PAGE TITLE
Overview
PAGE SUMMARY
Thousands of infants are born each year with abnormal physiology due to heart defects and structural disorders. The incidence of congenital heart defects is approximately 4–10 of every 10,000 live births. Those defects having the highest complexity, such as hypoplastic left heart syndrome and tricuspid atresia, lead to single ventricle physiology (SVP), requiring invasive heart surgery in the first year of life. Healthcare expenditures on the treatment of these disorders exceed $1.4 billion annually. Patients exhibiting SVP typically undergo three staged palliative cardiac surgeries that progressively offload the single ventricle while allowing time for growth, development, and adaptation to the altered physiology. The culminating Fontan procedure separates the pulmonary and systemic circulations and creates a total cavopulmonary connection (TCPC) where the inferior vena cava (IVC) and superior vena cava (SVC) are joined directly to feed the pulmonary arteries. In this configuration blood flows passively from the venous system into the lungs without a subpulmonary power source or right ventricle to provide a pressure boost to push blood to the left atrium. After the Fontan, elevated central venous pressures have been linked to mounting complications, such as liver disorders, cardiac arrhythmias, and thrombosis or clot formations. The main therapeutic alternative is a heart transplant, if patients survive the waiting period. Clinically approved blood pumps or ventricular assist devices (VADs) are not ideal treatment options since these have been designed for patients with normal anatomy, not for patients having dysfunctional or failing SVP.
As a new treatment strategy, Drexel’s biomedical engineers in collaboration with cardiac surgeons from the Children’s Hospital of Philadelphia have designed a collapsible, percutaneously-inserted, axial flow blood pump to support the cavopulmonary circulation of adolescent and adult Fontan patients. The design of this device takes into account biophysical factors such as hemolysis, biocompatibility, implantability, pump performance, biomaterials, and thrombosis. For Fontan patients, the target performance for this pump is to produce flow rates of 1–4 L/min with pressure rises of 2–25 mmHg for 1000–9000 RPM.
Impellers of varying designs have been produced and tested. Several impeller designs produced blood pressure rises of 4–26 mmHg for flow rates of 1–4 L/min for 6000–8000 RPM. A data regression analysis was completed and found the impeller with 400 °of blade twist to be the superior performer. A hydraulic test conducted on the prototype of the 400 ° impeller demonstrated pressure rises of 7–28 mmHg for flow rates of 1–4 L/min at 6000–8000 RPM.
APPLICATIONS
TITLE: Applications
Cardiac assist device as alternative to heart transplantation
A bridge to a heart transplant affording longer wait times for finding a matching donor heart
ADVANTAGES
TITLE:Advantages
The blades and filaments of the cage can flex and twist in a passive or controlled manner to improve the control of blood flow, the transfer of energy, and the reduction of irregular blood flow patterns.
Percutaneous placement. The pump is designed to function within the caval lumen / ECC, providing 4-weeks of support with no blood prime and minimal preparatory time of <1 hr. Longer-term support is achieved by removal and insertion of a new blood pump.
Biocompatibility. The cage assembly uses the native endothelial lining of the vessel as the housing and permits rapid pump exchange, thus reducing the risk of thrombosis.
Minimal pathway obstruction in the event of failure – the collapsible pump design allows blood flow across the pump.
The hydro-dynamically shaped cage of filaments provides hydraulic benefit similar to an inducer and diffuser blades.
FIGURES: Insert Figure Image Inside Figure Tags within Editor
Figure 1
Figure 1 Caption:
The figure illustrates the design consisting of three main components: the rotating impeller that imparts energy to the blood, the protective cage or stent that has radially arranged filaments as touchdown surfaces to protect the vessel wall from the rotating impeller blades, and the support catheter with a specially designed drive cable-fluid seal combination.
IP STATUS
Intellectual Property and Development Status
United States Patent Pending- 15/073,739
http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20160271309.PGNR.&OS=DN/20160271309&RS=DN/20160271309
PUBLICATIONS
References
Pubinfo should be the citation for your publication. Publink is the full url linking to the publication online or a pdf.
S. G. Chopski et al., “Physics-driven impeller designs for a novel intravascular blood pump for patients with congenital heart disease”. Medical Engineering and Physics 38 (2016) 622–632.
https://www.researchgate.net/publication/301764139_Physics-driven_impeller_designs_for_a_novel_intravascular_blood_pump_for_patients_with_congenital_heart_disease
Commercialization Opportunities
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Contact Information
Alexey Melishchuk, PhD
Associate Director, Licensing
Office of Technology Commercialization
Drexel University
3180 Chestnut Street, Suite 104
Philadelphia, PA 19104
T: 215-895-0304
amelishchuk@drexel.edu