Shape memory alloy clip and method of use thereof

• US 6,517,556 B1
• Filed: 10/26/2000
• Issued: 02/11/2003
• Est. Priority Date: 10/28/1999
• Status: Expired due to Fees

• Current Assignee: Niti Surgical Solutions Ltd.
• Original Assignee: Niti Alloys Technologies Ltd.
• Inventors: Monassevitch, Leonid
• Primary Examiner(s): Hale, Gloria M.
• Application Number:
  US09/697,441
• Time in Patent Office: 838 Days
• Field of Search: 606/151, 606/157, 606/158, 606/221, 606/153, 606/219, 245/43, 245/45, 245/56, 623/1.1, 623/1.11, 623/1.13, 623/1.15, 623/1.16, 623/1.18, 623/1.19, 623/1.34, 623/1.36
• US Class Current: 606/151
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

A surgical clip system which includes a surgical clip having a first clip portion including a first length of material having a closed geometrical shape having a first surface, the shape having a central axis therethrough and having a central opening therein; a pair of support portions associated with the first clip portion; a second clip portion including a second length of material having a closed geometrical shape having a second surface of substantially the same configuration and size as that of the first clip portion, the shape having a central axis therethrough; and a pair of fastening elements formed of a shape memory alloy, each of the fastening elements including a first end and a second end, each of the first ends being attached to the second clip portion; wherein, when at a first temperature or higher, the shape memory alloy is in an elastic state, such that the pair of fastening elements are maintained in a position such that they abut the support portions, and wherein, when at a second temperature or lower, below the first temperature, the shape memory alloy is in a plastic state, thereby enabling the second ends of the pair of fastening elements to be moved away from the second length of material and to be passed between the support portions such that, upon heating of the clip to at least the first temperature, the pair of fastening elements returns to the position such that they abut the support portions, thereby pressing against the pair of support portions, thereby pressing the first and second lengths of material towards each other, thereby to apply a compressive force to tissue located between the first and second lengths of material.

Claims

1. A surgical clip system which includes a surgical clip having:

a first clip portion including a first length of material having a closed geometrical shape having a first surface, said shape having a central axis therethrough and having a central opening therein;

a pair of support portions associated with said first clip portion;

a second clip portion including a second length of material having a closed geometrical shape having a second surface of substantially the same configuration and size as that of said first clip portion, said shape having a central axis therethrough; and

a pair of fastening elements formed of a shape memory alloy, each of said fastening elements including a first end and a second end, each of said first ends being attached to said second clip portion;

wherein, when at a first temperature or higher, said shape memory alloy is in an elastic state, such that said pair of fastening elements are maintained in a position such that they abut said support portions, and wherein, when at a second temperature or lower, below said first temperature, said shape memory alloy is in a plastic state, thereby enabling said second ends of said pair of fastening elements to be moved away from said second length of material and to be passed between said support portions such that, upon heating of said clip to at least said first temperature, said pair of fastening elements returns to said position such that they abut said support portions, thereby pressing against said pair of support portions, thereby pressing said first and second lengths of material towards each other, thereby to apply a compressive force to tissue located between said first and second lengths of material.

2. The surgical clip system according to claim 1, wherein said first clip portion, said support portions, and said second clip portion are fabricated from biocompatible material.

3. The surgical clip system according to claim 1, wherein each of said pair of support portions includes a pair of guide elements between which one of said fastening elements is positioned when in said elastic state and when said first and second lengths of material are pressed towards each other.

4. The surgical clip system according to claim 3, wherein said guide elements are fabricated from biocompatible material.

5. The surgical clip system according to claim 1, wherein said geometrical shape is an oval.

6. The surgical clip system according to claim 1, wherein upon heating of said clip to at least said first temperature, said pair of fastening elements press against said pair of support portions, thereby pressing said first and second lengths of material towards each other such that they are maintained a distance apart of approximately 0.1-1.5 mm.

7. The surgical clip system according to claim 1, wherein upon heating of said clip to at least said first temperature, said pair of fastening elements press against said pair of support portions, thereby pressing said first and second lengths of material against each other such that said first and second surfaces substantially abut each other.

8. The surgical clip system according to claim 1, said system further including spacer means for facilitating movement of said second ends of said fastening elements away from said second length of material.

9. The surgical clip system according to claim 8, said spacer means including means insertable through said second length of material of said second clip portion.

10. The surgical clip system according to claim 9, said insertable means including means for guiding movement of said fastening elements away from said second length of material.

11. The surgical clip system according to claim 8, said spacer means fabricated from biocompatible material.

12. A surgical clip system which includes a surgical clip having:

a first clip portion including a first length of material having a closed geometrical shape having a first surface, said shape having a central axis therethrough and having a central opening therein;

a pair of support portions associated with said first clip portion;

a second clip portion including a second length of material having a closed geometrical shape having a second surface of substantially the same configuration and size as that of said first clip portion, said shape having a central axis therethrough; and

a pair of fastening elements formed of a superelastic material, each of said fastening elements including a first end and a second end, each of said first ends being attached to said second clip portion;

wherein, in the absence of, an outside force, said pair of fastening elements are maintained in a position such that they abut said support portions, and wherein, by the application of an outside force, said second ends of said pair of fastening elements are movable away from said second length of material such that they may be passed between said support portions such that, upon removal of said outside force, said pair of fastening elements returns to said position such that they abut said support portions, thereby pressing thereagainst, thereby pressing said first and second lengths of material towards each other, thereby to apply a compressive force to tissue located between said first and second lengths of material.

