Implants and methods for using such implants to fill holes in bone tissue

• US 9,463,046 B2
• Filed: 08/22/2011
• Issued: 10/11/2016
• Est. Priority Date: 08/22/2011
• Status: Active Grant

• Current Assignee: Ossdsign AB
• Original Assignee: Ossdsign AB
• Inventors: Qwarnstrom, Bo, Engstrand, Thomas
• Primary Examiner(s): Snow, Bruce E
• Assistant Examiner(s): HOBAN, MELISSA A
• Application Number:
  US13/214,441
• Publication Number:
  US 20130053900A1
• Time in Patent Office: 1,877 Days
• Field of Search: 623/17.19, 623/23.56
• US Class Current: 1/1
• CPC Class Codes: A61B 17/688 for reattaching pieces of the skull
• CPC Class Codes: A61B 17/842 Flexible wires, bands or straps A61B17/72, A61B17/82, A61B17/86 take precedence
• CPC Class Codes: A61F 2/2875 Skull or cranium A61F2/2803 and A61F2/3099 take precedence
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2002/285 Fixation appliances for attaching bone substitute support means to underlying bone
• CPC Class Codes: A61F 2002/2878 for orbital repair
• CPC Class Codes: A61F 2002/30576 with extending fixation tabs
• CPC Class Codes: A61F 2002/30578 having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30878 with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2310/00353 Bone cement, e.g. polymethylmethacrylate or PMMA

Abstract

An implant includes a single moulded implant body and a plurality of wire anchoring arms moulded into and extending substantially laterally from the moulded ceramic implant body for filling a bore hole in a skull. The implant will not only provide filling of the bone defect, but also provide fixation of the bone flap. Methods for forming such implants and methods for using the implants for filing a bore hole in a skull are described.

Claims

1. An implant for filling a bore hole in a bone, comprising:

a. a single solid ceramic tile body, the tile body having a top surface, a bottom surface, and at least one lateral sidewall extending between the top surface and the bottom surface;

b. a plurality of wire anchoring arms, each anchoring arm having;

i. a first portion embedded in the tile body, the ceramic tile body being moulded around the first portions of the wire anchoring arms to provide an internal wire-supported implant body; and

ii. a second portion extending laterally outwardly from the tile body through a lateral sidewall of the tile body; and

c. at least two anchoring structures, wherein each anchoring structure is connected to the ceramic tile body by the second portion of a wire anchoring arm, and wherein one of the anchoring structures is positioned for securing the respective anchoring arm to a bone flap and another of the anchoring structures is positioned for securing the respective anchoring arm to surrounding bone structure.

2. The implant of claim 1, comprising more than two wire anchoring arms and more than two anchoring structures.

3. The implant of claim 1, wherein each anchoring structure has an opening adapted to receive a fastener for securing the implant to a bone structure.

4. The implant of claim 1, wherein the implant is sterilized and packaged.

5. The implant of claim 1, wherein the first portions of the anchoring arms are located in a first plane intermediate the top surface and the bottom surface.

6. The implant of claim 1, wherein the second portions of the anchoring arms extend laterally outwardly from the tile body at spaced locations about the at least one lateral sidewall.

7. The implant of claim 6, wherein the anchoring arms are uniformly spaced from each other about the at least one lateral sidewall.

8. The implant of claim 1, wherein the tile body has a circular cross-section and the anchoring arms extend radially outwardly from the lateral sidewall.

9. The implant of claim 8, comprising three or more anchoring arms and three or more anchoring structures.

10. The implant of claim 1, wherein the tile body has a width D between 8 and 20 mm.

11. The implant of claim 10, wherein the width D is between 9 and 15 mm.

12. The implant of claim 10, wherein the width D is between 10 and 14 mm.

13. The implant of claim 1, wherein the tile body has a thickness H between 1 and 10 mm.

14. The implant of claim 13, wherein the thickness H is between 2 and 8 mm.

15. The implant of claim 13, wherein the thickness H is between 3 and 6 mm.

16. The implant of claim 1, wherein the tile body comprises Monetite cement.

17. The implant of claim 1, wherein the tile body comprises Monetite cement formed from (a) β

-tricalcium phosphate, and (b) either monocalcium phosphate monohydrate or anhydrous monocalcium phosphate or a mixture thereof.

18. The implant of claim 17, wherein the implant body comprises Monetite cement formed from a 1:

1 ratio of (a) and (b).

