APPARATUS FOR DISCRETE TISSUE ANCHORING FOR SOFT TISSUE REPAIR AND METHOD OF USE

• US 20090171400A1
• Filed: 12/28/2007
• Published: 07/02/2009
• Est. Priority Date: 12/28/2007
• Status: Active Grant

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Original Assignee: Ross Creek Medical, Inc.
• Inventors: van der Burg, Erik, Cohen, Nathaniel
• Granted Patent: US 8,597,336 B2
• Time in Patent Office: Days
• US Class Current: 606/300
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0438 slotted, i.e. having a longitudinal slot for enhancing their elasticity
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0888 Anchor in or on a blind hole or on the bone surface without formation of a tunnel

Abstract

Disclosed herein are devices and methods for securing soft tissue to a rigid structure such as bone. Various directional anchors that allow for increasing the stability the attachment of soft tissue to bone are described. Also described is a delivery system for use with the directional anchors that allows for open surgical or arthroscopic application of one embodiment of the device. A method for repairing rotator cuff tears is also described.

Claims

1. A method for reattaching a tissue to bone, comprising:

providing at least one directional anchor having a tissue anchoring section and a bone anchoring section;

inserting the at least one directional anchor into bone so that the bone anchoring section penetrates the bone and the tissue anchoring section extends away from the bone;

placing tissue over the tissue anchoring section so that the tissue anchoring section penetrates only one surface of the tissue; and

applying force onto the tissue so that the tissue anchoring section extends into the tissue and enhances the mating engagement of the tissue to the bone.

2. The method of claim 1, wherein the at least one directional anchor has a longitudinal axis and the at least one directional anchor is inserted into the bone at an angle θ

which is the angle between the surface of the bone and the longitudinal axis.

3. The method of claim 2, wherein the at least one directional anchor is inserted into the bone at an angle θ

relative to a surface of the bone in a range of about 15°

to about 87°

.

4. The method of claim 3, wherein the tissue experiences at least one directional forces F tending to pull the tissue away from the bone, and wherein the directional anchor is angled in a direction substantially away from directional forces F on the tissue, thereby pulling the tissue onto the bone.

5. The method of claim 4, wherein a plurality of directional anchors are inserted into bone in a pattern corresponding to the surface of the tissue through which the tissue anchoring sections penetrate.

6. The method of claim 5, wherein the tissue anchoring sections have a length L, and the tissue has a thickness T, wherein L is less than T.

7. The method of claim 5, wherein the plurality of directional anchors are not connected to each other.

8. The method of claim 1, wherein the at least one directional anchor has an aperture for receiving a suture thread, and wherein a suture thread passes through the tissue on the side opposite the tissue anchoring section.

9. The method of claim 1, wherein the tissue engaging section does not engage the surface of the bone.

10. The method of claim 1, wherein the tissue being reattached to bone is the rotator cuff tendon, and wherein a plurality of directional anchors are inserted into bone in substantial alignment along the length of the rotator cuff tendon.

11. The method of claim 1, wherein a suture is passed along the tissue on the side of the tissue opposite the tissue engaging section to stabilize the tissue to the tissue engaging section.

12. The method of claim 1, wherein the tissue is the rotator cuff tendon which defines a footprint where the tendon mates with bone, further comprising inserting a plurality of directional anchors into the area of the footprint.

13. A method for reattaching a tissue to bone, comprising:

providing a first directional anchor, a second directional anchor, up to an Nth directional anchor, the directional anchors having a tissue anchoring section and a bone anchoring section;

inserting the directional anchors into bone so that the bone anchoring sections penetrate the bone and the tissue anchoring sections extend away from the bone;

placing tissue over the tissue anchoring sections so that the tissue anchoring sections penetrate only one surface of the tissue; and

applying force onto the tissue so that the tissue anchoring sections extend into the tissue thereby enhancing the mating engagement of the tissue to the bone.

14. The method of claim 13, wherein the directional anchors have a longitudinal axis and the directional anchors are inserted into the bone at an angle θ

which is the angle between the surface of the bone and the longitudinal axis.

15. The method of claim 14, wherein the directional anchors are inserted into the bone at an angle θ

relative to a surface of the bone in a range of about 15°

to about 87 .

16. The method of claim 13, wherein the tissue experiences at least one directional force F tending to pull the tissue away from the bone, and wherein the directional anchors are angled in a direction substantially away from directional forces F on the tissue, thereby pulling the tissue onto the bone.

17. The method of claim 13, wherein the tissue anchoring sections have a length L, and the tissue has a thickness T, wherein L is less than T.

18. The method of claim 13, wherein the directional anchors are spaced apart.

19. The method of claim 13, wherein the at least one directional anchor has an aperture for receiving a suture thread, and wherein a suture thread passes through the tissue on the side opposite the tissue anchoring section.

