阅读说明：本技术 用于部署血管植入装置的互锁环联接/脱离系统 (Interlocking ring coupling/decoupling system for deploying a vascular implant device ) 是由 马丁·沙巴兹 克劳迪奥·普拉萨 理查德·奎克 保罗·卢博克 布赖恩·J·考克斯 于 2018-11-09 设计创作，主要内容包括：在用于部署植入装置的系统和方法中,所述植入装置在其近端处包含第一环,并且部署工具在其远端处具有附接的第二环。可滑动地设置在所述部署工具内的释放线具有远端和近侧部分,所述远端延伸穿过所述第一环和所述第二环以将所述植入装置可释放地联接到所述部署工具,所述近侧部分从所述部署工具的近端延伸并保持在缩回装置中。所述缩回装置可操作以保持所述部署工具的所述近端,并且将所述释放线向近侧拉动穿过所述部署工具,直到所述释放线的所述远端从所述第一环和所述第二环中撤回,以将所述植入装置从所述部署工具上脱离。(In a system and method for deploying an implant device, the implant device includes a first ring at a proximal end thereof and a deployment tool has an attached second ring at a distal end thereof. A release wire slidably disposed within the deployment tool has a distal end extending through the first and second loops to releasably couple the implant device to the deployment tool and a proximal portion extending from a proximal end of the deployment tool and retained in a retraction device. The retraction device is operable to retain the proximal end of the deployment tool and pull the release wire proximally through the deployment tool until the distal end of the release wire is withdrawn from the first and second loops to disengage the implant device from the deployment tool.)

1. A system for deploying a vascular implant device, comprising:

a first ring attached to a proximal end of the implant device;

a deployment tool having a proximal end and a distal end, a second ring attached to the distal end of the deployment tool;

a release wire slidably disposed within the deployment tool and having a proximal end and a distal end, the distal end of the release wire extending through the first and second loops to releasably couple the implant device to the deployment tool, the proximal end of the release wire extending proximally from the proximal end of the deployment tool; and

a release wire retraction device operable to pull the release wire proximally through the deployment tool until the distal end of the release wire is withdrawn from the first and second loops to disengage the implant device from the deployment tool.

2. The system of claim 1, wherein the retraction device is configured to (a) retain the proximal end of the deployment tool, (b) releasably grasp the proximal end of the release wire, and (c) pull the release wire proximally through the deployment tool.

3. The system of claim 2, wherein the release wire retraction device comprises:

a housing having a distal opening configured to receive a proximal portion of the deployment tool containing the proximal end of the deployment tool;

a clamping assembly in the housing and configured to releasably clamp the proximal end of the release wire;

a guide assembly movably mounted in the housing between a distal position and a proximal position and operatively connected to the clamp assembly to move the clamp assembly between engagement and disengagement with the proximal end of the release wire; and

an actuator having an outer portion configured for distal and proximal manipulation by a user, and an inner portion operably connected to the guide assembly for moving the guide assembly between the distal and proximal positions.

4. The system of claim 3, wherein the guide assembly is operatively connected to the clamp assembly to engage the proximal end of the release wire when the guide assembly is in the intermediate position and to disengage from the proximal end of the release wire when the guide assembly is in the proximal position.

5. The system of claim 3, wherein the clamp assembly includes a fixed clamp element fixed in position in the housing, and a movable clamp element operatively connected to the guide assembly, the movable clamp element moving between a position engaged with the proximal end of the release wire when the guide assembly is in the intermediate position and a position disengaged from the proximal end of the release wire when the guide assembly is in the proximal position.

6. The system of claim 3, wherein the guide assembly is spring biased toward the distal position.

7. The system of claim 5, wherein the guide assembly comprises:

a lever having a first end in which the movable clamping element is disposed and a second end movably seated in a guide path defined in the guide assembly, wherein the guide path is configured to move the lever to engage the fixed clamping element with the proximal end of the release wire when the guide assembly is moved proximally and to disengage the fixed clamping element from the proximal end of the release wire when the guide assembly is moved distally.

8. The system of claim 7, wherein the guide path is configured as a closed loop.

9. The system of claim 7, wherein the guide path is defined by a track, and wherein the second end of the lever is configured as a guide arm movably engaged with the track.

10. The system of claim 1, further comprising an outer sleeve extending axially between the distal end of the deployment tool and the proximal end of the implant device.

11. The system of claim 10, further comprising:

a stopper attached to the outer sleeve; and

a ferrule attached to the release wire, the ferrule disposed proximal to the stopper to limit distal movement of the release wire (802) relative to the second ring.

12. The system of claim 11, wherein the stopper has an inner diameter and the ferrule has an outer diameter that is greater than the inner diameter of the stopper.

13. A method of coupling a vascular implant device to a deployment tool, comprising:

providing a first loop at a distal end of the deployment tool;

providing a second ring at a proximal end of the implant device; and

axially passing a release wire through the deployment tool such that a distal end of the release wire passes through the first and second rings to releasably couple the implant device to the deployment tool and such that a proximal portion of the release wire is exposed at the proximal end of the deployment tool.

