METHODS AND SYSTEMS FOR TREATING DIABETES AND RELATED DISEASES AND DISORDERS
Systems, device and methods treat target tissue to provide a therapeutic benefit to the patient. A tissue treatment device comprises a tissue treatment element constructed and arranged to treat target tissue, such as duodenal mucosa tissue.
1 . A system for modifying tissue to provide a therapeutic benefit to a patient, the system comprising:
a tissue treatment device for treating target tissue comprising:
a tissue treatment element comprising one or more ablative fluid delivery elements constructed and arranged to deliver an ablative fluid to the target tissue; and
a shaft with a proximal end, a distal portion, and a lumen, wherein the tissue treatment element is positioned on the distal portion of the shaft;
a delivery unit configured to deliver the ablative fluid to the tissue treatment element through the lumen; and
one or more deployable occluding elements for preventing migration of the ablative fluid to non-target tissue;
wherein the one or more deployable occluding elements are constructed and arranged to deploy from the shaft,
wherein the target tissue comprises duodenal mucosal tissue, and
wherein the system is configured to modify the target tissue to provide the therapeutic benefit.
2 . The system according to claim 1 , further comprising a translatable push rod configured to be advanced to deploy the one or more deployable occluding elements.
3 . The system according to claim 1 , wherein the ablative fluid comprises steam.
4 . The system according to claim 3 , wherein the steam comprises a temperature of 100° C. or above.
5 . The system according to claim 1 , wherein the ablative fluid comprises a vaporized fluid.
6 . The system according to claim 5 , wherein the vaporized fluid comprises a temperature below 100° C.
7 . The system according to claim 6 , wherein the vaporized fluid comprises a temperature between 70° C. and 90° C.
8 . The system according to claim 1 , wherein the ablative fluid comprises a gas between 70° C. and 90° C.
9 . The system according to claim 1 , wherein the system is configured to treat a cumulative length of duodenal mucosa of at least 3.4 cm to achieve the therapeutic benefit.
10 . The system according to claim 1 , wherein the system is configured to treat at least one of a disease or disorder selected from the group consisting of: diabetes; pre-diabetes; impaired glucose tolerance; insulin resistance; obesity or otherwise being overweight; a metabolic disorder; a metabolic disease; and combinations thereof.
11 . The system according to claim 1 , wherein the target tissue comprises duodenal mucosa located distal to the ampulla of Vater.
12 . The system according to claim 1 , wherein the tissue treatment device is configured to be inserted through an endoscope.
13 . The system according to claim 1 , wherein the ablative fluid is configured to cause necrosis of the target tissue.
14 . The system according to claim 1 , further comprising a neutralizing agent configured to stop and/or reverse the effects of the ablative fluid after its delivery to the target tissue.
15 . The system according to claim 1 , further comprising at least one deployable marker, wherein the target tissue comprises tissue locatable by the at least one deployable marker.
16 . The system according to claim 1 , wherein the one or more deployable occluding elements is/are biodegradable and configured to evacuate the body via the body's natural digestive system.
17 . The system according to claim 1 , wherein the one or more deployable occluding elements is/are arranged to be removed via a grasping element deployed through an endoscope.
18 . The system according to claim 1 , wherein the one or more deployable occluding elements comprise a first deployable occluding element configured to be deployed distal to the target tissue and a second deployable occluding element configured to be deployed proximal to the target tissue.
19 . The system according to claim 18 , wherein the one or more ablative fluid delivery elements are constructed and arranged to deploy the ablative fluid between the first and second deployable occluding elements.
20 . The system according to claim 1 , wherein the one or more deployable occluding elements are configured to radially expand to at least partially occlude a segment of the gastrointestinal tract.