EQUI-FLOW VALVE and SHUNT SYSTEMS

Transcription

1 Instructions for Use Mode d'emploi Gebrauchsanleitung Istruzioni per l'uso Instrucciones de uso EQUI-FLOW VALVE and SHUNT SYSTEMS VALVE ET SYSTEMES DE DERIVATION EQUI-FLOW EQUI-FLOW -VENTIL UND SHUNT-SYSTEME SISTEMI DI VALVOLA E DI DEVIAZIONE EQUI-FLOW SISTEMAS DE VALVULA Y DERIVACION EQUI-FLOW Latex Do not use if the package has been opened or damaged. Ne pas utiliser si le produit a été ouvert ou endommagé. Nicht verwenden, wenn die Verpackung geöffnet wurde oder beschädigt ist. Non utilizzare se la confezione è aperta o danneggiata. No utilizar si el embalaje ha sido abierto o está dañado. MANUFACTURER: Integra NeuroSciences Implants S.A Route des Dolines Sophia Antipolis cedex, France DISTRIBUTED BY: Distribué par/verstriebdurch Distributore/Distribuido por Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536, U.S.A. BL by Integra NeuroSciences. All Rights Reserved.

2 Figure 1/Figure 1/Abbildung 1/Figura 1/Figura 1 Captions/Légendes/Bildtexte/Didascalie/Textos Pressure/Pression/Druck/Pressione/Presión Water Hydrostatic Pressure/Pression Hydrostatique/Hydrostatischer Wasserdruck/ Acqua Pressione/Presión Hidrostática de Agua Flow Rate (ml/hr)/débit (ml/h)/flussrate (ml/std.)/flusso (ml/ora)/velocidad de Flujo (ml/h) Performance Level 0.5 Niveau de Performance 0,5 Leistungsebene 0,5 Livello di Prestazione 0,5 Nivel de Funcionamiento 0,5 Performance Level 1.0 Niveau de Performance 1,0 Leistungsebene 1,0 Livello di Prestazione 1,0 Nivel de Funcionamiento 1,0 2

3 Figure 1/Figure 1/Abbildung 1/Figura 1/Figura 1 (Continued) Captions/Légendes/Bildtexte/Didascalie/Textos Pressure/Pression/Druck/Pressione/Presión Water Hydrostatic Pressure/Pression Hydrostatique/Hydrostatischer Wasserdruck/ Acqua Pressione/Presión Hidrostática de Agua Flow Rate (ml/hr)/débit (ml/h)/flussrate (ml/std.)/flusso (ml/ora)/velocidad de Flujo (ml/h) Performance Level 1.5 Niveau de Performance 1,5 Leistungsebene 1,5 Livello di Prestazione 1,5 Nivel de Funcionamiento 1,5 Performance Level 2.0 Niveau de Performance 2,0 Leistungsebene 2,0 Livello di Prestazione 2,0 Nivel de Funcionamiento 2,0 3

