Method for ablating body tissue

• US 9,737,325 B2
• Filed: 11/18/2013
• Issued: 08/22/2017
• Est. Priority Date: 05/12/2006
• Status: Active Grant

• Current Assignee: Auris Health, Inc. (Johnson & Johnson)
• Original Assignee: VytronUS, Inc. (Johnson & Johnson)
• Inventors: Thapliyal, Hira V., Gallup, David A., Arenson, James W.
• Primary Examiner(s): Roane, Aaron
• Application Number:
  US14/083,242
• Publication Number:
  US 20140081302A1
• Time in Patent Office: 1,373 Days
• Field of Search: 601 2, 601 3, 606 27- 28, 606 41- 49
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22024 with a part reflecting mechanical vibrations, e.g. for focusing
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

A cardiac ablation method including the following steps: inserting a treatment catheter into an atrium of a heart, the treatment catheter including an ultrasound emitter; positioning the ultrasound emitter to face heart tissue within the left atrium outside of a pulmonary vein; emitting ultrasound energy from the ultrasound emitter while rotating the ultrasound emitter about a rotation axis; and ablating heart tissue with the ultrasound energy to form a lesion outside of a pulmonary vein.

Claims

1. A system for ablating tissue, said system comprising:

an ablation catheter comprising an elongate flexible shaft, the elongate flexible shaft having a proximal portion, a distal portion, and a rotation axis;

an ultrasound transducer adjacent the distal portion of the elongate flexible shaft, the ultrasound transducer being adapted to operate in an ablation mode and a diagnostic mode, wherein in the ablation mode the ultrasound transducer emits a beam of ultrasound energy towards a target tissue that is adapted to create a lesion in the target tissue to thereby ablate the target tissue, and wherein in the diagnostic mode the ultrasound transducer acts as a sensor to measure a reflected ultrasound signal, the reflected ultrasound signal comprising ultrasound energy from the beam of ultrasound energy that is reflected back towards the ultrasound transducer by the target tissue, thereby allowing the ultrasound transducer to sense information about the target tissue; and

a processor, operatively coupled to the ablation catheter, the processor configured to control the beam of ultrasound energy based on the information about the target tissue sensed by the ultrasound transducer,

wherein the beam of ultrasound energy ablates the target tissue without contact between the distal portion of the elongate flexible shaft and the target tissue, and

wherein the distal portion of the elongate flexible shaft rotates or translates while the ultrasound transducer operates in the ablation mode during an ablation procedure to sweep the beam of ultrasound energy along an intended ablation path, and

wherein the processor is configured to switch the ultrasound transducer between the ablation mode and the diagnostic mode on a timeshared basis during the ablation procedure in order to allow the ultrasound transducer to sense the information about the target tissue while the ablation procedure is occurring, thereby forming a continuous lesion in the target tissue.

2. The system of claim 1, wherein the information about the target tissue sensed by the ultrasound transducer comprises at least one of the following:

a gap distance between the ultrasound transducer and the target tissue, a thickness of the target tissue, or a depth of at least a portion of the lesion created in the target tissue.

3. The system of claim 1, wherein the beam of energy is a collimated beam of energy.

4. The system of claim 1, further comprising:

a bending mechanism coupled to the elongate flexible shaft configured to bend the distal portion of the elongate flexible shaft such that the ultrasound transducer is directed radially outward from the rotation axis.

5. The system of claim 4, wherein the bending mechanism is configured to bend the elongate flexible shaft into a plurality of curves.

6. The system of claim 4, wherein the processor is operatively coupled to the bending mechanism, and

wherein the processor is configured to control bending of the distal portion of the elongate flexible shaft based upon the sensed information about the target tissue.

7. The system of claim 4, wherein the bending mechanism comprises at least one pullwire coupled with the distal portion of the elongate flexible shaft, and wherein actuation of the at least one pullwire bends the distal portion of the elongate flexible shaft.

8. The system of claim 1, further comprising an ultrasound reflective surface disposed adjacent the ultrasound transducer and adapted to reflect the beam of ultrasound energy away from the transducer toward the target tissue.

9. The system of claim 8, wherein the ultrasound reflective surface is configured to reflect the beam of ultrasound energy in a direction transverse to the rotation axis of the elongate flexible shaft.

10. The system of claim 1, wherein the beam of ultrasound energy is emitted distally relative to the distal portion of the elongate flexible shaft.

11. A tissue ablation system comprising:

a fluid source;

an ablation catheter slidably disposed in an outer catheter, the ablation catheter comprising a proximal portion, a distal portion, a lumen extending therebetween, a rotation axis, a longitudinal axis along the length of the catheter, a distal portion, and an ultrasound transducer, wherein the ultrasound transducer is disposed within the distal portion of the ablation catheter and directs a collimated beam of ultrasound energy to a target tissue, the collimated beam of ultrasound energy being adapted to create a lesion in the target tissue thereby ablating the target tissue; and

a control mechanism operably coupled to the ablation catheter and adapted to rotate the ablation catheter about the rotation axis and to control energy supplied to the ultrasound transducer,

wherein the distal portion of the ablation catheter containing the ultrasound transducer is in fluid communication with blood, and

wherein a fluid from the fluid source exits the lumen of the ablation catheter and flows past the ultrasound transducer to provide cooling thereof, and

wherein the fluid provides a barrier between the ultrasound transducer and blood so as to prevent the blood from coagulating on the ultrasound transducer during ablation.

12. The tissue ablation system of claim 11, wherein the ultrasound transducer is disc shaped and comprises a front face, a back face, and a backing element adjacent the back face, the backing element configured to reflect ultrasound energy thereby directing the collimated beam of ultrasound energy to exit from the front face of the ultrasound transducer.

13. The tissue ablation system of claim 11, wherein the ultrasound transducer is further configured to sense a reflected ultrasound signal comprising ultrasound energy from the collimated beam of ultrasound energy that is reflected back towards the ultrasound transducer by the target tissue, and wherein the system further comprises a processor operably coupled to the control mechanism, the processor configured to receive the reflected ultrasound signal from the ultrasound transducer, and determine, based on the reflected ultrasound signal, one or more of the following parameters:

a distance between the target tissue and the ultrasound transducer, a thickness of the target tissue, or a depth of a lesion of the target tissue.

14. The tissue ablation system of claim 13, wherein the processor is configured to adjust the beam of ultrasound energy in response to the one or more parameters determined based on the reflected ultrasound signal.

15. The tissue ablation system of claim 11, wherein the ablation catheter is adapted to direct the collimated beam of ultrasound energy radially with respect to the longitudinal axis of the ablation catheter.

16. The tissue ablation system of claim 11, further comprising a reflecting element,

wherein the ultrasound transducer comprises a front face,

wherein the collimated beam of ultrasound energy is directed from the front face of the ultrasound transducer along the longitudinal axis of the ablation catheter, and

wherein the reflecting element reflects the collimated beam of ultrasound energy transversely with respect to the longitudinal axis of the ablation catheter.

17. The tissue ablation system of claim 11, wherein the ultrasound transducer comprises a front face and is oriented such that the front face is directed transversely with respect to the longitudinal axis of the ablation catheter and thereby directs the collimated beam of ultrasound energy transversely with respect to the longitudinal axis of the ablation catheter.

18. The tissue ablation system of claim 11, wherein the distal portion of the ablation catheter containing the ultrasound transducer is adapted to be disposed outside of a pulmonary vein.