US7179883B2
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Medical devices and applications of polyhydroxyalkanoate polymers
Assignee: Tepha Inc
•
Filing: 2004-12-22
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Granted: 2007-02-20
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Expires: 2024-12-22
Abstract
Abstract Devices formed of or including biocompatible polyhydroxyalkanoates are provided with controlled degradation rates, preferably less than one year under physiological conditions. Preferred devices include sutures, suture fasteners, meniscus repair devices, rivets, tacks, staples, screws (including interference screws), bone plates and bone plating systems, surgical mesh, repair patches, slings, cardiovascular patches, orthopedic pins (including bone filling augmentation material), adhesion barriers, stents, guided tissue repair/regeneration devices, articular cartilage repair devices, nerve guides, tendon repair devices, atrial septal defect repair devices, pericardial patches, bulking and filling agents, vein valves, bone marrow scaffolds, meniscus regeneration devices, ligament and tendon grafts, ocular cell implants, spinal fusion cages, skin substitutes, dural substitutes, bone graft substitutes, bone dowels, wound dressings, and hemostats. The polyhydroxyalkanoates can contain additives, be formed of mixtures of monomers or include pendant groups or modifications in their backbones, or can be chemically modified, all to alter the degradation rates. The polyhydroxyalkanoate compositions also provide favorable mechanical properties, biocompatibility, and degradation times within desirable time frames under physiological conditions.
Inventors
- 👤 Simon F. Williams
- 👤 David P. Martin
- 👤 Frank A. Skraly
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 17:58
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/50; A61L27/58; A61F; A61F2/00; A61F2/02; A61F2/04; A61F2/06; A61F2/07; A61K; A61K31/00; A61K31/70; A61K31/715; A61L17/00; A61L17/06; A61L17/10; A61L17/12; A61L27/14; A61L27/18; A61L31/00; A61L31/04; A61L31/06; A61L31/14; A61L31/148; A61L31/16; C; C08; C08G; C08G63/00; C08G63/02; C08G63/06; C08J; C08J9/00; C08J9/26; C08K; C08K5/00; C08K5/0008; C08K5/0033; C08L; C08L67/00; C08L67/04; C12; C12P; C12P7/00; C12P7/62; C12P7/625; A61F2210/00; A61F2210/0004; A61L2300/00; C08J2201/00; C08J2201/04; C08J2201/044; C08J2201/0444; C08J2201/048; C08J2201/0482; C08J2367/00; C08J2367/04; Y; Y10; Y10S; Y10S606/00; Y10S606/907; Y10S606/911
Claims Analysis
Total Claims: 33
Claim 1
Independent Claim
176 words
A device comprising a biodegradable polyhydroxyalkanoate polymer composition that has a controlled degradation rate of less than one year, under physiological conditions, wherein the degradation rate of the composition is manipulated through addition of components to the polymeric composition, selection of the chemical composition, molecular weight, processing conditions, or form of the composition, wherein the device is selected from the group consisting of rotator cuff repair devices, temporary wound support devices, bladder patches, pledgets, soft tissue reinforcement devices, vascular patches, devices for artrial wall repair, bone marrow scaffolds, ligament repair devices, rods, washers, screws, pins, struts, plates, and staples used in spinal fusion cages, stents, sewing rings, stiffners used in heart valve supports, cell encapsulation devices, coated devices, defect filling devices, organ patches, organ salvage devices, staple line reinforcement devices, pelvic floor reconstruction devices, devices for closure of ventricular septal defects, drug delivery devices, devices for delivery of biological factors, and devices comprising encapsulated proteins, antibodies, enzymes, peptides, polysaccharides, saccharides, organic drugs, inorganic drugs, nucleic acids, antigens, inhibitors, clot dissolving agents, hormones, nucleic acid, and/or lipids.
