Surgical clips without protrusions

• US 8,287,559 B2
• Filed: 01/21/2004
• Issued: 10/16/2012
• Est. Priority Date: 01/29/2003
• Status: Expired due to Term

• Current Assignee: Newtec Vascular Products Ltd.
• Original Assignee: UCL Business PLC (University of London)
• Inventors: Barker, Stephen George Edward, Hollingsworth, Simon John
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Bachman, Lindsey
• Application Number:
  US10/543,720
• Publication Number:
  US 20060200179A1
• Time in Patent Office: 3,191 Days
• Field of Search: 606/157, 606/158, 606/151, 623/2.38, 128/831, 128/843
• US Class Current: 606/158
• 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 17/1222 Packages or dispensers therefor clip magazines incorporated in a clip-applying instrument A61B17/128; for surgical articles A61B50/30
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00907 for light

Abstract

A surgical clip (5) is provided for clipping a tubular structure (9) in vivo to ligate the tubular structure. The clip comprises first and second clip portions (6, 7). A hinge portion (8) is provided connecting the clip portions together and to enable the clip portions to be hinged together from an open clip condition to a closed clip condition thereby to ligate a tubular structure placed between the clip portions. A lock is provided for locking the clip portions together in the closed clip condition. In the closed clip condition the clip has a substantially smooth external profile, for example including blunt ends (21), so as to reduce the possibility of the clip (in use) eroding surrounding tissue structures.

Claims

1. A surgical clip for ligating a tubular vessel in vivo, the clip consisting essentially of:

a first clip portion comprising;

a first external surface;

a first clamping surface positioned on a surface of the first clip portion opposite of the first external surface;

a second clip portion coupled to the first clip portion, comprising;

a second external surface;

a second clamping surface positioned on a surface opposite of the second external surface;

a hinge portion coupling the first and second clip portions positioned at a first end of the first and second clip portions, comprising;

a pivot axis about which the first and second clip portions are hinged such that the clip portions are configured to move from an open condition to a closed condition; and

a lock for locking the clip portions together when in use such that the tubular vessel placed between the first and second clip portions is ligated, comprising;

a first lock portion positioned proximate an end of the first clip portion opposite the hinge portion; and

a second lock portion positioned proximate an end of the second clip portion opposite the hinge portion;

wherein the first lock portion and the second lock portion are positioned to cooperate to lock the clip portions together during use;

wherein at least one of the clamping surfaces comprises surface undulation and at least a portion of the surface undulation contacts the tubular vessel during use;

wherein the clamping surfaces and hinge portion are positioned such that the clamping surfaces are substantially parallel to one another when the tubular vessel is ligated during use;

means providing a stand-off gap between the clamping surfaces of at least 0.1 mm across the length of clamping surfaces in the absence of the tubular vessel when the clip is in the closed position;

wherein a first maximum dimension of the clip in a first direction is between about 0.25 and about 1.0 times a second maximum dimension of the clip in a second direction and wherein the first and second directions are orthogonal to each other and the first and second directions are parallel with the clamping surfaces when the clip is in the closed condition;

wherein in use the tubular vessel is accommodated when positioned between the first clamping surface and the second clamping surface;

wherein in use the clip has a substantially smooth substantially spherical or substantially ovoid external 3-dimensional shape that is substantially free of;

i) external projections; and

ii) rough or sharp ends or rough or sharp edges so as to reduce the possibility of the clip eroding tissue structures surrounding the clip in vivo.

2. The clip of claim 1 wherein the first direction is parallel to the pivot axis of the hinge portion.

3. The clip of claim 1 wherein the first maximum dimension of the clip is at least about 0.6 times the second maximum dimension of the clip.

4. The clip of claim 1 wherein the first maximum dimension of the clip is at least about 0.7 times the second maximum dimension of the clip.

5. The clip of claim 1 wherein the first maximum dimension of the clip is at least about 0.8 times the second maximum dimension of the clip.

6. The clip of claim 1 wherein the first maximum dimension of the clip is at least about 0.9 times the second maximum dimension of the clip.

7. The clip of claim 1 wherein the means providing a stand-off gap between the clamping surfaces comprises the hinge portion.

8. The clip of claim 7 wherein the tubular vessel to be ligated is positioned between the hinge portion and the lock portions during use.

9. The clip of claim 1 wherein the first lock portion protrudes from the first clip portion and wherein the second lock portion is positioned to couple to the first clip portion.

