Cardiac ablation catheters for forming overlapping lesions

• US 9,033,961 B2
• Filed: 04/14/2009
• Issued: 05/19/2015
• Est. Priority Date: 07/14/1999
• Status: Expired due to Term

• Current Assignee: Cardiofocus Incorporated
• Original Assignee: Cardiofocus Incorporated
• Inventors: Melsky, Gerald, Stancampiano, Alfred, Arnold, Jeffrey M., Baxter, Lincoln S., Sagon, Stephen W.
• Primary Examiner(s): ROANE, AARON F
• Application Number:
  US12/423,178
• Publication Number:
  US 20090299354A1
• Time in Patent Office: 2,226 Days
• Field of Search: 606/2, 606 14- 16, 606/32, 606/41
• US Class Current: 606/2
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00061 spectrum
• CPC Class Codes: A61B 2018/0097 Cleaning probe surfaces
• CPC Class Codes: A61B 2018/2261 with scattering, diffusion or dispersion of light
• CPC Class Codes: A61B 2018/2266 with a lens, e.g. ball tipped
• CPC Class Codes: A61B 2018/2272 with reflective or refractive surfaces for deflecting the beam A61B2018/2261, A61B2018/2266 take precedence
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Methods and instruments are disclosed for creating lesions in tissue, especially cardiac tissue, for treatment of arrhythmias and the like, by employing an elastic balloon and an energy emitter, which is independently positionable within the lumen of the instrument and adapted to project a series of spots of ablative energy through a transmissive region of the balloon to a target tissue site. The energy emitter preferably is configured such the spots of energy result in a series of lesions formed in the target tissue region when the emitter is activated, the lesions having an average area ranging from about 5 mm² to about 100 mm². In one aspect of the invention, percutaneous ablation instruments are disclosed in the form of catheter bodies having one or more balloon structures at the distal end region of the instrument and an energy emitting element, which is independently positionable and rotatable within a lumen of the instrument and adapted to project ablative energy through a transmissive region of the balloon to a target tissue site in contact with, or proximal to, the balloon surface.

Claims

1. A cardiac tissue ablation system, comprising:

an elongate catheter that is formed of a material that is substantially transparent to radiant energy and is configured to deliver a distal end thereof to a patient'"'"'s heart;

an expandable member having a distal end that is attached to the distal portion of the catheter and a proximal end that is attached to a proximal portion of the catheter, the expandable member being substantially transparent to radiant energy and having an elastic portion configured to conform to the shape of a target tissue region upon expansion; and

an energy emitter assembly movably disposed within a lumen of the catheter such that the energy emitter assembly is surrounded by the catheter and a point of attachment between the expandable member and the distal portion of the catheter is distal to the energy emitter, the energy emitter assembly including an energy emitter that is configured to deliver a series of arc-shaped spots of radiant ablative energy through the material that forms the catheter and the expandable member to the target tissue region, wherein a distal end of the energy emitter includes a plurality of beveled faces that converge to define an energy emitting face at a distal tip of the energy emitter, the energy emitting face being of reduced cross-section relative to a proximal portion of the energy emitter so as to provide an arc-shaped exposure pattern upon impingement with the target tissue region;

wherein the beveled energy emitting face of the energy emitter is rectangular and is offset from an optical axis of a lens such that the radiant ablation energy is projected as an arc shaped beam.

2. The system of claim 1, wherein the energy emitter assembly is configured such that the spots of energy result in a series of lesions formed in the target tissue region when the emitter is activated, the lesions having an average area ranging from about 5 mm² to about 100 mm².

3. The system of claim 2, wherein the energy emitter is configured to form arc shaped lesions in the target tissue region subtending an angle ranging from about 5 degrees to about 45 degrees relative to the emitter so as to cause the radiant ablative energy to be forward projected relative to a perpendicular axis that intersects the energy emitter at a 90 °

degree angle relative to a longitudinal axis of the energy emitter.

