Drug – bio-affecting and body treating compositions – Designated organic nonactive ingredient containing other... – Solid synthetic organic polymer
Patent
1995-03-21
1998-05-26
Azpuru, Carlos A.
Drug, bio-affecting and body treating compositions
Designated organic nonactive ingredient containing other...
Solid synthetic organic polymer
424425, A61K 4730, A61F 206
Patent
active
057565538
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to a medical material such as a medical device which directly contacts with blood, and a process for producing the same. More particularly, it relates to a medical material which causes no blood coagulation (thrombogenesis) or platelet loss due to activation of platelet even if the material directly contacts with blood, and a process for producing the same.
BACKGROUND ART
In the medical field, thrombogenesis on the surface of polymer materials used for an artificial heart, artificial lung, vascular prosthesis, catheter, etc., which directly contact with blood is a serious problem. Therefore, medical materials having excellent anticoagulant or anti-thrombogenic activity have been required.
As a method for imparting the anti-thrombogenic activity to medical materials, for example, there have hitherto been known a method(1) of forming a composite of heparin and a polymer material, or a method(2) of example, see Japanese Laid-Open Patent Publication No. 54-68097 (Japanese Patent Publication No. 60-40861), Japanese Laid-Open Patent Publication No. 56-136564 (Japanese Patent Publication No. 59-51304), Japanese Laid-Open Patent Publication No. 57-75655 (Japanese Patent Publication No. 61-6662) and Japanese Laid-Open Patent Publication No. 57-14358 (Japanese Patent Publication No. 63-43107).
However, the above method (1) has a problem that, there are large restrictions on processing and manufacturing because heparin is thermally unstable, and that sustained release for a long period of time can not be expected because the retention amount of heparin in the material is small.
Further, the above method (2) has a problem that, there are extremely large restrictions on manufacturing because the processing is conducted by surface coating and the treatment is complicated and, further, fibrinolysis activity is liable to be deteriorated by heart, and that sustained effect can not be expected because the absolute amount of a fibrinolytic enzyme in the material is small.
Further, safety of a chemical structure, which is used for a ligand or spacer in case of formation of composite or immobilization, to the human body has not been worked out completely, at present.
On the other hand, materials superior in blood compatibility have also been developed so as not to cause thrombogenesis.
For example, in the field of vascular prosthesis, a vascular prosthesis comprising an expanded poly(tetrafluoroethylene) manufactured by Gore Co., U.S.A. is known. However, in these materials, it is indispensable to produce a porous structure by expanding in order to develop the anti-thrombogenic activity, which results in large restrictions on use application and production process.
Further, a medical material of the polyurethane or polyurethane urea having a microdomain structure, however, the material has a problem that the production process is complicated because of its hard thermal molding, which results in large restrictions on manufacturing, and that constant anti-thrombogenic activity can not be easily obtained because the microdomain structure varies largely depending upon the processing method.
Furthermore, a medical material wherein an antiplatelet agent is blended in a polyurethane or polyurethane urea is proposed, however, the material has a problem that the production process is complicated because of its difficult thermal molding, which results in large restrictions on manufacturing.
On the other hand, it is known that a HEMA (2-hydroxyethyl methacrylate)-styrene copolymer having a microdomain structure has anti-thrombogenic activity. However, it is limited to the coating material because of its small mechanical strength and the field of application is limited to a specific one.
It is a main object of the present invention is to provide a medical material which solves the above technical problems and can be easily produced, and which can uniformly contains an antiplatelet agent and enables continuous release of the antiplatelet agent, and a process for producing the same.
DISCLO
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Higashino Rika
Iguchi Seiichiro
Azpuru Carlos A.
Otsuka Pahrmaceutical Co., Ltd.
Otsuka Pharmaceutical Factory Inc.
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