DK2970572T3 - Sammensætninger og indretninger af poly-4-hydroxybutyrat - Google Patents
Sammensætninger og indretninger af poly-4-hydroxybutyrat Download PDFInfo
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- DK2970572T3 DK2970572T3 DK14723154.2T DK14723154T DK2970572T3 DK 2970572 T3 DK2970572 T3 DK 2970572T3 DK 14723154 T DK14723154 T DK 14723154T DK 2970572 T3 DK2970572 T3 DK 2970572T3
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- p4hb
- polymer
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- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
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- Extraction Or Liquid Replacement (AREA)
Claims (15)
1. Sammensætning omfattende poly-4-hydroxybutyrat-polymer, sammensætningen har et lipidindhold på mindre end 100 ppm palmitinsyre som målt ved gaskromatografianalyse efter butanolyse.
2. Sammensætningen ifølge krav 1, med mindst én egenskab valgt fra gruppen bestående af: (i) et nitrogenindhold på 40 ppm eller derunder som bestemt ved Kjeldahl-fremgangsmåden af nitrogenanalyse; (ii) et carbonindhold på 55,81%±0,5% som bestemt ved elementær forbrændingsanalyse; og (iii) et hydrogenindhold på 7,02%±0,3% som bestemt ved elementær forbrændingsanalyse.
3. Sammensætningen ifølge krav 1 eller 2, hvor sammensætningen har: (a) et restopløsningsmiddelindhold på mindre end 5 ppm som bestemt ved head space-gaskromatografi-massespektrometri (GC-MS); (b) et 4-hydroxybutyrat-indhold i poly-4-hydroxybutyratet på 99,7 ± 2 vægtprocent som bestemt ved gaskromatografi; (c) en rest ved tænding på mindre end 0,2% som bestemt ved fremgangsmåden ifølge United States Pharmacopeia (USP) <281>; (d) et tungmetalindhold på mindre end 20 ppm som bestemt ved fremgangsmåden ifølge USP <231 >; eller (e) et svovlindhold på mindre end 50 ppm som bestemt ved plasma optisk emissionsspektroskopi.
4. Sammensætningen ifølge kravene 1 eller 2, hvor sammensætningen er fremstillet ved at vaske en biomasse omfattende polymeren med ethanol, fortrinsvis hvor biomassen er vasket med mindst 4 gram ethanol pr. gram biomasse og/eller hvor biomassen er afledt fra en mikroorganisme, såsom Escherichia Co I i Kl 2.
5. Sammensætningen ifølge krav 4, hvor polymeren er ekstraheret fra den ethanol-vaskede biomasse med et opløsningsmiddel, og eventuelt hvor polymeren er præcipiteret fra opløsningsmidlet med et ikke-opløsningsmiddel for polymeren, høstet, og tørret.
6. Sammensætningen ifølge krav 5, hvor opløsningsmidlet er valgt fra gruppen bestående af methylenchlorid, chloroform, tetrahydrofuran, acetone, dioxan, ethylacetat, dimethylencarbonat, dimethylsulfoxid, dimethylformamid, methylethylketon, butylacetat, butylpropionat og diethylcarbonat.
7. Sammensætningen ifølge krav 5, hvor ikke-opløsningsmidlet til polymeren er en alkohol; vandig alkohol, såsom vandig ethanol, eller vand.
8. Sammensætningen ifølge krav 7, hvor ikke-opløsningsmidlet for polymeren omfatter ethanol, og ethanol er anvendt til at vaske biomassen.
9. Sammensætningen ifølge krav 1 eller 2, hvor sammensætningen anvendes til at danne en lægemiddelindretning med et pyrogenniveau på mindre end 20 endotoxin-enheder pr. indretning som bestemt ved limulus amebocyte lysate assay.
10. Lægemiddelindretning dannet ifølge krav 9, hvor indretningen er steriliseret med kold ethylenoxidgas, gamma-stråling, eller elektronstrålebestråling.
11. Lægemiddelindretningen ifølge krav 10, hvor indretningen anvendes til blød-eller hårdvævsreparation, regenerering eller erstatning, og eventuelt hvor indretningen er et implantat til blød- eller hårdvævsreparation, regenerering eller erstatning.