14. A method of deploying a vascular implant device at a target vascular site using a deployment tool endovascularly passed to the target vascular site, comprising:

providing a first loop at a distal end of the deployment tool;

providing a second ring at the proximal end of the implant assembly;

axially passing a release wire through the deployment tool such that a distal end of the release wire passes through the first and second rings to releasably couple the implant device to the deployment tool and such that a proximal portion of the release wire is exposed at the proximal end of the deployment tool;

gripping the exposed portion of the release wire; and

pulling the release wire proximally through the deployment tool until the distal end of the release wire is withdrawn from the first and second loops to disengage the implant device from the deployment tool.

15. The method of claim 14, wherein the step of gripping the exposed portion of the release wire is performed by a release wire retraction device, wherein the step of gripping the exposed portion of the release wire is performed by inserting the proximal end of the deployment tool into the release wire retraction device and securing the proximal end of the deployment tool in place within the retraction device, wherein the exposed portion of the release wire extends proximally from the proximal end of the deployment tool, and wherein the step of pulling proximally the release wire is performed by releasably gripping the exposed portion of the release wire and pulling proximally the release wire through the deployment tool.

16. The method of claim 14, wherein the gripping step is performed by a gripping assembly movable between a position engaged with the exposed portion of the release wire and a position disengaged from the exposed portion of the release wire, and wherein the step of pulling the release wire proximally is performed by:

(a) moving the clamp assembly proximally to pull the release wire proximally a distance sufficient to withdraw the distal end of the release wire from the first and second rings when the clamp assembly is in the engaged position;

(b) moving the clamping assembly to a non-engaging position; and

(c) moving the clamp assembly distally when the clamp assembly is in the unengaged position.

17. The method of claim 16, wherein the clamp assembly includes a fixed clamp element and a movable clamp element, and wherein the clamp assembly is placed in the engaged position by moving the movable clamp element toward the fixed clamp element to engage the proximal portion of the release wire to the fixed clamp element, and wherein the step of moving the clamp assembly to the unengaged position is performed by moving the movable clamp element away from the fixed clamp element to release the proximal portion of the release wire.

18. A device for retracting a release wire having a distal end releasably coupling a vascular implant device to a distal end of an intravascularly introduced deployment tool, wherein the deployment tool has a proximal portion from which a proximal portion of the release wire is exposed, the device comprising:

a housing having a distal opening configured to receive the proximal portion of the deployment tool, the proximal portion of the release wire being exposed from the proximal portion;

a clamping assembly in the housing and configured to releasably clamp the exposed proximal portion of the release wire;

a guide assembly movably mounted in the housing between a distal position and a proximal position and operatively connected to the clamp assembly to move the clamp assembly between engagement and disengagement with the exposed proximal portion of the release wire; and

an actuator having an outer portion configured for distal and proximal manipulation by a user, and an inner portion operably connected to the guide assembly for moving the guide assembly between the distal and proximal positions.

19. The device of claim 18, wherein the guide assembly is operatively connected to the clamp assembly to engage the exposed proximal portion of the release wire when the guide assembly is in the intermediate position and to disengage from the exposed proximal portion of the release wire when the guide assembly is in the proximal position.

20. The device of claim 18, wherein the clamp assembly includes a fixed clamp element fixed in position in the housing, and a movable clamp element operatively connected to the guide assembly, the movable clamp element moving between a position engaged with the exposed proximal portion of the release wire when the guide assembly is in the intermediate position and a position disengaged from the exposed proximal portion of the release wire when the guide assembly is in the proximal position.

21. The device of claim 18, wherein the guide assembly is spring biased toward the distal position.

22. The apparatus of claim 20, wherein the guide assembly comprises:

a lever having a first end in which the movable clamping element is disposed and a second end movably seated in a guide path defined in the guide assembly, wherein the guide path is configured to move the lever to engage the fixed clamping element with the exposed proximal portion of the release wire when the guide assembly is moved proximally and to disengage the fixed clamping element from the exposed proximal portion of the release wire when the guide assembly is moved distally.

23. The apparatus of claim 22, wherein the guide path is configured as a closed loop.

24. The device of claim 22, wherein the guide path is defined by a track, and wherein the second end of the lever is configured as a guide arm movably engaged with the track.

Background

The present disclosure relates to deployment of vascular implants, such as vaso-occlusive devices, and related methods. More particularly, the present disclosure relates to systems, devices, and methods for deploying and releasing a vascular implant device at a target vascular site.

In certain implantation procedures, such as those used for the occlusion of blood vessel lumens or other body lumens, implant devices are inserted into the body and released at a target site within the lumen. For example, vaso-occlusive implant devices can be inserted intravascularly to occlude or seal a vessel or to occlude a defect in the heart. To insert the implant device, the implant device may advantageously be removably or releasably coupled to an end of a deployment tool and deployed intravascularly by a delivery device, such as a microcatheter. After placement of the implant device at the target site, the implant device is released or detached from the deployment tool by a suitable release mechanism, and the deployment tool is free to withdraw.

