69d143cc Bdc1 492e 911c 8e586f539ec8

: Pdf 69D143Cc-Bdc1-492E-911C-8E586F539Ec8 69d143cc-bdc1-492e-911c-8e586f539ec8 10 2017 pdf

Open the PDF directly: View PDF .
Page Count: 16

The surgical technique shown is

for illustrative purposes only. The

technique(s) actually employed in each

case will always depend upon the medical

judgment of the surgeon exercised

before and during surgery as to the best

mode of treatment for eachpatient.

Please see the package insert for the

complete list of indications, warnings,

precautions, and other important medical

information.

Consult instructions for use at this

website www.medtronic.com/manuals.

Note: Manuals can be viewed using a

current version of any major internet

browser. For best results, use Adobe

Acrobat™ Reader with the browser.

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place

Memphis, TN 38132

(901) 396-3133

(800) 876-3133

Customer Service: (800) 933-2635

Medtronic

Spinal and Biologics Business

Worldwide Headquarters

2600 Sofamor Danek Drive

Memphis, TN 38132

medtronic.com

SURGICAL

TECHNIQUE

OsteoCool™ RF Ablation System

and Bone Access Kits

© 2017 Medtronic. All rights reserved. UC201605782b EN PMD016254-4.0

OSTEOCOOL RF ABLATION SYSTEM AND BONE ACCESS KITS

SUBHEAD

3 1

CONTENTS

3 System Setup

6 Patient Positioning

6 OsteoMAPSM Technique

Using Bone Access Kits — Spine

8 OsteoMAPSM Technique Using

Bone Access Kits — Sacrum,

Iliac, and Acetabulum

9 Sacrum

10 Iliac

11 Acetabulum

12 Use of the Precision Drill —

Spine

14 Use of the Precision Drill —

Sacrum, Iliac, and Acetabulum

16 Probe Selection and Tube Kit

Preparation

17 Filling the OsteoCool™ Tube Kit

19 Connecting the Probe to

the Tube Kit

20 Connecting to the Connector Hub

21 Performing RF Ablation — Spine

23 Performing RF Ablation — Sacrum,

Iliac, and Acetabulum

25 Optional Track RF Ablation

26 Optional Temperature

Monitoring with the Independent

Thermocouple

26 Performing RF Ablation Using

Custom Settings

27 Bone Access for Subsequent

Procedures

27 General Safety Guidelines

28 Product Ordering Information

28 Important Product Information

2 3

The OsteoCool™ RF ablation probe

uses a coaxial, bipolar technology that

delivers localized tumor ablation and

automatically moderates power to keep

RF heating within the desired treatment

range, reducing risks of potential thermal

damage to adjacent structures.

The active tip of the RF ablation probe

is internally cooled with circulating

water. RF energy heats the tissue

while circulating water moderates the

temperature in close proximity to the

active tip. This combination creates

large volume lesions without excessive

heating at the active tip.

The OsteoCool™ RF ablation probes are

sterile and intended for single use.

The OsteoCool™ Bone Access Kit is a

single-use device intended to contact

body tissues. Do not reuse, reprocess, or

resterilize.

The OsteoCool™ independent

thermocouple is for optional

temperature monitoring at or near the

site of ablation.

A physician using this equipment must

be familiar with bony anatomy, image-

guided procedures, and bone access

techniques.

Refer to the OsteoCool™ Instructions

for Use for complete generator and

pump setup.

The OsteoCool™ RF Ablation System is

indicated for palliative treatment in spinal

procedures by ablation of metastatic

malignant lesions in a vertebral body.

It also is intended for coagulation and

ablation of tissue in bone during surgical

procedures, including palliation of pain

associated with metastatic lesions

involving bone in patients who have

failed or are not candidates for standard

therapy.

The system contains an RF generator,

peristaltic pump, and the connector

hub, which provides two channels

for the use of the OsteoCool™ RF

ablation probes and two channels for

use of the OsteoCool™ independent

thermocouples.

