Implantable composite containing carbonated hydroxyapatite

Patent metadata

Field	Value
Publication number	US-2017333190-A1
Application number	US-201715491564-A
Country	US
Kind code	A1
Filing date	Apr 19, 2017
Priority date	Apr 19, 2016
Publication date	Nov 23, 2017
Grant date	—

Abstract

Provided is an implantable composite which includes a plurality of resorbable ceramic particles with or without a biodegradable polymer. The resorbable ceramic particles can be granules including carbonated hydroxyapatite and tricalcium phosphate in a ratio of 5:95 to 70:30. Some resorbable ceramic particles are granules, which include carbonated hydroxyapatite and β tricalcium phosphate in a ratio of 5:95 to 70:30. The resorbable ceramic particles have a particle size from about 0.4 to about 3.5 mm. The implantable composite is configured to tit at or near a bone defect as an autograft extender to promote bone growth. Methods of using the implantable composite are also provided.

First claim

What is claimed is:

1 . An implantable composite comprising a plurality of resorbable ceramic particles, the resorbable ceramic particles comprising carbonated hydroxyapatite and tricalcium phosphate in a ratio from about 5:95 to about 70:30.

2 . An implantable composite of claim 1 , wherein the implantable composite comprises a biodegradable polymer and the tricalcium phosphate is β tricalcium phosphate.

3 . An implantable composite of claim 1 , wherein the resorbable ceramic particles are granules having an average diameter in the range from about 0.4 to about 3.5 mm.

4 . An implantable composite of claim 1 , wherein a resorption rate of the implantable composite containing the carbonated hydroxyapatite increases from about 10% to about 40% when compared to a resorption rate of an implantable composite having resorbable ceramic particles comprising hydroxyapatite and β tricalcium phosphate in a ratio from about 5:95 to about 70:30 but no carbonated hydroxyapatite.

5 . An implantable composite of claim 2 , wherein the biodegradable polymer comprises one or more poly(L-lactide-co-D,L-lactide), polyglyconate, poly(acrylates), poly(anhydrides), poly(hydroxy acids), polyesters, poly(orthoesters), poly(alkylene oxides), polycarbonates, poly(propylene fumarates), poly(propylene glycol-co fumnaric acid), poly(caprolactones), polyamides, polyesters, polyethers, polyureas, polyamines, polyamine acids, polyacetals, poly(orthoesters), poly(pyrolic acid), poly(glaxanone), poly(phosphazenes), poly(organophosphazene), polylactides, polyglycolides, poly(dioxanones), polyhydroxybutyrate, polyhydroxyvalyrate, polyhydroxy-butyrate/valerate copolymers, poly(vinyl pyrrolidone), polcyanoacrylates, polyurethanes, and polysaccharides, or combinations thereof.

6 . An implantable composite of claim 2 , wherein (i) the biodegradable polymer comprises soluble collagen and insoluble collagen in a ratio of about 30:70; or (ii) the biodegradable polymer comprises only insoluble collagen.

7 . An implantable composite of claim 1 , wherein the plurality of resorbable ceramic particles comprise carbonated hydroxyapatite and tricalcium phosphate in a ratio of from about 99:1 to about 1:99 by weight of the implantable composite.

8 . An implantable composite of claim 1 , further comprising bone-derived material, the bone-derived material comprising non-demineralized bone particles, demineralized bone particles, deorganified bone particles, partially demineralized bone particles, superficially demineralized bone particles, an organic bone particles, or combinations thereof.

9 . An implantable composite of claim 1 , tii.rther comprises one or more of an initiator, accelerator, catalyst, solvent, wetting agent, lubricating agent, labeling agent, plasticizer, radiopacifier, porogen, bioactive agent, biostatic agent, cell, polynucleotide, protein, pharmaceutical agent or pharmaceutically acceptable excipient.

10 . An implantable composite of claim 1 , wherein the implantable composite is configured to be moldable after being wetted with a fluid, the fluid comprising water, sodium chloride, Lactated Ringer's solution, blood, marrow, bone marrow aspirate, bone marrow concentrate, autograft bone, or a combination thereof.

11 . An implantable composite configured to fit at or near a bone defect site to promote bone growth, the implantable composite comprising: a biodegradable polymer and a plurality of resorbable ceramic particles, the resorbable ceramic particles comprising carbonated hydroxyapatite and tricalcium phosphate in a ratio from about 5:95 to about 70:30 and having a particle size from about 0.4 to about 3.5 mm.

12 . An implantablecomposite of claim 11 , wherein the tricalcium phosphate is β tricalcium phosphate.

13 . An implantable composite of claim 11 , wherein the resorbable ceramic particles are granules having a particle size from about 0.4 to about 1.6 mm.

14 . An implantable composite of claim 1 wherein (i) the implantable composite is configured to be moldable after being wetted with a fluid or (ii) the implantable composite further comprises autograft bone or autologous bone.

15 . An implantable composite of claim 14 , wherein the fluid comprises water, sodium chloride, Lactated Ringer's solution, blood, marrow, bone marrow aspirate or a combination thereof.

16 . An implantable composite of claim 11 , wherein the biodegradable polymer comprises soluble collagen and insoluble collagen, the soluble collagen and insoluble collage being in a ratio of about 30:70.

17 . A method of treating a bone cavity in a subject in need thereof, the method comprising implanting into the bone cavity an implantable composite, the implantable composite comprising a plurality of resorbable ceramic particles and a biodegradable polymer, the resorbable ceramic particles comprising carbonated hydroxyapatite and β tricalcium phosphate in a ratio from about 5:95 to about 70:30.

18 . A method of treating according to claim 17 , wherein the implanting comprises mixing the implantable composite with a fluid comprising water, sodium chloride, Lactated Ringer's solution, blood, marrow, bone marrow aspirate or a combination thereof.

19 . A method of treating according to claim 17 , wherein the biodegradable polymer comprises soluble collagen and insoluble collagen, the soluble collagen and insoluble collagen being in a ratio of about 30:70.

20 . A method of treating according to claim 19 , wherein the ceramic particles are granules having an average particle diameter in the range from about 0.4 to about 3.5 mm.

Assignees

• Warsaw Orthopedic Inc

Inventors

• Vickers Scott M
• Scifert Jeffrey L
• Dunkley Ian R

Classifications

• A61K6/838

  Phosphorus compounds, e.g. apatite · CPC title

• A61K6/802

  comprising ceramics · CPC title

• A61K6/17

  Particle size · CPC title

• A61L27/58

  Materials at least partially resorbable by the body · CPC title

• A61F2/28 Primary

  Bones · CPC title