SynPOR HD Facial Shape System. For the augmentation or reconstruction of the craniomaxillofacial skeleton.

Transcription

1 SynPOR HD Facial Shape System. For the augmentation or reconstruction of the craniomaxillofacial skeleton. Technique Guide This publication is not intended for distribution in the USA. Instruments and implants approved by the AO Foundation

2

3 Table of Contents Introduction SynPOR HD Facial Shape System 2 Intended Use, Indications and Contraindications 4 Preoperative Considerations 5 Surgical Technique Surgical Technique: Chin 6 Surgical Technique: Malar 11 Patient Care Post-Operative Care 17 Product Information Implants 18 Instruments 21 SynPOR HD Facial Shape System 24 References 25 Image intensifier control Warning This description alone does not provide sufficient background for direct use of the product. Instruction by a surgeon experienced in handling these instruments is highly recommended. Reprocessing, Care and Maintenance of Synthes Instruments For general guidelines, function control and dismantling of multi-part instruments, please contact your local sales representative or refer to: SynPOR HD Facial Shape System Technique Guide DePuy Synthes 1

4 SynPOR HD Facial Shape System. For the augmentation or reconstruction of the craniomaxillofacial skeleton. Introduction SynPOR HD Facial Shape Implants are designed for augmenting or reconstructing the contours of the craniofacial skeleton. Each implant is designed to minimize the need for intraoperative contouring. Features Registration tabs assist in symmetric and preferred implant positioning Semiflexible material allows the implant to conform to underlying bone during fixation Pre-shaped designs in multiple sizes to meet clinical needs Nonabsorbable, biocompatible material Porous structure supports fibrovascular ingrowth Smooth surface characteristics Can be trimmed with a scalpel or high speed burr SynPOR HD Malar Implants are designed for craniofacial reconstruction and augmentation of malar deficiencies. SynPOR HD Malar Implants are designed to enhance the malar midface and proximal zygomatic arch. Malar implant design features include: Registration tabs located medially and laterally to assist in positioning the implant Pre-shaped design mimics and conforms to the skeleton while avoiding impingement of the infraorbital nerve Two styles (shell and enhancer) are offered in a range of sizes to address patient needs Malar implant, left side, viewed from above 2 DePuy Synthes SynPOR HD Facial Shape System Technique Guide

5 SynPOR HD Chin Implants augment or reconstruct the contours of the retrusive or hypo plastic chin. SynPOR HD Chin Implants are designed to enhance the chin profile and mandibular border. Chin implant design features include: Registration tabs on the inferior border to assist in positioning the implant Pre-shaped design mimics and conforms to skeleton while avoiding impingement of the mental nerve Three-part assembly facilitating insertion Chin connector: Flexible titanium connector to allow adjustments for individual fit and implant positioning Two styles (round and square) are offered in a range of sizes to address patient needs SynPOR HD Facial Shape System Technique Guide DePuy Synthes 3

6 Intended Use, Indications and Contraindications Intended use Synthes SynPOR HD Facial Shape Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton. The MatrixMIDFACE screws included in the SynPOR HD Facial Shape System should be used for fixation of the SynPOR HD Facial Shape Implants. Indications Synthes SynPOR HD Facial Shape Implants are indicated for the augmentation or reconstruction of the craniomaxillofacial skeleton. Specific indications: Enhancement of the malar and chin Correction of deficiencies of the malar and chin Contraindications Synthes SynPOR HD Facial Shape Implants are not intended for use in: The presence of active or latent infections Inadequate coverage of healthy, vascularized tissue Full load-bearing applications or to lend structural support to bone Systemic disorders and/or limitations in blood supply that may cause slow healing and increase the possibility of infection and/or rejection of the implants Tissue that has been compromised by cancer therapies Any degenerative disease process that would adversely affect proper placement of the implants Procedures in which a non-sterile environment exists, such as sinuses 4 DePuy Synthes SynPOR HD Facial Shape System Technique Guide

