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