catheter assembly

Abstract

This utility model relates to a catheter assembly including a catheter, a catheter adapter, a proximal connector connected to a port of the catheter adapter, and an extension kit coupled to the proximal connector and including a distal connector. The proximal connector includes a distal port, a proximal port, and a side port, wherein the extension kit is connected to the side port and a split diaphragm valve is disposed in the proximal port. The proximal connector can be configured to withstand a proximal fluid back pressure greater than 30 psi to prevent fluid leakage during fluid injection through the distal connector, or the proximal connector can have a fluid path shut-off element attached thereto to selectively close the fluid path through the proximal connector and the split diaphragm valve to prevent fluid leakage from the proximal connector during fluid injection through the distal connector.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 644,693, filed May 9, 2024, entitled "CatheterAssembly Near Port Connector with Improved Backpressure Performance and LeakPrevention", the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to a conduit assembly, and more specifically, to a conduit assembly including a near-port connector with improved back pressure performance and leak-proof design. Background Technology

[0004] Vascular access devices (VADs) are used in the medical field to connect to a patient's peripheral vascular system for intravenous infusion and / or blood draw purposes. Common types of VADs include peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. VADs can be left in place for short periods (days), medium periods (weeks), or long periods (months to years).

[0005] In some cases, the VAD is part of a larger catheter system or component, where fittings extend from the VAD's adapter or connector to provide additional flexibility for healthcare professionals in administering and / or withdrawing fluid from the VAD—depending on various embodiments, such fittings are part of an extension kit integrated with the VAD (integrated catheter system) or an extension kit provided separately from the VAD (non-integrated catheter system). As a non-limiting example, examples of existing integrated catheter systems from Becton, Dickinson and Company (“BD”) include the BDNexiva. TM Closed peripheral IV catheter system, BD Nexiva TM Diffusics TM Closed IV catheter system and BDNexivaTM NearPort TM Closed peripheral IV catheter system.

[0006] Catheter systems (e.g., catheter systems as described above) typically include multiple connectors or access ports through which external devices can be connected to the catheter system to administer and / or aspirate fluid from the VAD. Such connectors can generally be characterized as “proximal” connectors and “distal” connectors. Proximal connectors may be well-suited for connecting blood collection devices (e.g., Becton Dickinson's PIVO). TM This device is configured to advance a flexible internal probe or flow tube into / through an indwelling catheter in a catheterization system. As a non-limiting example, the distal connector may be well-suited for attaching fluid delivery devices for intravenous infusion via gravity dripping, syringe push, or saline flushing. When using the distal port in these applications, back pressure can be known to be applied to the proximal connector's split diaphragm valve. The proximal connector is typically rated for back pressure at approximately 30 pounds per square inch (psi), so in most cases, the proximal connector can withstand the back pressure applied to it during fluid delivery through the distal port. However, in certain situations, such as when the indwelling catheter is blocked, the back pressure may exceed the proximal connector's approximately 30 psi limit, which can cause fluid to leak proximally through the split diaphragm valve, resulting in leakage from the proximal connector.

[0007] Therefore, a conduit system is needed that includes a near-port connector exhibiting improved back pressure performance. This near-port connector should be configured to withstand a back pressure greater than 30 psi to prevent leakage from the connector under high pressure conditions. Utility Model Content

[0008] This document provides a catheter assembly comprising: a catheter including a distal end and a proximal end; and a catheter adapter including an adapter body including a distal adapter port, a proximal adapter port, and a lateral adapter port, the adapter body defining an inner lumen extending between the distal adapter port and the proximal adapter port, wherein the proximal end of the catheter is secured to the distal adapter port, and wherein the lateral adapter port is in fluid communication with the inner lumen. The catheter assembly further includes: a first fluid conduit including a distal end and a proximal end, the distal end of the first fluid conduit being connected to the proximal adapter port; a proximal port connector including a distal connector port, a proximal connector port, and a lateral connector port, the distal connector port being connected to the proximal end of the first fluid conduit, the proximal port connector including a split-septum valve disposed in the proximal connector port; and an extension kit coupled to the lateral connector port. The extension kit includes a second fluid conduit comprising a distal end and a proximal end, the distal end being coupled to a side connector port; and a distal port connector disposed at the proximal end of the second fluid conduit. The proximal port connector is configured to withstand a proximal fluid back pressure greater than 30 pounds per square inch (psi) to prevent fluid leakage from the proximal port connector during fluid injection through the distal port connector.

[0009] In some embodiments, the near-port connector includes a duckbill valve positioned within the cavity of the near-port connector, near the side connector port and away from the split diaphragm valve, the duckbill valve having a higher back pressure rating than the split diaphragm valve.

[0010] In some embodiments, the near-port connector includes a secondary valve located within the cavity of the near-port connector, near the side connector port, and away from the split diaphragm valve, the secondary valve having a higher back pressure rating than the split diaphragm valve; and a valve actuator element located within the cavity of the near-port connector and near the secondary valve, the valve actuator element including a channel formed therethrough; wherein the valve actuator element is capable of distal movement within the cavity in response to the male connector being introduced into the split diaphragm valve, the valve actuator element opening the secondary valve upon such distal movement.

[0011] In some embodiments, the near-port connector includes a swing hinge valve located within the cavity of the near-port connector, near the side connector port and away from the split diaphragm valve, the swing hinge valve having a higher back pressure rating than the split diaphragm valve.

[0012] In some embodiments, the split diaphragm valve includes: a diaphragm having a slit formed therethrough; and a sidewall extending distally from the diaphragm, wherein the diaphragm and the sidewall define a cavity in the split diaphragm valve.

[0013] In some embodiments, the underside of the diaphragm has a duckbill shape.

[0014] In some embodiments, the lower side of the diaphragm has a dome shape.

[0015] In some embodiments, the split diaphragm valve comprises a dual-material component, wherein the sidewalls are formed of a first material and the diaphragm is formed of a second material having a higher elastic modulus than the first material.

[0016] In some embodiments, the near-port connector includes a distal housing portion and a proximal housing portion, which engage with each other to secure a split diaphragm valve within the near-port connector.

[0017] In some embodiments, the sidewall includes a pair of protrusions located on opposite sides thereof, wherein the pair of protrusions extend radially inward into the cavity to narrow the cavity, the pair of protrusions being configured to bias inward toward each other and contact each other when a radially inward pressure is applied thereto, thereby forming a secondary seal in the split diaphragm valve having a higher back pressure rating than the diaphragm.