Important

This guide does not replace the information in the Instructions for Use provided

with the components of the OsteoCool™ RF Ablation System, OsteoCool™ RF

Ablation Probes, OsteoCool™ Bone Access Kits, and the OsteoCool™ Independent

Thermocouple. The Instructions for Use includes important information such as

warnings, precautions, contraindications, and troubleshooting. It is important to read

the Instructions for Use and these precautions carefully prior to device operation.

Additional help information can be accessed through the “help” button located on the

generator screen.

Please note that the anatomy included in this guide reects some of the most

common locations for metastatic bone tumors — spine, pelvis, and hip — but it is not

all inclusive of areas in which the OsteoCool™ system can be used. The OsteoCool™

RF Ablation System is indicated for the palliative treatment in spinal procedures

by ablation of metastatic malignant lesions in a vertebral body. It is also intended

for coagulation and ablation of tissue in bone during surgical procedures, including

palliation of pain associated with metastatic lesions involving bone in patients who

have failed or are not candidates for standard therapy.

SYSTEM

SETUP

The system may be mounted on a rolling cart or a desk stand (see following instructions).

Desk Stand Assembly and Equipment Mounting

1. Assemble the desk stand by sliding the pole into

the base and tightening the set screw with the

provided Allen wrench (Figure 1).

2. Position the desk stand on a stable surface and in

close proximity to an electrical source.

3. Mount the pump by sliding the quick connect

bracket on the back of the pump down the

opposite mounting bracket located on the

bottom of the desk stand (Figure 2a). Mount the

generator by sliding the quick connect bracket

on the back of the generator down the opposite

mounting bracket located on the top of the desk

stand (Figure 2b).

4. Proceed to cable connection.

Figure 1 Figures 2a (Pump Bracket) and

2b (Generator Bracket)

Front View

Pump

Mount

RF-Generator

Mount

Isometric View

2a

2b

4 5

Cart Mounting

1. Position the cart in proximity to an electrical source.

2. Lock the wheels on the cart before mounting

the devices.

3. Mount the pump by sliding the quick connect bracket

on the back of the pump down the opposite mounting

bracket located on the bottom of the cart (Figure 3a).

Mount the generator by sliding the quick connect

bracket on the back of the generator down the

opposite mounting bracket located on the top of the

cart (Figure 3b).

4. Do not adjust the position of the mounting brackets.

5. Proceed to cable connection.

Connect Cables and Power on the Generator and Pump

1. After assembly, connect pump and the generator with the

connector cable to USB ports on the back of both pump and

generator (Figures 4a and 4b).

Plug the USB type A plug to the generator, and the USB type

B plug into the pump.

Generator

Quick Connect

and Release

Pump

Quick Connect

and Release

3b

3a

Figures 3a and 3b

Figure 5a Figure 5b

Figure 4b

Power Switch

USB Port

(for connecting

generator to

pump)

Figure 4a

Type B

Type A

Figure 6

2. Connect power cables to the back of both the

generator and pump.

a. Connecting Power Cables with the Desk Stand:

Route the cable to the backside of the pole and use

the clips on the desk stand to manage the power and

USB cables (Figure 5a).

b. Connecting Power Cables with the Cart:

The cart is provided with cables that are fed through

the cart pole. Attach the connections located near the

mounting brackets to the back of the generator and

pump. The socket end of the cables, which come out

near the bottom of the cart pole, should be connected

directly to the power cables provided with the generator

and pump.

3. Plug both power cables into a surge protector/power strip.

4. Turn on the generator using the power switch located on the

back of the device (Figure 5b).

Note

The circular power button located on the front (top right

corner) of the device is to initiate radiofrequency ablation,

not to turn on power to the generator.

5. After turning on the generator, turn on the pump using the

power switch located on the back of the device.

Note

Turning on the pump before turning on the generator is not

recommended as it could lead to system error.

6. Following the on-screen setup instructions, connect the

connector hub to the front of the generator (Figure 6).

Connect Cables and Power on the Generator and Pump

6 7

PATIENT POSITIONING

1. Place the patient in the prone position for access to the spine.

Note: For access to other areas of bone, a supine or lateral

patient positioning may be more eective for gaining

appropriate access.

