ES2834969T3 - Multipurpose Blood Monitoring Safety Catheter Assembly - Google Patents

Abstract

A valve actuator (744, 844, 900, 950) that moves in a catheter assembly (10, 300, 400, 500, 810) between a first position where a valve (172) is closed and a second position where the valve (172) is closed. valve (172) is open, the valve actuator (744, 844, 900, 950) comprising: a shaft portion (750) at a distal end (904, 954) of the valve actuator (744, 844, 900, 950 ) which is configured to pierce the valve (172); an engagement portion (754) at a proximal end of the valve actuator (744, 844, 900, 950) that is configured to engage with a Luer device; a diameter reduction region (752) connecting the shaft portion (750) and the coupling portion (754); and a plurality of windows (756) extending radially through the valve actuator (744, 844, 900, 950) to discharge fluid, the plurality of windows (756) are disposed in the diameter reduction region (752 ), where each of the plurality of windows (756) does not extend a full length of the diameter reduction region (752); and each of the plurality of windows (756) is elongated in a circumferential direction.

Description

DESCRIPTION

Multipurpose Blood Monitoring Safety Catheter Assembly

Related requests

This application claims the benefit of, and for the United States, is a continuation in part of International Patent Application No. PCT / US2015 / 026534, filed April 17, 2015, International Patent Application No. PCT / US2015 / 026536, filed April 17, 2015, and International Patent Application No. PCT / US2015 / 026542, filed April 17, 2015.

Field

Various exemplary embodiments of the invention relate to catheter assemblies.

Background

Catheter assemblies are used to properly place a catheter in the vascular system of a patient. Once in place, catheters such as intravenous catheters can be used to infuse fluids including normal saline, medicinal compounds, and / or nutritional compositions into a patient in need of such treatment. The catheters also allow the elimination of fluids from the circulatory system and the monitoring of conditions within the patient's vascular system. Examples of catheters can be found in US-A-2010204648, WO-A-2013137348 or US-A-2013090607.

Summary of the invention

The invention is defined in the claims. It is an aspect of the present invention to provide a catheter assembly in which a valve actuator includes a plurality of windows specifically sized and arranged to improve the washability of the saline solution. Additionally, a catheter connector includes a floating spring design that improves manufacturability and performance. Finally, the catheter connector also uses one of a plurality of materials to reduce magnetic susceptibility on the spring so that the catheter assembly can be used on a patient during a magnetic resonance imaging (MRI) procedure.

The above and / or other aspects can be achieved by providing a valve actuator that moves in a catheter assembly between a first position where a valve is closed and a second position where the valve is open, the valve actuator comprises a portion of shaft at a distal end of the valve actuator that is configured to pierce the valve, an engagement portion at a proximal end of the valve actuator that is configured to engage a Luer device, a diameter reduction region that connects the portion of shaft and the coupling portion, and a plurality of windows extending through the valve actuator for flushing fluid, the plurality of windows is disposed in the diameter reduction region, where each of the plurality of windows is not extends a full length of the diameter reduction region.

The above and / or other aspects can be further achieved by providing a valve actuator that moves in a catheter assembly between a first position where a valve is closed and a second position where the valve is open, the valve actuator comprises a portion shaft at a distal end of the valve actuator that is configured to pierce the valve, an engagement portion at a proximal end of the valve actuator that is configured to engage a Luer device, a diameter reduction region connecting the portion shaft and the coupling portion, and a plurality of windows extending through the valve actuator for flushing fluid, wherein the plurality of windows are disposed outside the diameter reduction region.

The above and / or other aspects of can also be achieved by providing a catheter assembly comprising a catheter, a needle having a sharp distal tip disposed within the catheter, a catheter connector connected to the catheter having the needle passing through Of this, the catheter connector includes a valve that selectively allows or blocks a flow of fluid through the catheter, a valve actuator that moves between a first position and a second position, and a return member that returns the actuator of the catheter. valve from the second position to the first position, and a needle guard member surrounding the sharp distal lip of the needle, wherein the valve actuator includes a diameter reduction region having a plurality of windows, and each of the plurality of windows does not extend the entire length of the diameter reduction region.

The above and / or other aspects can also be achieved by providing a catheter assembly comprising a catheter, a needle having a sharp distal tip disposed within the catheter, a catheter connector connected to the catheter having the needle passing through This, the catheter connector includes a valve that selectively allows or blocks a flow of fluid through the catheter, a valve actuator that moves between a first position and a second position, a return member that returns the valve actuator from the second position to the first position, and a needle shield member surrounding the sharp distal tip of the needle, where the valve actuator includes a diameter reduction region, and a plurality of windows extending through through the valve actuator for flushing fluid, the plurality of windows that are disposed outside the diameter reduction region.

The above and / or other aspects can also be achieved by providing a catheter assembly comprising a catheter, a needle having a sharp distal tip disposed within the catheter, a catheter connector connected to the catheter having the needle passing through This, the catheter connector includes an internal diameter, a valve that selectively allows or blocks fluid flow through the catheter, a valve actuator that moves between a first position and a second position, and a spring that returns the actuator from the second position to the first position, where a clearance adjustment is provided between the spring and the bore. The above and / or other aspects can also be achieved by providing a catheter assembly comprising a catheter, a needle having a sharp distal tip disposed within the catheter, a catheter connector connected to the catheter having the needle passing through This, the catheter connector includes a valve that selectively allows or blocks a flow of fluid through the catheter, a valve actuator that moves between a first position and a second position, and a return member that returns the valve actuator. from the second position to the first position, and a needle shield member surrounding the sharp distal tip of the needle, wherein the return member comprises a metal member with a relative magnetic permeability of less than 2.0.

Additional aspects and advantages and / or other aspects of the present invention will be set forth in the description that follows, or will be apparent from the description, or may be learned by practice of the invention.

Brief description of the drawings

The above aspects and features of the present invention will become more apparent from the description of the exemplary embodiments of the present invention taken with reference to the accompanying drawings, in which: Figure 1A is a perspective view of a catheter assembly copy;

Figure 1B is an exploded perspective view of the catheter assembly of Figure 1A;

Figure 2A is a sectional side view of an exemplary catheter driver and connector;

Figure 2B is a perspective view of an exemplary partition;

Figure 3 is a sectional side view of an exemplary catheter connector, actuator, and spring with an introducer needle inserted through the catheter connector;

Figure 4 is a sectional side view of the catheter assembly of Figure 3 with the introducer needle removed; Figure 5 is a sectional side view of the catheter connector of Figure 4 with a Luer connector inserted; Figure 6 is a sectional side view of the catheter connector of Figure 5 with the Luer connector pushing the actuator through the septum;

Figure 7 is a sectional side view of the catheter connector of Figure 6 with the Luer connector being removed; Figure 8 is a sectional side view of the catheter connector of Figure 7 with the Luer connector removed;

Figure 9 is a sectional side view of another exemplary embodiment of a catheter with an actuator and a biasing member;

Figure 10 is a sectional side view of another exemplary embodiment of a catheter with an actuator and a biasing member;

Figure 11 illustrates a sectional side view of another exemplary embodiment of a catheter with an actuator and a biasing member;

Figure 12 illustrates a sectional side view of another exemplary embodiment of a catheter with an actuator and a biasing member;

Figure 13 illustrates a sectional side view of another exemplary embodiment of a catheter with an actuator and a biasing member;

Figure 14 illustrates an isometric sectional view of another exemplary embodiment of a catheter with an actuator and a biasing member;

Figure 15A illustrates a sectional side view of another exemplary embodiment of a catheter with an actuator and a biasing member;

Figure 15B is a sectional side view of the catheter of Figure 15A with a Luer connector inserted;

Figure 16 illustrates a sectional side view of another exemplary embodiment of a catheter with an actuator and a biasing member;

Figure 17 illustrates a sectional perspective view of another exemplary embodiment of a catheter with an actuator and a biasing member;

Figure 18 illustrates a sectional side view of another exemplary embodiment of a catheter with an actuator and a biasing member;

Figure 19A illustrates a sectional side view of another exemplary embodiment of a catheter with an actuator and a biasing member;

Figure 19B is a sectional side view of the catheter of Figure 19A pushed through the septum;

Figure 20A illustrates a sectional side view of another exemplary embodiment of a catheter with an actuator and a biasing member;

Figure 20B is the catheter of Figure 20A with a Luer connector inserted;

Figure 21A illustrates a sectional side view of another exemplary embodiment of a catheter with an actuator and biasing member and an inserted Luer connector;

Figure 21B is a front view representation of the partition of Figure 21A;

Figure 21C is a sectional side view representation of the 21A actuator with an elastomer molded to the tip of the actuator;

Figure 22 is a perspective view of a side port catheter;

Figure 23 illustrates a sectional side view of an exemplary catheter embodiment with an actuator and biasing member for a side port catheter;

Figure 24 illustrates a sectional side view of another exemplary catheter embodiment with an actuator and biasing member for a side port catheter;

Figure 25 illustrates a sectional side view of another exemplary catheter embodiment with an actuator and biasing member for a side port catheter;

Figure 26 illustrates a sectional side view of another exemplary catheter embodiment with an actuator and biasing member for a side port catheter;

Figure 27 is a sectional side view of an exemplary catheter assembly having a needle tip shield;

Figure 28 is a perspective view of an exemplary outer sleeve of the needle tip guard;

Figure 29 is a side view of the outer sleeve of Figure 28;

Figure 30 is a top view of the outer sleeve of Figure 28;

Figure 31 is a top perspective view of an exemplary inner sleeve of the needle tip guard; Figure 32 is a bottom perspective view of the inner sleeve of Figure 31;

Figure 33 is a top perspective view of a needle tip guard clip;

Figure 34 is a side view of the clip of Figure 33;

Figure 35 is a sectional side view of the needle tip guard of Figure 27;

Figure 36 is another sectional side view of the needle tip guard of Figure 27;

derecha de otra realización ejemplar de un accionador;Figure 37 is a sectional side view of the needle tip guard with the clip in a closed position; Figure 38 illustrates a side view

right of another exemplary embodiment of an actuator;

Figure 39A illustrates a sectional view of the actuator of Figure 38 in a catheter connector assembly; Figure 39B illustrates a sectional view of the catheter connector assembly of Figure 39A when penetrating a partition;

Figure 39C illustrates a left perspective sectional view of the catheter connector assembly of Figure

39A when it penetrates a septum;

Figure 40A illustrates a sectional view of another exemplary embodiment of a catheter connector assembly;

Figure 40B illustrates a sectional view of the catheter connector assembly of Figure 40A as it penetrates a septum;

Figure 40C illustrates a left perspective sectional view of the catheter connector assembly of Figure

40A when penetrating a septum:

Figure 41 illustrates a sectional view of another exemplary embodiment of a catheter assembly in the needle extended position;

Figure 42 illustrates a sectional view of the catheter assembly of Figure 41 in the needle retracted position; Figure 43 illustrates a sectional view of another exemplary embodiment of a catheter assembly in the needle extended position;

del conjunto de conector de catéter y el conjunto de conector de aguja de la Figura 44;Figure 44 illustrates a sectional view of the catheter assembly of Figure 43 in the needle retracted position Figure 45 illustrates a sectional view

of the catheter connector assembly and needle connector assembly of Figure 44;

Figure 46 illustrates a sectional view of another exemplary embodiment of a catheter assembly in the extended needle position;

Figure 47 illustrates a sectional view of the catheter connector assembly and needle connector assembly of the

Figure 46 in the needle retracted position;

Figure 48 illustrates a bottom plan view of the catheter connector assembly and needle connector assembly of Figure 46 in the needle retracted position;

Figure 49 illustrates an exemplary embodiment of a flashback feature of a catheter assembly;

Figure 50 illustrates a needle in the catheter assembly of Figure 49;

Figure 51 illustrates another exemplary embodiment of a flashback feature of a catheter assembly;

Figure 52 illustrates a side perspective view of a valve actuator based on a further embodiment that includes a window in a diameter reduction region;

Figure 53 illustrates a side perspective view of a valve actuator based on a further embodiment that includes a window in a diameter reduction region;

