CA2363916A1 - Fibrin adhesive granulate and method for its preparation - Google Patents

Fibrin adhesive granulate and method for its preparation Download PDF

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Publication number
CA2363916A1
CA2363916A1 CA002363916A CA2363916A CA2363916A1 CA 2363916 A1 CA2363916 A1 CA 2363916A1 CA 002363916 A CA002363916 A CA 002363916A CA 2363916 A CA2363916 A CA 2363916A CA 2363916 A1 CA2363916 A1 CA 2363916A1
Authority
CA
Canada
Prior art keywords
granulate
accordance
preparation
fibrin adhesive
fibrinogen
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002363916A
Other languages
French (fr)
Other versions
CA2363916C (en
Inventor
Mirna Rapp
Armin Prasch
Bernhard Luy
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CSL Behring GmbH Deutschland
Glatt Process Technology GmbH
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27218889&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2363916(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from DE19859611A external-priority patent/DE19859611C2/en
Priority claimed from DE1999128372 external-priority patent/DE19928372A1/en
Priority claimed from DE1999128371 external-priority patent/DE19928371A1/en
Application filed by Individual filed Critical Individual
Publication of CA2363916A1 publication Critical patent/CA2363916A1/en
Application granted granted Critical
Publication of CA2363916C publication Critical patent/CA2363916C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L24/00Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/10Polypeptides; Proteins
    • A61L24/106Fibrin; Fibrinogen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/04Materials for stopping bleeding

Abstract

The invention relates to a flowable fibrin glue granulate containing thrombi n, factor XIII, fibrinogen and a calcium salt in the form of granules with a particle size of more than 50 .mu.m to 1000 .mu.m. Said granulate is useful for the healing of wounds in surgery, tissue therapy and/or as supporting material for biological factors. The invention also relates to an effervesce nt granulate and an effervescent powder for producing a foam that is suitable f or hemostasis. The invention further relates to preparations to arrest bleeding containing an nonwoven fabric for wounds consisting of a biodegradable supporting material that is coated with a fibrin glue granulate mixture or mixed granulate.

Claims (24)

