US6838493B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Medical devices and applications of polyhydroxyalkanoate polymers
Assignee: Tepha Inc
•
Filing: 2002-02-26
•
Granted: 2005-01-04
•
Expires: 2022-02-26
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
2026-10-22 23:53
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: 32
Claim 1
Independent Claim
197 words
A device comprising a biodegradable polyhydroxyalkanoate polymer composition that has a controlled degradation rate, under physiological conditions, wherein the average molecular mass loss of the polymer decreases 20% to 50% over a ten week time period in vivo or wherein the percent mass loss is greater than 5% over a six week period in vivo, wherein the degradation rate of the polyhydroxyalkanoate polymer 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 polyhydroxyalkanoate polymer has a weight average molecular weight of between 10,000 and 10,000,000 Daltons, 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, 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.
Claim 2
Independent Claim
197 words
A device comprising a biodegradable polyhydroxyalkanoate polymer composition that has a controlled degradation rate, under physiological conditions, wherein the average molecular mass loss of the polymer decreases 20% to 50% over a ten week time period in vivo or wherein the percent mass loss is greater than 5% over a six week period in vivo, wherein the degradation rate of the polyhydroxyalkanoate polymer 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 polyhydroxyalkanoate polymer has a weight average molecular weight of between 10,000 and 10,000,000 Daltons, 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, 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.
Claim 3
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 4
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 coating which alter water uptake by the composition.
Claim 5
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-hydxoxybutyrate, poly-4-hydroxybutyrate-co-2-hydroxybutyrate, and copolymers and blends thereof.
Claim 6
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 7
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 8
Dependent Claim
10 words
The device of claim 1 comprising unit(s) promoting chain scission.
Claim 9
Dependent Claim
14 words
The device of claim 7 wherein the units contain more than two functional groups.
Claim 10
Dependent Claim
15 words
The device of claim 1 wherein a heteroatom is incorporated into the polymer backbone chain.
Claim 11
Dependent Claim
19 words
The device of claim 9 wherein the heteroatom is selected from the group consisting of oxygen, sulfur or nitrogen.
Claim 12
Dependent Claim
30 words
The device 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
26 words
The device of claim 7 wherein the units are selected from the group consisting of 2-hydroxyacids, 2-hydroxyalkaoxyacetic acids, amino acids, amino alcohols, diacids, triols, and tetraols.
Claim 14
Dependent Claim
11 words
The device of claim 12 wherein the 2-hydroxyacids are 2-hydroxyalkanoic acids.
Claim 15
Dependent Claim
15 words
The device of claim 13 wherein the 2-hydroxyalkanoic acid is lactic acid or glycolic acid.
Claim 16
Dependent Claim
23 words
The device of claim 12 wherein the 2-hydroxyalkaoxyacetic acids are selected from the group consisting of 2-hydroxyethoxy acetic acid and 3-hydroxypropoxy acetic acid.
Claim 17
Dependent Claim
19 words
The device of claim 1 wherein the polymer comprises pendant groups that catalyze the degradation of the polymer backbone.
Claim 18
Dependent Claim
16 words
The device of claim 16 wherein the pendant groups are selected from acidic and basic groups.
Claim 19
Dependent Claim
14 words
The device of claim 16 comprising reactant pendant groups that cause polymer chain scission.
Claim 20
Dependent Claim
16 words
The device of claim 18 wherein the reactant pendant groups are selected from nucleophiles and electrophiles.
Claim 21
Dependent Claim
21 words
The device of claim 16 wherein the pendant groups are selected from the group consisting of alcohols, acids, and amine groups.
Claim 22
Dependent Claim
14 words
The device of claim 1 comprising additives altering the chemical stability of the polyhydroxyalkanoate.
Claim 23
Dependent Claim
11 words
The device of claim 21 wherein the additives promote chain scission.
Claim 24
Dependent Claim
32 words
The device of claim 21 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 25
Dependent Claim
9 words
The device of claim 1 comprising pore forming agents.
Claim 26
Dependent Claim
13 words
The device of claim 24 wherein the pore forming agents are lyophilizable particles.
Claim 27
Dependent Claim
12 words
The device of claim 24 wherein the pore forming agents absorb water.
Claim 28
Dependent Claim
12 words
The device of claim 1 further comprising one or more active agents.
Claim 29
Dependent Claim
25 words
The device of claim 27 wherein the active agent is selected from the group consisting of growth factors, alginates, silver salts, antiseptics, analgesics, and preservatives.
Claim 30
Dependent Claim
159 words
A method for making a device that has a controlled degradation rate under physiological conditions, wherein the average molecular mass of the polymer decreases 20% to 50% over a ten week period in vivo or wherein the percent mass loss is greater than 5% over a six week period in vivo, comprising providing a biocompatible polyhydroxyalkanoate composition, as defined by claim 1 ; and forming or incorporating the polyhydroxyalkanoate composition into a device 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, skin substitutes, dural substitutes, bone graft substitutes, bone dowels, heart valves and vascular grafts, wound dressings, and hemostats.
Claim 31
Dependent Claim
38 words
The method of claim 29 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 32
Dependent Claim
14 words
The method of claim 29 further comprising incorporating an active agent into the polyhydroxyalkanoate.
References Cited (Backward Citations)
US4910145A
Cited
GB2166354A
Cited
US4826493A
Cited
US4792336A
Cited
US5334698A
Cited
US5306286A
Cited
US5534432A
Cited
US5512669A
Cited
US5250430A
Cited
US5480794A
Cited
EP0349505A2
Cited
EP0754467A1
Cited
US5834582A
Cited
US5502158A
Cited
US5085629A
Cited
US5271961A
Cited
US5124371A
Cited
US5705187A
Cited
EP0452111A2
Cited
US5711933A
Cited
EP0507554A1
Cited
US5236431A
Cited
US5480394A
Cited
US5551954A
Cited
US5876452A
Cited
US5646217A
Cited
US5443458A
Cited
EP0628586A1
Cited
WO1995003356A1
Cited
US5625030A
Cited
US5536564A
Cited
US5502116A
Cited
US5489470A
Cited
WO1995023250A1
Cited
WO1995033874A1
Cited
US5855619A
Cited
US5629077A
Cited
WO1996008535A1
Cited
US5563239A
Cited
US5814071A
Cited
US5824751A
Cited
WO1997007153A1
Cited
US5935506A
Cited
US5670161A
Cited
WO1998039453A1
Cited
WO1998048028A1
Cited
US5994478A
Cited
WO1998051812A2
Cited
US6245537B1
Cited
US6623749B2
Cited
US5876455A
Cited
WO1999032536A1
Cited
US6514515B1
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2008-01-04 | 2008-07-05 | 2009-01-04 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2012-01-04 | 2012-07-05 | 2013-01-04 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2016-01-04 | 2016-07-05 | 2017-01-04 | $7700.00 | Window Closed / Lapsed |