Method to treat esophageal sphincters

• US 6,092,528 A
• Filed: 03/06/1998
• Issued: 07/25/2000
• Est. Priority Date: 06/24/1994
• Status: Expired due to Term

• Current Assignee: Mederi Therapeutics, Inc. (Respiratory Technology Corp.)
• Original Assignee: Venture Banking Group (Wells Fargo & Company)
• Inventors: Edwards, Stuart D.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/036,091
• Time in Patent Office: 872 Days
• Field of Search: 128/898, 606/41, 606/42, 606/45-50, 607/100-102, 607/116, 607/122, 607/133, 600/374
• US Class Current: 128/898
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• 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 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other in cannulas A61B17/3417
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/00077 : high, i.e. electrically conducting
• CPC Class Codes: A61B 2018/00083 : low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00113 : with foam
• CPC Class Codes: A61B 2018/00148 : with metal
• CPC Class Codes: A61B 2018/0016 : Energy applicators arranged in a two- or three dimensional array
• 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 2018/00494 : Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00553 : Sphincter
• CPC Class Codes: A61B 2018/00559 : Female reproductive organs
• 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 2018/00666 : using a threshold value
• CPC Class Codes: A61B 2018/00678 : upper
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00708 : switching the power on or off
• CPC Class Codes: A61B 2018/00726 : Duty cycle
• CPC Class Codes: A61B 2018/00738 : Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00744 : Fluid flow
• CPC Class Codes: A61B 2018/00755 : Resistance or impedance
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 : measured by a thermistor
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/00827 : Current
• CPC Class Codes: A61B 2018/00839 : Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00869 : Phase
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00886 : Duration
• CPC Class Codes: A61B 2018/00892 : Voltage
• 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 2018/00916 : with means for switching or controlling the main function of the 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 2018/0262 : using a circulating cryogenic fluid
• 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 2018/1273 : including multiple generators in one device
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2090/3614 : using optical fibre
• 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: A61F 7/12 : Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 16/0481 : through the cuff wall
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1086 : having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 1/056 : Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: C08L 2201/12 : Shape memory

Abstract

A method of treating a sphincter provides a treatment apparatus that includes an expandable device coupled to an introducer distal portion and an energy delivery device. The expandable device includes a first arm and a second arm each with proximal and distal section. The expandable member has a non-deployed configuration and a deployed configuration when the first and second arm distend away from each other. The expandable device is at least partially introduced in the sphincter. At least a portion of the energy delivery device is advanced from the expandable device into an interior of the sphincter. Sufficient energy is delivered from the energy delivery device to create a desired tissue effect in the sphincter. The expandable device is then removed from the sphincter.

Claims

1. A method of treating a sphincter, comprising:

providing treatment apparatus means including an expandable device means coupled to an introducer distal portion means and an energy delivery device means, the expandable device means including a first arm means and a second arm means each with proximal and distal section means, wherein the expandable device means has a non-deployed configuration and a deployed configuration when the first and second arm means distend away from each other;

introducing at least a portion of the expandable device means in the sphincter;

advancing the at least a portion of the energy delivery device means from the expandable device means into an interior of the sphincter;

delivering sufficient energy from the energy delivery device means to create a desired tissue effect in the sphincter; and

removing the expandable device means from the sphincter.

2. The method of claim 1, further comprising:

expanding the expandable device means in the sphincter to the deployed configured.

3. The method of claim 1, further comprising:

detecting a temperature of the sphincter at a selected treatment site.

4. The method of claim 1, further comprising:

detecting a temperature of the sphincter at a surface of the sphincter.

5. The method of claim 1, further comprising:

detecting a temperature of the sphincter in an interior of the sphincter.

6. The method of claim 1, wherein the desired tissue effect is a modification of sphincter tissue.

7. The method of claim 1, wherein the desired tissue effect is a contraction of sphincter tissue.

8. The method of claim 1, wherein the desired tissue effect is a creation of cell necrosis of sphincter tissue.

9. The method of claim 1, wherein the desired tissue effect is a creation of cell necrosis of a sub-mucosal sphincter tissue.

10. The method of claim 1, wherein the desired tissue effect is a creation of cell necrosis of a mucosal sphincter tissue.

11. The method of claim 1, wherein the sphincter is a lower esophageal sphincter.

12. The method of claim 11, wherein sufficient energy is applied to the lower esophageal sphincter to reduce a duration of lower esophageal sphincter relaxation.

13. The method of claim 11, wherein sufficient energy is applied to the lower esophageal sphincter to reduce a frequency of reflux of stomach contents into an esophagus.

14. The method of claim 11, wherein sufficient energy is applied to the lower esophageal sphincter to reduce a frequency of a symptom of reflux of stomach contents into an esophagus.

15. The method of claim 11, wherein sufficient energy is applied to the lower esophageal sphincter to reduce an incidence of a sequela of reflux of stomach contents into an esophagus.

16. The method of claim 11, wherein sufficient energy is delivered to create the desired tissue effect in the lower esophageal sphincter without permanently damaging anatomical structures near the sphincter.

