HK1255008B - Needle devices with dual diameter cannula and related methods - Google Patents

Description

Needle device with dual diameter cannula and related methods

Technical Field

The disclosed invention relates generally to needle devices, and more particularly to a needle and a needle guard that covers the needle tip upon activation to prevent inadvertent needle sticks.

Background Art

The insertion procedure for an IV catheter assembly involves four basic steps: (1) the healthcare provider inserts the needle and catheter together into the patient's vein; (2) after inserting the needle tip into the vein, the healthcare provider pushes the catheter with his or her fingers to advance the catheter into the patient's vein; (3) the healthcare provider withdraws the needle by grasping the hub end (opposite the tip) while simultaneously applying pressure to the patient's skin at the insertion site with his or her free hand to slow or stop blood flow through the catheter; and (4) the healthcare provider then tapes the exposed end of the catheter (catheter hub) to the patient's skin and connects it to a source of fluid to be delivered into the patient's vein.

The problem is that immediately after removing a needle from a patient's vein, the healthcare provider is involved in at least two emergency procedures, where they must immediately locate the exposed needle tip and handle the work required to achieve needle removal. It is at this juncture that the exposed needle tip creates the risk of accidental needle sticks, which in some cases can expose the healthcare provider to various dangerous blood-borne pathogens, such as AIDS and hepatitis.

Other needle types similarly expose healthcare workers to the risk of accidental needle sticks. For example, doctors administering injections using straight needles, Huber needles, epidural needles, and the like may place the used needle on a tray for subsequent disposal by a nurse. Between the time the used needle is placed on the tray or workbench and the time it is discarded, it represents a potential source of disease transmission for anyone working near or around the needle.

Therefore, the exposed needle tip should be covered immediately after use to ensure greater safety for medical personnel. Ideally, the procedure for covering the needle tip should be passive, self-activated, or at least simple to perform. In addition, the device for covering the needle should be reliable and robust.

Needle devices often include a safety system that covers the needle tip to prevent accidental needle sticks after the catheter tubing is placed in the patient's vasculature. These systems can be either passive or active. In some systems, the safety feature is located inside the catheter hub in the ready position, while in other systems, it is external to the catheter hub. In either position, the safety feature serves the same function: covering the needle tip to prevent accidental needle sticks after venipuncture. Therefore, care must be taken when installing the safety system to prevent dimensional changes or deformation that could interfere with or hinder the function and performance of the safety system.

Summary of the Invention

Aspects of the present disclosure include needle devices and related methods of forming and using the same.

The needle device may be a needle assembly or an IV catheter assembly. The needle device may also be an over-the-needle catheter assembly.

The needle device may have the configuration as described in the various embodiments, or may be modified by incorporating features from the described embodiments.

The needle device may include: a catheter hub having a catheter hub body with a proximal end and an inner lumen; a catheter tubing extending distally from the distal end of the catheter hub; a needle hub attached to the proximal end; and a cannula or needle extending distally of the needle hub and protruding through the proximal end and the catheter tubing, and having a needle tip extending distally of a distal opening of the catheter tubing in an installed or standby position. The needle tip extends distally of the distal end of the catheter tubing for accessing a patient's vasculature.

The needle guard may be slidably positioned over the needle and within the lumen of the catheter hub.

The proximal end of the catheter tube may be attached to the catheter hub using a hub or other conventional member.

The proximal end of the catheter hub can have a female Luer taper with external threads. In one example, the proximal end of the catheter hub is a threaded female Luer connector.

The female luer connector can be configured to matingly receive a male luer connector (such as an IV line, a luer access connector, a syringe tip, a vent plug, an IV set, an extension set, another known connector, or a future-developed IV set having a luer tip), each of which can be sized and configured to comply with International Organization for Standardization (ISO) standards for female and male luer connections, under current or future standards.

A threaded female luer connector can receive the nose section of the needle hub.

A physical abutment between the catheter hub and the needle hub may be provided to set the distance the needle tip extends beyond the distal end of the catheter tube.

The inner lumen of the catheter hub may be divided into an open chamber and a holding chamber distal to the open chamber.

The opening chamber may be separated from the holding chamber by a contour change within the lumen.

The profile change in the catheter hub may be defined by a first inner diameter located adjacent a second, larger inner diameter.

The first, smaller inner diameter may be considered a protrusion, and the contour change may therefore be referred to as a protrusion or inner protrusion, which may be configured to hold the needle guard in the ready position.

The protrusion may also be used to retain the needle guard during withdrawal of the needle after a successful venipuncture.

The profile alteration may be embodied as a single continuous protrusion formed around the perimeter or inner diameter of the lumen.

The protrusion may have two surfaces having an apex, and wherein the two surfaces may include a taper toward the open chamber and a taper toward the retaining chamber on the other side of the apex.

The two tapered surfaces may be symmetrical or asymmetrical.

The tapered portion of the protrusion interacts with the needle guard such that the needle guard can be easily mounted in the ready position and can be easily removed during needle withdrawal.

In one example, the protrusion may be a continuous annular ring formed around the perimeter of the lumen.

In another example, the protrusion may include two or more spaced-apart segments formed around the perimeter of the lumen rather than one continuous annular ring.

The catheter hub may include tabs on the exterior of the catheter hub to act as levers when maneuvering the device, to push against during insertion or removal of the needle.

A pair of wings may extend laterally of the catheter hub to support and stabilize the catheter hub against the patient after a successful venipuncture.

The lugs and wings are optional features. Either the lugs or the wings, or both, can be omitted.

When the needle device is assembled in the ready or standby position, the needle may protrude distally from the nose section of the needle hub through the catheter hub with the needle tip extending out of the distal end of the catheter tube for placement of the catheter tube into a vein.

The needle tip may be configured to penetrate the patient's epidermal layer and access the patient's vasculature.

The proximal end of the needle may extend into a flashback chamber of the needle hub, which may have an opening at the proximal end that may be closed by a vent plug.

The vent plug is optional. The vent plug may have a sampling feature that allows blood to be collected and dispensed (such as on a blood glucose test strip or Petri dish).

An exemplary hemostat may be similar to the hemostat disclosed in co-pending US Patent Application No. 14/576,802, filed December 19, 2014 (published as Publication No. US 2015/0173663).

The needle hub may have a needle guard extension extending from the nose section into the open chamber of the lumen for pushing the needle guard into the lumen during assembly.

The needle guard may be positioned completely within the lumen of the catheter hub in the ready position.

In another example, the needle guard may be positioned partially within the catheter hub body.

In yet another example, the needle guard may be positioned entirely outside of the catheter hub, such as in a shield or a separate needle guard housing located between the catheter hub and the needle hub.

An exemplary needle guard may be located in the needle guard housing disclosed in US Patent No. 8,460, 247. The needle guard may also be similar to the needle guard disclosed in US Patent No. 6,616,630.

The needle guard may have a proximal wall and two arms extending distally of the proximal wall.

Each arm of the needle guard may include an extension extending from the proximal wall, a distal wall for blocking the needle tip in the guarding position, and an elbow section coupling the distal wall to the extension.

The proximal wall may include a perimeter defining a proximal opening for passage of the needle therethrough.

The proximal wall may have a proximal-facing wall surface and a distal-facing wall surface and a perimeter defining an opening formed through the proximal-facing wall surface, the proximal wall, and the distal-facing wall surface.

The proximal opening may be configured to engage the profile change of the needle after placement of the catheter tubing into the patient's vasculature.

The profile change may be a corrugation, ridge, sleeve or accumulation of material formed on the needle shaft adjacent the needle tip to prevent the needle guard from being displaced distally away from the needle in the guard position.

The distal wall may include a curved lip at each end opposite the elbow section of the needle guard.

The curved lip can reduce friction between the distal wall and the shaft of the needle as the needle slides relative to the needle guard through the opening in the proximal wall.

In other examples, the distal side walls may each terminate in a straight edge.

The extended portions of the needle guard may intersect each other when viewed in side view in both the ready position and the protected position.

In other examples, the two arms may extend axially toward the proximal sidewall and not intersect each other when viewed in a side elevation in the standby position.

In still other examples, the needle guard may include only a single arm.

The needle can bias the two arms outwardly so that, in the ready position, the cross-sectional dimensions measured at the radially outer ends of the two elbow-shaped segments are greater than the dimensions of the protrusion within the lumen of the catheter hub, thereby preventing the needle guard from being pulled in a proximal direction until the two elbow-shaped segments are allowed to collapse or reduce in size when pulled in a proximal direction, thereby passing through the protrusion. In other words, when the arms are biased outwardly, the radial profile of the needle guard increases compared to when the arms are not biased outwardly.

The elbow section of the engagement projection may be utilized to maintain the distal wall of the needle guard within the retaining chamber to prevent the needle guard from moving proximally out of the retaining chamber when in the ready position and during needle removal.

In some examples, only one of the elbow sections may engage the protrusion.

The two elbow sections may be offset in the axial direction.

The shaft of the needle can be shown to have an almost constant outer diameter from just proximal to the bevel section of the needle tip to a distance proximal to the needle tip and proximal to the distal end of the catheter tube, at which point the outer diameter can decrease to an outer diameter that is less than the diameter of the needle shaft near the needle tip.

The needle may have a continuous shaft with two or more different outer needle diameters.

The needle shaft may include a profile change and two regions of different diameters, including a shaft diameter region and a reduced diameter region.The profile change may be located closer to the needle tip than to the proximal end of the needle.

The profile change portion may be formed at a rod diameter region having an outer diameter greater than that of the reduced diameter region.

The larger of the two diameters of the needle shaft may be referred to as the first diameter region or shaft diameter region, and the smaller of the two diameters may be referred to as the second diameter region or reduced diameter region. The different regions may also be referred to as segments.

Conventional extrusion or manufacturing methods may be used to form the stem diameter region to form the needle to a first or original extruded diameter, and the reduced diameter region may be formed by further swaging, pressing, or extruding the stem to a smaller diameter.

In other examples, the shank diameter region and the reduced diameter region may first be formed as two separate needle segments having different outer diameters, and then the two separate needle segments may be attached together (such as by welding) to form the needle.

A transition section, such as a reduction or expansion, may be located between the two different diameter sections.

The transition section may be gradual or abrupt.The length of the transition section may be approximately 0.5 to 3 times the diameter of the reduced diameter region.

The outer diameter of the shaft diameter region may taper a distance beginning proximal to the needle tip and proximal to the distal end of the catheter tube toward the reduced diameter region.

The tapered region may be referred to as a transition region.

In some examples, the shaft of the needle can have at least three regions or sections: (1) a shaft diameter region; (2) a reduced diameter region having an outer diameter smaller than the shaft diameter region; and (3) a transition region between the shaft diameter region and the reduced diameter region.

The shaft diameter region may extend from about the needle tip to the transition region.

The diameter of the shaft diameter region may be sized depending on the depth and type of tissue the needle is intended to penetrate.

The diameter of the shaft diameter region may also be selected depending on the infusion rate to be administered and therefore the catheter tubing size for use with the shaft diameter region.

In one example, a 14 gauge needle selected for the shaft diameter region can allow the needle to be used with a relatively larger catheter tubing, which then allows for relatively greater infusion rates than with a 16 gauge or 18 gauge needle. In other examples, the shaft diameter region can be a different size, such as 16 gauge, 18 gauge, or 20 gauge.

Additional aspects of the present disclosure may include a catheter assembly comprising a catheter tube positioned about or over a needle shaft, wherein the needle shaft may have at least two different shaft diameters, and wherein the aperture of the catheter tube may be sized and shaped to fit over the larger of the two diameters.

The bore of the catheter tubing connected to the catheter hub can also be sized and shaped to fit over two diameter regions of the needle shaft.

