Method and apparatus for gastrointestinal tract ablation to achieve loss of persistent and/or recurrent excess body weight following a weight-loss operation

• US 8,251,992 B2
• Filed: 07/03/2008
• Issued: 08/28/2012
• Est. Priority Date: 07/06/2007
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Utley, David S., de Csepel, John
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/167,902
• Publication Number:
  US 20090012512A1
• Time in Patent Office: 1,517 Days
• Field of Search: 606/21, 606/27, 606/28, 606/32, 606/34, 606/41, 606/47, 606/48, 606/50
• US Class Current: 606/41
• 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 comprising:

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.