Title: Hydrocephalus and Neuro Shunting
1Hydrocephalus and Neuro Shunting
- Sales Training
- April 2001
2Hydrocephalus From the Greek word hydro (water)
cephalo (head). A pathological condition where
there is a disturbance in production, circulation
and/or absorption of CSF, with subsequent
accumulation of CSF in the fluid-filled
compartments of the brain (ventricles).
3About CSF (Cerebrospinal Fluid)
- Clear, colorless fluid
- Bathes, nourishes protects brain and spinal
cord. - Average CSF production-20ml/hr adults and 8ml/hr
children - 400 to 500cc produced daily contains 15 to
45mg/100ml protein,some glucose, salts, urea and
WBCs
4Ventricular System
- Fluid filled cavities deep in cerebrum w/
pressure of 120-180mmH2O - Four ventricles
- 2 Lateral
- Third
- Fourth
- Connected by
- Foramen of Monro
- Aqueduct of Sylvius
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6- Choroid Plexus
- Very vascular
- Found throughout but mostly in lateral
- Responsible for ICP waveform/
- follows arterial pulse
7Brain Layers/CSF Absorption
A. - Arachnoid A.G. - Arachnoid
Granulation B. - Bone C.A. -
Cerebral Artery C.V. - Cerebral Vein
D. - Dura Mater F.C. - Falx Cerebri P.M. -
Pia Mater S. - Skin S.A.S. -
Sub-Arachnoid Space S.D.S. -
Sub-Dural Space S.S.S. - Superior Sagittal
Sinus
8CSF Flow-path
- CSF flows in a caudal direction through the
lateral, third and fourth ventricles - Exits through foramina of Luschka and Magendie
into subarachnoid space around spinal cord and
brain. - Absorption occurs through the arachnoid
granulations into the venous system.
9Types of Hydrocephalus
- Communicating
- Non-communicating or Obstructive
- Normal Pressure Hydrocephalus
- Congenital
- Acquired
10CT Scan Showing severe hydrocephalus
Normal CT Scan
11Etiology of Hydrocephalus
- Communicating
- Overproduction/underabsorption of CSF
- Choroid Plexus Papilloma-overproduces CSF
- SAH
- Infection
- Neoplasms affecting the meninges
- Trauma
12Etiology of Hydrocephalus
- Non-Communicating (Obstructive)
- Aqueductal Stenosis
- Arnold-Chiari Malformation (Cerebellar tonsils
protrude into Foramen Magnum) - Cysts
- Myelomeningocele
- IVH
- Tumors (particularly posterior fossa)
13Normal Pressure Hydrocephalus
- Usually present in elderly
- Ventricular dilation despite normal CSF pressure
- Triad of symptoms
- 1) dementia
- 2) gait disturbances (usually earliest)
- 3) urinary incontinence
-
14Signs Symptoms Associated with Hydrocephalus
- Infants
- Increased head size
- Bulging Fontanels
- Separation of Cranial Sutures
- Prominent Scalp Veins
- Persistent Vomiting
- Lethargy or irritability
- Setting Sun eyes
- Seizures
- Delayed Development
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16S/S Associated with Hydrocephalus, cont.
- Toddlers
- Increased head size
- Persistent vomiting
- Headache
- Lethargy or irritability
- Setting Sun eyes
- Blurred Vision
- Seizures
- Delayed Development
17Hydrocephalus
18S/S Associated with Hydrocephalus, cont.
- Older Children Adults
- Persistent Vomiting
- Headache
- Visual Problems
- Lethargy
- Behavior Changes
- Difficulty with schoolwork
- Seizures
19Diagnosis
- Clinical Evaluation
- Ultrasound (Intrauterine through Fontanels.
- CT Scan
- MRI
20Treatment Modalities
- Surgical Procedures
- Remove obstruction (Blood Clots, Tumors)
- Endoscopic Third Ventriculostomy
- Septal Fenestrations (Endoscopic)
- Cyst Fenestrations (Endoscopic)
- Shunt Insertion
21Interventions for Hydrocephalus
- If untreated
- 50-60 die of complications
- If treated
- 40 normal intelligence
- 70 live beyond infancy
22Questions???
23Historical Treatment of Hydrocephalous
- Hippocrates recognizes water accumulation in the
brain. - 1545-Thomas Phaire-1st non-surgical
treatment--Herbal plasters, head wraps - 18th Century--ventricular puncture--death from
meningitis common - 1800s-Variety of materials used to wick CSF
from ventricles to subarachnoid space (i.e.,
linen threads, glass wool, rubber tube) - 1898-first lumboperitoneal shunt
24Historical Treatment of Hydrocephalous, cont
- 1922-Dandy-third ventriculostomy through
subfrontal - approach
- 1923-Mixter-1st endoscopic 3rd Vent., choroid
plexectomy - (LEspinasse, Hildebrande, Dandy, Putnam
and Scarff) - 1950s-First effective CSF diversion with a
one-way valve - using biocompatible synthetic materials.