In one example, the needle can have two different diameter sections or regions. At least a portion of the two diameter sections can be located within the bore of the catheter tubing distal to the nose section of the catheter hub, and the larger of the two diameters can be located proximal to the distal opening of the catheter tubing.

The distal end of the catheter tubing may be necked or tapered to form a seal with the larger of the two diameters near the needle tip.

The transition region and at least a portion of the needle shaft having the smaller of the two diameters (e.g., the reduced diameter region) can be located within the bore of the catheter tubing. For example, the transition region and at least a portion of the needle shaft having the smaller of the two diameters can be located within the bore of the catheter tubing proximal to the distal opening of the catheter tubing.

The needle device may have at least two different annular spaces.

In one example, the annular space between the needle and the catheter tubing at a shaft diameter region proximal to the tapered distal end (such as proximal to the needle tip) can be smaller or narrower than the annular space between the needle and the catheter tubing at the reduced diameter region.

The catheter tubing may have generally constant outer and inner diameters, except for a reduced distal end and a constricted proximal end for securing the catheter tubing to the catheter hub.

One aspect of the present disclosure may include a variable annular space region at the transition region of the needle shaft and the bore of the catheter tube.

In one example, because the transition region tapers from the rod diameter region to the reduced diameter region, the annular space at the transition region may be variable along at least a portion of the length of the transition region.

In the prepared position, the distal end of the catheter tube may taper inwardly to form a seal against the shaft diameter region and facilitate insertion of the needle and catheter tube combination into the patient.

The shaft diameter region may extend from the needle tip to at least just proximal to the tapered distal end of the catheter tube such that at least some portion of the shaft diameter region may be proximal to the tapered distal end and form an annular space with the interior of the catheter tube.

In some examples, the length of the shaft diameter region proximal to the distal end (which may be referred to as the shaft diameter region recessed length) may be at least 0.1 times the length of the shaft diameter region distal to the distal end of the catheter tube.

In some examples, the shaft diameter region recessed length can be from about 0.5 times up to about 80% of the total length of the needle shaft. Thus, one aspect of the present disclosure can include a needle shaft having at least two different diameter sections and a transition section therebetween, and wherein the at least two different diameter sections and the transition section are all positioned within the bore of the catheter tube proximal to the distal opening of the catheter tube.

In one example, if the stem diameter region recessed length is relatively short, the remaining portion of the needle located within the bore of the catheter tubing may include a transition region and a reduced diameter region.

In certain examples, the stem diameter region recessed length may be from about 3 times the length distal to the distal end of the catheter tube to about 10 times the length distal to the distal end of the catheter tube.

A configuration in which the recessed length of the shaft diameter region is located proximal to the reduced distal end of the catheter tubing can allow the needle to support the distal end and distal segment of the catheter tubing during vascular access. This also allows the catheter tubing to be increased in size to accommodate the shaft diameter region and have a reduced diameter region at the proximal end for use with a needle guard, so that the two arms of the needle guard are not biased outward by the needle by the same amount as they would be if the full length of the needle had the same diameter as the shaft diameter region. Thus, the same needle guard can be used with needle devices having different shaft diameter regions.

Furthermore, because the catheter tubing size is increased in size to accommodate the larger of at least two cannula diameters, greater infusion flow rates can be pushed through the catheter tubing than a comparable catheter tubing used only in the reduced diameter region.

The transition region can be located at or near the distal end of the catheter hub and can have a tapered section that tapers inwardly toward the reduced diameter region.

The transition region may taper smoothly or suddenly from the rod diameter region to the reduced diameter region. In other words, the length of the transition region may vary, with a longer length being used to create a gentle taper and a shorter length being used to create a relatively steeper taper.

Alternatively, a step, rather than a transition region, may be included to connect the rod diameter region to the reduced diameter region.

The step that transitions from the large diameter region to the smaller diameter region (which may be closer to an abrupt reduction) may be considered a transition region.

A more gradual taper may reduce friction losses through the needle's bore at the transition.

The stepped transition may have higher friction losses than a smooth tapered transition. The reduced diameter region may not result in significantly slower blood return after a successful venipuncture. The primary blood return time may not be significantly affected using the dual diameter cannula of the present disclosure.

When the arms of the needle guard (such as the distal end of the needle guard) contact the cannula during cannula withdrawal, the more gradual taper can reduce friction and resistance, thereby enabling smooth removal.

The reduced diameter region may extend from the transition region to the proximal end of the needle. In some examples, the proximal end of the needle may have a larger needle diameter or a smaller needle diameter than the reduced diameter region.

The taper of the transition region and the diameter of the reduced diameter region may be produced by mechanical swaging or controlled extrusion of the drawn cannula either before or after forming the needle tip.

In some examples, a second transition region proximal to the transition region can be included to create a second reduced diameter region proximal to the reduced diameter region.

The end of the second reduced diameter region in this alternative embodiment may be attached to the needle hub.

In one example, a needle according to aspects of the present disclosure can include: a first large diameter section having a 14 gauge needle section at or adjacent to the needle tip; a transition section; a 16 gauge needle section; a second transition section; and an 18 gauge needle section at the proximal end of the needle shaft that is attached to the needle hub. In other examples, such as examples that include only a single transition section, a smaller diameter extends to the proximal end.

In the ready position, the needle guard may be located in the catheter hub with the curved lips of the two distal walls pressing against the reduced diameter region of the needle.

When the needle device is assembled, the needle guard can be slidably positioned on the needle proximal to the needle tip and proximal to the profile change. The proximal end of the needle can then be placed through the needle retaining hole of the needle hub and secured thereto (such as by an adhesive).

The proximal wall of the needle guard may be positioned to contact the needle guard extension at the distal end of the needle hub, or positioned distal to or spaced from the needle guard extension.

The proximal wall may abut a seating surface of the needle guard extension and align with a vertical support wall parallel to the axis of the needle.

The curved lip or distal wall (if not included) can contact the reduced diameter area. In other words, when the two curved lips or two distal walls contact the sides of the needle, the reduced diameter area of the rod can bias the elbow section outward.

The elbow section may be allowed to collapse or reduce in cross-sectional size when the two distal walls or curved lips are not contacting the sides of the needle.

When the needle guard is spaced from the needle guard extension during installation, the proximal wall can be distal to the needle guard extension, with the curved lip or distal wall pressing against the shaft diameter region, transition region, or reduced diameter region, depending on where the needle guard is initially positioned along the axial length of the needle.

With the needle guard positioned over the needle and the elbow section biased outwardly by the needle, the needle and needle hub may be inserted distally through the proximal opening into the catheter hub and into the lumen.

During needle insertion, the elbow segment may eventually encounter a protrusion that may prevent the needle guard from moving further distally into the holding chamber unless the two elbow segments are compressed and/or deflected. At this point, the needle may still be inserted further into the catheter hub and into the catheter tubing by advancing the needle distally relative to and through the enclosure defining the opening on the proximal wall until the proximal wall is pressed against the seating surface of the needle guard extension on the needle hub on its proximal-facing surface. At approximately or approximately about the same time, the elbow segment may be pushed distally to press against the internal protrusion. This point of installation may be referred to as the pre-seated position of the needle guard.

From the pre-seated position of the needle guard, additional insertion force at the needle hub causes the needle guard extension to push against the sidewall in the distal direction, forcing the elbow section against the protrusion and causing the elbow section and distal wall to resiliently bend radially inwardly toward the needle.

With the elbow-like section displaced radially inwards, the elbow-like section of the arm can now slide under and/or through the protrusion in the distal direction.

Once the elbow section leaves the protrusion and enters the holding chamber, the elbow section and the distal wall can elastically rebound outward inside the holding chamber and assume a seated position.

With the distal wall of the needle guard located within the retaining chamber, the needle hub may be inserted further until a physical stop is achieved between the catheter hub and the needle hub and the needle tip extends distally of the distal opening of the catheter tube.

In the ready position, both the protrusion and the needle guard extension may prevent the elbow section from moving proximally out of the retaining chamber.

For a given female Luer size of a catheter hub, a predetermined space or void is available for inclusion of various features within the catheter hub. Thus, if a relatively large needle diameter is used with a standard female Luer size, relatively little remaining space is available for inclusion of other features. Conversely, if a relatively smaller needle diameter is used with a standard female Luer size, relatively more remaining space is available for inclusion of other features. By including a needle having at least two different diameter sections, the larger of the at least two different diameter sections can be used with a relatively larger catheter tubing to maintain a high fluid flow rate through the catheter tubing, while the smaller of the two diameter sections can provide more operating space to include any number of features at the female Luer section of the catheter hub.

By utilizing a needle shaft having at least two diameter sections, it may be easier to assemble the needle guard into the catheter hub despite the needle having a relatively large needle diameter section for use with a relatively large catheter tubing.

In one example, a catheter assembly including a needle shaft having a 14 gauge shaft diameter region and an 18 gauge reduced diameter region can be used with a needle guard, the two diameter regions being connected to each other by a transition region. In another example, the 18 gauge section can be changed to a 16 gauge section or a 20 gauge section.

The catheter tubing may be sized for a 14 gauge needle section to allow a flow rate therethrough that is greater than the flow rate through a catheter tubing sized for an 18 gauge needle. However, due to the 18 gauge reduced diameter region at the proximal end of the needle shaft, the needle guard may be slidably positioned over the 18 gauge needle region and seated inside the catheter hub with greater clearance than if the needle were made entirely of a 14 gauge needle.

As an example, the difference in diameter between an 18 gauge needle and a 14 gauge needle may allow other components inside the catheter hub, such as a needle guard, to utilize the additional space.

In the pre-seated position, the elbow section of the needle guard may not be biased outward as much when biased by the 18 gauge reduced diameter region of the needle shaft of the present disclosure as when biased by a 14 gauge needle, and therefore the elbow or elbow section does not have to deflect as much to slide through the protrusion to be placed in the seated position.

In the seated position of the needle guard, since the needle guard is biased by the relatively smaller needle diameter section of the stem, the undercut or maximum inner diameter of the catheter hub at which the elbow of the needle guard is located can also be reduced. In examples, greater precision and shorter molding cycle times can be achieved by utilizing the reduced undercut or maximum inner diameter of the catheter hub.

Another aspect of the present disclosure may include a needle assembly comprising a catheter hub having a catheter tubing and a needle hub having a needle. The needle may include at least two regions or sections of different diameters connected to each other by a transition region. The catheter tubing may be sized for the larger of the two diameters of the needle so as to be able to accommodate an infusion flow rate that is greater than the infusion flow rate that would be accommodated if the catheter tubing were sized for only the smaller of the two diameter regions of the needle. Furthermore, because the needle has a reduced diameter section, the reduced diameter may not bias the two arms of the needle guard radially outward by the same amount as if the two arms were biased outward by the larger diameter region of the needle shaft.

The needle guard can be seated inside the catheter hub without having to excessively deflect or compress the two elbow sections of the needle guard when passing through the protrusion inside the catheter hub to the same extent or amount as when the same needle guard is seated inside the same catheter hub but using a needle having a single diameter, and wherein the single diameter is the same as the larger of the two diameters of the needle of the present invention.

After a successful venipuncture, the needle hub and needle can be detached from the catheter hub by holding the catheter hub and pulling the needle hub proximally away from the catheter hub.

When the needle is pulled from the catheter hub and the needle guard is held by the internal protrusion, the reduced diameter region can slide relative to the curved lip and contact the curved lip at the free end of the arm. The curved lip can be located at the end of the distal wall, which can be part of the arm.

As the needle continues to be withdrawn proximally, the transition region and shaft diameter region of the needle may slide relative to and contact the curved lip.

