Compatibility of the preloaded stylet valve

Abstract

Preloaded catheters are manufactured with a stylet, guidewire, or similar medical device placed within the catheter and extending through the valve of the connector at the proximal end. During storage and shipping, the stylet can remain in place for extended periods of time, potentially stretching, denting, and damaging the valve face. These dents can cause the valve to leak, resulting in total device failure. Embodiments disclosed herein relate to devices and methods that prevent contact between the medical device and the valve face, thereby reducing damage thereto.

Description

Technical Field

[0001] The present invention relates to the compatibility of a preloaded stylet valve.

Summary of the Invention

[0002] The embodiments disclosed herein relate, briefly summarized, to devices and methods that allow a long medical device, such as a stylet, to pass through a valve with little or no impact on the valve function. This is particularly important during storage and transportation of "preloaded" catheters and stylets, or for repeated insertion of medical devices over the life of the valve. For example, valves such as those used in catheters often include valve members that are deformable while opposing each other. The valve member is configured to form a seal by engaging along the valve surface and to prevent the flow of fluid therebetween. The valve member can be deflected to selectively allow fluid to flow or for a medical device to pass therebetween. When a stylet is "preloaded" within a catheter and through a valve, the stylet may cause indentations on the valve surface. Over time, for example, during transportation and storage, the indentations may be constantly formed on the valve surface, which may result in valve leakage and malfunction. Or, repeated insertion of a medical device through the valve may also damage the valve surface, leading to incomplete sealing and valve malfunction. The embodiments disclosed herein relate to devices and methods that reduce damage to a valve by preventing contact between the medical device and the valve surface.

[0003] Disclosed herein is a system for introducing a medical device through a valve, comprising a first valve member defining a first proximal surface and a first valve surface, and a second valve member defining a second proximal surface and a second valve surface, a valve configured to transition between a closed state and an open state, and a valve divider extending from a proximal end to a distal tip and defining a lumen, wherein the distal tip engages the valve and is configured to transition the valve from a closed state to an open state, enabling the medical device to pass between the first valve surface and the second valve surface in a spaced-apart relationship.

[0004] In some embodiments, in the closed state of the valve, the first valve surface contacts the second valve surface, and in the open state of the valve, the first valve surface is in a spaced-apart relationship from the second valve surface. One of the first proximal surface and the second proximal surface includes a protrusion extending in the proximal direction and configured to engage the distal tip of the valve divider. The first proximal surface includes a first cavity, the second proximal surface includes a second cavity, and the first cavity and the second cavity cooperate to define a recess in the proximal surface of the valve. 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 opposing center point of the proximal surface of the valve. In some embodiments, the maximum diameter of the recess is smaller than the outer diameter of the distal tip, and the rim portion of the recess is configured to engage the distal tip. The distal tip of the valve divider remains proximal to the first valve surface and the second valve surface.

[0005] In some embodiments, the valve is disposed within the connector, the valve divider further includes a shoulder portion and a nose portion, the shoulder portion is configured to engage an opening of the connector, and the nose portion is configured to extend a predetermined distance within the connector. The connector is disposed at the proximal end of the catheter. The nose portion defines a double convex cross-sectional shape and is configured to extend between a first valve surface and a second valve surface. In the closed state, the first valve surface and the second valve surface are aligned with the central longitudinal axis, and the axis of the divider lumen is offset from the central longitudinal axis. In the closed state, the first valve surface and the second valve surface are offset from the central longitudinal axis, and the axis of the divider lumen is aligned with the central longitudinal axis. One of the first valve member and the second valve member is formed of a material through which a needle can penetrate.

[0006] Also disclosed herein is a valve connector comprising a connector defining a lumen and including a valve including a valve member, the valve being configured to control the flow of fluid through the lumen of the connector and being biased to a closed state, the connector, an open holding tab comprising a body configured to engage the proximal end of the connector, and an arm extending distally from the body into the connector lumen, the distal tip of the arm being releasably attached to the valve member to maintain the valve in an open state.

