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 system for treating a patient comprising:
a delivery device comprising:
an elongate shaft with a distal portion, wherein the shaft is configured to position the delivery element in a region of the gastrointestinal tract below the pylorus when the shaft is introduced through the mouth of the patient; and
at least one delivery element positioned on the elongate shaft distal portion; and
an injectate comprising at least a first injectate material and a second injectate material, wherein at least one of the first and second injectate materials comprises a material selected from the group consisting of ethylene vinyl alcohol; dimethyl sulfoxide; a peptide polymer; polylactic acid; polymethylmethacrylate; hyaluronic acids; adhesives; hydrogels; and
combinations thereof;
wherein the delivery device is constructed and arranged to deliver the first injectate material and the second injectate material through separate delivery lumens to and through the at least one delivery element and into a submucosal tissue of the intestines to create a therapeutic restriction in the gastrointestinal tract; and
wherein the first and second injectate materials are delivered without mixing prior to their delivery into tissue and upon mixing in tissue undergo at least one of (1) a chemical change when brought into contact with each other, (2) a physical change when brought into contact with each other, and (3) more rapid absorption, degradation or migration of the second injectate relative to the first injectate material.
2. The system according to claim 1 , wherein the delivery device is constructed and arranged to create multiple therapeutic restrictions in the gastrointestinal tract.
3. The system according to claim 1 , wherein the delivery device is constructed and arranged to create the therapeutic restriction in the small intestine of the patient.
4. The system according to claim 3 , wherein the delivery device is constructed and arranged to create the therapeutic restriction in the duodenum of the patient.
5. The system according to claim 3 , wherein the delivery device is constructed and arranged to create the therapeutic restriction in at least one of the proximal small intestine, the duodenum or the proximal jejunum.
6. The system according to claim 1 , wherein the delivery device is constructed and arranged to create the therapeutic restriction to have an axial length between 1 mm and 100 mm.
7. The system according to claim 6 , wherein the delivery device is constructed and arranged to create the therapeutic restriction to have an axial length between 1 mm and 20 mm.
8. The system according to claim 1 , wherein the delivery device is constructed and arranged to create the therapeutic restriction to have an inner diameter of less than 5 mm.
9. The system according to claim 8 , wherein the delivery device is constructed and arranged to create the therapeutic restriction to have an inner diameter of less than 4 mm.
10. The system according to claim 8 , wherein the delivery device is constructed and arranged to create the therapeutic restriction to have an inner diameter of less than 3 mm.
11. The system according to claim 8 , wherein the delivery device is constructed and arranged to create the therapeutic restriction to have an inner diameter of less than 2 mm.
12. The system according to claim 8 , wherein the delivery device is constructed and arranged to create the therapeutic restriction to have an inner diameter of less than 1 mm.
13. The system according to claim 1 , wherein the delivery device is constructed and arranged to create the therapeutic restriction to have an inner diameter that is between 1% and 50% of the inner diameter of that portion of the gastrointestinal tract prior to creation of the therapeutic restriction.
14. The system according to claim 13 , wherein the delivery device is constructed and arranged to create the therapeutic restriction to have an inner diameter that is between 1% and 20% of the inner diameter of that portion of the gastrointestinal tract prior to creation of the therapeutic restriction.
15. The system according to claim 13 , wherein the delivery device is constructed and arranged to create the therapeutic restriction to have an inner diameter that is between 1% and 10% of the inner diameter of that portion of the gastrointestinal tract prior to creation of the therapeutic restriction.
16. The system according to claim 13 , wherein the delivery device is constructed and arranged to create the therapeutic restriction to have an inner diameter that is between 1% and 5% of the inner diameter of that portion of the gastrointestinal tract prior to creation of the therapeutic restriction.
17. The system according to claim 1 , wherein the delivery device is configured to create the therapeutic restriction to have a dimensional parameter that is based on a patient parameter.
18. The system according to claim 17 , wherein the therapeutic restriction dimensional parameter is selected from the group consisting of: volume; axial length; arc length; surface area; and combinations thereof.
19. The system according to claim 17 , wherein the patient parameter is selected from the group consisting of: body weight; body mass index; excess weight based on established norms; age; HbA1c level; cholesterol level; and combinations thereof.
