Surgical procedures and instruments

• US 6,620,185 B1
• Filed: 06/27/2000
• Issued: 09/16/2003
• Est. Priority Date: 06/27/2000
• Status: Expired due to Term

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Richardson, Peter, James, Adam, Harvie, Fraser, Huckle, James William
• Primary Examiner(s): Lewis, Ralph A.
• Application Number:
  US09/604,387
• Time in Patent Office: 1,176 Days
• Field of Search: 606/72, 606/92, 606/93, 606/215, 606/216, 606/219, 606/220, 606/232
• US Class Current: 606/232
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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 17/1637 Hollow drills or saws producing a curved cut, e.g. cylindrical A61B10/025, A61B17/1695 take precedence
• CPC Class Codes: A61B 17/1684 for the shoulder
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 2017/005 hardenable using external energy source, e.g. laser, ultrasound
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• 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 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0446 Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks

Abstract

Surgical instruments and methods are provided. In one aspect, a method of securing a fixation device within an opening in a tissue is provided, including delivering a material in a flowable state to said opening, and changing the state of the material so that the material forms an interference fit that secures the fixation device in the opening.

Claims

1. A method of anchoring soft tissue to bone comprising:

piercing the soft tissue;

forming an opening in an underlying area of the bone;

delivering a material, in a flowable state, to the opening; and

molding a portion of the material that is not in the opening to form a fixation device constructed to hold the soft tissue in place against the bone after the material changes state to a relatively less flowable state.

2. The method of claim 1 wherein the molding step includes forming a portion of the material into a shape that extends radially over a portion of the soft tissue surrounding the opening.

3. The method of claim 2 wherein the formed portion extending radially over the soft tissue is coextensive with the material in the opening, defining a bolt-like anchor.

4. The method of claim 1 wherein the forming step includes drilling or abrading.

5. The method of claim 1 wherein all of the steps are performed endoscopically.

6. The method of claim 1 further comprising incorporating bone fragments generated during the forming step into the material during or prior to the delivering step.

7. The method of claim 1 wherein the material comprises an osteoconductive filler.

8. The method of claim 1 further comprising causing the material to infiltrate the trabecular network.

9. The method of claim 1 wherein the opening has a diameter of less than about 3 mm.

10. The method of claim 1 wherein the opening has a diameter of from about 0.1 to 6.0 mm.

11. The method of claim 1 wherein the forming step is performed using micro-tooling.

12. The method of claim 1 wherein the material comprises a polymer.

65. The method of claim 1 wherein said material comprises a polymer.

66. The method of claim 65 wherein said polymer comprises a thermoplastic polymer.

13. A method of fixing soft tissue to bone comprising:

(a) at a first location, piercing through the soft tissue;

(b) forming an opening in the bone underlying the soft tissue;

(c) delivering a fixation device through the pierced tissue to the opening;

(d) delivering a material, in a non-liquid state, to the vicinity of the opening; and

(e) after delivery, liquifying and subsequently resolidifying the material to anchor at least a portion of the fixation device in the opening.

14. The method of claim 13, wherein said fixation device is selected from the group consisting of suture, anchors and screws.

15. The method of claim 14 wherein said fixation device is a suture.

16. The method of claim 15, further comprising:

(f) drawing the suture across the soft tissue to a second location, and

(g) repeating steps (a)-(e) at the second location to form a stitch with said suture between the first and second locations, the stitch securing the soft tissue to the bone.

17. The method of claim 16 further comprising, after step (g), (h) cutting the suture.

18. The method of claim 17 comprising performing steps (a) and (h) with a single tool.

19. The method of claim 16 further comprising repeating steps (f)-(g) at subsequent locations to form a line of connected stitches.

20. The method of claim 15 comprising delivering the suture as a continuous length from a supply of suture material.

21. The method of claim 13 further comprising gripping the soft tissue to hold it in place against the bone.

22. The method of claim 13 further comprising performing steps (a)-(d) endoscopically.

23. The method of claim 13 comprising performing steps (c) and (d) substantially simultaneously.

24. The method of claim 13 comprising performing step (c) prior to step (d).

25. The method of claim 13 comprising providing said material in the form of a pellet, powder, chips, flakes or rod, and further comprising melting the material prior to delivery.

