Tissue fixation system and method

• US 20060229623A1
• Filed: 02/21/2006
• Published: 10/12/2006
• Est. Priority Date: 10/26/2004
• Status: Active Grant

• Current Assignee: P TECH, LLC
• Original Assignee: P TECH, LLC
• Inventors: Bonutti, Peter M., Phillips, Glen A., Crainich, Larry
• Granted Patent: US 9,173,647 B2
• Time in Patent Office: Days
• US Class Current: 606/74
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/683 comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut
• CPC Class Codes: A61B 17/685 Elements to be fitted on the end of screws or wires, e.g. protective caps
• CPC Class Codes: A61B 17/7053 with parts attached to bones or to each other by flexible wires, straps, sutures or cables
• CPC Class Codes: A61B 17/82 for bone cerclage apparatus for manipulating wires or straps A61B17/8861; wires, bands or straps other than cerclage A61B17/842
• CPC Class Codes: A61B 17/842 Flexible wires, bands or straps A61B17/72, A61B17/82, A61B17/86 take precedence
• CPC Class Codes: A61B 17/844 with expandable anchors or anchors having movable parts
• CPC Class Codes: A61B 17/8861 Apparatus for manipulating flexible wires or straps devices for inserting Kirschner wires A61B17/1697
• CPC Class Codes: A61B 17/8863 Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
• CPC Class Codes: A61B 17/8869 Tensioning devices
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/2926 : Details of heads or jaws
• CPC Class Codes: A61B 2090/035 : preventing further rotation
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 90/40 : Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 2/08 : Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/28 : Bones joints A61F2/30
• CPC Class Codes: A61F 2/442 : Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2002/2817 : Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30062 : (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/4435 : Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite

Abstract

A tissue fixation system is provided for dynamic and rigid fixation of tissue. A fastener connected with an elongate fastening member, such as a cable, wire, suture, rod, or tube, is moved through a passage between opposite sides of tissue. The fastener is provided with a groove that accommodates at least a portion of the fastening member to reduce the profile during the movement through the passage. The fastener is then pivoted to change its orientation. A second fastener can then be connected with the fastening member. While tension is maintained in the fastening member, the fasteners are secured against relative movement. This may be done by deforming the fastening member, either the first or second fasteners, or a bushing placed against the second fastener.

Claims

1. A tissue fixation system comprising:

an elongate fastening member; and

a fastener positionable on the elongated fastening member and movable from a first orientation to a second orientation, the fastener having a body with a tissue contacting surface that includes a groove configured and dimensioned to receive a portion of the elongate fastening member in the first orientation.

2. The tissue fixation system of claim 1 wherein the fastener body has a free surface opposite the tissue contacting surface, the free surface including a channel configured and dimensioned to receive a portion of the elongate member in the first orientation.

3. The tissue fixation system of claim 2 wherein the fastener body includes a through bore extending from the tissue contacting surface through the free surface.

4. The tissue fixation system of claim 3 wherein the fastener body includes leading and trailing ends, the groove terminating at the through bore and extending toward one of the leading and trailing ends and the channel terminating at the through bore and extending toward the other of the leading and trailing ends.

5. The tissue fixation system of claim 4 wherein the groove extends toward the leading end and the channel extends toward the trailing end.

6. The tissue fixation system of claim 5 wherein the free surface of the fastener body includes a well surrounding the through bore.

7. The tissue fixation system of claim 6 wherein a distal end of the elongate fastening member includes a stop larger than the through bore.

8. The tissue fixation system of claim 7 wherein the well is configured and dimensioned to receive at least a portion of the stop.

9. The tissue fixation system of claim 8 wherein the leading end of the fastener body is tapered.

10. The tissue fixation system of claim 1 further comprising a biasing means maintaining the fastener in the first orientation.

11. The tissue fixation system of claim 10 wherein the biasing means comprises an adhesive between the groove and the portion of the elongate fastening member received in the groove.

12. The tissue fixation system of claim 10 wherein the biasing means comprises a frangible connection between the groove and the portion of the elongate fastening member received in the groove.

13. A tissue fixation system for fixation of a first tissue member to a second tissue member, comprising:

an elongate fastener member positionable though the first and second tissues members and including first and second ends, such that the first and second tissue members are interposed between the first and second ends of the elongate fastener member;

a first fastener positionable on the first end on the elongate fastener member, adjacent to the first tissue member; and

a second fastener positionable on the second end on the elongate fastener member, adjacent to the second tissue member;

wherein a tension is provided through the elongate fastener member between the first and second fasteners, affixing the first tissue member to the second tissue member.

14. A tissue fixation system as set forth in claim 13 wherein the first fastener is moveable with respect to the elongate fastener member from a first orientation to a second orientation, the first fastener having a body with a tissue contacting surface that includes a groove configured and dimensioned to receive a portion of the elongate fastener member in the first orientation.

15. The tissue fixation system as set forth in claim 14 wherein the first fastener body has a free surface opposite the tissue contacting surface, the free surface including a channel configured and dimensioned to receive a portion of the elongate fastener member in the first orientation.

16. The tissue fixation system as set forth in claim 15 wherein the first fastener body includes a through bore extending from the tissue contacting surface through the free surface, through which the elongate fastener member extends.

17. The tissue fixation system as set forth in claim 14 wherein the first fastener body includes leading and trailing ends, the groove terminating at the through bore and extending toward one of the leading and trailing ends and the channel terminating at the through bore and extending toward the other of the leading and trailing ends.

18. The tissue fixation system as set forth in claim 17 wherein the groove extends toward the leading end and the channel extends toward the trailing end.

