# US 2010/0166879 A1 · Cancellous bone graft substitute and method of manufacturing the same

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- Number: US 2010/0166879 A1
- Document ID: US20100166879A1
- Status: Published application
- Kind: A1
- Application number: 12/359,125
- Filed: 2009-01-23
- Published: 2010-07-01
- Earliest claimed: 2008-12-31
- Assignees: Korea Bone Bank Co., Ltd.
- Inventors: Young Bock Shim; Ju Woong Jang; Hyang Kim; Kwang Il Lee; Keun Soo Lee; Il Hwan Kim
- Web page: https://patentgrep.com/patent/US20100166879A1

## CPC

- A61K 35/32: Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

A cancellous bone graft substitute and a method of manufacturing the cancellous bone graft substitute are provided, and more particularly, a cancellous bone graft substitute and a method of manufacturing the cancellous bone graft substitute by which defatting, demineralizing, cleaning, and sterilizing processes are performed within a short time using a supersonic cabitation without damaging a surface and an inside of a bone tissue so as to further rapidly, effectively supply an allogeneic or xenogeneic bone graft substitute. Internal and external concentrations of Ca++ of the allogeneic or xenogeneic bone graft substitute are effectively removed so as to maintain physical properties of the allogenetic or xenogeneic bone graft substitute.

## Claims

### Claim 1

A method of manufacturing a cancellous bone graft substitute, comprising:
cutting an extracted allogeneic or xenogeneic bone tissue into block patterns and removing a soft tissue;
defatting, dehydrating, and disinfecting the allogeneic or xenogeneic bone tissue using an ethanol aqueous solution;
removing a residual tissue from the allogeneic or xenogeneic bone tissue which has been defatted, dehydrated, and disinfected;
sterilizing and oxidizing the allogeneic or xenogeneic bone tissue using a peroxide;
cutting the allogeneic or xenogeneic bone tissue, which has been disinfected and oxidized, into bone particles having hexahedral shapes;
demineralizing the bone particles having the hexahedral shapes using a hydrochloric acid;
cleaning the demineralized bone particles using an ethanol aqueous solution;
neutralizing the cleaned bone particles using a phosphate buffered saline (PBS);
steeping the neutralized bone particles in a RSC solution;
cleaning and drying the bone particles which have steeped in the RSC (Radio protective Stable Chemical) solution; and
vacuum-freeze-drying the dried bone particles.

### Claim 2 (depends on 1)

The method of claim 1, wherein defatting, dehydrating, and sterilizing of the bone tissue using the ethanol aqueous solution and cleaning of the bone tissues using the ethanol aqueous solution are performed in an ethanol aqueous solution of 83% for about 30 minutes using a supersonic cabitation.

### Claim 3 (depends on 1)

The method of claim 1, wherein sterilizing and oxidizing of the bone tissue using the peroxide is performed in peroxide of 3% for about 90 minutes using the supersonic cabitation.

### Claim 4 (depends on 1)

The method of claim 1, wherein demineralizing of the bone particles having the hexahedral shapes is performed in a hydrochloric acid of 0.5N for 30 to 90 minutes using the supersonic cabitation.

### Claim 5 (depends on 1)

The method of claim 1, wherein in which the RSC solution, in which the neutralized bone tissue is steeped, has a composition of propylene glycol of 15 to 20%, dimethyl sulfoxide (DMSO) of 20 to 25%, manitol of 1 to 5%, tetrahalose of 1 to 5%, and distilled water of 40 to 60%, wherein the bone particles are steeped in the RSC solution having the composition to be processed in a constant-temperature water bath of 40° C. for 5 hours and then are processed in a freezer of 4° C. for 20 hours.

### Claim 6 (depends on 1)

The method of claim 1, wherein the RSC solution, in which the neutralized bone tissue is steeped, has a composition of glycine of 15 to 20%, stachyose of 20 to 25%, manitol of 1 to 5%, dextran of 1 to 5%, and distilled water of 40 to 60%, wherein the bone particles are steeped in the RSC solution having the composition to be processed in a constant-temperature water bath of 40° C. for 5 hours and are processed in a freezer of 4° C. for 20 hours.

### Claim 7 (depends on 1)

The method of claim 1, further comprising vacuum-wrapping the vacuum-freeze-drying the cancellous bone graft substitute in a disinfected vial, capping the cancellous bone graft substitute with aluminum, packing the cancellous bone graft substitute with plastic and box.

### Claim 8 (depends on 1, 2, 3, 4, 5, 6, 7)

An allogeneic or xenogeneic cancellous bone graft substitute which is manufactured using the method of claims 1 through 7, wherein the cancellous bone graft substitute maintains its physical and active characteristics, is not easily dissolved or inactivated after being implanted, and is protected without breaking osteogenesis induction factors so as to have osteoconductive and osteoinductive capabilities.

### Claim 9 (depends on 8)

The allogeneic or xenogeneic cancellous bone graft substitute of claim 8, wherein the allogeneic or xenogeneic cancellous bone graft substitute is hexahedral bone particles.
