Bone graft materials, devices and methods of use

Patent metadata

Field	Value
Publication number	US-2016166303-A1
Application number	US-201514940979-A
Country	US
Kind code	A1
Filing date	Nov 13, 2015
Priority date	Nov 14, 2014
Publication date	Jun 16, 2016
Grant date	—

Abstract

A device for mixing a bone material with a liquid is provided. The device comprises a chamber having a proximal end and a distal end, and the bone material disposed within the chamber, the bone material comprising a coherent mass of milled and lyophilized demineralized bone fibers; and a plunger having at least a portion slidably disposed within the proximal end of the chamber and configured to dispense the bone material mixed with liquid from the distal end of the chamber, when the plunger is in an extended position.

First claim

What is claimed is:

1 . A device for mixing a bone material with a liquid, the device comprising a chamber having a proximal end and a distal end, and the bone material disposed within the chamber, the bone material comprising a coherent mass of milled and lyophilized demineralized bone fibers; and a plunger having at least a portion slidably disposed within the proximal end of the chamber and configured to dispense the bone material mixed with liquid from the distal end of the chamber, when the plunger is in an extended position.

2 . A device of claim 1 , wherein the chamber comprises a syringe barrel.

3 . A device of claim 1 , wherein the coherent mass of milled and lyophilized demineralized bone fibers does not contain a binder.

4 . A device of claim 1 , wherein the coherent mass of milled and lyophilized demineralized bone fibers comprises cartridge milled fibers having a curled portion.

5 . A device of claim 1 , wherein the coherent mass of milled and lyophilized demineralized bone fibers comprises autograft or allograft bone.

6 . A device of claim 1 , wherein the bone fibers have a diameter from about 100 μm to about 2 mm.

7 . A device of claim 1 , wherein the bone fibers have a length from about 0.5 mm to about 50 mm.

8 . A device of claim 1 , wherein the bone fibers have a length from about 0.5 cm to about 10 cm.

9 . A device 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.

10 . A device of claim 1 , wherein the liquid comprises blood, water, saline or a combination thereof.

11 . A device of claim 1 , wherein the liquid is mixed with the milled and lyophilized demineralized bone fibers to form moldable lyophilized demineralized bone fiber.

12 . A device of claim 1 , wherein (i) the liquid is mixed with the milled and lyophilized demineralized bone fibers using negative pressure created in the chamber by the plunger or (ii) the distal end of the chamber comprises a removable cap.

13 . A device for mixing a bone material with a liquid, the device comprising a first chamber having a proximal end and a distal end, and the bone material disposed within the first chamber, the bone material comprising a coherent mass of milled and lyophilized demineralized bone fibers; and a first plunger having at least a portion slidably disposed within the proximal end of the first chamber; a second chamber having a proximal end and a distal end, and a liquid disposed within the second chamber, the liquid configured to hydrate the coherent mass of milled and lyophilized demineralized bone fibers; and a second plunger having at least a portion slidably disposed within the proximal end of the second chamber; a connector fluidly coupling the distal end of the first chamber to the distal end of the second chamber, wherein movement of the second plunger to an extended position causes liquid to flow to hydrate the coherent mass of milled and lyophilized demineralized bone fibers in the first chamber.

14 . A device of claim 13 , wherein movement of the second plunger to a retracted position causes the coherent mass of milled and lyophilized demineralized bone fibers in the first chamber to enter the connector and into the second chamber to further hydrate the coherent mass of milled and lyophilized demineralized bone fibers.

15 . A device of claim 13 , wherein the first chamber is detachable from the connector to dispense the hydrated coherent mass of milled and lyophilized demineralized bone fibers that is moldable.

16 . A device of claim 13 , wherein the coherent mass of milled and lyophilized demineralized bone fibers does not contain a binder.

17 . A device of claim 13 , wherein the liquid comprises blood, water, saline or a combination thereof.

18 . A method of hydrating a bone material with a liquid, the method comprising mixing the liquid with the bone material comprising a coherent mass of milled and lyophilized demineralized bone fibers in a device comprising a first chamber having a proximal end and a distal end, and the bone material disposed within the first chamber; and a first plunger having at least a portion slidably disposed within the proximal end of the first chamber; a second chamber having a proximal end and a distal end, and the liquid disposed within the second chamber, the liquid configured to hydrate the coherent mass of milled and lyophilized demineralized bone fibers; and a second plunger having at least a portion slidably disposed within the proximal end of the second chamber; a connector fluidly coupling the distal end of the first chamber to the distal end of the second chamber, wherein movement of the second plunger to an extended position causes the liquid to flow to hydrate the coherent mass of milled and lyophilized demineralized bone fibers in the first chamber.

19 . A method according to claim 18 , wherein (i) the method further comprises detaching the first chamber from the connector to dispense the hydrated coherent mass of milled and lyophilized demineralized bone fibers that is moldable; (ii) the coherent mass of milled and lyophilized demineralized bone fibers does not contain a binder; or (iii) the liquid comprises blood, water, saline or a combination thereof.

20 . A device of claim 13 , wherein (i) the connector comprises a threading to fluidly couple the distal end of the first chamber to the distal end of the second chamber; (ii) the connector comprises a fitting to fluidly couple the distal end of the first chamber to the distal end of the second chamber; or (iii) the connector comprises a valve to provide an airtight seal between the first chamber to the distal end of the second chamber.

Assignees

• Warsaw Orthopedic Inc

Inventors

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

Classifications

• A61F2/28 Primary

  Bones · CPC title

• A61F2002/2835

  Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material · CPC title

• A61L27/54

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

• A61L2300/412

  Tissue-regenerating or healing or proliferative agents · CPC title

• A61L2430/02

  for reconstruction of bones; weight-bearing implants · CPC title