Technique Guide. Modular Sternal Cable System. Flexibility and strength in sternal closure and repair.

Transcription

1 Technique Guide Modular Sternal Cable System. Flexibility and strength in sternal closure and repair.

2 Table of Contents Introduction Modular Sternal Cable System 2 Indications 4 Modular Sternal Closure Options 4 Surgical Technique Preoperative Considerations 5 Peristernal Technique 6 Transsternal Technique 9 Using Cable, Cannulated Screws and Plates 15 Sternal Reduction 21 Securing Cables 22 Emergency Cable Removal 27 Postoperative Considerations 27 Product Information Implants 28 Instruments 30 Set Lists 32 Synthes In the Service of Health 37 Synthes CMF

3 Modular Sternal Cable System The Synthes Modular Sternal Cable System is a set of stainless steel implants* and instruments designed to facilitate sternal repair and reconstruction. This system addresses the unique requirements of sternal closures. The sternal cable can be placed around the bone, through cannulated screws, and/or through plates. The cable s flexibility and strength enable multiple closure options that provide stable fixation. The system s modular design provides flexibility for placement of implants depending on the patient s anatomy and bone integrity. Implants can be combined to meet a specific patient need. The Tensioner/Crimper/Cutter is a single, multipurpose instrument used to tension the cable, crimp the ferrule, and cut the cable. * Implant quality 316L stainless steel 2 Synthes CMF Modular Sternal Cable System

4 1.0 mm Sternal Cable Flexible cable contours to the shape of the sternum 1.0 mm diameter provides greater bone-to-implant contact area than wire Multifilament structure provides improved strength and flexibility compared to wire* Cable end is very soft when cut, increasing handling safety Works with various closure techniques Ferrules are crimped onto the end of the cable to secure the finished construct Low-profile parallel end fitting reduces implant palpability Available with or without a quick-release needle Ferrule Parallel End Fitting 4.5 mm Sternal Cannulated Screws Easily insert into the manubrium or sternal body using the adjustable screwdriver blade with spade point Eliminate the need to insert a needle through the sternum Cannulation provides a metal surface for cable to pass through for reinforcement in weak cancellous bone Blunt tip allows safe bicortical insertion Available in lengths from 8 mm to 28 mm, in 1 mm increments 4.5 mm Sternal Reconstruction Plates Used to reconstruct hemisterna, especially in cases with transverse fractures Distribute forces along the length of the sternum, reducing the likelihood of bony failure Attach to the sternum with cannulated screws Contourable, to closely match the sternum Available in several lengths (80 mm 192 mm) to minimize intraoperative plate cutting * Synthes Mechanical Test Number MT Synthes CMF 3

5 Indications and Modular Sternal Closure Options Indications Sternal repair and reconstruction Modular Sternal Closure Options Flexibility in sternal closure due to modular options Intraoperative choice depending on patient s needs Stable fixation in all configurations Sternal cable with an improved strength and stability compared to wire* Sternal cannulated screws for reinforcement of sternal bone quality Sternal reconstruction plates for repair of transverse fractures Peristernal using cable with needle Transsternal using cable and cannulated screws Sternal reconstruction using cable, cannulated screws and plates * Synthes Mechanical Test Numbers: MT03-055, MT03-006, MT03-007, MT04-455, SET_ and SET_ Synthes CMF Modular Sternal Cable System

6 Preoperative Considerations Preoperative considerations The 1.0 mm sternal cable is designed to be used alone (with needle) or with cannulated screws and plates (without needle). The benefits of each technique, the needs of the patient, and surgeon preference should be considered when selecting a method of closure. The method chosen will dictate the sternal cable sets that should be prepared for the surgical procedure. This guide outlines three surgical techniques for using cable to close the sternum: Peristernal (around the sternum) using cable with needle Transsternal (through the sternum) using cable and cannulated screws Sternal reconstruction using cable, cannulated screws, and plates Synthes CMF 5

7 Peristernal Technique Using Cable with Needle 1 Suture cable around sternum Suture the cable around the two halves of the sternum, using the attached cutting needle. The needle can be sutured through the manubrium and the intercostal spaces. 6 Synthes CMF Modular Sternal Cable System

8 2 Remove quick-release needle After weaving the cable, remove the quick-release needle from the end of the cable by holding the cable with one hand and pulling sharply on the needle with forceps. Remove the silicone tip guard from the parallel end fitting. Pass the end of the cable through the parallel end fitting. Important: After passing the end of the cable through the parallel end fitting, the cable ends should be on opposite sides of the parallel end fitting. Synthes CMF 7