2. Using appropriate image guidance, conrm the target location

for treatment and proceed with the necessary skin incision(s).

OSTEOMAP

TECHNIQUE USING

BONE ACCESS KITS — SPINE

1. Insert the stylet into the cannula to

form the osteointroducer.

2. Using uoroscopic image guidance,

insert the osteointroducer at the

desired site. Note

Markings on the cannulas should

be used as reference marks

only. They are not intended to

replace the use of uoroscopic

observation.

Note

The OsteoCool™ osteointroducer

oers an internal stylet that extends

beyond the distal end of the cannula.

This design is intended to provide a

visual indication under image guidance

of where the posterior margin of the

ablation zone with the OsteoCool™ RF

ablation probe will stop.

Caution

To maintain structural integrity, do

not advance the cannula without the

stylet fully inserted.

3. Using manual control and appropriate

image guidance, advance the

osteointroducer through the soft

tissues into the selected bone to the

desired depth.

4. A surgical mallet may be used

to augment the insertion of the

osteointroducer.

5. While holding the cannula, rotate

the handle 180 degrees counter-

clockwise to remove the stylet.

Proceed with the OsteoCool™

precision drill.

For bi-pedicular ablation, repeat the

steps above.

8 9

OSTEOMAP

TECHNIQUE USING

BONE ACCESS KITS — SACRUM,

ILIAC, AND ACETABULUM

1. Insert the stylet into the cannula to form the osteointroducer.

2. Using CT or uoroscopic image guidance, insert the osteointroducer at the desired site.

3. Using manual control and appropriate image guidance, advance the osteointroducer through the soft tissues into the

selected bone to the desired depth.

4. A surgical mallet may be used to augment the insertion of the osteointroducer.

5. While holding the cannula, rotate the handle 180 degrees counterclockwise to remove the stylet. Proceed with the

OsteoCool™ precision drill.

For ablation using two probes, repeat these steps.

SACRUM

One-probe approach:

Two-probe approach:

10 11

ILIAC

One-probe approach:

ACETABULUM

One-probe approach:

Two-probe approach:

Two-probe approach:

Note

Markings on the cannula should be used

as reference marks only. They are not

intended to replace the use of CT or

uoroscopic observation.

Note

The OsteoCool™ osteointroducer

oers an internal stylet that extends

beyond the distal end of the cannula.

The design is intended to provide a

visual indication under image guidance

of where the posterior margin of the

ablation zone with the OsteoCool™ RF

ablation probe will stop.

Caution

To maintain structural integrity, do not

advance the cannula without the stylet

fully inserted.

12 13

USE OF THE

PRECISION DRILL — SPINE

1. After gaining access to the vertebral

body using the osteoinducer, advance

the precision drill down the cannula

lumen into the vertebral body.

2. Using manual control and image

guidance, rotate clockwise and

advance the precision drill to the

desired depth. This depth will serve as

the anterior boundary for the ablation

zone.

Note

The color markings on the proximal

shaft of the OsteoCool™ precision

drill correlate with sizes of the

OsteoCool™ RF ablation probes.

3. Read the color marking on the

proximal end of the drill to aid in probe

selection. If the drill positioning is in

between color markings, advance or

retreat to a color marking. Select the

probe size that corresponds with the

color marking.

Note

Markings on the drill should be used

as reference marks only. They are

not intended to replace the use of

uoroscopic observation.

4. Remove the precision drill from

the cannula lumen using clockwise

rotation. The target site is now ready

for ablation probe placement.

For bi-pedicular ablation, repeat

the steps above. Product testing

recommends a distance of 8–10 mm

between the distal tips of the probes to

yield the largest ablation zone.

14 15

USE OF THE

PRECISION DRILL — SACRUM,

ILIAC, AND ACETABULUM

1. After gaining access into bone using the osteointroducer,

advance the precision drill down the cannula lumen into the

tissue.

2. Using manual control and image guidance, rotate clockwise

and advance the precision drill to the desired depth. This

depth will serve as the anterior boundary for the ablation

zone.

