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AIRCHILL · Product concept

Development-stage · no CE mark · no FDA clearance · not for patient use

Last reviewed 18 August 2026 · Trust Center / change history

One device. Ventilation and controlled cooling.

AIRCHILL is being developed as a transport ventilator with controlled respiratory cooling for structured emergency-care workflows. The current stage is product and clinical validation: measured mechanism and preclinical safety data support the next programme, which is designed to establish patient performance and safety and then test and size clinical benefit. Regulatory approval and outcome claims follow that evidence programme.

Discuss a collaborationEvidence status
University Medical Center Hamburg-EppendorfBMBF Go-Bio 031A530Therapeutic Hypothermia and Temperature ManagementISMRM 2016 · Magna cum laude

The device

The platform as it is designed — and what of it exists.

The rendering shows the AIRCHILL platform concept: a transport ventilator with controlled respiratory cooling, patient monitoring, and a detachable handheld control unit. It is a design study. The first regulatory product is not planned as a hardware-starved or throw-away MVP. The strategy is a minimum certifiable configuration (MCC): make the hardware platform as complete as rationally possible where mature purchased or OEM modules can be integrated without disproportionate regulatory burden, while deliberately keeping the first intended purpose and claim set focused. The demonstrator further down is what physically exists today.

AIRCHILL design concept

Design concept · rendering 2019 · not an approved product

The platform architecture is intended to be as complete as rationally possible from the first certifiable generation. AIRCHILL’s proprietary engineering novelty is concentrated in controlled respiratory cooling, the gas path, control logic and safe system integration. Most additional hardware is not intended to be developed as a new AIRCHILL subsystem. Monitoring, suction, ECG/defibrillation and telemedicine are planned primarily around established purchased components, OEM modules or standard interfaces. That makes a deliberately hardware-starved MVP less attractive: omitting mature components can save less than expected while still forcing a later integration and change-control programme. The main scope reduction therefore comes from avoiding unnecessary proprietary subsystem R&D and focusing the first intended purpose and clinical claims. Every included purchased subsystem still requires supplier qualification, interface engineering, electrical/software compatibility, risk management and system-level verification; functions that materially change classification or evidence requirements remain explicit regulatory gates.

  • In the MCCTransport ventilation with controlled respiratory cooling, including the safety-critical gas path, sensing, alarms and operator control required for the intended use.
  • Detachable unitHandheld control and monitoring at the patient, so the stack does not have to be reached over during a resuscitation.
  • Purchased / OEM modulesSuction, patient monitoring, ECG, defibrillation and telemedicine are planned primarily through established purchased components, OEM modules or standard interfaces. They are not the core proprietary hardware development, but any integrated function still has to meet system-level interface, risk and verification requirements.
  • StatusNo design freeze, no CE marking, not approved for patient use.

Rendering of the design concept, created in 2019; it illustrates the intended platform, not the current build state. No performance, safety or outcome claim is derived from it. Technology readiness of the physical demonstrator is conservatively rated at TRL ≈ 4.

Mechanism

Four controlled steps between the gas source and the patient.

The V1 media architecture is now defined: liquid oxygen is the sole media source. It is vaporized for ventilation and thermally conditioned through a gas-tight ambient heat exchanger to the target inspiratory temperature. The remaining engineering problem is control: temperature, flow, FiO₂, humidity, pressure, oxygen compatibility and airway integrity must all hold at once.

01 · SourceLiquid oxygenA cryogenic, oxygen-carrying source. Liquid oxygen boils at −183 °C, so the cold is already in the gas the patient needs anyway.
02 · ControlVaporization & heat exchangeLiquid oxygen is vaporized for ventilation and thermally conditioned through a gas-tight ambient heat exchanger. No second process medium is required in the V1 media path; temperature, flow, FiO₂, humidity and pressure still have to hold at once.
03 · DeliverySet inspiratory temperatureThe gas reaches the patient at the set temperature. In our own experiments this went down to −20 °C, endotracheally over six hours and endonasally in volunteers.
04 · EffectHeat leaves through the airwayHeat is drawn from airway, lung and perfusion. How much of it reaches the brain is the part we measured and bounded — see the figures below.
Laboratory demonstrator
Laboratory demonstrator

The demonstrator used in the preclinical experiments. Technology readiness is conservatively rated at TRL ≈ 4. The V1 media architecture is defined as a liquid-oxygen single-media path; detailed mechanical, control and manufacturable product implementation remains under development.

Own photograph. TRL classified per the EU definition, Horizon Europe Annex G.

Thermal imaging during delivery
Thermal imaging during delivery

Infrared thermography at the start of cold air delivery and 23 minutes in. Surface temperature drops visibly; quantification gave roughly 0.3 °C per minute under endonasal delivery.

