Preprosthetic augmentation with

Transcription

1 Preprosthetic Surgery GUIDED BONE REGENERATION AND PREPROSTHETIC AUGMENTATION CONCEPTS

2 Innovative Technique Preprosthetic augmentation with 2 Barrier fixation with SonicWeld Rx is very simple: Drill a pilot hole () and seat the tip of the SonicPin Rx into the hole (2). Place slight forward pressure on the SonicPin Rx then activate the switch and push into the bone (3). Allow the structure to consolidate for a moment, then twist and remove the sonotrode. Subsequently apply the foil or membrane and sonicweld a barrier to the pre-placed SonicPins Rx with similar insertion steps (4). SonicWeld Rx is a ground-breaking new technology in resorbable fixation. The revolutionary characteristics of this technology allow the polymer material of the pins to actually flow into the trabecular structures of the bone. Additionally, the pins weld to the barrier, effectively creating a welded, three dimensionally stable construct. This results in a faster, stronger and more reliable way to apply resorbable fixation. The process is applied to a special resorbable polymer; 00% amorphous non-crystalline Resorb-x poly-d-llactic acid, or PDLLA. Resorb x is a chemical substance made up of lactic acid molecular chains, which are, in fact, natural constituents of the human body. Resorb x breaks down first by hydrolysis, then by metabolic processes, becoming carbon dioxide and water. This polymer has been proven over many studies and years of clinical use in craniomaxillofacial bone fixation.

3 3 4 3 For the user, the SonicWeld Rx method has a number of very significant advantages: No second intervention, which would be a considerable physical and psychological trauma for the patient No risks or damage caused by a second intervention: No scarring, no risk of an infection, no damage to tissue and nerves, no anesthetic risk Extraordinarily high initial strength which is due to two important factors: Three-dimensional infiltration of the pin into the osseous structure. This may be referred to as a proper material-tissue interdigitation. Locking mechanism between the membrane and the SonicPin Rx. The head of the pin bonds to the membrane forming a three-dimensionally stable unit. Distinctly reduced intervention times: Implantation with SonicWeld Rx requires half the time of conventional resorbable screw systems Overall, the fixation method has far less complications than previous technologies and anchors well in all types of bone

4 Questions and Answers Clinical findings Biological basic research, comprehensive mechanical and histological test series and clinical validation give you the confidence and peace of mind you need as a user: SonicWeld Rx has an excellent initial strength, is perfectly biocompatible and characterized by a calculable and safe biological degradation process. 500 µm 200 µm 500 µm Longitudinal section through SonicPin Rx and supporting tissue twelve days after the intervention. Two weeks after the intervention. Thirty-two days after insertion of SonicPin Rx. Due to the biomechanical properties of the initial PDLLA material, best biocompatibility and a safe degradation process are obtained. Biocompatibility and degradation behavior have been proven with numerous animal and clinical studies, substantiating the following statements for SonicWeld Rx : - Excellent biocompatibility and safe degradation due to the biomechanical properties of PDLLA material - No inflammatory reaction in the drill hole - No signs of thermal damage or necroses - Uneventful cell reactions around the implants - No signs of plate dislocations or dehiscences - Complete resorption and bony healing - Completely intact carrier bone at any time during the degradation process Clinical testing and histological examination: Technical University of Dresden, Faculty of Medicine, Hospital and Policlinic for Oral and Maxillofacial Surgery Professor Dr. Dr. Uwe Eckelt (M.D.) Dr. Eckart Pilling (M.D.) Dr. Ronald Mai (M.D.) Mechanical basic research: Technical University of Dresden, Faculty of Medicine, Policlinic for Prosthetic Dentistry Professor Dr. Bernd Reitemeier (M.D.) Dr. Gert Richter (engineer) Heike Meißner (certified engineer)

5 5 The decomposition process what you cannot see: The complex polymer chains () of the PDLLA absorb the H 2O content of the surrounding body fluid (2) (hydrolysis). The embedded water splits the polymer chains in ever-shorter molecule chains (3) and (4). Human metabolism then transforms the D and L lactides into carbon dioxide and water, which are finally discharged through the metabolic channels. The decomposition takes place in a controlled manner free from residues. PDLLA Hydrolysis (C 3 H 4 O 2 )n n CO 2 +H 2 O Degradation cycle Molecular structure of the basic material: poly (D,L-lactide) 500 µm Three months after the intervention. Histological findings No thermal damage or necrosis has been observed No histological evidence of inflammatory response to SonicWeld Rx application has been found No damage to the surrounding bone Proven non-irritating soft tissue reactions Mechanical findings SonicPins Rx have a distinctly higher mechanical strength then conventional resorbable fixing systems The fact that is particularly striking is the increased primary stability of the SonicPins Rx due to a direct anchorage of the polymer in the trabecular meshwork of the bone

