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 ( 100 ) for treating target tissue comprising:
a tissue treatment element constructed and arranged to apply a tissue modifying agent to the target tissue, wherein the tissue treatment element is configured to expand prior to the delivery of the tissue modifying agent; and
a shaft ( 110 ) with a proximal end and a distal portion and a lumen ( 116 ), wherein the tissue treatment element is positioned on the distal portion of the shaft ( 110 );
a tissue modifying agent delivery unit configured to deliver the tissue modifying agent to the tissue treatment element through the lumen ( 116 ); and
one or more deployable occluding elements ( 193 ) for preventing migration of the tissue modifying agent to non-target tissue;
wherein the one or more deployable occluding elements ( 193 ) are positioned within the lumen;
a translatable push rod ( 138 ) configured to be advanced to deploy the one or more deployable occluding elements ( 193 ) from a distal end of the lumen ( 116 );
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 , wherein the system is configured to treat a cumulative length of duodenal mucosa of at least 3.4 cm to achieve the therapeutic benefit.
3. 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.
4. The system according to claim 1 , wherein the target tissue comprises duodenal mucosa located distal to the ampulla of Vater.
5. The system according to claim 1 , wherein the tissue treatment device ( 100 ) is configured to be inserted through an endoscope.
6. The system according to claim 1 , wherein the tissue treatment element is configured to expand when contacted with a fluid.
7. The system according to claim 6 , wherein the contacting fluid configured to cause the expansion comprises the tissue modifying agent.
8. The system according to claim 1 , wherein the tissue treatment element is configured to be radially compressed and captured within an endoscope.
9. The system according to claim 1 , wherein the tissue treatment element comprises a sponge material.
10. The system according to claim 9 , wherein the sponge material is selected from the group consisting of: a natural sponge material; a synthetic sponge material; a foamed polyurethane; a polyvinyl alcohol (PVA) sponge; a hydrogel; a super-absorbent polymer; and combinations thereof.
11. The system according to claim 1 , wherein the tissue treatment element comprises a balloon.
12. The system according to claim 11 , wherein the balloon comprises a permeable balloon, and wherein the tissue modifying agent is configured to be delivered to the target tissue through the permeable balloon.
13. The system according to claim 1 , wherein the tissue modifying agent is configured to cause necrosis of the target tissue.
14. The system according to claim 13 , wherein the tissue modifying agent is selected from the group consisting of: a chemical peeling agent; a mild acid; glycolic acid; trichloroacetic acid; a mild base; phenol; retinoic acid; and combinations thereof.
15. The system according to claim 1 , further comprising a neutralizing agent configured to stop and/or reverse the effects of the tissue modifying agent.
16. 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.
17. 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.
18. 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.