Post on 22-Jan-2018
S
GRAND FIX : Bioabsorbable Bone Fixation
Device
BIO DISTRIBUTION
Staff Training UZ Leuven, March 23
The product
Staff Training UZ Leuven, March 23
Indications
S Osteotomy : fixation of ribs and sternum afterthoracothomy
S Osteosynthesis : fixation of ribs and sternum after traumatic fracture, sternal closure
S Bone grafting
Staff Training UZ Leuven, March 23
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
Staff Training UZ Leuven, March 23
Material characteristics
PLLA Lactic acid
CO2,H2OStaff Training UZ Leuven, March 23
Bioabsorbability
Staff Training UZ Leuven, March 23
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
Staff Training UZ Leuven, March 23
Bending Strength
Staff Training UZ Leuven, March 23
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
Product line : rib pin
Length
Width
Depth
Staff Training UZ Leuven, March 23
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
Product line : sternum pin
Width
Depth
Length
Diameter
Staff Training UZ Leuven, March 23
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
Instructions for use
SRib pin
SSternum pin
Rib pin
Create a 2 cm space between each rib bone and hold them with
surgical suture
Staff Training UZ Leuven, March 23
Rib pin
Use the dedicated sizer to perform a hole of same depth at both
sides of rib bones
Staff Training UZ Leuven, March 23
Rib pin
Use the appropriate clamp to pick and insert the pin into the bone.
The green line denotes the midpoint of the pin
Staff Training UZ Leuven, March 23
Rib pin
Put surgical sutures 2 cm from the cut line
Staff Training UZ Leuven, March 23
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
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
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
Sternum pin
Pull toward each divided bone and insert the pin in each hole
Complete usual chest closure
Advantages
Conventional wires
Advantages
Sternal Talon®
ZipFix® System
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
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 )
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
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
Thank you !