System and method for catheter-based septal defect repair

• US 20060095052A1
• Filed: 10/29/2004
• Published: 05/04/2006
• Est. Priority Date: 10/29/2004
• Status: Active Grant

• Current Assignee: Chambers Technology Inc.
• Original Assignee: Jeffrey W. Chambers
• Inventors: Chambers, Jeffrey W.
• Granted Patent: US 7,722,629 B2
• Time in Patent Office: Days
• US Class Current: 606/139
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608

Abstract

The contents include occlusion and/or repair of congenital heart defects including methods, apparatuses, and systems utilizing catheter delivery in order to repair congenital heart defects. In particular, a method of repair includes suturing a septal tissue proximate defect in order to repair the defect with a device introduced through a bodily lumen of a patient. A repair device can include an expansion assembly, a suture delivering portion, and a suture receiving portion.

Claims

1. A method of repairing a septal defect in a septum defined by septal tissue, the method comprising:

introducing a guiding catheter into a bodily lumen of a patient;

delivering a repair device proximate the septal defect via the guiding catheter, wherein the repair device includes,

a suture delivering portion maintaining a suture, and

a suture receiving portion;

positioning the suture at a first location proximate the septal defect with the repair device;

positioning the suture at a second location proximate the septal defect with the repair device;

pressing opposing sides of the septum together with the repair device;

driving the suture through the septal tissue at the first location with the repair device;

driving the suture through the septal tissue at the second location with the repair device;

capturing the suture with the repair device; and

tying the suture.

2. The method of claim 1, wherein the suture is captured with the suture receiving portion after the suture has been driven through the septal tissue.

3. The method of claim 1, further comprising:

positioning a second suture at a third location proximate the septal defect with the repair device, wherein the second suture is maintained by the suture delivering portion;

driving the second suture through the septal tissue at the third location with the repair device;

positioning the second suture at a fourth location proximate the septal defect with the repair device;

driving the second suture through the septal tissue at the fourth location with the repair device;

capturing the second suture with the repair device; and

tying the second suture.

4. The method of claim 1, wherein capturing the suture with the repair device includes, capturing the suture within a mesh material of the suture receiving portion.

5. The method of claim 1, wherein capturing the suture with the repair device includes, capturing the suture within a porous material of the suture receiving portion.

6. The method of claim 1, wherein capturing the suture with the repair device includes, capturing the suture by magnetic attraction with the suture receiving portion.

7. The method of claim 1, wherein capturing the suture with the repair device includes, capturing the suture by frictional engagement with the suture receiving portion.

8. The method of claim 1, wherein the septum is the atrial septum and the septal defect is a defect in the atrial septum.

9. The method of claim 1, wherein the septal defect is a patent foramen ovale.

10. The method of claim 1, wherein the septum is the ventricular septum and the septal defect is a defect in the ventricular septum.

11. The method of claim 1, wherein positioning the suture at the first location with

the repair device includes:

positioning a first end of the suture at the first location proximate the septal defect;

wherein driving the suture through the tissue at the first location with the repair device includes;

driving the first end of the suture from a first side of the septum to a second side of the septum with the suture delivering portion;

wherein positioning the suture at the second location with the repair device includes;

positioning a second end of the suture at the second location proximate the septal defect;

wherein driving the suture through the tissue at the second location with the repair device includes;

driving the second end of the suture from the first side of the septum to the second side of the septum with the suture delivering portion; and

wherein capturing the suture with the repair device includes;

capturing the first end and the second end of the suture with the suture receiving portion at the second side of the septum.

12. The method of claim 11, wherein the repair device further includes:

a first unit defining the suture delivering portion; and

a second unit defining the suture receiving portion;

wherein the first unit and the second unit are coaxially received together and both the first unit and the second unit are coaxially received within the guide catheter; and

further wherein repairing a septal defect in a septum defined by septal tissue further comprises,

delivering the first unit to the first side of the septum;

delivering the second unit to the second side of the septum;

positioning the suture receiving portion and suture delivering portion relative to one another such that the suture receiving portion is aligned to capture the suture as delivered by the suture delivering portion; and

pressing the septal tissue between the first unit and the second unit.

13. The method of claim 12, further comprising:

delivering a transseptal needle proximate the septal defect via the repair unit;

puncturing the septum with a transseptal needle such that the needle extends between the first side of the septum and a second side of the septum; and

guiding the second unit over the transseptal needle and through the septal tissue from the first side of the septum to the second side of the septum.

14. The method of claim 12, further comprising:

guiding the second unit through the septal defect from the first side of the septum to the second side of the septum.

15. The method of claim 12, wherein the first end of the suture is affixed to a first suture needle and the second end of the suture is affixed to a second suture needle, and further wherein capturing the first and second ends of the suture with the suture receiving portion includes driving the first and second needles into the suture receiving portion.

16. The method of claim 1, wherein positioning the suture at the first location with

the repair device includes:

positioning a first end of the suture at the first location proximate the septal defect;

wherein driving the suture through the tissue at the first location with the repair device includes;

driving the first end of the suture from a first side of the septum to a second side of the septum with the suture delivering portion;

wherein positioning the suture at a second location with the repair device includes;

positioning the first end of the suture at the second location proximate the septal defect;

wherein driving the suture through the tissue at the second location with the repair device includes;

driving the first end of the suture from the second side of the septum to the first side of the septum with the suture delivering portion; and

wherein capturing the suture with the repair device includes;

capturing the first end of the suture with the suture receiving portion at the first side of the septum.

17. The method of claim 16, wherein the suture delivering portion includes a first end of the suture affixed to a needle configured to take a curvilinear shape, and further wherein driving the first end of the suture through the tissue at the first and second locations with the suture delivering portion includes driving the needle through the tissue at the first and second locations.

18. The method of claim 16, wherein the suture delivering portion includes a first end of the suture affixed to a needle, the needle removably connected to a push member configured to take a curvilinear shape, and further wherein driving the first end of the suture through the tissue at the first and second locations with the suture delivering portion includes driving the needle through the tissue at the first and second locations with the push member.

19. The method of claim 1, further comprising:

securing a patch across the septal defect at one side of the septum.

20. A septal defect repair system for repairing a septal defect in a septum defined by septal tissue, the system comprising:

a guide catheter disposed within a bodily lumen of a patient; and

a repair device disposed within the guide catheter, the repair device including;

an expansion assembly configured to press opposing sides of the septum together,

a suture delivering portion maintaining a suture and configured to drive an end of the suture through the septal tissue proximate the septal defect,

a suture receiving portion configured to capture the end of the suture from the suture delivering portion.

21. The system of claim 20, wherein the suture receiving portion is defined by a plurality of radially extending petals.

22. The system of claim 20, wherein the suture receiving portion includes a wire mesh material.

23. The system of claim 20, wherein the suture receiving portion includes a plurality of conical receptacles, each receptacle including a porous material at the base of the receptacle.

24. The system of claim 20, wherein the suture delivery portion includes at least one needle configured to take a curvilinear shape, the needle maintaining the end of the suture.

25. The system of claim 20, wherein the suture delivery portion includes a plurality of push wire assemblies, each one of the plurality of push wire assemblies including:

a needle catheter;

a push member slidably disposed within the needle catheter; and

a suture needle removably affixed to an end of the push wire;

wherein the end of the suture is affixed to the suture needle and the suture receiving portion is configured to capture the end of the suture from the suture delivering portion by capturing the suture needle.

26. The system of claim 25, wherein the push member is configured to take a curvilinear shape upon extension from the needle catheter.