Method to treat gastric reflux via the detection and ablation of gastro-esophageal nerves and receptors

• US 6,405,732 B1
• Filed: 10/01/1999
• Issued: 06/18/2002
• Est. Priority Date: 06/24/1994
• Status: Expired due to Fees

• Current Assignee: Mederi Therapeutics, Inc. (Respiratory Technology Corp.)
• Original Assignee: Curon Medical, Inc.
• Inventors: Utley, David S., Edwards, Stuart D., Gaiser, John
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/410,448
• Time in Patent Office: 991 Days
• Field of Search: 606/41, 606/42, 606/45, 606/50, 607/101, 607/102, 607/115, 607/116, 607/133, 128/898
• US Class Current: 128/898
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00077 high, i.e. electrically conducting
• CPC Class Codes: A61B 2018/00142 lubricating
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/0091 : Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00982 : combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/0237 : with a thermoelectric element in the probe for cooling purposes
• CPC Class Codes: A61B 2018/046 : in liquid form
• CPC Class Codes: A61B 2018/124 : switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61N 1/06 : for high-frequency therapy

Abstract

A method of treating a sphincter provides a sphincter electropotential mapping device with at least one of a mapping electrode or a treatment electrode. The sphincter electropotential mapping device is introduced into at least a portion of the sphincter, the lower esophageal sphincter, stomach, the cardia or the fundus. Bioelectric activity causing a relaxation of the sphincter is detected and energy is delivered from either the mapping electrode or the treatment electrode to treat the bioelectric activity.

Claims

1. A method of treating a sphincter, comprising:

providing a sphincter electropotential mapping device with at least one of a mapping electrode or a treatment electrode;

introducing the sphincter electropotential mapping device into at least a portion of one of the sphincter, a lower esophageal sphincter, a stomach, a cardia or a fundus;

detecting a electrical activity causing a transient relaxation of the sphincter; and

delivering energy from one of the mapping electrode or the treatment electrode to treat the electrical activity.

2. The method of claim 1, wherein the detection of the electrical activity is

a detection of one of a gastric-electrical activity, a neuro-electrical activity, a nerve pathway, an afferent pathway, an electrical pathway, a mechanoreceptor pathway or a chemoreceptor pathway.

3. The method of claim 1, further comprising:

delivering sufficient energy from one of the mapping electrode or the treatment electrode to ablate at least a portion of one of a nerve, a gastric nerve, a nerve plexus, a myenteric nerve plexus, a ganglia, a nerve pathway or an electrically conductive pathway.

4. The method of claim 1, further comprising:

conducting electromagnetic energy along one of a nerve, a nerve pathway or a ganglia.

5. The method of claim 4, further comprising:

delivering sufficient electromagnetic energy along one of the nerve, the nerve pathway or the ganglia to ablate at least a portion of one of a nerve, a gastric nerve, a nerve plexus, a myenteric nerve plexus, a ganglia, a nerve pathway or an electrically conductive pathway.

6. The method of claim 3, further comprising:

substantially preserving the function of one of a vagus nerve, an esophageal plexus, or an efferent nerve pathway from an oral cavity to an esophageal sphincter.

7. The method of claim 3, further comprising:

substantially preserving one of a swallowing reflex or an esophageal peristaltic wave.

8. The method of claim 1, further comprising:

delivering sufficient energy from one of the mapping electrode or the treatment electrode to heat at least a portion of one of a nerve, a gastric nerve, a nerve plexus, a myenteric nerve plexus, a ganglia, a nerve pathway or an electrically conductive pathway to a temperature of about 80°

C.

9. The method of claim 1, further comprising:

creating lesions in one of the sphincter, the lower esophageal sphincter, the stomach, the cardia or the fundus.

10. The method of claim 9, further comprising:

creating a pattern of lesions.

11. The method of claim 9, further comprising:

creating lesions having a distributed pattern, a radially distributed pattern, substantially circumferential pattern, a partially circumferential pattern, a semicircular pattern, an eccentric pattern or a concentric pattern.

12. The method of claim 9, further comprising:

creating lesions substantially positioned at one of a nerve, a gastric nerve, a nerve plexus, a myenteric nerve plexus, a ganglia, a nerve pathway or an electrically conductive pathway.

13. The method of claim 9, further comprising

producing a lesion along a portion of one of a nerve or nerve pathway.

14. The method of claim 9, further comprising:

substantially preserving the function of a vagus nerve, an esophageal plexus or an efferent nerve pathway from an oral cavity to an esophageal sphincter.

15. The method of claim 9, further comprising:

substantially preserving one of a swallowing reflex or an esophageal peristaltic wave.

16. The method of claim 9, wherein the mapping device is coupled to an imaging device.

17. The method of claim 16, wherein the imaging device is an endoscope, a fiberoptic viewing device or an ultrasound imaging device.

