Patent US5324519A successfully refreshed from Google Patents.
US5324519A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Biodegradable polymer composition
Assignee: Tolmar Therapeutics Inc
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Filing: 1991-10-28
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Granted: 1994-06-28
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Expires: 2011-10-28
Abstract
Abstract The invention is directed to a composition composed of a thermoplastic or thermosetting polymer which is capable of forming a biodegradable and/or bioerodible microporous, solid or gelatinous polymer matrix. The matrix is useful as an implant in animals for enhancing regeneration of cells and tissue, such as bone and nerve cells, or for delivery of biologically-active substances to tissue or organs. The composition is administered to an implant site as a liquid. The invention also includes a method of preventing and treating disorders and diseases, such as bone or nerve growth disorders, or of altering body functions such as birth control, using the compositions and implants of the invention.
Inventors
- 👤 Richard L. Dunn
- 👤 Arthur J. Tipton
- 👤 George L. Southard
- 👤 Jack A. Rogers
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 19:42
CPC Classifications
A; A61; A61L; A61L15/00; A61L15/07; A61L15/14; A61K; A61K9/00; A61K9/0012; A61K9/0019; A61K9/0024; A61K31/00; A61K31/74; A61K33/00; A61K33/42; A61K47/00; A61K47/30; A61K47/34; A61K6/00; A61K6/50; A61K6/58; A61K9/0053; A61K9/0063; A61K9/14; A61K9/16; A61K9/1605; A61K9/1629; A61K9/1641; A61K9/1647; A61L27/00; A61L27/14; A61L27/16; A61L27/18; A61L27/22; A61L27/227; A61L27/50; A61L27/54; A61L27/56; A61L27/58; A61L31/00; A61L31/04; A61L31/043; A61L31/047; A61L31/14; A61L31/146; A61L31/148; A61L31/16; B; B29; B29C; B29C41/00; B29C41/02; B29C41/08; B29C41/12; B29C67/00; B29C67/02; B29C67/06; A61L2300/00; A61L2300/40; A61L2300/404; A61L2300/406; A61L2300/412; A61L2300/60; A61L2300/602; A61L2300/604
Claims Analysis
Total Claims: 31
Claim 1
Independent Claim
112 words
A composition suitable for forming an in situ solid implant in an animal, comprising: a liquid formulation of a biodegradable, bioerodible, biocompatible thermoplastic polymer that is insoluble in aqueous or body fluid, and a biocompatible organic solvent that is miscible or dispersible in aqueous or body fluid and dissolves the thermoplastic polymer, the composition being capable of coagulating or solidifying to form a solid or gelatinous microporous matrix upon its contact with aqueous or body fluid, the matrix being a core surrounded by a skin, the core containing pores of diameters from about 1 to about 1000 microns, and the skin containing pores of smaller diameters than those of the core pores.
Claim 2
Dependent Claim
112 words
A composition suitable for forming an in situ solid implant in an animal, comprising: a liquid formulation of a biodegradable, bioerodible, biocompatible thermoplastic polymer that is insoluble in aqueous or body fluid, and a biocompatible organic solvent that is miscible or dispersible in aqueous or body fluid and dissolves the thermoplastic polymer, the composition being capable of coagulating or solidifying to form a solid or gelatinous microporous matrix upon its contact with aqueous or body fluid, the matrix being a core surrounded by a skin, the core containing pores of diameters from about 1 to about 1000 microns, and the skin containing pores of smaller diameters than those of the core pores.
Claim 3
Dependent Claim
26 words
A composition according to claim 1, wherein the skin pores are of a size such that the skin is functionally non-porous in comparison with the core.
Claim 4
Independent Claim
138 words
A method of forming an implant suitable for providing a biological, therapeutic or physiological effect in an animal, comprising: administering to the animal a composition in an amount effective to form in situ a solid implant, the composition being a liquid formulation of a biodegradable, bioerodable, biocompatible thermoplastic polymer that is insoluble in aqueous or body fluid, and a biocompatible organic solvent that is miscible or dispersible in aqueous or body fluid and dissolves the thermoplastic polymer, and the composition undergoing coagulation or solidification of the polymer and dispersion of the solvent into body fluid to form a solid or gelatinous microporous matrix, the matrix being a core surrounded by a skin, the core containing pores of diameters from about 1 to 1000 microns and the skin containing pores of small diameters than those of the core pores.
Claim 5
Independent Claim
138 words
A method of forming an implant suitable for providing a biological, therapeutic or physiological effect in an animal, comprising: administering to the animal a composition in an amount effective to form in situ a solid implant, the composition being a liquid formulation of a biodegradable, bioerodable, biocompatible thermoplastic polymer that is insoluble in aqueous or body fluid, and a biocompatible organic solvent that is miscible or dispersible in aqueous or body fluid and dissolves the thermoplastic polymer, and the composition undergoing coagulation or solidification of the polymer and dispersion of the solvent into body fluid to form a solid or gelatinous microporous matrix, the matrix being a core surrounded by a skin, the core containing pores of diameters from about 1 to 1000 microns and the skin containing pores of small diameters than those of the core pores.
