Endosteal fixation stud and system

• US 4,997,433 A
• Filed: 01/16/1990
• Issued: 03/05/1991
• Est. Priority Date: 01/16/1990
• Status: Expired due to Term

• Current Assignee: Mitek Surgical Products, Inc. (Johnson & Johnson)
• Original Assignee: Goble E. Marlowe, Somers W. Karl
• Inventors: Goble, E. Marlowe, Somers, W. Karl
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): Owens, Kerry
• Application Number:
  US07/465,914
• Time in Patent Office: 413 Days
• Field of Search: 606/62, 606/63, 606/64, 606/65, 606/68, 606/53, 623/13, 623/16, 623/16 A, 411/509, 411/510, 439/324, 439/818, 439/846, 439/848
• US Class Current: 606/64
• 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

An endosteal fixation for mounting a prosthetic or soft tissue graft or combination thereof, under tension at a cortex end of a bone tunnel and process for its use. The endosteal fixation stud includes a cylindrical body that is preferably manufactured from a somewhat resilient material, and is suitable for implantation in a human body. The cylindrical body is stepped outwardly, proximate to a rear end, into a bridge that has spaced rearwardly extending arms wherebetween the graft is secured. The cylindrical body forward end is split into equal parallel sections that can be flexed together, one of which sections includes a hook that extends and rearwardly, that will align with the cylindrical body surface when the two cylindrical body sections are compressed together. The endosteal fixation stud can be arranged to be pushed or pulled through a bone tunnel.

A single endosteal fixation stud is utilized to mount a graft and to the cortex at a bone tunnel end, the graft extending therefrom through the tunnel and out the opposite bone tunnel end, whereat it is bent and secured under tension, as with a staple, to the cortex surface adjacent to that bone tunnel end.

Claims

1. An endosteal fixation stud comprising, a cylindrical body that has a diameter to closely fit in a cortex end of a bone tunnel that is formed appropriately in a bone mass, which cylindrical body from a forward end thereof is slotted longitudinally, splitting said forward end into two segments;

and an arcuate hook means is secured to an end of one of said two segments extending outwardly and rearwardly therefrom, an outer edge of which said arcuate hook means is above the plane of said cylindrical body and can be flexed inwardly to below said plane when said two segments are flexed together.

2. An endosteal fixation stud as recited in claim 1, wherein the endosteal fixation stud is manufactured from a resilient material that is suitable for human implantation and will allow for flexure together of the two cylindrical body segments.

3. An endosteal fixation stud as recited in claim 2, wherein the endosteal fixation stud is manufactured from a plastic material that may be re-absorbable.

4. An endosteal fixation stud as recited in claim 1, wherein the cylindrical body forward end, at one of the two equal segments is sloped into a forward face of the arcuate hook means.

5. An endosteal fixation stud as recited in claim 4, wherein the arcuate hook means is less than one hundred eighty (180) degrees of arc across its forward face, and said forward face is formed at an angle of approximately sixty (60) degrees to a vertical plane at the cylindrical body forward end.

6. An endosteal fixation stud as recited in claim 4, wherein a rear face of the slope of the arcuate hook means to the surface of the cylindrical body is the same angle as the angle of the bone tunnel to the bone mass surface.

7. An endosteal fixation stud as recited in claim 6, wherein the arcuate hook rear face is angled at an angle of from twenty-five (25) to sixty-five (65) degrees to the cylindrical body surface.

8. An endosteal fixation stud as recited in claim 1, further including a bridge means that is secured to the cylindrical body rear end, which said bridge means includes spaced apart essentially parallel rearwardly facing arm means for receiving an end of a graft therebetween;

and means for securing said graft end between said bridge means arm means.

9. An endosteal fixation stud as recited in claim 8, wherein the bridge means arm means are stepped outwardly from the cylindrical body surface;

and the means for securing the graft end are screws fitted through each said arm means.

10. An endosteal fixation stud as recited in claim 8, further including a bone plug means that is arranged as a sandwich with the graft end, for facilitating mounting said graft end between the bridge means arms.

11. An endosteal fixation stud as recited in claim 1, further including means for moving the bone anchor stud through a bone tunnel.

