Composite staple for completing an anastomosis

• US 20030045902A1
• Filed: 08/28/2001
• Published: 03/06/2003
• Est. Priority Date: 08/28/2001
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Weadock, Kevin S.
• Granted Patent: US 6,629,988 B2
• Time in Patent Office: Days
• US Class Current: 606/219
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections

Abstract

An anastomosis staple comprising of a plurality of vessel engaging members and a binding structure holding the vessel engaging members together is described. The binding structure has at least one bioabsorbable element. The binding structure is rigid enough to allow for deployment and quickly resorbs to avoid problems associated with intimal hyperplasia and physical hindrance of secondary interventional procedures. The vessel engaging members may be comprised of superelastic or shape memory metal and are independent from one another. The members may be equidistant from one another and embedded within the binding structure. The composite staple can preferably serve as a drug delivery vehicle.

Claims

1. A composite staple effective for use in an anastomosis, comprising:

a plurality of vessel engaging members; and

a binding structure holding each of the plurality of vessel engaging members in a predefined spatial relationship with respect to each of the other vessel engaging members, the binding structure including at least one bioabsorbable element configured such that at least one vessel engaging member is free to move with respect to at least one other vessel engaging member after the bioabsorbable element has resorbed.

2. The composite staple of claim 1, wherein the binding structure is a bioabsorbable scaffold.

3. The composite staple of claim 2, wherein the bioabsorbable scaffold is radially expandable.

4. The composite staple of claim 3, wherein the bioabsorb able scaffold is annular in shape.

5. The composite staple of claim 3, wherein the bioabsorbable scaffold is elliptical in shape.

6. The composite staple of claim 1, wherein the binding structure forms a C-ring after the bioabsorbable element has resorbed.

7. The composite staple of claim 1, wherein the binding structure separates into at least two pieces after the bioabsorbable element has resorbed.

8. The composite staple of claim 1, wherein the vessel engaging members are formed from a material selected from the group comprising superelastic material and shape memory material.

9. The composite staple of claim 8, wherein the shape memory material is a nickel alloy.

10. The composite staple of claim 9, wherein the nickel alloy is nitinol.

11. The composite staple of claim 1, wherein the vessel engaging members are formed from stainless steel, titanium, or titanium alloy.

12. The composite staple of claim 2, wherein the bioabsorbable scaffold is formed from a mixture of polylactic acid and polyglycolic acid.

13. The composite staple of claim 2, wherein the bioabsorbable scaffold contains pharmaceutical or radioactive substances.

14. The composite staple of claim 13, wherein the pharmaceutical or radioactive substances are selected from the group comprising antibiotics, anticoagulants, procoagulants, and radioisotopes with a β

-component.

15. The composite staple of claim 14, wherein the radioisotopes are ³²P and ¹³¹I.

16. The composite staple of claim 1, wherein the vessel engaging members are coated with a radioactive substance.

17. The composite staple of claim 16, wherein the radioactive substance is ³²P or ¹³¹I.

18. A composite staple effective for use in an anastomosis, comprising:

a plurality of vessel engaging members; and

a bioabsorbable scaffold holding each of the plurality of vessel engaging members in a predefined spatial relationship with respect to each of the other vessel engaging members, the scaffold being configured such that at least one vessel engaging member is free to move with respect to at least one other vessel engaging member after the bioabsorbable scaffold has resorbed;

wherein each of the vessel engaging members is at least partially embedded within the scaffold and has at least one arm extending out of the scaffold for effecting an anastomotic connection between a graft vessel and a target vessel.

19. The composite staple of claim 18, wherein each vessel engaging member has two diametrically opposed arms extending out of the scaffold.

20. The composite staple of claim 18, wherein the scaffold is radially expandable.

21. The composite staple of claim 20, wherein the scaffold is annular in shape.

22. The composite staple of claim 20, wherein the scaffold is elliptical in shape.

23. The composite staple of claim 18, wherein the vessel engaging members are spaced substantially equidistally apart within the scaffold.

24. The composite staple of claim 18, wherein the vessel engaging members are not in direct contact with one another.

25. The composite staple of claim 18, wherein each vessel engaging member has a central body that is larger in diameter than the rest of the member to facilitate anchorage within the scaffold.

