grand fix presentation uz leuven 230316

S

GRAND FIX : Bioabsorbable Bone Fixation

Device

BIO DISTRIBUTION

Staff Training UZ Leuven, March 23

The product

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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

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

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Material characteristics

PLLA Lactic acid

CO2，H2OStaff Training UZ Leuven, March 23

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

Staff Training UZ Leuven, March 23

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

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

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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

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 !