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 and at least one delivery element positioned on the elongate shaft distal portion; and
an injectate configured to expand when delivered into tissue;
a sizing device configured to measure a luminal diameter; and
an injectate delivery unit configured to determine an amount of the injectate to be delivered based on the measured luminal diameter in order to narrow a lumen of a segment of an intestine to an inner diameter that is less than or equal to 10 mm;
wherein the delivery device is configured to deliver, based on the determined amount of injectate, the injectate through the at least one delivery element into luminal wall tissue of the intestine to narrow the lumen of the segment of the intestine to the inner diameter that is less than or equal to 10 mm.
2. The system according to claim 1 , wherein the at least one delivery element comprises at least two delivery elements.
3. The system according to claim 2 , wherein the at least two delivery elements comprises at least three delivery elements.
4. The system according to claim 1 , wherein the injectate comprises at least two materials.
5. The system according to claim 1 , wherein the delivery device is configured to deliver the injectate to narrow a lumen of a segment of the intestine to an inner diameter that is less than or equal to 5 mm.
6. The system according to claim 5 , wherein the delivery device is configured to deliver the injectate to narrow a lumen of a segment of the intestine to an inner diameter that is less than or equal to 4 mm.
7. The system according to claim 6 , wherein the delivery device is configured to deliver the injectate to narrow a lumen of a segment of the intestine to an inner diameter that is less than or equal to 3 mm.
8. The system according to claim 1 , wherein the injectate comprises a material selected from the group consisting of: peptide polymer; polylactic acid; polymethylmethacrylate; hydrogel; sclerosant; adhesive; cyanoacrylate; and combinations thereof.
9. The system according to claim 1 , wherein the injectate comprises a material selected from the group consisting of: fat cells; collagen; autologous collagen; bovine collagen; porcine collagen; bioengineered human collagen; dermis; a dermal filler; hyaluronic acid; conjugated hyaluronic acid; calcium hydroxylapatite; fibroblasts; and combinations thereof.
10. The system according to claim 1 , wherein the injectate is further configured to polymerize when delivered into tissue.
11. The system according to claim 1 , wherein the injectate comprises hyaluronic acid.
12. The system according to claim 2 , wherein the luminal wall tissue comprises submucosal tissue.