9 Peristernal Technique Using Cable with Needle continued 4 Place additional cables Continue with placement of additional cables as needed for the desired closure. A minimum of three cables placed in a figure of eight should be used for proper fixation. Proceed to page 21 for reducing the sternum and securing the cables. 8 Synthes CMF Modular Sternal Cable System

10 Transsternal Technique Using Cable (without Needle) and Cannulated Screws Bicortical screw insertion is critical for maximum effectiveness. Careful measurement and screw selection is necessary. 1 Identify screw locations Instrument Depth Gauge, for 4.5 mm Sternal Cannulated Screws Using a marking pen, identify locations for screw placement in the manubrium and sternal body. Using the depth gauge, measure the thickness of the sternum medial to the planned screw location. Select the appropriate length screw based on the depth gauge reading. If attaching a plate to the sternum with the screw, add 3 mm to the screw length. Synthes CMF 9

11 Transsternal Technique Using Cable (without Needle) and Cannulated Screws continued 2 Assemble screwdriver Instruments Screwdriver Handle with hex coupling mm Hexagonal Adjustable Screwdriver Blade with spade point Insert the 4.5 mm hexagonal adjustable screwdriver blade with spade point into the screwdriver handle. Turn the adjustable sleeve on the screwdriver blade until the screw length determined in Step 1 is indicated. Insert the tip of the screwdriver into the recess of the screw and press down to secure the screw to the blade. Important: The tip of the blade should protrude approximately 2 mm beyond the tip of the screw. 10 Synthes CMF Modular Sternal Cable System

12 3 Pierce outer cortex of sternum Instruments Screwdriver Handle with hex coupling mm Awl In dense cortical bone, use the 2.7 mm awl with the screwdriver handle to pierce the outer cortex of the sternum in the desired screw location. The awl can also be used through a plate if necessary. Synthes CMF 11

13 Transsternal Technique Using Cable (without Needle) and Cannulated Screws continued 4 Insert screws Insert the screw into the sternum. When the screw is properly seated, remove the screwdriver blade by pulling straight back. Repeat Steps 2 4 to implant additional screws. Proper screw insertion anterior cortex Proper screw insertion bicortical purchase 12 Synthes CMF Modular Sternal Cable System

14 5 Insert cable Instruments Obturator Cable Passer Insert the cable anterior to posterior through the first cannulated screw. Insert the cable passer with obturator into a screw in the opposite hemisternum. Remove the obturator. Pass the cable through the cable passer from the posterior aspect of the sternum. Note: The cable passer can also be used to pass the cable through the intercostal space. Synthes CMF 13

15 Transsternal Technique Using Cable (without Needle) and Cannulated Screws continued 6 Remove cable passer After pushing the end of the cable through the top of the cable passer, remove the cable passer while holding onto the cable. Continue by passing the cable through additional screws. When the cable weaving is complete, pass the end of the cable through the parallel end fitting. Repeat with additional cables as necessary. Important: After passing the end of the cable through the parallel end fitting, the cable ends should be on opposite sides of the parallel end fitting. Proceed to page 21 for reducing the sternum and securing the cables. 14 Synthes CMF Modular Sternal Cable System

16 Using Cable, Cannulated Screws and Plates 4.5 mm sternal reconstruction plates can be used to fixate transverse fractures of the sternum. Plate implantation should be performed in conjunction with muscle flap advancement to ensure adequate blood supply, and to provide additional soft tissue coverage to the region. 1 Select plate Instrument Bending Template Select the plate of appropriate length. Using the bending template, determine the contour of the hemisternum. Synthes CMF 15

17 Using Cable, Cannulated Screws and Plates continued 2 Contour plate Instrument Combination Bending Pliers With the bending template as a guide, use the combination bending pliers to contour the plate, in the following sequence: In-plane bend Place the plate into the jaws of the bender. Squeeze the handles together to bend the plate. Out-of-plane bend Place the plate into the jaws of the bender. Squeeze the handles together to bend the plate. OR Place the plate into the duckbill end of the bender. Squeeze the handles together to bend the plate. 16 Synthes CMF Modular Sternal Cable System

