Methods and systems for determining physiologic characteristics for treatment of the esophagus

• US 9,555,222 B2
• Filed: 10/01/2014
• Issued: 01/31/2017
• Est. Priority Date: 11/16/1999
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Jackson, Jerome, Stern, Roger A., Utley, David S.
• Primary Examiner(s): HUPCZEY, JR, RONALD JAMES
• Application Number:
  US14/503,472
• Publication Number:
  US 20150038958A1
• Time in Patent Office: 853 Days
• US Class Current: 1/1
• 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 a 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;

(i) measure an internal pressure of the balloon;

(ii) inflate the balloon with an expansion medium until the internal pressure is equal to a predetermined target pressure;

(iii) measure the expansion medium delivered to the balloon with a mass-flow meter until the predetermined target pressure is reached;

(iv) determine a dimension of the esophagus based on the amount of expansion medium in the balloon at the predetermined target pressure; and

(v) deliver energy to the electrode array.

2. The apparatus of claim 1, wherein the generator is further configured to deflate the balloon after delivery of energy to the electrode array.

3. The apparatus of claim 1, wherein the predetermined target pressure is between about 1 psig and about 10 psig.

4. The apparatus of claim 1, wherein the predetermined target pressure is between about 4 psig and about 7 psig.

5. The apparatus of claim 1, wherein the predetermined target pressure is between about 2 and about 3 psig.

6. The apparatus of claim 1, wherein the predetermined target pressure is sufficient to inflate the balloon to engage with and unfold the walls of the esophagus.

7. The apparatus of claim 1, wherein the generator is configured to deliver sufficient energy to the electrode array to accomplish ablation of mucosal or submucosal level esophageal tissue.

8. The apparatus of claim 1, wherein the generator is configured to deliver sufficient energy to the electrode array to sear the lining of the esophagus based on the determined dimension of the esophagus.

9. The apparatus of claim 1, wherein the generator is configured to deliver sufficient energy to the electrode array to sear the lining of the esophagus in less than 5 seconds.

10. The apparatus of claim 1, wherein the generator is configured to normalize the density of energy delivered to the electrode array over time based on the determined dimension of the esophagus.

11. The apparatus of claim 1, wherein the generator is configured to deliver sufficient energy to the electrode array to deliver an energy density from 1 J/cm2 to 50 J/cm2 to sear the lining of the esophagus.

12. The apparatus of claim 1, wherein the generator is configured to deliver sufficient energy to the electrode array to sear the lining of the esophagus by delivering energy to different circumferential sections of the esophageal wall sequentially in less than 5 seconds.

13. The apparatus of claim 1, wherein the balloon has a native diameter that is larger than an expected diameter of the esophagus.

14. The apparatus of claim 1, wherein the electrode array is positioned on an electrode support comprising a flexible, non-distensible backing.

15. The apparatus of claim 14, wherein the electrode support is furled around a circumference of the balloon.

16. The apparatus of claim 15, wherein the electrode support at least partially overlaps itself.

17. The apparatus of claim 15, wherein the electrode support is configured to unfurl as the balloon is inflated.

18. The apparatus of claim 17, further comprising an elastic member coupled with the electrode support configured to retain the electrode support in contact with the balloon.