Intraluminal method and apparatus for ablating nerve tissue

• US 9,707,034 B2
• Filed: 05/23/2012
• Issued: 07/18/2017
• 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
• Application Number:
  US13/478,825
• Publication Number:
  US 20130072928A1
• Time in Patent Office: 1,882 Days
• Field of Search: 600437, 600439, 600459, 600466, 600470, 601 2- 4, 601 41
• 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 method of intraluminal ablation of nerve tissue surrounding a bodily lumen of a subject, comprising:

delivering an ablation device within a bodily lumen of a subject, the ablation device comprising a catheter having a fluid passage, a balloon and an ultrasound transducer disposed along a distal end of the catheter within the balloon, the ultrasound transducer having a resonating region with a first diameter and an integral circumferential step that forms a non-resonating region with a second diameter, the fluid passage being in fluid communication with the balloon, and wherein the integral circumferential step is at an end of the ultrasound transducer;

advancing the ablation device within the bodily lumen to position the ultrasound transducer adjacent target nerve tissue of the subject, wherein the target nerve tissue is positioned in nerve pathways that run adjacent the bodily lumen;

delivering a cooling fluid through the fluid passage to inflate the balloon to a circular cross-sectional shape, coaxial with the ultrasound transducer, to center the ultrasound transducer within the bodily lumen so as to locate the ultrasound transducer at a pre-determined position relative to a wall of the bodily lumen;

circulating the cooling fluid through an interior of the balloon via the fluid passage to remove heat from the ultrasound transducer and to reduce a likelihood of heating a lining of the bodily lumen to the point of irreversible damage; and

activating the ultrasound transducer to excite the resonating region to deliver ultrasonic energy radially outwardly through the balloon and the wall of the bodily lumen while cooling fluid is circulated through the interior of the balloon, the ultrasound energy being delivered around an entire circumference of the bodily lumen to at least partially ablate the target nerve tissue in a uniform annulus of tissue at a depth of 1 mm to 10 mm from the wall of the bodily lumen, the non-resonating region reducing the transmission of ultrasonic energy to the distal end of the catheter.

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

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

C. to 95°

C.

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

C. to 80°

C.

5. The method of claim 1, wherein the balloon comprises at least one compliant material.

6. The method of claim 1, wherein the balloon comprises at least one non-compliant material.

7. A method of intraluminal ablation of nerve tissue surrounding a bodily lumen of a subject, comprising;

inserting an ablation device within a bodily lumen of a subject, the ablation device comprising a catheter, a balloon and ultrasound transducer disposed on a distal region of the catheter within the balloon, the ultrasound transducer having a resonating region of a first diameter and an integral circumferential step forming a non-resonating region of a second diameter, wherein the integral circumferential step is at an end of the ultrasound transducer;

advancing the ablation device within the bodily lumen to position the ultrasound transducer near a target anatomical location of the subject, wherein the target nerve tissue is positioned in nerve pathways that run adjacent the bodily lumen along the target anatomical location;

at least partially inflating the balloon by delivering a fluid 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, the balloon when inflated having a circular cross-sectional shape coaxial with the ultrasound transducer and that radially centers the ultrasound transducer within the bodily lumen at a pre-determined position relative to a wall of the bodily lumen; and

activating the ultrasound transducer to excite the resonating region to emit ultrasonic energy outwardly toward and through a wall of the bodily lumen, around an entire circumference of the bodily lumen, so as to ablate nerve tissue positioned adjacent the wall of the bodily lumen within a uniform annulus of tissue.

8. The method of claim 7, further comprising circulating a fluid through an interior of the balloon during activation of the ultrasound transducer to remove heat from the ultrasound transducer.

9. The method of claim 7, 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.

10. The method of claim 7, wherein activating the ultrasound transducer raises a temperature of a targeted anatomical tissue by 55°

C. to 95°

C.

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

inserting an ablation device, within a bodily lumen of a subject, the ablation device comprising a catheter having a distal region, a balloon disposed on the distal region and an ultrasound transducer disposed within the balloon, the ultrasound transducer having a resonating region of a first diameter and an integral circumferential step forming a non-resonating region of a second diameter, wherein the integral circumferential step is at an end of the ultrasound transducer;

advancing the ablation device within the bodily lumen to position the ultrasound transducer near a target anatomical location of the subject, wherein the target nerve tissue is positioned in nerve pathways that run adjacent the bodily lumen along the location of the ultrasound transducer;

at least partially inflating the balloon by circulating a cooling fluid through the interior of the balloon to transfer heat away from the ultrasound transducer to reduce the likelihood of heating an inner lining of the bodily lumen to the point of irreversible damage, the balloon, when inflated, centering the ultrasound transducer within the bodily lumen at a pre-determined position relative to a wall of the bodily lumen;

activating the ultrasound transducer to excite the resonating region to deliver ultrasonic energy outwardly toward a wall of the bodily lumen, around an entire circumference of the bodily lumen, to ablate nerve tissue positioned adjacent the wall of the bodily lumen in an annulus of tissue having a depth of 1 mm to 10 mm from the wall of the bodily lumen.

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

13. 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.