- John Holter-1st Silicone Valve
- Robert Pudenz-Silicone distal slit valve
- Peritoneum chosen as better absorptive site
than the - vascular system
25Heyer Schulte and Shunt Industry History
- 1953 Dr. Robert Pudenz and W.T. (Ted) Heyer
team up on hydrocephalus research - 1955 Pudenz ventriculo-atrial shunt is
developed - 1959 Rudy Schulte joins Heyer and Pudenz
- 1959 Pudenz flushing valve is developed
- 1960 Codman distributes Heyer-Schulte products
- 1960 Holter valve is created
- 1965 Cordis begins U.S. presence
- 1965 Extra-Corporeal buys Holter
- 1973 Codman dropped as Heyer-Schulte distributor
26Heyer Schulte and Shunt Industry History
- 1974 American Hospital Supply buys
Heyer-Schulte - 1975 Codman introduces their own product line
- 1977 Anasco, PR manufacturing facility is built
- 1978 Codman buys Extra-Corporeal
- 1983 AHS folds Heyer-Schulte into V. Mueller
- 1984 Dr. Pudenz and Rudy Schulte found P-S
Medical - 1986 Baxter-Travenol acquires AHS
27Heyer Schulte and Shunt Industry History
- The 90s
- NeuroCare Group acquires Heyer-Schulte
- Radionics introduces full shunt line
- Medtronic acquires P-S Medical
- Phoenix Biomedical enters the market
- Codman acquires Cordis
- Elekta acquires Cordis
- NMT acquires Cordis
- Integra acquires Heyer-Schulte
28What is a Shunt?
- A shunt is a device that diverts CSF from the
CNS (usually the lateral ventricle or the lumbar
subarachnoid space) to an alternate body cavity
(usually the peritoneum or the right atrium)
where it is reabsorbed.
29How Shunts Work
- Divert CSF from the CNS to another body cavity (R
atrium, peritoneum) for absorption. - Mechanical device that regulates flow out of the
ventricle. - One-way valve opens when the sum of the forces
acting on it exceed some threshold. (the
difference between the inlet or ventricular
pressure and outlet or peritoneal pressure.
30Shunt Systems
- Ventriculo-peritoneal
- Ventriculo-atrial
- Lumbar-peritoneal
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32Shunt Components
- Primary Components
- Proximal Catheter
- Valve (Proximal or Distal)
- Distal Catheter
- Optional Components
- Reservoir
- Siphon Limiting Mechanism (ASD, SCD, GCD)
- Accessories
- Connectors
- Guides
- Introducers/Stylets
- Catheter Passers
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34 35SHUNT ACCESSORIES
- Proximal catheter stylet (can use endoscope)
- Stylets for unitized shunts
- Shunt passers
- Connectors and Right angle guides
- Shunt tap kits
- Manometers
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41Valve Mechanisms
- Differential Pressure Valves
- Flow regulating devices
42Valve Mechanisms
- Differential Pressure Valves
- Valves open when difference between the
ventricular pressure and the peritoneal pressure
exceeds some threshold. - Pressure difference at which a valve opens is
called the opening pressure. - Pressure difference at which a valve closes is
called the closing pressure.
43Valve Types
- Burr Hole - shaped to fit the hole made in the
skull. - The reservoir is an integral part e.g. Pudenz
- Flat Bottom - rests flat against the skull distal
to the - ventricular catheter e.g. LPV II, Novus
- Cylindrical/In Line - appears seamless between
the - ventricular and peritoneal catheters
- e.g.. Ultra VS
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45Pudenz
46Mishler Dual-Chamber
47Ultra VS Cylindrical
48One Piece Hydro Shunt
49Ommaya
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51Internal Valve Components
- Slit
- Ball and Spring
- Miter
- Diaphragm
52Valve Mechanisms
Slit
Miter
53Valve Internal Mechanisms
- High spring rate valves- open slowly, close
quickly (miter, slit) - Low spring rate valves- open quickly, close
slowly (diaphragm, ball spring, prone to siphon)
54Valve Mechanisms
- Slit valves - a slit in a curved rubber layer.
The flow arriving from the concave side opens
slit, size of opening relating to the upstream
pressure - Can be proximal or distal
-
- Disadvantage
- stickiness of silicone rubber can affect
opening - Precision?
- Varies with age of valve?
55Slit Valves
- Codman
- Holter (proximal catheter/valve)
- Denver (proximal catheter)
- Accuflo (distal catheter)
- Uni-shunt (distal catheter)
- Radionics
- Proximal slit valve
- Phoenix
- Holter-Hausner valve
56One Piece Hydro Shunt
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58Valve Mechanisms
- Mitre valves - the leaves of the duckbill part
in response to the pressure differential.
