Bioactive soft tissue implant and methods of manufacture and use thereof

• US 10,729,548 B2
• Filed: 05/02/2017
• Issued: 08/04/2020
• Est. Priority Date: 05/02/2016
• Status: Active Grant

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Original Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Inventors: Sheth, Sonny, Arazawa, David, Burley, J. Brook, Smith, Sarah Elizabeth, Havener, Matthew B., San Antonio, James
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): Blanco, Javier G
• Application Number:
  US15/584,620
• Publication Number:
  US 20170312080A1
• Time in Patent Office: 1,190 Days
• Field of Search: None
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• 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 2002/3006 Properties of materials and coating materials
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3093 for promoting ingrowth of bone tissue
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/04 Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 27/02 Inorganic materials
• CPC Class Codes: A61L 27/025 Other specific inorganic materials not covered by A61L27/04 - A61L27/12
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: A61L 27/40 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/127 containing fillers of phosphorus-containing inorganic materials
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C12N 2533/18 : Calcium salts, e.g. apatite, Mineral components from bones, teeth, shells

Abstract

A bioactive filamentary structure includes a sheath coated with a mixture of synthetic bone graft particles and a polymer solution forming a scaffold structure. In forming such a structure, synthetic bone graft particles and a polymer solution are applied around a filamentary structure. A polymer is precipitated from the polymer solution such that the synthetic bone graft particles and the polymer coat the filamentary structure and the polymer is adhered to the synthetic bone graft particles to retain the graft particles.

Claims

1. A method of forming a bioactive filamentary structure, comprising the steps of:

applying synthetic bone graft particles around a filamentary structure;

after the synthetic bone graft particles applying step, applying a polymer solution to the bone graft particles and around the filamentary structure; and

after the polymer solution applying step, precipitating a polymer from the polymer solution such that the synthetic bone graft particles and the polymer coat the filamentary structure.

2. The method of claim 1, wherein the synthetic bone graft particles are applied around the filamentary structure by placing the filamentary structure into a container of synthetic bone graft particles and then removing the filamentary structure from the container.

3. The method of claim 2, wherein the container of the synthetic bone graft particles is shaken during placement of the filamentary structure into the container.

4. The method of claim 1, wherein the synthetic bone graft particles include either one or both of calcium phosphate and a bioactive additive.

5. The method of claim 4, wherein the bioactive additive is selected from the group consisting of bioactive glass, bone chips, demineralized bone chips or powder, living cells, lyophilized bone marrow, collagen, other bioactive proteins or growth factors, biologics, peptides, glycosaminoglycans, anti-inflammatory compounds, antibiotics, anti-microbial elements, and mixtures thereof.

6. The method of claim 4, wherein the calcium phosphate is selected from the group consisting of tetra-calcium phosphate, di-calcium phosphate, dicalcium phosphate dihydrous, dicalcium phosphate anhydrous, tri-calcium phosphate, mono-calcium phosphate, β

-tricalcium phosphate, α

-tricalcium phosphate, oxypatite, hydroxypatite, and mixtures thereof.

7. The method of claim 1, wherein the polymer is at least one selected from the group consisting of polycaprolactones (PCL), polyglycolides (PGA), polylactic acids (PLA), polyethylene, polypropylene, polystyrene, poly(D,L-lactic-co-glycolide) (PLGA), polyglycolic acid (PGA), poly-L-Lactic acid (PL-LA), polysulfones, polyolefins, polyvinyl alcohol (PVA), polyalkenoics, polyacrylic acids (PAA), polyesters, lower alkyl cellulose ethers, methylcellulose, sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethylcellulose, carboxymethyl cellulose, and mixtures thereof.

8. The method of claim 1, wherein the polymer solution includes at least one solvent selected from the group consisting of glacial acetic acid (GAA), acetic acid, anisole, chloroform, methylene chloride, acetylchloride, 2,2,2 trifluoroethanol, trifluoroacetic acid, 1,2-Dochloroethane, and mixtures thereof.