4 Occluder Silicone Dome Reservoir Tantalum Pressure Dots Tantalum Directional Arrow Occluder Siphon Limiting Device Inlet Connector Reinforced Sheeting Polypropylene Needle Guard Silicone Membrane Outlet Connector DESCRIPTION The Integra Equi-Flow Valve is a multi-function membrane valve incorporating a normally open Siphon Limiting Device, occluders, and integral tubing connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. It incorporates a central reservoir for pumping and injection, proximal and distal occluders, a Siphon Limiting Device and a fully flexible profile. The Siphon Limiting Device limits the reduction of intraventricular pressure and volume caused by the siphoning effect of hydrostatic pressure in the Distal Catheter. The Equi-Flow Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The flat silicone membrane seats on a conical polypropylene base which is integral to the Siphon Limiting Device. The Siphon Limiting Device contains a rigid outlet port. This design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Equi-Flow Valve is available in two sizes: Regular and Small. Both sizes are available in 4 pressure/flow characteristics ranges: Performance levels 0.5, 1.0, 1.5 and 2. The pressure/flow characteristics of both sizes of the Integra Equi-Flow Valve are shown in the graph (Figure 1) and chart (Figure 3). These pressure values are derived as the valve is tested at flow rates varying from 5 to 50 ml/hr. Each valve is individually tested to obtain its pressure/flow characteristics, closing pressure (Figure 2), and its ability to prevent retrograde fluid flow. The tantalum impregnated silicone arrow and pressure dot code on the valve housing allow identification of the pressure/flow rating. Each valve is dot-coded based on its horizontal and vertical operating pressures measured at the time of manufacture. The pressure of each valve has been verified to be within the pressure range limits indicated on the package label. The Equi-Flow Valve is designed with a fully flexible profile to conform to the curvature of the skull. The Valve s integral tubing connectors present an outer diameter of 1.8 mm for connection to standard catheters. The Equi-Flow Valve may be flushed in either the proximal or distal direction by pressing one of the occluders on the valve and pressing the reservoir. The reservoir is designed to allow penetration with a 25-gauge or smaller beveled needle. The reservoir contains a polypropylene needle guard to prevent overpenetration of the needle. The valve membrane is further protected from needle punctures by a rigid polypropylene cartridge. Magnetic Resonance Imaging (MRI)/CT Compatibility The Equi-Flow Valve is made of materials that are known not to interfere with CT scans or MRI imaging. Caution should be exercised to ensure that the device is not connected to components that may contain interfering or non-compatible materials. Materials The entire bottom surface of the Equi-Flow Valve is constructed of barium-sulfate impregnated silicone elastomer. It also contains polyester reinforced sheeting, which is fully encapsulated by silicone elastomer to prevent contact with tissues or fluids. The Equi-Flow Valve is latex free. Materials in contact with body tissues or body fluids are silicone elastomer with or without barium sulfate, polypropylene with or without barium sulfate, silicone ink and stainless steel. Configurations The System is available in different configurations; a system generally consists of a ventricular (proximal) catheter, a valve unit, and a drainage (distal) catheter. The drainage catheter may be integral (attached to the valve) or separate. Some configurations contain a burr hole cap and a burr hole reservoir. Included with the Equi-Flow shunt systems that have a ventricular catheter are one introducing rod (stylet) and one Right-Angle Guide (RAG). 4

5 Ventricular Catheters feature numbered length markers located 5 and 10 cm from the proximal end. Length marker dots are located at 1 cm increments 3 to 14 cm from the proximal end. The proximal end contains fourty (40) flow holes. Distal Catheter are 91 cm silicone elastomer barium sulfate striped tubings. Numbered length markers are located 5, 10, 15, 20, 25 and 30 cm from the distal end to assist catheter placement. The distal end of the catheter has four staggered rows of 5.5-mm slits, which are not easily visible. Burr Hole Reservoirs are made of radiopaque polypropylene and measure 6.4 mm in diameter and 0.8 mm in depth. INDICATIONS The Integra Equi-Flow Valve and Shunt Systems are used in the treatment of patients with hydrocephalus. The device is designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or to the peritoneal cavity. The Equi-Flow Valve is indicated in patients where excessive reduction of intraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the distal catheter of the shunt system. CONTRAINDICATIONS Hydrocephalus shunt systems should not be implanted when the patient has known or suspected infections in the vicinity of any of the implanted components (meningitis, ventriculitis, skin infections, bacteremia, septicemia, peritonitis, etc.). Avoid implanting hydrocephalus shunt systems if infection is present anywhere in the body. Shunting into the atrium of patients with congenital heart disease or other cardiopulmonary anomalies is contraindicated. WARNINGS: Patients with hydrocephalus shunt systems should be closely observed postoperative for signs and symptoms of shunt obstruction or overdrainage of CSF. Obstruction of the shunt system may lead to signs and symptoms of increased intracranial pressure. For an infant, the signs may be increased tension on the fontanelle, congestion of scalp veins, listlessness, drowsiness, nuchal rigidity, irritability, and vomiting. For older patients, the signs may be headaches, vomiting, diminished consciousness, nuchal rigidity, and blurred vision. Overdrainage by the shunt system may lead to signs and symptoms of reduced intracranial pressure and the development of a subdural hematoma, subdural hygroma, or collapse of the lateral ventricular walls leading to obstruction of the Ventricular Catheter. Shunt obstruction or overdrainage requires immediate surgical intervention. The surgeon is advised to use techniques to which he/she is accustomed. The Ventricular Catheter may become bound to the choroid plexus or by fibrous tissue. Use gentle rotation to free it. Forcible removal of the catheter may result in an intraventricular hemorrhage. Placement of the distal catheter into the right atrium of the heart may lead to embolization of the pulmonary arterial tree with resulting corpulmonale and pulmonary hypertension. PRECAUTIONS Patients or their representatives should be informed of the warnings and potential complications associated with use of this device prior to implantation. Avoid cutting or occluding catheter tubing when securing tubing to valve connector with ligatures. Do not kink catheters at any point. Other than trimming catheters or valve tubing, modifications are not recommended. Avoid use of sharp metal instruments when handling silicone components to avoid any damage. If a hypodermic injection into the reservoir is required, use a 25-gauge or smaller beveled needle and only inject into the reservoir dome. Have duplicates of each component available during implantation. Do not lubricate valves. They will be lubricated adequately by the CSF. Avoid contaminants such as glove talc and contact with skin oils when handling tubing. Do not puncture the Siphon Limiting Device with a needle. Do not place the Equi-Flow Valve under the skin of the neck, chest or abdomen. COMPLICATIONS Complications associated with use of this device may be similar to those associated with medication and anesthetic methods used in other surgical procedures, as well as the patient s degree of reaction or sensitivity to any foreign object implanted in the body. Common complications associated with the shunt system itself may include shunt obstruction, infection, mechanical failure of system components, and excessive lowering of intracranial pressure. 5

