Medical device with hydrophilic coating

Details Medical device with hydrophilic coating Medical device with hydrophilic coating

1997-07-31

2003-10-07

Hayes, Michael J. (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

Reexamination Certificate

active

06629961

ABSTRACT:

The present invention relates to medical devices which present an elongate shaft having an outer surface coating for insertion into a passageway in a human or animal body and is principally, but not exclusively, concerned with surface coated catheters.
Many medical devices incorporate elongate shafts such as tubes which are intended for insertion into and through passageways of a living body such as those of the urethral tract and the cardiovascular system. The most common type of this general grouping of medical devices are known as catheters. Exemplary catheters include those designated for urological, angioplasty and valvuloplasty uses, that is, adapted respectively for insertion into the urethra, the lumen of a blood vessel and heart passageway of a living body, normally a human body.
Because of the intended use of such medical devices certain parameters need to be satisfied by the material from which the elongate shaft is manufactured. The material must fulfil such requirements as softness, good kink resistance, good dimensional stability, processability, for example ease to form and glue, and the possibility to be sterilised by radiation, steam, ethylene oxide or other means. There is further the need for the material to accept a surface treatment which will impart desired surface properties to the medical device such as lubricity, hydrophilicity and blood compatibility. To this latter end, the chemistry of the substrate material is critical since this affects the possibility to coat the substrate.
For many years now polyvinyl chloride (PVC) has been used to manufacture medical devices having elongate shafts for insertion into a body passageway such as catheters due to PVC fulfilling the requirements mentioned in the preceding paragraph.
For instance, prior European patent application publication No. 0093093 (Astra Meditec. AB) makes known a process for manufacturing a PVC urinary catheter having a hydrophilic outer surface coating which exhibits a low coefficient of friction when wetted. The process involves forming a hydrophilic surface coating on the PVC catheter by sequentially applying a solution containing between 0.05-40% (weight/volume, that is, kg/l) of an isocyanate compound and a solution of polyvinylpyrrolidone (PVP) containing between 0.5-50% (weight/volume) to the outer surface of the catheter, for example by dipping, and then curing the hydrophilic coating at an elevated temperature advantageously in the presence of a water-containing gas such as ambient air.
The suitability of PVC for medical devices such as catheters, however, is now being questioned on environmental grounds and further because of the toxicity of the plasticisers added to PVC. Moreover, coating PVC catheters by, for example, the process of European patent application publication No. 0093093 results in an appreciable shrinkage of the PVC catheters in the longitudinal direction, typically 6-7% of the original length, due to the operating temperatures used in the coating process. The obvious disadvantage of such appreciable shrinkage is the wastage of material in the sense that PVC catheters of longer length than finally required have to be used to account for the shrinkage. In addition, quality control of the coating process is made more complicated than would be ideal by this marked degree of shrinkage.
There is therefore a need for a medical device which presents a hydrophilic surface coated. non-PVC elongate shaft for insertion into a body passageway which experiences no appreciable shrinkage on application of the hydrophilic surface coating.
To this end, the present invention provides a method for the manufacture of a medical device which presents a hydrophilic surface coated elongate shaft for insertion into a body passageway comprising the steps of having the elongate shaft formed from a thermoplastic elastomer material selected from the group consisting of a polyether block amide and a styrene block copolymer and forming the hydrophilic coating on the elongate shaft by applying sequentially to the surface of the elongate shaft a solution comprising between 0.05 to 40% (weight to volume) of an isocyanate compound and a solution containing between 0.5 and 50% (weight to volume) of polyvinylpyrrolidone and curing at an elevated temperature.
The use of a polyether block amide or a styrene block copolymer results in an elongate shaft which undergoes substantially no shrinkage in the longitudinal direction as compared to PVC on application of the hydrophilic coating as well as providing an elongate shaft with the normal properties required for insertion thereof into a body passageway. The present invention therefore enables a catheter to be provided which addresses the aforementioned disadvantages of PVC based catheters leading to inter alia less wastage of starting materials and the possibility to use TV monitors for quality control.
While the background section of prior European patent application publication No. 0566755 (Cordis Corp.) makes it known that the use of a polyether block amide in the manufacture of medical device tubing intended for insertion into a body passageway is known per se, European patent application publication No. 0566755 goes on to teach that undesirable blooming develops in such tubing material after it has been stored for a length of time which can interfere with the adherence of a coating thereto, for example a coating for imparting lubricity to the tubing. The solution to the blooming problem according to European patent application publication No. 0566755 is to blend the polyether block amide with a polyetheramide component having substantially no ester linkages.
No such problem with adherence of the hydrophilic coating to a polyether block amide manifests itself when the method according to the present invention is followed despite the fact that blooming is sometimes observed after some months storage. This can be attributed to the manner in which the hydrophilic coating is applied to the elongate shaft in the method
The polyether block amide used in the invention is believed to have a structure as follows:
wherein PA is a polyamide, PE is a polyether and n is an integer greater than 1 which represents the number of blocks of copolymer molecular repeating units within the molecular formula of the copolymer. Representative polyether block amide materials include the Pebax® polymers (Elf Atochem S. A.).
In an embodiment of the invention the styrene block copolymer is a styrene-ethylene/butylene-styrene block copolymer, for example Evoprene® G (Evode Plastics Ltd.).
Application of the isocyanate solution to the elongate shaft surface results in a coating having unreacted isocyanate groups being formed on the elongate shaft surface. Application of the polyvinylpyrrolidone solution to the elongate shaft surface then results in a hydrophilic polyvinylpyrrolidone-polyurea interpolymer coating being formed on the elongate shaft surface. Curing of this hydrophilic coating binds the isocyanate compounds together to form a stable non-reactive network that binds the hydrophilic polyvinylpyrrolidone. To advantage, curing takes place in the presence of a water-containing gas, for example ambient air, to enable the isocyanate groups to react with the water to yield an amine which rapidly reacts with other isocyanate groups to form a urea cross-link.
In an embodiment of the invention the method further comprises the steps of evaporating the solvent of the isocyanate solution prior to application of the polyvinylpyrrolidone solution and evaporating the solvent of the polyvinylpyrrolidone solution prior to curing of the hydrophilic coating. This may for example be done by air drying.
In an embodiment of the invention the isocyanate compound comprises at least two unreacted isocyanate groups per molecule. The isocyanate may be selected from 2,4-toluene diisocyanate and 4,4′-diphenylmethane diisocyanate, or a pentamer of hexamethylene diisocyanate and toluene diisocyanate of cyanurate type, or trimerized hexamethylene diisocyanate biuret or mixtures thereof
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