# Cerebral Spinal Fluid Shunt System with Dual Lumen Distal Catheter Redundancy to Minimize Revision Surgery

> **NIH NIH R43** · CEROVATIONS, LLC · 2020 · $55,000

## Abstract

Abstract
Significance: Cerebral spinal fluid (CSF) shunt failure resulting in revision surgery is a major problem for
hydrocephalus patients. Up to 50% of shunts fail within two years of implant. A NIH funded expert panel has
identified improved shunt design as a research priority to improve hydrocephalic patient outcomes. Occlusion
is the most common CSF shunt failure mode, and little has changed with shunt failure rates over several
decades of use. Innovation: The proposed product is a dual lumen distal catheter providing modular
redundancy, a well-known principle for increasing reliability by duplicating critical components. This catheter
design automatically reroutes flow through a pristine back-up channel upon occlusion of the primary channel,
eliminating the need for surgical shunt revision. This technological innovation is low cost, low risk, and easy to
implement novel shunt design compatible with current CSF shunt protocols. Hypothesis: Redundancy of the
distal catheter flow channel can extend the working life of CSF shunts. Longer shunt life will reduce patient
morbidity by preventing excessive intracranial pressures and by minimizing the need for costly revision
surgery. Preliminary Data: Applicant has performed bench experiments demonstrating proof of concept for
the dual lumen distal catheter. SBIR Phase I Project Objective: Develop a CSF shunt that minimizes the
need for revision surgery. Aim 1: Freeze dual lumen distal catheter design for feasibility testing. Distal
catheter design will be finalized to meet human use requirements based on (a) Aim 1 expert design input and
CSF shunt supplier input (b) bench and in vitro design studies. Milestone: Design studies of dual lumen distal
catheter prototypes will demonstrate the potential for meeting functional requirements. Aim 2: Dual lumen
distal catheter feasibility testing. The objective is to generate test data demonstrating feasibility for SBIR
Phase II further research, which will focus on distal catheter design verification testing for FDA submissions
and clinical studies. Aim 1 distal catheters connected to currently marketed and FDA cleared CSF shunt valve
and proximal catheter components will be assessed with results reported as descriptive analysis. The test
devices will be sterilized and aged prior to testing. Aim 1 distal catheter design will be evaluated first with
bench and in vitro tests (n=10 catheters per GLP test) and subsequently in vivo (n=16 catheters per GLP-like
experiment) with four test animals. This feasibility testing will include commonly accepted functional
requirements outlined in ISO 7197 as well as bench and in vitro testing of rerouting mechanism performance.
Milestone: The dual lumen distal catheters will demonstrate feasibility by meeting functional test success
criteria.
.

## Key facts

- **NIH application ID:** 10169627
- **Project number:** 3R43NS113655-01S1
- **Recipient organization:** CEROVATIONS, LLC
- **Principal Investigator:** Tom Viker
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $55,000
- **Award type:** 3
- **Project period:** 2019-09-15 → 2021-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10169627

## Citation

> US National Institutes of Health, RePORTER application 10169627, Cerebral Spinal Fluid Shunt System with Dual Lumen Distal Catheter Redundancy to Minimize Revision Surgery (3R43NS113655-01S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10169627. Licensed CC0.

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