7 Preoperative Considerations Evaluation and planning Successful implantation is technique sensitive and requires careful preoperative planning. Preoperative planning should include an understanding of the patient s desires and an analysis of both the skeleton and the soft tissue envelope. Radiologic evaluation can also be useful for defining the patient skeletal dimensions. Material SynPOR HD Facial Shape Implants are manufactured from an inert, nonabsorbable high density polyethylene (HDPE), which has a long history of use as a surgical implant. 1 The implant s network of open and interconnecting pores, approximately 50% greater than 100 µm in size, allows tissue ingrowth and relative host incorporation rather than host encapsulation observed with smooth-surface implants. 2 Handling SynPOR HD Facial Shape Implants are provided sterile, for single use. Warning: Implants must not be resterilized by any method. Resterilizing implants may compromise the mechanical properties and sterility cannot be assured. Do not remove SynPOR HD Facial Shape Implants from the protective packaging until the time of implantation. Handle the implant with clean, powder-free gloves to prevent contamination. Warning: Do not place implants on surgical drapes, surgical clothing or any other material that may contaminate the implants with lint or other particulate matter. Implants may be placed in sterile saline to prevent contamination. Preparation SynPOR HD Facial Shape Implants are designed to be placed directly on the recipient bone. Adequate subperiosteal exposure is important to allow visualization of the anatomical landmarks and proper placement of the implant. Warning: Proper aseptic technique is recommended to prevent contamination of the SynPOR HD Facial Shape Implants when using intraoral incisions. 3 SynPOR HD Facial Shape System Technique Guide DePuy Synthes 5

8 Surgical Technique: Chin 1 Approaches Chin implants can be placed through intraoral or submental approaches. The area for desired augmentation should be exposed by subperiosteal dissection. The subperiosteal pocket created should extend up to one centimeter beyond the area for augmentation. The large pocket allows easier insertion of the porous implant to which soft tissues tend to adhere and provides perspective for accurate implant placement. Exposing the inferior border of the anterior mandible allows positioning of registration tabs which aid in the symmetrical placement of the implant. Warning: Proper aseptic technique is recommended to prevent contamination of the SynPOR HD Facial Shape Implants when using intraoral incisions. 3 Notes: Shaded region indicates area of subperiosteal dissection. Identification of the mental nerve lessens the possibility of implant impingement on this structure. 6 DePuy Synthes SynPOR HD Facial Shape System Technique Guide

9 2 Sizing and shaping Instrument Cutting Board Chin sizer, round Chin sizer, square SynPOR HD Facial Shape Implants are available in a variety of sizes and styles to minimize the need for alteration. However, implants can be easily trimmed and contoured with a scalpel (using the cutting board provided) or with a high speed burr (holding the implant in your hand) to suit the individual needs of the patient. Rinse the implant thoroughly in sterile saline to remove any particle debris after contouring (cutting or burring). Optional Sizers are available to help determine the proper implant necessary to achieve the desired facial contour for each patient. Precaution: The implant positioning instrument is not recommended to be used with the sizers. Warnings: Do not cut or burr the implant in situ. When shaping and contouring the implant, sharp edges should be avoided to minimize trauma to the surrounding tissue. Implants must never be shaped by use of devices that produce intense heat such as cauteries, heated knives, or lasers. Do not implant sizers as they are not intended to be used for permanent augmentation. Do not re-use sizers if they have been cut, modified, or damaged. This prevents them from being properly sterilized and accurately representing their respective implant. Do not burr the implant directly on the cutting board. This can lead to damage of the cutting board and debris contamination of the implant. Do not place implants on surgical drapes, surgical clothing or any other material that may contaminate the implants with lint or other particulate matter. Implants may be placed in sterile saline to prevent contamination. SynPOR HD Facial Shape System Technique Guide DePuy Synthes 7

10 Surgical Technique: Chin Precautions: If the implant is burred, reestablish the open pore structure by shaving the outer surface with a scalpel. If the midline of the chin implant is modified, it could affect the implant s fit with the chin connector. Optional: Contouring SynPOR HD Facial Shape Implants can be contoured by submerging in hot sterile saline (over 70 C/160 F) for several minutes until the implant softens. Higher temperatures will improve the ability to contour the implant. Remove the implants from the hot saline and contour to the desired shape. If there is too much resistance, return the implant to the hot saline. Allow the implant to cool completely to maintain the achieved shape. Cold, sterile saline can accelerate the cooling process. Reheat the implant as needed to achieve the final form desired. 8 DePuy Synthes SynPOR HD Facial Shape System Technique Guide

