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

• US 20110022079A1
• Filed: 01/08/2010
• Published: 01/27/2011
• Est. Priority Date: 01/08/2009
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Whisenant, Brian K., Edmiston, Daryl R., Miles, Scott D., Davis, Clark C.
• Granted Patent: US 8,690,911 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

A medical device, system and method for modifying a left atrial appendage (“LAA”). The medical device system includes a tether anchored within the LAA and one or more tissue growth members or occluders configured to be slid over the tether and lodged within the LAA. With this arrangement, a physician may close-off the LAA with a selective number of tissue growth members to meet the varying LAA sizes as determined from imaging information while conducting the procedure.

Claims

1. A medical device system for modifying a left atrial appendage, comprising:

a catheter including a lumen extending therethrough;

a tether extending through the lumen of the catheter;

an anchoring member coupled with the tether;

at least one tissue growth member slidably coupled with the tether and sized and configured to be positioned within the left atrial appendage; and

a locking element associated with the at least one tissue growth member and the tether.

2. The medical device system of claim 1, wherein the at least one tissue growth member comprises polyurethane foam.

3. The medical device system of claim 1, wherein the at least one tissue growth member comprises a plurality of tissue growth members.

4. The medical device system of claim 3, wherein the plurality of tissue growth members comprises at least two tissue growth members having different configurations from one another.

5. The medical device system of claim 4, wherein the at least two tissue growth members exhibit different sizes

6. The medical device system of claim 4, wherein the at least two tissue growth members exhibit different shapes.

7. The medical device system of claim 1, further comprising a handle coupled with the catheter and having a lumen in communication with the lumen of the catheter.

8. The medical device system of claim 7, further comprising a pusher member configured to displace the at least one tissue growth member relative to the tether.

9. The medical device system of claim 8, further comprising a capturing member associated with the pusher member and configured to engage the tissue growth, the capturing member being selectively coupled with the handle.

10. The medical device system of claim 9, further comprising a loading member removably coupled with the capturing member and configured to assist displacement of the at least one tissue growth member within the capturing member in a constrained state.

11. The medical device system of claim 7, further comprising an actuator associated with the handle, the actuator configured to displace the catheter relative to the tether.

12. The medical device system of claim 1, wherein the locking element is configured to coupled with the tether and maintain the tissue growth member on the tether.

13. The medical device system of claim 12, further comprising a device for selectively severing the tether.

14. The medical device system of claim 1, wherein the anchoring member includes a plurality of anchoring legs, the anchoring member being configured to be in a first collapsed state within the lumen of the catheter and a second deployed state wherein the legs extend radially outward relative to the first collapsed state.

15. The medical device system of claim 14, wherein each of the plurality of anchoring legs includes one or more tapered nubs.

16. The medical device system of claim 14, wherein each of the plurality of anchoring legs exhibits at least one loop.

17. The medical device system of claim 14, wherein each of the plurality of includes a distal end that curves radially inward.

18. The medical device system of claim 14, wherein the plurality of anchoring legs comprise a nickel-titanium alloy.

19. The medical device system of claim 1, wherein the at least one tissue growth member further comprises a support structure.

20. A method for modifying a left atrial appendage, comprising:

positioning a catheter adjacent the left atrial appendage;

anchoring a tether within the left atrial appendage;

sliding at least one tissue growth member over the tether and deploying the at least one tissue growth member within the left atrial appendage; and

maintaining the at least one tissue growth member in the left atrial appendage with a locking element.

21. The method according to claim 20, wherein anchoring a tether further comprises:

positioning the catheter having an anchoring member in a constrained configuration within the catheter relative to the left atrial appendage; and

deploying the anchoring member in an expanded configuration to anchor the anchoring member in the left atrial appendage.

22. The method according to claim 20, wherein the sliding the at least one tissue growth member over the tether comprises sliding a plurality of tissue growth members over the tether and within the left atrial appendage.

23. The method according to claim 20, further comprising selectively choosing the at least one tissue growth member from a variety of differently configured tissue growth members to slide over the tether.

24. The method according to claim 23, further comprising obtaining imaging information regarding the left atrial appendage and wherein selectively choosing is based, at least in part, on the obtained imaging information.

25. The method according to claim 20, further comprising selectively choosing a specific number of tissue growth members for sliding within the left atrial appendage.

26. The method according to claim 20, further comprising selectively choosing a specific size from a plurality of tissue growth members for placing within the left atrial appendage.

27. The method according to claim 20, wherein sliding at least one tissue growth member over the tether further comprises positioning the catheter within the left atrial appendage and deploying the tissue growth member from the catheter while slidably coupled with the tether.

28. The method according to claim 20, wherein the sliding at least one tissue growth member over the tether further comprises sliding an expandable porous tissue growth member over the tether.

29. The method according to claim 20, wherein the sliding at least one tissue growth member over the tether further comprises pushing the at least one tissue growth member over the tether with a pusher member.

30. The method according to claim 20, further comprising loading the at least one tissue growth member into the lumen of a catheter in a constrained state prior to deploying the at least one tissue growth member in the left atrial appendage.

31. The method according to claim 20, wherein deploying the at least one tissue growth member within the left atrial appendage includes deploying the at least one tissue growth member within a first lobe of the left atrial appendage and wherein the method further comprises deploying at least one other tissue growth member in a second lobe of the left atrial appendage.