ME00587B - Nosač sa čvrstim fibrinogenom i čvrstim trombinom - Google Patents

Nosač sa čvrstim fibrinogenom i čvrstim trombinom

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Publication number
ME00587B
ME00587B MEP-2009-24A MEP2409A ME00587B ME 00587 B ME00587 B ME 00587B ME P2409 A MEP2409 A ME P2409A ME 00587 B ME00587 B ME 00587B
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Montenegro
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thrombin
fibrinogen
carrier
acid
solid
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MEP-2009-24A
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English (en)
French (fr)
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Dagmar Stimmeder
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Takeda As
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Publication of ME00587B publication Critical patent/ME00587B/me
Publication of ME00587A publication Critical patent/ME00587A/xx

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    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
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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
    • A61L15/225—Mixtures of macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32—Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • A61L15/325—Collagen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/425—Porous materials, e.g. foams or sponges
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    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
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    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/043—Proteins; Polypeptides; Degradation products thereof
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    • A—HUMAN NECESSITIES
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/043—Proteins; Polypeptides; Degradation products thereof
    • A61L31/046—Fibrin; Fibrinogen
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
    • A—HUMAN NECESSITIES
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    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08H—DERIVATIVES OF NATURAL MACROMOLECULAR COMPOUNDS
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    • C08H1/06—Macromolecular products derived from proteins derived from horn, hoofs, hair, skin or leather
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    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L89/00—Compositions of proteins; Compositions of derivatives thereof
    • C08L89/04—Products derived from waste materials, e.g. horn, hoof or hair
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    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
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Abstract

Ovaj se pronalazak odnosi na jednu čvrstu kompozicijupogodnu za lepljenje tkiva, zatvaranje tkiva i za hemostazu koja se, u suštini,sastoji od a) jednog nosača koji ima bar jedno od sledećih fizičkih svojstava:modul elastičnosti u opsegu od 5-100 N/cm, gustinu od 1-10 mg/cm 3 ,prečnik komore veći od 0,75 mm a manji od 4 mm i/ili koji ima prosečan prečnikkomore ispod 3 mm i ravnomemo raspoređen i fiksiran na pomenutom nosaču,b)čvrsti fibrinogen, i  e) čvrstitrombin. Nosač je jedan biološki razgradljiv polimer kao što je polihialuronskakiselina, polioksi kiselina, npr. mlečna kiselina, glukolska kiselina, hidroksibutanojskakiselina, neka celuloza, želatin ili kolagen, kao što je kolagenski sunđer,npr. kolagenski sunđer koji se u suštini sastoji o vlakana kolagena tipa LFibrinogen i thrombin su poželjno čovečiji, prešišćeni od nekog prirodnogizvora, ili trangenski ili rekombinantni čovečiji fibrinogen i/ili trombin. Kodjednog preporučljivog izvođenja kompozicija ne obuhvata ni jedanantifibrinolitički agens kao što je aprotinin, ɛ-aminokapronska kiselina ili α2-antiplazmin.

Claims (23)

