episealer® femoral twin

EPISEALER® FEMORAL TWIN
DESCRIPTION EPISEALER FEMORAL TWIN
EPISEALER FEMORAL TWIN
Episealer Femoral Twin is uniquely designed to fit each patient´s individual cartilage and bone damage,
regarding both size and location.
Description of Episealer Femoral Twin
Episealer Femoral Twin consists of both peg and hat in one piece. The implant is made of a cobalt-chrome alloy
with titanium and hydroxyapatite coated surfaces and a polished top surface. The Episealer Femoral Twin is
available in different sizes, whereas the topography and thickness of the articular surface have a patient-specific
design.
The Episealer Femoral Twin and the associated toolkit is available for the knee condyle and knee trochlea and
comes in four different sizes: 2xD15mm (total length 23mm), 2xD17mm (total length 26mm),
2xD20mm (total length 29mm) and 2xD25mm (total length 35mm).
All patient-specific parts are delivered sterile.
For training and marketing purposes only.
|2|
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
EPISEALER FEMORAL TWIN
PERFECT FIT
DESCRIPTION EPISEALER FEMORAL TWIN
EPISEALER FEMORAL TWIN
Cobalt-chrome
Patient-specific design
Titanium undercoating
Hydroxyapatite outer coating
Name
Episealer Femoral Twin 2xD15
Episealer Femoral Twin 2xD17
Episealer Femoral Twin 2xD20
Episealer Femoral Twin 2xD25
For training and marketing purposes only.
Article number
Total length
51115
51117
51120
51125
23 mm
26 mm
29 mm
35 mm
|4|
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
DESCRIPTION EPISEALER FEMORAL TWIN
INTENDED USE
Intended Use Episealer Femoral Twin
The Episealer Femoral Twin (hereinafter also referred to as Episealer) is a patient-specific endoprosthetic resurfacing implant,
intended to be used as a cartilage and bone replacement for femoral knee joint chondral and osteochondral defects, covering a part of
the joint. It is intended to give the patient improved knee function and pain relief.
It is applicable:
•
on the femoral knee joint,
•
for different lesion sizes,
•
for lesions of degenerative or traumatic etiology.
Indications and Intended Patient Population
The device is intended for patients with a focal femoral knee joint chondral or osteochondral lesion, causing pain and/or disability. The
patient has a history of failed conservative treatment and has a lesion requiring surgical treatment.
Contraindications
Absolute contraindications include:
•
non-focal defects
•
instability or malalignment in the knee joint
•
on-going infection in the tibiofemoral joint
•
inflammatory arthritis or radiographic osteoarthritis
•
sensitivity to materials typically used in orthopaedic prosthetics
•
inadequate bone stock where the Episealer is to be inserted
•
existing prosthesis in area of treatment or opposing surface
•
severe lesion (ICRS 3-4) on opposing surface
Relative contraindications include:
•
pain of unknown etiology
•
other diseases or medication that may affect the bone anchoring of the Episealer
•
uncooperative patient who is not willing to follow instructions
•
muscular insufficiency
•
vascular insufficiency
•
medical, hormonal, haematological, immunological and metabolic illnesses
•
demineralized bone
Possible Adverse Effects
General surgical complications:
•
endoprosthetic treatments always involve certain risks such as local swelling, temporary soreness, joint exudate, haematoma, thrombosis, inflammation, early or late post-operative infection in the operation area and bleeding
•
complications related to anaesthesia
Adverse effects related to the Episealer:
•
intra-operative or postoperative bone fracture
•
allergic reaction
•
loosening, migration or loss of fixation of the Episealer
•
wear and damage to the opposed articular cartilage surface
For training and marketing purposes only.
|5|
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
DESCRIPTION EPISEALER FEMORAL TWIN
FEMORAL TWIN TOOLKIT
Name
1
2
3
4
5
6
7
8
9
Article Number
53115/53117/53120/53125
53415/53417/53420/53425
57115/57215 - 57117/57217 - 57120/57220 - 57125/57225
55215/55217/55220/55225
52115/52117/52120/52125
54115/54117/54120/54125
53715/53717/53720/53725
Part of the Epiguide
51115/51117/51120/51125
Drilling socket
Adjustment socket
Epimandrel1
Epicut
Epidrill
Epidummy
Epiguide®
Epiguide insert
Episealer®
The Epimandrel comes in two versions. The Toolkit includes either a flat or a round Epimandrel,
depending on the patient-specific Episealer design (571XX = flat, 572XX = round)
1
Cleaning and Sterilisation
The Episealer is delivered sterile. Sterilisation is performed by gamma irradiation. The Episealer must not be re-sterilised.
