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Publication Number
US-8329450-B2
Publication Date
2012-12-11
Expiration Date
Abstract
An organ support apparatus includes: (a) a fluid circuit defining upstream and downstream legs adapted to be connected to an organ to be supported; (b) a circulation pump connected to the fluid circuit for circulating a process fluid through the fluid circuit and the organ; and (c) a first waveform generator connected to the fluid circuit for impressing a preselected pressure waveform on the process fluid.
Core Innovation
The invention describes an organ support apparatus as a cardiovascular emulator that includes a fluid circuit defining upstream and downstream legs adapted to be connected to an organ to be supported. A circulation pump is connected to the fluid circuit and is configured to circulate a process fluid in sequence through the upstream leg, the organ, and the downstream leg.
The apparatus includes a first waveform generator disposed in the upstream leg for impressing a preselected first pressure waveform on the process fluid before it is delivered to the organ. The first waveform generator comprises a first diaphragm-type pressure regulator and a first reference pressure source connected to the pressure regulator.
The apparatus also includes a second waveform generator connected in the downstream leg for impressing a preselected second pressure waveform on the downstream pressure applied to the organ. The second waveform generator comprises a second diaphragm-type pressure regulator and a second reference pressure source connected to the second pressure regulator.
The system is described as imposing preselected pressure waveforms using diaphragm-type pressure regulators and electropneumatic transducers driven by programmable controllers, with sensor array feedback and central controller feedback control using systolic and diastolic pressure set points. Additional components are described in embodiments to address process fluid conditioning and integrity, including bubble trap, oxygenator, heat exchanger, perfusate metering array, and a biological filter.
Claims Coverage
The independent claim recites 2 waveform-generation inventive features: upstream waveform shaping before the organ and downstream waveform shaping applied to the organ, each implemented with diaphragm-type pressure regulators and reference pressure sources. In the dependent claims referenced, additional inventive features refine the pressure-reference architecture with electropneumatic transducers and programmable electronic controllers and add further fluid conditioning, sensing/control, and optional stimulation functionality.
Upstream pressure waveform generation for process fluid delivery
A first waveform generator disposed in the upstream leg imposes a preselected first pressure waveform on the process fluid before it is delivered to the organ, wherein the first waveform generator comprises a first diaphragm-type pressure regulator and a first reference pressure source connected to the pressure regulator.
Downstream pressure waveform generation applied to organ
A second waveform generator connected in the downstream leg impresses a preselected second pressure waveform on the downstream pressure applied to the organ, wherein the second waveform generator comprises a second diaphragm-type pressure regulator and a second reference pressure source connected to the second pressure regulator.
Electropneumatic reference pressure control with programmable electronic controller
The first reference pressure source includes a first electropneumatic transducer and an electronic controller that sends a signal representing a preselected waveform to the transducer.
Foreign-material removal using a filter
The organ support apparatus includes a fluid circuit with at least one filter that removes foreign material from the process fluid.
Thermal conditioning using a heat exchanger
The organ support apparatus includes a fluid circuit with a heat exchanger that heats or cools the process fluid to a predetermined preselected temperature.
Closed-loop maintenance or dynamic adjustment using sensor-based control
The organ support apparatus further includes a centrally connected control unit that, based on sensor data, controls operating parameters to maintain or dynamically adjust a preselected condition of a process fluid.
Defined selection of organ preservation and physiological fluids
The process fluid is chosen from a defined list of aqueous organ preservative solution, whole blood, plasma, serum, oxygen-carrying molecules, crystalloid, non-crystalloid expanders, and combinations thereof.
Electrical stimulation of the organ with a preprogrammed pulse pattern
The organ support apparatus further includes an electrical stimulator that delivers a preprogrammed pattern of electrical pulses to the organ.
Across the independent claim and identified dependent refinements, the core claim coverage centers on generating preselected pressure waveforms both upstream and downstream using diaphragm-type pressure regulators with corresponding reference pressure sources, with optional electropneumatic transducer and electronic controller signaling. Additional dependent features include filtration, heat exchange to a preselected temperature, sensor-driven closed-loop control to maintain or adjust a preselected fluid condition, selecting process fluid from an enumerated set, and optional electrical stimulation.
Stated Advantages
Reduced capillary overpressurization.
Improved organ preservation and improved organ preservation/shelf life.
Documented Applications
Kidney flushing/transitioning of process fluid compositions.
Organ storage/transport outside the body.
In-body organ isolation during chemotherapy.
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