Tissue fixation device and method

• US 6,123,711 A
• Filed: 06/10/1999
• Issued: 09/26/2000
• Est. Priority Date: 06/10/1999
• Status: Expired due to Term

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Thomas F. Winters
• Inventors: Winters, Thomas F.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/329,563
• Time in Patent Office: 474 Days
• Field of Search: 606/65, 606/66, 606/69, 606/71, 606/72, 606/73, 606/75, 623/13
• US Class Current: 606/304
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• 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 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/0403 Dowels
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61F 2/0805 Implements for inserting tendons or ligaments
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0829 without deformation of anchor parts, e.g. fixation screws on bone surface, extending barbs, cams, butterflies, spring-loaded pins
• CPC Class Codes: A61F 2002/0841 Longitudinal channel for insertion tool running through the whole tendon anchor, e.g. for accommodating bone drill, guidewire
• CPC Class Codes: A61F 2002/0852 Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
• CPC Class Codes: A61F 2002/0858 Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
• CPC Class Codes: A61F 2002/0888 Anchor in or on a blind hole or on the bone surface without formation of a tunnel

Abstract

A system for fixing soft tissue within a bone tunnel includes a first fixation member that is adapted for insertion upon a piece of soft tissue positioned within a bone tunnel, with a portion of the soft tissue emerging therefrom. A second fixation member is adapted to engage the first fixation member at its proximal end and is restrainable against disengagement therewith. The proximal end has an element for engaging the soft tissue. In a particular embodiment the first fixation member includes a screw having a bore extending from the proximal end and the second fixation member has a distal post portion adapted for mating with the bore and driving the screw rotationally thereby. The second fixation member may include a tack member and a barbed washer that is rotatable about the post and retainable by a head portion on the tack member. The barbs on the washer are for engaging and restraining a movement of the soft tissue outside the bone tunnel. Alternatively, the second fixation member may include a tack-type element that has a barbed head. In another embodiment a cannula capable of restraining the washer against rotation is used to guide the screw into the bone tunnel.

Claims

1. A system for fixing soft tissue within a bone tunnel comprising:

a first fixation member having a proximal end and a distal end and adapted for insertion against a first portion of soft tissue positioned within a bone tunnel, a second portion of the soft tissue emerging from the bone tunnel; and

a second fixation member adapted to engage the first fixation member at the proximal end thereof, the second fixation member having means for restraining disengagement therewith and a proximal end having means for engaging the soft tissue second portion, wherein the second fixation member when engaged with the first fixation member is decoupled in at least one degree of freedom therefrom.

2. The fixation system recited in claim 1, wherein the first fixation member comprises a screw-type member having a bore extending at least partially therethrough from the proximal end, the bore having means for being driven by the second fixation member.

3. The fixation system recited in claim 2, wherein the second fixation member comprises:

a tack member having a distal post portion dimensioned for insertion into the screw member bore and a proximal head portion having a width greater than a width of the post portion; and

a barbed washer having a hole extending from a proximal face through to a distal face, the hole dimensioned for free rotation about the post and for retention by the tack head portion therebeneath, the distal face having a plurality of barbs extending generally distalward for engaging and restraining a movement of the soft tissue piece.

4. The fixation system recited in claim 3, wherein the tack member head portion has means for being driven by a driver.

5. The fixation system recited in claim 3, wherein the restraining means comprises a protrusion extending outwardly from the post portion and the screw-type member bore has a protruding lip therein adapted to restrainingly engage the protrusion.

6. The fixation system recited in claim 5, wherein the protrusion comprises a plurality of generally proximally extending barbs.

7. The fixation system recited in claim 3, wherein the washer has a generally rectangular shape in axial cross section having two wings, a barb extending from each wing.

8. The fixation system recited in claim 3, wherein the washer has a generally circular shape in axial cross section and the barbs extend circumferentially about an edge thereof.

9. The fixation system recited in claim 3, wherein the washer has a generally rectilinear shape in axial cross section and the barbs extend from adjacent each corner thereof.

