# US 10,368,930 B2 · Milled bone graft materials and methods of use

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,368,930 B2
- Document ID: US10368930B2
- Status: Granted
- Kind: B2
- Application number: 15/912,038
- Filed: 2018-03-05
- Published: 2018-07-12
- Granted: 2019-08-06
- Earliest claimed: 2014-11-14
- Assignees: Warsaw Orthopedic, Inc.
- Applicants: Warsaw Orthopedic, Inc.
- Inventors: Kelly W. Schlachter; Daniel A. Shimko; Kerem Kalpakci; Erick Vasquez; David R. Kaes; Subhabrata Bhattacharyya
- Web page: https://patentgrep.com/patent/US10368930B2

## CPC

- A61B 17/8816: {characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections}
- A61B 17/8805: {for introducing fluid filler into bone or extracting it (A61B17/7097, A61B17/8833 take precedence)}
- A61F 2/28: Bones
- A61F 2/30942: {for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques}
- A61F 2/4644: {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)}
- A61J 1/20: Arrangements for transferring {or mixing} fluids, e.g. from vial to syringe
- A61L 27/3608: {Bone, e.g. demineralised bone matrix [DBM], bone powder}
- A61L 27/365: {Bones}
- A61L 27/3683: {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}
- A61L 27/3691: {characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- B01F 33/50112: {of the syringe or cartridge type}
- B01F 33/70: Mixers specially adapted for working at sub- or super-atmospheric pressure, e.g. combined with de-foaming
- B01F 35/3202: {Hand driven}
- B01F 35/75425: {using pistons or plungers}
- A61B 2017/8838: {for mixing bone cement or fluid fillers}
- A61F 2/4601: {for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity}
- A61F 2002/2835: {Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material}
- A61L 2300/412: Tissue-regenerating or healing or proliferative agents
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- B01F: MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING (mixing paints B44D3/06)

## 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.

## Claims

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 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.

### Claim 8 (depends on 7)

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

### Claim 9 (depends on 8)

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.

### Claim 10 (depends on 8)

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

### Claim 11 (depends on 7)

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.

### Claim 12 (depends on 7)

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

### Claim 13 (depends on 7)

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.

### Claim 14 (depends on 7)

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

### Claim 15 (depends on 7)

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.

### Claim 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.

### Claim 17 (depends on 16)

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.

### Claim 18 (depends on 17)

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

### Claim 19 (depends on 17)

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.

### Claim 20 (depends on 17)

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.