Flexible feature for embolic implant deployment

Abstract

Various systems and methods for deploying an implantable medical device to a target location of a body vessel are disclosed. The delivery system may include a tubular body defining a longitudinal axis. The tubular body may include a lumen extending through the tubular body, a sidewall surrounding the lumen, and a feature formed by the sidewall. The feature may include an aperture. A pulling wire may extend through the lumen. The delivery system may include an implantable medical device that includes a locking portion. The locking portion may include an opening. The feature may be positioned within the opening of the locking portion. A distal end of the pulling wire may pass through the aperture of the feature to secure the implantable medical device to the delivery system.

Description

Technical Field

[0001] The present invention relates to aneurysm treatment devices and, more particularly, to improved delivery systems for embolic implants. Background Art

[0002] Many intravascular implant devices are known in the art. Many devices are mechanically deployed via a system combining one or more catheters and wires for delivery. Examples of implants that can be mechanically delivered include embolic elements, stents, grafts, drug delivery implants, deflection elements, filters, stimulation leads, sensing leads, or other implantable structures delivered by microcatheters. Some obstetric and gastrointestinal implants can also be implanted via a similar system combining one or more catheters and wires. Devices that can be released or deployed by mechanical means have significant differences in design, but similar delivery catheter and wire systems can be used. Many such catheter-based delivery systems include wires for keeping the implant in the catheter until the time of releasing the device. These systems are actuated by retracting or pulling the wire relative to the catheter. Such wires are referred to as "pull wires" in this article. Many such catheter-based delivery systems also implement "loop wires" that have an end attached to the tubular body of the catheter and form a loop through which the pull wire can be positioned to keep the implant in the catheter.

[0003] One problem with current catheter-based delivery systems is the complexity of attaching the loop wire to the tubular body of the catheter. The complexity of forming the loop wire and attaching the loop wire to the catheter delivery system reduces the reliability of the delivery system and increases the probability of the implant being detached prematurely from the catheter system.

[0004] Therefore, there is a need for an improved implant delivery system that does not utilize a loop wire to retain the implant to the catheter system. The present disclosure is directed to this and other considerations. Summary of the invention

[0005] Various systems and methods for deploying an implantable medical device to a target location in a body vessel are disclosed. A delivery system may include a tubular body defining a longitudinal axis. The tubular body may include an inner cavity extending through the tubular body, a sidewall surrounding the inner cavity, and a feature formed by the sidewall. The feature may include a hole. A pull wire may extend through the inner cavity. The delivery system may include an implantable medical device, the implantable medical device including a locking portion. The locking portion may include an opening. The feature may be positioned within the opening of the locking portion. The distal end of the pull wire may pass through the hole of the feature to secure the implantable medical device to the delivery system.

[0006] In one aspect, a delivery system for deploying an implantable medical device to a target location in a body vessel is disclosed. The delivery system may include a tubular body defining a longitudinal axis. The tubular body may include an inner cavity extending through the tubular body, a sidewall surrounding the inner cavity, and a feature formed by the sidewall. The feature may include a hole passing through the feature. The system may include a puller wire extending through the inner cavity. The delivery system may include an implantable medical device, and the implantable medical device may include a locking portion having an opening. The feature formed by the sidewall may be positioned within the opening of the locking portion of the implantable medical device. The distal end of the puller wire may pass through the hole of the feature to fix the implantable medical device to the delivery system.

[0007] In some embodiments, the feature may include a tab shape that is cut into the sidewall and bent into a folded configuration. The feature may be deflected toward the longitudinal axis of the tubular body to secure the implantable medical device to the delivery system. In some embodiments, the feature may be laser cut from the sidewall.

[0008] In some embodiments, the feature can be configured to return to a non-folded configuration when the distal end of the puller wire is removed from the aperture, thereby deploying the implantable medical device to a target location in a body vessel.

[0009] In some embodiments, the feature is configured to apply a spring force to the implantable medical device in response to the feature returning from the folded configuration to the unfolded configuration.

[0010] In some embodiments, the feature may be formed from a shape memory material.

[0011] In some embodiments, the puller wire can be coated with polytetrafluoroethylene (PTFE).

[0012] In some embodiments, the feature may be comprised of a resilient material.

