Method and Apparatus for Gastrointestinal Tract Ablation to Achieve Loss of Persistent and/or Recurrent Excess Body Weight Following a Weight-Loss Operation

• US 20090012512A1
• Filed: 07/03/2008
• Published: 01/08/2009
• Est. Priority Date: 07/06/2007
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Csepel, John de, Utley, David S.
• Granted Patent: US 8,251,992 B2
• Time in Patent Office: Days
• US Class Current: 606/21
• CPC Class Codes: A61B 18/0218 with open-end cryogenic probe, e.g. for spraying fluid directly on tissue or via a tissue-contacting porous tip
• 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 2018/0016 Energy applicators arranged in a two- or three dimensional array
• 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 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• 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 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1497 Electrodes covering only part of the probe circumference

Abstract

Devices and methods are provided for ablational treatment of regions of the digestive tract in post-bariatric surgery patients who fail to achieve or maintain the desired weight loss. Bariatric procedures include Roux-en-Y gastric bypass, biliopancreatic diversion, and sleeve gastrectomy. These procedures reconstruct gastrointestinal tract features, creating pouches, stoma, and tubes that restrict and/or divert the digestive flow. Post-surgical dilation of altered structures is common and diminishes their bariatric effectiveness. Ablation of compromised structures can reduce their size and compliance, restoring bariatric effectiveness. Ablation, as provided the invention, starts at the mucosa and penetrates deeper into the gastrointestinal wall in a controlled manner. Control may also be provided by a fractional ablation that ablates some tissue within a target region and leaves a portion substantially unaffected. 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 in a target area of a gastrointestinal tract feature formed by a bariatric procedure that has failed comprising:

delivering radiofrequency energy to a tissue surface in the target area, the target area being a contiguous radial portion of an anatomical structure formed or altered by the bariatric procedure; and

controlling the delivery of radiofrequency energy across the tissue surface in the target area and into tissue layers in the target area.

2. The method of claim 1 wherein bariatric procedure is any of a Roux-en-Y procedure, a biliopancreatic diversion, or a sleeve gastrectomy.

3. The method of claim 1 wherein the feature of a gastrointestinal tract formed by bariatric procedure is any of a gastric pouch, a stoma, or a gastric sleeve

4. The method of claim 3 wherein the feature of a gastrointestinal tract formed by bariatric procedure is a suture line of the gastric sleeve.

5. The method of claim 1 wherein delivering radiofrequency energy includes delivering radiofrequency energy from non-penetrating electrodes.

6. The method of claim 1 wherein controlling the delivery of radiofrequency energy across the tissue surface in the target area includes delivering sufficient radiofrequency energy to achieve ablation in one fraction of the tissue target surface and delivering insufficient radiofrequency energy to another fraction of the surface to achieve ablation.

7. The method of claim 6 wherein controlling the fraction of the target area surface that receives sufficient radiofrequency energy to achieve ablation includes configuring the 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.

8. The method of claim 6 wherein controlling the fraction of the target area surface that receives sufficient radiofrequency energy to achieve ablation includes operating the 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.

9. The method of claim 1 wherein controlling the delivery of radiofrequency energy into tissue layers includes controlling the delivery of radiofrequency energy 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.

10. The method of claim 1 wherein controlling the delivery of radiofrequency energy across the surface and into tissue layers in the target area is such that some fraction of the tissue volume is ablated and another fraction of the tissue volume is not ablated.

11. The method of claim 1 wherein controlling the delivery of energy into tissue layers consists of ablating a fraction of tissue in the epithelial layer.

12. The method of claim 1 wherein controlling the delivery of energy into tissue layers consists of ablating a fraction of tissue in the epithelial layer and the lamina propria.

13. The method of claim 1 wherein controlling the delivery of energy into the tissue layers consists of ablating a fraction of tissue in the epithelial layer, the lamina propria, and the muscularis mucosae.

14. The method of claim 1 wherein controlling the delivery of energy into tissue layers consists of ablating a fraction of tissue in the epithelial layer, the lamina propria, the muscularis mucosae, and the submucosa.

15. The method of claim 1 wherein controlling the delivery of energy into the depth of the tissue consists of ablating a fraction of tissue in the epithelial layer, the lamina propria, the muscularis mucosae, the submucosa, and the muscularis propria.

16. The method of claim 1 wherein controlling the delivery of radiofrequency energy across the tissue surface and into tissue layers causes fractional ablation in tissue layers of the gastrointestinal tract.

17. The method of claim 1 wherein delivering energy includes delivering energy from an electrode pattern configured circumferentially through 360 degrees around the ablation structure.

18. The method of claim 17 wherein delivering energy from the ablation structure includes transmitting energy asymmetrically through the 360 degree circumference such that ablation is focused in an arc of less than 360 degrees.

19. The method of claim 1 delivering energy includes delivering energy from an electrode pattern configured circumferentially through an arc of less than 360 degrees around the ablation structure.

20. 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.

21. The method of claim 20 wherein the evaluating step occurs in close time proximity after the delivery of energy, to evaluate the immediate post-treatment status of the site.

22. The method of claim 20 wherein the evaluating step occurs at least one day after the delivery of energy.

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

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

25. The method of claim 24 wherein the energy source is a generator

26. The method of claim 24 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.

27. The method of claim 1 further comprising:

advancing an ablation structure into the alimentary canal, the non-penetrating electrode pattern on the structure, the structure supported on an instrument;

positioning the ablation structure adjacent to the target area; and

moving the ablation structure toward the surface of the target area to make therapeutic contact on the target area prior to delivering energy.

