SYSTEM AND METHOD FOR SELECTIVE PRESSURE-CONTROLLED THERAPEUTIC DELIVERY
A treatment system includes a guide sheath, and a catheter provided with a pressure-controlled element. The pressure-control element preferably includes an expanded configuration adapted to extend across a small feeder vessel branching from the splenic vein. The pressure-control element is positioned with the feeder vessel, and a therapeutic agent is delivered under pressure directly into the feeder vessel, where it is forced to penetrate deep into tissue. Pressure responsive elements for monitoring intravascular pressure are also provided to time delivery of the therapeutic agent for maximum uptake by the target organ. Methods for treating tissues and organs via vascular pathways are provided.
1 - 25 . (canceled)
26 . A method of delivering a therapeutic agent to a pancreas of a patient, the method comprising:
advancing an expandable balloon in a contracted configuration through a portal vein between a liver and the pancreas of the patient and into a splenic vein of the patient;
expanding the balloon in the splenic vein to occlude portal venous flow to a spleen of the patient;
injecting a bolus of a contrast agent into the portal vein and through the splenic vein, wherein the expanded balloon prevents flow of the contrast agent into the spleen;
imaging the pancreas after injection of the contrast agent to visualize the splenic vein and feeder vessels extending from the splenic vein; and
injecting the therapeutic agent into one of the visualized feeder vessels and to pancreatic tissue of the patient.
27 . The method of claim 26 , wherein the method further comprises, prior to the advancement of the balloon, steps for:
inserting a guide sheath comprising a lumen extending longitudinally therethrough into the portal vein; and
advancing the balloon in the contracted configuration through the lumen and distally out of the guide sheath.
28 . The method of claim 26 , wherein the balloon is advanced through the portal vein and to a location in the splenic vein adjacent to the spleen, prior to the expansion of the balloon.
29 . The method of claim 26 , wherein the balloon is advanced through the portal vein traversing the pancreas and to the location.
30 . The method of claim 28 , wherein the location in the splenic vein is an origin of the spleen.
31 . The method of claim 26 , wherein the balloon remains expanded while the therapeutic agent is injected.
32 . The method of claim 26 , wherein the method further comprises contracting the balloon prior to the injection of the therapeutic agent.
33 . The method of claim 26 , wherein the therapeutic agent is injected at a fluid pressure above a systemic pressure of the patient.
34 . The method of claim 33 , wherein the fluid pressure is sufficiently above the systemic pressure to force the therapeutic agent into hypoxic regions of the pancreatic tissue, or regions of the pancreatic tissue not serviced by circulating blood flow.
35 . The method of claim 33 , wherein the therapeutic agent comprises a radioembolization agent.
36 . The method of claim 34 , wherein the fluid pressure is from 300 psi to 1200 psi.
37 . The method of claim 34 , wherein fluid pressure is 10 mmHg to 200 mmHg above the systemic pressure.
38 . The method of claim 33 , wherein the therapeutic agent comprises a solution of biologic cells.
39 . The method of claim 38 , wherein the solution of biologic cells comprise cells selected from the group consisting of CAR-T, CAR-NK, TCR-R, TCR-NK, B-cells, and combinations thereof.
40 . The method of claim 38 , wherein the fluid pressure is below a shear rate of the biologic cells to prevent damage to the biologic cells.
41 . The method of claim 40 , wherein the fluid pressure is below 300 psi.
42 . The method of claim 26 , wherein the expansion of the balloon comprises:
injecting an inflation solution in an amount sufficient to expand the balloon to occlude portal venous flow to the spleen.
43 . The method of claim 26 , wherein the injection of the therapeutic agent comprises:
injecting a solution comprising the therapeutic agent and an additional contrast agent into the one of the visualized feeder vessels and to the pancreatic tissue of the patient.
44 . The method of claim 43 , further comprising:
detecting the additional contrast agent to monitor penetration of the therapeutic agent in the pancreatic tissue.