Final report, BMBF grant 031A530, University Medical Center Hamburg-Eppendorf, 2017.

The gas path

Temperature is the axis, not a label.

The same four steps, drawn as what they are: a controlled temperature profile from a cryogenic source to the patient. The rise inside the airway at the right of the chart is the heat that leaves the patient.

The gas path, from cryogenic source to patientTemperature of the breathing gas along its path through the device. It leaves the liquid-oxygen source at minus 183 degrees Celsius, is warmed and mixed under control to a set inspiratory temperature of minus 20 degrees Celsius, and then warms to body temperature inside the airway. That last rise is the heat taken out of the patient. The horizontal axis is position along the gas path, not time.+370−20−100−183°C−183°Cboiling point of O₂−20°Cmeasured, own experiments+37°Cbody temperatureheat taken from the patient01 · SOURCELiquid oxygencryogenic, oxygen-carrying02 · CONTROLVaporization & heat exchangethe engineering problem03 · DELIVERYSet inspiratory temp.reached in our experiments04 · EFFECTHeat leaves the airwaythe gas warms to body temp.Horizontal: position along the gas path — not a time axis.

Swipe the chart sideways to follow the gas path →

The gas path, from cryogenic source to patient. −183 °C is the boiling point of oxygen. −20 °C is the lowest gas temperature delivered in our own experiments — endotracheally over six hours in pigs and endonasally for up to ten minutes in eleven healthy volunteers (final report, BMBF grant 031A530, Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, 28 March 2017). The rise from the set temperature to body temperature inside the airway is the heat that leaves the patient; the shaded area shows where that happens and does not quantify it. The temperature axis is linear.Own primary source

Airway safety

What six hours of cold gas did to the lung.

Nothing measurable. That is the finding, and it is the one a notified body asks for first.

Intraprocedural CT of the thorax after cold air ventilation showing normal bronchial calibre and no pulmonary oedema.
The lung after six hours of cold gas. Intraprocedural CT of the thorax after cold air ventilation: normal bronchial calibre, no pulmonary oedema. Airway tolerance is the first thing a notified body will ask about, so it is the first thing we measured.Final report, BMBF grant 031A530, University Medical Center Hamburg-Eppendorf, 2017. Endotracheal, −20 °C, six hours.Own primary source
MR perfusion measurement of the lung before and after cooled endonasal ventilation.
Perfusion, before and after. MR perfusion of the lung before and after cooled ventilation: no relevant change. Together with intact histology and stable cardiorespiratory parameters, this is the safety base the first clinical gate builds on.Final report, BMBF grant 031A530, University Medical Center Hamburg-Eppendorf, 2017.Own primary source

The circuit

The breathing circuit, drawn as a system.

A schematic rather than an anatomical section — this is the drawing a developer and a notified body actually read, and it is where the open-loop decision becomes visible.

The breathing circuit, drawn as a systemA schematic of the breathing circuit. Liquid oxygen at minus 183 degrees Celsius enters a controlled warming and mixing stage, which sets the inspiratory temperature to minus 20 degrees Celsius. The cold inspiratory limb runs to the patient interface; the expiratory limb returns gas at body temperature, and the difference is the heat removed. Sensors for temperature, flow, oxygen fraction, humidity and pressure report to a controller that the operator sets. The loop is deliberately open: the device does not steer therapy from a patient temperature, which would make it class three under MDR rule 22.Liquid oxygen−183 °CVaporization & heat exchangecontrolledInspiratory limb−20 °CPatient interfacetube or maskExpiratory limb · +37 °CThe difference between the two limbs is the heat removed.WHAT THE CONTROLLER HOLDSTemperature · flow · FiO₂ · humidity · pressure, simultaneously.That is the engineering problem — the cold itself is not.OPEN LOOP, ON PURPOSEThe device does not steer therapy from apatient temperature. That would be class III.

Swipe the schematic sideways →

The breathing circuit, drawn as a system. A schematic, not an anatomical section — this is the drawing a developer and a notified body actually read. Temperatures as in the gas-path chart: −183 °C at the source (boiling point of oxygen), −20 °C delivered in our own experiments, body temperature on the way out. The open loop is a design decision, not a limitation: a device that measures a patient temperature and steers therapy from it is a closed-loop system and class III under MDR Annex VIII rule 22. Automatic control stays a separate, later submission.Design concept · TRL ≈ 4

First certifiable configuration

A broad hardware platform with a deliberately focused first claim set.

The first approval programme is designed around hardware completeness where integration relies on mature purchased or OEM technology, while regulatory ambition stays focused. The minimum certifiable configuration (MCC) keeps proprietary development concentrated on ventilation, controlled cooling and safe system integration. Additional mature hardware can be designed into—and, where classification and verification burden remain proportionate, included in—the first certifiable platform. The primary scope lever is the first intended purpose and claim set, not an artificially incomplete hardware build.