During needle withdrawal, the needle guard may move proximally until it contacts the internal protrusion (if it is not already contacting the internal protrusion).

In one example, the elbow section can approach, but not contact, the inner wall of the holding chamber as the curved lip presses against the side of the stem diameter area during needle withdrawal.

In another example, the elbow section may contact the inner wall of the retaining chamber when the curved lip presses against the stem diameter area during needle withdrawal.

The needle can continue to move in the proximal direction until the needle tip moves to just proximal to the distal wall or proximal to the two curved lips. At about the same time or shortly thereafter, the profile change can contact the perimeter of the opening on the proximal wall of the needle guard.

The elbow section of the needle guard can be positioned adjacent to the protrusion in the holding chamber until the needle tip moves to just proximal of the two curved lips. At this point and no longer biased by the needle, the two arms can move radially inwards, primarily by the spring force built up by the elastic properties of the selected steel material and the specific bend prior to assembly onto the needle shaft, and the distal wall can cover the needle tip in the protective position.

With the needle tip protected by the needle guard and the elbow moved radially inward and no longer engaged or obstructed by the protrusion, the needle can be withdrawn further proximally away from the catheter hub with the needle guard covering the needle tip.

The profile change can engage a perimeter defining an opening in the proximal wall to pull the needle guard proximally from the catheter hub having the needle.

In other examples, the needle device may include a valve and valve opener inside the catheter hub for restricting flow in the proximal direction, such as for preventing blood flow out of the open proximal end of the catheter hub after a successful venipuncture.

The valve and valve opener may be similar to the valve and valve opener disclosed in US Pat. No. 9,149,625, the contents of which are expressly incorporated herein by reference.

Another aspect of the present disclosure may include a needle assembly comprising a needle hub, a needle extending distally of the needle hub, a catheter hub, a catheter tubing extending distally of a distal end of the catheter hub, and a needle guard positioned in a ready position within the catheter hub. The needle may have two transition regions, wherein the second transition region expands the needle from a reduced diameter region inversely to a second shaft diameter region proximal to the reduced diameter region.

The reduced diameter region of the needle may extend for a certain length before a second transition region increases the shaft back to the shaft diameter region.

In an example, the length of the reduced diameter region may be from about 20% to about 90% of the length of the needle guard.

In other examples, the length of the reduced diameter region may be longer than the length of the needle guard, such as 150% to 300% of the length of the needle guard.

In other examples, the minimum limit may be set by the shape of the distal wall of the needle guard.

One aspect of the present disclosure may include a needle assembly comprising a catheter hub having a catheter tube and a needle hub having a needle. The needle may include at least two regions or sections of different diameters and at least two transition sections or regions.

In one example, the needle may include a shaft diameter region, a transition region that tapers from a large diameter to a smaller diameter in a proximal direction, a reduced diameter region, a transition region that widens from a small diameter to a larger diameter in a proximal direction, and a shaft diameter region proximal to the second transition region.

The catheter tubing can be sized for the larger of the two needle diameters to accommodate an infusion flow rate that is greater than if it were sized only for the smaller of the two needle diameter regions. Furthermore, because the needle has a reduced diameter section, the reduced diameter does not bias the two arms of the needle guard radially outward by the same amount as if the arms were biased outward by the larger diameter region of the needle shaft.

The needle guard can be seated inside the catheter hub without having to excessively deflect or compress the two elbow sections of the needle guard when passing through the protrusion inside the catheter hub to the same extent or amount as when the same needle guard is seated inside the same catheter hub but using a needle having a single diameter, and wherein the single diameter can be the same as the larger of the two diameters of the needle of the present invention.

The two shaft diameter regions of the needle of the present invention may have substantially the same outer diameter, which is greater than the diameter of the reduced diameter region.

The needle may have a shaft diameter region extending proximally from the needle tip to a transition region that tapers inwardly to a reduced diameter region.

The reduced diameter region may extend a distance to another transition region that widens outwardly to another shaft diameter region that extends to the needle hub.

The more gradual the taper (or widening) in these transition areas, the lower the friction losses through the needle's hole.

In other examples, one or more of the transition regions may include a step rather than a smooth taper (or widening).

The reduction in diameter of the needle bore at the transition region and the reduced diameter region may not be significantly reduced by forming the reduced diameter region.

At least a portion of the shaft diameter region adjacent to the needle tip and the first transition region may be located within the bore of the catheter tube proximal to the distal opening of the catheter tube.

The reduced diameter region may be located along the length of the needle in the region where the two curved lips or distal wall of the needle guard contact the needle shaft, such as when in the standby position.

The two curved lips can contact a reduced diameter region in the ready position, the reduced diameter region being located between the two transition regions. In other words, the reduced diameter region can include a short length extending along the length of the needle and can be positioned adjacent to the protrusion or can be centrally located within the retaining chamber in the ready position. The two curved lips can contact a reduced diameter region that is positioned adjacent to the inner protrusion in the axial position.

The localized area of reduced diameter of the needle shaft may be produced by mechanical swaging or controlled extrusion of a drawn sleeve, the localized area being selected as the location where the distal wall or curved lip of the needle guard presses against the reduced diameter area in the ready position.

The localized area may be located at or near a protrusion of the catheter hub in the prepared position, with the distal wall or curved lip of the needle guard pressing against the localized area.

Because the reduced diameter region of the needle may extend only a short distance rather than to the proximal end of the needle, the mechanical swaging, forging, or controlled extrusion used to form the reduced diameter region can be limited to a relatively shorter length of the needle, as opposed to reducing the diameter of the needle all the way to the proximal end of the needle shaft, which is practicable.

When the needle device is assembled, the needle guard may be slidably positioned on the needle proximal to the needle tip with the proximal wall contacting or positioned distal to, such as spaced from, the needle guard extension.

With the needle guard positioned over the needle and the needle attached to the catheter hub, the needle may be inserted into the catheter hub until the catheter hub physically stops the needle hub.

During needle insertion, the elbow section of the needle guard can be advanced distally against the proximal side of the protrusion, which can hinder or limit further distal movement of the needle guard into the holding chamber. At this point, the needle can be further inserted into the catheter hub by sliding the needle through the opening in the proximal wall of the needle guard until the needle guard extension of the needle hub abuts the side wall. At this point in assembly, the two curved lips or distal walls can be biased outward by the reduced diameter region.

With the needle guard extension pressed against the proximal sidewall in the distal direction, the additional force applied to the needle hub can cause the elbow segment to push against the protrusion and cause the elbow segment and the distal wall to elastically bend inward against the reduced diameter area of the needle. The elbow segment (with its cross-sectional size reduced due to the deformation) can now slide through the internal protrusion and then elastically spring back outward once the elbow segment is inside the retaining chamber.

By utilizing a relatively smaller diameter section to bias the arm during installation, more space or headroom is available for the needle guard so that the elbow section is not deflected to the same amount or degree as compared to a single diameter rod, and wherein the single diameter rod is the same size as the larger of the two diameter sections of the device.

With the distal wall of the needle guard located inside the holding chamber, the needle hub can be inserted further until physically stopped by the catheter hub in the ready position.

In the ready position, both the protrusion and the needle guard extension can prevent the elbow section from moving proximally out of the holding chamber.After a successful venipuncture, the needle can be pulled from the catheter hub with the needle tip protected by the needle guard in the protected position.

Additional aspects of the present disclosure may include a catheter assembly comprising a catheter tube positioned about or over a needle shaft, and wherein the needle shaft has at least two different shaft diameters, and wherein the aperture of the catheter tube is sized and shaped to fit over the larger of the two diameters.

The size and shape of the catheter body's bore can also be designed to fit over two diameter regions of the needle shaft. For example, the catheter body can have a single inner bore diameter to accommodate two shaft diameter regions. In another example, the catheter body can have two different inner bore diameters to accommodate two different shaft diameter regions.

The distal end of the catheter tubing can be necked or tapered to form a seal with the larger of the two diameters near the needle tip. Because the transition region and the needle shaft having the smaller of the two diameters (e.g., the reduced diameter region) can be located within the bore of the catheter tubing, the needle assembly of the present invention can have at least two distinct annular spaces.

In one example, the annular space between the needle and the catheter tubing at the shaft diameter region proximal to the tapered distal end can be smaller or narrower than the annular space between the needle and the catheter tubing at the reduced diameter region.

Another aspect of the present disclosure may include a variable annular space area at the transition region of the needle shaft.

In one example, because the transition region tapers from the rod diameter region to the reduced diameter region, the annular space at the transition region may be variable along at least a portion of the length of the transition region.

The needle may have a second transition region and a separate shaft diameter region proximal to the second transition region, as well as additional annulus (i.e., a variable annulus region at the second transition region and a second smaller annulus at a second shaft diameter region proximal to the second transition region).

Additional aspects of the present disclosure may include a needle assembly comprising a needle hub, a needle extending distally of the needle hub, a catheter hub, a catheter tube extending distally of a distal end of the catheter hub, and a needle guard positioned in a ready position in the catheter hub.

The transition region of the needle (between the shaft diameter region of the needle and the reduced diameter region of the needle) may extend closer to the needle tip.

The needle may have a shaft diameter region that transitions to a reduced diameter region just proximal to a tapered distal opening of the catheter tube that forms a seal with the shaft diameter region.

The stem diameter region itself, together with the transition region, can act as a profile change for engaging the perimeter of the opening on the proximal wall of the needle guard without the need for corrugations or ridges.

In other examples, the profile change may be formed on or near the transition region.

The reduced diameter region may be produced by mechanical swaging or controlled extrusion of the drawn sleeve, either before or after grinding.

A portion of the shaft diameter region and the transition region may be located within the bore of the catheter tube proximal to the distal opening in the prepared position.

The catheter tubing may be selected to fit around the larger diameter region of the needle, while the reduced diameter region at the proximal end of the stem facilitates assembly of the needle guard into the catheter hub.

The needle guard may be slidably positioned on the needle proximal to the needle tip, with the proximal wall contacting or positioned distal to, such as spaced apart from, the needle guard extension.

The two curved lips or the distal wall (if no curved lips are included) can be biased against the reduced diameter area.With the needle guard positioned on the reduced diameter area and the needle attached to the needle hub, the needle can be inserted distally into the catheter hub.

During needle insertion, the elbow segment can be advanced distally against the protrusions, which can hinder further distal movement of the needle guard into the holding chamber. The needle can still be advanced distally by moving relative to the needle guard and sliding through the opening in the proximal wall of the needle guard until the needle guard extension abuts the side wall. With the needle guard extension pressing against the side wall, an additional distally directed force can be applied to the needle hub to push the elbow segment against the protrusions, thereby elastically bending the needle guard and radially compressing these elbows. The elbow segment (now with a reduced cross-sectional size) can slide over the protrusions and elastically rebound outward once inside the holding chamber. The needle hub can be advanced until it is physically stopped by the catheter hub in the ready position.

In the ready position, both the protrusion and the needle guard extension can prevent the elbow section from moving proximally out of the retaining chamber, and the needle tip can extend distally of the distal opening of the catheter tube.

By utilizing a relatively smaller diameter section to bias the arm during installation, more space or headroom is available for the needle guard so that the elbow section is not deflected to the same amount or degree as with a single diameter rod, and wherein the single diameter rod can be the same size as the larger of the two diameter sections of the needle assembly.

Further aspects of the present disclosure may include a needle assembly including a needle and a needle guard in a protected position, wherein the needle tip is covered by both distal walls (such as after a successful venipuncture and during withdrawal of the needle from a needle hub), and the curved lip of the needle guard is no longer biased against the needle. A profile change on the needle may abut the proximal sidewall, and more specifically, abut the perimeter defining an opening in the proximal sidewall, to prevent the needle guard from displacing distally away from the needle tip after the needle tip has been safely secured in the protected position.

