IP Library Granted Patent US 12,144,909
Granted Patent B2
US 12,144,909 · App. 17/136,584 · Granted Nov 19, 2024

Bone repair composition and kit

Inventors: Jeffrey Johnson (Flowood, MS); Nels J Lauritzen (Piscataway, NJ); Brent Mitchell (Haskell, NJ)
Assignee: ZAVATION MEDICAL PRODUCTS, LLC
A61L27/3847A61F2/28A61L27/12A61L27/24A61L27/54A61F2002/2817A61L24/02A61L27/46A61L2300/414A61L2400/06A61L2430/02
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Quick Facts
Patent No.
US 12,144,909
App. No.
17/136,584
Granted
Nov 19, 2024
Kind
B2
Abstract

A biocompatible material for bone repair is described. The bone repair composition includes a mixture of a type I collagen, a type I collagen-glycosaminoglycan coprecipitate, tricalcium phosphate; and bioactive glass. Methods of using the composition for bone repair, and a kit for the bone repair composition are also described.

Claims (38)

1. A bone repair composition, comprising

a particulate dispersion comprising a strip product and comprising a collagen component, a bone growth stimulator, and a bioactive glass,

wherein

the bioactive glass ranges from 15% to 25% by weight of the particulate dispersion and comprises bioactive glass particles having a size from 250 to 2000 microns,

the bone growth stimulator comprising calcium phosphate ranges from 75% to 85% by weight of the particulate dispersion and comprises bone growth stimulator particles having a size from 250 to 2500 microns,

the collagen component ranges from 0.5% to 10% by weight of the particulate dispersion, and

the strip product contains no hydroxyapatite in its formulation.

2. The composition of claim 1 , wherein the bone growth stimulator particles have a size from 400 to 1600 microns.

3. The composition of claim 1 , wherein the bioactive glass particles have a size from 250 to 1500 microns.

4. The composition of claim 1 , wherein the bioactive glass develops a hydroxyapatite surface layer upon implantation within a subject.

5. The composition of claim 1 , wherein the particulate dispersion is configured as a rectangular strip.

6. The composition of claim 1 , wherein the collagen component is blended into an aqueous dispersion before incorporation into the particulate dispersion.

7. The composition of claim 6 , wherein the particulate dispersion comprises a cross-linked dispersion formed from the aqueous dispersion of the collagen compound.

8. The composition of claim 7 , wherein the cross-linked dispersion is formed from the aqueous dispersion mixed with the bioactive glass and the bone growth stimulator, freeze-dried, and then cross-linked.

9. The composition of claim 1 , wherein the collagen compound comprises a type I collagen.

10. The composition of claim 9 , wherein the collagen compound further comprises a type I collagen-glycosaminoglycan coprecipitate.

11. A method of repairing a bone defect, comprising administering a composition according to claim 1 to the site of the bone defect.

12. The method of claim 11 , wherein the composition is hydrated before administering the bone repair composition to the site of the bone defect.

13. The method of claim 11 , wherein the bone repair composition is hydrated with autologous blood.

14. The method of claim 11 , wherein the bone defect is, or is the result, a simple fracture, a compound fracture, external fixation, internal fixation, joint reconstruction, arthroplasty, degenerative disc disease, avascular osteonecrosis, osteosarcoma fracture, fracture non-unions, spinal fusion, disc augmentation, or bone regeneration in orthopedic implants.

15. A bone repair kit, comprising:

the bone repair composition of claim 1 ; and

a packaging including a tray for holding the bone repair composition,

wherein

the tray includes a support region having a raised surface above a bottom of the tray, and

the raised surface holds the bone repair composition above the bottom of the tray.

16. The bone repair kit of claim 15 , wherein the bone repair composition is configured as a rectangular strip.

17. The bone repair kit of claim 15 , wherein the tray is configured to fit the shape of the bone repair composition.

18. The bone repair kit of claim 17 , wherein the tray includes one or more grip regions to facilitate access to the bone repair composition.

19. The bone repair kit of claim 15 , wherein the kit includes a cover that can be sealed with a sheet to hold the tray.

20. The bone repair kit of claim 15 , wherein the package comprises high density polyethylene.

21. A bone repair composition, comprising

a particulate dispersion comprising a strip product and comprising a collagen component, a bone growth stimulator, and a bioactive glass,

wherein

the bioactive glass ranges from 15% to 25% by weight of the particulate dispersion and comprises bioactive glass particles having a size from 250 to 2000 microns,

the bone growth stimulator ranges from 75% to 85% by weight of the particulate dispersion and comprises bone growth stimulator particles having a size from 250 to 2500 microns,

the collagen component ranges from 0.5% to 10% by weight of the particulate dispersion and comprises particles or flakes which are milled to pass through a 2000 micron mesh, and

the strip product contains no hydroxyapatite in its formulation.

Assignments (2)
SECURITY INTEREST Recorded Jun 30, 2021
From: ZAVATION MEDICAL PRODUCTS, LLC; PAN MEDICAL US CORPORATION
To: VARAGON CAPITAL PARTNERS AGENT, LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 056726/0881 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 21, 2021
From: JOHNSON, JEFFREY; LAURITZEN, NELS; MITCHELL, BRENT
To: ZAVATION MEDICAL PRODUCTS, LLC
Reel/Frame 054978/0016 →
Continuity (2)
Continuation 16230399 · Dec 21, 2018
Related Publication 20210113738A1 · Apr 22, 2021