Pre-loaded style valve compatibility

Abstract

A pre-loaded catheter is manufactured in which a probe, guide wire, or similar medical device is placed within the catheter, extending through a valve of a connection at a proximal end. During storage and transport, the probe may remain in place for extended periods, which can cause scratches, dents, and damage to the valve surface. Such dents can cause valve leakage, which can consequently lead to the failure of the entire device. The embodiments disclosed herein relate to a device and a method for mitigating such damage by preventing contact between the medical device and the valve surface.

Description

Technology Field

[0001] To summarize briefly, the embodiments disclosed herein relate to an apparatus and method for enabling a slender medical device, such as a probe, to pass through a valve without affecting the valve function with little or no effect. Background Technology

[0002] This is particularly important during the storage and transport of "pre-loaded" catheters and probes, or during the repeated insertion of medical devices over the lifespan of the valve. For example, valves, such as those used in catheters, often consist of opposing deformable valve members coupled along the valve face surfaces to create a seal between them and prevent fluid flow. The valve members can be deflected to optionally allow fluid to flow between them or to allow a medical device to pass through. When a probe is "pre-loaded" into the catheter and through the valve, the probe may cause concave areas within the valve faces. Over a long period, for example during transport and storage, these concave areas may permanently form within the valve faces, leading to valve leakage and failure. Alternatively, the repeated insertion of a medical device through the valve may also damage the valve face surfaces, resulting in incomplete seals and valve failure. Prior art literature

[65535] (Patent Document 0001) US 20140163516 A1

[0003] The embodiments disclosed herein relate to a device and a method for preventing contact between a medical device and a valve surface to mitigate damage.

[0004] A system for introducing a medical device through a valve is disclosed herein, and the system comprises a valve configured to transition between a closed configuration and an open configuration, comprising a first valve member forming a first proximal surface and a first valve surface, and a second valve member forming a second proximal surface and a second valve surface, and a valve splitter extending from a proximal end to a distal tip and forming a lumen, wherein the distal tip is coupled to the valve and configured to transition the valve from a closed configuration to an open configuration so that the medical device may pass between the first valve surface and the second valve surface in a spaced relationship.

[0005] In some embodiments, when the valve is in a closed configuration, the first valve face is in contact with the second valve face, and when the valve is in an open configuration, the first valve face is positioned apart from the second valve face. One of the first proximal surface and the second proximal surface includes a projection that extends proximally and is configured to engage with the distal end of the valve split. The first proximal surface includes a first cavity and the second proximal surface includes a second cavity, and the first cavity and the second cavity cooperate to form a depression within the proximal surface of the valve. The minimum diameter of the depression is greater than the outer diameter of the distal end, and the depression is configured to align the distal end with the diameter center point of the proximal surface of the valve. In some embodiments, the maximum diameter of the depression is smaller than the outer diameter of the distal end, and the rim of the depression is configured to engage with the distal end. The distal end of the valve split is maintained in close proximity to the first valve face and the second valve face.

[0006] In some embodiments, the valve is disposed within the connection, and the valve split further comprises a shoulder portion and a nose portion, the shoulder portion is configured to engage with the opening of the connection, and the nose portion is configured to extend into the connection by a predetermined distance. The connection is disposed at the proximal end of the catheter. The nose portion forms a biconvex cross-sectional shape and is configured to extend between a first valve face and a second valve face. In a closed configuration, the first valve face and the second valve face are aligned with the central longitudinal axis, and the axis of the split lumen is offset from the central longitudinal axis. In a closed configuration, the first valve face and the second valve face are offset from the central longitudinal axis, and the axis of the split lumen is aligned with the central longitudinal axis. One of the first valve member and the second valve member is formed of a needle-permeable material.

[0007] Additionally, a valve-type connection is disclosed, wherein the valve-type connection comprises a valve that forms a lumen and includes a valve member, wherein the valve is configured to control fluid flow through the lumen of the connection and is deflected toward a closed configuration; and a hold-open tab comprising a body configured to be coupled to a proximal end of the connection, and an arm extending distally from the body into the lumen of the connection, wherein the distal end of the arm is detachably attached to the valve member to hold the valve in an open configuration.

