; and

a connection layer extends over the interface and at least a portion of each of the first and second segments to attach the first and second segments together or to enhance attachment between the first and second segments.

Embodiment 285. The pathway system of embodiment 284, wherein the second segment comprises a metal tube.

Embodiment 286 the access system of embodiment 284 or embodiment 285, wherein the distal tip of the connection layer is proximally spaced from the distal tip of the cannula, and wherein the distal tip of the connection layer is configured to contact an inner surface of the catheter tube to define proximal movement of the cannula relative to the catheter tube.

Embodiment 287, the access system of embodiment 284 or embodiment 286, wherein the distal tip of the connection layer is proximally spaced from the distal tip of the cannula, and wherein the distal tip of the connection layer is configured to contact an inner surface of the catheter tube to provide tactile feedback to a user regarding the position of the cannula relative to the catheter tube.

Embodiment 288 the access system of embodiment 284 or embodiment 288, further comprising a catheter assembly.

Embodiment 289. Method, comprising:

coupling an access system including a reinforcing member and a movable sleeve with a pre-set closed catheter system including a valve flap and a catheter tube positioned within a vessel of a patient, the coupling including securing the access system to the pre-set closed catheter system such that at least one of the following conditions is met:

the distal tip of the reinforcement member is fixed in a position at the proximal end of the valve flap;

the distal tip of the reinforcement member is secured in a proximally recessed position from the proximal end of the valve flap;

no part of the reinforcing member is in contact with the valve flap; or (b)

No part of the reinforcing member extends through the valve flap; and

the cannula of the access system is advanced from a position within the reinforcement member through the valve flap of the closed conduit system and through at least a portion of the conduit tube body.

Embodiment 290 the method of embodiment 289, wherein the closed conduit system comprises a valve flap assembly comprising a valve flap and further comprising a diaphragm positioned proximal to the valve flap.

Embodiment 291 the method of embodiment 290, wherein the coupling comprises advancing the distal tip through the septum before the distal tip of the reinforcement member of the access system is secured in a position at or recessed proximally from the proximal end of the valve flap.

The method of any of embodiment 292, embodiment 289 to embodiment 291, wherein the reinforcing member comprises a tube.

Embodiment 293 the method of any of embodiments 289-292, wherein the coupling is achieved without any contact between the reinforcing member and the valve flap.

The method of any of embodiments 294, 289-293, wherein the coupling is achieved without passing any portion of the reinforcing member into or through the valve flap.

The method of any of embodiments 295, 289-294, wherein the valve flap of the closed catheter system comprises a closable opening configured to allow the puncture element to extend therethrough during insertion of the catheter tube into the blood vessel of the patient, wherein the sealable region is in a self-sealing state and the puncture element has been removed therefrom during the coupling, and wherein the advancing the cannula comprises advancing the cannula through the closable opening of the valve flap.

The method of any of embodiments 296, 289-295, wherein the advancing sleeve is achieved without distally advancing a distal tip of the reinforcing member past a proximal end of the valve flap.

Embodiment 297 the method of any one of embodiments 289-296, wherein the advancing sleeve is achieved without the reinforcing member contacting the valve flap.

The method of any of embodiments 298, 289-297, wherein the advancing sleeve is achieved without extending a reinforcing member through any portion of the valve flap.

Embodiment 299 the method of any of embodiments 289-298, wherein the closed conduit system further comprises a hub coupled with the conduit body at a first port of the hub, wherein the extension tube is coupled with a second port of the hub, and wherein a third port of the hub comprises a valve flap.

Embodiment 300 the method of embodiment 299, wherein coupling the access system with the pre-set closed conduit system comprises coupling a connector of the access system with a third port of the hub.

Embodiment 301 the method of embodiment 299 or embodiment 300, wherein advancing the distal portion of the cannula comprises advancing the distal portion of the cannula through the third port of the hub, then through the first port of the hub and into the catheter tube.

Embodiment 302 the method of any one of embodiments 299 to 301, wherein the hub of the pre-set closed catheter system is secured directly to the skin of the patient.

Embodiment 303 the method of embodiment 302, wherein said coupling and said advancing are accomplished without moving the hub of the pre-catheter system relative to the skin of the patient.

Embodiment 304. The method of embodiment 302 or embodiment 303, wherein the hub of the pre-set closed catheter system is positioned flat against the patient's skin without any other elements (e.g., wedges or other shapes) between the hub and the patient's skin.

