Operating a vessel occlusion catheter

• US 8,667,838 B2
• Filed: 11/29/2012
• Issued: 03/11/2014
• Est. Priority Date: 02/16/2010
• Status: Active Grant

• Current Assignee: Miracor Medical Systems Gmbh
• Original Assignee: Miracor Medical Systems Gmbh
• Inventors: Hoem, Jon H., Kohr, Oliver A.
• Primary Examiner(s): Macchiarolo, Peter
• Assistant Examiner(s): DEVITO, ALEX T
• Application Number:
  US13/688,725
• Publication Number:
  US 20130090678A1
• Time in Patent Office: 467 Days
• Field of Search: 731/49
• US Class Current: 73/149
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61M 2025/1022 driven by a rotary motor-activated pump
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3341 stabilising pressure or flow to avoid excessive variation
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10181 Means for forcing inflation fluid into the balloon
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 25/10188 Inflation or deflation data displays
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 60/143 inside the coronary sinus, e.g. for pressure-controlled intermittent coronary sinus occlusion
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/32 of heart muscle tissues, e.g. using coronary sinus occlusion
• CPC Class Codes: A61M 60/497 for balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/554 of blood pressure

Abstract

Some systems and methods for operating a vessel occlusion catheter may include a control and inflation device to control the filling of the balloon in such a manner that the vessel wall will not be overstressed while the safe occlusion of the blood vessel is achieved.

Claims

1. A control and inflation device for a balloon catheter, comprising:

a connection for an inflation lumen of a balloon catheter, a pressure tank, a vacuum tank and a pump, wherein switching valves are arranged in a manner that the connection for the inflation lumen is alternately connectable with the vacuum tank and with the pressure tank

a pressure measuring device and a connection to provide in fluid communication between the pressure measuring device and a central catheter lumen of the balloon catheter that is different from the inflation lumen of the balloon catheter; and

a second pressure measuring device and a connection to provide in fluid communication between the second pressure measuring device and an inflatable balloon of the balloon catheter,

wherein the switching valves are configured to switch the inflation lumen to a connection with the vacuum tank immediately in response to the second pressure measuring device detecting a pressure in the balloon reaching a value greater than an upper limit selected between 90 and 120 mm Hg.

3. The control and inflation device of claim 1, further comprising a pressure measuring device in fluid communication with a connection for a second catheter lumen of the balloon catheter different from the inflation lumen of the balloon catheter.

4. The control and inflation device of claim 1, wherein the pressure tank, the pump and the vacuum tank form a closed fluid loop together with the inflation lumen of the catheter.

5. The control and inflation device of claim 4, wherein the closed loop comprises a connection for filling the loop with fluid.

6. The control and inflation device of claim 1, further comprising a condensate pump connected to the vacuum tank.

7. The control and inflation device of claim 1, wherein a fluid system comprising the pressure tank, the pump, the vacuum tank, and the balloon catheter and any connection lines therebetween is filled with such an amount of fluid that the pressure within the fluid system is smaller than 2 bar at a full pressure equalization of all components.

8. The control and inflation device of claim 1, wherein the balloon catheter comprises a coronary sinus occlusion catheter having an inflatable balloon along a distal end portion that is sized to intermittent occlude a coronary sinus of a heart.

9. The control and inflation device of claim 1, wherein a fluid system comprising the pressure tank, the pump, the vacuum tank, and the balloon catheter is filled with fluid comprising helium.

10. The control and inflation device of claim 1, wherein an inflatable balloon of the balloon catheter is filled exclusively due to full pressure equalization between the pressure tank and the balloon when the switching valves are arranged in a manner that connects the connection for the inflation lumen with the pressure tank.

11. The control and inflation device of claim 10, wherein the inflatable balloon of the balloon catheter is evacuated exclusively due to full pressure equalization between the vacuum tank and the balloon when the switching valves are arranged in a manner that connects the connection for the inflation lumen with the vacuum tank.

12. The control and inflation device of claim 10, wherein an inflation time for filling the balloon is monitored to detect a time required to provide full pressure equalization between the pressure tank and the balloon, and wherein an error message is generated in response to the inflation time being detected below a lower limit value of 0.2 sec.

13. The control and inflation device of claim 10, wherein an inflation time for filling the balloon is monitored to detect a time required to provide full pressure equalization between the pressure tank and the balloon, and wherein an error message is generated in response to the inflation time being detected above an upper limit value of 0.50 sec.

14. The control and inflation device of claim 11, wherein an deflation time for evacuating the balloon is monitored to detect a time required to provide full pressure equalization between the vacuum tank and the balloon, and wherein an error message is generated in response to the deflation time being detected below a lower limit value of 0.5 sec.

15. The control and inflation device of claim 1, wherein the pressure tank is alternately connectable with the connection for the inflation lumen and a connection, via the pump, with the vacuum tank.

2. A control and inflation device for a balloon catheter, comprising:

a connection for an inflation lumen of a balloon catheter, a pressure tank, a vacuum tank and a pump, wherein switching valves are arranged in a manner that the connection for the inflation lumen is alternately connectable with the vacuum tank and with the pressure tank, and wherein the pressure tank is alternately connectable with the connection for the inflation lumen and a connection, via the pump, with the vacuum tank.

16. The control and inflation device of claim 2, further comprising a pressure measuring device in fluid communication with a connection for a second catheter lumen of the balloon catheter different from the inflation lumen of the balloon catheter.

17. The control and inflation device of claim 2, wherein the pressure tank, the pump and the vacuum tank form a closed fluid loop together with the inflation lumen of the catheter.

18. The control and inflation device of claim 17, wherein the closed loop comprises a connection for filling the loop with fluid.

19. The control and inflation device of claim 2, further comprising a condensate pump connected to the vacuum tank.

20. The control and inflation device of claim 2, wherein a fluid system comprising the pressure tank, the pump, the vacuum tank, and the balloon catheter and any connection lines therebetween is filled with such an amount of fluid that the pressure within the fluid system is smaller than 2 bar at a full pressure equalization of all components.

21. The control and inflation device of claim 2, wherein the balloon catheter comprises a coronary sinus occlusion catheter having an inflatable balloon along a distal end portion that is sized to intermittent occlude a coronary sinus of a heart.

22. The control and inflation device of claim 2, further comprising a pressure measuring device and a connection to provide in fluid communication between the pressure measuring device and a central catheter lumen of the balloon catheter that is different from the inflation lumen of the balloon catheter.

23. The control and inflation device of claim 22, further comprising a second pressure measuring device and a connection to provide in fluid communication between the second pressure measuring device and an inflatable balloon of the balloon catheter.

24. The control and inflation device of claim 23, wherein the switching valves are configured to switch the inflation lumen to a connection with the vacuum tank immediately in response to the second pressure measuring device detecting a pressure in the balloon reaching a predetermined upper limit value.

25. The control and inflation device of claim 2, wherein an inflatable balloon of the balloon catheter is filled exclusively due to full pressure equalization between the pressure tank and the balloon when the switching valves are arranged in a manner that connects the connection for the inflation lumen with the pressure tank.

26. The control and inflation device of claim 25, wherein the inflatable balloon of the balloon catheter is evacuated exclusively due to full pressure equalization between the vacuum tank and the balloon when the switching valves are arranged in a manner that connects the connection for the inflation lumen with the vacuum tank.