TM Inion S Graft Containment System Training Presentation - PowerPoint PPT Presentation

S-1 TM TM Inion S Graft Containment System Training Presentation December 2015

Table of contents  What is the Inion S-1™ system  Indications  Products  Basic spinal anatomy  Inion S-1™ features and benefits  Surgical technique  Clinical references

What is Inion S-1™? A biodegradable graft containment system for anterior cervical discectomy and fusion (ACDF)  Single and double level plates with radiopaque tantalum markers  Screws with radiopaque tantalum markers

What is Inion S-1™?  Made out of LPLA/DLPLA (i.e., combination of L-lactic acid and DL-lactic acid)  Implants retain min. 80% of their initial strength minimum 16 weeks  Biodegrades completely in 2-4 years  H 2 O and CO 2

Where Inion S-1™ is used?  Cervical spine (C2-T1)  Anterior approach  Anterior cervical discectomy and fusion procedures (ACDF) C2-T1

Indications Indications In conjunction with adjunctive immobilisation (i.e., simultaneous conservative treatment with a collar), intended for use in anterior cervical discectomy and fusion procedures as a means to maintain the relative position of block bone allografts or autografts.

Indication  Anterior cervical discectomy and fusion procedures (ACDF) , not for load bearing indications .

Inion S-1 TM plates and screws Article No Description Pcs./ pack Plates SPN-5110 Single level plate, 21x19x2.0 mm 1 SPN-5111 Single level plate, 23x19x2.0 mm 1 SPN-5112 Single level plate, 25x19x2.0 mm 1 SPN-5113 Single level plate, 27x19x2.0 mm 1 SPN-5114 Single level plate, 29x19x2.0 mm 1 SPN-5115 Single level plate, 31x19x2.0 mm 1 SPN-5116 Double level plate, 33x19x2.0 mm 1 SPN-5117 Double level plate, 36x19x2.0 mm 1 SPN-5118 Double level plate, 39x19x2.0 mm 1 SPN-5119 Double level plate, 42x19x2.0 mm 1 SPN-5120 Double level plate, 45x19x2.0 mm 1 SPN-5121 Double level plate, 48x19x2.0 mm 1 Screws SPN-5320 Screw 4.5x12 mm 2 SPN-5321 Screw 4.5x14 mm 2 SPN-5322 Screw 4.5x16 mm 2 SPN-5323 Screw 5.0x12 mm 1 SPN-5324 Screw 5.0x14 mm 1 SPN-5325 Screw 5.0x16 mm 1 Diameter 4.5 mm screws are the primary screws. Diameter 5.0 mm screws are the emergency screws.

Inion S-1 TM instruments Article No Description Pcs./ pack Pcs./set INS-9540 Drill bit 3.7 mm with stop for 12 mm screw 1 1 INS-9541 Drill bit 3.7 mm with stop for 14 mm screw 1 1 INS-9542 Drill bit 3.7 mm with stop for 16 mm screw 1 1 Drill bit 4.2 mm with stop for 12 mm screw 1 1 INS-9543 INS-9544 Drill bit 4.2 mm with stop for 14 mm screw 1 1 INS-9545 Drill bit 4.2 mm with stop for 16 mm screw 1 1 Bone tap 4.5 mm with stop for 12 mm screw 1 1 INS-9546 INS-9547 Bone tap 4.5 mm with stop for 14 mm screw 1 1 INS-9548 Bone tap 4.5 mm with stop for 16 mm screw 1 1 INS-9549 Bone tap 5.0 mm with stop for 12 mm screw 1 1 INS-9550 Bone tap 5.0 mm with stop for 14 mm screw 1 1 INS-9551 Bone tap 5.0 mm with stop for 16 mm screw 1 1 INS-9552 Drill bit 2.0 mm 1 1 INS-9553 Screw removal instrument 1 1 INS-9554 Drill guide, single 1 1 INS-9555 Drill guide, twin 1 1 INS-9556 Plate holder 1 1 INS-9527 Temporary fixation screw 1 3 INS-9558 Screwdriver shaft for temporary fixation screw 1 1 INS-9559 Screwdriver shaft 1 1 INS-9560 Awl 1 1 INS-9024 Plate bending pliers 1 2 INS-9120 Screwdriver handle, cannulated 1 2 Screwdriver handle, ratchet 1 1 INS-9121 ACC-9823 Plate template, 21 x 19 mm 1 1 ACC-9824 Plate template, 23 x 19 mm 1 1 Plate template, 25 x 19 mm 1 1 ACC-9825 ACC-9826 Plate template, 27 x 19 mm 1 1 ACC-9827 Plate template, 29 x 19 mm 1 1 ACC-9828 Plate template, 31 x 19 mm 1 1 ACC-9829 Plate template, 33 x 19 mm 1 1 ACC-9830 Plate template, 36 x 19 mm 1 1 ACC-9831 Plate template, 39 x 19 mm 1 1 ACC-9832 Plate template, 42 x 19 mm 1 1 ACC-9833 Plate template, 45 x 19 mm 1 1 ACC-9834 Plate template, 48 x 19 mm 1 1 ACC-9802 Inion Thermo drape 5 ACC-9810 Inion Thermo+ (water bath 230V) 1 1 ACC-9817 Water bath cable (UK plug) 1 ACC-9841 Sterilization tray for instruments 1 1