1. Flowable fibrin adhesive granulate, characterized in that it has granulate pellets with a particle size of over 50 to approximately 1000 µm which contain thrombin, Factor XIII, fibrinogen and a calcium salt.
2. Fibrin adhesive granulate in accordance with claim 1, characterized in that the granulate pellets have a particle size of 100 to 200 µm.
3. Fibrin adhesive granulate in accordance with claims 1 and 2, characterized in that it also contains albumin, fibronectin, and/or other substances that promote wound healing.
4. Effervescent granulate or effervescent powder to generate a foam suitable for hemostasis, characterized in that in addition to the flowable fibrin adhesive granulate of claims 1 to 3, it also contains the substances required for the formation of CO2.
5. Effervescent granulate or effervescent powder in accordance with claim 4, characterized in that it contains a mixture of a carbonate and a physiologically safe organic acid for the formation of CO2.
6. Preparation to arrest bleeding, characterized in that it contains a wound care fleece comprised of a biodegradable support medium which is coated with a flowable fibrin adhesive granulate of the claims 1 to 3.
7. Preparation in accordance with claim 6, characterized in that the wound care fleece is coated with a hydrophilic, non-aqueous salve base and that the fibrin adhesive of claims 1 to 3 is embedded in said salve base.
8. Wound care fleece in accordance with claims 6 and 7, characterized in that the biodegradable support medium is comprised of natural or chemically modified collagen, keratin, gelatin, carbohydrates or cellulose derivatives.
9. Wound care fleece in accordance with claims 6 and 7, characterized in that the biodegradable support medium is comprised of a polymer from the group of the polyhydroxy carboxylic acids, the polyesters, the polycyano acrylates, the polyamino acids, the polyalcohols or the silicones.
10. Wound care fleece in accordance with claims 6 to 9, characterized in that it contains fibrinogen in a quantity of 0.05 to 50 mg/cm2 and thrombin in a quantity of 1 µg to 20 mg/cm2.
11. Wound care fleece in accordance with claims 6 to 10, characterized in that the preparation containing the fibrin adhesive is applied to one or both sides of the support medium.
12. Bandage, characterized in that it is coated with a wound care fleece in accordance with claims 6 to 11 at the location that will be applied to the bleeding wound.
13. Plaster, characterized in that it is comprised of a water-proof or water-permeable surface material that is coated with a would care fleece in accordance with claims 6 to 11 at the location that will be applied to the bleeding wound and has adhesive surfaces at the edges.
14. Preparation to arrest bleeding, characterized in that it is comprised of a hydrophilic, non-aqueous salve base into which the particles of a fibrin adhesive in accordance with claims 1 to 3 are embedded.
15. Method for the preparation of the fibrin adhesive granulate in accordance with claims 1 to 3, characterized in that all components of the fibrin adhesive are suspended in an organic solvent and are spray-dried in an evacuatable container by means of a fluidization gas in the fluidized bed up to a particle size of more than 50 to 1000 µm, preferably 100 to 200 µm.
16. Method in accordance with claim 15, characterized in that it is prepared with or without a support medium placed into the container as receiver.
17. Method for the preparation of a fibrin adhesive in accordance with claims 1 to 3, characterized in that a fibrinogen granulate is prepared first, and that a suspension of an organic solvent containing thrombin is sprayed onto said fibrinogen granulate, whereby a calcium salt is added either to the fibrinogen granulate or to the thrombin solution.
18. Method for the preparation of a fibrin adhesive granulate in accordance with claims 1 to 3, characterized in that the separately prepared fibrinogen- and thrombin granulate pellets, each of which have a particle size of more than 50 µm to approximately 1000 µm, are mixed with one another.
19. Method for preparing a preparation in accordance with claims 6 to 14, characterized in that the fibrin adhesive, which is available as a granulate mixture or as mixed granulate, is layered on a biodegradable support medium.
20. Method for preparing the preparation in accordance with claim 14, characterized in that a fibrin adhesive that is available as a granulate mixture or as mixed granulate is impasted with the hydrophilic, non-aqueous salve base.
21 21. Method for preparing a preparation in accordance with claims 6 to 14, characterized in that other biological, vegetable or synthetic active substances such as immunoglobulins, chemotherapeutics or antibiotics, which promote wound healing, are added to the fibrin adhesive granulate.
22. Use of a fibrin adhesive granulate in accordance with claims 1 to 5 or a preparation in accordance with claims 6 to 14, characterized in that it is used for wound healing in surgery, tissue therapy, and/or as support medium for biological factors.
23. Use of the wound care fleece, the bandage, the plaster or the salve or gel-type preparation in accordance with claims 6 to 14 for the hemostasis of interior or exterior wounds.
24. Use of an effervescent granulate or an effervescent powder in accordance with claims 4 and 5 for the preparation of an effervescent pressed tablet.
CA2363916A 1998-12-23 1999-09-17 Fibrin adhesive granulate and method for its preparation Expired - Fee Related CA2363916C (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
DE19859611A DE19859611C2 (en) 1998-12-23 1998-12-23 Fibrin glue granules and process for their production
DE19859611.1 1999-06-21
DE1999128372 DE19928372A1 (en) 1999-06-21 1999-06-21 Fibrin-based glue granulate and methods of preparation, useful for wound healing in surgery or tissue therapy
DE19928372.9 1999-06-21
DE19928371.0 1999-06-21
DE1999128371 DE19928371A1 (en) 1999-06-21 1999-06-21 Fibrin-based glue granulate and methods of preparation, useful for wound healing in surgery or tissue therapy
PCT/EP1999/006898 WO2000038752A1 (en) 1998-12-23 1999-09-17 Fibrin-based glue granulate and corresponding production method

Publications (2)

Publication Number Publication Date
CA2363916A1 true CA2363916A1 (en) 2000-07-06
CA2363916C CA2363916C (en) 2010-12-07

Family

ID=27218889

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2363916A Expired - Fee Related CA2363916C (en) 1998-12-23 1999-09-17 Fibrin adhesive granulate and method for its preparation

Country Status (9)

Country Link
EP (1) EP1140235B2 (en)
JP (1) JP4651819B2 (en)
KR (1) KR100804434B1 (en)
AT (1) ATE222781T1 (en)
AU (1) AU754458B2 (en)
CA (1) CA2363916C (en)
DE (1) DE59902496D1 (en)
ES (1) ES2183606T5 (en)
WO (1) WO2000038752A1 (en)

