Plasticized bone and soft tissue grafts and methods of making and using same

• US 9,125,971 B2
• Filed: 03/15/2013
• Issued: 09/08/2015
• Est. Priority Date: 06/30/1998
• Status: Expired due to Fees

• Current Assignee: LifeNet Health, Inc.
• Original Assignee: LifeNet Health, Inc.
• Inventors: Wolfinbarger, Lloyd Jr., O'Leary, Robert K., Anderson, Billy G.
• Primary Examiner(s): Philogene, Pedro
• Assistant Examiner(s): Comstock, David C
• Application Number:
  US13/836,803
• Publication Number:
  US 20130218294A1
• Time in Patent Office: 907 Days
• Field of Search: 623/11.11, 623/16.11, 623/23.51, 623/23.58, 623/23.59, 623/23.61, 623/23.63, 424/422, 424/423, 435/1.2, 435/1.3
• US Class Current: 1/1
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: 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
• CPC Class Codes: A61F 2002/2825 Femur
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30535 Special structural features of bone or joint prostheses not otherwise provided for
• CPC Class Codes: A61F 2002/4646 Devices for cleaning bone graft
• CPC Class Codes: A61F 2002/4649 Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2250/0058 Additional features; Implant or prostheses properties not otherwise provided for
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/362 Skin, e.g. dermal papillae
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: 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
• CPC Class Codes: A61L 27/502 Plasticizers

Abstract

The present invention provides a plasticized dehydrated or freeze-dried bone and/or soft tissue product that does not require special conditions of storage, for example refrigeration or freezing, exhibits materials properties that approximate those properties present in normal hydrated tissue, is not brittle, does not necessitate rehydration prior to clinical implantation and is not a potential source for disease transmission. The invention replaces water in the molecular structure of the bone or soft tissue matrix with one or more plasticizers allowing for dehydration of the tissue, yet not resulting in an increase in brittleness of the plasticized product, and resulting in compressive and/or tensile properties similar to those of normal hydrated bone. Replacement of the chemical plasticizers by water prior to implantation is not required and thus, the dehydrated bone or soft tissue plasticized product can be placed directly into an implant site without significant preparation in the operating room.

Claims

1. A soft tissue graft, comprising:

soft tissue obtained from a human or animal donor; and

a plasticizer composition comprising one or more alcohols, wherein cellular elements are substantially removed from said soft tissue, and said plasticizer composition is contained in said soft tissue.

2. The graft of claim 1, wherein said one or more alcohols comprise ethanol or isopropyl alcohol.

3. The graft of claim 1, wherein said one or more alcohols comprise ethanol.

4. The graft of claim 1, wherein said soft tissue comprises one of cadaveric skin, pericardium, dura mater, fascia lata, ligaments, or tendons.

5. The graft of claim 1, wherein said soft tissue comprises cadaveric skin.

6. The graft of claim 1, wherein said soft tissue comprises human cadaveric skin.

7. The graft of claim 1, wherein said soft tissue graft is suitable to be stored at room temperature prior to transplantation into a human recipient.

8. The graft of claim 1, wherein said one or more alcohols comprise glycerol, adonitol, sorbitol, ribitol, galactitol, 1,3-dihydroxypropanol, ethylene glycol, triethylene glycol, propylene glycol, mannitol, xylitol, or mesoerythritol.

9. A method for producing a soft tissue graft, comprising:

substantially removing cellular elements from soft tissue obtained from a human or animal donor;

impregnating the soft tissue with a biocompatible, water-soluble plasticizer composition comprising one or more alcohols.

10. The method of claim 9, wherein said one or more alcohols comprise ethanol or isopropyl alcohol.

11. The method of claim 9, wherein said one or more alcohols comprise ethanol.

12. The method of claim 9, wherein the graft is suitable for transplantation after storage at room temperature.

13. The method of claim 9, wherein said soft tissue comprises cadaveric skin, pericardium, dura mater, fascia lata, ligaments, or tendons.