It is important that release or detachment of the implant device be accomplished by applying minimal axial force to the implant device, thereby minimizing movement of the device from its optimal position at the target vascular site. To this end, release mechanisms have been designed that use, for example, hot melt linkages that break in response to the application of thermal energy by, for example, an electrical current. Other release mechanisms use a linkage that is severed by a shearing or cutting tool. While these mechanisms may achieve the goal of minimizing the transmission of axial forces to the implant device to varying degrees, they are generally complex and costly to manufacture and/or cumbersome to use.

Furthermore, conventional endovascular implant deployment tools require engagement of the release wire during all stages of movement required to disengage the implant from the deployment tool. However, this means that in addition to the release wire being retracted by actuation of the deployment tool, the release wire may also be pushed by the deployment tool.

Accordingly, it remains an object of the related art to provide an implant device release/detachment mechanism that is simple to manufacture and easy to use, while still meeting the necessary clinical criteria.

Disclosure of Invention

The present disclosure relates to embodiments of a system for decoupling a deployed implant device from a deployment tool to which the implant device is coupled during deployment, wherein the deployment tool attaching the implant device to its distal end passes through an intravascular microcatheter to a vascular target site. The disclosed embodiments include a retraction device for engaging and retracting a release wire having a distal end that detachably couples the implant device to a deployment tool, and a system for detachably coupling the implant device to the distal end of the deployment tool. Particular embodiments of the detachment system disclosed use an interlocking ring to couple an implant device to a deployment tool.

In one aspect, the present disclosure relates to an interlocking ring coupling/decoupling system configured to allow a user to detach or release a vascular implant device from a deployment tool with a single action on a retraction device. More specifically, the systems disclosed herein include an interlocking ring coupling mechanism for detachably coupling an implant device to a deployment tool via a release wire, and a release wire retraction device that retracts the release wire to disengage the implant device from the deployment tool without applying any significant axial force to the implant device.

The single action retraction device of the present disclosure may avoid reinsertion of the release wire because the retraction device does not act on the release wire at all stages of movement. Instead, the retraction device acts on the release wire only during retraction of the release wire, and it allows for resetting of the retraction device for use with another deployment tool and implant device. The systems and methods described herein are particularly useful for endovascular deployment of vaso-occlusive implants, but they may also be used to deploy stents, coils, emboli, and other implanted devices that are therapeutically or diagnostically beneficial to a patient.

In one aspect, a system for deploying a vascular implant in accordance with the present disclosure includes: an implant assembly having a proximal end and a distal end, wherein the first loop is attached to the proximal end of the implant assembly; a deployment tool having a proximal end and a distal end, the second ring being attached to the distal end of the deployment tool; a release wire slidably disposed within the deployment tool and having a proximal end and a distal end, the distal end of the release wire extending through the first and second loops to releasably couple the implant device to the deployment tool, the proximal end of the release wire extending proximally from the proximal end of the deployment tool; and a release wire retracting device operable to (a) retain the proximal end of the deployment tool, (b) releasably grip the proximal end of the release wire, and (c) pull the release wire proximally through the deployment tool until the distal end of the release wire is withdrawn from the first and second rings to disengage the implant device from the deployment tool.

In another aspect, a method of coupling and decoupling an implant device to and from a deployment tool is disclosed.

Drawings

FIG. 1 illustrates a partial cross-sectional view of a release wire retraction device for use with an interlocking ring implant coupling system according to one aspect of the present disclosure.

Figure 2 shows a partial cross-sectional view of the retraction device in a first undamped, non-actuated state.

Figure 3 shows a partial cross-sectional view of the retraction device in a second grip non-actuated state.

Figure 4 shows a partial cross-sectional view of the retraction device in a third grip actuation state.

Figure 5 shows a partial cross-sectional view of the retraction device in a fourth non-clamping actuated state.

Fig. 6 shows a partial cross-sectional view of the retraction device in a fifth, reset state.

Fig. 7 shows a partial cross-sectional view of the retraction device in a sixth reset state.

Figure 8 illustrates a partial cross-sectional view of an interlocking ring coupling/decoupling system configured to decouple a deployed implant device from a release wire prior to actuation.

FIG. 9 illustrates a side view of the implant device and distal end of the interlocking ring coupling system of FIG. 8.

FIG. 10 shows a partial cross-sectional view of the interlocking ring coupling system after disengagement.

FIG. 11 shows a side view of the implant device and the distal end of the interlocking ring coupling system after disengagement.

Fig. 12 illustrates an exemplary guide track of the guide arm around the cam ramp of the retraction device of fig. 1-7.

FIG. 13 illustrates an embodiment of a coupling system with a release wire ferrule and a stop tube.

Fig. 14 shows a cross-sectional view taken along line a-a of fig. 13.

Fig. 15 shows a cross-sectional view taken along line B-B of fig. 13.

