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The MEDSTREAM Programmable Infusion System is intended for the intrathecal delivery of selected drugs for pain management or spasticity management. The implantable components of the system include the infusion pump, pump catheter, connector and strain-relief sleeve. The accessories needed to prepare the pump for implantation are included with the pump in the O.R.
MEDSTREAM ™ PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide Surgical Technique Guide PATIENT POSITIONING AND PREPARATION Page PREOPERATIVE PUMP PREPARATION Page PLACE THE INTRASPINAL CATHETER Page PREPARE THE PUMP Page PREPARE THE PUMP POCKET Page 10 TUNNEL THE INTRASPINAL CATHETER Page 11 TO THE PUMP POCKET PREPARE THE CATHETER CONNECTION Page 12...
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SU P P LIE S N E E D E D FR OM CO DM AN MEDSTREAM Implantable Pump (20 mL or 40 mL) MEDSTREAM OR Prep Kit CODMAN Pump Catheter MEDSTREAM Control Unit SURESTREAM ™ Intraspinal Catheter CODMAN Tunneler PRE O P E R AT I VE P L A N N I NG Identify pump location before surgery with patient.
MEDSTREAM ™ PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide PATIEN T P OS IT I O N I N G Place patient in a right or left lateral decubitus position with the lumbar region slightly flexed. The skin should be prepared using an appropriate antimicrobial solution over the desired area in the back, flank, chest, and lower abdomen where the catheter will be tunneled to the pump.
STEP 1. Place the Intraspinal Catheter PO S IT I ON T H E SP I N A L NE E DL E Under fluoroscopy, insert the 17 gauge Touhy needle using a shallow, oblique paramedian insertion technique. The skin entry point will be parallel to the vertebral pedicle, approximately ½...
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MEDSTREAM ™ PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide ENTE R T H E IN T R AT H E C A L S PAC E Advance the needle until the dura is penetrated. Remove the needle stylet to observe cerebrospinal fluid (CSF) backflow and confirm intrathecal location.
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M A KE A S K IN IN C I SI O N Make an incision centered at the needle insertion site. Expose an area of the fascia that is large enough to place the catheter anchor.
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MEDSTREAM ™ PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide PL ACE P U R S E -S T R I N G S U T U RE Place a purse-string suture through the lumbo-dorsal fascia and around the catheter. The purse-string suture should be placed before removing the Touhy needle.
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TE S T FOR IN T R A S P I N A L CAT HE T E R PAT E NC Y. Catheter patency may be confirmed by observing continuous CSF backflow through the catheter. If CSF backflow is inadequate, patency may be tested via saline injection detailed in the alternative technique.
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MEDSTREAM ™ PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide AN CHOR I N T R A S P I N A L C AT HE T E R T O T HE FA S CI A Attach the silicone anchor to the catheter where the catheter enters the lumbo-dorsal fascia.
STEP 2. Prepare the Pump AT TA C H T H E P U M P C AT HE T E R Aseptically deliver the pump and pump catheter to a sterile surface. Firmly press the catheter’s silicone connector onto the pump’s catheter port.
MEDSTREAM ™ PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide STEP 3. Prepare the Pump Pocket CON S ID E R T H E FO LL O WI NG B E FO RE P LA CI N G T HE P U MP The pump should be no more than 2.5 cm from the surface of the skin.
STEP 4. Tunnel the Intraspinal Catheter to the Pump Pocket CR E AT E S U B C U TA N E O US TU NNE L Bend the tunneler to conform to the patient’s contour. Insert the tunneler through the pump pocket wound and advance to the intraspinal catheter exit wound in the back.
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MEDSTREAM ™ PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide STEP 5. Prepare Catheter Connection TRIM T H E C AT H E T ER S Trim the MEDSTREAM pump catheter and the SURESTREAM catheter to the desired lengths. Provide sufficient slack in the pump catheter to allow the catheter to be coiled at least once under the pump.
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CO NN E C T T H E M E D S T RE AM P UM P C AT H E TE R TO T H E S U R E S T R E A M C O N NE CT O R Slide the small diameter end of the strain relief sleeve approximately 4 cm over the pump catheter.
MEDSTREAM ™ PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide STEP 6. Place and Secure Pump SECU R E T H E P U M P WI T H S UT UR E L O OP S Firmly secure the pump using heavy non-absorbable suture in a minimum of three of the four available suture loops.
Step 7. Post Operative Programming Refer to the MEDSTREAM Pump Instructions for Use and the MEDSTREAM Programming Guide for detailed programming instructions.
Essential Prescribing Information MEDSTR EAM ™ Pro g ram ma b le In fu s io n S ys tem E ssen tial Prescribi n g I n fo rm atio n : Product instructions for use and appropriate drug labeling must be reviewed prior to use for detailed disclosure.
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MEDSTREAM ™ PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide CONTAC T INFOR MAT IO N Ge rman y Johnson & Johnson MEDICAL GmbH Geschäftsbereich Codman Oststrasse I D-22844 Norderstedt e-Mail: codinfo@its.jnj.com Marketing and Vertrieb: Telefon: +49 040-5297 4614 Telefax: +49 040-5297 4617 Auftragsbearbeitung: Telefon: +49 01801-000 829 Telefax: +49 0800-1016 138...
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