Expandable fluoropolymer device for delivery of therapeutic agents and method of making
First Claim
1. A method of using a radially expandable fluid delivery device for delivery of one or more therapeutic agents, comprising:
- locating the radially expandable fluid delivery device within a body passage in need of treatment, the radially expandable fluid delivery device formed of a radially inelastic wall having at least one microporous portion formed of a microstructure of nodes interconnected by fibrils having spaces therebetween forming generally aligned micro-channels having a porosity sufficient to cause a fluid containing the one or more therapeutic agents and supplied thereto to provide a radial deployment force to expand the fluid delivery device and to permeate through the micro-channels, the micro-channels substantially controlling the permeation of the fluid from a location interior to the wall to a location exterior to the wall by passing through the wall; and
expanding the radially expandable fluid delivery device using a radial deployment force supplied by the fluid containing the one or more therapeutic agents in such a way that the radially expandable fluid delivery device expands and occludes the body passage and the fluid containing the one or more therapeutic agents flows from the location interior to the wall to the location exterior to the wall by flowing through the wall of the radially expandable fluid delivery device thereby delivering the one or more therapeutic agents to the body passage while also applying the radial deployment force.
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Accused Products
Abstract
A method of making a radially expandable fluid delivery device includes providing a tube of biocompatible fluoropolymer material with a predetermined porosity based on an extrusion and expansion forming process, applying a radial expansion force to the tube expanding the tube to a predetermined diameter dimension, and removing the radial expansion force. The tube is radially inelastic while sufficiently pliable to be collapsible and inflatable from a collapsed configuration to an expanded configuration upon introduction of an inflation force, such that the expanded configuration occurs upon inflation to the predetermined diameter dimension. The fluid delivery device is constructed of a microporous, biocompatible fluoropolymer material having a microstructure that can provide a controlled, uniform, low-velocity fluid distribution through the walls of the fluid delivery device to effectively deliver fluid to the treatment site without damaging tissue proximate the walls of the device.
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Citations
24 Claims
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1. A method of using a radially expandable fluid delivery device for delivery of one or more therapeutic agents, comprising:
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locating the radially expandable fluid delivery device within a body passage in need of treatment, the radially expandable fluid delivery device formed of a radially inelastic wall having at least one microporous portion formed of a microstructure of nodes interconnected by fibrils having spaces therebetween forming generally aligned micro-channels having a porosity sufficient to cause a fluid containing the one or more therapeutic agents and supplied thereto to provide a radial deployment force to expand the fluid delivery device and to permeate through the micro-channels, the micro-channels substantially controlling the permeation of the fluid from a location interior to the wall to a location exterior to the wall by passing through the wall; and expanding the radially expandable fluid delivery device using a radial deployment force supplied by the fluid containing the one or more therapeutic agents in such a way that the radially expandable fluid delivery device expands and occludes the body passage and the fluid containing the one or more therapeutic agents flows from the location interior to the wall to the location exterior to the wall by flowing through the wall of the radially expandable fluid delivery device thereby delivering the one or more therapeutic agents to the body passage while also applying the radial deployment force. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of using a radially expandable fluid delivery device for delivery of one or more therapeutic agents, comprising:
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locating the radially expandable fluid delivery device at a body location, the radially expandable fluid delivery device formed of a radially inelastic wall having at least one microporous portion formed of a microstructure of nodes interconnected by fibrils having spaces therebetween forming generally aligned micro-channels having a porosity sufficient to cause a fluid containing the one or more therapeutic agents and supplied thereto to provide a radial deployment force to expand the fluid delivery device and to permeate through the micro-channels, the micro-channels substantially controlling the permeation of the fluid through the wall, the method; and expanding the radially expandable fluid delivery device using a radial deployment force supplied by the fluid containing the one or more therapeutic agents in such a way that the fluid containing the one or more therapeutic agents flows from a location interior to the wall to a location exterior to the wall by flowing through the wall of the radially expandable fluid delivery device thereby delivering the one or more therapeutic agents to the body location. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A method of using a radially expandable fluid delivery device for delivery of one or more therapeutic agents, comprising:
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locating the radially expandable fluid delivery device within a body passage in need of treatment, the radially expandable fluid delivery device formed of a unitary, seamless and radially inelastic wall comprised of an expanded fluoropolymer, the radially inelastic wall constructed to be tubular and having a distal portion and a proximal portion, the wall having at least one microporous portion formed of a microstructure of nodes interconnected by fibrils having spaces therebetween forming generally aligned micro-channels having a porosity sufficient to cause a fluid containing the one or more therapeutic agents and supplied thereto to provide a radial deployment force to expand the fluid delivery device and to permeate through the micro-channels, the micro-channels substantially controlling the permeation of the fluid outwardly from a location interior to the radially inelastic wall to a location exterior to the radially inelastic wall by passing through the radially inelastic wall, the radially expandable fluid delivery device further comprising a catheter having a sidewall and extending from a proximal end of the radially inelastic wall to a distal end of the radially inelastic wall, at least one aperture in the catheter'"'"'s sidewall for establishing fluid communication between the catheter and the location interior to the radially inelastic wall; and expanding the radially expandable fluid delivery device using a radial deployment force supplied by the fluid containing the one or more therapeutic agents in such a way that the radially expandable fluid delivery device expands and occludes the body passage and the fluid containing the one or more therapeutic agents flows from the location interior to the wall to the location exterior to the wall by flowing through the radially inelastic wall of the radially expandable fluid delivery device thereby delivering the one or more therapeutic agents to the body passage while also applying the radial deployment force.
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Specification