Wire separator

The wire separating device addresses the challenge of wire identification and management in interventional procedures by using non-linear slots or gaskets to secure and separate wires, enhancing procedural safety and efficiency.

WO2025158409A1PCT designated stage Publication Date: 2025-07-31STALLION CATHETER INC +1
View PDF 5 Cites 0 Cited by

Patent Information

Application Number
PCT/IB2025/050855
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-01-25
Filing Date
2025-01-25
Publication Date
2025-07-31

AI Technical Summary

Technical Problem

During interventional procedures, identifying and managing multiple wires and their corresponding devices can be challenging due to their similar appearances, leading to increased procedural time and safety risks.

Method used

A wire separating device with a slot or door mechanism that secures wires in place using non-linear paths or gaskets, preventing inadvertent movement and allowing easy identification and manipulation through tactile feedback.

Benefits of technology

Enhances wire management and identification, reducing the risk of kinking and improving procedural efficiency by maintaining wire separation and control.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure IB2025050855_31072025_PF_FP_ABST
    Figure IB2025050855_31072025_PF_FP_ABST
Patent Text Reader

Abstract

A wire separating system includes a wire separating device comprising a proximal end, and a proximal face on the proximal end. The system includes a valve comprising a distal end, a proximal end, and an inner channel. The valve can be secured to the wire separating device, and the proximal face includes a slot defining a first portion, a second portion, and a path between the first portion and the second portion. The path includes a non-linear shape, and the slot can be in fluid communication with the inner channel of the valve. Each of the first portion and the second portion of the slot can receive and secure a wire. The non-linear shape of the path prevents the wire from moving from one of the first portion and the second portion to the other of the first portion and the second portion unless a minimum threshold force is applied.
Need to check novelty before this filing date? Find Prior Art

Description

WIRE SEPARATORCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 625243, entitled “WIRE SEPARATOR” and filed on January 25, 2024, which is hereby incorporated by reference in its entirety.TECHNICAL FIELD

[0002] The present invention relates generally to wire separating devices for interventional procedures including vascular procedures.BACKGROUND

[0003] During an interventional procedure the use of more than one interventional device may require the use of more than one corresponding wire to guide the interventional devices through the body. When more than one wire is deployed, identification of each wire and its corresponding interventional device may be difficult. For instance, the wires may look the same thus making it difficult to identify each of the wires and their corresponding interventional devices. To reduce the length of an interventional procedure and improve the safety thereof, it is essential that wires and their corresponding interventional devices can be easily identifiable. Further, wire management can ensure proper control of the corresponding interventional devices so that the corresponding interventional devices don’t become unmanageable. Conventional wires and / or valves may not provide any indications to allow for quick and easy identification of a wire. Thus, there is a need for devices, systems, and / or methods to allow for quick and easy identification and control of a wire and / or a corresponding interventional device during an interventional procedure.SUMMARY

[0004] There is provided with some aspects of the present disclosure, a wire separating system. The wire separating system can include a wire separating device including a proximal end, and a proximal face on the proximal end; a valve including a distal end, a proximal end, and an inner channel, wherein the valve is secured to the wire separating device; wherein the proximal face includes a slot defining a first portion, a second portion, and a path between the first portion and the second portion, wherein the path includes a non-linear shape; wherein the slot is in fluid communication with the inner channel of the valve; wherein each of the first portion and the second portion of the slot areconfigured to receive and secure a wire; wherein the non-linear shape of the path prevents the wire from moving from one of the first portion and the second portion to the other of the first portion and the second portion unless a minimum threshold force is applied.

[0005] In some aspects, the valve can include a hemostasis valve. The proximal face can form a non-orthogonal angle relative to a longitudinal axis of the valve. In some cases, the non-orthogonal angle can be between 75° and 85°. In some aspects, a distance between the proximal end of the valve and the proximal face of the wire separating device can be between .1 cm to 1 cm. The distal end of the valve can be connected to a catheter. The catheter can be in fluid communication with the inner channel of the valve.

[0006] In some cases, the techniques described herein relate to a wire separating system including: a wire separating device including a proximal end, a proximal face on the proximal end, and a door positioned distal to the proximal face; a valve including a distal end, a proximal end, and an inner channel, wherein the valve is secured to the wire separating device; wherein the proximal face includes an opening defining a first portion, a second portion, and a path between the first portion and the second portion; wherein the door includes a slot defining a first portion, a second portion, a path between the first portion and the second portion, and a projection at least partially abutting the path, wherein the slot is in fluid communication with the inner channel of the valve; wherein the door is configured to transition from a first position to a second position; wherein the door is configured to transition from one of the first position and the second position to the other of the first position and the second position by sliding perpendicular to a longitudinal axis of the wire separating device; wherein when the door is in the first position, the path of the opening is at least partially blocked by the projection of the door; wherein when the door is in the second position, the first portion, the second portion, and the path of the opening are aligned with the path of the slot.

[0007] In some aspects, the techniques described herein relate to a wire separating system, wherein the valve includes a hemostasis valve.

[0008] In some aspects, the techniques described herein relate to a wire separating system, wherein the proximal face forms a non-orthogonal angle relative to a longitudinal axis of the valve.

[0009] In some aspects, the techniques described herein relate to a wire separating system, wherein the non-orthogonal angle is between 75o and 85o.

[0010] In some aspects, the techniques described herein relate to a wire separating system, wherein a distance between the proximal end of the valve and the proximal face of the wire separating device is between .1 cm to 1 cm.