12. An endosteal fixation stud as recited in claim 11, wherein the means for moving the endosteal fixation stud through the bone tunnel is a center tapped hole that is formed longitudinally into the end of the longitudinal slot;

and a rod means having a threaded end for turning in said tapped hole.

13. An endosteal fixation stud as recited in claim 12, further including longitudinal groove means formed in the opposing surfaces of the cylindrical body segments for accommodating the rod means fitted therebetween;

and said rod means end opposite to the threaded end includes a handle means for manual manipulation.

14. A process for mounting a natural, prosthetic or soft tissue graft in tension in a prepared bone tunnel consisting of the steps of, attaching an end of a graft to an endosteal fixation stud, which said endosteal fixation stud includes, with a cylindrical body, arrangements for directly securing a forward end thereof to a bone cortex and for mounting a graft to its opposite rear end;

and forming a bone tunnel between femoral and tibial cortex surfaces, where, at least one said bone tunnel cortex end has a diameter to accommodate said endosteal fixation stud forward end fitted therein to connect to said bone cortex.

15. A process as recited in claim 14, wherein, the endosteal fixation stud includes, as the arrangement for directly securing a forward end thereof to a bone cortex, an outwardly extending hook formed on the forward end of the cylindrical body, which said cylindrical body is split longitudinally from said hook end forming opposing parallel sections that will flex together at said forward end such that an outer edge of said hook will align with said stud cylindrical body surface;

and said outer edge of said hook will flex outwardly when emerging from said bone tunnel cortex end to engage and bind into said bone cortex.

16. A process as recited in claim 15, wherein the endosteal fixation stud includes, as the arrangement for mounting a graft to its end, a bridge that includes spaced apart parallel arms that are for receiving therebetween said graft;

and installing connectors between said bridge arms, through said graft.

17. A process as recited in claim 16, wherein the bone tunnel is counter-bored to below the bone cortex end for accommodating travel of the endosteal fixation stud bridge and ligament therealong.

18. A process as recited in claim 15, wherein the bone tunnel is formed at an angle to the bone cortex surface to accommodate the endosteal fixation stud hook edge binding to said bone cortex surface.

19. A process as recited in claim 18, wherein the bone tunnel is formed at an angle of from twenty-five (25) to sixty-five (65) degrees to the femoral anterolateral cortex surface.

20. A process as recited in claim 15, wherein the graft end that is opposite to the endosteal fixation stud end is pulled from the opposite bone cortex tunnel end and is bent to engage that cortex surface;

and a fastener is installed in that cortex surface for maintaining that graft end secured in tension on said cortex surface.

21. A process as recited in claim 14, further including, connecting the endosteal fixation stud releasably to a rod means to move that rod means through the bone tunnel to where that endosteal fixation stud engages and secures to the cortex of said bone tunnel end.

22. A process as recited in claim 14, further including, from within an intra articular joint wherethrough the bone tunnel is formed, fitting an endosteal fixation stud and connected prosthetic or soft tissue graft end arthroscopic port or opening into said intra articular joint, and urging that endosteal fixation stud into the bone tunnel to where that endosteal fixation stud will engage and mount to the bone tunnel cortex end.

23. A process as recited in claim 14, wherein a straight tunnel is formed when the femoral and tibial segments are aligned.

24. A process as recited in claim 14, wherein the endosteal fixation stud is a stud having a cylindrical body, a forward end of which is slotted longitudinally to a mid-point so as to provide sections that can be urged together, one of which said sections includes an outwardly projecting hook that has an edge that will pass over and lock into the femoral anterolateral cortex.

25. A process as recited in claim 24, wherein the graft is secured to extend from the endosteal fixation stud cylinder body end opposite to the forward slotted end;

and the femoral and tibial tunnel segments are enlarged to accommodate travel of said graft and its coupling to said endosteal fixation stud.

26. A process as recited in claim 21, further including pulling the endosteal fixation stud, from the tibial end, through the aligned femoral and tibial segments to where said endosteal fixation stud engages and secures to the cortex of said femoral segment;

and attaching, under tension, the graft end to the tibial cortex with a staple driven into said tibial cortex, the staple legs straddling said prosthetic or soft tissue graft end.