18 Place the plate on the sternum to verify contour accuracy. Profile of plate on sternum Synthes CMF 17

19 Using Cable, Cannulated Screws and Plates continued 3 Attach plate to sternum Instruments Depth Gauge, for 4.5 mm Sternal Cannulated Screws Screwdriver Handle with hex coupling mm Awl mm Hexagonal Adjustable Screwdriver Blade Using 4.5 mm sternal cannulated screws, attach the plate to the sternum as outlined in Steps 2 4 of the transsternal technique on pages Placing screws every two to three plate holes is recommended. If spanning a transverse fracture, placing screws adjacent to (but not in) the fracture is also recommended. Repeat this process with the other hemisternum as needed. 18 Synthes CMF Modular Sternal Cable System

20 4 Weave the cable Weave the cable through the cannulated screws as described in Steps 5 6 of the transsternal technique on pages Note: It is recommended that a minimum of ten loops be used for closure with plates and screws, either using ten single loops, or five figure-of-eight loops (two loops each), or a combination of each totalling ten loops. Alternative Technique Alternatively, the cable may be used without the parallel end fitting and terminated with a ferrule after passing it through a side hole in the plate. To use this technique, first remove the parallel end fitting from the cable. Pass the cable through the first cannulated screw from anterior to posterior. The finished end of the cable will sit flush in the head of the screw, as shown. (Figure 1) Finished end of cable Side hole in plate Figure 1 Synthes CMF 19

21 Using Cable, Cannulated Screws and Plates continued 4 Weave the cable continued When finished weaving the cable, pass it through a side hole in the plate. Proceed to page 21 for reducing the sternum and securing the cables. 20 Synthes CMF Modular Sternal Cable System

22 Sternal Reduction 1 Reduce sternum Instruments mm Awl * Sternal Reduction Forceps Sternal Reduction Forceps, angled, with teeth Bone Reduction Forceps To achieve anatomical reduction of the sternum, the use of reduction forceps to approximate the sternal halves is recommended. The tips of the reduction forceps can be placed intercostally or, if necessary, the 2.7 mm awl can be used to create pilot holes in the body of the sternum. 2 Align sternal halves After the forceps are placed, tighten them to align the sternal halves into the correct anatomic position. Important: The tips of the forceps should not be placed against the plates, screws or cables during reduction. * Also available Synthes CMF 21

23 Securing Cables 1 Insert ferrule into instrument Instrument Tensioner/Crimper/Cutter Tighten all cables by hand. Pulling back on the gold collar of the tensioner/crimper/ cutter, place the ferrule into the flat side of the nose of the instrument. Release the gold collar to secure the ferrule in the nose of the instrument. Note: Handles must be completely open when placing the ferrule in the nose or it will not fit. 22 Synthes CMF Modular Sternal Cable System

24 2 Pass cable through ferrule Pass the cable through the flat side of the nose first. Note: The gold collar may need to be pulled back slightly to pass the cable through the ferrule. Make sure the ferrule is facing up before pulling back on the collar, to ensure that it does not fall out of the instrument. 3 Wrap cable into tensioning wheel Wrap the cable clockwise (in the direction of the arrow) and pull forward until one or two audible clicks are heard. Note: The gold collar can be used to rotate the nose of the tool. Synthes CMF 23

25 Securing Cables continued 4 Tension cable Ball detent Ensure tensioning wheel is set. Turn the wheel counterclockwise until the ball detent is engaged, if it is not already engaged. Ensure the parallel end fitting and ferrule are positioned straight and along the line of the cable. Important: The nose of the instrument should be square to the cable. Engaged (correct) Not engaged (incorrect) Turn the wheel clockwise (in the direction of the arrow) to tension the cable appropriately. The cable should fit snugly to the bone. Important: This instrument has a clutch mechanism which will slip when the maximum tension is achieved, preventing overtensioning of the cable. Note: Maximum tension is ensured when two audible clicks are heard. Avoid angling the ferrule during tensioning, as this may cut the cable prematurely. 24 Synthes CMF Modular Sternal Cable System

26 5 Crimp and cut cable When correct position and tension have been achieved, squeeze the handles together completely to crimp and cut the cable. Important: Not squeezing the handles together completely will result in an incomplete crimp. The handles must be fully squeezed together to complete the crimping and cutting sequence. Synthes CMF 25

27 Securing Cables continued 6 Remove instrument from crimped ferrule Pull back on the gold collar and remove the instrument from the crimped ferrule. Verify visually that the cable is tight and that the sternal halves are correctly approximated. 26 Synthes CMF Modular Sternal Cable System

