Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1997-10-02
2000-02-15
McDermott, Corrine
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
604524, 606194, A61M 2900
Patent
active
060247223
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
This invention relates to dilation balloon catheters, particularly those used in angioplasty. More specifically, it relates to the balloons on such catheters and to some extent to the catheter shaft as well. Angioplasty relates to opening of stenoses in the vascular system usually by means of a catheter having a balloon at its distal end. Such catheters may be single or multiple lumen, may be over-the-wire or non-over-the-wire. Very similar catheters may be used for placing stents. All such catheters are referred to herein collectively as "balloon catheters". The invention described herein could also be utilized in the production and manufacture of guide catheters or infusion catheters.
It is possible to make balloons from a variety of materials that are generally of the thermoplastic polymeric type. Such materials may include: polyethylenes and ionomers, ethylene-butylene-styrene block copolymers blended with low molecular weight polystyrene and, optionally, polypropylene, and similar compositions substituting butadiene or isoprene in place of the ethylene and butylene; poly(vinyl chloride); polyurethanes; copolyesters; thermoplastic rubbers; siliconepolycarbonate copolymers; and ethylene-vinyl acetate copolymers.
One material of choice for such catheters has been thermoset polyimide, primarily because of its high strength and flexibility in small diameter with very thin walls. Being thermoset, the polyimide used heretofore has involved complicated manufacturing procedures due to the fact that it is insoluble and "intractable" i.e., not meltable. For example, in forming catheter shafts, it has been necessary to build up the shaft with multiple layers of polyimide on a substrate which is subsequently dissolved away. This has also been necessary in making the catheter balloon in which multiple layers of thermoset polyimide were layered onto a form, of glass for example, which was later etched away leaving a polyimide balloon.
This type of polyimide is a heterochain polymer typically made of two base monomers, a diamine and a dianhydride (e.g. para-aminoaniline and pyromellitic dianhydride). Such polyimide is typically formed by two step reaction like the following example. First, a polyamide is formed from the monomers. The reaction proceeds at about 25.degree. C. and the product is soluble and stable in very polar solvents. Second, the polyamide is condensed to polyimide at about 120.degree. C. Further description of polyimides and their preparation can be found in Androva et al. Polyimide, A New Class of Hear-Resistant Polymers, pp. 4-13 (1969).
As already indicated other plastics have been used in catheter construction for shafts and balloons in which the plastic has been of the thermoplastic type. For example, polyethylene terephthalate (PET) has been used to make the balloons. Thermoplastic materials lend themselves to simpler manufacturing techniques, such as extrusion in forming shafts and blow molding in forming the balloons than do the aforementioned thermoset polyimide materials due to the fact that they are soluble and meltable. However, the art has failed to recognize that thermoplastic polyimide is available for balloon catheter construction.
Although many of the procedures employing balloon catheters are still in the experimental stage in the United States, there is a considerable amount of art available on the formation and use of balloon catheters. Illustrations of such art are: U.S. Pat. Nos. 4,952,357 to Euteneuer; 4,413,989 and 4,456,000 to Schjeldahl et al. and 4,490,421 as well as Reissue Patent Nos. 32,983 and 33,561 to Levy.
The Euteneuer patent relates to the prior art polyimide catheter/balloon construction. The Schjeldahl patents, incorporated herein by reference, pertain to catheter assemblies or attachments. These patents disclose expanders (balloons) formed from a thin, flexible, inelastic, high tensile strength, biaxially oriented, synthetic plastic material. The Levy patents, which issued several years after the Schjeldahl patents, sought to provid
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Buscemi Paul J.
Rau Bruce H.
Shoemaker Susan M.
McDermott Corrine
Sci-Med Life Systems, Inc.
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