Systems and Methods for Closing Internal Tissue Defects

• US 20060212071A1
• Filed: 06/07/2006
• Published: 09/21/2006
• Est. Priority Date: 12/11/2003
• Status: Abandoned Application

• Current Assignee: Joseph Karratt, Richard S. Ginn
• Original Assignee: Joseph Karratt, Richard S. Ginn
• Inventors: Ginn, Richard S., Karratt, Joseph
• Application Number:
  US11/422,869
• Publication Number:
  US 20060212071A1
• Time in Patent Office: Days
• US Class Current: 606/219
• 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• 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 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A delivery system having a steerable delivery device and an elastic clip for treating an internal tissue defect, such as septal defects and the like, is provided. The clip can be deformable between a relaxed state and a stressed state and biased towards the relaxed state. The delivery device can include a flexible tubular needle with a lumen for housing the clip while in the stressed state. When used to treat a septal defect, the needle is advancable through overlapping tissue flaps and a pusher member is advancable within the needle lumen to push the clip distally such that one end of the clip is deployed and engages a tissue flap. The needle can then be retracted allowing the clip to deploy over both flaps of tissue, where the biasing force returns the clip to the relaxed state drawing the tissue flaps together and closing the septal defect.

Claims

1. An apparatus for closing a septal defect, comprising:

an elastic clip having a first end, a second end and a body therebetween, the body having a longitudinal axis extending along its length;

wherein the clip is biased towards a relaxed state where each end is adjacent to the other, and wherein upon application of a mechanical stress the clip is deformable from the relaxed state to a stressed state where each end extends in a direction away from the other placing the body in torsion about the longitudinal axis.

2. The apparatus of claim 1, wherein the clip is formed from a shape memory material.

3. The apparatus of claim 2, wherein the clip is formed from nitinol and the Austenite finish temperature is below human body temperature.

4. The apparatus of claim 1, wherein the first and second ends of the clip overlap each other.

5. The apparatus of claim 1, wherein the body has a multi-sided shape while in the relaxed state.

6. The apparatus of claim 1, wherein the body has a curved shape while in the relaxed state.

7. The apparatus of claim 6, wherein the body is curved about a central axis while in the relaxed state.

8. The apparatus of claim 7, wherein the body is curved circularly about the central axis while in the relaxed state.

9. The apparatus of claim 1, wherein the clip is deformable upon application of the mechanical stress between each end such that each end moves laterally away from the other.

10. The apparatus of claim 9, wherein the body is curved about at least one axis and the clip is deformable upon initial application of the mechanical stress such that each end moves laterally away from the other along the axis.

11. The apparatus of claim 9, wherein the clip is biased to return to the relaxed state upon removal of the mechanical stress.

12. The apparatus of claim 1, wherein the body is elliptical in a radial cross-section taken along a plane, wherein a longitudinal axis of the body is normal to the plane.

13. The apparatus of claim 1, wherein the body is circular in a radial cross-section taken along a plane, wherein a longitudinal axis of the body is normal to the plane.

14. The apparatus of claim 1, wherein the body is rectangular in a radial cross-section taken along a plane, wherein a longitudinal axis of the body is normal to the plane.

15. The apparatus of claim 1, wherein each end of the clip is substantially blunt.

16. The apparatus of claim 1, wherein a surface of the body is roughened to engage human body tissue.

17. The apparatus of claim 1, wherein the body is substantially straightened in the stressed state.

18. The apparatus of claim 1, wherein the body is adapted to close a septal defect.

19. The apparatus of claim 1, wherein the body has a substantially straight midsection.

20. The apparatus of claim 19, wherein a first portion of the body including the first end is curved about a first axis, and a second portion of the body including the second end is curved about a second axis, and the midsection is located between the first and second portions.

21. An apparatus for closing a septal defect, comprising:

an elastic clip having a first substantially blunt end, a second substantially blunt end and a body therebetween, the clip being biased towards a relaxed state where the body is coiled, wherein upon application of a mechanical stress the clip is deformable from the relaxed state to a stressed state where the body is straightened such that each end extends in a direction at least partially away from the other.

22. The apparatus of claim 21, wherein the body has a first coiled segment and a second coiled segment, the first coiled segment being coiled at least 360 degrees while in the relaxed state.

23. The apparatus of claim 21, wherein the clip is deformable upon application of the mechanical stress between each end such that each end moves laterally away from the other placing the body in torsion about a longitudinal axis of the body.

24. The apparatus of claim 23, wherein the body is curved about at least one axis and the clip is deformable upon initial application of the mechanical stress such that each end moves laterally away from the other substantially along the axis.

25. The apparatus of claim 22, wherein the body has a second coiled segment being coiled at least 360 degrees while in the relaxed state, the second coiled segment having a smaller perimeter than the first.

26. The apparatus of claim 25, wherein the clip lies substantially within a plane while in the relaxed state and is deformable upon application of a mechanical stress between each coiled segment such that each segment moves laterally away from the other and out of the plane placing the body in torsion about a longitudinal axis of the body.

27. The apparatus of claim 26, wherein the first coiled segment is coiled about at least one axis and the second coiled segment is coiled about at least one different axis.

28. The apparatus of claim 27, wherein the first coiled segment is substantially circular and the second coiled segment is substantially circular.

29. The apparatus of claim 25, wherein the clip is deformable upon application of a mechanical stress between each coiled segment such that the second coiled segment passes within the first coiled segment.

30. The apparatus of claim 29, wherein the first coiled segment is coiled about at least one axis and the second coiled segment is coiled about at least one different axis.

31. The apparatus of claim 30, wherein the first coiled segment is substantially circular and the second coiled segment is substantially circular.

32. The apparatus of claim 21, wherein the body is elliptical in a radial cross-section taken along a plane, wherein a longitudinal axis of the body is normal to the plane.

33. The apparatus of claim 21, wherein the body is circular in a radial cross-section taken along a plane, wherein a longitudinal axis of the body is normal to the plane.

34. The apparatus of claim 21, wherein the body is substantially rectangular in a radial cross-section taken along a plane, wherein a longitudinal axis of the body is normal to the plane.

35. The apparatus of claim 34, wherein one side of the rectangular body is longer than at least one other side of the body, and the longer side is roughened to engage human body tissue.

36. The apparatus of claim 21, wherein a surface of the body is roughened to engage human body tissue.

37. The apparatus of claim 21, wherein the body is substantially straightened in the stressed state.