Shunt Training - Kyungwon Medical

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Hydrocephalus and
Neuro Shunting
Sales Training
April 2001
Hydrocephalus: 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).
About 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 WBC’s
Ventricular System
Fluid filled cavities deep in
cerebrum w/ pressure of 120180mmH2O
Four ventricles



2 Lateral
Third
Fourth
Connected by


Foramen of Monro
Aqueduct of Sylvius
Choroid Plexus



Very vascular
Found throughout but
mostly in lateral
Responsible for ICP
waveform/
follows arterial pulse
Brain 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
CSF 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.
Types of Hydrocephalus





Communicating
Non-communicating or Obstructive
Normal Pressure Hydrocephalus
Congenital
Acquired
Normal CT Scan
CT Scan Showing severe
hydrocephalus
Etiology of Hydrocephalus
Communicating






Overproduction/underabsorption of CSF
Choroid Plexus Papilloma-overproduces CSF
SAH
Infection
Neoplasms affecting the meninges
Trauma
Etiology of Hydrocephalus
Non-Communicating (Obstructive)






Aqueductal Stenosis
Arnold-Chiari Malformation (Cerebellar tonsils protrude into
Foramen Magnum)
Cysts
Myelomeningocele
IVH
Tumors (particularly posterior fossa)
Normal 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
Signs & 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
S/S Associated with Hydrocephalus,
Toddlers








Increased head size
Persistent vomiting
Headache
Lethargy or irritability
“Setting Sun” eyes
Blurred Vision
Seizures
Delayed Development
cont.
Hydrocephalus
“SETTING SUN” EYES
S/S Associated with Hydrocephalus,
Older Children & Adults







Persistent Vomiting
Headache**
Visual Problems
Lethargy
Behavior Changes
Difficulty with schoolwork
Seizures
cont.
Diagnosis




Clinical Evaluation
Ultrasound (Intrauterine & through Fontanels.
CT Scan
MRI
Treatment Modalities
Surgical Procedures





Remove obstruction (Blood Clots, Tumors)
Endoscopic Third Ventriculostomy
Septal Fenestrations (Endoscopic)
Cyst Fenestrations (Endoscopic)
Shunt Insertion
Interventions for Hydrocephalus
If untreated:
*50-60% die of complications
If treated:
*40% normal intelligence
*70% live beyond infancy
Questions???
Historical 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
1800’s-Variety of materials used to “wick” CSF from
ventricles to subarachnoid space (i.e., linen threads, glass
wool, rubber tube)
1898-first lumboperitoneal shunt
Historical Treatment of Hydrocephalous,
con’t
1922-Dandy-third ventriculostomy through subfrontal
approach
1923-Mixter-1st endoscopic 3rd Vent., choroid plexectomy
(L’Espinasse, Hildebrande, Dandy, Putnam and Scarff)
1950’s-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
Heyer 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
Heyer Schulte and Shunt Industry History
1974:
1975:
1977:
1978:
1983:
1984:
1986:
American Hospital Supply buys Heyer-Schulte
Codman introduces their own product line
Anasco, PR manufacturing facility is built
Codman buys Extra-Corporeal
AHS folds Heyer-Schulte into V. Mueller
Dr. Pudenz and Rudy Schulte found P-S Medical
Baxter-Travenol acquires AHS
Heyer Schulte and Shunt Industry History
The 90’s
 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
What 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.
How 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.
Shunt Systems



Ventriculo-peritoneal
Ventriculo-atrial
Lumbar-peritoneal
Shunt 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
SHUNT ACCESSORIES






Proximal catheter stylet (can use endoscope)
Stylets for unitized shunts
Shunt passers
Connectors and Right angle guides
Shunt tap kits
Manometers
Valve Mechanisms


Differential Pressure Valves
Flow regulating devices
Valve 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.
Valve 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
Pudenz
Mishler Dual-Chamber
Ultra VS Cylindrical
One Piece Hydro Shunt
Ommaya
Internal Valve Components




Slit
Ball and Spring
Miter
Diaphragm
Valve Mechanisms
Slit
Miter
Valve 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)
Valve 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?
Slit Valves
Codman




Holter (proximal catheter/valve)
Denver (proximal catheter)
Accuflo (distal catheter)
Uni-shunt (distal catheter)
Radionics

