Model 8709SC and Model 8731SC Intrathecal Catheters • Balanced blend of product and technique improvements • Simple, intuitive sutureless catheter connections • Fewer implant steps.
Download ReportTranscript Model 8709SC and Model 8731SC Intrathecal Catheters • Balanced blend of product and technique improvements • Simple, intuitive sutureless catheter connections • Fewer implant steps.
Slide 1
Model 8709SC and Model 8731SC
Intrathecal Catheters
• Balanced blend of product and
technique improvements
• Simple, intuitive sutureless
catheter connections
• Fewer implant steps
Slide 2
Sutureless Pump Connector
Clinical Training
Slide 3
Technology
• Simple, intuitive operation
– “Squeeze on, squeeze off” technology
– Works without catheter connector sutures
• Strong robust design
– Physiological testing (daily living and traumatic events)
• Tactile
– Can feel engagement fingers snapping in place
• Silicone boot
– Covers the entire connector
Slide 4
Sutureless Connector
Requirements Testing
•Impact Testing
5 connectors taken to failure by increasing the impact load until the connector
disconnected. All 5 connectors stayed connected up to the limits of the test
machine. Impact magnitudes ranged from 68 lbs – 87.7 lbs (3X requirement)
•Cyclic Testing
6 connectors were cycled to 6X the cyclic requirement. 5 of 6 stayed
connected at 6X cycles (2,004,326), and 1 of 6 disconnected at 5X cycles
(1,521,575).
Slide 5
Device Benefits
• Simple connection eliminates:
– Suturing
– The pinch and push implant technique used with the existing 8709
and 8731 pump connectors
• Other features:
– 8731SC catheter is now packaged with an extra Tuohy needle for
smaller patients
– Pump segment of the 8731SC catheter is now trimmable at the most
distal end (an extra connector pin is included in the catheter package)
– 8709SC now offers convenient, numerical markings to help identify
catheter insertion depth/length
Slide 6
Sutureless Pump Connector Interface
Components (Models 8709SC and 8578)
Sutureless
Connector
Strain-Relief
Sleeve
Connector
Pin
7.6 cm Length
Slide 7
Catheter Comparison
8709
8709SC
8731
8731SC
TOTAL LENGTH
89 cm
89 cm
104.1 cm
104.1 cm
SPINAL SEGMENT
89 cm
81.4 cm
38.1 cm
38.1 cm
PUMP SEGMENT
NA
7.6 cm
66.0 cm
66.0 cm
CONNECTOR PIN
NO
YES
YES
YES
PIN TYPE
NA
Sutureless
Suture
Grooves
Suture
Grooves
INTRODUCER NEEDLE
15 Gauge
Tuohy
15 Gauge
Tuohy
15 Gauge
Tuohy
15 Gauge
Tuohy
NEEDLE LENGTH
9.3 cm
9.3 cm
11.4 cm
11.4 cm
9.3 cm
NUMERIC MARKINGS
No
Yes
Yes
Yes
TRIMMABLE SEGMENTS
Spinal
Spinal
Spinal
Spinal
Pump
Slide 8
Sutureless Pump Connector Operation
STEP 1
With a thumb and forefinger, grasp the ovals on the tapered portion of
the pump connector.
STEP 2
At the pump pocket site, position the opening of the Sutureless Pump
Connector in line with the catheter port of the pump.
STEP 3
Firmly press the pump connector onto the catheter port until the
connector snaps into place or firmly squeeze on the oval marks of the
pump connector and carefully press onto the catheter port.
STEP 4
Confirm that the connector is properly attached by grasping the tapered
portion of the connector and tugging as if to remove the connector from
the pump. The connector should feel firmly attached.
Slide 9
Programming Scenarios
• Scenario 1 – 8709SC Implant
• Scenario 2 – 8731SC Implant
• Scenario 3 - Replacement
Slide 10
Programming Scenario #1: 8709SC Implant
A patient is implanted with a SynchroMed® II
pump using an 8709SC Catheter.
Step
Step1:
1: Select the 8709 Catheter from the
Catheter Information dropdown.
Step
Step2:
2: Enter 15 cm removed.*
An implanted Length of 74 cm and a Total
Catheter Volume of 0.163 mL are
automatically calculated by the N’Vision®
programmer.
*Remember the 8709SC has the same overall
length as the 8709.
Slide 11
Programming Scenario #2: 8731SC Implant
A patient is implanted with a SynchroMed® II pump
using an 8731SC Catheter. 11 cm have been
removed from the distal section at implant.
Step
Step 1:
1: Select the 8731 Catheter from the Catheter
Information dropdown.
Step
Step 2:
2: Enter 0 cm removed from the
Proximal Section.
Step
Step 3:
3: Enter 11 cm removed from the Distal
Section.
An Implanted Distal Length of 27.1 cm, an
implanted Proximal Length of 66 cm, and a Total
Catheter Volume of 0.205 mL are automatically
calculated by the N’Vision® programmer.