The profile change can be located on the transition region, on the shaft diameter region, or on the reduced diameter region. The shaft diameter region itself can act as the profile change. In the guard position, the two curved lips or distal walls can prevent the needle tip from moving distally of the needle guard, and the engagement between the profile change and the opening can prevent the needle guard from being removed from the needle.

Additional aspects of the present disclosure include a needle device that may include: a catheter tube attached to a catheter hub, the catheter hub including a hub body including an outer surface and an inner surface defining an inner lumen; a protrusion extending from the inner surface in the inner lumen; a needle protruding through the catheter tube and having: a needle tip extending distally of a distal end of the catheter tube in a standby position; a proximal end attached to the needle hub; and a shaft having a shaft diameter region, a reduced diameter region, and at least one transition region between the shaft diameter region and the reduced diameter region; and a needle guard including a proximal wall and two arms extending distally of the proximal wall, the two arms pressing against the shaft in the ready position and shielding the needle tip in the guard position.

The two arms can be pressed against the reduced diameter area in the ready position.

Each arm of the needle guard may include a distal wall and an elbow section that engages a protrusion inside the lumen of the catheter hub in the ready position, aided by the reduced diameter region of the needle that biases the two arms outward.

A curved lip may extend from each distal wall and press against the reduced diameter region in the prepared position.

The reduced diameter region may extend from the needle hub to the distal end of the catheter hub in the prepared position.

A profile change may be provided adjacent the needle tip, wherein the profile change is larger than a perimeter defining the opening in the proximal wall.

The reduced diameter region can be centered about the distal wall in the prepared position, and the transition regions can be located on opposite sides of the reduced diameter region.

A profile change may be provided adjacent the needle tip, wherein the profile change is larger than a perimeter defining the opening in the proximal wall.

The reduced diameter region may extend from the needle hub to adjacent the needle tip in the prepared position.

The stem diameter area may be larger than the perimeter defining the opening in the proximal wall.

Additional aspects of the present disclosure include a method for manufacturing a needle device. The method may include attaching a catheter tube to a catheter hub, the catheter hub including a hub body including an outer surface and an inner surface defining a lumen.

Yet another aspect of the present disclosure includes a needle assembly, such as an over-the-needle catheter assembly, comprising a catheter hub and a catheter tube having a distal end, a needle having a needle tip, and the needle hub. The needle protrudes through the catheter hub and the catheter tube, and the needle tip extends beyond the distal end of the catheter tube in a standby position.

The needle assembly may include a needle guard having a proximal wall having a proximal-facing wall surface and a distal-facing wall surface. The proximal wall may include a perimeter defining an opening for engaging a contour change on the needle. Two arms may extend distally of the proximal wall.

The needle may include at least two different needle diameters, and each of the two different diameters is longer than a typical profile change or corrugation over the length of the needle. These diameters may be generally circular. The reduced diameter portion may also have a different cross-sectional shape, such as an oval, semi-oval, or elliptical shape, having: a horizontal width, or the larger of the two diameters, approximately the same as the shaft diameter region; and a vertical width, orthogonal to the horizontal width, which decreases from the vertical width of the shaft diameter region.

The two different diameters may include a shaft diameter region or section and a reduced diameter region or section. A transition region may connect the shaft diameter region and the reduced diameter region. The needle may further include a second transition region. The reduced diameter region may be located between the transition region and the second transition region.

The needle may further include a shaft diameter region located proximal to the second transition region.

For embodiments having a single transition region, the length of the shaft diameter region may extend from the needle tip just proximal to the distal end of the catheter tube up to approximately the nose section of the catheter hub where the catheter tube enters or exits the catheter hub.

Thus, one aspect of the present disclosure is understood to include a needle assembly comprising a cannula having at least two different diameters, wherein the larger of the two diameters has a length extending from the needle tip to a location proximal to the distal opening of the catheter tubing and up to a location approximately in the nose section of the catheter hub where the catheter tubing enters or exits the catheter hub. The larger of the two diameters may be referred to as a shaft diameter region, and the smaller of the two diameters may be referred to as a reduced diameter region.

The needle guard can be seated within the interior of the catheter hub, and wherein one or both arms of the needle guard (such as an end wall or distal wall with an optional curved lip) are biased outwardly by the reduced diameter region to engage the catheter hub. For example, the arms can have elbows or elbow segments, and wherein the elbows are forced radially outwardly to engage the catheter hub by contact of the two distal walls or curved lips, such that at least one of the two elbows or elbow segments can engage an internal protrusion within the catheter hub.

Advantageously, a needle having at least two different diameters can be sized so that the catheter tubing fits over the larger of the two diameters, allowing for a greater infusion rate than when the catheter tubing is sized to fit around the smaller of the two diameters. The larger of the two diameters can be referred to as the shaft diameter region, and the smaller of the two diameters can be referred to as the reduced diameter region. Furthermore, because a needle guard having one or two arms can be biased by the reduced diameter region, the amount of bias (measured in distance) on one or both arms is less than when one or both arms are biased by the shaft diameter region (such as when a single-diameter needle having the same diameter as the shaft diameter region biases one or both arms). This can translate into less deformation on one or both arms for a given lumen space (such as for a lumen with a Luer taper).

The method may further include protruding a needle through the catheter tube so that a needle tip of the needle extends distally of a distal end of the catheter tube in a standby position, the needle having a proximal end attached to a needle hub and a shaft having a shaft diameter region, a reduced diameter region, and at least one transition region between the shaft diameter region and the reduced diameter region.

The method may further comprise providing a needle guard comprising a proximal wall and two arms extending distally of the proximal wall, the two arms pressing against the rod in the ready position and shielding the needle tip in the guard position.

The method may further comprise pressing the two arms against the reduced diameter region in the ready position.

The method may further include engaging the elbow section of each arm against a protrusion inside the lumen of the catheter hub in the ready position, aided by the reduced diameter region of the needle biasing the two arms outward.

A curved lip may extend from the distal wall of each arm and press against the reduced diameter region in the prepared position.

The reduced diameter region may extend from the needle hub to the distal end of the catheter hub in the prepared position.

A profile change may be provided adjacent the needle tip, wherein the profile change is larger than a perimeter defining the opening in the proximal wall.

The reduced diameter region may be centered about the distal wall in the prepared position, with the transition regions located on opposite sides of the reduced diameter region.

A profile change may be provided adjacent the needle tip, wherein the profile change is larger than a perimeter defining the opening in the proximal wall.

The reduced diameter region may extend from the needle hub to adjacent the needle tip in the prepared position.

The stem diameter area may be larger than the perimeter defining the opening in the proximal wall.

The method or apparatus may further include one or more structural features and/or steps described herein.

Another aspect of the present disclosure includes a needle device comprising: a catheter hub having a body defining an inner lumen and having a proximal opening; a catheter tube extending distally of the catheter hub and including a distal opening; a needle hub; a needle extending distally of the needle hub, the needle comprising a shaft and a needle tip extending distally of the distal opening of the catheter tube body in a standby position, the needle having a shaft diameter region and a reduced diameter region, the shaft diameter region and the reduced diameter region being connected to each other by a transition region, an outer diameter of the needle at the shaft diameter region being greater than an outer diameter of the needle at the reduced diameter region, and at least a portion of the shaft diameter region and the transition region being located in a bore of the catheter tube proximal to the distal opening; and a needle guard comprising a proximal wall and at least one arm extending distally of the proximal wall, the at least one arm pressing against the reduced diameter region in the ready position and shielding the needle tip in the guard position.

The needle guard may have two arms that press against the reduced diameter area in the ready position.

The two arms of the needle guard each include a distal wall and an elbow section, and at least one of the elbow sections engages a protrusion extending from the inner surface of the lumen in the ready position, with the reduced diameter region of the needle biasing the two arms outward.

A curved lip may extend from each distal wall and press against the reduced diameter region in the prepared position.

The reduced diameter region may extend from the needle hub to the distal end of the catheter hub in the prepared position.

The needle may further include a profile change adjacent the needle tip, wherein the profile change is larger than a perimeter defining the opening in the proximal wall.

The needle may further include a shaft diameter region proximal to the reduced diameter region.

The needle further includes a profile change adjacent to the needle tip, wherein the profile change is larger than a perimeter defining the opening in the proximal wall.

The reduced diameter region may extend from the needle hub to adjacent the needle tip in the prepared position.

The stem diameter area may be larger than the perimeter defining the opening in the proximal wall.

Another aspect of the present disclosure includes a method for manufacturing a needle device, the method comprising: attaching a catheter tube to a catheter hub, the catheter hub comprising a hub body, the hub body comprising an outer surface and an inner surface defining an inner cavity; protruding a needle through the catheter tube so that the needle tip of the needle extends distally of the distal end of the catheter tube body in a standby position, the needle having: a proximal end, the proximal end attached to the needle hub; and a rod, the rod having a rod diameter region, a reduced diameter region, and a transition region between the rod diameter region and the reduced diameter region; and providing a needle guard, the needle guard comprising a proximal wall and two arms extending distally of the proximal wall, the two arms pressing against the reduced diameter region in a ready position; and wherein the rod diameter region has an outer diameter that is larger than the outer diameter of the reduced diameter region, and wherein a portion of the rod diameter region and the transition region are located in the bore of the catheter tube body proximal to the distal end of the catheter tube body in the standby position.

The method may further comprise pressing the two arms against the reduced diameter region in the ready position.

The method may further include engaging an elbow section of at least one of the arms against a protrusion inside the lumen of the catheter hub in the prepared position, with the arms biased outwardly by the reduced diameter region of the needle.

A curved lip may extend from the distal wall of each arm and press against the reduced diameter region in the prepared position.

The reduced diameter region may extend from the needle hub to the distal end of the catheter hub in the prepared position.

The needle may further include a profile change adjacent the needle tip, wherein the profile change is larger than a perimeter defining the opening in the proximal wall.

The reduced diameter region may be centered about the distal wall in the prepared position, with the transition regions located on opposite sides of the reduced diameter region.

The needle may further include a profile change adjacent the needle tip, wherein the profile change is larger than a perimeter defining the opening in the proximal wall.

The reduced diameter region extends from the needle hub to adjacent the needle tip in the prepared position.

The stem diameter area may be larger than the perimeter defining the opening in the proximal wall.

Another aspect of the present disclosure may include a needle device comprising: a needle having: a proximal end attached to a needle hub; a needle tip located at the distal end; a reduced diameter region located proximal to the needle tip and proximal to a shaft diameter region, the shaft diameter region having an outer dimension greater than an outer diameter dimension of the reduced diameter region; and a profile changing portion; and a needle guard comprising: a proximal wall having a proximal-facing wall surface and a distal-facing wall surface; two arms extending distally of the distal-facing wall surface, and wherein the two arms press against the reduced diameter region.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present apparatus, systems and methods will become apparent as the same become better understood with reference to the specification, claims and accompanying drawings, in which:

1A is a cross-sectional side view of a needle device according to aspects of the present disclosure in a ready position.

1B is a side view of the needle of the needle device of FIG. 1A .

1C is a close-up view of the needle device of FIG. 1A .

1D is a cross-sectional side view of the needle device of FIG. 1A , with the needle shielded in a protected position.

2A is a cross-sectional side view of a needle device according to further aspects of the present disclosure in a ready position.

2B is a side view of the needle of the needle device of FIG. 2A .

3A is a cross-sectional side view of a needle device according to other further aspects of the present disclosure in a ready position.

3B is a side view of the needle of the needle device of FIG. 3A .

3C is a close up side view of the needle guarded by the needle guard in the protected position.