26. The method of claim 13 further comprising incorporating bone fragments generated during the forming step into the material during or prior to the delivering step.

27. The method of claim 13 further comprising incorporating an osteoconductive filler into said material.

28. The method of claim 27 wherein the opening has a diameter of from about 0.1 to 6.0 mm.

29. The method of claim 13 further comprising causing the material, in its flowable state, to infiltrate the trabecular network.

30. The method of claim 13 wherein the forming step comprises forming a opening having a diameter of less than about 3 mm.

31. The method of claim 13 wherein the forming step comprises drilling or abrading.

32. The method of claim 13 further comprising performing the forming step using micro-tooling.

33. The method of claim 13 wherein the method comprises performing the forming step in the bone of a human shoulder.

34. The method of claim 33 wherein the method comprises a rotator cuff repair.

101. A surgical instrument constructed to perform the steps of the method of claim 13 endoscopically.

35. A surgical instrument for tissue fixation comprising:

a handpiece constructed to be held by a surgeon during a fixation procedure; and

a fixation instrument, mounted on the handpiece and comprising a cannulated tube defining a lumen;

a piercing element constructed to be delivered through the lumen, to pierce through bone and form an opening therein;

a delivery device for delivering a flowable material and a fixation device through the lumen to the opening; and

a heating element for heating said material to a molten state.

36. The surgical instrument of claim 35 wherein the fixation device comprises a suture.

37. The surgical instrument of claim 36 further comprising a suture feed mechanism constructed to deliver the suture through the lumen to the opening.

38. The surgical instrument of claim 37 further comprising a probe configured to be positioned, in use, adjacent the opening, and constructed to move in a direction generally perpendicular to the direction of travel of suture material between a first attachment location and a second attachment location to tighten a stitch formed between the two locations with the suture.

39. The surgical instrument of claim 38 wherein said probe is mounted on an external surface of said fixation instrument.

40. The surgical instrument of claim 39 wherein said probe is constructed to be manually actuated by a surgeon during an endoscopic procedure.

41. The surgical instrument of claim 37 further comprising a drive mechanism constructed to drive the piercing element and the suture feed mechanism.

42. The surgical instrument of claim 41 further comprising a clutch mechanism constructed to allow a surgeon to selectively engage and disengage the drive of the piercing element and the drive of the suture feed mechanism.

43. The surgical instrument of claim 36 wherein said piercing element is constructed to cut said suture.

44. The surgical instrument of claim 35 further comprising a drive mechanism constructed to drive the piercing element.

45. The surgical instrument of claim 44 or 41 wherein the drive mechanism is disposed in said handpiece.

46. The surgical instrument of claim 35 wherein the surgical instrument is constructed for endoscopic use.

47. The surgical instrument of claim 35 wherein said heating element is mounted on said fixation instrument.

48. The surgical instrument of claim 37 wherein said suture feed mechanism comprises a movable needle positioned to be advanced at least partially into the lumen to feed the suture towards the opening.

49. The surgical instrument of claim 35 wherein said handpiece comprises a reservoir for receiving the material in solid form.

50. The surgical instrument of claim 49 wherein said reservoir is constructed to receive a supply of pellets of the material and said handpiece further comprises a mechanism for delivering said pellets from said reservoir to said lumen.

51. The surgical instrument of claim 49 wherein said reservoir is constructed to receive a supply of powdered material and said handpiece further comprises a mechanism for delivering a predetermined dose of powdered material from said reservoir to said lumen.

52. The surgical instrument of claim 35, wherein said fixation instrument is detachable from said handpiece.

53. The surgical instrument of claim 35 further comprising a mixing device, within the lumen, constructed to mix bone fragments and debris generated during opening forming into the material prior to delivery to the opening.

