Method of performing anterior cruciate ligament reconstruction using biodegradable interference screw

Abstract

A method of replacing an ACL with a graft. The method provides for the drilling bone tunnels in a femur and a tibia. A replacement graft is provided having first and second ends. A biodegradable composite screw is provided. The screw is made from a biodegradable polymer and a bioceramic or a bioglass. At least one end of the graft is secured in a bone tunnel using the biodegradable composite screw.

Claims

1. A method of manufacturing, comprising: introducing a dry bioceramic and a dry biodegradable polymer including poly(lactic acid) and poly(glycolic acid) into an extruder; blending the dry biodegradable polymer and the dry bioceramic in the extruder to form a composite; and molding the composite to form a surgical screw having a thread on an exterior surface thereof.

2. The method of claim 1, further comprising heating the dry biodegradable polymer and the dry bioceramic in the extruder.

3. The method of claim 1, further comprising cooling the composite before the molding of the composite.

4. The method of claim 1, further comprising creating pellets of the composite before the molding of the composite; wherein molding the composite includes molding the pellets.

5. A surgical apparatus, comprising: a bioabsorable screw made from a bioceramic and a bioabsorbable copolymer including poly(lactic acid) and poly(glycolic acid), the screw being formed by the method of claim 1.

6. The apparatus of claim 5, wherein the screw is bioabsorbable.

7. The apparatus of claim 5, wherein the screw is cannulated.

8. The apparatus of claim 5, wherein the bioceramic comprises a bioceramic selected from the group consisting of mono-, di-, tri, [alpha]-tri-, [beta]-tri and tetra-calcium phosphate, hydroxyapatite, calcium sulfates, calcium oxides, calcium carbonate, and magnesium calcium phosphates.

9. The apparatus of claim 5, wherein the bioabsorbable copolymer comprises about 85 mole percent to about 95 mole percent of poly(lactic acid) and about 5 mole percent to about 15mole percent of poly(glycolic acid).

10. A surgical method, comprising: introducing a graft into a bone; and after introducing the graft, inserting a screw into the bone such that an exterior surface feature of the screw penetrates into the bone, thereby securing the graft in a fixed position between the screw and the bone, the screw comprising poly(lactic acid), poly(glycolic acid), and a bioceramic.

11. The method of claim 10, further comprising, before inserting the screw, mounting the graft to the bone.

12. The method of claim 10, further comprising, before inserting the screw, mating a distal end of a driver tool to a proximal end of the screw; wherein inserting the screw includes rotating the driver tool having the screw mated to the distal end thereof.

13. The method of claim 10, wherein the exterior surface feature is a thread.

14. The method of claim 10, wherein the screw is bioabsorbable.

15. The method of claim 10, wherein the screw is cannulated.

16. The method of claim 10, wherein the screw is bioabsorbable and is cannulated.

17. A surgical method, comprising: forming a bone tunnel in bone; securing a graft to the bone within the bone tunnel; and rotating a screw into the bone tunnel such that the graft is pinned between the screw and a wall of the bone tunnel, the screw comprising poly(lactic acid), poly(glycolic acid), and a bioceramic.

18. The method of claim 17, wherein rotating the screw includes rotating a driver tool having the screw mounted on a distal end thereof.

19. The method of claim 17, wherein the screw is threaded, cannulated, and bioabsorbable.

20. The method of claim 17, wherein the bioceramic comprises a bioceramic selected from the group consisting of mono-, di-, tri, [alpha]-tri-, [beta]-tri and tetra-calcium phosphate, hydroxyapatite, calcium sulfates, calcium oxides, calcium carbonate, and magnesium calcium phosphates; and the copolymer comprises about 85 mole percent to about 95 mole percent of poly(lactic acid) and about 5 mole percent to about 15 mole percent of poly(glycolic acid).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

(2) FIG. 1A is a side view of a biodegradable interference bone screw useful in the method of the present invention.

(3) FIG. 1B is an end view of the interference bone screw of FIG. 1A.

(4) FIG. 1C is a cross-sectional view of the inference bone screw of FIG. 1B taken along view line A-A.

(5) FIG. 2 is a side view of a driver device useful for emplacing the bone screw of FIG. 1 in a bone tunnel.

(6) FIG. 3 illustrates a bone-tendon-bone graft prior to emplacement in a knee for an ACL reconstruction.

(7) FIG. 4 shows a guide wire placed into the femoral tunnel between the tunnel wall and the bone block.

(8) FIG. 5 illustrates a conventional tap being used to tap a hole between the wall and the bone block.

