1. Model 8709SC and Model 8731SC Intrathecal Catheters
Balanced blend of product and technique improvements
Simple, intuitive sutureless catheter connections
Fewer implant steps
Note: Fewer implant steps compared to the Models 8709, 8711 and 8731 catheters.

2. Sutureless Pump Connector Clinical Training
The sutureless pump connector’s intuitive “Squeeze on, squeeze off” design works without catheter connector sutures.

3. Technology Simple, intuitive operation Strong robust design Tactile
“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
Medtronic evaluated its “squeeze” technology from the physician’s perspective through surgeon feedback regarding the ease-of-use of the sutureless pump connector.

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).
Medtronic supports its sutureless pump connector’s intuitive “squeeze” design with simulated physiological testing based on both daily living and traumatic event scenarios.

5. Device Benefits Simple connection eliminates: Other features: 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
The sutureless pump connector catheter models maintain all the performance of the original with added benefits and features.

6. Sutureless Pump Connector Interface Components (Models 8709SC and 8578)
Strain-Relief
Sleeve
Connector
Pin
7.6 cm Length

7. Catheter Comparison 8709 8709SC 8731 8731SC TOTAL LENGTH
89 cm
104.1 cm
SPINAL SEGMENT
81.4 cm
38.1 cm
PUMP SEGMENT NA
7.6 cm
66.0 cm
CONNECTOR PIN NO
YES
PIN TYPE
Sutureless
Suture Grooves
INTRODUCER NEEDLE
15 Gauge Tuohy
NEEDLE LENGTH
9.3 cm
11.4 cm
NUMERIC MARKINGS No
Yes
TRIMMABLE SEGMENTS
Spinal
Pump
Here’s a comparison in device specifications between the old and new Models 8709 and 8731 Catheters now available with sutureless connectors.

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.
Here are the directions for attaching the sutureless connector to the pump.
The procedure for the sutureless pump connector differs from previous pump connector procedures. The instructions describe key elements for using the new connector. For more detailed instruction, please refer to the appropriate technical manual.
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.

9. Programming Scenarios
Scenario 1 – 8709SC Implant
Scenario 2 – 8731SC Implant
Scenario 3 - Replacement
No programming software updates are required in order to use the Models 8709SC and 8731SC Intrathecal Catheters with sutureless connectors. Programming catheter information using the 8840 N’Vision Programmer would involve the following steps.

10. Programming Scenario #1: 8709SC Implant
A patient is implanted with a SynchroMed® II pump using an 8709SC Catheter.
Step 1: Select the 8709 Catheter from the Catheter Information dropdown.
Step 2: Enter 15 cm removed.*
An implanted Length of 74 cm and a Total Catheter Volume of mL are automatically calculated by the N’Vision® programmer.
*Remember the 8709SC has the same overall length as the 8709.
Step 1:
Step 2:
Here’s how to program catheter information for a new SynchroMed II Implant using the Model 8709SC Intrathecal Catheter.

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 1: Select the 8731 Catheter from the Catheter Information dropdown.
Step 2: Enter 0 cm removed from the Proximal Section.
Step 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 mL are automatically calculated by the N’Vision® programmer.
Step 1:
Step 2:
Step 3:
Here’s a programming scenario for a new SynchroMed II Implant using a Model 8731SC Intrathecal Catheter.

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: Select a New Single Piece from the Catheter Information dropdown.
Step 2: Enter an implanted catheter volume of in the mL/cm field.
Step 3: Enter an implanted length of 96.6 cm in the Length field.
Step 4: Enter 0.0 removed at the Removed field.
An implanted length of 96.6 cm and a Total Catheter Volume of mL are automatically calculated by the N’Vision® programmer.
Step 1:
Step 2:
Step 3:
Step 4:
This last scenario presents the programming sequence for SynchroMed EL to SynchroMed II pump replacement using an existing/implanted Model 8709 Catheter.

