Fig 1.
The prototype Inspired Therapeutics NeoMate System.
(A) Prototype Inspired Therapeutics NeoMate System with integrated pump. (B) Pump housing, inflow, and outflow. (C) Exploded view of the pump and rotating group assembly. (D) Cross-section of the magnet, rotor, stator, voice coil actuator, and flow paths.
Fig 2.
Illustration of static (A) and dynamic (B) mock flow loop models for testing hydrodynamic and hemodynamic performance of the prototype Inspired Therapeutics NeoMate System. P, pressure sensor.
Fig 3.
Static mock flow loop data–ΔP circuit (pump and cannulae).
Relationship of the circuit head pressure (H) to flow (Q) (ΔP pump plus cannulae) for the Inspired Therapeutics NeoMate System in a static mock flow loop model over a range of pump speeds (RPM) and outflow resistances. H-Q curves for Systems A and B and three pairs of inflow and outflow cannula were generated (A-F).
Fig 4.
Static mock flow loop data—ΔP pump (inlet and outlet).
Relationship of pump head pressure (H) to flow (Q) (ΔP pump inlet and outlet pressures) for the Inspired Therapeutics NeoMate System in a static mock flow loop model over a range of pump speeds (RPM) and outflow resistances. H-Q curves for Systems A and B and three pairs of inflow and outflow cannula were generated (A-F).
Fig 5.
Relationship between pump flow, mock ventricular flow, and total mean flow for the Inspired Therapeutics NeoMate System and inflow (24F) and outflow (16F) cannula in a dynamic mock flow loop model over a range of pump speeds for Systems A and B. These data show increasing mean flows and diminishing pulsatility with increasing pump speeds.
Table 1.
Dynamic mock flow loop hemodynamic data.
Fig 6.
Representative hemodynamic waveforms recorded intraoperatively from one of the acute sheep (System A) at baseline (pre-pump implant, post-pump implant off and clamped/unclamped) and at increasing pump speeds.
Fig 7.
Transesophageal echocardiographic (TEE) images obtained via a modified 4-chamber view from one of the acute sheep (System B) showing leftward intraventricular septal shift with increasing pump speeds. Note the presence of air emboli visible at 6000 RPM resulting from challenges with de-airing the pump.
Table 2.
Summary of hemodynamic data.
Fig 8.
Photographs of the pump impellers, housing, and magnets at necropsy following the acute ovine model experiments for System A (panels A-C) and System B (panels D-F). Panels A, B, D, and E show the presence of small thrombi on the pump housing and under the impellers of both systems. Panels C and F show the presence of wear (yellow arrows) on the magnets. Note that in panels A and B, the pair of red dots at the 1 and 2 o’clock positions are not thrombi but ink dots marking the identity of the specific impeller used.