Preloaded stylet valve compatibility

Abstract

Pre-loaded catheters are manufactured with a stylet, guide wire, or similar medical device disposed within the catheter that extends through a valve of a connector at the proximal end. During storage and shipping, the stylet can remain in place for extended periods of time, which can cause stretching, indentations, and damage to the valve face. These indentations can cause valve leaks, leading to overall failure of the device. Embodiments disclosed herein relate to devices and methods for mitigating damage between a medical device and a valve face by preventing contact therebetween.

Description

[0001] priority

[0002] This application claims the priority of U.S. Provisional Patent Application No. 63 / 016,156, filed April 27, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to the compatibility of pre-loaded needle valves. Summary of the Invention

[0004] In brief, the embodiments disclosed herein relate to devices and methods that allow elongated medical devices, such as needles, to pass through valves with minimal or no impact on valve function. This is particularly important during the storage and transport of “pre-loaded” catheters and needles, or for repeated insertion of medical devices throughout the valve’s lifespan. Valves used, for example, in catheters typically include opposing deformable valve members configured to engage along valve face surfaces to form a seal and impede fluid flow therebetween. The valve members can be deflected to selectively allow fluid flow or allow a medical device to pass through therebetween. When a needle is “pre-loaded” within a catheter and passes through a valve, the needle may indent the valve face. Over a prolonged period, such as during transport and storage, this indentation may become permanently embedded in the valve face, leading to valve leakage and failure. Alternatively, repeated insertion of a medical device through the valve may also damage the valve face surface, resulting in incomplete sealing and valve failure. The embodiments disclosed herein relate to devices and methods for preventing contact between a medical device and the valve face to mitigate damage thereto.

[0005] This document discloses a system for introducing a medical device via a valve, comprising: a valve including 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, the valve being configured to switch between a closed configuration and an open configuration; and a valve separator extending from a proximal end to a distal tip and defining an inner cavity, the distal tip being configured to engage the valve and switch the valve from a closed configuration to an open configuration to allow the medical device to pass between the first valve face and the second valve face in a spaced-apart relationship.

[0006] In some embodiments, when the valve is in a closed configuration, the first valve face contacts the second valve face, and when the valve is in an open configuration, the first valve face and the second valve face are spaced apart. One of the first and second proximal surfaces includes a proximal projection configured to engage the distal tip of the valve separator. The first proximal surface includes a first cavity, and the second proximal surface includes a second cavity, the first and second cavities cooperating to define a recess in the proximal surface of the valve. The minimum diameter of the recess is greater than the outer diameter of the distal tip, and the recess is configured to align the distal tip with the diametrical center point of the proximal surface of the valve. In some embodiments, the maximum diameter of the recess is less than the outer diameter of the distal tip, and the edge portions of the recess are configured to engage the distal tip. The distal tip of the valve separator remains proximal to the first and second valve faces.

[0007] In some embodiments, a valve is disposed within a connector, and the valve separator further includes a shoulder portion and a nose portion, the shoulder portion being configured to engage an opening in the connector and the nose portion being configured to extend into the connector a predetermined distance. The connector is disposed at the proximal end of a conduit. The nose portion defines 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 and second valve faces are aligned with a central longitudinal axis, and the axis of the separator cavity is offset from the central longitudinal axis. In a closed configuration, the first and second valve faces are offset from the central longitudinal axis, and the axis of the separator cavity is aligned with the central longitudinal axis. One of the first and second valve members is formed of a needle-penetrable material.

[0008] A valve-equipped connector is also disclosed, comprising: a connector defining an inner cavity and including a valve including a valve member, the valve being configured to control fluid flow through the inner cavity of the connector and biased toward a closed configuration; and a retaining open tab including a body configured to engage a proximal end of the connector and an arm extending distally from the body into the inner cavity of the connector, the distal tip of the arm being releasably attached to the valve member to retain the valve in an open configuration.

[0009] In some embodiments, the retaining-open tab is configured to separate from the valve member to convert the valve to a closed configuration. The body of the retaining-open tab defines a cavity aligned with the connector lumen. In some embodiments, the retaining-open tab further includes an elongated medical device extending through the connector lumen to a point distal to the valve, the medical device being arranged in a spaced-apart relationship from the valve member. The elongated medical device includes one of a core needle, cannula, catheter, or guide.