11 3 Implantation 1 Instrument Implant Positioning Instrument The chin implants consist of right and left halves connected by a chin connector. The three-piece design facilitates implant insertion. It also allows adjustability in implant positioning. Registration tabs positioned at the inferior border of the implant assure that the implant is aligned with the inferior border of the mandible and lessens the possibility of impingement on the mental nerve. Removal of the tabs (which can be done easily with a scalpel or burr) allows more superior positioning of the implant. It may be helpful to mark the midline of the chin with a drill or marking pen to assist in implant placement. Separate the chin implant at the medial junction for two-part insertion. 2 Registration tab The implant positioning instrument may be used to facilitate placement of the implant. Align the lateral aspects of the implant along the inferior border of the mandible using the registration tab as a guide (Figure 1). Reconnect the chin implant halves using the chin connector and determine medial placement (Figure 2). The chin connector acts as a hinge to allow the implant to conform to the anatomy and needs of each mandible. As shown in the illustration, the hinge function allows the inferior border of the implant to mimic the specific inclination of the inferior border of any mandible while allowing variability in vertical positioning of the chin prominence. In most instances, there will be a gap between the medial aspects of the implant halves (Figure 3). 3 Medial gap SynPOR HD Facial Shape System Technique Guide DePuy Synthes 9

12 Surgical Technique: Chin 4 Stabilization Instrument Implant Positioning Instrument SynPOR HD Facial Shape Implants should be stabilized with screws. Screw fixation is recommended to achieve the best anatomical fit and planned reconstruction. Screw fixation immobilizes the positioned implant and eliminates any gaps between the inner surface of the implant and the surface of the facial skeleton. Screws placed in the central portion of the chin implant should avoid the titanium connecting bar. Two screws per implant half are recommended. The implant positioning instrument may be used to immobilize implants during fixation. Compress the implant to the facial skeleton before drilling and screw fixation. Drill with the appropriate drill bit and insert the appropriate length screw. Tighten screws sufficiently to eliminate the gaps between the implant and the facial skeleton as well as to minimize screw profile. Gaps between the implant and the skeleton will result in an unanticipated increase in projection equivalent to the size of the gap. This may limit predictability of the augmentation. Precautions: Confirm that implant positioning, drill bit length and screw length allow for adequate clearance of nerves, tooth roots and other critical structures. Drill rate should never exceed 1,800 rpm. Higher rates can result in thermally generated necrosis of the bone and an oversized hole to be drilled. The detriments of an oversized hole include reduced pullout force, increased risk of screws stripping in bone, and/or suboptimal fixation. Always irrigate during drilling. The implant can break or be damaged due to lack of fixation, excessive activity or trauma. Before closing all incisions, take care to remove all porous polyethylene particles from the surgical site. 10 DePuy Synthes SynPOR HD Facial Shape System Technique Guide

13 Surgical Technique: Malar 1 Approaches Depending on the surgeon s preference, malar implants may be placed through intraoral approaches, eyelid approaches, or combinations thereof. The area for desired augmentation should be exposed by subperiosteal dissection. The subperiosteal pocket should extend up to one centimeter beyond the area for augmentation. The large pocket allows for easier insertion of the porous implants to which soft tissues tend to adhere and provides perspective for accurate implant placement. The lateral aspect of the infraorbital rim and the superior edge of the zygomatic arch should be freed of soft tissues to allow positioning of the registration tabs. Warning: Proper aseptic technique is recommended to prevent contamination of the SynPOR HD Facial Shape Implants when using intraoral incisions. 3 Notes: Shaded region indicates area of subperiosteal dissection. Identification of the infraorbital nerve lessens the possibility of implant impingement on this structure. SynPOR HD Facial Shape System Technique Guide DePuy Synthes 11

14 Surgical Technique: Malar 2 Sizing and shaping Instruments Cutting Board Malar Enhancer Sizer XX SynPOR HD Malar Sizers SynPOR HD Facial Shape Implants are available in a variety of sizes and styles to minimize the need for alteration. However, implants can be easily trimmed and contoured with a scalpel (using the cutting board provided) or with a high speed burr (holding the implant in your hand) to suit the individual needs of the patient. Malar Shell Sizer Rinse the implant thoroughly in sterile saline to remove any particle debris after contouring (cutting or burring). Optional Sizers are available to help determine the proper implant necessary to achieve the desired facial contour for each patient. Precaution: The implant positioning instrument is not recommended to be used with the sizers. Warnings: Do not cut or burr the implant in situ. When shaping and contouring the implant, sharp edges should be avoided to minimize trauma to the surrounding tissue. Implants must never be shaped by use of devices that produce intense heat such as cauteries, heated knives, or lasers. Do not implant sizers as they are not intended to be used for permanent augmentation. Do not re-use sizers if they have been cut, modified, or damaged. This prevents them from being properly sterilized and accurately representing their respective implant. Do not burr the implant directly on the cutting board. This can lead to damage of the cutting board and debris contamination of the implant. Do not place implants on surgical drapes, surgical clothing or any other material that may contaminate the implants with lint or other particulate matter. Implants may be placed in sterile saline to prevent contamination. 12 DePuy Synthes SynPOR HD Facial Shape System Technique Guide