[0008] In some embodiments, the open-hold tab is configured to be detachable from the valve member to transition the valve to a closed configuration. The body of the open-hold tab forms a lumen that aligns with the connection lumen. In some embodiments, the open-hold tab further comprises an elongated medical device extending through the connection lumen to a point far from the valve, and the medical device is positioned spaced apart from the valve member. The elongated medical device comprises one of a probe, a trocar, a catheter, or an inducer.

[0009] Additionally, a method for inserting a medical device through a valve is disclosed, and the method comprises the steps of providing a valve having a first valve member forming a first proximal surface and a first valve surface, and a second valve member forming a second proximal surface and a second valve surface; advancing a valve split portion until a distal tip contacts one of the first proximal surface and the second proximal surface; transitioning the valve from a closed configuration to an open configuration; and advancing an elongated medical device between the first valve member and the second valve member in a relationship spaced apart from both the first valve surface and the second valve surface.

[0010] In some embodiments, a slit valve is positioned within the connection portion of the catheter. The valve is deflected toward a closed configuration. In the closed configuration, a first valve surface contacts a second valve surface to form a seal between them, and in the open configuration, the first valve surface is positioned spaced apart from the second valve surface to allow fluid to flow between them. Brief explanation of the drawing

[0011] The present disclosure will be described more specifically with reference to specific embodiments illustrated in the accompanying drawings. It will be understood that these drawings illustrate only typical embodiments of the invention and should not be construed as limiting the scope thereof. Embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. FIG. 1 shows a perspective view of an exemplary catheter according to an embodiment disclosed herein. FIG. 2a shows a perspective view of the connecting portion of the catheter of FIG. 1 according to an embodiment disclosed herein. FIG. 2b illustrates a side view of a medical line aligned with the exemplary connection of FIG. 2a according to an embodiment disclosed herein. FIG. 2c shows a perspective view of the valve of the connecting part of FIG. 2a according to an embodiment disclosed herein. FIG. 3a shows a cross-sectional view of a connecting portion including a valve and a valve splitter according to an embodiment disclosed herein. FIG. 3b shows a cross-sectional view of the valve of FIG. 3a in a closed configuration according to an embodiment disclosed herein. FIG. 4a illustrates a cross-sectional view of a valve and a valve splitter according to an embodiment disclosed herein. FIG. 4b shows a cross-sectional view of the valve of FIG. 4a in a closed configuration according to an embodiment disclosed herein. FIG. 5a illustrates a cross-sectional view of a valve and a valve splitter according to an embodiment disclosed herein. FIG. 5b shows a cross-sectional view of the valve of FIG. 5a in a closed configuration according to an embodiment disclosed herein. FIG. 5c shows a close side view of the valve of FIG. 5a in a closed configuration according to an embodiment disclosed herein. FIG. 5d illustrates a cross-sectional view of a valve in a closed configuration according to an embodiment disclosed herein. FIG. 6a illustrates a cross-sectional view of a valve and a valve splitter according to an embodiment disclosed herein. FIG. 6b shows a cross-sectional view of the valve of FIG. 6a in a closed configuration according to an embodiment disclosed herein. FIG. 6c shows a close side view of the valve of FIG. 6a in a closed configuration according to an embodiment disclosed herein. FIG. 7a illustrates a cross-sectional view of a connecting portion including a valve and a valve splitter according to an embodiment disclosed herein. FIG. 7b shows a cross-sectional view of the valve of FIG. 7a in a closed configuration according to an embodiment disclosed herein. FIG. 8a illustrates a cross-sectional view of a connecting portion including a valve and a valve splitter according to an embodiment disclosed herein. FIG. 8b shows a cross-sectional view of the valve of FIG. 8a in a closed configuration according to an embodiment disclosed herein. FIG. 9a illustrates a cross-sectional view of a connection comprising a valve and an open-holding tab attached to the valve, according to an embodiment disclosed herein. FIG. 9b illustrates a cross-sectional view of a connection comprising a valve and an open-holding tab detached from the valve, according to an embodiment disclosed herein. FIG. 10a illustrates a longitudinal cross-sectional view of a connecting portion including a valve and a valve splitter according to an embodiment disclosed herein. FIG. 10b illustrates a lateral cross-sectional view of a connecting portion including a valve and a valve splitter according to an embodiment disclosed herein. Specific details for implementing the invention

[0012] The present application claims the benefit of priority of U.S. Provisional Application No. 63 / 016,156 filed on April 27, 2020, the entirety of which is incorporated herein by reference.