[0018] In some embodiments, the proximal housing portion includes a diameter reduction portion formed by a pair of radially inwardly extending protrusions, wherein when the distal housing portion is secured to the proximal housing portion, the pair of radially inwardly extending protrusions press inwardly against the split diaphragm valve in the region of the protrusions, thereby deflecting the pair of protrusions to form the secondary seal.

[0019] In some embodiments, the proximal housing portion includes a housing frame and a sidewall includes a valve holder, wherein the housing frame engages with the valve holder to increase the contact surface area between the split diaphragm valve and the proximal housing portion to prevent the split diaphragm valve from moving proximal within the proximal housing portion in response to fluid back pressure directed proximal to the proximal side.

[0020] In some embodiments, the thickness of the sidewalls is increased or decreased to reduce or increase the compliance of the split diaphragm valve, respectively, in order to increase the back pressure rating of the split diaphragm valve.

[0021] In some embodiments, the thickness of the sidewall is reduced, wherein the sidewall of the split diaphragm valve has a rectangular cutout on its outer surface, a curved cutout on its outer surface, curved cutouts on its inner and outer surfaces, or an accordion-like profile from which material is removed from its inner and outer surfaces.

[0022] In some embodiments, the proximal housing portion includes an inner surface defining a compression zone that engages with a split diaphragm valve to hold the split diaphragm valve in a closed configuration, and wherein the inner surface in the compression zone has a taper angle between 25 degrees and 45 degrees.

[0023] In some embodiments, the inner surface of the compression zone includes a nearest side segment and a farthest side segment with different cone angles, wherein the cone angle of the nearest side segment is greater than that of the farthest side segment.

[0024] In some embodiments, the near-port connector is configured to withstand a proximal fluid back pressure of up to 60 psi to 80 psi, preferably up to 325 psi.

[0025] This document also provides a catheter assembly comprising: a catheter including a distal end and a proximal end; and a catheter adapter including an adapter body including a distal adapter port, a proximal adapter port, and a lateral adapter port, the adapter body defining an inner lumen extending between the distal adapter port and the proximal adapter port, wherein the proximal end of the catheter is secured to the distal adapter port, and wherein the lateral adapter port is in fluid communication with the inner lumen. The catheter assembly further includes: a first fluid conduit including a distal end and a proximal end, the distal end of the first fluid conduit being connected to the proximal adapter port; and a proximal port connector including a distal connector port, a proximal connector port, and a lateral connector port, the distal connector port being connected to the proximal end of the first fluid conduit, wherein the proximal port connector includes a split diaphragm valve disposed in the proximal connector port. The conduit assembly also includes an extension kit coupled to a side connector port, the extension kit comprising: a second fluid conduit including a distal end and a proximal end, the distal end being coupled to the side connector port; and a distal port connector disposed at the proximal end of the second fluid conduit. The conduit assembly also includes a fluid pathshut-off, which is attached to or integrated with the proximal port connector to selectively close the fluid path through the proximal port connector and the split diaphragm valve to prevent fluid leakage from the proximal port connector during fluid injection via the distal port connector.

[0026] In some embodiments, the fluid path shut-off includes an end cap coupled to a proximal connector port, wherein the end cap seals a split diaphragm valve.

[0027] In some embodiments, the end cap includes a sterile foam pad held within its cavity, wherein the foam pad is compressed when the end cap engages with the proximal connector port to seal and sterilize the split diaphragm valve.

[0028] In some embodiments, the end cap includes a tethered end cap comprising a cover member coupled to a proximal connector port to seal a split diaphragm valve; a coupling ring configured to engage with a proximal connector; and a tether connecting the cover member and the coupling ring.

[0029] In some embodiments, the fluid path shut-off element includes a Tuohy-Borst valve, which is integrated into the near-port connector for proximity to or integration with a split diaphragm valve, and is operable to close the fluid path through the near-port connector and the split diaphragm valve.

[0030] In some embodiments, the fluid path shut-off element includes a ball valve integrated into the near-port connector so as to be located on the distal side of the split diaphragm valve and the proximal side of the side connector port, the ball valve being operable to close the fluid path through the near-port connector and the split diaphragm valve.

[0031] In some embodiments, the fluid path shut-off element includes a push-pull valve integrated into the near-port connector to be located on the distal side of the split diaphragm valve and the proximal side of the side connector port. The push-pull valve is operable to close the fluid path through the near-port connector and the split diaphragm valve.

[0032] In some embodiments, the fluid path shut-off includes one of an inline pinless connector, a backflow prevention or two-way valve, or an interconnect connector, which is coupled to a near-port connector at a distal connector port or a proximal connector port. Attached Figure Description

[0033] Figure 1 This is a top view of a catheter assembly according to one aspect of this disclosure;

[0034] Figure 2 It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0035] Figure 3 It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0036] Figure 4 It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0037] Figure 5 It is based on one aspect of this disclosure. Figure 1A cross-sectional view of the proximal connector included in the catheter assembly;

[0038] Figure 6A It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0039] Figure 6B It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0040] Figure 6C It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0041] Figure 6D It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0042] Figure 7A It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0043] Figure 7B It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0044] Figure 8 It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0045] Figure 9 It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0046] Figure 10 It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0047] Figure 11 It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0048] Figure 12 It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0049] Figure 13A It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0050] Figure 13B It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0051] Figure 13C It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0052] Figure 13D It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0053] Figure 14 It is permissible to communicate with one aspect of this disclosure. Figure 2 A perspective view of the end cap used with the near-port connector;

[0054] Figure 15 yes Figure 14 A cross-sectional view of the end cap, shown in relation to engagement with a near-port connector;

[0055] Figure 16 It is permissible to communicate with one aspect of this disclosure. Figure 2 A perspective view of the end cap used with the near-port connector;

[0056] Figure 17 yes Figure 16 A cross-sectional view of the end cap, shown in relation to engagement with a near-port connector;

[0057] Figure 18 It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0058] Figure 19 It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the catheter assembly;

[0059] Figure 20A It is based on one aspect of this disclosure. Figure 1 A cross-sectional view of the proximal connector included in the conduit assembly, wherein its ball valve is in the open position;

[0060] Figure 20B This illustrates one aspect of the disclosure. Figure 20A The near-port connector, wherein its ball valve is in the closed position;

[0061] Figure 21ABased on one aspect of this disclosure Figure 1 A cross-sectional view of the proximal connector included in the conduit assembly, wherein its push-pull valve is in the open position;

[0062] Figure 21B This illustrates one aspect of the disclosure. Figure 21A The near-port connector, wherein its push-pull valve is in the closed position;

[0063] Figure 22 It is based on one aspect of this disclosure. Figure 1 A three-dimensional view of the catheter assembly; and

[0064] Figure 23 It is based on one aspect of this disclosure. Figure 1 A three-dimensional view of the catheter assembly. Detailed Implementation

[0065] The following description is provided to enable those skilled in the art to produce and use the described embodiments intended for implementing this invention. However, various modifications, equivalents, variations, and substitutions will still be apparent to those skilled in the art. Any and all of these modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of this invention.