9. The method of claim 1, wherein the polymer is precipitated from the polymer solution by applying to the polymer solution a precipitating agent selected from the group consisting of sodium phosphate buffer, water, ethanol, 1-propanol, isopropyl ether, 2-butanol, hexane, and mixtures thereof.

10. The method of claim 1, wherein the polymer solution is applied around the filamentary structure by spraying the polymer solution around the filamentary structure.

11. The method of claim 1, wherein the step of precipitating the polymer from the polymer solution includes immersing the polymer solution in a precipitating agent after applying both the synthetic bone graft particles and the polymer solution around the filamentary structure.

12. The method of claim 1, wherein the step of precipitating the polymer from the polymer solution includes applying a first buffer to the polymer solution after the polymer solution is applied around the filamentary structure to at least partially neutralize the polymer solution.

13. The method of claim 12, further comprising the step of drying the coated filamentary structure at least after the first buffer is applied to the polymer solution.

14. The method of claim 13, further comprising the step of packaging the dried coated filamentary structure disposed on an inserter.

15. The method of claim 12, further comprising the step of applying a second buffer to the polymer solution after the first buffer is applied around the filamentary structure to further dilute the polymer solution.

16. The method of claim 15, wherein the first and the second buffers are sodium phosphate buffers.

17. The method of claim 1, further comprising covering a portion of the filamentary structure such that the bone graft particles do not coat the covered portion of the filamentary structure during the synthetic bone graft particles applying step.

18. The method of claim 17, wherein the covering step includes applying a mask over openings defined by the filamentary structure.

19. The method of claim 18, wherein the mask is a tape or a film.

20. The method of claim 1, wherein the bone graft particles are wedged between fibers of the filamentary structure after the synthetic bone graft particles applying step.

21. A method of forming a bioactive filamentary structure, comprising the steps of:

mixing synthetic bone graft particles with a polymer solution to form a scaffold mixture;

applying the scaffold mixture around a filamentary structure;

applying a first buffer to the scaffold mixture after the scaffold mixture is applied around the filamentary structure to at least partially neutralize the polymer solution; and

precipitating a polymer from the polymer solution such that the synthetic bone graft particles and the polymer coat the filamentary structure,

wherein the bone graft particles are wedged between fibers of the filamentary structure after the scaffold mixture applying step.

22. The method of claim 21, wherein the polymer solution comprises polycaprolactone (PCL) and glacial acetic acid (GAA).

23. The method of claim 21, further comprising covering a portion of the filamentary structure such that the bone graft particles do not coat the covered portion of the filamentary structure during the scaffold mixture applying step.

24. The method of claim 21, further comprising any one or any combination of vibrating, translating and rotating a container containing the bone graft particles and the filamentary structure to wedge the bone graft particles between the fibers of the filamentary structure after the scaffold mixture applying step.

25. A method of forming a bioactive filamentary structure, comprising the steps of:

applying synthetic bone graft particles around a filamentary structure;

after the synthetic bone graft particles applying step, applying a polymer solution around the filamentary structure;

after the polymer solution applying step, precipitating a polymer from the polymer solution such that the synthetic bone graft particles and the polymer coat the filamentary structure,

wherein the precipitating step includes the steps of applying a first buffer to the polymer solution after the polymer solution is applied around the filamentary structure to at least partially neutralize the polymer solution and immersing the polymer solution in a precipitating agent after applying both the synthetic bone graft particles and the polymer solution around the filamentary structure, and

wherein the bone graft particles are wedged between fibers of the filamentary structure after the synthetic bone graft particles applying step.

26. The method of claim 25, further comprising any one or any combination of vibrating, translating, and rotating a container containing the bone graft particles and the filamentary structure to wedge the bone graft particles between the fibers of the filamentary structure after the synthetic bone graft particles applying step.