Catheter System and Method For Occluding A Body Vessel

• US 20110295301A1
• Filed: 05/25/2010
• Published: 12/01/2011
• Est. Priority Date: 05/25/2010
• Status: Active Grant

• Current Assignee: Miracor Medical Systems Gmbh
• Original Assignee: Miracor Medical Systems Gmbh
• Inventors: Hoem, Jon H., Kohr, Oliver A.
• Granted Patent: US 10,743,780 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• 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 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10188 Inflation or deflation data displays
• 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 60/531 using blood pressure data, e.g. from blood pressure sensors

Abstract

Some embodiments of a balloon catheter device for introduction into a body vessel, in particular the coronary sinus, can include a catheter shaft which carries an inflatable balloon on its distal portion and in which a plurality of different lumens are formed. In particular embodiments, a system for treating heart tissue can include a coronary sinus occlusion catheter configured for improved deliverability to the coronary sinus and for thereafter performing intermittent occlusion of the coronary sinus.

Claims

1. An occlusion catheter device for intermittently occluding a coronary sinus, comprising:

a catheter shaft that carries an inflatable balloon on a distal portion;

a pressure sensor lumen extending centrally through the catheter shaft to a plurality of distal ports that are positioned distally of the balloon for communication with fluid in a coronary sinus;

an inflation lumen to inflate and deflate the balloon;

a stiffening element extending along the catheter shaft, the stiffening element having a distal end portion that is positioned adjacent to the proximal end of the balloon and has a flexural strength reduced relative to a remaining proximal portion of the stiffening element.

2. The catheter device of claim 1, wherein the stiffening element comprises a hypotube surrounding the catheter shaft.

3. The catheter device of claim 2, wherein the stiffening element substantially extends over the entire portion of the catheter shaft between the balloon and a proximal hub portion.

4. The catheter device of claim 2, wherein the distal end portion of the stiffening element having the reduced flexural strength extends over a length of about 40 mm to about 90 mm.

5. The catheter device of claim 2, wherein the hypotube comprises at least one notch influencing the flexural strength.

6. The catheter device of claim 5, wherein the notch extends in a helical line-shaped manner, with the helical line having a smaller pitch in the distal end portion of the stiffening element having the reduced flexural strength than in the remaining proximal portion of the stiffening element.

7. The catheter device of claim 5, wherein the pitch of the helical line continuously increases in the distal end portion of the stiffening element having the reduced flexural strength, departing from the distal end of the hypotube.

8. The catheter device of claim 1, wherein the lumens extending through the catheter shaft have cross-sectional geometries differing from one another.

9. The catheter device of claim 8, wherein the inflation lumen has a ring segment-shaped in cross section and is arranged radially outside the pressure sensor lumen extending centrally through the catheter shaft.

10. The catheter device of claim 9, further comprising wherein a balloon pressure-monitoring lumen to measure the pressure in the balloon, the balloon pressure-monitoring lumen having a ring segment-shaped in cross section and being arranged the pressure sensing lumen extending centrally through the catheter shaft, wherein an arc-determining angle of the balloon pressure-monitoring lumen is smaller as compared to that of the inflation lumen.

11. The catheter device of claim 10, further comprising a circular or oval lumen provided between the neighboring ends of the ring segment-shaped cross sections of the inflation lumen and the balloon pressure-monitoring lumen.

12. The catheter device of claim 10, wherein the inflation lumen and the balloon pressure-monitoring lumen are each connected with the interior of the balloon via at least two radial openings arranged to be offset in an axial direction of the catheter shaft.

13. The catheter device of claim 1, further comprising a stiffening wire extending through a lumen of the catheter shaft in a region adjacent to the balloon, said wire extending along a length of the balloon.

14. The catheter device of claim 1, further comprising a catheter tip element in fluid communication with the pressure sensor lumen extending centrally through the catheter shaft, the catheter tip element defining the plurality of distal ports that are positioned distally of the balloon for communication with fluid in a coronary sinus, the plurality of distal ports comprising a plurality of radial openings that are substantially uniformly distributed over a circumferential periphery of the catheter tip element.

15. The catheter device of claim 14, wherein a distal edge of a distal opening of the catheter tip element is rounded off.

16. The catheter device of claim 15, wherein the catheter tip element conically tapers toward the distal opening.

17. The catheter device of claim 14, wherein the catheter tip element comprises a flexible material.

18. The catheter device of claim 14, wherein a distance between a distal end of the catheter tip element and the distal end of the inflatable portion of the balloon is about 35 mm to about 45 mm.

20. The catheter device of claim 1, further comprising a stiffening element extending along the catheter shaft, the stiffening element having a distal end portion that is positioned adjacent to the proximal end of the balloon and has a flexural strength reduced relative to a remaining proximal portion of the stiffening element.

19. A coronary sinus occlusion catheter device, comprising:

a catheter shaft that carries an inflatable balloon on a distal portion;

a pressure sensor lumen extending centrally through the catheter shaft to a plurality of distal ports that are positioned distally of the balloon for communication with fluid in a coronary sinus;

an inflation lumen to inflate and deflate the balloon; and

a balloon pressure-monitoring lumen to measure the pressure in the balloon, the balloon pressure-monitoring lumen being different from and adjacent to the inflation lumen, wherein both the inflation lumen and the balloon pressure-monitoring lumen are in fluid communication with an interior of the balloon.