[0013] Before specifically disclosing certain embodiments, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It will also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments and may be optionally combined with or substituted with features of any many other embodiments disclosed herein.

[0014] With respect to the terms used herein, it should be understood that the terms are intended for the purpose of describing certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide a sequential or numerical limitation. For example, "first," "second," and "third" features or steps do not necessarily need to appear in such an order, nor is a specific embodiment containing such features or steps necessarily limited to three features or steps. Labels such as "left," "right," "top," "bottom," "front," "rear," etc. are used for convenience and are not intended to imply, for example, any specific fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative position, orientation, or direction. Unless otherwise explicitly stated in the context, the singular forms (“a,” “an,” and “the”) include plural objects.

[0015] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein comprises the portion of the catheter intended to be close to the clinician when the catheter is used on a patient. Likewise, for example, the "proximal length" of a catheter comprises the length of the catheter intended to be close to the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter comprises the end of the catheter intended to be close to the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter may comprise the proximal end of the catheter; however, the proximal portion, proximal end portion, or proximal length of a catheter does not necessarily have to comprise the proximal end of the catheter. That is, unless otherwise indicated in the context, the proximal portion, proximal end portion, or proximal length of a catheter is not the distal portion or distal length of a catheter.

[0016] With respect to “distal,” for example, the “distal portion” or “distal end portion” of a catheter disclosed herein comprises a portion of the catheter intended to be positioned near or within the patient when the catheter is used for a patient. Likewise, for example, the “distal length” of a catheter comprises a length of the catheter intended to be positioned near or within the patient when the catheter is used for a patient. For example, the “distal end” of a catheter comprises a portion of the catheter intended to be positioned near or within the patient when the catheter is used for a patient. The distal portion, distal end portion, or distal length of the catheter may comprise the distal end of the catheter; however, the distal portion, distal end portion, or distal length of the catheter does not need to comprise the distal end of the catheter. That is, unless otherwise indicated in the context, the distal portion, distal end portion, or distal length of the catheter is not the distal portion or distal length of the catheter.

[0017] To aid in the description of the embodiments described herein, as illustrated in FIGS. 1 and 2a, the longitudinal axis extends substantially parallel to the axial length of the connection. The lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal and lateral axes.

[0018] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as generally understood by those skilled in the art.

[0019] FIG. 1 illustrates an exemplary catheter system (“catheter”) (100). As illustrated, the exemplary catheter (100) may be a Peripherally Inserted Central Catheter (“PICC”). However, it will be understood that the embodiments disclosed herein may be used with any catheter or medical device comprising a valve, such as central venous catheters (“CVC”), intravenous (“IV”), dialysis catheters, midline catheters, inducer sets, port access systems, etc., without limitation.

[0020] A catheter (100) generally comprises a catheter body (110), and the catheter body is supported by a catheter hub (120) coupled to its proximal end and forming one or more lumens. The catheter system (100) may further comprise an extension leg (130) extending proximally from the hub (120). The extension leg (130) may form an extension leg lumen that is fluidly in communication with the lumen of the catheter body (110). The catheter system (100) may comprise two or more extension legs, for example, a first extension leg (130A) and a second extension leg (130B), each of which is in communication with the lumen of the catheter body (110), for example, the first extension leg (130A) is in communication with the first lumen and the second extension leg (130B) is in communication with the second lumen. The extended leg portion (130) may further include a connecting portion (140) positioned at its proximal end.

[0021] As illustrated in FIG. 2a, in an embodiment, the connecting portion (140) comprises a main body (142) that forms a lumen (144). The lumen (144) extends axially and provides fluid communication between an extension leg portion (130) positioned at a proximal end and a distal end. The connecting portion main body (142) may include a coupler (146) positioned at the proximal end of the main body (142). The coupler (146) may include a luer lock, spin nut, twist nut, or similar coupling structure configured to secure a medical line, syringe, inducer, or similar device to the catheter (100). For example, as illustrated in FIG. 2b, a medical line (10) can be coupled to and secured to the connecting portion (140) using a female spin nut (20) configured to be coupled with the coupler (146).