[0011] In some aspects, the techniques described herein relate to a wire separating system, wherein each of the first portion and the second portion of the slot are configured to receive and secure a wire.

[0012] In some aspects, the techniques described herein relate to a wire separating system, wherein each of the first portion and the second portion of the opening are configured to receive and secure a wire.

[0013] In some aspects, the techniques described herein relate to a wire separating system, wherein the distal end of the valve is connected to a catheter, the catheter in fluid communication with the inner channel of the valve.

[0014] In some aspects, the techniques described herein relate to a wire separating system, wherein the door is configured to slide along two apertures of the wire separating device, wherein the two apertures are positioned distal to the proximal face.

[0015] There is also provided in accordance with some aspects of the present disclosure, a wire separating system. The wire separating system can include a wire separating device including a proximal end, and a proximal face on the proximal end; a valve including a distal end, a proximal end, and an inner channel, wherein the valve is secured to the wire separating device; wherein the proximal face includes a slot defining a first portion, a second portion, and a path between the first portion and the second portion; a gasket positioned distal to the proximal face and proximal to the proximal end of the valve; wherein the slot is in fluid communication with the inner channel of the valve; wherein each of the first portion and the second portion of the slot are configured to receive and secure a wire; wherein the gasket prevents the wire from moving from one of the first portion and the second portion to the other of the first portion and the second portion unless a minimum threshold force is applied.

[0016] In some aspects, the valve can include a hemostasis valve. The proximal face can form a non-orthogonal angle relative to a longitudinal axis of the valve. In some cases, the non-orthogonal angle can be between 75° and 85°. In some aspects, a distance between the proximal end of the valve and the proximal face of the wire separating device can be between .1 cm to 1 cm. The gasket can include a silicone gel. In some cases, the distal end of the valve can be connected to a catheter. The catheter can be in fluid communication with the inner channel of the valve. In some cases, the wire separatingsystem can include a gasket retainer. The gasket retainer can be positioned distal to the gasket. In some cases, the gasket retainer can be configured to secure the gasket in place.

[0017] There is also provided in accordance with some aspects of the present disclosure a wire separating system including one or more of the features of the foregoing description. There is also provided in accordance with some aspects of the present disclosure a method of using a wire separating system including one or more features of the foregoing description.

[0018] There is also provided in accordance with some aspects of the present disclosure a wire separating system including one or more of the features of the foregoing description for use in interventional cardiovascular procedures. There is also provided in accordance with some aspects of the present disclosure a method of using a wire separating system including one or more features of the foregoing description for use in interventional cardiovascular procedures.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIGS. 1A-1F illustrate an example of a wire separating device.

[0020] FIGS. 2A-2F illustrate an example of a wire separating device.

[0021] FIGS. 3A-3E illustrate an example of a wire separating device.DETAILED DESCRIPTION

[0022] Described herein are wire separating devices to assist in guide wire and device wire organization during interventional procedures. For example, the wire separating device can be applied to any vascular procedures, including but not limited to neurovascular, cardiovascular, and peripheral vascular procedures. A wire separating device can separate and / or combine two or more wires at the beginning, middle, or end of a procedure to allow a user to easily identify and manipulate the correct wire as required by the procedure. For example, the wire separating device can keep a guide wire separate from a device wire. Any of the wire separating devices described herein can be integral with or attached to a valve (e.g. , a hemostasis valve). For example, a wire separating device and / or a valve can be part of a unibody (e.g., single structure) device such that the wire separating device and / or the valve are not removable from each other. In some cases, however, the wire separating device can be attached and / or secured to existing valves. Other details regarding hemostatic valves and / or wire separating devices can be found in International Publication PCT / US2022 / 074029, which is hereby incorporated by reference in its entirety herein.

[0023] Figures 1A-3E illustrate example wire separating devices that can be integral with or attached to a proximal end of one or more catheters and / or valves. The wire control mechanisms can be used with any device or procedure that utilizes one or more wires. For example, all hemostatic valves in use today could benefit from the incorporation of the wire separating devices described herein.

[0024] FIGS. 1A-1F illustrate an example of a wire separating device 300. The wire separating device 300 can comprise a distal end 302, a proximal end 304, a proximal face 304a on the proximal end 304, and a slot 306 along the proximal face 304a. The slot 306 can be configured to separate two or more wires. For example, a first wire 309a and a second wire 309b can move along the slot 306 to position the first wire 309a and the second wire 309b along the same portion of the slot 306, as shown in FIGS. 1A and IB. The first wire 309a and the second wire 309b can be positioned along different portions of the slot 306, as shown in FIGS. 1C and ID.

[0025] As shown in FIG. IE, the slot 306 can include a one or more portions configured to secure one or more wires in place. For example, the slot can define a first main portion 306a and second portion 306b, and a path 306c between the first portion 306a and the second portion 306b. The first portion 306a and the second portion 306b can receive and secure the first wire 309a and / or the second wire 309b. In some cases, the path 306c can connect the first portion 306a and the second portion 306b. The path 306c can include a tortuous and / or non-linear shape. The tortuous shape of the path 306c can beneficially prevent the first wire 309a and / or the second wire 309b from inadvertently moving from the first portion 306a to the second portion 306b and vice versa, but are able to be easily moved from one portion to another by manipulation of the wire by the user. For example, the twist and tuns along the path 306c can prevent the first wire 309a and / or the second wire from moving from the first portion 306a of the slot 306 to the second portion 306b of the slot 306 unless the first wire 309a is manipulated to move through the twists and turns along the path 306c. This can beneficially allow users to easily identify and / or distinguish the first wire 309a from the second wire 309b.