Pressure characteristics of mitre valve are
related to size,shape, thickness and length of
leaves. -
- Disadvantage
- stickiness of silicone rubber can affect
opening
59Mitre Valves
- Heyer-Schulte
- Ultra-VS(cylindrical)
- Mishler Dual Chamber (flat bottom)
- Spetzler in-line Lumbar - Peritoneal valve
(cylindrical)
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61Valve Mechanisms
- Spring valves/Ball in cone - a metallic spring
which applies force to a ball (usually ruby or
sapphire) located in an orifice. Opening pressure
is defined by spring stiffness - Disadvantage
- prone to obstruction from CSF debris or high
protein content - subject to siphoning
62Ball-in-Cone Valves
- Codman Medos Hakim
- Medos Programmable
- NMT/Cordis
- Atlas
- Hakim
- Orbis Sigma II
- Sophysa
- Sophy Programmable
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64Valve Mechanisms
- Diaphragm valves - a round diaphragm rests on or
under a valve seat. Pressure causes the diaphragm
to be detracted from the seat allowing CSF to
flow - Disadvantage
- prone to siphoning
- in some designs flow is not laminar making it
prone to obstruction
65Diaphragm Valves
- Heyer-Schulte
- Pudenz (burr hole)
- LPV II (flat bottom)
- Novus (flat bottom)
- PS Medical/Medtronic
- Delta (Burr hole, flat bottom)
- Button(flat bottom)
- Contour (flat bottom)
66Diaphragm Valves
- Radionics
- Contour Flex
- Equi-flow
- Burr hole
- Codman
- Accu-flo valve
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68Valve Mechanisms
- Flow regulating mechanisms
- Maintains same flow rate at any differential
pressure by increasing or lowering its resistance
to pressure - May be achieved by a solid conical cylinder
inserted inside a ring attached to a pressure
sensitive membrane
69Valve Mechanisms
- Inner diameter of ring is
- greater than larger
- outer diameter of
- conical cylinder
- By reducing surface
- area, mechanism
- restricts amount of fluid
- that can go through
- Outer cylinder moves
- to compensate for
- reduced surface area
- to maintain flow rate.
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72Valve Mechanisms
- At very low pressures acts like a DP valve
- At high pressures the ring moves beyond the
central cylinder to give a blow off valve.
73Treatment for Siphoning
- In a vertical position, negative pressure from
hydrostatic column can cause overdrainage - Siphoning control achieved by adding siphon
resistive devices to the shunt system. - Functions as a second valve in line that closes
in response to peritoneal pressure
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75Shunt Failures and Complications
- Shunt failure is at a maximum in first few months
after surgery (25-40 at one year follow-up).
Then falls to 4-5 - The mean survival for a shunt is approx 5 years
76Shunt Failures and Complications
- Shunt obstruction (about 50 - 60 of all
failures) - Infection(between 5 - 10)
- Mechanical failure due to disconnection
- Valve failure
- Overdrainage
- Patient/shunt mismatch
77Shunt Placement Procedure
- Skin Incision
- Placement of Burr Hole
- Sbcutaneous dissection
- Tunnel the peritoneal catheter
- Open dura place ventricular catheter
- Connect valve, test clean
- Distal catheter insertion skin closure
78Shunt Implantation Approaches
Occipital Approach
Temporal Approach
Frontal Approach
79Metopic Suture
Coronal Suture
Anterior Fontanelle
Sagittal Suture
Posterior Fontanelle
Lamboidal Suture
Adult human skull seen from above
Skull of a newborn seen from above
80Indications For Use of a Lumbar-Peritoneal Shunt
- Communicating Hydrocephalus - when ventricles are
small and it would be difficult to cannulate with
a ventricular catheter. - Normal Pressure Hydrocephalus - shunting without
necessitating a cranial procedure.
81Goals of Shunt Design Development
- Restoration of normal physiology in the shunted
individual - Maximize the potential quality of life for each
patient - Expand the population of successfully treated
patients
82First Generation Diaphragm Valve
83Second Generation Diaphragm Valve
84Third Generation Diaphragm Valve
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86Integra NeuroSciencesConsistency by Design
87FLOW PATH
DELTA VALVE
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92LPV II Valve Performance at High Flow Rates
(45.8ml/hr)
LPV Valve Performance at High Flow Rates
(45.8ml/hr)
93LPV II Valve Performance at Low Flow Rates
(4.6ml/hr)
LPV Valve Performance at Low Flow Rates (4.6ml/hr)
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107Competitive Matrix
- Medtronic P.S. Medical
- Cordis
- Codman
- Radionics
- Sophysa
- Phoenix
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136Flat Bottom Diaphragm Competitive Matrix
137Flat Bottom Diaphragm Competitive Matrix
138Burr Hole Diaphragm Competitive Matrix
139Neonatal Valve Systems Competitive Matrix
140Product line strengths
- Consistency and predictability
- Broad product line
- Clnical support
- History
- Manufacturing expertise
- Pricing flexibility