Detailed Description

The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of an interlocking ring implant coupling/decoupling system with a release wire retraction device provided in accordance with aspects of the present disclosure. It is not intended to represent the only form in which the presently disclosed components, assemblies and methods may be constructed or utilized. The description sets forth the features and steps of the embodiments of the presently disclosed components, assemblies, and methods as constructed and used in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the disclosure. As shown elsewhere herein, the same element numbers are intended to represent the same or similar elements or features.

Fig. 1-7 illustrate partial cross-sectional views of an exemplary embodiment of a retraction device 10 for an interlocking ring implant coupling/decoupling system according to the present disclosure. The figures show one half of the housing 100, and a cross-sectional view of the guide assembly 200, actuator 300, and release wire guide 400. In some embodiments, the guide assembly 200 and the actuator 300 may be integrally formed as a unit. Alternatively, the guide assembly 200 and the actuator 300 may be separate, mechanically coupled components. The guide assembly 200 and actuator 300 may be understood as being symmetrical along an axis extending from the distal or front end 110 to the proximal or rear end 112 of the retraction device 10. (the terms "distal" and "proximal" as used in this disclosure are from the perspective of a user of the device 10). Thus, the other half (not shown) of the guide assembly 200 and actuator 300 may be understood as a reflection of the half shown in fig. 1-7. To facilitate assembly, the housing 100 may advantageously be made of two axial halves that are joined together after the internal components are installed by adhesive or other suitable bonding/welding means. To this end, each housing half may have complementary male locating pins 106 and female locating sockets 107. Suitable durable plastic or polymeric materials are preferred for the housing, although they may also be made of suitable metals or alloys. Embodiments of the retraction device 10 may be made from components formed by a manufacturing process such as injection molding or machining. Alternatively, a forming process such as 3D printing may also be used. When fully assembled, the outer dimensions of the housing 100 should advantageously be customized and configured as a hand piece that can be comfortably and safely held and manipulated while the device is in use.

The housing 100 of the retraction device 10 contains the guide assembly 200, the inner body 302 of the actuator 300, and the release wire guide 400. The actuator 300 and the guide assembly 200 are axially movable relative to the housing 100 between a distal position and a proximal position by manipulating a finger grip 304 on the exterior of the housing 100. Specifically, the inner body 302 of the actuator 300 is connected to the finger grip 304 by a connecting portion or rod 306 that extends through a longitudinal slot 308 in the top of the housing 100. The guide assembly 200 is in turn connected to the inner body 302 of the actuator 300 so as to be movable therewith. The top of the housing 100 is provided with a flat rail surface 104 on which a finger grip 304 slidably sits. The slot 308 and the track surface 104 are configured to define a path for longitudinal movement of the guide assembly 200 and the actuator 300 relative to the housing 100. The guide assembly 200 may include a side wall 200a, a bottom wall or base 200b, and a top wall 302, which together generally define a central space for the operative components of the guide assembly 200, as described below.

In an embodiment of the retraction device 10, the guide assembly 200 may include a guide slot or rail 120 that provides a guide path around the cam ramp 128, a guide rod 210, and a fixed release wire clamping element 220 (which may be referred to as an "anvil"). (it should be understood that the corresponding guide rails 120 are provided in the other half of the housing 100, not shown). The anvil 220 may be attached to at least one of the side wall 200a and the top wall 302 of the guide assembly 200. The anvil 220 may be aluminum or a similar metal, or it may be a durable polymer or composite material. The guide bar 210 may be rotatably pinned to at least one side wall 200a of the guide assembly 200 with a hinge pin 211 near its distal end. The guide rod 210 may further include a movable clamping element 212 disposed as an insert in the guide rod near the distal end of the guide rod 210 and configured such that when the guide rod 210 is pivoted (as described below), the movable clamping element 212 may be moved toward and away from the anvil 220, whereby the proximal end of a release wire 802 extending from the end of the deployment tool sheath 800 inserted into the distal end 110 of the housing 100 may be clamped between the movable clamping element 212 and the anvil 220. The movable clamping element 212 may be an insert in the guide bar 210, as shown, or may be integral therewith. It may have any suitable shape for providing a secure but releasable engagement with a guide wire on the fixed clamping member or anvil 220.

The guide bar 210 has a free proximal end that terminates in a pair of guide arms 216 (only one of which is shown), each of which is seated in a guide track 120 in a respective housing half. The guide bar 210 is biased upward by a guide bar biasing spring 214 (fig. 2-7) and it is guided to move along the continuous closed path provided by the guide rail 120 within which the arm 216 sits as the actuator 300 and guide assembly 200 move to their different positions, as described below with reference to fig. 2-7.

