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 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 cavity within a patient, comprising:
a. a treatment location on a distal portion of the catheter device;
b. an elongated flexible shaft which has a longitudinal axis, which is formed at least in part of a low durometer polymeric material and which has a plurality of radiation delivery lumens extending about the longitudinal axis having surfaces formed of the low durometer polymeric material and configured to receive a radiation source; and
c. each of said radiation delivery lumens having a coating that includes a polymeric solute material with a durometer substantially higher than the low durometer polymeric material of the flexible shaft that is deposited from a solution thereof onto the surfaces of said lumens so as to line said radiation delivery lumens and 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 coating is formed by applying solution of the high durometer polymeric solute material in a non-aqueous solvent to the surface of the lumen, evaporating the solvent and leaving a layer of the high durometer polymeric solute 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 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.
9. The device of claim 1 , wherein an inflatable balloon surrounds at least part of the treatment location.
10. The device of claim 9 , 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.
11. The device of claim 9 , wherein the balloon is configured to partially fill the body cavity when inflated to a turgid condition.
12. The device of claim 1 , wherein the distal portion has a vacuum port and a vacuum lumen in fluid communication with the vacuum port.
13. The device of claim 12 , wherein the vacuum lumen is configured to be in fluid communication with a vacuum source.
14. 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.
15. The elongated catheter device of claim 1 wherein the coating comprises pigment particles to provide an undulating or uneven coating surface which reduces contact with the radiation source and the friction between the radiation source and the coating.
16. The elongated catheter device of claim 15 wherein the pigment particles are selected from the group consisting of Reactive Blue, Prussian Blue, iron oxide, titanium dioxide, manganese violet and ultramarine blue.
17. The elongated catheter device of claim 1 wherein the improved frictional characteristics comprises reduced friction.
18. The elongated catheter device of claim 17 wherein the catheter has a friction reducing compound that is at least partially soluble in a solvent.
19. The elongated catheter device of claim 18 wherein the friction reducing compound is selected from the group consisting of mold release agents, surfactants and lubricants.
20. The elongated catheter device of claim 19 wherein the mold release agent is a zinc stearate.
21. The elongated catheter device of claim 19 wherein the surfactant is a polyvinyl alcohol.
22. The elongated catheter device of claim 19 wherein the lubricant is a Carnauba wax.