Non-thrombogenic and anti-thrombogenic polymers

Details Non-thrombogenic and anti-thrombogenic polymers Non-thrombogenic and anti-thrombogenic polymers

1999-04-30

2000-08-01

Nutter, Nathan M.

Synthetic resins or natural rubbers -- part of the class 520 ser

Synthetic resins

Processes of preparing a desired or intentional composition...

523112, 523113, 523114, 525212, 526286, 526287, 526320, 526333, 528391, A01N 100, A61F 200, C08F 1230, C08L 3314, C08L 4100

Patent

active

060967986

DESCRIPTION:

BRIEF SUMMARY
SUMMARY OF INVENTION

This invention relates to the synthesis of polymers which contain non-thrombogenic (NON-TH) as well as anti-thrombogenic (ANTI-TH) properties. Such polymers can be conveniently represented as follows:


______________________________________ POLYMER BACKBONE ______________________________________ ) ( [NON-TH] Type 1 and ) ) ( ( [NON-TH] [ANTI-TH] Type 2 ______________________________________
In schematic diagrams of this kind, as used herein, the designated side chains or groups can occur in any order and in any relative proportions along the polymer backbone.
In polymers of Type 1 the non-thrombogenic (NON-TH) component may consist of non-ionic hydrophilic domains, ionic domains, zwitterionic domains or combinations of such domains. In novel Type 1 polymers in accordance with the invention, such non-thrombogenic components may be selected from, but are not limited to, polymerisable sulphonates, polymerisable sulphates, polymerisable N-sulphates (also known as sulphamates), polymerisable zwitterionic compounds, and polymerisable polyethylene glycols. When we synthesised polymers of Type 1, without the anti-thrombogenic component, and coated various medical devices, we found blood cell and protein deposition reduced by greater than 90%. Greatly reduced (>95%) activation of white cells, platelets and complement was observed. This type of synthetic polymer can be described as a non-thrombogenic polymer.
The non-thrombogenic Type 1 polymer, as described, was synthesised with polymerisable Heparin to give a Type 2 polymer. Surprisingly, the activity of the heparin was retained in the Type 2 polymer and such polymers, when coated on to medical devices, had the additional property of reducing the thrombin-antithrombin complex concentration. This inclusion of heparin into the non-thrombogenic polymer gave a new polymer which additionally exhibited anti-thrombogenic properties.
Another aspect of this invention is the process by which the non-thrombogenic and anti-thrombogenic polymers are coated onto medical devices.


BACKGROUND TO THE INVENTION

There is a growing interest in the use of artificial materials in clinical practice where these materials are in continuous contact with blood. Medical devices made from these materials are required to perform in the harsh biological environment in a specific application, for a specific duration without stimulating a biological response which may prove to be detrimental. Hence, such devices are required to be accepted by the biological environment for a specific application and duration, ie need to be bioacceptable. Improvements in bioacceptability are highly desirable for medical devices manufactured from artificial materials. Such materials commonly include polyvinyl chloride, polyethylene, polypropylene, polyurethanes, polycarbonates, stainless steel, silicones and the like. The biological response to blood contact with an artificial surface can be regarded in terms of different contributions from protein, platelet and blood cell deposition, together with platelet and blood activation leading to thrombus formation.
Many investigations have been carried out to prevent an artificial surface from provoking thrombus formation, ie to form a bioacceptable surface. Such investigations include the use of polymers which are natural, hydrophilic, hydrophobic, zwitterionic and charged (anionic and cationic). These types of polymers are non-thrombogenic, have had limited success and therefore application. Surface modification of an artificial material by heparin (ie formation of an anti-thrombogenic surface) has also proved to be intractable. Although clot formation has been reduced, platelet activation and blood cell activation are however still prevalent. Similarly, a particular artificial surface may be resistant to protein, platelet and blood cell deposition but may still activate blood constituents.
Each surface, whether non-thrombogenic or anti-thrombogenic, has its own profile of desirable bioacceptable properties

REFERENCES:
patent: 3086959 (1963-04-01), Armen et al.
patent: 4200563 (1980-04-01), Komiya
patent: 5116361 (1992-05-01), Kim et al.
Heparin Derivatives of High Molecular Weight, by Mester, Amaya and Mester. Carbohydrate Sulfates, (1978) 113-120.

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