Ultrasound pulmonary vein isolation

• US 7,156,816 B2
• Filed: 11/26/2002
• Issued: 01/02/2007
• Est. Priority Date: 11/26/2002
• Status: Expired due to Term

• Current Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Original Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Inventors: Govari, Assaf, Schwartz, Yitzhack
• Primary Examiner(s): Peffley; Michael
• Assistant Examiner(s): ROANE, AARON F
• Application Number:
  US10/304,500
• Publication Number:
  US 20040102769A1
• Time in Patent Office: 1,498 Days
• Field of Search: 606 32- 52, 601/2
• US Class Current: 601/2
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

A catheter introduction apparatus provides an ultrasound assembly for emission of ultrasound energy. In one application the catheter and the ultrasound assembly are introduced percutaneously, and transseptally advanced to the ostium of a pulmonary vein. An anchoring balloon is expanded to center an acoustic lens in the lumen of the pulmonary vein, such that energy is converged circumferentially onto the wall of the pulmonary vein when a transducer is energized. A circumferential ablation lesion is produced in the myocardial sleeve of the pulmonary vein, which effectively blocks electrical propagation between the pulmonary vein and the left atrium.

Claims

1. An apparatus for electrically isolating a cardiac chamber, comprising:

a guidewire, the guidewire being insertable into a vessel;

an intravascular catheter having a distal end and a distal tip, said catheter also having a lumen therethrough, said catheter being slidably insertable over said guidewire through said lumen;

an anchor at said distal tip of said catheter, said anchor being a distal-most component of said catheter and deployable within said vessel and surrounding said guidewire for fixing said catheter near target tissue of an ostium of said vessel; and

an ultrasound transducer assembly on said catheter and located proximal to said anchor, said ultrasound assembly having a lumen therein for slidably inserting said catheter over said guidewire, said ultrasound assembly comprising a body section having a space therein, said body section shaped as a truncated cone, wherein said body section comprises an air-backing material, said body section also comprising an outer surface at an inclination angle, and said ultrasound assembly also having at least one piezoelectric element made of a ceramic material located within the space of the body section, whereupon in an operational position, said catheter is fixed near said target tissue of said ostium of said vessel by said anchor being deployed within said vessel along said guidewire as said distal-most component of said catheter, and said ultrasound transducer assembly is disposed external to said vessel and said ostium of said vessel and proximal to said anchor, said transducer assembly being spaced a distance away from said target tissue of said ostium of said vessel and said anchor for emitting ultrasound energy that is directed to a circumferential ablation region on said target tissue of said ostium of said vessel, said ultrasound energy emitted along a path substantially avoiding said anchor.

2. The apparatus according to claim 1, further comprising a sensor disposed in said catheter for detecting cardiac electrical activity.

3. The apparatus according to claim 2, further comprising a transmitting antenna disposed in said catheter for transmitting signals from said sensor.

4. The apparatus according to claim 1, wherein said anchor comprises a balloon.

5. The apparatus according to claim 1, wherein a body section of said ultrasound transducer assembly has a proximal cross section and a distal cross section, said proximal cross section being larger than said distal cross section.

6. The apparatus according to claim 5, wherein an inclination angle of said truncated cone is about 20 degrees.

7. The apparatus according to claim 1, wherein said ultrasound transducer assembly comprises an omnidirectional lens that focuses a beam of said ultrasound energy circumferentially on said ablation region.

8. The apparatus according to claim 7, wherein said ultrasound transducer assembly comprises an array of transducer elements, and a control unit for controlling individual ones of said transducer elements to shape said beam.

9. The apparatus according to claim 1, wherein said ultrasound transducer assembly operates at a frequency of between about 3 and 4 MHz.

10. The apparatus according to claim 1, wherein said ultrasound transducer assembly comprises:

a diffraction grating for directing said ultrasound energy that is output from said ultrasound transducer assembly in a desired direction; and

a transducer layer capable of transducing energy delivered thereto at different frequencies, said transducer layer being disposed within said catheter proximate said diffraction grating.

11. The apparatus according to claim 10, wherein said diffraction grating is a thin-film disposed on an external surface of said catheter.

12. The apparatus according to claim 1, wherein said ultrasound transducer assembly has a bandwidth that is between about 50% and about 80% of a primary operating frequency thereof.

13. An apparatus for electrically isolating a cardiac chamber, comprising:

a guidewire, the guidewire being insertable into a vessel;

an intravascular catheter having a lumen therethrough, said catheter being slidably insertable over said guidewire through said lumen;

an anchor at a distal tip of said catheter, said anchor being a distal-most component of said catheter and deployable within said vessel and surrounding said guidewire for fixing said catheter near target tissue of an ostium of said vessel; and

an ultrasound transducer assembly on said catheter and located proximal to said anchor, said ultrasound assembly having a lumen therein for slidably inserting said catheter over said guidewire, said ultrasound assembly comprising a body section having a space therein, said body section shaped as a truncated cone, wherein said body section comprises an air-backing material, said body section also comprising an outer surface at an inclination angle, and said ultrasound assembly also having at least one piezoelectric element made of a ceramic material located within the space of the body section, whereupon in an operational position, said catheter is fixed near said target tissue of said ostium of said vessel by said anchor being deployed in said vessel along said guidewire as said distal-most component of said catheter, and said ultrasound assembly is disposed external to said vessel and said ostium of said vessel and proximal to said anchor, said transducer assembly being spaced a distance away from said target tissue of said ostium of said vessel and said anchor for emitting ultrasound energy on said target tissue of said ostium of said vessel, said ultrasound energy emitted along a path substantially avoiding said anchor, wherein a body section of said ultrasound transducer assembly has a proximal cross sectional area and a distal cross sectional area, said proximal cross sectional area being larger than said distal cross sectional area, and wherein said ultrasound transducer assembly emits said ultrasound energy as a beam that is focused on an ablation region of said target tissue of said ostium of said vessel that substantially surrounds said ultrasound transducer assembly.

14. The apparatus according to claim 13, further comprising a sensor disposed in said catheter for detecting cardiac electrical activity.

15. The apparatus according to claim 14, further comprising a transmitting antenna disposed in said catheter for transmitting signals from said sensor.

16. The apparatus according to claim 13, wherein said anchor comprises a balloon.

17. The apparatus according to claim 13, wherein an inclination angle of said truncated cone is about 20 degrees.

18. The apparatus according to claim 13, wherein said ultrasound transducer assembly comprises an array of transducer elements, and a control unit for controlling individual ones of said transducer elements to shape said beam.

19. The apparatus according to claim 13, wherein said ultrasound transducer assembly operates at a frequency of between about 3 and 4 MHz.

20. The apparatus according to claim 13, wherein said ultrasound transducer assembly comprises:

a diffraction grating for directing said ultrasound energy that is output from said ultrasound transducer assembly in a desired direction; and

a transducer layer capable of transducing energy delivered thereto at different frequencies, said transducer layer being disposed within said catheter proximate said diffraction grating.

21. The apparatus according to claim 20, wherein said diffraction grating is a thin-film disposed on an external surface of said catheter.

22. The apparatus according claim 13, wherein said ultrasound transducer assembly has a bandwidth that is between about 50% and about 80% of a primary operating frequency thereof.