DETAILED DESCRIPTION

The detailed description set forth below in conjunction with the accompanying drawings is intended as a description of currently preferred embodiments of the needle device provided in accordance with various aspects of the present assembly, system, and method, and is not intended to represent the only forms in which the present device, system, and method may be constructed or utilized. This description sets forth features and steps for constructing and using embodiments of the present assembly, system, and method in conjunction with the illustrated embodiments. However, it is to be understood that the same or equivalent functions and structures may be implemented by different embodiments that are also intended to be included within the spirit and scope of the present disclosure. As indicated elsewhere herein, identical element numbers are intended to indicate identical or similar elements or features.

Referring now to FIG. 1A , a cross-sectional side view of an embodiment of a needle device 100 (such as one included in a needle-catheter assembly or IV catheter assembly) provided in accordance with aspects of the present disclosure is shown. FIG. 1A illustrates needle device 100 in an installed or ready position, in which the needle tip extends distally from distal end 50 of the catheter tubing for accessing a patient's vasculature. In an example, needle device 100 includes a catheter hub 106 having a catheter hub body with a proximal end 130 and an internal lumen 120; a catheter tubing 108 extending distally from the distal end of catheter hub 106; a needle hub 102 attached to proximal end 130; and a cannula or needle 104 extending distally of needle hub 102 and protruding through proximal end 130 and catheter tubing 108, with a needle tip 110 extending distally of a distal opening of the catheter tubing. A needle guard 122 is slidably positioned over needle 104 and located within lumen 120 of the catheter hub. The proximal end of the catheter tube 108 may be attached to the catheter hub 106 using a bushing 145 or other conventional member.

The proximal end 130 of the catheter hub 106 has a female Luer taper with external threads 132 (also referred to as a threaded female Luer connector). The female Luer connector is configured to matingly receive a male Luer connector (such as an IV line, a Luer access connector, a syringe tip, a vent plug, an IV set, an extension set, another known connector, or a future-developed IV device with a Luer tip). Each of these components can be sized and configured to comply with at least some International Organization for Standardization (ISO) standards for female and male Luer connections, whether current or future. For purposes of this discussion, any of these components, or any category of these components, may be referred to as a male medical device or male connector. As shown, the threaded female Luer connector receives the nose section 102a of the needle hub 102. Physical abutment between the catheter hub and the needle hub is provided to set the distance the needle tip extends beyond the distal end 50 of the catheter tubing.

The inner lumen 120 of the catheter hub 106 can be divided into an open chamber 120a and a holding chamber 120b distal to the open chamber 120a. The open chamber 120a is separated from the holding chamber 120b by a profile change 136 within the inner lumen 120. The profile change 136 can be defined by a first inner diameter that is located adjacent to a second, larger inner diameter. The smaller diameter can be considered a protrusion, and the profile change 136 can therefore be referred to as a protrusion 136 or an internal protrusion, which can be configured to hold the needle guard 122 in the ready position, as shown in Figures 1A, 1C, 2A, and 3A. The protrusion 136 can also be used to hold the needle guard 122 during withdrawal of the needle 104 after a successful venipuncture.

As shown, the profile changing portion 136 can be embodied as a single continuous protrusion formed around the perimeter or inner diameter of the inner cavity 120. The protrusion 136 can have two surfaces having an apex, and wherein the two surfaces can include a taper toward the opening chamber 120a and a taper on the other side of the apex toward the retaining chamber 120b. However, the two tapered surfaces need not be symmetrical to still practice the needle device of the present invention. The tapered portion of the protrusion 136 can be selected to interact with the needle guard 122 so that the needle guard 122 can be easily installed in the ready position and easily removed during needle 104 withdrawal, as discussed in further detail below. In another example, the protrusion 136 can include two or more spaced-apart segments formed around the perimeter of the inner cavity 120 rather than a continuous annular ring.

The catheter hub 106 can include lugs 131 on its exterior that are configured to act as levers when manipulating the device 100, so as to push against the needle 104 during insertion or removal. A pair of wings 109 can extend laterally from the catheter hub 106 to support and stabilize the catheter hub 106 against the patient after a successful venipuncture. Alternatively, the lugs 131 and wings 109 can be omitted.

In the ready position, the needle 104 protrudes distally from the nose section 102a of the needle hub 102 through the catheter hub 106. The needle 104 has a needle tip 110 that extends beyond the distal end of the catheter tube 108, as previously described. The proximal end of the needle 104 can extend into the blood flashback chamber 103 of the needle hub 102, which has an opening at the proximal end 102b that can be closed by a vent plug (not shown). Optionally, the vent plug can have a sampling feature that allows blood to be collected and dispensed (such as on a blood glucose test strip or Petri dish). An exemplary hemostat can be similar to the hemostat disclosed in co-pending U.S. patent application Ser. No. 14/576,802, filed on December 19, 2014, the contents of which are expressly incorporated herein by reference.

The needle tip 110 is configured to penetrate the epidermis of a patient and access the patient's vasculature. The needle hub 102 may have a needle guard extension 125 extending from the nose section 102a into the open chamber 120a of the lumen 120 for pushing the needle guard 122 into the lumen 120b during assembly, details of which will be further explained below.

As shown in FIG1A , the needle guard 122 is positioned completely within the lumen 120 of the catheter hub 106 in the ready position. In other examples, the needle guard 122 can be positioned partially within the catheter hub body 106, or completely outside the catheter hub 106, such as in a shield or a separate needle guard housing located between the catheter hub 106 and the needle hub 102. An exemplary needle guard located in a needle guard housing is disclosed in U.S. Patent No. 8,460,247, the contents of which are expressly incorporated herein by reference. The needle guard 122 can be similar to the needle guard 122 disclosed in U.S. Patent No. 6,616,630. As shown in FIG1A , the needle guard 122 can have a proximal wall 126 and two arms 124 a, 124 b extending distally from the proximal wall 126. Each arm 124a, 124b can include an extension 93a, 93b extending from the proximal wall 126; a distal wall 90a, 90b for blocking the needle tip 110 in a protected position (as shown in FIG. 1D ); and an elbow section 94a, 94b connecting the distal wall 90a, 90b to the extension 93a, 93b.

The proximal wall 126 can include a perimeter defining a proximal opening 127 for the needle 104 to pass therethrough. The proximal wall 126 can have a proximal-facing wall surface and a distal-facing wall surface and a perimeter defining an opening formed through the proximal wall, through the proximal-facing wall surface, and through the distal-facing wall surface. The proximal opening 127 is configured to engage a profile change 128 of the needle 104 after the catheter tubing 108 is placed into the patient's vasculature. The profile change can be a corrugation, ridge, sleeve, or accumulation of material formed on the needle shaft adjacent to the needle tip 110 to prevent the needle guard 122 from displacing distally away from the needle 104 in the protected position.

A curved lip 92a, 92b can be included at each end of the distal walls 90a, 90b opposite the elbow sections 94a, 94b. When included, the curved lips 92a, 92b can reduce friction between the distal walls 90a, 90b and the shaft of the needle 104 as the needle 104 slides through the opening 127 relative to the needle guard 122. In other examples, the distal walls 90a, 90b can simply terminate in a straight edge.

When viewed in the side view of FIG. 1A in both the prepared and protected positions, the extensions 93a, 93b may intersect one another ( FIG. 1D ). In other examples, the two arms 124a, 124b extend axially toward the proximal wall 126 and do not intersect one another in the standby position. In still other examples, the needle guard includes only a single arm 124a. The needle 104 biases the two arms 124a, 124b outwardly such that, in the prepared position, the cross-sectional dimensions measured at the radially outer ends of the two elbow segments 94a, 94b are greater than the dimensions of the protrusion 136 within the lumen of the catheter hub 106. This prevents the needle guard from being pulled in a proximal direction until the two elbow segments are allowed to collapse or reduce in size when pulled in a proximal direction, thereby passing through the protrusion 136.

As shown, distal walls 90a, 90b are maintained within retaining chamber 120b by elbow sections 94a, 94b engaging protrusion 136 to prevent needle guard 122 from moving proximally out of retaining chamber 102b when in the ready position and during needle 104 removal, as will be discussed in more detail below. In some examples, only one of elbow sections 94a, 94b may engage the protrusion. The two elbow sections may be offset in the axial direction. The physical characteristics of needle 104 in the needle device of FIG. 1A are more clearly illustrated in FIG. 1B .

Referring now to FIG. 1B , the shaft of needle 104 is shown as having a nearly constant outer diameter from just proximal to the bevel section of needle tip 110 to a distance proximal to needle tip 110 and proximal to the distal end 50 of the catheter tube, at which point the outer diameter decreases to an outer diameter that is less than the diameter of the needle shaft near the needle tip. Thus, needle 104 can have a continuous shaft with two different diameters. The term diameter, as used herein, is understood to mean the outer diameter of the needle. The needle shafts of the present disclosure having different diameters can be distinguished from folds or profile changes on a single diameter shaft that are confined to a single, distinct section of the single diameter shaft and wherein the dimensions of the single diameter shaft are substantially the same distally and proximal to the folds or profile changes. Furthermore, the folds typically include an enlarged portion along one plane and a recessed portion along another plane.

As shown in Figure 1D, the needle rod includes a profile changing portion 128 and two areas of different diameters, including a rod diameter area 104a and a diameter reduction area 104b, and wherein the profile changing portion 128 is formed at the rod diameter area 104a, which has an outer diameter larger than that of the diameter reduction area 104b.

For purposes of discussion, the larger of the two diameters may be referred to as the first diameter region or rod diameter region 104a, and the smaller of the two diameters may be referred to as the second diameter region or reduced diameter region 104b. The different regions may also be referred to as segments.

Conventional extrusion or manufacturing methods can be used to form the shank diameter region 104a to form the needle to a first or original extruded diameter, and the reduced diameter region 104b can be formed by further swaging, pressing, or extruding the shank to a smaller diameter. In other examples, the shank diameter region 104a and the reduced diameter region 104b are first formed as two separate needle segments having different outer diameters, and then the two separate needle segments are attached together (such as by welding) to form the needle 104. A transition section (such as a reduced or enlarged portion) can be placed between the two different diameter segments.

As shown, the outer diameter of the shaft diameter region 104a begins to taper a distance proximal to the needle tip 110 and the distal end of the catheter tubing toward the reduced diameter region 104b. The tapered region may be referred to as a transition region 104c. Thus, the shaft of the needle 104 in FIG. 1B may have at least three regions or sections: (1) a shaft diameter region 104a; (2) a reduced diameter region 104b having an outer diameter smaller than that of the shaft diameter region 104a; and (3) a transition region 104c located between the shaft diameter region 104a and the reduced diameter region 104b.

In the example, shaft diameter region 104a extends from needle tip 110 to transition region 104c. The diameter of shaft diameter region 104a can be sized depending on the depth and type of tissue to which needle 104 is intended to penetrate. The diameter of shaft diameter region 104a can also be selected depending on the infusion rate to be allocated and, therefore, the size of the catheter tubing to be used with the shaft diameter region. For example, a 14 gauge needle selected for shaft diameter region 104a will allow needle 104 to be used with a relatively larger catheter tubing 108, which in turn allows for a relatively greater infusion rate than that achieved with a 16 gauge or 18 gauge needle.

Thus, one aspect of the present disclosure is a catheter assembly comprising a catheter tube positioned about or over a needle shaft, and wherein the needle shaft has at least two different shaft diameters, and wherein the aperture of the catheter tube is sized and shaped to fit over the larger of the two diameters. The aperture of the catheter tube may also be sized and shaped to fit over two diameter regions of the needle shaft. For example, the needle may have two different diameter sections or regions, as discussed herein, and wherein at least a portion of the two diameter regions are located within the aperture of the catheter tube distal to a nose section of the catheter hub, and the larger of the two diameters is located proximal to a distal opening of the catheter tube.

