IP Library Granted Patent US 11,471,560
Granted Patent B2
US 11,471,560 · App. 16/685,942 · Granted Oct 18, 2022

Cancellous bone product including viable osteogenic cells

Inventors: Michelle Leroux Williams (Laurel, MD); Charles Randal Mills (Finksburg, MD); Rodney Monroy (Aberdeen, MD)
Assignee: NuVasive, Inc.
A61L27/3608A61L27/365A61L27/3683A61L27/3687A61L27/54C12N5/0654A61F2/28A61F2310/00359A61L2430/02
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Quick Facts
Patent No.
US 11,471,560
App. No.
16/685,942
Granted
Oct 18, 2022
Kind
B2
Abstract

A bone implant comprising cancellous bone that is essentially free of blood cells, and which has been treated with at least a loosening agent, such as collagenase and/or a digestive enzyme, for a time and at a concentration to loosen the osteogenic cells in the cancellous bone matrix. The osteogenic cells in the matrix are viable cells. The treatment of the cancellous bone with at least one loosening agent enables the osteogenic cells to be more available for carrying out their osteogenic function and to provide for an increased rate of bone formation.

Claims (23)

1. A bone implant comprising:

cancellous bone comprising a bone matrix and viable osteogenic cells native to the cancellous bone and contained within the bone matrix, and wherein the cancellous bone is essentially free of blood cells, wherein the bone implant is configured to be injected directly at an implantation site.

2. The bone implant of claim 1 further comprising demineralized bone.

3. The bone implant of claim 2 , wherein each of the cancellous bone and demineralized bone are 50% in volume of the bone implant.

4. The bone implant of claim 1 , wherein the cancellous bone is processed so that at least part of a cortical shell thereof is removed, and wherein the cancellous bone is cut or milled into desired sizes or shapes.

5. The bone implant of claim 1 , wherein the cancellous bone is treated with one or more antibiotics or one or more antimycotics.

6. The bone implant of claim 1 further comprising a cryopreservative or vitrification medium.

7. The bone implant of claim 6 , wherein the bone implant is frozen and then thawed prior to the injection.

8. The bone implant of claim 7 , when frozen, is stored at −80 degrees Celsius ±5 Celsius for a period of at least seventeen days.

9. The bone implant of claim 8 , wherein upon thawing of the bone product, at least 70% of the viable osteogenic cells are still viable.

10. The bone implant of claim 8 , wherein upon thawing of the bone product, density of the viable osteogenic cells native to the cancellous bone is at least 1×10 3 cells/cc.

11. The bone implant of claim 1 , wherein at least a part of the bone implant is configured to be retained at an implantation site long enough for initialization of bone formation.

12. A bone implant comprising:

cancellous bone comprising a bone matrix and viable osteogenic cells native to the cancellous bone and contained within the bone matrix, the cancellous bone being essentially free of blood cells; and

demineralized bone,

wherein at least a part of the bone implant is configured to be retained at an implantation site long enough for initialization of bone formation.

13. The bone implant of claim 12 , wherein each of the cancellous bone and demineralized bone are 50% in volume of the bone implant.

14. The bone implant of claim 12 , wherein the cancellous bone is processed so that at least part of a cortical shell thereof is removed, and wherein the cancellous bone is cut or milled into desired sizes or shapes.

15. The bone implant of claim 12 , wherein the cancellous bone is treated with one or more antibiotics or one or more antimycotics.

16. The bone implant of claim 12 further comprising a cryopreservative or vitrification medium.

17. The bone implant of claim 16 , wherein the bone implant is frozen and then thawed prior to a use.

18. The bone implant of claim 17 , when frozen, is stored at −80 degrees Celsius ±5 Celsius for a period of at least seventeen days.

19. The bone implant of claim 18 , wherein, upon thawing of the bone product, at least 70% of the viable osteogenic cells are still viable, and density of the viable osteogenic cells native to the cancellous bone is at least 1×10 3 cells/cc.

Assignments (3)
SECURITY INTEREST Recorded Feb 28, 2020
From: NUVASIVE, INC.; NUVASIVE CLINICAL SERVICES MONITORING, INC.; NUVASIVE CLINICAL SERVICES, INC.; NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 052918/0595 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 6, 2020
From: OSIRIS THERAPEUTICS, INC.
To: NUVASIVE, INC.
Reel/Frame 051746/0096 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 6, 2020
From: WILLIAMS, MICHELLE LEROUX; MILLS, CHARLES RANDAL; MONROY, RODNEY
To: OSIRIS THERAPEUTICS, INC.
Reel/Frame 051840/0467 →
Continuity (6)
Continuation 15596237 · May 16, 2017
Continuation 13915569 · Jun 11, 2013
Continuation 11799606 · May 2, 2007
Provisional Application 60831723 · Jul 18, 2006
Provisional Application 60798474 · May 8, 2006
Related Publication 20200101196A1 · Apr 2, 2020