Method and device for intermittent occlusion of a vein draining the organ system

• US 8,996,106 B2
• Filed: 08/05/2013
• Issued: 03/31/2015
• Est. Priority Date: 11/30/2006
• Status: Active Grant

• Current Assignee: Miracor Medical Systems Gmbh
• Original Assignee: Miracor Medical Systems Gmbh
• Inventors: Mohl, Werner
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Wu, Eugene
• Application Number:
  US13/959,176
• Publication Number:
  US 20130317284A1
• Time in Patent Office: 603 Days
• Field of Search: 600/485, 600/486, 600/488, 600 16- 18, 606/158, 623/3.1
• US Class Current: 607/17
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 5/02152 specially adapted for venous pressure
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 25/10181 Means for forcing inflation fluid into the balloon
• CPC Class Codes: A61M 60/143 inside the coronary sinus, e.g. for pressure-controlled intermittent coronary sinus occlusion
• CPC Class Codes: A61M 60/268 the displacement member being flexible, e.g. membranes, diaphragms or bladders
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/554 of blood pressure

Abstract

In a method for the intermittent occlusion of a vein draining the organ system, in which the vein is occluded by an occlusion device, the fluid pressure in the occluded vein is continuously measured and stored, the behavior of the fluid pressure is determined as a function of time, and the occlusion of the vein is triggered and/or released as a function of at least one characteristic value derived from the pressure measurements, pressure is applied during the occlusion in a pulsating manner. The device for the intermittent occlusion of a vein, including an occlusion device, a pressure measuring device for continuously measuring the fluid pressure in the occluded vein, and a memory for storing the fluid pressure behavior as a function of time, means are provided for applying a pulsating pressure in the occluded vein.

Claims

1. A method for intermittent occlusion of a coronary sinus, comprising the steps of:

occluding a coronary sinus of a patient using an occlusion device coupled to a distal end portion of the multi-lumen catheter and being in communication with a first lumen of the multi-lumen catheter, the occlusion device being adjustable between a non-occluding state and an occluding state that is configured to substantially occlude the coronary sinus;

measuring and storing fluid pressure values in the occluded coronary sinus during said occluding step;

during said occluding step, outputting a pulsating pressure into the occluded coronary sinus from the distal end portion of the multi-lumen catheter positioned in the coronary sinus, wherein the pulsating pressure is output into the coronary sinus using pressure waves at a frequency greater than a pulse rate of the patient, wherein said outputting the pulsating pressure into the occluded coronary sinus comprise outputting the pulsating pressure from a pulsating device attached to the distal end portion of the multi-lumen catheter and positioned in the coronary sinus, wherein said pulsating device comprises a pulsating membrane structure in communication with a second lumen of the multi-lumen catheter, the pulsating membrane structure being positioned at least partially distal of the occlusion device; and

releasing the occlusion of the coronary sinus as a function of at least one characteristic value derived from said pressure values in the occluded coronary sinus.

2. The method of claim 1, wherein said outputting the pulsating pressure occurs only during the occlusion of the coronary sinus when the occlusion device is in the occluding state.

3. The method of claim 1, wherein said outputting the pulsating pressure comprises applying the pulsating pressure pneumatically or hydraulically into an interior space defined by the pulsating membrane structure.

4. The method of claim 1, wherein said outputting the pulsating pressure into the occluded coronary sinus comprises outputting pressure waves into the occluded coronary sinus at a frequency between 50 and 250 per minute.

5. The method of claim 1, wherein said outputting the pulsating pressure into the occluded coronary sinus initiates at a lower threshold value of a detectable pressure increase after the occlusion and then stops upon release of the occlusion.

6. The method of claim 1, wherein said releasing the occlusion of the coronary sinus includes adjusting the occlusion device from the occluded state to the non-occluding state.

7. A method for intermittent occlusion of a coronary sinus, comprising the steps of:

occluding a coronary sinus of a patient using an occlusion device coupled to a distal end portion of the multi-lumen catheter and being in communication with a first lumen of the multi-lumen catheter, the occlusion device being adjustable between a non-occluding state and an occluding state that is configured to substantially occlude the coronary sinus;

measuring and storing fluid pressure values in the occluded coronary sinus during said occluding step;

during said occluding step, outputting a pulsating pressure into the occluded coronary sinus from a pulsating membrane structure coupled to the distal end portion of the multi-lumen catheter and positioned in the coronary sinus, wherein the pulsating membrane structure outputs pressure waves at a frequency greater than a pulse rate of the patient,

releasing the occlusion of the coronary sinus as a function of at least one characteristic value derived from said pressure values in the occluded coronary sinus.

8. The method of claim 7, wherein said outputting the pulsating pressure into the occluded coronary sinus comprises applying the pulsating pressure pneumatically or hydraulically to the pulsating membrane structure.

9. The method of claim 8, said outputting the pulsating pressure into the occluded coronary sinus comprises the pulsating membrane structure outputting pressure waves at the frequency between 50 and 250 per minute.

10. The method of claim 7, wherein said pulsating membrane comprises a distal balloon structure in communication with a second lumen of the multi-lumen catheter, the distal balloon structure being positioned at least partially distal of the occlusion device.

11. The method of claim 10, wherein said outputting the pulsating pressure comprises applying the pulsating pressure pneumatically or hydraulically into an interior space of the distal balloon structure.

12. The method of claim 7, wherein the pulsating membrane structure is positioned the distal end portion of the multi-lumen catheter at least partially distal of the occlusion device.

13. The method of claim 12, wherein said releasing the occlusion of the coronary sinus includes adjusting the occlusion device from the occluded state to the non-occluding state.

14. The method of claim 7, wherein said outputting the pulsating pressure occurs only during the occlusion of the coronary sinus when the occlusion device is in the occluding state.

15. The method of claim 7, wherein said outputting the pulsating pressure into the occluded coronary sinus initiates at a lower threshold value of a detectable pressure increase after the occlusion and then stops upon release of the occlusion.