The distal end 50 of the catheter tube 108 can be necked or tapered to form a seal with the larger of the two diameters 104a near the needle tip 110. Furthermore, because the transition region 104c and, if applicable, the portion of the needle shaft having the smaller of the two diameters (such as the reduced diameter region 104b) are located within the bore of the catheter tube, the needle assembly of the present invention has at least two distinct annular spaces. For example, the annular space between the catheter tube and the needle at the shaft diameter region 104a proximal to the tapered distal end 50 will be smaller or narrower than the annular space between the catheter tube and the needle at the reduced diameter region 104b. For clarity, the catheter tube is understood to have a generally constant outer and inner diameter, except for the tapered distal end 50 and the tapered proximal end for securing the catheter tube to the catheter hub.

One aspect of the present disclosure is further understood to include a variable annular space region at the transition region 104c of the needle shaft. For example, because the transition region 104c tapers from the shaft diameter region 104a to the reduced diameter region 104b, the annular space at the transition region 104c is variable along at least a portion of the length of the transition region 104c.

In the prepared position, the distal end 50 of the catheter tubing 108 can be tapered inwardly to form a seal against the shaft diameter region 104a and facilitate insertion of the needle and catheter tubing combination into the patient. The shaft diameter region 104a extends from the needle tip 110 to at least just proximal to the tapered distal end 50 of the catheter tubing 108, such that at least some portion of the shaft diameter region 104a is proximal to the tapered distal end 50 and forms an annular space with the interior of the catheter tubing.

In some examples, the length of the shaft diameter region 104a proximal to the distal end 50 (which can be referred to as the shaft diameter region recessed length) is at least 0.1 times the length of the shaft diameter region 104a distal to the distal end 50 of the catheter tubing. In some examples, the shaft diameter region recessed length is from about one-half to about 80% of the total length of the needle shaft. Thus, if the shaft diameter region recessed length is relatively short (e.g., only about 1 times the length of the portion extending distal to the distal end 50), the remaining portion of the needle located within the bore of the catheter tubing will include the transition region 104c and the reduced diameter region 104b.

In a specific example, the shaft diameter region recessed length is approximately 3 times the length distal to the distal end 50 of the catheter tubing to approximately 10 times the length distal to the distal end 50 of the catheter tubing. This configuration (where the shaft diameter region recessed length is proximal to the reduced distal end 50 of the catheter tubing) allows the needle to support the distal end and distal section of the catheter tubing during intubation; allows the catheter tubing to be increased in size to accommodate a relatively larger diameter section (i.e., the shaft diameter region 104a) and to have a reduced diameter region 104b at the proximal end for use with a needle guard, so that the two arms of the needle guard are not biased outward by the needle by the same amount as they would be if the full length of the needle had the same diameter as the shaft diameter region 104a. Furthermore, because the catheter tubing size is increased in size to accommodate the larger of at least two cannula diameters, a greater infusion flow rate can be forced through the catheter tubing than a comparable catheter tubing using only the reduced diameter region 104b.

Referring back to FIG. 1A , a transition region 104c is shown located at or near the distal end of the catheter hub 106 and having a tapered section that tapers inwardly toward the reduced diameter region 104b. The transition region 104c can taper gently or abruptly from the shaft diameter region 104a to the reduced diameter region 104b. In other words, the length of the transition region can vary, with a longer length for a gentle taper and a shorter length for a relatively steeper taper. Alternatively, a step can be included instead of the transition region 104c to connect the shaft diameter region 104a to the reduced diameter region 104b. When a step (which can be closer to an abrupt reduction) transitions from the larger diameter region to the smaller diameter region, it can be considered a transition region.

Generally, the more gradual the taper, the lower the frictional losses through the bore 104d of the needle 104 at the transition. A stepped transition will have higher frictional losses than a more gradual taper. It is undesirable that the reduced diameter region 104b causes significantly slower blood return after a successful venipuncture. Therefore, the primary blood return time is not significantly affected using the dual-diameter cannula of the present disclosure. Externally, the more gradual the taper, the less friction and resistance there will be when the arms 124a, 124b of the needle guard (e.g., the distal end of the needle guard) contact the cannula during cannula withdrawal, thereby enabling smoother removal.

Reduced diameter region 104b may extend from transition region 104c to the proximal end of needle 104. The taper of transition region 104c and the diameter of reduced diameter region 104b may be produced by mechanical swaging or controlled extrusion of the drawn cannula before or after needle tip 110 is formed.

In some examples, a second transition region is included proximal to transition region 104c to create a second reduced diameter region proximal to reduced diameter region 104b. The end of the second reduced diameter region in this alternative embodiment can be attached to a needle hub. For example, a needle according to aspects of the present disclosure can include: a first large diameter section having a 14 gauge needle section at the needle tip; a transition section; a 16 gauge needle section; a second transition section; and an 18 gauge needle section at the proximal end of the needle shaft that is attached to the needle hub.

FIG1C shows a close-up view of the needle guard 122 in the catheter hub 106 in the prepared position, with the curved lips 92a, 92b of the two distal walls 90a, 90b pressing against the reduced diameter region 104b of the needle in the prepared position. When the needle device 100 is assembled, the needle guard 122 can be slidably positioned on the needle 104 proximal to the needle tip 110 and proximal to the profile change 128. The proximal end 104d of the needle is then placed through the needle retaining aperture of the needle hub and secured thereto (e.g., by an adhesive). The proximal wall 126 of the needle guard 122 can be positioned either to contact the needle guard extension 125 on the needle hub or to be distal to or spaced from the needle guard extension 125.

Proximal wall 126 can abut seating surface 125a of needle guard extension 125 and align with vertical support wall 125b parallel to the axis of needle 104. Curved lips 92a, 92b or distal walls 90a, 90b (if no curved lips are included) contact reduced diameter region 104b. In other words, when the two curved lips or the two distal walls contact the sides of the needle, reduced diameter region 104b of the shaft biases elbow sections 94a, 94b outward. When the two distal walls or the curved lips do not contact the sides of the needle, the elbow sections are allowed to collapse or reduce in cross-sectional size, as shown in FIG. 1D . With the needle guard 122 spaced from the needle guard extension 125 during installation, the proximal wall 126 is distal to the needle guard extension 125, with the curved lip 92a, 92b or the distal wall 90a, 90b pressing against the shaft diameter region 104a, the transition region 104c, or the reduced diameter region 104b, depending on where the needle guard is initially positioned along the axial length of the needle.

With the needle guard 122 positioned over the needle 104 and the elbow segments 94a, 94b biased outward by the needle 104, the needle 104 and needle hub 102 can be inserted distally into the catheter hub 106 and into the lumen 120 through the proximal opening 130. During insertion of the needle 104, the elbow segments 94a, 94b eventually encounter the protrusion 136, which prevents the needle guard 122 from moving further distally into the retention chamber 120b unless the two elbow segments are compressed and/or deflected. At this point, the needle 104 can still be inserted further into the catheter hub 106 and into the catheter tubing by advancing the needle 104 distally relative to and through the opening 127 defined in the proximal wall until the proximal wall 126 is pressed against the seating surface 125a of the needle guard extension 125 on the needle hub on its proximal-facing surface. At approximately or about the same time, the elbow sections 94a, 94b are urged distally to press against the inner protrusion 136. This point in the installation may be referred to as the pre-seated position of the needle guard.

From the pre-seated position of the needle guard, additional insertion force at the needle hub 102 causes the needle guard extension 125 to be pushed in the distal direction against the sidewall, forcing the elbow segments 94a, 94b against the protrusion 136 and causing the elbow segments 94a, 94b and distal walls 90a, 90b to resiliently flex radially inwardly toward the needle 104. With the elbow segments 94a, 94b displaced radially inwardly, the elbow segments 94a, 94b of the arms 124a, 124b can now slide under and/or through the protrusion 136 in the distal direction.

Once the elbow segments 94a, 94b exit the protrusion 136 and enter the holding chamber 120b, the elbow segments 94a, 94b and distal walls 90a, 90b can resiliently rebound outward within the holding chamber 120b and assume a seated position. With the distal walls 90a, 90b of the needle guard 122 positioned within the holding chamber 120b, the needle hub 102 can be further inserted until a physical stop is achieved between the catheter hub and the needle hub, and the needle tip 110 extends distally of the distal opening 50 of the catheter tubing. In the ready position, both the protrusion 136 and the needle guard extension 125 prevent the elbow segments 94a, 94b from moving proximally out of the holding chamber 120b.

For a given female luer size of a catheter hub, a predetermined space or void can be used to include various features within the catheter hub. Thus, by utilizing a needle shaft having at least two diameter sections (such as the needle of FIG. 1B ), it is easier to assemble a needle guard (such as those described elsewhere herein) into a catheter hub, even though the needle has a relatively large needle diameter section for use with relatively large catheter tubing. For example, a catheter assembly including a needle shaft having a 14 gauge shaft diameter region 104a and an 18 gauge reduced diameter region 104b, connected to each other by a transition region 104c, can be used with a needle guard. The catheter tubing can be sized for a 14 gauge needle section. This allows for a greater flow rate through the catheter tubing than through a catheter tubing sized for an 18 gauge needle. However, due to the 18 gauge reduced diameter region 104b at the proximal end of the needle shaft, the needle guard can be slidably positioned over the 18 gauge needle region and seated inside the catheter hub with greater clearance than when the needle is made entirely of a 14 gauge needle. As an example, the difference in diameter between an 18 gauge needle and a 14 gauge needle allows other components inside the catheter hub, such as the needle guard, to utilize the additional space. Thus, in the pre-seated position, the elbow sections 94a, 94b of the needle guard are not biased outwardly as much when biased by the 18 gauge reduced diameter region of the needle shaft of the present disclosure as compared to when biased by a 14 gauge needle, and therefore the elbow or elbow sections do not have to deflect as much to slide past the protrusion 136 to be placed in the seated position. In the seated position of the needle guard, as shown in FIG. 1C , because the needle guard is biased by the relatively smaller needle diameter section of the stem, the undercut or maximum inner diameter of the catheter hub 106 where the elbow of the needle guard is located can also be reduced to achieve greater precision and shorter molding cycle time.

Another aspect of the present disclosure is understood to include a needle assembly comprising a catheter hub having a catheter tubing and a needle hub having a needle. The needle may include at least two regions or sections of different diameters connected to each other by a transition region. The catheter tubing can be sized for the larger of the two needle diameters to accommodate an infusion flow rate greater than that achieved if the needle were sized only for the smaller of the two diameter regions. Furthermore, because the needle includes a reduced diameter section, the reduced diameter does not bias the two arms radially outward by the same amount as when the arms of the needle guard are biased outward by the larger diameter region of the needle shaft. Thus, the needle guard can be seated within the catheter hub without excessively deflecting or compressing the two elbow sections of the needle guard when passing over a protrusion within the catheter hub to the same extent or amount as when the same needle guard is seated within the same catheter hub but using a needle having a single diameter, where the single diameter is the same as the larger of the two diameters of the needle of the present invention.

After a successful venipuncture, the needle hub 102 and needle 104 can be separated from the catheter hub 106 by holding the catheter hub 106 and pulling the needle hub 102 proximally away from the catheter hub 106. As the needle 104 is pulled from the catheter hub 106 and the needle guard is held by the internal protrusion 136, the reduced diameter region 104b slides relative to and contacts the curved lips 92a, 92b. Then, as the needle continues to be withdrawn proximally, the needle's transition region 104c and shaft diameter region 104a slide relative to and contact the curved lips 92a, 92b.

