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

• US 9,364,283 B2
• Filed: 07/26/2012
• Issued: 06/14/2016
• Est. Priority Date: 07/06/2007
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Utley, David S., de Csepel, John
• Primary Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US13/558,506
• Publication Number:
  US 20120289952A1
• Time in Patent Office: 1,419 Days
• Field of Search: 606/21, 606/32, 606/33, 606/41, 606/50, 606/27
• US Class Current: 1/1
• 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 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.

2. The method of claim 1 wherein the identifying step is performed endoscopically.

3. The method of claim 1 wherein the identifying step, the positioning step, and the performing step are conducted during a single endoscopic procedure.

4. The method of claim 1 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.

5. The method of claim 1 wherein performing the non-surgical reduction therapy on the surgically-formed gastrointestinal feature includes applying energy to the target area.

6. The method of claim 5 wherein the energy is radiofrequency energy.

7. The method of claim 5 wherein applying energy to the target includes controlling the delivery of energy across the tissue surface in the target area.

8. The method of claim 5 wherein applying energy to the target area includes controlling the depth of delivery of energy into tissue layers in the target area.

9. The method of claim 5 wherein applying energy to the target area includes applying energy more than once.

10. The method of claim 5 wherein applying energy to the target area includes applying energy to more than one site on the gastrointestinal feature.

11. The method of claim 1 wherein performing a non-surgical reduction therapy surgically-formed gastrointestinal feature includes applying cryogenic treatment to the target area.

12. The method of claim 11 wherein applying the cryogenic treatment includes spraying a cryogenic fluid on the target area.

13. The method of claim 11 wherein applying the cryogenic treatment includes drawing heat from the target area into a cryogenic fluid contained in the device.

14. The method of claim 1 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.

15. The method of claim 14 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.