As shown in fig. 1, the guide assembly 200 may further include a spring support 204 extending proximally from the top wall 302. An axially oriented forward biasing spring 700 may be disposed having a first end surrounding the spring support 204 and abutting a spring seat formed by the junction of the spring support 204 and the top wall 302. The forward biasing spring 700 extends proximally through the spring chamber defined between the upper chamber wall 114a and the lower chamber wall 114b and terminates at a second end seated on the proximal spring seat 115. In this manner, forward biasing spring 700 provides a distally directed biasing force to guide assembly 200, thereby biasing guide assembly 200 against rearward (i.e., proximal) movement within housing 100.

The distal end 110 of the housing 100 contains a distal opening 111 through which a deployment tool 800 containing a release wire 802 may enter the release wire guide 400 of the retraction device 10. In an embodiment of the present disclosure, the deployment tool 800 may be a sheath through which the release wire 802 is axially and slidably disposed. (for purposes of this discussion, the deployment tool will be referred to as a "sheath," although other configurations of deployment tools may be used). The release wire guide 400 may advantageously have a tapered entrance 402 that tapers inwardly and proximally to an axial channel 404. This tapered shape allows sheath 800 with release wire 802 to be inserted by a user while positioned for insertion through guide assembly 200. Sheath 800 may advantageously be retained within channel 404 by a sheath retaining means 450, such as a ball spring plunger or other similar retaining element or mechanism housed in proximal portion 410 of release wire guide 400, which provides a radial retaining force against sheath 800, whereby the proximal end of sheath is held in a fixed position when release wire 802 is pulled proximally through sheath 800 by retraction device 10, as described below. In some embodiments, the sheath holder 450 may be an integral unit, such as a spring plunger of the type sold by Vlier products corporation (www.vlier.com). In other embodiments, the sheath retaining device 450 may comprise separate components, such as ball bearings, springs, and set screws. The release wire guide 400 may be a separate component from the housing 100 or may be integrally molded with the housing 100. The sheath retaining device 450 may be attached to the release wire guide 400 by a threaded connection or alternatively, such as an adhesive, fastener, or other suitable means.

Fig. 2-7 show partial cross-sectional views of the retraction device 10 at various stages of the actuation cycle for moving the release wire proximally in a linear manner by manual manipulation of the actuator 300. The operation described below is defined as a series of steps or phases, each step or phase corresponding to the position of the actuator 300 and the guide assembly 200, and in particular the position of the guide arm 216 in the guide track 120. The path defined by the guide rail 120 followed by the guide arm 216 defines a closed loop shape, which may be, for example, generally oval, elliptical, trapezoidal, diamond-shaped, rectangular, or triangular. In the exemplary embodiment shown, the guide rail 120 has a substantially trapezoidal shape. In operation, the movable clamping element 212 can be disengaged from the release wire 802 in the distal-most and proximal-most positions of the pathway. The movable clamping element 212 may be engaged with the release wire 802 at a position intermediate the path between the distal-most position and the proximal-most position.

Fig. 2 shows the retraction device 10 in a first non-actuated stage, which is considered to be the "rest position". In this first stage, the guide arm 216 is located at a first or starting position 122b in the rail 120, wherein the starting position 122b is located between the lower distal portion 122a and the upper distal portion 122c of the rail 120. In this first stage, the actuator 300 is in the forward (distal) position and the forward biasing spring 700 biases the guide assembly 200 forward (distal). Additionally, the guide bar biasing spring 214 biases the guide bar 210 upward toward the actuator 300. The combined force of forward biasing spring 700 and guide bar biasing spring 214 causes guide arm 216 to contact and stop at home position 122b in guide rail 120. In this regard, in some embodiments, the guide rod 210 is positioned such that the movable clamp element 212 does not contact a proximal portion of the release wire 802 that extends proximally out of the sheath 800.

Fig. 3 shows the retraction device in a second gripping but non-actuation stage, wherein the actuator 300 is moved rearwardly (proximally) by the user to a first intermediate position along the top rail surface 104. In this position, the guide assembly 200 has been moved rearwardly (proximally) such that the guide arm 216 is moved away from the starting position 122b of the guide rail 120, thereby allowing the guide bar biasing spring 214 to urge the proximal end of the guide bar 210 upwardly as the guide arm 216 moves toward the upper distal portion 122c of the guide rail 120. In this state, the rearward movement of the actuator 300 and the guide assembly 200 compresses the forward biasing spring 700. As the guide rod 210 is pushed upward, the release wire 802 is clamped between the movable clamp member 212 and the anvil 220, and as the guide assembly 200 moves proximally with the actuator 300, the release wire 802 begins to retract proportionally rearward (proximally) into the housing 100.