6 Validated and Compatible The program with a system SonicWeld Rx is a modular and flexible system, fully compatible with KLS Martin s Resorb x foil barriers, meshes and plates. All SonicWeld Rx foil barriers, meshes and plates can be freely combined as required. The entire system has been validated. It carries the CE-mark and has obtained FDA approval. Foils and meshes 00% intrinsically amorphous PDLLA material Perfect contouring properties; foils, meshes and plates can be heat shaped. They become malleable at 55 C, then cool in seconds to form a rigid structure. Completely transparent perfect overview at any point in time, even after the intervention When welded in place, the result is a three-dimensional structure that is stable and resistant to pressure, thus making a collapse of the membrane impossible. The augmentate is always stationary in the desired volume. SonicPins Rx The SonicPins Rx are available in diameters of.6 mm and 2. mm The SonicPins Rx are self-retaining by friction-fit. They are picked up with the sonotrode tip. The optimized shape of the SonicPins Rx guarantees easy insertion with one hand and no twisting motion Clip magazines Pins are available in cartridges of 5 or 2 Sterile, ready-to-use delivery Safe removal from the clip magazine SonicPins Rx anchor in cortical as well as cancellous osseous structures Even small fragments can be fixated and become rotationally stable without screw-in resistance SonicPins Rx can be placed in narrow spaces and at different angles including right angles using the angled sonotrode

7 7 SonicWelder Rx and sonotrode are the heart of the SonicWeld Rx system. Sonotrodes Self-retaining SonicPins Rx and a handle that illuminates the surgical site offer a maximum of safety and convenience Completely sterilizable (34 C / 273 F, 2 bar) according to EN 285/ANSI/AAMI/ISO , ANSI/AAMI ST Easy replacement of all components An angled sonotrode permits safe work in regions difficult to access, such as f.e. the lateral tooth region SonicWelder Rx The micro-vibrations generated by a defined ultrasonic frequency cause the external surface of the pin to melt. When the user applies pressure and the switch is activated, the SonicPin Rx can be easily pushed into the bony structure. The handpiece and cable are fully sterilizable (34 C, 273 F, 2 bar) Simple operation can be accomplished using the Level 2 automatic setting. There is no need to change settings or provide irrigation during the SonicWeld Rx fixation process. Maintenance free, requiring only cleaning and sterilization Activation by foot switch Smoothing sonotrodes Guarantee perfect adaptation of the foil barrier to the bony surface by allowing changes to the shape of the polymer Apply the same process as SonicWeld Rx fixation Several membranes can be welded together to form a single structure

8 Methods of Bone Augmentation Shell technique acc. to Dr. Iglhaut A completely novel approach must be seen in the shell technique invented by Dr. Iglhaut. It makes conscious use of the rigidity of PDLLA membranes for building lateral volume. The required SonicPins Rx are prefixed and the membrane is then welded in place. Particulate autogenous bone and bone substitute materials are used for the augmentate. Crestal barrier and closure of the alveolar ridge is achieved with diffusion-open collagen membranes. These membranes offer the best soft tissue tolerance and counteract potential dehiscences. The shell technique not only avoids time-consuming dissection by bone splitting, but also eliminates the resorption risk associated with the transplantation of small bone blocks. Case example* Original situation of a buccal defect in region Laterally supported immediate implantation of the 0.-mm PDLLA membrane Complete 3D volume reconstruction Stable reconstruction result even 6 months after the operation Advancement flap plasty for stable soft tissue structure Prosthesis in place * Case photos provided by Dr. Gerhard Iglhaut, Memmingen (Germany)

9 9 Collagen barrier membrane PDLLA barrier foil for lateral support (shell technique) Order recommendation Shell technique acc. to Dr. Iglhaut Tension-free wound closure is key SonicPins Rx Dimensions in mm Order No. Order No. Pack of 2 Pack of 5.6 x x Rx membrane/mesh t =0. mm Dimensions in mm Order No. 25 x x Pilot drill for angle unit with dental attachment OPG year after the operation for.6-mm SonicPins Rx Dimensions in mm Order No..0 x 20 x x 20 x Sonotrodes straight angled Smoothing sonotrodes straight angled