26. The composite staple of claim 18, wherein the vessel engaging members are formed from a material selected from the group comprising superelastic material and shape memory material.

27. The composite staple of claim 26, wherein the shape memory material is a nickel alloy.

28. The composite staple of claim 27, wherein the nickel alloy is nitinol.

29. The composite staple of claim 18, wherein the vessel engaging members are formed from stainless steel, titanium, or titanium alloy.

30. The composite staple of claim 18, wherein the absorbable scaffold is formed from a mixture of polylactic acid and polyglycolic acid.

31. The composite staple of claim 18, wherein the absorbable scaffold has an arched geometry.

32. The composite staple of claim 18, wherein the absorbable scaffold contains pharmaceutical or radioactive substances.

33. The composite staple of claim 32, wherein the pharmaceutical or radioactive substances are selected from the group comprising antibiotics, anticoagulants, procoagulants, and radioisotopes with β

-components.

34. The composite staple of claim 33, wherein the radioisotopes are ³²P and ¹³¹I.

35. The composite staple of claim 18, wherein the vessel engaging members are coated with a radioactive substance.

36. The composite staple of claim 35, wherein the radioactive substance is ³²P or ¹³¹I.

37. A composite staple effective for use in an anastomosis, comprising:

a plurality of vessel engaging members; and

a radially expandable bioabsorbable scaffold holding each of the plurality of vessel engaging members in a predefined spatial relationship with respect to each of the other vessel engaging members, the scaffold being configured such that at least one vessel engaging member is free to move with respect to at least one other vessel engaging member after the bioabsorbable scaffold has resorbed;

wherein each of the vessel engaging members is at least partially embedded within the scaffold and has at least one arm extending out of the scaffold for effecting an anastomotic connection between a graft vessel and a target vessel.

38. The composite staple of claim 37, wherein each vessel engaging member has two diametrically opposed arms extending out of the scaffold.

39. The composite staple of claim 37, wherein the scaffold is annular in shape.

40. The composite staple of claim 37, wherein the scaffold is elliptical in shape.

41. The composite staple of claim 37, wherein the scaffold comprises a plurality of alternating nodes and arched bands.

42. The composite staple of claim 41, wherein each vessel engaging member is embedded within one of the plurality of nodes.

43. The composite staple of claim 41, wherein each vessel engaging member has a central body that is larger in diameter than the rest of the member to facilitate anchorage within the node.

44. The composite staple of claim 41, wherein the vessel engaging members are formed from a material selected from the group comprising superelastic material and shape memory material.

45. The composite staple of claim 44, wherein the shape memory material is a nickel alloy.

46. The composite staple of claim 45, wherein the nickel alloy is nitinol.

47. The composite staple of claim 37, wherein the vessel engaging members are formed from stainless steel, titanium, or titanium alloy.

48. The composite staple of claim 37, wherein the resorbable scaffold is formed from a mixture of polylactic acid and polyglycolic acid.

49. The composite staple of claim 37, wherein the resorbable scaffold contains pharmaceutical or radioactive substances.

50. The composite staple of claim 49, wherein the pharmaceutical or radioactive substances are selected from the group comprising antibiotics, anticoagulants, procoagulants, and radioisotopes with β

-components.

51. The composite staple of claim 50, wherein the radioisotopes are ³²P and ¹³¹I.

52. The composite staple of claim 37, wherein the vessel engaging members are coated with a radioactive substance.

53. The composite staple of claim 52, wherein the radioactive substance is ³²P or ¹¹³I.

54. A composite staple effective for use in an anastomosis, comprising:

a plurality of vessel engaging members; and

a binding structure holding each of the plurality of vessel engaging members in a predefined spatial relationship with respect to each of the other vessel engaging members, the binding structure comprising a plurality of bridges and at least one bioabsorbable element, and being configured such that at least one vessel engaging member is free to move with respect to at least one other vessel engaging member after the bioabsorbable element has resorbed;

wherein a pair of adjacent vessel engaging members is connected by at least one bridge, and at least one pair of adjacent vessel engaging members is connected by the at least one bioabsorbable element.

55. The composite staple of claim 54, further having an annular shape.

56. The composite staple of claim 54, further having an elliptical shape.

57. The composite staple of claim 54, wherein the vessel engaging members and bridges are formed from a material selected from the group comprising superelastic material and shape memory material.