10. The clip of claim 1 wherein the first lock portion is provided with at least one barb and the second lock portion is arranged to receive the at least one barb so as to lock the clip portions together in use.

11. The clip of claim 1 wherein the first lock portion is provided with at least one barb and the second lock portion is arranged to receive the at least one barb so as to lock the clip portions together, wherein the second lock portion is provided with at least one barb, and wherein at least one of the first and second lock portions is provided with a plurality of barbs to function like a locking ratchet when the clip portions are hinged to the closed clip condition.

12. The clip of claim 11, wherein both of the first and second lock portions are provided with a plurality of barbs and wherein in use at least two barbs of the first lock portion are in contact with at least two barbs of the second lock portion to provide a plurality of barb-to-barb contacts.

13. The clip of claim 12 wherein the plurality of barbs enable the clip portions to be locked together in a plurality of different closed clip conditions during use, each different closed clip condition representing a different spacing between the clip portions, such that the clip can ligate tubular vessels within a range of different sizes.

14. The clip of claim 1 wherein in use the clip has a substantially spherical external shape.

15. The clip of claim 1 wherein both of the clip portions are substantially hemispherical in shape.

16. The clip of claim 1 wherein in use the clip has a substantially oval external shape.

17. The clip of claim 1 wherein both of the clip portions are substantially hemioval in shape.

18. The clip of claim 1 wherein the stand-off gap between the clamping surfaces in a closed clip condition is at least 0.3 mm.

19. The clip of claim 1 wherein the stand-off gap between the clamping surfaces in a closed clip condition is less than about 1 mm.

20. The clip of claim 1 wherein the clip structure is non-metallic.

21. The clip of claim 1 wherein the clip structure comprises polypropylene.

22. The clip of claim 1 wherein the clip structure comprises nylon.

23. The clip of claim 1 wherein the clip structure comprises polydiaxonone.

24. The clip of claim 1 wherein the clip is provided in a sterile container.

25. The clip of claim 1, wherein the stand-off gap between the clamping surfaces in a closed clip condition is less than about 0.5 mm.

26. The clip of claim 1 further comprising surface undulation on the first clamping surface and the second clamping surface.

27. A cartridge or magazine comprising a plurality of surgical clips having the construction claimed in claim 1, the surgical clips being removably provided in a cartridge or magazine structure and the cartridge or magazine being provided in a sterile container.

28. A combination of a surgical clip application device and at least one surgical clip having the construction claimed in claim 1, wherein the application device is operable to apply the at least one clip around a tubular vessel to be ligated and to switch the at least one clip from its open clip condition to a closed clip condition so as to ligate the tubular vessel.

29. The combination of claim 28, wherein the application device is pre-loaded with a plurality of the clips and is provided in a sterile container.

30. A method of ligating a tubular vessel, in vivo, comprising:

providing a surgical clip as claimed in claim 1;

applying the clip in the open clip condition to the tubular vessel to be ligated, with the tubular vessel extending between the open clip portions;

arranging the clip such that the hinge is positioned on a first side of the tubular vessel and the lock is positioned on a second side when the lock is engaged; and

engaging the lock to lock the clip portions together.

31. A method for ligating a blood vessel in vivo, comprising:

providing a surgical clip consisting essentially of;

a first clip portion comprising;

a first external surface;

a first clamping surface positioned on a surface of the first clip portion opposite of the first external surface;

a second clip portion coupled to the first clip portion, comprising;

a second external surface;

a second clamping surface positioned on a surface opposite of the second external surface;

a hinge portion coupling the first and second clip portions positioned at a first end of the first and second clip portions, comprising;

a pivot axis about which the first and second clip portions are hinged such that the clip portions are configured to move from an open condition to a closed condition; and

a lock for locking the clip portions together when in use such that the blood vessel placed between the first and second clip portions is ligated, comprising;

a first lock portion positioned proximate an end of the first clip portion opposite the hinge portion; and

a second lock portion positioned proximate an end of the second clip portion opposite the hinge portion;

 

wherein the first lock portion and the second lock portion are positioned to cooperate to lock the clip portions together during use;

 

wherein at least one of the clamping surfaces comprises surface undulation;

 

the hinge portion provides a stand-off gap between the clamping surfaces of at least 0.1 mm across the length of clamping surfaces in the absence of the blood vessel when the clip is in the closed position;

