METHOD AND APPARATUS EMPLOYING ULTRASOUND ENERGY TO TREAT BODY SPHINCTERS

• US 20130072928A1
• Filed: 05/23/2012
• Published: 03/21/2013
• 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.
• Granted Patent: US 9,707,034 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• 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
• 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

1-26. -26. (canceled)

27. 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, said ablation device comprising a catheter and at least one energy delivery element positioned along a distal end of the catheter, said at least one energy delivery element comprising at least one ultrasound transducer, wherein the catheter comprises at least one fluid passage and a balloon positioned along a distal end of the catheter, said balloon configured to surround the at least one energy delivery element, said at least one fluid passage being in fluid communication with said balloon;

advancing the ablation device within the bodily lumen to position the at least one energy delivery element adjacent target nerve tissue of the subject;

at least partially inflating the balloon by delivering a cooling fluid through the at least one fluid passage of the catheter;

circulating a cooling fluid through an interior of the balloon via the at least one fluid passage of the catheter to remove heat away from the at least one energy delivery element; and

activating the at least one energy delivery element to deliver energy radially outwardly from said at least one energy delivery element through the balloon and toward a wall of the bodily lumen, wherein the at least one energy delivery element is activated so that sufficient energy is delivered to at least partially ablate nerve tissue adjacent the wall of the bodily lumen;

wherein cooling fluid is circulated through the interior of the balloon during at least a portion of the time when the at least one energy delivery element is activated; and

wherein circulating cooling fluid through an interior of the balloon reduces the likelihood of heating a lining of the bodily lumen to the point of irreversible damage.

28. The method of claim 27, wherein at least partially inflating the balloon comprises providing sufficient fluid within an interior of said balloon so that said balloon at least partially engages the wall of the bodily lumen.

29. The method of claim 27, wherein energizing the at least one energy delivery element raises a temperature of a targeted anatomical tissue by approximately 55°

C. to 95°

C.

30. The method of claim 27, wherein energizing the at least one energy delivery element raises a temperature of a targeted anatomical tissue by approximately 60°

C. to 80°

C.

31. The method of claim 27, wherein the balloon comprises at least one complaint material.

32. The method of claim 27, wherein the balloon comprises at least one non-complaint material.

33. The method of claim 27, wherein the at least one ultrasonic transducer is configured to emit unfocused acoustic energy.

34. 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, said ablation device comprising a catheter and an energy delivery element located along a distal end of the catheter, wherein the catheter comprises a balloon, said balloon generally surrounding the energy delivery element;

advancing the ablation device within the bodily lumen in order to position the energy delivery element near a target anatomical location of the subject;

at least partially inflating the balloon by delivering a fluid through at least one fluid passage of the catheter and into an interior of said balloon;

activating the energy delivery element to emit energy outwardly from said energy delivery element toward and through a wall of the bodily lumen so as to ablate nerve tissue positioned adjacent the wall of the bodily lumen;

wherein delivering a fluid to the interior of the balloon reduces the likelihood of heating an inner lining of the bodily lumen to the point of irreversible damage; and

wherein delivering a fluid to the interior of the balloon to at least partially inflate the balloon generally radially centers the energy delivery element within the bodily lumen.

35. The method of claim 34, further comprising circulating a fluid through an interior of the balloon, at least for a portion of a time when the energy delivery element is activated, via the at least one fluid passage to remove additional heat away from the energy delivery element.

36. The method of claim 34, wherein at least partially inflating the balloon comprises providing sufficient fluid within the interior of said balloon so that said balloon at least partially contacts the wall of the bodily lumen.

37. The method of claim 34, wherein the energy delivery element comprises at least one ultrasonic transducer.

38. The method of claim 34, wherein the energy delivery element comprises at least one radiofrequency (RF) electrode.

39. The method of claim 34, wherein the energy delivery element comprises at least one of a microwave emitter and a laser emitter.

40. The method of claim 34, wherein activating the energy delivery element raises a temperature of a targeted anatomical tissue by approximately 55°

C. to 95°

C.

41. 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, wherein the ablation device comprises a catheter and at least one energy delivery element located near a distal end of the catheter, said catheter comprising at least one fluid passage and a balloon generally surrounding the at least one energy delivery element, wherein the at least one fluid passage is in fluid communication with an interior of the balloon;

advancing the ablation device within the bodily lumen in order to position the energy delivery element near a target anatomical location of the subject;

at least partially inflating the balloon by circulating a cooling fluid through the least one fluid passage of the catheter and into the interior of said balloon;

activating the energy delivery element to deliver sufficient energy outwardly from said energy delivery element toward a wall of the bodily lumen to ablate nerve tissue positioned adjacent the wall of the bodily lumen;

wherein cooling fluid is circulated through the interior of the balloon during at least a portion of the time when the energy delivery element is activated to transfer heat away from the energy delivery element; and

wherein delivering a cooling fluid to the interior of the balloon reduces the likelihood of heating an inner lining of the bodily lumen to the point of irreversible damage.

42. The method of claim 41, wherein the at least one energy delivery element comprises at least one ultrasonic transducer.

43. The method of claim 41, wherein the at least one energy delivery element comprises at least one radiofrequency (RF) electrode.

44. The method of claim 41, wherein the at least one energy delivery element comprises at least one of a microwave emitter and a laser emitter.

45. The method of claim 41, wherein at least partially inflating the balloon comprises providing sufficient cooling fluid within the interior of said balloon so that said balloon at least partially contacts the wall of the bodily lumen.

46. The method of claim 41, wherein circulating a cooling fluid within the interior of the balloon comprises circulating said cooling fluid through at least two separate fluid passages of the catheter.