The Epiguide and Epidummy are delivered sterile. Sterilisation is performed by autoclaving. These tools must not be re-sterilised.
The Epidrill, Epicut, Epimandrel, Drilling socket and Adjustment socket are delivered non-sterile. The medical centre must clean and
sterilise these instruments according to Episurf’s instructions:
Cleaning
Disinfector (EN ISO 15883-1:2006).
Temperature: 90°C
Exposure time: at least 1 minute
Sterilisation
Steam autoclave (EN ISO 17665-1:2006)
Temperature: 134°C
Exposure time: 3 minutes
Minimum drying time: 30 minutes
Packaging: Double-Single or without packaging
Patient -specific parts
Epidummy
For training and marketing purposes only.
Episealer
|6|
Epiguide
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
Episealer Femoral Twin
Product overview
1
2
3
4
5
6
8
7
9
For training and marketing purposes only.
|7|
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
1
SURGICAL PROCEDURE
PLACING THE EPIGUIDE
Place the Epiguide on the articular cartilage surface. Make sure to use the
markings on the Epiguide, A (anterior) and P (posterior), to find the
correct orientation when positioning the Epiguide. Identify the correct
position by aligning the Epiguide’s base to the condyle’s medial and
lateral edges and the lesion. For a trochlea position, align the Epiguide’s
base to the knee’s anterior edge and the lesion.
Look through the opening of the Epiguide without the insert in place and
make sure the bottom surface is placed flush to the cartilage surface all
the way around the opening. This is important to achieve the correct
drilling angle and depth.
2
SECURING THE EPIGUIDE
Use a drilling machine and three surgical pins to attach and secure the
Epiguide to the bone. After inserting the first pin, check that the Epiguide
has not moved out of its position. Then insert the remaining pins.
WARNING!
Make sure the Epiguide is securely fastened to the bone.
For training and marketing purposes only.
|8|
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
3
SURGICAL PROCEDURE
ASSEMBLING THE EPIGUIDE
Place the insert in the Epiguide in any of the two positions. The insert
is used during both pre-cuttings of the cartilage and the drilling of both
holes.
Check that the insert is bottomed in the Epiguide with their top surfaces
aligned. This must be checked every time the insert is placed in the
Epiguide.
WARNING!
Ensure the insert is bottomed in the Epiguide with their top surfaces
aligned every time it is placed. This is essential to achieve the correct
drilling angle and depth.
4
ASSEMBLING THE DRILLING SOCKET
Mount the Drilling socket onto the Epiguide. The Drilling socket guides the
pre-cutting of cartilage and the first drill steps.
Check that the Drilling socket is set in its correct position relative the
Epiguide; the arrow on the rim of the Drilling socket must be in line with
the arrow on the insert.
Check that the Drilling socket has bottomed onto the Epiguide.
WARNING!
Ensure the Drilling socket is in a correct position before cutting and
drilling. Incorrect position may result in an incorrect drill depth and
incorrect Episealer placement.
Start position
For training and marketing purposes only.
|9|
Drilling socket bottoming
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
5
SURGICAL PROCEDURE
PRE-CUTTING THE CARTILAGE
A sharp cartilage edge is imperative in order to get a precise fit between
the cartilage and the Episealer. To obtain a sharp cartilage edge the Epicut
is used to pre-cut the cartilage before drilling.
Insert the Epicut into the Drilling socket. Use one hand to hold the Drilling
socket steady in the Epiguide and the other hand to rotate the Epicut one
turn clockwise while pushing it slightly downwards. Remove the
Epicut.
Lift up the insert from the Epiguide, turn it 180° and re-mount it in the
Epiguide. Check that the insert is bottomed in the Epiguide and that the
Drilling socket is correctly mounted to the insert.
Cut the cartilage in the position for the second drill hole in the same way
as the first hole.
6
DRILLING PROCEDURE - STEP ONE
Both holes are always drilled to the same depth before any adjustment is
made to another depth. This is important to ensure the hole depth can
be evaluated properly and to achieve a correct uniform depth for the
Episealer.
Attach the Epidrill to the assigned drilling machine. Check that the drilling
machine is adjusted for drilling clockwise. Make sure the insert is
bottomed in the Epiguide and that the Drilling socket is correctly mounted
to the insert. Ensure that both insert and Drilling socket have bottomed.