20. The method of claim 13, wherein the directional anchors are inserted into the bone a predetermined distance so that the tissue engaging sections do not contact the surface of the bone.

21. A method for attaching tissue to bone, comprising:

providing a plurality of directional anchors each having a tissue anchoring section and a bone anchoring section;

inserting the directional anchors into bone so that the bone anchoring sections penetrate bone and the tissue anchoring sections penetrate tissue;

placing tissue over the tissue anchoring sections so that the tissue anchoring sections penetrate only one surface of the tissue;

one of the directional anchors having an aperture for receiving a suture; and

inserting a suture thread into the tissue and through the aperture and tensioning the suture thread to secure the tissue onto the directional anchors.

22. The method of claim 21, wherein the suture is inserted into the side of the tissue opposite of the tissue engaging sections.

25. The method of claim 23, wherein the tissue is the rotator cuff tendon which defines a footprint where the tendon mates with bone, further comprising inserting the directional anchors into the area of the footprint and inserting the suture anchor into bone outside the area of the footprint.

26. A device for engaging bone and tissue, comprising:

an elongated anchor having a bone engaging section and a tissue engaging section being axially aligned;

the bone engaging section having a first length and the tissue engaging section having a second length, the first length being substantially longer than the second length.

27. The device of claim 26, wherein the anchor has a cylindrical shape.

28. The device of claim 27, wherein the cylindrically shaped anchor has a diameter in the range of approximately 0.5 mm to 2.0 mm.

29. The device of claim 26, wherein the bone engaging section has a first diameter and the tissue engaging section has a second diameter, the first diameter being greater than the second diameter.

30. The device of claim 26, wherein the elongated anchor has an overall length in the range of approximately 8 mm to 24 mm.

31. The device of claim 26, wherein the second length of the tissue engaging section is less than 5 mm.

32. The device of claim 26, wherein the second length of the tissue engaging section is less than 3 mm.

33. The device of claim 26, wherein a portion of the bone engaging section has threads for engaging bone.

34. The device of claim 26, wherein the tissue engaging section has a pointed tip for piercing tissue.

35. The device of claim 26, wherein the tissue engaging section has a barb for engaging tissue.

36. The device of claim 26, wherein the tissue engaging section has a hook for engaging tissue.

37. The device of claim 36, wherein the hook is formed from a shape memory alloy or a super-elastic alloy.

38. The device of claim 26, wherein the elongated anchor has a planar surface for engagement with a delivery device.

39. The device of claim 26, wherein the elongated anchor has at least two planar surfaces for engagement with a delivery device.

40. The device of claim 26, wherein the elongated anchor has a relief surface for mating engagement with a delivery device for imparting a distal force on the anchor.

41. The device of claim 26, wherein the elongated anchor is formed from a metal alloy.

42. The device of claim 26, wherein the elongated anchor is formed from a bioresorbable polymer or a biodegradable polymer.

43. The device of claim 26, wherein the elongated anchor has an aperture for receiving a suture thread.

128. The device of claim 26, wherein the anchor is coated with a therapeutic drug taken from the group of drugs consisting of alpha-interferon, genetically engineered epithelial cells, dexamethasone, and osteogenic or angiogenic factors.

44. An anchor for engaging bone and tissue, comprising:

an elongated member having a threaded bone engaging section and axially aligned with a tissue engaging section; and

the bone engaging section having a first length and the tissue engaging section having a second length, the second length being less than first length and being less than a thickness of the tissue which the tissue-engaging section pierces.

45. The anchor of claim 44, wherein the anchor has a cylindrical shape.

46. The anchor of claim 45, wherein the cylindrically shaped anchor has a diameter in the range of approximately 0.5 mm to 2.0 mm.

47. The anchor of claim 44, wherein the bone engaging section has a first diameter and the tissue engaging section has a second diameter, the first diameter being greater than the second diameter.

48. The anchor of claim 44, wherein the elongated anchor has an overall length in the range of approximately 8 mm to 24 mm.

49. The anchor of claim 44, wherein the second length of the tissue engaging section is less than 5 mm.

50. The anchor of claim 44, wherein the second length of the tissue engaging section is less than 3 mm.

51. The anchor of claim 44, wherein the tissue engaging section has a pointed tip for piercing tissue.

52. The anchor of claim 44, wherein the tissue engaging section has a barb for engaging tissue.

53. The anchor of claim 44, wherein the tissue engaging section has a hook for engaging tissue.

54. The anchor of claim 53, wherein the hook is formed from a shape memory alloy or a super-elastic alloy.

55. The anchor of claim 44, wherein the elongated anchor has a planar surface for engagement with a delivery device.

56. The anchor of claim 44 wherein the elongated anchor has at least two planar surfaces for engagement with a delivery device.

