Energetic modulation of nerves

• US 8,992,447 B2
• Filed: 06/14/2012
• Issued: 03/31/2015
• Est. Priority Date: 10/12/2009
• Status: Active Grant

• Current Assignee: Otsuka Medical Devices Co., Ltd. (Otsuka Holdings Company Limited)
• Original Assignee: Kona Medical, Inc.
• Inventors: Gertner, Michael, Perozek, David, Zhang, Jimin, Sabet, Arash
• Primary Examiner(s): REMALY, MARK DONALD
• Application Number:
  US13/523,835
• Publication Number:
  US 20120253239A1
• Time in Patent Office: 1,020 Days
• Field of Search: 600407-475, 601 2- 4
• US Class Current: 601/2
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 6/506 for diagnosis of nerves
• CPC Class Codes: A61B 8/4245 involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient
• CPC Class Codes: A61B 8/44 Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
• CPC Class Codes: A61B 8/485 involving measuring strain or elastic properties
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61N 2007/003 Destruction of nerve tissue
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 2007/0095 by modifying an excitation signal
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A system for applying focused ultrasound energy to a nerve surrounding an artery of a patient includes a piezoelectric array comprising a plurality of piezoelectric elements, a controller configured to control at least a subset of the piezoelectric elements so that at least one of the piezoelectric elements in the subset is in a signal transmitting mode, in a signal sensing mode, or both, a first platform on which the piezoelectric elements are coupled and a second platform, wherein the second platform is configured to support at least a part of the patient, a programmable generator configured to generate output power for one or more of the piezoelectric elements, and a programmable processor configured to process a signal sensed by at least one of the piezoelectric elements.

Claims

1. A system for applying focused ultrasound energy to a nerve surrounding a blood vessel of a patient comprising:

a piezoelectric array comprising a plurality of piezoelectric elements;

a controller configured to control at least a subset of the piezoelectric elements so that at least one of the piezoelectric elements in the subset is in a signal transmitting mode, in a signal sensing mode, or both;

a first platform on which the piezoelectric elements are coupled and a second platform, wherein the second platform is configured to support the patient, the first platform is moveable relative to the second platform, and the piezoelectric elements are next to a middle region of the second platform;

a generator configured to generate output power for one or more of the piezoelectric elements, wherein the generator is configured to generate the power at a power level for energizing the piezoelectric elements to provide a treatment effect, wherein the power level is calculated to account for a cooling effect due to blood flow; and

a programmable processor configured to process a signal sensed by at least one of the piezoelectric elements to determine whether the signal is reflected from the blood vessel or not;

wherein the controller is configured to control the piezoelectric array to deliver energy to nerve tissues at different respective positions that at least partially surround the blood vessel.

2. The system of claim 1, wherein a first one of the piezoelectric elements is configured to generate an output signal, and a second one of the piezoelectric elements is configured to sense the output signal after the output signal has been reflected from tissue in the patient, the sensed output signal being the signal for processing by the programmable processor.

3. The system of claim 1, wherein one of the piezoelectric elements is configured to both generate an output signal, and to sense the output signal after it has been reflected from the tissue, the sensed output signal being the signal for processing by the programmable processor.

4. The system of claim 1, wherein at least one of the piezoelectric elements is part of a component that includes a receiver to receive signals from a depth of greater than 8 cm and less than 14 cm from a skin of the patient.

5. The system of claim 1, wherein the controller is configured to control a phasing of at least some of the piezoelectric elements in response to the signal;

and

wherein the generator is configured to generate the output power which drives the one or more of the piezoelectric elements to create high intensity focused ultrasound.

6. The system of claim 1, wherein the piezoelectric elements are controlled by the controller to focus therapeutic ultrasound energy at a target in the patient located at a position that is greater than 7 cm from a skin of the patient, and wherein the signal comprises a flow signal from a renal artery.

7. The system of claim 1, wherein the processor is coupled to the piezoelectric array, and the processor is configured to determine a speed of blood, a direction of blood flow, or both.

8. The system of claim 1, further comprising a mechanical motion actuator coupled to the first platform, the mechanical motion actuator configured to mechanically move the piezoelectric array to follow a movement of the blood vessel within the patient.

9. The system of claim 1, wherein at least one of the piezoelectric elements includes a receiver configured to receive an ultrasound signal from an intravascular piezoelectric transmitter;

and

wherein the processor is configured to determine an acoustic parameter using at least in part on the signal, and wherein the acoustic parameter comprises a parameter related to acoustics.

10. The system of claim 1, further comprising a positioner for moving the first platform to track a motion of the blood vessel using the signal after the signal is processed by the processor.

