Non-invasive surgical ligation clip system and method of using

• US 7,338,503 B2
• Filed: 08/08/2002
• Issued: 03/04/2008
• Est. Priority Date: 08/08/2002
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Rosenberg, Michael S., Claude, Timothy J.
• Primary Examiner(s): Woo; Julian W.
• Application Number:
  US10/215,216
• Publication Number:
  US 20040087987A1
• Time in Patent Office: 2,035 Days
• Field of Search: 606/142, 606/143, 606/139, 606219-221, 606/157, 606/158, 606/151, 606/116, 604/116, 128/898
• US Class Current: 606/142
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• 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 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

A surgical ligation clip capable of remote deployment through a catheter.

Claims

1. A method of using a clip system, comprising:

(a) providing a clip having a pair of jaws coupled together and biased toward each other, at least one of the jaws being coupled to a flexing section;

(b) placing the clip in a lumen at a proximal opening of a needle, the needle engaging the flexing section to exert stress on the flexing section, thereby separating at least a portion of the first and second jaws;

(c) positioning a distal opening of the needle at an anatomical location within a patient'"'"'s body;

(d) reducing stress on the flexing section to allow the first and second jaws to move closer together around a tissue structure; and

(e) releasing the clip from the distal opening of the needle with the clip remaining in engagement with the tissue structure.

2. The method of claim 1 further comprising, before releasing the clip from the needle, re-exerting stress on the flexing section to move the jaws away from each other, repositioning the clip with the-needle to a different anatomical location, and reducing stress on the flexing section to allow the first and second jaws to move closer at the new tissue structure.

3. The method of claim 1 wherein exerting stress comprises engaging the flexing section with an inner wall of the needle.

4. The method of claim 3 wherein a push rod is movably disposed in the needle to longitudinally move the clip through the inner wall of the needle.

5. The method of claim 3 wherein the flexing section extends from a longitudinal axis defined by the first and second jaws to engage the inner wall of the needle.

6. The method of claim 1 wherein both jaws are configured to move when stress is exerted on the flexing section.

7. The method of claim 1 wherein, when the clip is placed in the lumen of the needle, a first clamping section of the first jaw and a second clamping section of the second jaw abut against one another at a heel portion.

8. The method of claim 7 wherein, when the clip is placed in the lumen of the needle, distal ends of the first and second clamping sections are separated while the first and second clamping section abut at the heel portion.

9. The method of claim 1 wherein the first and second jaws are coupled together such that the first jaw mirrors the shape of the second jaw relative to a longitudinal axis.

10. The method of claim 9 wherein a first clamping section of the first jaw is aligned with a second clamping section of the second jaw along the longitudinal axis so that the first clamping section contacts the second clamping section without crossing over the longitudinal axis.

11. The method of claim 1 wherein placing the clip in the lumen of the needle causes the clip to superelastically deform without forming a permanent set or kink.

12. The method of claim 11 wherein in the clip device comprises a superelastic alloy material that is mechanically processed to provide a predetermined clamping force upon the tissue structure after releasing the clip from the distal opening of the needle.

13. The method of claim 12 wherein the predetermined clamping forces is selected to provide a force that is sufficient to clamp the tissue structure but it below a threshold force to damage the tissue structure.

14. The method of claim 1 wherein the clip has a lateral dimension greater than an inner dimension of the needle lumen before placing the clip in the lumen of the needle.

15. The method of claim 14 wherein, when the needle engages the flexing section to exert stress on the flexing section, the clip has a lateral dimension smaller than the inner dimension of the needle lumen so that the entire clip is deliverable from the proximal opening of the needle to the distal opening of the needle.

16. The method of claim 1 wherein the pair of jaws are biased toward each other in that the jaws comprise opposing clamping sections biased toward one another.

17. A clip system for application to mammalian tissue, comprising:

a needle including a needle bore that extends from a proximal opening to a distal opening, the distal opening being insertable into a patient'"'"'s body; and

a clip device that inserts into the proximal opening, including;

a first jaw having a first clamping section and a second jaw having a second clamping section opposing the first clamping section, at least a portion of the first and second jaws being able to separate from each other, and

a first flexing section coupled to at least the first jaw, the first flexing section being adjustable between a first shape in which the first and second clamping sections at least partially engage one another and a stressed shape by compression of the first flexing section against the needle bore that causes the first and second clamping sections to be at least partially separated from one another;

wherein, when the first flexing section is in the stressed shape, the clip device has a lateral dimension smaller than the inner dimension of the needle bore so that the entire clip device is deliverable from the proximal opening of the needle bore to the distal opening of the needle bore.