Figure 54 illustrates a side perspective view of a valve actuator based on a further embodiment that includes a window in a diameter reduction region;

Figure 54A illustrates a cross-sectional view of the valve actuator in the embodiment of Figure 54;

Figure 55 illustrates a side perspective view of a valve actuator based on a further embodiment that includes a window in a diameter reduction region;

Figure 56 illustrates a side perspective view of a valve actuator based on a further embodiment that includes a window outside the diameter reduction region;

Figure 57 illustrates a side perspective view of a valve actuator based on a further embodiment that includes a window outside the diameter reduction region;

Figure 58 illustrates a rear perspective view of the valve actuator in the embodiment of Figure 57;

Figure 59 illustrates an amount of blood remaining in the valve actuator of Figure 3 after a saline flush;

Figure 60 illustrates an amount of blood remaining in the catheter connector with the valve actuator in the embodiment of Figure 52 after a saline flush;

Figure 61 illustrates a graphical comparison of the amount of blood remaining in the catheter connector with the valve actuators in the embodiments of Figures 3 and 53 after a saline flush;

Figure 62 illustrates a left perspective cross-sectional view of an alternate embodiment of the catheter assembly;

Figure 63 illustrates a left perspective cross-sectional view of the catheter connector and needle connector in the embodiment of Figure 62;

Figure 64 illustrates a cross-sectional view of the catheter connector in the embodiment of Figure 62;

Figure 65 illustrates a cross-sectional view of a valve actuator and spring in the embodiment of Figure 62;

Figure 66 illustrates a perspective view of another embodiment of the valve actuator;

Figure 67 illustrates a cross-sectional view of the valve actuator of Figure 66;

Figure 68 illustrates an enlarged view of a distal end of the valve actuator of Figure 67;

Figure 69 illustrates a perspective view of another embodiment of the valve actuator;

Figure 70 illustrates a cross-sectional view of the valve actuator of Figure 69; Y

Figure 71 illustrates an enlarged view of a distal end of the valve actuator of Figure 70.

Detailed description of exemplary embodiments

A catheter assembly 10, as shown in Figures 1A and 1B, includes a hollow introducer needle 12, a catheter connector 14, and a needle connector 16. Introducer needle 12 has a sharp distal end and extends through the catheter connector 14, a flexible catheter tube 18 extends from the distal end of catheter connector 14, with needle 12 passing through catheter tube 18. Initially, needle 12 is inserted into a patient's vein. Catheter tube 18 is pushed along needle 12 and into vein following needle 12. After inserting catheter tube 18, needle 12 is withdrawn from the patient's vein and catheter connector 14, leaving catheter tube 18 into the patient as needle 12 is discarded.

Based on various exemplary embodiments, the catheter connector 14 has a distal end 20, a proximal end 22, an inner surface 24, and an outer surface 26. The distal end 20 includes a catheter opening and the proximal end includes a catheter opening. Luer connector. Internal surface 24 surrounds a channel 28 that allows fluid to pass through catheter connector 14. External surface 26 includes one or more protrusions 30 to secure a Luer connector 32 (Figure 4) to catheter connector 14. The protrusions 30 can form a threaded connection with Luer connector 32 or can be connected to Luer connector 32 through a press fit or other twist connection. An example of a standard connection is a LUER-LOK © connection. Certain types of Luer connectors 32 use a sliding fit on catheter connector 14. Catheter connector 14 can be made of a polymeric material that is transparent or semi-transparent so that a user can observe the flow of fluid through the connector. catheter or may be made of an opaque material.

Flexible catheter tube 18 extends through the catheter opening. A metal wedge 34 may be placed in the channel to secure the catheter tube 18 in the catheter opening. The wedge 34 has a first end that couples to the catheter tube 18 and a second end that couples to the inner surface 24 of the catheter connector 14. The first end of the wedge 34 has a tapered nose that allows it to be easily coupled to the catheter tube 18. As wedge 34 is inserted into catheter tube 18, catheter tube 18 expands, creating an interference fit between catheter tube 18, wedge 34, and inner surface 24 of the connector The second end of the wedge 34 has a substantially truncated cone-shaped portion with an outer edge that engages the inner surface 24 of the catheter connector 14. A wedge flange 36 may be formed on the inner surface. 24 to create a limit for the distal movement of the wedge 34. A shoulder, tab or similar groove can limit the distal movement of the wedge 34.

A strong pre-cleaved septum 38 is positioned in channel 28 and functions as a valve that forms a fluid-tight seal and selectively admits fluid to or from the flexible catheter tube 18. In other words, the valve selectively allows or blocks the fluid flow through the flexible catheter tube 18. The septum 38 may seat against a flange of the septum 40 to limit distal movement. The protrusions or other internal structure may form an interference fit with the septum 38 to retain it in place or limit its proximal movement. As best shown in Figure 2B, the septum 38 has one or more preformed openings or slits 42 designed to selectively prevent unwanted fluid flow through the septum 38. The septum 38 preferably has three intersecting slots 42 forming three flaps that open when engaged by a valve actuator or a bulkhead actuator (hereinafter "actuator").

The septum 38 further includes a plurality of axial flow channels 39. The flow channels 39 are disposed on an outer circumference of the septum 38. Eight equidistant flow channels 39 are illustrated, although various amounts and positions are contemplated. Flow channels 39 are of adequate width and depth so that when septum 38 does not open, blood can enter and air can escape from the distal space of septum 38 at the front portion of catheter connector 14. At the same time, flow channels 39 are of sufficient size to prevent blood from flowing past septum 38 (at least for some period of time). Such a configuration is possible because the intermolecular forces in blood are greater than the intermolecular forces in air.

The septum 38 shown in Figure 2B can be used in any of the embodiments described in this invention. Other septum configurations can be used as understood by one of ordinary skill in the art. When catheter tube 18 is initially inserted into a patient and introducer needle 12 is withdrawn, septum 38 prevents blood from flowing through channel 28 and out of the distal end. The septum 38 is made of an elastic material to form the valve, eg, silicone rubber. Other elastic materials can be used and non-elastic materials can be incorporated into the septum 38 as needed.

Figure 2A depicts an exemplary embodiment of an actuator 44 having an actuator cylinder 46 surrounding an internal passage 46A. Actuators similar to those of Figure 2A can be used in any of the embodiments described in this invention. Actuator 44 is positioned in channel 28 and is movable axially in channel 28 to engage and open slots 42. Actuator cylinder 46 is a substantially tubular member and internal passage 46A is substantially cylindrical to allow fluid to flow. through actuator 44 and through septum 38 when septum 38 is opened or penetrated by actuator 44. The tubular member has a distal opening 46B, one or more side openings 46c, and a distal end 46D that engages and opens the slits 42. The side openings 46C of the actuator 44 allow flushing of fluids.

A conical section 48 forms the proximal end of actuator 44. Conical section 48 is a substantially truncated cone-shaped member that is tapered toward actuator cylinder 46 and has one or more proximal openings 48A to allow fluid flow. Tapered section 48 receives or engages or abuts the end of a Luer connector (not shown). One or more tabs 50 extend from actuator 44 to engage a respective flange 52 or one or more shoulders on internal surface 24 of catheter connector 14. Interaction between tabs 50 and flange 52 limits proximal movement of the actuator. 44. Proximal opening 48A and an internal passage 48B communicating with internal passage 46A preferably allow fluid to flow between the Luer connector and catheter tube 18. Side openings 48C in conical section 48 allow fluid flushing . The actuator 44 is preferably fabricated in one piece from a rigid or semi-rigid material, eg, a rigid polymeric material or a metal.

As a male Luer connector is inserted into catheter connector 14, the end of the Luer connector slides into conical section 48 and abuts actuator 44. Further movement of the Luer connector moves actuator 44 axially toward and through the septum 38 with the distal end 46D of actuator barrel 46 separating the one or more slits 42 to engage and open septum 38. After septum 38 is opened by actuator 44, fluid is allowed to flow from the connector Luer, through internal passageways 48B and 48D of actuator 44, and into flexible catheter 18 or vice versa. When the luer connector 32 is removed, the actuator cylinder 46 remains in the septum 38.

Figures 3-8 depict one embodiment of catheter assembly 10 that includes a return member 56 that provides an all-purpose function for blood monitoring, for example. The actuator 54 has an actuator cylinder 59A. surrounding an internal passage 59B, actuator cylinder 59A is a substantially tubular member and internal passage 59B is substantially cylindrical. The tubular member has one or more openings 55 to allow fluid flow through and around the actuator cylinder 59A. The openings 55 advantageously provide a greater area for fluid to move within the catheter connector assembly. The increased area advantageously allows fluid flushing and prevents fluid coagulation at the proximal and distal ends of septum 38. In addition, the openings 55 advantageously minimize fluid stagnation and allow greater mixing.

A first end of the actuator cylinder has a tip 58 with a beveled outer surface to engage the septum 38, a truncated cone-shaped section 61A extends from the second end of the actuator cylinder 59A, the truncated cone-shaped section 61A it has one or more openings 61B to allow fluid flow through it. A cylindrical section 61C extends from the truncated cone shaped section 61A to engage a male Luer connector 32. One or more hooks 60 having an angled front surface and a slot 62 extend from the actuator cylinder 59A.

In the exemplary embodiment shown in Figures 3-8, the return member 56 is a biasing member such as a helical spring, for example, a helical compression spring with a distal end 64 and a proximal end 66. The spring may be, but not limited to, rubber, silicone rubber, a thermal plastic, a thermal plastic elastomer, metal, plastic, an elastomeric member such as an elastomer or other suitable resistant material. The distal end 64 of the spring forms an interference fit with the inner surface 24 of the catheter connector 14. The interference fit may be sufficient to retain the spring, even during loading, or the distal end 64 The spring may also abut septum 38. Proximal end 66 of the spring connects to actuator 54, for example, by fitting over hook 60 and in slot 62.

In various other embodiments, actuator 54 and biasing member 56 are combined to be a unitary structure. In various exemplary embodiments, the inner surface 24 of the catheter connector 14 and / or the outer surface of the actuator 54 and / or biasing member 56 includes undercuts, protrusions, projections, teeth, or other suitable structure to form a snap connection between the bulge of catheter 14 and biasing member 56, and biasing member 56 and actuator 54. In various other exemplary embodiments, biasing member or spring 56 and actuator 54 can be joined together through a coupling that requires a press fit that includes a diametrical interference fit or a press fit.

Figures 3-7 illustrate the operation of catheter connector 14 having an actuator 54 and a return member such as a biasing member or spring 56. The return member operates by returning actuator 54 from a second position that engages the septum 38 (by opening or penetrating the septum, for example) to open the valve, to a first position at a proximal end of septum 38 (which does not engage septum 38) to close the valve. Needle 12 initially extends through actuator 54, septum 38, wedge 34, and catheter tube 18. After needle 12 and catheter tube 18 are inserted into a patient, needle 12 is withdrawn, closing the septum 38.

There are two basic ways to open the septum 38, either of which can be used in the practice of the present invention. In the first way, the septum 38 may be in an open state when the actuator 44 contacts or pushes against the grooves 42 of the septum 38. When the septum 38 is opened in this manner, the actuator 44 does not extend through the partition 38. Rather, the end surface of the actuator 44 is disposed in the indentations 42 of the partition 38. The resistant indentations 42 or the fins of the partition 38, or the spring 56, or both, may cause the actuator 44 to retract when the operation is completed and after removal of the axial pressure on the actuator 44. In the second way, the septum 38 may be in a penetrated state where the actuator 44 extends through the septum 38 causing the septum 38 to open. In this state, actuator 44 requires an external force, such as spring 56, to retract actuator 44 and close septum 38. In the penetrated state, resistant grooves 42 in septum 38 cannot retract actuator 44 on their own. . Both states of the septum can open the septum 38 and allow fluid to be exchanged.

