Slitted tissue fixation devices and assemblies for deploying the same

• US 20060167481A1
• Filed: 01/25/2005
• Published: 07/27/2006
• Est. Priority Date: 01/25/2005
• Status: Abandoned Application

• Current Assignee: Endogastric Solutions
• Original Assignee: EsophyX, Inc.
• Inventors: Kraemer, Stefan J. M., Baker, Steve G., Wolniewicz, Raymond Michael III
• Application Number:
  US11/043,903
• Publication Number:
  US 20060167481A1
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• 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 17/10 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 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61B 2017/0645 being elastically deformed for insertion
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/3937 Visible markers

Abstract

Tissue fasteners carried on a tissue piercing deployment wire fasten tissue layers of a mammalian body together include a first member, a second member, and a connecting member extending between the first and second members. One of the first and second members has a configuration alterable by a deployment wire to permit release of the fastener from the deployment wire after deployment and without causing excessive tissue trauma.

Claims

1. A fastener for use in a mammalian body, comprising:

a first member;

a second member,

the first and second members having first and second ends; and

a connecting member fixed to each of the first and second members intermediate the first and second ends and extending between the first and second members,

the first and second members being separated by the connecting member, and

one of the first and second members having a through channel along the axis arranged to be slidingly received on a tissue piercing deployment wire, and a slit extending between the first and second ends and communicating with the through channel.

2. The fastener of claim 1 wherein the slit includes an elongated slot portion dimensional to receive the tissue piercing deployment wire.

3. The fastener of claim 1 wherein the slit is substantially parallel to the through channel.

4. The fastener of claim 1 wherein the connecting member is flexible permitting another one of the first and second members to be next to the one of the first and second members when the one of the first and second members is on the tissue piercing deployment wire.

5. The fastener of claim 1 wherein one end of the one of the first and second members further includes a pointed tip.

6. The fastener of claim 1 wherein the through channel comprises a through bore.

7. The fastener of claim 1 wherein the first member, the second member, and the connecting member are all formed of plastic material.

8. The fastener of claim 7 wherein the first member, the second member, and the connecting member are all formed in one piece.

9. The fastener of claim 7 wherein the connecting member is formed of plastic elastic material.

10. The fastener of claim 7 wherein the plastic material includes a color pigment contrasting with body tissue color to enable visualization of the fastener with an endoscope.

11. The fastener of claim 1 wherein the through channel has a diameter, wherein the slit has a width, and wherein the width of the slit is less than the diameter of the through channel.

12. A fastener assembly for use in a mammalian body, comprising:

a fastener including a first member, a second member, wherein the first and second members have first and second ends, and a connecting member fixed to each of the first and second members intermediate the first and second ends and extending between the first and second members, wherein the first and second members are separated by the connecting member, and wherein one of the first and second members has a longitudinal axis, a through channel along the axis, and a slit extending between the first and second ends and communicating with the through channel;

a deployment wire arranged to be slidingly received by the through channel of the one of the first and second members and to pierce into the tissue and arranged to be received by the slit to enable early deployment of the one of the first and second members and reduced tissue compression; and

a pusher that pushes the one of first and second members into the tissue while on the deployment wire.

13. The assembly of claim 12 wherein the slit includes a slotted portion dimensioned to receive the deployment wire.

14. The assembly of claim 12 wherein the slit is substantially parallel to the through channel.

15. The assembly of claim 12 wherein the pusher is also arranged to be slidingly received on the deployment wire.

16. The assembly of claim 12 wherein the connecting member of the fastener is flexible, and wherein the assembly further comprises a guide tube extending over the deployment wire and the fastener, the other one of the first and second members being disposed next to the one of the first and second members within the guide tube.

17. The assembly of claim 12 wherein the first and second members are arranged to be side by side when the one of the first and second members is slidingly received on the deployment wire.

18. The assembly of claim 12 wherein one end of the one of the first and second members of the fastener further includes a pointed tip.

19. The assembly of claim 12 further comprising a guide tube extending over the deployment wire and the fastener.

20. The assembly of claim 12 wherein the first member, the second member, and the connecting member of the fastener are all formed of plastic material.

21. The assembly of claim 12 wherein the one of the first and second members of the fastener is self-deployable when the tissue piercing deployment wire is received by the slit.

22. The assembly of claim 12 wherein the through channel has a diameter, wherein the slit has a width, and wherein the width of the slit is less than the diameter of the through channel.