[0022] In an embodiment, the connecting portion (140) may include a valve (150) configured to control fluid flow through the lumen (144) of the connecting portion (140). As illustrated in FIGS. 2c through 3b, in an embodiment, the valve (150) may be a slit valve, but other types of valves including flap valves, duckbill valves, bileaflets, or others are also considered to be included within the scope of the invention. Additionally, it will be understood that the valve may include more than one slit, for example, that a first slit may be configured to allow fluid flow along a first direction and a second slit may be configured to allow fluid flow along a second direction opposite to the first direction. Additionally, it will be understood that although the valve (150) as described includes a recessed side surface and forms a substantially oval cross-sectional shape, the valve (150) may also include other common cross-sectional shapes such as circular, polygonal, etc., or surface configurations such as dome-shaped, flat, half-dome-shaped, etc., or combinations thereof. Such and similar configurations of the valve (150) are considered to be included within the scope of the present invention.

[0023] As illustrated in FIG. 2c, the slit valve (150) may be formed of a flexible material and comprises one or more valve members (152), for example, a first valve member (152A) and a second valve member (152B). In an embodiment, the flexible material may comprise a polymer, an elastomer, rubber, silicone, or a similar suitable material. As illustrated in FIG. 3b, each of the valve members comprises a valve face (154) that, when in the closed position, engages with a corresponding valve face of the opposing valve member. For example, the valve (150) comprises a normal-closed slit valve, and this slit valve comprises a first valve member (152A) that forms a first valve face (154A) that, when in the closed position, engages with a second valve face (154B) of the opposing second valve member (152B).

[0024] In an embodiment, the first valve member (152A) may be coupled with the second valve member (152B) in a closed position to create a seal between them and control fluid flow through the connecting lumen (144). The valve members (152A, 152B) may transition from a closed configuration (Fig. 3b) to an open configuration (Fig. 3a). In an embodiment, for example, a "pre-loaded catheter," an elongated medical device, for example, a probe (50), may be positioned between the valve members (152) and within the lumen of the catheter (100). The flexible valve member (152) may be deformed around the outer surface of the probe (50), thereby allowing the probe (50) to pass through while preventing fluid from flowing through it. It will be understood that the illustrated probe (50) is exemplary, and other slender medical devices including probes, trocars, catheters, injectors, combinations thereof, etc. are also considered.

[0025] It will be understood that during transport and storage, for extended periods, a "pre-loaded" catheter may have a probe (50) placed between the valve members. This may result in a permanent indentation within the valve face (154) as described herein. Additionally, any displacement of the probe (50) into the valve (150) may damage the valve face (154). Indentation and damage to the valve face (154) may result in leakage, valve failure, and replacement of the entire catheter system (100). The embodiment described herein may maintain a separation between the probe (50) and the valve face (154), thereby preventing such damage and maintaining the integrity of the valve (150).

[0026] As illustrated in FIG. 3a, a valve split section ("segment") (160) is provided. The valve split section (160) may include an elongated body (162) forming a split section lumen (164) extending from a proximal end to a distal end. The valve split section (160) may further include a nose section (166), which is positioned at the distal end and configured to be inserted into the lumen (144) of the connecting section (140) so that the distal tip (168) of the valve split section (160) can come into contact with the valve (150). In an embodiment, the split section lumen (164) may be configured to receive through an elongated medical device, e.g., a probe (50). In an embodiment, the inner diameter of the split portion lumen (164) may be equal to or slightly larger than the outer diameter of the slender medical device (50) so that the slender medical device (50) fits snugly inside. In an embodiment, the valve split portion (160) may be provided as a separate structure. In an embodiment, the valve split portion (160) may be provided as part of a medical line (10), a coupler (30), or other device, or a combination thereof, which can be coupled to the connection portion (140).

