WO1997040864A1 - Method for making autologous fibrin sealant - Google Patents
Method for making autologous fibrin sealant Download PDFInfo
- Publication number
- WO1997040864A1 WO1997040864A1 PCT/US1997/008472 US9708472W WO9740864A1 WO 1997040864 A1 WO1997040864 A1 WO 1997040864A1 US 9708472 W US9708472 W US 9708472W WO 9740864 A1 WO9740864 A1 WO 9740864A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- fibrin sealant
- thrombin
- plasma
- fibrin
- platelet rich
- Prior art date
Links
Classifications
-
- 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
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
- A61L24/10—Polypeptides; Proteins
- A61L24/106—Fibrin; Fibrinogen
Definitions
- the present invention relates to the preparation of fibrin based sealants, Background Art
- Human recombinant thromboplastin is presently available as a diagnostic reagent for use in performing various coagulation assays.
- Fibrin sealants are made from several different types of starting materials, including: 1) citrated plasma, 2) concentrated citrated plasma, 3) platelet rich citrated plasma. 4) cryoprecipitates, and 5) purified plasma fractions which contain high quantities of fibrinogen.
- the coagulation of blood is a rather complex process.
- the primary reaction of producing a clot is caused by the action of thrombin on the fibrinogen molecule which converts fibrinogen to fibrin. Fibrin spontaneously polymerizes, forming a net-like structure. This structure is later solidified and enhanced by the actions of several other factors in blood, which factors are also generated by the action of thrombin.
- Thrombin has an inactive form, prothrombin. Thus at some point there must be a trigger for the initiation of blood clotting.
- One of these mechanisms is tiiromboplastin. When blood or blood plasma is exposed to thromboplastin, it triggers the activation of these factors which leads to the generation of thrombin which in turn converts fibrinogen to fibrin.
- the present invention is embodied in a method for making a fibrin sealant adhesive or glue which does not introduce either imrnunologic or viral concerns. To this end, fibrin sealant is produced by utilizing human recombinant thromboplastin.
- the present invention is embodied in a method wherein human recombinant thromboplastin is mixed directly with the precursor of the fibrin sealant such as blood plasma, platelet rich blood plasma, concentrated blood plasma or cryoprecipitate.
- human recombinant thromboplastin is utilized to generate thrombin in a small aliquot of plasma or the supernatant from a cryoprecipitation, and then the thrombin thereby generated is combined with the precursor of the fibrin sealant. Both procedures produce a fibrin sealant which can then be used in the conventional manner.
- the platelet rich plasma is collected into a 1 :9 volume of 3.8% sodium citrate. Low speed centrifugation leads to the production of the platelet rich plasma.
- the platelet rich plasma is mixed with recombinant thromboplastin in a suitable container and sufficient calcium chloride is added to neutralize the citrate used as the anticoagulant.
- the ratios of recombinant thromboplastin, calcium, and platelet rich plasma are preferably determined in small test tubes. The desired result is to effect the formation of a fibrin sealant gel in one to two minutes after the combination of the above agents.
- Plasma Source for Thrombin Prepared by High Speed Centrifugation Blood plasma, citrated as described above, is mixed with recombinant thromboplastin and calcium. The resulting clot is agitated to break up the clot. The supernatant fluid, which contains thrombin, is separated by centrifugation. The thrombin is then used as in Method 1 to generate a fibrin sealant from the platelet rich plasma.
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicinal Preparation (AREA)
- External Artificial Organs (AREA)
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19781869A DE19781869B4 (en) | 1996-04-30 | 1997-04-30 | Production of fibrin sealants - e.g. by mixing platelet rich blood plasma with recombinant thromboplastin. |
JP9539306A JP2000509307A (en) | 1996-04-30 | 1997-04-30 | Method for producing autologous fibrin sealant |
DE19781869T DE19781869T1 (en) | 1996-04-30 | 1997-04-30 | Process for the production of an autologous fibrin hemostatic agent |
DE29723807U DE29723807U1 (en) | 1996-04-30 | 1997-04-30 | Autologous fibrin hemostatic agent |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US64027896A | 1996-04-30 | 1996-04-30 | |
US08/640,278 | 1996-04-30 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO1997040864A1 true WO1997040864A1 (en) | 1997-11-06 |
WO1997040864B1 WO1997040864B1 (en) | 1997-12-31 |
Family
ID=24567594
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1997/008472 WO1997040864A1 (en) | 1996-04-30 | 1997-04-30 | Method for making autologous fibrin sealant |
Country Status (4)
Country | Link |
---|---|
US (2) | US6444228B1 (en) |
JP (1) | JP2000509307A (en) |
DE (2) | DE29723807U1 (en) |
WO (1) | WO1997040864A1 (en) |
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US6596180B2 (en) | 1996-04-30 | 2003-07-22 | Medtronic, Inc. | System and method for the production of autologous platelet gel |
US6942880B1 (en) | 2001-04-09 | 2005-09-13 | Medtronic, Inc. | Autologous platelet gel having beneficial geometric shapes and methods of making the same |
US9096839B2 (en) | 2006-04-26 | 2015-08-04 | Arteriocyte Medical Systems, Inc. | Compositions and methods of preparation thereof |
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JP2000509307A (en) * | 1996-04-30 | 2000-07-25 | メドトロニック,インコーポレイテッド | Method for producing autologous fibrin sealant |
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1997
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- 1997-04-30 DE DE29723807U patent/DE29723807U1/en not_active Expired - Lifetime
- 1997-04-30 DE DE19781869T patent/DE19781869T1/en active Pending
- 1997-04-30 WO PCT/US1997/008472 patent/WO1997040864A1/en active Application Filing
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1998
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2008
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Also Published As
Publication number | Publication date |
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DE29723807U1 (en) | 1999-11-04 |
DE19781869T1 (en) | 2000-03-16 |
US20090026123A1 (en) | 2009-01-29 |
JP2000509307A (en) | 2000-07-25 |
US6444228B1 (en) | 2002-09-03 |
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