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US7244442B2
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Method for making devices using polyhydroxyalkanoate having pyrogen removed
Assignee: Tepha Inc
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Filing: 2003-08-15
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Granted: 2007-07-17
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Expires: 2023-08-15
Abstract
Abstract Polyhydroxyalkanoates (PHAs) from which pyrogen has been removed are provided for use in numerous biomedical applications. PHAs which have been chemically modified to enhance physical and/or chemical properties, for targeting or to modify biodegradability or clearance by the reticuloendothelial system (RES), are described. Methods for depyrogenating PHA polymers prepared by bacterial fermentation processes are also provided, wherein pyrogens are removed from the polymers without adversely impacting the polymers' inherent chemical structures and physical properties. PHAs with advantageous processing characteristics, including low melting points and/or solubility in non-toxic solvents, are also described. PHAs are provided which are suitable for use in in vivo applications such as in tissue coatings, stents, sutures, tubing, bone and other prostheses, bone or tissue cements, tissue regeneration devices, wound dressings, drug delivery, and for diagnostic and prophylactic uses. Properties which are selected for include degradability, elasticity, inclusion of functional groups or derivatized groups, which can in turn be used to attach targeting agents, and bioadhesion.
Inventors
- 👤 Simon F. Williams
- 👤 David P. Martin
- 👤 Tillman Gerngross
- 👤 Daniel M. Horowitz
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 08:25
CPC Classifications
C; C12; C12P; C12P7/00; C12P7/62; C12P7/625; A; A61; A61B; A61B42/00; A61K; A61K47/00; A61K47/50; A61K47/51; A61K47/56; A61K47/59; A61K47/593; A61K47/69; A61K47/6957; A61L; A61L15/00; A61L15/16; A61L15/22; A61L15/26; A61L17/00; A61L17/06; A61L17/10; A61L27/00; A61L27/14; A61L27/18; A61L27/28; A61L27/34; A61L29/00; A61L29/04; A61L29/06; A61L31/00; A61L31/04; A61L31/06; A61P; A61P17/00; A61P17/02; A61P19/00; A61P19/08; A61P9/00; C08; C08G; C08G63/00; C08G63/02; C08G63/06; C08G63/68; C08G63/685; C08G63/6852; C08G63/688; C08G63/6882; C08G63/91; C08G63/912; C12N; C12N5/00; C12N5/0068; A61B17/00; A61B17/04; A61B17/06; A61B17/06166; C12N2533/00; C12N2533/30; Y; Y10; Y10S; Y10S977/00; Y10S977/70; Y10S977/773; Y10S977/775; Y10T; Y10T428/00; Y10T428/13; Y10T428/1352; Y10T428/139
Claims Analysis
Total Claims: 26
Claim 1
Independent Claim
77 words
A method of forming a biocompatible medical device comprising selecting a polyhydroxyalkanoate, which is prepared using a process which introduces a pyrogen into the polyhydroxyalkanoate, removing the pyrogen from the polyhydroxyalkanoate from the polyhydroxyalkanoate to produce a pyrogen level of less than 20 endotoxin units (EU) per device by exposing the polyhydroxyalkanoate to an oxidizing agent and/or hydrolysis, so that the polyhydroxyalkanoate does not elicit a pyrogenic response when implanted into an animal, and forming the device.
Claim 2
Independent Claim
77 words
A method of forming a biocompatible medical device comprising selecting a polyhydroxyalkanoate, which is prepared using a process which introduces a pyrogen into the polyhydroxyalkanoate, removing the pyrogen from the polyhydroxyalkanoate from the polyhydroxyalkanoate to produce a pyrogen level of less than 20 endotoxin units (EU) per device by exposing the polyhydroxyalkanoate to an oxidizing agent and/or hydrolysis, so that the polyhydroxyalkanoate does not elicit a pyrogenic response when implanted into an animal, and forming the device.
Claim 3
Dependent Claim
20 words
The method of claim 1 wherein the pyrogen level is less than 20 endotoxin units (EU) per gram of polyhydroxyalkanoate.
Claim 4
Dependent Claim
93 words
The method of claim 1 wherein the polyhydroxyalkanoate includes at least one monomeric unit of the formula —OCR1R2(CR3R4)nCO— wherein n is an integer between one and 15; and wherein R1, R2, R3, and R4 are independently selected from the group consisting of hydrogen, methyl, C2–15 straight, branched or cyclic alkyl, alkenyl or alkynyl groups, alkaryl groups, aralkyl groups, heteroalkyl groups, heteroaryl groups, hydroxy groups, thiol groups, disulfides, ether groups, thiolether groups, ester groups, carboxylic acid groups, amine groups, amide groups, halogens, nitrogen-substituted radicals, and oxygen-substituted radicals, and the polyhydroxyalkanoate has been chemically modified.
