Engineering notes
SOLO-1 Organ Cradle
SOLO-1 Organ Cradle is Bunker Longevity’s investigational machine-perfusion platform in preclinical development. The first generation is a console for hypothermic machine perfusion of donor kidneys, using cold acellular perfusate, with no active oxygenation at launch. It is designed for transport.
Gen 1: sterile single-use cassette for donor kidneys. Hypothermic machine perfusion at launch, with hardware designed to accept an oxygenated (HOPE) mode later.
SOLO-1 has not been cleared or approved by the U.S. Food and Drug Administration or any other regulatory authority. It is not available for sale and is not in use with patients or donor organs. Drawings on this page are conceptual.
What it does
The cradle is meant to preserve a donor kidney between donor and recipient. Generation 1 is being designed to circulate a cold acellular preservation solution through the organ. That solution is not blood.
The approach builds on hypothermic machine perfusion studied by other groups. Moers and colleagues (2009) compared that method with static cold storage in deceased-donor kidneys. The evidence notes summarize the trials we cite. Those trials did not test SOLO-1. Nothing here is a claim that SOLO-1 improves graft survival, reduces complications, or matches any published result.
Published labeling for Belzer MPS, a cold acellular machine-perfusion solution used in kidney hypothermic perfusion, specifies an intended range of 4–8 °C (Belzer MPS instructions for use). That figure is the solution’s labeling, not a SOLO-1 measurement.
Architecture
A reusable console holds a sterile single-use organ cassette. The Generation 1 cassette is for a donor kidney. Liver is a later generation.
- Gen 1: sterile single-use cassette for donor kidneys. Hypothermic machine perfusion at launch, with hardware designed to accept an oxygenated (HOPE) mode later.
- Continuous pressure, flow, and temperature monitoring, with sensor provisions for oxygen in a future oxygenated mode.
- Alarms for conditions such as bubbles in the circuit and a blocked line.
- Redundant power with automatic switchover, and a defined safe state that holds the organ in passive cold storage if perfusion stops.
Fluid path
The figure is a block diagram of the Generation 1 hypothermic path: cold reservoir, pump, bubble trap and filter, pressure, flow, and temperature sensing, then the kidney in a cold basin, and back to the reservoir. The oxygenator is dashed because an oxygenated mode is not active at launch.
- Cold reservoir
- Pump
- Bubble trap / filter
- Pressure, flow, and temperature sensing
- Kidney in cold basin
Return to the cold reservoir.
Conceptual — not tested hardware. The drawing is not a tubing, valve, or cannula layout, and it is not tested hardware.
Sensing and control
Continuous pressure, flow, and temperature monitoring, with sensor provisions for oxygen in a future oxygenated mode.
- Pressure is limited to protect vessels.
- Flow and resistance are trends clinicians can review.
- Temperature is kept cold, and never freezing.
- Alarms cover bubbles and occlusion, when the line is blocked.
Sensor provisions are reserved for oxygen in a future oxygenated mode. That sensing is not a launch function. These signals are trends clinicians can review. SOLO-1 is not claimed to predict graft viability or transplant outcomes.
Electrical and power
SOLO-1 is being designed to keep perfusing through power interruptions. The console accepts wall power, an internal battery, and vehicle power, and switches between them automatically. If all power is lost or a critical fault occurs, the system is designed to stop perfusion in a controlled way and hold the organ in a passive cold state, the same static cold storage used in clinical practice today, while logging the event. The electrical design is being developed with IEC 60601-1 medical electrical safety requirements in mind. SOLO-1 is preclinical, has not been tested in clinical use, and is not cleared or approved by the FDA.
Data and records
Designed to keep a tamper-evident record of every event, preserved through power loss.
The record is meant to show if it has been altered, and to remain after power is lost. It is a log of events during a run, including the moment perfusion stops and cold storage begins.
Roadmap
Generation 1 is hypothermic machine perfusion of donor kidneys. The hardware is being designed to accept an oxygenated (HOPE) mode later. That mode is not active at launch. Liver is a later generation, as are other organs. van Rijn and colleagues (2021) studied hypothermic oxygenated perfusion in livers donated after circulatory death. That trial did not test SOLO-1.
Later generations are intended to explore normothermic perfusion, viability assessment, and heart and lung cassettes. Nasralla and colleagues (2018) studied normothermic preservation in liver transplantation. That trial did not test SOLO-1, and normothermic perfusion is not Generation 1.
Whole-body preservation and cryopreservation are long-term research goals on a separate horizon. They are not functions of SOLO-1. They depend on advances that have not been demonstrated in human organs, let alone a whole body, and may not be achieved. Han and colleagues (2023) reported vitrification and nanowarming in a rat kidney model, not in human organs. Bunker Longevity makes no claim that a person, or a whole body, can be preserved and later restored to life.
Disclosures
- SOLO-1 is investigational and in preclinical development. It is not FDA-approved and not for clinical use.
- It is not for sale and not in use with patients or donor organs.
- Illustrations, including the fluid-path diagram, are conceptual. They do not represent final or tested hardware.
- Published trials cited on this site are not studies of SOLO-1. This page states no clinical outcome for the device.
- No claim is made of whole-body restoration.
Contact
For research, clinical, or press enquiries, email [email protected].