Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1996-07-11
1998-04-07
Buiz, Michael Powell
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
604264, 525192, 26417123, A61M 2500
Patent
active
057358303
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
The invention concerns a medical instrument comprising at least one shaft section having a lumen, wherein the shaft section or sections are made from a flexible polymer material.
The invention also concerns a method for the production of a polymer material.
These types of medical instruments, for example, catheters, tubes, tracheal tubes, and the like are, as is known in the art, produced from a plurality of polymer materials. Towards this end, thermoplastics as well as elastomers are utilized. Among the range of thermoplastics, soft PVC materials are still normally used. Due to the low softening temperature of soft PVC materials, sterilization of medical instruments made from this material using hot steam is not possible. Conventional medical instruments made from soft PVC materials can therefore only be used one time in a sterile condition (disposable instruments). As a result, utilization of these medical instruments generates a large number of contaminated instruments which must be disposed of. One disposal possibility is incineration of the contaminated PVC material. Since dioxin is thereby produced, this type of disposal is controversial even when subjected to the most stringent safety conditions.
The PVC polymers which are utilized for medical instruments usually contain softeners for achieving the desired instrument flexibility. The softeners are usually simply physically mixed into the PVC polymer so that it is possible for these materials to diffuse out of the PVC material and into its immediate surroundings. In the event that medical instruments of this type are placed inside humans, it is possible for the softener to enter into the body.
Very-low-density polyethylene (VLDPE) and ultra-low-density polyethylene (ULDPE) are softener-free, soft polymers with characteristic features comparable to soft PVC material and have, as do the soft PVC materials, very low softening temperatures and are therefore not suitable for steam sterilization.
In addition to thermoplastic components such as the kind utilized in medicine, medical instruments are also made from rubber materials which have the advantage, due to their chemical cross-linked structure, of being steam-sterilizable. Rubber materials are non-transparent, require costly processing technology and, compared to thermoplastics, are relatively expensive raw materials.
It is therefore the purpose of the present invention to develop a polymer material for medical instruments which is physiologically unobjectionable, transparent, which can be sterilized by steam, and which has the necessary flexibility while maintaining a constantly open lumen.
It is furthermore the purpose of the present invention to present a method for the production of a polymer material of this type.
SUMMARY OF THE INVENTION
The purpose of the invention is achieved with respect to development of the polymer material in that the polymer material is formed from a first polyethylene component having low density (VLDPE) and/or a second polyethylene component having extreme low density (ULDPE), whereby an organic silane is grafted to the polymer material with the addition of an organic peroxide and the grafted polymer is cross-linked through storage in a humid environment and/or in water.
The above mentioned purpose in accordance with the invention is solved with respect to a method for production of a polymer material of this type in that the first polyethylene component and/or the second polyethylene component are dosed by weight and introduced as pourable bulk material to an extruder, preferably a double-worm extruder, and a mixture comprising organic silane and organic peroxide and, if appropriate, a catalyst is injected into the extruder, preferably using a membrane dosaging pump having a cooled injection valve, and a vacuum for degasing the melt is applied to the extruder in the vicinity of the product discharge with the extruder being heated at least between the region at which the organic silane and the organic peroxide is introduced up to the prod
REFERENCES:
patent: 4863784 (1989-09-01), Lustig et al.
patent: 5288806 (1994-02-01), Peacock
patent: 5516845 (1996-05-01), Heese et al.
patent: 5543223 (1996-08-01), Shah
Anderlik Rainer
Fritz Hans-Gerhard
Heider Michael
Singvogel Armin
Buiz Michael Powell
Smith Chalin
Vincent Paul J.
Willy Rusch AG
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