Johnson & Johnson Codman MedStream Surgical Technique Manual

Surgical Technique Guide

The MEDSTREAM Programmable Infusion System is intended for

the intrathecal delivery of selected drugs for pain management or

CONSULTING PHYSICIANS

Robert M. Levy, MD, PhD

Neurological Surgery
Northwestern University Hospital
Chicago, IL

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

This guide covers the implantation of the SURESTREAM

Catheter. For instructions on implantation of the CODMAN

®

Intraspinal Catheter Kit

SURESTREAM

™

Intraspinal Catheter Kit

™

Intraspinal

®

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.

Timothy R. Deer, MD

Anesthesiology, Pain Medicine
Center for Pain Relief
Charleston, WV

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.

MEDSTREAM™PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide

Surgical Technique Guide

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

SUPPLIES NEEDED FROM CODMAN

PREOPERATIVE PLANNING

MEDSTREAM Implantable Pump (20 mL or 40 mL)

MEDSTREAM OR Prep Kit
CODMAN Pump Catheter

MEDSTREAM Control Unit

™

SURESTREAM

CODMAN Tunneler

Intraspinal Catheter

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.

2

MEDSTREAM™PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide

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.

3

STEP 1. Place the Intraspinal Catheter

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.

4

MEDSTREAM™PROGRAMMABLE INFUSION SYSTEM Surgical Technique Guide

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.

INSERT THE INTRASPINAL CATHETER

If excessive bleeding is encountered, stop and
reevaluate.

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.

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.

6