10 Methods of Bone Augmentation Guided bone regeneration The development of the membrane technique for the regeneration of bone in dentistry bases on the assumption that various cellular components have a different migration rate into the wound region during the healing process. A mechanical barrier is used to prevent the fibroblasts and other soft-tissue cells to penetrate the bone defect so that the slower migrating cells can occupy the defect with osteogenetic potency (Dahlin et al., 988). At the beginning of the 980s already, Nyman et al. (982a, 982b) recognized the significance of this technique in dentistry. Case example* The patient before the intervention. Incision line and flap. Pre-drilling of the implant site and placing of the lateral SonicPins Rx. - The 0.-mm foil is transparent, making the full area visible to the user. - After exposure to heat, the foil can be shaped for a few seconds with only finger pressure. - After cooling, the custom structure forms a hard shell again. - The 0.-mm foils are flexible in two dimensions and require minimal contouring with heat. - Once welded on either side of the defect, the entire structure is very rigid. - Using the scalpel, the membrane can be cut to shape in situ. - If and when necessary, another membrane can be welded on top. After wound closure. * Case photos by courtesy of Dr. Ulrich Volz, D-Konstanz

11 Order recommendation Guided bone regeneration The implant placed is laterally supported by autologous bone, own blood plus bone replacement materials if required. SonicPins Rx Dimensions in mm Order No. Order No. Pack of 2 Pack of 5.6 x x Rx membrane/mesh t =0. mm Dimensions in mm Order No. 25 x x Pilot drill for angle unit with dental attachment for.6-mm SonicPins Rx Dimensions in mm Order No..0 x 20 x x 20 x Sonotrodes straight angled Smoothing sonotrodes straight angled

12 Methods of bone augmentation Membrane fixation with SonicPins Rx If the bone to be augmented is ground and enriched with own blood, bone replacement material or growth factors, it is sensible to use a membrane to protect the augmentation against the masticatory forces. The membrane prevents the migration of epithelial cells and is used as a placeholder for periodontal ligament and for bone regeneration. Usually, this membrane is laterally fixed by metal pins. However, these titanium pins have to be removed in a second intervention that can be very time-consuming (as they are grown in). Membrane fixation with SonicWeld Rx eliminates this time-consuming second intervention and permits the surgeon to work with a clear view of the site throughout. Case example* Sinus lift procedure with SonicWeld Rx First of all, the windows technique is used for sufficient preparation of the sinus. Then SonicPins Rx are welded in around the sinus. Only now is the augmentate inserted into the sinus. Subsequently, the site is safely closed with a 0.-mm membrane. In the process, the membrane is welded onto the pins. The moment the pins are placed, the operating site is usually invisible for the surgeon because the commercially available membranes are opaque. Thus, there is always some uncertainty as to where the pin is placed exactly. When using resorbable membranes, it is usually impossible to drill through the membrane into the carrier bone. The resorbable membrane always winds around the drill and is thus destroyed. In case of SonicWeld Rx, there is a simple but very efficient trick: First of all the pins are pre-positioned in the carrier bone, and afterwards the membrane is welded onto the already existing pins. As the membrane as well as the SonicPins Rx melt on the surface, a solid bond is produced. This process is very easy and fast. As all SonicWeld Rx implants are transparent, the operating site can be viewed completely at all times. * Case photos by courtesy of Dr. Ulrich Volz, D-Konstanz

13 3 Advantages of this special method: Distinctly faster than conventional resorbable pins or screws No risk of pin breakage Foils can be contoured very well with the aid of heat above 55 C 0.-mm foils may be slightly contoured in two dimensions without heat Thinner membranes can also be contoured to a certain extent in cold state Free view of the augmentation region at any time, even after the intervention No risk of membrane getting tangled No rotational forces on the foil barrier Order recommendation Membrane fixation SonicPins Rx Dimensions in mm Order No. Order No. Pack of 2 Pack of 5.6 x x x x Rx membrane/mesh t =0, mm Dimensions in mm Order No. 25 x x Pilot drill for angle unit with dental attachment for.6-mm SonicPins Rx Dimensions in mm Order No..0 x 20 x x 20 x for 2.-mm SonicPins Rx Dimensions in mm Order No..6 x 20 x x 20 x Sonotrodes straight angled Smoothing sonotrodes straight angled