13. The surgical clip system according to claim 12, wherein said first clip portion, said support portions, and said second clip portion are fabricated from biocompatible material.

14. The surgical clip system according to claim 12, wherein each of said pair of support portions includes a pair of guide elements between which one of said fastening elements is positioned when in said elastic state and when said first and second lengths of material are pressed towards each other.

15. The surgical clip system according to claim 14, wherein said guide elements are fabricated from biocompatible material.

16. The surgical clip system according to claim 12, wherein said geometrical shape is an oval.

17. The surgical clip system according to claim 12, wherein upon removal of said outside force, said pair of fastening elements press against said pair of support portions, thereby pressing said first and second lengths of material towards each other such that they are maintained a distance apart of approximately 0.1-1.5 mm.

18. The surgical clip system according to claim 12, wherein upon removal of said outside force, said pair of fastening elements press against said pair of support portions, thereby pressing said first and second lengths of material against each other such that said first and second surfaces substantially abut each other.

19. The surgical clip system according to claim 12, said system further including spacer means for facilitating movement of said second ends of said fastening elements away from said second length of material.

20. The surgical clip system according to claim 19, said spacer means including means insertable through said second length of material of said second clip portion.

21. The surgical clip system according to claim 20, said insertable means including means for guiding movement of said fastening elements away from said second length of material.

22. The surgical clip system according to claim 19, said spacer means fabricated from biocompatible material.

23. A method for anastomosing an organ of a gastrointestinal tract, said method comprising the following steps:

(a) providing a surgical clip system which includes a surgical clip having;

a first clip portion including a first length of material having a closed geometrical shape having a first surface, said shape having a central axis therethrough and having a central opening therein;

a pair of support portions associated with said first clip portion;

a second clip portion including a second length of material having a closed geometrical shape having a second surface of substantially the same configuration and size as that of said first clip portion, said shape having a central axis therethrough; and

a pair of fastening elements formed of a shape memory alloy, each of said fastening elements including a first end and a second end, each of said first ends being attached to said second clip portion;

wherein, when at a first temperature or higher, said shape memory alloy is in an elastic state, such that said pair of fastening elements are maintained in a position such that they abut said support portions, and wherein, when at a second temperature or lower, below said first temperature, said shape memory alloy is in a plastic state, thereby enabling said second ends of said pair of fastening elements to be moved away from said second length of material and to be passed between said support portions such that, upon heating of said clip to at least said first temperature, said pair of fastening elements returns to said position such that they abut said support portions, thereby pressing thereagainst, thereby pressing said first and second lengths of material towards each other, thereby to apply a compressive force to tissue located between said first and second lengths of material;

(b) cooling at least the fastening elements of the clip to a temperature below its lower phase transition temperature;

(c) moving the second ends of the fastening elements away from the second length of material;

(d) preparing open ends of first and second organ portions to be joined, such that a cross-sectional area of each organ portion is narrowed relative to the remainder of thereof;

(e) inserting the first clip portion into the first organ portion, such that the first length of material abuts the inside surface of the tissue thereof, adjacent the narrowed area thereof;

(f) inserting the second clip portion into the second organ portion, such that the second length of material abuts the inside surface of the tissue thereof, adjacent the narrowed area thereof and such that the fastening elements protrude out of the open end of the second organ portion;

(g) drawing together the open ends of the first and second organ portions wherein anastomosis is desired such that they face each other, and bringing the open ends closer together such that the fastening elements protruding out of the open end of the second organ portion pass into the open end of the first organ portion, through the first length of material, and through the pair of support portions;

(h) maintaining the relative positions of the first and second portions of the gastrointestinal tract and the first and second clip portions in relation thereto, while raising the temperature of at least the fastening elements to a temperature above its upper phase transition temperature, such that the elasticity thereof causes the fastening elements to return to a position such that the fastening elements press against the pair of support portions, thereby pressing the first and second lengths of material towards each other, thereby to apply a compressive force to tissue located between the first and second lengths of material.

24. A method for anastomosing an organ of a gastrointestinal tract according to claim 23, wherein in said step (h) the temperature of at least the fastening elements is raised to a temperature above its upper phase transition temperature by the artificial application of heat.

25. A method according to claim 23, wherein the first clip portion, the support portions, and the second clip portion are fabricated from biocompatible material.

26. A method according to claim 23, wherein each of the pair of support portions includes a pair of guide elements between which one of the fastening elements is positioned when in the elastic state and when the first and second lengths of material are pressed towards each other.