Claim 2
Independent Claim
176 words
A device comprising a biodegradable polyhydroxyalkanoate polymer composition that has a controlled degradation rate of less than one year, under physiological conditions, wherein the degradation rate of the composition is manipulated through addition of components to the polymeric composition, selection of the chemical composition, molecular weight, processing conditions, or form of the composition, wherein the device is selected from the group consisting of rotator cuff repair devices, temporary wound support devices, bladder patches, pledgets, soft tissue reinforcement devices, vascular patches, devices for artrial wall repair, bone marrow scaffolds, ligament repair devices, rods, washers, screws, pins, struts, plates, and staples used in spinal fusion cages, stents, sewing rings, stiffners used in heart valve supports, cell encapsulation devices, coated devices, defect filling devices, organ patches, organ salvage devices, staple line reinforcement devices, pelvic floor reconstruction devices, devices for closure of ventricular septal defects, drug delivery devices, devices for delivery of biological factors, and devices comprising encapsulated proteins, antibodies, enzymes, peptides, polysaccharides, saccharides, organic drugs, inorganic drugs, nucleic acids, antigens, inhibitors, clot dissolving agents, hormones, nucleic acid, and/or lipids.
Claim 3
Independent Claim
191 words
A method for making a device that has a controlled degradation rate of less than one year under physiological conditions, comprising providing a biocompatible polyhydroxyalkanoate composition, wherein the degradation rate of the composition is manipulated through addition of components to the polymeric composition, selection of the chemical composition, molecular weight, processing conditions, or form of the composition, and forming or incorporating the polyhydroxyalkanoate composition into a device selected from the group consisting of vein valves, rotator cuff repair devices, temporary wound support devices, bladder patches, pledgets, soft tissue reinforcement devices, vascular patches, devices for artrial wall repair, bone marrow scaffolds, meniscus regeneration devices, ligament repair devices, rods, washers, screws, pins, struts, plates, and staples used in spinal fusion cages, stents, sewing rings, stiffners used in heart valve supports, cell encapsulation devices, coated devices, defect filling devices, organ patches, organ salvage devices, staple line reinforcement devices, pelvic floor reconstruction devices, devices for closure of ventricular septal defects, drug delivery devices, devices for delivery of biological factors, and devices comprising encapsulated proteins, antibodies, enzymes, peptides, polysaccharides, saccharides, organic and inorganic drugs, nucleic acids, antigens, inhibitors, clot dissolving agents, hormones, nucleic acid, and/or lipids.
Claim 4
Independent Claim
191 words
A method for making a device that has a controlled degradation rate of less than one year under physiological conditions, comprising providing a biocompatible polyhydroxyalkanoate composition, wherein the degradation rate of the composition is manipulated through addition of components to the polymeric composition, selection of the chemical composition, molecular weight, processing conditions, or form of the composition, and forming or incorporating the polyhydroxyalkanoate composition into a device selected from the group consisting of vein valves, rotator cuff repair devices, temporary wound support devices, bladder patches, pledgets, soft tissue reinforcement devices, vascular patches, devices for artrial wall repair, bone marrow scaffolds, meniscus regeneration devices, ligament repair devices, rods, washers, screws, pins, struts, plates, and staples used in spinal fusion cages, stents, sewing rings, stiffners used in heart valve supports, cell encapsulation devices, coated devices, defect filling devices, organ patches, organ salvage devices, staple line reinforcement devices, pelvic floor reconstruction devices, devices for closure of ventricular septal defects, drug delivery devices, devices for delivery of biological factors, and devices comprising encapsulated proteins, antibodies, enzymes, peptides, polysaccharides, saccharides, organic and inorganic drugs, nucleic acids, antigens, inhibitors, clot dissolving agents, hormones, nucleic acid, and/or lipids.
Claim 5
Dependent Claim
38 words
The method of claim 2 wherein the processing forming or incorporating process is selected from the group consisting of solvent casting, melt processing, fiber processing, fiber spinning, fiber weaving, extrusion, injection molding, compression molding, lamination, and microparticle formation.
Claim 6
Dependent Claim
14 words
The method of claim 2 further comprising incorporating an active agent into the polyhydroxyalkanoate.
Claim 7
Dependent Claim
34 words
The device of claim 1 wherein the chemical composition of the polyhydroxyalkanoate is altered through selection of monomers which are incorporated into the polymer, by alteration of the linkages, chemical backbone or pendant groups.
Claim 8
Dependent Claim
41 words
The device of claim 1 wherein the polyhydroxyalkanoate composition comprises additives altering the degradation rate of the composition, wherein the additives are selected from the group consisting of hydrophilic substances, hydrophobic substances, and coatings which alter water uptake by the composition.
