US5037445A
Expired / Lapsed
US
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Method and kit for molding surgical implants
Assignee: United States Surgical Corp
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Filing: 1989-04-14
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Granted: 1991-08-06
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Expires: 2009-04-14
Abstract
Abstract A vacuum bag method for in-situ molding of surgical implants. The method comprises creating an implant precursor material composed of an aggregation of polymer beads coated with a hydrophilic monomer dispersion. A flexible bag containing the implant precursor is molded in-situ to a desired specific shape, and the implant precursor is then rigidified by applying a vacuum to the interior of the bag. The implant precursor is cured by heating to form a unitary porous prosthesis which may be implanted into body tissue to remedy bone defects.
Inventors
- 👤 Thomas Sander
- 👤 Robert D. Torgerson
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 01:18
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/28; A61L; A61L27/00; A61L27/50; A61L27/56; A61F2/30; A61F2/3094; A61F2002/30001; A61F2002/30316; A61F2002/30535; A61F2002/30581; A61F2002/30583; A61F2/46; A61F2002/465; A61F2002/4685; A61F2210/00; A61F2210/0085; Y; Y10; Y10S; Y10S623/00; Y10S623/909; Y10S623/911
Claims Analysis
Total Claims: 47
Claim 1
Independent Claim
100 words
A method for custom molding an implantable prosthesis, comprising: a) providing an implant precursor material within a flexible bag, said implant precursor material comprising an aggregation of individual particles of a structural polymeric material which is biocompatible after being cured; b) forming said bag of implant precursor material into a specific shape; c) compacting the implant precursor material into a rigid mass having said specific shape by applying a vacuum to the interior of the bag; d) curing the implant precursor material to provide a porous unitary prosthesis having said specific shape; and e) removing the bag from the prosthesis.
Claim 2
Independent Claim
100 words
A method for custom molding an implantable prosthesis, comprising: a) providing an implant precursor material within a flexible bag, said implant precursor material comprising an aggregation of individual particles of a structural polymeric material which is biocompatible after being cured; b) forming said bag of implant precursor material into a specific shape; c) compacting the implant precursor material into a rigid mass having said specific shape by applying a vacuum to the interior of the bag; d) curing the implant precursor material to provide a porous unitary prosthesis having said specific shape; and e) removing the bag from the prosthesis.
Claim 3
Dependent Claim
34 words
The method of claim 1 wherein the particles of the structural material each have an outer coating of a second material containing a monomer which is polymerizable into a biologically compatible hydrophilic polymeric material.
Claim 4
Dependent Claim
15 words
The method of claim 2 which additionally comprises washing the prosthesis to remove residual monomer.
Claim 5
Dependent Claim
12 words
The method of claim 1 wherein the polymeric structural material is polymethylmethacrylate.
Claim 6
Dependent Claim
22 words
The method of claim 1 wherein said curing comprises at least one method selected from the group consisting of sintering and polymerizing.
Claim 7
Dependent Claim
14 words
The method of claim 5 wherein the sintering and polymerization is accomplished by heating.
Claim 8
Dependent Claim
29 words
The method of claim 6 wherein the heating comprises at least one method selected from the group consisting of microwave heating, radio frequency heating, convection heating, and radiant heating.
Claim 9
Dependent Claim
10 words
The method of claim 1 wherein the prosthesis is bioabsorbable.
Claim 10
Dependent Claim
10 words
The method of claim 2 wherein said monomer is hydroxyethylmethacrylate.
Claim 11
Dependent Claim
14 words
The method of claim 2 wherein said second material additionally contains a radio-opaque substance.
Claim 12
Dependent Claim
12 words
The method of claim 10 wherein said radio-opaque substance is barium sulfate.
Claim 13
Dependent Claim
43 words
The method of claim 3 which additionally comprises incorporating at least one material into the porous prosthesis after the prosthesis has been washed, said material being selected from the group consisting of a bone growth promoter, a growth factor, blood and an antibiotic.
Claim 14
Dependent Claim
13 words
The method of claim 12 wherein said bone growth promoter is calcium hydroxide.
Claim 15
Dependent Claim
13 words
The method of claim 2 wherein said second material contains a crosslinking agent.
Claim 16
Dependent Claim
12 words
The method of claim 14 wherein said crosslinking agent is triethyleneglycol dimethacrylate.
