Therapeutic agent delivery system with delayed activation
Systems with 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 . A system for infusing a therapeutic agent through a primary vessel and into a feeder vessel in a target organ of a patient, comprising:
a) a catheter comprising a proximal end, distal end, an inner lumen extending between the proximal and distal ends, and an exterior surface;
b) an expandable vessel occluder coupled to a distal portion of the exterior surface, the occluder movable between an expanded configuration adapted to block reflux of the therapeutic agent in the primary vessel or the feeder vessel, and a collapsed configuration having a diameter smaller than a diameter of the expanded configuration;
c) a pressure detecting element positioned proximal of the expandable vessel occluder and in fluid communication with the distal end of the catheter through the inner lumen when the expandable vessel occluder is in the expanded configuration, the pressure detecting element configured to continuously sense a vessel pressure distal of the occluder;
d) an infusion system configured to infuse the therapeutic agent through the inner lumen of the catheter and into the feeder vessel at a rate of infusion, wherein the rate of infusion is dynamically adjusted based on the vessel pressure detected by the pressure detecting element to maintain an intended pressure value during infusion; and
e) a timing system operably connected to the infusion system, and configured to determine whether a change in pressure correlated to a cycle of a heart rate of the patient has been detected in the pressure sensed by the pressure detecting element, and to delay activation of the infusion system by a set time offset to a time in the cycle of the heart rate that increases pressure differential in the target organ during infusion when the change in pressure is detected.
2 . The system according to claim 1 , wherein the timing system is coupled to the infusion system.
3 . The system according to claim 1 , wherein the timing system is wirelessly connected to the infusion system.
4 . The system according to claim 1 , wherein the expandable vessel occluder is a dynamic occluder adapted to expand and collapse in response to relative fluid pressures proximal and distal of the dynamic occluder.
5 . The system according to claim 4 , comprising an additional expandable vessel occluder, wherein the additional expandable vessel occluder is a static occluder.
6 . The system according to claim 1 , further comprising an implantable injection port located at the proximal end of the catheter, the implantable injection port comprising a housing having a first chamber accessible through a first needle-pierceable septum, the first chamber in fluid communication with the inner lumen.
7 . The system according to claim 1 , wherein the rate of infusion is dynamically adjusted by a steady modification in the rate of infusion, a non-steady modification in the rate of infusion, or a pulsatile modification in the rate of infusion.
8 . The system of claim 1 , wherein the primary vessel is a portal vein or a splenic vein and the feeder vessel is a vein.
9 . The system of claim 8 , wherein the expandable vessel occluder is configured to block reflux of the therapeutic agent upon deployment of the expandable vessel occluder in the primary vessel.
10 . The system of claim 1 , wherein the pressure detecting element is coupled to the proximal end of the catheter.
11 . The system according to claim 1 , wherein the expandable vessel occluder is a static occluder.
12 . The system of claim 1 , wherein the timing system is configured to automatically activate infusion during a diastolic portion of the heart rate of the patient based on the vessel pressure sensed by the pressure detecting element.
13 . The system of claim 1 , wherein the pressure detecting element is positioned at the proximal end of the catheter.
14 . A system for infusing a therapeutic agent through a primary vessel and into a feeder vessel in a target organ of a patient, comprising:
a) a catheter comprising a proximal end, distal end, an inner lumen extending between the proximal and distal ends, and an exterior surface;
b) an expandable vessel occluder coupled to a distal portion of the exterior surface, the occluder movable between an expanded configuration adapted to block reflux of the therapeutic agent in the primary vessel or the feeder vessel, and a collapsed configuration having a diameter smaller than a diameter of the expanded configuration;
c) a sensor system configured to continuously monitor vital signs of the patient correlating to a pulse of the patient;
d) an infusion system configured to infuse the therapeutic agent through the inner lumen of the catheter and into the feeder vessel; and
e) a timing system operably connected to the sensor system and the infusion system, the timing system configured to determine whether a timing condition within the pulse of the patient is detected in the vital signs monitored by the sensor system, and to delay activation of the infusion system by a set time offset that increases pressure differential in the target organ during infusion when the timing condition is detected.
15 . The system according to claim 14 , wherein the timing system is coupled to the sensor system.
16 . The system according to claim 14 , wherein the timing system is wirelessly connected to the sensor system.
17 . The system according to claim 14 , wherein the sensor system comprises a pulse-oximeter.
18 . The system according to claim 14 , wherein the sensor system comprises an EKG system.
19 . The system according to claim 14 , wherein the infusion system is adapted to modulate a rate at which the infusion system infuses the therapeutic agent.
20 . The system of claim 14 , wherein the primary vessel is a portal vein or a splenic vein and the feeder vessel is a vein.
21 . The system of claim 20 , wherein the expandable vessel occluder is configured to block reflux of the therapeutic agent upon deployment of the expandable vessel occluder in the primary vessel.
22 . The system of claim 14 , wherein the system is configured to automatically activate infusion during a diastolic portion of the pulse of the patient detected by the sensor system.