Self-tensioning soft tissue fixation device and method

• US 6,036,694 A
• Filed: 08/03/1998
• Issued: 03/14/2000
• Est. Priority Date: 08/03/1998
• Status: Expired due to Term

• Current Assignee: Innovasive Devices Inc. (Johnson & Johnson)
• Original Assignee: Innovasive Devices Inc. (Johnson & Johnson)
• Inventors: Perkins, Daniel A., Goble, E. Marlowe, Fallin, Thomas Wade
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/128,210
• Time in Patent Office: 589 Days
• Field of Search: 606/60, 606/72, 606/73, 606/99, 606/104, 623/13
• US Class Current: 606/304
• 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 2002/0864 Fixation of tendon or ligament between anchor elements, e.g. by additional screws in the anchor, anchor crimped around tendon
• CPC Class Codes: A61F 2002/087 Anchor integrated into tendons, e.g. bone blocks, integrated rings
• CPC Class Codes: A61F 2002/0882 Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone

Abstract

The device for affixing a flexible load-bearing element within a bone tunnel includes a securing element that attaches to the flexible element. A bone tunnel fixation element has an outer surface that is adapted to movably engage the bone tunnel. A deformable biasing element is positionable within the fixation element bore adjacent the proximal end. A locking member is dimensioned for movement within the fixation element bore and is positionable adjacent the distal end thereof. The locking member is lockable to the securing element, and the biasing means is for biasing the locking member toward the bore'"'"'s distal end. Thus as a tension is applied to the securing means, a deformation of the biasing element is caused that is indicative of a magnitude of the applied tension. Therefore, a common element serves to perform pretensioning, and the need for a separate tensioning system is obviated.

Claims

1. A device for affixing a flexible load-bearing element within a bone tunnel, the device comprising:

securing means having a proximal portion having means for attaching to the flexible element and a distal portion having engagement means;

bone tunnel fixation means having a bore therethrough and an outer surface adapted to movably engage a bone tunnel;

deformable biasing means positionable within the fixation means bore adjacent a proximal end thereof; and

a locking member dimensioned for movement within the fixation means bore and positionable adjacent a distal end thereof, having means for locking the engagement means thereto, the biasing means for biasing the locking member toward the bore distal end, and the securing means for causing a deformation of the biasing means indicative of a magnitude of an applied tension.

2. The device recited in claim 1, wherein the securing means attaching means comprises at least one barb having a pointed end sufficiently sharp to impale a flexible element thereon.

3. The device recited in claim 1, wherein the securing means further has:

a central disk generally normal to a longitudinal axis; and

a proximal portion comprising an arm extending generally normal from an outer edge of the disk and a plurality of barbs extending inwardly from the arm.

4. The device recited in claim 3, wherein:

the securing means distal portion comprises a post extending from the disk, the post having an outer circumferential groove therein adjacent a distal end; and

the locking member has an opening dimensioned to admit at least a distal section of the securing means distal portion and a deformable member positioned within the opening, the member movable between a first position adapted to reside within the post groove and a second position adapted to permit the post distal section to pass thereby, the member biased to the first position.

5. The device recited in claim 1, wherein the bone tunnel fixation means comprises a generally cylindrical member having an outer surface having a helical ridge thereon for screwingly engaging a bone tunnel.

6. The device recited in claim 5, wherein the bone tunnel fixation means further has means at a distal end for being driven by a driver.

7. The device recited in claim 6, wherein the means for being driven comprises at least one slot for mating with a driver protrusion adapted to turn the bone tunnel fixation means.

8. The device recited in claim 6, wherein the bone tunnel fixation means bore has a first diameter at a distal end and a second diameter at a proximal end, the first diameter sufficiently large to admit the biasing means thereinto, the second diameter sufficiently small to prevent the biasing means from passing thereinto.

9. The device recited in claim 1, wherein the biasing means comprises a spring adapted to permit the securing means distal portion to pass therepast.

10. The device recited in claim 1, wherein the locking member has a bore generally coaxial with the fixation means bore and the securing means distal portion comprises a post dimensioned for insertion into the locking member bore.

11. The device recited in claim 10, wherein the post has an outer circumferential groove adjacent a distal end and the locking member has a deformable wire extending into the locking member bore in a generally off-center orientation, the wire movable between a first position residing within the post groove and a second position wherein the post distal section is permitted to pass thereby, the wire biased to the first position.

12. The device recited in claim 1, wherein the securing means distal portion comprises a post having means at a distal end for engaging a pulling element for drawing the distal portion into the bone tunnel fixation means bore from a distal end of the bone tunnel.

13. The device recited in claim 12, wherein the pulling element engaging means comprises a portal through the distal portion dimensioned for passing a flexible puller therethrough.

14. A method for affixing a flexible load-bearing element within a bone tunnel, the method comprising the steps of:

gripping a distal end of a flexible member;

inserting the flexible member distal end into a bone tunnel;

retaining the flexible member distal end within a fixation member movably affixed within the bone tunnel;

biasing the flexible member end in a proximal direction with spring means housed within the fixation member; and

determining a load upon the flexible member from a deformation of the spring means.

15. The method recited in claim 14, further comprising the step of adjusting the load upon the flexible member to a desired value by moving the fixation member within the bone tunnel in a direction appropriate for effecting the desired load adjustment.