[0013] In some embodiments, the distal end of the puller wire can be positioned through the hole of the feature such that the distal end of the puller wire interferes with the locking portion, which can secure the implantable medical device to the delivery system.

[0014] In some embodiments, when the pull wire is pulled proximally, the distal end of the pull wire is retracted from the aperture of the feature to release the implantable medical device from the delivery system.

[0015] In some embodiments, when the distal end of the puller wire is retracted from the aperture of the feature, the distal end of the puller wire no longer interferes with the locking portion, thereby facilitating release of the implantable medical device from the delivery system.

[0016] On the other hand, a method is disclosed. The method may include providing a tubular body including an inner cavity extending through the tubular body and a sidewall surrounding the inner cavity. The tubular body may define a longitudinal axis. The method may include forming a feature in the sidewall of the tubular body. The feature may include a hole. The feature may be bent from a non-folded structure to a folded structure so that the feature deflects toward the longitudinal axis of the tubular body. A pull wire may extend through the inner cavity. A locking portion of an implantable medical device may be positioned above the feature in the folded structure. The distal end of the pull wire may be positioned to pass through the hole of the feature, thereby fixing the implantable medical device to the tubular body. The implantable medical device may be positioned near a target location of a body vessel. The pull wire may translate toward the proximal side, thereby deploying the implantable medical device to the target location of a body vessel.

[0017] In some embodiments, the feature may include a tab shape that is cut into the sidewall and bent into a folded configuration. In some embodiments, forming the feature may include laser cutting the feature in the sidewall.

[0018] In some embodiments, deploying the implantable medical device to a target location in a body vessel may further include returning the feature from a folded configuration to an unfolded configuration.

[0019] In some embodiments, when the implantable medical device is deployed to a target location in a body vessel, the return of the feature to the unfolded configuration can apply a spring force to the implantable medical device.

[0020] In some embodiments, the method may include coating the puller wire with polytetrafluoroethylene (PTFE).

[0021] In some embodiments, when the pull wire is pulled proximally, the distal end of the pull wire is retracted from the aperture of the feature to release the implantable medical device from the tubular body.

[0022] In some embodiments, when the distal end of the puller wire is retracted from the aperture of the feature, the distal end of the puller wire no longer interferes with the locking portion of the implantable medical device, thereby facilitating release of the implantable medical device from the tubular body.

[0023] In some embodiments, the features may be formed from a shape memory material. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The above aspects and further aspects of the present invention will be further discussed with reference to the following description and in conjunction with the accompanying drawings, in which like numbers indicate similar structural elements and features in the various figures. The accompanying drawings are not necessarily drawn to scale, but instead, emphasis is placed on illustrating the principles of the present invention. The accompanying drawings depict one or more specific implementations of the present invention by way of example only and not by way of limitation.

[0025] Figure 1 is a diagrammatic representation of a delivery system and implant according to aspects of the present invention.

[0026] FIG. 2A to FIG. 2D A series of steps for securing an implantable medical device to features of a delivery system according to aspects of the present invention are shown.

[0027] FIG. 3A to FIG. 3C A series of steps for releasing an implantable medical device from a feature of a delivery system according to aspects of the present invention are shown.

[0028] Figure 4 is an illustration of an implantable medical device positioned within an aneurysm according to aspects of the present invention.

[0029] FIG. 5A to FIG. 5D A series of steps for releasing an implantable medical device from a delivery member according to aspects of the present invention are shown.

[0030] Figure 6 is a flow chart of an exemplary method of using a delivery system according to aspects of the present invention. DETAILED DESCRIPTION

[0031] The following description of certain examples of the present invention should not be used to limit the scope of the present invention. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the present invention. The detailed description illustrates the principles of the present invention by way of example and not by way of limitation. From the following description, other examples, features, aspects, embodiments and advantages of the present invention will become apparent to those skilled in the relevant art, and the following description is by way of example, which is one of the best ways contemplated for implementing the present invention. As will be appreciated, the present invention can have other different or equivalent aspects, all of which do not depart from the present invention. Therefore, the drawings and description should be considered to be illustrative in nature and not restrictive.

[0032] Any one or more of the teachings, expressions, patterns, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, patterns, examples, etc. described herein. Therefore, the following teachings, expressions, patterns, examples, etc. should not be considered separate from each other. With reference to the teachings herein, various suitable ways in which the teachings herein may be combined will be apparent to those skilled in the relevant art. Such modifications and variations are intended to be included within the scope of the claims.