[0066] As used in this specification, the terms "proximal" and "distal" refer to the directions closer to and further away from the user who places the device in contact with the patient, respectively. Thus, for example, the end of the device that first contacts the patient's body will be the distal end, while the opposite end of the device (e.g., the end of the device that is manipulated by the user) will be the proximal end of the device.

[0067] Spatial or directional terms (such as "left", "right", "inner", "outer", "up" and "down") should not be considered limiting, as the present invention can adopt various alternative orientations.

[0068] In the following description, for descriptive purposes, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the present invention as oriented as shown in the accompanying drawings. However, it should be understood that the present invention may take various alternative variations unless explicitly stated otherwise. It is also understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary aspects of the present invention.

[0069] The terms “first” and “second” are not intended to refer to any particular order or sequence, but rather to different conditions, properties or elements.

[0070] As used herein, “at least one of…” is synonymous with “one or more of…”. For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes: one or more of A alone; one or more of B alone; one or more of C alone; one or more of A and one or more of B; one or more of A and one or more of C; one or more of B and one or more of C; or one or more of A, one or more of B, and one or more of C.

[0071] refer to Figure 1 A non-limiting embodiment of a catheter assembly 10 for assisting in drawing blood and / or infusing fluids to a patient is shown. In the illustrated embodiment, the configuration of the catheter assembly 10 is similar to that of BD Nexiva. TM A closed peripheral IV catheter system, however, according to an additional aspect of this disclosure, it is recognized that the catheter assembly 10 may have another configuration.

[0072] like Figure 1 The catheter assembly 10 is configured / arranged as an integrated catheter assembly that includes an integrated proximal patient connector and an extension kit, as described in further detail below.

[0073] like Figure 2 As shown, the catheter assembly 10 includes a catheter adapter 12 and an associated catheter 14. The catheter adapter 12 may include an adapter body 16 having a distal adapter port 18 or distal end 18 and a proximal adapter port 20 or proximal end 20, and an additional adapter port or "side" adapter port 22 that may be disposed between the distal end 18 and the proximal end 20. The catheter adapter 12 may include a (first) lumen 24 extending through the distal end 18 and the proximal end 20. The catheter 14 extends from the distal end 18 of the catheter adapter 12 and may be configured as a PIVC (Portable Intravenous Catheter) placed in a patient's vein, wherein the distal end or distal tip of the catheter 14 is suitably positioned within the vein to enable blood draw from the patient. As known to those skilled in the art, the catheter 14 may be formed of any suitable material and may have any useful length.

[0074] although Figure 1Not shown, but it should be understood that the catheter assembly 10 may also include a needle assembly disposed at the proximal end 20 of the catheter adapter 12 for introducing the catheter 14 into the patient. The needle assembly will include a needle, for example, extending through the catheter adapter 12 (i.e., through the lumen 24 of the catheter adapter) and into the catheter 14 in a catheter-over-needle arrangement. The needle assembly may also include a body comprising a connector portion and wings, wherein the connector portion engages with the proximal end 20 of the catheter adapter 12, and the wings are configured to bend or deflect to control the movement of the needle relative to the catheter 14 and / or the catheter adapter 12, including during insertion of the needle into the patient's vascular system and during subsequent withdrawal of the needle from the catheter 14 and through the catheter adapter 12.

[0075] Still referencing Figure 1 In some non-limiting embodiments or aspects, the catheter assembly 10 may include a first fluid conduit 40 extending from the side port 22, wherein the first fluid conduit 40 is integrated with the side port 22. The first fluid conduit 40 may be formed of any suitable material known to those skilled in the art and may have a distal end 42 and a proximal end 44. The distal end 42 of the first fluid conduit 40 is coupled to the port 22, while the proximal end 44 of the first fluid conduit 40 may be coupled to a proximal patient or “proximal port” connector 46 (hereinafter “connector 46”). In some embodiments, the proximal port connector 46 may be integrated with the first fluid conduit 40, while in other embodiments, the proximal port connector 46 may be configured as a separate component that can be selectively attached to or detached from the first fluid conduit 40.

[0076] like Figure 1 As shown, and in Figure 2As shown in more detail below, according to an exemplary aspect of this disclosure, connector 46 includes a first or distal housing portion 48 and a second or proximal housing portion 50. Housing portion 48 includes a distal connector end or distal port 52 located thereon, while housing portion 50 includes a proximal connector end or proximal port 54 located thereon. Housing portion 48 also includes a side connector port 56 located thereon, disposed between the distal port 52 and the proximal port 54. According to some embodiments, connector 46 may be configured as a T-connector (e.g., one side port is arranged at a 90-degree angle relative to the longitudinal axis of connector 46) or a Y-connector (e.g., one side port is arranged at an angle of 15 to 85 degrees relative to the longitudinal axis of connector 46). The connector 46 includes a (second) cavity 58 therein, which is defined by housing portions 48, 50 and ports 52, 54, 56, wherein the cavity 58 has any number of branches suitable for the connector type, such as branches extending between the distal port 52 and the proximal port 54 and branches disposed to the side port 56.

[0077] According to some embodiments or aspects, the needleless access connector 60 can be configured as a split-septum valve (hereinafter "split-septum valve 60"), which is disposed in the proximal port 54 of the connector 46. When the distal housing portion 48 is coupled to the proximal housing portion 50, the split-septum valve 60 can be retained within the connector 46, wherein the split-septum valve 60 provides a proximal patient access port to the catheter assembly 10 through which external devices can be connected to the catheter assembly 10. In a non-limiting example, such as BD PIVO... TM The blood-drawing device can be connected to the catheter assembly via connector 46 and its split diaphragm valve 60.

[0078] In some non-limiting embodiments or aspects, the catheter assembly 10 may further include an extension kit 62 coupled to a side port 56 of the connector 46. The extension kit 62 may include a second fluid conduit 64 having a distal end 66 and a proximal end 68. The distal end 66 of the second fluid conduit 64 may be coupled to the side port 56 of the connector 46, while the proximal end 68 of the second fluid conduit 64 may include a proximal connector or a proximal port 70—hereinafter referred to as "distal port 70". In some embodiments, the distal port 70 may include a Luer connector to which a fluid delivery device may be connected. In some embodiments, a needleless access connector 72 may be provided in / on the distal port 70. A clamp 74 may be provided on the second fluid conduit 54, at a location between the ends 66 and 68 of the second fluid conduit, to allow closure of the second fluid conduit.