[0027] As illustrated in FIG. 3a, in an embodiment, the nose portion (166) can be inserted into the connecting lumen (144), and the distal tip portion (168) can be in contact with the valve member (152). By pressing the valve split portion (160) distally to slightly deflect the valve member (152), the valve faces (154) can be separated and an opening can be created between them. The probe (50) can be positioned in a spaced-away relationship from the valve face (154) through the opening. In an embodiment, the valve split portion (160) is held in place to prevent any contact between the probe (50) and the valve face (154). Advantageously, neither the valve split portion (160) nor the probe (50) comes into contact with the valve face (154), thereby maintaining the integrity of the valve (150). In an embodiment, the valve splitter (160) may be used to deflect the valve member (152) when the probe is applied to the catheter to prevent damage to the valve surface (154). When the catheter (100) is properly positioned, the probe (50) may be removed. Subsequently, the valve splitter (160) may be removed to allow the valve to resume a normal state-closed configuration.

[0028] In an embodiment, the valve split portion (160) may include a shoulder portion (170) disposed between the nose portion (166) and the main body (162). The distance (x) between the shoulder portion (170) and the distal tip portion (168) may be a predetermined length. Thus, the shoulder portion (170) may be coupled to the opening (148) of the connecting portion lumen (144), and the distal tip portion (168) may extend into the connecting portion lumen (144) by a predetermined distance (x). The predetermined distance (x) may sufficiently deform the valve member (152) to create an opening as described herein, without scratching or damaging the valve member (152). In an embodiment, for example as illustrated in FIG. 3a, the shoulder portion (170) may form a surface extending perpendicular to the longitudinal axis and is configured to be coupled with the opening (148) of the connection portion (140). In an embodiment, for example as illustrated in FIG. 4a, the shoulder portion (170) may form a curved cross-sectional profile or a truncated-conical profile to be coupled with the opening (148) and to align the valve split portion with the axial center line of the connection portion lumen (144). In an embodiment, the valve split portion (160) includes a female-type coupler configured to be coupled with the coupler (146) of the connection portion (140) and configured to extend the distal end portion (168) of the valve split portion (160) into the connection portion lumen (144) by a predetermined distance (x).

[0029] In an embodiment, as illustrated in FIG. 4a and FIG. 4b, the valve member (152) may include a protrusion (156), for example, a first valve protrusion (156A) and a second valve protrusion (156B). FIG. 4a illustrates the valve member in an open configuration. FIG. 4b illustrates the valve member (152) in a closed configuration. The valve protrusion (156) may extend proximally from the side surface of the valve member (152) and may form a hemispherical shape. However, it will be understood that other three-dimensional shapes included within the scope of the invention are also considered. As illustrated in FIG. 4a, the protrusion (156) provides a contact surface to which the distal tip (168) of the valve splitter (160) may abut, as described herein, and separates the valve faces (154). Advantageously, the protrusion (156) may provide a thick portion to provide a stand-off between the distal tip (168) and the valve face (154), thereby reducing wear or damage to the valve member (152) and / or the valve face (154) due to repeated engagement with the distal tip (168) of the valve splitter (160). Advantageously, the longitudinal extension of the protrusion (156) provides a lever, and this lever helps the valve face (154) rotate away from the surface of the probe (50) to create an opening. For clarity, it should be noted that FIGS. 4a through 6c illustrate only embodiments of the valve splitter (160) and the valve (150).

[0030] In an embodiment, as illustrated in FIGS. 5a through 5c, the valve member (152) may include a concave cavity or a depression (158). For example, the first valve member (152A) includes a first cavity (158A), and the second valve member (152B) includes a second cavity (158B). FIG. 5a illustrates a cross-sectional view of the valve member (152) in an open configuration. FIG. 5b illustrates a cross-sectional view of the valve member (152) in a closed configuration. FIG. 5c illustrates a close-up side view of the valve member (152) in a closed configuration. As illustrated in FIG. 5c, when the valve (150) is in a closed configuration, the first cavity (158A) and the second cavity (158B) may operate together to form a concave depression (158). As illustrated, the first cavity (158A) and the second cavity (158B) may be semi-circular and may work together to form a substantially circular depression (158). However, it will be understood that this is exemplary and that any one of the first cavity (158A), the second cavity (158B), or the depression (158) may form an oval, elliptical, polygonal, rectangular, or any regular or irregular polygonal shape of a closed curve. Additionally, the first cavity (158A) and the second cavity (158B) may have the same shape, may be "mirror-image" shapes of each other, or may have asymmetric shapes and may still work together to form the depression (158).