[0026] Although FIG. IE shows a slot 306 having an s-shaped path 306c, the path 306c can include other shapes. In some cases, the slot 306 can include more than two portions for securing wires in place (e.g., three, four, five, etc.). The main portion 306a is configured to be large enough to accept any device which is desired to be inserted into a valve 310 and thence into the patient (e.g., through a catheter). In a variation, slot 306 can include additional portions. For example, slot 306 can include three portions. In thisexample, slot 306 may be in a generally Y-shape, with a first portion at the base of the Y, and two additional portions at each upper arm of the Y. The arms connecting the three portions can have a tortuous path as in the previous version, to keep the wires in their portions unless manipulated by the user.

[0027] The wire separating device 300 can be integral with or configured to be removably coupled to other medical instruments and / or devices. For example, the wire separating device can be integral with or removably coupled to a valve 310. The valve 310 can be configured to couple to the wire separating device 300, such as through a distal end 302 of the wire separating device 300. For example, the valve 310 and the wire separating device 300 can be nested together. In some configurations, the valve 310 can include and be integral with the wire separating device 300. The valve 310 can include any valve, such as a tuohy force valve, a tuohy valve system, a hemostasis valve, a y-connector valve, and / or any other valve system used with or without a catheter. For example, the valve 310 can comprise a rotatable component configured to open or close a seal of the valve 310 and / or a button configured to be pressed to open or close a secondary seal of the valve 310. In some cases, the valve 310 can include a side port 313. The side port 313 can be used to deliver contrast agents, fluids, and / or medications to a patient during a procedure. The side port 313 can form a non-orthogonal angle relative to the a longitudinal axis of the valve 310.

[0028] The distal end 302 of the wire separating device 300 can be configured to receive or be received by a proximal end 310a of the valve 310. During a procedure, the user may couple the wire separating device 300 to the valve 310 and / or remove the wire separating device 300 from the valve 310. For example, the user may determine that a device such as a guide extension catheter with a proximal first wire 309a, is needed during the procedure. The user can insert the device with the first wire 309a into the valve 310 attached to the proximal end of the procedural guide catheter and then couple the wire separating device 300 to separate the multiple wires during the procedure. Alternately, the user may couple the wire separating device 300 to the valve 310 prior to inserting the device with the first wire 309a.

[0029] In some cases, the wire separating device 300 can be integral with the valve 310. For example, wire separating device 300 and the valve 310 can be part of a unibody (e.g., single structure) device such that the wire separating device 300 and the valve 310 are not removable from each other. In such embodiments, the valve 310 and thewire separating device 300 can be secured together with, for example, adhesive, a mechanical lock, welding, etc.

[0030] In the illustrated configuration, the distal end 302 of the wire separating device 300 can include a greater diameter than the proximal end 310a of the valve 310. In such cases, the proximal end 310a of the valve 310 can be received by the distal end 302 of the wire separating device 300. The distal end 302 of the wire separating device 300 can couple to the valve 310 via a push-fit engagement, a threaded engagement, a snap-fit engagement, and / or any suitable releasable couplings. When the wire separating device 300 is coupled to the valve 310, all portions of the slot 306 can align with an inner channel 311 of the valve 310 such that the slot 306 can be in communication with an inner channel 311 of the valve 310, as shown in FIG. IF. The inner channel 311 can extend an entire length of the valve 310. When the distal end of the valve 310 is connected to a catheter, the catheter can be in fluid communication with the inner channel 311 of the valve 310.

[0031] The proximal face 304a of the wire separating device 300 can form a non-orthogonal angle relative to a longitudinal axis of the valve 310. For example, the proximal face 304a can form an angle A2 relative to the longitudinal axis LAI of the valve 310. The angle A2 can be between about 10° and about 80°, between about 20° and about 70°, and / or between about 40° and about 50°. For example, the angle A2 can be about 35°, 40°, 45°, 50°, and / or 55°. The angle A2 can help increase the distance between the first portion 306a and the second portion 306b of the slot 306 thereby increase the distance between the first wire 309a and the second wire 309b when, for example, the first and second wire are positioned in the first portion 306a and the second portion 306b respectively. This can beneficially allow for easier identification and manipulation of the first wire 309a and the second wire 309b. The angled proximal face 304a can also allow the wires to be positioned at a greater angle from each other, and allow for more separation between the wires while preventing kinking.

[0032] In some cases, the slot 306 on the proximal face 304a of the wire separating device 300 can be spaced apart from the proximal end 310a of the valve 310 even when the wire separating device 300 is secured to the valve 310. For example, the slot 306 and the proximal end 310a of the valve 310 can define a gap 321, as shown in FIG. IF. The gap 321 can have a length LI between about .1 cm and about 1.5 cm, between about .2 cm and bout 1.4 cm, between about .4 cm and about 1.2 cm, between about .6 cm and about 1 cm, between about .7 cm and about .9 cm, and / or about between about .75 cm and about .85 cm.. For example, the gap 321 can have a length LI of about .7 cm, .75 cm, .80cm, .85 cm, and / or .9 cm. The gap 321 can prevent the first wire 309a and / or the second wire 309b from kinking as the first wire 309a and / or the second wire 309b pass through the slot 306 into the inner channel 311 of the valve. The gap 321 between the slot 306 and the proximal end 310a of the valve 310 where the inner channel 311 begins allows the transition of the first wire 309a and / or the second wire 309b from the slot 306 to the inner channel 311 to be smooth and thus reduce the risk of kinking.

