DK2771027T3 - Hæmostatiske sammensætninger - Google Patents
Hæmostatiske sammensætninger Download PDFInfo
- Publication number
- DK2771027T3 DK2771027T3 DK12778721.6T DK12778721T DK2771027T3 DK 2771027 T3 DK2771027 T3 DK 2771027T3 DK 12778721 T DK12778721 T DK 12778721T DK 2771027 T3 DK2771027 T3 DK 2771027T3
- Authority
- DK
- Denmark
- Prior art keywords
- gelatin
- weight
- composition
- hemostatic
- hemostatic composition
- Prior art date
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Claims (14)
1. Hæmostatisk sammensætning omfattende tværbunden gelatine i partikelform egnet til anvendelse ved hæmostase, hvor sammensætningen foreligger i form af en pasta, der indeholder 15,0 til 19,5 vægt% tværbunden gelatine, fortrinsvis 16,0 til 19,5 vægt%, 16,5 til 19,5vægt%, 17,0 til 18,5 vægt% eller 17,5 til 18,5vægt%, mere foretrukket 16,5 til 19,0 vægt% eller 16,8 til 17,8 vægt% og især 16,5 til 17,5 vægt%, og hvor sammensætningen omfatter et ekstrusionsfremmende middel, idet det ekstrusionsfremmende middel er albumin i en mængde mellem 0,5 og 5,0 vægt%.
2. Hæmostatisk sammensætning ifølge krav 1, hvori det ekstrusionsfremmende middel er albumin i en mængde mellem 1,0 og 5,0 vægt%, fortrinsvis 2,0 til 4,5 vægt%, mere foretrukket 1,5 til 5,0 vægt% og især ca. 1,5 vægt%.
3. Hæmostatisk sammensætning ifølge krav 1 til 2, hvori den tværbundne gelatine er glutaraldehyd-tværbunden gelatine eller genipin-tværbunden gelatine.
4. Hæmostatisk sammensætning ifølge et hvilket som helst af kravene 1 til 3, hvori den tværbundne gelatine er gelatine type B.
5. Hæmostatisk sammensætning ifølge et hvilket som helst af kravene 1 til 4, hvori den tværbundne gelatine foreligger som granuløst materiale.
6. Hæmostatisk sammensætning ifølge et hvilket som helst af kravene 1 til 5, hvori den tværbundne gelatine har en partikelstørrelse på 100 til 1000 pm, fortrinsvis 200 til 800 pm og især 350 til 550 pm.
7. Hæmostatisk sammensætning ifølge et hvilket som helst af kravene 1 til 6, hvor sammensætningen indeholder thrombin, fortrinsvis 10 til 1000 I.E. thrombin/ml, især 250 til 700 I.E. thrombin/ml.
8. Hæmostatisk sammensætning ifølge et hvilket som helst af kravene 1 til 7 til anvendelse ved behandling af en læsion valgt fra gruppen bestående af et sår, en blødning, skadet væv, blødende væv og/eller knogledefekter.
9. Sæt til fremstilling af en flydedygtig pasta af tværbunden gelatine til behandling af en læsion valgt fra gruppen bestående af et sår, en blødning, skadet væv og/eller blødende væv omfattende a) en tør hæmostatisk sammensætning omfattende tværbunden gelatine i partikelform til rekonstitution til en flydedygtig pasta, som indeholder 15,0 til 19,5 vægt% tværbunden gelatine, fortrinsvis 16,0 til 19,5vægt%, 16,5 til 19,5vægt%, 17,0 til 18,5 vægt% eller 17,5 til 18,5 vægt%, mere foretrukket 16,5 til 19,0 vægt% eller 16,8 til 17,8 vægt% og især 16,5 til 17,5 vægt%, og b) et farmaceutisk acceptabelt fortyndingsmiddel til rekonstitution af den hæmostatiske sammensætning, hvori enten sammensætningen eller fortyndingsmidlet omfatter albumin i en mængde, som fører til en albuminkoncentration i den rekonstituerede pasta mellem 0,5 og 5,0 vægt%, fortrinsvis 1,0 til 5,0 vægt%, fortrinsvis 2,0 til 4,5 vægt%, mere foretrukket 1,5 til 5,0 vægt% og især ca. 1,5 vægt%.