19. The tissue fixation system as set forth in claim 18 wherein the free surface of the first fastener body includes a well surrounding the through bore.

20. The tissue fixation system as set forth in claim 19 wherein the first end of the elongate fastener member includes a stop larger than the through bore.

21. The tissue fixation system as set forth in claim 20 wherein the well is configured and dimensioned to receive at least a portion of the stop.

22. The tissue fixation system as set forth in claim 21 wherein the leading end of the first fastener body is tapered.

23. The tissue fixation system as set forth in claim 14 further comprising a biasing means maintaining the first fastener in the first orientation.

24. The tissue fixation system as set forth in claim 23 wherein the biasing means comprises an adhesive between the groove and the portion of the elongate fastener member received in the groove.

25. The tissue fixation system as set forth in claim 23 wherein the biasing means comprises a frangible connection between the groove and the portion of the elongate fastener member received in the groove.

26. A tissue fixation system as set forth in claim 14 further comprising a bushing member positionable on the second end of the elongate fastener member, adjacent to the second fastener, wherein the bushing member is affixable about to the second end of the elongate fastener member.

27. A tissue fixation system as set forth in claim 26 wherein the second fastener comprises a second fastener body including:

a tissue contacting surface;

a free surface opposite the tissue contacting surface;

a through bore extending from the tissue contacting surface through the free surface, through which the elongate fastener member extends; and

a well surrounding the through bore, wherein the bushing is positionable in the well surrounding the bore.

28. A tissue fixation system as set forth in claim 14 wherein the second fastener comprises:

a tissue contacting surface;

a free surface opposite the tissue contacting surface; and

a through bore extending from the tissue contacting surface through the free surface, wherein the second end of the elongate fastener members extends through the bore and the bore is affixable about the second end of the elongate fastener member.

29. A tissue fixation system as set forth in claim 13 wherein the first fastener comprises:

a tissue contacting surface;

a free surface opposite the tissue contacting surface; and

first and second through bores, each extending from the tissue contacting surface through the free surface.

30. A tissue fixation system as set forth in claim 29 wherein the elongate fastener member is a suture including first and second free ends and the suture is threadable through the first and second through bores of the first fastener, such that first and second free ends of the suture extend from the second tissue member forming the second end of the elongate fastener member.

31. A tissue fixation system as set forth in claim 30 wherein the second fastener comprises:

a tissue contacting surface;

a free surface opposite the tissue contacting surface; and

first and second through bores, each extending from the tissue contacting surface through the free surface, wherein the first free end of the suture extends through the first through bore and the second free end of the suture extends through the second through bore, wherein the first and second through bores are affixable about the first and second free ends of the suture.

32. A tissue fixation system as set forth in claim 30 wherein the second fastener comprises:

a tissue contacting surface;

a free surface opposite the tissue contacting surface; and

a through bore extending from the tissue contacting surface through the free surface, wherein the first and second free ends of the suture extend through the bore and the bore is affixable about the first and second free ends of the suture.

33. A medical device for securing a fastener to an elongate member, comprising:

a handle;

a tubular member including first and second ends and defining a longitudinal passage along a central longitudinal axis, wherein the first end is slidably disposed in the handle;

a tensioning mechanism disposed on the handle for tensioning the elongate member; and

a crimp mechanism disposed in the first end on the tubular member for crimping the fastener about the elongate member.

34. A medical device as set for the in claim 33, wherein the crimp mechanism comprises:

a collett positioned in the first end of the tubular member and defining a collett passage longitudinally aligned with the central longitudinal axis, wherein an end portion of the collett is configured to receive the fastener; and

an elongate member tensioner slidably positioned in the handle and operably connected to the collett, the elongate member tensioner defining an elongate member passage longitudinally aligned with the central longitudinal axis, wherein the elongate member tensioner is movable along the central longitudinal axis from a first tension position to a second tension position with respect to the collett.

35. A medical device as set forth in claim 34, wherein the collett includes first and second collett arms each having a force application end portions which combine to form a fastener aperture, wherein the fastener aperture is configured to receive the fastener therein.

36. A medical device as set forth in claim 35, the crimp mechanism further comprising a tension lever connected to the elongate member tensioner and movable from a first lever position to a second lever position with respect to handle such that the elongate member tensioner is moved from the first tension position to the second tension position.

37. A medical device as set forth in claim 36, wherein the tension lever includes tension markings.

38. A medical device as set forth in claim 35, further comprising a tension bias member, wherein the tension bias member biases the elongated tension member into the first tension position.

39. A medical device as set forth in claim 35, wherein the elongate member tensioner includes a circumferential groove.

40. A medical device as set forth in claim 39, wherein the crimping mechanism comprising a collett closer affixed to the second end of the tubular member, about the collett, wherein the tubular member and the collett closer are a moveable from a first tube position to a second tube position such that the collett closer compresses the force application end portions of the first and second collett arms about the fastener aperture.

41. A medical device as set forth in claim 40, further comprising a trigger operably connected to the tubular member, the trigger positionable from a first trigger position to a second trigger position with respect to the handle, such that collett closer is moved from the first tubular position to the second tubular position.

42. A medical device as set forth in claim 41, further comprising a trigger bias member, wherein the trigger bias member biases the trigger into the first trigger position.

43. A medical device as set forth in claim 41, further comprising a cutting mechanism disposed in the second end of the tubular member, proximal to the collett, and operably connect to the trigger, such that movement of the trigger from the second trigger position to a third trigger position actuates the cutting mechanism.