[0031] In an embodiment, the recess (158) may extend over a portion of the side surface of the valve (150). In an embodiment, the recess (158) may extend substantially over the entire side surface of the valve (150). In an embodiment, the recess (158) may surround a portion of the valve slit (154) formed by the valve faces (154A, 154B) (e.g., FIG. 6c). In an embodiment, the recess (158) may surround the entire slit (154) of the slit valve so that the length of the valve faces (154A, 154B) is placed within the recess (158) (e.g., FIG. 5c). In an embodiment, the minimum diameter of the recess (158) is equal to or slightly larger than the outer diameter of the distal end (168) of the valve split (160) so that the distal end (168) fits inside. In an embodiment, for example as illustrated in FIG. 5d, the periphery surface of the recess (158) may extend substantially parallel to the longitudinal axis. In an embodiment, for example as illustrated in FIG. 5a and FIG. 5b, the periphery surface of the recess (158) may be chamfered or rounded to help guide the distal tip (168) toward the diagonal center point on the proximal side of the valve (150) ( FIG. 5a). Advantageously, the recess (158) may provide a receiving structure configured to receive the distal tip (168) of the valve splitter (160) and to align the splitter lumen (164) and any elongated medical device (50) disposed therein with the diagonal center point of the valve (150). Accordingly, as described herein, when the valve splitter is inserted into the connection part (140) to separate the valve faces (154), the recess can align the valve splitter (160) and the probe (50) with the opening, and accordingly, the probe (50) can pass through the opening without coming into contact with the valve face (154).

[0032] As illustrated in FIGS. 6a through 6c, in an embodiment, the maximum diameter of the recess (158) may be smaller than the outer diameter of the distal tip (168). Accordingly, the distal tip (168) contacts the valve member (152) at the edge portion (172) of the recess (158). Advantageously, the edge portion (172) is positioned close to the diagonal center point and provides a stand-off between the distal tip (168) and the valve surface (154). In an embodiment, the valve member (152) includes two or more recessed portions, the first recessed portion may form a diameter equal to or slightly larger than the outer diameter of the distal tip (168) as described in the present invention (Figs. 5a to 5c), and the second recessed portion may form a diameter smaller than the outer diameter of the distal tip (168) as described in the present invention (Figs. 6a to 6c).

[0033] As illustrated in FIGS. 7a and 7b, in an embodiment, the valve member (152) may be arranged symmetrically so that the valve faces (154A, 154B) are joined along a central axis. In an embodiment, the valve splitter (160) includes an offset lumen (164) that is axially offset from the central axis. Thus, a probe (50) inserted through the offset lumen (164) may be aligned with the valve member (152) away from the valve face (154). In an embodiment, the valve member (152) may be formed of permeable silicone rubber or other material. Thus, the probe (50) may be inserted through the valve member (152) away from the valve face (154) and prevent damage to the valve face (154). The valve member (152) may be configured to support multiple penetrations without compromising the integrity of the valve barrier or the flexibility of the valve member (152).

[0034] As illustrated in FIGS. 8a and 8b, in an embodiment, the valve member (152) may be arranged in an asymmetric configuration so that the valve faces (154A, 154B) are joined at a position offset with respect to the central axis. In an embodiment, the valve splitter (160) includes a centrally positioned lumen (164) that is axially aligned with the central axis. Thus, a probe (50) inserted through the lumen (164) can be aligned with the valve member (152) away from the valve face (154). As described herein, the valve member (152) may be formed of permeable silicone rubber or other materials. Thus, the probe (50) can be inserted through the valve member (152) away from the valve face (154) and damage to the valve face (154) can be prevented. The valve member (152) may be configured to support multiple penetrations without compromising the integrity of the valve barrier or the flexibility of the valve member (152).