6 Kinking of the catheters may cause mechanical failure and result in obstruction of the shunt system. Shunt obstructions in the Ventricular Catheter are commonly caused by particulate matter, blood clots, fibrin, tumor cell aggregates, etc. The Ventricular Catheter may become obstructed by being bound by choroid plexus, embedded within the brain, or by coaptation of ventricular walls. Shunt obstructions in the Distal Catheter are commonly caused by particulate matter, blood clots, debris, tumor cell aggregates within the lumen, adhesions surrounding slit openings at the tip, bacterial colonization, or withdrawal of catheter from the atrium or peritoneal cavity due to the growth of the infant or child. Placement of the Distal Catheter into the peritoneal cavity may result in obstruction due to intraluminal debris, investment in the greater omentum or bowel, or perforation of surrounding tissues. Growth of the infant or child may result in Distal Catheter withdrawal from the atrium into the jugular vein or from the peritoneal cavity into tissue planes where fluid cannot be easily absorbed. Local or systemic infection is a common and serious adverse effect of shunt implantation, and is primarily caused by skin contaminations at the surgical wound site. However, infections can also be caused by pathogens circulating in the bloodstream and/or skin lesions arising from irritation and breakdown of skin over the implanted shunt. Ventriculoatrial shunting may predispose the spread of bacteria to other areas of the body including vital organs. Mechanical failure of the shunt system may occur if any components become disengaged or fractured. This may also result in migration of shunt components into the peritoneal cavity, the right atrium, lateral ventricle of the brain, or surrounding areas. Placement of the distal catheter into the right atrium of the heart may lead to embolization of the pulmonary arterial tree with resulting corpulmonale and pulmonary hypertension. The incidence of epilepsy has been reported with the use of hydrocephalus shunt systems. Also, the incidence of seizures has increased with multiple catheter revisions. In the infant, excessive reduction of CSF pressure will cause marked depression of the anterior fontanelle. It may also cause overriding of cranial bones and change communicating into non-communicating hydrocephalus. HOW SUPPLIED Integra Equi-Flow Valve and Shunt Systems are supplied sterile and non-pyrogenic in a double-wrap packaging. This product is for single use only. Do not reuse. This product is sterilized with ethylene oxide. Do not use if the package is open or damaged. Use the device prior to the "Use by" date on the package label. Caution - Do not resterilize. Integra will not be liable for any direct, indirect, incidental, consequential or punitive damages resulting from or related to resterilization. INSTRUCTIONS FOR USE Surgical Procedure The implantation of a shunt system including placement of the Ventricular Catheter, Distal Catheter, and Valve may be accomplished through a variety of surgical techniques. The surgeon is best advised to use the method which his/her own practice and discretion dictate to be best for the patient. It is recommended the valve be placed in a surgically created subgaleal pocket and not under a scalp incision. The valve should not be placed under the skin of the neck, chest or abdomen. Ventricular Catheter Placement It is recommended that catheter insertion is the last step of the shunt placement to minimize CSF loss during the procedure. For systems with burr hole cap and reservoir, the burr hole should be larger than 6.5 mm. A stainless steel sytlet is provided with the catheter, inserted in the central lumen, to assist its introduction into the ventricle. Once the catheter is placed the stylet can be removed from the catheter. If the right angle guide is used, follow these steps: 1. The right angle guide may be used as a marker to plan the depth of catheter insertion. Prior to insertion, slide the right angle guide the approximate desired distance from the proximal tip of catheter. 2. Use the right angle guide to bend the Ventricular Catheter at a right angle where it exits the twist drill or burr hole. 3. After placement of the Ventricular Catheter, press the extracranial portion of the catheter into the split tubular segment of the right angle guide to form a right angle bend. Wetting the catheter with sterile isotonic fluid may facilitate sliding the right angle guide over the catheter. 6