12. Sammensætningen ifølge krav 1 eller 2, hvor sammensætningen anvendes som en coating på en lægemiddelindretning.
13. Lægemiddelindretningen ifølge krav 10, hvor indretningen er valgt fra gruppen: sutur, modhagesutur, flettet sutur, monofilamentsutur, hybridsutur af monofilament- og multifilamentfibre, snoninger, ligaturer, strikkede eller vævede tråde, strikkede rør, katetre, monofilamenttråde, multifilamenttråde, plastre, sårhelingsindretninger, bandage, sårforbindinger, brandsårsforbindinger, bandage til kronisk sår, hudsubstitut, hemostat, luftrørsrekonstruktionsindretning, organ salvageindretning, dural substitut, dural patch, nerveguide, nerveregeneration eller reparationsindretning, brok reparationsindretning, brok trådnet, hernia plug, indretning til temporært sår- eller vævsstøtte, vævskonstruktions scaffold, guided vævsreparations/regenerationsindretning, anti-adhæsionsmembran, adhæsionsbarriere, vævsseparationsmembran, retentionsmembran, slynge, indretning til bækkenbundrekonstruktion, urinrørsuspensionsindretning, indretning til behandling af urininkontinens, indretning til behandling af vesicoureteral reflux, blærereparationsindretning, lukkemuskel-reparationsindretning, injicerbare partikler, injicerbare mikrosfærer, bulk- eller fyldeindretning, knoglemarvscaffold, clips, klemme, skrue, tap, negl, benpibenegl, knogleplade, interferensskrue, syning, fastgørelsesmiddel, nagle, hæfteklamme, fixationsindretning til et implantat, knogletransplantationssubstitut, knogletomrumsfyldstof, suturforankring, knogleforankring, ligament-reparationsindretning, ligamentforøgelsesindretning, ligamenttransplantation, forreste krydsligament reparationsindretning, sene-reparationsindretning, sene-transplantation, seneforøgelsesindretning, drejemuskel- reparationsindretning, meniscus-reparationsindretning, meniscus-regenerationsindretning, kunstig bruskreparationsindretning, osteochondral reparationsindretning, spinal fusionsindretning, indretning til behandling af osteoarthritis, viscosupplement, stent, herunder hjerte, kardiovaskulær, perifer, urinleder, urinrør, urologi, gastroenterologi, nasale, okulære, eller neurologiske stents og stent-coatinger, stent-transplantation, kardiovaskulærklap, ballonkateter, vaskulær lukkeindretning, intrakardial septal defekt reparationsindretning, omfattende men ikke begrænset til atrial septal defekt reparationsindretninger og PFO (patent foramen ovale) lukkeindretninger, venstre atrial appendage (LAA) lukkeindretning, pericardia I klap, veneventil, hjerteventil, vaskulær transplantation, myokardial regenerationsindretning, periodontal trådnet, ført vævsregenerationsmembran til periodontalvæv, okulært celleimplantat, billeddannelsesindretning, øresneglimplantat, embolisationsindretning, anastomoseindretning, celle-podeindretning, celleindkapslingsindretning, styret frigivelsesindretning, lægemiddelindgivelsesindretning, plastisk-kirurgisk indretning, brystløfte-indretning, mammaplastikindretning, brystrekonstruktionsindretning, brystforøgelsesindretning (herunder indretninger til anvendelse med brystimplantater), brystreduktionsindretning (herunder indretninger til at fjerne, gendanne og reorientere brystvæv), indretninger til brystrekonstruktion efterfulgt af mastektomi med eller uden brystimplantater, ansigts-rekonstruktionsindretning, pandeløfteindretning, øjenbrynløfteindretning, øjenlågløfteindretning, ansigtsløfteindretning, rhytidectomiindretning, gevindløfteindretning (til at løfte og støtte nedsynkningsområder af ansigt, pande og hals), rhinoplastiindretning, indretning til kindbenforøgelse, otoplastiindretning, halsløfteindretning, mento-plastiindretning, kosmetisk reparationsindretning, og indretning til ansigts-ar-revision.
