US6413539B1
Expired / Lapsed
US
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Hydrogel-forming, self-solvating absorbable polyester copolymers, and methods for use thereof
Assignee: Poly Med Inc
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Filing: 1998-01-29
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Granted: 2002-07-02
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Expires: 2018-01-29
Abstract
Abstract The present invention provides novel hydrogel-forming, self-solvating, absorbable polyester copolymers capable of selective, segmental association into compliant hydrogels upon contacting an aqueous environment. Methods of using the novel polyester copolymers of the invention in humans are also disclosed for providing a protective barrier to prevent post-surgical adhesion, treatment of defects in conduits such as blood vessels, and controlled release of a biologically active agent for modulating cellular events such as wound healing and tissue regeneration or therapeutic treatment of diseases such as infection of the periodontium, dry socket, bone, skin, vaginal, and nail infections.
Inventors
- 👤 Shalaby W. Shalaby
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-07 18:19
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0019; A61K9/0024; A61K47/00; A61K47/30; A61K47/34; A61K47/50; A61K47/51; A61K47/56; A61K47/59; A61K47/593; A61K47/60; A61K47/69; A61K47/6921; A61K47/6927; A61K6/00; A61K6/60; A61K6/69; A61L; A61L24/00; A61L24/04; A61L24/046; A61L26/00; A61L26/0009; A61L26/0019; A61L26/0052; A61L26/0061; A61L26/008; A61L31/00; A61L31/04; A61L31/041; A61L31/06; A61L31/14; A61L31/145; C; C08; C08G; C08G63/00; C08G63/64; C08G63/66; C08G63/664
Claims Analysis
Total Claims: 63
Claim 1
Independent Claim
95 words
A hydrogel-forming, self-solvating absorbable polyester copolymer capable of selective, segmental association into a compliant hydrogel mass on contact with an aqueous environment, said copolymer comprising: a hydrophobic polyester block X and a hydrophilic block Y, said blocks X and Y being covalently bonded together in an arrangement selected from the group consisting of X-Y-X, (X-Y)n, and branched structures thereof; said hydrophobic block comprising greater than 50% of the mass of said copolymer and derived front a process selected from the group consisting of ring-opening of a cyclic carbonate and step-growth polymerization of an alkylene carbonate.
Claim 2
Dependent Claim
95 words
A hydrogel-forming, self-solvating absorbable polyester copolymer capable of selective, segmental association into a compliant hydrogel mass on contact with an aqueous environment, said copolymer comprising: a hydrophobic polyester block X and a hydrophilic block Y, said blocks X and Y being covalently bonded together in an arrangement selected from the group consisting of X-Y-X, (X-Y)n, and branched structures thereof; said hydrophobic block comprising greater than 50% of the mass of said copolymer and derived front a process selected from the group consisting of ring-opening of a cyclic carbonate and step-growth polymerization of an alkylene carbonate.
Claim 3
Dependent Claim
22 words
The copolymer of claim 1 , wherein said cyclic carbonate is selected from the group consisting of substituted or unsubstituted alkylene carbonate.
Claim 4
Dependent Claim
26 words
The copolymer of claim 1 , wherein said step-growth polymerization forms a polyalkylene carbonate corresponding to diols having more than 3-carbon atoms in a linear sequence.
Claim 5
Dependent Claim
11 words
The copolymer of claim 2 , further comprising microparticles of hydroxyproline.
Claim 6
Dependent Claim
62 words
A composition comprising: a hydrogel-forming, self-solvating absorbable polyester copolymer capable of selective, segmental association into a compliant hydrogel mass on contact with an aqueous environment; a low molecular weight component associated with said copolymer; and an absorbable microparticulate solid carrier associated with said copolymer and said component, said carrier having a biological active agent or mixtures of biologically active agents deposited thereon.
Claim 7
Dependent Claim
62 words
A composition comprising: a hydrogel-forming, self-solvating absorbable polyester copolymer capable of selective, segmental association into a compliant hydrogel mass on contact with an aqueous environment; a low molecular weight component associated with said copolymer; and an absorbable microparticulate solid carrier associated with said copolymer and said component, said carrier having a biological active agent or mixtures of biologically active agents deposited thereon.
Claim 8
Dependent Claim
15 words
The composition of claim 5 , wherein said carrier comprises surface or total bulk microporosity.
Claim 9
Dependent Claim
22 words
The composition of claim 6 , wherein said surface comprises ionizable functional groups capable of producing an anionic or cationic stationary phase.
Claim 10
Dependent Claim
30 words
The composition of claim 7 , wherein said anionic phase forms a complex with an immobilized biologically active agent or mixture of agents carrying one or more basic ionogenic groups.
Claim 11
Dependent Claim
26 words
The composition of claim 7 , wherein said cationic stationary phase forms a complex with an immobilized biologically active agent carrying one or more acidic groups.