[0079] As a non-limiting example, extension kit 62 can be used to provide a fluid path to or from catheter assembly 10 for fluid or drug delivery, blood aspiration, or connection to an extracorporeal hemodynamic monitoring device that monitors a patient's blood pressure, heart rate, and / or pulse curve. In some embodiments, as a non-limiting example, the fluid delivery device can be coupled to distal port 70 connector for intravenous infusion via gravity dripping, syringe push, or saline flushing.

[0080] According to various aspects of this disclosure, it is desirable to configure the near-port connector 46 to withstand increased pressure levels that may be encountered during use of the conduit assembly 10. For example, as described above, the distal port 70 is typically used for the purpose of delivering fluid in the conduit assembly 10, such as for brine flushing, wherein the brine solution is injected through the extension kit 62 into the side port 56 and flows distally through the connector 46, then through the first fluid conduit 40 and into / through the conduit adapter 12 and conduit 14. During such flushing, it is recognized that back pressure may be applied to the split diaphragm valve 60 of the connector 46, and in some instances, this back pressure may be significant. For example, if the indwelling conduit 14 becomes blocked during flushing, the back pressure applied to the split diaphragm valve 60 may increase considerably (e.g., back pressure exceeding 30 psi), and it is desirable to configure the connector 46 to withstand high back pressure levels to prevent leakage from the connector under high pressure conditions (i.e., fluid flowing proximally through the split diaphragm valve 60).

[0081] As described in further detail below, in some embodiments, connector 46 may include one or more features contained therein that increase the back pressure capability of the connector, while in other embodiments, separate components may be coupled to connector 46 to prevent leakage from the connector.

[0082] For reference Figures 3 to 5 According to a non-limiting aspect of this disclosure, an embodiment of a near-port connector 46 is shown, wherein the near-port connector 46 includes an additional valve to increase the back pressure capability of the connector 46.

[0083] First refer to Figure 3The diagram illustrates a near-port connector 46 that includes a duckbill valve 80. The duckbill valve 80 is located within the distal housing portion 48 (i.e., the cavity 58 of the distal housing portion 48). Specifically, the duckbill valve 80 is located within the distal housing portion 48 at a position close to the side port 56 and away from the split diaphragm valve 60. The duckbill valve 80 is configured to have a higher backpressure rating than the split diaphragm valve 60, thus increasing the backpressure rating of the connector 46. In some non-limiting embodiments, the duckbill valve 80 increases the backpressure rating of the connector 46 to more than 30 psi, for example up to 60 psi to 80 psi, and preferably up to 325 psi, to prevent fluid from flowing or leaking from the connector 46 to the proximal side under such backpressure.

[0084] Next reference Figure 4 The diagram illustrates a near-port connector 46, in which a secondary valve 82 is included, and a valve actuator 84 movable within the connector 46 to open the secondary valve 82. For example, the secondary valve 80 may comprise a disc-shaped valve in which a diaphragm is formed, and the secondary valve 80 may be positioned within a distal housing portion 48 (i.e., the cavity 58 of the distal housing portion 48) near the side port 56 and away from the split diaphragm valve 60, wherein the secondary valve 82 has a higher back pressure rating than the split diaphragm valve 60, thereby increasing the back pressure rating of the connector 46. The valve actuator 84 may comprise an elongated member through which a longitudinal channel 85 is formed. The valve actuator 84 may be partially located within the distal housing portion 48 (its inner cavity 58) and extend proximally back into the proximal housing portion 50, wherein the valve actuator 84 is located within a cavity 87 defined in the split diaphragm valve 60 (forming another part of the inner cavity 58).

[0085] When using connector 46, for example during flushing of conduit assembly 10 through distal port 66, the secondary valve 80 is normally closed to provide increased back pressure capability to connector 46. The secondary valve 80 can be opened when an external device is connected to the connector at proximal port 54. That is, when an external device is connected to the connector at proximal port 54, valve actuator 84 can be pushed distally within cavity 58, where a male Luer connector or blunt sleeve pushes valve actuator 84 distally until valve actuator 84 engages / opens secondary valve 80. When the external device is subsequently disconnected from connector 46, valve actuator 84 can then return to its original position via a return spring or a tapered design of the actuator / secondary valve interface.

[0086] Next reference Figure 5The diagram shows a near-port connector 46, which includes a swinging hinge valve 86. The swinging hinge valve 86 is located within the distal housing portion 48 (i.e., the cavity 58 of the distal housing portion 48) and is configured to be closed in the normal / unactuated state. Specifically, the swinging hinge valve 86 is located within the distal housing portion 48 at a position close to the side port 56 and away from the split diaphragm valve 60. The swinging hinge valve 86 is configured to have a higher back pressure rating than the split diaphragm valve 60, thus increasing the back pressure rating of the connector 46. In some non-limiting embodiments, the swinging hinge valve 86 increases the back pressure rating of the connector 46 to more than 30 psi, for example up to 60 psi to 80 psi, and preferably up to 325 psi, to prevent fluid from flowing or leaking from the connector 46 to the proximal side under such back pressure. When using connector 46, the swing hinge valve 86 can be opened when pressure is applied to the distal side through the proximal port 54 (e.g., fluid pressure or mechanical pressure applied through the male connector of the external device), but in other cases the swing hinge valve will be sealed and maintain back pressure on the body of the split diaphragm valve 60.

[0087] Now for reference Figures 6A to 6D According to a non-limiting aspect of this disclosure, an embodiment of a near-port connector 46 is shown, which includes an improved split-type diaphragm valve 60 that increases the back pressure capability of the connector 46. Specifically, the lower (far side) of the diaphragm 88 of the split-type diaphragm valve 60 has a specific profile to increase the back pressure capability of the split-type diaphragm valve 60. Figure 6A and Figure 6B In one embodiment, the lower side 89 of the diaphragm 88 has a duckbill configuration. Figure 6C In one embodiment, the lower side 89 of the diaphragm 88 has a generally duckbill-shaped configuration with truncated conical protrusions extending therefrom. Figure 6D In one embodiment, the lower side 89 of the diaphragm 88 has a dome-shaped configuration. Although Figures 6A to 6D The specific shape / profile of the underside 89 of the diaphragm 88 is shown, but it should be recognized that the underside 89 of the diaphragm 88 may have other suitable shapes / profiles, including trapezoidal configurations or other geometries that may be symmetrical or asymmetrical with respect to the slits in the diaphragm 88. In any suitable configuration, when back pressure is applied to the diaphragm 88, the shape / profile of the underside 89 of the diaphragm 88 causes the slits 90 in the diaphragm 88 to be pushed together. In some non-limiting embodiments, the shape / profile of the underside 89 of the diaphragm 88 increases the back pressure rating of the connector 46 to more than 30 psi, for example up to 60 psi to 80 psi, and preferably up to 325 psi, to prevent fluid from flowing or leaking from the connector 46 proximally under such back pressure.

