Modified demineralized cortical bone fibers

• US 10,531,957 B2
• Filed: 05/19/2016
• Issued: 01/14/2020
• Est. Priority Date: 05/21/2015
• Status: Active Grant

• Current Assignee: Musculoskeletal Transplant Foundation
• Original Assignee: Musculoskeletal Transplant Foundation
• Inventors: McAllister, Michele, Wang, David, Bubear, Michelle, Canales, Joed, Chang, Amy, Shikhanovich, Roman, Spilker, Mark, Semler, Eric
• Primary Examiner(s): Prone, Christopher D.
• Application Number:
  US15/159,406
• Publication Number:
  US 20160361171A1
• Time in Patent Office: 1,335 Days
• Field of Search: None
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• 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

Abstract

Surgical implants (or grafts) for the repair of bone defects, more particularly, surgical implants that include demineralized bone fibers, are disclosed. The surgical implants have a wettability time of less than 5 minutes and a residual moisture content of less than 6% by weight, and they remain cohesive and retain their shape upon complete rehydration. Methods for making such implants and for increasing their wettability and ensuring uniform density are also disclosed.

Claims

1. An implant for treating a defect in bone and which comprises demineralized cortical bone fibers, wherein said bone fibers have been subjected to soaking with a salt solution prior to any shaping and lyophilizing, and said implant has a residual moisture content of less than about 6% by weight, based on the total weight of the implant, and a complete rehydration time of less than about 30 minutes, and wherein said implant remains cohesive and retains its shape upon complete rehydration.

2. The implant of claim 1, wherein said implant has uniform density.

3. The implant of claim 1, further comprising one or more additional components selected from:

mineralized cortical bone fibers, cortical bone particles, cortical bone pieces, cancellous bone fibers, cancellous bone particles, cancellous bone pieces, cartilage fibers, cartilage particles, cartilage pieces, and periosteal tissue.

4. The implant of claim 1, further comprising a placental tissue.

5. The implant of claim 4, wherein said placental tissue comprises amnion, chorion, umbilical cord.

6. The implant of claim 1, wherein said implant has a wettability time of less than about 5 minutes.