Catheter assembly and system

Abstract

The utility model relates to a catheter assembly and system. A catheter assembly is provided that includes: a catheter having a catheter distal end and a catheter proximal end; a catheter adapter coupled to the catheter proximal end and including a lumen in fluid communication with the catheter and an adapter port in fluid communication with the lumen; a proximal patient adapter connected to the adapter port via an extension tube and including a distal end and a proximal end; and a needleless connector coupled to the proximal end of the proximal patient adapter. The needleless connector includes a body defining an internal cavity and including a distal port and a proximal port, a split septum valve retained within the proximal port and extending into the internal cavity, and a pressure resistance increasing feature incorporated into or disposed adjacent to the split septum valve, the pressure resistance increasing feature configured to increase the pressure capability of the needleless connector.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 672,271, filed July 17, 2024, entitled "Catheter Assembly with Near-Patient Connector Having Improved Back-Pressure Capability", the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to a catheter assembly for the insertion and access of an indwelling catheter, and more specifically, to a patient-proximity connector for an improved back pressure capability of the catheter assembly. Background Technology

[0004] Vascular access devices (VADs) are used in the medical field to connect to a patient's peripheral vascular system for infusion therapy and / or blood draw. 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 healthcare professionals with additional flexibility 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, one example of an existing integrated catheter system from Becton, Dickinson and Company (“BD”) is one with NearPort. TM BD Nexiva via the IV pathway TM Closed peripheral IV catheter system.

[0006] As mentioned above, it can have a NearPort TM BD Nexiva via the IV pathway TM Closed peripheral IV catheter systems and other VADs are used for fluid infusion and / or blood aspiration. It should be recognized that such fluid infusion and / or blood aspiration can be performed via one or more external devices or systems that can be used with the VAD to facilitate direct fluid infusion and / or blood aspiration from the indwelling catheter of the VAD. A VAD (e.g., the VAD described above) typically includes multiple connectors or access ports through which external devices can be connected to the catheter system to provide fluid administration and / or aspiration from the VAD. Such connectors can generally be characterized as “proximal” connectors and “distal” connectors. Proximal connectors are ideally suited for blood aspiration devices (e.g., the PIVO from Becton Dickinson). TM The blood-drawing device is configured to advance a flexible internal probe or flow tube into / through the indwelling catheter of the catheter system. As a non-limiting example, the distal connector can be ideally used for connection to a fluid delivery device for intravenous infusion via gravity flow dripping, syringe aspiration, or saline flushing.

[0007] As described above, when using a fluid delivery device with a VAD, the device is typically connected to the distal port of the VAD. Under normal use, the proximal port connector and its access valve are able to maintain the pressure within the system and accommodate fluid delivery without problems. However, there are situations where the pressure may exceed the capacity of the proximal port Luer access valve, and leakage may occur. For example, when administering medication at a rate higher than that the catheter can accommodate using a syringe (1) attached to the distal port and / or when the catheter is blocked, high pressure (back pressure) may be applied to the proximal port Luer access valve, which may lead to leakage through the valve.

[0008] Therefore, the following VADs are needed: These VADs include patient access valves or ports with improved back pressure capability, enabling them to better maintain or withstand higher internal pressures before leakage. Utility Model Content

[0009] This document provides a catheter assembly comprising: a catheter having a distal end and a proximal end; a catheter adapter coupled to the proximal end of the catheter and including a lumen in fluid communication with the catheter and an adapter port in fluid communication with the lumen; a proximal patient adapter connected to the adapter port via an extension tube and including a distal end and a proximal end; and a needleless connector coupled to the proximal end of the proximal patient adapter. The needleless connector includes: a body defining an inner lumen and including a distal port and a proximal port; a split diaphragm valve retained within the proximal port and extending into the inner lumen; and a pressure resistance-increasing feature incorporated into or adjacent to the split diaphragm valve, the pressure resistance-increasing feature being configured to increase the pressure capability of the needleless connector.

[0010] In some embodiments, the pressure resistance increase feature includes a circumferential protrusion formed on the inner surface of the body and extending radially inward into the cavity at a location adjacent to the split diaphragm valve.

[0011] In some embodiments, when the external male connector is inserted into the internal volume of the body through the slit of the split diaphragm valve, the circumferential protrusion increases the compressive force between the external male connector and the split diaphragm valve.

[0012] In some embodiments, the external male connector includes one of a male Luer connector and a blunt sleeve.

[0013] In some embodiments, the increased pressure resistance feature includes a secondary split-type diaphragm valve located within the cavity and remote from the split-type diaphragm valve.

[0014] In some embodiments, the split diaphragm valve is configured to receive a blunt sleeve of an external male connector, and the increased pressure resistance feature includes a slit of reduced length formed in the split diaphragm valve.

[0015] In some embodiments, the body further includes a side port located between the distal port and the proximal port, the side port being in fluid communication with the cavity, and the side port including a Luer connector.

