Intraluminal methods of ablating nerve tissue

• US 9,700,372 B2
• Filed: 11/19/2012
• Issued: 07/11/2017
• Est. Priority Date: 07/01/2002
• Status: Expired due to Term

• Current Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Inventors: Schaer, Alan
• Primary Examiner(s): Turchen, Rochelle
• Application Number:
  US13/681,311
• Publication Number:
  US 20130131668A1
• Time in Patent Office: 1,695 Days
• Field of Search: 600437, 600459, 600462, 600466, 600470, 600471
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61N 2007/003 Destruction of nerve tissue
• CPC Class Codes: A61N 2007/0043 intra-cavitary
• CPC Class Codes: A61N 2007/0065 Concave transducers
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 2007/0082 Scanning transducers
• CPC Class Codes: A61N 2007/0091 with moving parts, e.g. transducers, lenses, reflectors
• CPC Class Codes: A61N 2007/0095 by modifying an excitation signal
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

Methods and apparatus for treating gastroesophageal reflex and other luminal conditions provide for delivering acoustic energy to a body lumen to remodel tissue surrounding the body lumen. In the case of treating GERD, a catheter carrying an ultrasonic or other vibrational transducer is introduced to the lower esophageal sphincter, and acoustic energy is delivered to the sphincter in order to tighten or bulk the sphincter such that reflex is reduced.

Claims

1. A minimally-invasive method of intraluminal ablation of nerve tissue surrounding a bodily lumen of a subject, comprising:

delivering an ultrasound device within a bodily lumen of a subject, the ultrasound device comprising an elongated catheter and a cylindrical ultrasonic transducer positioned along a distal end of the elongated catheter, the elongated catheter comprising an inflatable balloon positioned to surround the cylindrical ultrasonic transducer and positioned proximal to a distal tip of the elongated catheter, the cylindrical ultrasonic transducer comprising an integral circumferential step machined into the cylindrical ultrasonic transducer to form a resonating region of a first diameter and a non-resonating region of a second diameter, wherein the integral circumferential step is at an end of the cylindrical ultrasonic transducer;

advancing the ultrasound device within the bodily lumen to position the ultrasonic transducer adjacent target nerve tissue positioned in nerve pathways that run along and adjacent the bodily lumen;

at least partially inflating the inflatable balloon by delivering a cooling fluid through at a fluid passage of the elongated catheter, such that when inflated, the inflatable balloon radially centers the ultrasonic transducer within the inflatable balloon and has a circular cross-sectional shape, coaxial with the cylindrical ultrasonic transducer;

circulating the cooling fluid through an interior of the inflatable balloon via the at fluid passage of the elongated catheter during a time when the cylindrical ultrasonic transducer is energized to remove heat away from the cylindrical ultrasound transducer and the interior of the inflatable balloon and to reduce the likelihood of heating a lining of the bodily lumen to the point of irreversible damage, such that ablation of tissue occurs at a depth of 1 mm to 10 mm from a wall of the bodily lumen around an entire circumference of the ultrasonic transducer;

energizing the ultrasonic transducer to excite the resonating region of the cylindrical ultrasonic transducer to emit acoustic energy radially outwardly from the cylindrical ultrasonic transducer through the inflatable balloon and toward the wall of the bodily lumen so as to deliver acoustic energy to at least partially ablate nerve tissue adjacent the wall of the bodily lumen, such that acoustic energy is delivered in the radial direction uniformly through the wall of the bodily lumen and toward the target nerve tissue while the non-resonating region of the cylindrical ultrasonic transducer remains unexcited; and

removing the ultrasound device from the subject after the cylindrical ultrasonic transducer is de-energized.

2. The method of claim 1, wherein at least partially inflating the inflatable balloon comprises providing fluid within an interior of the inflatable balloon so that the inflatable balloon at least partially engages the wall of the bodily lumen.

3. The method of claim 1, wherein the cylindrical ultrasonic transducer is configured to emit unfocused acoustic energy.

4. The method of claim 1, wherein the elongated catheter comprises another fluid lumen for circulating the cooling fluid.

5. The method of claim 1, wherein energizing the cylindrical ultrasonic transducer comprises operating the cylindrical ultrasonic transducer at a frequency of 1-40 MHz.

6. The method of claim 1, wherein energizing the cylindrical ultrasonic transducer comprises operating the cylindrical ultrasonic transducer at a frequency of 7-10 MHz.

7. The method of claim 1, wherein energizing the cylindrical ultrasonic transducer comprises operating the cylindrical ultrasonic transducer such that an acoustic energy emitted at a transducer surface of the cylindrical ultrasonic transducer is 10 W/cm² to 100 W/cm².

8. The method of claim 1, wherein energizing the cylindrical ultrasonic transducer comprises operating the cylindrical ultrasonic transducer such that an acoustic energy emitted at a transducer surface of the cylindrical ultrasonic transducer is 30 W/cm² to 70 W/cm².