11. The system of claim 1, wherein the generator is configured to transmit a phased output power to cause the piezoelectric elements to transmit a focused ultrasound output to one of the nerve tissues to inhibit a function of the one of the nerve tissues.

12. The system of claim 1, wherein the signal comprises a Doppler flow signal;

and

wherein the programmable processor is configured to determine a position of a focal zone of energy from the piezoelectric array that corresponds with the Doppler flow signal, the position being inside the vessel.

13. The system of claim 1, wherein the signal comprises a Doppler flow signal, and the system further includes a positioner for moving the first platform in response to the Doppler flow signal.

14. The system of claim 1, wherein the signal comprises a Doppler flow signal, and the controller is configured to control the piezoelectric elements in accordance with a phasing pattern so that the energy from the piezoelectric elements are focused at the different positions to at least partially surround the blood vessel.

15. The system of claim 1, wherein the processor is also configured to control the piezoelectric array to change a focus location of the energy in response to a movement of the blood vessel.

16. A system for delivering energy to nerves surrounding a blood vessel in a patient comprising:

a first ultrasound transducer configured to apply therapeutic energy at an energy level that provides a treatment effect, wherein the energy level is calculated to account for a cooling effect due to blood flow, wherein the first ultrasound transducer is configured to apply the therapeutic energy across the blood vessel to heat nerves on at least two sides of the blood vessel;

a receiver configured to receive reflected energy resulting from an ultrasound pulse; and

a processor configured to

receive first data from the receiver at a first time point,

receive second data from the receiver at a second time point,

compare the first data with the second data, and

provide an output signal to a mover to control a position of the first ultrasound transducer;

wherein the processor is further configured to identify the blood vessel using the received reflected energy.

17. The system of claim 16, further comprising the mover, wherein the mover is inside of a table, and the table is configured to support a patient while allowing the first ultrasound transducer to couple to the patient.

18. The system of claim 16, further comprising the mover, wherein the mover comprises a ball and a socket accommodating the ball.

19. The system of claim 18, further comprising a lock for securing the ball relative to the socket so that the ball and the socket are stationary relative to each other.

20. The system of claim 16, wherein the processor is further configured to change a focus location of the therapeutic energy in response to a movement of the blood vessel.

21. The system of claim 16, wherein the first ultrasound transducer is configured to apply the therapeutic energy to heat the nerves on the at least two sides of the blood vessel so that the therapeutic energy is not focused inside the blood vessel.

22. A system for applying focused ultrasound energy to a patient comprising:

a piezoelectric array comprising a plurality of piezoelectric elements;

a controller configured to control at least a subset of the piezoelectric elements so that at least one of the piezoelectric elements in the subset is in a signal transmitting mode, in a signal sensing mode, or both;

a first platform on which the piezoelectric elements are coupled, and a second platform, wherein the second platform is configured to support the patient, the first platform is moveable relative to the second platform, and the piezoelectric elements are located next to a middle region of the second platform;

a generator configured to generate output power for energizing one or more of the piezoelectric elements to affect a function of one or more renal nerves next to a blood vessel, wherein the output power is calculated to account for a cooling effect due to blood flow in the blood vessel.

23. The system of claim 22, wherein the signal comprises a Doppler flow signal.

24. The system of claim 22, wherein the at least one of the piezoelectric elements includes a sensor configured to sense the signal from an indwelling catheter.

25. The system of claim 22, wherein the piezoelectric array is configured to deliver the ultrasound energy to the blood vessel at a depth from about 7 cm to about 14 cm by utilizing varying outputs from the generator to the piezoelectric array.

26. The system of claim 22, wherein the piezoelectric array is configured to deliver the ultrasound energy to the circumference of the blood vessel over a blood vessel length of about 1-2 cm.

27. The system of claim 22, wherein the at least one of the piezoelectric elements is configured to emit an ultrasound pulse, and receive the ultrasound pulse as the signal after the ultrasound pulse is reflected from a region of the blood vessel.

28. The system of claim 22, wherein the second platform is configured for allowing delivery of focused ultrasound by the piezoelectric array through a back of the patient to the blood vessel that leads to a kidney.

29. The system of claim 22, further comprising:

a first mover, the first mover configured to move the first platform to track a movement of the blood vessel to maintain ultrasound foci about the blood vessel; and

a second mover, the second mover configured to move the first platform in at least one direction that is substantially parallel to a longitudinal axis of a patient support.

30. The system of claim 22, wherein the processor is configured to change a focus location of the ultrasound energy in response to a movement of the blood vessel.