Demineralized bone fiber composition for use in minimally invasive surgery

• US 10,639,157 B2
• Filed: 03/14/2018
• Issued: 05/05/2020
• Est. Priority Date: 03/14/2017
• Status: Active Grant

• Current Assignee: Theracell LLC
• Original Assignee: Theracell, Inc. (Titan Pharmaceuticals, Inc.)
• Inventors: Scarborough, Nelson L., Carter, Andrew J., Patt, Bradley E.
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US15/921,583
• Publication Number:
  US 20180263779A1
• Time in Patent Office: 783 Days
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/285 Fixation appliances for attaching bone substitute support means to underlying bone
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30588 filled with solid particles
• CPC Class Codes: A61F 2002/3096 trimmed or cut to a customised size
• CPC Class Codes: A61F 2310/00359 Bone or bony tissue

Abstract

A bone implant composition and methods thereof include bone material made into various implant shapes including a cylinder having an outermost layer and an inner layer completely surrounded by the outermost layer. The bone implant compositions and methods include a bag or cylindrical tube made from a bone material which may be filled with additional bone material.

Claims

1. A method of making a bone implant from a sheet of demineralized bone fibers (DBF) comprising a plurality of elongated bone fibers cut from demineralized bone in a direction parallel to the orientation of collagen fibers, the method comprising:

providing the DBF into a sheet mold to form a sheet of DBF; and

processing the sheet of DBF by;

i) rolling the sheet of DBF to form a cylindrical bone implant or a hollow tube bone implant;

or

ii) bonding a first sheet of DBF with a second sheet DBF to form a bone implant bag,

wherein the hollow tube bone implant or the cylindrical bone implant has a length of from about 1 cm to about 30 cm and a diameter of from about 3 mm to about 15 mm.

2. The method of claim 1, further comprising adding a second bone material to the sheet of DBF prior to rolling the sheet of DBF, the second bone material selected from synthetic bone graft substitute, allograft bone chips, xenograft bone chips, and/or demineralized bone matrix (DBM).

3. The method of claim 1, wherein rolling the sheet of DBF to form a cylindrical bone implant comprises using a cigarette roller technique.

4. The method of claim 1, wherein rolling the sheet of DBF to form a hollow tube bone implant comprises hand rolling the sheet around a mandrel.

5. The method claim 4, wherein the mandrel has an oval cross section.

6. The method of claim 4, further comprising heating the cylindrical bone implant or the hollow tube bone implant at between 30°

to 70°

Celsius for 1 minute up to 180 minutes.

7. The method of claim 6, further comprising filling the hollow tube bone implant with synthetic bone graft substitute, allograft bone chips, xenograft bone chips, and/or demineralized bone matrix (DBM), wherein the filling occurs after heating.

8. The method of claim 1, wherein the bonding of the first sheet of DBF with the second sheet of DBF to form a bone implant bag comprises annealing together three of four sides of the first sheet and the second sheet forming a cavity therebetween.

9. The method of claim 1, wherein the bone implant bag has a length from about 5 cm to about 11 cm and a width from about 5 cm to about 11 cm.

10. A method of making a bone implant bag from a sheet of demineralized bone fibers (DBF) comprising:

providing the DBF into a sheet mold to form a sheet of DBF; and

bonding a first sheet of DBF with a second sheet DBF to form a bone implant bag.