SURGICAL TECHNIQUE
A balloon-based vertebral augmentation system
SYNFLATE
Instruments and implants approved by the AO Foundation.This publication is not intended for distribution in the USA.
Image intensifier control
WarningThis description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.
Processing, Reprocessing, Care and MaintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance
Synfl ate Surgical Technique DePuy Synthes 1
Table of Contents
Introduction
Surgical Technique
Product Information
Bibliography
Synflate 2
AO Spine Principles 4
Indications and Contraindications 5
Preoperative Planning 6
Patient Positioning 8
Approach 9
Access 12
Biopsy 16
Creation of Access Channel and 18Determination of Balloon Size
Preparation of Inflation System 22
Preparation of Balloon Catheter 24
Inflation of Balloon 26
Deflation and Retrieval of Balloon 30
Injection of Bone Filler 32
Postoperative Care 35
Implants and Instruments 36
Recommended Bone Cements 39
Optional Instruments 40
Bibliography 41
2 DePuy Synthes Synfl ate Surgical Technique
Synflate.
3 standard balloon sizes Covers a large anatomical range with a low pre-infl ation profi le of 3.2 mm
Low profile10 Ga access
2 radiopaque markersFor X-ray visualization of the balloon to facilitate accurate placement
Synfl ate Surgical Technique DePuy Synthes 3
Insertion of the Synflate Vertebral Balloon
Access the Vertebral Body
Insertion of the Synflate Vertebral Balloon
Inflation of Synflate Vertebral Balloon
Injection of the bone filler(here Vertecem V+ Cement)
Small
Medium
Large
Broad shaft marker Helps to identify proper advancement into working sleeve and vertebral body
Cover sleeve To refold the balloon for re-use. Catheter validated for re-use once in the same surgery
Additional port for the stiffening wire Stiffening wire gives rigidity to facilitate the insertion of the catheter. Optional removal for infl ation upon surgeons pref-erence
Inflation port with valve One-step Catheter preparation using the vacuum syringe enclosed in the packaging
Different access trocars to suit physician preferences
Cannulated (with K-wire)
Diamond tip
Beveled tip
coronalaxial
sagittal
4 DePuy Synthes Synfl ate Surgical Technique
AO Spine Principles
The four principles to be considered as the foundation for proper spine patient management underpin the design and delivery of the Curriculum:Stability – Alignment – Biology – Function.
Copyright © 2012 by AOSpine
FunctionPreservations and restora-tion of function to prevent disability
StabilityStabilization to achieve a specifi c therapeutic outcome
AlignmentBalancing the spine in three dimensions
BiologyEtiology, pathogenesis, neural protection, and tissue healing
Synfl ate Surgical Technique DePuy Synthes 1
Indications and Contraindications
Intended useThe Synfl ate System is intended for the reduction of fractures and/or creation of a void in cancellous bone in the spine. It is intended to be used in combination with a legally-marketed bone fi ller adequately indicated for use in vertebroplasty or vertebral augmentation procedures.
Note: Refer to the manufacturer’s directions accompanying the bone fi ller for specifi c information on its use, indications, contraindications, precautions, warnings and side effects.
Indications– Painful vertebral compression fractures– Treatment of osteolytic lesions located within the vertebral
body
Contraindications– Stand-alone use with neurological defi cits– Stand-alone use with instability of posterior wall and/or
pedicles– Lesions requiring open anterior column reconstruction– If vertebral dimensions or fracture pattern do not allow
safe placement and infl ation of the balloon– Acute and chronic systemic or localized spinal infections– Allergies to contrast media
6 DePuy Synthes Synfl ate Surgical Technique
Preoperative Planning
Patient assessmentRequirements for assessing the indication:– Current x-ray images, if possible in standing position, of
the thoracic and lumbar spine in two planes to assess the fracture and spinal alignment
– A spiral CT and MRI scan (ideally with STIR frequency) of the painful region of the spine
– If an MRI scan is contraindicated, a bone scan may identify an acute fracture
– Ruling out another cause of pain – Feasibility of surgery and use of anaesthesia
Note: The patient should be checked for allergy to the contrast medium.
