Methods and apparatus for vascular access

Abstract

A catheter assembly configured to be used with a medical device is provided herein. The catheter assembly can include a catheter hub having an internal chamber and a valve disposed within the internal chamber. The valve can include a distal portion, a proximal portion, and a sidewall extending therebetween and defining the interior of the valve. The valve can include a barrier layer having a concave shape extending from the sidewall into the interior of the valve at the distal portion. The barrier layer can have at least one slit extending therethrough, and the at least one slit is in a normally closed configuration to prevent fluid from passing through the barrier layer. The catheter assembly can further include a sealing ring circumferentially disposed at the distal end of the valve distal to the barrier layer. The sealing ring can form a seal between the valve and the internal chamber at the distal end.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Patent Application No. 63 / 367,403, filed Jun. 30, 2022. This application is also a continuation - in - part of U.S. Patent Application No. 18 / 170,835, filed Feb. 17, 2023, which is a continuation of U.S. Patent Application No. 17 / 812,397, filed Jul. 13, 2022, now U.S. Patent No. 11,607,525, which claims priority to U.S. Patent Application No. 63 / 367,403, filed Jun. 30, 2022. This application is also a continuation - in - part of U.S. Patent Application No. 17 / 822,975, filed Aug. 29, 2022, which claims priority to U.S. Patent Application No. 63 / 367,403, filed Jun. 30, 2022. The entire contents of each of these are hereby incorporated by reference in their entirety.

[0002] The present disclosure relates to a valve assembly that selectively enables fluid flow through a medical device and has improved ability to prevent fluid leakage from the proximal end of the device. Such an improved valve assembly also prevents fluid leakage after repeatedly inserting and removing medical instruments or other devices, such as catheters, introducers, tubes, lines, and ports that can be used in blood vessels, through the valve. The valve assembly can also be used as a connection for needles (e.g., fistula needles), hemodialysis circuits, feeding tubes, urethral drainage catheters, or any other suitable means.

Background Art

[0003] A catheter enables a healthcare provider to inject or remove fluid from a patient. For example, a catheter can function as a conduit to inject fluid such as saline, therapeutic substances, and / or nutritional fluids into a patient. Alternatively, a catheter can also withdraw fluid such as blood or other body fluids required by a particular medical procedure. When a healthcare provider intends to place a catheter intravascularly, the healthcare provider will look for backflow of blood (a "flashback") into the catheter to confirm that the catheter opening is placed intravascularly. The number of different catheter insertion procedures and techniques is large and can include using a needle, dilator, stylet, or other medical device within the catheter when it is placed.

[0004] When properly positioned, the hub of the catheter (or a medical device placed within the catheter) can be coupled to an adapter (usually a luer fitting) to enable fluid coupling of the catheter to a fluid source or reservoir. However, if the connection between the catheter and the reservoir accidentally disconnects, there is a risk that the patient may bleed or air may be entrained leading to embolism, both of which can endanger the patient's life. The connection may accidentally disconnect if the fitting is not tightened securely. The fitting may also loosen from patient movement, poverty jerks, or other patient interference. Further, if the patient has any bloodborne pathogens (e.g., HIV, hepatitis, etc.), it can be fatal if a caregiver is exposed to the blood. Therefore, catheter insertion requires keeping the access point hygienic. During the period of catheter insertion and adapter coupling, there is a possibility that body fluid may escape through the catheter, causing an unhygienic condition for the healthcare provider who has to handle the catheter for adapter coupling and / or remove the medical device inserted through the catheter. Caregivers typically cover the open connection port with their finger to reduce blood flow until the mating connection is made. Since blood can be a medium for bacterial growth, the chance of infection may increase due to the exposure during catheter insertion.

Summary of the Invention

Problems to be Solved by the Invention

[0005] Therefore, there remains a need for a valve assembly that enables a controlled fluid flow by providing a tight seal against the catheter, thereby reducing the risk of infection. There also remains a need for a valve that delays bleeding, properly cleans the connection part, and gives the caregiver time to wipe off the blood remaining in the connection part. There also remains a need for a valve that minimizes the exposure of the caregiver to blood during catheter insertion, removal, or replacement.

Means for Solving the Problems

[0006] The descriptions and variations described herein are meant to provide examples of the methods and apparatuses of the present invention. Combinations of aspects of specific embodiments or combinations of specific embodiments themselves are considered to be within the scope of the present disclosure. The valve assembly described herein is not limited to catheter assemblies only and can be used in any tubing assembly, particularly medical tubing.

[0007] A catheter assembly configured to be used with a male luer is provided. The catheter assembly can include a catheter hub having an internal chamber and a valve disposed within the internal chamber. The valve can include a distal portion, a proximal portion, and a sidewall extending therebetween and defining the interior of the valve. The valve can include a barrier layer having an arcuate shape extending from the sidewall into the interior of the valve at the distal portion. The barrier layer can have at least one slit extending therethrough, and the at least one slit is normally closed to prevent fluid from passing through the barrier layer.

[0008] The catheter assembly can further include a sealing ring circumferentially disposed at the distal end of the valve distal to the barrier layer. The sealing ring can have an outer sealing surface that forms a seal between the valve and the internal chamber at the distal end. The outer diameter of the valve can be minimized at a recess portion disposed between the side wall and the barrier layer and adjacent proximally to the outer sealing surface. The recess portion can be configured to deform the valve. The thickness of the side wall at the recess portion can be less than the thickness of the barrier layer.

[0009] The catheter assembly can further include a protrusion on the outer surface of the side wall. The protrusion can be disposed proximally to the recess portion. The protrusion can fit within an opening in the internal chamber such that when a luer is inserted into the proximal portion of the valve, the protrusion reinforces the adjacent side wall to reduce elastic deformation of the valve at the protrusion and increase outward elastic deformation of the side wall at the recess portion. By advancing the luer further distally, the barrier layer elastically deforms to open at least one slit and allow fluid to pass through the barrier layer. A plurality of protrusions can be provided on the outer surface of the side wall. The plurality of protrusions can each be coupled to a plurality of openings within the internal chamber. A lubricant can be further provided within the internal chamber. As described herein, the protrusions enable any variant of the assembly discussed herein to incorporate the valve within the hub without the need for an adhesive. Alternative variants can include the use of an adhesive.

[0010] The sealing ring can include a rounded edge along the circumference of the sealing ring. This enables the option of assembling the device of the present specification without using additional fixtures for assembling the valve within the hub. When the male luer is engaged with the recess portion, the sealing ring can remain engaged with the inner surface of the chamber. The valve can include a flange at the proximal end. The flange can engage with the proximal end of the catheter hub. The thickness of the side wall can be less than the thickness of the barrier layer.

[0011] Another variant of the valve described herein includes a valve including a distal portion, a proximal portion, and a sidewall extending therebetween and defining the interior of the valve, the valve including a barrier layer extending from the sidewall into the interior of the valve at the distal portion, the barrier layer having a first contact surface, a second contact surface, and an internal recess therebetween, a slit extending through the barrier layer at the internal recess, the slit being in a normally closed configuration preventing fluid from passing through the barrier layer, and when a male luer is inserted into the interior of the valve, the male luer engages the first and second contact surfaces and deforms the barrier layer, as a result of which the slit opens.

[0012] The present disclosure also includes a guard assembly for use with a tubing hub. In one variant, the guard assembly is configured to be disposed on the hub and includes a valve including a distal portion, a proximal portion, and a sidewall extending therebetween and defining the interior of the valve, the valve including a barrier layer at the distal portion, the barrier layer having at least one slit extending therethrough, the at least one slit being in a normally closed configuration to prevent fluid from passing through the barrier layer, a valve, a needle extending through the hub and the slit of the barrier layer, and a clip having a pair of arms, the pair of arms extending from opposite ends of the rear wall of the clip and being elastic, the clip, each arm of the pair of arms extending obliquely distally toward the needle such that an intermediate portion of each arm crosses the needle and a distal segment of each arm is biased against the needle on both sides of the needle, a portion of each distal segment of each arm passing through an opening in the wall and engaging the sidewall during axial movement of the needle between the distal segments of each arm to retain the clip within the interior of the valve, by pulling the distal end of the needle proximally relative to the distal segments of each arm, the distal segments of each arm move to cover the distal end of the needle to protect the distal end of the needle, and as a result, the anchor portion of each arm disengages from the sidewall, and by continuing proximal movement of the needle relative to the wall, a stop surface on the needle engages an opening in the wall such that the clip moves with the needle and remains attached to the needle when removed from the valve and the tubing hub.