7 4. Secure the right angle guide to surrounding tissue with sutures. Note: If the right angle guide is not used, it may be removed at the time of surgery. It is recommended that the surgeon trim the rim of the twist drill or burr hole to provide a beveled notch for proper catheter curvature. Distal Catheter Patency Check Prior to use, check distal end of catheter to ensure slits are open. This is accomplished through the following: 1. Using thumb and forefinger, hold the section of catheter containing slits. Gently roll catheter slits between thumb and forefinger. 2. Next, hold catheter on both sides of slits, then push slits together. 3. Once again, gently roll slits between thumb and forefinger to ensure all slits are properly seated. To flush Distal Catheter before use, insert a full syringe of sterile fluid (e.g. irrigation water, physiological saline) into proximal end of catheter, and gently flush. A blunt 17-gauge needle may be used if necessary. Distal Catheter Placement During implantation, the proximal end of catheter may be trimmed to the appropriate length required for its particular use (Note: This applies to shunts with a separate Distal Catheter only). The distal end may be trimmed if wall slits are not required. Integra subcutaneous catheter passers are available for tunneling of the catheter. Assembling the Shunt 1. To connect Ventricular Catheter to the valve, insert valve s proximal connector into open end of catheter. For systems with burr hole cap, a burr hole reservoir is provided already connected to the cap: ensure the assembly is correctly connected and insert the ventricular catheter into the burr hole reservoir. Ensure catheter covers the entire connector. 2. Secure the connection with an encircling ligature. Note: If the Distal Catheter is not pre-attached to valve, follow steps 3 and 4 below. 3. Insert valve s distal connector into open end of catheter. Ensure Distal Catheter covers the entire connector. 4. Secure the connection with an encircling ligature. Injection The reservoir is designed to allow penetration with a 25-gauge, or smaller, beveled needle. The reservoir contains a polypropylene needle guard to prevent overpenetration of the needle. The valve membrane is protected from needle punctures by a polypropylene cartridge. However, care should be taken to avoid this area when inserting a needle. Puncturing the valve membrane may affect the pressure/flow characteristics of the valve. Note: Neither catheter tubing nor occluders should be used as injection sites. CAUTION: Low tear strength is a natural property of most non-reinforced silicone materials. Use care during insertion and removal of the needle. Insert needle at an angle approximately 45 from the scalp or base of the valve. If valve reservoir is to be punctured several times, insert needle at different locations to avoid multiple punctures at a single point. Take care not to puncture the Siphon Limiting Device. Flushing the Valve 1. To flush CSF from valve in both distal and proximal directions, use finger pressure to transcutaneaously depress the reservoir. 2. To flush in one direction only, depress the occluder opposite the reservoir from the catheter to be flushed, and pump reservoir. Note: A reservoir dome with noticeable resistance to compression could indicate an occluded catheter. CAUTION: Avoid unnecessary testing and pumping of valve. Frequent pumping can lead to overdrainage of the ventricles, particularly if ventricle size is small. Pre-Implant Valve Patency Test 1. Place inlet connector of valve into sterile fluid (e.g. irrigation water, physiological saline). 2. Repetitively depress reservoir until fluid flows from valve s outlet connector. Valve is patent if fluid flows from outlet connector with each press of the reservoir. 3. Ensure diaphragm of Siphon Limiting Device opens completely. If diaphragm does not open completely, gently squeeze sides of Siphon Limiting Device and repeat test. 7