Planning of balloon placementThe placement of the balloon(s) should be planned based on the AP and lateral image which helps to identify the proper insertion path.
Preplanning of appropriate balloon sizeThe balloon size for the procedure can roughly be planned preoperatively via CT scan.
Intraoperative x-ray imagingThe Synflate balloons must be applied under fluoroscopic control in both planes, with two C-arms, or one freely mobile C-arm.
Synfl ate Surgical Technique DePuy Synthes 7
Anatomical landmarksFor vertebral augmentation with Synflate, it is recommended to place two balloons per vertebra. Some anatomical situations may require the use of one balloon only.
If two balloons are used, make sure they are positioned in a symmetrical, paramedian way within the affected vertebral body to achieve optimum reduction of the spinal fracture without damaging the lateral vertebral body edges.
The position of the balloon(s) needs to be planned based on preoperative imaging. Take care to achieve the planned position by determining the landmarks accordingly.
The following landmarks should be defined on the spine:– Both pedicles – Spinous process – Endplates – Posterior wall of vertebral body
8 DePuy Synthes Synfl ate Surgical Technique
Patient Positioning
Place the patient in the prone position on a lumbar support. The table must be radiolucent to allow imaging of the targeted/affected levels in both planes.
Biplanar fluoroscopy is recommended for the most efficient use of imaging. A single, freely mobile C-arm may also be used. Set up the table, patient and fluoroscopy to facilitate AP and lateral imaging throughout the procedure.
Precautions: – The OR table should allow free manipulation of the C-arm
over the operative site in both planes.– The Synflate System may only be used under fluoroscopic
control with high quality imaging.
Synfl ate Surgical Technique DePuy Synthes 9
Approach
Instrument options
03.804.514S Access Kit, 10 G, Diamond Tip, with side-opening, Double Pack, sterile
03.804.515S Access Kit, 10 G, Beveled Tip, with side-opening, Double Pack, sterile
03.804.519S Access Kit, 10 G, Diamond Tip, with side-opening, Single Pack, sterile
03.804.520S Access Kit, 10 G, Beveled Tip, with side-opening, Single Pack, sterile
03.804.521S Access Drill, 10 G, sterile
Alternative Instrument
03.804.612S Access Kit 4.7
The access instruments (guide wire or trocar) can be inserted through either a transpedicular or extrapedicular approach.
10 DePuy Synthes Synfl ate Surgical Technique
Approach
Option A. Transpedicular
Under fluoroscopy, determine the location of the incision. The incision should facilitate insertion directly through the pedicle. As a general rule, the location of the skin incision for the transpedicular approach is 1–2 cm lateral and up to 1 cm cranial to the centre of the pedicle.
Make a skin incision.
Under fluoroscopy, insert the tip of the access instrumenta-tion through the incision until it contacts the base of the transverse process. Confirm the proper trajectory, then advance the instrumentation through the pedicle and into the vertebral body.
Precaution: Landmarks for placing the access instrumenta-tion must be respected. The tips of the access instrumenta-tion must not pass the midline wall in AP view until they have passed the posterior wall in the lateral view. When ad-vancing the access instrumentation, ensure that they are not inserted too far medially, to avoid penetration into the spinal canal. Also, it is essential to avoid overdriving the access instrumentation tip into vascular structures beyond the ante-rior cortical wall. The tip of the access instrumentation should not be closer than 5 mm to the anterior cortical wall of the vertebral body.
If considering a transpedicular approach, ensure that the diameter of the pedicle is large enough to be punctured by the chosen access system or by the 4.7mm access instrumen-tation respectively.
Synfl ate Surgical Technique DePuy Synthes 11
Option B. Extrapedicular
Under fluoroscopy, determine the location of the skin inci-sion according to the anatomical situation. The access instrumentation assembly should enter the vertebral body lateral to the pedicle.