14. Sammensætningen ifølge krav 1, hvor P4HB produceres af en mikroorganisme og oprenses fra en biomasse.
15. Sammensætningen ifølge krav 1 eller 14, hvor P4HB har en vægtgennemsnitsmolekylvægt, som målt ved gelpermeations-kromatografi (GPC) i forhold til polystyren, fra 20 kDa til 1200 kDa, mere fortrinsvis 50 kDa til 800 kDa og endnu mere fortrinsvis fra 200 kDa til 500 kDa.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US13/801,393 US9290612B2 (en) | 2013-03-13 | 2013-03-13 | Compositions and devices of poly-4-hydroxybutyrate |
| PCT/US2014/023373 WO2014164741A1 (en) | 2013-03-13 | 2014-03-11 | Compositions and devices of poly-4-hydroxybutyrate |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2970572T3 true DK2970572T3 (da) | 2017-06-06 |
Family
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| DK14723154.2T DK2970572T3 (da) | 2013-03-13 | 2014-03-11 | Sammensætninger og indretninger af poly-4-hydroxybutyrat |
| DK17158763.7T DK3205683T3 (da) | 2013-03-13 | 2014-03-11 | Sammensætninger og indretninger af poly-4-hydroxybutyrat |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK17158763.7T DK3205683T3 (da) | 2013-03-13 | 2014-03-11 | Sammensætninger og indretninger af poly-4-hydroxybutyrat |
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| US (2) | US9290612B2 (da) |
| EP (2) | EP3205683B1 (da) |
| CA (1) | CA2905765C (da) |
| DK (2) | DK2970572T3 (da) |
| ES (2) | ES2629282T3 (da) |
| PL (1) | PL3205683T3 (da) |
| PT (2) | PT3205683T (da) |
| WO (1) | WO2014164741A1 (da) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9290612B2 (en) * | 2013-03-13 | 2016-03-22 | Tepha, Inc. | Compositions and devices of poly-4-hydroxybutyrate |
| US9480780B2 (en) * | 2013-11-05 | 2016-11-01 | Tepha, Inc. | Compositions and devices of poly-4-hydroxybutyrate |
| US10364319B2 (en) | 2015-04-10 | 2019-07-30 | Colorado State University Research Foundation | Ring-opening polymerization methods and recyclable biorenewable polyesters |
| US12402885B2 (en) | 2017-09-23 | 2025-09-02 | Universität Zürich | Medical occlusion device |
| EP3459469A1 (en) | 2017-09-23 | 2019-03-27 | Universität Zürich | Medical occluder device |
| CN107596456A (zh) * | 2017-10-11 | 2018-01-19 | 广州新诚生物科技有限公司 | 一种具有止血功能的生物医用膜及其制备方法 |
| GB2568526A (en) * | 2017-11-20 | 2019-05-22 | Rebio Tech Oy | Composition |
| EP3720514B1 (en) | 2017-12-04 | 2022-04-13 | Tepha, Inc. | Vacuum membrane thermoformed poly-4-hydroxybutyrate medical implants |
| CA3102277C (en) | 2018-06-11 | 2024-11-12 | Tepha, Inc. | PROCESSES FOR 3D PRINTING POLY-4-HYDROXYBUTYRATE AND COPOLYMERS |
| WO2021059273A2 (en) | 2019-09-26 | 2021-04-01 | Universitat Zurich | Left atrial appendage occlusion devices |
| WO2021191833A1 (en) | 2020-03-25 | 2021-09-30 | Universitat Zurich | Medical occluder delivery systems |
| EP4153654B1 (en) | 2020-05-18 | 2024-04-03 | Venvirotech Biotechnology SL. | Process for isolating pha from a pha-rich bacterial biomass |
| CA3213145A1 (en) | 2021-03-11 | 2022-09-15 | Tepha, Inc. | Breast reconstruction implant |
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| CA1334430C (en) | 1989-04-06 | 1995-02-14 | Claude Chavarie | Separation of poly-.beta.-hydroxyalkanoic acids from microbial biomass |
| DE3937649A1 (de) | 1989-11-11 | 1991-05-16 | Boehringer Ingelheim Kg | Polyester auf der basis von 4-hydroxyalkansaeuren und verfahren zu ihrer herstellung |
| US5942597A (en) | 1995-08-21 | 1999-08-24 | The Procter & Gamble Company | Solvent extraction of polyhydroxyalkanoates from biomass |
| US5811272A (en) | 1996-07-26 | 1998-09-22 | Massachusetts Institute Of Technology | Method for controlling molecular weight of polyhydroxyalkanoates |
| EP0975788A1 (en) | 1997-04-15 | 2000-02-02 | Monsanto Company | Methods of pha extraction and recovery using non-halogenated solvents |
| US6087471A (en) | 1997-04-15 | 2000-07-11 | Monsanto Company | High temperature PHA extraction using PHA-poor solvents |
| US6610764B1 (en) | 1997-05-12 | 2003-08-26 | Metabolix, Inc. | Polyhydroxyalkanoate compositions having controlled degradation rates |