[0033] In some cases, the proximal face 304a of the wire separating device 300 does not include an angled surface. For instance, the proximal face 304a may be perpendicular to the longitudinal axis of the valve 310. In such embodiments, the wire separating device 300 may or may not include a gap 321 between the proximal end 310a of the valve 310 and the proximal face 304a.

[0034] In some cases, the wire separating device 300 does not include a gap 321 between the proximal end 310a of the valve 310 and the proximal face 304a. In such embodiments, the wire separating device 300 may or may not include an angled proximal face 304a.

[0035] FIGS. 2A-2F illustrate another example of a wire separating device 400. The wire separating device 400 can comprise a distal end 402, a proximal end 404, a proximal face 404a on the proximal end 404, and a door 406. The proximal face 404a can include an opening 405. The door 406 can be positioned distal to the proximal face 404a. In some cases, the door 406 can extend perpendicular to a longitudinal axis of the wire separating device 400 and along at least two apertures 401 of the wire separating device 400. The apertures 401 can be distal to the proximal face 404a. The door 406 can include one or more stoppers 412a and 412b and can define a slot 407 (shown in FIG. 2C) configured to separate two or more wires. For example, a first wire 409a and a second wire 409b can move along the slot 407 to position the first wire 409a and the second wire 409b along the same portion of the slot 407, as shown in FIG 2A. The first wire 409a and the second wire 409b can be positioned along different portions of the slot 407, as shown in FIG. 2B. As further described below, the door 406 can transition between at least a first position and a second position. The door 406 may prevent switching the first wire 409a and / or the second wire 409b from one portion of the slot 407 to another when the door 406 is in, for example, the first position but allow switching of the first wire 409a and / or the second wire 409b when the door is in, for example, the second position.

[0036] As shown in FIG. 2C, the slot 407 can include a one or more portions configured to secure one or more wires in place. For example, the slot 407 can define a firstportion 407a and second portion 407b, and a path 407c between the first portion 407a and the second portion 407b. The door 406 can also include a projection 408. The projection 408 can abut the slot 407. The first portion 407a and the second portion 407b of the slot 407 can receive and secure the first wire 409a and / or the second wire 409b. In some cases, the path 407c can connect the first portion 407a and the second portion 407b. As further described below, the path 407c may be blocked when the door is in a closed position. This can beneficially prevent the first wire 409a and / or the second wire 409b from inadvertently moving from the first portion 407a to the second portion 407b and vice versa when the door406 is in the closed position as described in more detail with reference to FIGS. 2D-2E.

[0037] As shown in FIGS. 2D and 2E, the door 406 can slide between at least a first position and a second position. The door 406 can be moved from the first position to the second position and vice versa by sliding the door 406 along the apertures 401 of the wire separating device 400, as indicate by arrows 421. In some cases, the door 406 can slide perpendicular to a longitudinal axis of the wire separating device 400. The stoppers 412a and 412b of the door 406 can prevent the door from sliding off the wire separating device 400. When the door 406 is in the first position (e.g., a closed position), as shown in FIG. 2D, the projection 408 of the door 406 can block at least a portion of the opening 405 of the proximal face 404a. This can isolate the first portion 407a and the second portion 407b of the slot 407 from each other and prevent any wires in the first portion 407a and / or second portion 407b from moving to the other portion. This can beneficially secure the first wire 409a and / or the second wire in the first portion 407a and / or the second portion 407b and prevent the wires from inadvertently moving from the first portion 306a to the second portion 306b and vice versa.

[0038] When the door 406 is in the second position (e.g, an open position), as shown in FIG. 2E, at least a portion of the opening 405 of the proximal face 404a is not blocked by the projection 408 of the door 406. This can allow any wires in the first portion 407a and / or second portion 407b to be moved to another position via the path 407c. The door may be moved to the first position (e.g, the closed position) after moving the first wire 409a and / or the second wire 409b from one portion of the slot 407 to another portion of the slot 407 thereby securing the first wire 409a and / or the second wire 409b in the slot407 and preventing the wires from inadvertently moving from the first portion 306a to the second portion 306b and vice versa.

[0039] The wire separating device 400 can beneficially allow moving and securing the wires 409a and / or 409b without visual feedback. For instance, users mayidentify the position of the door 406 (e.g., the first position and / or the second position) and / or the position of a wire along the slot 407 based on tactile feedback, move the position of the door 406 from the first position to the second position or vice versa, move the wire along the slot 407 and secure the wire to either the first portion 407a and / or the second portion 407b without having to visually identify the door 406, the position of the door 406 and / or the position of the wire along the slot 506.

[0040] The wire separating device 400 can also include features (not shown) that click or otherwise lock the door 406 in one position or another, such that the door 406 does not inadvertently move from one position to another during the procedure. For example, the door may include bumps or other protrusions that fit into mating receptables on slots corresponding to first and second positions. Alternately, the protrusions may be on the slot 407, and the receptacles on the door 406. In either case, a certain amount of force would be needed to move the door 406 out of position. Other temporary locking features are also possible.

