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Details of proposed research plan

Title: Design and Development of Intelligent Smart Stunt for hydrocephalus treatment.

Origin of the Proposal:


Hydrocephalus is a medical condition owing to abnormal accumulation of cerebrospinal fluid
(CSF) within the lateral ventricles present inside the brain. The CSF is a clear, colourless
liquid produced in the choroid plexuses at rate of approximately 20ml.h -1. The main function
of CSF is to cushion the brain within the skull serving as a shock absorber for the central
nervous system apart from circulating nutrients and chemicals filtered from the blood while
assisting in removing waste products[]. Hydrocephalus occurs when the production of CSF is
greater than the absorption or when the drainage path is blocked[]. This condition leads to
elevated pressure, referred to as intracranial pressure (ICP), exerted by the cranium on the
brain tissue, cerebrospinal fluid and the brain circulating blood volume and manifest itself in
symptoms such as headache, vomiting, nausea or coma[]. If left untreated, elevated ICP
causes expansion of the ventricles, thereby damaging the brain and even be fatal.
Ever since 1955, implantable shunts are used to treat hydrocephalus and the technology
remained relatively unchanged except for few appreciable changes []. This revolutionary,
simplistic in concept and design replaced the lost drainage capacity by diverting CSF from
the lateral ventricles to another body location, thus reducing ICP. Although, shunts are lifesaving devices their high failure rates (30% within the first year, 40% within two years and
98% within 10 years), difficulty of diagnosing failure and limited control options remained to
be long-standing problems is in fact much more challenging[Browd, et al]. Modes of failure
include obstruction along any segment, detachment or relocation of tubing, component
fractures and functional modes of failure such as over/under drainage, hemorrhage and slit
ventricle syndrome[]. Additional surgeries, hospitalization costs, and risks of infection
accounts to 15% due to above associated failure modes[]. A little has been changed in the
shunt designs since their inception causing little or no impact on these long-standing
problems. Existing devices are devised using three components (ventricular catheter, a valve
and distal tubing) either unitized into one system or as separate add-on components. These
devices often fail as they lack in corrective mechanisum to maintain condition resulting CSF
drainage disparity (over/under) to the peritoneal area. Currently, commercially available
shunt devices neither provide feedback regarding patient intracranial pressure (ICP) to adjust
shunt function to the current needs of patient []. There is an increasing need for improved
technology and a healthcare system to treat hydrocephalus.
Shunt insertion in hydrocephalus patients undoubtedly improved the lost imbalance in CSF
dynamics contributing towards the improvement of the quality of life. However, the
relationship between the changed hydrodynamic state and improved clinical performance is
not fully known as they are passive in nature. For this reason, realization of truly autonomous
(active) devices that can overcome the limitations in current treatment methods is essential. A
smart shunt can address various points of failure by design and control improvements in
existing shunt systems. These shunts are capable of self-diagnosing and adjusting ICP or CSF
pressure levels in the lateral ventricles based on the measurements from implanted sensors.

From the literature, hydrocephalus shunt systems are inbuilt with a variety of valves like
high, medium and low pressure valves to differential pressure valves, siphon-resistant valves,
flow regulating valves and externally adjustable valves produced mainly from four dominant
manufacturers (Medtronic, Codman, Aesculap and Integra Life Sciences) [x,x,x,x]. Despite
the most exciting and impactful developments, patients are yet to see a commercialized smart
shunt. Many key challenges like the inability to recalibrate the sensors, force generated by the
implanted micro-actuator, need for reliable energy scavenging systems, and protecting
electronics from moisture via proper housing hinder the technical progress on smart shunt
development [ ]. A smart shunt that can address aforementioned failure points by design and
control improvements still remain to be a desire.
In this proposal, a reliable smart shunt that can sense and control the disparity in CSF
pressure levels in the lateral ventricles is proposed to address the limitations of current
hydrocephalus shunts.

Objectives:
To design and develop a reliable smart cerebrospinal fluid shunt device for treatment of
hydrocephalus.

Methodology:
The proposed research work is focused principally on the design, development and control of
smart ventriculoperitoneal shunt capable of draining CSF from the patients ventricular space
to the peritoneal area. Experimental tests will be performed on the various test valve designs
developed using active component - i.e., Magnetic Shape Memory Alloy (MSMA). The
design features sensing the ICP or CSF drainage rate through a micropressure sensor located
at the tip of distal tubing; an actuator which helps to adjust opening of implanted MSMA
valve using a CSF drainage feedback from the sensor is integrated. A comprehensive
modeling and simulation study will be performed to arrive at optimal designs at microscale
on Finite Element Analysis (FEA) based general-purpose COMSOL Multiphysics platform.
Hardware-in-the-loop test bench will be developed to calibrate and characterize manufactured
ventriculoperitoneal shunt devices with necessary instrumentation. Several clinical laboratory
trials will be performed to validate simulation results. Finally, the optimized designs are
manufactured according to the standards (International standards of medical devices) as
complete products for real-time trails by medical professionals, followed by comparative data
analysis with microlevel simulation results.

Time schedule:
Below is the proposed tentative work plan to carry out the research work for a span of 3
years.

PhD induction Course, literature collection from books, research papers and review of

design principles of various hydrocephalus shunts (Six Months)

Comprehensive modeling and simulation and arrival at optimal shunt designs


(Six Months)

Setting up of hardware-in-the-loop test bench for the assessment of current and future
shunts. (Six Months)

Development and application of control strategies. (Three Months)

Validation of simulation results with experimental results. (Three Months)

Manufacturing experimental design as a product for real-time trails. (Six Months)

Comparative data analysis, thesis preparation and publication of results. (Six Months)

Innovativeness:
The proposed smart shunt will be first of its kind, developed based on the properties (Shape
Memory Effect) of MSMAs for applications in the field of health and well-being.
These devices with slight design modification can be turned into smart occupancy sensors
which can address energy conservation aspects in Smart homes.

Application of the Results:


The proposed smart shunt is designed based on smart technologies that provide inexpensive,
practical solutions with global applications in hydrocephalus patents (infants and adults).
Additional features of the device include the transmission of the ICP or CSF pressure levels
information through an android mobile phone to a physician so that he/she can take necessary
and appropriate actions.

References:
The technical challenges hydrocephalus poses are great and are apparent from the high-failure rates, which
will need further understanding. Solutions have to be found in terms of modifications to the catheter,
valves and indications for placement of the right materials. Then are we looking at a smart shunt in the
future? The smart shunt will need to possess technical attributes to overcome present difficulties, be costeffective, easily available and have good regulatory control with low risk to be successful.[5] When this
balance is struck, it may greatly influence patient care in the future. When technology can mimic the
complex cerebral physiological function, the survival of shunts may increase and improve outcomes.

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