28. The method of claim 27 wherein the moving step includes inflating a balloon member.

29. The method of claim 27 wherein the moving step includes expanding a deflection member.

30. The method of claim 27 wherein the moving step includes moving a deflection member.

31. The method of claim 27 wherein the moving step includes expanding an expandable member.

32. The method of claim 27 further including a position-locking step following the moving step.

33. The method of claim 32 the position-locking step includes developing suction between the structure and the ablation site.

34. The method of claim 27 further comprising evaluating the target area prior to the positioning step, the evaluating step to determine the status of the target area.

35. The method of claim 27 wherein multiple target areas are being treated, the method comprising the positioning, moving, and transmitting energy steps to a first target area, and further comprises the positioning, moving, and transmitting energy steps to another target area without removing the ablation structure from the patient.

43. The ablation system of claim 35 wherein the programming directs the generator to deliver energy to a subset of electrode elements that form a pattern which, when therapeutically contacted to a target tissue area, ablates a portion of tissue in the target area and does not ablate another portion of tissue in the target area.

44. The ablation system of claim 43 wherein the portion of tissue which is ablated is rendered at least partially dysfunctional, and wherein the portion of the tissue which is not ablated retains its functionality.

36. An ablation system for treating a target area in tissue in a portion of a gastrointestinal tract formed by bariatric procedure comprising:

an electrode pattern including a plurality of electrodes;

a longitudinal support member supporting the electrode pattern;

a generator coupled to the plurality of electrodes;

a computer controller in communication with the generator, the controller having programming to direct the generator to deliver energy to the plurality of electrodes, the programming including the ability to direct delivery of energy to a subset of the electrodes, the electrodes of the pattern configured such that, when receiving energy from the generator and in therapeutic contact with a tissue target area, the electrodes ablate a portion of tissue in the target area and leave a portion of tissue in the target area non-ablated.

37. The ablation system of claim 36 wherein the portion of the gastrointestinal tract formed by the bariatric procedure includes any of a gastric pouch, a stoma, or a gastric sleeve.

38. The ablation system of claim 36 wherein the electrode pattern, having a longitudinal axis, forms a fully circumferential surface orthogonal to its longitudinal axis, the pattern sized for contacting tissue in a target area in the gastrointestinal tract.

39. The ablation system of claim 36 wherein the electrode pattern forms a partially circumferential surface orthogonal to its longitudinal axis, the pattern sized for contacting tissue in a target area in the gastrointestinal tract.

40. The ablation system of claim 39 wherein the electrode pattern forms an arc of about 180 degrees.

41. The ablation system of claim 39 wherein the electrode pattern forms an arc of about 90 degrees.

42. The ablation system of claim 36 wherein the electrode elements are distributed into a pattern such that when the programming directs the generator to deliver energy to all the electrodes, the electrode pattern, when therapeutically contacted to a target tissue area, ablates a portion of tissue in the target area and does not ablate another portion of tissue in the target area.

45. An ablation system for treating targeted tissue in a target area of a gastrointestinal tract feature formed by a bariatric procedure that has failed comprising:

an ablation structure supported by an instrument,

an electrode pattern on the ablation support structure, the electrode pattern configured to control the delivery of energy to a target tissue such that a portion of the surface of the target area receives sufficient radiofrequency energy to achieve ablation and another portion of the surface of the target receives insufficient energy to achieve ablation;

means supported by the instrument by which to bring the ablation structure to gain therapeutic contact with tissue at the target area.

46. A method of treating a gastrointestinal tract feature formed by a bariatric surgical procedure that has become dilated comprising:

identifying a target area of the surgically-formed gastrointestinal feature;

positioning a therapy device in the gastrointestinal tract adjacent to a target area on the dilated feature; and

performing a non-surgical reduction therapy on the target area of the dilated feature.

47. The method of claim 46 wherein the identifying step is performed endoscopically.

48. The method of claim 46 wherein the identifying step, the positioning step, and the performing step are conducted during a single endoscopic procedure.

49. The method of claim 46 further comprising:

inserting an instrument having a reduction therapy device mounted thereon into the gastrointestinal tract before the identifying step; and

removing the instrument after the performing step.

50. The method of claim 46 wherein performing the non-surgical reduction therapy on the surgically-formed gastrointestinal feature includes applying energy to the target area.

51. The method of claim 50 wherein the energy is radiofrequency energy.

52. The method of claim 50 wherein applying energy to the target includes controlling the delivery of energy across the tissue surface in the target area.

53. The method of claim 50 wherein applying energy to the target area includes controlling the depth of delivery of energy into tissue layers in the target area.

54. The method of claim 50 wherein applying energy to the target area includes applying energy more than once.

55. The method of claim 50 wherein applying energy to the target area includes applying energy to more than one site on the gastrointestinal feature.

56. The method of claim 46 wherein performing a non-surgical reduction therapy surgically-formed gastrointestinal feature includes applying cryogenic treatment to the target area.

57. The method of claim 56 wherein applying the cryogenic treatment includes spraying a cryogenic fluid on the target area.

58. The method of claim 56 wherein applying the cryogenic treatment includes drawing heat from the target area into a cryogenic fluid contained in the device.

59. The method of claim 46 wherein the positioning step further includes moving an ablation structure of the device so as to make therapeutic contact with a target area on the dilated feature.

60. The method of claim 59 wherein moving the ablation structure includes any of inflating a balloon member, expanding a deflection member, moving a deflection member, or expanding an expandable member.