9. The method of claim 1, wherein energizing the cylindrical ultrasonic transducer raises a temperature of a targeted anatomical tissue by 55°

C. to 95°

C.

10. The method of claim 1, wherein energizing the cylindrical ultrasonic transducer raises a temperature of a targeted anatomical tissue by 60°

C. to 80°

C.

11. A minimally-invasive method of intraluminal ablation of nerve tissue surrounding a bodily lumen of a subject, comprising:

inserting an ultrasound device within a bodily lumen of a subject, the ultrasound device comprising a catheter and a cylindrical transducer located along a distal end of the catheter comprising an integral circumferential step machined into the cylindrical transducer to form a resonating region of a first diameter and a non-resonating region of a second diameter, the catheter further comprising a balloon, the balloon surrounding the cylindrical transducer, wherein the integral circumferential step is at an end of the cylindrical transducer;

advancing the ultrasound device within the bodily lumen in order to position the cylindrical transducer to a target anatomical location of the subject, such that the nerve tissue is positioned in nerve pathways that are adjacent and generally parallel to the bodily lumen at the target anatomical location;

at least partially inflating the balloon by delivering a fluid through a fluid passage of the catheter and into an interior of the balloon to reduce the likelihood of heating an inner lining of the bodily lumen to the point of irreversible damage, such that when inflated, the balloon comprises a circular cross-sectional shape and radially centers the cylindrical transducer within the balloon; and

after circulating the cooling fluid through the balloon to cool the cylindrical transducer and the bodily lumen, activating the cylindrical transducer to emit ultrasonic energy outwardly from the cylindrical transducer toward and through a wall of the bodily lumen and delivering acoustic energy from the cylindrical transducer to ablate nerve tissue positioned adjacent the wall of the bodily lumen, such that acoustic energy is delivered in the radial direction uniformly through the wall of the bodily lumen, around an entire circumference of the bodily lumen, and toward the nerve tissue.

12. The method of claim 11, further comprising circulating a fluid through an interior of the balloon, when the cylindrical transducer is activated, via the fluid passage to remove heat away from the cylindrical transducer.

13. The method of claim 11, wherein at least partially inflating the balloon comprises providing fluid within the interior of the balloon so that the balloon at least partially contacts the wall of the bodily lumen.

14. The method of claim 11, wherein energizing the cylindrical transducer comprises operating the cylindrical transducer at a frequency of 1-40 MHz.

15. The method of claim 11, wherein circulating a cooling fluid within the interior of the balloon comprises circulating the cooling fluid through at least two separate fluid passages of the catheter.

16. The method of claim 11, wherein energizing the cylindrical transducer comprises operating the cylindrical transducer such that an acoustic energy emitted at a transducer surface of the cylindrical transducer is 10 W/cm² to 100 W/cm².

17. The method of claim 11, wherein activating the cylindrical transducer raises a temperature of a targeted anatomical tissue by 55°

C. to 95°

C.

18. A minimally-invasive intraluminal ablation device configured to ablate nerve tissue surrounding a bodily lumen of a subject, the minimally-invasive intraluminal ablation device comprising:

a catheter comprising a distal end, a proximal end, and an interior fluid passage, the distal end of the catheter configured to be delivered intraluminally to the bodily lumen;

a cylindrical ultrasonic transducer disposed along the distal end of the catheter, the cylindrical ultrasonic transducer comprising an integral circumferential step machined into the cylindrical ultrasonic transducer to form a resonating region of a first diameter and a non-resonating region of a second diameter, the resonating region configured to emit acoustic energy radially outward in a uniform manner through a wall of the bodily lumen to ablate nerve tissue while the non-resonating region remains unexcited, wherein the integral circumferential step is at an end of the cylindrical ultrasonic transducer; and

an inflatable balloon disposed along the distal end of the catheter to surround the cylindrical ultrasonic transducer, the inflatable balloon configured to receive a cooling fluid through the interior fluid passage of the catheter to at least partially inflate the inflatable balloon.

19. The minimally-invasive intraluminal ablation device of claim 18, wherein the cylindrical ultrasonic transducer further comprises a central lumen within the cylindrical ultrasonic transducer, the central lumen configured to receive cooling fluid introduced to the inflatable balloon through the interior fluid passage of the catheter.

20. The minimally-invasive intraluminal ablation device of claim 19, wherein the inflatable balloon is in fluid communication with the central lumen within the cylindrical ultrasonic transducer.

21. The minimally-invasive intraluminal ablation of claim 18, further comprising an energy generator configured to be coupled to the proximal end of the catheter to establish electrical communication with the cylindrical ultrasonic transducer via a wired connection, the energy generator configured to deliver electrical signals to the cylindrical ultrasonic transducer to cause the resonating region to emit acoustic energy radially outward.

22. The minimally-invasive intraluminal ablation device of claim 18, further comprising a fluid pump configured to be placed in fluid communication with the interior fluid passage of the catheter, the fluid pump further configured to circulate the cooling fluid through the interior fluid passage of the catheter to at least partially inflate the inflatable balloon.