Devices for tissue repair and methods for preparation and use thereof

• US 6,083,522 A
• Filed: 01/08/1998
• Issued: 07/04/2000
• Est. Priority Date: 01/09/1997
• Status: Expired due to Term

• Current Assignee: Innovasive Devices Inc. (Johnson & Johnson), Surgical Specialties Corporation Limited (Ssc Holdco Ltd)
• Original Assignee: NeuColl, Inc. (Angiotech Pharmaceuticals Incorporated)
• Inventors: Shenoy, Vivek N., Rice, John, Chu, George H., Cassidy, James J., Schroeder, Jacqueline Anne, Brown, Melissa K. C., Yeung, Jeff E.
• Primary Examiner(s): Azpuru, Carlos A.
• Application Number:
  US09/004,550
• Time in Patent Office: 908 Days
• Field of Search: 424/423, 623/16
• US Class Current: 424/423
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/46 with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 31/044 Collagen
• CPC Class Codes: A61L 31/127 containing fillers of phosphorus-containing inorganic materials
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/12 Articles with an irregular circumference when viewed in cross-section, e.g. window profiles
• CPC Class Codes: B29C 48/70 comprising means for dividing, distributing and recombining melt flows
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin

Abstract

Disclosed herein are uniformly shaped swellable devices comprising polymeric materials, as well as apparatuses and processes for their manufacture. In one embodiment, the present invention relates to load bearing implant devices for use in tissue repair. The implants consist of a resorbable, swellable implant body which is formed from a dehydrated crosslinked biocompatible polymer. As such, the implants are capable of swelling after insertion to become anchored in place. The implants function to enhance the structural integrity of the hard tissue into which they are placed, and thereby improve the load bearing capacity of such tissues. The implants are particularly well suited for use in attaching a second (hard or soft) tissue to the first (hard) tissue into which the implant is inserted. They may also be used as a site for attachment of a surgical device such as a screw, rod or pin.

Claims

1. A load bearing hard tissue implant comprising:

a resorbable, swellable implant body, wherein the implant body contains at least one hollow channel adapted to receive at least one suture; and

a load-distributing device adapted to hold a suture, wherein said implant body has a length and a width and comprises a dehydrated crosslinked biocompatible polymer.

2. The implant of claim 1, wherein the length of the implant body is greater than the width.

3. The implant of claim 1, wherein the load-distributing device comprises a biodegradable material.

4. The implant of claim 1, wherein the implant body is cylindrical.

5. The implant of claim 1, wherein the biocompatible polymer is crosslinked with an aldehyde-containing crosslinking agent.

6. The implant of claim 5, wherein the aldehyde-containing crosslinking agent is selected from the group consisting of glutaraldehyde and formaldehyde.

7. The implant of claim 6, wherein the aldehyde-containing crosslinking agent is glutaraldehyde.

8. The implant of claim 1, wherein the crosslinking agent is a functionally activated synthetic hydrophilic polymer.

9. The implant of claim 1, wherein the crosslinking agent is a mixture of a functionally activated synthetic hydrophilic polymer and an aldehyde-containing crosslinking agent.

10. The implant of claim 8, wherein the functionally activated synthetic hydrophilic polymer is a multifunctionally activated polyethylene glycol.

11. The implant of claim 10, wherein the multifunctionally activated polyethylene glycol is selected from the group consisting of SG-PEG and SE-PEG.

12. The implant of claim 1, wherein the biocompatible polymer is noncovalently crosslinked.

13. The implant of claim 12, wherein crosslinking is achieved using a method comprising a step selected from the group consisting of:

drying, irradiation, heating and compression.

14. The implant of claim 1, wherein the biocompatible polymer is collagen.

15. The implant of claim 12, wherein the collagen is fibrillar collagen.

16. The implant of claim 1, wherein the implant body further comprises a particulate material.

17. The implant of claim 14, wherein the particulate material is selected from the group consisting of:

particulate collagen, poly(lactic acid), poly(glycolic acid), polytetrafluoroethylene, silicone rubber, calcium carbonate, calcium sulfate, and silicon carbide.