[0010] A method of inserting a medical device via a valve is also disclosed, comprising: providing a valve having 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 separator until its distal tip contacts one of the first and second proximal surfaces; changing the valve from a closed configuration to an open configuration; and advancing an elongated medical device between the first and second valve members in a relationship spaced apart from both the first and second valve faces.

[0011] In some embodiments, a slit valve is disposed within the connector portion of the conduit. The valve is biased toward a closed configuration. In the closed configuration, a first valve face contacts a second valve face to create a seal therebetween, and in the open configuration, the first valve face is spaced apart from the second valve face to allow fluid flow therebetween. Attached Figure Description

[0012] A more specific description of the invention will be presented with reference to specific embodiments of the invention illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and should not be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained in more specific and detailed manner using the accompanying drawings, in which:

[0013] Figure 1 A perspective view of an exemplary catheter according to an embodiment disclosed herein is shown.

[0014] Figure 2A The embodiments disclosed herein are shown. Figure 1 A perspective view of the connector of the conduit.

[0015] Figure 2B The embodiments disclosed herein are shown. Figure 2A A side view of an exemplary connector aligned with a medical line.

[0016] Figure 2C The open configuration according to the embodiment disclosed herein is shown. Figure 2A A perspective view of the valve of the connector.

[0017] Figure 3A A cross-sectional view of a connector including a valve and a valve divider according to an embodiment disclosed herein is shown.

[0018] Figure 3B A closed configuration according to the embodiment disclosed herein is shown. Figure 3A A cross-sectional view of the valve.

[0019] Figure 4A A cross-sectional view of a valve and valve divider according to an embodiment disclosed herein is shown.

[0020] Figure 4B A closed configuration according to the embodiment disclosed herein is shown. Figure 4A A cross-sectional view of the valve.

[0021] Figure 5A A cross-sectional view of a valve and valve divider according to an embodiment disclosed herein is shown.

[0022] Figure 5B A closed configuration according to the embodiment disclosed herein is shown. Figure 5A A cross-sectional view of the valve.

[0023] Figure 5C A closed configuration according to the embodiment disclosed herein is shown. Figure 5A A near-side view of the valve.

[0024] Figure 5D This is a cross-sectional view of a valve in a closed configuration according to the embodiment disclosed herein.

[0025] Figure 6A A cross-sectional view of a valve and valve divider according to an embodiment disclosed herein is shown.

[0026] Figure 6B A closed configuration according to the embodiment disclosed herein is shown. Figure 6A A cross-sectional view of the valve.

[0027] Figure 6C A closed configuration according to the embodiment disclosed herein is shown. Figure 6A A near-side view of the valve.

[0028] Figure 7A A cross-sectional view of a connector including a valve and a valve divider according to an embodiment disclosed herein is shown.

[0029] Figure 7B A closed configuration according to the embodiment disclosed herein is shown. Figure 7A A cross-sectional view of the valve.

[0030] Figure 8A A cross-sectional view of a connector including a valve and a valve divider according to an embodiment disclosed herein is shown.

[0031] Figure 8B A closed configuration according to the embodiment disclosed herein is shown. Figure 8A A cross-sectional view of the valve.

[0032] Figure 9A A cross-sectional view of a connector according to an embodiment disclosed herein is shown, the connector including a valve and a retaining-open tab attached to the valve.

[0033] Figure 9B A cross-sectional view of a connector according to an embodiment disclosed herein is shown, the connector including a valve and a retaining open tab separate from the valve.

[0034] Figure 10A A longitudinal sectional view of a connector including a valve and a valve divider according to an embodiment disclosed herein is shown.

[0035] Figure 10B A side cross-sectional view of a connector including a valve and a valve divider according to an embodiment disclosed herein is shown. Detailed Implementation

[0036] 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 provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments and optionally combined with or substituted for any of the features of any of the many other embodiments disclosed herein.