57. The anchor of claim 44, wherein the elongated anchor has a relief surface for mating engagement with a delivery device for imparting a distal force on the anchor.

58. The anchor of claim 44, wherein the elongated anchor is formed from a metal alloy.

59. The anchor of claim 44, wherein the elongated anchor is formed from a bioresorbable polymer or a biodegradable polymer.

60. The anchor of claim 44, wherein the elongated anchor has an aperture for receiving a suture thread.

129. The anchor of claim 44, wherein the anchor is coated with a therapeutic drug taken from the group of drugs consisting of alpha-interferon, genetically engineered epithelial cells, dexamethasone, and osteogenic or angiogenic factors.

61. An anchor for engaging bone and tissue, comprising:

an elongated member having a bone engaging section and a tissue engaging section; and

the bone engaging section having a first volume and the tissue engaging section having a second volume, the first volume being greater than the second volume.

62. The anchor of claim 61, wherein the first volume is configured for lying beneath the surface of the bone and the second volume is configured for lying above the surface of the bone.

63. The anchor of claim 61, wherein the anchor has a cylindrical shape.

64. The anchor of claim 63, wherein the cylindrically shaped anchor has a diameter in the range of approximately 0.5 mm to 2.0 mm.

65. The anchor of claim 61, wherein the bone engaging section has a first diameter and the tissue engaging section has a second diameter, the first diameter being greater than the second diameter.

66. The anchor of claim 61, wherein the elongated anchor has an overall length in the range of approximately 8 mm to 24 mm.

67. The anchor of claim 61, wherein the tissue engaging section has a length less than 5 mm.

68. The anchor of claim 61, wherein the tissue engaging section has a length less than 3 mm.

69. The anchor of claim 61, wherein a portion of the bone engaging section has threads for engaging bone.

70. The anchor of claim 61, wherein the tissue engaging section has a pointed tip for piercing tissue.

71. The anchor of claim 61, wherein the tissue engaging section has a barb for engaging tissue.

72. The anchor of claim 61, wherein the tissue engaging section has a hook for engaging tissue.

73. The anchor of claim 72, wherein the hook is formed from a shape memory alloy or a super-elastic alloy.

74. The anchor of claim 61, wherein the elongated anchor has a planar surface for engagement with a delivery device.

75. The anchor of claim 61, wherein the elongated anchor has at least two planar surfaces for engagement with a delivery device.

76. The anchor of claim 61, wherein the elongated anchor has a relief surface for mating engagement with a delivery device for imparting a distal force on the anchor.

77. The anchor of claim 61, wherein the elongated anchor is formed from a metal alloy.

78. The anchor of claim 61, wherein the elongated anchor is formed from a bioresorbable polymer or a biodegradable polymer.

79. The anchor of claim 61, wherein the elongated anchor has an aperture for receiving a suture thread.

130. The anchor of claim 61, wherein the anchor is coated with a therapeutic drug taken from the group of drugs consisting of alpha-interferon, genetically engineered epithelial cells, dexamethasone, and osteogenic or angiogenic factors.

80. A kit for attaching tissue to bone, comprising:

a plurality of directional anchors each having a bone engaging section and a tissue engaging section;

the bone engaging sections being inserted into bone and being substantially longer than the tissue engaging sections; and

a suture anchor having a suture thread attached thereto so that the suture thread is passed through the tissue to pull and hold the tissue onto the tissue engaging sections of the directional anchors.

81. The kit of claim 80, wherein the directional anchors have a cylindrical shape.

82. The kit of claim 81, wherein the cylindrically shaped directional anchor has a diameter in the range of approximately 0.5 mm to 2.0 mm.

83. The kit of claim 80, wherein the bone engaging sections have a first diameter and the tissue engaging sections have a second diameter, the first diameter being greater than the second diameter.

84. The kit of claim 80, wherein the directional anchors have an overall length in the range of approximately 8 mm to 24 mm.

85. The kit of claim 80, wherein the tissue engaging sections have a length less than 5 mm.

86. The kit of claim 80, wherein the tissue engaging sections have a length less than 3 mm.

87. The kit of claim 80, wherein the tissue engaging sections have a pointed tip for piercing tissue.

88. The kit of claim 80, wherein the tissue engaging section has a barb for engaging tissue.

89. The kit of claim 80, wherein the directional anchors have a planar surface for engagement with a delivery device.

90. The kit of claim 80, wherein the directional anchors have a relief surface for mating engagement with a delivery device for imparting a distal force on the anchor.

91. The kit of claim 80, wherein the directional anchors are formed from a bioresorbable polymer or a biodegradable polymer.

