Multi-function catheter and use thereof

• US 8,251,948 B2
• Filed: 03/17/2009
• Issued: 08/28/2012
• Est. Priority Date: 02/01/2002
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Vascular Designs, Inc.
• Inventors: Goldman, Robert J.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Landry, II, Gerald
• Application Number:
  US12/405,592
• Publication Number:
  US 20090182227A1
• Time in Patent Office: 1,260 Days
• Field of Search: 604 9601-10314
• US Class Current: 604/96.01
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter for delivering an agent to an area of treatment is presented. The catheter includes a catheter body, a balloon assembly coupled to the catheter body, a first lumen, and a second lumen. The balloon assembly has spaced-apart balloons that define an area between the balloons. The first lumen extends along the catheter body to pass an inflation material to the balloons to control an inflation level of the balloons. The second lumen extends along the catheter body and having an outlet in the area between the balloons. There may be a third lumen for bypassing a biological fluid such as blood while the catheter is being used. The method of using this catheter is also presented. The method entails simultaneously inflating the balloons to isolate a treatment area and adding an agent to the treatment area through one of the lumens.

Claims

1. A method of delivering a treatment material to a treatment area, the method comprising:

providing a catheter with a distally tapered body that is attached to spaced-apart balloons, the tapered body comprising a distal face and tapered sidewall with a diameter between 1.17 mm and 0.76 mm, the catheter having a first lumen for delivering inflation material to the spaced-apart balloons, a second lumen configured to directly deliver treatment material between the spaced-apart balloons a third lumen for holding a guide wire, the third lumen comprising a bypass opening in a sidewall of the third lumen for allowing biological fluid to pass simultaneously into and out of the third lumen while the spaced apart balloons are inflated, each lumen extending along the catheter, and wherein the first lumen is larger than the second lumen and the third lumen, and wherein the third lumen has a generally constant size along the distally tapered body of the catheter;

positioning the catheter with the aid of a guide wire located within the third lumen so that the area of treatment is between the spaced-apart balloons;

simultaneously controlling an inflation level of the spaced-apart balloons to create the treatment area between the spaced-apart balloons, wherein the controlling includes passing an inflation material through the first lumen that has an opening into each of the spaced-apart balloons;

withdrawing the guide wire to allow fluid to pass through the third lumen while the spaced-apart balloons are inflated; and

passing the treatment material through a second lumen into the treatment area.

2. The method of claim 1 further comprising inflating the spaced-apart balloons until the spaced-apart balloons touch the treatment area and form an isolated area between the spaced-apart balloons.

3. The method of claim 2 further comprising allowing a biological fluid to flow through a third lumen to allow a biological fluid to flow through the catheter and around the area between the spaced-apart balloons when the spaced-apart balloons are inflated.

4. The method of claim 1 further comprising positioning the spaced-apart balloons by using a marker that is located at predetermined positions relative to the spaced-apart balloons.

5. The method of claim 1, wherein the treatment material comprises a chemotherapy agent.

6. The method of claim 1, wherein the treatment material comprises an imaging agent.

7. The method of claim 1, wherein the treatment material is an embolic material.

8. The method of claim 1, wherein the treatment material further comprises a viscous treatment material that embolizes a tumor.

9. The method of claim 8, wherein the viscous treatment material further comprises a mixture of a contrast agent and a second material.

10. The method of claim 9, wherein the second material further comprises one of a chemotherapy agent and a saline agent.

11. The method of claim 1 further comprising perfusing a treatment material through an open distal end of the catheter.

12. A method of isolating an area of treatment, the method comprising:

providing a catheter with a distally tapered body that is attached to spaced-apart proximal and distal balloons, the tapered body comprising a distal face and a tapered sidewall with a diameter between 1.17 mm and 0.76 mm, the catheter having a treatment lumen extending along the catheter for directly delivering treatment material to a treatment chamber bounded by the proximal and distal balloon elements and a biological path wall upon inflation, a bypass lumen for holding a guide wire, wherein the bypass lumen comprises a bypass opening proximal to the proximal balloon to allow biological fluid to pass simultaneously into and out of the bypass lumen, wherein the bypass lumen has a generally constant size along the distally tapered body of the catheter;

positioning the catheter with the aid of a guide wire so that the area of treatment is between the spaced-apart balloons; and

simultaneously controlling an inflation level of the spaced-apart balloons by passing a first inflation material through an inflation lumen that has an opening into each of the spaced-apart balloons to isolate the area of treatment, and wherein the inflation lumen is larger than the treatment lumen and the bypass lumen;

withdrawing the guide wire from the catheter while the spaced-apart balloons are inflated to allow fluid to pass through the area of treatment.

13. The method of claim 12 further comprising adding an imaging agent to the area of treatment and inflating the balloons until there is no leakage of the imaging agent to areas around the area of treatment.