[0037] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments, and that they do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a set of features or steps, and do not provide for a series or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not necessarily appear in sequence, and a particular embodiment including these features or steps is not necessarily limited to these three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used, and are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such markings are used to reflect, for example, relative positions, orientations, or directions. Unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” include multiple reference objects.

[0038] For example, the terms "proximal," "proximal portion," or "proximal portion" of a catheter disclosed herein include the portion of the catheter intended to be close to the clinician when the catheter is used on a patient. Similarly, the term "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician when the catheter is used on a patient. For example, the term "proximal end" of a catheter includes one end of the catheter intended to be close to the clinician when the catheter is used on a patient. The proximal portion, proximal portion, or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion, or proximal length of a catheter does not necessarily include the proximal end of the catheter. That is, unless the context otherwise requires, the proximal portion, proximal portion, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0039] For example, the term "distal," "distal portion," or "distal part" of a catheter disclosed herein includes the portion of the catheter intended to be close to or in the patient when the catheter is used. Similarly, the term "distal length" of a catheter includes the length of the catheter intended to be close to or in the patient when the catheter is used. For example, the term "distal end" of a catheter includes the end of the catheter intended to be close to or in the patient when the catheter is used. The distal portion, distal part, or distal length of a catheter may include the distal end of the catheter; however, the distal portion, distal part, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless the context otherwise suggests, the distal portion, distal part, or distal length is not the distal portion or distal length of the catheter.

[0040] To help describe the implementation scheme described in this article, such as Figure 1-2A As shown, the longitudinal axis extends substantially parallel to the axial length of the connector. The lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal and lateral axes.

[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by a person of ordinary skill in the art.

[0042] Figure 1 An exemplary catheter system (“catheter”) 100 is illustrated. As shown, the exemplary catheter 100 may be a peripherally inserted central catheter (“PICC”). However, it should be understood that the embodiments disclosed herein can be used with any catheter or medical device including a valve, such as a central venous catheter (“CVC”), an intravenous (“IV”) catheter, a dialysis catheter, a midline catheter, a guide assembly, a port access system, etc., but are not limited thereto.

[0043] The catheter 100 generally includes a catheter body 110 that defines one or more lumens and is supported by a catheter bushing 120 coupled to its proximal end. The catheter system 100 may also include an extension leg 130 extending proximally from the bushing 120. The extension leg 130 may define an extension leg lumen in fluid communication with the lumen of the catheter body 110. It should be understood that the catheter system 100 may include two or more extension legs, such as a first extension leg 130A and a second extension leg 130B, each extension leg communicating with the lumen of the catheter body 110, for example, the first extension leg 130A communicating with a first lumen and the second extension leg 130B communicating with a second lumen. The extension leg 130 may further include a connector 140 disposed proximally thereon.

[0044] like Figure 2AAs shown, in one embodiment, connector 140 includes a body 142 defining a lumen 144. The lumen 144 extends axially and provides fluid communication between its proximal end and an extension leg 130 disposed at its distal end. Connector body 142 may include a coupling 146 disposed at the proximal end of body 142. Coupling 144 may include a Luer lock, a turn nut, a torsion lock, or a similar coupling configuration for securing a medical tubing, syringe, guide, or similar device to catheter 100. For example, as... Figure 2B As shown, the medical tubing 10 can be coupled to the connector 140 and secured to the connector 140 using a female swivel nut 20 configured to engage the connector 146.

[0045] In one embodiment, connector 140 may include valve 150 configured to control fluid flow through the cavity 144 of connector 140. Figure 2C-3B As shown, in this embodiment, valve 150 may be a slit valve; however, other types of valves, including flap valves, duckbill valves, double-leaf valves, etc., are also considered to fall within the scope of this invention. It will also be understood that the valve may include more than one slit, for example, a first slit may be configured to allow fluid flow in a first direction and a second slit may be configured to allow fluid flow in a second direction opposite to the first direction. Furthermore, while the illustrated valve 150 includes a recessed side surface and defines a substantially elliptical cross-sectional shape, it will be understood that valve 150 may also include other general cross-sectional shapes (e.g., circular, polygonal, etc.) or surface configurations (e.g., domed, flat, semi-domed, etc.) or combinations thereof. These and similar configurations of valve 150 are contemplated to fall within the scope of this invention.

[0046] like Figure 2C As shown, the slit valve 150 can be formed of a flexible material and includes one or more valve members 152, such as a first valve member 152A and a second valve member 152B. In embodiments, the flexible material may include polymers, elastomers, rubber, silicone, or similar suitable materials. Figure 3B As shown, each valve member includes a valve face 154, which, when in the closed position, engages with the corresponding valve face of an opposing valve member. For example, valve 150 includes a normally closed slit valve that includes a first valve member 152A defining a first valve face 154A, which, when in the closed position, engages with the second valve face 154B of an opposing second valve member 154B.

[0047] In one embodiment, the first valve member 152A can engage the second valve member 154B in a closed position to create a seal therebetween and control fluid flow through the connector cavity 144. Valve members 152A and 152B can be in a closed configuration ( Figure 3A ) converted to open configuration ( Figure 3B In an embodiment, a "pre-loaded catheter" (an elongated medical device, such as a needle 50) may be arranged between valve members 152 and enter the lumen of catheter 100. Flexible valve members 152 may deform around the outer surface of the needle 50 to allow the needle 50 to pass through therebetween while preventing fluid flow therethrough. It should be understood that the illustrated needle 50 is exemplary, and other elongated medical devices, including needles, cannulas, catheters, guides, combinations thereof, etc., are also contemplated.

[0048] It should be understood that during transport and storage, "pre-loaded" conduits can leave the mandrel 50 positioned between valve components for extended periods. As described herein, this can result in permanent indentations in the valve face 154. Furthermore, any movement of the mandrel 50 relative to the valve 150 can damage the valve face 154. Indentations and damage to the valve face 154 can lead to leaks, valve failure, and replacement of the entire conduit system 100. The embodiments described herein maintain a spaced relationship between the mandrel 50 and the valve face 154 to prevent damage to it and to maintain the integrity of the valve 150.

[0049] like Figure 3A As shown, a valve separator (“splitter”) 160 is provided. The valve separator 160 may include an elongated body 162 defining a separator cavity 164 extending from a proximal end to a distal end. The valve separator 160 may further include a nose portion 166 disposed at the distal end and configured to be inserted into the cavity 144 of the connector 140 such that a distal tip 168 of the valve separator 160 can contact a valve 150. In an embodiment, the separator cavity 164 may be configured to receive an elongated medical device (e.g., a needle 50) passing through it. In an embodiment, the inner diameter of the separator cavity 164 may be equal to or slightly larger than the outer diameter of the elongated medical device 50, such that the elongated medical device 50 fits snugly therein. In an embodiment, the valve separator 160 may be configured as a separate structure. In an embodiment, the valve separator 160 may be part of a medical line 10, a connector 30, or other device or combination thereof that may be coupled to the connector 140.

[0050] like Figure 3AAs shown, in one embodiment, the nose portion 166 can be inserted into the connector cavity 144 and the distal tip 168 can contact the valve member 152. The valve separator 160 can be pushed distally to slightly deflect the valve member 152, separating the valve faces 154 and creating an opening therebetween. The mandrel 50 can be arranged to be spaced apart from the valve face 154 through the opening. In one embodiment, the valve separator 160 is held in place to prevent any contact between the mandrel 50 and the valve face 154. Advantageously, neither the valve separator 160 nor the mandrel 50 contacts the valve face 154, thereby maintaining the integrity of the valve 150. In one embodiment, the valve separator 160 can be used to deflect the valve member 152 when the mandrel moves relative to the conduit to prevent damage to the valve face 154. Once the conduit 100 is properly positioned, the mandrel 50 can be removed. The valve separator 160 can then be removed to allow the valve to return to its normally closed configuration.

[0051] In one embodiment, the valve separator 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. Accordingly, the shoulder portion 170 may engage an opening 148 of the connector cavity 144, and the distal tip 168 may extend into the connector cavity 144 a predetermined distance (x). The predetermined distance (x) may be sufficient to deform the valve member 152 to create an opening, as described herein, without stretching or damaging the valve member 152. In one embodiment, for example... Figure 3A As shown, the shoulder portion 170 may define a surface extending perpendicular to the longitudinal axis and is configured to engage the opening 148 of the connector 140. In an embodiment, for example... Figure 4A As shown, shoulder portion 170 may define a curved cross-sectional profile or a truncated conical profile to engage opening 148 and align the valve divider with the axial centerline of connector cavity 144. In an embodiment, valve divider 160 includes a concave connector configured to engage connector 146 of connector 140 and configured such that the distal tip 168 of valve divider 160 extends into connector cavity 144 a predetermined distance (x).

[0052] In the implementation plan, such as Figures 4A-4B As shown, valve component 152 may include protrusions 156, such as a first valve protrusion 156A and a second valve protrusion 156B. Figure 4A The valve component in the open configuration is shown. Figure 4B A valve member 152 in a closed configuration is shown. A valve protrusion 156 may extend proximally from a side surface of the valve member 152 and may define a hemispherical shape. However, it should be understood that other three-dimensional shapes are also considered to fall within the scope of the invention. Figure 4AAs shown, protrusion 156 provides a contact surface, allowing the distal tip 168 of valve divider 160 to abut and separate from valve face 154, as described herein. Advantageously, protrusion 156 may provide a thickened portion to provide a stand-off between the distal tip 168 and valve face 154, thereby reducing wear or damage to valve member 152 and / or valve face 154 due to repeated engagement with the distal tip 168 of valve divider 160. Advantageously, the longitudinal extension of protrusion 156 provides a lever to facilitate rotation of valve face 154 away from the surface of needle 50 to form an opening. Note that, for clarity, Figure 4A-6C Only embodiments of valve separator 160 and valve 150 are shown.

[0053] In the implementation plan, such as Figures 5A-5C As shown, valve member 152 may include a concave cavity or recess 158. For example, first valve member 152A includes a first cavity 158A, and second valve member 152B includes a second cavity 158B. Figure 5A This is a cross-sectional view showing the valve member 152 in the open configuration. Figure 5B This is a cross-sectional view showing the valve member 152 in a closed configuration.

[0054] Figure 5C This is a near-end view showing the valve member 152 in a closed configuration. (Example) Figure 5C As shown, when valve 150 is in the closed configuration, the first cavity 158A and the second cavity 158B can cooperate to form a concave recess 158. As illustrated, the first cavity 158A and the second cavity 158B can be semi-circular and cooperate to form a substantially circular recess 158. However, it should be understood that this is exemplary, and one of the first cavity 158A, the second cavity 158B, or the recess 158 can define a regular or irregular polygonal shape, such as oval, elliptical, polygonal, rectangular, or any closed curve. Furthermore, the first cavity 158A and the second cavity 158B can be the same shape, can be a "mirror image" of each other, or can be asymmetrical shapes, and still cooperate to form the recess 158.

[0055] In one embodiment, the recess 158 may extend on a portion of the side surface of the valve 150. In another embodiment, the recess 158 may extend across substantially the entire side surface of the valve 150. In yet another embodiment, the recess 158 may surround a portion of the valve slit 154 defined by valve faces 154A, 154B, for example... Figure 6C In one embodiment, the recess 158 may surround the entire slit 154 of the slit valve, such that the lengths of the valve faces 154A and 154B are arranged within the recess 158, for example... Figure 5CIn one embodiment, the minimum diameter of the recess 158 is equal to or slightly larger than the outer diameter of the distal tip 168 of the valve divider 160, such that the distal tip 168 can be fitted therein. In another embodiment, for example... Figure 5D As shown, the peripheral surface of the recess 158 can extend substantially parallel to the longitudinal axis. In an embodiment, for example... Figures 5A-5B As shown, the circumferential surface of the recess 158 can be beveled or rounded to guide the distal tip 168 toward the center point of the diameter of the proximal end of the valve 150. Figure 5A Advantageously, the recess 158 can provide a receiving structure configured to receive the distal tip 168 of the valve divider 160 and align the divider cavity 164 and any elongated medical device 50 disposed therein with the diametrical center point of the valve 150. Accordingly, when the valve divider is inserted into the connector 140 to separate the valve face 154, as described herein, the recess allows the valve divider 160 and the mandrel 50 to align with the opening, allowing the mandrel 50 to pass through the opening without contacting the valve face 154.