Slide 12
Programming Scenario #3: Replacement
A patient’s SynchroMed EL® pump is replaced with a
SynchroMed® II pump using an 8578 Sutureless Connector
Revision Kit. The patient was previously implanted with an
8709 Catheter (89 cm implanted catheter length).
The new 8578 Sutureless Connector Revision Kit will add 7.6
cm to the existing/previously implanted catheter length (89
cm+7.6 cm=96.6 cm).
Step 1:
Step 2:
Step 3:
Step 4:
Select a New Single Piece from the Catheter
Information dropdown.
Enter an implanted catheter volume of 0.0022 in
the mL/cm field.
Enter an implanted length of 96.6 cm in the Length
field.
Enter 0.0 removed at the Removed field.
An implanted length of 96.6 cm and a Total Catheter Volume
of 0.213 mL are automatically calculated by the N’Vision®
programmer.
Slide 13
Model 8709SC and 8731SC
Intrathecal Catheter Features
Slide 14
Numbered markings and pre-attached
pump connector
8731SC Spinal Segment
Sutureless Pump
Connector
Slide 15
Pre-attached catheter anchor/connecting
pin with sutureless catheter connections
8731SC
Sutureless strain
relief sleeve (spinal)
Pre-attached
sutureless pump strain
relief sleeve
Pre-attached catheter
anchor/connecting pin
Slide 16
Longer introducer needle with markings
and catheter passer
Tip, Obturator end and catheter mating
Slide 17
Impact of catheter complications
Catheter related complications:
• Range in incidence from 10-89%
• Reported in most clinical studies as occurring in
approximately 20-25% of implanted systems
• May place patient at risk for adverse events
(e.g., from abrupt cessation of intrathecal drug therapy)
• Are a source of inconvenience to the physician and patient
• Diminish the cost-effectiveness of the therapy
Source: Follett KA. Naumann CP. A Prospective Study of Catheter-Related Complications of Intrathecal Drug Delivery
Systems. J Pain and Symptom Management 2000;3:209-215.
Slide 18
Potential impact of
catheter complications
# of new patients
implanted/year
20,000
Catheter complication rate
25%
Estimated # of catheter revisions/
repairs per year
5,000
Average cost per catheter
revision/repair
Total annual cost of catheter
revisions/repairs
$10,000
$50,000,000
Slide 19
Impact of catheter complications
on therapy adoption
Catheter
Complications
Referring or
Managing
Physician
Patient
Other
Physicians
Other
Patients
Scientific
Conferences
Internet Chat
Rooms
Medical
Journals
Family &
Friends
=
Therapy
Adoption
Slide 20
Technique variations
Medtronic Sponsored Clinical Study #1
Catheter Complication Rates By Center
60.0
56.3
53.8
55.6
50.0
50.0
Percent
40.0
35.0
30.0
30.0
22.2
20.0
26.7
15
16
20.0
16.7
16.7
14.3
25.0
10.0
6.7
5.9
5.0
0.0
1
4
5
6
Europe
7
8
9
10
2
Centers
3
11
12
1
14
North America
Source: Follett KA. Naumann CP. A Prospective Study of Catheter-Related Complications of Intrathecal Drug Delivery
Systems. J Pain and Symptom Management 2000;3:209-215.
Slide 21
Technique variations
Medtronic Sponsored Clinical Study #2
Catheter Complication Rate By Center
100.0
100.0
90.0
80.0
75.0
Percent
70.0
60.0
60.0
50.0
40.0
30.0
25.0
25.0
17.6
20.0
25.0
14.8
10.0
0.0
0.0
1
2
3
Europe
4
5
25.0
14.3
7.1
4.8
6
0.0
7
8
0.0
9
36.4
33.3
33.3
9.1
0.0
0.0
10 11 12 13 14 15 16 17 18 19 20 21
Centers
US
Source: Follett KA. Naumann CP. A Prospective Study of Catheter-Related Complications of Intrathecal Drug Delivery
Systems. J Pain and Symptom Management 2000;3:209-215.
Slide 22
Catheter complications from three
Medtronic sponsored clinical studies
Total Complication Rate in 3 Clinical Trials ~ 20%
7.0%
6.1%
% of Patients Affected
6.0%
5.1%
5.0%
4.0%
3.0%
4.0%
3.0%
2.0%
1.0%
0.7%
0.4%
0.3%
0.3%
0.1%
0.1%
0.1%
0.0%
Source: Follett KA. Naumann CP. A Prospective Study of Catheter-Related Complications of Intrathecal Drug Delivery
Systems. J Pain and Symptom Management 2000;3:209-215.
