Intravascular catheter to deliver unfocused energy to nerves surrounding a blood vessel

• US 9,358,401 B2
• Filed: 03/09/2012
• Issued: 06/07/2016
• 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
• Primary Examiner(s): Remaly, Mark
• Application Number:
  US13/417,194
• Publication Number:
  US 20120172723A1
• Time in Patent Office: 1,551 Days
• US Class Current: 1/1
• 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 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• 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 2090/3762 using computed tomography systems [CT]
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 5/0225 the pressure being controlled by electric signals, e.g. derived from Korotkoff sounds
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4047 afferent nerves, i.e. nerves that relay impulses to the central nervous system
• CPC Class Codes: A61B 5/4052 efferent nerves, i.e. nerves that relay impulses from the central nervous system
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/489 Blood vessels
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 6/03 : Computed tomography [CT] echo-tomography A61B8/14
• CPC Class Codes: A61B 6/032 : Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/037 : Emission tomography
• CPC Class Codes: A61B 6/506 : for diagnosis of nerves
• CPC Class Codes: A61B 8/00 : Diagnosis using ultrasonic, sonic or infrasonic waves imaging of objects using sonar G01S15/00
• CPC Class Codes: A61B 8/06 : Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/08 : Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• 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 8/485 : 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 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 2/006 : for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2005/063 : comprising light transmitting means, e.g. optical fibres
• CPC Class Codes: A61N 2007/0026 : Stimulation of nerve tissue
• CPC Class Codes: A61N 2007/003 : Destruction of nerve tissue
• CPC Class Codes: A61N 2007/0078 : with multiple treatment transducers
• CPC Class Codes: A61N 2007/025 : interstitial
• CPC Class Codes: A61N 5/00 : Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00
• CPC Class Codes: A61N 5/0601 : Apparatus for use inside the body
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 5/0622 : Optical stimulation for exciting neural tissue
• 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

In some examples, nerves surrounding arteries or leading to organs are targeted with energy sources to correct or modulate physiologic processes. In some examples, different types of energy sources are utilized singly or combined with one another. In some examples, bioactive agents or devices activated by the energy sources are delivered to the region of interest and the energy is enhanced by such agents or the agents are enhanced by the energy sources.

Claims

1. A method of inhibiting a nerve surrounding a blood vessel in a patient comprising:

placing an intravascular catheter inside the blood vessel in the patient, the catheter comprising a piezoelectric component; and

energizing the piezoelectric component to deliver unfocused ultrasound energy towards at least a majority portion of a circumference of the blood vessel to thereby reach the nerve surrounding the blood vessel;

wherein the act of energizing is performed to create a heated region having a toroidal configuration.

2. The method of claim 1, wherein the unfocused ultrasound energy is low intensity ultrasound.

3. The method of claim 1, wherein the unfocused ultrasound energy has an energy level that is anywhere from 50 mW/cm2 to 1000 mW/cm2.

4. The method of claim 1, wherein the unfocused ultrasound energy comprises cavitating energy.

5. The method of claim 1, further comprising delivering a bioactive agent to the nerve surrounding the blood vessel prior to delivering the unfocused ultrasound energy.

6. The method of claim 1, further comprising determining a degree of heat resulted from the delivery of the unfocused ultrasound energy.

7. The method of claim 1, further comprising determining a temperature of the nerve surrounding the blood vessel during the delivery of the unfocused ultrasound energy.

8. The method of claim 7, wherein the temperature is determined using a MRI scanner.

9. The method of claim 8, wherein the temperature is maintained between 40 and 60 degrees Celsius.

10. The method of claim 1, wherein the unfocused ultrasound energy is delivered so that a temperature of the nerve is anywhere from 40 to 60 degrees Celsius.

11. The method of claim 1, further comprising performing an imaging procedure during the delivery of the unfocused ultrasound energy, wherein the imaging procedure is performed on a part of the patient using an ultrasound imaging device positioned external to the patient.

12. The method of claim 1, wherein the intravascular catheter further comprises a cooling mechanism to protect an interior surface of the blood vessel.

13. The method of claim 1, wherein the intravascular catheter further comprises a stabilization mechanism for stabilizing a part of the intravascular catheter relative to the blood vessel.

14. The method of claim 1, wherein the unfocused ultrasound energy inhibits the nerve with vibration and not by heating the nerve.

15. The method of claim 1, further comprising detecting the unfocused ultrasound energy using a component placed external to the patient.

16. The method of claim 1, further comprising:

detecting the unfocused ultrasound energy by an external component; and

using the detected ultrasonic energy to facilitate treatment targeting.

17. The method of claim 1, wherein the unfocused ultrasound energy radiates outward from the intravascular catheter to intersect an interior wall of the blood vessel to thereby create the heated region having the toroidal configuration.

18. The method of claim 1, further comprising utilizing a device to detect a progress of the delivery of the ultrasound energy.

19. The method of claim 1, wherein the catheter further comprises a material which facilitates transmission of the unfocused ultrasound energy to a wall of the blood vessel.

20. The method of claim 1, wherein the blood vessel is a renal artery, and the nerve comprises a renal nerve.

21. The method of claim 1, further comprising detecting signals from an autonomic nervous system of the patient prior to, and after, the act of energizing.

22. A method to inhibit a renal nerve traveling to a kidney in a patient comprising:

inserting an intravascular catheter into a renal artery of the patient;

delivering energy from the intravascular catheter to the renal nerve around the artery;

utilizing a device to detect a progress of the delivery of the energy to the nerve;

wherein the act of delivering energy is performed to create a heated region having a toroidal configuration.

23. The method of claim 22, wherein the energy comprises ultrasound.

24. The method of claim 22, wherein the energy comprises unfocused ultrasound.

25. The method of claim 22, wherein the energy comprises radiofrequency energy.

26. The method of claim 22, wherein the energy comprises vibrational energy.

27. The method of claim 22, wherein the energy comprises cavitational energy.

28. The method of claim 22, wherein the progress is detected by measuring a temperature with the device.

29. The method of claim 22, wherein the progress is detected by measuring a tissue response using the device.

30. The method of claim 22, wherein the energy is delivered to heat the renal nerve to a temperature that is anywhere from 40 to 60 degrees Celsius.

31. The method of claim 30, further comprising detecting the temperature using the device.