58. The composite staple of claim 57, wherein the shape memory material is a nickel alloy.

59. The composite staple of claim 58, wherein the nickel alloy is nitinol.

60. The composite staple of claim 54, wherein the vessel engaging members and bridges are formed from stainless steel, titanium, or titanium alloy.

61. The composite staple of claim 54, wherein the bioabsorbable element is formed from a mixture of polylactic acid and polyglycolic acid.

62. The composite staple of claim 54, wherein the bioabsorbable element contains pharmaceutical or radioactive substances.

63. The composite staple of claim 62, wherein the pharmaceutical or radioactive substances are selected from the group comprising antibiotics, anticoagulants, procoagulants, and radioisotopes with β

-components.

64. The composite staple of claim 63, wherein the radioisotopes are ³²P and ¹³¹I.

65. The composite staple of claim 54, wherein vessel engaging members are coated with a radioactive substance.

66. The composite staple of claim 65, wherein the radioactive substance is ³²P or ¹³¹I.

67. A composite staple effective for use in an anastomosis, comprising:

a plurality of vessel engaging members; and

a bioabsorbable scaffold holding each of the plurality of vessel engaging members in a predefined spatial relationship with respect to each of the other vessel engaging members, the scaffold being configured such that at least one vessel engaging member is free to move with respect to at least one other vessel engaging member after the bioabsorbable scaffold has resorbed;

wherein each of the vessel engaging members is at least partially embedded within the bioabsorbable scaffold, each vessel engaging member having at least one protrusion extending beyond an outer surface of the scaffold for effecting an anastomotic connection between a graft vessel and a target vessel.

68. The composite staple of claim 67, wherein each vessel engaging member comprises a plurality of protrusions, each protrusion extending radially in 3-dimensions.

69. The composite staple of claim 67, wherein the bioabsorbable scaffold has a through-hole.

70. The composite staple of claim 67, wherein the bioabsorbable scaffold has an annular shape.

71. The composite staple of claim 67. wherein the bioabsorbable scaffold has an elliptical shape.

72. The composite staple of claim 67, wherein the bioabsorbable scaffold is formed from a mixture of polylactic acid and polyglycolic acid.

73. The composite staple of claim 67, wherein the resorbable scaffold contains pharmaceutical or radioactive substances.

74. The composite staple of claim 73, wherein the pharmaceutical or radioactive substances are selected from the group comprising antibiotics, anticoagulants, procoagulants, and radioisotopes with β

-components.

75. The composite staple of claim 74, wherein the β

-type emitters are ³²P and ¹³¹I.

76. The composite staple of claim 67, wherein the vessel engaging members are coated with a radioactive substance.

77. The composite staple of claim 76, wherein the radioactive substance is ³²P or ¹³¹I.

78. Method for anastomosing two vessels together, comprising:

providing a composite staple having a plurality of vessel engaging members and a binding structure holding each of the plurality of vessel engaging members in a predefined spatial relationship with respect to each of the other vessel engaging members, the binding structure including at least one bioabsorbable element configured such that at least one vessel engaging member is free to move with respect to at least one other vessel engaging member after the bioabsorbable element has resorbed;

attaching a graft vessel to the composite staple;

positioning the graft vessel and composite staple proximate an opening in a target vessel; and

deploying the composite staple so that a secure anastomosis is enabled.

79. The method of claim 78, wherein the anastomosis is a type selected from the group consisting of an end-to-side connection, a side-to-side connection, and an end-to-end connection.

80. The method of claim 78, wherein the step of deploying the composite staple includes allowing the vessel engaging members to conform to a pre-annealed shape.

81. The method of claim 78, wherein the step of deploying the composite staple includes applying force to the vessel engaging members to urge the members into the vessel walls.

82. The method of claim 78, wherein the composite staple is attached to the inside of the graft or target vessel.

83. The method of claim 78, wherein the composite staple is attached to the outside of the graft or target vessel.

84. The method of claim 78, wherein the step of attaching the graft vessel to the composite staple includes eversion of the graft vessel over the composite staple.

85. The method of claim 78, further including the step of allowing the bioabsorbable element to completely resorb.