BIOABSORBABLE INTERFERENCE SCREW FOR ENDOSTEAL FIXATION OF LIGAMENTS

Abstract

A bioabsorbable interference screw which, upon insertion, the screw engages cortical bone at the back end of the bone tunnel and fills all but 5-10 mm. of the tunnel, thereby providing increased fixation strength while also promoting fast healing. The screw includes a head provided with a specially designed drive socket with radially extending slots at its outer end for receiving corresponding protrusions on the shaft of screwdriver. The drive socket optimizes the torque capacity of the screw.

Description

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to endosteal fixation of a substitute ligament and, more specifically, to arthroscopic endosteal fixation of a substitute anterior cruciate ligament using a tapered bioabsorbable interference screw.

2. Description of the Related Art

When a ligament becomes detached from a bone, surgery usually is required to reconstruct the ligament. Often, a substitute ligament or graft is secured into bone tunnels to facilitate incorporation and permanent attachment.

Various methods of graft attachment are known, including the use of interference screws to secure the graft against the walls of a tunnel drilled through the tibia and a socket formed in the femur. A strong graft attachment is obtained by using a metal interference screw to wedge a graft bone block to the wall of a graft tunnel formed through the bone, as disclosed in U.S. Pat. No. 5,211,647 to Schmieding. If a bioabsorbable interference screw is used, the graft is often wedged directly against the bone by the screw, without a bone block.

Bioabsorbable interference screws are usually sized so that they are slightly larger that the diameter of the tunnel, so that they dilate the bone tunnel upon insertion. Dilation advantageously compacts the soft cancellous bone between the ends of the tunnel, providing better fixation. Conventional straight-sided bioabsorbable interference screws have an interference fit of about 1 mm., i.e, about 1 mm. of bone is dilated as the screw is inserted into the bone tunnel. Although it would be desirable to use larger diameter screws for increased fixation strength, larger screws have larger tips and are more difficult to align and insert correctly. Accordingly, a need exists for a bioabsorbable interference screw which provides increased dilation and interference fit without increased difficulty of insertion.

SUMMARY OF THE INVENTION

The present invention overcomes the disadvantages of the prior art and achieves the foregoing objectives by providing a bioabsorbable interference screw which, upon insertion, fills all but 5-10 mm. of the length of the tunnel, thereby providing increased fixation strength while also promoting healing.

The bioabsorbable interference screw of the present invention includes a head provided with a specially designed Delta drive socket for receiving a Delta drive screwdriver or a traditional hex-head screwdriver. The unique drive socket of the interference screw of the present invention optimizes the torque capacity of the screw.

The bioabsorbable interference screw of the present invention is preferably threaded along substantially the entire length of the screw to maximize fixation strength within the tunnel. Preferably, the distal end of the screw, the end closest to the joint, has a smooth, rounded tip profile so as to minimize abrasion with the graft.

The interference screw of the present invention may be optionally provided with a cannulation for insertion over a guide pin. In this embodiment of the invention, a cannulated Delta drive or hex drive screwdriver is used to insert the screw into the tunnel over the guide pin.

The bioabsorbable interference screw of the present invention is preferably formed of highly crystalline poly-(L-lactic acid) (PLLA) compound.

In the preferred method of ACL reconstruction of the present invention, the graft, preferably a hamstring tendon autograft or allograft, is secured, preferably by interference screw fixation, in a femoral socket formed through the tibial tunnel, as described, for example, in U.S. Pat. No. 5,320,626, the disclosure of which is incorporated herein. The hamstring graft is then drawn taut and secured in the tibial tunnel by insertion of the tapered bioabsorbable interference screw of the present invention. If the interference screw is fully cannulated, a guide pin may optionally be employed to guide the interference screw during delivery and installation.

Other features and advantages of the present invention will become apparent from the following description of the invention which refers to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional detail view, drawn along line A-A of FIG. 2, of the bioabsorbable interference screw of the present invention;

FIG. 2 is a rear elevational view of the bioabsorbable interference screw of the present invention;

FIG. 3 is a cross-sectional detail view, drawn along line C-C of FIG. 2, of the interference screw of the present invention;

FIG. 4 a cross-sectional detail view, drawn along line D-D of FIG. 2, of the interference screw of the present invention;

FIG. 5A is a side view of the interference screw driver and FIG. 5B is a detailed view of the tip of the driver; and

FIG. 6 shows the interference screw of the present invention being inserted into the tibial tunnel against a ligament graft.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIG. 1, a cross-sectional view of the bioabsorbable interference screw 10 of the present invention is shown. Screw 10 is preferably formed of a bioabsorbable material, such as PLA or PLDLA (Poly(L/D-lactide)Acid). Screw 10 has a main body portion 15, a proximal end 20, and a distal end 25, and is preferably provided with a cannula 30.