28 Emergency Cable Removal and Postoperative Considerations Emergency cable removal Instrument Cable Cutter In case of emergency, the cable can be cut using standard wire cutters; however, using the cable cutter is recommended. If cannulated screws have been used, they may be left in the sternum and used again as a channel for cable passage. Postoperative considerations Standard sternal precautions are recommended for a minimum of six weeks after surgery including: Do not lift more than ten pounds Do not pull or lift the patient by the arms Do not raise arms greater than 90 at shoulder level Avoid trunk twisting For strong cough, press pillow to chest Synthes CMF 27

29 Implants 1.0 mm Sternal Cable, with long crimping ferrule and parallel end fitting, sterile Available with or without needle 1.0 mm diameter Multifilament Implant quality 316L stainless steel Cables (without needle) S (1/pkg.) S (3/pkg.) Cables with needle S (1/pkg.) S (3/pkg.) Cable (without needle) 1.0 mm Sternal Crimping Ferrule (5/pkg.) 1.0 mm Sternal Parallel End Fitting (5/pkg.) Cable with needle Ferrule Parallel End Fitting 28 Synthes CMF Modular Sternal Cable System

30 4.5 mm Sternal Reconstruction Plates Lengths: 80 mm 192 mm (16 mm increments) Length (mm) Holes mm Sternal Cannulated Screws Lengths: 8 mm 28 mm (1 mm increments) Length (mm) Length (mm) Synthes CMF 29

31 Instruments Depth Gauge, for 4.5 mm Sternal Cannulated Screws Screwdriver Handle Bending Template Combination Bending Pliers mm Awl Obturator Cable Passer 30 Synthes CMF Modular Sternal Cable System

32 mm Hexagonal Adjustable Screwdriver Blade with Spade Point Replacement Blade, for 4.5 mm Hexagonal Adjustable Screwdriver Blade ( ) Tensioner/Crimper/Cutter Cable Cutter Sternal Reduction Forceps, angled, with teeth Reduction Forceps Synthes CMF 31

33 Modular Sternal Cable System Cable Instrument Set ( ) Graphic Case Graphic Case, for Modular Sternal Cable System Cable Instrument Set Instruments Tensioner/Crimper/Cutter, for 1.0 mm Sternal Cable, 2 ea Cable Cutter, standard Sternal Reduction Forceps, angled, with teeth, 2 ea Bone Reduction Forceps, large, 2 ea. Implants mm Sternal Crimping Ferrule, long, 1 pkg. of mm Sternal Parallel End Fitting, 1 pkg. of 5 Note: For additional information, please refer to package insert. 32 Synthes CMF Modular Sternal Cable System

34 Modular Sternal Cable System 4.5 mm Cannulated Screw and Plate Set ( ) Graphic Cases, Modules and Screw Length Markers Modular Sternal Cable System, 4.5 mm Cannulated Screw and Plate Set Graphic Case Screw Module, for 4.5 mm Sternal Cannulated Screws Plate Module, for 4.5 mm Sternal Reconstruction Plates Screw Length Markers (10/pkg.) pkg. of ea.: 8 mm 26 mm Instruments Depth Gauge, for 4.5 mm Sternal Cannulated Screws Screwdriver Handle with hex coupling, medium, 2 ea Combination Bending Pliers, for 2.0 mm/2.4 mm plates Bending Template, 37 holes, for reconstruction plates, 2 ea mm Awl, hex coupling Obturator, for Sternal Cable Passer, 37 mm Cable Passer, for 1.0 mm Sternal Cable mm Hexagonal Adjustable Screwdriver Blade, with spade point, hex coupling, 2 ea. Implants 4.5 mm Sternal Cannulated Screws ea.: 8 mm, 9 mm, 25 mm and 26 mm ea.: 10 mm 24 mm 4.5 mm Sternal Reconstruction Plates, 4 ea holes, 80 mm holes, 96 mm holes, 112 mm holes, 128 mm holes, 144 mm holes, 160 mm holes, 176 mm holes, 192 mm Synthes CMF 33

35 Modular Sternal Cable System 4.5 mm Cannulated Screw Set ( ) Graphic Cases, Modules and Screw Length Markers Modular Sternal Cable System Cannulated Screw Set Graphic Case Screw Module, for 4.5 mm Sternal Cannulated Screws Screw Length Markers, 8 mm 26 mm, (10/pkg.), 1 pkg. of each Instruments Depth Gauge for 4.5 mm Sternal Cannulated Screws Screwdriver Handle with hex coupling, medium, 2 ea mm Awl, hex coupling Obturator, for Sternal Cable Passer, 37 mm Cable Passer, for 1.0 mm Sternal Cable mm Hexagonal Adjustable Screwdriver Blade, with spade point, hex coupling, 2 ea. Implants 4.5 mm Sternal Cannulated Screws ea.: 8 mm, 9 mm, 25 mm and 26 mm ea.: 10 mm 24 mm 34 Synthes CMF Modular Sternal Cable System

