Systems, devices and methods for the creation of a therapeutic restriction in the gastrointestinal tract
A system for treating a patient comprises a delivery device and injectate. The delivery device comprises an elongate shaft with a distal portion and at least one delivery element positioned on the elongate shaft distal portion. The delivery device is constructed and arranged to deliver the injectate through the at least one delivery element and into tissue to create a therapeutic restriction in the gastrointestinal tract. Methods of creating a therapeutic restriction are also provided.
1. A method of reducing a patient's weight, said method comprising:
advancing a fluid delivery element to a location proximate a luminal segment of the gastrointestinal tract of the patient; and
delivering an injectate through the delivery element and into tissue proximate the luminal segment to create a therapeutic restriction in the luminal segment;
wherein the luminal segment is located in the patient's proximal or distal small intestine;
wherein the patient experiences a loss of weight in response to the therapeutic restriction.
2. The method of claim 1 , wherein the therapeutic restriction is constructed and arranged to restrict the passage of food through a portion of the gastrointestinal tract of the patient.
3. The method of claim 1 , wherein the therapeutic restriction is constructed and arranged to cause at least one of: early satiety; premature satiety; or satiety.
4. The method of claim 1 , wherein the therapeutic restriction is constructed and arranged to alter an absorptive property and/or a secretive property of the gastrointestinal tract of the patient.
5. The method of claim 1 , wherein the therapeutic restriction is created by injecting a volume of injectate of at least 1.0 mL.
6. The method of claim 5 , wherein the therapeutic restriction is created by injecting a volume of injectate of at least 3.0 mL.
7. The method of claim 1 , wherein the therapeutic restriction is created by injecting a volume of injectate of no more than 20.0 mL.
8. The method of claim 7 , wherein the therapeutic restriction is created by injecting a volume of injectate of no more than 10.0 mL.
9. The method of claim 1 , wherein at least 50% of the injectate remains in the patient at least one month after being delivered into tissue.
10. The method of claim 9 , wherein at least 50% of the injectate remains in the patient at least three months after being delivered into tissue.
11. The method of claim 10 , wherein at least 50% of the injectate remains in the patient at least six months after being delivered into tissue.
12. The method of claim 11 , wherein at least 50% of the injectate remains in the patient at least one year after being delivered into tissue.
13. The method of claim 1 , wherein the injectate comprises ethylene vinyl alcohol.
14. The method of claim 13 , wherein the injectate further comprises dimethyl sulfoxide.
15. The method of claim 13 , wherein the injectate further comprises a second material constructed and arranged to polymerize the ethylene vinyl alcohol.
16. The method of claim 13 , wherein the injectate further comprises saline.
17. The method of claim 1 , wherein the injectate comprises a peptide polymer.
18. The method of claim 1 , wherein the injectate comprises polylactic acid.
19. The method of claim 1 , wherein the injectate comprises polymethylmethacrylate.
20. The method of claim 1 , wherein the injectate comprises a hydrogel.
21. The method of claim 1 , wherein the therapeutic restriction comprises an inner diameter less than or equal to 10 mm.
22. The method of claim 21 , wherein the therapeutic restriction comprises an inner diameter less than or equal to 5 mm.
23. The method of claim 21 , wherein the therapeutic restriction comprises an inner diameter less than or equal to 4 mm.
24. The method of claim 21 , wherein the therapeutic restriction comprises an inner diameter less than or equal to 2 mm.
25. The method of claim 21 , wherein the therapeutic restriction comprises an inner diameter less than or equal to 1 mm.
26. The method of claim 1 , wherein the therapeutic restriction comprises an inner diameter that is between 1% and 50% of the inner diameter of the luminal segment prior to creation of the therapeutic restriction.
27. The method of claim 26 , wherein the therapeutic restriction comprises an inner diameter that is between 1% and 20% of the inner diameter of the luminal segment prior to creation of the therapeutic restriction.
28. The method of claim 26 , wherein the therapeutic restriction comprises an inner diameter that is between 1% and 10% of the inner diameter of the luminal segment prior to creation of the therapeutic restriction.
29. The method of claim 26 , wherein the therapeutic restriction comprises an inner diameter that is between 1% and 5% of the inner diameter of the luminal segment prior to creation of the therapeutic restriction.
30. The method of claim 1 , wherein the delivery element comprises multiple delivery elements positioned on an expandable element.
31. The method of claim 30 , wherein the multiple delivery elements are circumferentially spaced.
32. The method of claim 1 , wherein the delivery element comprises a first delivery element advanced toward a first luminal segment of the gastrointestinal tract of the patient and wherein the injectate comprises a first injectate delivered through the first delivery element and into tissue proximate the first luminal segment to create a first therapeutic restriction in the first lumen segment, the method further comprising:
advancing a second delivery element to a location proximate a second luminal segment of the gastrointestinal tract of the patient; and
delivering a second injectate through the second delivery element and into tissue proximate the second luminal segment to create a second therapeutic restriction in the second luminal segment.
33. The method of claim 32 , wherein the second therapeutic restriction and the first therapeutic restriction are created on the same day.
34. The method of claim 32 , wherein the second therapeutic restriction is created at least one week after the creation of the first therapeutic restriction.
35. The method of claim 32 , wherein the second therapeutic restriction is positioned at least 5 mm from the first therapeutic restriction.
36. The method of claim 1 , wherein the luminal segment is located in at least one of the patient's duodenum and proximal jejunum.
37. The method of claim 1 , wherein the luminal segment is located in at least one of the patient's distal jejunum and ileum.