10. The fixation system recited in claim 3, wherein:

the screw-type member has;

a distal portion having a narrowing cross section toward a distal end, wherein in use an insertion of the screw-type member into soft tissue is facilitated by the narrowed distal end; and

a variable-pitch helical protrusion along a central portion between a proximal end and the distal end, the helical protrusion having a helical pitch along the central portion, the helical pitch decreasing from the distal end to the proximal end; and

the bore has a noncircular cross-sectional shape for permitting an elongated driving device having a noncircular cross-sectional shape to pass into the bore and to advance the screw-type member into the soft tissue by being rotated in a direction having a handedness commensurate with the helically shaped protrusion.

11. A system for fixing soft tissue within a bone tunnel comprising:

a screw-type member having a proximal end, a distal end, and a bore extending at least partially therethrough from the proximal end, the screw-type member adapted for insertion against a first portion of soft tissue positioned within a bone tunnel, a second portion of the soft tissue emerging from the bone tunnel, the bore having a noncircular cross-sectional shape, the screw-type member further having a variable-pitch helical protrusion along a central portion between a proximal end and the distal end, the helical protrusion having a helical pitch along the central portion, the helical pitch decreasing from the distal end to the proximal end; and

a tack member adapted to engage the screw-type member at the proximal end thereof, the tack member having means for restraining disengagement therewith, having a distal post portion dimensioned for insertion into the screw-type member bore and having a noncircular cross-section adapted for driving the screw-type member, the tack further having a barbed head portion extending outwardly beyond the post portion, the head portion having a plurality of barbs extending generally distalward for engaging and restraining a movement of the soft tissue piece.

12. The fixation system recited in claim 11, wherein the tack member head portion has means for being driven by a driver.

13. The fixation system recited in claim 11, wherein the restraining means comprises a protrusion extending outwardly from the post portion and the screw-type member bore has a protruding lip therein adapted to restrainingly engage the protrusion.

14. The fixation system recited in claim 13, wherein the protrusion comprises a plurality of generally proximally extending barbs.

15. The fixation system recited in claim 11, wherein the head has a generally rectangular shape in axial cross section having two wings, a barb extending from each wing.

16. The fixation system recited in claim 11, wherein the head has a generally circular shape in axial cross section and the barbs extend circumferentially about an edge thereof.

17. The fixation system recited in claim 11, wherein the head has a generally rectilinear shape in axial cross section and the barbs extend from adjacent each corner thereof.

18. The fixation system recited in claim 11, wherein:

the screw-type member has;

a distal portion having a narrowing cross section toward a distal end, wherein in use an insertion of the screw-type member into soft tissue is facilitated by the narrowed distal end.

19. A method for affixing a piece of soft tissue within a bone tunnel comprising the steps of:

positioning a piece of soft tissue so that a portion thereof resides within a bone tunnel;

positioning a first fixation member upon the piece of soft tissue within the bone tunnel;

engaging a distal portion of a second fixation member with a proximal portion of the first fixation member;

restraining a disengagement between the first and the second fixation members; and

engaging a piece of the soft tissue outside the bone tunnel with an element at a proximal end of the second fixation member.

20. The method recited in claim 19, wherein:

the first fixation member comprises a screw having a bore extending from a proximal end, the bore noncircular in axial cross section;

the distal portion of the second fixation member comprises a post having a noncircular shape in axial cross section insertable into the screw bore; and

the first fixation member positioning step comprises screwing the screw into the bone tunnel.

21. The method recited in claim 20, wherein:

the second fixation member comprises a tack member having a distal post portion dimensioned for insertion into the screw member bore and a barbed head portion extending outwardly beyond the post portion, the head portion having a plurality of barbs extending generally distalward; and

the soft tissue engaging step comprises impaling the soft tissue piece outside the bone tunnel with the barbs.