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EP1759718A1 (en) * 2004-05-21 2007-03-07 Juridical Foundation, The Chemo-Sero-Therapeutic Research Institute Tissue closing preparation
US20090246238A1 (en) * 2004-10-20 2009-10-01 Anne Jessica Gorman Reinforced absorbable multilayered hemostatic wound dressing
US7727547B2 (en) 2000-04-04 2010-06-01 Tissuemed Limited Tissue-adhesive formulations
US8133504B2 (en) 2004-08-03 2012-03-13 Tissuemed Limited Tissue-adhesive materials
US8133336B2 (en) 2006-02-03 2012-03-13 Tissuemed Limited Tissue-adhesive materials
WO2015089626A1 (en) * 2013-12-16 2015-06-25 The University Of British Columbia Self-fueled particles for propulsion through flowing aqueous fluids

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DE19849589C1 (en) 1998-10-27 2000-06-15 Glatt Process Technology Gmbh Fibrin tissue adhesive formulation and process for its manufacture
US6730299B1 (en) * 1999-07-21 2004-05-04 Imedex Biomateriaux Adhesive protein foam for surgical and/or therapeutic uses
DE19962221A1 (en) * 1999-10-01 2001-05-23 Glatt Process Technology Gmbh Sustained-release medicament formulation, e.g. for parenteral or transdermal use, comprising drug and carrier system consisting of solid biodegradable blood plasma proteins obtained by fluidized bed drying
TWI237573B (en) * 2001-01-25 2005-08-11 Nycomed Pharma As A method of preparing a collagen sponge, a device for extracting a part of a collagen foam, and an elongated collagen sponge
US7052713B2 (en) 2001-02-13 2006-05-30 Nycomed Pharma As Carrier with solid fibrinogen and solid thrombin
US7923431B2 (en) 2001-12-21 2011-04-12 Ferrosan Medical Devices A/S Haemostatic kit, a method of preparing a haemostatic agent and a method of promoting haemostatis
US7846141B2 (en) 2002-09-03 2010-12-07 Bluesky Medical Group Incorporated Reduced pressure treatment system
JP3640655B2 (en) * 2002-10-23 2005-04-20 一知 井上 Angiogenesis inducer
GB0224986D0 (en) 2002-10-28 2002-12-04 Smith & Nephew Apparatus
PL377477A1 (en) 2002-12-11 2006-02-06 Ferrosan A/S Gelatine-based materials as swabs
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CA2554994C (en) 2004-01-30 2015-05-19 Ferrosan A/S Haemostatic sprays and compositions
US8062272B2 (en) 2004-05-21 2011-11-22 Bluesky Medical Group Incorporated Flexible reduced pressure treatment appliance
US10058642B2 (en) 2004-04-05 2018-08-28 Bluesky Medical Group Incorporated Reduced pressure treatment system
US7909805B2 (en) 2004-04-05 2011-03-22 Bluesky Medical Group Incorporated Flexible reduced pressure treatment appliance
GB0409446D0 (en) 2004-04-28 2004-06-02 Smith & Nephew Apparatus
US8021684B2 (en) 2004-07-09 2011-09-20 Ferrosan Medical Devices A/S Haemostatic composition comprising hyaluronic acid
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US20100291219A1 (en) * 2007-06-21 2010-11-18 Massachusetts Institute Of Technology Methods and compositions relating to progenitor cells
EP2217298B1 (en) 2007-11-21 2015-11-11 T.J. Smith & Nephew Limited Suction device and dressing
EP3254650B1 (en) 2007-11-21 2020-01-08 Smith & Nephew plc Wound dressing
GB0722820D0 (en) 2007-11-21 2008-01-02 Smith & Nephew Vacuum assisted wound dressing
US11253399B2 (en) 2007-12-06 2022-02-22 Smith & Nephew Plc Wound filling apparatuses and methods
GB0723875D0 (en) 2007-12-06 2008-01-16 Smith & Nephew Wound management
GB0803564D0 (en) 2008-02-27 2008-04-02 Smith & Nephew Fluid collection
US8642831B2 (en) 2008-02-29 2014-02-04 Ferrosan Medical Devices A/S Device for promotion of hemostasis and/or wound healing