14 Methods of Bone Augmentation Onlay grafts Core hole Ø.6 mm for SonicPins Rx Ø 2. mm By means of special long SonicPins Rx, it is possible to weld bone blocks in place horizontally or vertically. For this purpose, a gliding hole is created in the proximal bone, and a normal SonicWeld core hole in the distal. The SonicPin is seated in the augmentate and then welded in. As the head of the pin meets the proximal bone during the end of the insertion, it is also creating a secure fixation of the block. Case example* Typical traumatic anterior tooth defect in the maxilla Lateral appositioning of two onlay grafts, fixed in place with SonicWeld Rx Where access is difficult, an angled sonotrode can be very helpful Special advantages of this method for the patient No second intervention is required as the augmentation pin is completely resorbed and no metal parts have to be removed Perfect initial stability, even when placed at difficult angles Even very shallow anchoring depths are sufficient for a stable pin fixation The model shows several augmentation regions that have all been treated completely with SonicWeld Rx Only one surgery is required for resorbable materials, minimizing trauma to the soft tissue * Case pictures furnished by Dr. Richard Loukota, Leeds (UK)

15 5 2 Gliding hole Ø 2. mm 3 4 Pin can sink into core hole only. Bone graft is pulled in place. Onlay graft Bone base The principle of core hole and gliding hole Use the drill Ø.6 x 20 x 0 mm ( ) to drill through the augmentate into the receiving bone. Attention: Extend the hole in the receiving bone, still using the drill Ø.6 x 20 x 0 mm ( ), maintaining the previous angulation. Use the drill Ø 2. x 24 x 2 mm ( ) to enlarge the gliding hole in the augmentate Proceed the fixation with the SonicPin Rx of your choice Insert the SonicPin Rx through the gliding hole until you reach resistance of the core hole. The sonotrode is not activated yet The SonicPin Rx is fixed only in the distal end of the receiving bone while the pin head blocks the augmentate against the receiving bone Order recommendation Onlay grafts SonicPins Rx Dimensions in mm Order No. (Pack of 2) 2. x x x x x x Pilot drill for angle unit with dental attachment* Core hole drill for 2.-mm SonicPins Rx Dimensions in mm Order No..6 x 20 x x 20 x x 20 x Gliding hole drill for 2.-mm SonicPins Rx Dimensions in mm Order No. 2. x 24 x * Optionally segmented twist drill, as shown on page 6-7

16 Methods of Bone Augmentation Onlay grafts Segmented Step Drill The new segmented step drill represents the different diameters of core hole and gliding hole for pins with a diameter of 2. mm. By this mean the surgeon can predrill in one single step, without the need of changing the drill bits. With the help of the adjusting sleeve the user can easily define the working length of his choice. Gliding hole Intermediate zone Core hole (welding zone) 2 mm 4 mm 2 3 Example: SonicPin Rx with a diameter of 2. mm, 7 mm long: Pinhead mm 2. mm Shaft length 6 mm Bone base Onlay graft Adjusting sleeve Knurled nut Simply transfer the length of your pin minus mm for the pinhead on the segmented step drill f.e. pin 2. x 7 mm Definition of 6 mm. Therefore the adjusting sleeve must be loose. Details Loosen the adjustable sleeve by rotating the opposing portions. Slide the sleeve until the 6 is exposed on the shaft. Re-tighten the sleeve by rotating the parts together again. Predrill down to the stop of the segmented twist drill. Rinse burr residues after drilling. 0 2 mm 6 mm

17 Segmented step drill for 2.-mm SonicPins Rx mm intermediate zone 4 mm welding zone Insert the SonicPin Rx until you reach the resistance of the burr hole in the intermediate zone. The sonotrode is not activated yet. Apply pressure at the exact angle of the drill hole and activate the sonotrode to weld in the SonicPin Rx. Allow at least 5 seconds for consolidation of the pin mm 2 mm 2 mm 5 Sek. 6 mm 6 mm 6 mm

18 Order and Set Recommendations SonicWeld Rx Unit Order No. SonicWelder basic set consisting of: SonicWelder Foot switch Handpiece Sonotrode, straight Open-ended wrench for sonotrode separately available: Sonotrode, angled Extension cable for handpiece 3 m Smoothening electrode, straight Smoothening electrode, angled Component tray (also compatible with Level One) Category Order No. Component tray consisting of: Bottom part for drill bits Upper part for sonotrodes and small parts Alternatively: Sliding cover, transparent Alternatively: Small parts module Storage rack for clip magazines Level One storage and processing tray Unit Order No. Storage and processing tray, complete consisting of: Storage tray 26 x 26 cm Silicone mat Lid for storage tray Caution: for large sterilizers only!

