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Microfabricated Implantable Flowmeter for CSF Shunts Phase II

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44NS056628-02A1
Agency Tracking Number: R44NS056628
Amount: $3,003,413.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NINDS
Solicitation Number: PA09-206
Solicitation Year: 2011
Award Year: 2011
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
DUNS: 004627316
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (781) 259-4022
Business Contact
Phone: (937) 429-9008
Research Institution
DESCRIPTION (provided by applicant): An implantable wireless flow sensor system has been under development that would enable measurement of the flow of cerebrospinal fluid (CSF) through the ventriculoperitoneal (VP) shunt, currently used to treat hydrocephalus patients. CSF flow is a key indicator of shunt function, and there is currently no way to measure it in situ, resulting in the absence of clinical methods to directly assess shunt function or to predict its failure. Using MEMS microfabrication methods, the proposed flow sensor will be manufactured at a size small enough to be integrable with implanted VP shunts. The key elements in the flow meter are capacitive structures that change properties with change in CSF flow. Electromagnetic coupling between the internal passive circuitry and an external handheld circuit allows implantation of the flow sensor without the need for implanted batteries or transcutaneous wires. The proposed Phase II project will build on the encouraging results of Phase I, which demonstrated the wireless interrogation of proof-of-concept MEMS sensors and the presence of a readily measurable relationship of flow to the resonance of the sensor. In Phase II, fully-function flow-sensing MEMS chips will be manufactured, as well as arevised handheld unit that will display and output flow, based on the known relationship between flow rate and resonance. In vitro testing will establish calibration for the sensor implants, and will demonstrate measurement accuracy over the full physiological range of CSF flow, over long periods of time, and with appropriate phantom models. In parallel, a chronic sheep hydrocephalus model will be in preparation, along with implementation of appropriate packaging, biocompatibility, and sterilizability intothe sensor implant prototypes, as well as consideration of MR compatibility. Performance of an animal test protocol shall evaluate the sensor in regard to (1) sensitivity and specificity with regard to detection of flow obstruction, (2) CSF flow measurement accuracy, and (3) effect on shunt patency. PUBLIC HEALTH RELEVANCE: Every year there are approximately 23,000 shunt revisions performed in the U.S., in order to correct the relatively common failure of ventriculoperitoneal (VP) shunts used totreat hydrocephalus patients. However, children are still dying from shunt failure, and studies indicate that earlier detection would save a large fraction of these children. An implantable, wireless CSF flow meter would enable the clinician to monitor shunt function during routine office visits (rather than waiting for the re-appearance of hydrocephalus symptoms), allowing detection of impending shunt failure, avoidance of lifesaving treatment on an emergency basis, and reduction of mortality associated with VP shunt failure.

* Information listed above is at the time of submission. *

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