18. The method of claim 16, further comprising:

imaging a target tissue site; and

using an image from the imaging device to assist in placement one of the sphincter mapping device, the mapping electrode or the treatment electrode.

19. The method of claim 18, further comprising:

using the image to assist in a preservation of one of a vagus nerve, an esophageal plexus or an efferent nerve pathway from an oral cavity to an esophageal sphincter.

20. The method of claim 9, further comprising:

creating lesions in a smooth muscle layer while substantially preserving at least one of a mucosal layer or a submucosal layer.

21. The method of claim 9, further comprising:

creating lesions in a smooth muscle layer at a depth of about 2 mm to about 5 mm beneath a mucosal layer.

22. The method of claim 9, further comprising:

cooling a portion of one of a mucosal layer, a submucosal layer or a smooth muscle layer.

23. The method of claim 9, further comprising

creating lesions sufficient to create an area of electrical block to a electrical signal in at least a portion of one of the sphincter, the lower esophageal sphincter, the stomach, the cardia, the fundus, or a gastric body.

24. The method of claim 23, wherein the electrical signal is an afferent signal, an efferent signal, a gastric-electrical activity, a neuroelectrical activity or an esophageal-electrical activity.

25. The method of claim 1, wherein the mapping device includes a sensor, the method further comprising:

sensing a tissue property.

26. The method of claim 25, wherein the mapping device is coupled to at least one of a power source or a feedback control device, the method further comprising:

using a sensed tissue property to control a delivery of energy to a target tissue.

27. The method of claim 25, wherein the sensor is an impedance sensor, the method further comprising:

sensing an impedance of one of gastric or esophageal tissue; and

using a tissue impedance to locate a target nerve tissue.

28. The method of claim 26, further comprising:

delivering sufficient energy to ablate at least a portion of the nerve tissue;

sensing the impedance of the target nerve tissue after a delivery of energy; and

using an impedance change to assess one of a function of the target nerve tissue, an ablation of the target tissue or an endpoint for a treatment.

29. The method of claim 1, wherein the sphincter mapping device includes means for delivering an ablative agent to a treatment site, the method further comprising:

delivering an ablative agent to the treatment site to ablate at least a portion of one of a nerve, a gastric nerve, a nerve plexus, a myenteric nerve plexus, a ganglia, a nerve pathway or an electrically conductive pathway.

30. The method of claim 29, wherein the treatment site portion of one of the sphincter, the lower esophageal sphincter, the stomach, the cardia or the fundus.

31. The method of claim 29, wherein the ablative agent is selected from the group consisting of a chemical mixture, a nerve ablative agent, alcohol, ethanol and quinolinic acid.

32. The method of claim 1, further comprising:

creating an area of electrical block to an electrical signal in at I portion of one of the sphincter, the lower esophageal sphincter, the stomach, the cardia, the fundus, or a gastric body.

33. The method of claim 32, wherein the electrical signal is a gastric-electrical activity, a neuro-electrical activity, a nerve pathway, an afferent pathway, an electrical pathway, a mechanoreceptor pathway or a chemoreceptor pathway.

34. The method of claim 32, wherein in the area of electrical block is one of a line, a substantially rectangular area, an arc, a circumference, a crescent shaped area, a portion of a cylindrical area or a substantially cylindrical area.

35. The method of claim 1, further comprising:

acquiring a first time domain signal using the sphincter electropotential mapping device; and

performing a mathematical transform on the first time domain signal using signal processing means to convert the first time domain signal to a first frequency domain signal.

36. The method of claim 1 further comprising:

mapping the sphincter after a treatment to assess the effectiveness of a treatment for preventing a gastric electrical activity causing a transient relaxation of the sphincter.

37. The method of claim 36, further comprising:

acquiring a second time domain signal using the sphincter electropotential mapping device;

performing a mathematical transform on the second time domain signal using signal processing means to convert the second time domain signal to a second frequency domain signal;

comparing a second frequency domain signal to a first frequency domain signal; and

determining a clinical endpoint for the treatment.

38. A method of treating a sphincter, comprising:

providing a sphincter treatment device with at least one of a mapping electrode or a treatment electrode;

introducing the sphincter electropotential mapping device into at least a portion of one of the sphincter, a lower esophageal sphincter, a stomach, a cardia or a fundus;

stimulating one of the sphincter, the lower esophageal sphincter, the stomach, the cardia or the fundus to produce a transient relaxation of the sphincter; and

identifying a portion of one of the sphincter, the lower esophageal sphincter, the stomach, the cardia or the fundus causing a transient relaxation of the sphincter; and

delivering energy from the sphincter electropotential mapping device to treat the portion of one the sphincter, the lower esophageal sphincter, the stomach, the cardia or the fundus causing the transient relaxation of the sphincter.

39. The method of claim 38, further comprising:

stimulating the sphincter by one of an electrical stimulation, a mechanical stimulation, a stretch stimulation or a chemical stimulation.