8 4. Finally, be sure to remove all large bubbles from the shunt system. It is not necessary to remove small bubbles. Note: If Distal Catheter slits are stuck together, fill the shunt system with sterile fluid, then roll slits gently between fingers to lubricate and open the slits. Note: To perform an alternative patency test, attach a syringe to the valve s proximal inlet connector and gently flush with sterile fluid. Pre-Implant Valve Pressure Test Every Integra Equi-Flow Valve is individually tested to ensure it meets rigorous specifications and pressure/flow characteristics. If, however, the surgeon wishes to verify the closing pressure of the valve is as stated in the specifications, the following procedure may be performed in the operating room. CAUTION: Use extreme care to maintain sterility and avoid particulate contamination. Equipment needed (sterile) 1. Fluid reservoir or water bath cm or larger manometer, graduated in centimeters wih a 3-way stopcock cc 60 cc syringe 4. Tubing 5. Blunt needle to connect syringe to tubing 6. Sterile distilled water or physiological saline Test procedure 1. Connect tubing to both sides of the manometer. 2. Place one tube into water bath. 3. Align the manometer so the zero mark is level with fluid in the water bath. 4. Purge all air from system by flushing with syringe. 5. Attach the proximal connector of valve to be tested to the tube submerged in water bath. 6. Gently flush valve with sterile fluid and submerge completely in the water bath. 7. Fill manometer to approximately 30 cm H 2 O. 8. While maintaining a gentle flow of fluid through valve using the syringe, isolate syringe from valve with the 3-way stopcock. 9. The water column will begin to fall as fluid flows through valve. After minutes, read fluid level in manometer. The valve must be submerged in the water bath to obtain the correct results. Closing Pressure Results Performance Level (Regular or Small) Acceptable Closing Pressure Flow Rate cm H 2 O cm H 2 O cm H 2 O cm H 2 O Fig. 2 Pressure/Flow Characteristics Performance Level ml/hr, 0 cm H 2 O Hydrostatic Pressure 1-4 cm H 2 O 1-7 cm H 2 O cm H 2 O 6-13 cm H 2 O 50 ml/hr, 0 cm H 2 O Hydrostatic pressure 5 ml/hr, -50 cm H 2 O Hydrostatic Pressure 50 ml/hr, -50 cm H 2 O Hydrostatic Pressure Valve Marking 2-6 cm H 2 O 2-9 cm H 2 O cm H 2 O 8-14 cm H 2 O cm H 2 O cm H 2 O cm H 2 O cm H 2 O cm H 2 O cm H 2 O cm H 2 O 8-17 cm H 2 O Fig. 3 8

9 PRODUCT INFORMATION DISCLOSURE INTEGRA HAS EXERCISED REASONABLE CARE IN THE SELECTION OF MATERIALS AND THE MANUFACTURE OF THESE PRODUCTS. INTEGRA EXCLUDES ALL WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. INTEGRA SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM USE OF THIS PRODUCT. INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME FOR IT ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS. Returned Goods Policy Products must be returned in unopened packages with manufacturer s seals intact to be accepted for replacement or credit unless returned due to a complaint of product defect. Determination of a product defect will be made by Integra. Products will not be accepted for replacement if they have been in the possession of the customer for more than 90 days. Product Order Information All products can be ordered through your Integra NeuroSpecialist or customer service representative or by contacting: Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536, USA Telephone: Outside the US: Fax: Integra NeuroSciences Implants S.A Route des Dolines Sophia Antipolis cedex, France Telephone: Fax: Integra NeuroSciences Ltd Newbury Road Andover Hampshire SP10 4DR, England Telephone: +44 (0) Fax: +44 (0)