Make a skin incision.
Under fluoroscopy, insert the tip of the access instrumenta-tion through the incision until it contacts the posterolateral border of the vertebral body. Confirm the proper trajectory, and then advance the instrumentation into the vertebral body in order to reach the center of the vertebral body.
Precaution: It is essential to avoid overdriving the access instrumentation tip into vascular structures beyond the anterior cortical wall. The tip of the access instrumentation should not be closer than 5 mm to the anterior cortical wall of the vertebral body.
2
1
12 DePuy Synthes Synfl ate Surgical Technique
Access
Access options include trocar or guide wire access. The tro-car allows access in a single step while the guide wire is first used to create a path for the access instruments.
Option A. Trocar
Either a transpedicular or extrapedicular access may be selected depending on the anatomy of the vertebral body to be treated.
To position the working sleeve, insert the access construct into the vertebral body in a single step.
For double pack Access Kits, the trocar instrumentation (trocar in working sleeve) can be assembled by removing the pre-assembled cannulated trocar followed by inserting the trocar into the working sleeve. Once inserted, lock the as-sembly by turning the blue handle clockwise (1).
Under fluoroscopy, insert the trocar instrumentation until the end of the working sleeve is tightly seated approximately3 mm into the vertebral body (2). The end of the working sleeve can be identified by locating the step in diameter be-tween trocar and the working sleeve .
3
4
Synfl ate Surgical Technique DePuy Synthes 13
The sleeves are marked with equidistant depth markers to allow monitoring of the insertion process. If necessary, carefully hammer on the blue handle of the trocar to gently advance the trocar instrumentation.
Precautions: – Ensure that the trocar instrumentation does not breach
the anterior wall of the vertebral body.– Only hammer on the blue plastic handles of the access
instrumentation.
Confirm proper positioning of the access instrumentation under fluoroscopy in both AP and lateral view.
Warning: Do not insert or advance the working sleeve in the bone without the trocar. This could damage the working sleeve and obstruct balloon insertion.
Warning: Do not redirect the instrument assembly without removing it and re-accessing the vertebral body.
For bilateral procedures, repeat on the contralateral side (3).
Note: Hold the working sleeve(s) in place and carefully remove the trocar(s) leaving the working sleeve(s) in the vertebral body (4).
2
1
14 DePuy Synthes Synfl ate Surgical Technique
Option B. Guide Wire
The guide wire option is available in the double pack access kits only.
Insert the guide wire to create the access path, and position appropriately (1). Insert the working sleeve and cannulated trocar assembly over the guide wire and into the vertebral body (2).
Under fluoroscopy, position the tip of the guide wire approximately 5 mm from the anterior wall of the vertebral body in the lateral view. The guide wires are marked with equidistant depth markers to allow monitoring of the inser-tion process. Monitor the guide wire position with fluoro-scopy while inserting the working sleeve and cannulated trocar assembly over the guide wire, until the end of the working sleeve is tightly seated approximately 3 mm into the vertebral body. The end of the working sleeve can be identi-fied by locating the step in diameter between trocar and the working sleeve.
The sleeves are marked with equidistant depth markers to allow monitoring of the insertion process. If necessary, carefully hammer on the blue handle of the cannulated trocar to gently advance the instrumentation.
Precautions: – Under fluoroscopy, while advancing the cannulated tro-
car, ensure that neither the guide wire nor the cannulated trocar breaches the anterior wall of the vertebral body at any time.
– Make sure that the opening on the plastic handle of the cannulated trocar is cleared at all times while advancing the cannulated trocar in order to avoid obstruction of the guide wire passage.
– Only hammer on the blue plastic handles of the access instrumentation.
– The guide wire will extend out the back of the handle. Advance the instruments carefully to avoid injury to the physician’s hand.