[0033] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of ±10% of the value of the recited value, for example, "about 90%" may refer to a range of values ​​from 81% to 99%. In addition, as used herein, the terms "patient", "recipient", "user" and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but the use of the subject invention in human patients represents a preferred embodiment.

[0034] Turning to the attached figure, Figure 1 An exemplary delivery system 10 for deploying an implantable medical device 12 to a target location in a body vessel is shown. The delivery system 10 may include a tubular body 90 having an inner cavity 508 extending therethrough. The tubular body may define a longitudinal axis LL. The inner cavity 508 may be surrounded by a sidewall 96 of the tubular body 90. Positioned proximate the distal end 94 of the tubular body 90 may be a feature 150. The feature 150 may be formed by the sidewall 96 of the tubular body 90. According to some embodiments, the feature 150 may be in the shape of a tab cut into the sidewall 96. According to some embodiments, the feature may be laser cut from the sidewall. The feature 150 may have a non-folded configuration when at rest, and may automatically or elastically return to a non-folded configuration from a folded configuration unless otherwise constrained. According to some embodiments, the feature 150 may be formed of an elastic material or a shape memory alloy such as nitinol to allow the feature 150 to elastically return to a non-folded configuration from a folded configuration. As Figure 1 As shown, the feature 150 is in a folded configuration and can be positioned through the opening 20 of the locking portion 18 of the implantable medical device 12. The folded configuration of the feature 150 is characterized in that the feature 150 is deflected toward the longitudinal axis LL of the tubular body. According to some embodiments, the feature 150 can be composed of a shape memory material such as nitinol. As shown, the implantable medical device 12 is positioned near the distal end 94 of the tubular body 90. The pull wire 140 can extend through the lumen 508 of the tubular body 90. After the feature 150 is positioned through the opening 20 of the locking portion 18, the distal end 144 of the pull wire 140 can be positioned through the hole 152 of the feature 10. Once the distal end 144 of the pull wire 140 is positioned through the hole 152 of the feature 150, the implantable medical device 12 is fixed to the delivery system 10. The pull wire 140 can be composed of any suitable material, for example, the pull wire 140 can be composed of stainless steel or a shape memory material such as nitinol. According to some embodiments, the puller wire 140 is coated with a polymer, such as polytetrafluoroethylene (PTFE).

[0035] FIG. 2A to FIG. 2DA series of steps for securing an implantable medical device to features of a delivery system according to aspects of the present invention are shown. Figure 2A A feature 150 is shown formed from the sidewall 96 of the tubular body 90. The feature 150 may include an aperture 152. Figure 2A As shown, the feature 150 is in a unfolded configuration 154 . Figure 2B The feature 150 is shown folded toward the longitudinal axis LL and the locking portion 18 of the implantable medical device 12 is positioned within the lumen 508. Figure 2C The feature 150 is shown in a folded configuration 156, wherein the locking portion 18 of the implantable medical device 12 (not shown) is positioned over the feature 150. As shown, the locking portion 18 is positioned over the feature 150 such that the portion of the feature 150 including the aperture 152 is positioned through the locking portion 18. Figure 2D , after the feature 150 is positioned through the locking portion 18 of the implantable medical device 12, the distal end 144 of the puller wire 140 is positioned through the hole 152. In this configuration, the implantable medical device 12 is now secured to the delivery system 10.

[0036] FIG. 3A to FIG. 3C A series of steps for releasing an implantable medical device from a feature of a delivery system according to aspects of the present invention are shown. Figure 3A In FIG. 1 , an implantable medical device 12 (not shown) is secured to the delivery system 10 via a pull wire 140 that engages the feature 150 and the locking portion 18. Figure 3B , the distal end 144 of the puller wire 140 is retracted from the aperture 152 of the feature 150. The feature 150 is now free to elastically move from the folded configuration 156 to the unfolded configuration 154. Figure 3C The moment after the distal end 144 of the puller wire 140 has exited the hole 152 of the feature 150 is shown. The arrow indicates that the feature 150 elastically moves from the folded configuration 156 to the unfolded configuration 154. The movement of the feature 150 thereby allows the locking portion 18 of the implantable medical device to be disengaged from the delivery system 10. In addition, the movement of the feature 150 can apply a spring force E that pushes the implantable medical device 18 toward the treatment site.