Claim 6
Dependent Claim
112 words
A composition suitable for forming an in situ solid implant in an animal, comprising: a liquid formulation of a biodegradable, bioerodable, biocompatible thermoplastic polymer that is insoluble in aqueous or body fluid, a biocompatible organic solvent that is miscible or dispersible in aqueous or body fluid and dissolves the thermoplastic polymer, and a pore-forming agent, the composition being capable of coagulating or solidifying to form a solid or gelatinous microporous matrix upon its contact with an aqueous or body fluid, the matrix being a core surrounded by a skin, and the skin and core containing pores within the same range of diameters, that range being from about 1 to about 1000 microns.
Claim 7
Dependent Claim
112 words
A composition suitable for forming an in situ solid implant in an animal, comprising: a liquid formulation of a biodegradable, bioerodable, biocompatible thermoplastic polymer that is insoluble in aqueous or body fluid, a biocompatible organic solvent that is miscible or dispersible in aqueous or body fluid and dissolves the thermoplastic polymer, and a pore-forming agent, the composition being capable of coagulating or solidifying to form a solid or gelatinous microporous matrix upon its contact with an aqueous or body fluid, the matrix being a core surrounded by a skin, and the skin and core containing pores within the same range of diameters, that range being from about 1 to about 1000 microns.
Claim 8
Dependent Claim
27 words
A composition according to claim 4, wherein the pore-forming agent is a sugar, salt, or water-soluble polymer, or water-insoluble substance that degrades to a water soluble substance.
Claim 9
Dependent Claim
53 words
A composition according to claim 1, wherein the thermoplastic polymer is selected from the group consisting of polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyamides, polyurethanes, polyesteramides, polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyorthocarbonates, polyphosphazenes, polyhydroxybutyrates, polyhydroxyvalerates, polyalkylene oxalates, polyalkylene succinates, polymalic acid, polyamino acids, polymethyl vinyl ether, chitin, chitosan, and copolymers, terpolymers, and any combination thereof.
Claim 10
Dependent Claim
52 words
A composition according to claim 1, wherein the solvent is selected from the group consisting of N-methyl-2-pyrrolidone, 2-pyrrolidone, ethanol, propylene glycol, propylene carbonate, acetone, acetic acid, ethyl acetate, ethyl lactate, methyl acetate, methyl ethyl ketone, dimethylformamide, dimethyl sulfoxide, dimethyl sulfone, tetrahydrofuran, caprolactam, decylmethylsulfoxide, oleic acid, N,N-diethyl-m-toluamide, and 1-dodecylazacycloheptan-2-one, and any combination thereof.
Claim 11
Dependent Claim
13 words
A composition according to claim 1, further comprising at least one biologically-active agent.
Claim 12
Dependent Claim
22 words
A composition according to claim 8, wherein the biologically-active agent is a polypeptide derived from a natural, synthetic, or recombinant DNA source.
Claim 13
Dependent Claim
56 words
A composition according to claim 8, wherein the biologically-active agent is selected from a group consisting of anti-inflammatory agents, antibacterial agents, antiparasitic agents, antifungal agents, antiviral agents, anti-neoplastic agents, analgesic agents, anaesthetics, vaccines, central nervous system agents, growth factors, hormones, antihistamines, osteoinductive agents, cardiovascular agents, anti-ulcer agents, bronchodilators, vasodilators, birth control agents, and fertility enhancing agents.
Claim 14
Dependent Claim
100 words
A composition suitable for forming an in situ solid implant in an animal, comprising: a liquid formulation of a biodegradable, bioerodable, biocompatible thermoset polymer that is insoluble in aqueous or body fluid, and an agent selected from the group consisting of a pore-forming agent, a biocompatible organic solvent that is miscible or dispersible in aqueous or body fluid and a releasible, pore-forming moiety within the thermoset polymer; the composition being capable of forming a solid microporous matrix, the matrix being a core surrounded by a skin and the core containing pores of diameters from about 1 to about 1000 microns.
Claim 15
Dependent Claim
100 words
A composition suitable for forming an in situ solid implant in an animal, comprising: a liquid formulation of a biodegradable, bioerodable, biocompatible thermoset polymer that is insoluble in aqueous or body fluid, and an agent selected from the group consisting of a pore-forming agent, a biocompatible organic solvent that is miscible or dispersible in aqueous or body fluid and a releasible, pore-forming moiety within the thermoset polymer; the composition being capable of forming a solid microporous matrix, the matrix being a core surrounded by a skin and the core containing pores of diameters from about 1 to about 1000 microns.
Claim 16
Dependent Claim
32 words
A composition according to claim 11, wherein the skin contains pores of smaller diameters than those of the core pores such that the skin is functionally non-porous in comparison with the core.
Claim 17
Dependent Claim
19 words
A composition according to claim 11, wherein the core and skin contain pores within the same range of diameters.