Claim 9
Dependent Claim
26 words
The device of claim 1 wherein the polyhydroxyalkanoate comprises a polymer selected from the group of consisting of poly-4-hydroxybutyrate, poly-4-hydroxybutyrate-co-3-hydroxybutyrate, poly-4-hydroxybutyrate-co-2-hydroxybutyrate, and copolymers and blends thereof.
Claim 10
Dependent Claim
25 words
The device of claim 1 wherein the polyhydroxyalkanoate comprises a polymer selected from the group consisting of poly-3-hydroxybutyrate-co-3-hydroxyhexanoate, poly-3-hydroxybutyrate-co-3-hydroxyoctanoate, poly-3-hydroxybutryrate-co-3-hydroxydecanoate, and copolymers and blends thereof.
Claim 11
Dependent Claim
22 words
The device of claim 1 wherein the polyhydroxyalkanoate comprises one or more units which alter the chemical stability of the polymer backbone.
Claim 12
Dependent Claim
10 words
The device of claim 1 comprising units promoting chain scission.
Claim 13
Dependent Claim
14 words
The device of claim 10 wherein the units contain more than two functional groups.
Claim 14
Dependent Claim
15 words
The device of claim 1 wherein a heteroatom is incorporated into the polymer backbone chain.
Claim 15
Dependent Claim
19 words
The device of claim 12 wherein the heteroatom is selected from the group consisting of oxygen, sulfur or nitrogen.
Claim 16
Dependent Claim
30 words
The device of claim 10 wherein the units are incorporated into the polymer backbone with chemical linkages selected from the group consisting of ester, amide, ether, carbamate, anhydride, and carbonate.
Claim 17
Dependent Claim
26 words
The device of claim 10 wherein the units are selected from the group consisting of 2-hydroxyacids, 2-hydroxyalkaoxyacetic acids, amino acids, amino alcohols, diacids, triols, and tetraols.
Claim 18
Dependent Claim
11 words
The device of claim 15 wherein the 2-hydroxyacids are 2-hydroxyalkanoic acids.
Claim 19
Dependent Claim
15 words
The device of claim 16 wherein the 2-hydroxyalkanoic acid is lactic acid or glycolic acid.
Claim 20
Dependent Claim
23 words
The device of claim 15 wherein the 2-hydroxyalkoxyacetic acids are selected from the group consisting of 2-hydroxyethoxy acetic acid and 3-hydroxypropoxy acetic acid.
Claim 21
Dependent Claim
19 words
The device of claim 1 wherein the polymer comprises pendant groups that catalyze the degradation of the polymer backbone.
Claim 22
Dependent Claim
16 words
The device of claim 19 wherein the pendant groups are selected from acidic and basic groups.
Claim 23
Dependent Claim
14 words
The device of claim 19 comprising reactant pendant groups that cause polymer chain scission.
Claim 24
Dependent Claim
16 words
The device of claim 21 wherein the reactant pendant groups are selected from nucleophiles and electrophiles.
Claim 25
Dependent Claim
21 words
The device of claim 19 wherein the pendant groups are selected from the group consisting of alcohols, acids, and amine groups.
Claim 26
Dependent Claim
15 words
The device of claim 1 comprising providing additives altering the chemical stability of the polyhydroxyalkanoate.
Claim 27
Dependent Claim
11 words
The device of claim 24 wherein the additives promote chain scission.
Claim 28
Dependent Claim
32 words
The device of claim 24 wherein the additives are selected from the group consisting of acids, bases, electrophiles, nucleophiles, plasticizers, polymers, pore forming agents, and agents designed to reduce the polymer crystallinity.
Claim 29
Dependent Claim
10 words
The device of claim 1 comprising providing pore forming agents.
Claim 30
Dependent Claim
13 words
The device of claim 27 wherein the pore forming agents are lyophilizable particles.
Claim 31
Dependent Claim
12 words
The device of claim 27 wherein the pore forming agents absorb water.
Claim 32
Dependent Claim
12 words
The device of claim 1 further comprising one or more active agents.
Claim 33
Dependent Claim
25 words
The device of claim 30 wherein the active agent is selected from the group consisting of growth factors, alginates, silver salts, antiseptics, analgesics, and preservatives.
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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) | 2010-02-19 | 2010-08-21 | 2011-02-20 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2014-02-19 | 2014-08-21 | 2015-02-20 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2018-02-19 | 2018-08-21 | 2019-02-20 | $7700.00 | Window Closed / Lapsed |