[0037] Figure 4 2 is an illustration of an embolic implant 12 delivered by a catheter 250 and positioned within an aneurysm A on a blood vessel BV. The implant may loop with the aneurysm sac and bend to form a thrombus mass. The implant may loop back on itself and / or loop adjacent to other implants. As the aneurysm A becomes more and more packed, the overlapping portions of the implant 12 may press into each other.

[0038] FIG. 5A to FIG. 5DShown is a timing sequence of steps for releasing the embolic implant 12 from the delivery system 10. The delivery system 10 may be constructed such as shown in the previous figures and otherwise described herein. Figure 5A An engagement system is shown including a feature 150 and a pull wire 140 locked into the locking portion 18 of the medical device 12. The feature 150 may be in a folded configuration 156, and the feature may be positioned through the opening 20 of the locking portion 18 of the implantable medical device 12. When the distal end 144 of the pull wire 140 is placed through the hole 152 of the feature 150, the implantable medical device 12 is now secured. Figure 5B Pull wire 140 is shown being pulled proximally to initiate a release sequence of implantable medical device 12 . Figure 5C The moment when the distal end 144 of the puller wire exits the hole 152 and the puller wire 140 is pulled out of the feature 150 is shown. The feature 150 moves from the folded configuration 156 to the unfolded configuration 154 and out of the opening 20 of the locking portion 18. It can be seen that now there is nothing holding the medical device 12 to the delivery system 10. Figure 5D The end of the release sequence is shown. Here, the feature 150 has returned from the folded configuration 156 to the unfolded configuration 154. The feature 150 applies a spring force E to the implantable medical device 12 to "push it open" to ensure complete separation and delivery of the implantable medical device 12.

[0039] Figure 6 Flowchart of an exemplary method of using a delivery system according to aspects of the present invention. In block 604, the method may include providing a tubular body 90. The tubular body 90 includes a lumen 508 extending therethrough. The tubular body may define a longitudinal axis LL. The lumen 508 may be surrounded by a sidewall 96.

[0040] In frame 608, the method may include forming a feature 150 in the sidewall 96 of the tubular body. The feature may include a hole 152. In frame 612, the method may include bending the feature 150 from a non-folded configuration 154 to a folded configuration 156. Once bent, the feature 150 may deflect toward the longitudinal axis LL of the tubular body 90.

[0041] In frame 616, the puller wire 140 may extend through the lumen 508. In frame 620, the method may include positioning the locking portion 18 of the implantable medical device 12 over the feature 150 when the feature 150 is in the folded configuration 156. In frame 624, the method may include positioning the distal end 144 of the puller wire 140 through the hole 152 of the feature 150. Once the distal end 144 of the puller wire 140 is positioned through the hole 152, the implantable medical device may be secured to the tubular body 90 of the delivery system 10.

[0042] In block 628, the method may include positioning the implantable medical device 12 proximate the target location of the body vessel. In block 632, the method may include translating the puller wire 140 proximally to deploy the implantable medical device 12 to the target location of the body vessel.

[0043] In some embodiments, the feature may be formed as a tab shape that is cut into the sidewall 96 and bent into the folded configuration 156 .

[0044] In some embodiments, forming the features may also include laser cutting features 150 in the sidewall 96 .

[0045] In some embodiments, deploying the implantable medical device 12 to a target location in a body vessel may also include returning the feature from the folded configuration 156 to the unfolded configuration 154 .

[0046] In some embodiments, when implantable medical device 12 is deployed to a target location in a body vessel, feature 150 returning to unfolded configuration 154 can apply an elastic force (E) to the implantable medical device.

[0047] In some embodiments, the method may include coating the puller wire 140 with PTFE.

[0048] In some embodiments, when the pull wire 140 is pulled proximally, the distal end 144 of the pull wire 140 is retracted from the aperture 152 of the feature to release the implantable medical device from the tubular body 90 .

[0049] In some embodiments, when the distal end 144 of the puller wire 140 is retracted from the hole 152 of the feature 150, the distal end 144 of the puller wire 140 no longer interferes with the locking portion 18, thereby facilitating the release of the implantable medical device from the tubular body 90. In some embodiments, the feature 150 can be formed of a shape memory material.