[0007] In some embodiments, the open holding tab is configured to be removed from the valve member to transition the valve to a closed state. The body of the open holding tab defines a lumen that is aligned with the connector lumen. In some embodiments, the open holding tab further includes an elongate medical device extending through the connector lumen to a distal point of the valve, the medical device being disposed in a spaced relationship from the valve member. The elongate medical device includes one of a stylet, a trocar, a catheter, or an introducer.

[0008] Also disclosed herein is a method of inserting a medical device through a valve, the method comprising providing a valve comprising a first valve member defining a first proximal surface and a first valve face, and a second valve member defining a second proximal surface and a second valve face; advancing a valve divider until its distal tip contacts one of the first proximal surface and the second proximal surface; transitioning the valve from a closed state to an open state; and advancing a elongate medical device between the first valve member and the second valve member while spaced apart from both the first valve face and the second valve face.

[0009] In some embodiments, a slit valve is disposed within a connector portion of a catheter. The valve is biased to a closed state. In the closed state, the first valve face contacts the second valve face to form a seal therebetween, and in the open state, the first valve face is spaced from the second valve face to permit fluid flow therebetween.

[0010] The present disclosure will be described in more detail by reference to the specific embodiments shown in the accompanying drawings. It is to be understood that these drawings illustrate only typical embodiments of the invention and are not to be considered limiting of its scope. Exemplary embodiments of the invention are described and explained in further detail with reference to the accompanying drawings.

Brief Description of the Drawings

[0011]

Figure 1

Figure 2A

Figure 2B

Figure 2C

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 5A

Figure 5B

Figure 5C

Figure 5D

Figure 6A

Figure 6B

Figure 6C

Figure 7A

Figure 7B

Figure 8A

Figure 8B

Figure 9A

Figure 9B

Figure 10A

Figure 10B

DETAILED DESCRIPTION OF THE INVENTION

[0012] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It should also be understood that the specific embodiments disclosed herein can be easily separated from that specific embodiment and may have features that can be optionally combined or substituted with the features of any of the plurality of other embodiments disclosed herein.

[0013] Regarding the terms used in this specification, it should also be understood that each term is for the purpose of explaining some specific embodiments and does not limit the scope of the concepts presented in this specification. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps among a group of multiple features or steps, and do not impose an order limitation or a numerical limitation. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in this order, and a specific embodiment including such features or steps does not necessarily have to be limited to three features or steps. Expressions such as "left", "right", "up", "down", "front", "rear", etc. are used for convenience and do not mean any specific fixed position, orientation, or direction. Rather, such expressions are used to indicate, for example, relative positions, orientations, or directions. The singular forms "a", "one", and "the" include plural references unless the context clearly indicates otherwise.

[0014] Regarding "proximal", for example, the "proximal portion" or "proximal end portion" of a catheter disclosed in this specification includes the portion of the catheter that is near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter may include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of a catheter does not necessarily have to include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0015] Regarding "distal", for example, the "distal portion" or "distal end portion" of a catheter as disclosed herein includes the portion of the catheter that is near or within the patient when the catheter is used on the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is near or within the patient when the catheter is used on the patient. For example, the "distal end" of a catheter includes the end of the catheter that is near or within the patient when the catheter is used on the patient. The distal portion, distal end portion, or distal length of a catheter may include the distal end of the catheter, but the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0016] To assist in the description of the embodiments described herein, as shown in FIGS. 1 and 2A, the vertical axis extends substantially parallel to the axial length of the connector. The horizontal axis extends perpendicular to the vertical axis, and the transverse axis extends perpendicular to both the vertical axis and the horizontal axis.

[0017] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. FIG. 1 shows an exemplary catheter system (catheter) 100. As shown, the exemplary catheter 100 may be a PICC (peripherally inserted central catheter). However, it will be understood that the embodiments disclosed herein may be used with any catheter or medical device that includes a valve, such as a CVC (central venous catheter), an IV (intravenous) catheter, a dialysis catheter, a midline catheter, an introducer set, a port access system, etc.