[0056] like Figures 6A-6C As shown, in an embodiment, the maximum diameter of the recess 158 may be smaller than the outer diameter of the distal tip 168. Thus, the distal tip 168 contacts the valve member 152 at the edge portion 172 of the recess 158. Advantageously, the edge portion 172 is arranged proximal to the center point of the diameter and tangentially provides a gap between the distal tip 168 and the valve face 154. In an embodiment, the valve member 152 includes two or more recess portions, the first recess portion of which may define a diameter that is the same as or slightly larger than the outer diameter of the distal tip 168, as described herein. Figures 5A-5C ), and the second recessed portion may define a diameter smaller than the outer diameter of the distal tip 168, as described herein ( Figures 6A-6C ).

[0057] like Figures 7A-7B As shown, in one embodiment, valve member 152 can be arranged symmetrically such that valve faces 154A and 154B engage along a central axis. In another embodiment, valve separator 160 includes an offset cavity 164 axially offset from the central axis. Thus, a mandrel 50 inserted through the offset cavity 164 can be aligned with valve member 152 away from valve face 154. In another embodiment, valve member 152 can be formed of a permeable silicone rubber or the like. This allows the mandrel 50 to be inserted through valve member 152, away from valve face 154, without damaging valve face 154. Valve member 152 can be configured to withstand multiple penetrations without compromising the integrity of the valve barrier or the flexible function of valve member 152.

[0058] like Figures 8A-8BAs shown, in one embodiment, valve member 152 can be arranged in an asymmetrical configuration such that valve faces 154A and 154B engage at offset positions relative to the central axis. In another embodiment, valve separator 160 includes a centrally located cavity 164 axially aligned with the central axis. Thus, a mandrel 50 inserted through the cavity 164 can be aligned with valve member 152 away from valve face 154. As described herein, valve member 152 can be formed of a permeable silicone rubber or the like. This allows mandrel 50 to be inserted through valve member 152, away from valve face 154, without damaging valve face 154. Valve member 152 can be configured to withstand multiple penetrations without compromising the integrity of the valve barrier or the flexible function of valve member 152.

[0059] like Figures 9A-9B As shown, in one embodiment, connector 140 may include a retaining open tab (“tab”) 180. The retaining open tab 180 includes a body 182 whose width is greater than the diameter of the inner cavity opening 148 of connector 140 to prevent the body 182 from being pushed into the inner cavity 144. In one embodiment, the body 182 includes a concave connector configured to engage a connector 146 of connector 140. Tab 180 may further include a first arm 186A and a second arm 186B, each extending distally from the body 182 into the inner cavity 144. The distal tip 188 of the arm 186 may be releasably attached to a portion of valve member 152 to retain valve member 152 in an open configuration. As shown, the distal tip 188 is coupled to the intersection between valve face 154 and side surface; however, it should be understood that this is exemplary and the arm 186 may be coupled to any portion of valve member 152.

[0060] In one embodiment, the distal tip 188 may be attached to the valve member 152 by adhesive, bonding, ultrasonic welding, or a combination thereof. In another embodiment, the arm 186 and the valve member 152 may be formed as a single integral piece and include a slit line substantially disposed at the distal tip 188. The slit line may include a scribing, perforation, laser-cut line, or similar weak line configured to facilitate separation of the tab 180 from the valve 150 when the tab 180 is pushed proximally. In yet another embodiment, the distal tip 188 may be releasably coupled to the valve member 152 by a fragile bridge or similar fragile structure (which may facilitate separation of the tab 180 from the valve 150 when the tab 180 is pushed proximally).