54. The surgical instrument of claim 35 further comprising a reservoir for receiving supply of the material.

55. The surgical instrument of claim 35 wherein said handpiece is constructed to receive attachments other than said fixation instrument.

56. The surgical instrument of claim 35 wherein said fixation instrument is constructed to perform a complete fixation procedure without removing the fixation instrument from the surgical site.

57. The surgical instrument of claim 35 wherein the delivery device is constructed to deliver the material in a flowable state.

58. A method of securing a first layer of soft tissue to a second layer of soft tissue comprising:

forming an opening extending through both layers of soft tissue;

delivering a material, in a flowable state, through the opening so that the flowable material extends beyond the soft tissue at each end of the opening; and

causing the material to change state, to a relatively less flowable state, forming an anchor to secure the two layers of soft tissue together.

59. A method of securing a fixation device within an opening in a tissue, comprising:

forming an opening in the tissue using a consumable cutting tool;

delivering a material in a flowable state to said opening, the delivery comprising causing the cutting tool to melt in response to frictional heat generated during the forming step; and

changing the state of the material so that the material forms an interference fit that secures the fixation device in the opening.

60. The method of claim 59 wherein said tissue comprises bone.

61. The method of claim 59 wherein said tissue comprises soft tissue.

62. The method of claim 59 wherein said fixation device is selected from the group consisting of suture, anchors, and screws.

63. The method of claim 59 wherein the changing step comprises allowing the material to at least partially harden.

64. The method of claim 59 wherein the changing step comprises at least partially cross-linking the material.

67. The method of claim 59 wherein said material comprises a hydrogel.

68. The method of claim 59 further comprising using the fixation device to secure a second tissue to the tissue having the opening.

69. The method of claim 68 wherein the tissue having the opening comprises bone and the second tissue comprises soft tissue.

70. The method of claim 69 further comprising, prior to delivery of the material:

piercing the soft tissue;

forming the opening in an underlying area of the bone; and

delivering the fixation device through the pierced tissue;

wherein the fixation device is constructed to hold the soft tissue in place against the bone.

71. The method of claim 70 wherein the fixation device comprises a suture.

72. The method of claim 71 wherein the suture includes a region of increased surface area to enhance anchoring.

73. The method of claim 72 wherein said region is selected from the group consisting of knots, barbs, braided areas, balls and shaped elements.

74. The method of claim 70 wherein all of the steps are performed endoscopically.

75. The method of claim 70 further comprising incorporating bone fragments generated during the forming step into the material during or prior to the delivering step.

76. The method of claim 70 further comprising causing the material to infiltrate the trabecular network.

77. The method of claim 59 further comprising incorporating bone fragments into the flowable material during or prior to the delivering step.

78. The method of claim 59 wherein the flowable material includes an osteoconductive filler.

79. The method of claim 59 further comprising causing the flowable material to infiltrate the trabecular network.

80. The method of claim 59 wherein the forming step is performed using micro-tooling.

81. The method of claim 59 wherein the opening has a diameter of less than about 3 mm.

82. The method of claim 59 wherein all of the steps are performed using a single endoscopic surgical tool having a plurality of attachments, and the tool is not removed from the patient until after the steps are completed.

83. A method of securing a fixation device within an opening in a tissue, comprising:

forming an opening in a tissue with a cutting tool having a detachable portion;

detaching the detachable portion in the opening after the forming step is completed, to serve as the fixation device;

delivering a material in a flowable state to said opening; and

changing the state of the material so that the material forms an interference fit that secures the fixation device in the opening.

84. A method of fixing soft tissue to bone comprising:

(a) at a first location, piercing through the soft tissue;

(b) forming an opening in the bone underlying the soft tissue;

(c) delivering a fixation device through the pierced tissue to the opening;

(d) providing a material in the form of a pellet, powder, chips, flakes or rod;

(e) melting the material to a flowable state;

(d) delivering the material to the opening; and

(e) causing the material to change state, to a relatively less flowable state, to anchor at least a portion of the fixation device in the opening.