27. A method according to claim 26, wherein the guide elements are fabricated from biocompatible material.

28. A method for anastomosing a gastrointestinal tract according to claim 23, wherein the geometrical shape is an oval.

29. The method according to claim 23, wherein upon heating of said clip to at least said first temperature, said pair of fastening elements press against said pair of support portions, thereby pressing said first and second lengths of material towards each other such that they are maintained a distance apart of approximately 0.1-1.5 mm.

30. The method according to claim 23, wherein upon heating of said clip to at least said first temperature, said pair of fastening elements press against said pair of support portions, thereby pressing said first and second lengths of material against each other such that said first and second surfaces substantially abut each other.

31. The method according to claim 23, wherein:

said surgical clip system further includes spacer means for facilitating movement of said second ends of said fastening elements away from said second length of material; and

, between said steps (e) and (f), said method includes the additional step (e1) of;

inserting the spacer means into the second organ portion.

32. The method according to claim 31, wherein, between said steps (f) and (g), said method includes the additional step (f1) of inserting the spacer means through the second length of material of the second clip portion.

33. The method according to claim 32, the fastening elements being guided away from said second length of material during said step (f1).

34. The method according to claim 31, the spacer means fabricated from biocompatible material.

35. A method for anastomosing an organ of a gastrointestinal tract, said method comprising the following steps:

(a) providing a surgical clip system which includes a surgical clip having;

a first clip portion including a first length of material having a closed geometrical shape having a first surface, said shape having a central axis therethrough and having a central opening therein;

a pair of support portions associated with said first clip portion;

a second clip portion including a second length of material having a closed geometrical shape having a second surface of substantially the same configuration and size as that of said first clip portion, said shape having a central axis therethrough; and

a pair of fastening elements formed of a superelastic material, each of said fastening elements including a first end and a second end, each of said first ends being attached to said second clip portion;

wherein, in the absence of an outside force, said pair of fastening elements are maintained in a position such that they abut said support portions and wherein, by the application of an outside force, the second ends of the pair of fastening elements are moved away from said second length of material such that they are able to be passed between said support portions such that, upon removal of the outside force, the pair of fastening elements returns to the position such that they abut said support portions, thereby pressing, thereby pressing the first and second lengths of material towards each, thereby to apply a compressive force to tissue located between the first and second lengths of material;

(b) moving the second ends of the fastening elements away from the second length of material;

(c) preparing open ends of first and second organ portions to be joined, such that a cross-sectional area of each organ portion is narrowed relative to the remainder of thereof;

(d) inserting the first clip portion into the first organ portion, such that the first length of material abuts the inside surface of the tissue thereof, adjacent the narrowed area thereof;

(e) inserting the second clip portion into the second organ portion, such that the second length of material abuts the inside surface of the tissue thereof, adjacent the narrowed area thereof and such that the fastening elements protrude out of the open end of the second organ portion;

(f) drawing together the open ends of the first and second organ portions wherein anastomosis is desired such that they face each other, and bringing the open ends closer together such that the fastening elements protruding out of the open end of the second organ portion pass into the open end of the first organ portion, through the first length of material, and through the pair of support portions;

(g) maintaining the relative positions of the first and second portions of the gastrointestinal tract and the first and second clip portions in relation thereto, while removing the outside force, thereby allowing the fastening elements to return to a position such that the fastening elements press against the pair of support portions, thereby pressing the first and second lengths of material towards each other, thereby to apply a compressive force to tissue located between the first and second lengths of material.

36. A method according to claim 35, wherein the first clip portion, the support portions, and the second clip portion are fabricated from biocompatible material.

37. A method according to claim 35, wherein each of the pair of support portions includes a pair of guide elements between which one of the fastening elements is positioned when in the elastic state and when the first and second lengths of material are pressed towards each other.

38. A method according to claim 37, wherein the guide elements are fabricated from biocompatible material.

39. A method for anastomosing a gastrointestinal tract according to claim 35, wherein the geometrical shape is an oval.

40. A method for anastomosing a gastrointestinal tract according to claim 35, wherein upon removing said outside force, said pair of fastening elements press against said pair of support portions, thereby pressing said first and second lengths of material towards each other such that they are maintained a distance apart of approximately 0.1-1.5 mm.

41. A method for anastomosing a gastrointestinal tract according to claim 35, wherein upon removing said outside force, said pair of fastening elements press against said pair of support portions, thereby pressing said first and second lengths of material against each other such that said first and second surfaces substantially abut each other.

42. The method according to claim 35, wherein:

said surgical clip system further includes spacer means for facilitating movement of said second ends of said fastening elements away from said second length of material; and

, between said steps (d) and (e), said method includes the additional step (d1) of;

inserting the spacer means into the second organ portion.

43. The method according to claim 42, wherein, between said steps (e) and (f), said method includes the additional step (e1) of inserting the spacer means through the second length of material of the second clip portion.

44. The method according to claim 43, the fastening elements being guided away from said second length of material during said step (e1).

45. The method according to claim 42, the spacer means fabricated from biocompatible material.