Claim 12
Dependent Claim
13 words
The composition of claim 8 , wherein said active agent is an antibiotic.
Claim 13
Dependent Claim
11 words
The composition of claim 10 , wherein said antibiotic is doxycycline.
Claim 14
Dependent Claim
16 words
The composition of claim 11 , further comprising said microparticulate being encased in an absorbable polymer.
Claim 15
Dependent Claim
18 words
The composition of claim 12 , wherein said microparticulate is encased in said polymer individually or in groups.
Claim 16
Dependent Claim
57 words
A composition comprising: a hydrogel-forming, self-solvating absorbable polyester copolymer capable of selective, segmental association into a compliant hydrogel mass on contact with an aqueous environment; and an absorbable microparticulate, microporus, carrier associated with said copolymer, said carrier having a biological active agent deposited thereon; and the surface of said carrier being anionic and complexing with said agent.
Claim 17
Dependent Claim
57 words
A composition comprising: a hydrogel-forming, self-solvating absorbable polyester copolymer capable of selective, segmental association into a compliant hydrogel mass on contact with an aqueous environment; and an absorbable microparticulate, microporus, carrier associated with said copolymer, said carrier having a biological active agent deposited thereon; and the surface of said carrier being anionic and complexing with said agent.
Claim 18
Dependent Claim
19 words
The composition of claim 14 , wherein said micorparticulate is encased individually or in groups with an absorbable polymer.
Claim 19
Dependent Claim
57 words
A composition comprising: a hydrogel-forming, self-solvating absorbable polyester copolymer capable of selective, segmental association into a compliant hydrogel mass on contact with an aqueous environment; and an absorbable microparticulate, microporus, carrier associated with said copolymer, said carrier having a biological active agent deposited thereon; and the surface of said carrier being cationic and complexing with said agent.
Claim 20
Dependent Claim
57 words
A composition comprising: a hydrogel-forming, self-solvating absorbable polyester copolymer capable of selective, segmental association into a compliant hydrogel mass on contact with an aqueous environment; and an absorbable microparticulate, microporus, carrier associated with said copolymer, said carrier having a biological active agent deposited thereon; and the surface of said carrier being cationic and complexing with said agent.
Claim 21
Dependent Claim
19 words
The composition of claim 16 , wherein said micorparticulate is encased individually or in groups with an absorbable polymer.
Claim 22
Independent Claim
53 words
A method of treating ocular diseases or disorders in a patient suffering from such diseases comprising, placing at the site of said disease a formulation comprising a hydrogel-forming, self-solvating absorbable polyester copolymer capable of selective, segmental association into a compliant hydrogel mass on contact with an aqueous environment and a pharmaceutically acceptable carrier.
Claim 23
Independent Claim
53 words
A method of treating ocular diseases or disorders in a patient suffering from such diseases comprising, placing at the site of said disease a formulation comprising a hydrogel-forming, self-solvating absorbable polyester copolymer capable of selective, segmental association into a compliant hydrogel mass on contact with an aqueous environment and a pharmaceutically acceptable carrier.
Claim 24
Dependent Claim
14 words
The method of claim 18 , wherein said formulation is an intraocular injectable formulation.
Claim 25
Independent Claim
52 words
A method of accelerating incisional wound healing and reducing scaring in a patient comprising placing at the site of said disease a formulation consisting of a hydrogel-forming, self-solvating absorbable polyester copolymer capable of selective, segmental association into a compliant hydrogel mass on contact with an aqueous environment and a pharmaceutically acceptable carrier.
Claim 26
Independent Claim
52 words
A method of accelerating incisional wound healing and reducing scaring in a patient comprising placing at the site of said disease a formulation consisting of a hydrogel-forming, self-solvating absorbable polyester copolymer capable of selective, segmental association into a compliant hydrogel mass on contact with an aqueous environment and a pharmaceutically acceptable carrier.
Claim 27
Dependent Claim
47 words
A method for assisting the approximation of wound edges and healing in conjunction with a limited number of suture stitches, or staples in a patient suffering from such conditions, comprising placing at the site of said condition of said person the copolymer according to claim 3 .
Claim 28
Dependent Claim
12 words
The composition of claim 12 , wherein said polymer is a polyester.
Claim 29
Dependent Claim
13 words
The composition of claim 22 , wherein said polyester is a lactide/glycolide copolymer.
Claim 30
Dependent Claim
13 words
A mixture comprising the polyester copolymer of claim 1 and an alkoxyalkyl cyanoacrylate.
Claim 31
Dependent Claim
13 words
The mixture of claim 24 , wherein said alkoxyalkyl cyanoacrylate is methoxy-propyl cyanoacrylate.
Claim 32
Dependent Claim
21 words
The mixture as in claim 25 , wherein said alkoxy cyanoacrylate comprises 5 to 50 percent by weight of the mixture.
Claim 33
Dependent Claim
12 words
The mixture of claim 26 , wherein said mixture facilitates wound repair.