Color coding of the Drill bits and the Bone taps  The Drill bits and the Bone taps are color coded. Color code is specific for screw length and diameter.  Green Screw length 12 mm  Blue Screw length 14 mm  Magenta Screw length 16 mm  One color stripe Screw diameter 4.5 mm  Two color stripes Screw diameter 5.0 mm (emergency screw)

Basic spinal anatomy  Between each vertebral body there is an intervertebral disc.  There are 2 parts to the discs:  Annulus fibrosus (outer)  Nucleus pulposus (inner)

Basic spinal pathology Degenerative The term “degenerative” refers to a condition resulting from the loss of normal structure and function. The spinal structures most affected by degenerative disease are intervertebral discs and facet joints.

Trauma Trauma  Due to an accident Note: Inion S-1 TM is not indicated to fixation of unstable spine

Benefits – Load sharing with graft F  Plate-screw construct is semirigid and ”viscoelastic” (polymer characteristic) x  Material ”gives in” under constant load  Allows load sharing with the graft  The construct’s modulus of elasticity is close to that of the bone  Allows micromovement 37C

Rigid or dynamic? – Strong or strong enough? Cervical Graft Vertebral bodies plate

Rigid or dynamic? – Strong or strong enough? Load transferred through the graft Immediately post op

Rigid or dynamic? – Strong or strong enough? Load transferred through the plate Graft shrinks Rigid plate Immediately post op Follow-up

Rigid or dynamic? – Strong or strong enough? Graft shrinks -> Stress on the plate and graft is shielded Rigid plate Immediately post op Follow-up

Rigid or dynamic? – Strong or strong enough? Load transferred through the graft Plate adjusts Rigid plate Dynamic plate Immediately post op Follow-up Follow-up

Benefits – Constrained screw plate design  Screw is fixed to the plate at a chosen angle (+/- 5° recommended) when fully inserted  Allows optimal screw angulation and monocortical screw fixation

”Custom Implants”

Translucent ”See through plate”

Radiolucent  Interference with imaging techniques is eliminated due to low material density  Consequently, the fusion result can be assessed easier  No disturbance in MRI X-RAY RAY

Radiolucent  Interference with imaging techniques is eliminated due to low material density  Consequently, the fusion result can be assessed easier  No disturbance in MRI Titanium Inion S-1™

X-ray

MRI

Degradation – strength retention

Degradation – mass loss

Surgical technique

Water bath set-up instructions (1/3) Open the sterile drape peel pouch and unfold the sterile drape onto a sterile table. The scrub nurse places both hands inside the The sterile drape pouch is turned inside out. The sterile drape pouch while the circulating opening of the sterile pouch remains around the assistant inserts the water bath against the power cable. drape’s closed end.

Water bath set-up instructions (2/3) The water bath is now ready to be placed on a sterile table close to the operating surgeon. 6 6 After placing the draped water bath on the sterile table, make a depression into which sterlile water or saline can be poured. Ensure that the drape lines the bottom of the water bath and that no air is left between the drape and the water bath basin. This is important to ensure correct temperature of the sterile fluid during procedure. Note! Use Inion Therm o + water bath with the Inion S-1 ™ (T: 70°C / 158°F).

Water bath set-up instructions (3/3) 7 7 Pour sterile water or saline into the bath. Fill the bath just over half full (ca. 0.5l). Rem ember to ensure that this am ount of fluid is in the bath during the procedure. Once m ore ensure there is no air between the bath and the sterile drape. Once fluid is in the bath, plug the cable in. 9 9 The water bath can now be switched on. Note! Heating of the water takes ~ 30minutes.

Plate selection and contouring Determine the correct plate size with the 1. plate template. Precondition the Inion S-1™ plate in the Inion 2. Thermo+ water bath for approximately 1 minute. Preconditioning can be repeated up to 3 times. Maximum total immersion time is 30 minutes. (Note: Do not put the Inion S-1™ screws in the hot water bath.) Contour the plate to the bone anatomy 3. immediately after preconditioning. The plate is malleable for approximately 10 seconds after taken out from the water bath.

Drilling and tapping Insert the temporary fixation screws to fix the 4. Inion S-1™ plate on the bone. Two temporary fixation screws are used, one in each end of the plate. Create starting holes with the Awl before inserting the temporary fixation screws. Select the correct size Drill bit and drill the screw 5. hole in the plate and bone through the Drill guide. Drill until the stop of the Drill bit meets the end of the Drill guide. Tap the screw hole through the Drill guide. Tap 6. until the stop of the Drill bit meets the end of the Drill guide. Flush the hole with sterile water or saline.