19. The implant of claim 17, wherein the implant body comprises Monetite cement formed from (a) β

-tricalcium phosphate having a grain size in a range of from 0.1 to 100 micrometers, and (b) either monocalcium phosphate monohydrate or anhydrous monocalcium phosphate or a mixture thereof, wherein the grain size of (b) has a spread of from 1 to 800 micrometers.

20. The implant of claim 1, wherein first portions of at least two wire anchoring arms intersect in the ceramic tile body.

21. The implant of claim 1, wherein the tile body has a thickness H between 1 and 6 mm.

22. The implant of claim 1, wherein the tile body has a thickness H between 2 and 6 mm.

23. The implant of claim 1, wherein the anchoring structures are positioned at spaced locations around the perimeter of the ceramic tile body.

24. The implant of claim 1, wherein each second portion of the wire anchoring arms extends not more than 10 mm from the ceramic tile body.

25. The implant of claim 1, wherein each second portion of the wire anchoring arms extends not more than 8 mm from the ceramic tile body.

26. Method of forming an implant according to claim 1, comprising the steps of moulding a cement composition around the first portions of the anchoring arm wires and subsequently allowing said cement composition to cure.

27. The method of claim 26, comprising the steps of:

a) providing a mould with at least one cavity having a depth equal to the thickness of the tile body and having the shape of the tile body, wherein each cavity has a closable bottom end and is open at the opposite open end to allow filling of the cavity, wherein the wall of each cavity is pierced by a plurality of wire-retaining channels of width T corresponding with the anchoring arms;

b) placing a wire in each wire-retaining channel and extending into the cavity, c) filling said mould with a cement composition; and

d) allowing said cement composition to harden.

28. Method according to claim 26, comprising the steps of:

i) providing a first mould half with at least one cavity having a depth less than the thickness of the tile body and having the shape of the tile body, wherein each cavity has a closable bottom end and is open at the opposite open end to allow filling of the cavity, ii) filling said first mould half with an excess of cement composition;

iii) placing wire anchoring arms over the open end of said cavity and extending laterally outwardly from the cavity;

iv) placing a second mould half with a cavity having a depth less than the thickness of the tile body and having the shape of the tile body, arranged as a mirror-image of the first mould half, on top of the wire and compressing the second mould half towards the first mould half; and

v) allowing said cement composition to harden.

29. Method of implanting the implant of claim 1 in a bore hole between a bone flap and surrounding bone, comprising the steps of placing the tile body in the bore hole, and fixing one of the anchoring structures to the bone flap and another of the anchoring structures to the surrounding bone.

30. Method according to claim 29, wherein the step of fixing the anchoring structures to the bone flap and surrounding bone is achieved by using sutures, clamps, screws, plates with screws, or a combination thereof.

31. Method according to claim 29, comprising the step of attaching one anchoring structure by at least one screw to the bone flap before the bone flap is positioned in the surrounding bone.

32. An implant for filling a bore hole in a bone, comprising:

a. a single solid ceramic tile body, the tile body having a top surface, a bottom surface, and one or more lateral sidewalls extending between the top surface and the bottom surface;

b. a plurality of radially-extending wire anchoring arms, each anchoring arm having;

i. a first portion embedded in the tile body, the ceramic tile body being moulded around the first portions of the wire anchoring arms to provide an internal wire-supported implant body; and

ii. a second portion extending laterally outwardly from the tile body through a lateral sidewall of the tile body, wherein the second portions of the respective anchoring arm wires extend laterally outwardly from the tile body at uniformly spaced locations around a perimeter of the tile body; and

c. a plurality of anchoring structures, wherein each anchoring structure is connected to the ceramic tile body by the second portion of a wire anchoring arm, wherein the anchoring structures are located at uniformly spaced locations around the tile body perimeter, and wherein the anchoring structures comprise screw-receiving openings.

33. The implant of claim 32, wherein two adjacent anchoring structures are connected to each other by a wire segment.

34. The implant of claim 32, wherein the plurality of anchoring arms comprises three or more anchoring arms extending laterally outwardly from the tile body at uniformly spaced locations around the perimeter of the tile body.

35. The implant of claim 32, wherein the plurality of anchoring arms comprises more than three anchoring arms extending laterally outwardly from the tile body at uniformly spaced locations around the perimeter of the tile body.

36. The implant of claim 32, wherein first portions of at least two wire anchoring arms intersect in the ceramic tile body.

37. The implant of claim 32, wherein the tile body has a thickness H between 1 and 6 mm.

38. The implant of claim 32, wherein the tile body has a thickness H between 2 and 6mm.