MEDICAL DEVICE FOR MODIFICATION OF LEFT ATRIAL APPENDAGE AND RELATED SYSTEMS AND METHODS

• US 20100228285A1
• Filed: 01/08/2010
• Published: 09/09/2010
• Est. Priority Date: 01/08/2009
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Edmiston, Daryl R., Miles, Scott D.
• Granted Patent: US 8,840,641 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• 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
• CPC Class Codes: A61B 2017/00884 : enhancing wound closure
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors
• 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
• 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

Medical devices, systems and methods for modifying a left atrial appendage (“LAA”). In one embodiment, a medical device system includes a jailing member or structure positioned over the ostium of an LAA and at least one tissue growth member positioned within the LAA and retained within the LAA by the jailing member. In another embodiment, a medical device includes an atrial stent coupled with a patch that is configured to cover the ostium of an LAA. The patch may have a tissue growth member associated therewith. In another embodiment, the patch may include an open-cell frame which may be used as a jailing member or structure.

Claims

1. A medical device system for modification of a left atrial appendage (LAA) comprising:

a medical device having a framework including a jailing portion configured to be positioned against a sidewall of the left atrium of the heart and over an ostium of the LAA and

a tissue growth member configured to be retained within the LAA, the tissue growth member configured to be separate and discreet from the framework of the medical device.

2. The medical device system of claim 1, wherein the tissue growth member comprises a plurality of tissue growth elements.

3. The medical device system of claim 2, wherein the plurality of tissue growth elements are coupled to one another via a tether.

4. The medical device system of claim 1, wherein the tissue growth member comprises a self expanding foam.

5. The medical device system of claim 1, wherein the framework is formed of a material comprising a nickel-titanium alloy.

6. The medical device system of claim 1, wherein the framework is formed as a stent structure sized and configured to be positioned within the left atrium of the heart and biased against the walls of the left atrium with the jailing portion positioned over an ostium of the LAA.

7. The medical device system of claim 1, wherein the medical device further includes an anchoring portion coupled with the framework, the anchoring portion being sized and configured to engage tissue within an LAA.

8. The medical device system of claim 7, wherein the medical device further includes a biasing member coupled between the anchoring portion and the jailing portion.

9. The medical device system of claim 8, wherein the anchoring portion further includes a plurality of anchor legs having a coiled portion configured to engage the tissue of an LAA.

10. The medical device system of claim 9, further comprising one or more nubs associated with each coiled portion.

11. The medical device system of claim 1, wherein the jailing portion is formed of a plurality of frame segments that are substantially coplanar.

12. The medical device system of claim 1, wherein the medical device is configured to exhibit a first, constrained configuration within a delivery mechanism and a second, deployed configuration when released from the delivery mechanism.

13. A medical device configured to modify a left atrial appendage, comprising:

a patch including a framework and a tissue growth member, the patch being sized and configured to extend against a sidewall of a left atrium to cover an ostium of the left atrial appendage; and

at least one looped structure extending from the patch and configured to engage and bias against the sidewall of the left atrium of the heart.

14. The medical device of claim 13, wherein the at least one looped structure includes a first loop extending from a first portion of the patch and a second loop extending from a second portion of the patch.

15. The medical device of claim 13, wherein the at least one looped structure includes a framework defining an open cell structure.

16. The medical device of claim 13, wherein the tissue growth member is formed of a porous foam or fabric.

17. The medical device of claim 13, wherein the framework comprises a nickel-titanium alloy.

18. The medical device of claim 13, further comprising a plurality of anchors associated with the patch.

19. A medical device configured to modify a left atrial appendage comprising:

a framework sized and configured to bias against the sidewall of the left atrium of the heart and over the ostium of a left atrial appendage; and

a tissue growth member on at least a portion of the framework, the tissue growth member being sized and configured to cover the ostium of a left atrial appendage.

20. The medical device of claim 19, wherein the framework includes a radial inner periphery and a radial outer periphery, and wherein the tissue growth member is disposed substantially over the entirety of at least one of the radial inner periphery and the radial outer periphery.

21. The medical device of claim 19, wherein the tissue growth member is formed of a porous foam or fabric.

22. The medical device of claim 19, wherein the framework comprises a nickel-titanium alloy.

23. The medical device of claim 19, further comprising a plurality of anchors associated with the framework.

24. A method of modifying a left atrial appendage, the method comprising:

positioning a jailing member over the ostium of a left atrial appendage;

inserting a catheter through an opening within the jailing member;

disposing at least one tissue growth member within the left atrial appendage; and

retaining the at least one tissue growth member within the left atrial appendage with the jailing member.

25. The method according to claim 24, wherein positioning a jailing member over the ostium of a left atrial appendage includes engaging walls of the left atrial appendage with an anchoring member coupled with the jailing member.

26. The method according to claim 25, further comprising providing a tensile bias between the anchoring member and the jailing member.

27. The method according to claim 24, wherein positioning a jailing member over the ostium of a left atrial appendage includes delivering the jailing member to the left atrial appendage with a first catheter, and wherein inserting a catheter through an opening within the jailing member and disposing at least one tissue growth member within the left atrial appendage includes inserting a second catheter through an opening within the jailing member and delivering the at least one tissue growth member with the second catheter.

28. The method according to claim 27, further comprising advancing the first catheter through a primary catheter to access the left atrial appendage, withdrawing the first catheter from the primary catheter subsequent delivering the jailing member to the left atrial appendage, and advancing the second catheter through the primary catheter subsequent withdrawing the first catheter.

29. The method according to claim 24, wherein disposing at least one tissue growth member within the left atrial appendage further includes disposing a plurality of a tissue growth elements within the left atrial appendage.

30. The method according to claim 29, further comprising connecting the plurality of tissue growth members with a tether.