[0018] The catheter 100 generally includes a catheter body 110 that defines one or more lumens and is supported by a catheter hub 120 coupled to its proximal end. The catheter system 100 may further include an extension leg 130 extending proximally from the hub 120. The extension leg 130 may define an extension leg lumen that is in fluid communication with the lumen of the catheter body 110. The catheter system 100 may include two or more extension legs, for example, a first extension leg 130A and a second extension leg 130B, and it will be understood that each extension leg is in communication with the lumen of the catheter body 110. For example, the first extension leg 130A is in communication with a first lumen while the second extension leg 130B is in communication with a second lumen. The extension leg 130 may further include a connector 140 disposed at its proximal end.

[0019] As shown in FIG. 2A, in one embodiment, the connector 140 includes a body 142 that defines a lumen 144. The lumen 144 extends axially and provides fluid communication between the proximal end and the extension leg 130 disposed at the distal end. The connector body 142 may include a coupler 146 disposed at the proximal end of the body 142. The coupler 144 may include a luer lock, a spinner nut, a twist lock, or a similar connection structure configured to secure a medical line, syringe, introducer, or the like to the catheter 100. For example, as shown in FIG. 2B, the medical line 10 may be coupled and secured to the connector 140 using a female spinner nut 20 configured to engage the coupler 146.

[0020] In one embodiment, the connector 140 may include a valve 150 configured to control the flow of fluid through the lumen 144 of the connector 140. As shown in FIGS. 2C through 3B, in one embodiment, the valve 150 may be a slit valve, although other types of valves including flap valves, duckbill valves, bi-leaflets, etc. are also considered to be within the scope of the present invention. The valve may include two or more slits. For example, it should be understood that the first slit may be configured to allow fluid flow in a first direction and the second slit may be configured to allow fluid flow in a second direction opposite to the first direction. Further, the valve 150 includes a concave side surface as shown and defines a generally elliptical cross-sectional shape, although the valve 150 may also include other common cross-sectional shapes such as circular, polygonal, etc., surface configurations such as dome-shaped, flat, semi-dome-shaped, etc., or combinations thereof. These and similar configurations of the valve 150 are considered to be within the scope of the present invention.

[0021] As shown in FIG. 2C, the slit valve 150 may be formed of a flexible material and include one or more valve members 152, such as a first valve member 152A and a second valve member 152B. In one embodiment, the flexible material may include a polymer, elastomer, rubber, silicone, or similar suitable material. As shown in FIG. 3B, each of the valve members includes a valve surface 154 that engages a corresponding valve surface of the opposing valve member in the closed position. For example, the valve 150 includes a normally closed slit valve that includes a first valve member 152A that defines a first valve surface 154A that engages the second valve surface 154B of the opposing second valve member 154B in the closed position.

[0022] In one embodiment, in the closed position, the first valve member 152A engages the second valve member 154B to form a seal therebetween and can control the flow of fluid through the connector lumen 144. The valve members 152A, 152B can transition from a closed state (FIG. 3B) to an open state (FIG. 3A). In one embodiment, for example, a “pre-loaded” catheter, a long medical device, such as a stylet 50, may be disposed within the lumen of the catheter 100 between the valve members. The flexible valve members 152 can deform around the outer surface of the stylet 50 to allow the stylet 50 to pass therethrough while suppressing the flow of fluid passing therethrough. The illustrated stylet 50 is exemplary, and it will be understood that other long medical devices, including stylets, trocars, catheters, introducers, combinations thereof, etc., are contemplated.

[0023] It will be understood that a “pre-loaded” catheter can have a stylet 50 disposed between the valve members for an extended period during transportation and storage. This can result in a permanent indentation on the valve surface 154, as described herein. Further, minor movement of the stylet 50 relative to the valve 150 can cause damage to the valve surface 154. Indentation and damage to the valve surface 154 can result in leakage, valve malfunction, and ultimately replacement of the entire catheter system 100. The embodiments described herein can prevent damage thereto and maintain the integrity of the valve 15 by maintaining a spaced relationship between the stylet 50 and the valve surface 154.