During needle withdrawal, the needle guard 122 can move proximally until it contacts the inner protrusion 136 (if it is not already contacting the inner protrusion). In one example, when the curved lips 92a, 92b press against the sides of the shaft diameter region 104a during needle withdrawal, the elbow sections 94a, 94b approach the inner wall of the retaining chamber 120b, but do not contact the inner wall of the retaining chamber 120b. In another example, when the curved lips 92a, 92b press against the shaft diameter region 104a during needle withdrawal, the elbow sections 94a, 94b contact the inner wall of the retaining chamber 120b.

The needle continues to move in the proximal direction until the needle tip 110 moves to just proximal to the distal walls 90a, 90b or proximal to the two curved lips 92a, 92b, as shown and discussed below with reference to FIG1 D. At about the same time or shortly thereafter, the profile change 128 contacts the perimeter of the opening in the proximal wall of the needle guard 122.

Referring now to Figures 1C and 1D, the elbow section of the needle guard 122 is positioned adjacent to the protrusion 136 in the retaining chamber 120b until the needle tip 110 moves just proximal to the two curved lips 92a, 92b. At this point, and no longer biased by the needle, the two arms 124a, 124b move radially inward, primarily due to the spring force built up by the selected spring steel material and the specific bend prior to assembly onto the needle shaft, and the distal walls 90a, 90b cover the needle tip 110 in the protected position. With the needle tip 110 protected by the needle guard 122 and the elbow moved radially inward and no longer engaged or obstructed by the protrusion 136, the needle 104 can be further withdrawn proximally away from the catheter hub with the needle guard 122 covering the needle tip 110. The profile change 128 engages the perimeter defining the opening 127 in the proximal wall 126 to pull the needle guard 122 proximally away from the catheter hub 106 with the needle.

In other examples, the needle device 100 can include a valve and a valve opener within the catheter hub 106 for restricting flow in the proximal direction, such as for preventing blood flow from the open proximal end of the catheter hub after a successful venipuncture. The valve and valve opener can be similar to those disclosed in U.S. Patent No. 9,149,625, the contents of which are expressly incorporated herein by reference.

Turning now to FIGURES 2A and 2B , a cross-sectional side view of a needle device 100 and a side view of an alternative needle 104 are shown, provided in accordance with further aspects of the present disclosure. The needle device 100 includes a needle hub 102, a needle 104 extending distally of the needle hub 102, a catheter hub 106, a catheter tubing 108 extending distally of the distal end of the catheter hub 106, and a needle guard 122 positioned in a ready position within the catheter hub 106. The embodiment of the needle device 100 of FIGURE 2A is similar to the needle device 100 of FIGURE 1A , except that the needle 104, as shown in FIGURE 2B , has two transition regions 104c. The second transition region 104c reverses the needle's expansion from the reduced diameter region 104b to a second shaft diameter region 104a proximal to the reduced diameter region 104b. The reduced diameter region 104b of the needle 104 of FIGURE 2B extends for a certain length, after which the second transition region 104c increases the shaft's expansion back to the shaft diameter region 104a. In an example, the length of the reduced diameter region 104b can be from about 20% to about 90% of the length of the needle guard. In other examples, the length of the reduced diameter region 104b can be longer than the length of the needle guard, such as from 150% to 300% of the length of the needle guard. In other examples, the minimum limit can be set by the shape of the distal walls 90a, 90b of the needle guard.

Thus, one aspect of the present disclosure is understood to include a needle assembly comprising a catheter hub having a catheter tubing and a needle hub having a needle. The needle may include at least two regions or sections of different diameters and at least two transition regions or sections. In this embodiment, the needle may include a shaft diameter region 104a, a transition region 104c that tapers proximally from a larger diameter to a smaller diameter, a reduced diameter region 104b, a transition region 104c that widens proximally from a smaller diameter to a larger diameter, and a shaft diameter region 104a proximal to the second transition region 104c. The catheter tubing may be sized for the larger of the two needle diameters to accommodate an infusion flow rate greater than that which would be accommodated if the catheter tubing were sized only for the smaller of the two needle diameter regions. Furthermore, because the needle includes a reduced diameter section, the reduced diameter does not bias the two arms of the needle guard radially outward by the same amount as when the arms are biased outward by the larger diameter region of the needle shaft, as discussed elsewhere herein. Thus, the needle guard can be seated inside the catheter hub without having to excessively deflect or compress the two elbow sections of the needle guard when passing through the protrusion inside the catheter hub to the same extent or amount as when the same needle guard is seated inside the same catheter hub but using a needle having a single diameter, and wherein the single diameter is the same as the larger of the two diameters of the needle of the present invention.

The two shaft diameter regions 104a of the needle of the present invention have substantially the same outer diameter, which is greater than the diameter of the reduced diameter region 104b. Specifically, as shown in FIG2B , the needle 104 has a shaft diameter region 104a extending proximally from the needle tip 110 to a transition region 104c, which tapers inwardly to the reduced diameter region 104b. The reduced diameter region 104b extends a certain distance to another transition region 104c, which widens outwardly to another shaft diameter region 104a extending to the needle hub 102. The more gradual the taper (or widening) in these transition regions 104c, the lower the friction loss through the bore 104d of the needle 104. In other examples, one or more of the transition regions 104c may include a step rather than a gradual taper (or widening). The reduction in diameter of the bore 104d of the needle 104 at the transition region 104c and the reduced diameter region 104b is not significantly reduced by the formation of the reduced diameter region 104b. Furthermore, at least a portion of the shaft diameter region 104 adjacent the needle tip and the first transition region 104c are located within the bore of the catheter tubing proximal to the distal opening of the catheter tubing.

As shown, the reduced diameter region 104b can be located along the length of the needle in an area where the two curved lips 92a, 92b, or the distal walls 90a, 90b (if no curved lips are included) of the needle guard 122 contact the needle shaft, such as when in the standby position. Thus, as shown in FIG2A , the two curved lips 92a, 92b contact the reduced diameter region 104b in the ready position, which is located between the two transition regions 104c. In other words, the reduced diameter region 104b comprises a short length extending along the length of the needle and, in the ready position, is positioned adjacent to the protrusion 136 or centrally located within the retaining chamber 102b. The two curved lips 92a, 92b contact the reduced diameter region 104b, which is positioned adjacent to the internal protrusion 136 in the axial position.

The localized area of reduced diameter region 104b can be created by mechanically swaging or controlled extrusion of the drawn sleeve, with the localized area being selected to be where the distal sidewalls 90a, 90b or curved lips 92a, 92b press against the reduced diameter region 104b in the prepared position. In other words, the localized area is located at or near the protrusion 136 in the prepared position, and the distal sidewalls 90a, 90b or curved lips 92a, 92b of the needle guard press against the localized area. Because the reduced diameter region 104a of the needle 104 of FIG. 2B extends only a short distance, rather than extending to the proximal end of the needle 104 (as shown with reference to the needle 104 of FIG. 1B ), the mechanical swaging, forging, or controlled extrusion used to form the reduced diameter region 104a is limited to a relatively shorter length than that used for the needle of FIG. 1B .

2A , the needle guard 122 can be slidably positioned over the needle 104 proximal to the needle tip 110, with the proximal wall 126 contacting or positioned distal to, such as spaced from, the needle guard extension 125. With the needle guard 122 positioned over the needle 104 and the needle attached to the catheter hub, the needle 104 can then be inserted into the catheter hub 106 until the catheter hub physically stops the needle hub.

As described above with respect to assembly of the needle device 100 of FIG1A , during insertion of the needle 104, the elbow sections 94a, 94b of the needle guard will advance distally against the proximal side of the protrusion 136, which impedes or limits further distal movement of the needle guard 122 into the retaining chamber 120b. At this point, the needle 104 can be further inserted into the catheter hub 106 by sliding the needle 104 through the opening 127 in the proximal wall 126 of the needle guard 122 until the needle guard extension 125 of the needle hub abuts the sidewall 126. At this point in assembly, as discussed above with respect to the needle assembly of FIG1A , the two curved lips 92a, 92b or distal walls 90a, 90b are biased outwardly by the reduced diameter region 104b.

With the needle guard extension 125 pressed distally against the proximal sidewall 126, the additional force applied to the needle hub 102 causes the elbow segments 94a, 94b to push against the protrusion 136, causing the elbow segments 94a, 94b and distal sidewalls 90a, 90b to elastically flex inward against the reduced diameter region 104b of the needle. The elbow segments 94a, 94b (whose cross-sectional dimensions have been reduced due to the deformation) can now slide through the internal protrusion 136 and then elastically spring back outward once the elbow segments 94a, 94b are located within the retaining chamber 120b. By utilizing a relatively smaller diameter segment to bias the arms during installation, more space or slack is available for the needle guard so that the elbow segments are not deflected to the same amount or degree as compared to a single-diameter rod having the same dimensions as the larger of the two diameter segments of the present device.

With the distal walls 90a, 90b of the needle guard 122 positioned within the holding chamber 120b, the needle hub 102 can be further inserted until physically stopped by the catheter hub 106 in the ready position. In the ready position, both the protrusion 136 and the needle guard extension 125 prevent the elbow sections 94a, 94b from moving proximally out of the holding chamber 120b. After a successful venipuncture, the needle 104 can be pulled from the catheter hub 106 with the needle tip 110 protected by the needle guard 122 in the protected position, as described above with reference to the needle device of FIG. 1D .

Therefore, one aspect of the present disclosure is a catheter assembly comprising a catheter tube positioned around or over a needle shaft, wherein the needle shaft has at least two different shaft diameters, and wherein the aperture of the catheter tube is sized and shaped to fit over the larger of the two diameters. The aperture of the catheter tube can also be sized and shaped to fit over two diameter regions of the needle shaft. The distal end 50 of the catheter tube 108 can be necked or tapered to form a seal with the larger of the two diameters 104a near the needle tip 110. Furthermore, because the transition region 104c and the needle shaft having the smaller of the two diameters (such as the reduced diameter region 104b) are located within the aperture of the catheter tube, the needle assembly of the present invention has at least two different annular spaces. For example, the annular space between the needle and the catheter tube at the shaft diameter region 104a proximal to the tapered distal end 50 will be smaller or narrower than the annular space between the needle and the catheter tube at the reduced diameter region 104b.

One aspect of the present disclosure is further understood to include a variable annular space region at the transition region 104c of the needle shaft. For example, because the transition region 104c tapers from the shaft diameter region 104a to the reduced diameter region 104b, the annular space at the transition region 104c is variable along at least a portion of the length of the transition region 104c. Still further, because the needle of the present invention has a second transition region 104c and a separate shaft diameter region 104a proximal to the second transition region 104c, the needle device of the present invention has additional annular space, namely, a variable annular space region at the second transition region 104c and a second, smaller annular space at the second shaft diameter region 104a proximal to the second transition region.

3A and 3B , there are shown a cross-sectional side view of a needle device 100 and a side view of an alternative needle 104 provided in accordance with further aspects of the present disclosure. The needle device 100 includes a needle hub 102, a needle 104 extending distally of the needle hub 102, a catheter hub 106, a catheter tube 108 extending distally of a distal end of the catheter hub 106, and a needle guard 122 positioned in a prepared position within the catheter hub 106.

The embodiment of needle device 100 of FIG3A is similar to needle device 100 of FIG1A , except that transition region 104 c of needle 104 (between shaft diameter region 104 a of needle 104 and reduced diameter region 104 b of needle 104 ) extends closer to needle tip 110 than the transition region and shaft diameter region of the needle of FIG1B .

