US6376573B1
Expired / Lapsed
US
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Porous biomaterials and methods for their manufacture
Assignee: Biomet Manufacturing LLC
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Filing: 1996-06-07
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Granted: 2002-04-23
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Expires: 2016-06-07
Abstract
Abstract An improved porous ceramic biomaterial is disclosed in which a polymer such as polylactic acid is polymerized in situ to fill the micropores substantially without filling the macropores. The polymer reinforcement helps improve the strength of the implant while preserving its ability to support ingrowth of bone to help integrate the implant into its surgical environment.
Inventors
- 👤 Eugene W. White
- 👤 Jack C. Debes
- 👤 Clayton G. Harris
- 👤 Edwin C. Shors
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-08 22:51
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/40; A61L27/44; A61L27/46; A61F; A61F2/00; A61F2/02; A61F2/28; A61L27/42; A61L27/425; A61L27/50; A61L27/56; C; C08; C08L; C08L67/00; C08L67/04; A61F2/2803; A61F2/30; A61F2/44; A61F2/4455; A61F2/46; A61F2/468; A61F2002/30001; A61F2002/30003; A61F2002/30004; A61F2002/30011; A61F2002/3006; A61F2002/30062; A61F2002/30108; A61F2002/30199; A61F2002/30261; A61F2002/30316; A61F2002/30535; A61F2002/30581; A61F2002/30583; A61F2/30767; A61F2/30771; A61F2002/30838; A61F2210/00; A61F2210/0004; A61F2210/0085; A61F2230/00; A61F2230/0063; A61F2230/0082; A61F2250/00; A61F2250/0014; A61F2250/0023; A61F2310/00; A61F2310/00005; A61F2310/00179; A61F2310/00293; A61F2310/00341
Claims Analysis
Total Claims: 32
Claim 1
Independent Claim
65 words
A method of strengthening a porous ceramic biomaterial which comprises: a) preparing a biomonomer polymerizable mixture or solution; and b) infiltrating micropores and macropores included in the porous ceramic biomaterial with the biocompatible, polymerizable mixture or solution under conditions wherein the mixture or solution will polymerize in the micropores and only minimally coat interior passages of the macropores with polymer while substantially filling the micropores.
Claim 2
Independent Claim
65 words
A method of strengthening a porous ceramic biomaterial which comprises: a) preparing a biomonomer polymerizable mixture or solution; and b) infiltrating micropores and macropores included in the porous ceramic biomaterial with the biocompatible, polymerizable mixture or solution under conditions wherein the mixture or solution will polymerize in the micropores and only minimally coat interior passages of the macropores with polymer while substantially filling the micropores.
Claim 3
Dependent Claim
19 words
A method in accordance with claim 2 , wherein the microporous biomaterial is coralline hydroxyapatite or reticulated foam ceramic.
Claim 4
Dependent Claim
31 words
A method in accordance with claim 1 wherein the biocompatible polymerizable mixture contains lactide or a derivative thereof and the polymer formed by polymerization is a polylactic acid or derivative thereof.
Claim 5
Dependent Claim
33 words
A method in accordance with claim 1 wherein the biocompatible polymerizable mixture or solution contains glycolide or a derivative thereof and the polymer formed by polymerization is polyglycolic acid or a derivative thereof.
Claim 6
Dependent Claim
31 words
A method in accordance with claim 1 wherein a catalyst is added to the biocompatible polymerizable mixture or solution before the biocompatible, polymerizable mixture or solution infiltrates the porous ceramic biomaterial.
Claim 7
Dependent Claim
18 words
A method in accordance with claim 5 wherein the monomer is lactide, glycolide, a co-polymer or a derivative.
Claim 8
Dependent Claim
93 words
An improved biomaterial comprising: a hydroxyapatite structure having a substantially uniform three dimensional porosity connected to an exterior surface of the biomaterial, said porosity including interconnected macropores having diameters in the range from about 100 microns to about 1000 microns, and micropores having pore sizes of about 1 micron or less, the macropores and micropores of said biomaterial infiltrated with a biocompatible polymer such that the biocompatible polymer covers interior walls and passageways of the macropores of the biomaterial substantially without filling the macropores but substantially filling the micropores contained in the biomaterial.
Claim 9
Dependent Claim
93 words
An improved biomaterial comprising: a hydroxyapatite structure having a substantially uniform three dimensional porosity connected to an exterior surface of the biomaterial, said porosity including interconnected macropores having diameters in the range from about 100 microns to about 1000 microns, and micropores having pore sizes of about 1 micron or less, the macropores and micropores of said biomaterial infiltrated with a biocompatible polymer such that the biocompatible polymer covers interior walls and passageways of the macropores of the biomaterial substantially without filling the macropores but substantially filling the micropores contained in the biomaterial.
Claim 10
Dependent Claim
36 words
An improved biomaterial in accordance with claim 7 , wherein the hydroxyapatite structure is derived from coral or a ceramic material having interconnected porosity, and the polymer is polymerized within the porosity of the hydroxyapatite structure.
Claim 11
Dependent Claim
13 words
A dental prosthesis comprising the improved biomaterial in accordance with claim 8 .
Claim 12
Dependent Claim
13 words
An orthopedic prosthesis comprising the improved biomaterial in accordance with claim 8 .
Claim 13
Dependent Claim
14 words
A plastic surgery prosthesis comprising the improved biomaterial in accordance with claim 8 .