[0024] As shown in FIG. 3A, a valve divider (divider) 160 is provided. The valve divider 160 may include an elongate body 162 that defines a divider lumen 164 extending from a proximal end to a distal end. The valve divider 160 may further include a nose portion 166 disposed at the distal end. The nose portion 166 is configured such that the distal tip 168 of the valve divider 160 can be inserted into the lumen 144 of the connector 140 in contact with the valve 150. In one embodiment, the divider lumen 164 may be configured to receive a long medical device, such as a stylet 50, therethrough. In one embodiment, the inner diameter of the divider lumen 164 may be the same as or slightly larger than the outer diameter of the long medical device 50 such that the long medical device 50 fits therein. In one embodiment, the valve divider 160 may be provided as a separate structure. In one embodiment, the valve divider 160 may be provided as part of the medical line 10, the coupler 30, or other devices that can be coupled to the connector 140, or combinations thereof.

[0025] As shown in FIG. 3A, in one embodiment, the nose portion 166 may be inserted into the connector lumen 144 and the distal tip 168 may contact the valve member 152. The valve divider 160 may be biased distally to separate the valve surface 154 and create an opening therebetween by slightly bending the valve member 152. The stylet 50 may be disposed through the opening in a spaced-apart relationship from the valve surface 154. In one embodiment, the valve divider 160 remains in place to prevent any contact between the stylet 50 and the valve surface 154. Advantageously, the integrity of the valve 150 is maintained by neither the valve divider 160 nor the stylet 50 contacting the valve surface 154. In one embodiment, by using the valve divider 160, the valve member 152 can be bent to prevent damage to the valve surface 154 when the stylet is moving relative to the catheter. Once the catheter 100 is accurately positioned, the stylet 50 can be removed. Next, when the valve divider 160 is removed, the valve can return to its normally closed state.

[0026] In one embodiment, the valve divider 160 may include a shoulder portion 170 disposed between the nose portion 166 and the body 162. The distance (x) between the shoulder portion 170 and the distal tip 168 may be a predetermined length. Thus, the shoulder portion 170 can engage the opening 148 of the connector lumen 144, and the distal tip 168 can extend a predetermined distance (x) into the connector lumen 144. The predetermined distance (x) may be sufficient to create an opening as described herein by deforming the valve member 152 without stretching or damaging the valve member 152. In one embodiment, as shown, for example, in FIG. 3A, the shoulder portion 170 may define a plane extending perpendicular to the longitudinal axis and is configured to engage the opening 148 of the connector 140. In one embodiment, as shown, for example, in FIG. 4A, the shoulder portion 170 may engage the opening 148 and define a curved cross-sectional profile or a frustoconical profile so as to align the valve divider with the axis of the connector lumen 144. In one embodiment, the valve divider 160 is configured to engage the coupler 146 of the connector 140 and includes a female coupler configured such that the distal tip 168 of the valve divider 160 extends a predetermined distance (x) into the connector lumen 144.

[0027] In one embodiment, as shown in FIGS. 4A and 4B, the valve member 152 may include protrusions 156, such as a first valve protrusion 156A and a second valve protrusion 156B. FIG. 4A shows the valve member in an open state. FIG. 4B shows the valve member 152 in a closed state. The valve protrusions 156 may extend in a proximal direction from the side surface of the valve member 152 and may define a hemispherical shape. However, it will be understood that other three-dimensional shapes may also fall within the scope of the present invention. As shown in FIG. 4A, the protrusions 156 have a contact surface against which the distal tip 168 of the valve divider 160 can abut, as described herein, and separate the valve surface 154. Advantageously, the protrusions 156 may have a thickened portion for reducing wear or damage to the valve member 152 and / or the valve surface 154 by repeatedly engaging the distal tip 168 of the valve divider 160 by providing a standoff between the distal tip 168 and the valve surface 154. Advantageously, the longitudinal extension of the protrusions 156 has a lever that allows the valve surface 154 to rotate away from the surface of the stylet 50, thereby forming an opening. For ease of understanding, note that FIGS. 4A through 6C show only embodiments of the valve divider 160 and the valve 150.

