System and method for selective pressure-controlled therapeutic delivery

A method for delivering a therapeutic agent under pressure to a target organ for treatment of a solid tumor in the target organ, the target organ in fluid communication with a vein in a patient, the method comprising:

• a) introducing a treatment system into the vein of the patient, the treatment system comprising a microvalve comprising a filamentary braid coated with a polymeric filter comprising pores, the microvalve movable between a collapsed configuration for delivery through the vein, and an expanded configuration adapted to extend across the vein;
• b) advancing the microvalve in the collapsed configuration into the vein, wherein the vein is subject to a systemic venous pressure on a distal side of the microvalve;
• then
• c) expanding the microvalve into the expanded configuration across the vein to block flow within the vein in a distal to proximal direction past the microvalve;
• and
• d) injecting the therapeutic agent at a first pressure below 300 psi to exit distal of the microvalve and into the vein to cause the therapeutic agent to flow through the vein at a pressure higher than the systemic venous pressure and into the target organ, the therapeutic agent comprising a biologic agent selected from the group consisting of one of CAR-T cells, CAR-NK cells, TCR-R cells, TCR-NK cells, B-cells, and a combination of two or more of the cells.

A method for delivering a therapeutic agent under pressure to a target organ for treatment of a solid tumor in the target organ, the target organ in fluid communication with a vein in a patient, the method comprising:

• a) introducing a treatment system into the vein of the patient, the treatment system comprising a microvalve comprising a filamentary braid coated with a polymeric filter comprising pores, the microvalve movable between a collapsed configuration for delivery through the vein, and an expanded configuration adapted to extend across the vein;
• b) advancing the microvalve in the collapsed configuration into the vein, wherein the vein is subject to a systemic venous pressure on a distal side of the microvalve;
• then
• c) expanding the microvalve into the expanded configuration across the vein to block flow within the vein in a distal to proximal direction past the microvalve;
• and
• d) injecting the therapeutic agent at a first pressure below 300 psi to exit distal of the microvalve and into the vein to cause the therapeutic agent to flow through the vein at a pressure higher than the systemic venous pressure and into the target organ, the therapeutic agent comprising one or more of a biologic cell, a checkpoint inhibitor, and an oncolytic virus.

A method for delivering a therapeutic agent under pressure to a target organ for treatment of a solid tumor in the target organ, the target organ in fluid communication with one or more vessels in a patient, the method comprising:

• a) introducing a treatment system into a vessel of the patient in fluid communication with the target organ, the treatment system comprising a microvalve comprising a filamentary braid coated with a polymeric filter comprising pores, the microvalve having shape memory to an expanded configuration adapted to extend across the vessel;
• b) advancing the microvalve into the vessel, wherein the vessel is subject to a systemic venous pressure on a distal side of the microvalve;
• then
• c) expanding the microvalve across the vessel to block flow within the vessel in a distal to proximal direction past the microvalve;
• d) injecting the therapeutic agent at a first pressure below 300 psi to exit distal of the microvalve and into the vessel to cause the therapeutic agent to flow through the vessel at a pressure higher than the systemic venous pressure and into the target organ, the therapeutic agent comprising a biologic agent selected from the group consisting of one of CAR-T cells, CAR-NK cells, TCR-R cells, TCR-NK cells, β-cells, and a combination of two or more of the cells;
• and
• e) injecting a bolus of a second fluid different than the therapeutic agent at a second pressure at or above 300 psi, the second fluid entering the vessel and forcing the therapeutic agent to flow deeper through the vessel to therapeutically treat the solid tumor in the target organ with the therapeutic agent.

A method for delivering a therapeutic agent under pressure to a target organ for treatment of a solid tumor in the target organ, the target organ in fluid communication with one or more vessels in a patient, the method comprising:

• a) introducing a treatment system into a vessel of the patient in fluid communication with the target organ, the treatment system comprising a microvalve comprising a filamentary braid coated with a polymeric filter comprising pores, the microvalve having shape memory to an expanded configuration adapted to extend across the vessel;
• b) advancing the microvalve into the vessel, wherein the vessel is subject to a systemic venous pressure on a distal side of the microvalve;
• then
• c) expanding the microvalve across the vessel to block flow within the vessel in a distal to proximal direction past the microvalve;
• d) injecting the therapeutic agent at a first pressure below 300 psi to exit distal of the microvalve and into the vessel to cause the therapeutic agent to flow through the vessel at a pressure higher than the systemic venous pressure and into the target organ, the therapeutic agent comprising one or more of a biologic cell, a checkpoint inhibitor, and an oncolytic virus;
• and
• e) injecting a bolus of a second fluid different than the therapeutic agent at a second pressure at or above 300 psi, the second fluid entering the vessel and forcing the therapeutic agent to flow deeper through the vessel to therapeutically treat the solid tumor in the target organ with the therapeutic agent.