Methods, systems and devices for reducing the luminal surface area of the gastrointestinal tract
Methods, systems and devices for treating a patient include providing a tissue treatment element constructed and arranged to deliver energy to tissue and treating tissue of the gastrointestinal tract by causing the tissue treatment element to deliver energy to an energy delivery zone. Treatment results in a reduction in the luminal surface area of at least a portion of the gastrointestinal tract. In particular embodiments, the methods, systems and devices are used to treat diabetes.
1. A method for performing a medical procedure in an intestine of a patient comprising:
providing a system comprising:
a catheter for insertion into the intestine, the catheter comprising:
an elongate shaft with a distal portion;
a tissue treatment element positioned on the elongate shaft, wherein the tissue treatment element is configured to deliver energy to target tissue positioned in at least one energy delivery zone; and
an energy delivery unit configured to control energy delivery to each zone of the tissue treatment element;
introducing the catheter into the patient;
treating target tissue with the tissue treatment element;
wherein the method is configured to safely reduce the luminal surface area of at least a portion of the duodenum and wherein the tissue treatment element is constructed and arranged to reduce the surface area of the treated portion of the duodenum by at least 90%.
2. A method for performing a medical procedure in an intestine of a patient comprising:
providing a system comprising:
a catheter for insertion into the intestine, the catheter comprising:
an elongate shaft with a distal portion;
a tissue treatment element positioned on the elongate shaft, wherein the tissue treatment element is configured to deliver energy to target tissue positioned in at least one energy delivery zone; and
an energy delivery unit configured to control energy delivery to each zone of the tissue treatment element;
introducing the catheter into the patient;
treating target tissue with the tissue treatment element;
wherein the method is configured to safely reduce the luminal surface area of at least a portion of the duodenum and wherein the tissue treatment element is constructed and arranged to cause a reduction in the average villi length of the treated portion of the duodenum.
3. A method for performing a medical procedure in an intestine of a patient comprising:
providing a system comprising:
a catheter for insertion into the intestine, the catheter comprising:
an elongate shaft with a distal portion;
a tissue treatment element positioned on the elongate shaft, wherein the tissue treatment element is configured to deliver energy to target tissue positioned in at least one energy delivery zone; and
an energy delivery unit configured to control energy delivery to each zone of the tissue treatment element;
introducing the catheter into the patient;
treating target tissue with the tissue treatment element;
wherein the method is configured to safely reduce the luminal surface area of at least a portion of the duodenum and wherein the tissue treatment element is constructed and arranged to cause a reduction in the quantity of villi of the treated portion of the duodenum.
4. The method of any one of claims 1 , 2 , and 3 , wherein the tissue treatment element is selected from the group consisting of: RF energy; microwave energy; laser energy; sound energy; subsonic sound energy; ultrasound energy; chemical energy; thermal energy; heat energy; cryogenic energy; mechanical energy; energy configured to cut tissue; energy configured to resect tissue; and combinations thereof.
5. The method of any one of claims 1 , 2 , and 3 , wherein the energy delivery unit comprises a controller configured to control and/or monitor a system parameter selected from the group consisting of: a priming procedure parameter such as priming temperature or priming duration; target tissue treatment parameter such as target tissue temperature or target tissue treatment duration; fluid flow rate such as treatment fluid flow rate; a pressure parameter such as a tissue treatment element pressure maintained during treatment of target tissue; a tissue treatment element diameter such as a tissue treatment element diameter maintained during treatment of target tissue; and combinations thereof.
6. The method of any one of claims 1 , 2 , and 3 , wherein the tissue treatment element has between 50 and 3000 inward facing surfaces per square centimeter configured to treat multiple tissue segments.
7. The method of claim 6 , wherein the inward facing surfaces of the tissue treatment element each have an equivalent diameter between approximately 20 and 200 microns.
8. The method of claim 6 , wherein the tissue treatment element is configured to treat target tissue at a temperature at or above 60° C.
9. The method of claim 8 , wherein the tissue treatment element is configured to treat target tissue at a temperature at or above 100° C.
10. The method of any one of claims 1 , 2 , and 3 , where the tissue treatment element comprises an expandable portion configured to expand to a diameter between 10 and 40 mm.
11. The method of any one of claims 1 , 2 , and 3 , wherein the tissue treatment element is constructed and arranged to deliver energy to fewer than all of a multiplicity energy delivery zones.
12. The method of any one of claims 1 , 2 , and 3 , wherein the shaft comprises a bulbous element positioned on the distal portion.
13. The method of any one of claims 1 , 2 , and 3 , further comprising a tissue expansion element configured to expand a wall of the duodenum.
14. The method of any one of claims 1 , 2 , and 3 , wherein the tissue treatment element is configured to deliver energy to multiple tissue segments of the duodenum.
15. The method of claim 14 , wherein t the tissue treatment element is configured to deliver energy to between 2 and 50 tissue segments of the duodenum.
16. The method of claim 14 , wherein the multiple tissue segments each comprise a length less than 15 cm.
17. The method of any one of claims 1 , 2 , and 3 , further comprising a pumping assembly constructed and arranged to deliver or remove fluid from the tissue treatment element.
18. The method of any one of claims 1 , 2 , and 3 , wherein the energy delivery unit is configured to reduce at least one of absorption or secretion of the at least a portion of the duodenum.
19. The method of any one of claims 1 , 2 , and 3 , wherein the system is constructed and arranged to treat diabetes.
20. The method of any one of claims 1 , 2 , and 3 , wherein the tissue treatment element is constructed and arranged to cause a reduction in a duodenal tissue characteristic selected from the group consisting of: average height of mucosal folds; surface area of mucosal folds; number of mucosal folds; and combinations thereof.
21. The method of any one of claims 2 and 3 , wherein the tissue treatment element is constructed and arranged to reduce the surface area of the treated portion of the duodenum by at least 5%.
22. The method of any one of claims 2 and 3 , wherein the tissue treatment element is constructed and arranged to reduce the surface area of the treated portion of the duodenum by at least 10%.
23. The method of any one of claims 2 and 3 , wherein the tissue treatment element is constructed and arranged to reduce the surface area of the treated portion of the duodenum by at least 20%.
24. The method of any one of claims 2 and 3 , wherein the tissue treatment element is constructed and arranged to reduce the surface area of the treated portion of the duodenum by at least 50%.
25. The method of any one of claims 1 , 2 , and 3 , wherein the surface area reduction occurs at least one day after treating the target tissue.