Method and apparatus for gastrointestinal tract ablation for treatment of obesity

• US 8,641,711 B2
• Filed: 05/02/2008
• Issued: 02/04/2014
• Est. Priority Date: 05/04/2007
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Kelly, Douglas, Utley, David S., Ganz, Robert A., Wallace, Michael P., Every, Nathan
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): Scott, Amanda
• Application Number:
  US12/114,628
• Publication Number:
  US 20080275445A1
• Time in Patent Office: 2,104 Days
• Field of Search: 606 41- 45
• US Class Current: 606/45
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• 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 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe

Abstract

Devices and methods for ablating tissue in the wall of various organs of the gastrointestinal tract of a patient in order to cure or ameliorate metabolic pathophysiological conditions such as obesity, insulin resistance, or type 2 diabetes mellitus are provided. Ablational treatment of target areas may be fractional or partial, rendering a post-treatment portion of target tissue ablated and another portion that is substantially intact. Fractional ablation is achieved by controlling the delivery of ablational energy across the surface area being treated, and controlling the depth of energy penetration into tissue. Surface area control of energy delivery may controlled by the spatial pattern of distributed ablation elements or by the selective activation of a subset of a dense pattern of ablation elements. Embodiments of the device include an ablational electrode array that spans 360 degrees and an array that spans an arc of less than 360 degrees.

Claims

1. A method of ablationally-treating tissue at a target area in a gastrointestinal tract of a patient with a pathophysiological metabolic condition comprising:

delivering energy from an ablation structure to a tissue surface within the target area, the target area being a portion of the gastrointestinal tract that includes at least a portion of a jejunum; and

controlling the delivery of energy to the tissue surface within the target area and into a depth of tissue within the target area to treat the pathophysiological metabolic condition.

2. The method of claim 1 wherein controlling the delivery of energy into depth of the tissue includes controlling the delivery of energy inwardly from the tissue surface such that sufficient energy to achieve ablation is delivered to some layers and insufficient energy is delivered to other layers to achieve ablation.

3. The method of claim 1 wherein controlling the delivery of energy to the tissue surface within the target area includes delivering sufficient energy to achieve ablation in one portion of the tissue target area to achieve ablation and delivering insufficient energy to another portion of the surface to achieve ablation.

4. The method of claim 3 wherein delivering sufficient energy to achieve ablation includes configuring an electrode pattern such that some spacing between electrodes is sufficiently close to allow conveyance of a level of energy sufficient to ablate and other spacing between electrodes is insufficiently close to allow conveyance of the level of energy sufficient to ablate.

5. The method of claim 3 wherein delivering sufficient energy to achieve ablation includes operating an electrode pattern such that the energy delivered between some electrodes is sufficient to ablate and energy sufficient to ablate is not delivered between some electrodes.

6. The method of claim 1 wherein controlling the delivery of energy into inwardly from the surface of the tissue consists of ablating some portion of tissue within the epithelial layer.

7. The method of claim 1 wherein controlling the delivery of energy into inwardly from the surface of the tissue consists of ablating some portion of tissue within the epithelial layer and the lamina propria.

8. The method of claim 1 wherein controlling the delivery of energy into inwardly from the surface of the tissue consists of ablating some portion of tissue within the epithelial layer, the lamina propria, and the muscularis mucosae.

9. The method of claim 1 wherein controlling the delivery of energy into inwardly from the surface of the tissue consists of ablating some portion of tissue within the epithelial layer, the lamina propria, the muscularis mucosae, and the submucosa.

10. The method of claim 1 wherein controlling the delivery of energy into inwardly from the surface of the tissue consists of ablating some portion of tissue within the epithelial layer, the lamina propria, the muscularis mucosae, the submucosa, and the muscularis propria.

11. The method of claim 1 wherein the pathophysiological metabolic condition includes any one or more of type 2 diabetes, insulin resistance, obesity, or metabolic syndrome.

12. The method of claim 1 further comprising restoring the pathophysiological metabolic condition of the patient toward a normal metabolic condition.