85. A surgical instrument for tissue fixation comprising:

a handpiece constructed to be held by a surgeon during a fixation procedure; and

a fixation instrument, mounted on the handpiece and comprising

a cannulated tube defining a lumen;

a piercing element constructed to be delivered through the lumen, to pierce through bone and form an opening therein;

a delivery device for delivering a flowable material and a fixation device through the lumen to the opening; and

a heating element for heating said material to a molten state.

86. The instrument of claim 85 wherein said heating element is mounted on said fixation instrument.

87. A surgical instrument for tissue fixation comprising:

a handpiece constructed to be held by a surgeon during a fixation procedure; and

a fixation instrument, mounted on the handpiece and comprising

a cannulated tube defining a lumen;

a piercing element constructed to be delivered through the lumen, to pierce through bone and form an opening therein;

a delivery device for delivering a flowable material and a fixation device comprising a suture through the lumen to the opening; and

a suture feed mechanism constructed to deliver the suture through the lumen to the opening, comprising a movable needle.

88. A surgical instrument for tissue fixation comprising:

a handpiece constructed to be held by a surgeon during a fixation procedure; and

a fixation instrument, mounted on the handpiece and comprising

a cannulated tube defining a lumen;

a piercing element constructed to be delivered through the lumen, to pierce through bone and form an opening therein; and

a delivery device for delivering a flowable material and a fixation device through the lumen to the opening;

said handpiece including a reservoir for receiving a supply of pellets of the material and a mechanism for delivering the pellets from the reservoir to the lumen.

89. A surgical instrument for tissue fixation comprising:

a handpiece constructed to be held by a surgeon during a fixation procedure; and

a fixation instrument, mounted on the handpiece and comprising

a cannulated tube defining a lumen;

a piercing element constructed to be delivered through the lumen, to pierce through bone and form an opening therein;

a delivery device for delivering a flowable material and a fixation device comprising a suture through the lumen to the opening; and

a suture feed mechanism constructed to deliver the suture through the lumen to the opening;

the handpiece including a drive mechanism constructed to drive the piercing element and suture feed mechanism.

90. The instrument of claim 89 further comprising a clutch mechanism constructed to allow a surgeon to selectively engage and disengage the drive of the piercing element and the drive of the suture feed mechanism.

91. A method of securing a tissue to bone, comprising:

forming an opening in the bone at a first location;

delivering a flowable material and a suture to said opening,

allowing the flowable material to at least partially solidify and secure a portion of the suture in the opening,

drawing a free portion of the suture that extends from the secured portion across the soft tissue to a second location;

forming a second opening in the bone at the second location;

delivering a flowable material and a portion of the suture to said second opening; and

allowing the flowable material to at least partially solidify, the suture defining a stitch between the first and second locations.

92. The method of claim 91 further comprising repeating the drawing, forming, delivering and allowing steps at subsequent locations to form a line of connected stitches.

93. The method of claim 91 further comprising feeding the suture as a continuous length from a supply of suture material.

94. The method of claim 91 further comprising melting the flowable material.

95. The method of claim 94 further comprising causing the molten material to infiltrate the trabecular network.

96. The method of claim 91 wherein the flowable material is in the form of a pellet.

97. The method of claim 91 wherein the flowable material comprises a thermoplastic polymer.

98. The method of claim 91 wherein the forming step comprises forming an opening having a diameter of less than about 3 mm.

99. The method of claim 91 wherein the flowable material comprises a hydrogel.

100. A surgical instrument constructed to perform the steps of the method of claim 91 endoscopically.

102. A method of securing a fixation device within an opening in bone to secure a soft tissue to the bone, comprising:

piercing the soft tissue;

forming the opening in an underlying area of the bone using a consumable cutting tool;

delivering the fixation device through the pierced tissue, the fixation device being constructed to hold the soft tissue in place against the bone;

delivering a material in a flowable state to said opening by causing the cutting tool to melt in response to frictional heat generated during the forming step; and

changing the state of the material so that the material forms an interference fit that secures the fixation device in the opening.