Fig. 4 shows the retraction device in a third stage of actuation, wherein the actuator 300 is moved further rearwardly (proximally) by the user to a second intermediate position along the top rail surface 104, moving rearwardly (proximally) from the first intermediate position shown in fig. 3. In this position, guide assembly 200 has been moved rearwardly (proximally) such that guide arm 216 is now positioned at first or upper proximal portion 126 of guide rail 120 and at the proximal end of cam ramp 128. In the exemplary embodiment shown, wherein the guide rail 120 has a generally trapezoidal shape, rearward movement of the guide bar 210 causes the guide arm 216 to be located at the first proximal portion 126 of the guide rail 120, while the distal end of the guide bar 210 (in which the clamp movable clamp element 212 is located) moves away from the release wire 802. Due to the inclination of the proximal portion of the guide rail 120, the guide rod 210 is pushed downward, against the biasing force of the guide rod biasing spring 214, thereby removing the grip insert 212 from its engagement with the release wire 802 and thus stopping the proximal movement of the release wire 802 within the housing 100. The distance that the release wire 802 advances proximally into the housing between the second and third stages (fig. 3 and 4, respectively) before stopping is determined primarily by the length of the path traveled by the guide arm 216 in the guide track 120 from its second distal portion 122c to the first proximal portion 126.

Fig. 5 shows the retraction device in a fourth stage of actuation, wherein the actuator 300 is in a final (proximal) position along the top rail surface 104. In this position, guide assembly 200 is moved rearwardly such that guide arm 216 passes over the proximal end of cam ramp 128 to second or lower proximal portion 127 of guide rail 120, where actuator 300 and the guide assembly reach the proximal limit of their travel against the biasing force of forward biasing spring 700. Similarly, the guide bar 210 moves downwardly to a lower portion of its range of movement against the biasing force of the guide bar biasing spring 214, thereby moving the movable clamping member 212 further away from (and out of engagement with) the release wire 802.

As shown in fig. 12, the guide arm 216 may move in a closed path, wherein the longitudinal (parallel to the axis of movement of the sheath 800 and release wire 802) distance L is greater than the transverse distance T. In some embodiments, the ratio of the longitudinal distance to the lateral distance (L/T) is at least 1.25, and may be between about 1.5 and 15. In some embodiments, the path may define a closed shape having about 3 to 6 substantially linear sides. An exemplary closed-loop path of travel 216p of guide arm 216 about cam ramp 128 is indicated in fig. 12 by dashed lines showing the different positions 216', 216", and 216'" in the path of travel.

Fig. 6 and 7 show the retraction device in a fifth, reset phase, wherein the actuator 300 and guide assembly 200 are advanced forward toward the distal end 110 of the retraction device 10. When finger grip 304 of actuator 300 is released, forward biasing spring 700 urges actuator 300 and the guide assembly in a distal direction. Due to the geometry of guide track 120, guide arm 216 follows a path of travel below cam ramp 128, as opposed to a phase of actuation in which guide arm 216 follows a path of travel above cam ramp 128 (i.e., the third and fourth phases shown in fig. 4 and 5, respectively). As guide arm 216 moves distally in the portion of guide track 120 below cam ramp 120, the proximal end of guide rod 210 rotates downward (clockwise as viewed in the figures) against the upward biasing force of further compressed guide rod biasing spring 214. Clockwise rotation of the guide rod 210 moves the movable clamp element 212 further away from the release wire so that the axial position of the release wire 802 within the housing 100 is not changed or affected when the actuator 300 and guide assembly 200 are moved distally back to the first stage shown in fig. 2 by the forward biasing spring 700.

In fig. 7 it is shown that the actuator 300 and the guide assembly 200 have been moved distally back to the position shown in fig. 2, closer to the distal end 110 of the retraction device 10 than shown in fig. 6. Guide arms 216 continue along the path of travel below cam ramp 128 until they reach the distal edge of cam ramp 128. In the path of travel of the guide arm 216 below the cam ramp 128, the guide bar 210 remains in the lower portion of its range of travel shown in fig. 6, while the movable clamp element 212 maintains its disengagement from the release wire 802. Further distal movement of guide arm 216 in guide track 120 causes guide arm 216 to clear the distal end of cam ramp 128. When the guide arm 216 enters the first distal portion 122a of the guide rail 120, the guide bar biasing spring 214 biases the guide bar 210 back to the first or starting position 122b in the guide rail, as shown in fig. 2, wherein the clamping element 212 does not contact the release wire 802. At this point, the retraction means is reset back to the first or rest stage shown in figure 2. During or after the retraction device is reset (i.e., once the movable clamping element releases the guide wire 802), the retraction device 10 can be disengaged from the sheath 800 and the guide wire 802, allowing the retraction device 10 to be used for another implant device disengagement application after reset.

In summary, fig. 2-7 illustrate a series of operational steps or stages of the retraction device 10, wherein the retraction device 10 is operable to retract or withdraw the release wire 802 from the implant deployed at the target vascular site, whereby the withdrawal is accomplished unidirectionally (i.e., proximally) without interfering or moving the implant or subjecting the implant or deployment tool to any significant axial force.

Different geometries may be provided for the guide track 120 and the cam member 128. In the exemplary embodiment shown, the generally trapezoidal shape of the guide rail 120 is provided with a ramp-like cam element 128. However, alternative guide rail and cam element geometries may be used to achieve the result of retracting the release wire during actuation while allowing the guide assembly to be reset (i.e., without advancing the release wire 802) without reversing the direction of movement of the release wire 802.