The method of any one of embodiments 305, 302-304, wherein a portion of the catheter tube is positioned within an insertion site extending through the skin of the patient, and wherein the coupling and the advancing are accomplished without contacting an outer surface of one or more of the hub or the catheter tube to adjust a position of the portion of the catheter tube extending through the insertion site.

Embodiment 306 the method of any of embodiments 289-305, wherein the access system further comprises an additional connector at the proximal end of the cannula, and wherein the method further comprises:

coupling a fluid collection device to the further connector; and

after the cannula of the propulsion pathway system, blood is drawn through the cannula into the fluid collection device.

Embodiment 307 the method of embodiment 306 further comprising, after said drawing blood, retracting the cannula of the access system from the catheter tube.

Embodiment 308 the method of embodiment 307 further comprising, after said retracting the cannula, decoupling the access system from the pre-set closed catheter system.

Embodiment 309 the method of embodiment 307 or embodiment 308 further comprising, after said retracting the cannula, dynamically injecting fluid into the patient via a pre-set closed catheter system.

Embodiment 310 the method of any one of embodiments 289-309, wherein the catheter tube of the pre-set closed catheter system is inserted into a vein of the patient at any one of a dorsal arch, forearm, or antecubital fossa position of the hand.

Embodiment 311. An access system comprising:

a connector configured to couple with a catheter assembly including a catheter tube predisposed into a blood vessel of a patient;

a reinforcing tube fixedly secured to the connector; and

a cannula movable relative to the connector from a retracted state to a deployed state, the cannula comprising:

a distal section comprising at least a portion of a flexible tube and/or a polymeric tube; and

an inner section extending proximally from the distal section, the inner section comprising a metal tube sized to pass through the reinforcement tube,

wherein the distal tip of the inner section is positioned within the stiffening tube when the cannula is in the retracted state.

Embodiment 312. The pathway system of embodiment 311, wherein the reinforcement tube is metallic.

Embodiment 313 the access system of embodiment 312, wherein the reinforcement tube comprises stainless steel.

Embodiment 314 the access system of any of embodiments 311-313, wherein at least a portion of the metal tube of the inner section is positioned within the reinforcement tube throughout movement of the cannula from the retracted state to the deployed state.

Embodiment 315 the access system of any of embodiments 311 to 314, wherein a portion of the metal tube of the inner section extends distally beyond the distal tip of the reinforcement tube when the cannula is in the deployed state.

Embodiment 316 the access system of any of embodiments 311-315, wherein the flexible tube and/or the polymer tube of the distal section comprises at least one of polyimide, polyamide, PEEK, and polyurethane.

Embodiment 317 the access system of any of embodiments 311 to 316, wherein the distal section is configured to extend through the catheter tube such that when the cannula is in the deployed state, at least a distal end of the distal section extends distally beyond a distal tip of the catheter tube.

Embodiment 318 the access system of any of embodiments 311 to 317, wherein the metal tubing of the inner section and the flexible tubing and/or polymer tubing of the distal section are joined together via a heat-shrinkable tubing.

Embodiment 319 the pathway system of any one of embodiments 311-317, wherein the flexible tube and/or the polymeric tube is longer than the first section of the cannula, wherein the distal section comprises a first portion of the flexible tube and/or the polymeric tube, and wherein the inner section comprises a second portion of the flexible tube and/or the polymeric tube, the second portion extending proximally continuously from the first portion of the flexible tube and/or the polymeric tube.

Embodiment 320 the access system of embodiment 319, wherein the metal tube of the inner section surrounds the second portion of the flexible tube and/or the polymer tube.

Embodiment 321. The pathway system of embodiment 320, wherein the metal tube of the inner section comprises an inner tubular surface that approximates an outer tubular surface of the second portion of the flexible tube and/or the polymer tube, thereby supporting the second portion of the flexible tube and/or the polymer tube.

Embodiment 322 the access system of embodiment 320 or embodiment 321, wherein the metal tube of the inner section prevents one or more of bending, buckling, or kinking of the flexible tube and/or the second portion of the polymer tube as the cannula is advanced from the retracted state to the deployed state when the flexible tube and/or the polymer tube encounters proximally oriented resistance.

Any suitable combination of the various features of the various embodiments and examples disclosed herein is contemplated. The term "coupled to" may mean connected in any suitable manner, whether directly or indirectly. The separate components may be coupled to each other. Furthermore, in some cases, when separately identified components are integrally formed from a unitary piece of material or, in other words, are included together in a single element, the elements may also be referred to as being coupled to one another.

