METHODS AND SYSTEMS FOR DETERMINING PHYSIOLOGIC CHARACTERISTICS FOR TREATMENT OF THE ESOPHAGUS

• US 20100234840A1
• Filed: 05/25/2010
• Published: 09/16/2010
• Est. Priority Date: 11/16/1999
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: BARRX Medical LLC
• Inventors: Utley, David S., Jackson, Jerome, Stern, Roger A.
• Granted Patent: US 8,012,149 B2
• Time in Patent Office: Days
• US Class Current: 606/34
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00296 mounted on an endoscope
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00178 Electrical connectors
• 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 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00488 Esophagus
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 : with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00738 : Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• 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 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1807 : using light other than laser radiation
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/053 : Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 : invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1076 : for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4233 : oesophagus
• CPC Class Codes: A61B 5/6885 : Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61M 25/10181 : Means for forcing inflation fluid into the balloon
• CPC Class Codes: A61M 25/10184 : Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 2005/0609 : Stomach and/or esophagus
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent

Abstract

A method and apparatus for treating abnormal mucosa in the esophagus is disclosed, such that the depth of the treated tissue is controlled. The depth of ablation is controlled by monitoring the tissue impedance and/or the tissue temperature. A desired ablation depth is also achieved by controlling the energy density or power density, and the amount of time required for energy delivery. A method and apparatus is disclosed for measuring an inner diameter of a body lumen, where a balloon is inflated inside the body lumen at a fixed pressure.

Claims

1. An apparatus for treating an esophagus, comprising:

a generator having a source of RF energy connected to an generator electrical connector and a pump connected to a generator pneumatic connector; and

a sizing and treatment catheter having a proximal end and a distal end, an electrical connector configured for attachment to the generator electrical connector and a pneumatic connector on the proximal end configured for attachment to the generator pneumatic connector and a balloon on the distal end of the catheter in communication with the pneumatic connector and an electrode array on an exterior surface of the balloon in communication with the electrical connector;

wherein, when the sizing and treatment catheter is connected to the generator electrical connector and the generator pneumatic connector, the generator is configured to determine a dimension of the esophagus by inflating the sizing and treatment catheter to a sizing pressure and to deliver sufficient energy to the electrode array for treatment of the esophagus based on the dimension of the esophagus determined by the generator.

2. An apparatus for treating an esophagus according to claim 1 wherein the generator is further configured to deflate the sizing and treatment catheter after delivery of energy to the electrode array.

3. An apparatus for treating an esophagus according to claim 1 wherein the generator is configured to use a sizing pressure of between 1-10 psig.

4. An apparatus for treating an esophagus according to claim 1 wherein the generator is configured to use a sizing pressure of between 4-7 psig.

5. An apparatus for treating an esophagus according to claim 1 wherein the generator is configured to use a sizing pressure of between 2-3 psig.

6. An apparatus for treating an esophagus according to claim 1 wherein the generator is configured to use a sizing pressure that will engage with and unfold the walls of the esophagus.

7. An apparatus for treating an esophagus according to claim 1 wherein the generator is configured to deliver sufficient energy to the electrode array for treatment of the esophagus to accomplish ablation of mucosal or submucosal level esophageal tissue.

8. An apparatus for treating an esophagus according to claim 1 wherein the generator is configured to deliver sufficient energy to the electrode array for treatment of the esophagus by delivering to different circumferential sections of the esophageal wall sequentially in less than 5 seconds.

9. An apparatus for treating an esophagus according to claim 1 wherein the generator is configured to deliver sufficient energy to the electrode array for treatment of the esophagus by activating the electrode array to deliver an energy density from 1 J/cm² to 50 J/cm².

10. An apparatus for treating an esophagus according to claim 1 wherein the generator is adapted to normalize the density of energy delivered to the tissue over time based on dimension of the esophagus determined by the generator.

11. An apparatus for treating an esophagus according to claim 1 wherein the generator is configured to deliver sufficient energy to the electrode array for treatment of the esophagus in less than 5 seconds.

12. An apparatus for treating a tissue inside a body lumen comprising:

a treatment catheter having an expansion member, an electrode array on the expansion member, a pneumatic connector in communication with the interior of the expansion member and an electrical connection connected to the electrode array;

a generator having an RF energy source and a generator electrical connector to attach to the electrical connection, a pump and a generator pneumatic connector to attach to the pneumatic connector wherein, when a sizing catheter is connected to the generator electrical connector and the generator pneumatic connector, the generator is configured to inflate the sizing catheter to distend the body lumen and to determine a dimension of the distended body lumen and thereafter, when a treatment catheter is connected to the generator pneumatic connector and the generator electrical connector, the generator is configured to inflate the expansion member and provide sufficient energy to the electrode array to sear the lining of the distended lumen.

13. An apparatus for treating a tissue inside a body lumen according to claim 12 wherein the generator is configured to inflate the treatment catheter to the same pressure used to inflate the sizing catheter.

14. An apparatus for treating a tissue inside a body lumen according to claim 12 wherein the generator is configured to provide sufficient energy to the electrode array to sear the lining of the distended body lumen in less than 5 seconds.

15. An apparatus for treating a tissue inside a body lumen according to claim 14 wherein the generator is configured to provide sufficient energy to the electrode array to produce an energy density of 1 J/cm² to 50 J/cm² to sear the lining of the distended body lumen.

16. An apparatus for treating a tissue inside a body lumen according to claim 12 wherein the generator is configured to inflate the sizing catheter to distend the body lumen with a pressure of between 1-10 psig.

17. An apparatus for treating a tissue inside a body lumen according to claim 12 wherein the generator is configured to provide sufficient energy to the electrode array to sear the lining of the distended body lumen based on the determined dimension of the distended body lumen.

18. An apparatus for treating a tissue inside a body lumen according to claim 12 wherein after connecting and inflating the sizing catheter, the generator is configured to display a recommended treatment catheter size.

19. An apparatus for treating a tissue inside a body lumen according to claim 12 wherein the generator is configured to provide sufficient energy to the electrode array for sear the lining of the distended lumen by delivering energy to different circumferential sections of the distended lumen wall sequentially in less than 5 seconds.

20. An apparatus for treating a tissue inside a body lumen according to claim 12 wherein the generator is further configured to inflate the sizing catheter to unfold the walls of the body lumen.

21. An apparatus for treating a tissue inside a body lumen according to claim 12 wherein the generator is further configured to inflate the expansion member to unfold the walls of the body lumen while providing sufficient energy to the electrode array to sear the lining of the distended lumen.