Seeking laboratory access for the next validation stage.

Three modules are manufactured and a circulatory bench loop is built and running. The next step requires an environment that cannot be built privately — and partners who work with blood, circulation and measurement.

SINCE 2017BENCH LOOP RUNNING15.6 L/MIN
Circulatory bench loop in operation. Displayed load point: 15.2 l/min at 208/92 mmHg.

Project status

Three modules exist as manufactured hardware: the pulsatile membrane chamber for the systemic circuit, the microaxial pump for the pulmonary circuit, and the pulse chamber. They were produced additively, from standard components and by hand.

A circulatory bench loop is built and in operation. It has circulated fluid at blood-like viscosity.

The sensing system is built and in operation: flow, pressure and oxygenation, on both sides and before and after each inlet, plus preload and afterload. It is the prerequisite for balancing the systemic and pulmonary circuits against each other.

Energy storage, battery management and inductive charging exist as concept and design work, not as hardware.

Six to fifteen design revisions have been produced since 2017. The work is done alongside employment, at 15 to 30 hours per week.

In earlier phases, the concept was discussed with Prof. Dr. Christoph Bode, former Medical Director of the Department of Cardiology and Angiology at Freiburg University Medical Center.

Design and control range

Both chambers run on a single drive, so their volume ratio is fixed by geometry. Control acts through stroke, rate and the continuously variable pump.

QuantityValue
Systemic chamber, maximum output130 ml
Pulse chamber, pulmonary circuit30 ml
Continuous pump, pulmonary circuit0–12 l/min, continuously variable
Beat rate40–150 /min
System output at full stroke15.6 l/min at 120 /min
System output at reduced strokeup to 16.5 l/min at 150 /min
Turndown ratiobetter than 10 : 1

The systemic and pulmonary circuits are in series and must deliver the same volume. Because the chambers are coupled, the required continuous-pump flow follows directly from stroke minus pulse-chamber volume, times rate. At full stroke the continuous pump reaches its ceiling at 120 beats — that is the design point.

Daily activity and light running are covered. Competitive sport lies deliberately outside the design envelope.

What is measured — and what is not

This distinction is deliberate and applied consistently. Every figure in the technical dossier is a design target, not a validated measurement.

QuantityStatus
Pressuremeasured on the bench
Temperaturemeasured on the bench
Runtime and endurancemeasured on the bench
Volumetric flowderived by calculation — not measured
Mean arterial pressurecalculated from systolic and diastolic
Operation at blood-like viscosityachieved, with model fluid
Haemolysis and blood compatibilityopen — no blood testing performed
Flow simulation (CFD)not performed
Structural simulation (FEA)not performed
Standards-compliant testingopen
Pressure trace at rest: systolic 109–125, diastolic 72–84 mmHg, 64–79 beats per minute. Stroke volume is adjustable; this is a part-load point.
Ten consecutive measurements, spread 6 mmHg. Pressure measured directly; mean arterial pressure calculated by the standard formula.

Why pulsatile

Current support systems mostly use rotary pumps at 20,000 to 50,000 revolutions per minute. Reduced pulsatility there is associated with acquired von Willebrand syndrome, bleeding from arteriovenous malformations and aortic insufficiency; the cause is destruction of high-molecular-weight von Willebrand multimers by shear.

This displacement pump operates at roughly 2 Hz — four orders of magnitude fewer cycles and correspondingly lower shear. That is a design rationale, not a claim of efficacy.

Pulsatility also matters demonstrably for the pulmonary circuit: in the Fontan and Glenn circulation, where the lung is perfused without pulsation, impaired endothelial function, reduced nitric oxide availability and rising pulmonary vascular resistance are documented.

Manufactured pump housing, shown for scale. The final form factor of the pulmonary pump is not fixed — three variants are under consideration.

What is being sought

The next development step is a measurement series using animal blood: behaviour under real viscosity and cellular loading rather than model fluid. Laboratory access and a measurement environment are what is missing.

  • Access to a circulatory test bench or perfusion laboratory
  • The ability to work with animal blood — anticoagulation, cold chain, proper disposal
  • Time-resolved flow measurement, so that pressure and flow can be evaluated together
  • Specialist guidance on haemocompatibility and flow measurement
  • In due course: flow simulation and standards-compliant testing

With access in place, six to eighteen months to meaningful data is a realistic horizon.

Three open questions to work on

All three are bounded, workable on the existing bench, and not conclusively answered in the literature.

  1. At what ejection profile does a 30 ml stroke deliver maximum surplus hemodynamic energy without raising mean pulmonary arterial pressure above 20 mmHg? The pulmonary circuit leaves only a few mmHg of headroom before benefit turns into harm.
  2. At what stroke volume does pulmonary pulsatility become physiologically effective? No threshold is defined in the literature. Pulsatile cardiopulmonary bypass, at roughly 5,000 ergs/cm³ at the patient, serves as the reference figure.
  3. What ramp limit keeps the output control loop outside the baroreflex time constant without delaying demand response? Pump and body are two controllers acting on the same plant; overlapping time constants lead to hunting.

Who this is addressed to

Academic chairs

Medical engineering, fluid mechanics or cardiovascular technology — with an existing circulatory test bench.

Doctoral researchers

Anyone looking for a bounded, practically workable question for their own research.

Perfusion and cardiovascular technology

Practitioners with daily experience of extracorporeal circulation, pumps and blood.

Manufacturers

Medical device companies with their own development and testing infrastructure.

What the project brings

Eight years of prior work. Design, dimensioning, manufactured modules, installed sensing and a running bench loop. A partner does not start from zero, but at a point where the mechanics demonstrably operate.

Co-authorship. Results from joint work are published jointly.

Free use of results. The project pursues no commercial interest. The aim is technology that reaches people — not a protected portfolio.

Open points, stated explicitly

What is missing is listed here so that nobody has to ask for it:

  • No flow or structural simulation has been performed
  • No work to ISO 14971, IEC 60601 or ISO 5840 so far
  • Volumetric flow is calculated and unvalidated
  • No time-resolved flow measurement, and therefore no energy-based assessment of pulsatility
  • No blood testing, no haemolysis data
  • Form factor of the pulmonary pump not fixed
  • Energy storage, battery management and inductive charging exist on paper only
  • No institutional affiliation, no third-party funding

Contact

For technical enquiries, a direct message to info@kanzlerbiologicals.com is sufficient. The contact form is available for everything else.

Responses that contradict the project are equally welcome. A well-founded objection is worth more than agreement.