1. Synchromed II programmable implantable drug pump
Medtronic Neuromodulation

2. Learning Objectives Describe the N’Vision® Clinician Programmer
Describe the Synchromed II programming strategy
Demonstrate programmer functions
Exercises
Practice using clinician programmer functions

3. Intrathecal Therapy Why? Drug dose intrathecally 1/300th oral
Minimise side effects and reduce systemic dose and oral meds
Programmable pump allows varied infusion rates/regimens to reflect pain pattern
Cost-effective
Treatment of chronic pain by using intrathecal drug therapy compared with conventional pain therapies: a cost-effectiveness analysis.
Kumar K, Hunter G, Demeria DD. J Neurosurg Oct;97(4):803-10

4. Intrathecal Therapy Synchromed II Pump Indications
Chronic infusion of Lioresal™ Intrathecal (baclofen injection) for the management of severe spasticity of spinal or cerebral origin
Chronic intrathecal or epidural infusion of sterile, preservative-free morphine sulfate for chronic, intractable pain of malignant and/or non-malignant origin
Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain
Medtronic Synchromed II Infusion System: Information for Prescribers.

5. Intrathecal Therapy – In reality….
Multiple-drug combinations for pain are common
Baclofen is used in multiple dilutions
500, 1000, 1500, 2000, 3000mcg/ml
Polyanalgesic Consensus Conference 2012: recommendations for the management of pain by intrathecal (intraspinal) drug delivery: report of an interdisciplinary expert panel.
Deer TR, Prager J, Levy R, Rathmell J, Buchser E, Burton A, Caraway D, Cousins M, De Andrés J, Diwan S, Erdek M, Grigsby E, Huntoon M, Jacobs MS, Kim P, Kumar K, Leong M, Liem L, McDowell GC 2nd, Panchal S, Rauck R, Saulino M, Sitzman BT, Staats P, Stanton-Hicks M, Stearns L, Wallace M, Willis KD, Witt W, Yaksh T, Mekhail N.
Neuromodulation Sep-Oct;15(5):436-64; discussion doi: /j x. Epub 2012 Jul 2.

6. Synchromed II Overview
System Components:
Programmable pump
20 and 40ml reservoirs
Catheter
One or two piece
Physician Programmer

7. The Pump Catheter Access Port (CAP) 2 D barcode (tracking)
Test hole (used to test top shield weld integrity)
Refill Port
Suture Loops
© Medtronic Inc Version 1.0

8. Inside Synchromed II… Internal tubing Peristaltic pump Motor Battery
Refill Port
Hybrid
Reservoir

9. Ascenda Catheter Design: Summary of Benefits
Polyurethane Outer Layer
Resistance to leaks and breaks
Silicone Inner Layer
Drug compatible
PET stands for polyester per design engineer Amy Gjoraas
Thermoplastic PET Braid
Six times stronger than our previous silicone catheters
Offers improved resistance to kinking and occlusions

10. Implantable components SynchroMed® II infusion pump
Stores and precisely delivers baclofen at rate tailored to each individual patient
Wide range of programmable parameters and modes
Prescriptions can be programmed for combinations of bolus and continuous infusion doses
Battery-powered:
Longevity up to 7 years at 0.9 ml/day
Two reservoir sizes:
20 and 40 ml
Thin profile with contoured shape for comfort:
Width 20 vs. 40 ml pump: 19.5 mm vs. 26 mm
Contains alarm to indicate need for refill or pump replacement
Abbreviations
ITB = intrathecal baclofen
CAP = catheter access port
CSF = cerebrospinal fluid

11. Implantable components How SynchroMed® II infusion pump works
Bellows design allows reservoir to expand/contract according to drug volume
At normal body temperatures:
Pressurized gas in space below reservoir expands and exerts constant pressure on reservoir
Drug advances into pump tubing
Battery-powered electronics and motor cause roller arm in peristaltic pump to rotate
Precisely pushes programmed dose through catheter port and into catheter
Valve protects pump reservoir from being over-filled or over-pressurized
CAP allows direct access to catheter and CSF and may be used for diagnostic tests
Catheter Access Port (CAP) has funneled design that only allows 24-gauge or smaller needle to pass through
Safety feature that helps prevent inadvertent access during pump refill procedures (uses 22-gauge needle)
Equipped with suture loops to secure pump in pocket site
Abbreviations
ITB = intrathecal baclofen
CAP = catheter access port
CSF = cerebrospinal fluid

