Ablation in the gastrointestinal tract to achieve hemostasis and eradicate lesions with a propensity for bleeding

• US 8,439,908 B2
• Filed: 07/03/2008
• Issued: 05/14/2013
• 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., Wallace, Michael P., Gerberding, Brent C.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): STOHR, LEAH C
• Application Number:
  US12/167,931
• Publication Number:
  US 20090012513A1
• Time in Patent Office: 1,776 Days
• Field of Search: 606/21, 606 27- 33, 606/40, 606/41, 606/49
• US Class Current: 606/34
• 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 18/1485 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 2017/22069 Immobilising; Stabilising
• 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 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00577 Ablation
• 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 2018/00738 Depth, e.g. depth of ablation
• 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 the ablation of regions of the digestive tract to achieve hemostasis and to eradicate chronically bleeding lesions as occur with gastric antral vascular ectasia (GAVE), portal hypertensive gastropathy (PHG), radiation proctopathy and colopathy, arteriovenous malformations, and angiodysplasia. Ablation is typically provided in a wide-field manner, and in conjunction with sufficient pressure to achieve coaptive coagulation. Ablation, as provided the invention, starts at the mucosa and penetrates deeper into the gastrointestinal wall in a controlled manner. Ablation control may be exerted by way of electrode design and size, energy density, power density, number of applications, pattern of applications, and pressure. 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 an area of bleeding in a gastrointestinal tract comprising:

identifying the area of bleeding utilizing an endoscope;

positioning a therapy device coupled with a distal end of the endoscope in the gastrointestinal tract adjacent to a target site within the area of bleeding;

pressuring the bleeding area utilizing both the therapy device and the endoscope to diminish the amount of blood within blood vessels in the bleeding area; and

applying a non-surgical hemostatic therapy utilizing the therapy device to a target site in the area while continuing to pressure the area.

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

3. The method of claim 1 further comprising:

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

removing the instrument after the applying step.

4. The method of claim 1 wherein applying non-surgical hemostatic therapy on the target site includes applying energy to the target site.

5. The method of claim 4 wherein the energy is radiofrequency energy.

6. The method of claim 4 wherein applying energy to the target site includes controlling the delivery of energy across the tissue surface in the target site.

7. The method of claim 4 wherein applying energy to the target site includes controlling the depth of delivery of energy into tissue layers in the target site.

8. The method of claim 4 wherein applying energy to the target site includes applying energy more than once.

9. The method of claim 4 wherein applying energy to the target site includes applying energy to more than one target site in the area of bleeding.

10. The method of claim 1 wherein applying non-surgical hemostatic therapy on the target site includes applying cryogenic treatment to the target site.

11. The method of claim 10 wherein applying the cryogenic treatment includes spraying a cryogenic fluid on the target site.

12. The method of claim 10 wherein applying the cryogenic treatment includes drawing heat from the target area into a cryogenic fluid contained in the device.

13. 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 site within the area of bleeding.

14. The method of claim 13 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.

15. The method of claim 1 pressuring the bleeding area includes applying pressure of about 1 psig to about 15 psig.

16. The method of claim 1 pressuring the bleeding area includes applying pressure of about 3 psig to about 7 psig.

17. The method of claim 1 pressuring the bleeding area includes applying pressure of about 4 psig.

18. A method of ablationally-treating a target site within an area of bleeding in a gastrointestinal tract comprising:

pressuring the bleeding area utilizing both a therapy device and an endoscope to diminish the amount of blood within blood vessels in the bleeding area, wherein the therapy device is coupled to a distal end of the endoscope; and

delivering radiofrequency energy to a tissue surface within the target area utilize the therapy device coupled with the distal end of the endoscope, the target area being a contiguous radial portion of the gastrointestinal tract; and

controlling the delivery of radiofrequency energy across the tissue surface within the target area and into a depth of tissue within the target area.

19. The method of claim 18 wherein the area of bleeding may be any of a site of acute bleeding, chronic bleeding, or a site identified as having a propensity to bleed.

20. The method of claim 19 wherein the site of acute bleeding may include any of a bleeding varix within the esophagus, an exposed bleeding vessel within a gastric or duodenal ulcer, or an arteriovenous malformation within the bowel.

21. The method of claim 19 wherein the site of chronic bleeding may include any of a site of gastric antral vascular ectasia (GAVE), radiation induced proctopathy or colopathy, portal hypertensive gastropathy (pHG), angiodysplasia, small arteriovenous malformations (AVM), or small bleeding ulcers.

