Weeping balloon catheter with drug delivery balloon in fluid communication with combination lumen

• US 9,028,443 B2
• Filed: 04/21/2014
• Issued: 05/12/2015
• Est. Priority Date: 07/01/2013
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: McCullough, Adam Brian
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): DARB, HAMZA A.
• Application Number:
  US14/257,250
• Publication Number:
  US 20150005743A1
• Time in Patent Office: 386 Days
• Field of Search: 604/101.01, 604/101.02, 604/509, 604/510, 604/103.01, 604/103.02, 604/102.01, 604/102.02
• US Class Current: 604/101.02
• CPC Class Codes: A61M 2025/0035 characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall
• CPC Class Codes: A61M 2025/091 having a lumen for drug delivery or suction
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2025/1063 having only one lumen used for guide wire and inflation, e.g. to minimise the diameter
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A weeping balloon catheter includes a catheter having an elongate tubular body defining an inflation lumen and a combination lumen that terminates at an open distal end of the elongate tubular body. A dilation balloon is disposed at a distal end of the elongate tubular body and is in fluid communication with the inflation lumen. A drug delivery balloon is disposed at least partially over the dilation balloon and includes at least one drug release opening through an outer wall of the drug delivery balloon. The drug delivery balloon is in fluid communication with the combination lumen through a sidewall opening of the elongate tubular body.

Claims

1. A weeping balloon catheter, comprising:

a catheter having an elongate tubular body defining an inflation lumen and a combination lumen, wherein the combination lumen terminates at an open distal end of the elongate tubular body;

a dilation balloon mounted on the elongate tubular body and in fluid communication with the inflation lumen; and

a drug delivery balloon disposed at least partially over the dilation balloon and including at least one drug release opening through an outer wall of the drug delivery balloon, wherein the drug delivery balloon is in fluid communication with the combination lumen through a sidewall opening of the elongate tubular body.

2. The weeping balloon catheter of claim 1, further including a wire guide received within the combination lumen, wherein a drug delivery path of the weeping balloon catheter is defined by a first clearance between the wire guide and a wall of the combination lumen and the drug delivery balloon.

3. The weeping balloon catheter of claim 2, wherein the sidewall opening is proximal to the dilation balloon.

4. The weeping balloon catheter of claim 2, wherein the sidewall opening is proximal to a transition of the catheter from a dual lumen catheter to a single lumen catheter.

5. The weeping balloon catheter of claim 2, wherein a distal segment of the catheter has a reduced clearance between the wire guide and the wall of the combination lumen that is less than the first clearance, wherein the distal segment is positioned between the sidewall opening and the open distal end.

6. The weeping balloon catheter of claim 5, wherein, in an expanded state of the dilation balloon, the dilation balloon radially compresses the wall of the combination lumen to define the reduced clearance.

7. The weeping balloon catheter of claim 2, wherein the catheter includes a transition from a dual lumen catheter corresponding to a proximal portion of the catheter to a single lumen catheter corresponding to a distal portion of the catheter.

8. The weeping balloon catheter of claim 7, wherein the dual lumen catheter includes the inflation lumen and the combination lumen arranged in a side-by-side configuration.

9. The weeping balloon catheter of claim 8, wherein the combination lumen includes a wire guide retention feature for restricting movement of the wire guide relative to a high clearance infusion area of the combination lumen.

10. The weeping balloon catheter of claim 7, wherein the dual lumen catheter includes the inflation lumen and the combination lumen arranged in a coaxial configuration.

11. The weeping balloon catheter of claim 2, wherein a distal segment of the wire guide has an increased profile relative to a proximal segment of the wire guide.

12. The weeping balloon catheter of claim 1, further including a wire guide received within the combination lumen, wherein a drug delivery path of the weeping balloon catheter is defined by a hollow tubular body of the wire guide and the drug delivery balloon.

13. A method of operating a weeping balloon catheter, the weeping balloon catheter including a catheter having an elongate tubular body defining an inflation lumen and a combination lumen, wherein the combination lumen terminates at an open distal end of the elongate tubular body, a dilation balloon mounted on the elongate tubular body and in fluid communication with the inflation lumen, and a drug delivery balloon disposed at least partially over the dilation balloon and including at least one drug release opening through an outer wall of the drug delivery balloon, wherein the drug delivery balloon is in fluid communication with the combination lumen through a sidewall opening of the elongate tubular body, the method comprising steps of:

advancing the combination lumen over a wire guide toward a target site within a body lumen;

advancing a therapeutic agent along a drug delivery path defined by a first clearance between the wire guide and a wall of the combination lumen and the drug delivery balloon; and

releasing the therapeutic agent from the drug delivery balloon at the target site.

14. The method of claim 13, wherein the step of advancing the therapeutic agent includes advancing the therapeutic agent through the sidewall opening positioned proximal to the dilation balloon.

15. The method of claim 13, wherein the step of advancing the therapeutic agent includes advancing the therapeutic agent through the sidewall opening positioned proximal to a transition of the catheter from a dual lumen catheter to a single lumen catheter.

16. The method of claim 13, further including reducing leakage of the therapeutic agent through the open distal end using a reduced clearance between the wire guide and the wall of the combination lumen that is less than the first clearance.

17. The method of claim 16, further including inflating the dilation balloon to an expanded state, and radially compressing the wall of the combination lumen using the dilation balloon to define the reduced clearance.

18. The method of claim 13, wherein the step of advancing the therapeutic agent includes increasing the first clearance by radially expanding the wall of the combination lumen using the therapeutic agent.

19. The method of claim 18, further including advancing the therapeutic agent through the combination lumen arranged coaxially with the inflation lumen.

20. The method of claim 13, further including restricting movement of the wire guide relative to a high clearance infusion area of the combination lumen using a wire guide retention feature of the combination lumen.