[0041] The wire separating device 400 can be integral with or configured to be removably coupled to other medical instruments and / or devices. For example, the wire separating device 400 can be integral with or removably coupled to a valve 410. The valve 410 can be configured to couple to the wire separating device 400, such as through a distal end 402 of the wire separating device 400 . For example, the valve 410 and the wire separating device 400 can be nested together. In some cases, the valve 410 can include and be integral with the wire separating device 400. The valve 410 can include any valve, such as a tuohy force valve, a tuohy valve system, a hemostasis valve, a y-connector valve, and / or any other valve system used with or without a catheter. For example, the valve 410 can comprise a rotatable component configured to open or close a seal of the valve 410 and / or a button configured to be pressed to open or close the seal of the valve 410. In some cases, the valve 410 can include a side port 413. The side port 413 can be used to deliver contrast agents, fluids, and / or medications to a patient during a procedure.

[0042] The distal end 402 of the wire separating device 400 can be configured to receive or be received by a proximal end 410a of the valve 410. During a procedure, a user may couple the wire separating device 400 to the valve 410 and / or remove the wire separating device 400 from the valve 410. For example, the user may determine that a device such as a guide extension catheter with a proximal first wire 409a, is needed during the procedure. The user can insert the device with the first wire 409a into the valve 310 attached to the proximal end of the procedural guide catheter and then couple the wireseparating device 400 to separate the multiple wires during the procedure. Alternatively, the user may couple the wire separating device 400 to the valve 410 prior to inserting the device with the first wire 409a.

[0043] In some cases, the wire separating device 400 can be integral with the valve 410. For example, the wire separating device 400 and the valve 410 can be part of a unibody (e.g., single structure) device such that the wire separating device 400 and the valve 410 are not removable from each other. In such embodiments, the valve 410 and the wire separating device 400 can be secured together with, for example, adhesive, a mechanical lock, welding, etc.

[0044] In the illustrated configuration, the distal end 402 of the wire separating device 400 can include a greater diameter than the proximal end 410a of the valve 410 such that proximal end 410a of the valve 410 can be received by the distal end 402 of the wire separating device 400. The distal end 402 of the wire separating device 400 can couple to the valve 410 via a push-fit engagement, a threaded engagement, a snap-fit engagement, and / or any suitable releasable couplings. When the wire separating device 400 is coupled to the valve 410, the slot 407 and / or the opening 405 can align with an inner channel 411 of the valve 410 such that the slot 407 and / or the opening 405 can be in communication with the inner channel 411 of the valve 410. The inner channel 411 can extend an entire length of the valve 410. When the distal end of the valve 410 is connected to a catheter, the catheter can be in fluid communication with the inner channel 411 of the valve.

[0045] In some cases, the wire separating device 400 can include features similar or identical to the features of the wire separating device 300. For instance, the proximal face 404a on the proximal end 404 of the wire separating device 400 can form a non-orthogonal angle relative to a longitudinal axis of the valve 410. For example, the proximal face 404a can form an angle relative to the longitudinal axis of the valve 410. The angle can be similar or identical to the angle A2 which is described in relation to FIG. IF. The angle can be between about 15° and about 75°, between about 30° and about 60°, and / or between about 40° and about 50°. For example, the angle can be about 35°, 40°, 45°, 50°, and / or 55°. The angle can increase the distance between the first portion 407a and the second portion 407b of the slot 407 thereby increasing the distance between the first wire 409a and the second wire 409b when, for example, the first and second wires are positioned in the first portion 407a and the second portion 407b respectively. This can beneficially allow for easier identification and manipulation of the first wire 409a and the second wire 409b.

[0046] In some cases, the slot 407 of the wire separating device 400 can be spaced apart from the proximal end 410a of the valve 410 even when the wire separating device 400 is secured to the valve 410. For example, the slot 407 and the proximal end 410a of the valve 410 can define a gap 422, as shown in FIG. 2F. The gap 422 can have a length between about .1 cm and about 1.5 cm, between about .2 cm and bout 1.4 cm, between about .4 cm and about 1.2 cm, between about .6 cm and about 1 cm, between about .7 cm and about .9 cm, and / or about between about .75 cm and about .85 cm. For example, the gap 422 can have a length of about .05 cm, .10 cm, .15 cm, .20 cm, and / or .25 cm. The gap 422 can prevent the first wire 409a and / or the second wire 409b from kinking as the first wire 409a and / or the second wire 409b pass through the slot 407 into the inner channel 411 of the valve 410. The gap 422 between the slot 407 and the proximal end 410a of the valve 410 where the inner channel 411 begins allows the transition of the first wire 409a and / or the second wire 409b from the slot 407 to the inner channel 411 to be smooth and thus reduce the risk of kinking.

[0047] In some cases, the proximal face 404a of the wire separating device 400 does not include an angled surface. For instance, the proximal face 404a may be perpendicular to the longitudinal axis of the valve 410. In such embodiments, the wire separating device 400 may or may not include a gap 422 between the proximal end 410a of the valve 410 and the proximal face 404a.

[0048] In some cases, the wire separating device 400 does not include a gap 422 between the proximal end 410a of the valve 410 and the proximal face 404a. In such embodiments, the wire separating device 400 may or may not include an angled proximal face 404a.

[0049] FIGS. 3A-3E illustrate another example of a wire separating device 500. The wire separating device 500 can comprise a distal end 502, a proximal end 504, a proximal face 504a on the proximal end 504, and a slot 506 along the proximal face 504a. The slot 506 can be configured to separate two or more wires. For example, a first wire 509a and a second wire 509b can move along the slot 506 to position the first wire 509a and the second wire 509b along the same portion of the slot 506, as shown in FIG. 3A. The first wire 509a and the second wire 509b can be positioned along different portions of the slot 506, as shown in FIGS. 3B and 3C. As further described below, the slot 506 and / or a portion adjacent to the slot can include a gasket to prevent wires from inadvertently moving from one portion of the slot 506 to another. The gasket can include a slitted elastomeric gasket.