As shown in Figures 5 and 6, as male Luer connector 32 is inserted into catheter connector 14, Luer connector 32 moves actuator 54 in the distal direction, compressing spring 56. Further insertion of the connector Luer 32 moves actuator 54 through septum 38, opening slits 42 and allowing fluid to flow through catheter connector 14. As best shown in Figures 7 and 8, when Luer connector 32 is removed, the Spring 56 removes actuator 54 from septum 38, closing slits 42 and preventing fluid from flowing through. This allows catheter assembly 10 to be reused through multiple Luer connections, rather than a single use catheter where the actuator would remain in septum 38 after removal of a Luer connector. The features of the exemplary embodiments of Figures 3-8 may be combined with the features of the other exemplary embodiments described in this invention, as appropriate.

Although the return member 56 is shown as a biasing member (eg, spring or other resistant member) in all of the embodiments described in this invention this description is not so limited. The return member can be any element or assembly that returns the actuator from its second position to its first position when a Luer connector is removed. When constituted as a biasing member, the return member 56 may be, but is not limited to, rubber, silicone rubber, a thermal plastic, or a thermal plastic elastomer. The return member 56 may also be constituted by the sturdy grooves 42 or fins of the septum 38, as discussed above.

Figure 9 depicts an alternate embodiment of actuator 68 and biasing member 70A. The actuator 68 has an actuator cylinder 69A that surrounds an internal passage 69B. The actuator cylinder 69A is a substantially tubular member and the internal passage 69B is substantially cylindrical. A series of openings 69C are formed in the actuator cylinder 69A to allow fluid to flow through and around the actuator 68. The actuator cylinder 69A has a distal end 69D that engages and opens the septum 38. The distal end 69D includes a nose that has a beveled outer surface. A conical section 71A extends from the proximal end 71B of the actuator cylinder 69A. Tapered section 71A is a substantially truncated cone-shaped member that receives or engages the end of a Luer connector,

The biasing member is a helical metal compression spring 70A with a distal end 70B and a proximal end 70C. The distal end 70B of the spring 70A has a first outer diameter and a first inner diameter. The proximal end 71B of the spring 70A has a second outer diameter and a second inner diameter. The second outside diameter can be different from the first outside diameter and the second inside diameter can be different from the first inside diameter. The spring 70A can have a general conical shape,

In various exemplary embodiments, the first outer diameter is dimensioned to create a first interference fit with the inner surface of the catheter connector 14. The first interference fit may be sufficient to allow compression of spring 70A without contact between spring 70A and septum 38. In alternative embodiments, septum 38 can help limit axial movement of spring 70A. The second internal diameter is dimensioned to create a second interference fit with actuator 68, eg, actuator cylinder 69A. The second interference fit is sufficient to retain and hold the actuator 68 in place in an unstressed condition, both axially and radially, relative to the catheter connector 14. The second interference fit may be sufficient to allow compression of the spring. 70A with no contact between spring 70A and catheter connector 14. Due to the support provided by spring 70A, actuator 68 remains substantially self-centered and does not touch the internal walls of catheter connector 14 as shown. The spring 70A that retains the actuator 68 in the catheter connector 14 provides an advantage over the catheter shown in Figure 2, because the tabs of the 50 and the corresponding shoulder 52 extending from the inner surface are removed. Removal of the tabs 50 and shoulder 52 reduces the complexity of the device. In various alternative embodiments, tabs 50 are used to retain actuator and spring 70A is loosely positioned in catheter connector 14 without an interference fit with catheter connector 14 or actuator 68.

Depending on the illustrated embodiment, the first outer and inner diameters of the spring are larger than the second outer and inner diameters. The pitch of the spring 70A also varies from the distal end to the proximal end. The spring 70A may have one or more turns that are touching or very closely positioned at the distal end and one or more turns that are touching or very closely positioned at the proximal end in a discharged state. The variable pitch of spring 70A allows stiffness to be concentrated at the distal and proximal ends to help retain the interference fit while also allowing sufficient compression through the middle of spring 70A. Features of exemplary actuator 68 and biasing member 70A depicted in Figure 10 may be combined with features of the other exemplary embodiments described in this invention, as appropriate.

As a Luer connector (not shown) is inserted into catheter connector 14, the end of the Luer connector abuts the tapered section of actuator 68. Further movement of the Luer connector moves actuator 68 axially toward and through septum 38 With the first end of the actuator cylinder separating the one or more grooves, movement of actuator 68 toward septum 38 compresses spring 70A. After opening the septum 38, fluid is allowed to flow through the catheter connector 14. The compression of the spring 70A is maintained by the Luer connector. As the Luer connector is removed, the spring 70A returns the actuator to its initial position, removing the actuator 68 from the septum. 38. After removing the actuator 68, the septum 38 returns to the closed position, preventing fluid from flowing through it. The features of the exemplary embodiments of Figure 9 may be combined with the features of the other exemplary embodiments described in this invention, as appropriate.

Figure 10 depicts another alternate embodiment of a catheter connector 14 having an actuator 72 and a return or biasing member 74. Actuator 72 has an actuator cylinder 73A surrounding an internal passage. The actuator cylinder 73A is a tubular member that surrounds a cylindrical internal passageway. A series of openings 73B are formed in the tubular member to allow fluid to flow through and around the actuator 72. The actuator cylinder 73A has a first end 75A that engages and opens the slits in the septum 38. The first end 75A includes a tip having a beveled outer surface. A cylindrical section 75C extends from the second end 75B of the tubular portion. The cylindrical section 75C can have a conical opening to receive a Luer connector or the opening can be a continuation of the cylindrical inner passage.

The deflection or return member in Figure 10 is a helical metal compression spring 74 with a distal end and a proximal end. The distal end is an interference fit with the inner surface of catheter connector 14 and the proximal end is an interference fit with actuator 72. The inner surface may have a channel, groove, groove, or other depression 76 to receive the distal end of the spring 74. Spring 74 depicted in Figure 10 may be similar or the same as spring 70A depicted in Figure 9.

As discussed above, the conical spring 74 supports the end of the actuator and therefore allows the tabs to be removed from the actuator 50. Catheter 10 is designed for use with Luer connectors of different sizes that penetrate the inner channel through different lengths. Because the tabs 50 of the exemplary actuator 44 depicted in Figure 2 cannot travel through the septum 38, the length of the tubular portion is increased to accommodate Luer connectors of different sizes. As best shown in the exemplary embodiment of Figure 10, by removing tabs 50, actuator 72 and catheter connector 14 can be shortened, reducing the size and cost of the device. Features of the exemplary embodiments of Figure 10 may be combined with features of the other exemplary embodiments described in this invention, as appropriate.

Figure 11 depicts another alternate embodiment of a catheter connector 14 having an actuator 78 and a return or biasing member 80. Actuator 78 has an actuator barrel surrounding an internal passage. The actuator barrel and internal passageway have a tapered shape that tapers from the proximal end to the distal end of the catheter connector. The actuator cylinder has a first end that engages and opens the slots 42. The first end includes a tip having a beveled outer surface. One or more protrusions 82 extend radially from the cylinder to engage biasing member 80. The protrusions 82 may be a single truncated cone-shaped flange extending around the outer surface of the cylinder, one or more tabs extending from the cylinder or other similar structure.

The deflection member 80 in Figure 11 is preferably an elastomer spring having an outer surface that engages the inner surface of the catheter connector 14 and an opening that receives at least a portion of the actuator 78. The deflection member 80 It can also be, but is not limited to, rubber, silicone rubber, a thermal plastic or a thermal plastic elastomer. Based on an exemplary embodiment, the aperture includes a proximal aperture 84, a central aperture 86, and a distal aperture 88. The proximal aperture 84 has a substantially cylindrical shape with a first diameter. The central opening 86 has a second diameter larger than the first diameter. The central opening 86 may be cylindrical or it may be joined by one or more corner walls to have a substantially truncated cone shape. For example, the central aperture 86 may be housed by walls that have an angle that corresponds to the angle of the actuator protrusions 82. The distal aperture 88 has a substantially cylindrical shape and diameter that is less than the diameter of the proximal aperture 84 and a diameter smaller than intermediate aperture 86. In various exemplary embodiments, the size, shape, and configuration of the elastomer spring and apertures may be varied based on catheter connector 14 and actuator 78.

Actuator 78 is positioned on elastomer spring 80 such that at least a portion of the first end of the actuator cylinder extends through and protrudes from elastomer spring 80. Actuator bosses 82 are located in central aperture 86 to retain actuator 78 in place and resist proximal movement of actuator 78. The second end of actuator extends from proximal aperture 84 to receive or engage a male Luer connector. (not shown). As a Luer connector is inserted, the actuator 78 moves in the distal direction against the bias of the elastomer spring 80, elastically deforming the elastomer spring 80. As the Luer connector is removed, the elastomer spring 80 returns actuator 78 substantially to its initial position. Features of the exemplary actuator and biasing member depicted in Figure 11 can be combined with features of the other exemplary embodiments described in this invention.

Figure 12 depicts another alternate embodiment of a catheter connector 14 having an actuator 90 and a return or biasing member 92. A first end of actuator 90 has an actuator cylinder surrounding an internal passage. The actuator barrel is substantially in the shape of a truncated cone that tapers from the distal end to the proximal end of the catheter connector. The actuator cylinder has one or more openings that allow fluid flow through the actuator. Actuator 90 includes a second end for receiving or engaging a Luer connector. The second end is substantially in the shape of a truncated cone. The second end can also include one or more openings and an internal passageway. A middle portion 94 connects the first end and the second end of the actuator 90. The middle portion 94 has a substantial cylindrical shape surrounding an internal passageway.

The biasing member 92 in Figure 12 is preferably a spring washer. The washer 92 has an outer surface that engages the inner surface of the catheter connector 14. The inner surface of the catheter connector may include a groove or groove 96 to receive and retain the washer 92. The washer 92 has an inner diameter that receives the middle portion 94 from the actuator 90. The middle portion 94 may have a diameter that is smaller than the stem of the second end and smaller than the base of the first end, retaining the washer against a first flange formed by the first end and a second flange formed by the second end. The shape, size, and configuration of actuator 90 and washer 92 can vary to suit each other.

Actuator 90 is positioned on washer 92 so that the first end of actuator 90 extends through and protrudes from one side of washer 92 to engage septum 38. Second end of actuator 90 extends from washer 92 to receive or engage a male Luer connector 32. As the Luer connector 32 is inserted, the actuator 90 moves in the distal direction against the bias of the washer 92, elastically stretching the washer 92. The additional insertion of the Luer connector 32 moves actuator 90 through septum 38, opening slits 42. As luer connector 32 is removed, washer 92 returns actuator 90 to its initial position. In various additional embodiments, washer 92 may be, but is not limited to, rubber, silicone rubber, a thermal plastic, a thermal plastic elastomer, a spring washer, an elastomeric washer, a plurality of elastic bands, a rubber spring. compression, an extension spring, a disc spring, or other suitable biasing member. Features of the exemplary actuator 90 and biasing member 92 depicted in Figure 12 may be combined with features of the other exemplary embodiments described in this invention, as appropriate.

Figure 13 depicts another alternate embodiment of a catheter connector 14 having an actuator 98 and a return or biasing member 100. Actuator 98 has an actuator barrel surrounding an internal passageway. The actuator cylinder has a first end that engages and opens slots 42. Actuator 98 includes a second end for receiving or engaging a male Luer connector (not shown).

The deflection member in Figure 13 may be, but is not limited to, one or more elastic members 100, for example, a circular or radially extending silicone member, a plurality of elastic bands, rubber, silicone rubber, a thermal plastic or a thermal plastic elastomer. In various exemplary embodiments, the elastic bands are made of silicone or silicone rubber. The deflection member 100 is connected to a fixed support 102 attached to the inner surface of the catheter connector 14. The fixed support can be a single member that extends radially around the inner surface or it can be one or more isolated blocks depending of the deflection member type.