 

wherein a first maximum dimension of the clip in a first direction is between about 0.25 and about 1.0 times a second maximum dimension of the clip in a second direction and wherein the first and second directions are orthogonal to each other and the first and second directions are parallel with the clamping surfaces when the clip is in the closed condition;

positioning the surgical clip proximate the blood vessel;

applying the clip in the open clip condition to the blood vessel to be ligated, with the blood vessel extending between the open clip portions;

arranging the clip such that the hinge is positioned on a first side of the blood vessel and the lock is positioned on a second side when the lock is engaged; and

engaging the lock to lock the clip portions together; and

thereby ligating the blood vessel;

wherein at least a portion of the surface undulation contacts the blood vessel during use;

wherein during use the first clamping surface and the second clamping surface are substantially parallel to one another and the blood vessel is positioned between the hinge portion and the lock portions when the blood vessel is ligated between the clamping surfaces in the closed position;

wherein in use the clip has a substantially smooth substantially spherical or substantially ovoid external 3-dimensional shape that is substantially free of;

i) external projections; and

ii) rough or sharp ends or rough or sharp edges so as to reduce the possibility of the clip eroding tissue structures surrounding the clip in vivo.

32. The method of claim 31 wherein in the clip the first direction is parallel to the pivot axis of the hinge portion.

33. The method of claim 31 wherein in the clip the first maximum dimension of the clip is at least about 0.6 times the second maximum dimension of the clip.

34. The method of claim 31 wherein in the clip the first maximum dimension of the clip is at least about 0.7 times the second maximum dimension of the clip.

35. The method of claim 31 wherein in the clip the first maximum dimension of the clip is at least about 0.8 times the second maximum dimension of the clip.

36. The method of claim 31 wherein in the clip the first maximum dimension of the clip is at least about 0.9 times the second maximum dimension of the clip.

37. The method of claim 31 wherein the blood vessel is a varicose vein.

38. The method of claim 31 wherein in the clip the first lock portion protrudes from the first clip portion and wherein the second lock portion is positioned to couple to the first clip portion.

39. The method of claim 31 wherein in the clip the first lock portion is provided with at least one barb and the second lock portion is arranged to receive the at least one barb so as to lock the clip portions together in use.

40. The method of claim 31 wherein in the clip the first lock portion is provided with at least one barb and the second lock portion is arranged to receive the at least one barb so as to lock the clip portions together, wherein the second lock portion is provided with at least one barb, and wherein at least one of the first and second lock portions is provided with a plurality of barbs to function like a locking ratchet when the clip portions are hinged to the closed clip condition.

41. The method of claim 40, wherein in the clip both of the first and second lock portions are provided with a plurality of barbs and wherein in use at least two barbs of the first lock portion are in contact with at least two barbs of the second lock portion to provide a plurality of barb-to-barb contacts.

42. The method of claim 41 wherein the plurality of barbs enable the clip portions to be locked together in a plurality of different closed clip conditions during use, each different closed clip condition representing a different spacing between the clip portions, such that the clip can ligate blood vessels within a range of different sizes.

43. The method of claim 31 wherein in the clip in use the clip has a substantially spherical external shape.

44. The method of claim 31 wherein in the clip both of the clip portions are substantially hemispherical in shape.

45. The method of claim 31 wherein in the clip in use the clip has a substantially oval external shape.

46. The method of claim 31 wherein in the clip both of the clip portions are substantially hemioval in shape.

47. The method of claim 31 wherein in the clip the stand-off gap between the clamping surfaces in a closed clip condition is at least 0.3 mm.

48. The method of claim 31 wherein in the clip the stand-off gap between the clamping surfaces in a closed clip condition is less than about 1 mm.

49. The method of claim 31 wherein in the clip the clip structure is non-metallic.

50. The method of claim 31 wherein in the clip the clip structure comprises polypropylene.

51. The method of claim 31 wherein in the clip the clip structure comprises nylon.

52. The method of claim 31 wherein in the clip the clip structure comprises polydiaxonone.

53. The method of claim 31 wherein in the clip the clip is provided in a sterile container.

54. The method of claim 31 wherein in the clip the stand-off gap between the clamping surfaces in a closed clip condition is less than about 0.5 mm.

55. The method of claim 31 wherein the clip further comprises surface undulation on the first clamping surface and the second clamping surface.

56. The method of claim 37 wherein the varicose vein comprises tributaries of the femoral vein.

57. The method of claim 31 wherein the blood vessel comprises saphenous vein tributaries.

58. The method of claim 31 wherein the blood vessel is a cystic artery.