Multi layer radiation delivery balloon
First Claim
1. A multilayer radiation delivery source, comprising:
- a first bonding layer, having a first side;
a second bonding layer, having a second side which faces toward the first side; and
an isotope layer in between the first side and the second side;
wherein the first side and the second side are secured together through the isotope layer to produce a multilayer radiation delivery source.
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Accused Products
Abstract
Disclosed is a sealed radiation source, which may be used to deliver a radioactive dose to a site in a body lumen. The source comprises a thin flexible substrate, and a layer of radioisotope attached thereto. The source may further comprise additional layers such as one or more tie layers disposed between the substrate and the radioisotope layer and one or more outer coating layers. In one embodiment, the source is wrapped around an inflatable balloon. Inflation of the balloon at a treatment site positions the source directly adjacent to the vessel wall, and allows irradiation of the site following or simultaneously with a balloon angioplasty, stent implantation, or stent sizing procedure.
54 Citations
50 Claims
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1. A multilayer radiation delivery source, comprising:
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a first bonding layer, having a first side;
a second bonding layer, having a second side which faces toward the first side; and
an isotope layer in between the first side and the second side;
wherein the first side and the second side are secured together through the isotope layer to produce a multilayer radiation delivery source. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A radiation delivery balloon catheter, comprising:
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an elongate flexible tubular body, having a proximal end and a distal end;
an inflatable balloon on the tubular body near the distal end thereof, said balloon in fluid communication with an inflation lumen extending axially through the tubular body;
a balloon bonding surface carried by the outer surface of the balloon;
a radiation source on the balloon bonding surface; and
an encapsulant surrounding the radiation source, the encapsulant having at least an encapsulant bonding surface on its radially inwardly facing surface for fusing with the balloon bonding surface at least proximally and distally of the radiation source. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A method of treating a site within a vessel, comprising the steps of:
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identifying a site in a vessel to be treated;
providing a radiation delivery catheter having an expandable balloon with a thin film radiation source thereon, said thin film comprising a substrate layer having an isotope thereon, said isotope encapsulated by an outer encapsulant layer fused to the substrate throughout the length of the source;
positioning the balloon within the treatment site;
inflating the balloon within the treatment site;
delivering a dose of radiation from the delivery balloon to the treatment site; and
thereafter deflating the balloon and removing the balloon from the treatment site. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35)
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36. A method of simultaneously performing balloon dilatation of a stenosis in a body lumen and delivering radiation to the body lumen, comprising the steps of:
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identifying a stenosis in a body lumen;
providing a treatment catheter having an elongate flexible tubular body with an inflatable balloon near the distal end thereof, a cylindrical thin film radiation delivery layer on the balloon, an encapsulant layer over the radiation delivery layer, a continuous seal between the encapsulant, the delivery layer and the balloon along at least the length of the radiation delivery layer;
transluminally advancing the balloon through the lumen;
positioning the balloon within the stenosis;
inflating the balloon to radially expand the lumen in the area of the stenosis; and
simultaneously delivering radiation from the thin film into the lumen wall.
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37. A method of simultaneously performing balloon dilatation of a stenosis in a body lumen, delivering a stent, and delivering radiation to the body lumen, comprising the steps of:
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identifying a stenosis in a vessel;
providing a treatment catheter having an elongate flexible tubular body with an inflatable balloon carrying an expandable stent near the distal end thereof, and a cylindrical thin film radiation delivery layer on the balloon, an encapsulant layer over the radiation delivery layer, a continuous seal between the encapsulant, the delivery layer and the balloon along at least the length of the radiation delivery layer;
transluminally advancing the balloon through the vessel;
positioning the balloon within the stenosis;
inflating the balloon to radially expand the vessel in the area of the stenosis; and
simultaneously expand and deliver the stent; and
delivering radiation from the thin film to the vessel wall.
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38. A method of manufacturing a sealed source radiation delivery balloon catheter, comprising the steps of:
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extruding a tube for producing a balloon, having a bonding layer on a radially outwardly facing surface thereof;
positioning an annular radiation delivery source on the balloon bonding layer;
extruding a tubular encapsulant having a sealing layer on a radially inwardly directed surface thereof;
positioning the encapsulant concentrically around the radiation source and the balloon to produce a balloon-source-encapsulant stack;
exposing the balloon-source-encapsulant stack to elevated temperature to bond at least one of the balloon and the encapsulant to the source thereby producing a sealed source. - View Dependent Claims (39, 40, 41, 42, 43, 44, 45, 46, 47, 48)
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49. A multilayer radiation delivery source, comprising:
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a first portion comprising a first support layer having a first bonding layer thereon;
a second portion comprising a second support layer having a second bonding layer thereon; and
a third portion comprising an isotope;
wherein the third portion lies between the first and second bonding layers and the first and second bonding layers begin to melt at a different temperature than the first and second support layers. - View Dependent Claims (50)
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Specification