[0050] As shown in FIG. 3C, the slot 506 can include a one or more portions configured to secure one or more wires in place. For example, the slot can define a first portion 506a and second portion 506b, and a path 506c between the first portion 306a and the second portion 506b. In some cases, the first portion 506a and the second portion 506b can be positioned on opposite ends of the slot 506. The first portion 506a and the second portion 506b can receive and secure the first wire 509a and / or the second wire 509b. In some cases, the path 506c can connect the first portion 506a and the second portion 506b. As further described below, the path 506c and or a region abutting the path 506c can include a slitted gasket 507 (shown in FIG. 3D and 3E). The gasket 507 can beneficially prevent the first wire 509a and / or the second wire 509b from inadvertently moving from the first portion 506a to the second portion 407b and vice versa.

[0051] In some cases, the gasket 507 can be positioned distal to the proximal face 504a of the wire separating device 500 , as shown in FIG. 3D. As shown in Figure 3E, the gasket 507 includes two holes 508a and 508b, which align with the first portion 506a and the second portion 506b respectively, when the gasket 507 is secured to the wire separating device 500. A slit 508c can connect the holes 508a and 508b. The gasket 507 is configured to beneficially prevent the first wire 509a and / or the second wire 509b from inadvertently moving along the slot 506 but allow movement of the first wire 509a and / or second wire 509b by pushing the wires and / or or other equipment through the slit 508c of the gasket 507. The gasket 507 may require application of a minimum threshold force to move the first wire 509a and / or the second wire 509b through the gasket 507 thus securing the wires in place along the first portion 506a and / or the second portion 506b unless the minimum threshold force is applied. The appropriate minimal threshold force can be achieved by proper selection of the gasket durometer, thickness, and compression when assembled. The gasket 507 can also beneficially allow moving and securing the first wire 509a and / or the second wire 509b without visual feedback. For instance, users may identify the position of a wire along the slot 506 based on tactile feedback, move the wire along the slot 506 and secure the wire to either the first portion 506a and / or the second portion 506b without having to visually identify the wire and / or the position of the wire along the slot 506.

[0052] The wire separating device 500 can be integral with or configured to be removably coupled to other medical instruments and / or devices. For example, the wire separating device can be integral with or removably coupled to a valve 510. The valve 510 can be configured to couple to the distal end 502 of the wire separating device 500, such asthrough a distal end 502 of the wire separating device 500. For example, the valve 510 and the wire separating device 500 can be nested together. In some configurations, the valve 510 can include and be integral with the wire separating device 500. The valve 510 can include any valve, such as a tuohy force valve, a tuohy valve system, a hemostasis valve, a y-connector valve, and / or any other valve system used with or without a catheter. For example, the valve 510 can comprise a rotatable component configured to open or close a seal of the valve 510 and / or a button configured to be pressed to open or close the seal of the valve 510. In some cases, the valve 510 can include a side port 513. The side port 513 can be used to deliver contrast agents, fluids, and / or medications during a procedure. The side port 513 can form a non-orthogonal angle relative to the a longitudinal axis of the valve 510

[0053] The distal end 502 of the wire separating device 500 can be configured to receive or be received by a proximal end 510a of the valve 510. During a procedure, a user may couple the wire separating device 500 to the valve 510 and / or remove the wire separating device 500 from the valve 510. For example, the user may determine that a device such as a guide extension catheter with a proximal first wire 509a is needed during the procedure. The user can insert the device with the first wire 509a into the valve 510 attached to the proximal end of the procedural guide catheter and then couple the wire separating device 500 to separate the multiple wires during the procedure. Alternatively, the user may couple the wire separating device 500 to the valve 510 prior to inserting the device with the first wire 509a.

[0054] In some cases, the wire separating device 500 can be integral with the valve 510. For example, the wire separating device 500 and the valve 510 can be part of a unibody (e.g., single structure) device such that the wire separating device 500 and the valve 510 are not removable from each other. In such embodiments, the valve 510 and the wire separating device 500 can be secured together with, for example, adhesive, a mechanical lock, welding, etc.

[0055] In the illustrated configuration, the distal end 502 of the wire separating device 500 can include a greater diameter than the proximal end 510a of the valve 510 such that proximal end 510a of the valve 510 can be received by the distal end 502 of the wire separating device 500. The distal end 502 of the wire separating device 500 can couple to the valve 510 via a push-fit engagement, a threaded engagement, a snap-fit engagement, and / or any suitable releasable couplings. When the wire separating device is coupled to the valve 510, all portions of the slot 506 can align with an inner channel 511 of the valve 510such that the slot 506 can be in communication with an inner channel 511 of the valve 510. The inner channel 511 can extend an entire length of the valve 510. When the distal end of the valve 510 is connected to a catheter, the catheter can be in fluid communication with the inner channel 511 of the valve.

