Devices, systems, and methods for closing the left atrial appendage

• US 8,771,297 B2
• Filed: 03/25/2008
• Issued: 07/08/2014
• Est. Priority Date: 03/30/2007
• Status: Active Grant

• Current Assignee: SentreHeart, LLC (Atricure, Inc.)
• Original Assignee: SentreHEART Incorporated (Atricure, Inc.)
• Inventors: Miller, Gary H., Seiber, Russell A., Fung, Gregory W.
• Primary Examiner(s): Tyson, Melanie
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US12/055,213
• Publication Number:
  US 20080243183A1
• Time in Patent Office: 2,296 Days
• Field of Search: 606/139, 606/144, 606/148, 606/140, 606/141, 606/151, 606/157, 606/158, 606/113, 623/2.11, 600/37
• US Class Current: 606/148
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Described here are devices, systems and methods for closing the left atrial appendage. Some of the methods described here utilize one or more guide members having alignment members to aid in positioning of a closure device. In general, these methods include advancing a first guide having a first alignment member into the left atrial appendage, advancing a second guide, having a second alignment member, into the pericardial space, aligning the first and second alignment members, advancing a left atrial appendage closure device into the pericardial space and adjacent to the left atrial appendage, and closing the left atrial appendage with the closure device. In these variations, the closure device typically has an elongate body having a proximal end and a distal end, and a closure element at least partially housed within the elongate body. The closure element comprises a loop defining a continuous aperture.

Claims

1. A device for closing the left atrial appendage comprising:

an elongate body having a proximal end and a distal end;

a closure element comprising a loop defining a continuous aperture therethrough, the closure element at least partially housed within the elongate body and comprising a first end fixed relative to the elongate body and a second end moveable relative to the elongate body to change the size of the aperture;

a suture loop, the suture loop at least partially housed within the elongate body; and

a retention member, wherein the retention member is configured to releasably couple the closure element and the suture loop, wherein the retention member comprises first and second coextensive lumens, wherein the closure element is housed within the first lumen and the suture loop is housed within the second lumen.

2. The device of claim 1, wherein the closure element is made from a shape-memory material.

3. The device of claim 2, wherein the closure element is made from a nickel titanium alloy.

4. The device of claim 1, wherein the suture loop is bioabsorbable.

5. The device of claim 1, wherein the suture loop is non-bioabsorbable.

6. The device of claim 1, wherein the second lumen has a weakened region configured to release the suture with the application of a force.

7. The device of claim 1, wherein the second lumen has a perforated region configured to release the suture with the application of a force.

8. The device of claim 1, wherein the second lumen has a slit extending along at least a portion of the retention member.

9. The device of claim 1, wherein the elongate body has one or more curves along its length.

10. The device of claim 1, wherein the elongate body is steerable.

11. The device of claim 1, wherein the elongate body is a catheter.

12. The device of claim 1, wherein the closure element, suture loop, or both comprise a radiopaque or echogenic material.

13. The device of claim 1, wherein the closure element and the suture loop are separately actuatable.

14. The device of claim 1, further comprising a cutting element.

15. A system for closing a left atrial appendage comprising:

a first guide having a size and length adapted for accessing the left atrial appendage through the vasculature, wherein the first guide comprises a first alignment member;

a second guide having a size and length adapted for accessing the pericardial space from a subthoracic region, wherein the second guide comprises a second alignment member; and

a closure device comprising an elongate body having a proximal end and a distal end, a closure element housed at least partially therein, wherein the closure element comprises a loop defining a continuous aperture therethrough, a first end fixed relative to the elongate body and a second end moveable relative to the elongate body to change the size of the aperture, a suture loop at least partially housed in the elongate body, and a retention member configured to releasably couple the suture loop and the closure element, wherein the retention member comprises first and second coextensive lumens, wherein the closure element is housed within the first lumen and the suture loop is housed within the second lumen.

16. The system of claim 15, further comprising an expandable member.

17. The system of claim 16, wherein the expandable member has one or more apertures therein.

18. The system of claim 16, wherein the expandable member is couplable to the first guide.

19. The system of claim 16, wherein the expandable member is a balloon.

20. The system of claim 15, further comprising a device for severing a suture from the suture loop.

21. The system of claim 15, wherein the closure device is couplable to the second guide.

22. The system of claim 15, wherein the first and second alignment members are magnets.

23. The system of claim 22, wherein the magnets are located at distal ends of the first and second guides.

24. The system of claim 15, wherein the first and second alignment members comprise radiopaque or echogenic markers.

25. The system of claim 15, wherein the first and second alignment members comprise interconnecting members.

26. The system of claim 15, wherein one of the first or second alignment members comprises a vacuum member.

27. The system of claim 15, further comprising instructions for using the first guide, second guide, closure device, or combination thereof.

28. The system of claim 15, wherein the elongate body of the closure device has one or more curves along its length.

29. The system of claim 28, further comprising a straightening tube, configured to temporarily straighten the one or more curves.

30. The system of claim 15, wherein the closure element is made from a shape-memory material.

31. The system of claim 30, wherein the closure element is made from a nickel titanium alloy.

32. The system of claim 15, wherein the suture loop is bioabsorbable.

33. The system of claim 15, wherein the suture loop is non-bioabsorbable.

34. The system of claim 15, wherein the second lumen has a weakened region configured to release the suture with the application of a force.

35. The system of claim 15, wherein the second lumen has a perforated region configured to release the suture with the application of a force.

36. The system of claim 15, wherein the second lumen has a slit extending along at least a portion of the retention member.

37. The system of claim 15, wherein the elongate body has one or more curves along its length.

38. The system of claim 15, wherein the elongate body is steerable.

39. The system of claim 15, wherein the elongate body is a catheter.

40. The system of claim 15, wherein the closure element, suture loop, or both comprise a radiopaque or echogenic material.

41. The system of claim 15, wherein the closure element and the suture loop are separately actuatable.