Milled bone graft materials and methods of use

Patent metadata

Field	Value
Publication number	US-10368930-B2
Application number	US-201815912038-A
Country	US
Kind code	B2
Filing date	Mar 5, 2018
Priority date	Nov 14, 2014
Publication date	Aug 6, 2019
Grant date	Aug 6, 2019

Abstract

A bone material for hydration with a liquid is provided, the bone material comprising a coherent mass of milled and demineralized bone fibers, the coherent mass having no binder disposed in or on the coherent mass. In some embodiments, a bone material for hydration with a liquid is provided, the bone material comprising a coherent mass of cartridge milled, lyophilized and demineralized bone fibers, the coherent mass having no binder on the coherent mass. In some embodiments, a method of implanting a bone material is provided, the method comprising contacting the bone material with a liquid, the bone material comprising a coherent mass of cartridge milled, lyophilized and demineralized bone fibers, the coherent mass having no binder disposed in or on the coherent mass; molding the bone material into a shape to implant the bone material; and implanting the bone material at the target tissue site.

First claim

The invention claimed is:

1. A method of implanting a bone material to a target tissue site, the method comprising contacting the bone material with a liquid, the bone material comprising a coherent mass of cartridge milled, lyophilized and demineralized bone fibers, the coherent mass of bone fibers having no binder disposed in or on the coherent mass; molding the coherent mass of the bone material into a cylinder to implant the bone material, wherein the cylinder has hydration channels on an exterior surface, the hydration channels extending along a longitudinal axis of the cylinder; and implanting the bone material at the target tissue site.

2. A method of implanting of claim 1 , wherein the liquid comprises blood, water, saline or a combination thereof that is contacted with the bone material to form moldable bone material.

3. A method of implanting of claim 1 , wherein the fibers have an aspect ratio of from about 50:1 to about 1000:1, from about 50:1 to about 950:1, from about 50:1 to about 750:1, from about 50:1 to about 500:1, from about 50:1 to about 250:1, from about 50:1 to about 100:1, from about 10:1 to about 50:1, or from about 5:1 to about 10:1.

4. A method of implanting of claim 1 , wherein the coherent mass comprises a first end having a first diameter and a second end having a second diameter, the first diameter is wider than or the same size as the second diameter.

5. A method of implanting of claim 1 , wherein the hydration channels have a rounded inner surface.

6. A method of implanting of claim 1 , wherein the hydration channels have a straight inner surface.

7. A method of implanting a bone material to a target tissue site, the method comprising providing the bone material and contacting the bone material with a liquid, the bone material comprising a coherent mass of milled and demineralized bone fibers, the coherent mass of milled and demineralized bone fiber having no binder disposed in or on the coherent mass, wherein the coherent mass is shaped into a cylinder and the cylinder has hydration channels on an exterior surface of the coherent mass, the hydration channels extending along a longitudinal axis of the cylinder.

8. A method of implanting of claim 7 , wherein the bone material is lyophilized.

9. A method of implanting of claim 8 , wherein the coherent mass of milled and lyophilized demineralized bone fibers are cartridge milled fibers having a ribbon-like shape, increased surface area and a curled portion.

10. A method of implanting of claim 8 , wherein the coherent mass of milled and lyophilized demineralized bone fibers comprise autograft or allograft bone.

11. A method of implanting of claim 7 , wherein the milled and demineralized bone fibers are cartridge milled and have a ribbon-like shape with increased surface area compared to demineralized bone powder.

12. A method of implanting of claim 7 , wherein the bone fibers have a diameter from about 100 μm to about 2 mm.

13. A method of implanting of claim 7 , wherein the fibers have an aspect ratio of from about 50:1 to about 1000:1, from about 50:1 to about 950:1, from about 50:1 to about 750:1, from about 50:1 to about 500:1, from about 50:1 to about 250:1, from about 50:1 to about 100:1, from about 10:1 to about 50:1, or from about 5:1 to about 10:1.

14. A method of implanting of claim 7 , wherein the liquid comprises blood, water, saline or a combination thereof.

15. A method of implanting of claim 7 , wherein the liquid is mixed with the coherent mass of milled and demineralized bone fibers that are lyophilized without a binder to form moldable lyophilized demineralized bone fibers.

16. A method of implanting a bone material to a target tissue site, the method comprising contacting the bone material for hydration with a liquid, the bone material comprising a coherent mass of cartridge milled, lyophilized and demineralized bone fibers, the coherent mass of milled, lyophilized and demineralized bone fibers having no binder disposed in or on the coherent mass, wherein the coherent mass is shaped as a cylinder and the cylinder has hydration channels on an exterior surface, the hydration channels extending along a longitudinal axis of the cylinder.

17. A method of implanting of claim 16 , wherein the coherent mass of cartridge milled and lyophilized demineralized bone fibers have a ribbon-like shape and increased surface area compared to demineralized bone powder.

18. A method of implanting of claim 17 , wherein the coherent mass of cartridge milled and lyophilized demineralized bone fibers comprise autograft or allograft bone.

19. A method of implanting of claim 17 , wherein the fibers have an aspect ratio of from about 50:1 to about 1000:1, from about 50:1 to about 950:1, from about 50:1 to about 750:1, from about 50:1 to about 500:1, from about 50:1 to about 250:1, from about 50:1 to about 100:1, from about 10:1 to about 50:1, or from about 5:1 to about 10:1.

20. A method of implanting of claim 17 , wherein the liquid is mixed with the coherent mass of cartridge milled and demineralized bone fibers that are lyophilized without a binder to form moldable lyophilized demineralized bone fibers.

Assignees

• Warsaw Orthopedic Inc

Inventors

• Schlachter Kelly W
• Shimko Daniel A
• Kalpakci Kerem
• Vasquez Erick
• Kaes David R
• Bhattacharyya Subhabrata

Classifications

• A61F2/4644

  Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material (bone material A61F2/28; disintegrating or milling devices B02C) · CPC title

• A61B17/8805

  for introducing fluid filler into bone or extracting it (A61B17/7097, A61B17/8833 take precedence) · CPC title

• A61L27/3691

  characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation · CPC title

• A61L27/3683

  subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment · CPC title

• A61L27/54

  Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} · CPC title