Claim 17
Dependent Claim
13 words
The method of claim 2 wherein said second material contains a polymerization initiator.
Claim 18
Dependent Claim
12 words
The method of claim 16 wherein said polymerization initiator is benzoyl peroxide.
Claim 19
Dependent Claim
21 words
The method of claim 1 wherein the particles of the structural material have diameters ranging from about 590 to 700 microns.
Claim 20
Dependent Claim
25 words
The method of claim 1 wherein the flexible bag is made from a material selected from the group consisting of fluorocarbon polymer sheeting and latex.
Claim 21
Dependent Claim
23 words
The method of claim 2 wherein the second material comprises a dispersion of barium sulfate and benzoyl peroxide in hydroxyethylmethacrylate and triethyleneglycol dimethacrylate.
Claim 22
Dependent Claim
17 words
The method of claim 3 wherein the washing of said implant is accomplished in boiling saline solution.
Claim 23
Dependent Claim
10 words
The method of claim 1 wherein said bag is biodegradable.
Claim 24
Independent Claim
135 words
A method for custom molding an implantable prosthesis for hard tissue comprising: a) providing an implant precursor within a flexible bag, said implant precursor comprising an aggregation of individual particles of polymethylmethacrylate, said particles each having an outer coating comprising a dispersion of barium sulfate and benzoyl peroxide in hydroxyethylmethacrylate and triethyleneglycol dimethacrylate, b) forming said bag of implant precursor to a specific shape, c) compacting the implant precursor into a rigid mass having said specific shape by applying a vacuum to the interior of the bag; d) providing a porous, unitary and porous prosthesis having said specific shape by curing the implant precursor material; e) removing said bag from the prosthesis; f) washing said implant in boiling saline solution to remove residual monomer; g) incorporating calcium hydroxide into the prosthesis for promoting bone growth.
Claim 25
Independent Claim
135 words
A method for custom molding an implantable prosthesis for hard tissue comprising: a) providing an implant precursor within a flexible bag, said implant precursor comprising an aggregation of individual particles of polymethylmethacrylate, said particles each having an outer coating comprising a dispersion of barium sulfate and benzoyl peroxide in hydroxyethylmethacrylate and triethyleneglycol dimethacrylate, b) forming said bag of implant precursor to a specific shape, c) compacting the implant precursor into a rigid mass having said specific shape by applying a vacuum to the interior of the bag; d) providing a porous, unitary and porous prosthesis having said specific shape by curing the implant precursor material; e) removing said bag from the prosthesis; f) washing said implant in boiling saline solution to remove residual monomer; g) incorporating calcium hydroxide into the prosthesis for promoting bone growth.
Claim 26
Independent Claim
96 words
A method for custom molding an implantable prosthesis, comprising: a) providing an implant precursor material within a flexible bag, said bag being biodegradable, said implant precursor material comprising an aggregation of individual particles of a structural polymeric material which is biocompatible after being cured; b) forming said bag of implant precursor material into a specific shape; c) compacting the implant precursor material into a rigid mass having said specific shape by applying a vacuum to the interior of the bag; d) curing the implant precursor material to provide a porous unitary prosthesis having said specific shape.
Claim 27
Independent Claim
96 words
A method for custom molding an implantable prosthesis, comprising: a) providing an implant precursor material within a flexible bag, said bag being biodegradable, said implant precursor material comprising an aggregation of individual particles of a structural polymeric material which is biocompatible after being cured; b) forming said bag of implant precursor material into a specific shape; c) compacting the implant precursor material into a rigid mass having said specific shape by applying a vacuum to the interior of the bag; d) curing the implant precursor material to provide a porous unitary prosthesis having said specific shape.
Claim 28
Dependent Claim
34 words
The method of claim 24 wherein the particles of the structural material each have an outer coating of a second material containing a monomer which is polymerizable into a biologically compatible hydrophilic polymeric material.
Claim 29
Dependent Claim
15 words
The method of claim 25 which additionally comprises washing the prosthesis to remove residual monomer.
Claim 30
Dependent Claim
12 words
The method of claim 26 wherein the polymeric structural material is polymethylemthacrylate.
Claim 31
Dependent Claim
22 words
The method of claim 24 wherein said curing comprises at least one method selected from the group consisting of sintering and polymerizing.
