Multi-function catheter and use thereof

• US 8,062,251 B2
• Filed: 01/09/2008
• Issued: 11/22/2011
• 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 ERNEST
• Application Number:
  US11/971,859
• Publication Number:
  US 20080208118A1
• Time in Patent Office: 1,413 Days
• Field of Search: 604/103.01, 604/509, 604/96.01, 604/103.1
• US Class Current: 604/103.01
• 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 catheter for delivering an agent to an area of treatment, the catheter comprising:

a catheter body;

an inflatable balloon assembly coupled to a distal end of the catheter body, the balloon assembly having at least a proximal balloon element and a distal balloon element spaced apart relative to one another, the balloon assembly defining a treatment chamber bounded by the balloon elements and a biological path wall upon inflation;

a first lumen extending along the catheter body to pass an inflation material to the balloon elements to control an inflation level thereof;

a second lumen extending along the catheter body and having an outlet in the treatment chamber; and

a third lumen extending through the catheter body configured for guidewire passage and to allow a biological fluid to flow through the catheter and around the treatment chamber when the balloon elements are inflated;

wherein the first lumen is larger in size than the second lumen and the third lumen; and

wherein the catheter further comprises a first marker and a second marker on the catheter body, wherein the first marker and the second marker are positioned at predetermined locations between the proximal balloon element and the distal balloon element to indicate a placement of the catheter relative to the treatment chamber.

2. The catheter of claim 1, wherein the first lumen, the second lumen, and the third lumen are separate throughout the catheter body.

3. The catheter of claim 1, wherein the balloon elements comprise polyisoprene.

4. The catheter of claim 1, further comprising a tip made of a radiopaque material.

5. The catheter of claim 1, wherein the outlet is through a side wall of the catheter body.

6. The catheter of claim 5, wherein the second lumen is configured to deliver a treatment material to the outlet, the treatment material being a saline solution.

7. The catheter of claim 5, wherein the second lumen is configured to deliver a treatment material to the outlet, the treatment material being a chemotherapy agent.

8. The catheter of claim 5, wherein the second lumen is configured to deliver a treatment material to the outlet, the treatment material being a mixture of a chemotherapy agent and an imaging agent.

9. The catheter of claim 5, wherein the second lumen is configured to deliver an embolic material to the outlet.

10. The catheter of claim 1, wherein the outlet is on an outer surface of the catheter body.

11. The catheter of claim 1, wherein at least one of the first and the second lumens extend through the catheter body.

12. The catheter of claim 1, wherein each of the proximal and distal balloon elements inflate around the catheter body.

13. The catheter of claim 1, wherein the inflation material is a saline solution.

14. The catheter of claim 1, wherein the catheter has an open distal end and wherein the catheter further comprises a guidewire lumen that is capable of delivering a treatment material through the open distal end of the catheter.

15. The catheter of claim 1, wherein the second lumen is configured to deliver a treatment material to the outlet, the treatment material being a viscous treatment material that embolizes a tumor.

16. The catheter of claim 15, wherein the viscous treatment material further comprises a mixture of a contrast agent and a second material.

17. The catheter of claim 16, wherein the viscous treatment material further comprises one of a chemotherapy agent and a saline agent.

18. A catheter for delivering an agent to an area of treatment, the catheter comprising:

a catheter body;

an inflatable balloon assembly coupled to the catheter body, the balloon assembly having at least a proximal balloon element and a distal balloon element spaced apart relative to one another, the balloon assembly defining a treatment chamber bounded by the balloon elements and a biological path wall upon inflation;

a first lumen extending along the catheter body that is capable of providing an inflation material to the balloon elements, to control an inflation level thereof; and

a second lumen extending along the catheter body and having an outlet in the treatment chamber;

wherein the first lumen is larger than the second lumen; and

wherein the catheter further comprises a first marker and a second marker on the catheter body, wherein the first marker and the second marker are positioned at predetermined locations between the proximal balloon element and the distal balloon element to indicate a placement of the catheter relative to the treatment chamber.

19. The catheter of claim 18 further comprising a third lumen extending through the catheter body to allow a biological fluid to flow through the catheter and around the treatment chamber when the balloon elements are inflated;

and wherein the first lumen is larger than the third lumen.

20. The catheter of claim 19, wherein the first lumen, the second lumen, and the third lumen are separate throughout the catheter body.

21. The catheter of claim 18, wherein the balloon elements comprise polyisoprene.

22. The catheter of claim 18, further comprising a tip made of a radiopaque material.

23. The catheter of claim 18, wherein the outlet is through a side wall of the catheter body.

24. The catheter of claim 23, wherein the second lumen is configured to deliver an agent to the outlet, the agent being a saline solution.

25. The catheter of claim 23, wherein the second lumen is configured to deliver an agent to the outlet, the agent being a chemotherapy agent.

26. The catheter of claim 23, wherein the second lumen is configured to deliver an agent to the outlet, the agent being a mixture of a chemotherapy agent and an imaging agent.

27. The catheter of claim 23, wherein the second lumen is configured to deliver an embolic material to the outlet.

28. The catheter of claim 18, wherein the outlet is on an outer surface of the catheter body.

29. The catheter of claim 18, wherein at least one of the first and the second lumens extend through the catheter body.

30. The catheter of claim 18, wherein each of the proximal and distal balloon elements inflate around the catheter body.

31. The catheter of claim 18, wherein the inflation material is a saline solution.

32. The catheter of claim 18, wherein the catheter has an open distal end and wherein the catheter further comprises a guidewire lumen that is capable of delivering an agent through the open distal end of the catheter.

33. The catheter of claim 18, wherein the second lumen is configured to deliver an agent to the outlet, the agent being a viscous agent that embolizes a tumor.

34. The catheter of claim 33, wherein the viscous agent further comprises a mixture of a contrast agent and a second material.

35. The catheter of claim 34, wherein the viscous agent further comprises one of a chemotherapy agent and a saline agent.