[0016] In some embodiments, the body defines a bowl-shaped portion forming part of the cavity, the bowl-shaped portion extending distally through the split diaphragm valve, and wherein the side port enters the bowl-shaped portion distally from the split diaphragm valve.

[0017] In some embodiments, the side port is offset from the centerline of the pinless connector to provide a rotational element for the flow of flushing fluid injected into the cavity.

[0018] In some embodiments, the conduit assembly further includes an extension kit coupled to the side port.

[0019] In some embodiments, the increased pressure resistance feature includes a bellows-shaped tube disposed on the split diaphragm valve, the bellows-shaped tube extending distally from a slit formed in the split diaphragm valve, the bellows-shaped tube being configured to receive an external male connector in the bellows-shaped tube when engaged with the split diaphragm valve.

[0020] In some embodiments, the external male connector includes a blunt sleeve, wherein the corrugated tube includes a lubricant applied to its inner surface to reduce friction during insertion of the blunt sleeve into the corrugated tube.

[0021] In some embodiments, the distal port includes a male Luer connector, and the proximal port includes a female Luer connector.

[0022] This document also provides a catheter assembly capable of being used with a fluid transfer device having a blunt sleeve distal connector. The catheter assembly includes: a catheter having a distal end and a proximal end; and a catheter adapter coupled to the proximal end of the catheter and including a lumen in fluid communication with the catheter, the catheter adapter including an adapter port in fluid communication with the lumen. The catheter assembly further includes: a proximal patient adapter including a distal end and a proximal end, the distal end of the proximal patient adapter being coupled to the adapter port via an extension tube; and a valve retained within the proximal end of the proximal patient adapter, wherein the valve is configured to receive a blunt sleeve connector of the fluid transfer device therein for fluid connection of the fluid transfer device to an endometrium, wherein the blunt sleeve has a diameter of 3 mm or less.

[0023] In some embodiments, the valve includes a duckbill valve.

[0024] In some embodiments, the valve includes a split-type diaphragm valve.

[0025] This document also provides a system comprising: a catheter having a distal end and a proximal end; and a catheter adapter coupled to the proximal end of the catheter and including a lumen in fluid communication with the catheter, the catheter adapter including an adapter port in fluid communication with the lumen. The system further includes a proximal patient adapter including a distal end and a proximal end, the distal end of the proximal patient adapter being coupled to the adapter port via an extension tube. The system further includes a needleless connector coupled to the proximal end of the proximal patient adapter, wherein the needleless connector includes: a body defining an inner lumen and including a distal port and a proximal port; a split diaphragm valve retained within the proximal port and extending into the inner lumen; and a pressure resistance increasing feature incorporated into or adjacent to the split diaphragm valve, the pressure resistance increasing feature being configured to increase the pressure capability of the needleless connector. The system also includes a blood-drawing device connected to the proximal port via the split diaphragm valve. The blood-drawing device includes a flow tube configured to extend distally from the blood-drawing device and enter or pass through the catheter to enable blood aspiration. The blood-drawing device includes a distal male connector engaging the split diaphragm valve, wherein the pressure resistance enhancement feature prevents leakage from the needleless connector during blood aspiration.

[0026] In some embodiments, the distal male connector includes a locking element comprising: a blunt sleeve configured to engage the split diaphragm valve; and a pair of clamping arms configured to secure the locking element to the body of the pinless connector.

[0027] In some embodiments, the distal male connector includes a male Luer connector.

[0028] In some embodiments, the pinless connector is rated to accommodate internal pressures up to 300 psi. Attached Figure Description

[0029] Figure 1 A system for facilitating blood drawing and / or fluid administration to a patient, according to one aspect of this disclosure, is shown;

[0030] Figure 2 for Figure 1 An isolated view of the conduit components included in the system;

[0031] Figure 3 For the purposes of this disclosure Figure 2 A perspective view of the needleless connector included in the catheter assembly;

[0032] Figure 4A for Figure 3A cross-sectional view of a pinless connector, in which the split diaphragm valve is in the closed state;

[0033] Figure 4B for Figure 3 A cross-sectional view of a pinless connector, wherein the male connector engages with the pinless connector and the split diaphragm valve is in the open state;

[0034] Figure 5A and Figure 5B For another aspect of this disclosure Figure 2 An exploded perspective view of the needleless connector included in the catheter assembly;

[0035] Figure 6 for Figure 5A and Figure 5B A cross-sectional view of a pinless connector;

[0036] Figure 7 For another aspect of this disclosure Figure 2 A cross-sectional view of the needleless connector included in the catheter assembly;

[0037] Figure 8 For the purposes of this disclosure Figure 2 A perspective view of the needleless connector included in the catheter assembly;

[0038] Figure 9 For another aspect of this disclosure Figure 2 A three-dimensional view of the patient-near adapter included in the catheter assembly; and

[0039] Figure 10 for Figure 9 A three-dimensional view of the access valves included in the patient adapter. Detailed Implementation

[0040] 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 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.