Access
3
4
Synfl ate Surgical Technique DePuy Synthes 11
Confirm proper positioning of the access instrumentation under both AP and lateral fluoroscopy.
Warning: Do not insert or advance the working sleeve in the bone without the trocar. This could damage the working sleeve and obstruct balloon insertion.
For bilateral procedures, repeat on the contralateral side (3).
Note: Hold the working sleeve(s) in place and carefully remove the guide wire and cannulated trocar leaving the working sleeve(s) in the vertebral body (4).
Warnings: – Do not redirect the instrument assembly without
removing it and re-accessing the vertebral body.– Do not use excessive force on the guide wire to avoid
potentially deforming the guide wire.
2
1
16 DePuy Synthes Synfl ate Surgical Technique
After placement of the working sleeve (see chapters Approach and Access before), an optional biopsy can be taken using the biopsy kit.
Instruments
03.804.522S Biopsy Kit, 10 G, sterile
Alternative Instrument
09.804.613S Biopsy Kit 4.7*
Remove plunger from the biopsy needle.
Under fluoroscopy, insert the biopsy needle. The tip of the biopsy needle leaves the working sleeve when the first marking on the shaft of the needle disappears into the working sleeve (1).
Under fluoroscopy, advance the biopsy needle further and rotate it at least one full turn (360°). This will help to remove the biopsy.
Warning: Do not insert the biopsy needle beyond the anterior cortical wall of the vertebral body, as this could damage vascular structures.
Attach a luer lock syringe to the biopsy needle and create a vacuum to retain the bone biopsy in the needle (2). Remove the biopsy needle with the attached syringe from the work-ing sleeve.
Note: Hold the working sleeve in place and carefully remove the biopsy needle leaving the working sleeve in the vertebral body.
Biopsy
* Only if Access Kit 4.7 (Art. No. 03.804.612S) is used for access creation.
3
Synfl ate Surgical Technique DePuy Synthes 17
Release the vacuum, remove the syringe and use the biopsy plunger to push the collected bone tissue out of the biopsy needle (3).
2
1
3
18 DePuy Synthes Synfl ate Surgical Technique
The plunger has two important uses:a) To create an access channel for balloon insertionb) To determine the appropriate balloon size
1Create access channel
The access channel for the Synfl ate balloon is created using the plunger (1).
Under lateral fl uoroscopy, insert the plunger through the working sleeve and into the vertebral body. The plunger may be advanced by hand or gently hammering on the blue handle (2).
As an additional option, the plunger can be removed and the access channel can be created with the access drill (3). Advance the drill slowly by turning the handle clockwise. Remove the drill and insert the plunger to size and verify balloon position. It is also possible to use the access drill prior to the use of the plunger.
Creation of Access Channel and Determination of Balloon Size
Synfl ate Surgical Technique DePuy Synthes 19
Warning: Do not use a hammer to drive the drill forward. The drill may aggressively advance with rotation.
Note: The distal (first) marking on the plunger and drill indicates when the tip leaves the working sleeve whereas the three following markers show the initial lengths of the balloon sizes S/M/L, respectively.
Warning: Always use fluoroscopy when advancing the drill or plunger. It is essential to avoid overdriving the drill or plunger tip into vascular structures beyond the anterior corti-cal wall of the vertebral body.
Warning: While using drill or plunger, it is important to ensure that the working sleeves do not move. Do not use the drill or plunger to manipulate or correct the direction of the working sleeve.
For bilateral procedures, repeat on the contralateral side.
11
20 DePuy Synthes Synfl ate Surgical Technique
2Determine balloon size
The Synfl ate Vertrebral Balloon is available in three sizes.
Article no. Ballon Initial Max. Max. Max. Max. Length Length B* Length* Vol. Presure
03.804.700S 10 mm 14.0 mm 16.3 mm 18.1 mm 4 ml 30 barSmall 440 PSI
03.804.701S 15 mm 19.0 mm 16.1 mm 23.3 mm 5 ml 30 barMedium 440 PSI
03.804.702S 20 mm 24.0 mm 16.3 mm 28.9 mm 6 ml 30 barLarge 440 PSI
The plunger has three grooves towards the distal tip that correspond to the three initial lengths of the Synfl ate balloons: small, medium and large. In (1), an example of a large size balloon is shown. Its initial length corresponds to the distance between tip and third groove of the plunger.
Note: If the Access Kit 4.7 (Art. No. 03.804.612S) is used, be aware that the initial length of each balloon is smaller than the distance between tip and the corresponding groove of the plunger.
* At maximum inflation volume in water bath at 37°C. Depending on the bony structure dimensions (diameter and length) may vary inside the vertebral body.
Creation of Access Channel and Determination of Balloon Size
Initial length
2
3
Synfl ate Surgical Technique DePuy Synthes 21
Once the plunger has been positioned appropriately (2), uselateral fluoroscopy to determine the maximum Synflate balloon size (3).
From distal tip, the first groove visible outside the working sleeve:Synflate Vertebral Balloon, Small
From distal tip, the second groove visible outside the working sleeve:Synflate Vertebral Balloon, Medium
From distal tip, the third groove visible outside the working sleeve:Synflate Vertebral Balloon, Large
Note: If no plunger grooves are visible under fluoroscopy, adjust the working sleeve and/or the plunger if possible. Ifthe instrumentation cannot be safely adjusted to reveal at least one groove, then the Synflate balloon procedure will not be possible and an alternative augmentation procedure should be used.
For bilateral procedures, repeat on the contralateral side.
Technique tip: When using two single packs for bilateral procedures, two plungers are available which can be used simultaneously on both sides to check alignment of the access channel.
In this case 3 grooves are visible allowing for a maximum balloon size of large
1
22 DePuy Synthes Synfl ate Surgical Technique
Preparation of Inflation System
Instrument
03.804.413S Inflation System, sterile
The inflation system has an angled manometer that shows the pressure in the balloon in pounds/inch2 (psi) and bar. Thevolume scale on the fluid chamber displays milliliters (mlor cc).
It is necessary to prepare one inflation system per balloon.
The 3-way-valve contained in the package will not be used for the Synflate procedure.
Fill the inflation system with saline solution and a liquid contrast medium.
Precaution: Follow the manufacturer’s recommendations for contrast medium use in the vertebral body.
Note: It is essential to fill the inflation system with saline/contrast agent mixture to ensure visibility of the Synflate balloon during inflation. The ratio of contrast medium to saline solution should be about 1:2.
Prepare the contrast medium mixture in a cup (about 15 ml per inflation system) and place the end of the flexible tube of the inflation system in the solution. Push forward on the white wings on the inflation system and pull back on the handle until the plunger bottoms out (1, inset).
Precaution: Patients should be checked for allergy to the contrast medium.
White handle
Plunger with red marking
White wings
2
Synfl ate Surgical Technique DePuy Synthes 23
With the handle pointing downwards, tap the unit to clear the gauge portion of the inflation system of air (2).Rotate the handle clockwise to expel all the air in the barrel. Continue turning the handle clockwise, until solution starts to emerge and the leading edge of the red mark on the plunger reaches the zero mark (2, inset).
Technique tip: To make gross adjustments to the plunger, slide the wings forward to unlock the plunger.
Warning: If the white wings do not return to the locked po-sition, do not force them as this could damage the plunger. Turn the handle gently, and the white wings will return auto-matically to the locked position.
3
1
2
�
�
24 DePuy Synthes Synfl ate Surgical Technique
Instruments
03.804.700S Synflate Vertebral Balloon, small, sterile
03.804.701S Synflate Vertebral Balloon, medium, sterile
03.804.702S Synflate Vertebral Balloon, large, sterile
The Synfl ate vertebral balloon catheter is designed on a double lumen principle. This includes the inner lumen with the stiffening wire � and the outer lumen � which delivers theinfl ation medium to the balloon (1). Both lumens are in-dependent and therefore it is the surgeon’s choice to remove the stiffening wire during infl ation. If removed keep stiffening wire for further reuse.