[0050] The description contained herein is an example of an embodiment of the present invention, and is not intended to limit the scope of the present invention in any way. As described herein, the present invention contemplates many variations and modifications of implant systems and related methods, including alternative geometries of system components, alternative materials, additional or alternative method steps, etc. Modifications that are obvious to those skilled in the relevant art are intended to be within the scope of the appended claims.

Claims

1. A delivery system for deploying an implantable medical device to a target location in a body vessel, the delivery system comprising: A tubular body defining a longitudinal axis, the tubular body comprising: an inner lumen extending through the tubular body; a side wall surrounding the inner cavity; and a feature formed by the sidewall, the feature comprising an aperture; a puller wire extending through the lumen; a locking portion of the implantable medical device, the locking portion comprising an opening, the feature being positioned within the opening of the locking portion; The distal end of the puller wire is passed through the hole of the feature to secure the implantable medical device to the delivery system.

2. A delivery system according to claim 1, wherein the feature portion includes a tab shape that is cut into the side wall and bent into a folded structure, wherein the feature portion is deflected toward the longitudinal axis of the tubular body to secure the implantable medical device to the delivery system.

3. The delivery system of claim 1, wherein the feature is laser cut from the sidewall.

4. The delivery system of claim 2, wherein the feature is configured to return to a non-folded configuration when the distal end of the puller wire is removed from the hole, thereby deploying the implantable medical device to the target location of the body vessel.

5. The delivery system of claim 4, wherein the feature is configured to apply a spring force to the implantable medical device in response to the feature returning from the folded configuration to the unfolded configuration. The delivery system of claim 1 , wherein the feature is formed of a shape memory material.

7. The delivery system of claim 1, wherein the puller wire is coated with polytetrafluoroethylene.

8. The delivery system of claim 1, the feature comprising an elastic material.

9. The delivery system of claim 1, wherein the distal end of the puller wire is positioned through the hole of the feature portion such that the distal end of the puller wire interferes with the locking portion, thereby securing the implantable medical device to the delivery system.

10. The delivery system of claim 1, wherein when the pull wire is pulled proximally, the distal end of the pull wire is retracted from the aperture of the feature to release the implantable medical device from the delivery system.

11. The delivery system of claim 10, wherein when the distal end of the puller wire is retracted from the hole of the feature portion, the distal end of the puller wire no longer interferes with the locking portion, thereby facilitating the release of the implantable medical device from the delivery system.

12. A method comprising: providing a tubular body including a lumen extending through the tubular body and a sidewall surrounding the lumen, the tubular body defining a longitudinal axis; forming a feature in the sidewall of the tubular body, the feature comprising a hole; bending the feature from an unfolded configuration to a folded configuration such that the feature is deflected toward the longitudinal axis of the tubular body; extending a puller wire through the lumen; positioning a locking portion of an implantable medical device over the feature in the folded configuration; positioning a distal end of the puller wire through the aperture of the feature to secure the implantable medical device to the tubular body; positioning the implantable medical device proximate a target location in a body vessel; and The puller wire is translated proximally to deploy the implantable medical device to the target location in the body vessel.

13. The method of claim 12, wherein the feature comprises a tab shape cut into the sidewall and bent into a folded configuration.

14. The method of claim 12, wherein forming the feature further comprises laser cutting the feature in the sidewall.

15. The method of claim 12, wherein deploying the implantable medical device to the target location in the body vessel further comprises returning the feature to the unfolded configuration.

16. The method of claim 15, wherein when the implantable medical device is deployed to the target location of the body vessel, the feature returns to the unfolded configuration to apply a spring force to the implantable medical device.

17. The method of claim 12, further comprising coating the puller wire with polytetrafluoroethylene.

18. The method of claim 12, wherein when the puller wire is pulled proximally, the distal end of the puller wire is retracted from the aperture of the feature to release the implantable medical device from the tubular body.

19. The method of claim 18, wherein when the distal end of the puller wire is retracted from the aperture of the feature, the distal end of the puller wire no longer interferes with the locking portion, thereby facilitating release of the implantable medical device from the tubular body.

20. The method of claim 12, wherein the feature is formed of a shape memory material.

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