Device for in vivo radiation delivery and method for delivery
First Claim
1. A medical device for radiation treatment of a body lumen, compromising:
- an elongated tubular member having an proximal end and a distal end;
an inflatable member having a proximal end, distal end, and a inflatable member wall defining a cavity therein being filled with a radioactive compound;
an inflation lumen having a substantially circularly shaped cross-section longitudinally extending throughout the entire length of the tubular member from the proximal end of the elongated tubular member to the distal end of the tubular member, wherein the inflation lumen terminates at the proximal end of the inflatable member, and is in fluid communication with the cavity of the inflatable member wherein a ratio of an inner diameter of the inflated inflatable member to an inner diameter of the inflation lumen is about 3.33 or greater; and
further wherein the inflation lumen contains the radioactive compound;
a guidewire lumen having a proximal end and a distal end, the guidewire lumen longitudinally extending through the tubular member;
a guidewire access port being connected to the elongated tubular member at the distal end of the tubular member; and
a seal defining a seal inflation lumen, the seal inflation lumen being in fluid communication with the inflation lumen as well as with the cavity of the inflatable member with a passage providing a single access to the cavity of the inflatable member via the inflation lumen.
1 Assignment
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Accused Products
Abstract
A method and an apparatus are provided for delivery of radiation in vivo. A device includes a seal located proximal to a balloon through which a cavity of the balloon is inflated with a composition including a radioactive compound. The seal includes a passage therethrough which provides the only access to the balloon cavity and terminates at the proximal end of the balloon. The passage through the seal provides fluid communication with an inflation lumen within the medical device lumen, wherein a ratio of an inner diameter of the inflatable member to an inner diameter of the inflation lumen is about 0.5 or greater. In such a construction, inflation and evacuation can be accomplished without contamination of the entire medical device lumen. Thus, substantially all of the solution including the radioactive compound can be evacuated from the balloon cavity after treatment due to the positioning of the passage in the seal.
77 Citations
28 Claims
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1. A medical device for radiation treatment of a body lumen, compromising:
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an elongated tubular member having an proximal end and a distal end; an inflatable member having a proximal end, distal end, and a inflatable member wall defining a cavity therein being filled with a radioactive compound; an inflation lumen having a substantially circularly shaped cross-section longitudinally extending throughout the entire length of the tubular member from the proximal end of the elongated tubular member to the distal end of the tubular member, wherein the inflation lumen terminates at the proximal end of the inflatable member, and is in fluid communication with the cavity of the inflatable member wherein a ratio of an inner diameter of the inflated inflatable member to an inner diameter of the inflation lumen is about 3.33 or greater; and
further wherein the inflation lumen contains the radioactive compound;a guidewire lumen having a proximal end and a distal end, the guidewire lumen longitudinally extending through the tubular member; a guidewire access port being connected to the elongated tubular member at the distal end of the tubular member; and a seal defining a seal inflation lumen, the seal inflation lumen being in fluid communication with the inflation lumen as well as with the cavity of the inflatable member with a passage providing a single access to the cavity of the inflatable member via the inflation lumen. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A catheter for radiation treatment of a body lumen compromising:
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a one piece tubular member having a proximal end, a distal end, and a lumen; a balloon having a distal end, a proximal end, an outer surface, and an inner surface defining a cavity therein, the proximal end being attached to the tubular member in proximity to the distal end, wherein the balloon contains a radioactive compound; a guidewire lumen and an inflation lumen longitudinally disposed within the lumen of the tubular member; a seal located in the proximal end of the balloon defining a seal inflation lumen, the seal inflation lumen being in fluid communication with the inflation lumen as well as with the cavity of the balloon; a delivery lumen having a substantially circularly shaped cross-section longitudinally disposed throughout the length of the lumen of the tubular member, wherein the delivery lumen is in fluid communication with the cavity of the balloon through the seal and is filled with the radioactive compound; and a flexible extension tube located in proximity to the proximal end of the tubular member, the flexible extension defining an extension tube lumen, the flexible extension tube lumen being in fluid communication with the delivery lumen and is filled with radioactive compound. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16)
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17. A method for delivery localized radiation in vivo comprising the steps of:
providing a catheter compromising; a one piece tubular member having a proximal end, a distal end and a lumen; a balloon having a distal end, a proximal end and a wall defining a cavity therein, the proximal end being sealed to the tubular member; a guidewire lumen and an inflation lumen longitudinally disposed within the tubular member from the proximal end to the distal end; a seal defining a seal inflation lumen, the seal inflation lumen being in fluid communication with the inflation lumen as well as with the cavity of the balloon, wherein the seal sealingly engages the distal end of the tubular member to the proximal end of the balloon; a delivery lumen having a substantially circularly shaped cross-section longitudinally disposed throughout the entire length of the tubular member, wherein the delivery lumen is in fluid communication with the cavity of the balloon through the passage in the seal, wherein a ratio of an inner diameter of the inflated balloon to an inner diameter of the inflation lumen is about 3.33 or greater; positioning the catheter in proximity to a desired in vivo location; and inflating the balloon with a solution including a radioactive material through the delivery lumen. - View Dependent Claims (18)
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19. A system for in vivo delivery of radiation therapy comprising:
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a radiation source; and a medical device operably linked to the radiation source, wherein the medical device comprises; an elongated tubular member having an proximal end, a distal end, and a inflatable member wall defining a cavity therein; an inflation lumen adapted for receiving a radioactive compound, the inflation lumen having a substantially circularly shaped cross-section longitudinally extending throughout the entire length of the tubular member from the proximal end of the elongated tubular member to the distal end of the tubular member, wherein the inflation lumen terminates at the proximal end of the inflatable member and a passageway providing access to the cavity of the inflatable member via the inflation lumen; a guidewire lumen longitudinally extending substantially from a guidewire access port operatively connected to the elongated tubular member to the distal end of the tubular member; a seal defining a seal inflation lumen, the seal inflation lumen being in fluid communication with the inflation lumen as well as with the cavity of the inflatable member, wherein the seal sealingly engages the tubular member to the inflatable member; and a flexible extension tube located in proximity to the proximal end of the tubular member, the flexible extension defining an extension tube lumen the flexible extension tube lumen being in fluid communication with the inflation lumen. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26, 27, 28)
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Specification