(9) FIG. 6 shows a biodegradable interference screw being inserted into the femoral tunnel between the tunnel wall and the bone block.

(10) FIG. 7 illustrates a guide wire placed into the tibial tunnel between the tunnel wall and the bone block.

(11) FIG. 8. illustrates a conventional tap device being used to tap a hole between the tunnel wall and the bon e block.

(12) FIG. 9 illustrates the screw being inserted into the tibial tunnel between the tunnel wall and the bone block.

(13) FIG. 10 is a side view of the knee after the ACL replacement procedure has been completed.

(14) FIG. 11A is a histological section of a PLA/PGA bone pin containing [beta]-tricalcium phosphate and surrounding tissue.

(15) FIG. 11B is a histological section of a PLA bone pin and surrounding tissue.

(16) FIG. 11C is a histological section of a PLA bone pin and surrounding tissue.

(17) FIG. 11D is a histological section of a PLA bone pin containing [beta]-tricalcium phosphate and surrounding tissue.

(18) FIG. 11E is a histological section of a PLA/PGA bone pin containing [beta]-tricalcium phosphate and surrounding tissue.

DETAILED DESCRIPTION

(19) The novel interference screws of the present invention are a composite of a biodegradable polymer or copolymer and a bioceramic. The term biodegradable as used herein is defined to mean materials that degrade in the body and then are either absorbed into or excreted from the body. The term bioceramic as defined herein is defined to mean ceramic and glass materials that are compatible with body tissue. The bioceramics are preferably biodegradable.

(20) The biodegradable polymers that can be used to manufacture the composite screws used in the novel process of the present invention include biodegradable polymers selected from the group consisting of aliphatic polyesters, polyorthoesters, polyanhydrides, polycarbonates, polyurethanes, polyamides and polyalkylene oxides. Preferably, the biodegradable polymers are aliphatic polyester polymers and copolymers, and blends thereof. The aliphatic polyesters are typically synthesized in a ring opening polymerization. Suitable monomers include but are not limited to lactic acid, lactide (including L-, D-, meso and D, L mixtures), glycolic acid, glycolide, .epsilon.-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate (1,3-dioxan-2-one), delta.-valerolactone, and combinations thereof. These monomers generally are polymerized in the presence of an organometallic catalyst and an initiator at elevated temperatures. The organometallic catalyst is preferably tin based, e.g., stannous octoate, and is present in the monomer mixture at a molar ratio of monomer to catalyst ranging from about 10,000/1 to about 100,000/1. The initiator is typically an alkanol (including diols and polyols), a glycol, a hydroxyacid, or an amine, and is present in the monomer mixture at a molar ratio of monomer to initiator ranging from about 100/1 to about 5000/1. The polymerization typically is carried out at a temperature range from about 80.degree. C. to about 240.degree. C., preferably from about 100.degree. C. to about 220.degree. C., until the desired molecular weight and viscosity are achieved. It is particularly preferred to use a copolymer of poly(lactic acid) and poly(glycolic acid). In particular, a copolymer of about 85 mole percent poly(lactic acid) and about 15 mole percent poly(glycolic acid).

(21) The bioceramics that can be used in the composite screws used in the novel process of the present invention include ceramics comprising mono-, di-, tri-, [alpha]-tri-, [beta]-tri-, and tetra-calcium phosphate, hydroxyapatite, calcium sulfates, calcium oxides, calcium carbonates, magnesium calcium phosphates. It is particularly preferred to use a [beta]-tritricalcium phosphate.

(22) In addition to bioceramics, bioglasses may also be used in the composite screws. The bioglasses may include phosphate glasses and bioglasses.

(23) The amount of the bioceramic or bioglass in the composite interference screw will be sufficient to effectively promote bone in-growth. Typically the amount will be about 2.0 Vol. % to about 25.0 Vol. %, and preferably about 15.0 Vol. %.

(24) The composite, biodegradable interference screws useful in the present invention are manufactured in conventional extrusion and molding processes using conventional extruding and molding equipment. In a typical process, dry biodegradable polymer pellets and dry bioceramic or bioglass are metered into a conventional heated screw extruder. The materials are heated and blended in the extruder for a sufficiently effective residence time to provide a viscous composite having a uniform distribution of the particles of bioglass or bioceramic. Then the viscous composite is cooled and chopped to form pellets of the homogenous composite. The interference screws may be molded in a conventional injection molder. In a typical injection molder, pellets of composite are fed into a barrel, passed through a heating zone to melt the polymer, then pushed forward through a nozzle and into the cavity of a chilled mold. After cooling, the mold is opened, and the part is ejected.