[0028] In one embodiment, as shown in FIGS. 5A through 5C, the valve member 152 may include a recessed cavity or recess 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 shows a cross-sectional view of the valve member 152 in an open state. FIG. 5B shows a cross-sectional view of the valve member 152 in a closed state. FIG. 5C shows a proximal side view of the valve member 152 in a closed state. As shown in FIG. 5C, when the valve 150 is in the closed state, the first cavity 158A and the second cavity 158B may cooperate to form a recessed recess 158. As shown, the first cavity 158A and the second cavity 158B are semi-circular and may cooperate to form a generally circular recess 158. However, this is exemplary, and it will be understood that one of the first cavity 158A, the second cavity 158B, or the recess 158 may define an oval, elliptical, polygonal, rectangular, or any closed curve of a regular or irregular polygon. Further, the first cavity 158A and the second cavity 158B may be of the same shape, mirror images of each other, or asymmetric shapes and cooperate to form the recess 158.

[0029] In one embodiment, the recess 158 may extend across a portion of the side surface of the valve 150. In one embodiment, the recess 158 may extend across substantially the entire side surface of the valve 150. In one embodiment, as shown, for example, in FIG. 6C, the recess 158 may surround a portion of the valve slit 154 defined by the valve surfaces 154A, 154B. In one embodiment, as shown, for example, in FIG. 5C, the recess 158 may surround the entire slit 154 of the slit valve such that the lengths of the valve surfaces 154A, 154B are disposed within the recess 158. In one embodiment, the minimum diameter of the recess 158 is the same as or slightly larger than the outer diameter of the distal tip 168 of the valve divider 160 such that the distal tip 168 can fit therein. In one embodiment, as shown, for example, in FIG. 5D, the outer peripheral surface of the recess 158 may extend substantially parallel to the longitudinal axis. In one embodiment, as shown, for example, in FIGS. 5A and 5B, the outer peripheral surface of the recess 158 may be chamfered or curved (FIG. 5A) to enable guiding the distal tip 168 towards the opposing central points on the proximal side of the valve 150. Advantageously, the recess 158 may have a receiving structure configured to receive the distal tip 168 of the valve divider 160 and to align the divider lumen 164, and any elongate medical device 50 disposed therein, with the opposing central points of the valve 150. Thus, as described herein, when the valve divider is inserted into the connector 140 to separate the valve surfaces 154, the recess may align the valve divider 160 and the stylet 50 with the opening such that the stylet 50 passes through the opening without contacting the valve surfaces 154.

[0030] As shown in FIGS. 6A through 6C, in one 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 rim portion 172 of the recess 158. Advantageously, the rim portion 172 is disposed in the proximal direction of the opposing center points and provides a standoff between the distal tip 168 and the valve surface 154. In one embodiment, the valve member 152 includes two or more concave portions. The first concave portion may define a diameter that is the same as or slightly larger than the outer diameter of the distal tip 168, as described herein (FIGS. 5A through 5C). The second concave portion may define a diameter that is smaller than the outer diameter of the distal tip 168, as described herein (FIGS. 6A through 6C).

[0031] As shown in FIGS. 7A and 7B, in one embodiment, the valve member 152 may be symmetrically arranged such that the valve surfaces 154A, 154B engage along the central axis. In one embodiment, the valve divider 160 includes an offset lumen 164 that is axially offset from the central axis. Accordingly, the stylet 50 inserted into the offset lumen 164 may be aligned with the valve member 152 away from the valve surface 154. In one embodiment, the valve member 152 may be formed of a penetrable silicone rubber or the like. Accordingly, the stylet 50 can be inserted through the valve member 152 away from the valve surface 154 and avoid damaging the valve surface 154. The valve member 152 may be configured to withstand multiple penetrations without compromising the integrity of the valve wall or the flexible function of the valve member 152.