Biasing member 100 receives and / or connects to actuator 98 to retain actuator 98 in an untensioned position. As a male Luer connector is inserted, actuator 98 is moved in the distal direction by stretching biasing member 100. As the Luer connector is withdrawn, biasing member 100 returns actuator 98 to its initial position. Features of the exemplary actuator 98 and biasing member 100 depicted in Figure 13 may be combined with features of the other exemplary embodiment described in this invention, as appropriate,

Figure 14 depicts another alternate embodiment of a catheter connector 14 having an actuator 104 and a return or biasing member 106. The biasing member 106 is similar to those discussed above with respect to Figure 13. The actuator has a actuator cylinder surrounding an internal passage. The actuator cylinder has a first end that engages and opens slots 42. The actuator includes a second end for receiving or engaging a Luer connector (not shown). The actuator barrel and catheter connector 14 are shorter than those depicted in other embodiments, although any of the actuators or catheter connectors described in this invention can be used with this embodiment. The deflection member 106 may be, but is not limited to, rubber, silicone rubber, a thermal plastic, a thermal plastic elastomer, one or more bands, a radially extending member, or other suitable deflection member. The biasing member 106 includes a flange 108 that fits into a groove or groove in the catheter connector 14. The features of the exemplary actuator 104 and biasing member 106 depicted in Figure 14 can be combined with features of the other exemplary embodiments described. in this invention, as appropriate.

Figures 15A-15B depict another alternate embodiment of a catheter connector 14 having an actuator 110 and a return or biasing member 112, actuator 110 has an actuator cylinder surrounding an internal passage. The actuator cylinder has a first end that engages and opens the slots 42. The first end includes a tip having a beveled outer surface. The second end of the actuator barrel receives or mates with a male Luer connector 32.

The biasing member is an elastic band or disk 112 that is connected near the second end of the actuator 110. The elastic band 112 may be made, but not limited to, latex, rubber, silicone rubber, a thermal plastic, an elastomer. made of thermal plastic or other suitable elastic material. A first end of the elastic band 112 is connected to the catheter connector 14. A second end of the elastic band 112 is connected to the actuator 110, for example, by an interference fit or other mechanical connection, or through such a chemical bond as an adhesive or molded bond. Features of exemplary actuator 110 and biasing member 112 depicted in Figures 15A-B may be combined with features of the other exemplary embodiments described in this invention, as appropriate.

Figure 16 depicts another alternate embodiment of a catheter connector 14 having an actuator 114 and a return member comprising a first biasing member 116 and a second biasing member 118. Actuator 114 has an actuator cylinder surrounding an actuator. internal passage. The actuator cylinder has a first end that engages and opens the slots 42. The first end includes a tip having a beveled outer surface. A cylindrical member extends from the second end of the actuator cylinder to receive or engage a Luer connector (not shown). A compressible section 120 is placed in the actuator cylinder. The compressible section 120 is made of a suitable compressible material, for example, an elastomer or a polymer.

Similar to the biasing members depicted in Figures 13-15B, the first and second biasing members 116, 118 of Figure 16 may be one or more bands of elastic material, a radially extending member, or another member of proper deviation. In various additional embodiments, the biasing members depicted in Figures 13-16 may be, but not limited to, a spring washer, an elastomeric washer, a plurality of elastic bands, a compression spring, an extension spring, a disc spring, rubber, silicone rubber, a thermal plastic, a thermal plastic elastomer, or other suitable biasing member. The first and second biasing members 116, 118 are connected to the catheter connector 14 through one or more support blocks 122. In various exemplary embodiments, only a single biasing member is used.

As a Luer connector is inserted, the Luer connector engages the compressible insert 120 and moves the actuator 114 in the distal direction against the bias of the first and second biasing members 116, 118. Further insertion of the Luer connector moves the actuator through the septum (not shown), opening the slits 42. The first and second biasing members 116, 118 and the compressible insert 120 are configured so that the actuator 114 can advance a certain distance until the resisting force of the members deflection 116, 118 is greater than the force necessary to compress insert 120. At this point, insert 120 is deformed so that further insertion of the Luer connector does not cause additional distal movement of actuator 114. As it is withdrawn the Luer connector, the insert 120 expands to its normal volume and the first and second biasing members 116, 118 return the actuator 114 to its initial position. The features of the exemplary actuator 114 and biasing members 116, 118 depicted in Figure 16 can be combined with features of the other exemplary embodiments described in this invention.

Figure 17 depicts another alternate embodiment of a catheter connector 14 having an actuator 122 and a return or biasing member 124. Actuator 122 has an actuator cylinder surrounding an internal passageway. The actuator cylinder has a first end that engages and opens slots 42. A member (not shown) extends from the second end of the actuator cylinder to receive or engage a Luer connector. One or more protrusions 126 extend from the actuator radially toward the inner surface of catheter connector 14. The protrusions 126 engage tabs (not shown) on catheter connector 14 to limit axial movement of actuator 122, similar to that of embodiment represented in Figure 2.

Deflection member 124 of Figure 17 extends from septum 128 in the distal direction. Diverting member 124 includes two or more arms 130 connected to a central connector 132. Central shaft 132 is shown as a cylindrical member having an opening. Central connector 132 is configured to mate with at least a portion of a front end of actuator 122. Various sizes, shapes, and configurations of central connector 132 can be used depending on catheter connector 14 and actuator 122. Diverting member 124 it is preferably made of an elastic material, for example a silicone rubber. The biasing member 124 may also be made, but not limited to, of rubber, silicone rubber, a thermal plastic, or a thermal plastic elastomer. The septum 128 and the deflection member 124 may be formed unitarily or the septum 128 and / or the grooves 42 may be formed separately from the deflection member.

In various exemplary embodiments, the septum 38 is configured to return the actuator to its initial position. As a male Luer connector (not shown) is inserted, actuator 122 moves in the distal direction, opening slits 42 and passing through septum 128, septum 38 includes one or more slits 134 with slits 134 that define two or more fins. In the exemplary embodiment illustrated in Figure 17, the septum 38 has three grooves 134 defining three triangular fins. As actuator 122 is inserted into septum 38, the fins move in the distal direction to receive actuator 122. The fins are strong and exert a biasing force on actuator 122, which may be sufficient, depending on the insertion depth of actuator 122, to return actuator 122 substantially to its initial position or at least to a position that allows slits 42 to close.

As mentioned above, the length of a Luer connector varies, and the depth of penetration of the Luer connector into the catheter connector 14 and the resulting motion of the actuator 122 varies depending on the Luer connector. At a certain travel distance of the actuator 122 through the septum 38, the septum 38 is not capable of returning the actuator 122 to a position that allows the slits 42 to close. Based on the exemplary embodiment, biasing member 124 is configured to bias actuator 122 at least to a point where slits 42 can move actuator 122 to a position that allows septum 38 to close. If the penetration of the Luer connector is long enough, the first end of the actuator 122 moves through the septum 38 and engages the biasing member 124, for example, the center connector 132, further movement of the actuator 122 stretches the arms. 130. As the Luer connector is removed, the biasing member 124 moves the actuator 122 in the proximal direction until the biasing member 124 is in an untensioned state. At this point, septum 38 moves actuator 122 in the proximal direction a sufficient distance to allow slits 42 to close. Features of exemplary actuator 122 and biasing member 124 depicted in Figure 17 may be combined with features of the other exemplary embodiments described in this invention, as appropriate.

Figure 18 depicts another alternate embodiment of a catheter connector 14 having an actuator 134 and a return or biasing member 136. Actuator 134 has an actuator cylinder surrounding an internal passage. The actuator cylinder has a first end that engages and opens a septum 38. The first end includes a tip having a beveled outer surface. The second end of the actuator cylinder receives or mates with a Luer connector (not shown). A pin 138 extends radially opposite the side of the actuator cylinder. Pin 138 mates with a slot 140 formed in catheter connector 14. In an exemplary embodiment, slot 140 is a cam slot having a first portion that extends substantially in an axial direction of catheter connector 14 and a second portion extending obliquely, axially in the distal direction and radially upward, from the first portion.

The biasing member 136 of Figure 18 may be, but is not limited to, rubber, silicone rubber, a thermal plastic, a thermal plastic elastomer, a spring, leaf spring, an elastic band, or other strong member. The biasing member 136 can exert a force on the actuator 134 in the axial and radial directions or only in the radial direction. In an exemplary embodiment, the majority of the force exerted by biasing member 136 is in the radial direction. As the Luer connector is inserted into the catheter connector 14, the Luer connector moves the actuator 134 in the distal direction. Movement of actuator 134 causes pin 138 to slide in cam slot 140, forcing actuator 134 to move radially as well as axially. As the Luer connector is removed, the biasing member 136 forces the actuator back, moving the pin 138 along the cam slot 140 to its initial position. In various exemplary embodiments, biasing member 136 can only act in the radial direction, for example radially downward in the orientation shown, with sufficient force to slide pin 138 along cam slot 140 to the initial position. Features of exemplary actuator 134 and biasing member 136 depicted in Figure 18 may be combined with features of the other exemplary embodiments described in this invention, as appropriate.

Figures 19A-19B depict another alternative embodiment of a catheter connector 14 where the actuator and the return or bias member are constituted by a single spring 142, the spring 142 has a first series of turns 144 that extend in the axial direction. . The first series of turns 144 has a first end that extends through the septum 38. The first series of turns 144 may have a first internal diameter at a distal end and a second internal diameter greater than the first internal diameter at a proximal end. . A second series of turns 146 extends around at least a portion of the first series of turns 144. The second series of turns 146 may be coaxial with the first series of turns 144 and have a first internal diameter at a proximal end and a second internal diameter greater than the first internal diameter at a distal end. The second series of turns 146 has at least one turn that forms an interference fit with the catheter connector 14, the catheter connector 14 may have a shoulder that extends around the internal surface to limit movement of the first and second turns. rounds 144, 146.

As a male Luer connector is inserted, the first series of turns 144 move in the distal direction, compressing the second series of turns 146. Further insertion of the Luer connector moves the first set of turns 144 through septum 38, opening the slits 42. As the Luer connector is removed, the second set of turns 146 returns the first set of turns 144 to its initial position. Features of the exemplary actuator and biasing member 142 depicted in Figures 19A-19B may be combined with features of the other exemplary embodiments described in this invention, as appropriate.

Figures 20A-20B depict another alternative embodiment of a catheter connector 14 having an actuator 148 and a return or bias member 150. Actuator 148 has an actuator cylinder surrounding an internal passage, the actuator cylinder has a first end that engages and opens slits 42. The first end includes a rounded nose. A flange 152 for engaging the Luer connector 32 extends from the second end of the actuator cylinder. Flange 152 is positioned in a slot 154 formed in the catheter connector. Engagement of flange 152 with slot 154 limits axial movement of the actuator.

The biasing member in Figures 20A-20B is preferably an elastomer tube 150 that is positioned around the actuator cylinder. However, the biasing member can also be, but is not limited to, rubber, silicone rubber, a thermal plastic, or a thermal plastic elastomer. In various exemplary embodiments, elastomer tube 150 is molded to actuator 148, for example, in a multi-shot molding process, although other suitable mechanical and chemical connections may be used. The elastomer tube 150 has one or more slits 151 that open to allow passage of the actuator therethrough.

As a male Luer connector 32 is inserted, the actuator 148 moves in the distal direction so that the elastomer tube 150 engages the septum 38. Further insertion of the Luer connector 32 causes the actuator barrel to pass through from the slits in elastomer tube 150 and compress elastomer tube 150 as actuator 148 moves through septum 38. As Luer connector 32 is removed, elastomer tube 150 returns actuator 148 to your starting position. In various exemplary embodiments, septum 38 can help move actuator 148 in the proximal direction. The features of the exemplary actuator 148 and biasing member 150 depicted in Figures 20A-B may be combined with any features of the other exemplary embodiments described in this invention, as appropriate.

Figures 21A-21C depict another alternate embodiment of a catheter connector 14 having an actuator 152 and a diverting or return member 154. Actuator 152 has an actuator cylinder surrounding an internal passageway. The actuator cylinder has a first end that engages and opens the slots 42. Extending from the second end of the actuator cylinder is a cylindrical member for engaging the male Luer connector 32. The actuator is made of a rigid or semi-rigid material.