23. A fastener assembly for use in a mammalian body, comprising:

a fastener including a first member, a second member, wherein the first and second members have first and second ends, and a connecting member fixed to each of the first and second members intermediate the first and second ends and extending between the first and second members, wherein the first and second members are separated by the connecting member, and wherein one of the first and second members has a cross-sectional dimension and a slit extending between the first and second ends and communicating with the through channel;

a deployment wire arranged to be slidingly received by the through channel of the one of the first and second members and having a pointed tip to pierce into tissue, the pointed tip having a cross-sectional dimension equal to or greater than the cross-sectional dimension of the through channel; and

a pusher that pushes the one of first and second members into the tissue while on the deployment wire.

24. The assembly of claim 23 wherein the slit includes a slot portion dimension to receive the deployment wire.

25. The assembly of claim 23 wherein the pusher is also arranged to be slidingly received on the deployment wire.

26. The assembly of claim 23 wherein the connecting member of the fastener is flexible, and wherein the assembly further comprises a guide tube extending over the deployment wire and fastener, the other one of the first and second members being disposed next to the one of the first and second members within the guide tube.

27. The assembly of claim 23 wherein the first and second members are arranged to be side by side when the one of the first and second members is slidingly received on the deployment wire.

28. The assembly of claim 25 wherein one end of the one of the first and second members of the fastener further includes a pointed tip.

29. The assembly of claim 28 wherein the pointed tip comprises a truncated cone.

30. The assembly of claim 23 further comprising a guide tube extending over the deployment wire and the fastener.

31. The assembly of claim 23 wherein the one of the first and second members is formed of a flexible material to permit the deployment wire to be received within the through channel through the slit.

32. The assembly of claim 31 wherein the first member, the second member, and the connecting member of the fastener are all formed of plastic material.

33. The assembly of claim 31 wherein the first member, the second member, and the connecting member of the fastener are all formed in one piece.

34. The assembly of claim 31 wherein the fastener is formed of one of polyurethane, thermoplastic elastomer, and polypropylene.

35. The assembly of claim 31 wherein the fastener is formed of metal.

36. The assembly of claim 23 wherein the one of the first and second members of the fastener is self-deployable when the tissue piercing deployment wire is received by the slit during retraction.

37. The assembly of claim 23 wherein the through channel has a diameter, wherein the slit has a width, and wherein the width of the slit is less than the diameter of the through channel.

52. The assembly of claim 28 wherein the fastener member has a slit communicating with the through channel to enable the through channel to be received by the deployment wire and wherein the deployment wire includes a piercing tip, the piercing tip having a cross-sectional dimension and the fastener member having a cross-sectional dimension and wherein the cross-sectional dimension of the piercing tip is greater than the cross-sectional area of the fastener member.

38. A fastener assembly for use in a mammalian body, comprising:

a deployment wire having an end arranged to pierce into tissue to be fastened;

a fastener including a member having a through channel dimensioned to be slidingly received on the deployment wire; and

a pusher that pushes the fastener into the tissue while on the deployment wire,

the pusher being tubular having a distal end, a sidewall, a lumen, and an opening in the sidewall communicating with the lumen,

wherein the pusher is carried on the deployment wire, the deployment wire extending through the sidewall opening, into the lumen, and beyond the distal end of the pusher, and

wherein the fastener member is carried on the deployment wire between the deployment wire end and the distal end of the pusher arranged to pierce into the tissue upon being pushed by the pusher.

39. The assembly of claim 38 wherein the fastener member includes first and second ends and a slit extending between the first and second ends and communicating with the through channel.

40. The assembly of claim 39 wherein the through channel has a diameter, wherein the slit has a width, and wherein the width of the slit is less than the diameter of the through channel.

41. The fastener assembly of claim 38 wherein the fastener member is a first member, and wherein the fastener includes the first member, a second member and a connecting member extending between the first and second members.

42. The assembly of claim 41 wherein the first member, the second member, and the connecting member of the fastener are all formed of plastic material.

43. The assembly of claim 41 wherein the first member includes first and second ends and a slit extending between the first and second ends and communicating with the through channel.

44. The assembly of claim 43 wherein the slit includes an elongated slot.

45. The assembly of claim 44 wherein the first member of the fastener is self-deployable when the tissue piercing deployment wire is received by the elongated slot.

46. The assembly of claim 41 wherein the connecting member of the fastener is flexible, and wherein the assembly further comprises a guide tube extending over the deployment wire and the fastener, the second member being disposed next to the first member within the guide tube.