To prepare the Synfl ate balloon catheter, remove the Synfl ate catheter from the sterile packaging.
Note: Since the stiffening wire is NOT attached, make sure not to loose it while removing the catheter from the package and make sure to attach it tightly to the inner lumen luer (1). If the stiffening wire sticks, gently push it towards the luer lock by a back- forward movement.
If not mounted already attach the valve with the red cap tightly to the outer lumen (2). Remove the red cap from the side arm of the luer (3).
Preparation of Balloon Catheter
5
6
4
Synfl ate Surgical Technique DePuy Synthes 21
It is mandatory to create a vacuum in the balloon catheter prior to its insertion into the working sleeve. For this, remove the enclosed vacuum syringe from the package, connect ittothe side luer of the Y-connector and draw a vacuum by drawing back the syringe plunger until bottomed out (4). Make sure that the syringe is tightened well on the side luer in order to maintain the vacuum.
In this position, the syringe plunger can be blocked by turning it a quarter turn up to marking (5).
Remove the whole syringe from the side luer. The vacuum in the catheter is kept by the valve.
Remove the white cover sleeve from the balloon (6). This cover sleeve can be used later for folding back the balloon after catheter removal for reuse.
Note: Do not slide the cover sleeve towards the luer lock since this may lubricate the shaft reducing the grip for catheter introduction.
A white marking on the balloon catheter shaft indicates the initial length of the balloon (6).
Note: The Synfl ate balloon catheter may be reused once within one surgery.
Shaft marking
Connection for Infl ation System
Stiffening wire on luer
1
2
26 DePuy Synthes Synfl ate Surgical Technique
Inflation of Balloon
1Insert balloon
Insert the balloon catheter under lateral fluoroscopy (1). The balloon is completely outside the working sleeve when the proximal end of the white marking of the catheter shaft dis-appears into the working sleeve (2, inset).
Notes:– Check the balloon position by identifying the markers of
the balloon under fluoroscopy in AP and lateral view.– If it is not possible to completely insert the balloon cathe-
ter so that the white marking of the catheter shaft dis-appears, it may be necessary to clear the path again using the plunger.
– For insertion, the catheter stiffening wire must always be mounted to the catheter.
– If the balloon experiences high friction in the working sleeve, the catheter can be pulled back and forth for lubrication resulting in a decreased insertion force.
2
1
Synfl ate Surgical Technique DePuy Synthes 27
2
Connect the inflation system(s)
Connect the infl ation system to the side port of the catheter (1,2).
Notes: – Do not connect the infl ation system prior to catheter
insertion since this may hamper the insertion.– Do not connect the infl ation system to the connection of
the stiffening wire.
4
28 DePuy Synthes Synfl ate Surgical Technique
Inflation of Balloon
3Inflate balloon
To inflate the balloon (4), slowly rotate the handle of the inflation system clockwise while monitoring the pressure and volume. Monitor the balloon inflation under fluoroscopy.
Proceed with inflation slowly, stopping every few seconds to allow the bone to adjust to the pressure/volume changes.
5
Synfl ate Surgical Technique DePuy Synthes 29
Stop increasing inflation in any of the following cases:– The desired outcome is reached– The pressure reaches 30 atm (440 psi)– The maximum balloon volume is achieved – 4.0 ml for the small balloon – 5.0 ml for the medium balloon – 6.0 ml for the large balloon– Any part of the inflated balloon length touches the
cortical bone
Note: Expansion of balloons, pressure and volume on the inflation system have to be monitored carefully (5).
Precautions: – The balloons may leak if they are filled beyond their
maximum volume or pressure. – The performance of the balloon catheter may be adversely
affected if it comes into contact with bone splinters, bone cement and/or surgical instruments.