17. The method of claim 11, wherein sufficient energy is delivered to create the desired tissue effect in the lower esophageal sphincter without permanently disrupting an aorta positioned near the lower esophageal sphincter.

18. The method of claim 11, wherein sufficient energy is delivered to create the desired tissue effect in the lower esophageal sphincter without permanently damaging a vagus nerve positioned near the lower esophageal sphincter.

19. The method of claim 11, wherein the energy delivery device delivers a sufficient amount of energy to create the desired tissue effect in the lower esophageal sphincter without permanently damaging an esophageal plexus of nerves and veins positioned near the lower esophageal sphincter.

20. The method of claim 11, wherein the energy delivery device delivers a sufficient amount of energy to create the desired tissue effect in the lower esophageal sphincter while preserving a blood supply to the lower esophageal sphincter.

21. The method of claim 1, wherein energy delivered to the sphincter produces the desired tissue effect without creating a permanent impairment of the sphincter'"'"'s ability to achieve a physiologically normal state of closure.

22. The method of claim 1, wherein sufficient energy is delivered to cause a proliferation of fibroblast cells in the sphincter.

23. The method of claim 1, wherein sufficient energy is delivered to cause an infiltration of fibroblast cells in the sphincter.

24. The method of claim 1, wherein sufficient energy is delivered to cause a proliferation of myofibroblast cells in the sphincter.

25. The method of claim 1, wherein sufficient energy is delivered to cause an infiltration of myofibroblast cells in the sphincter.

26. A method of treating a sphincter, comprising:

providing treatment apparatus means including an expandable device means coupled to an introducer distal portion means and an energy delivery device means, the expandable device means including a first arm means and a second arm means each with proximal and distal section means, wherein the expandable member means has a non-deployed configuration and a deployed configuration;

introducing the expandable device means in the sphincter;

delivering sufficient energy from the energy delivery device means to create a desired tissue effect in the sphincter; and

removing the expandable device means from the sphincter.

27. The method of claim 26, further comprising:

expanding the expandable device means in the sphincter to the deployed configured.

28. The method of claim 26, further comprising:

detecting a temperature of the sphincter at a selected treatment site.

29. The method of claim 26, further comprising:

detecting a temperature of the sphincter at a surface of the sphincter.

30. The method of claim 26, further comprising:

detecting a temperature of the sphincter in an interior of the sphincter.

31. The method of claim 26, wherein the desired tissue effect is a modification of sphincter tissue.

32. The method of claim 26, wherein the desired tissue effect is a contraction of sphincter tissue.

33. The method of claim 26, wherein the desired tissue effect is a creation of cell necrosis of sphincter tissue.

34. The method of claim 26, wherein the desired tissue effect is a creation of cell necrosis of a sub-mucosal sphincter tissue.

35. The method of claim 26, wherein the desired tissue effect is a creation of cell necrosis of a mucosal sphincter tissue.

36. The method of claim 26, wherein the sphincter is a lower esophageal sphincter.

37. The method of claim 36, wherein sufficient energy is applied to the lower esophageal sphincter to reduce a duration of lower esophageal sphincter relaxation.

38. The method of claim 36, wherein sufficient energy is applied to the lower esophageal sphincter to reduce a frequency of reflux of stomach contents into an esophagus.

39. The method of claim 36, wherein sufficient energy is applied to the lower esophageal sphincter to reduce a frequency of a symptom of reflux of stomach contents into an esophagus.

40. The method of claim 36, wherein sufficient energy is applied to the lower esophageal sphincter to reduce an incidence of a sequela of reflux of stomach contents into an esophagus.

41. The method of claim 36, wherein sufficient energy is delivered to create the desired tissue effect in the lower esophageal sphincter without permanently damaging anatomical structures near the sphincter.

42. The method of claim 36, wherein sufficient energy is delivered to create the desired tissue effect in the lower esophageal sphincter without permanently disrupting an aorta positioned near the lower esophageal sphincter.

43. The method of claim 36, wherein sufficient energy is delivered to create the desired tissue effect in the lower esophageal sphincter without permanently damaging a vagus nerve positioned near the lower esophageal sphincter.

44. The method of claim 36, wherein the energy delivery device delivers a sufficient amount of energy to create the desired tissue effect in the lower esophageal sphincter without permanently damaging an esophageal plexus of nerves and veins positioned near the lower esophageal sphincter.

45. The method of claim 36, wherein the energy delivery device delivers a sufficient amount of energy to create the desired tissue effect in the lower esophageal sphincter while preserving a blood supply to the lower esophageal sphincter.

46. The method of claim 26, wherein energy delivered to the sphincter produces the desired tissue effect without creating a permanent impairment of the sphincter'"'"'s ability to achieve a physiologically normal state of closure.

47. The method of claim 26, wherein sufficient energy is delivered to cause a proliferation of fibroblast cells in the sphincter.

48. The method of claim 26, wherein sufficient energy is delivered to cause an infiltration of fibroblast cells in the sphincter.

49. The method of claim 26, wherein sufficient energy is delivered to cause a proliferation of myofibroblast cells in the sphincter.

50. The method of claim 26, wherein sufficient energy is delivered to cause an infiltration of myofibroblast cells in the sphincter.