[0013] The guard assembly can have an anchor assembly in which the anchor portion of each arm elastically deforms the side wall and the side wall returns to its pre-deformed state when disengaged.

[0014] A variation of the guard assembly can include an anchor portion of each arm that includes an edge of the distal segment that faces an edge of the distal segment biased against the needle. In an additional variation, the anchor portion of each arm includes a protrusion extending from the top edge on each distal segment that faces an edge of the distal segment biased against the needle. In yet another variation, the anchor portion of each arm includes a protrusion extending from each side of the distal segment on each distal segment.

[0015] A variation of the guard assembly can have a distal segment of each arm that is a curved lip.

[0016] In another variant, a guard assembly for use with a tubing hub is configured to be disposed on the hub and includes a valve having a distal portion, a proximal portion, and a sidewall extending therebetween and defining the interior of the valve, the valve including a barrier layer at the distal portion, the barrier layer having at least one slit extending therethrough, the at least one slit being normally closed to prevent fluid from passing through the barrier layer, a valve, a needle extending through the hub and the slit of the barrier layer, and a clip having a first arm, the first arm extending from one end of the rear wall of the clip and being elastic, the first arm extending obliquely distally toward the needle such that an intermediate portion of the first arm crosses the needle and a distal segment of the first arm is biased against the needle, a portion of the distal segment including an anchor portion that engages the sidewall during axial movement of the needle through an opening in the wall to retain the clip inside the valve, by pulling the distal end of the needle proximally relative to the distal segment, the distal segment moves to cover the distal end of the needle to protect the distal end of the needle, and as a result, the anchor portion disengages from the sidewall and by continuing proximal movement of the needle relative to the wall, a stop surface on the needle engages an opening in the wall such that the clip moves with the needle and remains attached to the needle when removed from the valve and the tubing hub.

[0017] The present disclosure also includes a medical assembly for protecting the needle tip when removing the needle from the hub. For example, such a medical assembly is a valve configured to be disposed within an internal chamber of the hub and includes a distal portion, a proximal portion, and a sidewall extending therebetween and defining an interior of the valve, the valve including a barrier layer at the distal portion, the barrier layer having at least one slit extending therethrough, the at least one slit being normally closed to prevent fluid from passing through the barrier layer, a clip having a rear wall with an opening allowing passage of the needle, the rear wall having a first end and a second end on a side radially opposed to the needle, a first arm extending obliquely and distally from the first end toward the needle, the first arm including a first arm portion including a first dimension and a second arm portion including a second dimension, the first dimension being greater than the second dimension, a second arm extending obliquely and distally from the second end toward the needle, the second arm including a first arm portion including a first dimension and a second arm portion including a second dimension, the first dimension being greater than the second dimension, the first arm and the second arm being elastic, the first arm portions of the first arm and the second arm respectively having the second arm portions of the first arm and the second arm on opposite sides of the needle and being biased against the needle, across the axis of the needle, and the anchor portions of the second arm portions of the first arm and the second arm being tethered to the sidewall of the valve by deforming the sidewall of the valve to prevent movement of the clip relative to the needle during axial movement of the needle through the rear opening of the clip.

[0018] In another alternative embodiment, the present disclosure includes a needle catheter assembly. For example, the catheter assembly includes a catheter hub having an internal chamber, and a valve disposed within the internal chamber and including a distal portion, a proximal portion, and a sidewall extending therebetween and defining the interior of the valve, the valve including a barrier layer having at least one slit extending therethrough, the at least one slit being normally closed to prevent fluid from passing through the barrier layer, a valve, a needle disposed within the valve, the needle having a needle shaft terminating at a sharp tip at the distal needle end, the shaft further including a stop surface having an increased diameter relative to the normal diameter of the needle shaft, a clip having a rear wall at the proximal end, a first arm extending from a first end of the rear wall, a second arm extending from a second end of the rear wall, the first end and the second end being on opposite sides of the needle shaft, the first arm having a first intermediate portion, the second arm having a second intermediate portion, both the first intermediate portion and the second intermediate portion extending distally and laterally from the wall such that the first intermediate portion and the second intermediate portion intersect the longitudinal needle axis of the needle shaft and extend away from the needle shaft, a portion of the proximal end of the first arm extending laterally from the first intermediate portion toward the needle shaft to form a first needle guard, a portion of the proximal end of the second arm extending laterally from the second intermediate portion toward the needle shaft to form a second needle guard, the first arm and the second arm being elastic such that the first needle guard and the second needle guard are biased against opposite sides of the needle shaft, the first needle guard having a first anchor portion, the second needle guard having a second anchor portion, each of the first anchor portion and the second anchor portion engaging the inner wall of the valve to prevent movement of the needle guard when the needle shaft moves relative to the clip through an opening in the rear wall, by withdrawing the distal end of the needle shaft proximally relative to the first needle guard and the second needle guard, the first engagement surface and the second engagement surface disengage from the inner wall, the first needle guard and the second needle guard cover the sharp tip, and by continuing to withdraw the needle shaft, the stop surface engages the rear wall such that the needle guard remains attached to the needle shaft when the needle shaft is removed from the valve.

[0019] This disclosure is related to the following commonly assigned patents and applications: U.S. Patent No. 11,324,939, issued May 10, 2022; U.S. Patent No. 8,105,288, issued January 31, 2012; U.S. Patent No. 8,591,469, issued November 26, 2013; U.S. Patent No. 9,775,973, issued October 3, 2017; U.S. Patent No. 9,604,035, issued March 28, 2017; U.S. Patent 10,828,465, issued November 10, 2020; U.S. Patent Application Publication No. 2020 / 0016375A1, published January 16, 2020; and U.S. Patent Application Publication No. 2021 / 0031009A1, published February 4, 2021; Provisional Application No. 62 / 993,493, filed March 23, 2020; Application No. 63 / 037,496, filed June 10, 2020; and Application No. 63 / 037,841, filed June 11, 2020; U.S. Patent Application No. 63 / 367,403, filed June 30, 2022; U.S. Application No. 18 / 170,835, filed February 17, 2023; U.S. Application No. 17 / 812,397, filed July 13, 2022, now U.S. Patent No. 11,607,525; U.S. Application No. 17 / 822,975, filed August 29, 2022, each of which is hereby incorporated by reference in its entirety.

[0020] Each of the following figures schematically shows embodiments and variations for a better understanding of the present invention. Variations of the present invention from the embodiments shown in the figures are contemplated.

Brief Description of the Drawings

[0021]

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[0022] For a better understanding of the present invention, reference is made to the following description of embodiments, which should be read in conjunction with the accompanying drawings, which are incorporated herein and form a part hereof, and which illustrate some aspects of the subject matter disclosed herein and, together with the description, serve to explain some of the principles associated with the disclosed implementations.

[0023] As used herein, the terms "a" or "an" are defined as one or more than one. As used herein, the term "plural" is defined as two or more than two. As used herein, the term "another" is defined as at least second or more. As used herein, the terms "comprising" and / or "having" are defined as comprising (i.e., open language). As used herein, the term "coupled" is defined as being connected, not necessarily directly and not necessarily mechanically.

[0024] References throughout this specification to "some embodiments", "one embodiment", "certain embodiments", and "an embodiment" or similar terms mean that a particular feature, structure, or characteristic described in connection with the embodiments is included in at least one embodiment of the present invention. Thus, appearances of such phrases throughout this specification in various places are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments without limitation.

[0025] Figure 1A shows a catheter valve assembly 100 having a catheter hub 102, a valve 104, and a male luer 106 inserted therethrough. The catheter hub 102 can include a proximal end 108 and a distal end 110. A catheter tubing 112 can be coupled to the catheter and extended from the distal end 110. As seen in Figure 1B and further described herein, the valve 104 is attached to the open proximal end 108 of the catheter hub 102 and is adapted to allow the male luer 106 to be inserted through the proximal end of the valve 104. The valves described herein can be used with any medical device such as a needle or other component that allows for fluid coupling. Such devices can include a luer or hub that is commercially used in the medical field. For the purposes of this application, the male luer 106 can represent a medical device such as a needle or other fluid source. As discussed below, the catheter hub 102 can include a pocket or hole 306 that houses a protrusion 206 on the valve 104. The pocket 306 can extend partially within the catheter hub 102 or extend through the catheter hub 102 to form a hole 306 as shown in Figures 1A and 1B.