Note

The color markings on the proximal shaft of the OsteoCool™

precision drill correlate with sizes of the OsteoCool™ RF

ablation probes.

3. Read the color marking on the proximal end of the drill to aid

in probe selection. If the drill positioning is in between color

markings, advance or retreat to a color marking. Select the

probe size that corresponds with the color marking.

Note

Markings on the drill should be used as reference marks only.

They are not intended to replace the use of CT or uoroscopic

observation.

4. Remove the precision drill from the cannula lumen using

clockwise rotation. The target site is now ready for ablation

probe placement.

For ablation using two probes, repeat the steps above.

A. Sacrum A1 A2

B1 B2

C1 C2

B. Iliac

C. Acetabulum

16 17

FILLING THE OSTEOCOOL TUBE KIT

INSERTING IT INTO THE PUMP UNIT

Once a probe kit has been chosen, remove the tube kit and

probe from the sterile package and place in the sterile eld.

Fill the burette with sterile water

1. Fill the burette to the 70 mL mark with room temperature sterile water, using one of the following options:

Option 1 – Inject water through the port in the lid.

Option 2 – Remove the lid and pour the water directly into the burette.

Option 1 — Injecting sterile water using the lid port

a. Place sterile syringe in the port.

b. Inject 70 mL of sterile water at room temperature

into the burette.

Option 2 — Removing the lid and pouring sterile water

directly into the burette

a. Open the lid by pressing in and up with your thumbs

around one of the three petals.

b. Observe proper sterile handling technique while lling the

burette; do not place the lid of the burette on a non-sterile

surface.

c. The ll lines on the burette represent 70 mL and 80 mL

respectively.

d. After lling to between the lines, snap the lid back into

place on the burette.

PROBE SELECTION AND

TUBE KIT PREPARATION

Select the OsteoCool™ RF ablation probe size for the procedure.

Note

If the OsteoCool™ precision drill was used, select the probe size that

coordinates with the color marking on the drill shaft.

7 mm Active Tip

11×10 mm Ablation Zone

10 mm Active Tip

17×13 mm Ablation Zone

15 mm Active Tip

23×18 mm Ablation Zone

20 mm Active Tip

29×21 mm Ablation Zone

18 19

CONNECTING

THE PROBE

TO THE TUBE KIT

1. Pass the tubing and electrical connections on the probe out

of the sterile eld.

2. Remove the caps on the male and female luer locks for both

the tube kit and the chosen probe. Connect the appropriate

luer lock on the tube kit to the corresponding luer lock on the

probe.

Warning

DO NOT over tighten the connection. Maintain sterility of the

tubing’s inner pathway so if water is spilled in the sterile eld,

sterility will not be compromised.

2. Put the burette into the pump unit’s burette holder.

3. Open the pump head lid and thread the thicker tubing

from the bottom of the burette into the pump head

tube holder.

4. Ensure that the tubing is properly placed between the

notches and along the center channel beneath the

pump head.

Warning

Improper positioning of the tubing can pinch the tube

and restrict water ow.

5. Close the lid to hold the tubing in place. Leave the luer

lock caps on the tubing until you are ready to connect

the probes, so the inner pathway of the tube kit

remains sterile.

Open lid

Closed lid holds tubing in place

20 21

PERFORMING RF ABLATION —

SPINE

1. The ablation probes come with a pre-

assembled spacer. Discard or keep

the spacer, based on the bone access

tool used. Reference chart below:

2. Place the ablation probe through the

bone access cannula, ensuring it is

fully seated in the cannula.

Warning

Never force the probe if you feel

signicant resistance.

3. Under image guidance, conrm the

proximal radiopaque marker has

fully surpassed the distal end of

the cannula.

Warning

Incorrect use of the spacer may result

in inadequate probe clearance from

the cannula.

Description/Size Part Number Directions

OsteoCool™ Bone Access Kit 10G 090 OCN002 Use with Spacer

OsteoCool™ Bone Access Kit 8G 090 OCN003 Use with Spacer

OsteoCool™ Bone Access Kit 10G 095 OCN004 Discard Spacer

OsteoCool™ Bone Access Kit 13G 100 OCN005 Discard Spacer

Remove spacer for use with

OCN004 and OCN005.

