System architecture: a compact, pulsatile artificial heart

The current development architecture combines a pulsatile chamber for the systemic circulation with a smaller pulse chamber and a continuous-flow pump for the pulmonary circulation. What is new is the combination as an overall system. Dimensions and values are under development and are given here only as a direction.

Non-clinical / benchtop research. Not an approved medical device.

Principle drawing of the current development architecture. Not to scale, not finished hardware.

Where development is heading — each with a status

None of these points is validated yet.

TopicDirectionStatus
Output rangefrom rest to physical exertion, with reserveDesign target
Systemic pressurereserve for exertion peaks, pressure only when neededDesign target
Pulmonary pressurelow pressure, limited and controlledDesign target
Size and shapeoriented on the human heart; fits the pericardium of the large majority of adultsDesign target
Paediatric variantsmaller model with lower outputPlanned
Membraneseveral hundred million load cyclesDesign target
Implantabilitybattery, electronics and energy transfer outside the pericardiumCurrent architecture

Chamber for the systemic circulation

The systemic chamber provides the pulsatile output into the systemic circulation. The membrane keeps blood space and drive separate; no shaft or piston seal through the blood space is planned. Volume and geometry are studied in variants.

Drive research is described on the Drive page; the membrane is the subject of membrane research.

Pulmonary support: pulse chamber plus continuous flow

The pulmonary circulation works at much lower pressure. Two elements therefore share the task:

  • Pulse chamber — maintains a pulsatile share in the pulmonary circulation.
  • Continuous-flow pump — provides the base flow at low pressure; it runs permanently and is controlled.

Different size ratios of the chambers are being studied. Which pulsatile share is useful remains an open research question — see open research questions.

Valves

Each chamber needs an inlet and an outlet — at least four valve functions in the two-chamber model. Biological and mechanical valves have been discussed as options; no specific valve platform has been selected yet. Reusing the patient's own valves is not a fixed design feature.

Materials under investigation

ComponentCandidatesStatus
Housing, highly loaded structuresTi-6Al-4VUnder investigation
Technical and insulating partsPEEKUnder investigation
Membrane / elastomerPU, PCU, BPU, silicone, EPDM — as a multilayer membraneUnder investigation
Housing wallthin-walled titanium, locally reinforced at load paths and connection zonesUnder investigation

Energy supply

Battery, charging electronics and control are implanted outside the pericardium — space there is tight, a few centimetres of cable are not critical.

ComponentConceptStatus
Energy transfertranscutaneous (TET), designed redundantlyUnder investigation
Energy storageimplanted battery with reserveUnder investigation
Emergency powerseparate connectionUnder investigation
Power demandbeing recalculated for the current architectureOpen

Sensing and control

Pressure and flow signals at several points are meant to adapt output, filling and pulmonary base flow to demand:

  • Pressure: venous return, pulmonary circulation before and after the pump, chambers, systemic circulation
  • Flow: venous return, pulmonary circulation, systemic circulation

The flows of both circulations are balanced against each other over several beats instead of reacting to every single beat. How sensor contradictions are to be detected is described under Safety & redundancy.