grand fix presentation uz leuven 230316
TRANSCRIPT
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S
GRAND FIX : Bioabsorbable Bone Fixation
Device
BIO DISTRIBUTION
Staff Training UZ Leuven, March 23
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The product
Staff Training UZ Leuven, March 23
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Indications
S Osteotomy : fixation of ribs and sternum afterthoracothomy
S Osteosynthesis : fixation of ribs and sternum after traumatic fracture, sternal closure
S Bone grafting
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Material characteristics
S Bioabsorbable bone fixation device for ribs and
sternum
S PLLA ( Poly-L-Lactic-Acid )
S PLLA reacts with water by hydrolysis and is finally
metabolized to water and carbon dioxide
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Material characteristics
PLLA Lactic acid
CO2,H2OStaff Training UZ Leuven, March 23
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Bioabsorbability
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Bioabsorbability
1. Molecular weight is reduced and then bendingstrength is decreased ( T1/2 = 4-6 months )
2. Weight decreases and completes the degradation process
3. PLLA completely dissolved after 3 years
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Bending Strength
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0 200 400 600 800 1000 1200
チタン合金
ステンレス(SUS316)
ヒト皮質骨
グランドフィックス
Bending strength (MPa)
GRAND FIX
Human Cortical Bone
Stainless Steel (SUS316)
Titanium
Close value to human cortex bone
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Product line : rib pin
Length
Width
Depth
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Product line : rib pin
Product TypeLength
( mm )
Width
( mm )
Depth
( mm )
Rib Pin
RA-2722 27 2 2
RA-2732 27 3 2
RA-3432 34 3 2
RA-2733 27 3 3
RA-2743 27 4 3
RA-3433 34 3 3
RA-3443 34 4 3
RA-3833 38 3 3
RA-3843 38 4 3
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Product line : sternum pin
Width
Depth
Length
Diameter
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Product line : sternum pin
Product TypeLength
( mm )
Width
( mm )
Depth
( mm )
Sternum Pin
for
Pediatrics
BBS-1022 10 2 2
BBS-1522 15 2 2
BBS-1510 10 D = 1.5
Sternum Pin
BA-1533 15 3 3
BA-1833 18 3 3
BA-2033 20 3 3
BA-2333 23 3 3
BA-2053 20 5 3
BA-2353 23 5 3
BA-2753 27 5 3
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Instructions for use
SRib pin
SSternum pin
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Rib pin
Create a 2 cm space between each rib bone and hold them with
surgical suture
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Rib pin
Use the dedicated sizer to perform a hole of same depth at both
sides of rib bones
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Rib pin
Use the appropriate clamp to pick and insert the pin into the bone.
The green line denotes the midpoint of the pin
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Rib pin
Put surgical sutures 2 cm from the cut line
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Sternum pin
Identify the point of insertion of the pin
Place the dedicated reamer vertically and drill a hole on both
sides
The hole shoudn’t be larger than the diameter of the pin
3mm2mm
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Sternum pin
Insert the dedicated sizert into the holes until the target line ( marked on the sizer ) meets the size of the pin
Use side② for eventual enlargement of the hole
The sizer shoudn’t be rotated in order not to create too large holes
② same sized sideproduct number is marked on
this side
① smaller sized side
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Sternum pin
Grip the pin with the dedicated clamp
If the pin has a blue mark on its center, grip it on the line
If the pin has a curvature, adjust the pin’s curvature to bone’s
curvature
red arrow shows curvature of the pin
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Sternum pin
Pull toward each divided bone and insert the pin in each hole
Complete usual chest closure
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Advantages
Conventional wires
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Advantages
Sternal Talon®
ZipFix® System
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Advantages
Adult patients vs. wires
S Prevention of sternum and periosteum from rubbing
S Reduction of pain, infection and inflammation of the
wound area
S Complete absorption
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Advantages
Children vs. wires
S Bone union process is 20 – 30 % faster. Percentage of
costal cartilage is higher.
S Decrease of malunion and chest deformity
S Radiolucency of the sternum pin ( invisible to X-Ray )
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Clinical litterature
Biosorbable Poly-L-Lactide Rib-Connecting Pins May
Reduce Acute Pain after Thoracotomy
A. Iwasaki, D. Hamatake and T. Shirakusa
Thorac Cardiov Surg. 2004; 52: 49 - 53
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Clinical litterature
Sternal Closure With Reabsorbable Pin and Cord in
Pediatric Less Invasive Cardiac Surgery
H. Oiwa, R. Ishida and K. Sudo
Ann Thorac Surg. 2004; 78: 358–9
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Thank you !