Intraluminal method and apparatus for ablating nerve tissue

• US 10,368,944 B2
• Filed: 07/17/2017
• Issued: 08/06/2019
• Est. Priority Date: 07/01/2002
• Status: Active Grant

• Current Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Inventors: Schaer, Alan K.
• Primary Examiner(s): Turchen, Rochelle D
• Application Number:
  US15/651,987
• Publication Number:
  US 20170312029A1
• Time in Patent Office: 750 Days
• 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 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;

a cylindrical ultrasonic transducer disposed along the distal end of the catheter, the cylindrical ultrasonic transducer comprising an integral circumferential arrangement machined into the cylindrical ultrasonic transducer to form an end region and a center region of the cylindrical ultrasonic transducer, wherein the end region is thinner than the center region of the cylindrical ultrasonic transducer and the cylindrical ultrasonic transducer is configured to emit unfocused acoustic energy radially outward in a uniform manner through a wall of the bodily lumen to ablate nerve tissue; 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 circulating through an interior of the inflatable balloon via the interior fluid passage of the catheter when the cylindrical ultrasonic transducer is energized.

2. The minimally-invasive intraluminal ablation device of claim 1, wherein the distal end of the catheter is configured to be delivered intraluminally to the bodily lumen.

3. The minimally-invasive intraluminal ablation device of claim 1, 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.

4. The minimally-invasive intraluminal ablation device of claim 3, wherein the inflatable balloon is in fluid communication with the central lumen within the cylindrical ultrasonic transducer.

5. The minimally-invasive intraluminal ablation device of claim 1, wherein the cooling fluid received by the inflatable balloon at least partially inflates the inflatable balloon.

6. The minimally-invasive intraluminal ablation device of claim 5, wherein the inflatable balloon, when inflated, radially centers the cylindrical ultrasonic transducer within the inflatable balloon and has a circular cross-sectional shape, coaxial with the cylindrical ultrasonic transducer.

7. The minimally-invasive intraluminal ablation device of claim 1, farther 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 cylindrical ultrasonic transducer to emit the unfocused acoustic energy radially outward.

8. The minimally-invasive intraluminal ablation device of claim 1, 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 of the inflatable balloon via the interior fluid passage of the catheter when the cylindrical ultrasonic transducer is energized.

9. The minimally-invasive intraluminal ablation device of claim 8, wherein circulation of the pooling fluid through the interior of the inflatable balloon via the interior fluid passage of the catheter when the cylindrical ultrasonic transducer is energized removes heat away from the cylindrical ultrasound transducer and the interior of the inflatable balloon, and reduces the likelihood of heating a lining of the bodily lumen to the point of irreversible damage.

10. A minimally-invasive method of intraluminal ablation of nerve tissue surrounding a bodily lumen of a subject, the method 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 arrangement machined into the cylindrical ultrasonic transducer to form an end region and a center region of the cylindrical ultrasonic transducer, wherein the end region is thinner than a center region of the cylindrical ultrasonic transducer and the cylindrical ultrasonic transducer is configured to emit unfocused acoustic energy;

advancing the ultrasound device within the bodily lumen to position the cylindrical 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 a fluid passage of the elongated catheter;

circulating the cooling fluid through an interior of the inflatable balloon via the 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;

energizing the cylindrical ultrasonic transducer to emit unfocused 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 the unfocused acoustic energy to at least partially ablate nerve tissue adjacent the wall of the bodily lumen; and

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

11. The method of claim 10, 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.

12. The method of claim 10, wherein the elongated catheter comprises another fluid lumen for circulating the cooling fluid.

13. The method of claim 10, wherein energizing the cylindrical ultrasonic transducer comprises operating the cylindrical ultrasonic transducer at a frequency of 1-40 MHz.

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

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

16. The method of claim 10, wherein energizing the cylindrical ultrasonic transducer comprises operating the cylindrical ultrasonic transducer such that the unfocused acoustic energy emitted at a transducer surface of the cylindrical ultrasonic transducer is 30 W/cm² to 70 W/cm².

17. The method of claim 10, wherein energizing the cylindrical ultrasonic transducer raises a temperature of a targeted anatomical tissue by 55°

C. to 95°

C.

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

C. to 80°

C.