4. The system of claim 2, wherein the energy emitter assembly is configured to form arc shaped lesions in the target tissue region subtending an angle of less than about 30 degrees relative to the emitter.

5. The system of claim 1, wherein the energy emitter assembly is slidably and rotatably disposed within an inner lumen of the catheter thereby allowing the energy emitter to effectively ablate any of a plurality of regions within the target tissue area.

6. The system of claim 1, wherein the energy emitter assembly is configured to project energy toward the target tissue area at an angle ranging from about 5 degrees to about 110 degrees relative to a longitudinal axis of the catheter.

7. The system of claim 6, wherein the energy emitter assembly includes a reflector element coupled to a distal end of the energy emitter.

8. The system of claim 7, wherein the reflector element is a quartz reflector.

9. The system of claim 1, wherein the energy emitter assembly is configured to project energy toward the target tissue area at an angle ranging from about 60 to about 90 °

degrees relative to a longitudinal axis of the catheter.

10. The system of claim 1, wherein the energy emitter comprises assembly includes an optic fiber with the lens coupled to a distal end of the fiber, the energy emitter assembly further having a reflector element positioned distal of the grins lens, the reflector element configured to deliver ablative energy to the cardiac tissue at an angle of about 90 °

relative to a longitudinal axis of the catheter.

11. The system of claim 10 that further includes at least one radiopaque marker visible via x-ray imaging shaped in such a manner as to allow the determination of the rotational orientation of the expandable member relative to the patients anatomy.

12. The system of claim 11 wherein the radiopaque marker resides at a known location relative to the view seen in the endoscope such that the orientation of the patients anatomy relative to the endoscopic view may be determined.

13. The system of claim 1, further including an endoscope configured to allow direct visualization of the tissue treatment area.

14. The system of claim 1, wherein the expandable member includes a plurality of markers defining a number of power-level segments, each power-level segment corresponding to an amount of ablation energy to be delivered to the segment by the energy emitter.

15. The system of claim 1, wherein the expandable member is a blunt-nosed balloon configured to impede passage of the balloon into a pulmonary vein when the balloon is deployed in proximity to the vein.

16. The system of claim 1, wherein the expandable member is a balloon with a tapered distal end that impedes passage of the balloon into a pulmonary vein when the balloon is deployed in proximity to the vein.

17. The system of claim 1 wherein the expandable member is a balloon whose distal portion gradually decreases in diameter.

18. A cardiac tissue ablation system, comprising:

an elongate catheter that is formed of a material that is substantially transparent to radiant energy and is configured to deliver a distal end thereof to a patient'"'"'s heart;

an expandable member having a distal end that is attached to the distal portion of the catheter and a proximal end that is attached to a proximal portion of the catheter, the expandable member being substantially transparent to radiant energy and having an elastic portion configured to conform to the shape of a target tissue region upon expansion; and

an energy emitter assembly movably disposed within a lumen of the catheter such that the energy emitter assembly is surrounded by the catheter and a point of attachment between the expandable member and the distal portion of the catheter is distal to the energy emitter, the energy emitter assembly including an energy emitter that is configured to deliver a series of arc-shaped spots of radiant ablative energy through the material that forms the catheter and the expandable member to the target tissue region, wherein a distal end of the energy emitter includes a plurality of beveled faces that converge to define an energy emitting face at a distal tip of the energy emitter, the energy emitting face being of reduced cross-section relative to a proximal portion of the energy emitter so as to provide an arc-shaped exposure pattern upon impingement with the target tissue region;

wherein the energy emitter assembly further comprises a lens configured to receive radiant energy from the energy emitting face of the optical fiber and focus the energy prior to passing through the expandable member, the lens being disposed distal to the energy emitting face of the optical fiber and the energy emitting face of the optical fiber and the lens being configured and arranged such that light propagating through the lens is bent into an arc-shaped exposure pattern.