[0088] Now for reference Figure 7A and Figure 7B An embodiment of the near-port connector 46 is shown. As a non-limiting example, the near-port connector 46 provides the required back pressure capability while also being optimized so that the split diaphragm valve 60 opens consistently and has a reduced activation force when engaging with various types of connectors, including blunt sleeves and male Luer connectors. Specifically, the inner surface of the proximal housing portion 50 is configured such that the cone angle A between the compression zone 91 of the proximal housing portion 50 and the lower sidewall of the split diaphragm valve 60 is... T Within a specific range. According to an exemplary embodiment, the compression zone 91 is configured to have a cone angle A between 25 degrees and 45 degrees. T Such a cone angle allows the split diaphragm valve 60 (i.e., the slit 90 in the split diaphragm valve 60) to open earlier during connector engagement, thereby reducing the required activation force and lowering the likelihood of damage to the split diaphragm valve 60 during valve activation. In some embodiments, and as... Figure 7A As shown, the compression zone 91 can be configured to have a constant / single cone angle A along its length. T In other embodiments, and as... Figure 7B As shown, the compression zone 91 can be configured to include multiple segments 91a, 91b formed at different angles, wherein the cone angle A of the closest side segment 91a is... T_1 The cone angle A is greater than that of the farthest side segment 91b. T_2 This allows for more uniform wall thickness to improve filling during injection molding.

[0089] According to other non-limiting aspects of this disclosure, a near-port connector 46 may be provided, comprising an improved split-type diaphragm valve 60, which is (at least partially) formed of a harder material, thereby increasing the back pressure capability of the connector 46. In some embodiments, the entire split-type diaphragm valve 60 may be formed of a material with a higher elastic modulus (i.e., a harder material grade), which reduces the compliance of the system and thus increases the back pressure performance of the split-type diaphragm valve 60. In other embodiments, the split-type diaphragm valve 60 may be formed as a bi-component / bi-material valve, wherein only a portion of the split-type diaphragm valve (i.e., the diaphragm 88 including the slit 90) is formed of a material with a higher elastic modulus (i.e., a harder material grade). In such a bi-component / bi-material embodiment, the first valve portion 92 and the second valve portion 94 may be joined together by material crosslinking, melting together, or by screw-in features. Figure 8 and Figure 9Two examples of screw-in features are provided, wherein a stiffer first valve portion 92 (including at least the diaphragm 88) is screwed into a more compliant second valve portion 94. In some non-limiting embodiments, forming at least a portion of the split diaphragm valve 60 from a stiffer material increases the back pressure rating of the connector 46 to above 30 psi, for example up to 60 psi to 80 psi, and preferably up to 325 psi, to prevent fluid from flowing or leaking proximally from the connector 46 under such back pressure.

[0090] Now for reference Figure 10 and Figure 11 According to a non-limiting aspect of this disclosure, an embodiment of a near-port connector 46 is shown, which includes an improved split diaphragm valve 60 and a connector housing (distal housing portion 48 and proximal housing portion 50), which increases the back pressure capability of the connector 46.

[0091] First refer to Figure 10 The diagram illustrates a near-port connector 46, which includes a split diaphragm valve 60 on which a secondary seal 96 is formed, wherein the secondary seal 96 has a higher back pressure rating than the first seal 98 formed by the diaphragm 88. Therefore, in some embodiments, the first seal 98 may be primarily designed to prevent microbial ingress, while the secondary seal 96 may be designed for a maximum back pressure rating (e.g., exceeding 30 psi, and up to, for example, 60 psi to 80 psi, and preferably up to 325 psi). Figure 10 As shown, the secondary seal 96 is formed by a pair of protrusions 100 that extend inward to reduce the cavity 85 in the split diaphragm valve 60. The protrusions 100 are configured to deflect inward toward each other and contact each other when a radially inward pressure is applied to them, for example when the distal housing portion 48 and the proximal housing portion 50 are secured together (where the split diaphragm valve 60 is housed), to provide the secondary seal 96. To achieve this deflection of the protrusions 100, the proximal housing portion 50 includes a reduced-diameter portion 102 (formed by radially inwardly extending protrusions 104) that presses inward against the region of the split diaphragm valve 60 that includes the secondary seal 96. When using connector 46, when the split diaphragm valve 60 engages with the male connector of an external device, the split diaphragm valve 60 moves downward, causing the secondary seal 96 to be no longer compressed by the reduced diameter portion 102 of the proximal housing portion 50, thereby opening the secondary seal 96. In some embodiments, lubricating oil can be added to the interface between the proximal housing portion 50 and the split diaphragm valve 60 to allow the split diaphragm valve 60 to slide more freely.

[0092] Next reference Figure 11The diagram illustrates a near-port connector 46, which includes a split diaphragm valve 60 and a near-side housing portion 50. The near-side housing portion 50 has features that prevent the split diaphragm valve 60 from moving proximally. Specifically, a valve shelf 105 and a housing shelf 106 are added to the split diaphragm valve 60 and near-side housing portion 50, respectively, to increase surface area. This counteracts a back pressure applied to the connector 46 that could cause the split diaphragm valve 60 to be pulled out of the circumferential compression pocket (i.e., near-side port 54) of the near-side housing portion 50. In some embodiments, a second valve shelf 108 may be added to the split diaphragm valve 60 near the valve shelf 105, further increasing the contact surface area and counteracting the back pressure applied to the connector 46 that could cause the split diaphragm valve 60 to be pulled out of the circumferential compression pocket (i.e., near-side port 54) of the near-side housing portion 50. By preventing the split diaphragm valve 60 from moving proximally relative to the proximal housing portion 50, the back pressure rating of the connector 46 can be increased to more than 30 psi, for example up to 60 psi to 80 psi, and preferably up to 325 psi, to prevent fluid from flowing or leaking proximally from the connector 46 under such back pressure.