Claim 5
Dependent Claim
27 words
The method of claim 1 wherein the device is in a form selected from the group consisting of stents, coatings on prosthetic devices, sutures, staples, and tubing.
Claim 6
Dependent Claim
31 words
The method of claim 1 wherein the device is in a form selected from the group consisting of tissue regeneration devices, cell culture devices, wound dressings, arid cell or tissue coatings.
Claim 7
Dependent Claim
12 words
The method of claim 1 wherein the device is a porous membrane.
Claim 8
Dependent Claim
16 words
The method of claim 1 wherein the device is in the form of microparticles or nanoparticles.
Claim 9
Dependent Claim
22 words
The method of claim 1 wherein the device comprises a material selected from the group consisting of therapeutic, prophylactic and diagnostic agents.
Claim 10
Dependent Claim
31 words
The method of claim 8 , wherein the therapeutic agent is selected from the group consisting of peptides and proteins, nucleic acids, saccharides, polysaccharides, lipids, synthetic drug molecules, and imaging agents.
Claim 11
Dependent Claim
16 words
The method of claim 8 wherein the device is formulated for administration to a mucosal surface.
Claim 12
Dependent Claim
14 words
The method of claim 1 wherein the polyhydroxyalkanoate is a polymer blend or copolymer.
Claim 13
Dependent Claim
16 words
The method of claim 11 wherein the polyhydroxyalkanoate is blended or copolymerized with a biodegradable polymer.
Claim 14
Dependent Claim
19 words
The method of claim 11 wherein the polyhydroxyalkanoate is blended with a second polymer which is not a polyhydroxyalkanoate.
Claim 15
Dependent Claim
43 words
The method of claim 1 wherein molecules are bound to the polyhydroxyalkanoate, and the molecules are selected from the group consisting of molecules which are bioactive, molecules which can be detected, targeting molecules, and molecules affecting charge, lipophilicity or hydrophilicity of the polyhydroxyalkanoate.
Claim 16
Dependent Claim
28 words
The method of claim 14 wherein the targeting molecule is selected from the group consisting of compounds specifically reactive with a cell surface component, antibodies and antibody fragments.
Claim 17
Dependent Claim
17 words
The method of claim 1 wherein the polyhydroxyalkanoate is modified to decrease uptake by the reticuloendothelial system.
Claim 18
Dependent Claim
22 words
The method of claim 1 wherein the device is for tissue engineering and further comprising seeding cells onto or within the device.
Claim 19
Dependent Claim
15 words
The method of claim 1 further comprising implanting the device into a human or animal.
Claim 20
Dependent Claim
17 words
The method of claim 18 wherein the device is implanted on tissue to form a skin equivalent.
Claim 21
Dependent Claim
15 words
The method of claim 18 , wherein the device is formed into a bone prosthesis.
Claim 22
Dependent Claim
25 words
The method of claim 20 wherein filler materials are mixed with the polyhydroxyalkanoate in an amount effective to enhance the strength of the bone prosthesis.
Claim 23
Dependent Claim
19 words
The method of claim 1 further comprising mixing the polyhydroxyalkanoate structural and adhesive materials to form a bone cement.
Claim 24
Dependent Claim
20 words
The method of claim 1 wherein the polyhydroxyalkanoate has a melting point or glass transition temperature less than 136° C.
Claim 25
Independent Claim
52 words
A method of forming a biocompatible medical device comprising selecting a polyhydroxyalkanoate which is prepared using a process which introduces a pyrogen into the polyhydroxyalkanoate, removing the pyrogen so that the polyhydroxyalkanoate has less than 6 endotoxin units (EU) per gram of polyhydroxyalkanoate when implanted into an animal, and forming the device.
Claim 26
Independent Claim
52 words
A method of forming a biocompatible medical device comprising selecting a polyhydroxyalkanoate which is prepared using a process which introduces a pyrogen into the polyhydroxyalkanoate, removing the pyrogen so that the polyhydroxyalkanoate has less than 6 endotoxin units (EU) per gram of polyhydroxyalkanoate when implanted into an animal, and forming the device.
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| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 7.5 Years (Year 8) | 2014-07-16 | 2015-01-15 | 2015-07-17 | $3760.00 | Window Closed / Lapsed |
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