Olia, Salim Esmail
(2018)
DESIGN OPTIMIZATION AND PRECLINICAL TESTING OF PEDIATRIC ROTARY BLOOD PUMPS AND COMPONENTS: TOWARDS THE PEDIAFLOW® VAD.
Doctoral Dissertation, University of Pittsburgh.
(Unpublished)
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Abstract
Limited options exist for children (BSA<1.5 m2) requiring long-term mechanical circulatory support (MCS). Unlike adults where compact, 3rd generation, continuous-flow, implantable rotary blood pumps (RBPs) are now the standard for ventricular assist device (VAD)-indications, the only pediatric-approved chronic MCS device is the Berlin Heart® EXCOR®: a 1st generation pulsatile, pneumatically-driven, paracorporeal life-saving technology albeit with a substantial risk profile associated with frequent neurological and coagulation-related serious adverse events.
In support of the smallest and most vulnerable patients, the goal of this research is to facilitate the development and translation of next-generation pediatric RBPs, including the University of Pittsburgh-led Consortium’s PediaFlow®: a miniature, implantable, rotodynamic, fully magnetically levitated, continuous-flow pediatric VAD intended to support patients between 3 to 15 kg at a flow rates of 0.3-1.5 L/min for up to six months.
Presented here is the i) development of a standardized method for in vitro mechanical blood trauma testing of pediatric MCS devices; ii) design and ex vivo evaluation of a novel, pediatric-appropriate, suction resistant, placement insensitive, left ventricular drainage cannula; iii) creation of an MCS-tailored monitoring software for preclinical testing; iv) development of a PediaFlow®-specific flow estimation algorithm; and v) hemocompatibility findings in vitro and in vivo of the 4th generation PediaFlow® (PF4) VAD.
The PF4, comparable in size to an AA battery, is the embodiment of more than a decade of extensive computational and experimental efforts over the span of four device iterations to minimize size, optimize performance, and maximize safety. This dissertation represents the work and results to date of PediaFlow® PF4 on the path to preclinical testing to submit an Investigation Device Exception (IDE) application in anticipation of eventual clinical trials.
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Details
| Item Type: |
University of Pittsburgh ETD
|
| Status: |
Unpublished |
| Creators/Authors: |
|
| ETD Committee: |
|
| Date: |
25 September 2018 |
| Date Type: |
Publication |
| Defense Date: |
16 July 2018 |
| Approval Date: |
25 September 2018 |
| Submission Date: |
4 July 2018 |
| Access Restriction: |
No restriction; Release the ETD for access worldwide immediately. |
| Number of Pages: |
197 |
| Institution: |
University of Pittsburgh |
| Schools and Programs: |
Swanson School of Engineering > Bioengineering |
| Degree: |
PhD - Doctor of Philosophy |
| Thesis Type: |
Doctoral Dissertation |
| Refereed: |
Yes |
| Uncontrolled Keywords: |
pediatric heart failure, congenital heart disease, mechanical circulatory support, continuous flow, rotary blood pump, blood trauma, hemocompatibility, biocompatibility |
| Date Deposited: |
25 Sep 2018 14:59 |
| Last Modified: |
25 Sep 2018 14:59 |
| URI: |
http://d-scholarship.pitt.edu/id/eprint/34987 |
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