Systems, devices, and methods for controllably and selectively occluding, restricting, and diverting flow within a patient's vasculature
Inventors
Quadri, Arshad • Ratz, J. Brent • Cooper, Alexander H. • Schwartz, Juliet Laura
Assignees
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Publication Number
US-11974751-B2
Publication Date
2024-05-07
Expiration Date
Abstract
Various systems, devices, components and methods are disclosed for controllably and selectively occluding, restricting, and/or diverting flow within a patient's vasculature. The flow restriction systems can include an implant having a flow restrictor and an implantable controller having an actuator for actuating the flow restrictor. The flow restriction systems can also include an external device for controlling operation of the implant via the implantable controller.
Core Innovation
The invention relates to a method of controllably and selectively occluding, restricting and/or diverting flow of a patient's vasculature by using a chronic implant positioned in the inferior vena cava upstream of renal veins. The implant includes an expandable body with a distal end and a proximal end and a flow restrictor extending distally of the distal end, positioned upstream of the expandable body in regard to a direction of blood flow in the inferior vena cava and configured to first receive blood flow as it enters the implant.
The method includes measuring an inferior vena cava pressure from the implant, transmitting the inferior vena cava pressure from an implantable controller positioned within the patient to an external device, executing an instruction to activate the implant, and activating the implant. Activating the implant causes the flow restrictor to at least partially occlude blood flow through the inferior vena cava.
The disclosed system supports multiple ways to actuate occlusion, including magnetic actuation using a magnet, fluidic actuation using an inflatable balloon with an implanted subcutaneous reservoir or an external port, mechanical actuation using hinged flow restrictor petals or an occluder, and heat/induction actuation using shape-changing wire/material closing flow. The system can include pressure sensors for measuring central and/or renal venous pressures and using sensor readings for closed-loop control.
Claims Coverage
Across the independent claims, 5 inventive features are identified. The core coverage centers on an implantable expandable-body device with a distally extending flow restrictor positioned upstream of the renal veins, an activation instruction executed on an implantable controller, and activation causing the flow restrictor to at least partially occlude inferior vena cava blood flow. One independent claim further requires measuring inferior vena cava pressure upstream of renal veins and transmitting that pressure to an external device.
Measuring inferior vena cava pressure upstream of renal veins with an implanted expandable-body device
Measuring an inferior vena cava pressure from an implant implanted in the inferior vena cava of the patient upstream of renal veins of the patient, the implant having an expandable body with a distal end and a proximal end and a flow restrictor extending distally of the distal end of the expandable body, the flow restrictor positioned upstream of the expandable body in regard to a direction of blood flow in the inferior vena cava and configured to first receive blood flow as it enters the implant.
Transmitting inferior vena cava pressure to an external device
Transmitting the inferior vena cava pressure from an implantable controller positioned within the patient to an external device.
Executing and activating an instruction to occlude inferior vena cava flow
Executing, by the implantable controller, an instruction to activate the implant; and activating the implant; wherein activating the implant causes the flow restrictor of the implant to at least partially occlude blood flow through the inferior vena cava.
Executing an activation instruction on an implantable controller for upstream inferior vena cava occlusion
Executing on an implantable controller positioned within the patient an instruction to activate an implant implanted in an inferior vena cava of the patient upstream of renal veins of the patient, the implant having an expandable body having a distal end and a proximal end and a flow restrictor extending distally of the distal end of the expandable body, the flow restrictor positioned upstream of the expandable body in regard to a direction of blood flow in the inferior vena cava and configured to first receive blood flow as it enters the implant.
Activating the implant to at least partially occlude inferior vena cava blood flow
Activating the implant; wherein activating the implant causes the flow restrictor of the implant to at least partially occlude blood flow through the inferior vena cava.
The claim coverage centers on an implantable expandable-body device with a distally extending flow restrictor positioned upstream of the renal veins, an activation instruction executed on an implantable controller, and activation causing the flow restrictor to at least partially occlude inferior vena cava blood flow. One independent claim further requires measuring inferior vena cava pressure upstream of renal veins and transmitting that pressure to an external device.
Stated Advantages
Reduce renal/central venous pressure as stated in the description.
Enhance renal circulation as stated in the description.
Promote/control diuresis as stated in the description.
Reduce cardiac preload as stated in the description.
Reduce renal congestion / promote renal decongestion as stated in the description.
The method is controllably and selectively occluding, restricting and/or diverting flow of a patient's vasculature.
Activating the implant to at least partially occlude blood flow through the inferior vena cava enhances renal circulation.
Activating the implant to at least partially occlude blood flow through the inferior vena cava enhances diuresis.
Activating the implant to partially occlude blood flow through the inferior vena cava thereby reducing renal venous pressure.
Documented Applications
Physiological treatment outcomes using controllably and selectively occluding inferior vena cava blood flow, including reducing renal/central venous pressure, reducing cardiac preload, enhancing renal circulation, and promoting/control diuresis.
Closed-loop, autonomous therapy guided by inferior vena cava pressure measurements and pressure thresholds, with manual, semi-automatic, and automatic therapy modes as described.
Chronic, implantable flow restriction/occlusion for heart failure by occluding/restricting/influencing vasculature flow, including inferior vena cava occlusion upstream of renal veins for renal congestion/diuresis effects.
Closed-loop control using pressure sensor readings including central/renal venous pressures.
System-level control architectures using wireless communication and external device integration for activation/deactivation.
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