[0056] In some cases, the wire separating device 500 can include features similar or identical to the features of the wire separating devices 300 and / or 400. For instance, the proximal face 504a of the wire separating device 500 can form a non- orthogonal angle relative to a longitudinal axis of the valve 510. For example, the proximal face 505a can form an angle relative to the longitudinal axis of the valve 510. The angle can be similar or identical to the angle A2 which is described in relation to FIG. IF. The angle can be between about 10° and about 80°, between about 20° and about 70°, and / or between about 40° and about 50°. For example, the angle can be about 35°, 40°, 45°, 50°, and / or 55°. The angle can increase the distance between the first portion 506a and the second portion 506b of the slot 506 thereby increasing the distance between the first wire 509a and the second wire 509b when, for example, the first and second wires are positioned in the first portion 506a and the second portion 506b respectively. This can beneficially allow for easier identification and manipulation of the first wire 509a and the second wire 509b.

[0057] In some cases, the slot 506 of the wire separating device 500 can be spaced apart from the proximal end 510a of the valve 510 even when the wire separating device 500 is secured to the valve 510. For example, the slot 506 and the proximal end 510a of the valve 510 can define a gap 522, as shown in FIG. 3D. The gap 522 can have a length between about .1 cm and about 1.5 cm, between about .2 cm and bout 1.4 cm, between about .4 cm and about 1.2 cm, between about .6 cm and about 1 cm, between about .7 cm and about .9 cm, and / or about between about .75 cm and about .85 cm. For example, the gap 522 can have a length of about .05 cm, .10 cm, .20 cm, .30 cm, .35 cm, and / or .40 cm. The gap 522 can prevent the first wire 509a and / or the second wire 509b from kinking as the first wire 509a and / or the second wire 509b pass through the slot 506 into the inner channel 511 of the valve 510. The gap 522 between the slot 506 and the proximal end 510a of the valve 510 where the inner channel 511 begins allows the transition of the first wire 509a and / or the second wire 509b from the slot 506 to the inner channel 511 to be smooth and thus reduce the risk of kinking.

[0058] In some cases, the proximal face 504a of the wire separating device 500 does not include an angled surface. For instance, the proximal face 504a may beperpendicular to the longitudinal axis of the valve 510. In such embodiments, the wire separating device 500 may or may not include a gap 522 between the proximal end 510a of the valve 510 and the proximal face 504a.

[0059] In some cases, the wire separating device 500 does not include a gap 522 between the proximal end 510a of the valve 510 and the proximal face 504a. In such embodiments, the wire separating device 500 may or may not include an angled proximal face 504a.

[0060] In some cases, the gasket 507 can be positioned along the gap 522, between the proximal face 504a of the wire separating device 500 and the proximal end 510a of the valve 510. A gasket retainer 507a can be positioned distal and / or proximal to the gasket 507. For example, the gasket retainer 507a can be positioned between the gasket 507 and the proximal end 510a of the valve 510. The retainer 507a can secure the gasket 507 in place and prevent the gasket from moving when, for example, a wire is moved from one position to another positioned along the slot 506.

[0061] Any of the wire separating devices, including the wire separating devices 300, 400, and / or 500, and / or the valves, including the valves 310, 410, and 510, described herein can be used with other medical device and / or instruments including, for example, an introducer sheath, a guide catheter, or the like.Other Variations

[0062] Although some embodiments may describe vascular procedures, the systems, devices, and / or methods disclosed herein can be applied to other types of therapies usable standalone or in addition to vascular procedures.Materials

[0063] The wire separating devices described herein may be manufactured from standard materials known in the art for medical devices. For example, the main housing and moving components of the devices 300, 400, 500 may be manufactured from polycarbonate, ABS, nylon, blends, or other appropriate material. The elastomeric gasket of device 500 could be manufactured from an elastomeric material such as silicone rubber, silicone gel, polyurethane, thermoplastic elastomer, or other appropriate material.

[0064] Any value of a threshold, limit, duration, etc. provided herein is not intended to be absolute and, thereby, can be approximate. In addition, any threshold, limit, duration, etc. provided herein can be fixed or varied either automatically or by a user. Furthermore, as is used herein relative terminology such as exceeds, greater than, less than, etc. in relation to a reference value is intended to also encompass being equal to thereference value. For example, exceeding a reference value that is positive can encompass being equal to or greater than the reference value. In addition, as is used herein relative terminology such as exceeds, greater than, less than, etc. in relation to a reference value is intended to also encompass an inverse of the disclosed relationship, such as below, less than, greater than, etc. in relations to the reference value.

[0065] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and / or all of the steps of any method or process so disclosed, can be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0066] While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of protection. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the form of the methods and systems described herein may be made. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and / or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. For example, the actual steps and / or order of steps taken in the disclosed processes may differ from those shown in the figure. Depending on the embodiment, certain of the steps described above may be removed, others may be added.

[0067] Conditional language used herein, such as, among others, “can,” “could”, “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or states. Thus, such conditional language is not generally intended to imply that features, elements and / or states are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or withoutauthor input or prompting, whether these features, elements and / or states are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Further, the term “each,” as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term “each” is applied. Additionally, the words “herein,” “above,” "below," and words of similar import, when used in this application, refer to this application as a whole and not to any particular portions of this application.

[0068] Conjunctive language, such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is to be understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z, or a combination thereof. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present.

[0069] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree.

[0070] Unless otherwise explicitly stated, articles such as “a” or “an” should generally be interpreted to include one or more described items. Accordingly, phrases such as “a device configured to” are intended to include one or more recited devices. Such one or more recited devices can also be collectively configured to carry out the stated recitations.

[0071] Although the present disclosure includes certain embodiments, examples and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternativeembodiments and / or uses and obvious modifications and equivalents thereof, including embodiments which do not provide all of the features and advantages set forth herein. Accordingly, the scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments herein, and may be defined by claims as presented herein or as presented in the future.