13. Model 8709SC and 8731SC Intrathecal Catheter Features

14. Numbered markings and pre-attached pump connector
The Model 8731SC spinal catheter section has numeric markings to assist in determining how much catheter has been implanted. The pump end of the catheter has a pre-attached sutureless pump connector with “squeeze-on, squeeze-off” design that simplifies the implant, requiring no catheter connector sutures.
Sutureless Pump
Connector
8731SC Spinal Segment

15. Pre-attached catheter anchor/connecting pin with sutureless catheter connections
Sutureless strain relief sleeve (spinal)
Pre-attached sutureless pump strain relief sleeve
The pump segment of the Model 8731SC Intrathecal Catheter contains a pre-attached strain relief sleeve and connector/catheter anchor. Slide the spinal strain relief sleeve over the spinal catheter tubing. Once the spinal catheter segment is placed over the connecting pin, the pin’s unique barbed fitting provides the holding power required to keep the spinal catheter segment connected without a suture. In addition, no sutures are needed to hold the clear distal strain relief to the connecting pin.
Once assembled, the connector/anchor has 2 grooves in which sutures are placed to anchor the catheter to the fascia. This anchor is designed to be the primary anchor for preventing catheter dislodgements.
Pre-attached catheter anchor/connecting pin

16. Longer introducer needle with markings and catheter passer
The Model 8731SC Intrathecal Catheter features 2 introducer needles. One longer introducer needle with centimeter markings and a shorter needle option for smaller patients. The centimeter markings can be used to gauge needle insertion depth.
The obturator can be used to carry the catheter through the catheter passer or it can be removed if the catheter will be suctioned or manually pushed through the catheter passer. The procedure varies depending on which method is preferred.
Tip, Obturator end and catheter mating

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:

18. Potential impact of catheter complications
# of new patients 20,000 implanted/year
Catheter complication rate 25%
Estimated # of catheter revisions/ 5,000 repairs per year
Average cost per catheter $10,000 revision/repair
Total annual cost of catheter $50,000,000 revisions/repairs
There is a significant potential financial impact on overall healthcare costs and more importantly, an impact on 5,000 patients annually due to catheter complications.
Assuming that 20,000 new patients are implanted with pumps for pain or spasticity each year and at a 25% catheter complication rate, 5,000 patients will have to undergo a procedure to correct a catheter related complication. With the average cost of a surgical revision of $10,000, over $50,000,000 annually is spent to correct catheter-related problems.

19. Impact of catheter complications on therapy adoption
Referring or Managing Physician
Catheter Complications
Patient =
Therapy Adoption
Other Physicians
Other Patients
Scientific Conferences
Internet Chat Rooms
In addition to the financial and patient impact of catheter complications, the adoption of intrathecal drug delivery is negatively affected. If there are catheter complications, the referring or managing physician may or may not continue to refer patients for intrathecal drug delivery. The referring or managing physician may spread negative messages about the therapy to other physicians via scientific papers, conferences and the internet.
Patients can also impact the adoption of intrathecal drug delivery when they have a catheter-related complication. Negative messages from patients can be spread to other patients via patient advocacy groups, internet chat rooms and family/friends.
The end result is a decrease in therapy adoption which then denies many patients the benefit of receiving a therapy they may benefit from.
Medical Journals
Family & Friends

20. Technique variations Medtronic Sponsored Clinical Study #1
Catheter Complication Rates By Center
56.3
55.6
53.8
50.0
35.0
30.0
Percent
25.0
26.7
22.2
20.0
16.7
16.7
14.3
Results from a Medtronic clinical study demonstrate the variability of the catheter complication rates by centers. All patients represented in this study had their infusion system implanted by neurosurgeons. Each center implanted approximately 20 pumps/catheters during the study, and both one-piece and two-piece catheters were used. Three centers had complication rates around 5%, and 4 centers had complication rates around 50%, a tenfold difference.
This data suggests that currently marketed catheters can have a low complication rate. To understand if variations in implant technique could account for differences in catheter complication rates, Medtronic conducted a survey to identify what the high complication implanters were doing differently from the low complication implanters. Medtronic approached each North American implanter in the study centers and surveys were completed by interview. The interviewer(s) were blinded to the complication rate for the center to prevent bias when completing the survey.
5.9
6.7
5.0
Europe
North America
Centers
Source: Follett KA. Naumann CP. A Prospective Study of Catheter-Related Complications of Intrathecal Drug Delivery Systems. J Pain and Symptom Management 2000;3:

21. Technique variations Medtronic Sponsored Clinical Study #2
Catheter Complication Rate By Center
100.0
75.0
60.0
Percent
36.4
33.3
33.3
25.0
25.0
25.0
25.0
17.6
Another catheter clinical study, which included both neurosurgeons and anesthesiologists, revealed similar variability in implant technique and catheter complications by participating centers. The number of infusion systems implanted in the study varied by center. Statistical analysis of the overall complication rates by implanter type (neurosurgeon vs. anesthesiologist) showed no significant difference in overall catheter complication rates. However, the rate of specific catheter complications by implanter type did vary. Neurosurgeons had a higher incidence of catheter fractures/breaks when compared to anesthesiologists.
This data suggests that currently marketed catheters can have a low complication rate. The data also prompted Medtronic to look at other factors, such as implant technique, that could account for differences in complication rate by center.
Five centers had no catheter complications. At center number 7, all catheter complications were dislodgements/migrations. This center did not use a catheter anchor during the implant procedure.
14.8
14.3
9.1
7.1
4.8
0.0
0.0
0.0
0.0
0.0
Europe US
Centers
Source: Follett KA. Naumann CP. A Prospective Study of Catheter-Related Complications of Intrathecal Drug Delivery Systems. J Pain and Symptom Management 2000;3:

22. Catheter complications from three Medtronic sponsored clinical studies
Total Complication Rate in 3 Clinical Trials ~ 20%
6.1%
5.1%
4.0%
% of Patients Affected
3.0%
Combined clinical data on catheter complications from three Medtronic clinical studies show the overall catheter complication rates including both one-and two-piece catheter designs to be approximately 20%.
The four most common complications as reported in the clinical studies were:
-Dislodgements/migrations – 6.1%
-Fractures/breaks – 5.1%
-Kinks/occlusions – 4.0%
-Cuts/punctures – 3.0%
Based on this data, Medtronic performed market research to understand what were the most common catheter complications and how they occurred in vivo.
0.7%
0.4%
0.3%
0.3%
0.1%
0.1%
0.1%
fracture/ break
kink/ occlusion
cut/ puncture
leak
tip fibrosis
distal segment in CSF
unknown
disconnected from pump
dislodgement/ Migration
disconnect
misplacement
Source: Follett KA. Naumann CP. A Prospective Study of Catheter-Related Complications of Intrathecal Drug Delivery Systems. J Pain and Symptom Management 2000;3:

23. Primary Sources of Catheter Complications Catheter fracture from midline needle placement
One of the most significant findings of the catheter complication market research was that catheter insertion technique had an impact on complications. With a midline needle placement technique, which is similar to an ordinary lumbar puncture, the needle passes between the spinous processes. Midline placement makes the needle nearly perpendicular to the spinal canal, so the catheter must take a sharp bend as it exits the needle into the spinal canal. This can make advancement of the catheter difficult. In some cases, difficulty advancing the catheter requires the implanting physician to make repeated needle punctures to advance the catheter, thus creating multiple dural holes. Once a catheter is inserted through a midline needle placement, withdrawal of the guide wire can be difficult. Again, this is because the catheter must make a sharp turn as it enters the spinal canal. Even with successful placement, the catheter still must pass between the lumbar spinous processes. Over time, the spinous processes may compress or abrade the catheter due to the friction or pressure from the spinous processes. This creates another potential cause for fractures and breaks at the level of the lumbo-dorsal fascia.

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
If the catheter must be partially or completely removed for repositioning, it should not be withdrawn through the Tuohy needle. Withdrawal through the needle can cut the catheter, shear the end completely off or cause holes. A cut can cause leakage, while a sheared catheter can leave a disconnected segment within the intrathecal or epidural space.

25. Primary Sources of Catheter Complications Catheter kinks
Catheter kinks and occlusions from various causes can occur both at the spinal anchoring site and in the pump pocket.
At the spinal anchor site, body movements may cause a catheter to twist or kink if there is insufficient slack in the system. Kinks can also occur if the catheter and anchor are sharply angled — either due to improper anchor orientation or changes in catheter and anchor position when the incision is closed.
Sutures should never be placed directly around the catheter tubing. These sutures may kink or occlude the catheter. If sutures are used to secure an anchoring device to the catheter, be careful not to tie the sutures too tightly. This may kink or otherwise damage the catheter.
Kinks can occur in the pump pocket if there is insufficient catheter slack or if the pump is oriented improperly. Either of these situations can subject the catheter to increased tension from body movement particularly at the pump connection site. Excessive pump movement within the pocket can also kink the catheter, especially if the pump flips or spins on its axis.