22. The method of claim 18 wherein controlling the delivery of radio frequency energy across the surface and into a depth of tissue within the target area includes delivering sufficient radio frequency energy to achieve ablation in one portion of the tissue target area and delivering insufficient radiofrequency energy to another portion of the surface to achieve ablation.

23. The method of claim 18 wherein controlling the delivery of radiofrequency energy into depth of the tissue includes controlling the delivery of radio frequency energy in from the tissue surface such that sufficient energy to achieve ablation is delivered to one or more tissue layers near the surface and insufficient energy is delivered to other deeper layers to achieve ablation.

24. The method of claim 18 wherein controlling the delivery of radiofrequency energy across the target area surface includes configuring the electrode pattern such that some spacing between electrodes is sufficiently close to allow conveyance of sufficient enemy to ablate and other spacing between electrodes is insufficiently close to allow conveyance of sufficient energy to ablate.

25. The method of claim 18 wherein controlling the delivery of radio frequency energy across the target area surface 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.

26. The method of claim 18 wherein controlling the delivery of energy commencing at the mucosal surface and emanating into the organ wall includes ablating some portion of the blood vessels within the epithelial layer.

27. The method of claim 18 wherein controlling the delivery of energy commencing at the mucosal surface and emanating into layers of the organ wall includes ablating some portion of the blood vessels within the epithelial layer and the lamina propria.

28. The method of claim 18 wherein controlling the delivery of energy commencing at the mucosal surface and emanating into the organ wall includes ablating some portion of the blood vessels within the epithelial layer, the lamina propria, and the muscularis mucosae.

29. The method of claim 18 wherein controlling the delivery of energy commencing at the mucosal surface and emanating into the organ wall includes ablating some portion of the blood vessels within the epithelial layer, the lamina propria, the muscularis mucosae, and the submucosa.

30. The method of claim 18 wherein controlling the delivery of energy commencing at the mucosal surface and emanating into the organ wall includes ablating some portion of the blood vessels within the epithelial layer, the lamina propria, the muscularis mucosae, the submucosa, and the muscularis propria.

31. The method of claim 18 wherein controlling the delivery of radiofrequency energy across the tissue surface within the target area and into the depth of tissue within the target area includes achieving of a partial ablation in tissue layers of the gastrointestinal tract.

32. The method of claim 18 wherein delivering radiofrequency energy is by way of an electrode pattern configured circumferentially through 360 degrees around the ablation structure.

33. The method of claim 32 wherein delivering energy from the ablation structure includes transmitting energy asymmetrically through the 360 degree circumference such that ablation is focused within an arc of less that 360 degrees.

34. The method of claim 18 wherein delivering radiofrequency energy is by way of an electrode pattern configured circumferentially through an arc of less than 360 degrees around the ablation structure.

35. The method of claim 18 further comprising evaluating the target area at a point in time after the delivering energy step to determine the status of the area.

36. The method of claim 35 wherein the evaluating step occurs in close time proximity after the delivery of energy, to evaluate the immediate post-treatment status of the site.

37. The method of claim 35 wherein the evaluating step occurs at least one day after the delivery of energy.

38. The method of claim 18 wherein the delivering energy step is performed more than once.

39. The method of claim 18 further compromising deriving energy for transmitting from an energy source that is controlled by a control system.

40. The method of claim 39 wherein the energy source is a generator.

41. The method of claim 39 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.

42. The method of claim 18 further comprising:

advancing an ablation structure into the alimentary canal, a non-penetrating electrode pattern on the structure, the structure supported on an instrument, wherein the ablation structure comprises at least a portion of the therapy device;

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.

43. The method of claim 42 wherein the moving step includes inflating a balloon member.

44. The method of claim 42 wherein the moving step includes expanding a deflection member.

45. The method of claim 42 wherein the moving step includes moving a deflection member.

46. The method of claim 42 wherein the moving step includes expanding an expandable member.

47. The method of claim 42 further including a position-locking step following the moving step.

49. The method of claim 42 further comprising evaluating the target area prior to the positioning step, the evaluating step to determine the status of the target area.

50. The method of claim 42 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.

48. A method of ablationally-treating a target area within an area of bleeding in a gastrointestinal tract comprising:

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

positioning the ablation structure adjacent to the target area;

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

position-locking the ablation on structure, wherein the position-locking includes developing suction between the structure and an ablation site;

pressuring the bleeding area to diminish the amount of blood within blood vessels in the bleeding area; and

delivering radiofrequency energy to the tissue surface within the target area, the target area being a contiguous radial portion of the gastrointestinal tract; and

controlling the delivery of radiofrequency energy across the tissue surface within the target area and into a depth of tissue within the target area.