92. The anchor of claim 80, wherein at least one of the directional anchors has an aperture for receiving a suture thread.

131. The kit of claim 80, wherein the directional anchors are coated with a therapeutic drug taken from the group of drugs consisting of alpha-interferon, genetically engineered epithelial cells, dexamethasone, and osteogenic or angiogenic factors.

93. An anchor for engaging bone and tissue, comprising:

an elongated member having a threaded section for engaging bone and a pointed section for engaging tissue; and

the threaded section being longer than the pointed section.

94. The anchor of claim 93, wherein the anchor has a cylindrical shape.

95. The anchor of claim 94, wherein the cylindrically shaped anchor has a diameter in the range of approximately 0.5 mm to 2.0 mm.

96. The anchor of claim 93, wherein the threaded section has a first diameter and the pointed section has a second diameter, the first diameter being greater than the second diameter.

97. The anchor of claim 93, wherein the elongated anchor has an overall length in the range of approximately 8 mm to 24 mm.

98. The anchor of claim 97, wherein the second length of the pointed section is less than 5 mm.

99. The anchor of claim 97, wherein the second length of the pointed section is less than 3 mm.

100. The anchor of claim 93, wherein a portion of the threaded section has threads for engaging bone.

101. The anchor of claim 93, wherein the pointed section has a pointed distal tip for piercing tissue.

102. The anchor of claim 93, wherein the pointed section has a barb for engaging tissue.

103. The anchor of claim 93, wherein the pointed section has a hook for engaging tissue.

104. The anchor of claim 103, wherein the hook is formed from a shape memory alloy or a super-elastic alloy.

105. The anchor of claim 93, wherein the elongated anchor has a planar surface for engagement with a delivery device.

106. The anchor of claim 93, wherein the elongated anchor has at least two planar surfaces for engagement with a delivery device.

107. The anchor of claim 93, wherein the elongated anchor has a relief surface for mating engagement with a delivery device for imparting a distal force on the anchor.

108. The anchor of claim 93, wherein the elongated anchor is formed from a metal alloy.

109. The anchor of claim 93, wherein the elongated anchor is formed from a bioresorbable polymer or a biodegradable polymer.

110. The anchor of claim 93, wherein the elongated anchor has an aperture for receiving a suture thread.

132. The anchor of claim 93, wherein the anchor is coated with a therapeutic drug taken from the group of drugs consisting of alpha-interferon, genetically engineered epithelial cells, dexamethasone, and osteogenic or angiogenic factors.

111. An anchor for engaging bone and tissue, comprising:

an elongated member having a threaded bone engaging section and axially aligned with a tissue engaging section; and

the bone engaging section having a first transverse cross-sectional perimeter and the tissue engaging section having a second transverse cross-sectional perimeter, the second transverse cross-sectional perimeter being less than first transverse cross-sectional perimeter.

112. The anchor of claim 111, wherein the anchor has a cylindrical shape.

113. The anchor of claim 112, wherein the cylindrically shaped anchor has a diameter in the range of approximately 0.5 mm to 2.0 mm.

114. The anchor of claim 111, wherein the bone engaging section has a first diameter and the tissue engaging section has a second diameter, the first diameter being greater than the second diameter.

115. The anchor of claim 111, wherein the elongated anchor has an overall length in the range of approximately 8 mm to 24 mm.

116. The anchor of claim 111, wherein the tissue engaging section has a length less than 5 mm.

117. The anchor of claim 111, wherein the tissue engaging section has a length less than 3 mm.

118. The anchor of claim 111, wherein the tissue engaging section has a pointed tip for piercing tissue.

119. The anchor of claim 111, wherein the tissue engaging section has a barb for engaging tissue.

120. The anchor of claim 111, wherein the tissue engaging section has a hook for engaging tissue.

121. The anchor of claim 120, wherein the hook is formed from a shape memory alloy or a super-elastic alloy.

122. The anchor of claim 111, wherein the elongated anchor has a planar surface for engagement with a delivery device.

123. The anchor of claim 111, wherein the elongated anchor has at least two planar surfaces for engagement with a delivery device.

124. The anchor of claim 111, wherein the elongated anchor has a relief surface for mating engagement with a delivery device for imparting a distal force on the anchor.

125. The anchor of claim 111, wherein the elongated anchor is formed from a metal alloy.

126. The anchor of claim 111, wherein the elongated anchor is formed from a bioresorbable polymer or a biodegradable polymer.

127. The anchor of claim 111, wherein the elongated anchor has an aperture for receiving a suture thread.

133. The anchor of claim 111, wherein the anchor is coated with a therapeutic drug taken from the group of drugs consisting of alpha-interferon, genetically engineered epithelial cells, dexamethasone, and osteogenic or angiogenic factors.