Claim 32
Dependent Claim
14 words
The method of claim 28 wherein the sintering and polymerization is accomplished by heating.
Claim 33
Dependent Claim
29 words
The method of claim 29 wherein the heating comprises at least one method selected from the group consisting of microwave heating, radio frequency heating, convection heating, and radiant heating.
Claim 34
Dependent Claim
11 words
The method of claim 24 wherein the implant material is bioabsorbable.
Claim 35
Dependent Claim
43 words
The method of claim 26 which additionally comprises incorporating at least one material into the porous prosthesis after the prosthesis has been washed, said material being selected from the group consisting of a bone growth promoter, a growth factor, blood and an antibiotic.
Claim 36
Dependent Claim
10 words
The method of claim 26 wherein said monomer is hydroxyethylmethacrylate.
Claim 37
Dependent Claim
13 words
The method of claim 32 wherein said bone growth promoter is calcium hydroxide.
Claim 38
Dependent Claim
19 words
The method of claim 25 wherein said second material contains a crosslinking agent, said crosslinking agent is triethyleneglycol dimethacrylate.
Claim 39
Dependent Claim
13 words
The method of claim 25 wherein said second material contains a polymerization initiator.
Claim 40
Dependent Claim
12 words
The method of claim 36 wherein said polymerization initiator in benzoyl peroxide.
Claim 41
Dependent Claim
21 words
The method of claim 24 wherein the particles of the structural material have diameters ranging from about 590 to 700 microns.
Claim 42
Dependent Claim
23 words
The method of claim 24 wherein the second material comprises a dispersion of barium sulfate and benzoyl peroxide in hydroxyethylmethacrylate and triethyleneglycol dimethacrylate.
Claim 43
Dependent Claim
17 words
The method of claim 26 wherein the washing of said implant is accomplished in boiling saline solution.
Claim 44
Independent Claim
107 words
A method for implanting a custom molded prosthesis into body tissue comprising: a) providing an implant precursor material within a flexible bag, said bag being biodegradable, said implant precursor material comprising an aggregation of individual particles of a structural polymeric material which is biocompatable after being cured; b) forming said bag of implant precursor material into a specific shape; c) compacting the implant precursor material into a rigid mass having said specific shape by applying a vacuum to the interior of the bag; d) curing the implant precursor material to provide a porous unitary prosthesis having said specific shape; and e) implanting said prosthesis into body tissue.
Claim 45
Independent Claim
107 words
A method for implanting a custom molded prosthesis into body tissue comprising: a) providing an implant precursor material within a flexible bag, said bag being biodegradable, said implant precursor material comprising an aggregation of individual particles of a structural polymeric material which is biocompatable after being cured; b) forming said bag of implant precursor material into a specific shape; c) compacting the implant precursor material into a rigid mass having said specific shape by applying a vacuum to the interior of the bag; d) curing the implant precursor material to provide a porous unitary prosthesis having said specific shape; and e) implanting said prosthesis into body tissue.
Claim 46
Independent Claim
110 words
A method for implanting a custom molded prosthesis into body tissue comprising: a) providing an implant precursor material within a flexible bag, said implant precursor material comprising an aggregation of individual particles of a structural polymeric material which is biocompatable after being cured; b) forming said bag of implant precursor material into a specific shape; c) compacting the implant precursor material into a rigid mass having said specific shape by applying a vacuum to the interior of the bag; d) curing the implant precursor material to provide a porous unitary prosthesis having said specific shape; e) removing said bag from the prosthesis; and f) implanting said prosthesis into body tissue.
Claim 47
Independent Claim
110 words
A method for implanting a custom molded prosthesis into body tissue comprising: a) providing an implant precursor material within a flexible bag, said implant precursor material comprising an aggregation of individual particles of a structural polymeric material which is biocompatable after being cured; b) forming said bag of implant precursor material into a specific shape; c) compacting the implant precursor material into a rigid mass having said specific shape by applying a vacuum to the interior of the bag; d) curing the implant precursor material to provide a porous unitary prosthesis having said specific shape; e) removing said bag from the prosthesis; and f) implanting said prosthesis into body tissue.
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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) | 1994-08-05 | 1995-02-04 | 1995-08-06 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1998-08-05 | 1999-02-04 | 1999-08-06 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2002-08-05 | 2003-02-04 | 2003-08-06 | $7700.00 | Window Closed / Lapsed |