[0026] Figures 2A through 2E show a valve having a proximal end 200, a distal end 202, and a sidewall 204 therebetween. In this variation, the sidewall can have a protrusion 206 disposed on the outer surface of the valve 104. The protrusions 206 can be on both sides of the sidewall 204 and can be circular, although other shapes can be considered. Additionally, the valve 104 can have a recessed portion 208 distal to the protrusion 206 and the sidewall 204. The recessed portion 208 is located where the valve 104 has its minimum outer diameter and allows the valve 104 to deform when engaged by the male luer 106. The figures show two protrusions 206, although any number of protrusions are within the scope of the present disclosure.

[0027] Valve 104 includes a barrier layer 210 that extends from a sidewall within the valve to prevent fluid flow. A variant of valve 104 includes a barrier layer 210 that opens through elastic deformation rather than the pressure within the catheter assembly. For example, in a variant of valve 104, it is required of the osseous 106 to elastically deform valve 104 and / or the barrier layer 210 so as to allow fluid flow through valve 104. In an additional variant, the barrier layer includes an arcuate or concave shape within the valve. The barrier layer 210 includes at least one slit 212 extending therethrough and has a normally closed configuration that prevents fluid from passing through the barrier layer 210. Alternatively, the barrier layer 210 can have a plurality of slits 212 that form a plurality of leaflet structures or flaps that open upon deformation of valve 104.

[0028] The barrier layer 210 generally includes a flexible or semi-flexible material that is compatible with exposure to blood, drugs, and other fluids commonly encountered during catheter insertion / injection procedures. The valve 104 can be manufactured from a flexible and elastic material such that insertion of the osseous 106 deforms the barrier layer 210 into an extended and open configuration.

[0029] In an additional alternative embodiment, the distal end 202 of the valve 104 can have a sealing ring 214 disposed circumferentially around the valve and distal to the barrier layer 210. As shown, the alternative embodiment of the valve can have a sealing ring 214 that includes a radius. This radius can enable assembly of the valve 104 to the hub without additional fixtures. The sealing ring 214 can have an outer sealing surface that forms a seal between the valve 104 and the hub 102 at the distal end 202 of the valve. The sealing ring 214 will engage circumferentially with the inner surface of the hub 102, so that the seal during insertion of the male luer 106 is maintained by the sealing ring 214, ensuring that fluid does not pass from the catheter hub 102 to the outer surface of the valve 104. The alternative embodiment of the valve can include a sealing ring 214 made of the same material as the rest of the valve 104. Alternatively, the sealing ring 214 can include a material different from the rest of the valve. Additionally, the angle by which the sealing ring 214 is offset with respect to the longitudinal axis can be changed to compress the valve 104 against the hub 102 at various diameters.

[0030] As seen in FIG. 3A, the catheter hub 102 has a chamber 300 that extends from the proximal surface at the proximal end 108. The chamber 300 is in fluid communication with the catheter tubing 112 (FIGS. 1A and 1B) coupled to the hub 102. An alternative embodiment of the chamber 300 can have a straight wall, or the wall can taper obliquely and can have a tapered portion 302 that forms a female luer shape. As seen in FIG. 3B, when the valve is inserted into the chamber, the exterior of the valve 104 engages the inner surface 304 of the chamber 300. As shown in FIGS. 3B and 3C, the recessed portion 208 is offset from the inner surface 304 of the chamber 300. This offset, combined with the reinforcement of the valve wall adjacent the protrusion 206, causes most of the deformation of the valve to occur at the recessed portion 208 of the wall distal to the protrusion.

[0031] A modification of the catheter hub 102 can include pockets or openings 306 disposed near the proximal end 108 of the hub 102, which seat the protrusions 206 of the valve 104 when the valve 104 is disposed in the chamber 300. The placement of the valve 104 in the chamber 300 can be done via insertion of the valve into the chamber 300 or via molding. As described above, the protrusions 206 reinforce the sidewall 204 with the protrusions 206 and increase the outward elastic deformation of the sidewall 204 at the recessed portion 208. The protrusions 206 fit into the openings 306 to hold the valve 104 in place and are configured to limit the longitudinal extension of the valve wall adjacent to the protrusions. With the protrusions 206 in the design disclosed herein, the need for an adhesive to hold the valve in place can also be eliminated. This effect creates a preferential area for stretching and / or deforming the valve to open the barrier layer. With the protrusions 206 in the design disclosed herein, the need for an adhesive to hold the valve in place can also be eliminated.

[0032] The protrusions 206 can additionally have a protrusion sealing ring that provides additional interference along the openings 306. The protrusion sealing ring is received in the outer portion of the protrusion where the protrusion 206 contacts the edge of the opening 306. The protrusion sealing ring has a larger diameter than the rest of the protrusion to provide a seal against the opening 306 of the hub 102. This seal prevents fluid leakage through the assembly, similar to the seal ring 214.

[0033] Both the hub 102 and the valve 104 can each include flanges 216, 308 at their respective proximal ends that engage with each other when the protrusions 206 fit into the openings 306. The valve flange portion 216 includes a diameter larger than the diameter of the sidewall 204 to seal against the proximal surface of the catheter hub flange 308. Alternatively, in some modifications, the valve flange portion 216 can include an opening or segment so as not to be circumferentially continuous around the sidewall 204.

[0034] As seen in FIG. 3C, the male luer 106 is inserted into the valve interior 218 of the valve 104 and ultimately engages the wall / partition to elastically expand the valve and open the barrier layer 210. The valve variant shown in FIG. 3C includes a valve interior 218 that is recessed near the recessed portion 208 and has walls that taper externally and / or internally. During insertion, as seen in FIG. 3D, the distal end 310 of the male luer 106 can engage the recessed portion 208 of the valve 104 and open the barrier layer 210 in the distal direction. As the luer engages and advances, the barrier layer undergoes elastic deformation and can open at least one slit 212, allowing fluid to pass through the barrier layer 210 and into the lumen 312 of the male luer 106. A small gap can be provided between the valve interior 218 and the male luer 106 to allow the male luer 106 to move longitudinally easily when the diameter of the valve 104 at the protrusion 206 decreases during insertion of the luer 106. In some variants, inserting the male luer 106 into the valve interior 218 can position the distal end of the barrier layer 210 in a fully open position while the lateral surface of the male luer 106 engages the side wall 204 of the valve 104. However, in an alternative variant, the barrier layer 210 may simply flex to allow sufficient fluid flow.

[0035] In an additional modification of the valve, the thickness of the barrier layer 210 is greater than the thickness of the sidewall 204 at the recessed portion 208 and the thickness of the sidewall (excluding the region where the protrusion 206 joins the sidewall). For example, an increase in the thickness of the barrier layer 210 enables the luer 106 to be elastically returned to the position closing the slit 212 when removed. The relatively thin sidewall 204 reduces the displacement distance between the inner diameter of the valve interior 218 and the inner surface 304 of the chamber 300. By reducing this displacement distance, the male luer 106 can be inserted along the longitudinal axis to a sufficient depth to open the slit 212 with the barrier layer 210 of the valve 104 without being obstructed by the sidewall 204 of the valve 104. For example, if the sidewall 204 is too thin, the valve 104 may have an increased risk of failure (e.g., cracking or splitting). The thickness of the barrier layer 210 increases the relative rigidity compared to the rest of the valve 104, enables the slit 212 to be completely closed, increases the likelihood that the slit returns to its original state to close the valve 104, and prevents leakage. In some modifications, the difference in thickness can also enable valve deformation to occur in the barrier layer rather than the sidewall or recessed portion 208.

[0036] Figures 4A through 4H show various views of another modification of the catheter valve assembly. In this modification, the valve 104 can have one or more lips 400 at the proximal end 200. As seen in FIGS. 4G and 4H, the lips 400 can engage with one or more recesses 402 on the catheter hub 102. When engaged with the recesses 402, the lips 400 can project onto the recesses 402 on the hub 102 to secure the valve 104 onto the hub 102 for use with the male luer 106 or another medical device. In another modification of the device, threads 404 on the catheter hub 102 can be used to hold the lips 400 and prevent the valve 104 from being pushed too far into the catheter hub 102.

[0037] Similar to the features in the variations shown in FIGS. 3A - 3D, the catheter hub 102 can have a chamber 300 that extends from the proximal face at the proximal end 108. The chamber 300 is in fluid communication with the catheter tubing coupled to the hub 102. For purposes of illustration, the tubing is omitted from some of the figures. A variation of the chamber 300 can have a straight wall, or the wall can be tapered obliquely and can also have a tapered portion 302 that forms a female luer shape. As seen in FIG. 4G, when the valve is inserted into the chamber, the exterior of the valve 104 engages the inner surface 304 of the chamber 300. As shown in FIG. 4G, the recessed portion 208 is offset from the inner surface 304 of the chamber 300. Due to this offset, most of the deformation of the valve occurs at the recessed portion 208 of the wall.

