Radiation delivery balloon catheter

• US 6,176,821 B1
• Filed: 07/21/1998
• Issued: 01/23/2001
• Est. Priority Date: 01/31/1997
• Status: Expired due to Fees

• Current Assignee: Radiance Medical Systems, Inc.
• Original Assignee: Radiance Medical Systems, Inc.
• Inventors: Kick, George F., Crocker, Michael, Siminuk, Mark A.
• Primary Examiner(s): Gilbert, Samuel G.
• Application Number:
  US09/119,828
• Time in Patent Office: 917 Days
• Field of Search: 600/1-9
• US Class Current: 600/3
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 2005/1004 having expandable radiation sources
• CPC Class Codes: A61N 2005/1005 with asymmetrical radiation pattern
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

Disclosed is a balloon catheter having an inflatable balloon having a radiation carrier such as a radiation delivery layer thereon. In one embodiment, the radiation delivery layer comprises one or more layers of metal foil, such as gold. The foil is irradiated, and the balloon is thereafter positioned at a treatment site in a vessel and expanded to bring the metal foil layer into close proximity with the vessel wall. In another embodiment, the radiation carrier is in the form of a dopant in the balloon material. Methods of using the balloon include radiation dosing a site following a balloon dilatation or other procedure, and simultaneously performing balloon angioplasty and radiation dosing.

Claims

1. A radiation delivery balloon catheter, comprising:

an elongate flexible tubular body having a proximal end and a distal end;

an inflatable balloon on the tubular body having a proximal end, a distal end and a working length there between, said balloon in fluid communication with an inflation lumen extending axially through the tubular body;

a tubular non-liquid substantially inelastic radiation source secured to the balloon; and

an outer tubular sleeve surrounding the radiation source, wherein the sleeve is necked down to the tubular body proximally and distally of the balloon.

2. A radiation delivery balloon catheter as in claim 1, wherein the radiation source is no more than about 0.001 inches thick.

3. A radiation delivery balloon catheter as in claim 2, wherein the radiation source is within the range of from about 0.0001 inch to about 0.009 inch thick.

4. A radiation delivery balloon catheter as in claim 1, further comprising a guide wire lumen extending axially throughout at least a portion of the catheter.

5. A radiation delivery balloon catheter as in claim 4, further comprising a proximal guide wire access port on the tubular body, positioned distally of the proximal end of the tubular body.

6. A radiation delivery balloon catheter as in claim 1, further comprising a perfusion conduit extending through the tubular body from a proximal side of the inflatable balloon to a distal side of the inflatable balloon, at least a first perfusion port on the tubular body on the proximal side of the balloon and at least a second perfusion port on the tubular body on the distal side of the balloon.

7. A radiation delivery balloon catheter as in claim 1, further comprising an implantable stent mounted on the balloon.

8. A radiation delivery balloon catheter as in claim 1, wherein the balloon comprises a cylindrical section having a larger inflated diameter than a proximal cylindrical section and a distal cylindrical section.

9. A radiation delivery balloon catheter as in claim 1, wherein the radiation delivery source comprises a metal.

10. A radiation delivery balloon catheter as in claim 1, wherein the radiation delivery source is selected from the group consisting of Pt, P-32, Y-90, Au-198, Ir-192, Mo-99, and combinations thereof.

11. A radiation delivery balloon catheter as in claim 1, wherein the radiation delivery source is doped into the material of the balloon.

12. A radiation delivery balloon catheter as in claim 1, wherein the radiation delivery source comprises a non metal.

13. A method of treating a site within a vessel, comprising the steps of:

identifying a site in a vessel to be treated;

providing a radiation delivery catheter including an elongate flexible tubular body having an expandable balloon with a continuous, annular, substantially inelastic radiation delivery layer thereon and an outer sleeve surrounding the radiation delivery layer, wherein the outer sleeve is necked down to the tubular body proximally and distally of the balloon;

positioning the balloon within the treatment site;

inflating the balloon to position the radiation delivery layer against the vessel wall;

delivering a circumferentially substantially uniform dose of radiation from the delivery balloon to the vessel wall; and

thereafter deflating the balloon and removing the balloon from the treatment site.

14. A method as in claim 13, wherein the providing step comprises providing a radiation delivery catheter having an expandable balloon with a stent thereon.

15. A method of simultaneously performing balloon dilatation of a stenosis in a body lumen and delivering radiation to the body lumen, comprising the steps of:

identifying a stenosis in a body lumen;

providing a treatment catheter having an elongate flexible tubular body with an inflatable balloon near the distal end thereof, a cylindrical non liquid substantially inelastic radiation delivery layer on the balloon, and an outer sleeve surrounding the radiation delivery layer wherein the outer sleeve is necked down to the tubular body proximally and distally of the balloon;

percutaneously inserting and transluminally advancing the balloon through the vessel;

positioning the balloon within the stenosis;

inflating the balloon to radially expand the vessel in the area of the stenosis;

simultaneously delivering radiation from the radiation delivery layer to the vessel wall; and

thereafter deflating the balloon and removing the balloon from the lumen.

16. A method as in claim 15, wherein the catheter further comprises a perfusion conduit extending through the tubular body from a proximal side of the inflatable balloon to a distal side of the inflatable balloon, at least a first perfusion port on the tubular body proximally of the balloon and at least a second perfusion port on the tubular body distally of the balloon.