[0032] As shown in FIGS. 8A and 8B, in one embodiment, the valve member 152 may be arranged in an asymmetric configuration such that the valve surfaces 154A, 154B engage at an offset position with respect to the central axis. In one embodiment, the valve divider 160 includes a centrally disposed lumen 164 that is axially aligned with the central axis. Accordingly, the stylet 50 inserted into the lumen 164 may be aligned with the valve member 152 away from the valve surface 154. As described herein, the valve member 152 may be formed of a penetrable silicone rubber or the like. Accordingly, the stylet 50 can be inserted through the valve member 152 away from the valve surface 154 and can avoid damaging the valve surface 154. The valve member 152 may be configured to withstand multiple penetrations without compromising the integrity of the valve wall or the flexible function of the valve member 152.

[0033] As shown in FIGS. 9A and 9B, in one embodiment, the connector 140 may include an open-holding tab (tab) 180. The open-holding tab 180 includes a body 182. The body 182 has a width greater than the diameter of the lumen opening 148 of the connector 140, thereby preventing the body 182 from advancing into the lumen 144. In one embodiment, the body 182 includes a female coupler configured to engage the coupler 146 of the connector 140. The tab 180 may further include a first arm 186A and a second arm 186B, and each arm extends distally from the body 182 into the lumen 144. The distal tip 188 of the arm 186 may be releasably attached to a portion of the valve member 152 to hold the valve member 152 in an open state. As shown, the distal tip 188 is coupled to the intersection of the valve surface 154 and the side surface, but this is exemplary, and it will be understood that the arm 186 may be coupled to any portion of the valve member 152.

[0034] In one embodiment, the distal tip 188 may be attached to the valve member 152 by an adhesive, bonding, ultrasonic welding, combinations thereof, and the like. In one embodiment, the arm 186 and the valve member 152 are formed as a single unitary component and may include a dashed line disposed substantially at the distal tip 188. The dashed line may include a cut line, perforation, laser cut line, or similar weak line configured to allow the tab 180 to be separable from the valve 150 when the tab 180 is biased in the proximal direction. In one embodiment, the distal tip 188 is releasably coupled to the valve member 152 using a frangible bridge or similar frangible structure that allows the tab 180 to be separable from the valve 150 when the tab 180 is biased in the proximal direction.

[0035] As shown in FIG. 9A, in one embodiment, the open-holding tab 180 may maintain the valve member 152 in an open state. The stylet may then be disposed through the opening between the tab lumen 184, the connector lumen 144, and the valve surface 154. Once the catheter 100 is positioned, the stylet 50 can be removed. As shown in FIG. 9B, the valve member may then be allowed to transition to a closed state by pulling the open-holding tab 180 in the proximal direction, separating the first distal tip 188A from the first valve member 152 and the second distal tip 188B from the second valve member 152B. The open-holding tab 180 may be removed and discarded. Advantageously, the open-holding tab 180 may be positioned during the manufacture of the "pre-loaded" catheter and remain in place during storage and transportation to prevent a depression from constantly forming in the valve surface 154.

[0036] As shown in FIGS. 10A and 10B, in one embodiment, the nose portion 166 of the valve divider 160 defines a bi-convex cross-sectional shape having a lateral width greater than the transverse height. In one embodiment, the distal tip 168 may include a chamfered edge. In one embodiment, the nose portion 166 may be inserted between the valve faces 154. As shown in FIG. 10B, the bi-convex cross-sectional shape may prevent dents from forming in the valve faces 154 during long-term storage or transportation by dispersing pressure across the entire valve faces 154.

[0037] In an exemplary method of use, the valve divider 160 is provided as described herein and includes a long medical device such as a stylet 50 disposed therethrough. The nose portion 166 of the valve divider 160 may be inserted into the lumen 144 of the connector 140 until its distal tip abuts the valve member, thereby transitioning the valve from a closed state to an open state in which the valve faces 154 separate to form an opening. The stylet 50 may then advance distally through the lumen 164 of the valve divider 160 between the valve faces 154 in a spaced-apart relationship from the valve faces 154.

