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US6623749B2 Expired / Lapsed US ⏱️ 0.0 years remaining

Medical device containing polyhydroxyalkanoate treated with oxidizing agent to remove endotoxin

Assignee: Tepha Inc
•
Filing: 2001-03-28
•
Granted: 2003-09-23
•
Expires: 2021-03-28
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Abstract

Abstract Polyhydroxyalkanoate (PHA) that contains a pyrogen such as an endotoxin due to a process of producing the PHA is treated to remove the pyrogen by a process that does not affect the inherent chemical and physical properties of the PHA to obtain a biocompatible PHA. PHA produced by fermentation with a Gram negative bacteria can be treated with an oxidizing agent such as hydrogen peroxide or benzoyl peroxide to reduce the endotoxin content to less than 20 endotoxin units/gram of PHA to produce PHA that does not elicit an acute inflammatory response when implanted in an animal. The PHA may have a melting point or glass transition temperature less than 136° C., and can be chemically modified or derivatized such as by covalently coupling an attachment or targeting molecule. The PHA may be used to form various medical devices, and can be used for in vivo applications including tissue coatings, stents, sutures, tubing, bone and other prostheses, bone and tissue cements, issue regenerating devices, wound dressings, drug delivery, and diagnostic and prophylactic uses.

Inventors

  • 👤 Simon F. Williams
  • 👤 David P. Martin
  • 👤 Tillman Gerngross
  • 👤 Daniel M. Horowitz

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-25 04:10
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: 18
Claim 1
Independent Claim 78 words
A biocompatible medical device comprising a polyhydroxyalkanoate which does not elicit an acute inflammatory response when implanted into an animal, wherein the polyhydroxyalkanoate is prepared by a process that introduces pyrogen into the polyhydroxyalkanoate such that the polyhydroxyalkanoate contains an endotoxin and the endotoxin is removed to less than 20 units/grain of polyhydroxyalkanoate by treating the polyhydroxyalkanoate with an oxidizing agent to remove the endotoxin but not to adversely affect the polybydroxyalkanoate's inherent chemical structures and physical properties.
Claim 2
Dependent Claim 78 words
A biocompatible medical device comprising a polyhydroxyalkanoate which does not elicit an acute inflammatory response when implanted into an animal, wherein the polyhydroxyalkanoate is prepared by a process that introduces pyrogen into the polyhydroxyalkanoate such that the polyhydroxyalkanoate contains an endotoxin and the endotoxin is removed to less than 20 units/grain of polyhydroxyalkanoate by treating the polyhydroxyalkanoate with an oxidizing agent to remove the endotoxin but not to adversely affect the polybydroxyalkanoate's inherent chemical structures and physical properties.
Claim 3
Dependent Claim 27 words
The device 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 4
Dependent Claim 33 words
The device of claim 1 wherein the device is in a form selected from the group consisting of tissue regeneration devices, cell culture devices, vascular grafts, wound dressings, and cell or tissue coatings.
Claim 5
Dependent Claim 24 words
The device of claim 1 wherein the device is in a form selected from the group consisting of drug, diagnostic or prophylactic delivery devices.
Claim 6
Dependent Claim 12 words
The device of claim 1 wherein the device is a porous membrane.
Claim 7
Dependent Claim 16 words
The device of claim 1 wherein the device is in the form of microparticles or nanoparticles.
Claim 8
Dependent Claim 22 words
The device of claim 1 wherein the device comprises a material selected from the group consisting of therapeutic, prophylactic and diagnostic agents.
Claim 9
Dependent Claim 33 words
The device of claim 7 wherein the device comprises a therapeutic agent selected from the group consisting of peptides and proteins, nucleic acids, saccharides and polysaccharides, lipids, synthetic drug molecules, and imaging agents.
Claim 10
Dependent Claim 15 words
The device claim 1 wherein the device is formulated for administration to a mucosal surface.
Claim 11
Dependent Claim 14 words
The device of claim 1 wherein the polyhydroxyalkanoate is a polymer blend or copolymer.
Claim 12
Dependent Claim 43 words
The device of claim 1 wherein molecules are bound to the polymer, 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 particle.
Claim 13
Dependent Claim 21 words
The device of claim 1 wherein the device is for tissue engineering further comprising cells seeded onto or within the device.
Claim 14
Dependent Claim 14 words
The device of claim 1 wherein the device is formed into a bone prosthesis.
Claim 15
Dependent Claim 16 words
The device of claim 1 further comprising structural and adhesive materials to form a bone cement.
Claim 16
Dependent Claim 25 words
The device of claim 1 in the form of a heart prosthetic selected from the group consisting of heart valves, heart leaflets, and heart annulus.
Claim 17
Dependent Claim 12 words
The device of claim 1 in the form of a periodontal graft.
Claim 18
Dependent Claim 12 words
The device of claim 1 in the form of a pericardial patch.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2006-09-22 2007-03-24 2007-09-23 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2010-09-22 2011-03-24 2011-09-23 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2014-09-22 2015-03-24 2015-09-23 $7700.00 Window Closed / Lapsed

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