18. The implant of claim 14, wherein the particulate material comprises calcium phosphate ceramic particles.

19. The implant of claim 15, wherein the ceramic particles are selected from the group consisting of:

tricalcium phosphate particles, hydroxyapatite particles, and a mixture of tricalcium phosphate particles and hydroxyapatite particles.

20. The implant of claim 1, wherein the implant body further comprises an effective amount of one or more biologically active agents.

21. The implant of claim 18, wherein the biologically active agent comprises a growth factor.

22. The implant of claim 19, wherein said growth factor is a member of the transforming growth factor supergene family.

23. The implant of claim 1, wherein the implant body has an outer surface, and wherein the outer surface is not smooth.

24. The implant of claim 21, wherein the outer surface of the implant body is ribbed.

25. The implant of claim 22, wherein the outer surface of the implant body has three or more ribs running the entire length of the implant body.

26. The implant of claim 23, wherein the outer surface of the implant body has eight ribs running the entire length of the implant body.

27. The implant of claim 1 for use in repairing a rotator cuff, wherein the average width of the implant body is between about 1.0 to about 6.0 mm, and wherein the average length of the implant body is between about 3.0 and about 30 mm in length.

28. The implant of claim 24, wherein the average width of the implant body is between about 2.0 and about 5.0 mm, and the average length of the implant body is between about 8.0 mm and about 18.0 mm.

29. The implant of claim 25, wherein the average width of the implant body is between about 2.5 and about 4.5 mm in diameter, and the average length of the implant body is between about 8.0 mm and about 18.0 mm.

34. The implant of claim 1 wherein said load distributing device is made from a non-biodegradable material.

35. The implant of claim 34 wherein said load distributing device is made from a material selected from the group consisting of ceramic, a polymer and metal.

36. The implant of claim 22 wherein said growth factor is selected from the group consisting of beta transforming growth factors, bone morphogenetic proteins, heparin binding growth factors, platelet-derived growth factors, insulin-like growth factors, inhibins, growth differentiating factors, and activins.

30. A process for preparing an implant body for use in a load bearing implant device for hard tissue repair in the body of a mammalian subject, comprising the steps:

(a) mixing together a biocompatible polymer with a crosslinking agent to form a reaction mixture;

(b) introducing the reaction mixture into a mold having a desired shape before substantial crosslinking has occurred between the biocompatible polymer and the crosslinking agent;

(c) allowing the biocompatible polymer and the crosslinking agent to react within the mold to form a matrix;

(d) drying the matrix to form a dehydrated implant body.

31. A method for joining a second tissue to a first tissue in a body of a mammalian subject, wherein the first tissue is a hard tissue, comprising the steps:

(a) forming a cavity in the first tissue;

(b) inserting a load bearing implant into the cavity, wherein the implant comprises;

(i) a resorbable, swellable implant body comprising a dehydrated crosslinked biocompatible polymer; and

(ii) a load-distributing device adapted to hold a suture;

(c) allowing the implant body to rehydrate in situ to anchor the implant into the first tissue; and

(d) attaching a second tissue to the implant using the suture.

32. A method for anchoring a surgical device into a hard tissue, comprising the steps of:

(a) forming a cavity in the hard tissue;

(b) inserting a load bearing implant into the cavity, wherein the implant comprises a resorbable, swellable implant body comprising a dehydrated crosslinked biocompatible polymer;

(c) inserting the surgical device into the implant; and

(d) before or after step (c), allowing the implant body to rehydrate in situ to anchor the implant into the hard tissue.

33. A method for securing a second tissue to a first tissue in a body of a mammalian subject, wherein the first and second tissues are hard tissues, comprising the steps of:

(a) inserting at least one load bearing implant into said hard tissues, such that each load bearing implant transverses both of said hard tissues, wherein the load bearing implant comprises a resorbable, swellable implant body comprising a dehydrated crosslinked biocompatible polymer; and

(b) allowing the implant body to rehydrate in situ to anchor the implant into the first and second tissues.