[0038] While several specific embodiments are disclosed herein and some specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be understood by those skilled in the art. In a broader aspect, these adaptations and / or modifications are also included. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. A system for introducing a medical device through a valve, comprising: a first valve member defining a first proximal surface and a first valve surface, and a second valve member defining a second proximal surface and a second valve surface, the valve being configured to transition between a closed state and an open state; a valve divider extending from a proximal end to a distal tip and defining a dividual lumen, the distal tip being releasably engageable with the valve and configured to bend the first valve member and the second valve member in a proximal direction to transition the valve from the closed state to the open state, thereby enabling the medical device to pass between the first valve surface and the second valve surface in a relationship spaced apart from both the first valve surface and the second valve surface.

2. The system of claim 1, wherein when the valve is in the closed state, the first valve surface contacts the second valve surface, and when the valve is in the open state, the first valve surface is spaced apart from the second valve surface.

3. The system of claim 1 or claim 2, wherein one of the first proximal surface and the second proximal surface includes a protrusion extending in a proximal direction and configured to engage the distal tip of the valve divider.

4. The system according to any one of claims 1 to 3, wherein the first proximal surface includes a first cavity, the second proximal surface includes a second cavity, and the first cavity and the second cavity cooperate to define a recess in the proximal surface of the valve.

5. The system of claim 4, wherein a minimum diameter of the recess is larger than an outer diameter of the distal tip, and the recess is configured to align the distal tip with an opposing center point on the proximal surface of the valve.

6. The system of claim 4, wherein a maximum diameter of the recess is smaller than an outer diameter of the distal tip, and a rim portion of the recess is configured to engage the distal tip.

7. The distal tip of the valve divider remains proximal to the first valve surface and the second valve surface. The system according to any one of claims 1 to 6.

8. The valve is disposed within the connector, the valve divider further includes a shoulder portion and a nose portion, the shoulder portion is configured to engage an opening of the connector, and the nose portion is configured to extend a predetermined distance within the connector. The system according to any one of claims 1 to 7.

9. The connector is disposed at a proximal end of the catheter. The system according to claim 8.

10. The distal tip is configured to releasably engage the valve by a frangible bridge. The system according to claim 1.

11. In the closed state, the first valve surface and the second valve surface are aligned with a central longitudinal axis, and the axis of the divider lumen is offset from the central longitudinal axis. The system according to any one of claims 1 to 10.

12. In the closed state, the first valve surface and the second valve surface are offset from a central longitudinal axis, and the axis of the divider lumen is aligned with the central longitudinal axis. The system according to any one of claims 1 to 11.

13. One of the first valve member and the second valve member is formed of a material through which a needle can penetrate. The system according to any one of claims 1 to 12.

14. A connector with a valve, A connector including a valve including a valve member and defining a connector lumen, the valve being configured to control the flow of fluid through the connector lumen and being biased to a closed state, the connector, An open holding tab, A body configured to engage a proximal end of the connector, An arm extending distally from the body into the connector lumen, the distal tip of the arm being releasably attached to the valve member to bend the valve member proximally to maintain the valve in an open state. An open holding tab comprising an arm. A connector with a valve comprising.

15. The open holding tab is configured to be removed from the valve member to move the valve to the closed state. The connector with a valve according to claim 14.

16. The body of the open holding tab defines a lumen aligned with the connector lumen. The connector with a valve according to claim 14 or 15.

17. Further comprising a long medical device extending through the connector lumen to a point distal to the valve, the medical device being disposed in a spaced-apart relationship from the valve member, the valve-equipped connector according to any one of claims 14 to 16.

18. The valve-equipped connector according to claim 17, wherein the long medical device includes one of a stylet, a trocar, a catheter, or an introducer.

Images