Slide 23
Primary Sources of Catheter Complications
Catheter fracture from midline needle placement
Midline
Slide 24
Primary Sources of Catheter Complications
Catheter fracture in introducer needle
• Pulling the catheter back
through the introducer needle
may shear or create holes in
the catheter
Sheared
Catheter
Slide 25
Primary Sources of Catheter Complications
Catheter kinks
Slide 26
Primary Sources of Catheter Complications
Catheter holes
Pump connector pin
Slide 27
Primary Sources of Catheter Complications
Catheter dislodgements
Slide 28
Complication research outcomes
Major Findings:
Fractures
– Occur in spinous process area with midline catheter placement
– Occur when catheter is withdrawn through needle
Kinks
– Occur at connections and anchors from lack of slack or not using a strain
relief sleeve
Holes
– Occur due to missing or failed strain relief sleeve at pump connector on
one-piece Catheter
– Several reports of small holes in one-piece catheter under pump. No
reports of holes under the pump with the two-piece catheter
Dislodgements
– Occur from pump movement and lack of catheter slack at pump causing
the catheter to slip through anchor
– Occur from ligament motion or CSF pressure and no anchor or purse
string suture at fascial entry point
Source: Data on file at Medtronic.
Slide 29
Implant technique consensus statement
Authored by:
Dr. Ken Follett
Dr. Kim Burchiel
Dr. Tim Deer
Dr. Stuart DuPen
Dr. Joshua Prager
Dr. Michael Turner
Dr. Robert Coffey
Slide 30
Low Complication Catheter
Implant Technique
Source: Retrospective analysis data on file at Medtronic. “Prevention of Intrathecal Drug Delivery CatheterRelated Complications,” Neuromodulation, February 2003.
Slide 31
Overview for low complication
implant technique
Source: Data on file at Medtronic.
Slide 32
Prep the patient
Image courtesy of Dr. Joseph Dunn and Dr. Peter Kosek, Pain Consultants of Oregon, Eugene, OR.
Slide 33
Place the needle
Spinous Processes
Pedicles
Needle
Slide 34
Place the needle – continued
~ 30°
Paramedian Oblique
Slide 35
Place the needle – continued
Slide 36
Thread the catheter through the needle
Introducer Needle Catheter
Slide 37
Thread the catheter
through the needle – continued
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 38
Cut down to the lumbo-dorsal fascia
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 39
Undermine the incision
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 40
Remove the needle and guide wire
Introducer Needle
Guide Wire Handle
Slide 41
Place the anchor (8709SC Catheter)
90 Degree
Anchor
Straight
Anchor
V-wing
Anchor
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 42
Using the V-wing Anchor with
the 8731SC Catheter
2 Suture
Points
Place the V-wing anchor as
close as possible to the
fascia entry point.
Secure the V-wing anchor wings
together at the notch and secure
to the lumbo-dorsal fascia.
Slide 43
Prepare the pump pocket
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 44
Tunnel and pass the catheter
Image Courtesy of Dr. Joseph Dunn and Dr. Peter Kosek, Pain Consultants of Oregon, Eugene, OR.
Slide 45
Trim the distal catheter
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 46
Anchor the connector pin
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 47
Attach the sutureless pump
connector to the pump
Slide 48
Place and suture pump into the pocket,
coiling excess catheter behind pump
Image Courtesy of Dr. Alessandro Dario, Centro di Neuromodulazione, Divisone di Neurochirurgia, Ospedale Macchi, Varese, Italy.
Slide 49
SynchroMed® II Drug Infusion
System Brief Summary
Product technical manuals and the appropriate drug labeling must be reviewed prior to use for detailed disclosure.
Indications:
Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution (and preservative-free morphine hydrochloride outside of the
United States) in the treatment of chronic intractable pain, chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe
chronic pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity; chronic intravascular infusion of
floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer.
Contraindications:
When infection is present; when the pump cannot be implanted 2.5 cm or less from the surface of the skin; when body size is not sufficient to accept pump bulk and
weight; when contraindications exist relating to the drug. Do not use the Personal Therapy Manager accessory to administer opioid to opioid-naïve patients or to
administer ziconotide.
Warnings:
Comply with all product instructions for initial preparation and filling, implantation, programming, refilling, and injecting into the catheter access port
(CAP) of the pump. Failure to comply with all instructions can lead to technical errors or improper use of implanted infusion pumps and result in additional
surgical procedures, a return of underlying symptoms, or a clinically significant or fatal drug under- or overdose. Refer to the appropriate drug labeling for
specific under- or overdose symptoms and methods of management. Avoid using short wave (RF) diathermy within 30 cm of the pump or catheter. Diathermy may
produce significant temperature rises in the area of the pump and continue to heat the tissue in a localized area. If overheated, the pump may over infuse the drug,
potentially causing a drug overdose. Effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. An inflammatory mass that can result
in serious neurological impairment, including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients on intraspinal opioid therapy
carefully for any new neurological signs or symptoms. For intraspinal therapy, use only preservative-free sterile solution indicated for intraspinal use. Use only
Medtronic components indicated for use with this system. Failure to firmly secure connections can allow drug or cerebrospinal fluid (CSF) leakage into tissue and
result in tissue damage or inadequate therapy. A postoperative priming bolus should not be programmed if the pump is a replacement and the catheter has not been
aspirated.
Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures.
Physicians must be familiar with the drug stability information in the technical manual and must understand the dose relationship to drug concentration and pump flow
rate before prescribing pump infusion. Implantation and ongoing system management must be performed by individuals trained in the operation and handling of the
infusion system.
Inform patients of the signs and symptoms of drug under- or overdose, appropriate drug warnings and precautions regarding drug interactions, potential side effects,
and signs and symptoms that require medical attention. Instruct patients to notify their clinician of travel plans, to return for refills at prescribed times, avoid activities
such as strenuous exercise or contact sports that jar, impact, twist, or stretch the body, to always carry their Medtronic device identification card, to avoid manipulating
the pump through the skin, and to notify healthcare professionals of the implanted pump before medical tests/procedures. Patients must consult their physician before
engaging in activities involving pressure or temperature changes (e.g., scuba diving, saunas, hot tubs, hyperbaric chambers, flights, skydiving, etc.) Inform patients
that pump has an Elective Replacement Indicator (ERI) that sounds when the pump is nearing its end of service. When the alarm sounds, patients must contact their
doctor to schedule pump replacement.
Slide 50
SynchroMed® II Drug Infusion
System Brief Summary
SynchroMed® II Drug Infusion System Brief Summary (continued):
Precautions:
The pump is ethylene oxide sterilized. Do not use if the product or package is damaged, the sterile seal is broken, or the “Use By” date has expired. Do not reuse or
resterilize the pump; it is intended for “single use only.” Do not expose the pump to temperatures above 43°C or below 5°C. Consider use of peri- and post-operative
antibiotics for pump implantation, for any subsequent surgical procedure, or if infection is present. For patients prone to CSF leaks, clinicians should consider special
procedures, such as a blood patch. Follow instructions for emptying and filling the pump during a replacement or revisions that require removal of the pump from the
pocket. Explant the pump postmortem if incineration is planned (to avoid explosion), or if local environmental regulations mandate removal. Return explanted devices
to Medtronic for analysis and safe disposal. Do not implant a pump dropped onto a hard surface or showing signs of damage. Implant the pump less than 2.5 cm from
the surface of the skin. Ensure pump ports will be easy to access after implant, that the catheter is not kinked and secured well away from pump ports before
suturing. Keep the implant site clean, dry, and protected from pressure or irritation. If therapy is discontinued for an extended period of time, fill the reservoir with
preservative-free saline in intraspinal applications or appropriate heparinized solution (if not contraindicated) in vascular applications.
The magnetic field or telemetry signals produced by the programmer may cause sensing problems and inappropriate device responses with an implantable
pacemaker and/or defibrillator. Electromagnetic interference (EMI) is an energy field generated by equipment found in the home, work, medical, or public
environments. Most EMI normally encountered will not affect the operation of the pump. Exceptions include: injury resulting from heating of the pump which can
damage surrounding tissue (diathermy, MRI), system damage which can require surgical replacement or result in loss/change in symptom control (defibrillation,
electrocautery, high-output ultrasonics, radiation therapy), and operational changes to the pump causing the motor to stop, loss of therapy, return of underlying
symptoms, and require confirmation of pump function (diathermy, high magnetic field devices, hyperbaric/hypobaric conditions, magnetic resonance imaging (MRI)).
MRI will temporarily stop the pump motor’s rotor due to the magnetic field of the MRI scanner and suspend drug infusion during MRI exposure which will cause the
pump alarm to sound. The pump should resume normal operation upon termination of MRI exposure. Prior to MRI, the physician should determine if the patient can
safely be deprived of drug delivery. If not, alternative delivery methods for the drug can be utilized during the MRI scan. Prior to scheduling an MRI scan and upon its
completion, pump status should be confirmed.
Adverse Events:
Include, but are not limited to, cessation of therapy due to end of device service life or component failure, change in flow performance due to component failure,
inability to program the device due to programmer failure, CAP component failure; inaccessible refill port due to inverted pump, pocket seroma, hematoma, erosion,
infection, post-lumbar puncture (spinal headache), CSF leak, radiculitis, arachnoiditis, bleeding, spinal cord damage, meningitis (intrathecal applications), anesthesia
complications, damage to the pump, catheter and catheter access system due to improper handling and filling before, during, or after implantation; change in catheter
performance due to catheter kinking, disconnection, leakage, breakage, occlusion, dislodgement, migration, or catheter fibrosis; body rejection phenomena, surgical
replacement of pump or catheter due to complications; local and systemic drug toxicity and related side effects, complications due to use of unapproved drugs and/or
not using drugs in accordance with drug labeling, or inflammatory mass at the tip of the catheter in patients receiving intraspinal morphine or other opioid drugs.
!USA Rx Only
September 2005
UC200304074IE
Model 8709SC and Model 8731SC
Intrathecal Catheters
• Balanced blend of product and
technique improvements
• Simple, intuitive sutureless
catheter connections
• Fewer implant steps
Slide 2
Sutureless Pump Connector
Clinical Training
Slide 3
Technology
• Simple, intuitive operation
– “Squeeze on, squeeze off” technology
– Works without catheter connector sutures
• Strong robust design
– Physiological testing (daily living and traumatic events)
• Tactile
– Can feel engagement fingers snapping in place
• Silicone boot
– Covers the entire connector
Slide 4
Sutureless Connector
Requirements Testing
•Impact Testing
5 connectors taken to failure by increasing the impact load until the connector
disconnected. All 5 connectors stayed connected up to the limits of the test
machine. Impact magnitudes ranged from 68 lbs – 87.7 lbs (3X requirement)
•Cyclic Testing
6 connectors were cycled to 6X the cyclic requirement. 5 of 6 stayed
connected at 6X cycles (2,004,326), and 1 of 6 disconnected at 5X cycles
(1,521,575).
Slide 5
Device Benefits
• Simple connection eliminates:
– Suturing
– The pinch and push implant technique used with the existing 8709
and 8731 pump connectors
• Other features:
– 8731SC catheter is now packaged with an extra Tuohy needle for
smaller patients
– Pump segment of the 8731SC catheter is now trimmable at the most
distal end (an extra connector pin is included in the catheter package)
– 8709SC now offers convenient, numerical markings to help identify
catheter insertion depth/length
Slide 6
Sutureless Pump Connector Interface
Components (Models 8709SC and 8578)
Sutureless
Connector
Strain-Relief
Sleeve
Connector
Pin
7.6 cm Length
Slide 7
Catheter Comparison
8709
8709SC
8731
8731SC
TOTAL LENGTH
89 cm
89 cm
104.1 cm
104.1 cm
SPINAL SEGMENT
89 cm
81.4 cm
38.1 cm
38.1 cm
PUMP SEGMENT
NA
7.6 cm
66.0 cm
66.0 cm
CONNECTOR PIN
NO
YES
YES
YES
PIN TYPE
NA
Sutureless
Suture
Grooves
Suture
Grooves
INTRODUCER NEEDLE
15 Gauge
Tuohy
15 Gauge
Tuohy
15 Gauge
Tuohy
15 Gauge
Tuohy
NEEDLE LENGTH
9.3 cm
9.3 cm
11.4 cm
11.4 cm
9.3 cm
NUMERIC MARKINGS
No
Yes
Yes
Yes
TRIMMABLE SEGMENTS
Spinal
Spinal
Spinal
Spinal
Pump
Slide 8
Sutureless Pump Connector Operation
STEP 1
With a thumb and forefinger, grasp the ovals on the tapered portion of
the pump connector.
STEP 2
At the pump pocket site, position the opening of the Sutureless Pump
Connector in line with the catheter port of the pump.
STEP 3
Firmly press the pump connector onto the catheter port until the
connector snaps into place or firmly squeeze on the oval marks of the
pump connector and carefully press onto the catheter port.
STEP 4
Confirm that the connector is properly attached by grasping the tapered
portion of the connector and tugging as if to remove the connector from
the pump. The connector should feel firmly attached.
Slide 9
Programming Scenarios
• Scenario 1 – 8709SC Implant
• Scenario 2 – 8731SC Implant
• Scenario 3 - Replacement
Slide 10
Programming Scenario #1: 8709SC Implant
A patient is implanted with a SynchroMed® II
pump using an 8709SC Catheter.
Step
Step1:
1: Select the 8709 Catheter from the
Catheter Information dropdown.
Step
Step2:
2: Enter 15 cm removed.*
An implanted Length of 74 cm and a Total
Catheter Volume of 0.163 mL are
automatically calculated by the N’Vision®
programmer.
*Remember the 8709SC has the same overall
length as the 8709.
Slide 11
Programming Scenario #2: 8731SC Implant
A patient is implanted with a SynchroMed® II pump
using an 8731SC Catheter. 11 cm have been
removed from the distal section at implant.
Step
Step 1:
1: Select the 8731 Catheter from the Catheter
Information dropdown.
Step
Step 2:
2: Enter 0 cm removed from the
Proximal Section.
Step
Step 3:
3: Enter 11 cm removed from the Distal
Section.
An Implanted Distal Length of 27.1 cm, an
implanted Proximal Length of 66 cm, and a Total
Catheter Volume of 0.205 mL are automatically
calculated by the N’Vision® programmer.
Slide 12
Programming Scenario #3: Replacement
A patient’s SynchroMed EL® pump is replaced with a
SynchroMed® II pump using an 8578 Sutureless Connector
Revision Kit. The patient was previously implanted with an
8709 Catheter (89 cm implanted catheter length).
The new 8578 Sutureless Connector Revision Kit will add 7.6
cm to the existing/previously implanted catheter length (89
cm+7.6 cm=96.6 cm).
Step 1:
Step 2:
Step 3:
Step 4:
Select a New Single Piece from the Catheter
Information dropdown.
Enter an implanted catheter volume of 0.0022 in
the mL/cm field.
Enter an implanted length of 96.6 cm in the Length
field.
Enter 0.0 removed at the Removed field.
An implanted length of 96.6 cm and a Total Catheter Volume
of 0.213 mL are automatically calculated by the N’Vision®
programmer.
Slide 13
Model 8709SC and 8731SC
Intrathecal Catheter Features
Slide 14
Numbered markings and pre-attached
pump connector
8731SC Spinal Segment
Sutureless Pump
Connector
Slide 15
Pre-attached catheter anchor/connecting
pin with sutureless catheter connections
8731SC
Sutureless strain
relief sleeve (spinal)
Pre-attached
sutureless pump strain
relief sleeve
Pre-attached catheter
anchor/connecting pin
Slide 16
Longer introducer needle with markings
and catheter passer
Tip, Obturator end and catheter mating
Slide 17
Impact of catheter complications
Catheter related complications:
• Range in incidence from 10-89%
• Reported in most clinical studies as occurring in
approximately 20-25% of implanted systems
• May place patient at risk for adverse events
(e.g., from abrupt cessation of intrathecal drug therapy)
• Are a source of inconvenience to the physician and patient
• Diminish the cost-effectiveness of the therapy
Source: Follett KA. Naumann CP. A Prospective Study of Catheter-Related Complications of Intrathecal Drug Delivery
Systems. J Pain and Symptom Management 2000;3:209-215.
Slide 18
Potential impact of
catheter complications
# of new patients
implanted/year
20,000
Catheter complication rate
25%
Estimated # of catheter revisions/
repairs per year
5,000
Average cost per catheter
revision/repair
Total annual cost of catheter
revisions/repairs
$10,000
$50,000,000
Slide 19
Impact of catheter complications
on therapy adoption
Catheter
Complications
Referring or
Managing
Physician
Patient
Other
Physicians
Other
Patients
Scientific
Conferences
Internet Chat
Rooms
Medical
Journals
Family &
Friends
=
Therapy
Adoption
Slide 20
Technique variations
Medtronic Sponsored Clinical Study #1
Catheter Complication Rates By Center
60.0
56.3
53.8
55.6
50.0
50.0
Percent
40.0
35.0
30.0
30.0
22.2
20.0
26.7
15
16
20.0
16.7
16.7
14.3
25.0
10.0
6.7
5.9
5.0
0.0
1
4
5
6
Europe
7
8
9
10
2
Centers
3
11
12
1
14
North America
Source: Follett KA. Naumann CP. A Prospective Study of Catheter-Related Complications of Intrathecal Drug Delivery
Systems. J Pain and Symptom Management 2000;3:209-215.
Slide 21
Technique variations
Medtronic Sponsored Clinical Study #2
Catheter Complication Rate By Center
100.0
100.0
90.0
80.0
75.0
Percent
70.0
60.0
60.0
50.0
40.0
30.0
25.0
25.0
17.6
20.0
25.0
14.8
10.0
0.0
0.0
1
2
3
Europe
4
5
25.0
14.3
7.1
4.8
6
0.0
7
8
0.0
9
36.4
33.3
33.3
9.1
0.0
0.0
10 11 12 13 14 15 16 17 18 19 20 21
Centers
US
Source: Follett KA. Naumann CP. A Prospective Study of Catheter-Related Complications of Intrathecal Drug Delivery
Systems. J Pain and Symptom Management 2000;3:209-215.
Slide 22
Catheter complications from three
Medtronic sponsored clinical studies
Total Complication Rate in 3 Clinical Trials ~ 20%
7.0%
6.1%
% of Patients Affected
6.0%
5.1%
5.0%
4.0%
3.0%
4.0%
3.0%
2.0%
1.0%
0.7%
0.4%
0.3%
0.3%
0.1%
0.1%
0.1%
0.0%
Source: Follett KA. Naumann CP. A Prospective Study of Catheter-Related Complications of Intrathecal Drug Delivery
Systems. J Pain and Symptom Management 2000;3:209-215.
Slide 23
Primary Sources of Catheter Complications
Catheter fracture from midline needle placement
Midline
Slide 24
Primary Sources of Catheter Complications
Catheter fracture in introducer needle
• Pulling the catheter back
through the introducer needle
may shear or create holes in
the catheter
Sheared
Catheter
Slide 25
Primary Sources of Catheter Complications
Catheter kinks
Slide 26
Primary Sources of Catheter Complications
Catheter holes
Pump connector pin
Slide 27
Primary Sources of Catheter Complications
Catheter dislodgements
Slide 28
Complication research outcomes
Major Findings:
Fractures
– Occur in spinous process area with midline catheter placement
– Occur when catheter is withdrawn through needle
Kinks
– Occur at connections and anchors from lack of slack or not using a strain
relief sleeve
Holes
– Occur due to missing or failed strain relief sleeve at pump connector on
one-piece Catheter
– Several reports of small holes in one-piece catheter under pump. No
reports of holes under the pump with the two-piece catheter
Dislodgements
– Occur from pump movement and lack of catheter slack at pump causing
the catheter to slip through anchor
– Occur from ligament motion or CSF pressure and no anchor or purse
string suture at fascial entry point
Source: Data on file at Medtronic.
Slide 29
Implant technique consensus statement
Authored by:
Dr. Ken Follett
Dr. Kim Burchiel
Dr. Tim Deer
Dr. Stuart DuPen
Dr. Joshua Prager
Dr. Michael Turner
Dr. Robert Coffey
Slide 30
Low Complication Catheter
Implant Technique
Source: Retrospective analysis data on file at Medtronic. “Prevention of Intrathecal Drug Delivery CatheterRelated Complications,” Neuromodulation, February 2003.
Slide 31
Overview for low complication
implant technique
Source: Data on file at Medtronic.
Slide 32
Prep the patient
Image courtesy of Dr. Joseph Dunn and Dr. Peter Kosek, Pain Consultants of Oregon, Eugene, OR.
Slide 33
Place the needle
Spinous Processes
Pedicles
Needle
Slide 34
Place the needle – continued
~ 30°
Paramedian Oblique
Slide 35
Place the needle – continued
Slide 36
Thread the catheter through the needle
Introducer Needle Catheter
Slide 37
Thread the catheter
through the needle – continued
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 38
Cut down to the lumbo-dorsal fascia
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 39
Undermine the incision
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 40
Remove the needle and guide wire
Introducer Needle
Guide Wire Handle
Slide 41
Place the anchor (8709SC Catheter)
90 Degree
Anchor
Straight
Anchor
V-wing
Anchor
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 42
Using the V-wing Anchor with
the 8731SC Catheter
2 Suture
Points
Place the V-wing anchor as
close as possible to the
fascia entry point.
Secure the V-wing anchor wings
together at the notch and secure
to the lumbo-dorsal fascia.
Slide 43
Prepare the pump pocket
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 44
Tunnel and pass the catheter
Image Courtesy of Dr. Joseph Dunn and Dr. Peter Kosek, Pain Consultants of Oregon, Eugene, OR.
Slide 45
Trim the distal catheter
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 46
Anchor the connector pin
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.
Slide 47
Attach the sutureless pump
connector to the pump
Slide 48
Place and suture pump into the pocket,
coiling excess catheter behind pump
Image Courtesy of Dr. Alessandro Dario, Centro di Neuromodulazione, Divisone di Neurochirurgia, Ospedale Macchi, Varese, Italy.
Slide 49
SynchroMed® II Drug Infusion
System Brief Summary
Product technical manuals and the appropriate drug labeling must be reviewed prior to use for detailed disclosure.
Indications:
Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution (and preservative-free morphine hydrochloride outside of the
United States) in the treatment of chronic intractable pain, chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe
chronic pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity; chronic intravascular infusion of
floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer.
Contraindications:
When infection is present; when the pump cannot be implanted 2.5 cm or less from the surface of the skin; when body size is not sufficient to accept pump bulk and
weight; when contraindications exist relating to the drug. Do not use the Personal Therapy Manager accessory to administer opioid to opioid-naïve patients or to
administer ziconotide.
Warnings:
Comply with all product instructions for initial preparation and filling, implantation, programming, refilling, and injecting into the catheter access port
(CAP) of the pump. Failure to comply with all instructions can lead to technical errors or improper use of implanted infusion pumps and result in additional
surgical procedures, a return of underlying symptoms, or a clinically significant or fatal drug under- or overdose. Refer to the appropriate drug labeling for
specific under- or overdose symptoms and methods of management. Avoid using short wave (RF) diathermy within 30 cm of the pump or catheter. Diathermy may
produce significant temperature rises in the area of the pump and continue to heat the tissue in a localized area. If overheated, the pump may over infuse the drug,
potentially causing a drug overdose. Effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. An inflammatory mass that can result
in serious neurological impairment, including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients on intraspinal opioid therapy
carefully for any new neurological signs or symptoms. For intraspinal therapy, use only preservative-free sterile solution indicated for intraspinal use. Use only
Medtronic components indicated for use with this system. Failure to firmly secure connections can allow drug or cerebrospinal fluid (CSF) leakage into tissue and
result in tissue damage or inadequate therapy. A postoperative priming bolus should not be programmed if the pump is a replacement and the catheter has not been
aspirated.
Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures.
Physicians must be familiar with the drug stability information in the technical manual and must understand the dose relationship to drug concentration and pump flow
rate before prescribing pump infusion. Implantation and ongoing system management must be performed by individuals trained in the operation and handling of the
infusion system.
Inform patients of the signs and symptoms of drug under- or overdose, appropriate drug warnings and precautions regarding drug interactions, potential side effects,
and signs and symptoms that require medical attention. Instruct patients to notify their clinician of travel plans, to return for refills at prescribed times, avoid activities
such as strenuous exercise or contact sports that jar, impact, twist, or stretch the body, to always carry their Medtronic device identification card, to avoid manipulating
the pump through the skin, and to notify healthcare professionals of the implanted pump before medical tests/procedures. Patients must consult their physician before
engaging in activities involving pressure or temperature changes (e.g., scuba diving, saunas, hot tubs, hyperbaric chambers, flights, skydiving, etc.) Inform patients
that pump has an Elective Replacement Indicator (ERI) that sounds when the pump is nearing its end of service. When the alarm sounds, patients must contact their
doctor to schedule pump replacement.
Slide 50
SynchroMed® II Drug Infusion
System Brief Summary
SynchroMed® II Drug Infusion System Brief Summary (continued):
Precautions:
The pump is ethylene oxide sterilized. Do not use if the product or package is damaged, the sterile seal is broken, or the “Use By” date has expired. Do not reuse or
resterilize the pump; it is intended for “single use only.” Do not expose the pump to temperatures above 43°C or below 5°C. Consider use of peri- and post-operative
antibiotics for pump implantation, for any subsequent surgical procedure, or if infection is present. For patients prone to CSF leaks, clinicians should consider special
procedures, such as a blood patch. Follow instructions for emptying and filling the pump during a replacement or revisions that require removal of the pump from the
pocket. Explant the pump postmortem if incineration is planned (to avoid explosion), or if local environmental regulations mandate removal. Return explanted devices
to Medtronic for analysis and safe disposal. Do not implant a pump dropped onto a hard surface or showing signs of damage. Implant the pump less than 2.5 cm from
the surface of the skin. Ensure pump ports will be easy to access after implant, that the catheter is not kinked and secured well away from pump ports before
suturing. Keep the implant site clean, dry, and protected from pressure or irritation. If therapy is discontinued for an extended period of time, fill the reservoir with
preservative-free saline in intraspinal applications or appropriate heparinized solution (if not contraindicated) in vascular applications.
The magnetic field or telemetry signals produced by the programmer may cause sensing problems and inappropriate device responses with an implantable
pacemaker and/or defibrillator. Electromagnetic interference (EMI) is an energy field generated by equipment found in the home, work, medical, or public
environments. Most EMI normally encountered will not affect the operation of the pump. Exceptions include: injury resulting from heating of the pump which can
damage surrounding tissue (diathermy, MRI), system damage which can require surgical replacement or result in loss/change in symptom control (defibrillation,
electrocautery, high-output ultrasonics, radiation therapy), and operational changes to the pump causing the motor to stop, loss of therapy, return of underlying
symptoms, and require confirmation of pump function (diathermy, high magnetic field devices, hyperbaric/hypobaric conditions, magnetic resonance imaging (MRI)).
MRI will temporarily stop the pump motor’s rotor due to the magnetic field of the MRI scanner and suspend drug infusion during MRI exposure which will cause the
pump alarm to sound. The pump should resume normal operation upon termination of MRI exposure. Prior to MRI, the physician should determine if the patient can
safely be deprived of drug delivery. If not, alternative delivery methods for the drug can be utilized during the MRI scan. Prior to scheduling an MRI scan and upon its
completion, pump status should be confirmed.
Adverse Events:
Include, but are not limited to, cessation of therapy due to end of device service life or component failure, change in flow performance due to component failure,
inability to program the device due to programmer failure, CAP component failure; inaccessible refill port due to inverted pump, pocket seroma, hematoma, erosion,
infection, post-lumbar puncture (spinal headache), CSF leak, radiculitis, arachnoiditis, bleeding, spinal cord damage, meningitis (intrathecal applications), anesthesia
complications, damage to the pump, catheter and catheter access system due to improper handling and filling before, during, or after implantation; change in catheter
performance due to catheter kinking, disconnection, leakage, breakage, occlusion, dislodgement, migration, or catheter fibrosis; body rejection phenomena, surgical
replacement of pump or catheter due to complications; local and systemic drug toxicity and related side effects, complications due to use of unapproved drugs and/or
not using drugs in accordance with drug labeling, or inflammatory mass at the tip of the catheter in patients receiving intraspinal morphine or other opioid drugs.
!USA Rx Only
September 2005
UC200304074IE