Radiation catheter with multilayered balloon
View Patent ↗A catheter device for irradiating tissue surrounding a body site within a body of a patient, includes an elongated shaft which has a distal portion configured to be deployed within the body site. A treatment location at the distal portion has one or more radiation guides configured to receive a radiation source to irradiate tissue at least in part surrounding the body site. An inflatable multilayered balloon is located to surround the treatment location with a wall thereof having at least two layers including a first layer separate from, inside, and in contact with a second layer around an entire periphery of the first layer, and each of the first layer and the second layer being secured to the distal portion of the elongated shaft.
1. A catheter device for irradiating tissue surrounding a body site within a body of a patient, comprising:
an elongated shaft which has a distal portion configured to be deployed within the body site;
a radiation source;
a treatment location at the distal portion having one or more radiation guides configured to receive the radiation source to irradiate tissue at least in part surrounding the body site; and
an inflatable multilayered balloon located to surround the treatment location with a wall thereof having at least two layers including a first layer separate from, inside, and in contact with a second layer around an entire periphery of the first layer when in an as formed configuration and an inflated configuration, and each of the first layer and the second layer being secured to the distal portion of the elongated shaft and configured to surround the treatment location in the as formed configuration and the inflated configuration.
2. The catheter device of claim 1 , wherein the inflatable multilayered balloon has a predetermined size and shape when the at least two layers thereof are in the turgid condition.
3. The catheter device of claim 1 , wherein the inflatable multilayered balloon has an expansion of at least 25% but less than 200% from the as formed configuration when the inflatable multilayered balloon is inflated to a turgid condition.
4. The catheter device of claim 1 , wherein the at least two layers of the inflatable multilayered balloon have expansions of about 50% to about 150% when inflated from the as formed configuration to the turgid condition.
5. The catheter device of claim 1 , wherein the at least two layers of the inflatable multilayered balloon has an expansion of less than 175% when inflated from the as formed configuration to the turgid condition.
6. The catheter device of claim 1 , wherein each of the first layer and the second layer of the inflatable multilayered balloon has an individual thickness of about 0.0003 to about 0.006 inch thick.
7. The catheter device of claim 1 , wherein the at least two layers of the inflatable multilayered balloon are about 0.001 inch to about 0.002 inch thick.
8. The catheter device of claim 1 , wherein the total combined thickness of the first layer and the second layer of the inflatable multilayered balloon is about 0.002 inch to about 0.004 inch.
9. The catheter device of claim 1 , comprising an off-set tubular member configured to receive the radiation source, which is off-set from a central longitudinal axis so that in the treatment location the radiation source is closer to a first portion of tissue at the body site than a second portion of tissue.
10. The catheter device of claim 1 , wherein the one or more radiation guides in the distal portion of the elongated shaft comprises a plurality of radiation delivery tubes configured to receive the radiation source.
11. A catheter device for irradiating tissue surrounding a body site within a body of a patient, comprising:
an elongated shaft which has a distal portion configured to be deployed within the body site and a central longitudinal axis;
a radiation source
a treatment location at the distal portion having one or more radiation guides configured to receive the radiation source, with at least one radiation guide off-set from the central longitudinal axis to position the radiation source at a location offset from the central longitudinal axis; and
an inflatable multilayered balloon located to surround the treatment location, the inflatable multilayered balloon having a wall that has at least two layers including a first layer separate from, inside, and in contact with a second layer around an entire periphery of the first layer when in an as formed configuration and an inflated configuration, and each of the first layer and the second layer being secured to the distal portion of the elongated shaft and configured to surround the treatment location in the as formed configuration and the inflated configuration.
12. The catheter device of claim 11 , wherein the inflatable multilayered balloon has a predetermined size and shape when the at least two layers thereof are in the turgid condition.
13. The catheter device of claim 11 , wherein the inflatable multilayered balloon has an expansion of at least 25% but less than 200% from the as formed configuration when the inflatable multilayered balloon is inflated to a turgid condition.
14. The catheter device of claim 11 , wherein the at least two layers of the inflatable multilayered balloon has an expansion of less than 175% when inflated from the as formed configuration to the turgid condition.
15. The catheter device of claim 11 , wherein the at least two layers of the inflatable multilayered balloon have expansions of about 50% to about 150% when inflated from the as formed configuration to the turgid condition.
16. The catheter device of claim 11 , wherein each of the first layer and the second layer of the inflatable multilayered balloon has an individual thickness of about 0.0003 inch to about 0.006 inch thick.
17. The catheter device of claim 11 , wherein the at least two layers of the inflatable multilayered balloon are about 0.001 inch to about 0.002 inch thick.
18. The catheter device of claim 11 , wherein the total combined thickness of the first layer and second layer of the inflatable multilayered balloon is about 0.002 inch to about 0.004 inch.
19. The catheter device of claim 11 , wherein the one or more radiation guides in the distal portion of the elongated shaft comprise a plurality of radiation delivery tubes in fluid communication with a respective plurality of tubular members that extend through the elongated shaft, and with each of the plurality of tubular members configured to receive the radiation source and advance the radiation source to a respective radiation delivery tube of the plurality of radiation delivery tubes.
20. The catheter device of claim 11 , comprising:
at least one vacuum port, each vacuum port being located on the elongated shaft at a location that is one of proximal and distal to the inflatable multilayered balloon; and
a vacuum lumen longitudinally extending through the elongate shaft and configured to be in fluid communication with the at least one vacuum port.