Systems and methods for imaging and ablating body tissue

• US 9,737,323 B2
• Filed: 05/31/2013
• Issued: 08/22/2017
• Est. Priority Date: 11/17/2008
• 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., Mohr, III, John Paul, Proulx, Tim, Brommer, Robert A.
• Primary Examiner(s): Smith, Ruth S
• Application Number:
  US13/907,412
• Publication Number:
  US 20130261455A1
• Time in Patent Office: 1,544 Days
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 8/0883 for diagnosis of the heart
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4494 characterised by the arrangement of the transducer elements devices for short-range imaging using particular transducer elements arrangements under G01S15/8909; arrangements of transducers in generation of mechanical vibrations of infrasonic, sonic or ultrasonic frequency B06B1/0607
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

A transducer subassembly with combined imaging and therapeutic capabilities is disclosed. The subassembly includes heat sinks that are configured to maintain the transducer at a low operating temperature so that the transducer operates at high efficiency and also can handle a wider range of frequencies. The subassembly is also configured to allow cooling fluid to flow past the transducer element. One heat sink in the subassembly also acts as an acoustic matching layer and another heat sink acts as a backing Alternatively, the second heat sink which acts as a backing is optional. The transducer is configured to transmit at one power level for imaging, and at a second power level for ablating. The transducer may comprise sub-elements transmitting at different power levels. The subassembly may be operated at one power level for imaging and a second power level for ablating.

Claims

1. A transducer system comprising:

a transducer element comprising a proximal surface and a distal surface, wherein the proximal surface is a continuous surface;

a processor coupled to the transducer element, wherein the processor controls a voltage to operate the transducer element at a first power level and a second power level, wherein the transducer element is configured for both imaging and ablation of the tissue, wherein the transducer element is operated at the first power level to image the tissue, wherein the transducer element is operated at the second power level to ablate the tissue, wherein the first power level is different than the second power level, and wherein the transducer element is alternating between imaging and ablation;

a first bonding portion attached to the distal surface of the transducer element, wherein the first bonding portion serves as a first acoustic matching layer and as a distal heat sink;

a coating on the first bonding portion that serves as a second acoustic matching layer;

a proximal heat sink having a second bonding portion attached to the proximal surface of the transducer element, wherein the second bonding portion is bonded to the continuous proximal surface of the transducer element to conduct heat away from the transducer element; and

a base coupled to the proximal heat sink, wherein the base is configured to anchor the proximal heat sink and allow fluid flow past the transducer element for cooling the proximal surface and the distal surface of the transducer element.

2. The system of claim 1, further comprising a tubular jacket configured to house the base, the transducer element, the proximal heat sink and the distal heat sink, wherein the tubular jacket comprises at least one fluid exit port configured to allow fluid to exit the tubular jacket.

3. The system of claim 1, wherein the first bonding portion is a material chosen from the group consisting of aluminum, graphite, metal-filled graphite, ceramic, copper, an amalgam of graphite and copper, an amalgam of graphite and tungsten, and an epoxy-filled metal.

4. The system of claim 1, wherein a thickness of the second bonding portion is 0.0001 to 0.01 inches.

5. The system of claim 1, wherein the second bonding portion comprises a material whose composition is acoustically mismatched to an acoustic impedance of the transducer element, thereby providing a reflective backing layer on the proximal surface of the transducer element.

6. The system of claim 1, further comprising an air pocket disposed between the proximal surface of the transducer and the proximal heat sink.

7. The system of claim 1, wherein the transducer element comprises a flat circular disc.

8. The system of claim 7, wherein the transducer element has a dimension less than 0.2 inches, thereby allowing the transducer element to fit in a catheter.

9. The system of claim 1, wherein the transducer element operates at the first power level in a first frequency range and the second power level in a second frequency range, the second frequency range being different from the first frequency range.

10. The system of claim 9, wherein the first frequency range is 5 MHz to 30 MHz and the second frequency range is 10 to 18 MHz.

11. The system of claim 1, wherein the second bonding portion comprises perforations such that the second bonding portion is acoustically mismatched to an acoustic impedance of the transducer element.

12. The system of claim 1, further comprising an elongate flexible shaft having a proximal end and a distal end, and wherein the transducer element is disposed adjacent the distal end of the shaft.

13. The system of claim 1, further comprising a cooling fluid in fluid communication with the transducer element.

14. The system of claim 1, further comprising a temperature sensor adjacent the transducer element for monitoring temperature.

15. The transducer system of claim 1, wherein the coating that serves as the second acoustic matching layer is parylene.

16. A method of imaging and ablating tissue, said method comprising:

introducing an ablation device into a patient, wherein the device comprises;

a) a transducer element comprising a proximal surface and a distal surface, wherein the proximal surface is a continuous surface;

b) a first bonding portion attached to the distal surface of the transducer element, wherein the first bonding portion serves as a first acoustic matching layer and as a distal heat sink;

wherein a coating on the first bonding portion serves as a second acoustic matching layer;

c) a proximal heat sink having a second bonding portion attached to the proximal surface of the transducer element, wherein the heat sink comprises a bent portion, wherein the second bonding portion is bonded to the proximal surface of the transducer element, and wherein the bent portion forms one or more legs that protrude proximally from the transducer element and is configured to allow fluid flow therethrough in a direction along the legs; and

d) a base coupled to the proximal heat sink, wherein the base is configured to anchor the proximal heat sink,

operating the transducer element at a first power level to image a portion of the tissue and identify a target tissue, and at a second power level to ablate the target tissue, wherein the first power level is different than the second power level, and wherein the transducer element is alternating between imaging and ablation;

conducting heat away from the transducer element to the bent portion using the second bonding portion of the proximal heat sink; and

flowing fluid through the bent portion and past the transducer element, wherein fluid flow is in a direction along the legs;

wherein the steps of conducting heat away and flowing fluid provide cooling of the proximal surface and the distal surface of the transducer element.

17. The method of claim 16, further comprising monitoring temperature of the fluid and adjusting fluid flow based on the monitored temperature.

18. The method of claim 16, wherein the transducer element comprises first and second portions, wherein the operating of the transducer element at the first power level is performed by the first portion, and the operating of the transducer element at the second power level is performed by the second portion.

19. The method of claim 18, wherein the operating of the transducer element at the first power level is performed concurrently with the operating of the transducer element at the second power level.

20. The method of claim 16, wherein the introducing step comprises passing the ablation device transseptally across a septal wall of the patient'"'"'s heart.

21. The method of claim 16, wherein the introducing step comprises positioning the ablation device into a left atrium of the patient'"'"'s heart.

22. The method of claim 16, wherein there is no contact between the transducer element and the target tissue.

23. The method of claim 16, further comprising monitoring temperature of the transducer element and adjusting either the first or the second power level based on the monitored temperature.

24. A transducer system comprising:

a transducer element comprising a proximal surface and a distal surface;

a first bonding portion attached to the distal surface of the transducer element wherein the first bonding portion serves as a first acoustic matching layer and as a distal heat sink;

a coating on the first bonding portion that serves as a second acoustic matching layer;

a proximal heat sink having a second bonding portion attached to the proximal surface of the transducer element; and

a base coupled to the proximal heat sink, wherein the base is configured to anchor the proximal heat sink; and

wherein the proximal heat sink comprises a bent portion, and wherein the bent portion comprises a plurality of legs that protrude proximally from the transducer element and form a plurality of elongate channels configured to allow fluid flow therethrough in a direction along the legs to cool the transducer element.