[0038] As seen in FIGS. 4G and 4H, the male luer 106 is inserted into the valve interior 218 of the valve 104 and ultimately engages the wall / partition to elastically stretch the valve and open the barrier layer 210. The valve variation shown in FIGS. 4G and 4H includes a valve interior 218 that is recessed near the recessed portion 208 and has walls that are tapered externally and / or internally. During insertion, as seen in FIG. 4H, the distal end 310 of the male luer 106 engages the recessed portion 208 of the valve 104 and opens the barrier layer 210 in the distal direction. As the luer engages and advances, the barrier layer undergoes elastic deformation and can open at least one slit 212, allowing fluid to pass through the barrier layer 210 and into the lumen 312 of the male luer 106. A small gap can be provided between the valve interior 218 and the male luer 106 to allow the male luer 106 to move longitudinally easily when the diameter of the valve 104 decreases during insertion of the luer 106. In some variations, inserting the male luer 106 into the valve interior 218 can position the distal end of the barrier layer 210 in a fully open position, while the lateral surface of the male luer 106 engages the side wall 204 of the valve 104. However, in an alternative variation, the barrier layer 210 may simply flex to allow sufficient fluid flow.

[0039] Figures 5A through 5G show valve 104 having a proximal end 200, a distal end 202, and a sidewall 204 therebetween. As described above, sidewall 204 can have optional protrusions 206 disposed on the outer surface of valve 104 on either side of sidewall 204 or valve 104. As described above, valve 104 can optionally include a recessed portion 208 distal to protrusions 206 and sidewall 204. The distal end 202 of the valve can include a sealing ring 214 with an optional flange 220.

[0040] As described herein, valve 104 includes a barrier layer 210 that opens through elastic deformation rather than by pressure within valve 104 or a catheter assembly (not shown). A modified example of the valve shown in 5B, which is a cross-sectional view of valve 104 of FIG. 5A, includes a barrier layer 210 with an internal recess 222 for disposing slit 212. As a result of the presence of internal recess 222 within barrier layer 210 and adjacent to the interior 218 of the valve, two contact surfaces 224, 226 or ridges are created on the surface of barrier layer 210 that is within interior 218 of the valve. As shown, since barrier layer 210 can be solid, when force is applied to contact surfaces 224, 226, barrier layer 210 deforms, thereby deforming slit 212 and opening the valve. As shown, barrier layer 210 can include a dimension that is thicker in the region adjacent to contact surfaces 224, 226 as compared to the thickness of barrier layer 210 at slit 212 or adjacent to internal recess 222. In an additional modified example as shown in FIG. 5C, the portion of barrier layer 210 that forms contact surfaces 224, 226 can have a recess or space 228 that separates the portion of barrier 210 that forms contact surfaces 224, 226 from wall 204.

[0041] In an additional variant, the slits 212 are arranged to extend longitudinally between the two protrusions 206. Since the internal recess 222 also runs parallel to the slit, the contact surfaces 224 and 226 deform the portions of the valve 104 and the side wall 204 that are not supported by the protrusions 206. As a result, the barrier layer 210 deforms selectively and the slit 212 opens. It is noted that in the variant of the valve 104, the protrusions 206, the sealing ring 214, and / or the recessed portion 208 are not required. Such a variant can include the internal recess 222 alone or in combination with any of the aforementioned features.

[0042] FIG. 5D shows a rear view showing the interior 218 of the valve 104 of FIGS. 5A and 5B showing the proximal end 200 of the valve 104. As shown, the slit 212 is disposed within an internal recess 222 disposed within the barrier layer 210. As a result of forming the internal recess 222, first and second contact surfaces 224, 226 are created on both sides of the slit 212 and the internal recess 222. FIG. 5E shows a front view showing the distal end 202 of the valve 104 of FIG. 5A. As shown, the slit 212 is formed through the barrier layer 210 and extends between the two protrusions 206.

[0043] Figures 5F and 5G show cross-sectional views of the valve 104 as shown in Figures 5A and 5B inserted into the medical device hub 102, with the male luer 106 inserted into the interior 218 of the valve 104. As discussed above, the valve 104 includes a barrier layer 210 having an internal recess 222 disposed adjacent to the interior 218 of the valve 104. A slit 212 is disposed in the internal recess 222 and extends through the barrier layer 210. The barrier layer 210 also includes first and second contact surfaces 224, 226. As shown, the valve 104 is in a normally closed configuration such that the barrier layer 210 provides a fluid seal or block between the chamber 300 of the hub 102 and the fluid path 314 of the male luer 106. Figure 5F shows the state before the distal end 310 of the male luer engages the barrier layer 210 of the valve 104. As previously described, the valve 104 can optionally include a recessed portion 208 that assists in deforming the barrier layer 210. However, the outer wall of the valve 104 engages the inner surface 304 of the hub 102.

[0044] Figure 5G shows the state where the distal end 310 of the male luer 106 advances against the contact surfaces 224 and 226 of the barrier layer 210, deforming the barrier layer 210 to open the slit 212 and fluidly coupling the chamber 300 of the hub 102 to the fluid path 314 of the male luer 106. Engagement of the luer 106 with the barrier layer 210 causes elastic deformation of the valve sidewall and the barrier layer 210 of the valve 104, whereby the slit 212 elastically deforms and the valve 104 opens.

[0045] In an additional modification of the valve, the thickness of the barrier layer 210 is greater than the thickness of the side wall 204 at the recessed portion 208 as well as the thickness of the side wall. For example, due to the increase in the thickness of the barrier layer 210, when the luer 106 is removed, it becomes possible to elastically return to the position where the slit 212 is closed. The relatively thin side wall 204 reduces the displacement distance between the inner diameter of the valve interior 218 and the inner surface 304 of the chamber 300. By reducing this displacement distance, it becomes possible to insert the male luer 106 to a sufficient depth along the longitudinal axis and open the slit 212 with the barrier layer 210 of the valve 104 without being obstructed by the side wall 204 of the valve 104. For example, if the side wall 204 is too thin, the valve 104 may have an increased risk of failure (e.g., cracking or tearing). The thickness of the barrier layer 210 can increase the relative rigidity compared to the rest of the valve 104, enabling the slit 212 to be completely closed, increasing the likelihood that the slit returns to its original state and closes the valve 104, and preventing leakage. In some modifications, due to the difference in thickness, it also becomes possible for the valve to deform at the barrier layer rather than at the side wall or the recessed portion 208.

[0046] Figures 6A, 6B, and 6C show perspective, top, and side views, respectively, of another variant of the valve 104 of the present disclosure having one or more elongated protrusions 206 disposed on the outer surface of the valve 104. As described above, the protrusions 206 may be symmetrically or asymmetrically disposed relative to the side surface of the side wall 204 and may be disposed proximal to the recessed portion 208 as shown in FIGS. 6A through 6C. As described above, any number of protrusions 206 are within the scope of the present disclosure. In the variant shown in FIG. 6B, the valve 104 includes at least one elongated protrusion 206 having an elongated shape in which the length along the axis of the valve (e.g., the axial length 232) is greater than the width along the circumference of the valve (i.e., the circumferential width 234). This elongated protrusion 206 supports a longer length of the inner wall of the valve to prevent deformation as discussed above. Additionally, as shown in FIG. 6C, the protrusion 206 is disposed proximal to the minimum diameter of the recessed portion 208. The valve 104 is also shown with a slit 212 in the barrier layer 210 extending transverse to the protrusion 206. As described herein, the variant includes a valve slit 212 extending between the protrusions 206. The recessed portion 208 has a minimum diameter and allows the valve 104 to deform when engaged by a medical device inserted into the inner chamber, while the protrusions 206 limit the deformation of the wall portion adjacent to the protrusions.

[0047] Figures 7A through 7C show another variant of the valve 104 having an elongated protrusion 206 in which the axial length 232 is greater than the width 234 in the circumferential direction 23. In this variant, the protrusion shows a valve similar to the valve shown in FIGS. 6A through 6C, and the valve 104 includes an elongated protrusion 206 having a length along the axis or axial length 232 that is greater than the width along the circumference or circumferential width 234. In the variant shown in FIGS. 7A through 7C, one or more of the protrusions 206 extend beyond the minimum diameter of the recessed portion 208.