In an example, the needle 104 shown in FIG3B has a shaft diameter region 104a that transitions to a reduced diameter region 104b just proximal to the tapered distal opening 50 of the catheter tube, which forms a seal with the shaft diameter region 104a. In addition, the shaft diameter region 104a itself, together with the transition region 104c, can serve as a profile change 128 for engaging the opening on the proximal wall of the needle guard. Alternatively, the profile change 128 can be formed on the transition region 104c, as shown in FIG3C and discussed below. The reduced diameter region 104b can be produced by mechanically swaging or controlled extrusion of the drawn sleeve before or after grinding.

3A and similar to the embodiment of FIG1A , a portion of the shaft diameter region 104a and the transition region 104c are located within the bore of the catheter tubing in the prepared position proximal to the distal opening 50. Thus, the catheter tubing is selected to fit within the larger diameter region surrounding the needle, while the reduced diameter region at the proximal end of the shaft facilitates assembly of the needle guard into the catheter hub, as previously discussed with reference to the needle assembly of FIG1A .

When the needle device 100 of FIG3A is assembled, the needle guard 122 is slidably positioned over the needle 104 proximal to the needle tip 110, with the proximal wall 126 contacting or positioned distal to, such as spaced apart from, the needle guard extension 125. The two curved lips 92a, 92b or the distal walls 90a, 90b (if no curved lips are included) are biased against the reduced diameter region 104b. With the needle guard 122 positioned over the reduced diameter region 104b and the needle attached to the needle hub, the needle 104 can be inserted distally into the catheter hub 106.

As described above with respect to assembly of the needle device 100 of FIG1A , during insertion of the needle 104, the elbow segments 94a, 94b advance distally against the protrusion 136, which hinders further distal movement of the needle guard 122 into the retaining chamber 120b. However, the needle can still be advanced distally by moving relative to the needle guard and sliding through the opening 127 of the proximal wall 126 of the needle guard 122 until the needle guard extension 125 abuts the sidewall 126. With the needle guard extension 125 pressed against the sidewall 126, additional distally directed force can be applied to the needle hub 102 to push the elbow segments 94a, 94b against the protrusion 136, thereby elastically flexing the needle guard and radially compressing the elbows. The elbow segments 94a, 94b (now with a reduced cross-sectional size) slide over the protrusion 136 and, once located within the retaining chamber 120b, elastically spring back outward. The needle hub 102 can be advanced until physically stopped by the catheter hub 106 in the ready position. In the ready position, both the protrusion 136 and the needle guard extension 125 prevent the elbow segments 94a, 94b from moving proximally out of the retaining chamber 120b, and the needle tip extends distally of the distal opening 50 of the catheter tubing. By utilizing a relatively smaller diameter segment to bias the arm during installation, more space or slack is available for the needle guard so that the elbow segment is not deflected to the same amount or degree as with a single diameter rod, and in the case of a single diameter rod having the same dimensions as the larger of the two diameter segments of the device of the present invention.

Turning now to FIG. 3C , a side view of another embodiment of a needle 104 and needle guard 122, discussed elsewhere herein, is shown in a protected position, with the needle tip 110 covered by two distal walls 90 a, 90 b, such as after a successful venipuncture and during needle withdrawal from a needle hub. As shown, the curved lips 92 a, 92 b of the needle guard 122 are no longer biased against the needle 104. A profile change 128 on the needle 104 is shown adjacent to the proximal wall 126, and more specifically, adjacent to the perimeter defining the opening 127 in the proximal wall 126, to prevent the needle guard 122 from displacing distally away from the needle tip 110 after the needle tip 110 has been safely secured in the protected position. The profile change 128 is located in the transition region 104 c, as shown in FIG. 3C . However, the profile change 128 could be located in either the shaft diameter region 104 a or the reduced diameter region 104 b. 3A and 3B , the shaft diameter region 104 a itself may serve as the profile change 128. In the guard position, the two curved lips 92 a, 92 b or distal walls 90 a, 90 b prevent the needle tip 110 from moving distally of the needle guard 122, and the engagement between the profile change 128 and the opening 127 prevents removal of the needle guard 122 from the needle 104.

Methods of making and using needle devices shown and described elsewhere herein are within the scope of the present disclosure.

While limited embodiments of needle devices and components thereof have been expressly described and illustrated herein, numerous modifications and variations will be apparent to those skilled in the art. Furthermore, it is to be understood and contemplated that features explicitly discussed with respect to one needle device embodiment may be employed to include features of another needle device embodiment, provided that the functions are compatible. For example, the embodiment of Figures 2A through 3C may include various features disclosed with respect to the embodiment of Figures 1A through 1D, provided that the functions do not conflict. Therefore, it will be understood that needle devices and components thereof constructed in accordance with the principles of the disclosed devices, systems, and methods may be embodied in manners other than as expressly described herein. The present disclosure is further defined in the appended claims.

Claims (21)

1. A needle device (100), comprising: The catheter hub (106) has a body defining an inner lumen (120) and a proximal opening (130). The catheter body (108) extends distally to the catheter hub (106) and includes a distal opening (50). Needle hub (102); A needle (104) extending distally to the needle hub (102), the needle (104) comprising a shaft and a needle tip (110) extending distally to the distal opening (50) of the catheter body (108) in a ready position, the needle (104) comprising: a first shaft diameter region (104a); a first transition region (104c) tapering from a large diameter to a smaller diameter along the proximal direction; a diameter reduction region (104b); and a second transition region (104c) widening from a small diameter to a larger diameter along the proximal direction; and a second shaft diameter. Region (104a), the second rod diameter region (104a) is located proximal to the second transition region (104c), the outer diameter of the needle (104) at the first rod diameter region (104a) and the second rod diameter region (104a) is greater than the outer diameter of the needle (104) at the diameter reduction region (104b), and at least a portion of the first rod diameter region (104a) and the second rod diameter region (104a) and the first transition region (104c) and the second transition region (104c) are located in the hole of the catheter body (108) proximal to the distal opening (50); and The needle protector (122) includes a proximal sidewall (126) and at least one arm (124a, 124b) extending distally from the proximal sidewall (126), the at least one arm (124a, 124b) pressing against the diameter reduction region (104b) in the ready position and protecting the needle tip (110) in the protective position. 2. The needle device (100) according to claim 1, wherein the needle protector has two arms (124a, 124b) that press against the diameter reduction region (104b) in the prepared position. 3. The needle device according to claim 2, wherein each of the two arms (124a, 124b) of the needle protector (122) includes a distal wall (90a, 90b) and an elbow segment (94a, 94b), and at least one of the elbow segments engages in the prepared position a protrusion (136) extending from the inner surface of the cavity (120), and the diameter-reducing region (104b) of the needle (104) biases the two arms (124a, 124b) outward. 4. The needle device (100) according to claim 3, wherein the curved lips (92a, 92b) extend from each distal sidewall (90a, 90b) and press against the diameter-reducing region (104b) in the prepared position. 5. The needle device (100) according to any one of claims 1-4, wherein the diameter reduction region (104b) extends from the needle hub (102) to the distal end of the catheter hub (106) in the prepared position. 6. The needle device (100) according to any one of claims 1-4, wherein the needle (104) further includes a contour-changing portion (128) adjacent to the needle tip (110), wherein the contour-changing portion (128) is larger than the boundary defining the opening on the proximal sidewall (126). 7. The needle device according to any one of claims 1-4, wherein the needle (104) further includes a rod diameter region (104a) proximal to the diameter reduction region (104b). 8. The needle device (100) according to any one of claims 1-4, wherein the needle (104) further includes a contour-changing portion (128) adjacent to the needle tip (110), wherein the contour-changing portion (128) is larger than the boundary defining the opening on the proximal sidewall (126). 9. The needle device (100) according to any one of claims 1-4, wherein the diameter reduction region (104b) extends from the needle hub (102) to the vicinity of the needle tip (110) in the prepared position. 10. The needle device (100) according to any one of claims 1-4, wherein the rod diameter region (104a) is larger than the boundary defining the opening on the proximal sidewall (126). 11. A method for manufacturing a needle device (100), the method comprising: The catheter body (108) is attached to the catheter hub (106), the catheter hub (106) including a hub body including an outer surface and an inner surface defining an inner lumen (120); The needle (104) is protruding through the catheter body (108) such that the needle tip (110) of the needle (104) extends distally to the distal end (50) of the catheter body (108) in the ready position. The needle (104) has: a proximal end attached to a needle hub (102); and a rod comprising: a first rod diameter region (104a); a first transition region (104c) tapering from a large diameter to a smaller diameter proximally; a diameter reduction region (104b); a second transition region (104c) widening from a small diameter to a larger diameter proximally; and a second rod diameter region (104a) located proximal to the second transition region (104c); and A needle protector (122) is provided, the needle protector (122) comprising a proximal wall (126) and two arms (124a, 124b) extending distally from the proximal wall (126), the two arms (124a, 124b) pressing against the diameter-reducing region (104b) in the prepared position; and Wherein, the first rod diameter region (104a) and the second rod diameter region (104a) have an outer diameter that is larger than the outer diameter of the diameter reduction region (104b), and wherein at least a portion of the first rod diameter region (104a) and the second rod diameter region (104a) and the first transition region (104c) and the second transition region (104c) are located in the preparation position in the hole of the catheter body (108) near the distal end (50) of the catheter body (108). 12. The method of claim 11, further comprising pressing the two arms (124a, 124b) against the diameter-reducing region (104b) in the prepared position. 13. The method according to any one of claims 11-12, further comprising, in the prepared position, engaging an elbow-shaped section (94a, 94b) of at least one of the arms (124a, 124b) against a protrusion (136) inside the lumen (120) of the catheter hub (106), and the two arms being outwardly biased by a diameter-reducing region (104b) of the needle (104). 14. The method according to any one of claims 11-12, wherein the curved lip (92a, 92b) extending from the distal sidewall (90a, 90b) of each arm (124a, 124b) presses against the diameter-reducing region (104b) in the prepared position. 15. The method according to any one of claims 11-12, wherein the diameter reduction region (104b) extends from the needle hub (102) to the distal end of the catheter hub (106) in the prepared position. 16. The method according to any one of claims 11-12, wherein the needle (104) further comprises a contour-changing portion (128) adjacent to the needle tip (110), wherein the contour-changing portion (128) is larger than the boundary defining the opening on the proximal sidewall (126). 17. The method according to any one of claims 11-12, wherein the diameter reduction region (104b) is centered in the prepared position with respect to the distal sidewalls (90a, 90b) of each arm (124a, 124b), and the transition region (104c) is located on the opposite side of the diameter reduction region (104b). 18. The method according to any one of claims 11-12, wherein the needle (104) further comprises a contour-changing portion (128) adjacent to the needle tip (110), wherein the contour-changing portion (128) is larger than the boundary defining the opening on the proximal sidewall (126). 19. The method according to any one of claims 11-12, wherein the diameter reduction region (104b) extends from the needle hub (102) to adjacent to the needle tip (110) in the prepared position. 20. The method according to any one of claims 11-12, wherein the rod diameter region (104a) is larger than the boundary defining the opening on the proximal sidewall (126). 21. A needle device (100), comprising: A needle (104) having: a proximal end attached to a needle hub (102); a needle tip (110) located at a distal end; a first rod diameter region (104a); a first transition region (104c) tapering from a large diameter to a smaller diameter along a proximal direction; a diameter reduction region (104b) located proximal to the needle tip (110); a second transition region (104c) widening from a small diameter to a larger diameter along a proximal direction; a second rod diameter region (104a) located proximal to the second transition region (104c), wherein the first rod diameter region and the second rod diameter region have an outer dimension larger than the outer diameter dimension of the diameter reduction region (104b); and a contour changing portion (128); and A needle protector (122) comprising: a proximal wall (126) having a proximal wall surface and a distal wall surface; two arms (124a, 124b) extending distally to the distal wall surface, wherein the two arms (124a, 124b) press against the diameter-reducing region (104b).