[0093] Now for reference Figure 12 and Figures 13A to 13D According to a non-limiting aspect of this disclosure, an embodiment of a near-port connector 46 is shown, which includes an improved split diaphragm valve 60 that increases the back pressure capability of the connector 46.

[0094] First refer to Figure 12 The diagram illustrates a near-port connector 46, which includes a split diaphragm valve 60 with a sidewall 110 having increased thickness (compared to existing split diaphragm valves in near-port connectors). With the increased thickness of the sidewall 110, the stiffness of the split diaphragm valve 60 also increases because the gap between the sidewall 110 and the inner surface of the near-side housing portion 50 is smaller, thus reducing the space for deflection of the sidewall 110 when back pressure is applied to the split diaphragm valve 60. Therefore, the increased stiffness of the split diaphragm valve 60 increases the back pressure rating of the connector 46 to over 30 psi, for example up to 60 psi to 80 psi, preferably up to 325 psi, to prevent fluid from flowing or leaking from the connector 46 to the near side under such back pressure.

[0095] Next reference Figures 13A to 13DAn embodiment of a near-port connector 46 is shown, which includes a split diaphragm valve 60 with a sidewall 110 having reduced thickness (compared to existing split diaphragm valves in near-port connectors). According to the embodiment, material can be removed from the sidewall 110 according to any of a variety of suitable patterns / profiles. Material can be removed from the inner surface, outer surface, or both of the inner and outer surfaces of the sidewall 110 to reduce the thickness of the sidewall. Figures 13A to 13D Various non-limiting embodiments of an exemplary near-port connector 46 with reduced-thickness sidewalls 110 are shown, wherein Figure 13A A split-type diaphragm valve 60 with a rectangular cutout 111 on its outer surface is shown. Figure 13B A split-type diaphragm valve 60 with an accordion-like profile is shown, wherein material has been removed from the inner and outer surfaces of the sidewall 110, and Figure 13C and Figure 13D It is shown on its inner and outer surfaces ( Figure 13C ), or only on its outer surface ( Figure 13D 60 is a split-type diaphragm valve with one or more curved cuts.

[0096] With the reduced thickness of the sidewall 110, the compliance of the split diaphragm valve 60 in this region also increases—this increased compliance allows the split diaphragm valve 60 additional space to absorb some of the back pressure applied to it before the proximal end (diaphragm 88) of the split diaphragm valve 60 is moved out of the compression zone of the proximal port 54 of the proximal housing portion 50 (i.e., the sidewall 110 may deflect further outward). Therefore, the connector 46 can exhibit an increased back pressure rating of more than 30 psi, for example up to 60 psi to 80 psi, and preferably up to 325 psi, to prevent fluid from flowing or leaking proximal to the connector 46 under such back pressure.

[0097] exist Figure 12 and Figures 13A to 13D In some embodiments, the diaphragm 88 may have a modified shape that alters the compression of the slit 90 therein. For example, the diaphragm 88 may have an elliptical profile (instead of a circle) to concentrate compression on the slit 90 (i.e., the major axis of the ellipse would be perpendicular to the slit). According to embodiments, the slit 90 in the diaphragm 88 may be molded into the body of the diaphragm 88, or may be formed (i.e., cut) into the body of the diaphragm 88 after molding.

[0098] although Figures 3 to 13DThe embodiment of connector 46 shown and described functions to increase the back pressure rating of the connector; however, other embodiments of this disclosure may involve connector 46 having (included therein or attached thereto) one or more features to prevent leakage from the connector, for example by closing a fluid path through connector 46. Such a component may generally be referred to as a "fluid path shut-off element" and functions to prevent leakage from connector 46 (via split diaphragm valve 60) when a large back pressure is applied to the connector.

[0099] refer to Figure 14 and Figure 15 According to one embodiment of this disclosure, a connector 46 is shown, to which an end cap 114 is coupled to prevent leakage from the connector 46 when a large back pressure is applied. The end cap 114 may include a closed proximal end 116 and an open distal end 118, wherein the open distal end defines a cavity 120 within the end cap 114. A central projection 122 may extend from the closed proximal end 116 into the cavity 120. In some embodiments, the central projection 122 is configured to engage with a split diaphragm valve 60 (i.e., penetrate the diaphragm 88), while in other embodiments, the central projection 122 may be configured to be "non-actuated," i.e., not engage with the split diaphragm valve 60. The inner surface of the end cap 114 defining the cavity 120 may include a threaded surface that engages with a proximal port 54 of the connector 46. The foam pad 124 can be held within the cavity 120 and can contact the connector 46 (and the split diaphragm valve 60), wherein the foam pad 124 holds a disinfectant (e.g., isopropanol, iodine). When the end cap 114 engages with the connector 46, the foam pad 124 can be compressed, thereby sealing and disinfecting the split diaphragm valve 60.

[0100] When end cap 114 is connected to connector 46, end cap 114 serves to retain the split diaphragm valve 60 within connector 46 (i.e., prevent proximal movement within the proximal housing portion 50) and to keep the slit 90 of diaphragm 88 closed. Therefore, when a large back pressure is applied to end cap 114, end cap 114 prevents fluid from flowing proximal through connector 46 and split diaphragm valve 60, thereby preventing fluid leakage from connector 46 during fluid flushing of conduit assembly 10.

[0101] refer to Figure 16 and Figure 17 According to another embodiment of this disclosure, a connector 46 is shown, wherein an end cap 126 is coupled to the connector 46 to prevent leakage from the connector 46 when a large back pressure is applied to the connector 46. Figure 14 and Figure 15Compared to end cap 114, end cap 126 is configured to be physically connected to catheter assembly 10 using a tether. Therefore, end cap 126 includes a coupling ring 128, a cap member 130, and a tether 132. The coupling ring 128 can be secured around a component of catheter assembly 10 (e.g., connector 46 or catheter adapter 12), the cap member 130 can be screwed onto the proximal port 54, and the tether 132 connects the coupling ring 128 and the cap member 130 together. According to an embodiment, the cap member 130 of end cap 126 can be configured to... Figure 14 and Figure 15 The end cap 114 (including the sterile foam pad 124) is identical to that in the previous embodiment. In other embodiments, the cap member 130 of the end cap 126 may be a simple dead-end cap screwed onto the proximal port 54. According to some embodiments, the end cap 126 may first be covered in a protective wrapping to provide a sterile component. According to some embodiments, the tether 132 may include a weakness that allows a user to twist the tether 132 and disconnect it after using the end cap 126 to remove the cap member 130 and discard it.