13. The method of claim 12 wherein restoring the metabolic condition toward a normal metabolic condition includes any of decreasing blood glucose levels, decreasing blood insulin levels, decreasing insulin resistance, decreasing body weight, or decreasing body mass index.

14. The method of claim 1 wherein the ablation target area includes cells that support the secretion of insulin in the patient, and wherein upon receiving transmitted energy from the ablation structure are rendered at least partially dysfunctional.

15. The method of claim 14 wherein the cells supporting the effect of insulin are endocrine cells.

16. The method of claim 14 wherein the cells supporting the effect of insulin are nerve cells.

17. The method of claim 1 wherein the ablation target area includes cells that support the response of the patient to insulin, and wherein upon receiving transmitted energy from the ablation structure are rendered at least partially dysfunctional.

18. The method of claim 17 wherein supporting the response to insulin includes any of promoting the greater effectiveness of secreted insulin or decreasing the effect of agents that have an anti-insulin effect.

19. The method of claim 17 wherein the cells supporting the effect of insulin are endocrine cells.

20. The method of claim 17 wherein the cells supporting the effect of insulin are nerve cells.

21. The method of claim 1 wherein the target area is located in the gastric antrum.

22. The method of claim 1 wherein the target area is located in the pylorus.

23. The method of claim 1 wherein controlling the delivery of energy across the tissue surface within the target area and into the depth of tissue within the target area allows achievement of a partial ablation in tissue layers of the gastrointestinal tract.

24. The method of claim 23 wherein the target area is in the epithelial layer of the gastric antrum.

25. The method of claim 23 wherein the target area is in epithelial layer of the any of the duodenum or jejunum.

26. The method of claim 23 wherein partial ablation in the epithelial layer slows the rate of nutrient absorption through the epithelial layer.

27. The method of claim 23 wherein the target area includes the muscularis of the gastric antrum causing a slowing of gastric emptying.

28. The method of claim 23 wherein the target area includes the muscularis of the pyloris causing a slowing of gastric emptying.

29. The method of claim 23 wherein the target area includes the muscularis of the duodenum causing a slowing of gastric emptying.

30. The method of claim 1 wherein the ablation has a permanent effect on the function of the target area.

31. The method of claim 1 wherein the ablation has a transient effect on the function of the target area.

32. The method of claim 31 wherein the transient effect has duration that ranges from a period of about one day to about one year.

33. The method of claim 31 wherein during the time when the function of the target region is transiently affected, the method further includes evaluating the patient for a beneficial therapeutic effect of the ablation.

34. The method of claim 33 wherein in the event of a beneficial therapeutic effect, the method further includes repeating the ablation of the target region.

35. The method of claim 34 wherein the repeated ablation is a transient ablation.

36. The method of claim 34 wherein the repeated ablation is a permanent ablation.

37. The method of claim 1 wherein the electrode pattern is configured circumferentially through 360 degrees around the ablation structure.

38. The method of claim 37 wherein transmitting energy from the ablation structure includes transmitting energy asymmetrically through the 360 degree circumference such that ablation is focused within an arc of less than 360 degrees.

39. The method of claim 1 wherein the electrode pattern is configured circumferentially through an arc of less than 360 degrees around the ablation structure.

40. The method of claim 1 further comprising evaluating the target area at a point in time after the delivering energy step to determine the status of the area.

41. The method of claim 40 wherein the evaluating step occurs in close time proximity after the delivery of energy, to evaluate the immediate post-treatment status of the site.

42. The method of claim 40 wherein the evaluating step occurs at least one day after the delivery of energy.

43. The method of claim 1 wherein the delivering energy step is performed more than once.

44. The method of claim 1 further compromising deriving energy for transmitting from an energy source that is controlled by a control system.

45. The method of claim 44 wherein the energy source is a generator.

46. The method of claim 44 further comprising feedback controlling the energy transmission so as to provide any of a specific power, power density, energy, energy density, circuit impedance, or tissue temperature.

47. The method of claim 1 wherein the energy comprises at least radiofrequency energy or steam heat.

48. The method of claim 1 wherein, the target area being a portion of the gastrointestinal tract that includes at least a portion of a duodenum.