36 Modular Sternal Cable System Compact 4.5 mm Cannulated Screw and Plate Set ( ) Graphic Case, Module and Screw Length Markers Graphic Case for Compact 4.5 mm Cannulated Screw and Plate Set Compact 4.5 mm Cannulated Screw and Plate Module Screw Length Markers, 8 mm 26 mm, (10/pkg.), 1 pkg. of each Instruments Depth Gauge, for 4.5 mm Sternal Cannulated Screws Screwdriver Handle with hex coupling, medium Ratcheting Screwdriver Handle, 2 ea Combination Bending Pliers, for 2.0 mm/2.4 mm plates Bending Template, 37 holes, for reconstruction plates, 2 ea mm Awl, hex coupling Obturator, for Sternal Cable Passer, 37 mm Cable Passer, for 1.0 mm Sternal Cable mm Hexagonal Adjustable Screwdriver Blade, with spade point, hex coupling, 2 ea. Implants 4.5 mm Sternal Cannulated Screws ea.: 8 mm, 9 mm, 10 mm, 11 mm and 26 mm ea.: 12 mm 25 mm 4.5 mm Sternal Reconstruction Plates, 2 ea holes, 80 mm holes, 96 mm holes, 112 mm holes, 128 mm holes, 144 mm holes, 160 mm holes, 176 mm holes, 192 mm Synthes CMF 35

37 Also Available mm Sternal Cannulated Screws, mm 28 mm Label Clips, for sternal plates LC for plate LC for plate LC for plate LC for plate LC for plate LC for plate LC for plate LC for plate LC for Sternal Module LC blank S S S S 1.0 mm Sternal Cables, with long crimping ferrule and parallel end fitting, sterile (without needle), 1 per pkg. (without needle), 3 per pkg. with needle, 1 per pkg. with needle, 3 per pkg Screw Length Markers, mm 28 mm Replacement Blade, for 4.5 mm Hexagonal Adjustable Screwdriver ( ) Sternal Reduction Forceps 36 Synthes CMF Modular Sternal Cable System

38 Synthes In the Service of Health Synthes is an internationally leading company in medical technology. Over 8,400 Synthes employees worldwide are involved in serving the needs of surgeons, surgical support staff and patients. Synthes a company specializing in the field of osteosynthesis develops, produces and markets surgical instruments, implants, and biomaterials for the surgical treatment of bone fractures and reconstructions of the human skeleton and its associated soft tissue. The main goal of Synthes is to provide safe and highly advanced implants, surgical instruments and technologies that enable reliable operations, fast healing and a complaint-free life after surgery. We gua rantee high quality, continuous innovation and a focused customer orientation. AO A medically oriented nonprofit organization in the service of surgeons and patients Synthes works closely with the AO Foundation, and is licensee of the products bearing the brand name Synthes. AO stands for Arbeitsgemeinschaft für Osteosynthesefragen (Association for the Study of Internal Fixation). The foundation boasts more than 5,000 surgeons who participate in AO activities throughout the world one of the largest networks in the field of medicine. In the professional world, this surgeon-led, scientific nonprofit organization focused on treating bone fractures and diseases of the musculoskeletal system is a pioneer in research, documentation and development. The Technical Commission of the AO monitors the implementation of medical studies of new products, as a fully independent institution administered by health professionals. Only when it confirms the effectiveness and quality of a product does it award the seal of quality of the Synthes brand. Surgeons throughout the world place great trust in Synthes products because they know they have been carefully evaluated and tested. Yet even the best implants and instruments are useless if they are not used properly. AO International, the arm of the foundation responsible for training, annually organizes more than 160 AO courses throughout the world that offer practical exercises and discussions. Since the beginnings of the AO, experienced AO physicians have provided theoretical and practical training for more than 500,000 surgeons and more than 150,000 surgical support staff members. Synthes products are a familiar sight in nearly every operating room in the world. AO Foundation, Davos, Switzerland The AO Foundation offers numerous training courses worldwide. Synthes CMF 37

39 Synthes CMF 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) Synthes (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 7/08 J6041-E