20. The system according to claim 1 , wherein the therapeutic restriction is configured to treat obesity.
21. The system according to claim 1 , wherein the injectate is configured to expand after delivery into tissue.
22. The system according to claim 1 , wherein the injectate is configured to elute into tissue over time.
23. The system according to claim 1 , wherein the injectate is configured such that at least 50% of the injectate remains in the patient at least one month after being delivered into tissue.
24. The system of claim 23 , wherein the injectate is configured such that at least 50% of the injectate remains in the patient at least three months after being delivered into tissue.
25. The system of claim 24 ; wherein the injectate is configured such that at least 50% of the injectate remains in the patient at least six months after being delivered into tissue.
26. The system of claim 25 , wherein the injectate is configured such that at least 50% of the injectate remains in the patient at least one year after being delivered into tissue.
27. The system according to claim 1 , wherein the system is configured to deliver a pre-determined amount of injectate into the tissue to create the therapeutic restriction.
28. The system according to claim 27 , wherein the amount delivered is based on a measured parameter.
29. The system according to claim 28 , wherein the measured parameter comprises the inner diameter of the gastrointestinal segment prior to injectate delivery.
30. The system according to claim 28 , wherein the measured parameter comprises a patient parameter.
31. The system according to claim 30 , wherein the patient parameter comprises a parameter selected from the group consisting of: body weight; body mass index; excess weight based on established norms; age; HbA1c level; cholesterol level; and combinations thereof.
32. The system according to claim 28 , wherein the measured parameter is selected from the group consisting of: pressure within the therapeutic restriction; pressure within tissue proximate the therapeutic restriction; volume of the therapeutic restriction; diameter of the therapeutic restriction; and combinations thereof.
33. The system according to claim 1 , wherein the delivery device is constructed and arranged to deliver less than 20 ml of the injectate to create the therapeutic restriction.
34. The system according to claim 33 , wherein the device is constructed and arranged to deliver less than 10 ml of the injectate to create the therapeutic restriction.
35. The system according to claim 1 , wherein the delivery device is constructed and arranged to deliver between 3.0 ml and 20.0 ml to create the therapeutic restriction.
36. The system according to claim 1 , wherein the injectate comprises a pharmaceutical agent.
37. The system according to claim 1 , wherein the first injectate material and the second injectate material are configured to form a hydrogel after mixing together.
38. The system according to claim 37 , wherein the first injectate material comprises ethylene vinyl alcohol (EVOH) and the second injectate material comprises saline which combine to form a hydrogel.
39. The system according to claim 37 , wherein the first and second injectate materials undergo at least more rapid absorption, degradation or migration of the second injectate relative to the first injectate material.
40. The system according to claim 1 , wherein the second injectate material is configured to polymerize the first injectate material when delivered into the tissue.
41. The system according to claim 1 , wherein the at least one delivery element comprises a needle with a gauge of at least 30.
42. The system according to claim 1 , wherein the at least one delivery element comprises at least two delivery elements.
43. The system according to claim 1 , wherein each delivery element is constructed and arranged to deliver between 1.0 ml and 10 ml of injectate.
44. The system according to claim 1 , further comprising an injectate delivery unit constructed and arranged to provide the injectate to the delivery device.
45. The system according to claim 1 , further comprising a heater constructed and arranged to apply heat to the injectate.
46. The system according to claim 45 , wherein the heater is constructed and arranged to apply heat to the injectate prior to delivery of the injectate into tissue.
47. The system according to claim 45 , wherein the heater is configured to reduce viscosity of the injectate.
48. The system according to claim 1 , further comprising a luminal sizing device configured to provide diameter information of a gastrointestinal lumen.
49. The system according to claim 48 , wherein the luminal sizing device comprises a catheter with a distal portion and a balloon on the distal portion.
50. The system according to claim 1 , further comprising an algorithm configured to determine a therapeutic restriction parameter.
51. The system according to claim 50 , wherein the therapeutic restriction parameter comprises a parameter selected from the group consisting of: amount of injectate to be delivered into the tissue; a dimensional parameter of the therapeutic restriction; and combinations thereof.
52. The system according to claim 1 , wherein the first and second injectate materials undergo at least a chemical change when brought into contact with each other.
53. The system according to claim 1 , wherein the first and second injectate materials undergo at least a physical change when brought into contact with each other.