The fulcrum of the guide bar 210 (i.e., the pin 211) and/or the shape of the guide bar 210 may be defined such that the movement of the guide arm 216 is different than the movement of the embodiment shown in fig. 2-7. For example, an embodiment may be provided in which the fixed clamping member ("anvil") 220 and the movable clamping member 212 act on the release wire 802 when the guide arms 216 engage the bottom of the rail 120 rather than the top. Further, the guiding function provided by the guide rail 120 may be provided by raised walls or ribs on the inner surface of the housing 100 along which each of the guide arms 216 travels.

Further, the variation of the actuator may be implemented by other mechanisms. For example, a unidirectional rotary spool may be used, in which case a rotary dial may be provided for user actuation. This arrangement may allow the release wire to be retracted by rotating in one direction and sliding in the opposite direction, as can be appreciated from a ratchet socket wrench.

The retraction device 10 is shown in fig. 8-11 in combination with an implant assembly 900 that is releasably coupled to a deployment tool (e.g., sheath 800) via an interlocking ring coupling system. The implant assembly 900 may include an implant device 901 (e.g., a vaso-obturator, as shown), and an implant ring 904 attachable to the implant device 901 by a crimped portion 906 at a proximal end of the implant device 901.

Fig. 8 and 9 illustrate the interlocking ring coupling system in a non-disassembled state, i.e., when the implant assembly 900 is coupled to a deployment tool (e.g., sheath 800) during deployment at a target vascular site. Fig. 8 shows the retraction means 10 engaging a proximal portion of a release wire 802 extending proximally from the proximal end of the sheath 800, the distal end of which extends distally from the distal end of the sheath 800, as shown in fig. 9. Still referring to fig. 9, a tool ring 804 is attached to the distal end of the sheath 800 containing the release wire 802, whereby the tool ring 804 may be placed through or overlap the implant ring 904. The distal end or portion of the release wire 802 extends through the tool ring 804 and the implant ring 904 to removably couple the rings 804, 904. Placement of the release wire 802 through the loops 804, 904 thus releasably couples the implant assembly 900 to the deployment tool (sheath) 800, preventing their disengagement. In some embodiments, the crimp 906 may have a groove for receiving the distal end of the release wire 802 when the tool ring 804 and the implant ring 904 are coupled together as an interlocking ring. Alternatively, the implant ring 904 may be disposed within the tool ring 804, or the implant ring 904 and tool ring 804 may be assembled in an overlapping manner without either ring entering the other.

In aspects of the implant assembly 900, the implant ring 904 may be a ring that extends only into the crimped portion 906, wherein the implant ring 904 is secured to the implant 901 by crimping, welding, gluing, or other suitable methods. In this way, the amount of material required to implant the ring 904 may be reduced, and the implant ring 904 may be independently adjusted according to the implant technique. Although the exemplary embodiment uses rings, alternative geometries may be used. For example, a braid, cable or wound loop or coil structure may be provided in the loop.

Fig. 10 and 11 illustrate the interlocking ring coupling system in a disassembled state, i.e., when the implant assembly 900 has been released or disengaged from the sheath 800 after deployment. To disassemble the implant assembly, the release wire 802 is withdrawn (in a proximal direction) from both the tool ring 804 and the implant ring 904 by a means such as the retraction device 10 described above. Thus, the retraction device 10 (or functional equivalent) is operated to retract the release wire 802, thereby disengaging the implant ring 904 from the tool ring 804. Because the implant ring 904 and the tool ring 804 are not tied together or mechanically coupled to one another, they release from one another only in response to retraction of the release wire 802, thereby releasing or decoupling the implant assembly 900 from the sheath 800. Thus, once the implant assembly is positioned and deployed at the target vascular site, detachment of the implant assembly is accomplished without significant axial force being applied to the implant, thereby minimizing the chance of the implant becoming dislodged or displaced from the target site.

The release wire 802 is withdrawn from engagement with the tool ring 804 and the implant ring 904, releasing the implant, which may be detected by a sensor (not shown) within the retraction device 10 that may indicate to the user that confirmation of detachment has occurred. The sensor may detect proximity or contact with the release wire 802 or an element connected to the release wire. The sensor may be in mechanical or electrical communication with an indicator element that is in visual or physical contact with or visible to a user. For example, a small light or Light Emitting Diode (LED) may be incorporated into the retraction device 10 that is connected to a power source and sensor to indicate that movement of the release wire 802 is sufficient to release the implant.

In some embodiments, as shown in fig. 13-15, an outer sleeve 808 may extend axially between the distal end of the sheath 800 and the proximal end of the implant assembly 900 (e.g., the crimp 906), thereby extending coaxially around the rings 804, 904 and the distal end of the release wire 802 interconnecting them. The outer sleeve 808 may be a single or multi-wire helical coil made of metal, polymer, or composite material. As further shown in fig. 13-15, an embodiment of an interlocking ring coupling system may include a tubular or annular stop 812 attached proximally to the outer sleeve 808 from the tool ring 804, and a tubular collar 810 attached proximally to the release wire 802 from the stop 812. As described below, the collar 810 and the stop 812 are configured to reduce the likelihood of undesired movement of the release wire 802.