(25) A biodegradable interference screw 5 of the present invention is seen in FIGS. 1A-C. The screw 5 is seen to have an elongate body 10 having a cannulated passage 20 therethrough, with proximal socket opening 22 and distal opening 26. The body 10 is seen to have a plurality of thread flights 30 extending from the outer surface 12. The body 10 is seen to have distal end 14 and proximal end 16. A driver 50 for inserting or emplacing the crew 5 in a bone tunnel is seen in FIG. 2. The driver 50 has an elongated rod member 60 having distal end 62 and proximal end 64. Distal end 62 is seen to have a driver 63 extending therefrom having a hexagonal configuration for mating with socket 22. The screw 5 is mounted to driver 50 by inserting the driver 63 of distal end 62 into the mating proximal socket end 22 of the passage 20.

(26) The biodegradable composite interference screws described herein are used in the novel ACL reconstruction procedure of the present invention in the following manner as illustrated if FIGS. 3-10. Prior to reconstructing the ACL using a bone-tendon-bone graft, a patient is prepared for surgery in a conventional manner. The patient's knee 100 is prepared for surgery in a conventional manner including swabbing the skin around the knee with a conventional antiseptic solution, and draping the knee. The knee 100 is then angulated by the surgeon in a conventional manner to facilitate the surgical procedure. The patient is then anesthetized in a conventional manner using conventional anesthetics, either general or local at the discretion of the surgeon. As seen in FIG. 1, the knee 100 is seen to have a femur 150 having a distal end 160 and a tibia 130 having a proximal end 140. Proximal end 140 is seen to have a tibial plateau 141. Extending from the distal end 160 of femur 150 are the femoral condyles 170 separated by notch 175. For the sake of illustration, the tendons, cartilage, fascia, soft tissue and skin are not shown. The knee 100 is accessed by the surgeon using a conventional arthroscope that is inserted though a conventional cannula, that has been previously emplaced in the knee 100 in a conventional manner through an incision in the skin covering the knee 100. A flow of sterile saline is initiated through channels in the arthroscope into the knee 100. The stumps of the ACL are removed from the surfaces of the tibial plateau 141 and the chondryl notch 175 using conventional shavers that are inserted through the cannula. A bone-tendon-bone graft 200 is harvested and prepared by the surgeon in a conventional manner. The graft 200 is harvested by making an incision in the skin over the knee 100 down the anterior patella to the tibial. A conventional sagittal saw is then used to harvest the opposed bone plugs 220 that are connected by harvested patellar tendon segment 210. The tendon segment 210 is cut from the patellar tendon in a conventional manner using a scalpel. If desired, a graft without bone blocks attached may also be used in the method of the present invention.

(27) The procedure continues by mounting a conventional tibial drill guide (not shown) to the proximal end of the tibia 130. A conventional guide pin 250 is inserted into the drill guide and mounted to a conventional surgical drill. The guide pin 250 is seen to have elongated body 252 having distal cutting end 254 and proximal end 255 with suture mounting opening 257. The guide pin 250 is drilled into the front of the tibia 130 in a conventional manner until the distal end 254 exits out from the tibial plateau 141. The drill guide is then removed from the tibia 130 and a conventional surgical reamer is placed over the guide pin 250 and turned to ream out a tibial tunnel 280 having a passage 282, an inner tunnel wall 283, a top opening 284 out of the tibial plateau 141 and a bottom opening 286 out through the tibia 130. Then the reamer and the guide pin 250 are removed from the tibial tunnel 280 and a conventional femoral aimer device (not shown) is inserted into tibial tunnel 280 and manipulated until the distal end of the femoral aimer engages the appropriate location on the femoral notch 175. Then the guide pin 250 is inserted through a passage in the femoral aimer, and the guide pin 250 is mounted to a conventional surgical drill and drilled into the femoral notch such that the distal end exits out through the lateral side of the femur 150 and through the skin overlying that section of the femur 150. Next, the femoral aimer is removed from the knee 100 and a conventional surgical bone reamer is placed over the guide pin 250 and moved through the tibial tunnel 280, and a femoral tunnel 290 is drilled though the femur having a passage 292, an inner tunnel wall 293, an upper opening 294 out through the lateral side of the femur 130 and a bottom opening 296 out of the femoral notch 175. The reamer is then removed from the bone tunnel 290.

