Double balloon catheter and methods for homogeneous drug delivery using the same
First Claim
1. A method for site-specific delivery of a therapeutic agent to a blood vessel of a patient comprising the steps of:
- inflating first and second balloons of a catheter to define a treatment window between the first and second balloons;
maintaining a fluid within the treatment window;
selectively opening a closed drain passage that extends through the catheter to allow the fluid within the treatment window to be displaced from the treatment window and into the catheter through a leak aperture defined within a shaft of the catheter;
delivering a therapeutic agent to the treatment window to displace the fluid from within the treatment window; and
upon opening the drain passage, displacing the fluid through the drain passage by moving the fluid from the leak aperture to an opening defined in a distal end of the catheter that is positioned distally of the first and second balloons.
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Accused Products
Abstract
The present disclosure is directed to a catheter for site-specific delivery of a therapeutic agent to a blood vessel of a patient. The catheter further includes an elongated shaft having at least one inner lumen, a distal end and a proximal end and proximal and distal vessel-conforming balloons where each is separately positionable and inflatable, and when inflated, substantially restricts blood flow in the vessel and creates a treatment window of a defined but variable length for delivery of the therapeutic agent. The catheter optionally includes at least one marker band adjacent to the proximal balloon and at least one marker band adjacent to the distal balloon. At least one lateral aperture positioned in the window is in fluid communication with a drug delivery conduit located within either the inner shaft or the outer shaft to provide a homogeneous concentration of the therapeutic agent to the window.
94 Citations
17 Claims
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1. A method for site-specific delivery of a therapeutic agent to a blood vessel of a patient comprising the steps of:
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inflating first and second balloons of a catheter to define a treatment window between the first and second balloons; maintaining a fluid within the treatment window; selectively opening a closed drain passage that extends through the catheter to allow the fluid within the treatment window to be displaced from the treatment window and into the catheter through a leak aperture defined within a shaft of the catheter; delivering a therapeutic agent to the treatment window to displace the fluid from within the treatment window; and upon opening the drain passage, displacing the fluid through the drain passage by moving the fluid from the leak aperture to an opening defined in a distal end of the catheter that is positioned distally of the first and second balloons. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method for site-specific delivery of a therapeutic agent to a blood vessel of a patient comprising the steps of:
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inflating first and second balloons of a catheter to define a treatment window between the first and second balloons; maintaining a fluid within the treatment window; selectively opening a leak aperture defined within the catheter to allow the fluid within the treatment window to be displaced from the treatment window and into a drain passage that extends through the catheter; delivering a therapeutic agent to the treatment window to displace the fluid from within the treatment window; and positioning a guidewire within the catheter to block the leak aperture and prevent displacement of the fluid from the treatment window. - View Dependent Claims (9)
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10. A method of site-specific delivery of a therapeutic agent to a blood vessel of a patient comprising:
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inserting a catheter into the vessel, the catheter supporting a proximal balloon and a distal balloon and defining a plurality of apertures; inflating the proximal balloon to substantially restrict blood flow through the vessel; inflating the distal balloon to form a treatment window between the proximal balloon and the distal balloon; positioning a guidewire within the catheter to block a distal leak aperture defined within the catheter; moving the guidewire to enable fluid within the treatment window to be displaced from the treatment window through the distal leak aperture and distally through a distal end of the catheter; and delivering the therapeutic agent through at least one of the plurality of apertures to displace the fluid disposed within the treatment window through the distal leak aperture to provide a substantially homogenous concentration of therapeutic agent within the treatment window. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17)
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Specification