26. Primary Sources of Catheter Complications Catheter holes
Holes in the catheter may occur if a strain relief sleeve is not used on the catheter at the pump connection site (e.g. InDura 1P 8709 Catheter). Repetitive motion can cause the catheter connecting pin to puncture the catheter if it is not protected. To avoid these types of punctures, always use the strain relief sleeve packaged with the catheter.
Use caution when handling sharp surgical instruments such as suture needles and scalpels near the catheter. To protect the catheter during initial placement, leave the introducer needle in place when making the incision at the percutaneous insertion site. If using a purse string suture, the introducer needle can also protect the catheter while the purse string suture is placed in the underlying fascia around the catheter entry site. When closing both the spinal and pocket incisions, carefully note the location of the catheter to prevent a suture needle from puncturing it.
Catheter holes can also be prevented during pump refill and catheter access port procedures by coiling the catheter under the pump during implant. It is also important to use the templates provided in the appropriate Medtronic kit. The templates help locate the correct septum, reducing the chance that a needle will miss the septum and damage the catheter.
Pump connector pin

27. Primary Sources of Catheter Complications Catheter dislodgements
Catheter dislodgement analysis has revealed that two different mechanisms are the main causes of catheter dislodgements.
Catheter slipping through the anchor 
The first cause of dislodgement is the catheter pulling out of the intrathecal space because it slips through the anchor or when no anchor is used. When a catheter is not securely anchored to the lumbo-dorsal fascia, it may become dislodged by forces transmitted from body movement. Even if an anchor is secured around the catheter using suture ligatures, chronic or intermittent forces can stretch the catheter, causing it to decrease in diameter and pull through the anchor.
Excessive pump movement
Catheter dislodgement can also be caused by excessive pump movement within the abdominal pocket. Failure to properly secure the pump increases the likelihood that it will become inverted, rotate, or move in a way that places strain on the catheter, eventually dislodging the catheter from the intrathecal space. In some cases, this has caused the entire catheter to become coiled within the pump pocket.
A less common cause for catheter dislodgement involves movement of the vertebrae, ligaments, or other paraspinal soft tissues during patient activities. If not properly anchored, this type of movement causes the catheter to inch out of the intrathecal space and coil within the lumbar incision site.

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
Catheter complication clinical research findings conducted by Medtronic have shown the failure modes on this slide.
There have been several reports of small holes in one-piece catheters under the pump. The cause may include the thinner walled one-piece catheter rubbing against the pump and/or catheter which over time may abrade the catheter material. This failure has not been reported with the thicker walled two-piece catheter
Source: Data on file at Medtronic.

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
In October 2001, Medtronic sponsored a consensus conference on the prevention of catheter complications. The consensus panel consisted of four neurosurgeons and three anesthesiologists, each of whom have many years of experience with intrathecal drug delivery therapy. The consensus panel came to agreement on the major issues related to reducing catheter complications via implant technique.
A manuscript titled, “Prevention of Intrathecal Drug Delivery Catheter-Related Complications” was published in the February 2003 issue of Neuromodulation. The authors included: Dr. Ken Follett, Dr. Kim Burchiel, Dr. Tim Deer, Dr. Stuart Du Pen, Dr. Joshua Prager, Dr. Michael Turner and Dr. Robert Coffey.

30. Low Complication Catheter Implant Technique
Source: Retrospective analysis data on file at Medtronic. “Prevention of Intrathecal Drug Delivery Catheter-Related Complications,” Neuromodulation, February 2003.

31. Overview for low complication implant technique
Key points of the low complication implant technique include:
Paramedian oblique entry
Helps stabilize the catheter against dislodgement
Reduced wear on catheter compared to midline entry
V-wing anchor at spinal entry point
Reduces catheter dislodgements
Catheter connector/primary anchor
Strain-relief sleeve on catheter tubing
Reduces catheter kinks and holes
Loop of catheter under pump
Reduces catheter kinks
Slack in catheter by connector
Thick wall proximal catheter
Pump anchor using suture loops or mesh pouch
Reduces catheter kinks and dislodgements
Source: Data on file at Medtronic.

32. Prep the patient
Prior to surgery, identify the pump pocket site.
Mark the planned implant site with consideration of physical activities, comfort positioning, belt lines, wheelchair arms, prostheses, and other rehabilitation matters.
Place the patient in a lateral position with the lumbar region slightly flexed.
Position the table and drape the patient to allow fluoroscopic visualization of the spine in regions where the catheter will be inserted and advanced.
Position the patient’s hips, legs and arms to avoid pressure points and interference with fluoroscopic imaging of the spine.
Administer the appropriate anesthesia.
Image courtesy of Dr. Joseph Dunn and Dr. Peter Kosek, Pain Consultants of Oregon, Eugene, OR.

33. Place the needle Spinous Processes Needle Pedicles
Insert the spinal needle. A shallow, paramedian oblique insertion technique (approximately 30 off the spine) is recommended.
In the paramedian oblique placement, the site of the needle entry through the skin is lateral to the spinous processes, and approximately 1-1 ½ vertebral levels below the interlaminar space through which the needle will pass. Under fluoroscopic monitoring, the lateral coordinate for skin entry is approximately parallel to the vertebral pedicle; the imaging target for the needle tip is the midline of the selected interlaminar space.
Insert the catheter at the L2-3 or L3-4 level unless the patient’s anatomy, disease process, previous surgery or other unusual circumstances dictate otherwise.
Pedicles

34. Place the needle – continued
~ 30°
Use a shallow-angle (approximately 30 off the spine), paramedian oblique needle insertion trajectory. The entry point of the needle into the skin (or fascia if the needle insertion is performed through an open incision) should be approximately 1 to 1 ½ vertebral levels below the interlaminar space selected for dural puncture and 2 cm lateral to the midline, on the side of the intended pump pocket.
The needle stylet should be kept in place during dural puncture, keeping the beveled needle tip oriented rostrally when the catheter is inserted. A return of CSF through the needle signals entry into the subarachnoid space.
Paramedian Oblique

35. Place the needle – continued
Repeated from the previous slide, use a shallow-angle (approximately 30 off the spine), paramedian oblique needle insertion trajectory. The entry point of the needle into the skin (or fascia if the needle insertion is performed through an open incision) should be approximately 1 to 1 ½ vertebral levels below the interlaminar space selected for dural puncture and 2 cm lateral to the midline, on the same side as the intended pump pocket.
Repeated from the previous slide, the needle stylet should be kept in place during dural puncture, keeping the beveled needle tip oriented parallel to the longitudinal dural fibers. A return of CSF through the needle signals entry into the subarachnoid space.

36. Thread the catheter through the needle
Orient the needle bevel cephalad, remove the stylet and thread the distal tip of the catheter through the needle to the desired location. When the tip of the catheter reaches the curved point of the needle, a slight increase in advancement pressure will be noted and the most distal centimeter marking will be located at the needle hub.
Make certain the catheter guide wire is seated completely, with its hub against the proximal end of the catheter. The guide wire should remain in place during all maneuvers to insert or position the catheter.
Do not pull the catheter back for any reason while the needle is still inserted in the spinal canal.
Catheter
Introducer Needle

37. Thread the catheter through the needle – continued
Repeated from previous slide, orient the needle bevel cephalad, remove the stylet and thread the distal tip of the catheter through the needle to the desired location. When the tip of the catheter reaches the curved point of the needle, a slight increase in advancement pressure will be noted and the most distal centimeter marking will be located at the needle hub.
Repeated from previous slide, Make certain the catheter guide wire is seated completely, with its hub against the proximal end of the catheter. The guide wire should remain in place during all maneuvers to insert or position the catheter.
Repeated from previous slide, Do not pull the catheter back to adjust its position while the needle is still inserted in the spinal canal.
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.

38. Cut down to the lumbo-dorsal fascia
If using the Model 8731SC catheter
Following placement of the spinal catheter segment and with the needle still in place, make an incision at the needle site at least 5 cm (2 inches) long to expose an area of the fascia that is large enough to place the V-wing anchor and tubing connector/anchor.
If using the Model 8709SC catheter
Following placement of the spinal segment of the catheter and with the needle still in place, make an incision at the needle site at least 5 cm (2 inches) long to expose an area of the fascia that is large enough to place the V-wing anchor.
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.

39. Undermine the incision
Undermine the edges of the incision to develop a smooth facial plane for the anchoring hardware and to permit gentle bends in the catheter.
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.

40. Remove the needle and guide wire
Introducer Needle
Carefully remove the needle from the fascia and grasp the catheter near the exit site.
Remove the needle and guide wire from the catheter simultaneously.
Hold the catheter securely while the guide wire is being removed, be careful not to pinch the catheter tightly between your fingers or with an instrument.
Remove the guide wire slowly and evenly. Removing the guide wire too quickly causes the catheter to bunch up, making guide wire removal difficult.
Tie a purse string suture to close the ligament around the catheter.
Guide Wire Handle

41. Place the anchor (8709SC Catheter)
Place one of the following anchors on the catheter as close as possible to the fascia entry point using the technique described:
90 degree angle anchor – Place the catheter in the groove of the anchor.
Straight anchor – Place the catheter in the slit of the anchor. If the slit is not visible, pull on the suture tabs of the anchor until the slit opens. A significant amount of force may be required to open the slit.
V-wing anchor – Attach the v-wing anchor to the catheter by threading on the end of the catheter.
Using rubber-tipped forceps, clamp the catheter to prevent CSF loss during tunneling and pocket formation.
Secure the V-wing anchor to the surrounding fascia using heavy, non-absorbable sutures and the associated technique described:
90 degree angle anchor – Suture through the suture holes and over the notched ends.
Straight anchor – Suture the two tabs through the suture holes so that the tabs are flat against each other.
V-wing anchor – Suture the anchor wings together at the notch with the wings flat against each other and suture the anchor wings together through the holes. The wings must lie flat against each other to properly engage and grasp the catheter body. Attach to the surrounding fascia.
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.

42. Using the V-wing Anchor with the 8731SC Catheter
2 Suture
Points
If using the 8731SC Catheter:
Attach the V-wing anchor to the catheter by threading the anchor onto the end of the spinal catheter.
Place the V-wing anchor as close as possible to the fascia entry point.
Clamp the end of the spinal catheter with a rubber-shod clamp to prevent CSF loss during tunneling and pocket formation. When unclamped, trim any damaged catheter.
Secure the V-wing anchor to the lumbo-dorsal fascia, not to the subcutaneous fat, suing heavy, non-absorbable sutures. Suture the anchor wings together at the notch with the wings flat against each other and suture the anchor wings together through the holes. The wings must lie flat against each other to properly engage and grasp the catheter body. Attach to the surrounding fascia.
Cautions:
Always use an anchor to secure the catheter to the surrounding tissue to prevent catheter dislodgement or kinking.
Do not tie sutures directly onto the catheter which could damage or occlude the catheter.
Do not overtighten sutures on the anchor which may damage the component.
Do not use metallic sutures for ligation, which could damage the component.
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.

43. Prepare the pump pocket
Prepare the subcutaneous pump pocket in the abdominal area. The pocket should be of sufficient size that the incision does not overlie the pump after the wound closes. Avoid locations that may interfere with patient mobility, clothing and belt lines. The pocket should be no more than 2.5 cm beneath the skin.
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.

44. Tunnel and pass the catheter
Tunnel the catheter as follows:
If using the Model 8709SC Catheter:
Tunnel subcutaneously from the spinal incision site toward the pump implant site using the appropriate catheter passer.
Pass the catheter from the spinal incision site to the pump pocket site. Pass enough catheter to the pump pocket to allow for one or two complete catheter coils behind the pump.
Note: If using a catheter passer with a non-removable handle, tunnel from the pump implant site toward the spinal incision site.
If using the Model 8731SC Catheter:
Tunnel subcutaneously from the spinal incision site toward the pump implant site.
Pass the pump segment from the pump pocket site to the spinal incision site. Leave enough catheter near the pump pocket to allow for one or two complete catheter coils behind the pump.
If using the Model 8583/8586 catheter passers, unlock the obturator tab from the handle of the catheter passer and remove the obturator from the passer.
At this point, the obturator can be used to carry the catheter through the catheter passer, or it can be removed if the catheter will be suctioned or manually pushed through the catheter passer. The procedure varies, depending on which method is preferred.
Image Courtesy of Dr. Joseph Dunn and Dr. Peter Kosek, Pain Consultants of Oregon, Eugene, OR.

45. Trim the distal catheter
If using the Model 8709SC catheter
Trim the pump end of the placed catheter as necessary. Leave enough catheter to allow for one or two complete catheter coils behind the pump. This will provide enough slack to allow for patient movement.
Note: The catheter interface will add 7.6 cm of catheter to the catheter length.
If using the Model 8731SC catheter
At the spinal incision site, trim the spinal catheter tubing as necessary, leaving approximately 5 cm outside the fascia entry point to allow for patient movement and to prevent kinking.
Note: Both the pump and spinal segments of the 8731SC Catheter are trimmable.
Save the trimmed catheter for catheter volume calculations.
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.

46. Anchor the connector pin
Slide the transparent strain-relief sleeve, small end first, onto the previously placed spinal segment.
Connect the spinal catheter tubing to the pump segment tubing. Insert the connector pin using one of the following methods.
If using the Model 8709SC catheter
Insert the connector pin into the placed catheter until the catheter is against the connector pin large ring taking care not to disrupt spinal catheter placement.
Slide the transparent strain-relief sleeve of the placed catheter towards the connector pin until the sleeve snaps into place.
If using the Model 8731SC catheter
Insert the connector pin into the spinal segment until the spinal segment is against the closest large pin ring taking care not to disrupt spinal catheter placement.
Unclamp the catheter and confirm catheter patency by verifying CSF flow through the pump connector. Clamp the pump segment to prevent further CSF loss.
Allow for slack between the secondary V-wing anchor and the connecting pin.
Slide the transparent strain-relief sleeve of the spinal segment towards the connector pin until the sleeve of the spinal segment snaps into place.
Place a heavy nonabsorbable suture in each of the two grooves in the center of the connector pin and attach to the fascia.
Image Courtesy of Dr. Robert Plunkett, Department of Neurosurgery, SUNY at Buffalo, Buffalo General Hospital, Buffalo, NY.

47. Attach the sutureless pump connector to the pump
Place non-absorbable sutures in the pump pocket fascia. If using a pump with suture loops the location of the sutures should roughly correspond to the locations of the suture loops on the pump’s perimeter.
With a thumb and forefinger, grasp the tapered portion of the sutureless pump connector.
At the pump pocket site, position the opening of the Sutureless Pump Connector in line with the catheter port of the pump.
Method 1 – Firmly press the pump connector onto the catheter port until the connector fully covers the catheter port. The connector snaps into place.
Method 2 – Firmly squeeze precisely on the oval marks of the pump connector. While squeezing, carefully press the pump connector onto the catheter port until the connector fully covers the catheter port. The connector snaps into place.
Release the thumb and forefinger.
Check to see that the sutureless pump connector is properly attached by grasping the tapered portion of the connector and tugging as if to remove the connector from the pump. The connection should feel firmly attached.

48. Place and suture pump into the pocket, coiling excess catheter behind pump
Place the pump into the pocket, coiling the excess catheter behind the pump.
Place the pump in the pocket so that the catheter is not twisted or kinked and so that the catheter tubing will not be punctured by needles used to refill the pump.
Securely anchor the pump to the fascia using either suture loops or a mesh pouch.
If using the pump suture loops:
Pull one suture through each suture loop and clamp.
Coil the excess catheter behind the pump before tying knots in the sutures.
Draw the pump into the pocket using all four sutures.
Avoid entangling the catheter in the pump tie-down sutures.
Image Courtesy of Dr. Alessandro Dario, Centro di Neuromodulazione, Divisone di Neurochirurgia, Ospedale Macchi, Varese, Italy.

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.

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
UC IE