[0102] refer to Figure 18 and Figure 19 The diagram shows that connector 46 has an integrated (separate from the split diaphragm valve 60) additional component that selectively opens / closes the fluid path through connector 46. That is, connector 46 may include a Tuohy-Borst type valve 134, which is integrated into the distal housing portion 48 so as to be adjacent to / below the split diaphragm valve 60. Figure 18 Alternatively, the Tuohy-Borst type valve 134 can be integrated into / with the split diaphragm valve 60. Figure 19 When the internal fluid back pressure may exceed the capacity of the split diaphragm valve, the Tuohy-Borst valve 134 allows the user to isolate the split diaphragm valve 60 from the rest of the fluid path (in the conduit assembly 10). In some embodiments, the Tuohy-Borst valve 134 can close the slit 90 of the split diaphragm valve 60 by axially compressing the valve, for example by screwing the housing portions 48, 50 of the connector 46 together via a locking collar 136 disposed on the connector.

[0103] refer to Figure 20A and Figure 20B as well as Figure 21A and Figure 21B The connector 46 may also include a separate valve component integrated therein (i.e., integrated into the distal housing portion 48), which can be controlled to selectively open / close the fluid path (i.e., the cavity 58) through the connector 46.

[0104] First refer to Figure 20A and Figure 20B The diagram shows a near-port connector 46, which includes a ball valve 140 integrated into a distal housing portion 48. The ball valve 140 may include a lever 142 extending to the exterior of the connector 46, wherein the lever 142 is rotatable to selectively open / close a fluid path (i.e., cavity 58) through the connector 46. That is, the lever 142 can be rotated in a first direction to open the ball valve 140 and open the fluid path through the connector 46. Figure 20A ), and can be rotated in the second direction to close the ball valve 140 and shut off the fluid path through connector 46 ( Figure 20B ).

[0105] Next reference Figure 21A and Figure 21B The diagram shows a near-port connector 46, which includes a pull / push valve 144 integrated into a distal housing portion 48. The pull / push valve 144 extends from the connector 46 and can be "pulled" or "push" to selectively open / close the fluid path through the connector 46 (i.e., the cavity 58). That is, when the pull / push valve 144 is in the "pulled" state ( Figure 21A The valve opens and the fluid path through connector 46 is open, and when the pull / push valve 144 is in the "push" state ( Figure 21B The valve closes and shuts off the fluid path through connector 46. Therefore, when the internal fluid pressure might exceed the back pressure capacity of connector 46, the pull / push valve 144 allows the user to isolate the near-port connector 46 from the rest of the fluid path in the conduit assembly 10. In some embodiments, and as in Figure 21A and Figure 21B As shown, the pull / push valve 144 is integrated into the distal housing portion 48. In other embodiments not shown herein, the pull / push valve 144 is integrated into the proximal housing portion 50—then the pull / push valve 144 operates to compress the split diaphragm valve 60 within the proximal port 54 to withstand internal fluid pressure.

[0106] refer to Figure 22 and Figure 23 In another embodiment, a separate inline pinless connector, anti-backflow or bidirectional valve or interconnect type connector (accessible via a blunt plastic sleeve), typically designated 146, is added / connected to connector 46 to provide an additional layer of pressure capability. The separate inline pinless connector 146 may be positioned distal to the main connector 46. Figure 22 ) or proximal ( Figure 23However, in any embodiment, a separate inline pinless connector 146 is positioned near the connection point / port of the second fluid conduit 64.

[0107] Advantageously, embodiments of this disclosure therefore provide a proximal connector for a conduit assembly that provides improved back pressure capability and / or leak-proofness. In some embodiments, the proximal connector may include one or more pressure-increasing features configured to increase the pressure capability of a split diaphragm valve therein. In other embodiments, a separate cap or valve may be added / attached to the proximal connector to selectively open / close the fluid path passing through it, thereby preventing leakage from the connector during high back pressure conditions / occurrences.

[0108] Although this disclosure has been described in detail based on embodiments or aspects currently considered to be most practical and preferred for illustrative purposes, it should be understood that such detail is for that purpose only, and this disclosure is not limited to the disclosed embodiments or aspects. Rather, this disclosure is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that this disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A catheter assembly, characterized in that, The catheter assembly includes: The catheter includes a distal end and a proximal end; A catheter adapter includes an adapter body comprising a distal adapter port, a proximal adapter port, and a lateral adapter port, wherein the adapter body defines an inner lumen extending between the distal adapter port and the proximal adapter port, wherein the proximal end of the catheter is secured to the distal adapter port, and wherein the lateral adapter port is in fluid communication with the inner lumen. A first fluid conduit, the first fluid conduit including a distal end and a proximal end, the distal end of the first fluid conduit being connected to the proximal adapter port; A near-port connector, comprising a distal connector port, a proximal connector port, and a side connector port, wherein the distal connector port is connected to the proximal end of the first fluid conduit, and wherein the near-port connector includes a split-type diaphragm valve disposed in the proximal connector port; and Extension kit, the extension kit being coupled to the side connector port, the extension kit comprising: A second fluid conduit, comprising a distal end and a proximal end, the distal end of which is connected to the side connector port; and A remote connector, wherein the remote connector is disposed at the proximal end of the second fluid conduit; The near-port connector is configured to withstand a proximal fluid back pressure of more than 30 pounds per square inch (psi) to prevent fluid leakage from the near-port connector during fluid injection through the far-port connector.

2. The catheter assembly according to claim 1, characterized in that, The near-port connector includes a duckbill valve positioned within the cavity of the near-port connector, near the side connector port and away from the split diaphragm valve, the duckbill valve having a higher back pressure rating than the split diaphragm valve.

3. The catheter assembly according to claim 1, characterized in that, The near-port connector includes: A secondary valve, positioned within the cavity of the near-port connector, close to the side connector port and away from the split-type diaphragm valve, the secondary valve having a higher back pressure rating than the split-type diaphragm valve; and A valve actuator element, the valve actuator element being positioned within the cavity of the near-port connector and proximal to the sub-valve, the valve actuator element including a channel formed therethrough; The valve actuator element is capable of moving distally within the cavity in response to the male connector being introduced into the split diaphragm valve, wherein the valve actuator element opens the secondary valve during this distal movement.

4. The catheter assembly according to claim 1, characterized in that, The near-port connector includes a swing hinge valve located within the cavity of the near-port connector, close to the side connector port and away from the split diaphragm valve, the swing hinge valve having a higher back pressure rating than the split diaphragm valve.