The biasing member of Figures 21A-21C preferably includes a compressible elastic sleeve 154. However, the biasing member can also be, but is not limited to, rubber, silicone rubber, a thermal plastic, or a thermal plastic elastomer. In various exemplary embodiments, elastic sleeve 154 is unitarily formed with septum 156. In a further embodiment, septum 156 and biasing member 154 are unitarily formed with actuator 152, for example, by a multi-shot molding process. which overmolds septum 156 and biasing member 154 onto the actuator. In other alternative embodiments, septum 156 and biasing member 154 may be connected, wrapped, or held together by an interference fit, for example, with the cylindrical member pressing a portion of the elastic sleeve 154 against the internal surface of the catheter connector 14. The septum 156 and elastic sleeve 154 include a silicone material although other suitable materials may be used.

As best shown in Figure 21B, septum 156 has an oval configuration and is formed with a single slit 158. Slit 158 can be formed during molding or cut into septum 156 after the molding operation. The septum 156 is configured so that the slit is in an open orientation in an untensioned condition. The septum 156 fits into a groove or groove in the internal surface of catheter connector 14. The groove is dimensioned to compress the groove in a closed orientation, forming a fluid-tight seal. As best shown in Figure 21C, an elastomer 160 can be overmolded or assembled to the leading edge of the conductor.

As a male Luer connector 32 is inserted, the actuator moves in the distal direction, compressing the sleeve 154. Further insertion of the Luer connector 32 moves the actuator 152 through the septum 156, opening the slits 42. As Luer connector 32 is removed, sleeve 154 returns actuator 152 to its initial position. The septum 38 can also help move the actuator 152 in the proximal direction. Features of exemplary actuator 152 and biasing member 154 depicted in Figures 21A-21C may be combined with features of the other exemplary embodiments described in this invention, as appropriate.

Figure 22 illustrates a side port catheter connector 162 and Figures 23-26 illustrate various exemplary embodiments of an actuator 164 and a return or deflection member 166 used with a side port catheter connector 162. The catheter connector 162 includes a channel and a side port 168 that extends substantially orthogonal to the channel. A septum 170 that forms a first valve is placed in the channel. A side valve, for example a valve sleeve 172, is also positioned in the channel to form a second valve for the side port 168. The valve sleeve is an elastic member, for example a length of silicone or rubber tubing. . Valve sleeve 172 is a compression fit on the catheter connector. When fluid is introduced into side port 168, valve sleeve 172 deforms in the radial direction, allowing fluid to flow around valve sleeve 172 and into the channel. Reference is made to US Patent No. 4,231,367, for a side port catheter with a valve cuff of the type described in this invention.

Figures 23-26 depict an actuator 164 having an actuator cylinder surrounding an internal passageway. The actuator cylinder has a first end that engages and opens the valve. A truncated cone or cylindrical member extends from the second end of the actuator cylinder to engage a male Luer connector. The biasing member 166 is depicted as a metal spring. However, the biasing member 166 can also be, but is not limited to, rubber, silicone rubber, a thermal plastic, or a thermal plastic elastomer.

In the exemplary configuration of Figure 23, septum 170 is positioned on catheter connector 162 distal to lateral valve 172 and diverting member 166 is positioned on catheter connector 162 proximal to lateral valve 172. Deflector 166 is connected at a first end to the inner surface of catheter connector 162 and at a second end to actuator 164, for example, by a pair of interference fits. Diverting member 160 may also abut lateral valve 172 to limit distal movement.

In the exemplary configuration of Figure 24, septum 170 and diverter member 166 are positioned distal to lateral valve 172. Diverter member 166 is connected at a first end to the inner surface of catheter connector 162 and at a second end to actuator 164, for example, through a pair of interference fits. Actuator 164 includes a flange 174 or one or more tabs radially extending from the actuator cylinder to receive or abut the second end of biasing member 166.

In the exemplary configuration of Figure 25, septum 170 and biasing member 166 are positioned proximal to side valve 172, biasing member 166 connects at a first end to the inner surface of catheter connector 162 and at a second end to actuator 164, for example, through a pair of interference fits. The biasing member may also abut septum 170 to limit distal movement.

In the exemplary configuration of Figure 26, the septum 170 and the side rate valve 172 are unitarily formed. Biasing member 166 is connected at a first end to the inner surface of catheter connector 162 and at a second end to actuator 164, for example, by a pair of interference fits. Diverting member 166 may also abut lateral valve 172 to limit distal movement. Features of the exemplary actuator and biasing member depicted in Figures 22-26 may be combined with features of the other exemplary embodiments described in this invention, as appropriate.

Any of the catheters described in this invention can be used in combination with the features as depicted in Figures 27-37. Needle connector 14 extends around a needle tip guard 176 and retains a proximal end of a needle 12. A needle cover 178 initially covers needle 12, catheter tube 18, and at least a portion of the needle connector. catheter 14. Needle cover 178 can be connected to catheter connector 14 or needle connector 16. Needle 12 initially extends through needle tip guard 176 and catheter connector 14. Catheter tube Flexible tube 18 extends from the distal end of catheter connector 14, with needle 12 passing through catheter tube 18. Initially, needle 12 is inserted into a patient's vein. Catheter tube 18 is pushed along needle 12 and into vein following needle 12. After inserting catheter tube 18, needle 12 is withdrawn from the patient's vein and through the catheter connector 14. The needle tip guard 176 provides protection against jamming of the needle 12 as it is retracted from the catheter connector.

Based on the exemplary embodiments depicted in Figures 27-36, needle tip shield 176 includes an outer sleeve 178, an inner sleeve 180, and a strong metal clip 182. The outer sleeve 178 connects to catheter connector 14 and surrounds the inner sleeve 180 and clip 182. The inner sleeve 180 fits into the outer sleeve 178 and is movable in the axial direction. Clip 182 is connected and movable axially with inner sleeve 180.

Based on the exemplary embodiments depicted in Figures 28-30, the outer sleeve 178 includes an outer surface 184, an inner surface 186, a channel joined by the inner surface 186, a proximal opening, and a distal opening. The outer surface 184 has an octagonal configuration with eight flat sides, although other curvilinear and / or rectilinear shapes can be used. The inner surface 186 has a flat top wall and a flat bottom wall connected by a pair of curved sides. A slot 188 extends through a wall of the outer sleeve 178.

A retainer 190 extends from the outer surface to engage a protrusion on catheter connector 14. In the exemplary embodiment, the protrusion on the catheter connector is a luer connector receiving thread, for example, a LUER-LOK® style thread. . The retainer 190 has a leading edge, a trailing edge, and a pair of side edges. An opening or depression is formed between the leading edge and the trailing edge to receive the protrusion of the catheter connector. The opening allows the retainer 190 to be formed with a clearance approximately equal to or slightly greater than the height of the boss, allowing the retainer 190 to engage the front, rear, and / or side of the connection while minimizing the amount of material and space required. In various exemplary embodiments, the retainer 190 is formed without the aperture. Retainer 190 resists premature release of needle tip shield 176 from catheter connector 14.

Based on the exemplary embodiments depicted in Figures 31 and 32, the inner sleeve 180 includes a base 192, a distal side 194, and a proximal side 196. A sturdy arm 198 and a tab 200 extend from an outer surface of the base. 192. Resilient arm 198 and tab 200 engage slot 188 in outer sleeve 184, one or more clip retainers 202 extend from an internal surface of base 192, clip is positioned between clip retainers 202 and the proximal side 196. An opposing member 204 extends from the distal side 194 in the distal direction. Opposite member 204 is tubular and configured to insert into catheter connector 14, proximal side 194, distal side 196, and opposite member 204 each have an opening to receive needle 12.

Based on the exemplary embodiments depicted in Figures 33 and 34, the strong metal clip 182 includes a base 206 having an opening to receive the needle 12, a first arm 208, and a second arm 210 extending from the base 206. The first arm 208 extends further in the axial direction than the second arm 210, the first arm 208 has a first hook 212, and the second arm 210 has a second hook 214. A first tab 218 is formed on the first arm 208 and is forms a second tab 220 on second arm 210.

Initially, needle 12 passes through outer sleeve 178, inner sleeve 178, and clip 182. Needle 12 biases clip 182 into an open position so that first and second hooks 212, 214 rest along of the needle shaft. In the assembled position, retainer 190 engages Luer threads on the outer surface of catheter connector 14 and opposing member 204 extends into the proximal opening of catheter connector 14. To remove retainer 190 from catheter connector 14 , the outer sleeve 178 of the needle tip guard 176 must be raised so that the retainer 190 can slide over the Luer threads. However, elevation of needle tip guard 176 relative to catheter connector 14 is initially prevented by opposing member 204 extending toward catheter connector 14.

As needle 12 is withdrawn from catheter connector 14, needle tip 12 releases first and second hooks 212, 214, as illustrated in Figure 37, causing first and second arms 208, 210 to close. and the first and second hooks 212, 214 surround the tip of needle 12. As such, clip 182 is in a closed position where the distal tip of needle 12 is locked. This needle protection mechanism, via clip 182, works passively (automatically) when needle 12 is withdrawn from catheter connector 14 because user action is not required to initiate needle protection.

As needle 12 is pulled further, the needle shaft slides through needle tip guard 176 until a deformation, for example, a ripple or bulge 250 forms near the distal end of needle 12 To increase its diameter in at least one direction, it is attached to the base of the clip 206. The opening in the base of the clip 206 is dimensioned to interact with the deformation so that the axis of the needle passes through, but not the deformation . Accordingly, clip 182 surrounds a sharp distal tip area, including the sharp distal tip and deformity of needle 12, for example.

Further movement of needle 12 results in inner sleeve 180 pulling further into outer sleeve 178, withdrawing opposing member 204 from catheter connector 14. When opposing member 204 is withdrawn from catheter connector 14, the retainer 190 can be removed from the luer thread boss and needle tip guard 176, needle 12 and needle connector 16 can be detached from catheter 10.

Figure 35 shows arm 198 and tab 200 of inner sleeve 180 positioned in slot 188 of outer sleeve 178. After needle tip 12 passes first and second hook 212, 214 and first and second arm 208 , 210 move toward a closed orientation, tab 200 may engage slot 188 to resist separation of inner sleeve 180 and outer sleeve 178 and possible exposure of needle 12.

Figure 36 shows the first and second tabs 216, 218 that engage a first shoulder 220 and a second shoulder 222 on the outer sleeve. Tabs 220, 222 help prevent clip 182 and inner sleeve 180 from inadvertently slip into outer sleeve 178, for example, during shipping. Needle 12 biases first and second arms 208, 210 into an open position so that tabs 216, 218 engage outer sleeve 178.

Any of the various exemplary embodiments discussed in this invention may include an antimicrobial system, such that one or more antimicrobial agents or coatings can be incorporated or applied to any of the catheter components discussed in this invention. For example, the spring can be coated with a UV curable antimicrobial adhesive coating. The coating can be applied by spraying, batch agitation or during the formation of the spring turns. A suitable coating is described in US Patent No. 8,691,887.

Antimicrobial agents suitable for use in this type of application include chlorhexidine gluconate, chlorhexidine diacetate, chloroxylenol, triclosan, hexetidine, and may be included in an applied actuator lubricant to aid in easy penetration and opening of the septum, and return of septum. actuator to dosed position after Luer connector disconnection.

Figure 38 illustrates an example / embodiment of an actuator 54. Actuator 54 can be used in any of the embodiments described in this invention. Actuator 54 includes a tip 58 that reduces friction when actuator 54 penetrates a septum 38 of a catheter connector assembly. Actuator 54 further includes apertures 55 that extend through actuator 54 in a direction perpendicular to a center line of actuator 54. For example, actuator 54 may include two rectangular-shaped apertures 55, although more or less are contemplated,

The actuator 54 also includes a plurality of grooves 57 that extend axially along the distal portion of an outer surface of the actuator 54 in a plane parallel to the center line of the actuator 54. For example, four grooves 57, substantially radially equidistant relative to each other, may be present along an outer surface of the distal portion of actuator 54, although more or fewer grooves 57 are contemplated. Grooves 57 may have varying depths in actuator 54. Grooves 57 are different from openings 55 because the grooves 57 do not extend completely through the thickness of the actuator 54.