[0061] like Figure 9A As shown, in this embodiment, holding the tab 180 open can keep the valve member 152 in an open configuration. A mandrel 50 can then be positioned through the tab cavity 184, through the connector cavity 144, and through the opening between the valve face 154. Once the conduit 100 has been placed, the mandrel 50 can be removed. Figure 9BAs shown, the retaining-open tab 180 can then be retracted proximally, separating the first distal tip 188A from the first valve member 152 and the second distal tip 188B from the second valve member 152B, thereby allowing the valve member to convert to a closed configuration. The retaining-open tab 180 can be removed or discarded. Advantageously, the retaining-open tab 180 can be positioned during the manufacture of the "pre-loaded" conduit and held in place during storage and transport to prevent permanent indentation in the valve face 154.

[0062] like Figures 10A-10B As shown, in one embodiment, the nose portion 166 of the valve separator 160 defines a biconvex cross-sectional shape having a lateral width greater than its lateral 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. Figure 10B As shown, the double-convex cross-sectional shape can distribute pressure across the entire valve face 154, thereby preventing any indentations from forming in the valve face 154 during long-term storage or transportation.

[0063] In the exemplary method used, a valve separator 160 as described herein is provided, and includes an elongated medical device, such as a needle 50, disposed therethrough. The nose portion 166 of the valve separator 160 can be inserted into the lumen 144 of the connector 140 until its distal tip abuts against a valve member, thereby changing the valve from a closed configuration to an open configuration in which the valve faces 154 are separated, creating an opening. The needle 50 can then be advanced distally through the lumen 164 of the valve separator 160 between the valve faces 154 in a spaced-apart relationship.

[0064] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will be apparent to those skilled in the art, and are included in a broader sense. Therefore, deviations from the specific embodiments disclosed herein are permissible without departing from the scope of the concepts provided herein.

Claims

1. A system for introducing a medical device via a valve, characterized in that, include: A connector comprising a connector body and a valve, the valve including a first valve member and a second valve member, the first valve member defining a first proximal surface and a first valve face, the second valve member defining a second proximal surface and a second valve face, the valve being configured to switch between a closed configuration and an open configuration; and A valve separator extending from a proximal end to a distal tip, the valve separator including a separator body having a nasal portion and defining an inner lumen, the distal tip being configured to engage the valve and convert the valve from a closed configuration to an open configuration to allow the medical device to pass between a first valve face and a second valve face in a spaced-out relationship. When in the closed configuration, the first valve face and the second valve face are aligned with the central longitudinal axis, and the axis of the inner cavity of the separator is offset from the central longitudinal axis; or when in the closed configuration, the first valve face and the second valve face are offset from the central longitudinal axis, and the axis of the inner cavity of the separator is aligned with the central longitudinal axis.

2. The system according to claim 1, characterized in that, When the valve is in the closed configuration, the first valve face contacts the second valve face, and when the valve is in the open configuration, the first valve face and the second valve face are spaced apart.

3. The system according to claim 1, characterized in that, One of the first proximal surface and the second proximal surface includes a protrusion that extends proximally and is configured to engage the distal tip of the valve separator.

4. The system according to claim 1, characterized in that, The first proximal surface includes a first cavity and the second proximal surface includes a second cavity, the first cavity and the second cavity cooperating to define a recess in the proximal surface of the valve.

5. The system according to claim 4, characterized in that, The minimum diameter of the recess is greater than the outer diameter of the distal tip, and the recess is configured such that the distal tip is aligned with the center point of the diameter of the proximal surface of the valve.

6. The system according to claim 4, characterized in that, 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 engage the distal tip.

7. The system according to claim 1, characterized in that, The distal tip of the valve separator remains near the first valve face and the second valve face.

8. The system according to claim 1, characterized in that, The valve is disposed within the connector, and the valve separator further includes a shoulder portion configured to engage an opening of the connector, and a nose portion configured to extend into the connector by a predetermined distance.

9. The system according to claim 8, characterized in that, The connector is positioned at the proximal end of the conduit.

10. The system according to claim 8, characterized in that, The nose portion defines a biconvex cross-sectional shape and is configured to extend between the first valve face and the second valve face.

11. The system according to claim 1, characterized in that, One of the first valve component and the second valve component is formed of a needle-penetrable material.

Images