Core configuration

Minimum certifiable configuration (MCC)

Transport ventilation with controlled respiratory cooling · complete safety-critical gas path · temperature, flow, FiO₂, humidity and pressure control · sensors, alarms, operator controls, cleaning and service concept · the verification package needed for the intended use.

Purchased / OEM hardware

Platform functions beyond the proprietary core

Monitoring, suction, ECG/defibrillation and telemedicine are expected primarily to use established purchased components, OEM modules or standard interfaces. That can avoid duplicating mature subsystem R&D; the remaining work is supplier qualification, interface definition, risk management and verification of the integrated AIRCHILL system.

Clinical workflow

Designed for gated adoption, not for a shortcut.

Any clinical workflow needs inclusion criteria, airway-management rules, monitoring, stop criteria and training. Those belong in protocol, usability and risk-management work before routine use.

Before use

Eligibility and setup

Protocol-defined selection, device checks, trained operators.

During use

Ventilation and monitoring

Controlled intervention with respiratory, temperature and safety monitoring.

After use

Handover and follow-up

Documented transition into the receiving hospital’s temperature-control pathway.

Differentiation

How AIRCHILL’s engineering path differs from earlier selective-cooling systems.

What is defensible

Integration, safety data, timing

Cooling that runs on the ventilation already in place rather than as a second device. Preclinical airway safety for the endotracheal route is documented over six hours at −20 °C. RhinoChill works with perfluorohexane; our route does not.

Next engineering proof point

Make lower-airway cooling measurably stronger and more uniform

The 2017 setup showed low, locally limited endotracheal cooling because of dead-space ventilation while the endonasal route produced a stronger local effect. That result defines a concrete optimisation target: flow, inspiratory temperature, circuit geometry, humidity/condensation and treatment timing. The next programme is designed to quantify whether a redesigned lower-airway system can create a larger, reproducible target-organ thermal effect while preserving ventilation and airway safety.

RhinoChill has carried a CE mark for commercial use, class IIb, since April 2011 (NICE MIB4). PRINCESS (Nordberg P et al., JAMA 2019;321:1677–1685, n = 677) missed its primary endpoint of good neurological outcome at 90 days. No CE-marked device was found that cools through the lower airway in combination with ventilation; the absence of a find is not proof, and EUDAMED and freedom-to-operate searches are outstanding.

Granted intellectual property

One patent family, granted in Europe and the United States.

The core idea — a transportable device that lowers body temperature through the airway with a cooled, oxygen-carrying gas flow — is protected by granted rights in Europe and the United States from a September 2016 priority. The public patent records are linked below. Inventor Fabian Temme is the sole patent holder; the university is not a co-owner of the patents.

EP3509683B1

Transportable device and system for lowering the body temperature of a mammal over the airways, in particular of a human, by means of a cooled, oxygen-containing gas flow

  • StatusGranted
  • Grant date24 January 2024
  • ApplicationEP17790957.9
  • A1 publication17 July 2019
  • OfficeEuropean Patent Office
US11395900B2

Transportable device, system and method for providing a cooled, oxygen-containing gas flow

  • StatusGranted
  • Grant date26 July 2022
  • ApplicationUS 16/331,782
  • A1 publicationUS2020/0164173A1
  • OfficeUSPTO
2016Priority application LU93200, 9 September
2017PCT/EP2017/001065 filed, 9 September
2018Published as WO2018046128A1
2022US patent granted
2024European patent granted
Clear founder-controlled ownership

The granted rights are held solely by inventor Fabian Temme. The university is not part of the patent ownership structure, so there is no institutional co-owner. This creates a concentrated chain of title and a direct path for any future corporate assignment or exclusive licence to the operating company.

Checked against the public patent registers on 8 August 2026. Inventor and sole patent holder: Fabian Temme. The university is not a co-owner of the granted patent rights; the ownership structure is concentrated with the founder. Records: EP3509683B1 · US11395900B2 · WO2018046128A1. Term runs to 9 September 2037 subject to fees and legal validity. Validation states, annuity payments, opposition status and the scope of the granted claims against the planned product have not been assessed.

Validation pathway

From development platform to clinical validation.

The next programme is designed to progress AIRCHILL from TRL ≈ 4 through product verification, first-in-patient performance and safety, and indication-specific efficacy studies. CE marking, FDA clearance and clinical claims remain development milestones until the required evidence and regulatory review are complete.

Regulatory pathwayEvidence status

Ventilation, thermal systems, verification.

If you build emergency ventilators, thermal systems or airway consumables, we would like to talk.

Contact Medical Cooling