18. The clip system of claim 17 wherein at least a portion of the first flexing section comprises a material that exhibits superelasticity characteristics at a predetermined temperature.

19. The clip system of claim 18 wherein the at least a portion of the first flexing section comprises a nitinol material that exhibits superelasticity characteristics at a temperature of about 37 degrees C.

20. The clip system of claim 18 wherein the first flexing section exhibits superelasticity characteristics when the first flexing section returns to the first shape after being deformed to the stressed shape while the entire clip device is disposed in the needle bore.

21. The clip system of claim 17 wherein the first flexing section shifts toward the first shape when the clip device is advanced distally from an opening at the distal opening of the needle bore so that the first and second clamping sections shift toward one another.

22. The clip system of claim 21 wherein the clip device is configured to engage an anatomical structure when the first and second clamping section shift toward one another.

23. The clip system of claim 17 wherein the needle engages the first flexing section to releasably retain the first flexing section in the stressed shapes when the entire clip device is disposed in the needle bore.

24. The clip system of claim 17 further comprising a push rod movably disposed in the needle bore to deliver the clip device distally through the needle bore from the proximal opening to the distal opening.

25. The clip system of claim 17 wherein the clip device further comprises a second flexing section coupled to at least the second jaw, the second flexing section having a stressed shape that causes the first and second clamping sections to be at least partially separated from one another.

26. The clip system of claim 17 wherein the first clamping section of the first jaw and the second clamping section of the second jaw abut against one another at a heel portion when the first flexing section is in the stressed shape.

27. The clip system of claim 26 wherein distal ends of the first clamping section and the second clamping section separate from one another when the first and second clamping section abut at the heel portion.

28. The clip system of claim 27 wherein the distal ends of the first clamping section and the second clamping section comprise blunt tips.

29. The clip system of claim 17 wherein the first jaw of the clip device mirrors the shape of the second jaw relative to a longitudinal axis.

30. The clip system of claim 29 wherein the first clamping section of the first jaw is aligned with the second clamping section of the second jaw along the longitudinal axis so that the first clamping section contacts the second clamping section without crossing over the longitudinal axis.

31. The clip system of claim 29 wherein the first and second jaws cross over the longitudinal axis so that at least a portion of the first clamping section is arranged on an opposing side of the longitudinal axis from at least a portion of the first flexing section.

32. The clip system of claim 17 wherein the clip device comprises a single wire that defines the first jaw and the second jaw, the wire having a cross-sectional shape in a lateral plane of the clip device.

33. The clip system of claim 32 wherein the cross-sectional shape in the lateral plane is D-shaped.

34. The clip system of claim 32 wherein the cross-sectional shape in the lateral plane is rectangular.

35. The clip system of claim 32 wherein the cross-sectional shape in the lateral plane is circular.

36. The clip system of claim 17 wherein the first clamping section comprises wave-shaped grips that are matable with complementary wave-shaped grips of the second clamping section.

37. The clip system of claim 36 wherein the wave-shaped grips facilitate engagement with targeted bodily tissue between the first and second clamping sections.

38. The clip system of claim 17 wherein the first clamping section of the first jaw comprises an indentation that at least partially defines a gap between the first clamping section and the second clamping section.

39. The clip system of claim 38 wherein the indentation causes the clip device to exert a predetermined amount of force against targeted bodily tissue that is engaged between the first and second clamping sections.

40. The clip system of claim 38 wherein the gap that is at least partially defined by the indentation provides a seat structure that retains targeted bodily tissue engaged between the first and second clamping sections.

41. The clip system of claim 17 wherein the clip device superelastically deforms when inserted in the needle bore without forming a permanent set or kink.

42. The clip system of claim 41 wherein in the clip device comprises a superelastic alloy material that is mechanically processed to provide a predetermined clamping force between the first and second clamping sections.

43. The clip system of claim 42 wherein the predetermined clamping forces is selected to provide a force that is sufficient to clamp targeted bodily tissue between the first and second clamping sections and that is below a threshold force to damage the targeted bodily tissue.

44. The clip system of claim 17 wherein the clip device comprises an outer roughened surface that enhances ultrasonography characteristics of the clip device.

45. The clip system of claim 17 wherein the clip device comprises an unpolished surface to provide a level of porosity that enhances ultrasonography characteristics of the clip device.

46. The clip system of claim 17 wherein, when the first flexing section is in the first shape, the clip device has a lateral dimension greater than the inner dimension of the needle bore.