22. The method recited in claim 20, wherein:

the second fixation member comprises a tack member having a distal portion comprising the post and a proximal head portion having a width greater than a width of the post portion;

the second fixation member engaging element comprises a barbed washer having a hole extending from a proximal face through to a distal face, the hole dimensioned for free rotation about the post and for retention by the tack head portion therebeneath, the distal face having a plurality of barbs extending generally distalward; and

the soft tissue engaging step comprises impaling the soft tissue piece outside the bone tunnel with the barbs.

23. The method recited in claim 22, wherein:

the tack member post has a plurality of generally proximally extending barbs;

the screw bore has a lip extending thereinto; and

the disengagement restraining step comprises inserting the post so that the post barbs extend distal of the lip.

24. A method for affixing a piece of soft tissue into a bone tunnel comprising the steps of:

positioning a piece of soft tissue with a first portion within a bone tunnel and a second portion extending therefrom;

inserting a cannula into a surgical site with a distal end positioned adjacent a hole in the bone and against the soft tissue second portion, the cannula having a doubly flared proximal portion;

inserting a screw having a head through a hole in a washer having distally protruding barbs from a pair of laterally extending wings adapted for retention within the cannula proximal portion, the washer dimensioned for axial retention by the screw head and for rotational freedom of motion about the screw distal portion;

inserting the screw and washer assemblage into the cannula;

driving the screw into the bone tunnel and against the soft tissue, the washer permitted to spin against the screw while being retained within the cannula proximal portion;

removing the cannula from the surgical site; and

permitting the barbs to bear against the soft tissue second portion adjacent the tunnel.

25. A system for affixing a piece of tissue to a bone comprising:

a generally cylindrical cannula member adapted for insertion into a surgical site adjacent a tunnel in the bone;

a generally cylindrical screw member dimensioned for insertion through the cannula member, the screw member having a head at a proximal end and a bore extending at least partially therethrough from the proximal end, the bore having means for being driven by a driver; and

a barbed washer having a hole extending from a proximal face through to a distal face, the hole dimensioned for free rotation about the screw member and for retention by the screw head therebeneath, the distal face having a plurality of barbs extending generally distalward for engaging and retraining a movement of a distal tissue piece, wherein the washer when engaged with the screw member is decoupled in at least one degree of freedom therefrom.

26. The system recited in claim 25, wherein:

the screw member has;

a distal portion having a narrowing cross section toward a distal end, wherein in use an insertion of the screw member into tissue is facilitated by the narrowed distal end; and

a variable-pitch helical protrusion along a central portion between a proximal end and the distal end, the helical protrusion having a helical pitch along the central portion, the helical pitch decreasing from the distal end to the proximal end; and

the bore has a noncircular cross-sectional shape for permitting a driver having a noncircular cross-sectional shape to pass into the bore and to advance the screw member into the distal piece of tissue by being rotated in a direction having a handedness commensurate with the helically shaped protrusion.

27. The system recited in claim 25, wherein:

the washer hole has a threaded portion; and

the screw member has a threaded distal portion and a threaded proximal portion adjacent the head, the distal portion for engaging the tissue piece and the bone and the proximal portion for engaging the washer hole threaded portion.

28. The system recited in claim 27, wherein:

the washer comprises a flexible head having a pair of outwardly extending wings and a barb extending distal of each wing;

the cannula member has a doubly flared proximal portion dimensioned to house the washer head and prevent a rotation thereof.

29. A method of affixing a distal and a proximal piece of bone together comprising the steps of:

making a hole through the distal bone piece;

making a tunnel in the proximal bone piece;

inserting a cannula through the distal bone piece hole with a distal end positioned adjacent the tunnel in the proximal bone piece, the cannula having a doubly flared proximal portion;

inserting a screw having a head through a hole in a washer having distally protruding barbs from a pair of laterally extending wings adapted for retention within the cannula proximal portion, the washer dimensioned for axial retention by the screw head and for rotational freedom of motion about the screw distal portion;

inserting the screw and washer assemblage into the cannula;

driving the screw into the distal bone piece tunnel, the washer permitted to spin against the screw while being retained within the cannula proximal portion;

removing the cannula from the proximal bone piece hole; and

permitting the barbs to bear against the proximal bone portion adjacent the tunnel.