[0048] FIG. 8A shows another variant of the catheter valve assembly 100 having a catheter hub 102, a valve 104, and a needle 120 inserted therethrough. A variant of the needle 120 can include a standard hub 122 that couples to the threads on the catheter hub 102. The needle 120 can include a clip 150 that functions as a needle guard as described below. Additionally, the needle can include a stop surface 124, which can have a larger diameter relative to the rest of the needle 120 or can include a material attached to the needle 120.

[0049] FIG. 8B shows a front perspective view of the clip 150 of FIG. 8A, and FIG. 8C shows a rear perspective view. As shown, this variant of the clip 150 includes a first arm 152 and a second arm 154, each attached to or continuous with a rear wall 156. The clip 150 can be of an integral structure or can have components attached to form the clip. As shown in FIGS. 8B and 8C, the first arm 152 extends from a first end 162 of the rear wall 156, and the second arm 154 extends from a second end 164 of the rear wall 156. Typically, when attached to a needle (not shown in FIGS. 8B or 8C), the needle extends through an opening 158 such that the first end 162 and the second end 164 are on opposite sides of the needle. For purposes of showing the features of the clip 150, the needle is omitted. Instead, a longitudinal needle axis 126 representing the needle is shown. Additionally, the direction from the back wall 156 toward the front of the clip 150 is the proximal to distal direction of the needle and the clip 150.

[0050] As shown, the arms 152, 154 extend distally along the needle axis 126, and the intermediate portions 166, 168 also extend at an oblique or transverse angle from the ends 162, 164 of the wall 156 toward the needle axis 126, where the intermediate portions 166, 168 intersect the longitudinal needle axis 126 and the distal segments / ends 170 of the first arm 152 and 172 of the second arm 154 continue to extend away from the longitudinal needle axis 126 on both sides until they engage the needle at those locations on the rear wall 156.

[0051] The distal segments / ends 170, 172 of the arms 152, 154 continue to extend obliquely or transversely back towards the longitudinal needle axis 126 from their respective intermediate portions 166, 168, such that each needle guard has ends 174, 176 that are biased against the needles by the elasticity of the arms 152, 154 and / or the clip 150. In the variant of the clip 150 shown in FIGS. 8B and 8C, the distal portions or ends 174, 176 of one or both of the distal segments 170, 172 include a curved lip configuration that can further assist in covering the tip of the needle. Also, the width of each needle guard can be made wider than the diameter of the needle. In an additional variant, the arms 152, 154 include regions where the width varies over the length of the arms 152, 154.

[0052] The clip 150 described herein also includes one or more anchor portions that engage the valve wall to prevent movement of the clip 150 during movement of the needle. In the variants of FIGS. 8B and 8C, the edges 184 of the first needle guard 170 and the second needle guard 172 function as anchor portions. In additional variants, the anchor portions can be roughened or otherwise treated to increase the gripping force against the valve wall.

[0053] In the variants shown in FIGS. 8B and 8C, the clip 150 can include any number of reinforcement structures 160 that preferentially bend the clip at a desired location. For example, the reinforcement structure 160 can include stiffening members disposed on the clip 150, or can include ribs of increased thickness manufactured or deposited on the surface of the clip 150.

[0054] Figures 8D and 8E show partial cross-sectional views of a variant of the clip 150 of FIGS. 8A - 8C disposed around the needle 120 extending through the valve 104, the medical device hub 102, and the back wall 156 of the clip 150. As shown, the needle 120 can extend through the barrier layer 210 and the slit 212. Thus, the needle 120 will move relative to the hub 102, the valve 104, and the clip 150. As shown, the ends 174, 176 of the needle guards on the first arm 152 and the second arm 154 bias against the needle 120, and the anchor portions, in this case the edges 182, 184 of the needle guards, engage the valve wall 204 to retain the clip 150 within the valve 104. The deformation of the valve wall 204 shown in the figure is intended for illustrative purposes only. Variants of the device can include clips 150 that deform the valve wall 204 to various degrees. FIG. 8D shows the anchor portions 182, 184 engaging a portion of the valve wall 204 without protrusions. Alternatively, FIG. 8E shows the anchor portions 182, 184 engaging the valve wall 204 in the region adjacent to the protrusion 206.

[0055] Figure 8F shows a partial cross-sectional view of the clip 150 of FIG. 8E with the needle 120 being withdrawn in the proximal direction 130 relative to the hub 102 and the valve 104. The arms 152, 154 of the clip 150 remain engaged with the wall 204 of the valve 104 to prevent the clip 150 from moving with the needle. Thus, the needle 120 slides through the opening in the back wall 156 and through the needle guard portions 170, 172 of the clip 150. As shown, the stop surface 124 of the needle 120 is not yet engaged with the clip 150.

[0056] FIG. 8G shows the state of the clip 150 when the tip of the needle has moved proximally from the needle guard portions 170, 172. Since the arms 152, 154 are elastic (i.e., elastically deformable), pulling out the needle 120 causes the needle guards 170, 172 to move together to effectively protect the tip of the needle 120. Since the arms 152, 154 pivot and move closer to each other, they disengage from the wall 204 of the valve 104 and the wall returns to its normal configuration. As shown, the needle guard portion 170 overlaps the needle guard portion 172 distally in front of the tip of the needle 120 to form a barrier that prevents inadvertent contact with the needle tip and also prevents distal movement of the needle tip. By continuing the movement of the needle 120 within the clip 150, the stop surface 124 engages the rear wall 156 so that the clip 150 remains attached to the needle 120 when removing the needle from the valve and hub 102.

[0057] By using the valve 104 to hold the clip 150, the clip 150 is effectively fixed within the valve 104 due to the ability of the valve wall 204 to deform. This prevents inadvertent release of the clip as compared to grooves or other seats in relatively hard materials such as catheter hubs.

[0058] FIGS. 9A and 9B show front and rear perspective views of another variant of the clip 150 similar to the clip 150 described above. In this variant, the clip 150 includes needle guards 170, 172 having an anchor portion that includes first and second arms 152, 154 and fingers 186, 188 that extend outwardly to engage the wall of the valve. These anchor portions 186, 188 have a reduced surface area relative to the edges 182, 184 of the clip 150 of FIGS. 8A - 8C. Thus, due to the reduced surface area, the anchor portions apply more stress to the wall 204 of the valve 104, making it possible to increase the holding force of the clip 150 as shown in FIG. 9C.

[0059] Figures 10A and 10B show front and rear perspective views of another variant of clip 150 similar to clip 150 described above. In this variant, clip 150 includes first and second arms 152, 154 and needle guards 170, 172 which have one or more wings 190 extending from the sides of needle guards 170, 172 and functioning as anchor portions. As in the variant of Figure 9A, side wings 190 have a reduced surface area that increases the stress on the wall of valve 104 to hold clip 150 within valve 104 as shown in the top view of clip 150 in Figure 10C.

[0060] It is intended that any of the anchor portions described herein can be combined into a single spring. Also, the shapes of the anchor portions shown above are for illustrative purposes only and the anchor portions can take various shapes as required.

[0061] Figures 11A and 11B show partial cross-sectional views of hub 102, valve 104 and needle 120 extending within clip 150, the clip being clip 150 of single arm 152. Since rear wall 156 receives needle 120 and single arm 152 extends from one end of wall 156, clip 150 of Figures 11A and 11B functions in the same manner as clip 150 described above. Single arm 152 includes a single needle guard 170 that engages the wall 204 of valve 104. Figure 11B shows a configuration where when needle 120 is withdrawn from hub 102 and valve 104 and the needle moves proximally of guard 170, single needle guard 170 moves to cover the tip of needle 120. As described above, by further withdrawing needle 120, stop surface 124 engages rear wall 156 and clip 150 remains attached to needle 120. Figures 11A and 11B do not show an anchor with a reduced surface area, but such a feature can be combined with single arm clip 150.

[0062] It is contemplated that any variation or aspect of one variation can be combined with any other variation (for example, even if the various features such as the valves, clips, hubs, etc. shown above are shown separately in the figures, the present disclosure includes such combinations of features).

[0063] The foregoing description of the disclosed embodiments has been provided to enable a person skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. For example, various materials can be selected for the various components of the embodiments. Accordingly, it is desired that the appended claims and the foregoing description be referred to in order to indicate the scope of the invention, and that the embodiments be regarded as illustrative in all respects and not restrictive.