Claim 34
Dependent Claim
13 words
The mixture of claim 26 , wherein said mixture is a hemostat agent.
Claim 35
Dependent Claim
19 words
The composition of claim 12 , wherein said carrier is dispersed in a sterile aqueous formulation for parenteral administration.
Claim 36
Dependent Claim
13 words
The composition of claim 5 , wherein said active agent is a polypeptide.
Claim 37
Dependent Claim
13 words
The composition of claim 29 , wherein said active agent is a polypeptide.
Claim 38
Dependent Claim
13 words
The copolymer of claim 2 , wherein said cyclic carbonate is trimethylene carbonate.
Claim 39
Dependent Claim
13 words
The composition of claim 5 , wherein said active agent is a protein.
Claim 40
Dependent Claim
24 words
The composition of claim 33 , wherein said protein is selected from the group consisting of insulin, interferon, growth hormone, erythropoitin and ricin A-chain.
Claim 41
Dependent Claim
13 words
The composition of claim 29 , wherein said active agent is a protein.
Claim 42
Dependent Claim
24 words
The composition of claim 35 , wherein said protein is selected from the group consisting of insulin, interferon, growth hormone, erythropoitin and ricin A-chain.
Claim 43
Dependent Claim
16 words
The copolymer of claim 1 further comprising a hydroxy terminal group acylated with a cyclic anhydride.
Claim 44
Dependent Claim
13 words
The copolymer of claim 37 , wherein said cyclic anhydride is glutaric anhydride.
Claim 45
Dependent Claim
16 words
The copolymer of claim 2 , further comprising microparticles of hydroxyproline encased in an absorbable polyester.
Claim 46
Dependent Claim
16 words
The copolymer of claim 4 , further comprising microparticles of the free acid of naproxin sodium.
Claim 47
Independent Claim
33 words
A method for preventing post-surgical adhesion in a person suffering from such a condition comprising placing at the site of the condition the copolymer according to claims 4 , 39 or 40 .
Claim 48
Dependent Claim
13 words
A mixture comprising the polyester copolymer of claim 1 and anhydrous ferric chloride.
Claim 49
Independent Claim
41 words
A method for achieving homeostasis or temporary blocking of blood vessels and biological conduits in a person suffering from such a condition comprising placing at the site of the condition the mixture according to claims 26 , 27 or 42 .
Claim 50
Independent Claim
32 words
A method for sealing damaged soft tissue in a person suffering from such a condition comprising placing at the site of the condition the formulation according to claims 27 or 42 .
Claim 51
Dependent Claim
35 words
The copolymer of claim 2 , wherein said copolymer further comprises an absorbable microparticulate solid carrier associated with said copolymer, said carrier having a biological active agent or mixtures of biologically active agents deposited thereon.
Claim 52
Dependent Claim
17 words
The copolymer of claim 45 , wherein said active agent is doxycycline encased in an absorbable polymer.
Claim 53
Dependent Claim
13 words
The copolymer of claim 46 , wherein said polymer is a lactide/glycolide copolymer.
Claim 54
Dependent Claim
28 words
A method for treating periodontitis in a person suffering from such a condition comprising placing at the site of the condition the formulation according to claim 46 .
Claim 55
Independent Claim
29 words
A method for treating osteomyelitis in a person suffering from such a condition comprising placing at the site of the condition the formulation according to Examples XX and XXVII.
Claim 56
Independent Claim
29 words
A method for treating osteomyelitis in a person suffering from such a condition comprising placing at the site of the condition the formulation according to Examples XX and XXVII.
Claim 57
Dependent Claim
29 words
A method for accelerating wound healing in a person suffering from such a condition comprising placing at the site of the condition the formulation according to claim 1 .
Claim 58
Dependent Claim
13 words
The composition of claim 5 , wherein said active agent is a vaccine.
Claim 59
Dependent Claim
19 words
A process for making an encased microparticle comprising the step of encasing a bound microparticle with an absorbable polymer.
Claim 60
Dependent Claim
19 words
A process for making an encased microparticle comprising the step of encasing a bound microparticle with an absorbable polymer.
Claim 61
Dependent Claim
31 words
The process according to claim 52 , wherein a dispersion of said bound microparticle in a solution comprising said absorbable polymer and a solvent is dropped onto a pre-cooled organic medium.
Claim 62
Dependent Claim
16 words
The process according to claim 53 , wherein said medium comprises isopropyl alcohol and carbon dioxide.
Claim 63
Dependent Claim
17 words
The process according to claim 53 , wherein said medium comprises a supercritical fluid as a non-solvent.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 2005-07-01 | 2005-12-31 | 2006-07-02 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2009-07-01 | 2009-12-31 | 2010-07-02 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2013-07-01 | 2013-12-31 | 2014-07-02 | $7700.00 | Window Closed / Lapsed |