[0041] As used in this specification, the terms "proximal" and "distal" refer to the directions closer to and further away from the user who will bring the device into 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 manipulated by the user) will be the proximal end of the device.

[0042] Spatial or directional terms, such as “left,” “right,” “inner,” “outer,” “up,” “down,” etc., should not be considered as limitations, as this utility model can adopt various alternative orientations.

[0043] 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 to the contrary. It should also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary aspects of the present invention.

[0044] The terms “first”, “second”, etc., do not refer to any specific order or sequence, but rather to different conditions, characteristics, or elements.

[0045] 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 two or more of A, B, or C. For example, “at least one of A, B, and C” includes only one or more of A; or only one or more of B; or only one or more of C; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or all or one or more of A, B, and C.

[0046] refer to Figure 1 , Figure 1 A non-limiting embodiment of a system 10 is shown that facilitates blood drawing and / or fluid administration to a patient. (As...) Figure 1 As shown, system 10 may include catheter assembly 12, which provides access to a patient's vascular system. According to embodiments of this disclosure, catheter assembly 12 may have any of a variety of suitable configurations, including integrated or non-integrated catheter assemblies configured / arranged to include an extension kit with a proximal patient access port. Therefore, although... Figure 1 An integrated catheter assembly 12 is shown, but it should be understood that aspects of this disclosure may relate to other catheter assemblies. Figure 1In this embodiment, catheter assembly 12 includes a catheter adapter 14 and an associated catheter 16. Catheter adapter 14 may include a distal end 18 and a proximal end 20. In some embodiments, catheter adapter 14 may include an additional adapter port 22, which may be disposed between the distal end 18 and the proximal end 20 or at the proximal end 20. Catheter adapter 14 may include a first lumen 24 extending through the distal end 18 and the proximal end 20, and the first lumen 24 may be sealed at the proximal end 20 of catheter adapter 14, for example, by means of a split diaphragm connector or a self-healing diaphragm connector 25. Catheter 16 extends from the distal end 18 of catheter adapter 14 and may be configured for placement in a patient's vein in a PIVC, wherein the distal or distal tip 26 of catheter 16 is properly positioned within the vein to enable blood aspiration from the patient. As those skilled in the art will appreciate, catheter 16 may be formed of any suitable material and may have any useful length.

[0047] In some non-limiting embodiments or aspects, the catheter assembly 12 may include a first fluid catheter 30 extending from port 22. The first fluid catheter 30 may be formed of any suitable material known to those skilled in the art and may have a distal end 32 and a proximal end 34. The distal end 32 of the first fluid catheter 30 is coupled to port 22, while the proximal end 34 of the first fluid catheter 30 may be coupled to a near-patient connector or near-patient adapter 36.

[0048] The near-patient adapter 36 may include a distal port 38, a proximal port or "near-patient" access port 40, and a side port 42. Therefore, the near-patient adapter 36 may be configured as a T-connector (e.g., a side port arranged at a 90-degree angle relative to the longitudinal axis of the near-patient adapter 36), a Y-connector (e.g., a side port arranged at a 15- to 85-degree angle relative to the longitudinal axis of the near-patient adapter 36), or any other type of connector known in the art. In some embodiments, one or more ports of the near-patient adapter 36 may be configured as Luer connectors, for example, the proximal port 40 may be configured as a female Luer connector. The near-patient adapter 36 includes a lumen 44 formed therethrough, the lumen having any number of branches suitable for the connector type, such as branches extending between the distal port 38 and the proximal port 40 of the near-patient adapter 36 and branches provided to the side port 42 of the near-patient adapter 36.

[0049] According to various aspects of this disclosure, the needleless connector 46 is coupled to or coupled to the proximal port 40 of the patient adapter 36. The needleless connector 46 is configured to provide catheter access to peripheral devices, such as blood collection devices (e.g., PIVO from Becton Dickinson), as examples of which are non-limiting. TMIn other words, when the patient adapter 36 is connected to the catheter adapter 14 via the fluid conduit 30 and the side port 22, the needleless connector 46 provides an entry point from the peripheral device for introducing the fitting through the indwelling catheter 16 for blood aspiration or other fluid transfer purposes.

[0050] In some non-limiting embodiments or aspects, the catheter assembly 12 may further include an extension kit 48 coupled to a side port 42 near the patient adapter 36. The extension kit 48 may include a second fluid catheter 50 coupled to the side port 42 at one end 52 and to a distal port connector 54 (e.g., a needleless access connector) at the opposite end 56, wherein a clamp 58 is disposed on the second fluid catheter 50 to allow occlusion of the second fluid catheter. As a non-limiting example, the extension kit 48 may be used to provide a fluid path in and out of the catheter assembly 12 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 profile.

