DEMINERALIZED BONE FIBER COMPOSITION FOR USE IN MINIMALLY INVASIVE SURGERY

• US 20180263779A1
• Filed: 03/14/2018
• Published: 09/20/2018
• 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.
• Granted Patent: US 10,639,157 B2
• Time in Patent Office: 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 bone implant, comprising:

a bone material in a form of a cylinder, the cylinder having a length from about 1 cm to about 30 cm and a diameter from about 3 mm to about 15 mm, the bone material selected from demineralized bone fibers (DBF), a mixture of DBF and cancellous bone, mineralized cortical bone, partially demineralized cortical bone, demineralized cortical bone, or a synthetic bone graft substitute.

2. The bone implant of claim 1, wherein the cylinder has an outermost layer of bone material that is annealed by heating and/or dehydrothermal treatment.

3. The bone implant of claim 1, where the cylinder comprises an outermost layer made from a first bone material and an inner layer comprising a second bone material.

4. The bone implant of claim 1, wherein the outermost layer comprises DBF fibers and the inner layer comprises synthetic bone graft substitute, allograft bone chips, xenograft bone chips, and/or demineralized bone matrix (DBM).

5. A bone implant bag, comprising:

a first sheet of bone material and a second sheet of bone material each sheet being of approximately the same size and each sheet having four sides, the first sheet overlaying the second sheet, and three of the four sides of the first sheet being bonded to the second sheet forming a cavity between the first sheet and the second sheet, the bone material being selected from demineralized bone fibers (DBF), a mixture of DBF and cancellous bone, mineralized cortical bone, demineralized cortical bone, partially demineralized cortical bone, partially demineralized bone fibers, or a synthetic bone graft substitute.

6. The bone implant bag of claim 5, wherein the first sheet is bonded to the second sheet by heat sealing.

7. The bone implant bag of claim 5, further comprising synthetic bone graft substitute, allograft bone chips, xenograft bone chips, DBF, or any form of DBM added into the cavity between the first sheet and the second sheet.

8. The bone implant bag of claim 5, 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.

12. A method of delivering a bone repair composition to a subject, comprising implanting the bone implant bag of claim 5 into the subject.

13. The method of claim 12, further comprising:

suturing the cavity of the bone implant bag closed prior to implanting into the subject.

9. A method of making a bone implant for minimally invasive surgery (MIS), comprising:

compressing a first bone material into a mold to form a sheet of compressed bone material; and

rolling the sheet to form a cylindrical bone implant.

10. The method of claim 9, further comprising adding a second bone material to the sheet prior to rolling, the second bone material selected from synthetic bone graft substitute, allograft bone chips, xenograft bone chips, and/or demineralized bone matrix (DBM).

11. The method of claim 9, wherein rolling comprises using a cigarette roller machine, hand rolling around a mandrel, heat sealing, or suturing