ABLATION SYSTEMS, DEVICES AND METHODS FOR THE TREATMENT OF TISSUE
A device for ablating target tissue of a patient with an ablative fluid is provided. An elongate shaft includes a proximal portion and a distal portion, and at least one fluid delivery element is attached to the distal portion. The device can be configured to ablate the duodenal mucosa of a patient while avoiding damage to the duodenal adventitial tissue. Systems and methods of treating target tissue are also provided.
1 . (canceled)
2 . A device for ablating duodenal mucosal tissue of a duodenum of a patient with a delivered vapor comprising:
an elongate shaft having a proximal portion and a distal portion;
a proximal expandable element positioned on the proximal portion of the elongate shaft;
a distal expandable element positioned on the distal portion of the elongate shaft; and
a fluid delivery element positioned on the elongate shaft between the proximal and distal expandable elements, wherein the fluid delivery element is constructed and arranged to deliver ablative fluid to directly contact a target tissue;
wherein the device is constructed and arranged to ablate the duodenal mucosal tissue,
wherein the proximal and distal expandable elements are configured to expand to position the fluid delivery element at a fixed distance from the target tissue,
wherein the proximal and distal expandable elements are configured to, in an expanded state, contain delivered ablative fluid within a volume of the patient's duodenum between the proximal and distal expandable elements, and
wherein the elongate shaft is configured to be advanced to the patient's duodenum though the working channel of an endoscope.
3 . The device of claim 2 , wherein at least one of the proximal expandable element and the distal expandable element comprises a radially expandable element.
4 . The device of claim 2 , wherein the fluid delivery element comprises multiple nozzles constructed and arranged to self-position relative to gastrointestinal luminal wall tissue with multiple reactive forces, wherein the multiple reactive forces result when the ablative fluid is delivered through the multiple nozzles.
5 . The device of claim 2 , wherein the working channel defines an inner diameter between 6.0 mm and 2.8 mm.
6 . The device of claim 2 , wherein the proximal and the distal expandable elements are configured to be in a contracted state within the working channel and to be able to expand to the expanded state when the elongate shaft is advanced beyond a distal end of the endoscope.
7 . The device of claim 2 , wherein at least one of the proximal and the distal expandable elements comprises a radially expandable material resiliently biased in a radially expanded condition.
8 . The device of claim 2 , wherein at least one of the proximal and the distal expandable elements is configured to seal a portion of a gastrointestinal tract of the patient in the expanded state.
9 . The device of claim 8 , wherein the proximal and distal expandable elements are configured to, in the expanded state, form an enclosed volume in the gastrointestinal tract therebetween.
10 . The device of claim 2 , wherein the ablative fluid comprises steam.
11 . The device of claim 2 , wherein the device is constructed and arranged to be operated by a controller such that the controller enables ablation of the duodenal mucosal tissue while avoiding damaging duodenal adventitial tissue.