Medical device for modification of left atrial appendage and related systems and methods

• US 9,750,505 B2
• Filed: 05/26/2014
• Issued: 09/05/2017
• Est. Priority Date: 01/08/2009
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Miles, Scott D., Edmiston, Daryl R., Davis, Clark C.
• Primary Examiner(s): Nguyen, Victor
• Assistant Examiner(s): HOLLM, JONATHAN A
• Application Number:
  US14/287,103
• Publication Number:
  US 20140343594A1
• Time in Patent Office: 1,198 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 : Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 : Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/0061 : Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00632 : Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00867 : shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00884 : enhancing wound closure
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 : having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 : having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0437 : the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0446 : Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/0448 : Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0459 : Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/1205 : Introduction devices
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

Abstract

A medical device and system for modifying a left atrial appendage (“LAA”), as well as related methods, are provided. In accordance with one embodiment, a medical device includes a plurality of frame segments coupled with at least one ring member, the at least one ring member having an inner surface defining notches radially spaced therein, each of the frame segments configured to be positioned within one of the notches of the at least one ring member to collectively form a frame structure. Each frame segment includes a hub portion and at least one leg portion, the hub portion having an upper surface configured to be captured in one of the notches defined in the at least one ring member, and the at least one leg portion extending from the hub portion. With this arrangement, a tissue growth member is coupled to the frame segments.

Claims

1. A medical device for modifying an atrial appendage, the medical device comprising:

a plurality of frame segments coupled with at least one ring member, the at least one ring member having an inner surface defining notches radially spaced therein, each of the plurality of frame segments configured to be positioned within one of the notches of the at least one ring member to collectively form a frame structure, each frame segment including;

a hub portion having an upper surface configured to be captured in one of the notches defined in the at least one ring member; and

at least one leg portion extending from the hub portion; and

a tissue growth member coupled with the plurality of frame segments to define a substantially convex surface and a substantially concave surface.

2. The medical device of claim 1, wherein the tissue growth member comprises a porous material.

3. The medical device of claim 1, wherein the tissues growth member comprises expanded polytetrafluoroethylene.

4. The medical device of claim 1, wherein the plurality of frame segments are formed of a nickel-titanium alloy.

5. The medical device of claim 1, wherein the at least one leg portion comprises an expanding leg and a collapsing leg each extending from its associated hub portion.

6. The medical device of claim 1, wherein the plurality of frame segments are cooperatively configured to define a central opening therethrough.

7. The medical device of claim 1, wherein at least a portion of each of the at least one leg portion is positioned adjacent the convex surface of the tissue growth member.

8. The medical device of claim 7, wherein at least a portion of each of the at least one leg portion is positioned adjacent the concave surface of the tissue growth member.

9. The medical device of claim 1, wherein each frame segment includes a coupling mechanism configured to attach to the tissue growth member.

10. The medical device of claim 1, wherein the at least one leg portion comprises a coupling mechanism configured to attach to the tissue growth member.

11. The medical device of claim 1, wherein the tissue growth member comprises a first portion and a second portion, the second portion positioned over a proximal side of the first portion.

12. The medical device of claim 11, wherein the first portion comprises a porous foam material and the second portion comprises expanded polytetrafluoroethylene.

13. The medical device of claim 11, wherein the first portion is coupled to the frame segments and extends along the frame segments between a proximal end and a distal end of the first portion, the second portion extending over the first portion to cover a proximal side of the first portion and extends distally toward the distal end of the first portion such that the distal end of the first portion extends more distal than a distal end of the second portion.

14. The medical device of claim 11, wherein the first portion extends more distal than the second portion such that an outer surface of the first portion at a distal portion of the tissue growth member is exposed.

15. A medical device system comprising:

a medical device comprising;

a plurality of frame segments coupled with at least one ring member, the at least one ring member having an inner surface defining notches radially spaced therein, each of the plurality of frame segments configured to be positioned within one of the notches of the at least one ring member to form a frame structure, each frame segment including;

a hub portion having an upper surface configured to be captured in one of the notches defined in the at least one ring member; and

at least one leg portion extending from the hub portion;

a tissue growth member coupled with the plurality of frame segments to define a substantially convex surface and a substantially concave surface;

a catheter; and

a pusher member configured to displace the medical device relative to the catheter.

16. The medical device system of claim 15, wherein the pusher member is releaseably coupled with the medical device.

17. The medical device system of claim 15, wherein the pusher member is threadably coupled with the medical device.

18. The medical device system of claim 15, wherein the tissue growth member comprises a first portion and a second portion, the second portion positioned over a proximal side of the first portion.

19. The medical device system of claim 18, wherein the first portion extends more distal than the second portion such that an outer surface of the first portion at a distal portion of the tissue growth member is exposed.

20. The medical device of claim 18, wherein the first portion of the tissue growth member comprises a porous foam material.

21. The medical device of claim 18, wherein the second portion of the tissues growth member comprises expanded polytetrafluoroethylene.

22. A method of forming a medical device, the method comprising:

forming a plurality of frame segments, each frame segment including a hub portion and at least one leg portion;

coupling the hub portion of each of the plurality of frame segments with at least one ring member such that the at least one ring member includes an inner surface defining notches radially spaced therein so that an upper surface of the hub portion of each of the plurality of frame segments is captured in one of the notches of the at least one ring member; and

coupling a tissue growth member with the plurality of frame segments.

23. The method according to claim 22, wherein coupling a tissue growth member with the plurality of frame segments further includes forming a substantially concave surface and a substantially convex surface with the tissue growth member.

24. The method according to claim 22, wherein coupling a tissue growth member comprises attaching a first portion of the tissue growth member to the plurality of frame segments.

25. The method according to claim 24, wherein the coupling a tissue growth member comprises attaching a second portion of the tissue growth member to a proximal side of the first portion of the tissue growth member such that a distal outer portion of the first portion is exposed.

26. The method according to claim 25, wherein the coupling a tissue growth member comprises attaching the first portion being a porous foam material and attaching the second portion being an expanded polytetrafluoroethylene.

27. The method according to claim 22, further comprising forming the hub portion of a given frame segment to be substantially coplanar with the at least one leg portion.

28. The method according to claim 22, wherein forming a plurality of frame segments includes cutting each frame segment from a substantially flat sheet of nickel-titanium alloy.