[0035] As illustrated in FIGS. 9a and 9b, in an embodiment, the connecting portion (140) may include an open-holding tab ("tap") (180). The open-holding tab (180) includes a body (182), and this body has a width greater than the diameter of the lumen opening (148) of the connecting portion (140) to prevent the body (182) from advancing into the lumen (144). In an embodiment, the body (182) includes a female type coupler configured to be coupled with the coupler (146) of the connecting portion (140). The tab (180) further includes a first arm (186A) and a second arm (186B), each extending distally from the body (182) into the lumen (144). The distal end (188) of the arm (186) is detachably attached to a portion of the valve member (152) so as to maintain the valve member (152) in an open configuration. As illustrated, the distal end (188) is coupled to the intersection between the valve face (154) and the side surface, but it will be understood that this is exemplary and the arm (186) can be coupled to any portion of the valve member (152).

[0036] In an embodiment, the distal tip (188) may be attached to the valve member (152) by adhesive, bonding, ultrasonic welding, a combination thereof, or otherwise. In an embodiment, the arm (186) and the valve member (152) may be formed as a single integral cross-section and may include a breach line substantially disposed at the distal tip (188). The breach line may include a score line, a perforation, a laser cut line, or a similar weak line configured to help separate the tap (180) from the valve (150) when the tap (180) is proximally compressed. In an embodiment, the distal tip (188) is disengagedly coupled to the valve member (152) by a frangible bridge or a similar weak structure that can help separate the tap (180) from the valve (150) when the tap (180) is proximally compressed.

[0037] As illustrated in FIG. 9a, in an embodiment, the open-hold tab (180) can maintain the valve member (152) in an open configuration. Subsequently, a probe can be positioned through the tab lumen (184), through the connecting lumen (144), and through the opening between the valve faces (154). Once the catheter (100) is positioned, the probe (50) can be removed. As illustrated in FIG. 9b, the open-hold tab (180) can then be retracted proximally, which separates the first distal tip (188A) from the first valve member (152A) and the second distal tip (188B) from the second valve member (152B), thereby allowing the valve member to transition to a closed configuration. The open-hold tab (180) can be removed and discarded. Advantageously, the open-hold tab (180) can be placed during the manufacture of a "pre-loaded" catheter and held in place during storage and transport to prevent a permanent indentation from forming on the valve surface (154).

[0038] As illustrated in FIG. 10a and FIG. 10b, in an embodiment, the nose portion (166) of the valve split portion (160) forms a bilateral convex cross-sectional shape in which the lateral width is wider than the transverse height. In an embodiment, the distal tip portion (168) may include a chamfered edge. In an embodiment, the nose portion (166) may be inserted between the valve faces (154). As illustrated in FIG. 10b, the bilateral convex cross-sectional shape can distribute pressure across the entire valve face (154) and thereby prevent any concave area from forming on the valve face (154) during long-term storage and transport.

[0039] In an exemplary use, a valve splitter (160) is provided that includes an elongated medical device, such as a probe (50) positioned through the interior as described herein. The nose portion (166) of the valve splitter (160) can be inserted into the lumen (144) of the connection portion (140) until its distal tip contacts the valve member, thereby transitioning the valve from a closed configuration to an open configuration, in which the valve faces (154) are separated to create an opening. Subsequently, the probe (50) can be advanced distally through the lumen (164) of the valve splitter (160) between the valve faces (154) in a spaced-away relationship from the valve faces (154).

[0040] While certain specific embodiments have been disclosed herein and some specific embodiments have been disclosed in some detail, such specific embodiments are not intended to limit the scope of the concept provided herein. Further applications and / or modifications may be made by those skilled in the art, and in a broader sense, such applications and / or modifications are also included. Accordingly, applications and / or modifications may be made from the specific embodiments disclosed herein without departing from the scope of the concept provided herein.