15 Precaution: If the implant is burred, reestablish the open pore structure by shaving the outer surface with a scalpel. Optional: Contouring SynPOR HD Facial Shape Implants can be contoured by submerging in hot sterile saline (over 70 C/160 F) for several minutes until the implant softens. Higher temperatures will improve the ability to contour the implant. Remove the implants from the hot saline and contour to the desired shape. If there is too much resistance, return the implant to the hot saline. Allow the implant to cool completely to maintain the achieved shape. Cold, sterile saline can accelerate the cooling process. Reheat the implant as needed to achieve the final form desired. SynPOR HD Facial Shape System Technique Guide DePuy Synthes 13

16 Surgical Technique: Malar 3 Implantation Instrument Lateral tab Implant Positioning Instrument Malar implants are designed with registration tabs which allow ideal and symmetric placement. The medial tab lies on the lateral aspect of the infraorbital rim and the lateral tab lies on the superior edge of the zygomatic arch. If a different orientation is desired, the registration tabs can be removed easily with a scalpel or burr. Medial tab The implant positioning instrument may be used to facilitate placement of the implant. Align the implant along the infraorbital rim and zygomatic arch using the registration tabs on the implant as a guide to ensure symmetrical placement of the left and right implants. 14 DePuy Synthes SynPOR HD Facial Shape System Technique Guide

17 4 Stabilization Instruments Implant Positioning Instrument X Handles with Hexagonal Coupling X Screwdriver Shaft Matrix MIDFACE, self-holding, with Hexagonal Coupling SynPOR HD Facial Shape Implants should be stabilized with screws. Screw fixation is recommended to achieve the best anatomical fit and planned reconstruction. Screw fixation immobilizes the positioned implant and eliminates any gaps between the inner surface of the implant and the surface of the facial skeleton. The implant positioning instrument may be used to immobilize implants during fixation. Immobilization and application of the malar implant to the skeleton often requires the placement of 2 screws. One is placed in the malar prominence, another is placed just anterior to the zygomatic arch. When an intraoral approach has been used the lateral extent of a blepharoplasty (crow s feet) incision provides access to the second (lateral) screw position. Compress the implant to the facial skeleton before drilling and screw fixation. Drill with the appropriate drill bit and insert the appropriate length screw. SynPOR HD Facial Shape System Technique Guide DePuy Synthes 15

18 Surgical Technique: Malar Tighten screws sufficiently to eliminate the gaps between the implant and the facial skeleton as well as to minimize screw profile. Gaps between the implant and the skeleton will result in an unanticipated increase in projection equivalent to the size of the gap. This may limit predictability of the augmentation. Precautions: Confirm that implant positioning, drill bit length and screw length allow for adequate clearance of nerves, tooth roots and other critical structures. Drill rate should never exceed 1,800 rpm. Higher rates can result in thermal generated necrosis of the bone, and an oversized hole to be drilled. The detriments of an oversized hole include reduced pullout force, increased risk of screws stripping in bone, and/or suboptimal fixation. Always irrigate during drilling. The implant can break or be damaged due to lack of fixation, excessive activity or trauma. Before closing all incisions, take care to remove all porous polyethylene particles from the surgical site. 16 DePuy Synthes SynPOR HD Facial Shape System Technique Guide

19 Post-Operative Care Adequate patient instruction is a key factor in determining the success of the surgical procedure. Postoperative followup and care are very important. The patient must be made aware that the implants are not as strong as natural tissue and that excessive physical activity or load bearing may cause loosening, migration, deformation, or fracture of the implants. SynPOR HD Facial Shape System Technique Guide DePuy Synthes 17

20 Implants SynPOR HD Implants Must be ordered separately, not part of set ( ) A SynPOR HD Chin Implants, round, sterile A B C S 60 mm 36 mm 4 mm S 60 mm 39 mm 6 mm S 60 mm 41 mm 9 mm C B A SynPOR HD Chin Implants, square, sterile A B C S 60 mm 36 mm 4 mm S 60 mm 39 mm 6 mm S 60 mm 41 mm 9 mm C B SynPOR HD Malar Enhancer Implants, sterile A B C S 48 mm 21 mm 3 mm Right S 48 mm 21 mm 3 mm Left S 47 mm 21 mm 4 mm Right S 47 mm 21 mm 4 mm Left S 48 mm 21 mm 5 mm Right S 48 mm 21 mm 5 mm Left A C B SynPOR HD Malar Shell Implants, sterile A B C S 44 mm 22 mm 3 mm Right S 44 mm 22 mm 3 mm Left S 47 mm 23 mm 4 mm Right S 47 mm 23 mm 4 mm Left S 52 mm 23 mm 5 mm Right S 52 mm 23 mm 5 mm Left A C B 18 DePuy Synthes SynPOR HD Facial Shape System Technique Guide