40. The method of claim 38, further comprising:

performing a post treatment stimulation one of the sphincter, the lower esophageal sphincter, the stomach, the cardia or the fundus; and

assessing an effectiveness of treatment in preventing a sphincter transient relaxation.

41. The method of claim 38, further comprising:

providing one of an external stimulation device or an internal stimulation device; and

positioning the external stimulation device on the skin near the stomach or the internal stimulation device in the portion of one the sphincter, the lower esophageal sphincter, the stomach, the cardia or the fundus.

42. The method of claim 41, wherein the stimulation includes one of an internal stimulation or a transdermal stimulation.

43. A method of treating a sphincter, comprising:

providing a sphincter electropotential mapping device with a mapping electrode or a treatment electrode;

introducing the sphincter electropotential mapping device into at least a portion of one of the sphincter, a lower esophageal sphincter, a stomach, a cardia or a fundus;

detecting a bioelectric activity causing a transient relaxation of the sphincter;

providing a sphincter treatment apparatus with a treatment energy delivery device;

introducing the sphincter treatment apparatus into at least a portion of one of the sphincter, a lower esophageal sphincter, a stomach, a cardia or a fundus; and

delivering energy from the treatment energy delivery device to treat the bioelectric activity.

44. The method of claim 43, wherein the bioelectric activity is one of a electrical activity, a gastric-electrical activity, a neuro-electrical activity, a nerve pathway, an afferent pathway, a electrical pathway, a mechanoreceptor pathway or a chemoreceptor pathway.

45. The method of claim 43, wherein the energy delivery device is an RF electrode, the method further comprising:

delivering RF energy to a treatment site to at least partially ablate one of a nerve pathway, an afferent pathway, an electrical pathway, a mechanoreceptor pathway or a chemoreceptor pathway.

46. The method of claim 43, wherein the treatment apparatus further comprises:

a basket assembly including a first and a second arm, the basket assembly being coupled to the elongated member and having a deployed and a non-deployed configuration;

an inflatable member coupled to the elongated member and positioned in an interior of the basket assembly, the inflatable member being coupled to the inflation lumen, the inflatable member having a deployed state and a non-deployed state, wherein in the deployed state the inflatable member expands the basket assembly to the basket assembly deployed configuration;

a first energy delivery device positionable in the first arm and advanceable from the first arm to a selected treatment site; and

a second energy delivery device positionable in the second arm and advanceable from the second arm to a selected treatment site;

the method further comprising;

delivering RF energy to a treatment site in one of the sphincter, a lower esophageal sphincter, a stomach, a cardia or a fundus to at least partially ablate one of a nerve pathway, an afferent pathway, a electrical pathway, a mechanoreceptor pathway or a chemoreceptor pathway; and

minimizing injury to a mucosal tissue layer.

47. A method of treating a sphincter, comprising:

providing a gastroesophageal sensing device with a stimulating electrode or a mapping electrode;

introducing the gastroesophageal sensing device into a portion of the upper gastroesophageal tract;

stimulating a portion of the upper gastroesophageal tract to produce one of a swallowing reflex, peristaltic wave or a relaxation of the lower esophageal sphincter;

observing for a swallowing reflex, a peristaltic wave or a relaxation of a lower esophageal sphincter;

providing a sphincter electropotential treatment device with a mapping electrode or a treatment electrode;

introducing the sphincter electropotential treatment device into at least a portion of one of the esophagus, a lower esophageal sphincter, a stomach, a cardia or a fundus;

treating one of the esophagus, the lower esophageal sphincter, the stomach, the cardia or the fundus;

restimulating the portion of the upper gastroesophageal tract to produce one of the swallowing reflex, the peristaltic wave or the relaxation of the lower esophageal sphincter; and

observing for the swallowing reflex, the peristaltic wave or the relaxation of the lower esophageal sphincter.

48. A method of treating a sphincter, comprising:

providing a sphincter treatment device having an elongated member, the elongated member including at least one of a stimulating electrode, a mapping electrode or a treatment electrode, the stimulating electrode positioned proximally to one of the mapping electrode or the treatment electrode;

introducing the sphincter treatment device into at least a portion of one of the esophagus, a lower esophageal sphincter, a stomach, a cardia or a fundus;

stimulating a portion of the upper gastroesophageal tract to produce one of a swallowing reflex, a peristaltic wave or a relaxation of the lower esophageal sphincter;

observing for a swallowing reflex, a peristaltic wave or a relaxation of a lower esophageal sphincter;

treating one of the esophagus, the lower esophageal sphincter, the stomach, the cardia or the fundus;

restimulating the portion of the upper gastroesophageal tract to produce one of the swallowing reflex, the peristaltic wave or the relaxation of the lower esophageal sphincter; and

observing for the swallowing reflex, and the peristaltic wave or the relaxation of the lower esophageal sphincter.

49. The method of claim 48, further comprising:

positioning the stimulating electrode in one of the oral cavity or an upper portion of the esophagus.