Soft body catheter with low friction lumen
The disclosure is directed to radiation catheter devices, methods for controlled application of irradiation to tissue at a body site, such as a cavity formed after removal of tissue, e.g. cancer, using such radiation catheter devices, solutions for forming a more lubricious luminal surface and method for lining lumens of such devices to improve the frictional characteristics thereof. The catheter device includes a flexible elongated shaft which is formed of low durometer polymeric material, which can be readily folded or coiled for securing the shaft to or under the skin of the patient and a radiation lumen lined with high durometer polymeric material and finely divided particulate to improve the frictional characteristics. The elongated shaft has at least one inner lumen for receiving a radiation source which has a layer of high durometer polymeric material that provides lower surface friction to facilitate advancement of a radiation source therein.
1 . An elongated catheter device for irradiating tissue surrounding a body site within a patient, comprising:
a. a treatment location on a distal portion of the catheter device;
b. an elongated flexible shaft which is formed at least in part of a low durometer polymeric material and which has at least one radiation lumen extending within a portion of the shaft formed of the low durometer polymeric material to the treatment location and configured to receive a radiation source; and
c. a coating of high durometer polymeric material lining at least in part one of the radiation lumens to provide improved frictional characteristics thereto.
2 . The device of claim 1 , wherein the low durometer material has a durometer hardness of about 70A to 25D Shore.
3 . The device of claim 1 , wherein the high durometer material has a durometer hardness of at least 40D Shore.
4 . The device of claim 1 , wherein the lining is formed by applying a solution of high durometer polymeric material in a non-aqueous solvent to the surface of the lumen, evaporating the solvent and leaving a layer of the high durometer polymeric material deposited on the lumen surface.
5 . The device of claim 4 , wherein the non-aqueous solvent is selected from the group consisting of tetrahydrofuran, cyclohexanone, dimethyl formamide, or a combination thereof.
6 . The device of claim 4 , wherein the solvent contains about 0.1 to about 5% (by wt.) high durometer polymeric material.
7 . The device of claim 6 , wherein the solvent contains about 0.5 to about 2% (by wt.) high durometer polymeric material.
8 . The device of claim 1 , wherein a plurality of lumens extending within the flexible portion of the shaft are lined with high durometer polymeric material.
9 . The device of claim 6 , wherein the high durometer polymeric material of a layer on the surface of the inner lumen has a Shore durometer hardness of about 50D to about 80D.
10 . The device of claim 1 , wherein an inflatable balloon surrounds at least part of the treatment location.
11 . The device of claim 10 , wherein the flexible elongated shaft has at least one inflation lumen extending therein to the treatment location and in fluid communication with the interior of the balloon.
12 . The device of claim 10 , wherein the balloon is configured to partially fill the body cavity when inflated to a turgid condition.
13 . The device of claim 1 , wherein a distal portion of the device comprises a plurality of tubular members with an inner lumen extending through each of the plurality of tubular members configured to receive a radiation source.
14 . The device of claim 13 , wherein one or more of the tubular members are deflected or deflectable toward the first portion of tissue surrounding the body cavity to be closer thereto.
15 . The device of claim 13 , which includes a support member extending within the distal portion of the shaft to support the tubular members extending within the distal portion.
16 . The device of claim 1 , wherein the distal shaft portion has a vacuum port and a vacuum lumen in fluid communication with the vacuum port.
17 . The device of claim 16 , wherein the vacuum lumen is configured to be in fluid communication with a vacuum source.
18 . The device of claim 1 , wherein a radiation source is slidably disposed within the radiation delivery lumen and configured to be disposed in the treatment location.
19 . The device of claim 1 wherein the coating of high durometer polymeric material lining at least in part one of the radiation lumens contains particulate.
20 . The device of claim 19 wherein the particulate is less than about 0.002 inch in diameter.
21 . The device of claim 19 wherein the particulate is about 0.00025 to about 0.0005 inch in diameter.
22 . The device of claim 19 wherein the coating is formed by applying a slurry of particulate in a solution of high durometer polymeric material in a non-aqueous solvent to the surface of the lumen, evaporating the solvent and leaving a layer of the high durometer polymeric material and particulate deposited on the lumen surface.
23 . The device of claim 22 wherein the particulate is not soluble in the solvent.
24 . The device of claim 23 wherein the particulate is formed of starch.