Johnson & Johnson Codman MedStream Bedienungsanleitung

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

492192.QX7:Layout 1 4/14/09 4:08 PM Page 3

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

492192.QX7:Layout 1 4/14/09 4:09 PM Page 1

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

492192.QX7:Layout 1 4/14/09 4:09 PM Page 5

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.

492192.QX7:Layout 1 4/14/09 4:09 PM Page 7

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.

492192.QX7:Layout 1 4/14/09 4:09 PM Page 8

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