System and method of treating abnormal tissue in the human esophagus

• US 8,398,631 B2
• Filed: 10/27/2008
• Issued: 03/19/2013
• Est. Priority Date: 11/16/1999
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Ganz, Robert A., Zelickson, Brian D., Stern, Roger A.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Price, Nathan R
• Application Number:
  US12/259,136
• Publication Number:
  US 20090048593A1
• Time in Patent Office: 1,604 Days
• Field of Search: 606 27- 52, 607100-102, 607/115, 607/116, 607/133, 128/898
• US Class Current: 606/50
• 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 method of ablating mucosal tissue in an esophagus, comprising:

positioning an ablation device at a desired site in the esophagus, the ablation device comprising a highly compliant balloon capable of expanding in the esophagus;

inflating the balloon to an appropriate pressure thereby extending at least a portion of the ablation device to a mucosal tissue surface at the site; and

ablating the tissue surface using the ablation device;

wherein the ablating causes necrosis to at least 75% of a mucosa layer and a submucosa layer and less than 25% of an underlying muscalaris layer.

2. The method of claim 1, wherein the inflating comprises expanding at least a portion of a circumference of the balloon into contact with the tissue surface.

3. The method of claim 1, wherein the inflating comprises injecting expansion fluid into the balloon.

4. The method of claim 1, wherein the inflating comprises expanding the balloon to a diameter conforming to an inner lumen of the esophagus.

5. The method of claim 1, wherein the inflating comprises expanding the balloon to apply pressure to the tissue surface.

6. The method of claim 5, further comprising applying a pressure to the tissue surface to at least partially occlude the vasculature of the submucosa layer.

7. The method of claim 1, wherein the ablating comprises delivering sufficient energy to the mucosal tissue surface to create a lesion in the mucosal tissue.

8. The method of claim 7, wherein the ablating comprises delivering between 15 Watts and 40 Watts to the tissue surface.

9. The method of claim 1, wherein the ablating causes necrosis to at least 95% of the mucosa and submucosa layers.

10. The method of claim 9, wherein the ablating causes necrosis to less than or equal to 10% of the underlying muscalaris layer.

11. The method of claim 10, wherein the ablating causes necrosis to none of the underlying muscalaris layer.

12. The method of claim 1, wherein ablation device is configured to deliver radiofrequency (RF) energy.

13. The method of claim 12, the ablation device comprising bipolar alternating rings, wherein the ablating comprises delivering RF energy through simultaneous activation of the bipolar alternating rings.

14. The method of claim 12, the ablation device comprising bipolar alternating rings, wherein the ablating comprises delivering RF energy through sequential activation of the bipolar alternating rings.

15. The method of claim 12, the ablation device comprising monopolar rectangles, wherein the ablating comprises sequential activation of sets of rectangles.

16. The method of claim 1, further comprising:

determining impedance at the mucosal tissue surface of the esophagus during the ablating; and

ceasing the ablating based on the determined impedance.

17. The method of claim 16, wherein the ceasing ablating is performed based on an observed increase in the determined impedance.

18. The method of claim 16, wherein the ablating comprises delivering 40 Watts to the tissue surface and the ceasing occurs when the determined impedance reaches a terminal impedance value.