CN-113633884-B - Preloaded stylet needle compatibility

Abstract

Preloaded catheters are manufactured with a stylet, guidewire or similar medical device disposed within the catheter that extends proximally through the valve of the connector. During storage and transport, the stylet may remain in place for long periods of time, which may cause stretching, indentation, and damage to the valve face. These indentations may cause valve leakage, resulting in overall failure of the device. Embodiments disclosed herein relate to devices and methods for preventing contact between a medical device and a valve face to mitigate damage thereto.

Inventors

• D.B. Blanchard

Assignees

• 巴德阿克塞斯系统股份有限公司

Dates

Publication Date

20260512

Application Date

20210426

Priority Date

20200427

Claims (11)

1. 1. A system for introducing a medical device through a valve, comprising: A connector includes a connector body and 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 configured to transition between a closed configuration and an open configuration, and A valve divider extending from a proximal end to a distal tip, the valve divider comprising a divider body having a nose portion and defining an interior cavity, the distal tip configured to engage the valve and transition the valve from the closed configuration to the open configuration to allow passage of the medical device in a spaced-apart relationship between the first valve face and the second valve face, Wherein the first and second valve faces are aligned with a central longitudinal axis and the axis of the spacer cavity is offset from the central longitudinal axis when in the closed configuration, or wherein the first and second valve faces are offset from a central longitudinal axis and the axis of the spacer cavity is aligned with the central longitudinal axis when in the closed configuration.
2. 2. The system of claim 1, wherein the first valve face contacts the second valve face when the valve is in the closed configuration, and wherein the first valve face is in a spaced apart relationship with the second valve face when the valve is in the open configuration.
3. 3. The system of claim 1, wherein one of the first proximal surface and the second proximal surface comprises a protrusion extending proximally and configured to engage a distal tip of the valve spacer.
4. 4. The system of claim 1, wherein the first proximal surface comprises a first cavity and the second proximal surface comprises a second cavity, the first cavity and the second cavity cooperating to define a recess in the proximal surface of the valve.
5. 5. The system of claim 4, wherein a minimum diameter of the recess is greater than an outer diameter of the distal tip, the recess configured to align the distal tip with a diametric center point of a proximal surface of the valve.
6. 6. The system of claim 4, wherein a maximum diameter of the recess is less than an outer diameter of the distal tip, and an edge portion of the recess is configured to engage the distal tip.
7. 7. The system of claim 1, wherein a distal tip of the valve divider is maintained proximal of the first valve face and the second valve face.
8. 8. The system of claim 1, wherein the valve is disposed within a connector and the valve divider further comprises a shoulder portion configured to engage an opening of the connector and the nose portion is configured to extend a predetermined distance into the connector.
9. 9. The system of claim 8, wherein the connector is disposed at a proximal end of a catheter.
10. 10. The system of claim 8, wherein 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. 11. The system of claim 1, wherein one of the first valve member and the second valve member is formed of a needle-penetrable material.

Description

Preloaded stylet needle compatibility Priority The present application claims priority from U.S. provisional patent application No. 63/016,156, filed on even 27, 4/2020, the entire contents of which are incorporated herein by reference. Technical Field The present application relates to the field of medical devices, and more particularly to preloaded stylet needle compatibility. Disclosure of Invention Briefly summarized, embodiments disclosed herein relate to apparatus and methods that allow an elongate medical device, such as a stylet or the like, to pass through a valve with little or no effect on the valve function. This is particularly important during storage and transport of "pre-loaded" catheters and stylets or for repeated insertion of medical devices over the life of the valve. Valves, such as those used in catheters and the like, typically include opposing deformable valve members configured to engage along a valve face surface to form a seal and prevent fluid flow therebetween. The valve member may be deflected to selectively permit fluid flow or to permit passage of a medical device therebetween. In the event that the stylet is "preloaded" within the catheter and through the valve, the stylet may create an indentation in the valve face. Over an extended period of time, such as during shipping and storage, the indentations may permanently set into the valve face, causing the valve to leak and fail. Alternatively, repeated insertion of the medical device through the valve may also damage the valve face surface, resulting in incomplete sealing and valve failure. Embodiments disclosed herein relate to devices and methods for preventing contact between a medical device and a valve face to mitigate damage thereto. A system for introducing a medical device through a valve includes 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 configured to transition between a closed configuration and an open configuration, and a valve divider extending from a proximal end to a distal tip and defining a lumen, the distal tip configured to engage the valve and transition the valve from the closed configuration to the open configuration to allow passage of the medical device in a spaced-apart relationship between the first valve face and the second valve face. In some embodiments, the first valve face contacts the second valve face when the valve is in the closed configuration, and the first valve face is in spaced apart relation to the second valve face when the valve is in the open configuration. One of the first proximal surface and the second proximal surface includes a protrusion extending proximally and configured to engage a distal tip of the valve spacer. 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. The minimum diameter of the recess is greater than the outer diameter of the distal tip, the recess being configured to align the distal tip with a 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 portion of the recess is configured to engage the distal tip. The distal tip of the valve spacer is retained at the proximal ends of the first and second valve faces. In some embodiments, the valve is disposed within the connector and the valve spacer further includes a shoulder portion and a nose portion, the shoulder portion configured to engage the opening of the connector and the nose portion configured to extend a predetermined distance into the connector. The connector is disposed at the proximal end of the catheter. The nose portion defines a biconvex cross-sectional shape and is configured to extend between the first valve face and the second valve face. When in the closed configuration, the first and second valve faces are aligned with the central longitudinal axis and the axis of the spacer lumen is offset from the central longitudinal axis. When in the closed configuration, the first and second valve faces are offset from the central longitudinal axis and the axis of the spacer lumen is aligned with the central longitudinal axis. One of the first valve member and the second valve member is formed of a needle-penetrable material. Also disclosed is a valved connector including a connector defining a lumen and including a valve member configured to control fluid flow through the lumen of the connector and biased toward a closed configuration, and a hold-open tab including a body configured to engage a proximal end of the connector and an arm extending distally from the body into the lumen of the connector, a distal tip of the arm being releasably attached to the valve memb