| US6867248B1 (en) | 1997-05-12 | 2005-03-15 | Metabolix, Inc. | Polyhydroxyalkanoate compositions having controlled degradation rates |
| ATE354600T1 (de) * | 1997-05-12 | 2007-03-15 | Metabolix Inc | Polyhydroxyalkanoate für in vivo anwendungen |
| US6828357B1 (en) | 1997-07-31 | 2004-12-07 | Metabolix, Inc. | Polyhydroxyalkanoate compositions having controlled degradation rates |
| US6309659B1 (en) | 1997-09-02 | 2001-10-30 | Gensci Orthobiologics, Inc. | Reverse phase connective tissue repair composition |
| ES2281147T3 (es) | 1997-12-22 | 2007-09-16 | Metabolix, Inc. | Composiciones de polihidroxialcanoato con tasas controladas de degradacion. |
| AU778081B2 (en) | 1999-03-25 | 2004-11-11 | Tepha, Inc. | Medical devices and applications of polyhydroxyalkanoate polymers |
| US7025980B1 (en) | 1999-09-14 | 2006-04-11 | Tepha, Inc. | Polyhydroxyalkanoate compositions for soft tissue repair, augmentation, and viscosupplementation |
| DE10013514C2 (de) | 2000-03-14 | 2002-06-27 | Ufz Leipzighalle Gmbh | Verfahren zur Gewinnung von Polyhydroxyalkanoaten (PHA) oder deren Copolymeren |
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| PT1638615E (pt) | 2003-05-08 | 2015-02-04 | Tepha Inc | Fibras e tecidos médicos de polihidroxialcanoato |
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| US7435567B2 (en) | 2004-03-04 | 2008-10-14 | Kaneka Corporation | Method for degradation of nucleic acids and use thereof |
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| ES2624589T3 (es) | 2006-02-07 | 2017-07-17 | Tepha, Inc. | Métodos y dispositivos para la reparación del manguito de los rotadores |
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| WO2009085823A1 (en) | 2007-12-19 | 2009-07-09 | Tepha, Inc. | Medical devices containing melt-blown non-wovens of poly-r-hydroxybutyrate and copolymers |
| CN102781901B (zh) | 2010-02-11 | 2016-08-03 | 梅塔玻利克斯公司 | 用于从经遗传修饰的聚羟基链烷酸酯生物质制备单体组分的方法 |
| EP2558133B1 (en) | 2010-03-26 | 2020-01-22 | Tepha, Inc. | Coatings for the manufacture and application of polyhydroxyalkanoate medical devices |
| EP2582866B1 (en) | 2010-06-15 | 2014-09-17 | Tepha, Inc. | Medical devices containing dry spun non-wovens of poly-4-hydroxybutyrate and copolymers |
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| BR112014002859A2 (pt) | 2011-08-10 | 2017-06-13 | Metabolix Inc | purificação pós-processamento para produção de gama-butiro lactona |
| US9290612B2 (en) * | 2013-03-13 | 2016-03-22 | Tepha, Inc. | Compositions and devices of poly-4-hydroxybutyrate |
| US9480780B2 (en) * | 2013-11-05 | 2016-11-01 | Tepha, Inc. | Compositions and devices of poly-4-hydroxybutyrate |
-
2013
- 2013-03-13 US US13/801,393 patent/US9290612B2/en active Active
-
2014
- 2014-03-11 PT PT171587637T patent/PT3205683T/pt unknown
- 2014-03-11 EP EP17158763.7A patent/EP3205683B1/en active Active
- 2014-03-11 ES ES14723154.2T patent/ES2629282T3/es active Active
- 2014-03-11 DK DK14723154.2T patent/DK2970572T3/da active
- 2014-03-11 PL PL17158763T patent/PL3205683T3/pl unknown
- 2014-03-11 EP EP14723154.2A patent/EP2970572B1/en active Active
- 2014-03-11 PT PT147231542T patent/PT2970572T/pt unknown
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- 2014-03-11 DK DK17158763.7T patent/DK3205683T3/da active
- 2014-03-11 CA CA2905765A patent/CA2905765C/en active Active
- 2014-03-11 WO PCT/US2014/023373 patent/WO2014164741A1/en not_active Ceased
-
2016
- 2016-02-11 US US15/041,370 patent/US20160158402A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| PL3205683T3 (pl) | 2020-11-02 |
| CA2905765C (en) | 2020-07-21 |
| CA2905765A1 (en) | 2014-10-09 |
| ES2805785T3 (es) | 2021-02-15 |
| DK3205683T3 (da) | 2020-07-06 |
| WO2014164741A1 (en) | 2014-10-09 |
| EP2970572B1 (en) | 2017-04-19 |
| US9290612B2 (en) | 2016-03-22 |
| US20160158402A1 (en) | 2016-06-09 |
| US20140275325A1 (en) | 2014-09-18 |
| ES2629282T3 (es) | 2017-08-08 |
| PT3205683T (pt) | 2020-07-14 |
| EP2970572A1 (en) | 2016-01-20 |
| PT2970572T (pt) | 2017-07-04 |
| EP3205683B1 (en) | 2020-04-22 |
| EP3205683A1 (en) | 2017-08-16 |
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