Fixation Devices and Method of Repair

• US 20080234730A1
• Filed: 03/21/2008
• Published: 09/25/2008
• Est. Priority Date: 03/23/2007
• Status: Abandoned Application

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Brown, Malcolm, Montes de Oca Balderas, Horacio, Cotton, Nicholas, Blough, Rebecca A., Hall, Michael, Egan, Melissa J.
• Application Number:
  US12/053,264
• Publication Number:
  US 20080234730A1
• Time in Patent Office: Days
• US Class Current: 606/232
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• 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: A61L 31/128 containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
• CPC Class Codes: C08K 3/26 Carbonates; Bicarbonates
• CPC Class Codes: C08L 2666/14 Macromolecular compounds according to C08L59/00 - C08L87/00; Derivatives thereof
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

Abstract

In one aspect, the present disclosure relates to a surgical device including an anchor body having an opening, the anchor body having a copolymer composition including polylactide-co-glycolide and calcium carbonate, wherein the calcium carbonate comprises more than 30% but less than 40% of the weight of the composition; and a flexible member passing through the opening, wherein deformation of the device occurs at body temperature. The present disclosure also relates to an oriented polymer material having a copolymer composition including a polylactide-co-glycolide and calcium carbonate, the calcium carbonate comprising more than 30% but less than 40% of the weight of the composition, wherein the material changes shape upon introduction to an environment having a temperature that is lower than a relaxation temperature of the material. A method of repairing soft tissue and other surgical devices are also disclosed.

Claims

1. A surgical device comprising:

an anchor body including an opening, the anchor body having a copolymer composition including polylactide-co-glycolide and calcium carbonate, wherein the calcium carbonate comprises more than 30% but less than 40% of the weight of the composition; and

a flexible member passing through the opening, wherein deformation of the device occurs at body temperature.

2. The surgical device of claim 1 wherein the opening comprises a through hole.

3. The surgical device of claim 1 wherein the anchor body is configured for rotary advancement into a target tissue.

4. The surgical device of claim 1 wherein the anchor body includes screw threads.

5. The surgical device of claim 1 wherein the anchor body is configured for axially oriented advancement into a target tissue.

6. The surgical device of claim 1 wherein the anchor body includes circumferential ribs.

7. The surgical device of claim 1 wherein the device is injection molded.

8. The surgical device of claim 1 wherein deformation of the device occurs at about 37°

C.

9. The surgical device of claim 1 wherein the device is bioabsorbable.

10. A method for repairing a soft tissue comprising:

placing a surgical device in bone, the surgical device having a flexible member coupled thereto and having a copolymer composition including polylactide-co-glycolide and calcium carbonate, wherein the calcium carbonate comprises more than 30% but less than 40% of the weight of the composition;

passing the flexible member through a soft tissue located adjacent to the bone; and

tying the flexible member to secure the soft tissue to the bone,

wherein deformation of the surgical device occurs at body temperature after placement of the device in the bone.

11. The method of claim 10 wherein the surgical device comprises a suture anchor.

12. The method of claim 10 wherein deformation of the device provides an increase in fixation of the device to the bone.

13. The method of claim 12 wherein the increase in fixation comprises an increase in fixation strength of the device of between about 50% to about 200%.

14. The method of claim 10 wherein deformation of the device provides an increase in width of the device and a decrease in length of the device.

15. An oriented polymer material including a copolymer composition having a polylactide-co-glycolide and calcium carbonate, the calcium carbonate comprising more than 30% but less than 40% of the weight of the composition, wherein the material changes shape upon introduction to an environment having a temperature that is lower than a relaxation temperature of the material.

16. The polymer material of claim 15 wherein the polylactide-co-glycolide comprises poly(D,L lactide-co-glycolide).

17. The polymer material of claim 15 wherein the copolymer includes at least one mobile polymer.

18. The polymer composition of claim 17 wherein the copolymer further comprises at least one rigid polymer.

19. The polymer material of claim 15 wherein the copolymer includes at least one rigid polymer and one mobile polymer.

20. The polymer material as in claim 17 or 19 wherein the mobile polymer comprises polyethylene glycol.

21. The polymer material as in claim 18 dr 19 wherein the rigid polymer is selected from a group consisting essentially of L-lactide, D-lactide, and D,L-lactide.

22. The polymer material of claim 15 wherein the material includes a porogen.

23. The polymer material of claim 22 wherein the porogen includes sodium chloride.

24. The polymer material of claim 15 wherein the temperature of the environment is about 37°

C.

25. The polymer material of claim 15 wherein the temperature of the environment comprises body temperature.

26. The polymer material of claim 15 wherein the relaxation temperature is about 50°

C.

27. The polymer material of claim 15 wherein the polymer material comprises a fixation strength of above 500 N.

28. A surgical device comprising a copolymer composition including polylactide-co-glycolide and a porogen.

29. The surgical device of claim 28 wherein the surgical device comprises an oriented polymer material.

30. The surgical device of claim 28 wherein the porogen includes sodium chloride.

31. The surgical device of claim 28 wherein the porogen is selected from a group consisting essentially of lithium bromide, lithium iodide, calcium chloride, sodium iodide, magnesium sulphate, and calcium sulphate.

32. The surgical device of claim 28 wherein the surgical device is selected from a group consisting essentially of pins, rods, nails, screws, sutures, plates, anchors, and wedges.

38. The surgical device in any of claims 29 or 33 wherein the oriented polymer material is made by a process selected from a group consisting essentially of die drawing, hydrostatic extrusion, and roll drawing.

33. A surgical device comprising a first component including a shaft, a second component coupled to the first component, and a flexible member coupled to the shaft, wherein the first component is an injection molded component and the second component includes an oriented polymer material.

34. The surgical device of claim 33 wherein the flexible member is coupled to the shaft via an eyelet, the eyelet coupled to the shaft.

35. The surgical device of claim 33 wherein the flexible member is coupled to the shaft via an opening in the shaft.

36. The surgical device of claim 33 wherein the first component includes a copolymer composition having polylactide-co-glycolide and calcium carbonate and the second component includes a copolymer composition having polylactide-co-glycolide and a porogen.

37. A surgical device comprising a first component including a shaft and second component coupled to the first component, wherein the first component includes a copolymer composition having polylactide-co-glycolide and calcium carbonate and the second component includes a copolymer composition having polylactide-co-glycolide and a porogen.