Proximal slit valve
Phoenix

Holter-Hausner valve
One Piece Hydro Shunt
Valve 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
Mitre Valves
Heyer-Schulte



Ultra-VS(cylindrical)
Mishler Dual Chamber (flat bottom)
Spetzler in-line Lumbar - Peritoneal valve (cylindrical)
Valve 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
Ball-in-Cone Valves
Codman Medos Hakim

Medos Programmable
NMT/Cordis



Atlas
Hakim
Orbis Sigma II
Sophysa

Sophy Programmable
Valve 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
Diaphragm 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)
Diaphragm Valves
Radionics



Contour Flex
Equi-flow
Burr hole
Codman

Accu-flo valve
Valve 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
Valve 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.
Valve 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.
Treatment 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
Shunt 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
Shunt 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
Shunt 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
Shunt Implantation Approaches
Occipital Approach
Temporal Approach
Frontal Approach
Metopic
Suture
Coronal
Suture
Anterior
Fontanelle
Sagittal
Suture
Lamboidal
Suture
Posterior
Fontanelle
Skull of a newborn seen from above
Adult human skull seen from above
Indications 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.
Goals 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
First Generation Diaphragm Valve
Second Generation Diaphragm Valve
Third Generation Diaphragm Valve
Integra NeuroSciences
Consistency by Design
FLOW PATH
DELTA VALVE
LPV II Valve Performance
at High Flow Rates (45.8ml/hr)
12.00
10.00
10.00
8.00
8.00
LSL
UNIT NO.
61
58
55
52
49
46
43
40
37
34
31
28
25
22
19
85
82
79
76
73
70
67
64
61
58
55
52
49
46
43
40
37
34
31
28
25
22
19
16
0.00
13
0.00
7
2.00
10
2.00
4
4.00
16
USL
4.00
UNIT NO.
L/N
13
USL
L/N
6.00
7
LSL
10
6.00
L/N
4
L/N 1953277
L/N
1
L/N 1953276
PRESSURE (CM H2O)
12.00
1
PRESSURE (CM H2O)
LPV Valve Performance
at High Flow Rates (45.8ml/hr)
LPV II Valve Performance
at Low Flow Rates (4.6ml/hr)
12.00
10.00
10.00
8.00
8.00
L/N 199
L/N 1953277
6.00
LSL
L/N 199
USL
LSL
UNIT. NO.
61
58
55
52
49
46
43
40
37
34
31
28
25
22
19
16
13
7
85
82
79
76
73
70
67
64
61
58
55
52
49
46
43
40
37
34
31
28
25
22
19
16
0.00
13
0.00
7
2.00
10
2.00
4
4.00
10
USL
4.00
UNIT NO.
L/N 199
4
6.00
L/N 199
L/N 1953276
1
n
PRESSURE (CM H2O)
12.00
1
PRESSURE (CM H2O)
LPV Valve Performance
at Low Flow Rates (4.6ml/hr)
Competitive Matrix