Although the foregoing detailed description contains many specifics for the purpose of illustration, those skilled in the art will appreciate that various modifications and adaptations to the following details can be made and are intended to be included herein. Accordingly, the foregoing embodiments are set forth without any loss of generality to, and without imposing limitations upon, any claims set forth. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

The claims following this written disclosure are hereby expressly incorporated into this written disclosure, with each claim standing on its own as a separate embodiment. The present disclosure includes all permutations of the independent claims and their dependent claims. Furthermore, other embodiments that can be derived from the appended independent and dependent claims are also expressly incorporated into this written description. These other embodiments are determined by substituting the phrase "claim x" to any one of the immediately preceding claims "for the dependencies of a given dependent claim, wherein the term" x "in parentheses is substituted with the number of the newly recited independent claim. For example, for a first set of claims starting with independent claim 1, claim 3 may be dependent on either of claims 1 and 2, these independent dependencies yielding two different embodiments; claim 4 may be dependent on any of claims 1, 2 or 3, these independent dependencies yielding three different embodiments; claim 5 may be dependent on any of claims 1, 2, 3 or 4, these independent dependencies yielding four different embodiments; and so on.

Recitation of the term "first" in a claim with respect to a feature or element does not necessarily mean that there is a second or additional such feature or element. The embodiments of the invention requiring exclusivity or privileges are defined as follows.

Claims

1. Pathway system, including:

A connector configured to engage with a catheter assembly, the catheter assembly including a catheter body configured to be positioned in a patient's blood vessel;

A reinforcing member, which is securely fixed to the connector; and

A sleeve, movable relative to the reinforcing member from a retracted position to an advanced position within the reinforcing member at least a portion of the sleeve, the sleeve comprising:

The polymer tube defining the distal tip; and

A support tube, rigider than the polymer tube, surrounds a portion of the polymer tube. The support tube defines an inner diameter slightly larger than the outer diameter of the polymer tube to prevent kinking. The support tube is fixed to the polymer tube for synchronized movement. The support tube defines a distal edge that, as the sleeve transitions from the retracted position to the advanced position, is positioned proximally and externally to the reinforcing member when the distal tip of the polymer tube is first positioned distally and externally. This distal edge is spaced from the distal tip of the polymer tube proximally and configured to be within the reinforcing member.

When the connector and the catheter assembly are in the connected state, as the cannula changes from the retracted position to the advanced position, at least a portion of the polymer tube extending distally beyond the distal edge of the support tube is configured to advance through at least a portion of the catheter body.

2. The passage system according to claim 1, wherein the inner diameter of the support tube is no more than 30% larger than the outer diameter of the polymer tube.

3. The access system according to claim 1 or claim 2, wherein at each stage of the entire movement of the sleeve from the retracted position to the advanced position, at least a portion of the support tube is positioned within the reinforcing member.

4. The access system according to claim 1 or claim 2, wherein, when the sleeve is in the advance position, the distal edge of the support tube is configured to extend distally past the distal tip of the reinforcing member.

5. The access system according to claim 1 or claim 2, wherein when the sleeve is in the retracted position, the distal edge of the support tube is within the reinforcing member.

6. The access system according to claim 1 or claim 2, wherein when the sleeve is in the advance position, the distal edge of the support tube is distal to the distal tip of the reinforcing member.

7. The access system of claim 1 or claim 2, further comprising a sheath coupled to the connector, wherein the sleeve extends through at least a portion of the sheath, the sleeve being movable relative to the sheath from the retracted position to the advanced position.

8. The access system according to claim 1 or claim 2, wherein the catheter assembly includes a valve.

9. The access system of claim 8, wherein when the connector is coupled to the conduit assembly, no portion of the reinforcing member extends through the valve disc.

10. The access system of claim 8, wherein, when the connector is coupled to the catheter assembly, the distal tip of the reinforcing member is located at or spaced proximally from the proximal surface of the valve disc.

11. The access system of claim 8, wherein, when the connector is coupled to the catheter assembly, as the sleeve moves from the retracted position to the advanced position, the reinforcing member causes the sleeve to be aligned with the sealable opening of the valve disc such that the distal tip of the polymer tube is advanced through the sealable opening of the valve disc.

12. The access system of claim 11, wherein the sealable opening is substantially centered relative to the valve disc, and wherein, when the connector is coupled to the conduit assembly, the reinforcing member is substantially centered to align with the sealable opening.

