US6867247B2
Expired / Lapsed
US
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Medical devices and applications of polyhydroxyalkanoate polymers
Assignee: Tepha Inc
•
Filing: 2002-05-01
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Granted: 2005-03-15
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Expires: 2022-05-01
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 12:50
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: 31
Claim 1
Independent Claim
200 words
A method of enhancing the healing of a wound, injury, or defect in a site in a patient, comprising administering at the site a device comprising a biocompatible polyhydroxyalkanoate composition wherein the degradation rates of the polyhydroxyalkanoates 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 mass loss of the polyhydroxyalkanoate, as measured by gas chromatography, is greater than 5% over a six week period in vivo, or wherein the average molecular mass of the polyhydroxyalkanoate, as measured by gel permeation chromatography, decreases 20% to 50% over a ten week period in vivo, and wherein the device is selected from the group consisting of sutures, suture fasteners, meniscus repair devices, rivets, tacks, staples, screws, bone plates and bone plating systems, surgical mesh, repair patches, slings, cardiovascular patches, orthopedic pins, 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, ligament and tendon grafts, ocular cell implants, spinal fusion cages, heart valves, vascular grafts, skin substitutes, dural substitutes, bone graft substitutes, bone dowels, wound dressings, and hemostats.
Claim 2
Independent Claim
200 words
A method of enhancing the healing of a wound, injury, or defect in a site in a patient, comprising administering at the site a device comprising a biocompatible polyhydroxyalkanoate composition wherein the degradation rates of the polyhydroxyalkanoates 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 mass loss of the polyhydroxyalkanoate, as measured by gas chromatography, is greater than 5% over a six week period in vivo, or wherein the average molecular mass of the polyhydroxyalkanoate, as measured by gel permeation chromatography, decreases 20% to 50% over a ten week period in vivo, and wherein the device is selected from the group consisting of sutures, suture fasteners, meniscus repair devices, rivets, tacks, staples, screws, bone plates and bone plating systems, surgical mesh, repair patches, slings, cardiovascular patches, orthopedic pins, 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, ligament and tendon grafts, ocular cell implants, spinal fusion cages, heart valves, vascular grafts, skin substitutes, dural substitutes, bone graft substitutes, bone dowels, wound dressings, and hemostats.
Claim 3
Dependent Claim
41 words
The method of claim 1 wherein the chemical composition of the polyhydroxyalkanoate is altered through selection of monomers which are incoporated into the polymer, by alteration of the linkages, chemical backbone or pendant groups, or by manipulation of the molecular weight.
Claim 4
Dependent Claim
43 words
The method of claim 1 wherein the polyhydroxyalkanoate composition comprises an additive altering the degradation rate of the polyhydroxyalkanoate composition, wherein the additive is selected from the group consisting of hydrophilic substances, hydrophobic substances, and coatings which alter water uptake by the composition.
Claim 5
Dependent Claim
26 words
The method of claim 1 wherein to 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 6
Dependent Claim
25 words
The method 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 7
Dependent Claim
22 words
The method of claim 1 wherein the polyhydroxyalkanoate comprises one or more units which alter the chemical stability of the polymer backbone.
Claim 8
Dependent Claim
10 words
The method of claim 1 comprising unit(s) promoting chain scission.
Claim 9
Dependent Claim
14 words
The method of claim 7 wherein the units contain more than two functional groups.
Claim 10
Dependent Claim
15 words
The method of claim 1 wherein a heteroatom is incorporated into the polymer backbone chain.
Claim 11
Dependent Claim
19 words
The method of claim 9 wherein the heteroatom is selected from the group consisting of oxygen, sulfur or nitrogen.
Claim 12
Dependent Claim
30 words
The method of claim 7 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 13
Dependent Claim
27 words
The method of claim 11 wherein the units are a selected from the group consisting of 2-hydroxyacids, 2-hydroxyalkoxyacetic acids, amino acids, amino alcohols, diacids, triols, and tetraols.
Claim 14
Dependent Claim
11 words
The method of claim 12 wherein the 2-hydroxyacids are 2-hydroxyalkanoic acids.
Claim 15
Dependent Claim
15 words
The method of claim 13 wherein the 2-hydroxyalkanoic acid is lactic acid or glycolic acid.
Claim 16
Dependent Claim
11 words
The method of claim 12 wherein the 2-hydroxyacids are 2-hydroxyalkenoic acids.
Claim 17
Dependent Claim
23 words
The method of claim 12 wherein the 2-hydroxyalkoxyacetic acids are selected from the group consisting of 2-hydroxyethoxy acetic acid and 3-hydroxypropoxy acetic acid.
Claim 18
Dependent Claim
19 words
The method of claim 1 wherein the polymer comprises pendant groups that catalyze the degradation of the polymer backbone.
Claim 19
Dependent Claim
16 words
The method of claim 17 wherein the pendant groups are selected from acidic and basic groups.
Claim 20
Dependent Claim
14 words
The method of claim 17 comprising reactant pendant groups that cause polymer chain scission.
Claim 21
Dependent Claim
16 words
The method of claim 19 wherein the reactant pendant groups are selected from nucleophiles and electrophiles.
Claim 22
Dependent Claim
21 words
The method of claim 17 wherein the pendant groups are selected from the group consisting of alcohols, acids, and amine groups.
Claim 23
Dependent Claim
14 words
The method of claim 1 comprising additives altering the chemical stability of the polyhydroxyalkanoate.
Claim 24
Dependent Claim
11 words
The method of claim 22 wherein the additives remote chain scission.
Claim 25
Dependent Claim
32 words
The method of claim 22 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 26
Dependent Claim
13 words
The method of claim 1 comprising providing pore forming agents in the composition.
Claim 27
Dependent Claim
13 words
The method of claim 25 wherein the pore forming agents are lyophilizable particles.
Claim 28
Dependent Claim
12 words
The method of claim 25 wherein the pore forming agents absorb water.
Claim 29
Dependent Claim
16 words
The method of claim 1 further comprising providing one or more active agents in the composition.
Claim 30
Dependent Claim
25 words
The method of claim 28 wherein the active agent is selected from the group consisting of growth factors, alginates, silver salts, antiseptics, analgesics, and preservatives.
Claim 31
Dependent Claim
20 words
The method of claim 1 wherein the mass loss of the polyhydroxyalkanoate composition is from about 5% to about 75%.
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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) | 2008-03-14 | 2008-09-13 | 2009-03-15 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2012-03-14 | 2012-09-13 | 2013-03-15 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2016-03-14 | 2016-09-13 | 2017-03-15 | $7700.00 | Window Closed / Lapsed |