12. Implantable components Catheter
Thin, elastic and flexible tube
Delivers baclofen from pump to intrathecal space
Made of durable radiopaque silicone rubber
Trimmable at pump end of placed catheter
Sutureless pump connector
Facilitates connection to pump
Spinal end of catheters has closed tip and side holes for drug delivery
Marked at 1-cm increments to aid catheter placement
Guide wire in lumen:
Provides additional stiffness and catheter tip control during placement
Abbreviations
ITB = intrathecal baclofen
CAP = catheter access port
CSF = cerebrospinal fluid

13. Synchromed II – in detail (2)
Programming options
Simple continuous, flexible dosing, patient activated bolus, minimum infusion rate
Pump data log
Patient demographics, drug details, catheter information, time stamped event log
MRI Compatibility
Up to 3 Tesla
Alarm functions
Critical alarm: end of service, empty reservoir, stalled pump, critical memory error, stopped pump duration exceeded
Non-critical alarm: low reservoir, elective replacement indicator (90 days pre-EOS)

14. Programming options Simple Continuous mode Single bolus - continuous
Details of modes and boluses covered in the SynchroMed II and SynchroMed EL programming modules.
Flex mode

15. External component N’Vision® programmer
Handheld portable device
Allows physicians to program pump and tailor therapy to patient
Weighs 680 g
Uses AA batteries
Contains:
Touch screen display with icon-based navigation for data entry
Telemetry module for device programming
Integrated calculator
Infrared port through which communications can be established with compatible printers
Single programming platform
N’Vision offers single programming platform for all of Medtronic’s implantable drug delivery and neurostimulation devices
Patient therapy manager (PTM) also available with SynchroMed II
However, although CE mark for PTM is broad and covers ITB Therapy, actual clinical experience is low
PTM for ITB currently not recommended due to lack of substantial clinical data or practical experience

16. N’Vision® Programmer
N’Vision clinician programmer communicates with pump via telemetry
Radio-frequency (RF) communication
SynchroMed® EL pump requires Model 8529 magnet
Attaches to programming head

17. N’Vision® Programmer The pump is programmed during:
System implant (initial pump fill)
Patient management
Optimize therapy
Pump refill with same drug and drug concentration
Change drug or drug concentration
Troubleshooting

18. Programming Features SynchroMed® II Pump SynchroMed® EL Pump
Full patient information
Includes name and address
Pump serial and model numbers
Catheter information
Model number
Catheter volume
Drug information
Name (25 characters)
Concentration
Infusion prescription
Calibration constant
Notes
Event logs
Note: Telemetry takes seconds because of the amount of information transmitted
Patient ID (3 characters)
Pump model number
Drug Information
Name (5 characters)

19. Programming Features
Alarms—Pump sounds an alarm when certain events occur:
SynchroMed II® Pump
SynchroMed® EL Pump
Critical alarm—3-second, 2-tone
Empty reservoir
End of Service (EOS)
Motor stall
Stopped pump exceeds 48 hours
Critical pump memory error
Non-critical alarm—1-second, single-tone
Low reservoir volume reached
Elective Replacement Indicator (ERI)
Non-critical pump memory error
1-tone alarm
Low battery
2-tone alarm
Pump memory error

20. Calibration Constant
Number of electrical pulses required for specific pump to dispense one mcL (µL) of fluid
Specific value for each pump determined during manufacturing
Displayed on Pump Status screen of N’Vision® clinician programmer
Verify before implant
Match calibration constant printed on pump package
Troubleshoot pump
Match calibration constant written in patient record or printed on patient ID card

21. Prepare for Programming Session
Ensure software application card is inserted
Turn the programmer on
Check programmer battery status
Install batteries if needed
Select the Pump Application button
To turn the programmer on or off: Slide and momentarily hold the POWER key on the side of the programmer.

22. Prepare for Programming Session
Select Synchromed II demo
Select Interrogate

23. Overview Screen This screen shows: Minimise screen using small cross
Pump in shelf state (for a new pump), serial number, model number and calibration constant.
Minimise screen using small cross

24. Questions?