Use one hand to hold the Drilling socket steady in the Epiguide and the
other hand to handle the drilling machine. Insert the Epidrill into the
Drilling socket. Start drilling and drill until the Epidrill stops at the top of
the Drilling socket. Use moderate speed and keep the drilling machine
steady while applying only moderate force. Use vigorous lavage through
the openings at the Epiguide during drilling to minimise heat effects to
adjacent bone and cartilage tissue and to rinse away bone and tissue
debris.
WARNING!
Make sure the drill is not misaligned and that the drill does not load the
Epiguide in any direction.
Before pre-drilling
For training and marketing purposes only.
After pre-drilling
|10|
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
7
SURGICAL PROCEDURE
DRILLING PROCEDURE - STEP TWO
Lift up the insert from the Epiguide, turn it 180° and re-mount it in the
Epiguide. Check that the insert is bottomed in the Epiguide and that the
Drilling socket is correctly mounted to the insert. In order to achieve
correct depth of the hole, it is important that the Drilling socket is always
placed in the insert with its arrow in line with the arrow on the insert.
Drill the second hole, following the instructions for the first one.
Remove the Drilling socket from the Epiguide.
8
ASSEMBLING THE ADJUSTMENT SOCKET
Insert the Adjustment socket in the Epiguide in its START position; the
arrow on the Adjustment socket must be in line with the arrow on the
insert. Make sure the Adjustment socket is inserted all the way to the
bottom of the insert.
WARNING!
Ensure the Adjustment socket is in a correct position and that the insert
is bottomed in the Epiguide before drilling. Incorrect positions may
result in an incorrect drill depth and incorrect Episealer placement.
Start position
For training and marketing purposes only.
|11|
Adjustment socket bottoming
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
9
SURGICAL PROCEDURE
DRILLING PROCEDURE - STEP THREE
Insert the Epidrill into the Adjustment socket. When inserting the Epidrill
into the Adjustment socket, make sure that the tip of the Epidrill is
inserted into the pre-drilled hole but that the drill body is not in contact
with the surface when the drilling procedure starts. Use one hand to hold
the Adjustment socket steady in the Epiguide and the other hand to
handle the drilling machine.
Drill until the Epidrill stops at the top of the Adjustment socket. Use
moderate speed and keep the drilling machine steady while applying only
moderate force. Use vigorous lavage through the openings at the Epiguide
during drilling to minimise heat effects to adjacent bone and cartilage
tissues and to rinse away bone and tissue debris.
Remove the Epidrill.
PRECAUTION
If the drilling gets harder during the drilling process, residues might be
stuck in the drilling channels. If that is the case stop drilling, remove the
Epidrill and cleanse the Epidrill from residues. Re-insert the Epidrill all the
way to the bottom of the drilled hole and continue the drilling
process. Keep drilling until the Epidrill stops on top of Adjustment
socket.
10
Epidrill at start position
DRILLING PROCEDURE - STEP FOUR
Lift up the insert from the Epiguide, turn it 180° and re-mount it in the
Epiguide.
Perform the adjustment drilling for the second hole, following the
instructions for the first hole.
WARNING!
Ensure both holes are drilled with identical Adjustment socket drill
depth setting. Different hole depths may prevent the Episealer from
being placed correctly and/or becoming osseointegrated.
Epidrill bottoming
For training and marketing purposes only.
|12|
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
11
SURGICAL PROCEDURE
REMOVAL OF DEBRIS AND LOOSE CARTILAGE
Note the Adjustment socket position and remove the Adjustment socket
and insert from the Epiguide. Use the flushing device and suction device
to cleanse the drilled hole.
WARNING!
Ensure there are no fringes on the cartilage edge after drilling. Fringes
on the cartilage edge should be removed using a standard tweezer. If
residues of bone and/or cartilage are left in the drilled hole, the
Episealer may be prevented from becoming osseointegrated.
12
EVALUATING THE DRILLED DEPTH
Insert the Epidummy into the drilled hole with its direction mark aligned
with the direction mark of the Epiguide.
Compare the depth of the Epidummy top surface with the surrounding
cartilage edge and assess the height difference. Use the openings in the
Epiguide to evaluate the depth. If the Epidummy top surface is positioned
approximately 0.5-1 mm below the adjacent articular cartilage surface the
drilling is finished. Proceed to step 14. If not, continue adjusting the drill
depth according to step 13.
WARNING!
Ensure the top surface of the Epidummy is positioned approximately
0.5-1 mm below the adjacent cartilage surface. If the Episealer is placed
proud or too deep it may damage surrounding and opposing soft
tissues.
