Self-tapping resorbable two-piece bone screw

• US 6,916,321 B2
• Filed: 09/28/2001
• Issued: 07/12/2005
• Est. Priority Date: 09/28/2001
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Overaker, David W., Yuan, J. Jenny, Cooper, Kevin L., TenHuisen, Kevor S., Janas, Victor F.
• Primary Examiner(s): Lewis, Ralph A.
• Application Number:
  US09/969,779
• Publication Number:
  US 20030065332A1
• Time in Patent Office: 1,383 Days
• Field of Search: 606/72, 606/73, 606/74, 606/76, 606/77, 606/79, 606/80
• US Class Current: 606/312
• CPC Class Codes: A61B 17/8635 Tips of screws
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/8645 Headless screws, e.g. ligament interference screws
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 17/8685 comprising multiple separate parts
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• 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 2002/0858 Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
• CPC Class Codes: A61F 2002/0882 Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
• CPC Class Codes: A61F 2250/0019 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: Y10S 606/909 Bone

Abstract

An orthopedic interference screw has a hard, self-threading front section and a bioabsorbable rear section. The two sections are conjoined and threaded such that the hard front section cuts threads into the bone and the softer rear section follows the threads into the bone. Preferably, the screw has an axial bore for matingly receiving a turning tool such as a hex wrench.

Claims

1. An orthopedic screw for introduction into a bone tunnel, comprising:

a first section having a first end forming a tip of said screw, said first section extending from said first end to an intermediate point along the length of said screw, said first section including external threads along at least a portion of the length thereof, and said first section being made from a first material having a hardness such that said first section is self-threading when said first section is screwed into the bone tunnel; and

a second section coupled to said first section and extending from said intermediate point to a second end of said screw distal to said tip, said second section being formed from a bioabsorbable material which is different than said first material and said second section including external threads along at least a portion of the length thereof.

2. The screw of claim 1, further including a projection extending from one of said first section and said second section to the other of said first section and said second section to be received in a mating recess provided therein to conjoin said first section and said second section.

3. The screw of claim 2, wherein said projection is a hexagonal boss and said recess is a mating hexagonal recess.

4. The screw of claim 2, wherein said projection is asymmetric and said recess is matingly asymmetric establishing a single assembly orientation of said first section relative to said second section.

5. The screw of claim 4, wherein said projection is substantially cylindrical with at least one radially extending side prominence.

6. The screw of claim 1, further including an axial bore extending through said second section for at least a portion of the length thereof, said bore matingly receiving a tool for applying a turning force to said screw.

7. The screw of claim 6, wherein said axial bore is hexagonal along a portion of its length, said hexagonal portion being a tool receiving portion for receiving a hex wrench therein.

8. The screw of claim 6, wherein said axial bore extends through the entire length of said screw from said first end to said second end.

9. The screw of claim 8, wherein said axial bore proximate said first end has a shape for matingly receiving a guide pin.

10. The screw of claim 1, wherein said threads of said first section and said threads of said second section are continuous relative to one another when said first section is conjoined to said second section and have the same direction of rotational advancement.

11. The screw of claim 10, wherein said first end is tapered to aid in introducing said screw into a hole in bone.

12. The screw of claim 11, wherein said first end has at least one longitudinal flute cutting across at least one of said threads in said first section.

13. The screw of claim 12, wherein at least one of said threads on said first section is a starter thread.

14. The screw of claim 1, wherein said first section is bioabsorbable.

15. The screw of claim 14, wherein said first section is made from a material selected from the group consisting of mono-, di-, tri-, α

-tri, β

-tri, and tetracalcium phosphate, hydroxyapatite, calcium sulfates, calcium oxides, calcium carbonates, magnesium calcium phosphates, phosphate glasses, bioglasses, mixtures thereof, polyglycolic acid polymers and bone tissues.

16. The screw of claim 1, wherein said first section is made from a material selected from the group consisting of stainless steel, cobalt-chrome alloys, glasses, ceramics and polymers.

17. The screw of claim 1, wherein said second section is made from a material selected from the group consisting of aliphatic polyesters, polyorthoesters, polyanhydrides, polycarbonates, polyurethanes, polyamides and polyalkylene oxides.

18. The screw of claim 1, wherein said first section is conjoined to said second section by gluing.

19. The screw of claim 1, wherein said first section is conjoined to said second section by welding.

20. A two-piece interference screw, comprising:

a front section made from biocompatible material with a strength and hardness equivalent to that of bone; and

a rear section made from a bioabsorbable polymer and coupled to said front section.

21. The screw of claim 20, wherein said front section is bioabsorbable.

22. A method for securing a bone plug in a bone hole using a two-piece interference screw, comprises the steps of:

providing a front screw section composed of biocompatible material having strength and hardness at least equivalent to that of bone;

providing a rear screw section composed of bioabsorbable polymer;

coupling the front screw section to the rear screw section thereby forming the interference screw;

placing a tip of the interference screw into the bone hole;

turning the interference screw while simultaneously urging the interference screw into the bone hole;

cutting threads into the bone hole with the front screw section; and

permitting the rear screw section to thread into the threads cut by the front screw section.