For bilateral procedures, inflate each balloon alternately in increments.
Note: For bilateral procedures, it is important to ensure balloon inflation does not induce misalignment (e.g. unsym-metrical height restoration). However, it may be desirable to inflate the balloons to different volumes to prevent or correct misalignment.
Volume
Pressure
1
2
30 DePuy Synthes Synfl ate Surgical Technique
Deflation and Retrieval of Balloon
Gradually decrease the pressure by turning the handle of the inflation system counterclockwise (1), until the manometer indicates approximately 10 atm (150 psi). Slide the white wings forward while pulling the handle all the way back (2) slowly and wait a few seconds to fully deflate the balloon and draw a vacuum. Release the wings with the handle pulled all the way back, to seal the vacuum.
Notes: – Hold the working sleeve in place and pull firmly on the
catheter to retrieve the balloons.– If the balloon does not deflate, check the connections to
the inflation system, draw a vacuum again, or assemble the vacuum syringe to draw a vacuum and deflate the balloon.
– If it becomes difficult to remove the balloon catheter through the working sleeve, twist the catheter while firmly pulling the catheter.
If removal is still difficult, remove the balloon catheter(s) along with the working sleeve(s), then re-access the vertebral body using the working sleeve with the trocar assembly. Once the re-access is completed, remove the trocar.
Precaution: Only reinsert the stiffening wire when balloon is outside the patient.
For bilateral procedures, deflate and retrieve each balloon alternately in increments.
2
Synfl ate Surgical Technique DePuy Synthes 31
Reuse of balloon catheter
The Synfl ate balloon catheter may be reused once within one surgery.
For balloon catheter reuse, remove the infl ation system and carefully insert the catheter back into the white cover sleeve to properly refold the balloon (2). Then start over with the balloon catheter preparation see pages 24 and 25.
Precautions: Prior to reinserting the catheter back into the white cover sleeve, rinse the balloon to remove any resi-dueswith saline solution. Do not clean the balloon by meth-ods of direct contact (e.g. wiping). Since the fi rst infl ation may stretch the balloon material, the length may become larger than the original length. Therefore always insert the catheter under fl uoroscopic control.
1a
2
1b
32 DePuy Synthes Synfl ate Surgical Technique
Injection of Bone Filler
Preparation of injection needle
Remove the injection needle assembled with the clip from package (1a).
Precaution: Move the clip to the starting marker position identified in image (1b). In this position, the distal tip of the injection needle is in line with the distal end of the working sleeve after insertion.
Clip Injection needle
Starting marker
Insertion of injection needle
Under fluoroscopy, insert the injection needle with clip into the working sleeve (2) and fix the clip to the working sleeve.
Notes:– Do not use the grey colored biopsy kit for cement
application.– Check the compatibility of the bone filler with the
injection needle prior to bone filler application.
The filling volume of the injection needle is 1 ml.
Note: If the Access Kit 4.7mm is used, the filling volume of the injection needle is 1.8ml.
3
Synfl ate Surgical Technique DePuy Synthes 33
Under lateral fluoroscopy, inject the bone filler. The direction of the bone filler flow can be changed by orienting the han-dle of the injection needle with the side-opening. Make sure to apply the appropriate amount of bone filler according to the surgical situation.
Notes: – Check the position of the side-opening while injecting the
bone filler. The arrow on the handle of the injection needle indicates the position of the side opening.
– If using a bilateral approach, alternately fill both sides in increments. It is important to see the filling behavior of both needles. Once the filling of one side is accomplished, the lateral view of the opposite side may be hidden by the cement, which makes monitoring the flow more difficult.
34 DePuy Synthes Synfl ate Surgical Technique
Injection of Bone Filler
Warning: Closely monitor the bone filler injection under fluoroscopy to reduce the risk of bone filler leakage. Severe leakage can cause death or paralysis. If bone filler leakage is observed during the procedure, STOP injecting and consider the following: wait for the injected bone filler to harden, reposition the needle, adjust the needle direction, or stop the procedure. If desired, continue bone filler injection slowly, and carefully evaluate for further leakage. If further leakage is observed, cease bone filler injection.