Not deep enough
For training and marketing purposes only.
|13|
OK
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
13
SURGICAL PROCEDURE
ADJUSTING THE DRILL DEPTH
Re-assemble the Adjustment socket and insert in the Epiguide. Adjust the
drilling depth by turning the Adjustment socket to the desired setting; the
desired setting on the Adjustment socket shall be in line with the arrow on
the insert. The drilling depth is increased by 0.2 mm in each step.
Check that the insert is bottomed in the Epiguide and that the Adjustment
socket is bottomed in the insert.
Repeat steps 9 through 12 until the Epidummy top surface is positioned
approximately 0.5-1 mm below the adjacent articular cartilage surface.
It is recommended that the additional drilling is performed incrementally,
increasing the drill depth by small increments at a time.
Note the drill depth setting. In case of removal of the Adjustment socket, it
needs to be replaced at the correct depth to avoid unintentionally drilling
too deep.
WARNING!
Ensure the Adjustment socket is in a correct position and that the insert
is bottomed in the Epiguide before drilling. Incorrect positions may
result in an incorrect drill depth and incorrect Episealer placement.
14
MARKING THE DIRECTION OF THE EPISEALER POSITION
Use a sterile pen to mark the direction for the Episealer. Make the mark on
the cartilage surface aligning the direction mark of the Epiguide.
Remove the Epiguide.
Mark here
For training and marketing purposes only.
|14|
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
15
SURGICAL PROCEDURE
PLACING THE EPISEALER
Gently place the Episealer Femoral Twin into the drilled hole. Check that
the direction mark on the Episealer is aligned with the direction mark on
the cartilage. Use your fingers to gently press the Episealer down into the
drilled holes.
Direction mark
16
DRIVING DOWN THE EPISEALER
Use the Epimandrel and a hammer to gently tap down the Episealer into
the bone until bottomed. Make sure to distribute the tapping evenly over
the top surface of the Episealer. When bottomed, the top surface of the
Episealer should be approximately 0.5-1 mm below the adjacent articular
cartilage surface.
WARNING!
Make sure to gently tap the Episealer until bottomed. This is indicated
by a more distinct sound.
Improper handling of the Episealer can cause scratches, nicks or dents
that may have adverse clinical effects on opposing joint surfaces.
For training and marketing purposes only.
|15|
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
RESULT
FINAL PLACEMENT
For training and marketing purposes only.
|16|
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
WARNINGS
WARNINGS
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
The surgeon should contact Episurf or their local representatives for more information about the surgical technique and training.
Expected results may not be accomplished if the Femoral Twin toolkit is not used.
Improper positioning and implantation of the Episealer may reduce the effective lifetime of the Episealer.
The Episealer, Epiguide and Epidummy must not be re-sterilised.
The Episealer and Femoral Twin toolkit must not be re-used.
Episealers and instruments that have been damaged, mishandled or removed from the sterile
field must not be used.
Epicut and Epidrill contain sharp edges and should be handled with care.
If implantation is not performed within 6 months from the MR scan, the physician must judge if the MR is still valid to ensure the patient-specific fit.
Improper handling of the Episealer can cause scratches, nicks or dents that may have adverse clinical effects on opposing joint surfaces.
Unless the operative field is fully exposed, expected results might not be achieved.
Do not proceed with the surgery if the Epiguide is not securely fastened to the bone. A loosely fastened Epiguide may cause improper implantation and incorrect Episealer placement.
Ensure the insert is bottomed in the Epiguide with their surfaces aligned every time it is placed. This is essential to achieve the correct drilling angle and depth.
Always ensure the Drilling socket and Adjustment socket are in a correct position before drilling. Incorrect position may result in an incorrect drill depth and incorrect Episealer placement.
Ensure there are no fringes on the cartilage edge after drilling. Fringes on the cartilage edge should be removed using standard tweezers. If residues of bone and/or cartilage are left in the drilled hole, the Episealer may be prevented from becoming osseointegrated with the bone.
Ensure both holes are drilled with identical Adjustment socket drill depth settings. Different hole depths may prevent the Episealer from being place correctly and/or becoming osseointegrated.
Ensure the Episealer articular surface is positioned approximately 0.5-1 mm below the adjacent cartilage surface. If the Episealer is placed proud or too deep, it may damage surrounding and
opposing soft tissues.
For training and marketing purposes only.
|17|
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
NOTES
NOTES
For training and marketing purposes only.
|18|
EPISURF MEDICAL | EPISEALER FEMORAL TWIN
CONTACT INFORMATION
STORA SKUGGANS VÄG 11 | 115 42 STOCKHOLM | SWEDEN
+46 8 612 00 20 | INFO@EPISURF.COM
WWW.EPISURF.COM
NASDAQ OMX - B-SHARE
PMR_5001 v01