Claims

WHAT IS CLAIMED IS:

1. A wire separating system comprising: a wire separating device comprising a proximal end, and a proximal face on the proximal end; a valve comprising a distal end, a proximal end, and an inner channel, wherein the valve is secured to the wire separating device; wherein the proximal face comprises a slot defining a first portion, a second portion, and a path between the first portion and the second portion, wherein the path comprises a non-linear shape; wherein the slot is in fluid communication with the inner channel of the valve; wherein each of the first portion and the second portion of the slot are configured to receive and secure a wire; wherein the non-linear shape of the path prevents the wire from moving from one of the first portion and the second portion to the other of the first portion and the second portion unless a minimum threshold force is applied.

2. The wire separating system of Claim 1, wherein the valve comprises a hemostasis valve.

3. The wire separating system of Claim 1, wherein the proximal face forms a non-orthogonal angle relative to a longitudinal axis of the valve.

4. The wire separating system of Claim 3, wherein the non-orthogonal angle is between 75° and 85°.

5. The wire separating system of Claim 1, wherein a distance between the proximal end of the valve and the proximal face of the wire separating device is between . 1 cm to 1 cm.

6. The wire separating system of Claim 1, wherein the distal end of the valve is connected to a catheter, the catheter in fluid communication with the inner channel of the valve.

7. A wire separating system comprising: a wire separating device comprising a proximal end, a proximal face on the proximal end, and a door positioned distal to the proximal face; a valve comprising a distal end, a proximal end, and an inner channel, wherein the valve is secured to the wire separating device;wherein the proximal face comprises an opening defining a first portion, a second portion, and a path between the first portion and the second portion; wherein the door comprises a slot defining a first portion, a second portion, a path between the first portion and the second portion, and a projection at least partially abutting the path, wherein the slot is in fluid communication with the inner channel of the valve; wherein the door is configured to transition from a first position to a second position; wherein the door is configured to transition from one of the first position and the second position to the other of the first position and the second position by sliding perpendicular to a longitudinal axis of the wire separating device; wherein when the door is in the first position, the path of the opening is at least partially blocked by the projection of the door; wherein when the door is in the second position, the first portion, the second portion, and the path of the opening are aligned with the path of the slot.

8. The wire separating system of Claim 7, wherein the valve comprises a hemostasis valve.

9. The wire separating system of Claim 7, wherein the proximal face forms a non-orthogonal angle relative to a longitudinal axis of the valve.

10. The wire separating system of Claim 9, wherein the non-orthogonal angle is between 75° and 85°.

11. The wire separating system of Claim 7, wherein a distance between the proximal end of the valve and the proximal face of the wire separating device is between . 1 cm to 1 cm.

12. The wire separating system of Claim 7, wherein each of the first portion and the second portion of the slot are configured to receive and secure a wire.

13. The wire separating system of Claim 7, wherein each of the first portion and the second portion of the opening are configured to receive and secure a wire.

14. The wire separating system of Claim 7, wherein the distal end of the valve is connected to a catheter, the catheter in fluid communication with the inner channel of the valve.

15. The wire separating system of Claim 7, wherein the door is configured to slide along two apertures of the wire separating device, wherein the two apertures are positioned distal to the proximal face.

16. A wire separating system comprising: a wire separating device comprising a proximal end, and a proximal face on the proximal end; a valve comprising a distal end, a proximal end, and an inner channel, wherein the valve is secured to the wire separating device; wherein the proximal face comprises a slot defining a first portion, a second portion, and a path between the first portion and the second portion; a gasket positioned distal to the proximal face and proximal to the proximal end of the valve; wherein the slot is in fluid communication with the inner channel of the valve; wherein each of the first portion and the second portion of the slot are configured to receive and secure a wire; wherein the gasket prevents the wire from moving from one of the first portion and the second portion to the other of the first portion and the second portion unless a minimum threshold force is applied.

17. The wire separating system of Claim 16, wherein the valve comprises a hemostasis valve.

18. The wire separating system of Claim 16, wherein the proximal face forms a non-orthogonal angle relative to a longitudinal axis of the valve.

19. The wire separating system of Claim 18, wherein the non-orthogonal angle is between 75° and 85°.

20. The wire separating system of Claim 16, wherein a distance between the proximal end of the valve and the proximal face of the wire separating device is between . 1 cm to 1 cm.

21. The wire separating system of Claim 16, wherein the gasket comprises a silicone gel.

22. The wire separating system of Claim 16, wherein the distal end of the valve is connected to a catheter, the catheter in fluid communication with the inner channel of the valve.

23. The wire separating system of Claim 16, further comprising a gasket retainer positioned distal to the gasket, the gasket retainer configured to secure the gasket in place.

24. A wire separating system comprising one or more of the features of the foregoing description.

25. A method of using the wire separating system comprising one or more features of the foregoing description.

26. A wire separating system comprising one or more of the features of the foregoing description for use in a vascular procedure, including but not limited to neurovascular, cardiovascular, and peripheral vascular procedures.

27. A method of using a wire separating system comprising one or more features of the foregoing description for use in a vascular procedure, including but not limited to neurovascular, cardiovascular, and peripheral vascular procedures.

Citation Information

Patent Citations

  • Rapid exchange interventional devices and methods

    US20080097299A1

  • Exchange accessory for use with a monorail catheter

    US6106487A

  • Guidewire separator device and method of use

    WO2005112798A2

  • Guide wire exchange catheter system

    WO2008008428A1

  • KR20220167974A