System and method of treating abnormal tissue in the human esophagus

• US 6,551,310 B1
• Filed: 11/16/2000
• Issued: 04/22/2003
• Est. Priority Date: 11/16/1999
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Brian D. Zelickson, Robert A. Ganz, Roger A. Stern
• Inventors: Zelickson, Brian D., Ganz, Robert A., Stern, Roger A.
• Primary Examiner(s): Gibson, Roy D.
• Assistant Examiner(s): VRETTAKOS, PETER J
• Application Number:
  US09/714,344
• Time in Patent Office: 887 Days
• Field of Search: 606/41, 606/7, 606/10, 606/27-34
• US Class Current: 606/41
• 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 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 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe

Abstract

An ablation catheter system and method of use is provided to endoscopically access portions of the human esophagus experiencing undesired growth of columnar epithelium. The ablation catheter system and method includes controlled depth of ablation features and use of either radio frequency spectrum, non-ionizing ultraviolet radiation, warm fluid or microwave radiation, which may also be accompanied by improved sensitizer agents.

Claims

1. A system for ablation of abnormal tissue from a human esophagus, comprising:

an elongated member;

an expandable member coupled to a distal portion of the elongated member and sized to be positioned and expanded in the esophagus; and

a plurality of RF electrode pairs at least partially extending around a circumference of the expandable member, a width of each RF electrode and a spacing between adjacent RF electrodes selected to provide a selectable ablation of an esophagus mucosal layer, a spacing between adjacent RF electrodes being no more than 2 mm, and the plurality of REF electrode pairs being arranged in a pattern.

2. The system of claim 1, wherein the expandable member is a balloon.

3. The system of claim 1, wherein the plurality of RF electrode pairs form an RF electrode array.

4. The system of claim 1, further comprising:

an RF power source coupled to the plurality of RF electrode pairs.

5. The system of claim 1, further comprising:

a control device coupled to the plurality of RF electrode pairs, the control device providing controlled positioning of the expandable member.

6. The system of claim 1, wherein the expandable member is sized in an expanded state to stretch the esophagus and thin a mucosal layer of the esophagus.

7. The system of claim 1, further comprising:

an expandable medium source coupled to the expandable member.

8. The system of claim 1, wherein the plurality of RF electrode pairs are in a pattern.

11. The system of claim 1, wherein each of an RF electrode in the plurality of RF electrode pairs is parallel to an adjacent RF electrode.

12. The system of claim 1, wherein the plurality of RF electrode pairs are formed on a sheet coupled to the expandable member.

13. The system of claim 1, further comprising:

a temperature sensor coupled to the plurality of RF electrode pairs.

14. The system of claim 1, further comprising:

a multiplexer coupled to the plurality of RF electrode pairs.

15. The system of claim 1, wherein the expandable member is made of a electroconductive elastomer.

16. The system of claim 1, wherein the plurality of RF electrode pairs has a length in the range of 1 to 10 cm.

17. The system of claim 1, wherein in an expanded state, the expandable member has a dimater in the range of 12 to 25 mm.

18. The system of claim 1, further comprising:

a multiple-pin electrical connector coupled to the plurality of RF electrode pairs.

19. The system of claim 1, wherein the elongated member is flexible.

20. The system of claim 1, wherein the expandable member is expandable to a fixed size in the expandable state.

21. The system of claim 1, wherein the expandable member is expandable to a variable size in the expandable state.

22. The system of claim 1, wherein the expandable member in an expandable state is sized to provide sufficient stretching of an esophagus to impede blood flow in an esophagus vasculature.

9. A system for ablation of abnormal tissue from a human esophagus, comprising:

an elongated member;

an expandable member coupled to a distal portion of the elongated member and sized to be positioned and expanded in the esophagus; and

a plurality of RF electrode pairs at least partially extending around a circumference of the expandable member, the plurality of RF electrodes being arranged in a pattern of bipolar axial interlaced finger electrodes, a width of each RF electrode and a spacing between adjacent RF electrodes selected to provide a selectable ablation of an esophagus mucosal layer.

10. A system for ablation of abnormal tissue from a human esophagus, comprising:

an elongated member;

an expandable member coupled to a distal portion of the elongated member and sized to be positioned and expanded in the esophagus; and

a plurality of RF electrode pairs at least partially extending around a circumference of the expandable member, the plurality of RF electrodes being arranged in a pattern of RF monopolar electrodes, a width of each RF electrode and a spacing between adjacent RF electrodes selected to provide a selectable ablation of an esophagus mucosal layer.

23. A system for ablation of abnormal tissue from a human esophagus, comprising:

an elongated member;

an expandable member coupled to a distal portion of the elongated member and sized to be positioned and expanded in the esophagus; and

a plurality of bipolar RF electrode pairs at least partially extending around a circumference of the expandable member, a width of each RF electrode and a spacing between adjacent RF electrodes in a pair selected to provide a selectable ablation of an esophagus mucosal layer, the plurality of RF electrodes being arranged in a pattern of bipolar axial interlaced finger electrodes, wherein a spacing of electrodes in an electrode pair is 2 mm or less.

24. The system of claim 23, wherein the RF electrodes are configured to provide a power in the range of 50 to 60 Watts per square centimeter.

25. The system of claim 24, wherein the RF electrodes are configured to provide an energy of at least 10 Joules per square centimeter.

26. A system for ablation of abnormal tissue from a human esophagus, comprising:

an elongated member;

an expandable member coupled to a distal portion of the elongated member and sized to be positioned and expanded in the esophagus; and

a plurality of RF electrode at least partially extending around a circumference of the expandable member, a width of each RF electrode and a spacing between adjacent RF electrodes selected to provide a selectable ablation of an esophagus mucosal layer, the RF electrodes being arranged as a contiguous sequence of arrays and a spacing between adjacent RF electrodes being no more than 2 mm.

27. The system of claim 26, wherein the arrays have a length of at least 1 m.

28. A system for ablation of abnormal tissue from a human esophagus, comprising:

an elongated member;

an expandable member coupled to a distal portion of the elongated member and sized to be positioned and expanded in the esophagus; and

a plurality of bipolar RF electrode pairs at least partially extending around a circumference of the expandable member, a width of each RF electrode and a spacing between adjacent RF electrodes is selected to provide a selectable ablation of an esophagus mucosal layer, a spacing between adjacent RF electrodes being no more than 2 mm, the RF electrodes being arranged as a contiguous sequence of arrays with a single common RF electrode along an entire length of the arrays, each electrode pair having an electrode that is divided into a sequence of selectable lengths.