(28) Referring to FIG. 3., the graft 200 is illustrated proximal to the knee 100 having the tibial tunnel 280 and femoral tunnel 290 drilled and reamed in the tibia 130 and femur 150, respectively. The guide pin 250 is seen to reside in the knee 100 with the elongated body 252 of guide pin 250 substantially contained within tibial tunnel 280 and femoral tunnel 290, with distal end 254 exiting out through opening 294 and proximal end 255 exiting out from opening 286. Next, the surgeon threads sutures 230 through the suture tunnels 222 in bone blocks 220. The suture through the top bone block 220 is also threaded through opening 257 of guide pin 250. The surgeon then pulls guide pin 250 distally such that the graft 200 is displaced into the knee 100 with upper bone graft 220 located in passage 292 of femoral tunnel 290 and lower bone block 220 located in passage 282 of tibial tunnel 280. An optional step of tapping the bone block and boned tunnel is illustrated in FIGS. 4 and 5. A guide wire 300 is seen to be inserted into femoral bone tunnel 290 between bone block 220 and inner tunnel wall 293. Then, a conventional cannulated bone tap 310 is inserted over guide wire 300. The bone tap 310 has elongated cannulated member 310, having a transverse handle 314 mounted to proximal end 312 and a tapping/cutting end 318 mounted to distal end 316. The tapping cutting end 318 is rotated by rotating handle 314, causing an opening to be cut and threads to be tapped between inner wall 293 and bone block 220 in the femoral tunnel 290. Then, as seen in FIG. 6, a biodegradable interference screw 5 mounted to a driver 50 is mounted to the guide wire 300 and threaded into the femoral tunnel 290 between the bone block 220 and the inner wall 293, thereby securing the upper bone block 220 in the passage 292 of femoral tunnel 290. The guide wire is then removed from the femoral tunnel 290 and inserted into opening 286 of and into passage 280 of tibial tunnel 280 between the lower bone block 220 and the inner wall 183 as seen in FIG. 7. Then, the surgeon tensions the graft 200 by pulling proximally on sutures 230 connected to lower bone block 220. Then, the bone tap 310 is inserted into tibial tunnel 280 over the guide wire 300 and an opening and threads are cut and tapped between inner wall 283, and bone block 220. Finally, the bone tap 310 is removed and as seen in FIG. 9, a biodegradable interference screw 5 is mounted over the guide wire 300 and threaded into the tibial tunnel 280 between inner wall 282 and lower bone block 220, thereby securing the lower bone block 220 in tibial tunnel 280. This completes the ACL reconstruction, and the graft 200 is now secured in the knee 100. The complete reconstructed knee 100 is seen in FIG. 10. The surgeon then checks the knee for proper flexion and completes the procedure in a conventional manner by removing the scope and portal, and conventionally closing and/or suturing and bandaging all incisions.

(29) The following examples are illustrative of the principles and practice of the present invention although not limited thereto.

EXAMPLE 1

(30) Biodegradable composite bone pins 1 were prepared in a conventional manner and into the femurs of mammalian laboratory animals. The pins were of the following three compositions: A) composites of 15/85% by volume [beta]-tricalcium phosphate and (85/15)poly (lactide co-glycolide); B) poly(lactide); and C) composite of 15%/85% by volume [beta]-tricalcium phosphate and poly(lactide). About 24 months after implantation, the animals were euthanized and histological sections were obtained. As seen in FIG. 11A, a bone pin 500 having a Composition (A)demonstrated a significant degree of absorption when compared with the original diameter indicated by arrows 505, and significant tissue (bone) in-growth. In addition, minimal tissue reaction was observed. As seen if FIGS. 11B and 11C, bone pins 510 and 520 having Composition (B) exhibited minimal absorption compared with the original diameters indicated by arrows 515 and 525, respectively. As seen in FIG. 11D, a bone pin 530 having Composition C showed minimal absorption compared with the original diameter indicated by arrows 535. And, as seen in FIG. 11E, a bone pin 540 having Composition A demonstrated a significant degree of absorption compared with the original diameter indicated by arrows 545, and significant tissue (bone) in-growth. Minimal tissue reaction was observed.

(31) The novel ACL graft replacement method of the present invention using a composite interference screw made from a bioaborbable polymer and a bioceramic or bioglass has many advantages. The advantages include having improved bioabsorption and bone replacement, improved tissue in-growth, and minimizing tissue trauma. In addition, there is an optimal balance between stiffness and elasticity of the screws.

(32) Although this invention has been shown and described with respect to detailed embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail thereof may be made without departing from the spirit and scope of the claimed invention.