Claims

Claim 1 A system for introducing a medical device through a valve, comprising: a valve including a first valve member forming a first proximal surface and a first valve face, and a second valve member forming a second proximal surface and a second valve face—the valve being configured to transition between a closed configuration and an open configuration—; and a valve split extending from a proximal end to a distal tip and forming a lumen—the distal tip being disengageably coupled to the valve and configured to allow the medical device to pass between the first valve face and the second valve face in a spaced-apart manner by bending at least one of the first valve member and the second valve member in a proximal direction to maintain the valve in an open configuration. Claim 2 A system according to claim 1, wherein when the valve is in a closed configuration, the first valve surface is in contact with the second valve surface, and when the valve is in an open configuration, the first valve surface is positioned apart from the second valve surface. Claim 3 A system according to claim 1 or 2, wherein one of the first proximal surface and the second proximal surface comprises a protrusion that extends proximally and is configured to be coupled with the distal tip of the valve split portion. Claim 4 A system according to claim 1 or 2, wherein the first proximal surface comprises a first cavity, the second proximal surface comprises a second cavity, and the first cavity and the second cavity cooperate to form a depression within the proximal surface of the valve. Claim 5 A system according to claim 4, wherein the minimum diameter of the recess is larger than the outer diameter of the distal tip, and the recess is configured to align the distal tip with the diameter center point of the proximal surface of the valve. Claim 6 A system according to claim 4, wherein the maximum diameter of the recess is smaller than the outer diameter of the distal tip, and the edge portion of the recess is configured to be coupled with the distal tip. Claim 7 A system according to claim 1 or 2, wherein the distal tip of the valve split portion is maintained in close proximity to the first valve surface and the second valve surface. Claim 8 A system according to claim 1 or 2, wherein the valve is disposed within a connection portion, the valve split portion further comprises a shoulder portion and a nose portion, and the shoulder portion is configured to be coupled with an opening of the connection portion, and the nose portion is configured to extend into the connection portion by a predetermined distance. Claim 9 A system according to claim 8, wherein the above-mentioned connecting portion is positioned at the proximal end of the catheter. Claim 10 In claim 8, the nose portion is configured to form a biconvex cross-sectional shape and extend between the first valve surface and the second valve surface, a system. Claim 11 A system according to claim 1 or 2, wherein the first valve surface and the second valve surface are aligned with the central longitudinal axis when in the closed configuration, and the axis of the lumen of the split section is offset from the central longitudinal axis. Claim 12 A system according to claim 1 or 2, wherein the first valve surface and the second valve surface are offset from the central longitudinal axis when in the closed configuration, and the axis of the lumen of the split section is aligned with the central longitudinal axis. Claim 13 A system according to claim 1 or 2, wherein one of the first valve member and the second valve member is formed of a needle-penetrable material. Claim 14 A valve-type connection comprising: a connection comprising a valve that forms a lumen and includes a valve member, wherein the valve is configured to control fluid flow through the lumen of the connection and is deflected toward a closed configuration; and an open-holding tab; wherein the open-holding tab comprises: a body configured to be coupled to a proximal end of the connection; and an arm extending distally from the body into the lumen of the connection, wherein the distal end of the arm is detachably attached to the valve member to bend the valve member proximally and maintain the valve in an open configuration. Claim 15 In paragraph 14, the above-mentioned open-holding tab is configured to be detachable from the valve member in order to transition the valve to a closed configuration, a valve-type connection. Claim 16 In claim 14 or 15, the body of the open-hold tab is a valve-type connection forming a lumen that aligns with the lumen of the connection. Claim 17 In claim 14 or 15, the open-hold tab further comprises an elongated medical device extending through the lumen of the connection portion to a point far from the valve, and the medical device is a valve-type connection portion disposed in a spaced-apart relationship from the valve member. Claim 18 In claim 17, the above-mentioned elongated medical device comprises a valve-type connection including one of a probe, a trocar, a catheter, or an inducer. Claim 19 A method for inserting a medical device through a valve of a connection portion, comprising the step of providing a valve and an open-hold tab, wherein the valve comprises a first valve member forming a first proximal surface and a first valve face, and a second valve member forming a second proximal surface and a second valve face, and an arm extending from the body of the open-hold tab to a connection portion lumen is detachably attached to at least one of the first valve member and the second valve member to bend at least one of the first valve member and the second valve member in a proximal direction to maintain an open configuration of the valve; and the step of advancing an elongated medical device between the first valve member and the second valve member in a relationship spaced apart from both the first valve face and the second valve face; the method. Claim 20 A method according to claim 19, further comprising the step of separating the arm from the first valve member or the second valve member by pressing the open-hold tab proximally with respect to the connection. Claim 21 In paragraph 19 or 20, the method wherein the valve is deflected toward a closed configuration. Claim 22 A method according to claim 19 or 20, wherein in a closed configuration, the first valve surface contacts the second valve surface to create a seal between them, and in an open configuration, the first valve surface is positioned apart from the second valve surface so that fluid can flow between them.

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