Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1998-10-19
2000-02-29
Coggins, Wynn Wood
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
604 96, 604916, 604919, A61M 2900
Patent
active
06030362&
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The subject of the present invention is a catheter intended to be introduced into a bodily canal in which a fluid flows, particularly in order to deliver thereto a therapeutically active substance in a localised region of said canal, without interrupting the flow of said fluid.
The main application of the invention is in the field of treating blood vessels and, even more particularly, in the treatment of restenosis.
The catheter according to the present invention may, however, be used for treating a variety of disorders of various morphological canals in the human or animal body, such as, in particular, the urinary canals and, in particular, the urethra, or else the digestive canals and, in particular, the oesophagus.
This catheter is mainly intended for locally delivering a therapeutically active substance, but also enables isolating a segment of the wall of a bodily canal, for example for assisting a surgical operation upon said wall segment thus isolated.
In order to clarify the explanation, the catheter according to the present invention will be described in its preferred particular application to the preventive treatment of restenosis.
BACKGROUND OF THE INVENTION
It is known that restenosis can be defined as a recurrent reduction in the calibre of the coronary lumen at the site initially expanded with success during a coronary transluminal angioplasty.
This disorder remains the main current limitation on balloon coronary angioplasty since it leads to a new angioplasty in approximately 15 to 30% of cases within the 6 months following a successful angioplasty.
Various solutions have been envisaged to date for the prevention of restenosis, and these have led to more or less satisfactory results.
Thus, the use of so-called "ablative" angioplasty techniques such as, for example, laser angioplasty or atherectomy have not permitted a significant reduction in the incidence of restenosis.
In contrast, fitting a coronary endoprosthesis after angioplasty constitutes a relatively effective treatment in the prevention of restenosis, since it leads to a reduction by approximately 30% in the risk of restenosis.
However, the systematic fitting of endoprostheses cannot be envisaged, insofar as this could lead to operating unnecessarily on a large number of patients who would have suffered no restenosis without an endoprosthesis, and insofar as there would still be a relatively large number of patients suffering restenosis in spite of the fitting of an endoprosthesis.
Systemic administration of pharmacologically active substances such as antithrombins, converting enzyme inhibitors, some vasodilators or some hypolipidemic agents has to date not led to entirely satisfactory results.
This is why the use of devices intended for local delivery of therapeutically active substances constitutes a more promising prospect in the prevention of restenosis.
In fact, this method makes it possible to administer, at the dilated site, products which are specifically targeted against the mechanisms of restenosis, including products which are toxic for the rest of the body, in predetermined concentrations and over a variable period of time.
In order to be usable in the context of this method, the device must permit local delivery of the active substance without interruption to the flow of fluid in the bodily canal.
A catheter satisfying this requirement has been proposed in the document EP 0.526.102.
This catheter is generally composed of an elongate tubular element including an inflatable structure arranged at its distal part.
This inflatable structure consists of a set of identical toric balloons and a membrane fixed to these balloons, this structure being designed in such a way that, when it is inflated, it defines: contain said therapeutically active substance and defined by the balloons, by the outer surface of the membrane and by the inner surface of the bodily canal.
The catheter body includes a first internal channel which communicates, on the one hand, with the balloons and, on the other hand, with a m
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Boussignac Georges
Lagarde Vincent
Coggins Wynn Wood
Finkel Sharon
Laboratories Nycomed SA
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