Balloon catheter for delivering a therapeutic agent
First Claim
1. A balloon intraluminal drug delivery catheter assembly, comprising:
- a catheter shaft extending from a proximal end to a distal end and comprising an inflation lumen and a fluid delivery lumen extending through at least a portion of the catheter shaft, the catheter shaft further comprising a thermoformable polymer disposed around the inflation lumen and fluid delivery lumen;
a first balloon mounted on a distal region of the catheter shaft in communication with the inflation lumen; and
a second balloon disposed around the first balloon and defining an annular balloon fluid delivery lumen between the first balloon and the second balloon in communication with the fluid delivery lumen, the second balloon including a plurality of apertures in communication with the annular balloon fluid delivery lumen, the plurality of apertures being disposed along a longitudinal portion of the second balloon;
wherein the catheter shaft further comprises an intermediate region interposed between a proximal region and a distal region and a wire guide port disposed along the intermediate region, the catheter shaft comprising a guide wire lumen extending through at least a portion of the distal region and being adjacent the inflation lumen and fluid delivery lumen, and the guide wire lumen being in communication with the wire guide port; and
wherein the catheter shaft further comprises a first portion having the inflation lumen and the fluid delivery lumen in a coaxial configuration and a second portion having the inflation lumen and the fluid delivery lumen in a side-by-side configuration, the second portion extending from the second balloon to at least a portion of the proximal region, and the first portion extending from the second portion to a manifold comprising an inflation port in communication with the inflation lumen and an injection port in communication with the fluid delivery lumen.
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Accused Products
Abstract
Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel. Preferably, the catheter balloon assemblies include a stiffening′ member (210) within the proximal portion and/or a plurality of lumens lined with a fluorinated hydrocarbon to independently inflate the inner balloon, deliver the therapeutic agent through the outer balloon and house a wire guide (50). The catheter balloon assemblies may provide improved tractability and/or pushability characteristics.
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Citations
20 Claims
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1. A balloon intraluminal drug delivery catheter assembly, comprising:
- a catheter shaft extending from a proximal end to a distal end and comprising an inflation lumen and a fluid delivery lumen extending through at least a portion of the catheter shaft, the catheter shaft further comprising a thermoformable polymer disposed around the inflation lumen and fluid delivery lumen;
a first balloon mounted on a distal region of the catheter shaft in communication with the inflation lumen; and a second balloon disposed around the first balloon and defining an annular balloon fluid delivery lumen between the first balloon and the second balloon in communication with the fluid delivery lumen, the second balloon including a plurality of apertures in communication with the annular balloon fluid delivery lumen, the plurality of apertures being disposed along a longitudinal portion of the second balloon; wherein the catheter shaft further comprises an intermediate region interposed between a proximal region and a distal region and a wire guide port disposed along the intermediate region, the catheter shaft comprising a guide wire lumen extending through at least a portion of the distal region and being adjacent the inflation lumen and fluid delivery lumen, and the guide wire lumen being in communication with the wire guide port; and wherein the catheter shaft further comprises a first portion having the inflation lumen and the fluid delivery lumen in a coaxial configuration and a second portion having the inflation lumen and the fluid delivery lumen in a side-by-side configuration, the second portion extending from the second balloon to at least a portion of the proximal region, and the first portion extending from the second portion to a manifold comprising an inflation port in communication with the inflation lumen and an injection port in communication with the fluid delivery lumen. - View Dependent Claims (2, 3, 4, 5, 6, 7)
- a catheter shaft extending from a proximal end to a distal end and comprising an inflation lumen and a fluid delivery lumen extending through at least a portion of the catheter shaft, the catheter shaft further comprising a thermoformable polymer disposed around the inflation lumen and fluid delivery lumen;
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8. A balloon intraluminal drug delivery catheter assembly, comprising:
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a catheter shaft extending from a proximal end to a distal end and comprising an inflation lumen and a fluid delivery lumen extending through at least a portion of the catheter shaft, the catheter shaft further comprising a thermoformable polymer disposed around the inflation lumen and fluid delivery lumen; a first balloon mounted on a distal region of the catheter shaft in communication with the inflation lumen; and a second balloon disposed around the first balloon and defining an annular balloon fluid delivery lumen between the first balloon and the second balloon in communication with the fluid delivery lumen, the second balloon including a plurality of apertures in communication with the annular balloon fluid delivery lumen, the plurality of apertures being disposed along a longitudinal portion of the second balloon; and
having a total cross sectional area that increases in a distal longitudinal direction along the second balloon;wherein the catheter shaft further comprises an intermediate region interposed between a proximal region and a distal region and a wire guide port disposed along the intermediate region, the catheter shaft comprising a guide wire lumen extending through at least a portion of the distal region and being adjacent the inflation lumen and fluid delivery lumen, and the guide wire lumen being in communication with the wire guide port; wherein the catheter shaft further comprise a first portion having the inflation lumen and the fluid delivery lumen in a coaxial configuration and a second portion having the inflation lumen and the fluid delivery lumen in a side-by-side configuration, the second portion extending from the second balloon to at least a portion of the proximal region, and the first portion extending from the second portion to a manifold comprising an inflation port in communication with the inflation lumen and an injection port in communication with the fluid delivery lumen; and wherein the catheter shaft further comprises a first tubular member defining the inflation lumen and a second tubular member defining the fluid delivery lumen, the first and second tubular members comprising fluorinated hydrocarbon liners, and the thermoformable polymer having a lower melting temperature than the fluorinated hydrocarbon liners. - View Dependent Claims (9, 10, 11, 12, 13, 14)
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15. A balloon intraluminal drug delivery catheter assembly, comprising:
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a catheter shaft extending from a proximal end to a distal end and comprising an inflation lumen and a fluid delivery lumen extending through at least a portion of the catheter shaft, the catheter shaft further comprising a thermoformable polymer disposed around the inflation lumen and fluid delivery lumen; a first balloon mounted on a distal region of the catheter shaft in communication with the inflation lumen; and a second balloon disposed around the first balloon and defining an annular balloon fluid delivery lumen between the first balloon and the second balloon in communication with the fluid delivery lumen, the second balloon including a plurality of apertures in communication with the annular balloon fluid delivery lumen, the plurality of apertures being disposed along a longitudinal portion of the second balloon; wherein the catheter shaft further comprises an intermediate region interposed between a proximal region and a distal region and a wire guide port disposed along the intermediate region, the catheter shaft comprising a guide wire lumen extending through at least a portion of the distal region and being adjacent the inflation lumen and fluid delivery lumen, and the guide wire lumen being in communication with the wire guide port; wherein the catheter shaft further comprises a first portion having the inflation lumen and the fluid delivery lumen in a coaxial configuration and a second portion having the inflation lumen and the fluid delivery lumen in a side-by-side configuration, the second portion extending from the second balloon to at least a portion of the proximal region, and the first portion extending from the second portion to a manifold comprising an inflation port in communication with the inflation lumen and an injection port in communication with the fluid delivery lumen; and wherein the catheter shaft further comprises a first tubular member defining the inflation lumen and a second tubular member defining the fluid delivery lumen, the first and second tubular members comprising fluorinated hydrocarbon liners, and the thermoformable polymer having a lower melting temperature than the fluorinated hydrocarbon liners. - View Dependent Claims (16, 17, 18, 19, 20)
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Specification