[0051] According to various aspects of this disclosure, system 10 also includes a fluid transfer device 60 operable to introduce a catheter fitting (as a non-limiting example) into a patient's vascular system, for example, wherein the fitting is capable of drawing blood or administering fluid. Figure 1 As shown, according to a non-limiting embodiment, the fluid transfer device 60 is configured as a blood aspiration device, which includes at least a housing 62, a coupling device 64, a catheter fitting 66, and a propulsion member 68. The catheter fitting 66 is movable within the housing 62 so that it can advance from a first or retracted position within the housing 62 to a second or forward position outside the housing 62, such that the distal end of the catheter fitting can enter the catheter assembly 12 and enter or exit the indwelling catheter 16.

[0052] According to some embodiments, the coupling device 64 is configured as a "locking member" (hereinafter referred to as "locking member 64") to physically and fluidly couple the fluid transfer device 60 to the catheter assembly 12. The locking member 64 has a connector 70, a blunt sleeve 72, a first arm 74, and a second arm 76. Furthermore, the locking member 64 defines a lumen (not shown) extending through the connector 70 and the blunt sleeve 72. The connector 70 is configured to couple the locking member 64 to the housing 62. The blunt sleeve 72 serves as a male connector and extends from the connector 70, wherein the blunt sleeve is disposed between the first arm 74 and the second arm 76. The blunt sleeve 72 may have any suitable shape, size, and / or configuration. In some embodiments, the length of the blunt sleeve 72 may be sufficient to mate with the needleless connector 46 and allow fluid communication between the fluid transfer device 60 and the catheter 16 of the catheter assembly 12. The blunt sleeve 72 may have an inner diameter similar to or slightly larger than the outer diameter of a portion of the conduit fitting 66 (the diameter at least partially defining the surface of the lumen of the blunt sleeve) such that when the fluid transfer device 60 changes between a first position and a second position, the locking member 64 can receive a portion of the conduit fitting 6.

[0053] According to other embodiments, the coupling device 64 may be configured as a male Luer connector. Therefore, the coupling device 64 may include a protruding projection having a collar formed therearound, which, according to some embodiments, may be a rotating collar. The length of the protruding projection may be sufficient to mate with the needleless connector 46 and to allow fluid transfer device 60 to fluidly communicate with conduit 16 of conduit assembly 12.

[0054] According to various aspects of this disclosure, the needleless connector 46 located at the proximal port 40 near the patient adapter 36 is specifically configured to have an increased pressure rating or capacity to accommodate the use of the catheter assembly 12 with a fluid delivery device that provides fluid via the distal port connector 54. That is, in certain operations of the fluid delivery device that injects fluid via the distal port connector 54, such as when a dose of medication is delivered at a rate higher than the catheter's tolerance and / or when the catheter is blocked, it will be recognized that high pressure may be applied to the needleless connector 46 near the patient adapter 36. In this situation, if the needleless connector 46 does not have sufficient internal pressure capacity, it may leak in response to such a high-pressure fluid flow.

[0055] To prevent leakage of the needleless connector 46, the needleless connector 46 may be configured to include one or more pressure resistance increasing features configured to increase the pressure capability of the needleless connector 46. These one or more pressure resistance increasing features may improve the seal between the needleless connector 46 and the fluid transfer device (i.e., the seal with the coupling device 64) and / or provide improved back pressure capability within the needleless connector 46, allowing the proximal patient access valve or port to better maintain a higher internal pressure before leakage. In some embodiments, the needleless connector 46 may be rated to accommodate internal pressures up to 300 psi.

[0056] Now for reference Figure 3 , Figure 4A and Figure 4B The diagram illustrates a pinless connector 46 according to an embodiment of the present disclosure. The pinless connector 46 can generally be described as including a body or housing 80, a split diaphragm valve 82 retained within the body 80, and one or more pressure resistance increasing features for increasing the back pressure capability of the pinless connector 46, which will be explained in further detail below.

[0057] The main body 80 may be composed of a distal body portion 84 and a proximal body portion 86, which may be connected together, for example, by means of threaded connection, snap-fit ​​connection, welding, or adhesive bonding. The main body 80 defines an inner cavity 88 extending between a distal port 90 and a proximal port 92. The main body 80 is configured such that a male Luer connector 94 is located at the distal port 90, and a female Luer connector 96 is located at the proximal port 92.

[0058] The male Luer connector 94 of the pinless connector 46 includes a tapered rod or elongated member 98 having a tapered outer surface. The tapered rod 98 can be received by a corresponding tapered cavity of the female Luer connector. The male Luer connector 94 may also include an annular shield 100 extending around the tapered rod 98, the annular shield including threads 102 on its inner surface configured to engage corresponding threads on the outer surface of the female Luer connector. Regarding the pinless connector 46 and... Figure 1 With the use of the catheter assembly 12, the male Luer connector 94 of the needleless connector 46 can be connected to the female Luer connector of the proximal port 40 of the patient adapter 36.