Apertures 55 and grooves 57 advantageously provide a greater area for fluid to move within the catheter connector assembly. The increased area advantageously allows fluid flushing and avoids fluid coagulation at the proximal and distal ends of the septum. Additionally, the openings 55 and the plurality of grooves 57 advantageously minimize fluid stagnation and allow for greater mixing. Grooves 57 further prevent the septum from sealing to an external surface of the actuator during operation. By not forming a sealing interface, fluid is allowed to seep through the septum through grooves 57 and provide additional flushing.

Figure 39A illustrates the actuator 54 of Figure 38 in the catheter connector assembly. Similar to the embodiments described above, the catheter connector assembly further includes a catheter connector 14, a septum 38, and a biasing member 56. As illustrated, the openings 55 and grooves 57 of the actuator 54 provide more area for fluid flow within catheter connector 14, thus achieving the advantages described above.

Figures 39B and 39C illustrate the catheter connector assembly when biasing member 56 is compressed and actuator 54 penetrates septum 38. The catheter connector assembly can be configured so that openings 55 and / or grooves 57 of actuator 54 optionally penetrate septum 38. In this embodiment, openings 55 in actuator 54 do not penetrate septum 38. However, grooves 57 in actuator 54 penetrate septum 38. This configuration allows greater fluid flow from the proximal end to the distal end of the septum 38 through the grooves 57, in addition to the advantages described above. After operation of the catheter assembly is complete, actuator 54 retracts from septum 38 through force exerted by biasing member 56. The catheter assembly is configured for multiple uses upon depression of actuator 54. Features described in this embodiment, such as the actuator, can be used in combination with features described throughout this application.

Figure 40A illustrates another embodiment of an actuator 164 in a catheter connector assembly. The catheter connector assembly includes a catheter connector 162 having a side port 168. The side port 168 provides secondary access to fluid flow in the catheter connector 162. The intersection of the main port of the catheter connector 162 and the port Side 168 includes a sleeve 172, sleeve 172 provides selective fluid communication between side port 168 and catheter connector 162. Specifically, when sufficient fluid pressure is applied through side port 168, sleeve 172 compresses. Compression of sleeve 172 allows fluid to enter catheter connector 162. The catheter connector assembly further includes a septum 170 and a biasing member 166 that provides tension to actuator 164.

Actuator 164 includes a plurality of openings 165 that extend through actuator 164 in a manner similar to that described above. Actuator 164 includes two rows of four openings 165 having different sizes and spacing, although various amounts, sizes, and spacing of openings 165 are contemplated. As illustrated, openings 165 provide more area for fluid flow within the connector of the actuator. catheter 14, thus achieving advantages similar to those described above with respect to Figures 38-39C.

Figures 40B and 40C illustrate the catheter connector assembly as the actuator 164 penetrates the septum 170 and compresses the biasing member 166. The catheter connector assembly is configured so that the openings 165 of the actuator 164 optionally penetrate the septum 170. In this embodiment, openings 165 in actuator 164 do not penetrate septum 170. This configuration allows greater fluid flow between side port 168 and catheter connector 162 at the proximal end of septum 38, in addition to the advantages described above. If openings 165 in actuator 164 penetrate septum 170, increased fluid mixing would also occur at a distal end of septum 38.

When the operation of the catheter assembly is complete, the actuator 164 retracts from the septum 170 through the force exerted by the biasing member 166. The catheter assembly is configured for multiple uses after depression of the actuator 164. The described features in this embodiment, such as the actuator, they can be used in combination with the features described throughout this application.

Figure 41 illustrates a cross-sectional view of another exemplary embodiment of a catheter assembly 300 with a different type of needle guard mechanism, in this case one that houses the entire needle within a guard tube or barrel, rather than protect only the tip of the needle. Catheter assembly 300 employs active (rather than passive or automatic) needle protection because activation by the user is required, through the depressing of an activation button 308, to initiate needle protection. However, both active and passive needle protection are within the scope of the present disclosure.

The operation of catheter assembly 300 is described as follows. Catheter 302 and needle 304 are inserted into a vein of a patient. When needle 304 and catheter 302 are securely disposed, activation button 308 is depressed. Upon pressing the activation button 308, as illustrated in Figure 42, a needle connector or internal housing 312 disengages from a wall (not shown) of the activation button 308. The needle 304 then retracts into a catheter connector. 306. A spring 310 surrounding the inner needle housing 312 is released by the activation button 308 which causes the inner needle housing 312 to move toward the opposite end of the outer needle housing 314. Therefore, the needle 304 is now in a retracted position where the entire needle 304 (including its sharp distal tip) is retained in the outer needle housing 314. The inner needle housing 312 that holds the needle 304 is retained in the outer needle housing 314 to through the force exerted by the spring 310. Accordingly, the combination of the inner needle housing 312, the outer needle housing 314 and the spring 310 is an exemplary needle protection member.

More information regarding the active needle protection mechanism used in this embodiment can be found in US Patent Nos. 4,747,831, 5,501,675, 5,575,777, 5,700,250, 5,702,367, 5,830. 190, 5,911,705, 8,361,038, 8,388,583, 8,469,928. 8,864,715 and 8,932,259. The features described in this embodiment, including the active needle protection features, can be used in combination with the catheter assemblies described throughout this application.

Figure 43 illustrates a cross-sectional view of another exemplary embodiment, of a catheter assembly 400 with a different type of needle protection mechanism, in this case one like the one in Figures 27-37 that protects only the tip of the needle. needle. The needle protection mechanism described in catheter assembly 400 works passively (automatically) when needle 402 is withdrawn from catheter connector 406 because user actuation is not required to initiate needle protection. The operation of catheter assembly 400 is described as follows. Catheter 404 and needle 402 are inserted into a vein of a patient. When needle 402 and catheter 404 are securely disposed, a user removes needle 402.

Needle 402 is withdrawn from catheter 404 as the user pulls on external needle housing or connector 414. Needle 402 is subsequently retracted into catheter connector 406 and a sharp distal tip of needle 402 finally enters the internal needle housing. needle 408. Before the distal tip of needle 402 enters the internal needle housing 408, needle 402 contacts and biases a longitudinal metal clip 412 to an open position. Longitudinal clip 412 can be, for example, a leaf spring that extends and compresses in a longitudinal direction. When the distal tip of needle 402 sufficiently enters inner needle housing 408, as illustrated in Figure 44, clip 412 extends on inner needle housing 408 toward a center line of needle 402. Accordingly, clip 412 is no longer deflected and enters a closed position where the distal tip of needle 402 is locked.

Needle 402 further includes a deformity 403 adjacent its distal tip. In at least one direction, the diameter of the warp 403 is greater than the diameter of the remainder of the needle 402. The warp 403 prevents the needle 402 from exiting the internal housing of the needle 408 during retraction of the needle 402. Specifically, When the distal tip of the needle 402 is in the inner needle housing 408, the deformation 403 contacts a rear wall of the inner needle housing 408 and prevents the needle 402 from coming out of the inner needle housing 408. Therefore , the distal tip and deformation 403 of the needle 402 are surrounded by the inner needle housing 408. The clip 412, the needle 402, the inner needle housing 408 and the outer needle housing 414 are an example of a guard member. needle.

As illustrated in Figure 45, as the user continues to pull on outer needle housing 414, inner needle housing 408 and catheter connector 406 disengage and separate. Specifically, a protrusion 410 on inner needle housing 408 disengages from a hole in catheter connector 406.

After using the needle 402, the inner needle housing 408 surrounding the needle tip 402 and the outer needle housing 414 are discarded. The catheter connector assembly can then be used. Specifically, the user can mate a Luer connector 416 with catheter connector 406 to cause the actuator to open or penetrate the septum and establish fluid communication.

More information regarding the needle tip protection mechanism used in this embodiment can be found in US Patent Nos. 5,215,528 and 5,558,651. The features described in this embodiment, including passive needle protection, can be used in combination with the catheters described throughout this application.

Figure 46 illustrates a cross-sectional view of another exemplary embodiment of a catheter assembly 500 with a needle tip shield. The needle protection mechanism described in catheter assembly 500 works passively (automatically) when needle 512 is removed from catheter connector 514 because user actuation is not required to initiate needle protection. The operation of catheter assembly 500 is described as follows. During operation, a needle 512 extends through an actuator 528 that pierces a septum 526 in a catheter connector 514, as similarly described in the previous embodiments. A V-clip 540, located in a needle tip guard 520, is biased by needle 512 to an open position (V-clip 540 contracts) to allow needle 512 to pass past V-clip 540. The V-clip 540 comprises a strong metal clip. After operation of catheter assembly 500, biasing member 530 retracts actuator 528 into catheter connector 514.

Figure 47 illustrates a cross-sectional view of catheter assembly 500 when needle 512 is in a retracted position. When a distal tip of needle 512 enters needle tip guard 520 and is positioned at the proximal end of V-clip 540, V-clip 540 is no longer deflected. Rather, V-clip 540 expands in needle tip guard 520 in a closed position (V-clip expands) to prevent needle 512 from moving past V-clip 540. Expansion of the V-clip 540 on the needle tip guard 520 forms one or more barriers (as described below) that prevent the distal tip of the needle 512 from exiting the needle tip guard 520.

The needle tip guard 520 includes a metal washer 542 and the needle 512 includes a warp 596 adjacent the distal tip of the needle 512. In at least one radial direction, the diameter of the warp is greater than the diameter of the warp. remainder of needle 512. In at least one radial direction, the diameter of deformation 596 is greater than a through hole in washer 542 where needle 512 travels. Therefore, deformation 596 prevents needle 512 from coming out of washer 542 during retraction of needle 512. Accordingly, when needle 512 is in the retracted position, the distal tip of needle 512 and strain 596 are surrounded by washer 542 and V-clip barrier 540.

Figure 48 illustrates a bottom plan view of the catheter connector assembly and the needle connector assembly when the needle is retracted. Catheter connector 514 includes a collar 534 having a collar opening 536 and Luer threads 532. When needle 512 biases the V-clip 540 to an open position as described above, a latch 584 that is connected to a foot 582 of V-clip 540 engages collar 534. V-clip 540 that engages collar 534 maintains catheter connector 514 and needle tip shield 520 connected.

On the other hand, when the needle 512 is in the retracted position and no longer deflects the V-clip 540, the V-clip 540 moves to the closed position. In the closed position, latch 584 and foot 582 of V-clip 540 move into axial alignment with opening in collar 536. Thus, opening in collar 536 allows catheter connector 514 to disengage from the shield. needle tip 520.

In addition, when the V-clip 540 is moved to the closed position, a barrier 578 on the V-clip 540 prevents the distal tip of needle 512 from exiting the needle tip shield 520. Preferably, barrier 578 includes two barriers although they are more or less contemplated. The combination of V-clip 540 and washer 542 is an example of a needle guard member.

V-clip 540 further includes an outer wall 570 and a blade 566 that are configured to engage V-clip 540 to an outer wall of needle tip shield 520. The outer wall of needle tip shield 520 includes projections 589 that secure the V-clip 540 by creating friction between the V-clip 540 and the needle tip guard 520. This configuration advantageously secures the V-clip 540 to the needle tip guard 520 and avoids the use of a housing. external for mounting. Accordingly, the width of the needle tip guard 520 is advantageously reduced.

After removal of the catheter connector assembly and needle tip shield 520, the catheter connector assembly can later be used as a multipurpose blood monitor. Specifically, actuator 528 can be engaged multiple times using Luer threads 532 in a manner similar to that described in previous embodiments.

More information regarding the needle tip protection mechanism used in this embodiment can be found in US Patent Nos. 6,749,588, 7,604,616 and US Patent Application Publication No. 2014 / 0364809. Features described in this embodiment, including passive needle protection features, can be used in combination with features described throughout this application.

Needle guard members other than those described in this invention may be used in this invention. These may be needle tip guards as exemplified by the embodiments of Figures 27-37, 43-45 and 46 48, tubes or cylinders surrounding the needle as exemplified by the embodiment of Figures 41-42 or other arrangements . They can function passively (automatically) when the needle is removed from the catheter connector as in the embodiments of Figures 27-37, 43-45 and 46-48, or they may require active user actuation as in the embodiments of Figures 41 -42.