5. The catheter assembly according to claim 1, characterized in that, The split-type diaphragm valve includes: A diaphragm having a slit formed therethrough; and A sidewall extending distally from the diaphragm, wherein the diaphragm and the sidewall define a cavity in the split diaphragm valve.

6. The catheter assembly according to claim 5, characterized in that, The lower side of the diaphragm has a duckbill shape.

7. The catheter assembly according to claim 5, characterized in that, The lower side of the diaphragm has a dome shape.

8. The catheter assembly according to claim 5, characterized in that, The split-type diaphragm valve comprises two material components, wherein the sidewall is formed of a first material and the diaphragm is formed of a second material, the second material having a higher elastic modulus than the first material.

9. The catheter assembly according to claim 5, characterized in that, The near-port connector includes a distal housing portion and a proximal housing portion, which engage with each other to secure the split diaphragm valve within the near-port connector.

10. The catheter assembly according to claim 9, characterized in that, The sidewall includes a pair of protrusions located on opposite sides thereof, wherein the pair of protrusions extend radially inward into the cavity to narrow the cavity, wherein the pair of protrusions are configured to deflect inward toward each other and contact each other when a radially inward pressure is applied thereto, thereby forming a secondary seal in the split diaphragm valve, the secondary seal having a higher back pressure rating than the diaphragm.

11. The catheter assembly according to claim 10, characterized in that, The proximal housing portion includes a reduced diameter portion formed by a pair of radially inwardly extending protrusions, wherein when the distal housing portion is fixed to the proximal housing portion, the pair of radially inwardly extending protrusions press inwardly against the split diaphragm valve in the region of the pair of protrusions, thereby deflecting the pair of protrusions to form the secondary seal.

12. The catheter assembly according to claim 9, characterized in that, The proximal housing portion includes a housing frame, and the sidewall includes a valve frame, wherein the housing frame engages with the valve frame to increase the contact surface area between the split diaphragm valve and the proximal housing portion to prevent the split diaphragm valve from moving proximal within the proximal housing portion in response to proximal fluid back pressure.

13. The catheter assembly according to claim 9, characterized in that, The thickness of the sidewall is increased or decreased to reduce or increase the compliance of the split diaphragm valve, respectively, so as to increase the back pressure rating of the split diaphragm valve.

14. The catheter assembly according to claim 13, characterized in that, The thickness of the sidewall is reduced, wherein the sidewall of the split diaphragm valve has a rectangular cut on its outer surface, a curved cut on its outer surface, a curved cut on its inner and outer surfaces, or an accordion-shaped profile from which material is removed from its inner and outer surfaces.

15. The catheter assembly according to claim 9, characterized in that, The proximal housing portion includes an inner surface defining a compression zone that engages with the split diaphragm valve to hold the split diaphragm valve in a closed configuration, wherein the inner surface in the compression zone has a taper angle between 25 degrees and 45 degrees.

16. The catheter assembly according to claim 15, characterized in that, The inner surface of the compression zone includes a nearest side segment and a farthest side segment with different cone angles, wherein the cone angle of the nearest side segment is greater than that of the farthest side segment.

17. The catheter assembly according to claim 1, characterized in that, The near-port connector is configured to withstand proximal fluid back pressures of up to 60 psi to 80 psi.

18. The catheter assembly according to claim 1, characterized in that, The near-port connector is configured to withstand a proximal fluid back pressure of up to 325 psi.

19. A catheter assembly, characterized in that, The catheter assembly includes: The catheter includes a distal end and a proximal end; A catheter adapter includes an adapter body comprising a distal adapter port, a proximal adapter port, and a lateral adapter port, wherein the adapter body defines an inner lumen extending between the distal adapter port and the proximal adapter port, wherein the proximal end of the catheter is secured to the distal adapter port, and wherein the lateral adapter port is in fluid communication with the inner lumen. A first fluid conduit, the first fluid conduit including a distal end and a proximal end, the distal end of the first fluid conduit being connected to the proximal adapter port; A near-port connector, comprising a distal connector port, a proximal connector port, and a side connector port, wherein the distal connector port is connected to the proximal end of the first fluid conduit, and wherein the near-port connector includes a split-type diaphragm valve disposed in the proximal connector port; Extension kit, the extension kit being coupled to the side connector port, the extension kit comprising: A second fluid conduit, comprising a distal end and a proximal end, the distal end of which is connected to the side connector port; and A remote connector, wherein the remote connector is disposed at the proximal end of the second fluid conduit; and A fluid path shut-off element, which is attached to or integrated with the near-port connector to selectively close the fluid path through the near-port connector and the split diaphragm valve, in order to prevent fluid leakage from the near-port connector during fluid injection through the far-port connector.

20. The catheter assembly according to claim 19, characterized in that, The fluid path shut-off component includes an end cap connected to the proximal connector port, wherein the end cap seals the split diaphragm valve.

21. The catheter assembly according to claim 20, characterized in that, The end cap includes a sterile foam pad held within its cavity, wherein the foam pad is compressed when the end cap engages with the proximal connector port to seal and sterilize the split diaphragm valve.

22. The catheter assembly according to claim 20, characterized in that, The end cap includes a tether end cap, the tether end cap comprising: A cover member, the cover member being connected to the proximal connector port to seal the split diaphragm valve; A coupling ring, configured to engage with the near-port connector; and A tether connects the cover component and the connecting ring.

23. The catheter assembly according to claim 19, characterized in that, The fluid path shut-off element includes a Tuohy-Borst valve, which is integrated into the near-port connector for proximity to or integration with the split diaphragm valve, and is operable to close the fluid path through the near-port connector and the split diaphragm valve.

24. The catheter assembly according to claim 19, characterized in that, The fluid path shut-off element includes a ball valve integrated into the near-port connector to be located distal to the split diaphragm valve and proximal to the side connector port. The ball valve is operable to close the fluid path through the near-port connector and the split diaphragm valve.

25. The catheter assembly according to claim 19, characterized in that, The fluid path shut-off element includes a push-pull valve integrated into the near-port connector to be located distal to the split diaphragm valve and proximal to the side connector port. The push-pull valve is operable to close the fluid path through the near-port connector and the split diaphragm valve.

26. The catheter assembly according to claim 19, characterized in that, The fluid path shut-off element includes one of an inline pinless connector, a backflow prevention or bidirectional valve, or an interconnect connector, wherein the inline pinless connector, the backflow prevention or bidirectional valve, or the interconnect connector is connected to the near port connector at the distal connector port or the proximal connector port.

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