1. Čvrsta kompozicija koja se, u suštini, sastoji od a) jednog nosača koji ima bar jedno od sledećih fizičkih svojstava: modul elastičnosti u opsegu od 5-1 OO N/cm, gustinu od 1-10 mg/cm3, prečnik komore veći od 0,75 mm a manji od 4 mm i /ili koji ima prosečan prečnik komore ispod 3 mm i ravnomemo raspoređen i fiksiran na pomenutom nosaču b) čvrsti fibrinogen, i e) čvrsti trombin.
2. Kompozicija prema zahtevu l , naznačena time, što je nosač jedan biološki razgradljiv polimer kao što je polihialuronska kiselina, polioksi kiselina, npr. mlečna kiselina, glukolska kiselina, hidroksibutanojska kiselina, neka celuloza, želatin ili kolagen, kao što je kolagenski sunđer, npr. kolagenski sunđer koji se u suštini sastoji od vlakana kolagena tipa L
3. Nosač prema zahtevu 2, naznačen time, što je nosač jedan kolagensi sunđer koji sadrži materijal od kolagena tipa I od sisarskih, transgenskih ili rekombinantnih izvora.
4. Kompozicija prema bilo kom od zahteva 1-3, naznačena time, što nosač ima jednu ili više aktivnih strana, pri čemu se fibrinogen nalazi u količini od 2-1 O mg/cm2 , na primer 4,3- 6,7 mg/cm2, najbolje oko 5,5 mg/cm 2 , dok se trombin nalazi u količini od 1,5-5,5 IU/cm2 ,najbolje oko 2,0 IU/cm2 .
5. Kompozicija prema bilo kom od zahteva 1-4, naznačena time, što je fibrinogen čovečiji, prečišćen od nekog prirodnog izvora, ili transgenski ili rekombinantni čovečiji fibrinogen.
6. Kompozicija prema bilo kom od zahteva 1-5, naznačena time, što je fibrinogen prečišćen od nekog prirodnog izvora.
7. Kompozicija prema bilo kom od zahteva l-5, naznačena time, što je fibrinogen transgenski ili rekombinantni .
8. Kompozicija prema bilo kom od zahteva 1-7, naznačena time, što je trombin čovečiji , prečišćen od nekog prirodnog izvora, ili transgenski ili rekombinantni čovečiji trombin.
9. Kompozicija prema bilo kom od zahteva 1-8, naznačena time, što je trombin prečišćen od nekog prirodnog izvora.
10. Kompozicija prema bilo kom od zahteva 1-9, naznačena time, što je trombin transgenski ili rekombinantni.
11. Materijal za hemostazu, za zatvaranje tkiva i za lepljenje tkiva koji sadrži jedan savitljiv nosač koji ima bar jedno od sledećih fizičkih svojstava: modul elastičnosti u opsegu od 5-100 N/cm, gustinu od 1-10 mg/cm3, prečnik komore veći od 0,75 mm a manji od 4 mm i/ili koji ima prosečan prečnik komore ispod 3 mm i koji dalje obuhvata čvrsti fibrinogen, i čvrsti trombin, a ne obuhvata ni jedan antifibrinolitički agens kao što je aprotinin, E-amino-kapronska kiselina ili a.2-antiplazmin, pri čemu su čvrsti fibrinogen i čvrsti trombin pričvrščeni na nosač tako da je abrazija manja od 1,0 mg/cm 2 kada se uzorak obloženog materijala vibrira na jednom "Vibrofix" vibratoru na frekvenci od oko 1000 m-1 u trajanju od 2 minuta i kada se obložen materijal nosača umetne u jedan endoskopski aparat i potom iz njega izvadi, materijal je u suštini nepromenjen i ima gubitak materijala obloge manji od 20% kao indikaciju savitljivosti nosača i čvrstog prianjanja čvrstog fibrinogena i čvrstog trobina, pri čemu je pomenuti materijal u suštini nepropustljiv za vazduh i tečnosti i ima koeficijent elastičnosti od najmanje 1,25 što se određuje eksperimentom koji obuhvata pričvršćivanje obloženog nosača na list lateksa, širenje lateksa pritiskom tri puta i merenjem trećeg puta površine obloženog nosača na najvišoj tački širenja lista lateksa i poređenjem proširene površine obloženog nosača sa početnom veličinom obložene površine.
12. Primena nosača koji ima bar jedno od sledećih fizičkih svojstava: modul elastičnosti u opsegu od 5-100 N/cm , gustinu od 1-1 O mg/cm3, prečnik komore veći od 0,75 mm a manji od 4 mm i/i li koji im a prosečan prečnik komore ispod 3 mm i dovoljnu količinu fibrinogena i dovoljnu količinu trombina za pripremanje proizvoda za zatvaranje tkiva.
