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Development of Inspired Therapeutics Pediatric VAD: Computational Analysis and Characterization of VAD V3

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Abstract

Purpose

Pediatric heart failure patients remain in critical need of a dedicated mechanical circulatory support (MCS) solution as development efforts for specific pediatric devices continue to fall behind those for the adult population. The Inspired Pediatric VAD is being developed as a pediatric specific MCS solution to provide up to 30-days of circulatory or respiratory support in a compact modular package that could allow for patient ambulation during treatment.

Methods

Hydrodynamic performance (flows, pressures), impeller/rotor mechanical properties (torques, forces), and flow shear stress and residence time distributions of the latest design version, Inspired Pediatric VAD V3, were numerically predicted and investigated using computational fluid dynamics (CFD) software (SolidWorks Flow Simulator).

Results

Hydrodynamic performance was numerically predicted, indicating no change in flow and pressure head compared to the previous device design (V2), while displaying increased impeller/rotor torques and translation forces enabled by improved geometry. Shear stress and flow residence time volumetric distributions are presented over a range of pump rotational speeds and flow rates. At the lowest pump operating point (3000 RPM, 0.50 L/min, 75 mmHg), 79% of the pump volume was in the shear stress range of 0–10 Pa with < 1% of the volume in the critical range of 150–1000 Pa for blood damage. At higher speed and flow (5000 RPM, 3.50 L/min, 176 mmHg), 65% of the volume resided in the 0–10 Pa range compared to 2.3% at 150–1000 Pa.

Conclusions

The initial computational characterization of the Inspired Pediatric VAD V3 is encouraging and future work will include device prototype testing in a mock circulatory loop and acute large animal model.

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Author Contributions

All authors contributed equally to this manuscript.

Funding

This development effort and study was supported by National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Grant No. 1R43HL144214-01.

Data Availability

Additional data from this study is made available as a Supplementary Materials document.

Conflict of interest

LHT is a consultant for Inspired Therapeutics LLC. BNG is the CTO and a co-Founder of Inspired Therapeutics LLC, and served as Co-Investigator on grant R43HL144214-01. SRP was a sub-contract consultant with Veritium Research LLC for NIH SBIR phase I grant R43HL144214-01. GFM was a sub-contract consultant with Veritium Research on grant R43HL144214-01. TR, JAK, and SJW are faculty at the University of Louisville. PCP is an employee of Inspired Therapeutics LLC. SCK and MSS were Co-Investigators with sub-contract University of Louisville on grant R43HL144214-01. KAD is the CEO and co-Founder of Inspired Therapeutics LLC, and served as Principal Investigator on grant R43HL144214-01. Additional Affiliations Unrelated to the Presented Work LHT is a co-owner of MAST LLC, engineer with Cor Habere Corp., and consultant with VADovations Inc. BNG is a consultant to Paragonix Technologies, Inc., Vivante Health, Inc., and Cardiac Assist Holdings. SCK and MSS are co-founders of Cor Habere Corp. and MAST LLC developing medical devices supported by NIH SBIR phase I grants R43HL142337-01, R43HL142385-01, R43HL152894-01. MSS is also a consultant with Magenta Medical. KAD is a Co-Investigator on NIH SBIR phase I grant R43HL142385-01 and consultant on NIH SBIR grant R43HL158430-01. KAD is also President and COO of VADovations Inc, and serves as a consultant to BiVACOR Inc, CH-Biomedical USA Inc, Jarvik Heart International, Vortronix Medical LLC, Teal Health Inc., CAH Holdings LLC, and “The Kidney Project” affiliated with the University of California San Francisco and Vanderbilt University. KAD serves on the Board of Directors for Makana Therapeutics and Artio Medical. All of these additional author affiliations are unrelated to the work presented in this manuscript.

Ethical Approval

No human studies were carried out by the authors for this article. No animal studies were carried out by the authors for this article.

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Authors and Affiliations

  1. Department of Bioengineering, University of Louisville, Louisville, KY, 40202, USA

    Landon H. Tompkins, Thomas Roussel, Jonathan A. Kopechek, Steven C. Koenig & Kurt A. Dasse

  2. Inspired Therapeutics LLC, 125 E. Merritt Island Cswy, #107-341, Merritt Island, FL, 32925, USA

    Barry N. Gellman, Priscilla C. Petit & Kurt A. Dasse

  3. BLDC Designs LLC, Rocklin, CA, 95677, USA

    Steven R. Prina

  4. Veritium Research LLC, Fort Lee, NJ, 07024, USA

    Gino F. Morello

  5. Department of Mechanical Engineering, University of Louisville, Louisville, KY, 40202, USA

    Stuart J. Williams

  6. Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, KY, 40202, USA

    Mark S. Slaughter, Steven C. Koenig & Kurt A. Dasse

Authors
  1. Landon H. Tompkins
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  2. Barry N. Gellman
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  6. Jonathan A. Kopechek
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  8. Priscilla C. Petit
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  10. Steven C. Koenig
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Correspondence to Steven C. Koenig or Kurt A. Dasse.

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Associate Editor Ajit P. Yoganathan oversaw the review of this article

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Tompkins, L.H., Gellman, B.N., Prina, S.R. et al. Development of Inspired Therapeutics Pediatric VAD: Computational Analysis and Characterization of VAD V3. Cardiovasc Eng Tech 13, 624–637 (2022). https://doi.org/10.1007/s13239-021-00602-2

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