47. The clip system of claim 46 wherein the first flexing section comprises a curved structure without a bend that defines a corner.

48. A clip system for application to mammalian tissue, comprising:

a needle including a needle bore that extends from a proximal opening to a distal opening, the distal opening being deliverable to a targeted internal tissue; and

a clip device that inserts into the proximal opening of the needle bore and superelastically deforms therein without forming a permanent kink, the clip device including;

a first jaw having a first clamping section and a second jaw having a second clamping section opposing the first clamping section and being biased toward the first clamping section, the distal portions of the first and second jaws being able to separate from each other, and

a first flexing section coupled to at least the first jaw, the first flexing section being adjustable between a first shape in which the first and second clamping sections extend generally parallel to one another and a stressed shape that causes at least distal ends of the first and second clamping sections to separate from one another, wherein the first flexing section adjusts to the stressed shape by compression of the first flexing section against the needle bore;

wherein, when the first flexing section is in the first shape, the clip device has a lateral dimension greater than the inner dimension of the needle bore, and

wherein, when the first flexing section is in the stressed shape, the clip device superelastically deforms to a lateral dimension that is smaller than the inner dimension of the needle bore so that the entire clip device is deliverable from the proximal opening of the needle bore to the distal opening of the needle bore.

49. The clip system of claim 48 wherein the first clamping section of the first jaw and the second clamping section of the second jaw abut against one another at a heel portion when the first flexing section is in the stressed shape.

50. The clip system of claim 49 wherein distal ends of the first clamping section and the second clamping section separate from one another when the first and second clamping section abut at the heel portion.

51. The clip system of claim 50 wherein the distal ends of the first clamping section and the second clamping section comprise blunt tips.

52. The clip system of claim 48 wherein the clip device comprises a material that exhibits superelasticity characteristics at a temperature of about 37 degrees C.

53. The clip system of claim 52 wherein the first flexing section exhibits superelasticity characteristics when the first flexing section returns to the first shape after being deformed to the stressed shape while the entire clip device is disposed in the needle bore.

54. The clip system of claim 48 wherein the first flexing section shifts toward the first shape when the clip device is advanced distally from an opening at the distal opening of the needle bore so that the first and second clamping sections shift toward one another.

55. The clip system of claim 54 wherein the clip device is configured to engage an anatomical structure when the first and second clamping section shift toward one another.

56. The clip system of claim 48 wherein the needle engages the first flexing section to releasably retain the first flexing section in the stressed shapes when the entire clip device is disposed in the needle bore.

57. The clip system of claim 48 further comprising a push rod movably disposed in the needle bore to deliver the clip device distally through the needle bore from the proximal opening to the distal opening.

58. The clip system of claim 48 wherein the clip device further comprises a second flexing section coupled to at least the second jaw, the second flexing section having a stressed shape that causes the distal ends of the first and second clamping sections to be separate from one another.

59. The clip system of claim 48 wherein the first jaw of the clip device mirrors the shape of the second jaw relative to a longitudinal axis.

60. The clip system of claim 59 wherein the first clamping section of the first jaw is aligned with the second clamping section of the second jaw along the longitudinal axis so that the first clamping section contacts the second clamping section without crossing over the longitudinal axis.

61. The clip system of claim 48 wherein the clip device comprises a single wire that defines the first jaw and the second jaw, the wire having a cross-sectional shape in a lateral plane of the clip device.

62. The clip system of claim 61 wherein the cross-sectional shape in the lateral plane is D-shaped.

63. The clip system of claim 48 wherein the first clamping section comprises wave-shaped grips that are matable with complementary wave-shaped grips of the second clamping section.

64. The clip system of claim 63 wherein the wave-shaped grips facilitate engagement with the targeted internal tissue between the first and second clamping sections.

65. The clip system of claim 48 wherein the first clamping section of the first jaw comprises an indentation that at least partially defines a gap between the first clamping section and the second clamping section.

66. The clip system of claim 65 wherein the gap that is at least partially defined by the indentation provides a seat structure that retains the targeted internal tissue engaged between the first and second clamping sections.

67. The clip system of claim 48 wherein in the clip device comprises a superelastic alloy material that is mechanically processed to provide a predetermined clamping force between the first and second clamping sections.

68. The clip system of claim 67 wherein the predetermined clamping forces is selected to provide a force that is sufficient to clamp the targeted internal tissue between the first and second clamping sections and that is below a threshold force to damage the targeted internal tissue.