ChM Inter-rib Distraction Stabilizer • IMPLANTS • INSTRUMENT SET 40.5576.000 • SURGICAL TECHNIQUE

SYMBOLS DESCRIPTION Caution - pay attention to a special procedure. Perform the activity under X-Ray control. Information about the next stages of a procedure. Proceed to the next stage. Return to the specified stage and repeat the activity. Review date The manufacturer reserves the right to introduce design changes. Updated INSTRUCTIONS FOR USE are available at the following website: ifu.chm.eu

I. INTRODUCTION 5 I.1. INTRODUCTION 5 Inter-rib DIstraction Stabilizer is a system of metal bars/rods bent to match patient’s chest and spine. It is used for treatment of primary Thoracic Insufficiency Syndrome in young, skeletally immature patients. The stabilizer may be extended to follow child’s growth and to stabilize and mechanically extend the chest to improve breathing efficiency and allow for lungs growth. 5 I.2. INDICATIONS 5 I.3. CONTRAINDICATIONS 5 I.4. WARNINGS AND PRECAUTIONS 5 II. DESCRIPTION OF IDS SYSTEM 6 II.1. IMPLANTS 6 II.2. CONFIGURATIONS 10 III. INSTRUMENT SET 11 IV. SURGICAL...

I. INTRODUCTION I.1. INTRODUCTION Inter-rib DIstraction Stabilizer is a system of metal bars/rods bent to match patient’s chest and spine. It is used for treatment of primary Thoracic Insufficiency Syndrome in young, skeletally immature patients. The stabilizer may be extended to follow child’s growth and to stabilize and mechanically extend the chest to improve breathing efficiency and allow for lungs growth. Usage of the IDS system allows to: • increase throracic volume, • scoliosis correction, • improve thoracic function, • avoid growth-inhibiting procedures, • recovery or improvement of thoracic...

II. DESCRIPTION OF IDS SYSTEM All elements of IDS system are made of titanium alloy Ti6Al4V which is characterized by high biocompatibility and mechanical strength. Iliac hook Catalogue no. ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec Kościelny, POLAND, tel. + 48 85 86 86 100, fax + 48 85 86 86 101, [email protected], www.chm.eu

Sliding clamp R220 Size Locking clip Catalogue no. 3.6002.100 ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec Kościelny, POLAND, tel. + 48 85 86 86 100, fax + 48 85 86 86 101, [email protected], www.chm.eu

IMPLANTS Spinal hooks Size Small Standard Large Locking screw Catalogue no. 3.3283.006 Spinal hooks Small Standard Laminar hook Laminar hook, narrow blade Laminar hook, extended body Laminar hook, offset Laminar hook, angled blade Thoracic laminar hook * additionally available ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec Kościelny, POLAND, tel. + 48 85 86 86 100, fax + 48 85 86 86 101, [email protected],

Spinal hooks Small Standard Thoracic laminar hook, narrow blade Thoracic laminar hook, offset 3.6010.103 – small offset, right 3.6010.104 – small offset, left 3.6010.105 – large offset, right 3.6010.106 – large offset, left * additionally available Palette for IDS CHARSPINE implants Catalogue no. 40.5578.000 ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec Kościelny, POLAND, tel. + 48 85 86 86 100, fax + 48 85 86 86 101, [email protected], www.chm.eu

II.2. CONFIGURATIONS Rib-to-rib [1] Rib-to-lumbar lamina [2] Rib-to-ilium [3] ChM sp. z o.o., Lewickie 3b, 16-061 Juchnowiec Kościelny, POLAND, tel. + 48 85 86 86 100, fax + 48 85 86 86 101, [email protected], www.chm.eu

ChM Inter-rib Distraction Stabilizer Screwdriver T30 Rod bender 6.0 left Rod bender 6.0 right Adjustable rod bender Star screwdriver T15 Screwdriver tip T30 Torque wrench Hook holder Impactor for hooks Forceps Laminar raspatory for hooks Costal raspatory Locking clip extractor Holding forceps Temporary persuader Distraction forceps Trocar Guide sleeve Hammer 165g × 22mm Stand for IDS CHARSPINE instrument set Stand for IDS CHARSPINE instrument set Container with solid bottom Perforated aluminum lid 1. Screwdriver T30 [40.5265.100] Screwdriver T30 is used for insertion of the compression screw...

Forceps are used for inserting and manipulating of the stabilizer elements. 12. Laminar raspatory for hooks [40.5290.000] Laminar raspatory for hooks is used for preparation of the site for spinal hook placement. 14. Locking clip extractor [40.5586.000] Locking clip extractor is used for removal of the locking clips. Correction forceps are used for distraction of the stabilizer elements (especially during corrective reoperations). 13. Costal raspatory [40.5584.000] Costal raspatory is used for separation of peririb tissues from the rib. 15. olding forceps [40.5587.100] H Holding forceps are used...

SURGICAL TECHNIQUE IV. SURGICAL TECHNIQUE IV.1. PATIENT POSITIONING Patient should be placed in the lateral position (similar to positioning required during standard thoracotomy). To protect the brachial plexus from injury, the shoulder should not be extended more than 90°. IV.2. SURGICAL APPROACH Make a J-shaped incision without injuring the rib periosteum. Pull the skin flap aside. Continue the incision and pull the spinal muscles medially to the apex of transverse process. Gently lift the scapulae to expose the middle and posterior scalene muscles. The above description is not detailed instruction...

SURGICAL TECHNIQUE IV.3. IMPLANTATION IN THE UPPER PART IV.3.1. SELECTIONANDPREPARATIONOFTHEIMPLANTATION SITE Determine which rib head is to be used as the upper point of implant attachment. Mark this spot. Use the X-Ray to confirm the selection of implantation site. NOTE: Do not use the first rib (rib head) as a support point as there is a risk of pressure on the shoulder plexus. Perform one-centimeter incision of the intercostal muscles above and below the chosen point of the rib head. Use the costal raspatory [40.5584.000] to prepare the place for introduction of fixed clamp and closing arch....

SURGICAL TECHNIQUE IV.3.3. INSERTION OF THE CLOSING ARCH Size of the closing arch shall be chosen on the basis of the patient’s anatomy and the number of ribs to be clipped (one or two). Use the holding forceps [40.5587.100] to insert the closing arch between the rib and periosteum through the incision made above the rib. Insert the tip of closing arch into the socket of fixed clamp. The above description is not detailed instruction of conduct. The surgeon decides about choosing the operating procedure.