Method for treating a sphincter

• US 6,009,877 A
• Filed: 02/19/1998
• Issued: 01/04/2000
• 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:
  US09/026,296
• Time in Patent Office: 684 Days
• Field of Search: 606/41, 606/42, 606/45, 606/46, 606/48-50, 606/27-31, 128/898, 607/100-102, 607/116
• 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 2018/00232 : having an irregular shape
• CPC Class Codes: A61B 2018/00267 : having a basket shaped structure
• CPC Class Codes: A61B 2018/00291 : using suction
• 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 2018/1425 : Needle
• 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: A61B 5/01 : Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0535 : Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/392 : Detecting gastrointestinal contractions
• CPC Class Codes: A61B 8/00 : Diagnosis using ultrasonic, sonic or infrasonic waves imaging of objects using sonar G01S15/00
• CPC Class Codes: A61F 7/12 : Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 16/0438 : Liquid-filled
• 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 that provides an expandable basket structure with a first energy delivery device. The basket structure is introduced in a sphincter. The first energy delivery device is advanced from the basket structure into an interior of the sphincter. Sufficient energy is delivered from the first energy delivery device to create a desired tissue effect in the sphincter. Thereafter, the basket structure is removed from the sphincter.

Claims

1. A method of treating a sphincter, comprising:

providing an expandable basket structure with a coupled first, a second and a third arm, the expandable basket structure further including a first energy delivery device coupled to the first arm, wherein the basket structure has a non-deployed state and a deployed state;

introducing the basket structure in the sphincter;

advancing the first energy delivery device from the basket structure into an interior of the sphincter;

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

removing the basket structure from the sphincter.

2. The method of claim 1, wherein the expandable basket further includes a second and a third energy delivery device each coupled to one of the second and third arms.

3. The method of claim 2, wherein the first energy delivery device is positioned in a lumen of the first arm and introduced from the first arm into the sphincter, the second energy delivery device is positioned in a lumen of the second arm and introduced from the second arm into the sphincter and the third energy delivery device is positioned in a lumen of the third arm and introduced from the third arm into the sphincter.

4. The method of claim 2, wherein the first energy delivery device is positioned along an exterior surface of the first arm and introduced from the first arm into the sphincter, the second energy delivery device is positioned along an exterior surface of the second arm and introduced from the second arm into the sphincter and the third energy delivery device is positioned along an exterior surface of the third arm and introduced from the third arm into the sphincter.

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

6. The method of claim 5, wherein the desired tissue effect is a creation of a plurality of lesions in the lower esophageal sphincter and reduces a duration of lower esophageal sphincter relaxation.

7. The method of claim 5, wherein the desired tissue effect is a creation of a plurality of lesions in the lower esophageal sphincter and reduces a frequency of reflux of stomach contents into an esophagus.

8. The method of claim 5, wherein the desired tissue effect is a creation of a plurality of lesions in the lower esophageal sphincter and reduces a frequency of a symptom of reflux of stomach contents into an esophagus.

9. The method of claim 5, wherein the desired tissue effect is a creation of a plurality of lesions in the lower esophageal sphincter that reduces an incidence of a sequela of reflux of stomach contents into an esophagus.

10. The method of claim 5, wherein the desired tissue effect is a tightening of the lower esophageal sphincter.

11. The method of claim 1, wherein energy delivered to the sphincter produces lesions in an interior of the sphincter without creating a permanent impairment of the sphincter'"'"'s ability to achieve a physiologically normal state of closure.

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

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

14. The method of claim 1, wherein the energy delivery device delivers sufficient energy to cause a proliferation of myofibroblast cells in the sphincter.

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

16. The method of claim 1, wherein the energy delivery device delivers sufficient energy to create a tightening of the sphincter without permanently damaging anatomical structures near the sphincter.

17. The method of claim 5, wherein the energy delivery device delivers sufficient energy to create a tightening of a lower esophageal sphincter without permanently disrupting an aorta positioned near the lower esophageal sphincter.

18. The method of claim 5, wherein the energy delivery device delivers a sufficient amount of energy to create a tightening of the lower esophageal sphincter without permanently damaging a vagus nerve positioned near the lower esophageal sphincter.

19. The method of claim 5, wherein the energy delivery device delivers a sufficient amount of energy to create a tightening of 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 5, wherein the energy delivery device delivers a sufficient amount of energy to create a tightening of the lower esophageal sphincter while preserving a blood supply to the lower esophageal sphincter.

21. The method of claim 1, wherein the energy delivery device creates a tightening of the lower esophageal sphincter while creating submucosal lesions in the lower esophageal sphincter.

22. The method of claim 1, further comprising:

introducing a fluid to the sphincter.

23. The method of claim 1, wherein the expandable basket structure further includes an electrolytic solution housed in an expanded expandable structure.

24. The method of claim 1, wherein the first, second and third energy delivery devices are each RF electrodes.

25. The method of claim 2, wherein the expandable basket member is delivered to a lower esophageal sphincter transorally without an endoscope.

26. The method of claim 1, wherein the expandable basket member is delivered to a lower esophageal sphincter with an endoscope.