16. A device for affixing a flexible load-bearing element within a bone tunnel, the device comprising:

sleeve means having a proximal portion adapted to reside within a bone tunnel having a passage extending from a proximal end and a distal portion having means for resisting movement into the bone tunnel;

securing means having a proximal portion having means for attaching to the flexible element and a distal portion having engagement means;

sleeve fixation means having a bore therethrough and an outer surface adapted to movably engage the sleeve means passage;

deformable biasing means positionable within the fixation means bore adjacent a proximal end thereof; and

a locking member dimensioned for movement within the sleeve fixation means bore and positionable adjacent a distal end thereof, having means for locking the engagement means thereto, the biasing means for biasing the locking member toward the bore distal end, and the securing means for causing a deformation of a biasing means indicative of a magnitude of the applied tension.

17. The device recited in claim 16, wherein the sleeve means passage has a threaded proximal portion and the sleeve fixation means comprises a generally cylindrical member having an outer surface having a helical ridge thereon for screwingly engaging the sleeve means passage threaded proximal portion.

18. The device recited in claim 16, wherein the sleeve means passage extends from the proximal end through to a distal end, and wherein the movement-resisting means comprises flange means in surrounding relation to the passage adapted to abut a distal end of the bone tunnel.

19. The device recited in claim 16, wherein the sleeve means passage extends from the proximal end through to a distal end, and wherein the movement-resisting means comprises a tab extending outwardly from the sleeve away from the passage and adapted to abut a distal end of the bone tunnel.

20. A method for affixing a flexible load-bearing element within a bone tunnel, the method comprising the steps of:

positioning a sleeve within a bone tunnel, the sleeve having a passage therethrough and means for resisting a movement into the bone tunnel at a distal end;

gripping a distal end of a flexible member;

inserting the flexible member distal end into a bone tunnel;

retaining the flexible member distal end within a fixation member movably affixed within the sleeve;

biasing the flexible member end in a proximal direction with spring means housed within the fixation member; and

determining a load upon the flexible member from a deformation of the spring means.

21. The method recited in claim 20, further comprising the step of adjusting the load upon the flexible member to a desired value by moving the fixation member within the sleeve in a direction appropriate for effecting the desired load adjustment.

22. A system for affixing a flexible load-bearing element within a bone tunnel and for determining a load upon the load-bearing element, the system comprising:

an affixing device comprising;

securing means having a proximal portion having means for attaching to the flexible element and a distal portion having engagement means;

bone tunnel fixation means having a bore therethrough and an outer surface adapted to movably engage a bone tunnel;

deformable biasing means positionable within the fixation means bore adjacent a proximal end thereof; and

a locking member dimensioned for movement within the fixation means bore and positionable adjacent a distal end thereof, having means for locking the engagement means thereto, the biasing means for biasing the locking member toward the bore distal end, and the securing means causing a deformation of the biasing means indicative of a magnitude of an applied tension; and

an indicating driver comprising;

an elongated driving portion having a bore therethrough and means at a first end for drivably engaging the fixation means;

plunger means positioned for movement within the driving portion bore having a first end biased for protrusion from the driving portion first end and adapted for contacting the locking member; and

indicator means positioned in spaced relation from the first end having means for indicating a distance between the driving portion first end and the plunger means first end, the distance indicative of a deformation of the biasing means.

23. The system recited in claim 22, further comprising a handle affixed to a second end of the driving portion.

24. The system recited in claim 22, wherein the fixation means further has at least one slot at a distal end, and the driving portion engaging means comprises at least one protrusion dimensioned for insertion into the fixation means slot.

25. The system recited in claim 24, wherein the fixation means outer surface has a helical ridge thereon for screwingly engaging a bone tunnel.

26. The system recited in claim 22, wherein the driver further comprises spring means positioned in biasing relation between the plunger and the driving portion.

27. The system recited in claim 22, wherein the driving portion has a window extending from an outer surface through to the bore, and wherein the indicator means comprises a marking on the plunger positioned for visualization through the window.

28. The system recited in claim 22, wherein the driving portion has a plurality of windows positioned in staggered relation to each other and extending from an outer surface through to the bore, and wherein the indicator means comprises a marking on the plunger positioned for successive visualization through the windows as the plunger is moved within the driving portion bore.

29. The system recited in claim 28, wherein the driving portion has an indicium adjacent each window commensurate with an applied tension effected when the marking is visualizable therethrough.

30. A system for affixing a flexible load-bearing element within a bone tunnel and for determining a load upon the load-bearing element, the system comprising:

an affixing device comprising;

sleeve means having a proximal portion adapted to reside within a bone tunnel having a passage extending from a proximal end and a distal portion having means for resisting movement into the bone tunnel;

securing means having a proximal portion having means for attaching to the flexible element and a distal portion having engagement means;

sleeve fixation means having a bore therethrough and an outer surface adapted to movably engage the sleeve means passage;

deformable biasing means positionable within the fixation means bore adjacent a proximal end thereof; and

a locking member dimensioned for movement within the sleeve fixation means bore and positionable adjacent a distal end thereof, having means for locking the engagement means thereto, the biasing means for biasing the locking member toward the bore distal end, and the securing means for causing a deformation of the biasing means indicative of a magnitude of an applied tension; and

an indicating driver comprising;

an elongated driving portion having a bore therethrough and means at a first end for drivably engaging the fixation means;

plunger means positioned for movement within the driving portion bore having a first end biased for protrusion from the driving portion first end and adapted for contacting the locking member; and

indicator means positioned in spaced relation from the first end having means for indicating a distance between the driving portion first end and the plunger means first end, the distance indicative of a deformation of the biasing means.

31. The system recited in claim 30, wherein the fixation means further has at least one slot at a distal end, and the driving portion engaging means comprises at least one protrusion dimensioned for insertion into the fixation means slot.

32. The system recited in claim 31, wherein the sleeve means passage has a threaded proximal portion and the sleeve fixation means comprises a generally cylindrical member having an outer surface having a helical ridge thereon for screwingly engaging the sleeve means passage threaded proximal portion.