Figures 49-51 illustrate various exemplary embodiments of blood flashback features in the catheter assembly. Sudden recoil is the visibility of the blood that confirms the entry of the needle tip into the vein. Primary flashback 600 is seen through the catheter tube as blood travels toward the open distal end of hollow needle 612, out of a notch or opening 602 in needle 612 near the tip of the needle, and up through the internal annular space between needle 612 and the interior of the catheter tube. Secondary flashback 604 is seen at the needle grip / connector as it exits the back of the needle 612 and enters a flash chamber at the needle grip / connector. Air is vented through the plug. On the back of the connector / needle grip by a porous membrane or microgrooves. Tertiary flashback 606 is visible in catheter connector 614 as blood from primary flashback 600 flows into it and stops at the blood control septum. The air is ventilated by the microgrooves on the periphery of the blood control septum. The features described in these embodiments, including the flashback characteristics of blood, can be used in combination with the features described throughout this application.

In another embodiment similar to the embodiment illustrated in Figures 3-8, the mount 10 does not include a return member 56. Rather, as described above, the fins defined by the indentations 42 of the resilient septum 38 act as the return member. return 56. Before operation, actuator 44 is in a free state and does not come into contact with septum 38 (actuator 44 first position). In operation, septum 38 is in an open state where actuator 44 (second position of actuator 44) contacts or pushes against grooves 42 in septum 38. The open state of septum 38 allows fluid communication. In the open state of septum 38, actuator 44 does not extend through septum 38. In other words, actuator 44 does not penetrate septum 38. As a result, strong fins defined by open slits 42 of septum 38 cause actuator 44 retracts to the first position when the operation is completed and after removal of axial pressure on actuator 44.

In another embodiment, as illustrated in Figures 52-55, the valve actuators 744 function similarly to the valve actuators of the catheter assembly as described in the embodiments of Figure 3-8. For reasons described below, the valve actuators 744 of the following embodiments improve the washability of the catheter assembly during a saline flush.

Similar to the embodiment of Figures 3-8, valve actuators 744 include a shaft portion 750, a diameter reduction region 752, and a coupling portion 754. Valve actuators 744 can be approximately 0.529 inches in diameter. length (13.44 mm). Shaft portion 750 is configured to penetrate a septum of a catheter assembly. Specifically, shaft portion 750 includes a distal opening 746b that provides an entry into a hollow internal passage 746a that extends through a length of valve actuator 744. When valve actuator 744 enters the septum, fluid, such as blood or saline, it travels through the hollow internal passage 746a. Valve actuator 744 also includes a plurality of openings 746c that provide a passage for fluid to exit the hollow internal passage 746a.

Coupling portion 754 is disposed at a distal end of valve actuator 744. An external diameter of coupling portion 754 can be approximately 0.138 inches (3.5 mm). The outer diameter of the coupling portion 754 is greater than an outer diameter of the shaft portion 750 so that the coupling portion 754 can be engaged and disengaged with a Luer connector.

The diameter reduction region 752 is an inclined member disposed near a proximal end of an internal diameter of the valve actuator 744. The diameter reduction region 752 is disposed between the shaft portion 750 and the coupling portion 754 to connect the shaft portion 750 and the coupling portion 754 and to provide a continuous outer surface of the valve actuator 744. The diameter reduction region 752 includes a plurality of protrusions 758 on an outer diameter as illustrated in Figures 52-57 as well as an internal diameter as illustrated in Figure 58. The protrusions 758 advantageously assist in mounting a spring and securing the spring in the catheter assembly during operation.

The diameter reduction region 752 further includes a plurality of windows 756. As illustrated in Figures 3-8, the windows can extend the entire length of the valve actuator diameter reduction region. In a 744 valve actuator that has a length of approximately 0.529 inches (13.44 mm) and a maximum outside diameter of approximately 0.138 inches (3.5 mm), the reed length (or height) of the The diameter reduction region of Figures 3-8 can be 0.035-0.040 inches (0.89-1.02 mm), for example. However, in Figures 52-55 the windows 756 extend only a portion of the diameter reduction region 752.

Specifically, Figures 52-55 illustrate that for an actuator of the aforementioned full size, the windows 756 can extend approximately 0.005 inches, 0.010 inches, 0.015 inches, and 0.020 inches (0.127mm, 0.254mm, 0.38mm, and 0.51mm). respectively) from a distal end of diameter reduction region 752, respectively. Other embodiments include windows 756 at any length less than the sheet length of the diameter reduction region 752. Alternatively, the windows 756 may extend approximately 1/2 or 1/3 the length of the diameter reduction region. 752. Figures 56 and 57 illustrate windows 756 adjacent to a distal end of diameter reduction region 752 but outside of diameter reduction region 752. Windows 756 of Figures 56 and 57 are in the coupling portion 754 from valve actuator 756. Windows 756 of Figures 56 and 57 may extend to a length of approximately 0.010 inches and 0.020 inches (0.254mm and 0.51mm), respectively. The advantages of windows 756 are provided below.

During use, valve actuator 756 is typically flushed with saline, for example, to remove any remaining blood or fluid. However, deposits of blood or fluid can remain even after saline flushing. Windows 756 are reduced in size and positioned at a proximal end of diameter reduction region 752 to advantageously enhance saline flushing.

Specifically, the size (length or height) of the windows 756 increases the speed of the saline flow. The saline flow 748 of Figure 54A is representative of each of the windows 756 of Figures 52 55. As illustrated in Figure 54A, the fluid wash rate of the saline flow is almost completely in one direction. radial as it exits the windows 756. This is because the windows 756 are smaller in size than the valve actuator windows in Figures 3-8. The size of the windows 756 causes fluid traveling through the internal passage 746a in a longitudinal direction (axial direction) to move in a perpendicular direction (radial direction) to exit valve actuator 744. For an actuator of the size overall, the preferred optimal size (length or height) is approximately 0.0125 ± 0.005 inches (0.31 ± 0.127 mm).

The closer the size of the windows 756 is to the preferred size, the more radial the direction of fluid flow will exit the windows 756. Radial flow at a higher velocity will optimize washing performance.

When compared to the embodiments of Figures 52-58, the velocity of the discharge fluid traveling through the windows of the valve actuators in Figures 3-8 has a higher axial component and travels at a lower velocity. due to the large window size. As a result, a small reduced wash section can remain near a corner between the ID of the adapter and the proximal end of the wash window.

The placement of the windows 756 at the distal end of the diameter reduction region 752 improves the speed and direction of flow. Windows 756 outside diameter reduction portion 752 cause fluid flow in internal passage 746a to change direction more abruptly compared to windows in valve actuators of Figures 3-8. This is because the fluid flowing through the internal passage 746a travels a shorter space when the flow reaches the windows 756. Therefore, the windows 756 outside the proximal end of the diameter reduction portion 750 forces the flow to change to a more radial direction when exiting windows 756.

Fluid traveling through windows 756 in diameter reduction region 752 responds similarly. In these embodiments, the distance of windows 756 from the centerline of valve actuator 744 is variable between the distal end and the proximal end of the diameter reduction region 752. This variable flow path length slightly alters the performance of the window washing 756. As described above, for an actuator of the full size mentioned, the optimum window size (length or height) is approximately 0.0125 ± 0.005 inches (0.31 ± 0.127 mm).

The combination of the radial flow direction and the increased velocity advantageously improves washing. Figures 59 and 60 are graphic illustrations of the improved flushing performance of the valve actuator. Figure 59 represents the valve actuator with the windows of Figures 3-8 and Figure 60 represents the valve actuator with the windows 756 of Figure 53. The dashed lines identified by a number represent the amount of blood remaining on the catheter after a saline flush. The remaining blood is measured by a ratio of blood mass to 3 milliliters of saline where 760 has a ratio of 1.0, 762 has a ratio of 0.9, 764 has a ratio of 0.8, 766 has a ratio of 0.7 and 764 has a ratio of 0. As indicated in the window section of Figures 59 and 60, the amount of blood remaining in the reduced window design of Figure 60 is significantly less than the amount of blood remaining. in the normal window layout of Figure 59.

Figure 61 shows another illustration of the amount of blood remaining after a 3 milliliter saline wash. The data points show the amount of blood remaining after a saline flush in the various sizes of the windows 756 in the valve actuators 744 of Figures 52-55 and in the valve actuator window of Figures 3- 8. Specifically, the amount of blood remaining is approximately 2.2% with the window height of 0.0125 inches (0.31 mm). The amount of blood remaining is approximately 4.3% with the window height of 0.0375 inches (0.95 mm) in Figures 3-8. Therefore, as illustrated, fluid wash performance is improved by approximately 50% when the window is approximately 0.0125 inches (0.31 mm) compared to the windows in the valve actuators of Figures 3- 8.

Figures 62-65 illustrate an alternate embodiment of catheter assembly 810 with various components that function similarly to the embodiments described above. In particular, a needle connector 816 functions similarly to the embodiment of Figures 46-48. Catheter connector 814 operates in a similar manner to the embodiment of Figures 4-8, except for the differences detailed below.

The needle and catheter tube of catheter assembly 810 are surrounded by a needle cover 878 when not in use. Needle cover 878 is removed to begin operation of catheter assembly 810. Catheter assembly 810 also includes a flow control plug 820 which is similarly described in Figure 51, specifically plug 820 includes a membrane. porous or microgrooves that are disposed at a proximal end of needle connector 816 to vent air while containing blood.

Figure 63 illustrates catheter connector 814 and needle connector 816 of catheter assembly 810. Specifically, catheter connector 814 includes a metal wedge 834 made, for example, of 302, 304 or 305 stainless steel in a annealed state. Alternatively, the metal wedge 834 may be 302 or 304 stainless steel in the annealed or near annealed state. 302 and 304 stainless steels have very low magnetic susceptibility in the annealed state, which is advantageous when the catheter assembly is left in place in a patient during a magnetic resonance imaging (MRI) procedure.

Figure 64 illustrates catheter connector 814 and Figure 65 illustrates valve actuator 844 of catheter connector 814 prior to operation. Specifically, catheter connector 814 includes an internal diameter 815, as well as an undercut 813. The internal diameter 815 is larger than undercut 813. Undercut 813 is used to secure a spring 856, as further described below.

The catheter connector 814 also includes a septum 838. The septum 838 is secured by an interference fit to the internal diameter 815 of the catheter connector 814 to ensure proper function of the septum 838. The septum 838 contacts an internal wall of the catheter connector 814 for proper positioning. Septum 838 passes through undercut 813 when assembled from a proximal end of catheter connector 814.

Valve actuator 844 is configured to penetrate septum 838 during operation of catheter assembly 810. Spring 856 is compressed when valve actuator 844 penetrates septum 838. Thereafter, spring 856 retracts valve actuator 844 after piercing septum 838. Spring 856 includes center turns 857 and two or more end turns 858. End turns 858 have a larger outside diameter than center turns 857.

Tests show that the 834 metal wedge material does not cause magnetic problems during MRI procedures, but this is not necessarily the case for the 856 spring. 302 or 304 stainless steel is the conventional material used for springs due to its higher carbon content and ease of manufacture. However, the catheter assembly, including the 302 or 304 stainless steel composite spring, has very high magnetic properties when hardened to the level that a spring requires. Specifically, the spring metal must be cold worked to temper the spring to have the highest shear strength, which consequently makes the metal more magnetically susceptible.

Consequently, the 302 or 304 stainless steel composite springs in the catheter assembly may not be compatible for use during magnetic resonance imaging (MRI) procedures, this is because the magnets in an MRI device can cause the Susceptible metals in the catheter assembly are pulled, twisted and heated. As a result, a 302 or 304 stainless steel composite spring catheter assembly must be removed from the patient prior to MRI procedures.

316 stainless steel is not commonly used as a spring material due to its low strength, high cost, and difficulty in processing. However, 316 stainless steel is the preferred material for spring 856 and advantageously improves in strength as the temper of the material changes. In this embodiment, the temper of 316 stainless steel is increased to meet an ASTM F138-08 material strength standard for stainless steel surgical implant devices. Preferably, the strength requirement for spring 856 exceeds that specified in ASTM F138.