47. The assembly of claim 41 wherein the first and second members are arranged to be side by side when the first member is a slidingly received on the deployment wire.

48. The assembly of claim 41 wherein one end of the first member of the fastener further includes a pointed tip.

49. The assembly of claim 47 wherein the first member, the second member, and the connecting member of the fastener are all formed in one piece.

50. The assembly of claim 41 wherein the fastener is formed of a shape memory material.

51. The assembly of claim 41 further comprising a guide tube extending over the deployment wire and the fastener.

53. A fastener for use in a mammalian body, comprising:

a first member;

a second member,

the first and second members having first and second ends; and

a connecting member fixed to each of the first and second members intermediate the first and second ends and extending between the first and second members,

the first and second members being separated by the connecting member, and

one of the first and second members having a through channel arranged to be slidingly received on a tissue piercing deployment wire, and a configuration alterable by the tissue piercing deployment wire that permits release of the fastener from the tissue piercing deployment wire.

54. The fastener of claim 53, wherein the configuration of the one of the first and second members is tearable by the tissue piercing deployment wire.

55. The fastener of claim 54, wherein the one of the first and second members has a sidewall, and wherein the sidewall is tearable by the tissue piercing deployment wire.

56. The fastener of claim 55, wherein the sidewall has a varying thickness.

57. The fastener of claim 53, wherein the configuration of the one of the first and second members is deformable by the tissue piercing deployment wire.

58. The fastener of claim 57, wherein the one of the first and second members has a sidewall, and wherein the sidewall is deformable by the tissue piercing deployment wire.

59. The fastener of claim 58, wherein the sidewall includes a lengthwise slit.

60. The fastener of claim 59, wherein the lengthwise slit is continuous from the first end to the second end.

61. The fastener of claim 60, wherein the slit includes a slot portion.

62. A fastener assembly for use in a mammalian body, comprising:

a fastener including a first member, a second member, wherein the first and second members have first and second ends, and a connecting member fixed to each of the first and second members intermediate the first and second ends and extending between the first and second members, wherein the first and second members are separated by the connecting member, and wherein one of the first and second members has a longitudinal axis and a through channel along the axis;

a deployment wire arranged to be slidingly received by the through channel of the one of the first and second members and to pierce into the tissue; and

a pusher that pushes the one of first and second members into the tissue while on the deployment wire,

the one of the first and second members having a configuration that is alterable by the tissue piercing deployment wire that permits release of the fastener from the tissue piercing deployment wire upon relative movement of the one of the first and second members and the tissue piercing deployment wire.

63. The fastener assembly of claim 62, wherein the configuration of the one of the first and second members is tearable by the tissue piercing deployment wire.

64. The fastener assembly of claim 63, wherein the one of the first and second members has a cross-sectional dimension and wherein the tissue piercing deployment wire has a tip end having a cross-sectional dimension that is greater than or equal to the cross-sectional dimension of the through channel.

65. The fastener assembly of claim 63, wherein the one of the first and second members has a sidewall, and wherein the sidewall is tearable by the tissue piercing deployment wire.

66. The fastener assembly of claim 65, wherein the sidewall has a varying thickness.

67. The fastener assembly of claim 62, wherein the configuration of the one of the first and second members is deformable by the tissue piercing deployment wire.

68. The fastener assembly of claim 67, wherein the one of the first and second members has a cross-sectional dimension and wherein the tissue piercing deployment wire has a tip end having a cross-sectional dimension that is greater than or equal to the cross-sectional dimension of the through channel.

69. The fastener assembly of claim 67, wherein the one of the first and second members has a sidewall, and wherein the sidewall is deformable by the tissue piercing deployment wire.

70. The fastener assembly of claim 69, wherein the sidewall includes a lengthwise slit.

71. The fastener assembly of claim 70, wherein the lengthwise slit is continuous from the first end to the second end.

72. The fastener assembly of claim 71, wherein the slit includes a slot portion.

73. The fastener assembly of claim 62, wherein the pusher is tubular having a distal end, a sidewall, a lumen, and an opening in the sidewall communicating with the lumen, wherein the pusher is carried on the tissue piercing deployment wire, the tissue piercing deployment wire extending through the sidewall opening, into the lumen, and beyond the distal end of the pusher, and wherein the one of the first and second members is carried on the deployment wire between the deployment wire end and the distal end of the pusher arranged to pierce into the tissue upon being pushed by the pusher.