Bone graft materials, devices and methods of use

Patent metadata

Field	Value
Publication number	US-10660685-B2
Application number	US-201514940979-A
Country	US
Kind code	B2
Filing date	Nov 13, 2015
Priority date	Nov 14, 2014
Publication date	May 26, 2020
Grant date	May 26, 2020

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 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 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, the connector having a first threading configured to engage the distal end of the first chamber and a second threading configured to engage the distal end of the second chamber, the connector having a channel disposed between the first threading and the second threading, 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 to form a hydrated moldable coherent mass, wherein the device further comprises a cap having a threading configured to engage the distal end of the first chamber and when the cap is removed from the first chamber, the first plunger is configured to deliver the hydrated moldable coherent mass from the distal end of the first chamber, wherein the coherent mass of milled and lyophilized demineralized bone fibers comprises surface demineralized fibers.

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

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

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

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

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

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

8. The device of claim 1 , wherein the bone fibers have an average length from about 0.5 cm to about 10 cm.

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

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

12. A device of claim 1 , wherein movement of the second plunger to a retracted position causes a gas to move into the second chamber and mix with the liquid and cause pressure to generate in the second chamber causing the second plunger to move in the extended position to cause fluid to enter the connector and into the first chamber to hydrate the coherent mass of milled and lyophilized demineralized bone fibers in the first chamber.

13. The device of claim 1 , further comprising an extension member disposed within the channel, the extension member configured to create turbulent flow between first and second chambers.

14. The device of claim 13 , wherein the extension member is cross shaped.

15. The device of claim 1 , wherein the bone material is in the form of granules.

16. The device of claim 1 , wherein the coherent mass of milled and lyophilized demineralized bone fibers has a cylinder shape wherein the cylinder has hydration channels on an exterior surface, the hydration channels extending along a longitudinal axis of the cylinder.

17. The device of claim 1 , wherein after the cap is applied to the first chamber, and the first plunger is configured to move multiple times to pressurize the device and further hydrate the hydrated moldable coherent mass.

18. 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 milled and lyophilized demineralized bone fibers and clumps of coherent 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 the liquid disposed within the second chamber, the liquid configured to hydrate the milled and lyophilized demineralized bone fibers and clumps of coherent 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, the connector having a first threading configured to engage the distal end of the first chamber and a second threading configured to engage the distal end of the second chamber, the connector having a channel disposed between the first threading and the second threading, wherein movement of the second plunger to an extended position causes the liquid to flow to hydrate the milled and lyophilized demineralized bone fibers and clumps of coherent demineralized bone fibers in the first chamber to form a hydrated moldable coherent mass comprising surface demineralized fibers, wherein the device further comprises a cap having a threading configured to engage the distal end of the first chamber and after the cap is applied to the first chamber, and the first plunger is configured to move multiple times to pressurize the device and further hydrate the hydrated moldable coherent mass, wherein when the cap is removed from the first chamber, the first plunger is configured to deliver the hydrated moldable coherent mass from the distal end of the first chamber, the connector having an extension member disposed within the channel, the extension member configured to create turbulent flow between the first and second chambers.

Assignees

• Warsaw Orthopedic Inc

Inventors

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

Classifications

• A61F2/4601

  for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity · 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

• A61F2/30942

  for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques · CPC title

• 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

• A61L27/3608

  Bone, e.g. demineralised bone matrix [DBM], bone powder · CPC title