As the temper of 316 stainless steel increases, the magnetic attraction also increases. However, the magnetic properties of 316 stainless steel are less than 302 or 304 stainless steel due to the lower carbon content. Specifically, the composition of 316 series stainless steel or its equivalents, especially the chromium and nickel content and the ratio of the Cr / Ni content in these alloys, helps the austenite phase remain stable throughout the working procedure. cold and resist transformation to martensite. The low carbon content of a 316 "L" grade stainless steel also aids in the stability of the alloy. Therefore, when 316 stainless steel reaches spring temper, spring 856 in catheter assembly 810 is compatible for use during MRI procedures.

In particular, spring 856 is advantageously made of 316 stainless steel that is cold worked to spring temper. Other preferred 856 spring materials include 316L stainless steel, 316 lVm stainless steel (bare wire without nickel coating having a minimum tensile strength of 240ksi), titanium, beryllium, copper, magnesium, and magnesium alloys such as Elgiloy. Alternatively, or in addition, spring 856 is coated with a diamagnetic material, such as palladium, to achieve the desired magnetic permeability. Spring 856 may be magnetically sensitive but is plated with a diamagnetic material to substantially cancel the overall magnetism of the material. Therefore, the diamagnetic material can help to achieve zero net attractive force of the metal.

These material and method selections allow spring 856 in catheter assembly 810 to achieve a relative magnetic permeability that is less than 2.0 and preferably less than 1.1. Magnetic relative permeability is a dimensionless value that is commonly understood by one of ordinary skill in the art. The material and associated processing selection for spring 856 advantageously allows catheter assembly 810 to remain attached to the patient during MRI procedures. In other words, the correct alloys and tempers of metals are used in catheter assembly 810 to keep magnetic susceptibility low enough that there are no compatibility issues with catheter assembly 810 during MRI procedures.

During assembly, one of the end turns 858 of spring 856 travels past undercut 813 and snaps into place. Specifically, end turns 858 is movably captured between septum 838 and undercut 813. End turns 858 of spring 856 advantageously do not have to be arranged in a precise location. The outer diameter of end turns 858 is greater than the diameter of undercut 813 to movably retain spring 856. Thus, spring 856 and catheter connector 814 advantageously prevent inadvertent removal of valve actuator 844. Furthermore, the improved assembly advantageously causes less variation in the function of catheter assembly 810.

An outer diameter of the center turns 857 is less than the diameter of the undercut 813. This advantageously avoids interference and allows the spring 856 to move axially in the catheter connector 814 in a limited amount, until a Luer connector is connected.

A clearance adjustment is present between the inner diameter 815 of the catheter connector 814 and the outer diameter of the terminal turns 858 of the spring 856. A clearance adjustment advantageously facilitates assembly and operation of the spring 856. Specifically, once the terminal turns 858 pass undercut 813 during assembly, spring 856 is properly located. The other end turn 858 is immovably attached to valve actuator 844. Thus, spring 856 and valve actuator 844 can move axially "or float" (within limits) within catheter connector 814 when no luer connector present. The actuator does not come into contact with the internal diameter 815 of the catheter connector 814.

When there is an interference fit between the spring and the inner diameter of the catheter connector as described in the embodiment of Figures 3-8, it can be difficult to get the spring in the correct position. Specifically, it can be difficult to establish the exact position of the spring due to the length of the internal diameter in the catheter connector. Also, the shoulder on which the septum rests is deep within the length of the internal diameter of the catheter connector.

Furthermore, an interference fit requires very tight tolerances on the outer diameter of the spring, as well as the inner diameter of the catheter connector. If the interference fit is too severe, the life of the spring may be compromised. If the interface between the spring and the inner diameter of the catheter connector becomes loose, then the spring and valve actuator can be inadvertently removed.

The interference fit can also present problems in operation because the septum can move with the spring during retraction. This is because the interference fit between the spring and the ID of the catheter connector can create a jam where the septum moves with the spring. High forces in an interference fit can overcome the friction forces of the septum and cause the septum to move with the spring. Additionally, the interference fit can cause undue pressure on valve actuator 844 during retraction. Also, if spring 856 is compressed too distally so that septum 838 compresses, an interference fit may not allow septum 838 to retract or relax. As a result, the septum 838 can leak over time due to excessive and continuous compression,

On the other hand, when there is a clearance fit between spring 856 and inner diameter 815 of catheter connector 814, spring 856 can move axially when no Luer connector is present and can apply pressure. to a proximal face of septum 838 only when inserting a Luer connector. Therefore, the combination of the clearance adjustment and undercut 813 advantageously improves the operation, the ability to position the spring 856, and the manufacturability of the catheter assembly.

In function of another embodiment, as illustrated in Figures 66-68, a valve actuator 900 with a single stage distal tip includes a side opening 902, a distal end 904, a distal end opening 905, a stage 906 , radii 908, and an outer diameter 910. Apertures 902, 905 provide fluid discharge and flow through valve actuator 900 when coupled to a septum in a catheter connector. Apertures 902, 905 function in a similar manner described above in previous embodiments.

Stage 906 is disposed between distal end 904 and outer diameter 910 of valve actuator 900. Since valve actuator 900 is injection molded, no sharp edges are formed on its outer surface. Instead, spokes 908 are disposed on any end surface of stage 906. Specifically, a spoke 908 is disposed at the interface of stage 906 and distal end 904, as well as at the interface between stage 906 and the outside diameter. 910. Step 906 at the distal end 904 of the valve actuator 900 replaces the taper at the distal end of the valve actuators of previous embodiments. Radii 908 advantageously allow ease of fabrication during injection molding,

Figures 69-71 illustrate a valve actuator 950 with a dual stage distal tip based on another embodiment. In this embodiment, valve actuator 950 includes an aperture 952, a distal end 954, a distal end aperture 955, spokes 958, and an outer diameter 960 in a manner similar to that described in the embodiment of Figures 66-68. However, the valve actuator 950 has two stages 956 between the outer diameter 960 and the distal end 954. The two stages 956 have two different diameters with appropriate radii 958 on each end surface. In the same way, the spokes 908 advantageously allow to facilitate manufacturing during injection molding.

The foregoing detailed description of certain exemplary embodiments has been provided for the purpose of explaining the principles of the invention and its practical application, thus allowing others skilled in the art to understand the invention for various embodiments and with various modifications that are suitable for the purpose. private use contemplated. This description is not necessarily intended to be exhaustive or to limit the invention to the precise embodiments described. Any of the embodiments and / or elements described in this invention can be combined with each other to form various additional embodiments not specifically described. Accordingly, additional embodiments are possible and are intended to be within this specification and the scope of the invention. The specification describes specific examples to achieve a more general objective that can be achieved in another way.

As used in this application, the terms "front", "rear", "top", "bottom", "up", "down", and other indicative descriptors are intended to facilitate description of the exemplary embodiments herein. invention, and are not intended to limit the structure of the exemplary embodiments of the present invention to any particular position or orientation. It is understood by those skilled in the art that terms of degree, such as "substantially" or "about" refer to reasonable ranges outside of the given value, for example, general tolerances associated with the manufacture, assembly and use of the described embodiments.

Claims (12)

1. A valve actuator (744, 844, 900, 950) that moves in a catheter assembly (10, 300, 400, 500, 810) between a first position where a valve (172) is closed and a second position where valve (172) is open, valve actuator (744, 844, 900, 950) comprising: a shaft portion (750) at a distal end (904, 954) of the valve actuator (744, 844, 900, 950) that is configured to pierce the valve (172); an engagement portion (754) at a proximal end of the valve actuator (744, 844, 900, 950) that is configured to engage with a Luer device; a diameter reduction region (752) connecting the shaft portion (750) and the coupling portion (754); and a plurality of windows (756) extending radially through the valve actuator (744, 844, 900, 950) to discharge fluid, the plurality of windows (756) are disposed in the diameter reduction region (752) , where each of the plurality of windows (756) does not extend the entire length of the diameter reduction region (752); Y each of the plurality of windows (756) is elongated in a circumferential direction. The valve actuator (744, 844, 900, 950) of claim 1, wherein the plurality of windows (756) extend to a length of approximately half the length of the diameter reduction region (752) from a proximal end of the diameter reduction region (752). The valve actuator (744, 844, 900, 950) of claim 1, wherein the plurality of windows (756) extend to a length of approximately one-third the length of the diameter reduction region (752) from a proximal end of the diameter reduction region (752). The valve actuator (744, 844, 900, 950) of claim 1, wherein the plurality of windows (756) extend to a length of approximately 0.0125 inches (0.31 mm) The valve actuator (744, 844, 900, 950) of claim 1, further comprising one or more openings extending through the valve actuator (744, 844, 900, 950), wherein the one or More openings are provided in the shaft portion (750). 6. A valve actuator (744, 844, 900, 950) that moves in a catheter assembly (10, 300, 400, 500, 810) between a first position where a valve (172) is closed and a second position where valve (172) is open, valve actuator (744, 844, 900, 950) comprising: a shaft portion (750) at a distal end (904, 954) of the valve actuator (744, 844, 900, 950) that is configured to pierce the valve (172); an engagement portion (754) at a proximal end of the valve actuator (744, 844, 900, 950) that is configured to engage with a Luer device; a diameter reduction region (752) connecting the shaft portion (750) and the coupling portion (754); and a plurality of windows (756) extending radially through the valve actuator (744, 844, 900, 950) to discharge fluid, where the plurality of windows (756) are disposed outside the diameter reduction region (752); Y each of the plurality of windows (756) is elongated in a circumferential direction. The valve actuator (744, 844, 900, 950) of claim 6, wherein the plurality of windows (756) is adjacent to a proximal end of the diameter reduction region (752). The valve actuator (744, 844, 900, 950) of claim 6, wherein the plurality of windows (756) extend to a length of approximately 0.0125 inches (0.31 mm) The catheter assembly (10, 300, 400, 500, 810) of claim 6, wherein The valve actuator (744, 844, 900, 950) further includes one or more openings that extend through the valve actuator (744, 844, 900, 950), and the openings are disposed in the shaft portion (750 ). 10. A catheter assembly (10, 300, 400, 500, 810) comprising: a catheter; a needle (12) having a sharp distal tip disposed within the catheter; a catheter connector (14, 162, 306, 406, 514, 614, 814) connected to the catheter having the needle (12) passing through it, the catheter connector (14, 162, 306, 406, 514 , 614, 814) which includes: a valve (172) that selectively allows or blocks a flow of fluid through the catheter; a valve actuator (744, 844, 900, 950) that moves between a first position and a second position; Y a return member (56) that returns the valve actuator (744, 844, 900, 950) from the second position to the first position; Y a needle shield member surrounding the sharp distal tip of the needle (12), wherein the valve actuator (744, 844, 900, 950) includes a diameter reduction region (752) having a plurality of windows that radially extending (756), each of the plurality of windows (756) does not extend a full length of the diameter reduction region (752); Y each of the plurality of windows (756) is elongated in a circumferential direction. 11. A catheter assembly (10, 300, 400, 500, 810) comprising: a catheter; a needle (12) having a sharp distal tip disposed within the catheter; a catheter connector (14, 162, 306, 406, 514, 614, 814) connected to the catheter having the needle (12) that passes through it, the catheter connector (14, 162, 306, 406, 514, 614, 814) including: a valve (172) that selectively allows or blocks a flow of fluid through of the catheter; a valve actuator (744, 844, 900, 950) that moves between a first position and a second position; a return member (56) that returns the valve actuator (744, 844, 900, 950) from the second position to the first position; Y a needle shield member surrounding the sharp distal tip of the needle (12), where valve actuator (744, 844, 900, 950) includes a diameter reduction region (752), a plurality of windows (756) extending radially through the valve actuator (744, 844, 900, 950) to discharge fluid, the plurality of windows (756) are disposed outside the diameter reduction region (752) ; Y each of the plurality of windows (756) is elongated in a circumferential direction. The valve actuator (744, 844, 900, 950) of claim 1, wherein the shaft portion (750) at the distal end of the valve actuator (744, 844, 900, 950) includes a stage (956 ).