10. Sæt ifølge krav 9, hvori det farmaceutisk acceptable fortyndingsmiddel omfatter en puffer eller et puffersystem, fortrinsvis ved en pH-værdi på 3,0 til 10,0.
11. Sæt ifølge krav 9 eller 10, hvori det farmaceutisk acceptable fortyndingsmiddel omfatter thrombin, fortrinsvis 10 til 1000 I.E. thrombin/ml, især 250 til 700 I.E. thrombin/ml.
12. Sæt ifølge et hvilket som helst af kravene 9 til 11, hvori det farmaceutisk acceptable fortyndingsmiddel indeholder et stof valgt fra gruppen bestående af NaCI, CaCb og natriumacetat.
13. Fremgangsmåde til tilvejebringelse af en brugsfærdig form af en hæmostatisk sammensætning ifølge et hvilket som helst af kravene 1 til 7, ved hvilken den hæmostatiske sammensætning tilvejebringes i en første sprøjte, og et fortyndingsmiddel til rekonstitution tilvejebringes i en anden sprøjte, den første og den anden sprøjte forbindes med hinanden, og fluidet bringes ind i den første sprøjte for at danne en flydedygtig form af den hæmostatiske sammensætning; og eventuelt tilbageføring af den flydedygtige form af den hæmostatiske sammensætning til den anden sprøjte mindst én gang.
14. Fremgangsmåde ifølge krav 13, ved hvilken den flydedygtige form af den hæmostatiske sammensætning indeholder partikler, hvoraf mere end 50 vægt% har en størrelse på 100 til 1000 pm, fortrinsvis mere end 80 vægt% har en størrelse på 100 til 1000 pm.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
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| US201161552270P | 2011-10-27 | 2011-10-27 | |
| PCT/EP2012/071136 WO2013060770A1 (en) | 2011-10-27 | 2012-10-25 | Hemostatic compositions |
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| DK2771027T3 true DK2771027T3 (da) | 2015-11-02 |
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| DK12778721.6T DK2771027T3 (da) | 2011-10-27 | 2012-10-25 | Hæmostatiske sammensætninger |
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| WO2009109194A2 (en) | 2008-02-29 | 2009-09-11 | Ferrosan A/S | Device for promotion of hemostasis and/or wound healing |
| ES2553702T3 (es) | 2011-10-27 | 2015-12-11 | Baxter International Inc | Composiciones hemostáticas |
| JP6241624B2 (ja) * | 2012-03-06 | 2017-12-06 | フェロサン メディカル デバイシーズ エイ／エス | 止血ペーストを収容する加圧容器 |
| CN104349797B (zh) | 2012-06-12 | 2017-10-27 | 弗罗桑医疗设备公司 | 干止血组合物 |
| EP3010419B1 (en) | 2013-06-21 | 2020-05-20 | Ferrosan Medical Devices A/S | Vacuum expanded dry composition and syringe for retaining same |
| EP3079731B1 (en) | 2013-12-11 | 2018-08-08 | Ferrosan Medical Devices A/S | Dry composition comprising an extrusion enhancer |
| CN105412975B (zh) | 2014-09-18 | 2019-05-31 | 苏州安德佳生物科技有限公司 | 一种生物相容性止血制品及其制备方法 |
| JP6726852B2 (ja) | 2014-10-13 | 2020-07-22 | フェッローサン メディカル ディバイス エー／エス | 止血および創傷治癒に使用するための乾燥組成物 |
| RU2705905C2 (ru) | 2014-12-24 | 2019-11-12 | Ферросан Медикал Дивайсиз А/С | Шприц для удерживания и смешивания первого и второго веществ |
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- 2012-10-25 KR KR1020147013752A patent/KR101975624B1/ko active Active
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