Injectable and moldable bone substitute materials

• US 9,333,080 B2
• Filed: 08/21/2013
• Issued: 05/10/2016
• Est. Priority Date: 12/12/2002
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Tunc, Deger C., Winterbottom, John, Kaes, David R., Boyce, Todd M., Knaack, David, Russell, James, Bhattacharyya, Subhabrata
• Primary Examiner(s): DAVIS, RUTH A
• Application Number:
  US13/972,640
• Publication Number:
  US 20140121781A1
• Time in Patent Office: 993 Days
• Field of Search: 424/400, 424/422
• US Class Current: 1/1
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00359 Bone or bony tissue
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2400/08 Methods for forming porous structures using a negative form which is filled and then removed by pyrolysis or dissolution
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/446 with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
• CPC Class Codes: A61L 27/46 with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body

Abstract

An osteoimplant composite comprising a plurality of particles of an inorganic material, a bone substitute material, a bone-derived material, or any combination thereof; and a polymer material with which the particles are combined. The composite is either naturally moldable or flowable, or it can be made moldable or settable. After implantation, the composite may be set to provide mechanical strength to the implant. The inventive composite have the advantage of being able to fill irregularly shape implantation site while at the same time being settable to provide the mechanical strength required for most orthopedic applications. The invention also provides methods of using and preparing the moldable and flowable composites.

Claims

1. A composite osteoimplant comprising:

a plurality of particles comprising an inorganic material, a bone substitute material, a bone-derived material, or any combination thereof; and

a polymer with which the plurality of particles has been combined;

wherein the composite is moldable or flowable; and

wherein the composite becomes set upon exposure to suitable conditions for setting the composite, the suitable conditions comprising cooling.

2. The composite osteoimplant of claim 1, wherein the polymer has penetrated the pores, spaces, or voids of the particles.

3. The composite osteoimplant of claim 1, wherein the composite is moldable.

4. The composite osteoimplant of claim 1, wherein the composite can be shaped manually.

5. The composite osteoimplant of claim 1, wherein the composite can be shaped using a surgical instrument.

6. The composite osteoimplant of claim 1, wherein the composite can be shaped using a machine.

7. The composite osteoimplant of claim 1, wherein the composite is injectable.

8. The composite osteoimplant of claim 7, whereby the composite is suitable for injection through a 3 gauge or narrower needle.

9. The composite osteoimplant of claim 7, whereby the composite is suitable for injection through a 5 gauge or narrower needle.

10. The composite osteoimplant of claim 7, whereby the composite is suitable for injection through a 7 gauge or narrower needle.

11. The composite osteoimplant of claim 7, whereby the composite is suitable for injection through a 10 gauge or narrower needle.

12. The composite osteoimplant of claim 7, whereby the composite is suitable for injection through a 12 gauge or narrower needle.

13. The composite osteoimplant of claim 1, wherein the suitable conditions for setting the composite include changing the temperature of the composite, changing the osmotic pressure of the composite, exposing the composite to electromagnetic radiation, cross-linking the composite, exposing the composite to a chemical agent, changing the water or solvent content of the composite, changing the content of a component of the composite, or changing a diffusion gradient.

14. The composite osteoimplant of claim 1, wherein the suitable conditions for setting the composite includes cooling the composite to body temperature of approximately 37°

C.

15. A composite osteoimplant comprising:

a plurality of bone-derived particles; and

a polymer with which the particles have been combined;

wherein the composite has an initial phase and a set phase;

wherein the set phase is more resistant to mechanical deformation relative to the initial phase and the composite transitions to the set phase upon exposure to suitable conditions comprising cooling.

16. A composite osteoimplant comprising:

a plurality of bone-derived particles; and

a polymer with which the particles have been combined;

wherein the composite has a first phase and a second phase;

wherein the second phase is more resistant to mechanical deformation relative to the first phase and the composite transitions to the second phase upon exposure to suitable conditions comprising cooling.

17. The composite osteoimplant of claim 16, wherein the composite can be converted reversibly between the first and second phase.

18. The composite osteoimplant of claim 16, wherein conversion from the first to second phase is irreversible.

19. A composite osteoimplant comprising:

a plurality of bone-derived particles; and

a polymer with which the particles have been combined;

wherein the composite has a first phase and a second phase;

wherein the first phase is more moldable, flowable, or injectable relative to the second phase and the composite transitions to the second phase upon exposure to suitable conditions comprising cooling.