It may be advantageous to minimize any bending movement of the release wire 802 and avoid the release wire 802 from extending beyond the distal end of the outer sleeve 808. In particular, it is advantageous to avoid the loose end of the release wire 802 from extending away from the outer sleeve 808 or implant assembly 900. For example, the implant assembly 900 may experience bending movement when high friction is encountered in the delivery microcatheter. As the user continues to push on the proximal end of the delivery device, the outer sleeve 808 may begin to compress as the friction increases. When the implant position is axially fixed, the distal end of the release wire 802 may extend in an undesirable direction when the outer sleeve 808 is compressed. The release wire collar 810 and stop tube 812 help minimize unwanted movement of the release wire 802 during movement of the delivery device and positioning of the implant assembly 900 in the target location. The ferrule 810 and the stop 812 may be made of any suitable metallic or non-metallic material, such as stainless steel, a polymer, or a composite material. The ferrule 810 may be attached to the release wire 802 by any suitable means, such as an adhesive, or by crimping, welding, brazing, or other suitable method. The inner dimensions of the collar 810 and the stop 812 are customized such that the tool ring 804 and the release wire 802 can move freely within the outer sleeve 808. The stopper 812 may be attached to the inner surface of the outer sleeve 808 at one or more connection points 814, such as by laser welding, sonic welding, adhesives, or other methods. The stop 812 is located distally of the collar 810 and thus may act as a stop to limit distal movement of the collar 810. The stop 812 thus also acts as a stop to limit distal movement of the release wire 802 relative to the rings 804, 904 when the ferrule 810 is attached to the release wire 802.

The inner diameter of the stop 812 is sized to advantageously allow the tool ring 804 and release wire 802 to pass freely through, but not the ferrule 810. Thus, even in a high friction scenario, the collar 810 is pushed against the stopper 812 and the release wire 802 is prevented from moving further distally relative to the outer sleeve 808. Furthermore, since the release wire 802 is allowed to pass freely, the stop 812 will not impede reverse movement, which is required for implant removal. The ferrule 810 is thus prevented from further distal advancement because its outer diameter does not fit through the inner diameter of the stopper 812.

Fig. 14 is a cross-sectional view taken along line a-a of fig. 13, showing the placement of the collar 810 coaxially around the release wire 802. The tool ring 804 may be within the outer sleeve 808 adjacent to the release wire ferrule 810. FIG. 15 is a cross-sectional view taken along line B-B of FIG. 13, showing the placement of the stopper 812 within the outer sleeve 808. Both the tool ring 804 and the release wire 802 may be within the stop 812. That is, the stop 812 coaxially surrounds both the tool ring 804 and the release wire 802.

The implant coupling/decoupling system according to the presently disclosed subject matter may operate as follows:

a release wire is provided that is slidably disposed within a deployment tool having a proximal end and a distal end terminating in a first loop, the release wire having a proximal end extending proximally a short distance from the proximal end of the deployment tool and a distal end of a second loop that passes through the first loop and is located at the proximal end of the implant device for releasably coupling the implant device to the distal end of the deployment tool. The proximal end of the deployment tool is introduced into the distal opening of the release wire retraction device and secured within the retraction device, with the proximal end of the release wire extending proximally from the proximal end of the deployment tool. The retraction device is operated to (1) grip the proximal end of the release wire, (2) pull the release wire proximally by the deployment tool to withdraw the release wire from the first and second loops, thereby disengaging the implant device from the deployment tool, and (3) disengage from the release wire after the release wire has been moved proximally.

In another aspect, a method according to the present disclosure may include: (1) providing a deployment tool having a first ring attached to a distal end thereof; (2) providing an implant device having a second ring at a proximal end thereof; (3) axially passing the release wire through the deployment tool such that a distal end of the release wire passes through the first and second loops to releasably couple the implant device to the deployment tool and such that a portion of the release wire is exposed at a proximal end of the deployment tool; (4) clamping the exposed portion of the release wire; and (5) pulling the release wire proximally through the deployment tool until the distal end of the release wire is withdrawn from the first and second loops to disengage the implant device from the deployment tool.

Although exemplary embodiments of the presently disclosed subject matter have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. Accordingly, it should be understood that the retraction devices and interlocking ring coupling systems disclosed herein, their respective components, and related methods may be implemented in ways other than those described herein. It will also be appreciated that the interlocking ring coupling system described above is well suited for use with the aforementioned release wire retraction device. Thus, it is envisioned that there will be many applications and situations in which they will be used together in implant device deployment systems and methods, wherein the implant devices are deployed through a release wire. However, in other applications and circumstances, it may be advantageous to use the interlocking ring coupling system described above with other types of retraction devices or to use the retraction devices described above with other types of implant/release wire coupling systems and arrangements.