13. The access system of claim 1 or claim 2, wherein the catheter assembly further comprises a removable puncture member extending through the valve and through the catheter body to assist in positioning the catheter body in the patient's blood vessel, and wherein the puncture member is configured to be removed from the catheter assembly prior to coupling the connector of the access system to the catheter assembly.

14. The access system according to claim 1 or claim 2, wherein the catheter assembly is one of a closed intravenous catheter system and an open intravenous catheter system.

15. The passage system of claim 1 or claim 2 further includes a sealing member coupled to each of the reinforcing member and the support tube to form a fluid-impermeable seal, thereby preventing fluid from flowing out of the space between the support tube and the reinforcing member.

16. The passage system according to claim 1 or claim 2, wherein the sealing member is securely fixed to the reinforcing member, and the support tube is movable relative to the sealing member.

17. The access system according to any one of the preceding claims, further comprising the catheter assembly.

18. Set, including:

The pathway system according to any one of the preceding claims; and

The instruction manual for using the kit includes the following guidance:

When the catheter body of the catheter assembly is positioned in the patient's blood vessel, the connector is coupled to the catheter assembly; and

The sleeve is advanced from the retracted position to the advanced position.

19. The kit of claim 18, wherein the instruction manual for using the kit further includes the following guidance:

Connect the fluid transfer device to the sleeve; and

Blood is drawn from the blood vessel through the cannula and enters the fluid transfer device.

20. A method using the pathway system of any one of claims 1 to 17, the method comprising:

The sleeve is advanced from the retracted position to the advanced position.

21. Pathway system, including:

A connector configured to engage with a closed intravenous catheter system, the closed intravenous catheter system including a valve and a catheter body configured to be positioned in a patient's blood vessel;

A reinforcing member, which is securely fixed to the connector and stationary relative to it, and is oriented such that, when the connector is coupled to the closed intravenous catheter system, the distal tip of the reinforcing member is located at or spaced proximally from the proximal surface of the valve valve; and

A sleeve, which is movable relative to the reinforcing member from a retracted position to an advanced position.

When the connector and the closed intravenous catheter system are in the connected state, as the cannula changes from the retracted position to the advanced position, at least a portion of the cannula is configured to be advanced distally through the reinforcing member, then through the valve, and subsequently into the catheter body.

22. The access system of claim 21, wherein the cannula comprises a first segment at its distal end and a second segment extending proximally from the first segment and being relatively stiffer than the first segment.

23. The access system of claim 22, wherein the second segment of the sleeve comprises a polymer tube and a support member surrounding at least a portion of the polymer tube.

24. The passage system of claim 23, wherein the support member is fixed relative to the polymer tube so as to move in unison with it.

25. The access system of claim 23 or claim 24, wherein when the sleeve is in the retracted position, at least the distal end of the support member is surrounded by the reinforcing member.

26. The passage system of claim 23 or claim 24, wherein when the sleeve is in the retracted position, at least a middle portion of the polymer tube, extending continuously along at least a portion of each of the first and second segments, is surrounded by one or more of the reinforcing member and the supporting member along the full length of the middle portion.

27. The passage system of claim 23 or claim 24, wherein when the first segment encounters a force resisting the distal tip of the sleeve to propel distally, the support member prevents the polymer tube from kinking by an amount that would otherwise be sufficient to cause the polymer tube to kink within the support member.

28. The pathway system of claim 21, wherein the first segment includes a first tube including a first end face, the second segment includes a second tube including a second end face, and the first end face and the second end face are adjacent to each other at an interface located at the distal end of the second segment.

29. The access system of claim 28, further comprising a connecting layer extending over at least a portion of the interface and each of the first tube and the second tube, respectively, of the first segment and the second segment, to attach the first tube and the second tube together or to enhance the attachment between the first tube and the second tube.

30. The access system of claim 21, wherein when the sleeve encounters a force resisting the distal tip of the sleeve to propel distally, the reinforcing member prevents the sleeve from twisting by an amount that would otherwise be sufficient to cause the sleeve to twist within the reinforcing member.

31. The access system of claim 21 or claim 30, wherein the cannula includes a first distal segment that is relatively more flexible than a second segment proximally adjacent to the first segment, and wherein the second segment includes a distal terminal that is located within the reinforcing member when the cannula is in the retracted position.

32. The access system of claim 31, wherein when the sleeve is in the advance position, the distal end of the second segment of the sleeve is distal to the distal tip of the reinforcing member.