19 9 Alternative storage: Storage and sterilization container for dental sterilizer Category Order No. MicroStop - MiniSet container Ext. dimensions 30 x 89 x 85 mm (L x W x H) Int. dimensions 283 x 77 x 60 mm (L x W x H) Possibly: Scope x identification label w. text Logistic frame, red colour for container Identification label MiniSet container w. text Tray for Miniset container Category Order No. Tray for MiniSet container 277 x 7 x 54 mm (L x W x H) incl. lid incl. small parts module incl. small parts module Tray for Miniset container Category Order No. Tray for MiniSet container 277 x 7 x 54 mm (L x W x H) incl. lid Storage component tray Sliding cover Component tray incl. component tray Xcelsior water bath Category Scope Order No. Water bath complete consisting of: Thermal unit alone Water container alone Cover hood alone

20 Order and Set Recommendations Pilot drill for SonicPins Rx Ø.6 mm Pilot drill for SonicPins Rx Ø 2. mm Gliding hole drill Ø 2. mm Pilot drill for the angle unit with dental attachment Category Order No. for.6-mm SonicPins Rx.0 x 20 mm, stop 5 mm x 20 mm, stop 6 mm for 2.-mm SonicPins Rx.6 x 20 mm, stop 5 mm x 20 mm, stop 6 mm x 20 mm, stop 0 mm Gliding hole drill 2. x 24 x 2 mm Pilot drill for J-latch* attachment Category Order No. for.6-mm SonicPins Rx.0 x 50 mm, stop 4 mm x 50 mm, stop 5 mm x 50 mm, stop 6 mm x 50 mm, stop 7 mm x 50 mm, stop 8 mm für 2,-mm SonicPins Rx.6 x 50 mm, stop 4 mm x 50 mm, stop 5 mm x 50 mm, stop 6 mm x 50 mm, stop 8 mm x 50 mm, stop 0 mm Gliding hole drill for long 2.-mm pins 2.2 x 70 mm * fitting to Stryker couplings Segmented step drill for 2.-mm SonicPins Rx J-latch* attachment w/o adjusting sleeve.6 x 70 mm BOS attachment w/o adjusting sleeve.6 x 70 mm Adjusting sleeve * fitting to Stryker couplings

21 2 Icon explanations: unit(s) Packaging unit(s) Plate profile Titanium Sterile packed implants unit(s) unit(s) 26 x 26 mm 5 x 5 mm = 0.3 mm = 0.3 mm unit(s) unit(s) 25 x 25 mm 50 x 20 mm = 0. mm = 0. mm x 29 mm = 0.3 mm unit(s) unit(s) unit(s) 26 x 26 mm 5 x 5 mm = 0.3 mm = 0.3 mm unit(s) unit(s) 25 x 25 mm 50 x 50 mm Template Template

22 Order and Set Recommendations SonicPins Rx Category Order No. Order No. Pack of 2 Pack of 5.6 x 4 mm x 5 mm x 6 mm x 7 mm x 4 mm x 5 mm x 7 mm x 9 mm x mm x 3 mm x 5 mm x 7 mm

23 Info and More 23 If you still have any questions......we will be glad to answer them anytime, for example with additional information in the form of product brochures and a CD-ROM that vividly describe and illustrate the SonicWeld Rx principle exactly as it works in practice. Of course, you can also reach us personally, either by or through our customer hotline.

24 KLS Martin Group Karl Leibinger GmbH & Co. KG Mühlheim Germany Tel Stuckenbrock Medizintechnik GmbH Tuttlingen Germany Tel verwaltung@stuckenbrock.de KLS Martin GmbH + Co. KG Umkirch Germany Tel info@klsmartin.com Rudolf Buck GmbH Mühlheim Germany Tel info@klsmartin.com KLS Martin France SARL Colmar France Tel france@klsmartin.com Martin Italia S.r.l Vimercate (MB) Italy Tel italia@klsmartin.com Martin Nederland/Marned B.V. 270 AG Huizen The Netherlands Tel nederland@klsmartin.com Nippon Martin K.K. Osaka Japan Tel nippon@klsmartin.com Gebrüder Martin GmbH & Co. KG Representative Office 247 Moscow Russia Tel. +7 (499) russia@klsmartin.com KLS Martin L.P. Jacksonville, Fl USA Office phone usa@klsmartin.com Orthosurgical Implants Inc. Miami, Fl 3386 USA Office phone sales@orthosurgical.com Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group Ludwigstaler Str. 32 D Tuttlingen Postfach 60 D-7850 Tuttlingen Tel Fax info@klsmartin.com Printed in Germany Copyright by Gebrüder Martin GmbH & Co. KG Alle Rechte vorbehalten Technische Änderungen vorbehalten We reserve the right to make alterations Cambios técnicos reservados Sous réserve de modifications techniques Ci riserviamo il diritto di modifiche tecniche