Medtronic P.S. Medical
Cordis
Codman
Radionics
Sophysa
Phoenix
Flat Bottom Diaphragm Competitive Matrix
Manufacturer/
Brand Name
Valve
Mechanism
Shape
Reservoirs
Heyer-Schulte/N
ovus
3rd
Generation
Diaphragm
"T" Valve
Flat Bottom
Proximal,
Integral
2nd
Generation
Diaphragm
Flat Bottom
PS Medical/
Delta
Proximal,
Integral
ASD
Catalogue #
Yes
NL850-9010 series
Normally depending on pressures and
Open
sizes (standard & mini)
Yes
Normally
Closed
42812 series (small)
42822 series (standard)
92822 Regular w/BioGlide
92812 Small w/BioGlide
Radionic's/
Equi-Flow
2nd
Generation
Diaphragm
Codman J&J not
available
N/A
Cordis NMT not
available
N/A
Cordis NMT/
Orbis Sigma II
Ball and
Spring
Flat Bottom
Proximal,
Integral
Optional
SLR-L, SLR-M (standard)
SLS-L, SLS-M (small)
Pricing
$665.00
valve only
$765.00 kit
$730.00
valve only
909-612
Snap Reservoir
Option
$840.00 kit
$820.00
valve only
w/BioGlide
$630.00
valve only
$780.00 kit
Flat Bottom
Other
$675.00
valve only
$745.00 kit
No
peritoneal
Only available
in low and
medium
pressure
Flow specified not
really equal to
others but the
Orbis Sigma is
their top line valve
Flat Bottom Diaphragm Competitive Matrix
Manufacturer/
Brand Name
Valve
Mechanism
Shape
Reservoirs
ASD
Catalogue #
Pricing
Heyer-Schulte/
LPV II
3rd
Generation
Diaphragm
"T" Valve
Flat Bottom
Proximal,
Integral
No
NL850-9810 series
depending on sizes
(standard and mini) and
pressures (high,
medium, low)
$450.00
valve only
2nd
Generation
Diaphragm
Flat Bottom
PS Medical/
Contour
Proximal,
Integral
No
42419 series (small)
42322 series (standard)
92322 Regular
w/BioGlide
92312 Small
w/BioGlide
Radionic's/
Contour-Flex
Codman J&J not
available
Cordis NMT not
available
2nd
Generation
Diaphragm
Flat Bottom
Proximal,
Integral
Yes
Other
$595.00 kit
$445.00
valve only
$505.00 kit
$525.00
w/BioGlide
CFR-L, CFR-M, CFR-H
(standard)
$400.00
valve only
CFS-L, CFS-M, CFS-H
(small)
No kit
available
BioGlide--catheter coating
Burr Hole Diaphragm Competitive Matrix
Manufacturer/
Brand Name
Valve
Mechanism
Shape
Reservoirs
ASD
Catalogue #
Pricing
Heyer-Schulte/P
udenz
3rd
Generation
Diaphragm
"T" Valve
Burr Hole
(12mm and
16mm)
Distal, Integral
No
NL850-1330 series
depending on size and
pressure
$279.00
valve only
Heyer-Schulte/P
udenz
3rd
Generation
Diaphragm
"T" Valve
Burr Hole
(12mm and
16mm)
Distal, Integral
Yes
NL850-1410 series
depending on size and
pressure
$569.00
w/ASD
valve only
PS Medical/
Delta Burr Hole
2nd
Generation
Diaphragm
Burr Hole
(12mm and
16mm)
Proximal,
Integral
Yes
42832 series (12mm)
$670.00
42842 series (16mm)
$765.00
w/BioGlide
92832 12mm
w/BioGlide
92842 16mm
w/BioGlide
PS Medical/
CSF Flow
Control Valve
2rd
Generation
Diaphragm
Burr Hole
(12mm and
16mm)
Proximal,
Integra
No
42542, 42544, 42546
Low, medium, high
pressure
$290.00
valve only
Radionic's/
Burr Hole
2nd
Generation
Diaphragm
Burr Hole
(12mm and
16mm)
Distal, Integral
No
BHV-12L or BHV-16L
Series depending on
pressure
$270.00
Codman J&J
Accuflow
2nd
Generation
Diaphragm
Burr Hole
(16mm only)
Distal, Integral
Optional
Other
Snap Reservoir
Option
Neonatal Valve Systems Competitive Matrix
Manufacturer/
Brand Name
Valve
Mechanism
Shape
Reservoirs
ASD
Catalogue #
Pricing
Heyer-Schulte/Ul
tra VS
Miter Valve
Cylindrical
Optional,
Proximal
No
NL850-1126 series
depending on size and
pressure
$375.00
valve only
PS Medical/
Ultra Small
PS Medical/
Button
2nd
Generation
Diaphragm
Flat Bottom
2nd
Generation
Diaphragm
Flat Bottom
Codman J&J
N/A
Cordis NMT/
Omnishunt
Neonatal Valve
System
Ball and
Spring
Optional,
Proximal
No
42410 series depending
on pressure
Other
$625.00 kit
$405.00
valve only
Snap Reservoir
Option
$625.00 kit
Optional,
Proximal
No
24003LL series
46544
Cylindrical
Optional,
Proximal
Optional
908-222 series
908-322 series
908-344 series
depending on size and
pressure
$365.00
valve only
$580.00
$475.00
Gravity
Compensating
Accessory
Product line strengths






Consistency and predictability
Broad product line
Clnical support
History
Manufacturing expertise
Pricing flexibility
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