# Characterization and testing of a blood pump maintenance system

> **NIH NIH R43** · BONDE INNOVATIONS, LLC · 2020 · $555,358

## Abstract

ABSTRACT
Heart failure (HF), a global pandemic affecting 23 million people worldwide and 6 million in the
US, with 650,000 new cases diagnosed in the US each year. It is a relentless disease that
progresses to end stages with very poor prognosis, in which heart transplantation or left
ventricular assist device (LVAD) therapy becomes the only available treatment option. A
significant rise in the LVAD use for end-stage HF is due to critical donor shortage. However,
continuous pump operation, 24/7/365, with no ability to maintain or clean the pump leads to clots,
stroke, and infection, which greatly limits the clinical benefit. This is akin to driving a car without
changing its oil and filter or doing any maintenance for five to ten years.
Not only is regular pump maintenance necessary for cars, it is also an essential and standard
practice in the entire pump industry to keep them running properly. However, current LVADs do
not have access to clean the pump once it is implanted unless another highly invasive open-heart
surgery is performed. Device durability to ensure 24/7/365 continuous operation without
mechanical failure has been the major technical focus throughout generations of LVAD, which
comes at the price of invasiveness, 24-hour care, infection, bleeding, thrombosis, and reduced
quality of life for the remainder of the patient’s life. Ability to clean and maintain the LVAD in-vivo
may completely change the management of LVAD patients. Clinical experience demonstrates
that an LVAD can be safely turned off for short durations while supporting circulation with
inotropes, giving an opportunity to clean and carry out maintenance in-vivo.
Bonde Innovations LLC and the Artificial Heart Laboratory at Yale University have developed a
VAD maintenance system incorporating a unique component called BiO-valve (Balloon isolation
Occluding valves) that can isolate the pump in-vivo and allows to clean, maintain, and service the
pump when it is still implanted within a human body. Two BiO-valves are connected to a single
access port designed to control all four steps of the procedure - isolation, purging, maintenance,
and service with no exposure to blood or body fluids. It is a simple all-in-one unit applicable to any
implantable VAD. In this SBIR phase I proposal, we will demonstrate the feasibility of in-vivo VAD
maintenance system, and then plan to submit a Phase II proposal to develop product level of VAD
maintenance system through design optimization, design freeze, and extensive pre-clinical
studies to make it ready for clinical trials. An unprecedented opportunity of providing routine pump
maintenance in-vivo has potential to reduce common and severe complications, promote patient
recovery, and shorten hospitalizations, bringing innovations in VAD technology and management.

## Key facts

- **NIH application ID:** 10010071
- **Project number:** 1R43HL151054-01A1
- **Recipient organization:** BONDE INNOVATIONS, LLC
- **Principal Investigator:** Michael E Theran
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $555,358
- **Award type:** 1
- **Project period:** 2020-09-01 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10010071

## Citation

> US National Institutes of Health, RePORTER application 10010071, Characterization and testing of a blood pump maintenance system (1R43HL151054-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10010071. Licensed CC0.

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