21 Screws MatrixMIDFACE Screws 1.5 mm, self-drilling, Titanium Alloy (TAN), pack of 1 unit in Clip Length C 6 mm C 8 mm MatrixMIDFACE Screws 1.5 mm, self-tapping, Titanium Alloy (TAN), pack of 1 unit in Clip Length C 6 mm C 8 mm C 10 mm C 12 mm C 14 mm C 16 mm C 18 mm MatrixMIDFACE Emergency Screws 1.8 mm, self-tapping, length 6 mm, Titanium Alloy (TAN), pack of 1 unit in Clip Length C 6 mm C 8 mm C 10 mm C 12 mm C 14 mm C 16 mm C 18 mm Chin Connector SynPOR HD Facial Shape System Technique Guide DePuy Synthes 19

22 Implants Screw overview Pack of 1 unit Pack of 4 units Labelling clips(lc) Self-tapping screws XX.01C XX.04C XXLC Self-drilling screws X.01C X.04C XLC Emergency screws XX.01C XXLC 20 DePuy Synthes SynPOR HD Facial Shape System Technique Guide

23 Instruments SynPOR HD Chin Sizer, round mm mm mm SynPOR HD Chin Sizer, square mm mm mm SynPOR HD Malar Enhancer Sizer Right, 3 mm Left, 3 mm Right, 4 mm Left, 4 mm Right, 5 mm Left, 5 mm SynPOR HD Malar Shell Sizer Right, 3 mm Left, 3 mm Right, 4 mm Left, 4 mm Right, 5 mm Left, 5 mm Implant Positioning Instrument SynPOR HD Facial Shape System Technique Guide DePuy Synthes 21

24 Instruments Cutting Board Drill Guide Holding Forceps for Plates Handle with Hexagonal Coupling small medium large 22 DePuy Synthes SynPOR HD Facial Shape System Technique Guide

25 Drill Bit 1.1 mm, for J-Latch Coupling, with Stop Length 44.5/6 mm Length 44.5/8 mm Length 65/12 mm Length 65/25 mm Drill Bit 1.1 mm, for J-Latch Coupling, with Stop, sterile S Length 44.5/6 mm S Length 44.5/8 mm Drill Bit 1.1 mm, for Mini Quick Coupling, with Stop Length 44.5/6 mm Length 44.5/8 mm Length 65/12 mm Length 65/25 mm Drill Bit 1.1 mm, for Mini Quick Coupling, with Stop, sterile S Length 44.5/6 mm S Length 44.5/8 mm Screwdriver Shaft MatrixMIDFACE, self-holding, with Hexagonal Coupling Short, length 52 mm Medium, length 76 mm Long, length 96 mm Screwdriver Shaft MatrixMIDFACE, with Holding Sleeve, with Hexagonal Coupling Medium, length 79 mm Long, length 95 mm SynPOR HD Facial Shape System Technique Guide DePuy Synthes 23

26 SynPOR HD Facial Shape System Sets Screw and Instrument Set for SynPOR HD Facial Shapes Chin Implants for SynPOR HD Facial Shapes Malar Implants for SynPOR HD Facial Shapes Module Module for SynPOR HD Facial Shapes, for Implants and Instruments, with Lid, without Contents 24 DePuy Synthes SynPOR HD Facial Shape System Technique Guide

27 References 1. Romano, James J., Nicholas T. Iliff. and Paul N. Manson. Use of Medpor Porous Polyethylene Implants in 140 Patients with Facial Fractures. Journal of Craniofacial Surgery 4.3 (1993): Print. 2. Yaremchuk, MJ. (2007). Atlas of facial implants. Saunders Elsevier Inc. 3. Potter, J. and Ellis, E. (2004). Biomaterials for Reconstruction of the Internal Orbit. Journal of Oral and Maxillofacial Surgery, 62: SynPOR HD Facial Shape System Technique Guide DePuy Synthes 25

28 Manufacturer: Synthes GmbH Eimattstrasse 3 CH-4436 Oberdorf This publication is not intended for distribution in the USA. All technique guides are available as PDF files at Ö öABUä version AB 12/ Synthes, Inc. or its affiliates Subject to modifications Synthes is a trademark of Synthes, Inc. or its affiliates