IP Library Granted Patent US 11,622,865
Granted Patent B2
US 11,622,865 · App. 17/088,245 · Granted Apr 11, 2023

Expandable bone grafts and methods of manufacture thereof

Inventors: Mark Schallenberger (Bozeman, MT); Helena Lovick (N. Great Falls, MT); Todd Meyer (Bozeman, MT)
Assignee: Bacterin International, Inc.
A61F2/4455A61L27/3608A61L27/54A61F2002/30187A61F2310/00359A61L27/365A61L27/56A61L2300/404
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Quick Facts
Patent No.
US 11,622,865
App. No.
17/088,245
Granted
Apr 11, 2023
Kind
B2
Abstract

The present invention relates to compressed bone-based products and methods to make the same. The maintained compressed state of the product serves to enhance the product's inherent osteoconductivity.

Claims (25)

1. A method of forming a bone-based product, comprising:

cutting bone into bone fibers;

entangling the bone fibers in an aqueous solution to produce entangled fibers;

placing the entangled fibers into a mold; and

drying the entangled fibers in the mold;

wherein the product is compressible to about 20% to about 80% of a pre-dehydrated state.

2. The method of claim 1 , wherein the mold is a surgical implant.

3. The method of claim 1 , wherein the surgical implant is a spinal fusion implant.

4. The method of claim 1 , wherein the bone is selected from the group consisting of cortical bone, cancellous bone, and combinations thereof.

5. The method of claim 1 , wherein the bone is demineralized, partially demineralized, or mineralized.

6. The method of claim 1 , wherein the drying step comprises heating the mold to a temperature from about 30° C. to about 80° C.

7. The method of claim 1 , wherein the drying step comprises heating the mold under reduced pressure of between about 1 nTorr to about 740 Torr.

8. The method of claim 1 , wherein the bone-based product is adapted to fit within a void.

9. The method of claim 8 , wherein the bone-based product exerts an expansion pressure of about 1 MPa to about 10 MPa within the void when the bone-based product is within the void.

10. The method of claim 8 , wherein the void is a skeletal void within a patient.

11. The method of claim 8 , wherein the void is contained within a medical apparatus.

12. The method of claim 11 , wherein the medical apparatus is a medical implant.

13. The method of claim 11 , wherein the medical apparatus is a cage implant.

14. The method of claim 1 , wherein the bone-based product comprises a material selected from the group consisting of bone chips, bone particles, bone fibers, bone chunks, bone sponge, and combinations thereof.

15. The method of claim 1 , wherein the bone-based product is partially dehydrated, fully dehydrated, or fully hydrated.

16. The method of claim 1 , wherein the bone-based product is dehydrated and when rehydrated expands to about 50% to about 99% of a pre-dehydrated state.

17. The method of claim 1 , wherein the bone-based product demonstrates enhanced osteoconductivity.

18. The method of claim 1 , the bone-based product comprises a void to bone ratio of between about 1:99 and about 1:11.

19. The method of claim 1 , wherein the bone fibers are entangled such that at least one property of shape retention, cohesive, pliability and compression state are maintained for a period of between about 10 minutes and about 1 year upon rehydration.

20. The method of claim 1 , wherein when the bone-based product comprises entangled bone fibers, and is within the void, the bone-based product exerts an active expansion pressure on a surface of the void of about 1 MPa to about 10 MPa, wherein the bone-based product is a body, wherein the bone-based product comprises a void to bone ratio of between about 1:99 and about 1:11, and wherein the bone fibers are entangled such that at least one property of shape retention, cohesive, pliability and compression state are maintained for a period of between about 10 minutes and about 1 year upon rehydration.

Assignments (5)
SECURITY INTEREST Recorded Aug 11, 2024
From: XTANT MEDICAL, INC.; BACTERIN INTERNATIONAL, INC.; X-SPINE SYSTEMS, INC.; SURGALIGN SPV, INC.; XTANT MEDICAL HOLDINGS, INC.
To: MIDCAP FUNDING IV TRUST
Reel/Frame 068539/0492 →
SECURITY INTEREST Recorded Aug 11, 2024
From: XTANT MEDICAL, INC.; BACTERIN INTERNATIONAL, INC.; X-SPINE SYSTEMS, INC.; SURGALIGN SPV, INC.; XTANT MEDICAL HOLDINGS, INC.
To: MIDCAP FINANCIAL TRUST
Reel/Frame 068539/0665 →
SECURITY INTEREST (REVOLVING) Recorded May 21, 2021
From: XTANT MEDICAL HOLDINGS, INC.; XTANT MEDICAL, INC.; BACTERIN INTERNATIONAL, INC.; X-SPINE SYSTEMS, INC.
To: MIDCAP FINANCIAL TRUST
Reel/Frame 056323/0536 →
SECURITY INTEREST (TERM) Recorded May 21, 2021
From: XTANT MEDICAL HOLDINGS, INC.; XTANT MEDICAL, INC.; BACTERIN INTERNATIONAL, INC.; X-SPINE SYSTEMS, INC.
To: MIDCAP FINANCIAL TRUST
Reel/Frame 056323/0586 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 16, 2021
From: SCHALLENBERGER, MARK; LOVICK, HELENA; MEYER, TODD
To: BACTERIN INTERNATIONAL, INC.
Reel/Frame 055274/0001 →