Claim 18
Independent Claim
124 words
A method of forming an implant suitable for providing a biological, therapeutic or physiological effect in an animal, comprising: administering to the animal a composition in an amount effective to form in situ a solid implant, the composition being a liquid formulation of a biodegradable, bioerodable, biocompatible thermoset polymer that is insoluble in aqueous or body fluid, and an agent selected from the group consisting of a pore-forming agent, a biocompatible organic solvent that is miscible or dispersible in aqueous or body fluid and a releasible, pore-forming moiety within the thermoset polymer; and the composition undergoing curing to form a microporous matrix, the matrix being a core surrounded by a skin and the core containing pores of diameters from about 1 to 1000 microns.
Claim 19
Independent Claim
124 words
A method of forming an implant suitable for providing a biological, therapeutic or physiological effect in an animal, comprising: administering to the animal a composition in an amount effective to form in situ a solid implant, the composition being a liquid formulation of a biodegradable, bioerodable, biocompatible thermoset polymer that is insoluble in aqueous or body fluid, and an agent selected from the group consisting of a pore-forming agent, a biocompatible organic solvent that is miscible or dispersible in aqueous or body fluid and a releasible, pore-forming moiety within the thermoset polymer; and the composition undergoing curing to form a microporous matrix, the matrix being a core surrounded by a skin and the core containing pores of diameters from about 1 to 1000 microns.
Claim 20
Dependent Claim
20 words
A composition according to claim 11 wherein the pore-forming agent is a sugar, salt, water-soluble polymer, or water-miscible organic solvent.
Claim 21
Dependent Claim
23 words
A composition according to claim 11, wherein the polymer is an acrylic ester-terminated biodegradable prepolymer capable of cross-linking to form a polymer matrix.
Claim 22
Dependent Claim
56 words
A composition according to claim 16, wherein the acrylic ester-terminated biodegradable prepolymer is selected from the group consisting essentially of polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyamides, polyurethanes, polyesteramides, polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyorthocarbonates, polyphosphazenes, polyhydroxybutyrates, polyhydroxyvalerates, polyalkylene oxalates, polyalkylene succinates, polymalic acid, polyamino acids, polymethyl vinyl ether, chitin, chitosan, and copolymers, terpolymers, and any combination thereof.
Claim 23
Dependent Claim
11 words
A composition according to claim 11, further comprising a curing agent.
Claim 24
Dependent Claim
30 words
A composition according to claim 11, further comprising at least one biologically-active agent that is free of functional groups that would interfere with the thermosetting reaction of the thermoset polymer.
Claim 25
Dependent Claim
22 words
A composition according to claim 19, wherein the biologically-active agent is a polypeptide derived from a natural, synthetic, or recombinant DNA source.
Claim 26
Dependent Claim
56 words
A composition according to claim 19, wherein the biologically-active agent is selected from a group consisting of anti-inflammatory agents, antibacterial agents, antiparasitic agents, antifungal agents, antiviral agents, anti-neoplastic agents, analgesic agents, anaesthetics, vaccines, central nervous system agents, growth factors, hormones, antihistamines, osteoinductive agents, cardiovascular agents, anti-ulcer agents, bronchodilators, vasodilators, birth control agents and fertility enhancing agents.
Claim 27
Dependent Claim
15 words
A method according to claim 3, wherein the implant is capable of enhancing tissue regeneration.
Claim 28
Dependent Claim
17 words
A method according to claim 3, wherein the implant is capable of filling in defects in tissue.
Claim 29
Dependent Claim
16 words
A method according to claim 3, wherein the composition further comprises at least one biologically-active agent.
Claim 30
Dependent Claim
57 words
A method according to claim 24, wherein the biologically active agent is selected from the group consisting of anti-inflammatory agents, antibacterial agents, antiparasitic agents, antifungal agents, antiviral agents, anti-neoplastic agents, analgesic agents, anaesthetics, vaccines, central nervous system agents, growth factors, hormones, antihistamines, osteoinductive agents, cardiovascular agents, anti-ulcer agents, vasodilators, bronchodilators, birth control agents, and fertility enhancing agents.
Claim 31
Dependent Claim
20 words
A method of claim 24, wherein the biologically-active agent has a biological or physiological therapeutic effect of the reproductive system.
References Cited (Backward Citations)
US3068188A
Cited
US3975350A
Cited
US3919773A
Cited
US3949073A
Cited
US4761471A
Cited
US4294753A
Cited
US4789732A
Cited
US4451452A
Cited
US4455256A
Cited
US4619989A
Cited
US4526938A
Cited
US4904478A
Cited
US4795804A
Cited
US4932973A
Cited
US4526909A
Cited
US4563489A
Cited
US4596574A
Cited
US4894373A
Cited
US4939131A
Cited
US4857456A
Cited
US4921697A
Cited
US4946870A
Cited
US4942157A
Cited
US4905680A
Cited
US4902296A
Cited
US4911931A
Cited
US4961707A
Cited
US4916241A
Cited
GB2223027A
Cited
US4938763A
Cited
US4938763B1
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1997-06-27 | 1997-12-27 | 1998-06-28 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-06-27 | 2001-12-27 | 2002-06-28 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-06-27 | 2005-12-27 | 2006-06-28 | $7700.00 | Window Closed / Lapsed |