KR20120125465A (en) * 2010-01-08 2012-11-15 프로피브릭스 비.브이. Dry powder fibrin sealant
US9061095B2 (en) 2010-04-27 2015-06-23 Smith & Nephew Plc Wound dressing and method of use
GB201011173D0 (en) 2010-07-02 2010-08-18 Smith & Nephew Provision of wound filler
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GB201020005D0 (en) 2010-11-25 2011-01-12 Smith & Nephew Composition 1-1
RU2013155713A (en) 2011-07-06 2015-08-20 Профибрикс Бв COMPOSITIONS FOR TREATMENT OF THE RAS
US20150159066A1 (en) 2011-11-25 2015-06-11 Smith & Nephew Plc Composition, apparatus, kit and method and uses thereof
US9056092B2 (en) * 2011-12-02 2015-06-16 Ethicon, Inc. Hemostatic bioabsorbable device with polyethylene glycol binder
WO2013131520A2 (en) 2012-03-06 2013-09-12 Ferrosan Medical Devices A/S Pressurized container containing haemostatic paste
RU2636240C2 (en) 2012-06-12 2017-11-21 Ферросан Медикал Дивайсиз А/С Dry haemostatic composition
US20160120706A1 (en) 2013-03-15 2016-05-05 Smith & Nephew Plc Wound dressing sealant and use thereof
JP6390873B2 (en) 2013-06-21 2018-09-19 フェッローサン メディカル ディバイス エー/エス Dry composition expanded under reduced pressure and syringe for holding the same
US10765774B2 (en) 2013-07-09 2020-09-08 Ethicon, Inc. Hemostatic pad assembly kit and method
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JP6747650B2 (en) 2014-12-24 2020-08-26 フェロサン メディカル デバイシーズ エイ/エス Syringe for holding and mixing the first substance and the second substance
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US11413335B2 (en) 2018-02-13 2022-08-16 Guangzhou Bioseal Biotech Co. Ltd Hemostatic compositions and methods of making thereof
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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7727547B2 (en) 2000-04-04 2010-06-01 Tissuemed Limited Tissue-adhesive formulations
EP1759718A1 (en) * 2004-05-21 2007-03-07 Juridical Foundation, The Chemo-Sero-Therapeutic Research Institute Tissue closing preparation
EP1759718A4 (en) * 2004-05-21 2011-03-02 Chemo Sero Therapeut Res Inst Tissue closing preparation
US8133504B2 (en) 2004-08-03 2012-03-13 Tissuemed Limited Tissue-adhesive materials
US20090246238A1 (en) * 2004-10-20 2009-10-01 Anne Jessica Gorman Reinforced absorbable multilayered hemostatic wound dressing
US9358318B2 (en) * 2004-10-20 2016-06-07 Ethicon, Inc. Method of making a reinforced absorbable multilayered hemostatic wound dressing
US8133336B2 (en) 2006-02-03 2012-03-13 Tissuemed Limited Tissue-adhesive materials
WO2015089626A1 (en) * 2013-12-16 2015-06-25 The University Of British Columbia Self-fueled particles for propulsion through flowing aqueous fluids
EP3082866A4 (en) * 2013-12-16 2017-06-14 The University Of British Columbia Self-fueled particles for propulsion through flowing aqueous fluids
US10238598B2 (en) 2013-12-16 2019-03-26 The University Of British Columbia Self-fueled particles for propulsion through flowing aqueous fluids
US11266596B2 (en) 2013-12-16 2022-03-08 The University Of British Columbia Self-fueled particles for propulsion through flowing aqueous fluids

Also Published As

Publication number Publication date
AU5863899A (en) 2000-07-31
ATE222781T1 (en) 2002-09-15
EP1140235B2 (en) 2007-12-19
DE59902496D1 (en) 2002-10-02
ES2183606T3 (en) 2003-03-16
JP4651819B2 (en) 2011-03-16
CA2363916C (en) 2010-12-07
KR20010099897A (en) 2001-11-09
AU754458B2 (en) 2002-11-14
EP1140235A1 (en) 2001-10-10
KR100804434B1 (en) 2008-02-20
WO2000038752A1 (en) 2000-07-06
JP2002533164A (en) 2002-10-08
ES2183606T5 (en) 2008-05-16
EP1140235B1 (en) 2002-08-28

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Effective date: 20190917