Johnson & Johnson Codman MedStream User manual

Surgical Technique Guide
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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. prep kit.
The pump must be connected to a suitable intraspinal catheter.
The following intraspinal catheters are designed for use with the
MEDSTREAM pump:
CODMAN®Intraspinal Catheter Kit
SURESTREAM™Intraspinal Catheter Kit
This guide covers the implantation of the SURESTREAM™Intraspinal
Catheter. For instructions on implantation of the CODMAN®
Intraspinal Catheter, please refer to its instructions for use.
The MEDSTREAM Control Unit is an external part of the system that is
required to prepare the pump for implantation, and to program the daily
dosage postoperatively. The control unit uses radio frequency to create
two-way communication with the pump. It is used to retrieve status
information from and transmit programming changes to the pump.
The control unit also must be used each time the reservoir is refilled.
CAUTION: Do not implant the MEDSTREAM Pump without ensuring
a thorough familiarity with the information contained in this manual,
the Control Unit instructions and the MEDSTREAM Programming Guide.
CONSULTING PHYSICIANS
Robert M. Levy, MD, PhD
Neurological Surgery
Northwestern University Hospital
Chicago, IL
Timothy R. Deer, MD
Anesthesiology, Pain Medicine
Center for Pain Relief
Charleston, WV
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PATIENT POSITIONING AND PREPARATION Page 3
PREOPERATIVE PUMP PREPARATION Page 3
PLACE THE INTRASPINAL CATHETER Page 4
PREPARE THE PUMP Page 9
PREPARE THE PUMP POCKET Page 10
TUNNEL THE INTRASPINAL CATHETER Page 11
TO THE PUMP POCKET
PREPARE THE CATHETER CONNECTION Page 12
PLACE AND SECURE PUMP Page 14
POSTOPERATIVE PROGRAMMING Page 15
ESSENTIAL PRESCRIBING INFORMATION Page 16
Surgical Technique Guide
MEDSTREAM™PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide
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SUPPLIES NEEDED FROM CODMAN
MEDSTREAM Implantable Pump (20 mL or 40 mL)
MEDSTREAM OR Prep Kit
CODMAN Pump Catheter
MEDSTREAM Control Unit
SURESTREAM™Intraspinal Catheter
CODMAN Tunneler
PREOPERATIVE PLANNING
Identify pump location before surgery with patient.
The pump is usually located between costal margin and
iliac crest however optimal placement is patient specific.
Draw position on skin while patient stands or sits upright.
Avoid positioning the incision line directly over refill
septum.
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PATIENT POSITIONING
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.
Sterile drapes should be applied.
PREOPERATIVE PUMP PREPARATION
Follow the pump preparation procedure detailed in the
MEDSTREAM Pump Instructions for Use.
Using the MEDSTREAM Control Unit, perform the pump
internal check and ensure that pump is deemed ready for
implant.
MEDSTREAM™PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide
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POSITION THE SPINAL NEEDLE
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 to 2 cm off of midline and
½ to 1 ½ vertebral levels below the targeted
interlaminar space.
Note:
In patients with difficult spinal anatomy, the
needle angle may need to be adjusted.
ALTERNATIVE TECHNIQUE:
A small incision, centered around the desired needle
entry point, may be made before needle insertion.
STEP 1. Place the Intraspinal Catheter
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ENTER THE INTRATHECAL SPACE
Advance the needle until the dura is penetrated.
Remove the needle stylet to observe cerebrospinal fluid
(CSF) backflow and confirm intrathecal location.
Replace needle stylet to prevent CSF leakage.
Caution:
If parathesia occurs, redirect the needle to avoid
neural injury.
If the patient develops neurological signs or
symptoms, discontinue.
If excessive bleeding is encountered, stop and
reevaluate.
INSERT THE INTRASPINAL CATHETER
When the needle position is properly located and
confirmed by fluoroscopy, remove the stylet. Orient the
needle bevel cephalad and thread the distal tip of
catheter through the needle.
When the wide marker band on the catheter is at the
hub of the needle, the catheter tip is at the tip of the
needle. A slight increase in advancement pressure may
be noted.
Advance the catheter with the guidewire to the desired
location in the intrathecal space.
Markers are provided on the SURESTREAM catheter in
centimeter increments.
Caution:
Pulling back on the guide wire while the catheter
and guide wire are still inserted in the Touhy
needle may damage the catheter.
MEDSTREAM™PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide
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MAKE A SKIN INCISION
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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REMOVE NEEDLE AND GUIDE WIRE
Carefully remove the needle tip from the fascia.
Gently tighten the purse-string suture around the
catheter taking care not to occlude or kink the catheter.
Before removing the guide wire, grasp the catheter near
the fascial exit site and carefully slide the needle to the
end of the catheter.
Remove the guide wire and needle from the catheter
simultaneously.
MEDSTREAM™PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide
PLACE PURSE-STRING SUTURE
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.
The purse-string suture will help the surrounding tissue
fibrose and may reduce the likelihood of CSF leakage,
subcutaneous CSF collection and/or postoperative
headache.
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TEST FOR INTRASPINAL CATHETER PATENCY.
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.
ALTERNATIVE TECHNIQUE:
Insert the proximal end of the catheter into the
SNAPLOCK™Adaptor until the catheter bottoms out.
While maintaining the catheter position, tighten the
adaptor by squeezing the black collar toward the luer
hub until the gap between the pieces is closed.
To ensure that the connection is secure, gently tug the
catheter near the adaptor.
Attach a 10ml syringe filled with preservative free saline
and flush the catheter to test for patency.
Replace the SNAPLOCK™cap to prevent CSF leakage.
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