Description of Reference Numerals

[0064] 100 Catheter valve assembly 102 Catheter hub, medical device hub 104 Valve 106 Male luer 108 Proximal end 110 Distal end 112 Catheter tubing 120 Needle 122 Standard hub 124 Stop surface 126 Needle shaft 130 Proximal direction 150 Clip 152 First arm, single arm 154 Second arm 156 Rear wall 158 Opening 160 Reinforcing structure 162 First end 164 Second end 166, 168 Intermediate portion 170 First needle guard, distal segment / end, needle guard portion 172 Second needle guard, distal segment / end, needle guard portion 174, 176 Ends 182, 184 Edges 186, 188 Fingers 190 Wing 200 Proximal end 202 Distal end 204 Side wall, valve wall 206 Protrusion 208 Recessed portion 210 Barrier layer 212 Slit 214 Sealing ring 216 Valve flange portion 218 Inside the valve 220 Flange 222 Internal recess 224, 226 Contact surfaces 228 Space 232 Axial length 234 Circumferential width 300 Chamber 302 Tapered portion 304 Inner surface 306 Opening, pocket, hole 308 Catheter hub flange 310 Distal end 312 Lumen 314 Fluid path 400 Lip 402 Recess 404 Screw

Claims

Claim 1 A guard assembly for use with a tubing hub, the guard assembly comprising: A valve configured to be disposed on the tubing hub, the valve including a distal portion, a proximal portion, and sidewalls extending therebetween to define an interior of the valve, the valve including a barrier layer at the distal portion, the barrier layer having at least one slit extending therethrough, the at least one slit being normally closed to prevent fluid from passing through the barrier layer; A needle extending through the tubing hub and through the at least one slit of the barrier layer; A clip having a pair of arms, the pair of arms extending from opposite ends of a rear wall of the clip and being resilient, each arm of the pair of arms extending obliquely distally toward the needle such that an intermediate portion of each arm crosses the needle and a distal segment of each arm is biased against the needle on opposite sides of the needle, each distal segment of each arm including an anchor portion configured to engage the sidewalls to retain the clip within the valve while the needle axially moves between the distal segments of each arm through an opening in the rear wall; Comprising; By withdrawing the distal end of the needle proximally relative to the distal segments of each arm, the distal segments of each arm move to cover the distal end of the needle to protect the distal end of the needle, and as a result, the anchor portion of each arm disengages from the sidewall; By continuing proximal movement of the needle relative to the rear wall, a stop surface on the needle engages the opening in the rear wall such that the clip moves with the needle and remains attached to the needle when removed from the valve and the tubing hub. A guard assembly. Claim 2 The guard assembly of claim 1, wherein the anchor portion of each arm elastically deforms the sidewall and the sidewall returns to its pre-deformed state upon disengagement. Claim 3 The guard assembly of claim 1, wherein the anchor portion of each arm includes an edge of the distal segment facing an edge of the distal segment biased against the needle. Claim 4 The guard assembly according to claim 1, wherein the anchor portion of each arm includes a protrusion extending from the top edge opposite the edge of the distal segment biased against the needle on each distal segment.

5. The guard assembly according to claim 1, wherein the anchor portion of each arm includes a protrusion extending from each side of the distal segment on each distal segment.

6. The guard assembly according to claim 1, wherein the distal segment of each arm biased against the needle includes a curved lip.

7. The guard assembly according to claim 1, wherein at least one width of the pair of arms varies over the length.

8. The guard assembly according to claim 1, wherein the needle includes a needle hub at the proximal end.

9. The guard assembly according to claim 1, wherein at least one arm includes a reinforcing structure.

10. The guard assembly according to claim 1, wherein the rear wall includes a reinforcing structure.

11. The guard assembly according to claim 1, wherein the width of the distal segment of each arm is greater than the diameter of the needle.

12. The guard assembly according to claim 1, wherein the distal segments of each of the arms overlap.

13. The guard assembly according to claim 1, wherein the distal segments of each of the arms are equidistant from the rear wall.

14. The valve includes a first contact surface, a second contact surface, and an internal recess therebetween, a slit extends through the barrier layer in the internal recess, the slit is in a normally closed configuration preventing fluid from passing through the barrier layer, and when a force is applied to the first contact surface and the second contact surface, the barrier layer deforms, and as a result, the slit opens, the guard assembly according to claim 1.

15. The valve includes a sealing ring circumferentially disposed at the distal end of the valve distal to the barrier layer, the sealing ring has an external sealing surface forming a seal between the valve and the internal chamber of the tubing hub at the distal end, the outer diameter of the valve is minimum in a recessed portion disposed between the side wall and the barrier layer and adjacent proximally to the external sealing surface, the recessed portion is configured to deform the valve, and the thickness of the side wall in the recessed portion is less than the thickness of the barrier layer, the guard assembly according to claim 1.

16. The valve includes a protrusion on the outer surface of the side wall, the protrusion fits into an opening in the tubing hub, and when a medical device is inserted into the proximal portion of the valve, the protrusion reinforces the adjacent side wall to reduce elastic deformation of the valve at the protrusion and increase outward elastic deformation of the side wall at the recessed portion. By further advancing the medical device distally, the barrier layer elastically deforms and the at least one slit opens so that the fluid can pass through the barrier layer. The guard assembly according to claim 1.

17. A guard assembly for use with a tubing hub, the guard assembly comprising: A valve configured to be disposed in the tubing hub, the valve including a distal portion, a proximal portion, and a side wall extending therebetween and defining an interior of the valve, the valve including a barrier layer at the distal portion, the barrier layer having at least one slit extending therethrough, the at least one slit being normally closed to prevent fluid from passing through the barrier layer; and A needle extending through the tubing hub and through the at least one slit in the barrier layer; A clip having a first arm, the first arm extending from one end of the rear wall of the clip and being elastic, the first arm extending obliquely distally toward the needle such that an intermediate portion of the first arm crosses the needle and a distal segment of the first arm is biased against the needle, and a portion of the distal segment includes an anchor portion that engages the side wall during axial movement of the needle through an opening in the rear wall to retain the clip inside the valve; Comprising By pulling the distal end of the needle proximally relative to the distal segment, the distal segment moves to cover the distal end of the needle to protect the distal end of the needle, and as a result, the anchor portion disengages from the side wall; By continuing proximal movement of the needle relative to the rear wall, a stop surface on the needle engages the opening in the rear wall such that the clip moves with the needle and remains attached to the needle when removed from the valve and the tubing hub. The guard assembly.

18. A medical assembly for protecting the needle tip when removing the needle from a hub, the medical assembly comprising: A valve configured to be disposed within an internal chamber of the hub, the valve including a distal portion, a proximal portion, and a sidewall extending therebetween and defining an interior of the valve, the valve including a barrier layer at the distal portion, the barrier layer having at least one slit extending therethrough, the at least one slit being normally closed to prevent fluid from passing through the barrier layer; A clip having a rear wall with an opening to permit passage of the needle, the rear wall having a first end and a second end on a side radially opposed to the needle; A first arm extending obliquely and distally from the first end toward the needle, the first arm including a first arm portion having a first dimension and a second arm portion having a second dimension, the first dimension being greater than the second dimension; A second arm extending obliquely and distally from the second end toward the needle, the second arm including a first arm portion having a first dimension and a second arm portion having a second dimension, the first dimension being greater than the second dimension, the first arm and the second arm being elastic; Comprising; The first arm portion of the first arm and the first arm portion of the second arm are respectively on opposite sides of the needle with respect to the second arm portion of the first arm and the second arm portion of the second arm, and are biased against the needle, across the axis of the needle; An anchor portion of the second arm portion of the first arm and an anchor portion of the second arm portion of the second arm engage the sidewall of the valve by deforming the sidewall of the valve to prevent movement of the clip relative to the needle during axial movement of the needle through the opening in the rear wall. Claim 19 The medical assembly according to claim 18, wherein both the anchor portion of the first arm and the anchor portion of the second arm elastically deform the sidewall, and the sidewall returns to its pre-deformed state when disengaged. Claim 20 The medical assembly according to claim 18, wherein the anchor portion of the first arm and the anchor portion of the second arm include edges facing an edge biased against the needle.

21. The medical assembly according to claim 18, wherein the anchor portion of the first arm or the anchor portion of the second arm includes a protrusion extending from a top edge facing an edge of the second arm portion biased against the needle.

22. The medical assembly according to claim 18, wherein the anchor portion of the first arm or the anchor portion of the second arm includes one or more wings extending from each side of the clip.

23. The medical assembly according to claim 18, wherein at least the distal portion of the first arm or the second arm biased against the needle includes a curved lip.

24. The medical assembly according to claim 18, wherein the width of at least the first arm and / or the second arm varies over its length.