Screw 10 is provided in a preferred length of 35 mm., with threads 16 extending substantially from proximal end 20 to distal end 25. The edges 17 of the thread(s) 16 are flattened to prevent severing tissue during screw insertion.

Referring to FIG. 2, the proximal end 20 of screw 10 is provided with an elongated socket 35 configured to receive a Delta drive screwdriver 56, described below. To that end, socket 35 is provided, at its outer end, with radially-extending slots 40 in every other annular face of socket 35. The slots 40 receive correspondingly-shaped protrusions 42 (shown in FIGS. 5A and 5B) on the proximal end of the shaft 58 of driver 56. The Delta drive socket 35 permits increased torque capacity while minimizing the problem of stripping the drive portion of the screw 10. Advantageously, the Delta drive socket can also be used with a traditional hex drive screwdriver.

The interference screw of the present invention is preferably provided in four sizes: (1) a screw which tapers from a 7.5 mm. diameter at its tip to 9 mm. at the socket; (2) a screw which tapers from a 8.5 mm. diameter at its tip to 10 mm. at the socket; (3) a screw which tapers from a 9.5 mm. diameter at its tip to 11 mm. at the socket; and (4) a screw which tapers from a 9.5 mm. diameter at its tip to 12 mm. at the socket.

As screw 10 threadingly advances through a bone tunnel, the screw dilates bone outwardly around the bone tunnel and creates an interference fit therewith. The present interference screw promotes about a 1.5 mm interference fit; i.e., the diameter of the proximal end 20 of the screw 15 is 1.5 mm larger than the diameter of the bone tunnel. Typical bone screws, which are not tapered, provide a maximum of 1.0 mm interference fit. The additional interference provides 28% more pull out strength.

Screw 10 is configured to be sufficiently long so as to fill all but the top 5-10 mm of the tibial bone tunnel. This configuration secures a large portion of the ligament graft against the bone tunnel while also providing threading engagement of the threads 16 of screw 10 against cortical bone at outer end of the bone tunnel. Because cortical bone is significantly harder than the interior soft, cancellous core, cortical bone provides significantly more load bearing capability. As a result, the invention eliminates the need for multiple, shorter interference screws in a bone tunnel.

FIGS. 5A and 5B show the driver 56 for inserting interference screw 10. Driver 56 has an taped elongated hexagonally shaped shaft 58 at its distal end, best shown in the magnified view of FIG. 5B, which is provided with protrusions 42 to mate with the Delta drive recess 35 of screw 10.

Referring to FIG. 6, the method of endosteal fixation of a ligament graft using the bioabsorbable interference screw of the present invention includes the steps of securing one end of a graft 60 in the femoral socket 62, pulling the opposite end of the graft 60 (extending through the tibial tunnel) taut, and fixating the graft 60 in the tibial tunnel 64 by mounting the bioabsorbable interference screw 10 on driver 56 and, using the driver, driving screw 10 in the tibial tunnel against graft 60 to the level of the anterior cortex in the distal portion of the tibial tunnel, such that the interference screw fills all but the top 5-10 mm. of the tunnel. Driver 66 is then removed, leaving screw 10 in place with an interference fit of up to 1.5 mm.

Although the present invention has been described in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art. It is preferred, therefore, that the present invention be limited not by the specific disclosure herein, but only by the appended claims.

Claims

1. A bioabsorbable interference screw for ACL reconstruction, comprising: an elongated threaded bioabsorbable body having a proximal end, a distal end, and a length of 35 mm for substantially longitudinally filling a tibial tunnel, the threads of the elongated threaded bioabsorbable body extending along substantially the entire length of the elongated threaded body, the screw having a width dimensioned to provide an interference fit in the tibial tunnel; a tip disposed at the distal end of the elongated body, the tip having a taper to facilitate insertion of the screw into the tibial tunnel; and a drive socket disposed within the screw and extending from the proximal end of the elongated threaded body, wherein the drive socket includes a plurality of radially extending slots configured to receive corresponding radially extending protrusions on a shaft of a screwdriver.

2. The bioabsorbable interference screw of claim 1, wherein the screw is fully cannulated for receiving a guide pin.

3. The bioabsorbable interference screw of claim 1, wherein the screw has a diameter of 9 mm. at the drive socket.

4. The bioabsorbable interference screw of claim 1, wherein the screw has a diameter of 10 mm. at the drive socket.

5. The bioabsorbable interference screw of claim 1, wherein the screw has a diameter of 11 mm. at the drive socket.

6. The bioabsorbable interference screw of claim 1, wherein the screw has a diameter of 12 mm. at the drive socket.