Weeping balloon catheter with drug delivery through dilation balloon

• US 9,724,495 B2
• Filed: 03/27/2014
• Issued: 08/08/2017
• Est. Priority Date: 06/10/2013
• 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): FLICK, JASON E
• Application Number:
  US14/226,882
• Publication Number:
  US 20140364834A1
• Time in Patent Office: 1,230 Days
• Field of Search: 60410301
• 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 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/10186 One-way valves
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A weeping balloon catheter includes a catheter having an elongate tubular body defining a medical device lumen and a liquid delivery lumen. A dilation balloon is disposed at a distal end of the elongate tubular body and is in fluid communication with the liquid delivery lumen. The dilation balloon includes a fluid communication channel through an outer wall of the dilation balloon. A flow restriction member is positioned along the fluid communication channel and has an open position permitting fluid communication along the fluid communication channel and a closed position blocking fluid communication along the fluid communication channel. A drug delivery path of the weeping balloon catheter is defined by the liquid delivery lumen and the dilation balloon.

Claims

1. A weeping balloon catheter, comprising:

a catheter having an elongate tubular body defining a medical device lumen and a liquid delivery lumen;

a dilation balloon disposed at a distal end of the elongate tubular body and in fluid communication with the liquid delivery lumen, wherein the dilation balloon includes a fluid communication channel through an outer wall of the dilation balloon; and

a flow restriction member positioned along the fluid communication channel and having an open position permitting fluid communication along the fluid communication channel and a closed position blocking fluid communication along the fluid communication channel;

wherein a drug delivery path of the weeping balloon catheter is defined by the liquid delivery lumen and the dilation balloon.

2. The weeping balloon catheter of claim 1, further including:

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 dilation balloon along the fluid communication channel;

wherein the drug delivery path is defined sequentially by the liquid delivery lumen, the dilation balloon, and the drug delivery balloon.

3. The weeping balloon catheter of claim 2, wherein the flow restriction member is a valve biased to the closed position.

4. The weeping balloon catheter of claim 3, wherein the valve is a check valve.

5. The weeping balloon catheter of claim 3, wherein the valve is a pressure actuated valve having a threshold opening pressure at which the pressure actuated valve transitions from the closed position to the open position.

6. The weeping balloon catheter of claim 5, wherein the pressure actuated valve has a threshold closing pressure at which the pressure actuated valve returns to the closed position, wherein the threshold opening pressure is at least double the threshold closing pressure.

7. The weeping balloon catheter of claim 2, wherein the flow restriction member is a valve biased to the open position.

8. The weeping balloon catheter of claim 7, wherein the valve is a flow actuated valve having a threshold at which the flow actuated valve transitions from the open position to the closed position.

9. The weeping balloon catheter of claim 1, wherein the elongate tubular body defines exactly two lumens including the medical device lumen and the liquid delivery lumen.

10. A method of operating a weeping balloon catheter, the weeping balloon catheter including a catheter having an elongate tubular body defining a medical device lumen and a liquid delivery lumen, a dilation balloon disposed at a distal end of the elongate tubular body and in fluid communication with the liquid delivery lumen, wherein the dilation balloon includes a fluid communication channel through an outer wall of the dilation balloon, and a flow restriction member positioned along the fluid communication channel and having an open position permitting fluid communication along the fluid communication channel and a closed position blocking fluid communication along the fluid communication channel, and wherein a drug delivery path of the weeping balloon catheter is defined the liquid delivery lumen and the dilation balloon, the method comprising steps of:

advancing the distal end of the weeping balloon catheter toward a target site within a body lumen;

advancing a therapeutic agent through the liquid delivery lumen and into the dilation balloon; and

inflating the dilation balloon using the therapeutic agent while the flow restriction member is in the closed position.

11. The method of claim 10, further including releasing the therapeutic agent from the dilation balloon while the flow restriction member is in the open position.

12. The method of claim 10, further including advancing the therapeutic agent sequentially through the liquid delivery lumen, the dilation balloon, the fluid communication channel, and a drug delivery balloon disposed at least partially over the dilation balloon.

13. The method of claim 12, further including releasing the therapeutic agent from the drug delivery balloon through at least one drug release opening through an outer wall of the drug delivery balloon.

14. The method of claim 12, further including:

advancing the therapeutic agent at a nominal pressure;

blocking advancement of the therapeutic agent along the fluid communication channel using a pressure actuated valve having a biased closed position and a threshold opening pressure; and

inflating the dilation balloon to an expanded position responsive to the nominal pressure and the biased closed position.

15. The method of claim 14, further including:

increasing a pressure of the therapeutic agent from the nominal pressure to an increased pressure that is greater than the threshold opening pressure;

transitioning the pressure actuated valve from the biased closed position to an actuated open position responsive to the increased pressure; and

releasing the therapeutic agent from the drug delivery balloon with the dilation balloon in the expanded position.

16. The method of claim 15, further including:

decreasing the pressure of the therapeutic agent from the increased pressure to a decreased pressure that is less than a threshold closing pressure of the pressure actuated valve after releasing the therapeutic agent from the drug delivery balloon; and

transitioning the pressure actuated valve from the actuated open position to the biased closed position responsive to the decreased pressure.

17. The method of claim 16, wherein the threshold closing pressure is less than half the threshold opening pressure.

18. The method of claim 12, further including:

advancing the therapeutic agent at a nominal pressure through a flow actuated valve positioned along the fluid communication channel and having a biased open position and a threshold at which the flow actuated valve transitions from the biased open position to an actuated closed position; and

releasing the therapeutic agent from the drug delivery balloon with the dilation balloon in a non-expanded position.

19. The method of claim 18, further including:

increasing a flow of the therapeutic agent to exceed the threshold;

transitioning the flow actuated valve from the biased open position to the actuated closed position in response to increasing the flow;

blocking advancement of the therapeutic agent along the fluid communication channel using the actuated closed position of the flow actuated valve; and

inflating the dilation balloon to an expanded position after the therapeutic agent is released from the drug delivery balloon in response to the actuated closed position.