25. The medical assembly according to claim 18, wherein the needle includes a needle hub at its proximal end.

26. The medical assembly according to claim 18, further comprising one or more reinforcing structures on the clip.

27. The medical assembly according to claim 18, wherein the width of the second arm portion of the first arm and the width of the second arm portion of the second arm are greater than the diameter of the needle.

28. The medical assembly according to claim 18, wherein the second arm portion of the first arm and the second arm portion of the second arm overlap.

29. The medical assembly according to claim 18, wherein the second arm portion of the first arm and the second arm portion of the second arm are equidistant from the rear wall.

30. A needle catheter assembly, the needle catheter assembly comprising a catheter hub having an internal chamber, a valve disposed in the internal chamber, the valve including a distal portion, a proximal portion, and side walls extending therebetween to define an interior of the valve, the valve including a barrier layer having at least one slit extending therethrough, the at least one slit being normally closed to prevent fluid from passing through the barrier layer. A needle disposed within the valve, the needle having a needle shaft that terminates at a distal needle tip with a sharp point, the needle shaft further including a stop surface having an increased diameter relative to the normal diameter of the needle shaft, the needle; A clip having a rear wall at its proximal end, a first arm extending from a first end of the rear wall, a second arm extending from a second end of the rear wall, the first end and the second end being on opposite sides of the needle shaft, the clip; comprising; The first arm has a first intermediate portion, the second arm has a second intermediate portion, and both the first intermediate portion and the second intermediate portion extend distally and laterally from the rear wall such that the first intermediate portion and the second intermediate portion intersect the longitudinal needle axis of the needle shaft and extend away from the needle shaft; A part of the proximal end of the first arm extends laterally from the first intermediate portion toward the needle shaft to form a first needle guard, a part of the proximal end of the second arm extends laterally from the second intermediate portion toward the needle shaft to form a second needle guard, and the first arm and the second arm are elastic such that the first needle guard and the second needle guard are biased against opposite sides of the needle shaft; The first needle guard has a first anchor portion, the second needle guard has a second anchor portion, and each of the first anchor portion and the second anchor portion engages the side wall of the valve to prevent movement of the first needle guard and the second needle guard when the needle shaft moves relative to the clip through an opening in the rear wall. By pulling the distal end of the needle shaft proximal to the first needle guard and the second needle guard, the first anchor portion and the second anchor portion disengage from the side wall, and the first needle guard and the second needle guard come to cover the sharp point. By continuing to pull out the needle shaft, the stop surface engages the rear wall so that the clip remains attached to the needle shaft when removing the needle shaft from the valve. Needle catheter assembly.

31. The needle catheter assembly according to claim 30, wherein both the first anchor portion and the second anchor portion elastically deform the side wall, and when the engagement is released, the side wall returns to its state before deformation.

32. The needle catheter assembly according to claim 30, wherein the first anchor portion and the second anchor portion include edges facing the edges biased against the needle.

33. The needle catheter assembly according to claim 30, wherein the first anchor portion or the second anchor portion includes a protrusion extending from the top edge facing the edge biased against the needle.

34. The needle catheter assembly according to claim 30, wherein the first anchor portion or the second anchor portion includes one or more wings extending from each side of the clip.

35. The needle catheter assembly according to claim 30, wherein at least the distal portion of the first needle guard or the second needle guard biased against the needle includes a curved lip.

36. The needle catheter assembly according to claim 30, wherein the width of at least the first arm and / or the second arm varies over the length.

37. The needle catheter assembly according to claim 30, wherein the needle includes a needle hub at the proximal end.

38. The needle catheter assembly according to claim 30, further including one or more reinforcing structures on the clip.

39. The needle catheter assembly according to claim 30, wherein the width of the first needle guard and the width of the second needle guard are greater than the diameter of the needle.

40. The needle catheter assembly according to claim 30, wherein the first needle guard and the second needle guard overlap.

41. The needle catheter assembly according to claim 30, wherein the first needle guard and the second needle guard are equidistant from the rear wall.

42. A catheter assembly configured to be used with a medical device, the catheter assembly comprising: a catheter hub having an internal chamber; A valve disposed in the internal chamber, including a distal portion, a proximal portion, and side walls extending therebetween to define the interior of the valve, the valve including a barrier layer having an arcuate shape extending from the side walls into the interior of the valve at the distal portion, the barrier layer having at least one slit extending therethrough, the at least one slit being in a normally closed configuration to prevent fluid from passing through the barrier layer, and a valve, A sealing ring circumferentially disposed at the distal end of the valve distal to the barrier layer, the sealing ring having an outer sealing surface forming a seal between the valve and the internal chamber at the distal end, the outer diameter of the valve being minimized at a recess portion disposed between the side wall and the barrier layer and adjacent proximal to the outer sealing surface, the recess portion being configured to deform the valve, and the thickness of the side wall at the recess portion being less than the thickness of the barrier layer, and a sealing ring, A protrusion disposed on the outer surface of the side wall, the protrusion fitting into an opening in the internal chamber, and when the medical device is inserted into the proximal portion of the valve, the protrusion reinforces the adjacent side wall to reduce elastic deformation of the valve at the protrusion and increase outward elastic deformation of the side wall at the recess portion, and by further advancing the medical device distally, the barrier layer elastically deforms and the at least one slit opens, allowing the fluid to pass through the barrier layer, and a protrusion, A catheter assembly including.

43. The catheter assembly according to claim 42, wherein the protrusion is disposed proximal to the recess portion.

44. The catheter assembly according to claim 42, wherein the protrusion extends beyond the recess portion.

45. The catheter assembly according to claim 42, wherein the axial length of the protrusion is greater than the circumferential width.

46. The catheter assembly according to claim 42, wherein the sealing ring includes a rounded edge along the circumference of the sealing ring.

47. The catheter assembly according to claim 42, further including a plurality of protrusions on the outer surface of the side wall, each of the plurality of protrusions being coupled to a plurality of openings in the internal chamber.

48. The catheter assembly according to claim 42, further including a lubricant in the internal chamber.

49. The catheter assembly according to claim 42, wherein when the medical device is within the valve, the sealing ring remains engaged with the interior of the side wall.

50. The catheter assembly according to claim 42, wherein the valve includes a flange at its proximal end, and the flange engages the proximal end of the catheter hub.

51. The catheter assembly according to claim 42, wherein the thickness of the side wall is less than the thickness of the barrier layer.

52. A catheter assembly configured for use with a medical device, the catheter assembly comprising: a catheter hub having an internal chamber; a valve disposed within the internal chamber, the valve including a distal portion, a proximal portion, and a side wall extending therebetween and defining an interior of the valve, the valve including a barrier layer having an arcuate shape extending from the side wall into the interior of the valve at the distal portion, the barrier layer having at least one slit extending therethrough, the at least one slit being in a normally closed configuration to prevent fluid from passing through the barrier layer; a sealing ring circumferentially disposed at the distal end of the valve distal to the barrier layer, the sealing ring having an outer sealing surface that forms a seal between the valve and the internal chamber at the distal end, the outer diameter of the valve being minimized at a recessed portion disposed between the side wall and the barrier layer and proximally adjacent to the outer sealing surface, the thickness of the side wall at the recessed portion being less than the thickness of the barrier layer, the recessed portion being configured to deform the valve when the medical device is advanced into the interior of the valve, and further advancing the medical device distally causes the barrier layer to elastically deform and the at least one slit to open, allowing fluid to pass through the barrier layer; The catheter assembly comprising.

53. The catheter assembly according to claim 52, wherein the sealing ring includes a rounded edge along the circumference of the sealing ring.

54. The outer surface of the side wall further includes a plurality of protrusions, each of the plurality of protrusions being coupled to a plurality of openings within the internal chamber, such that when the medical device is inserted into the proximal portion of the valve, the protrusions reinforce the adjacent side walls to reduce elastic deformation of the valve at the protrusions and increase outward elastic deformation of the side wall at the recessed portion. The catheter assembly according to claim 52.

55. The catheter assembly according to claim 54, wherein at least one of the plurality of protrusions is disposed proximal to the recessed portion.

56. The catheter assembly according to claim 54, wherein at least one of the plurality of protrusions extends beyond the recessed portion.

57. The catheter assembly according to claim 54, wherein at least one of the plurality of protrusions includes an axial length that is greater than a circumferential width.

58. The catheter assembly according to claim 52, further including a lubricant within the internal chamber.

59. The catheter assembly according to claim 52, wherein when the medical device is engaged with the recessed portion, the sealing ring remains engaged with the inner surface of the internal chamber.