33. The pathway system according to claim 21, wherein:

The closed intravenous catheter system also includes a diaphragm spaced from the valve valve; and

When the connector is attached to the closed intravenous catheter system, the distal tip of the reinforcing member is configured to be positioned proximal to the diaphragm.

34. The pathway system according to claim 21, wherein:

The closed intravenous catheter system includes a diaphragm spaced from the valve.

The reinforcing member includes a protrusion extending distally from the surface of the connector; and

When the connector is attached to the closed intravenous catheter system, at least a portion of the extension of the reinforcing member is configured to extend through the diaphragm of the closed intravenous catheter system.

35. The passage system of claim 33 or claim 34, wherein the diaphragm includes an opening that is unsealed before the protrusion of the reinforcing member is inserted through the diaphragm.

36. The passage system of claim 34, wherein the protrusion of the reinforcing member is configured to insert into an opening through the diaphragm.

37. The access system of claim 34, wherein the protrusion extends distally through the distal end of the connector.

38. The access system of claim 34, wherein the protrusion is recessed proximally relative to the distal end of the connector.

39. The access system of claim 21, wherein, when the connector is connected to the closed intravenous catheter system, as the cannula moves from the retracted position to the advanced position, the reinforcing member causes the cannula to be aimed at the sealable opening of the valve valve such that the distal tip of the cannula is advanced through the sealable opening of the valve valve.

40. The access system of claim 21 or claim 39, wherein the sealable opening is substantially centered relative to the valve disc, and wherein, when the connector is coupled to the closed intravenous catheter system, the reinforcing member is substantially centered to align with the sealable opening.

41. The access system of claim 21, wherein the closed intravenous catheter system further comprises a removable puncture member extending through the valve and through the catheter body to assist in positioning the catheter body in the patient's blood vessel, and wherein the puncture member is configured to be removed from the closed intravenous catheter system prior to coupling the connector of the access system to the closed intravenous catheter system.

42. The access system of claim 21, wherein the closed intravenous catheter system includes an integral side port through which fluid can be transferred to or from the catheter body.

43. The access system of claim 42, wherein the side port includes an extension tube and another connector attached to the proximal end of the extension tube.

44. The access system of claim 43, wherein as the sleeve moves between the retracted position and the advanced position, no portion of the sleeve passes through the extension tube.

45. The access system of claim 21, wherein the closed intravenous catheter system includes a sleeve defining a lumen, and wherein the valve is positioned within the lumen.

46. The passage system of claim 45 further includes a diaphragm positioned at the proximal end of the cavity and spaced from the valve disc.

47. The access system of claim 46, wherein the diaphragm defines a permanent opening and the valve flap defines a sealable opening aligned with a longitudinal axis extending through the conduit body.

48. The access system of claim 47, wherein the closed intravenous catheter system further comprises a puncture member extending through the openings of the diaphragm and the valve and further extending through the catheter body, and wherein the puncture member is configured to be removed from the catheter body, the valve and the diaphragm prior to coupling the connector to the closed intravenous line.

49. The access system according to any one of claims 46 to 48, wherein as the cannula changes from the retracted position to the advanced position, the distal tip of the cannula is advanced substantially linearly through the diaphragm, the valve flap and into the catheter body.

50. The access system of claim 46, wherein when the connector is connected to the closed intravenous catheter system, the reinforcing member extends through the diaphragm.

51. The access system of claim 21, wherein the cannula comprises a first segment at its distal end and a second segment extending proximally from the first segment, wherein the second segment is more rigid than the first segment.

52. The passage system of claim 51, wherein when the sleeve is in the advance position, at least a portion of the second segment extends through the valve disc.

53. The passage system according to claim 51 or claim 52, wherein the second segment comprises a rigid tube surrounding the flexible tube.

54. The passage system of claim 53, wherein the rigid tube is formed of a metallic material, and wherein the flexible tube is formed of a polymer material.

55. The access system according to any one of claims 21 to 54, further comprising a closed intravenous catheter system.

56. Set, including:

The pathway system according to any one of claims 21 to 55; and

The instruction manual for using the kit includes the following guidance:

The sleeve is advanced from the retracted position to the advanced position.

57. The kit of claim 56, wherein the instruction manual for using the kit further includes the following guidance:

Connect the fluid transfer device to the sleeve; and

58. A method using the pathway system of any one of claims 21 to 55, the method comprising:

The sleeve is advanced from the retracted position to the advanced position.