Use spacer with

OCN002 and OCN003.

CONNECTING TO

THE CONNECTOR HUB

The connector hub provides two channels for the use of the

ablation probes and two channels for use of the independent

thermocouples.

The white ports (top) accept the RF ablation probes. The black

ports (bottom) accept the independent thermocouples.

1. Connect the male connector on the ablation probe to the

female connector on the connector hub.

2. Conrm via on-screen information that the probe has been

detected and is ready for use.

Note

The generator will quickly detect the probe and indicate a

“High Impedance” error while the probe is outside of tissue.

When the probe is placed in tissue, the “High Impedance”

error will disappear.

22 23

4. When the screen shows “Ready,”

press the RF power button. Ablation

time is pre-set based on the active tip

size of the probe(s) being used.

a. Pre-set ablation times are shown

at right.

Note

Modications to standard procedure

settings can be adjusted on the RF

generator user interface. Refer to

the user manual for instruction on

changing these settings.

5. Allow the generator to complete the

ablation, monitoring for error signs on

the generator screen.

a. The ablation will terminate

automatically as soon as the set

ablation time is reached.

6. After the ablation is complete, remove

the probe from the cannula and

detach from the tube kit. Discard as

biohazardous waste. Detach the tube

kit from the generator and discard as

biohazardous waste.

7. The OsteoCool™ bone access

cannula is still in place and ready to

accept other instrumentation.

Label Color Product Code Active Tip Lesion Size Ablation Time

Yellow OCP107 and OCP207 7 mm 11 × 10 mm 6:30 min

Blue OCP110 and OCP210 10 mm 17 × 13 mm 7:30 min

Orange OCP115 and OCP215 15 mm 23 x 18 mm 11:30 min

Green OCP120 and OCP220 20 mm 29 × 21 mm 15:00 min

PERFORMING RF ABLATION —

SACRUM, ILIAC, AND ACETABULUM

Note

The ablation process will remain the same

for all bony anatomy. Follow steps 1–7 under

“PERFORMING RF ABLATION — SPINE” for

detailed instructions regarding this process.

One-probe approaches:

A3

B3

C3

24 25

OPTIONAL TRACK

RF ABLATION

1. To ablate the track, select “Retract” on the generator screen.

2. Press the RF power button.

3. The screen will signal when the track ablation starts.

4. Slowly pull back on the RF ablation probe and cannula

simultaneously (approximately 1–2 mm/second) or pull back and

track ablate while stationary. When the desired end point for track

ablation is reached, press the RF power button to stop RF delivery.

Warning

Track ablation is the use of uncooled RF ablation during which time

the peristaltic pump is not circulating water. Ablating the track all

the way to the skin can result in skin burns. It is recommended to

end the track ablation prior to this point.

Two-probe approaches:

A4

B4

C4

26 27

OPTIONAL

TEMPERATURE

MONITORING

WITH THE INDEPENDENT

THERMOCOUPLE

The independent thermocouple provides real-time temperature

information to gauge ablation zone margins and help prevent

thermal damage to adjacent critical structures. The temperature

detected by the independent thermocouple is displayed on the

generator screen.

1. Insert the thermocouple into the provided introducer.

2. Connect the male connector on the thermocouple to the female

connector on the connector hub.

3. Conrm via on-screen information that the thermocouple

(sensor) has been detected.

4. Access the site. Place the thermocouple in the tissue to be

monitored.

PERFORMING RF

ABLATION USING

CUSTOM SETTINGS

The OsteoCool™ system generator screen includes the ability to

change procedure settings. These settings should only be adjusted

by physician experts in RF ablation. To access the custom settings

on the generator, complete the following steps:

1. Press the “Settings” button.

2. Select “Procedure Settings.”

3. Edit settings based on procedural need. Each probe can be

individually adjusted by time, temperature, power limit, ramp

rate, and impedance cut o. Additionally, each independent

thermocouple sensor can be individually adjusted by

temperature.