[0059] The female Luer connector 96 of the pinless connector 46 includes an elongated proximal portion 104, wherein a split diaphragm valve 82 is positioned above an opening of a tapered cavity 106, which is configured to receive and engage a corresponding tapered rod or elongated member of the male connector. The female Luer connector 96 may also include an outer surface including threads 108 configured to engage corresponding threads on the inner surface of an annular sheath of the male Luer connector. Regarding the pinless connector 46 and... Figure 1 With the use of the catheter assembly 12, the female Luer connector 94 of the needleless connector 46 can be connected to the fluid transfer device 60 (e.g., a blood collection device), for example, to the locking member 64.

[0060] The body 80 may define a bowl-shaped region (also referred to as a bowl portion) 110 that forms part of the cavity 88, wherein the bowl portion is formed by the distal body portion 84. Compared to the rest of the cavity 88, the bowl portion 110 may have an increased diameter, and the bowl portion may be sized to fit within the blunt sleeve 72 of the locking member 64 on the split diaphragm valve 82 and an external device (e.g., the male connector of the locking member 64 on the fluid transfer device 60, such as...). Figure 1 (As shown) When engaged, the split diaphragm valve 82 is allowed to flex / deform.

[0061] like Figure 3 , Figure 4A and Figure 4B As shown, the split diaphragm valve 82 is held within the body 80, for example, within an elongated proximal portion 104 and between a distal body portion 84 and a proximal body portion 86. The split diaphragm valve 82 typically includes a proximal side 112, a distal side 114, and an elongated central portion 116 extending between the proximal and distal sides. The elongated central portion 116 is oriented along the longitudinal axis of the pinless connector 46 and extends through a portion of the lumen 88 formed by the proximal body portion 86. The proximal side 112 and the distal side 114 of the split diaphragm valve 82 extend radially outward from the elongated central portion 116, thereby forming annular flanges at their ends. The proximal side 112 extends beyond the elongated proximal portion 104 of the body 80, while the distal side 114 is positioned to be held between the distal body portion 84 and the proximal body portion 86 when the distal body portion 84 and the proximal body portion 86 are joined together. In some embodiments, a circumferential groove or channel 118 may be formed in the distal surface of the distal side 114, the distal surface being configured to engage the protruding end 120 of the distal body portion 84 in order to better retain the distal side 114 between the distal body portion 84 and the proximal body portion 86.

[0062] A slit 122 is formed in the split-type diaphragm valve 82 for selectively opening or closing a fluid path through the cavity 88 of the pinless connector 46. The slit 122 extends the entire length of the pinless connector 46—through the proximal side 112, through the elongated central portion 116, and through the distal side 114. The slit 122 is sized to receive a tapered rod or elongated member of a male connector, wherein the male connector opens the slit 122 to form a fluid path through the cavity 88 of the pinless connector 46.

[0063] According to one embodiment, and as Figure 4A and Figure 4B As shown, a pressure resistance increasing feature is provided in the pinless connector 46. This pressure resistance increasing feature takes the form of one or more protruding features 124 formed on the inner surface of the body 80, adjacent to the split diaphragm valve 82, and extending radially inward into the inner cavity 88. In an exemplary embodiment, the protruding feature 124 may be configured as a circumferential protrusion (hereinafter also referred to as "circumferential protrusion 124") formed on the inner surface of the elongated proximal portion 104 of the body 80. The circumferential protrusion 124 is thus aligned (in the longitudinal direction) with the elongated central portion 116 of the split diaphragm valve 82.

[0064] like Figure 4A As shown, the circumferential protrusion 124 extends radially inward from the inner surface of the elongated proximal portion 104 of the body 80, thereby creating a gap between the circumferential protrusion 124 and the elongated central portion 116 of the split diaphragm valve 82 when the split diaphragm valve 82 is in a closed configuration (i.e., no male connector engages with the split diaphragm valve 82, and the slit 122 is closed). However, when the male connector 72 engages with the split diaphragm valve 82 and is inserted and passes through the slit 122 (as shown), a gap is created between the circumferential protrusion 124 and the elongated central portion 116 of the split diaphragm valve 82. Figure 4B When (as shown), the elongated central portion 116 of the split diaphragm valve 82 expands radially outward, bringing it into contact with the circumferential protrusion 124. In this state, the circumferential protrusion 124 applies a radially inward compressive force to the elongated central portion 116, thus preventing further outward expansion of the elongated central portion 116. Therefore, a tighter seal is maintained between the male connector 72 and the split diaphragm valve 82 (compared to the absence of the circumferential protrusion 124), thereby increasing the back pressure capability of the pinless connector 46.

[0065] In some embodiments, the configuration of the slit 122 itself can serve as a feature that increases pressure resistance of the pinless connector 46. That is, the size of the slit 122 formed in the split diaphragm valve 82 (compared to the slit of a pinless connector included in an existing near-port connector) is reduced, thereby forming a tighter fit with the male connector 72 inserted into the split diaphragm valve 82. According to various aspects of this disclosure, the male connector engaging with the split diaphragm valve 82 is a blunt sleeve 72 (e.g., Figure 1 In the system shown, when the blunt sleeve engages with the split diaphragm valve 82, the size / length of the slit 122 decreases to form a compression fit with the blunt sleeve 72. Therefore, a tighter seal is maintained between the blunt sleeve 72 and the split diaphragm valve 82, thereby increasing the back pressure capability of the needleless connector 46.

[0066] Now for reference Figure 5A , Figure 5B and Figure 6 According to another embodiment of this disclosure, a pressure resistance increasing feature is provided in the pinless connector 46, which takes the form of a secondary split diaphragm valve 126 included in the pinless connector 46. The secondary split diaphragm valve 126 can be positioned in the body 80 / within a bowl-shaped portion 110 defined by the body 80 (i.e., within the distal body portion 84), wherein the bowl-shaped portion 110 houses and holds the secondary split diaphragm valve 126 therein. With the secondary split diaphragm valve 126 positioned within the bowl-shaped portion 110, the secondary split diaphragm valve 126 is thus positioned distal to the (main) split diaphragm valve.

[0067] The inclusion of the secondary split-type diaphragm valve 126 within the pinless connector 46 enhances the back pressure capability of the pinless connector 46, as the primary split-type diaphragm valve 82 and the secondary split-type diaphragm valve 126 are sequentially arranged within the inner cavity 88. This arrangement of the primary split-type diaphragm valve 82 and the secondary split-type diaphragm valve 126 allows the pinless connector 46 to maintain a high internal pressure prior to leakage.

[0068] According to other embodiments of this disclosure, additional features can be added to the pinless connector 46 to provide additional functionality to the pinless connector. For example... Figure 7 As shown, the needleless connector 46 may include a side port 128 therein, through which additional connections to the catheter assembly 12 can be made. In one example, an extension kit (e.g., Figure 1 The extension kit 48 can be connected to the side port 128. The side port 128 can be formed in / on the body 80 at a location between the distal port 90 and the proximal port 92, wherein the side port 128 is in fluid communication with the inner cavity 88. The side port 128 can be configured as a (female) Luer connector, with another external Luer connector mating with it.

[0069] According to an exemplary embodiment, the side port 128 is positioned to enter the bowl-shaped portion 110 distal to the split diaphragm valve 82. To accommodate this positioning of the side port 128, the bowl-shaped portion 110 (and...) Figure 4A , Figure 4B and Figure 7 The bowl-shaped portion (compared to the other portion) can be elongated to provide space for the side port 128 to enter. This positioning of the side port 128 allows it to enter the inner cavity 88 at a point just distal to the split diaphragm valve 82, providing better flushing from the side port 128 without having to flush the entire needleless connector 46 to remove all residual fluid. In some embodiments, the side port 128 can be positioned offset from the centerline of the needleless connector 46 to provide a rotational element for better flushing.

[0070] Now for reference Figure 8 , Figure 8 A pinless connector 130 according to another embodiment of the present disclosure is shown. The pinless connector 130 can generally be described as including a body or housing 132, a split diaphragm valve 134 retained within the body 132, and one or more pressure resistance increasing features for increasing the back pressure capability of the pinless connector 46, which will be explained in further detail below.

[0071] The body 132 can be configured to define an inner cavity 135 extending between a distal port 136 and a proximal port 140 of the body 132. The body 132 can be configured such that a male Luer connector 131 is located at the distal port 136, and a female Luer connector 138 is located at the proximal port 140. The male Luer connector 131 at the distal port 136 includes an elongated member 141 and an annular shroud 143 extending around the elongated member. The female Luer connector 138 at the proximal port 140 includes an elongated proximal portion 142, wherein a split diaphragm valve 134 is positioned over an opening of a conical cavity configured to receive and engage a corresponding conical rod or elongated member of the male connector.

[0072] like Figure 8As shown, a split diaphragm valve 134 is held within a body 132, for example, within an elongated proximal portion 142, and further distally into the body 132. The split diaphragm valve 134 typically includes a proximal side 144 and an elongated distal portion 146. The elongated distal portion 146 is oriented along the longitudinal axis of the pinless connector 130 and extends through a portion of the cavity 135 formed by the body 132. A slit 148 is formed in the split diaphragm valve 134 for selectively opening or closing a fluid path through the cavity 135 of the pinless connector 130. The slit 148 extends through the proximal side 144 and is sized to receive a tapered rod or elongated member of a male connector therein, wherein the male connector opens the slit 148 to form a fluid path into the cavity 135 of the pinless connector 130.

[0073] The split-type diaphragm valve 134 is specifically configured to include / integrate features that increase pressure resistance. Specifically, the elongated distal portion 146 of the split-type diaphragm valve 134 is configured as a bellows-shaped tube (or accordion-shaped tube) extending distally from the proximal side 144 of the split-type diaphragm valve 134, wherein the bellows-shaped tube 146 is sized and configured to receive a male connector therein. In some embodiments, the bellows-shaped tube 146 may accommodate a large portion of the length of a blunt sleeve therein, for example, provided... Figure 1 The fluid transfer device 60 has a blunt sleeve 72 on the locking member 64. The bellows-shaped tube 146 can form an extended seal with the blunt sleeve 72 along its length, which increases the back pressure capacity of the connector 46 and prevents leakage from the connector 46.

[0074] In some embodiments, a lubricant may be applied to the inner surface of the bellows-shaped tube 146 to reduce friction during insertion of the blunt sleeve 72 into the bellows-shaped tube 146. The lubricant will allow for easier insertion of the blunt sleeve 72 and easier mating with the pinless connector 130 without negatively affecting the seal formed between the bellows-shaped tube 146 and the blunt sleeve.

[0075] Now for reference Figure 9 and Figure 10According to another embodiment of this disclosure, a proximal patient adapter 36 including a access valve 150 is shown. The proximal patient adapter 36 may have the configuration described above—the proximal patient adapter 36 has a distal port 38, a proximal port or “proximal patient” access port 40, and a side port 42. In some embodiments, the proximal port 40 is configured as a female Luer connector having external threads and a tapered cavity thereon. The proximal patient adapter 36 includes a lumen 44 formed therethrough, the lumen 44 having any number of branches suitable for a connector type, such as branches extending between the distal port 38 and the proximal port 40 of the proximal patient adapter 36 and branches providing access to the side port 42 of the proximal patient adapter 36.

[0076] like Figure 9 and Figure 10 As shown, the proximal patient adapter 36 includes a passage valve 150 (hereinafter referred to as "valve 150"), which is retained within the proximal port 40. According to a non-limiting embodiment, valve 150 may include a duckbill valve (such as...). Figure 9 As shown), or alternatively, valve 150 may comprise a split-type diaphragm valve or other suitable valve. Valve 150 is specifically configured to engage with a blunt sleeve (e.g., located in...). Figure 10 The blunt sleeve 72 on the locking member 64 of the fluid transfer device 60 engages. That is, the valve 150 (and the slit or opening 152 in the valve 150) is specifically sized to receive the elongated blunt sleeve 72 to fluidly connect an external device (e.g., a blood-drawing device or other fluid transfer device) to the lumen 44 of the patient adapter 36 (and the entire catheter assembly 12). According to an embodiment, the valve 150 is specifically sized / configured to receive a blunt sleeve 72 with a diameter of 3 mm or less.

[0077] According to some aspects of the present invention, when valve 150 is configured as a duckbill valve, the increased fluid pressure on the distal / duckbill side of valve 150 applies additional pressure to slit 152, thereby contributing to a slit seal (i.e., pressure counteracts its own pressure to seal slit 152). According to other aspects of the present disclosure, when valve 150 is configured as a simple diaphragm valve with slit 152 (which has a reduced size, accommodating only the blunt sleeve 72), the smaller slit 152 increases the pressure capacity of valve 150—due to the smaller slit-to-diaphragm thickness ratio. Therefore, a tighter seal is maintained in valve 150, thereby increasing the back pressure capacity near the patient adapter 36.

[0078] Advantageously, embodiments of this disclosure provide a patient proximity adapter for catheter assemblies that offers improved back pressure capability. The patient proximity adapter may include a needleless connector comprising one or more pressure resistance increasing features configured to increase the pressure capability of the needleless connector. These one or more pressure resistance increasing features may improve the seal between the needleless connector and a male connection (e.g., a male Luer member or blunt sleeve) of the fluid transfer device and / or provide improved back pressure capability within the needleless connector, allowing it to better maintain a higher internal pressure before leakage.

[0079] 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 comprising: The catheter assembly includes: The catheter has a distal end and a proximal end; A catheter adapter, the catheter adapter being coupled to the proximal end of the catheter and including a lumen in fluid communication with the catheter, the catheter adapter including an adapter port in fluid communication with the lumen; A patient proximity adapter, the patient proximity adapter including a distal end and a proximal end, the distal end of the patient proximity adapter being connected to the adapter port via an extension tube; and A needleless connector, which is coupled to the proximal end of the near-patient adapter, includes: A body defining an internal cavity and including a distal port and a proximal port; A split-type diaphragm valve, wherein the split-type diaphragm valve is retained within the proximal port and extends into the inner cavity; and A pressure resistance increasing feature, which is incorporated into or adjacent to the split diaphragm valve, is configured to increase the pressure capability of the needleless connector.

2. The catheter assembly of claim 1, wherein, The increased pressure resistance feature includes a circumferential protrusion formed on the inner surface of the body and extending radially inward into the cavity at a location adjacent to the split diaphragm valve.

3. The catheter assembly of claim 2, wherein, When the external male connector is inserted into the internal volume of the body through the slit of the split diaphragm valve, the circumferential protrusion increases the compressive force between the external male connector and the split diaphragm valve.

4. The catheter assembly of claim 3, wherein, The external male connector includes either a male Luer connector or a blunt sleeve.

5. The catheter assembly of claim 1, wherein, The increased pressure resistance feature includes a secondary split-type diaphragm valve located within the cavity and away from the split-type diaphragm valve.

6. The catheter assembly of claim 1, wherein, The split-type diaphragm valve is configured to receive a blunt sleeve of an external male connector, and wherein the pressure resistance increasing feature includes a slit of reduced length formed in the split-type diaphragm valve.

7. The catheter assembly of claim 1, wherein, The main body also includes a side port located between the distal port and the proximal port, the side port being in fluid communication with the inner cavity, and the side port including a Luer connector.

8. The catheter assembly of claim 7, wherein, The main body defines a bowl-shaped portion forming part of the inner cavity, the bowl-shaped portion extending distally through the split diaphragm valve, and wherein the side port enters the bowl-shaped portion distally from the split diaphragm valve.

9. The catheter assembly of claim 7, wherein, The side port is offset from the centerline of the needleless connector to provide a rotational element for the flow of flushing fluid injected into the cavity.

10. The catheter assembly according to claim 7, characterized in that, The catheter assembly also includes an extension kit that is coupled to the side port.

11. The catheter assembly according to claim 1, characterized in that, The increased pressure resistance feature includes a bellows-shaped tube disposed on the split diaphragm valve, the bellows-shaped tube extending distally from a slit formed in the split diaphragm valve, the bellows-shaped tube being configured to receive an external male connector in the bellows-shaped tube when engaged with the split diaphragm valve.

12. The catheter assembly according to claim 1, characterized in that, The external male connector includes a blunt sleeve, wherein the corrugated tube includes a lubricant applied to its inner surface to reduce friction during insertion of the blunt sleeve into the corrugated tube.

13. The catheter assembly according to claim 1, characterized in that, The distal port includes a male Luer connector, and the proximal port includes a female Luer connector.

14. A catheter assembly, characterized in that, The catheter assembly is compatible with fluid transfer devices having a blunt-sleeve distal connection, and the catheter assembly includes: The catheter has a distal end and a proximal end; A catheter adapter, the catheter adapter being coupled to the proximal end of the catheter and including a lumen in fluid communication with the catheter, the catheter adapter including an adapter port in fluid communication with the lumen; A patient proximity adapter, the patient proximity adapter including a distal end and a proximal end, the distal end of the patient proximity adapter being connected to the adapter port via an extension tube; and A valve, held within the proximal end of the near-patient adapter, wherein the valve is configured to receive a blunt sleeve connector of the fluid transfer device therein for fluid connection of the fluid transfer device to the lumen, wherein the blunt sleeve has a diameter of 3 mm or less.

15. The catheter assembly according to claim 14, characterized in that, The valve includes a duckbill valve.

16. The catheter assembly according to claim 14, characterized in that, The valve includes a split-type diaphragm valve.

17. A system, characterized in that, The system includes: The catheter includes a distal end and a proximal end; A catheter adapter, the catheter adapter being coupled to the proximal end of the catheter and including a lumen in fluid communication with the catheter, the catheter adapter including an adapter port in fluid communication with the lumen; A patient proximity adapter, the patient proximity adapter including a distal end and a proximal end, the distal end of the patient proximity adapter being connected to the adapter port via an extension tube; A needleless connector, which is coupled to the proximal end of the near-patient adapter, includes: A body defining an internal cavity and including a distal port and a proximal port; A split-type diaphragm valve, wherein the split-type diaphragm valve is retained within the proximal port and extends into the inner cavity; and A pressure resistance increasing feature, which is incorporated into or adjacent to the split diaphragm valve, is configured to increase the pressure capability of the needleless connector; and A blood-drawing device connected to the proximal port via the split diaphragm valve, the blood-drawing device including a flow tube configured to extend distally from the blood-drawing device and enter or pass through the catheter to enable blood drawing; The blood-drawing device includes a distal male connector that engages with the split diaphragm valve, wherein the pressure resistance enhancement feature prevents leakage from the needleless connector during blood drawing.

18. The system according to claim 17, characterized in that, The distal male connector includes a locking element, the locking element comprising: A blunt sleeve, configured to engage the split-type diaphragm valve; and A pair of clamping arms configured to secure the locking member to the body of the pinless connector.

19. The system according to claim 17, characterized in that, The distal male connector includes a male Luer connector.

20. The system according to claim 17, characterized in that, The pinless connector is rated to withstand internal pressures up to 300 psi.

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