Claim 14
Dependent Claim
16 words
An ear, nose and throat prosthesis comprising the improved biomaterial in accordance with claim 8 .
Claim 15
Dependent Claim
13 words
A neurosurgery prosthesis comprising the improved biomaterial in accordance with claim 8 .
Claim 16
Dependent Claim
13 words
A podiatric prosthesis comprising the improved biomaterial in accordance with claim 8 .
Claim 17
Dependent Claim
21 words
A bone void filler comprising the improved biomaterial in accordance with claim 7 , wherein the bone void filler comprises granules.
Claim 18
Dependent Claim
14 words
A bone void filler comprising the improved biomaterial in accordance with claim 8 .
Claim 19
Dependent Claim
22 words
A bone void filler comprising the improved biomaterial in accordance with claim 7 , wherein the bone void filler is a block.
Claim 20
Dependent Claim
62 words
A method of replacing bone tissue in an organism comprising: locating the void in or adjacent to bone to be filled, and implanting the biomaterial according to claim 8 into the organism under conditions which permit bone tissue to grow into the macroporosity of the biomaterial in order that the biomaterial can be integrated substantially into the skeletal system of the organism.
Claim 21
Dependent Claim
84 words
A composition of material useful as an interconnected porosity including micropores and macropores, at least some of said macropores open to said surface and interconnected with one another; the macropores substantially coated and the micropores substantially filled by a polylactic acid polymer, polyglycolic acid polymer, or co-polymer thereof, the polymer polymerized in situ from a lactide or glycolide monomer or mixture thereof introduced into the porosity of the porous hydroxyapatite structure under conditions which cause polymerization in the microporosity and macroporosity of the material.
Claim 22
Dependent Claim
84 words
A composition of material useful as an interconnected porosity including micropores and macropores, at least some of said macropores open to said surface and interconnected with one another; the macropores substantially coated and the micropores substantially filled by a polylactic acid polymer, polyglycolic acid polymer, or co-polymer thereof, the polymer polymerized in situ from a lactide or glycolide monomer or mixture thereof introduced into the porosity of the porous hydroxyapatite structure under conditions which cause polymerization in the microporosity and macroporosity of the material.
Claim 23
Dependent Claim
16 words
A composition in accordance with claim 19 wherein the monomer mixture additionally includes a polymerization catalyst.
Claim 24
Dependent Claim
14 words
A composition in accordance with claim 19 wherein the polymerization catalyst is stannous octoate.
Claim 25
Independent Claim
101 words
A method of making a biomaterial, comprising: providing a porous coralline hydroxyapatite or synthetic porous ceramic structure having an internal porosity including micropores and macropores, with at least some of the macropores interconnected through internal passageways and open to an outer surface of the structure; introducing into the porosity a monomer mixture or solution containing lactide, glycolide or mixtures thereof under conditions wherein the monomer mixture or solution fills the microporosity substantially without filing the macroporosity in the structure, and polymerizing the monomer mixture or solution in situ into a polylactic acid or polyglycolic acid polymer or copolymer under polymerizing conditions.
Claim 26
Independent Claim
101 words
A method of making a biomaterial, comprising: providing a porous coralline hydroxyapatite or synthetic porous ceramic structure having an internal porosity including micropores and macropores, with at least some of the macropores interconnected through internal passageways and open to an outer surface of the structure; introducing into the porosity a monomer mixture or solution containing lactide, glycolide or mixtures thereof under conditions wherein the monomer mixture or solution fills the microporosity substantially without filing the macroporosity in the structure, and polymerizing the monomer mixture or solution in situ into a polylactic acid or polyglycolic acid polymer or copolymer under polymerizing conditions.
Claim 27
Dependent Claim
26 words
A method in accordance with claim 22 , further comprising introducing a catalyst into the mixture or solution prior to polymerization porosity of the structure polymerization.
Claim 28
Dependent Claim
14 words
A method in accordance with claim 23 , wherein said catalyst is stannous octoate.
Claim 29
Dependent Claim
22 words
A method in accordance with claim 23 , wherein said monomer mixture or solution is introduced into said porosity using capillary action.
Claim 30
Dependent Claim
35 words
A method in accordance with claim 22 , wherein the viscosity of the lactide or glycolide monomer mixture or solution permits the mixture or solution to infiltrate the porosity of the structure by capillary action.
Claim 31
Independent Claim
62 words
A method for strengthening a porous ceramic biomaterial having micro porosity and macroporosity, comprising: providing the porous ceramic biomaterial; and infiltrating the porosity of the porous ceramic biomaterial with a liquid biocompatible polymer under conditions wherein the polymer infiltrates the porosity of the porous ceramic biomaterial, substantially filing micropores contained therein while coating walls of the macroporosity, minimally without filing the macroporosity.
Claim 32
Independent Claim
62 words
A method for strengthening a porous ceramic biomaterial having micro porosity and macroporosity, comprising: providing the porous ceramic biomaterial; and infiltrating the porosity of the porous ceramic biomaterial with a liquid biocompatible polymer under conditions wherein the polymer infiltrates the porosity of the porous ceramic biomaterial, substantially filing micropores contained therein while coating walls of the macroporosity, minimally without filing the macroporosity.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2005-04-22 | 2005-10-22 | 2006-04-23 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2009-04-22 | 2009-10-22 | 2010-04-23 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2013-04-22 | 2013-10-22 | 2014-04-23 | $7700.00 | Window Closed / Lapsed |