Optional injection needle cleaning can be performed using the cleaning stylet contained in the single pack access kit.
Refer to the system’s instructions for proper use and waiting times required prior the removal of injection needle and working sleeves.
Warning: The timing of the release of the bone filler is dependent on the bone filler selection. Its preparation, injec-tion and setting times vary by product, refer to the system’s instructions prior to surgery and plan accordingly. If the in-jection needle with the working sleeve is removed too early, there may be a risk of pulling cement fibers into the muscle tissue. If the injection needle is removed too late the injec-tion needle may not or only hardly be removed.
Precaution: For bilateral approach, leave both injection needles inserted while applying the bone filler to avoid backflow into the working sleeve.
Close the wound.
Synfl ate Surgical Technique DePuy Synthes 31
Postoperative Care
Place the patient in the supine position after surgery to compress the wound. Bruising may occur at the puncture sites. The patient may then be mobilized at the physician’s discretion.
36 DePuy Synthes Synfl ate Surgical Technique
Implants and Instruments
Art. No. Description Max. volume Balloon length
03.804.700S Synflate Vertebral Balloon, small, sterile 4 ml 10 mm
03.804.701S Synflate Vertebral Balloon, medium, sterile 5 ml 15 mm
03.804.702S Synflate Vertebral Balloon, large, sterile 6 ml 20 mm
03.804.514S Access Kit, 10 G, Diamond Tip, with side-opening, Double Pack, sterile03.804.515S Access Kit, 10 G, Beveled Tip, with side-opening, Double Pack, sterile
Instruments for double access with trocar or Kirschner wire.
S
M
L
Small
Medium
Large
Set includes:– 2guide Wire– 2Working Sleeve with cannulated trocar– 2Trocar (diamond or beveled)– 1Access Drill– 1Plunger– 2Cement needle with clip
Synfl ate Surgical Technique DePuy Synthes 37
03.804.519S Access Kit, 10 G, Diamond Tip, with side-opening, Single Pack, sterile03.804.520S Access Kit, 10 G, Beveled Tip, with side-opening, Single Pack, sterile
Instruments for monolateral access with trocar. Includes a cleaning stylet for the injection needle.
03.804.521S Access Drill, 10 G, sterile (optional together with Single Pack Access Kits)
03.804.522S Biopsy Kit, 10G, sterile (optional)
Set includes:– 1Working Sleeve with trocar (diamond or beveled)– 1Plunger– 1Injection needle with clip and cleaning stylet
03.804.413S Infl ation System, sterile
38 DePuy Synthes Synfl ate Surgical Technique
Alternative Instruments
03.804.612S Access Kit 4.7 mm
Instruments for double access with trocar or Kirschner wire.
Set includes:– 2Guide Wire– 2Working Sleeve with cannulated trocar– 2Trocar (Diamond Tip)– 1Access Drill– 1Plunger– 2Cement needle with clip
03.804.613S Biopsy Kit 4.7 mm
Implants and Instruments
Synfl ate Surgical Technique DePuy Synthes 39
Recommended Bone Cements
07.702.016S Vertecem V+ Cement Kit, sterile
03.702.215S Vertecem V+ Syringe Kit, sterile
2839-99-002 Adaptor: Confidence Reservoir to Standard Luer
2839-07-000 CONFIDENCE Needleless Kit 7 cc2839-13-000 CONFIDENCE Needleless Kit 11 cc
40 DePuy Synthes Synfl ate Surgical Technique
399.410 Hammer 300 g
Optional Instruments
292.210S Kirschner Wire B 2.0 mm with trocar tip, length 280 mm, Stainless Steel, sterile
Synfl ate Surgical Technique DePuy Synthes 41
Bibliography
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