4. Once desired settings have been achieved, press the “X” button

to return to the generator’s home screen user interface.

5. Proceed with the RF ablation procedure.

Note

All ablation zone sizing is based on default settings. Using custom

settings by manipulating the procedure settings will change the

ablation zone sizing. To reset the generator settings to default

settings, select the “Refresh” button.

BONE ACCESS

FOR SUBSEQUENT

PROCEDURES

The bone access can be used for subsequent physician-

directed procedures such as cementoplasty, sacroplasty,

vertebroplasty, or kyphoplasty. Conrm such procedures are

compatible with the OsteoCool™ Bone Access Introducer

length and gauge.

GENERAL

SAFETY GUIDELINES

For desired tissue heating and anatomical access:

Avoid advancing the probe into bone tissue without rst using

the introducer and drill to create a clear channel for the probe.

Forcing the probe through bone tissue may cause damage to

the probe.

Indications for Use

Kyphon Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis,

cancer, or benign lesions using a cementoplasty (i.e., kyphoplasty or vertebroplasty) procedure. It is also indicated for the xation

of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple

myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include

hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by

appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

Kyphon HV-R™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis,

cancer, or benign lesions using a cementoplasty (i.e., kyphoplasty or vertebroplasty) procedure. Cancer includes multiple myeloma

and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and

giant cell tumor. Pathologic fracture may include a symptomatic vertebral microfracture (as documented by appropriate imaging

and/or presence of a lytic lesion) without obvious loss of vertebral body height.

28 29

OsteoCool™ RF Ablation Capital Equipment

OsteoCool™ RF Generator OC01

OsteoCool™ RF Pump OC02

OsteoCool™ RF Pump Cable OC03

OsteoCool™ Connector Hub OC04

OsteoCool™ RF Ablation Probes

Probe Kit OsteoCool™ RF 17G 7 mm OCP107

Probe Kit OsteoCool™ RF 17G 10 mm OCP110

Probe Kit OsteoCool™ RF 17G 15 mm OCP115

Probe Kit OsteoCool™ RF 17G 20 mm OCP120

Dual Probe Kit OsteoCool™ RF 17G 7 mm OCP207

Dual Probe Kit OsteoCool™ RF 17G 10 mm OCP210

Dual Probe Kit OsteoCool™ RF 17G 15 mm OCP215

Dual Probe Kit OsteoCool™ RF 17G 20 mm OCP220

OsteoCool™ Bone Access Kits

OsteoCool™ Bone Access Kit 10G 090 OCN002

OsteoCool™ Bone Access Kit 8G 090 OCN003

OsteoCool™ Bone Access Kit 10G 095 OCN004

OsteoCool™ Bone Access Kit 13G 100 OCN005

OsteoCool™ Carts and Stands

OsteoCool™ Cart Stand OCA01

OsteoCool™ Desk Stand OCA02

Temperature Monitoring

Thermocouple OsteoCool™ ITC 180 mm OCN001

PRODUCT ORDERING

INFORMATION IMPORTANT PRODUCT

INFORMATION

§ The OsteoCool™ RF Ablation System is intended

for the palliative treatment in spinal procedures by

ablation of metastatic malignant lesions in a vertebral

body. It is also intended for coagulation and ablation

of tissue in bone during surgical procedures, including

palliation of pain associated with metastatic lesions

involving bone in patients who have failed or are not

candidates for standard therapy.

Risks of the system include damage to surrounding

tissue through iatrogenic injury as a consequence of

electrosurgery; pulmonary embolism; nerve injury

including thermal injury, puncture of the spinal cord

or nerve roots potentially resulting in radiculopathy,

paresis, and paralysis.

§ OsteoCool™ Bone Access Kits: Indicated for

percutaneous access to bone.

§ OsteoCool™ Independent Thermocouple: Intended

for measuring tissue temperature throughout an RF

ablation procedure.

OSTEOCOOL RF ABLATION SYSTEM

AND BONE ACCESS KITS

NOTES: