Development path: from the first concept to the current architecture

Three development tracks in sequence: overall system, membrane and drives. Earlier architecture stages stay visible and are marked as such.

Overall artificial-heart system

Phase 1

First membrane-pump concepts Completed

Chamber, membrane and controllable stroke as the basic principle.

Phase 2

Mechanical membrane principle Completed

Force transfer to the membrane, valve phases and reproducible stroke.

Phase 3

Separating systemic and pulmonary circulation Completed

High-pressure and low-pressure side as separate tasks.

Phase 4

Pulmonary continuous flow Completed

Miniaturised continuous-flow pump for the pulmonary base flow.

Phase 5

Earlier architecture stage Earlier stage

Modular two-circulation architecture with systemic chamber, pulse chamber and continuous-flow pump. Three modules were built and a circulation test rig was set up. The design values of that stage have been superseded.

Phase 6

Current architecture Current architecture

  • pulsatile chamber for the systemic circulation
  • pulse chamber and continuous-flow pump for the pulmonary circulation
  • reserve functions for the failure of individual components
  • shape oriented on the human heart
  • battery, electronics and energy transfer outside the pericardium
Phase 7

System integration Planned

Bringing together chamber geometry, membrane, drive, sensing, energy supply and safety concept.

Phase 8

Next benchtop system generation Planned

Combining CAD, simulation, prototypes and endurance data into a further-developed benchtop system generation.

High-cycle polymer membrane system for a pulsatile artificial-heart pump

Separate, documented R&D project in six work packages. The packages partly run in parallel.

WP 1

Requirements analysis and membrane design In progress

Stroke, pressure and installation-space requirements; parametric design of different membrane geometries.

WP 2

Material selection, membrane casting and specimen production In progress

Selection of suitable elastomers; production and characterisation of single- and multilayer membrane specimens with varied wall thickness, rolling radius and preload.

WP 3

CAD design, numerical FE simulation and prototype manufacturing In progress

Non-linear FE simulation with hyperelastic or viscoelastic material models; local principal strains, stresses and bending radii; iterative prototypes.

WP 4

Functional tests and iterative geometry adjustment In progress

Functional tests of the prototypes and iterative adjustment of geometry and membrane clamping.

WP 5

Development of the multi-station endurance test rig In progress

Test rig with defined stroke and back pressure plus cycle, pressure, temperature and leakage monitoring.

WP 6

Endurance, frequency validation and failure analysis In progress

Parallel endurance runs at different frequencies; analysis of cracks, creep, abrasion, fatigue and layer failure; comparison with simulation.

Drives

Phase 1

Linear stroke as a concept Completed

First concepts with a controllable linear stroke.

Phase 2

Electromechanical approach Earlier stage

Motor with screw drive as the earlier favourite, designed in CAD.

Phase 3

Concept comparison In progress

Several drive principles are compared by installation space, heat, wear, controllability and lifetime.

Phase 4

Test-rig comparison Planned

Selected drives are tested under identical conditions — same chambers, pressures and measuring methods.

Phase 5

Selection Planned

Decision based on test-rig data, not theory.