13. Primena nosača koji ima bar jedno od sledećih fizičkih svojstava: modul elastičnosti u opsegu od 5-1 OO N/cm, gustinu od 1-10 mg/cm3, prečnik komore veći od 0,75 mm a manji od 4 mm i/ili koji ima prosečan prečnik komore ispod 3 mm i dovoljnu količinu fibrinogena dovoljnu količinu trombina za pripremanje proizvoda za hemostazu.
14. Primena nosača koji ima bar jedno od sledećih fizičkih svojstava: modul elastičnosti u opsegu od 5-1 OO N/cm , gustinu od 1-1 O mg/cm3, prečnik komore veći od 0,75 mm a manji od 4 mm i/ili koji ima prosečan prečnik komore ispod 3 mm i dovoljnu količinu fibrinogena dovoljnu količinu trombina za pripremanje proizvoda za zatvaranje tkiva.
15. Primena prema ma kom od za hteva 12-14 kod hirurških intervencija u gastrointestinalnom sistemu, kao što je jednjak, želudac, tanko crevo, debelo crevo, rectum, na parenhimalnim organima kao što je jetra, slezina, pankreas, bubrezi , pluća, adrenalne žlezde, tiroidni i limfni čvorovi, kardiovaskulama hirurgija, grudna hirurgija uključujući hirurške intervencije na dušniku, bronhijama ili plućima, hirurške intervencije u području uva, nosa ili grla (ENT), uključujući dentalnu hirurgiju, ginekološku i urološku hirurgiju, hirurgiju krvnih sudova, hirurgiju kosti (npr. isecanje sunđerastog dela kosti), hirurške intervencije u hitnim slučajevima, neurološke hirurgije, l imfne, bilijame i cerebrospinalne (CSF) fistule, i prodor vazduha tokom grudne i plućne hirurgije.
16. Primena prema bilo kom od zahteva 12 do 15, naznačena time, što je nosač jedan biološki razgradljiv polimer kao što je polihialuronska kiselina, polioksi kiselina, npr. mlečna kiselina, glukolska kiselina, hidroksibutanojska kiselina, neka celuloza, želatin ili kolagen, kao što je kolagenski sunđer, npr. kolagenski sunđer koji se u suštini sastoji od vlakana kolagena tipa I.
17. Primena prema bilo kom od zahteva 12 do 16, naznačena time, što nosač ima jednu ili više aktivnih strana, pri čemu se fibrinogen nalazi u količini od 2-10 mg/cm2 , na primer 4,3-6,7 mg/cm2, najbolje oko 5,5 mg/cm2 , dok se trombin nalazi u količini od 1,5-5,5 IU/cm2 ,najbolje oko 2,0 IU/cm2 .
18. Primena prema bilo kom od zahteva 12-17, naznačena time, što je fibrinogen čovečiji, prečišćen od nekog prirodnog izvora, ili je to transgenski ili rekombinantni čovečiji fibrinogen.
19. Primena prema bilo kom od zahteva 12-18, naznačena time, što je fibrinogen prečišćen od nekog prirodnog izvora.
20. Primena prema bilo kom od zahteva 12-18, naznačena time, što je fibrinogen transgenski ili rekombinantni.
21. Primena prema bilo kom od zahteva 1 2-20, naznačena time, što je trombin čovečiji, prečišćen od nekog prirodnog izvora, ili transgenski ili rekombinantni čovečiji trombin.
22. Primena prema bilo kom od zahteva 12-21, naznačena time, što je trombin prečišćen od nekog prirodnog izvora.
23. Primena prema bilo kom od zahteva 12-21, naznačena time, što je trombin transgenski ili rekombinantni.
MEP-24/09A 2001-01-25 2002-01-25 Carrier with solid fibrinogen and solid thrombin ME00587A (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DKPA200100135 2001-01-25
DKPA200100235 2001-02-13
PCT/IB2002/001453 WO2002058749A2 (en) 2001-01-25 2002-01-25 Carrier with solid fibrinogen and solid thrombin
YUP-670/03A RS50866B (sr) 2001-01-25 2002-01-25 Nosač sa čvrstim fibrinogenom i čvrstim trombinom

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ME00587B true ME00587B (me) 2011-12-20
ME00587A ME00587A (en) 2011-12-20

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