60. The catheter assembly according to claim 52, wherein the valve includes a flange at the proximal end, the flange being engaged with the proximal end of the catheter hub.

61. The catheter assembly according to claim 52, wherein the thickness of the side wall is less than the thickness of the barrier layer.

62. A catheter assembly configured for use with a medical device, the catheter assembly comprising: a catheter hub having an internal chamber; a valve disposed within the internal chamber, the valve including a distal portion, a proximal portion, and a side wall extending therebetween and defining an interior of the valve, the valve including a barrier layer having an arcuate shape extending from the side wall within the interior of the valve at the distal portion, the barrier layer having at least one slit extending therethrough, the at least one slit being in a normally closed configuration to prevent fluid from passing through the barrier layer, the outer diameter of the valve being minimized at a recessed portion disposed between the side wall and the barrier layer, the recessed portion being configured to deform the valve, and the thickness of the side wall at the recessed portion being less than the thickness of the barrier layer. A protrusion on the outer surface of the side wall disposed proximal to the recessed portion, the protrusion fitting within an opening in the internal chamber, and when the medical device is inserted into the proximal portion of the valve, the protrusion reinforces the adjacent side wall to reduce elastic deformation of the valve at the protrusion and increase outward elastic deformation of the side wall at the recessed portion, and when the medical device is advanced further distally, the barrier layer elastically deforms to open the at least one slit so that the fluid can pass through the barrier layer, the protrusion; A catheter assembly comprising. **Claim 63** The catheter assembly according to claim 62, further comprising a sealing ring circumferentially disposed at the distal end of the valve distal to the barrier layer, the sealing ring having an external sealing surface that forms a seal between the valve and the internal chamber at the distal end, the sealing ring including a rounded edge along the circumference of the sealing ring. **Claim 64** The catheter assembly according to claim 63, wherein when the medical device is engaged with the recessed portion, the sealing ring remains engaged with the inner surface of the internal chamber. **Claim 65** The catheter assembly according to claim 62, further comprising a plurality of protrusions on the outer surface of the side wall, each of the plurality of protrusions being coupled to a plurality of openings within the internal chamber. **Claim 66** The catheter assembly according to claim 62, further comprising a lubricant within the internal chamber. **Claim 67** A catheter assembly configured to be used with a medical device, the catheter assembly comprising: A catheter hub having an internal chamber; A valve disposed within the internal chamber, including a distal portion, a proximal portion, and a side wall extending therebetween and defining the interior of the valve, the valve including a barrier layer extending from the side wall into the valve interior at the distal portion, the barrier layer having a first contact surface, a second contact surface, and an internal recess therebetween, a slit extending through the barrier layer at the internal recess, the slit being in a normally closed configuration that prevents fluid from passing through the barrier layer, and when the medical device is inserted into the valve interior, the medical device engages the first contact surface and the second contact surface to deform the barrier layer, as a result of which the slit opens, the valve; A catheter assembly comprising.

68. The catheter assembly according to claim 67, wherein the barrier layer is solid.

69. The catheter assembly according to claim 67, further comprising a first protrusion and a second protrusion disposed on both sides of the outer surface of the side wall, each of the first protrusion and the second protrusion being received in a first opening and a second opening in the inner chamber, respectively. When the medical device is inserted into the proximal portion of the valve, the first protrusion and the second protrusion reinforce the adjacent side walls to reduce elastic deformation of the valve at the protrusions and increase outward elastic deformation of the side walls at the recessed portion. By further advancing the medical device distally, the barrier layer elastically deforms to form at least one slit, allowing the fluid to pass through the barrier layer.

70. The catheter assembly according to claim 69, wherein the inner recess extends between the first protrusion and the second protrusion.

71. The catheter assembly according to claim 67, further comprising a sealing ring circumferentially disposed at the distal end of the valve distal to the barrier layer. The sealing ring has an outer sealing surface that forms a seal between the valve and the inner chamber at the distal end. The outer diameter of the valve is minimized in a recessed portion disposed between the side wall and the barrier layer and adjacent proximally to the outer sealing surface. The recessed portion is configured to deform the valve, and the thickness of the side wall at the recessed portion is less than the thickness of the barrier layer disposed proximally to the recessed portion.

72. The catheter assembly according to claim 71, wherein the sealing ring includes a rounded edge along the circumference of the sealing ring.

73. The catheter assembly according to claim 71, wherein the sealing ring remains engaged with the inner surface of the inner chamber when the medical device is engaged with the recessed portion.

74. The catheter assembly according to claim 67, further comprising a plurality of protrusions on the outer surface of the side wall, each of the plurality of protrusions being coupled to a plurality of openings in the inner chamber.

75. The catheter assembly according to claim 67, further comprising a lubricant in the inner chamber.

76. The catheter assembly according to claim 67, wherein the valve includes a flange at its proximal end, and the flange engages with the proximal end of the catheter hub.

77. The catheter assembly according to claim 67, wherein the thickness of the side wall is less than the thickness of the barrier layer.

78. The catheter assembly according to claim 67, wherein the first protrusion and the second protrusion are aligned with the longitudinal direction of at least one slit.

79. A catheter assembly configured to be used with a medical device, the catheter assembly comprising: a catheter hub having an internal chamber; a valve disposed in the internal chamber, the valve including a distal portion, a proximal portion, and a side wall extending therebetween and defining an interior of the valve, the valve including a barrier layer extending from the side wall into the interior of the valve at the distal portion, the barrier layer having a first contact surface, a second contact surface, and an internal recess therebetween, a slit extending through the barrier layer at the internal recess, the slit being in a normally closed configuration that prevents fluid from passing through the barrier layer, and when the medical device is inserted into the interior of the valve, the medical device engages the first contact surface and the second contact surface to deform the barrier layer, as a result of which the slit opens; a sealing ring circumferentially disposed at the distal end of the valve distal to the barrier layer, the sealing ring having an external sealing surface that forms a seal between the valve and the internal chamber at the distal end, the outer diameter of the valve being minimized at a recessed portion disposed between the side wall and the barrier layer and proximal and adjacent to the external sealing surface, the recessed portion being configured to deform the valve, and the thickness of the side wall at the recessed portion being less than the thickness of the barrier layer; A protrusion on the outer surface of the side wall disposed proximal to the recessed portion, the protrusion fitting within an opening in the internal chamber, and when the medical device is inserted into the proximal portion of the valve, the protrusion reinforces the adjacent side wall to reduce elastic deformation of the valve at the protrusion and increase outward elastic deformation of the side wall at the recessed portion, and when the medical device is advanced further distally, the barrier layer elastically deforms to open at least one slit so that the fluid can pass through the barrier layer, the protrusion; A catheter assembly including the same. **Claim 80** The catheter assembly according to claim 79, wherein the sealing ring includes a rounded edge along the circumference of the sealing ring. **Claim 81** The catheter assembly according to claim 79, further including a plurality of protrusions on the outer surface of the side wall, each of the plurality of protrusions being coupled to a plurality of openings within the internal chamber, and when the medical device is inserted into the proximal portion of the valve, the protrusions reinforce the adjacent side walls to reduce elastic deformation of the valve at the protrusions and increase outward elastic deformation of the side walls at the recessed portion. **Claim 82** The catheter assembly according to claim 81, wherein the plurality of protrusions are aligned with the longitudinal direction of the at least one slit. **Claim 83** The catheter assembly according to claim 79, further including a lubricant within the internal chamber. **Claim 84** The catheter assembly according to claim 79, wherein the sealing ring remains engaged with the inner surface of the internal chamber when the medical device is engaged with the recessed portion. **Claim 85** The catheter assembly according to claim 79, wherein the valve includes a flange at the proximal end, and the flange engages with the proximal end of the catheter hub. **Claim 86** The catheter assembly according to claim 79, wherein the thickness of the side wall is less than the thickness of the barrier layer. **Claim 87** The catheter assembly according to claim 79, wherein the valve is disposed within the catheter hub without an adhesive. **Claim 88** A valve for use with a catheter assembly for receiving a medical device, the valve comprising: It includes a distal portion, a proximal portion, and a side wall extending therebetween to define the interior of the valve. The valve includes a barrier layer extending from the side wall into the interior of the valve at the distal portion. The barrier layer has a first contact surface, a second contact surface, and a recess therebetween. A slit extends through the barrier layer at the recess. The slit is in a normally closed configuration that prevents fluid from passing through the barrier layer. When the medical device is advanced into the interior of the valve, the medical device engages the first contact surface and the second contact surface to deform the barrier layer, as a result of which the slit opens. Valve.

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