Documentation

Recommended Scanning Protocol

Recommended Sterilisation Protocol

Temporalis Suspension Design

Recent Publications




Recommended Scanning Protocol for Implants

  • Position the patient's head in the CT scanner headrest making sure that the patient does not move during the scan (this is to avoid movement artefacts in the scan)

  • Scan the defect and at least 2cm of the surrounding tissue, using contiguous sequential 1mm-thick slices. If using a CBCT scanner for scanning a one-sided defect, please ensure that the field of view is large enough to include both sides of the head (this is to achieve as good an outcome as possible post-operatively)

  • If possible, do not use gantry tilt, unless to avoid critical structures that do not need imaging

  • For orbital floor or wall defect, it is very important to use very thin contiguous slices to be able to image correctly the bone still present in this area

  • Send us the scan via our FTP server or on a DICOM CD. On your request, it is also possible for us to collect the data from your IT network. Your IT manager can contact us directly regarding this facility.

Do not hesitate to contact us if you have any queries about scanning or data transfer - better before the patient is scanned but never too late!


Download in Adobe Acrobat (pdf) Format.

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Recommended Sterilisation Protocol for our Products

  • All our Products are delivered NON STERILE.

  • It is not our responsibility to ensure sterilisation and validation of sterilisation equipments.

  • Your sterilisation manager can contact us directly if they have any question that we may be able to help with.

  • Re-sterilisation: If re-sterilisation is required, ensure that the Product is
    1. not damaged or contaminated and
    2. still fits the model of the defect and does not contain sharp edges before re-sterilising it using the methods described below.

    Titanium Implants

  • The titanium patient specific implants are delivered NON STERILE. Prior to implementation, clean the implant with mild detergent (4<ph<10). An automated cleaning process running standard HTM2010 parameters is adequate. Then steam sterilise the implant using an autoclave. The autoclave should operate within the parameters set out in HTM 2010 with the sterilisation hold time of 134-137 degrees centigrade for 15 minutes in a porous load sterilizer. Do not use the implants if the package was opened or damaged in delivery.

  • PEEK Implants

  • The PEEK patient specific implants are delivered NON STERILE. Prior to implementation, clean the implant with mild detergent (4<ph<10). An automated cleaning process running standard HTM2010 parameters is adequate. Then steam sterilise the implant using an autoclave. The autoclave should operate within the parameters set out in HTM 2010 with the sterilisation hold time of 134-137 degrees centigrade for 15 minutes in a porous load sterilizer. Do not use the implants if the package was opened or damaged in delivery.

  • Nylon Defect Model/Cutting Guide

  • Nylon models and cutting guides are supplied NON STERILE. If sterility is required clean with mild detergent (5<ph<8) and the steam sterilise using an autoclave. The autoclave should operate within the parameters set in HTM 2010 with the sterilization hold time of 134-137 degrees centigrade for 15 minutes in a porous load sterilizer.

  • Resin Defect Model/Cutting Guide

  • The custom made model of the defect is delivered NON STERILE. If sterility is required use 25-35kGy gamma irradiation.

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Temporalis Suspension Design

Cranioplasty plates which cross the border of the temporalis muscle are now drilled with a set of paired holes for the re-attachment, by permanent suture, of the temporalis. The hole spacing is designed to allow a standard 3/8 circular suture needle of 12mm-radius to be used. This improves the cosmetic outcome.

Click here to see this design in-situ in a Case Study.


titanium, titanium plate, Temporalis Suspension, Cranioplasty titanium, Temporalis, cranioplasty plate, Suspension,Cranioplasty
Titanium Cranioplasty illustrating Temporalis Suspension


 PEEK Cranioplasty  PEEK Cranioplasty,
PEEK Cranioplasty illustrating Temporalis Suspension


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Recent Publications

Publication3D FIRG in Bruges, Belgium. 9 September 2011
TitleCustom surgical templates for facial bone contouring - a new technique.
AuthorsJ Collier, R Richards, V Sauret-Jackson, A Dawood, W Grant and N Kirkpatrick (London)
Abstract

Institutions

    1 Department of Craniofacial Surgery, Chelsea & Westminster Hospital
    2 Cavendish Implants, London
    3 Cavendish Imaging, London
    4 Dawood&Tanner Dental Practice

Aim of investigation

To develop a novel method of using custom surgical templates to provide intra-operative guides for facial bone contouring to treat massive fibrous dysplasia.

Material & Methods

Virtual planning of osseointegrated dental implant placement using CT/CBCT data is a well established technique. Custom drill guides produced by this process allows the accurate surgical delivery of implants to the pre-planned sites. We adapted this process to facilitate the facial recontouring required in a case of massive polyostotic facial fibrous dysplasia.

CT data was manipulated in 3D to determine the best possible final contour within the significantly expanded temporal, orbital, zygomatic, maxillary and mandibular components of the disease (Figure 1). These plans were based on normal anatomy from the contralateral side. Custom-made surgical templates were made using rapid-prototyping to allow the operating surgeon to drill to pre-determined depths within the abnormal bone using 3.8mm zygomatic implant drill bits (Figure 2). These multiple drill holes then acted as multiple “depth gauges” for bony re-contouring using conventional methods.

Results and Conclusions

This technique allows the operating surgeon to quickly and accurately contour bone, of particular benefit when normal anatomy is significantly altered by pathology. This facilitated delivery of optimal postoperative symmetrisation and reduced both surgical time and morbidity. From our careful search of the literature we believe that this is the first time such a technique has been used in the facial skeleton.




PublicationBRITISH ASSOCIATION OF ORAL AND MAXILLOFACIAL SURGEONS
IssueVolume 49, Supplement 1. June 2011. Page S46
Title "Use of Custom Surgical Stents for Facial Bone Contouring- A New Technique."
Authors J. Collier, R. Richards, V. Sauret-Jackson, A. Dawood, W. Grant and N. Kirkpatrick
Abstract Custom computer software and computer-generated surgical drill guides are widely used in the planning and placement of osseointegrated dental implants. Manipulation and interaction with facial CT data in three dimensions (3D) permits the experienced operator to predictably place implants into predetermined sites both intra- and extra-orally. Similar technology allows manipulation of the 3D data in cases of pathological bony deformity in order to determine a surgical plan. However, whilst on screen planning may be straight forward, translating the ‘virtual’ plan into reality is far from straightforward.

We present a novel method of designing and using surgical drill guides of variable thickness to permit accurate drilling to pre-determined depths using a single drill bit. This allows the operating surgeon to quickly and accurately contour bone, of particular benefit when normal anatomy is significantly altered by pathology. From our careful search of the literature we believe that this is the first time that such a technique has been used in the facial skeleton.

We will illustrate the usefulness of this technique with a case of hemifacial recontouring performed for massive, stable polyostic fibrous dysplasia. We will demonstrate how the 3D computer modelling and drill guides manufactured by rapid prototyping significantly facilitated the recontouring procedure. This reduced both surgical time and morbidity, and allowed delivery of the optimal post-operative symmetrisation.




PublicationArchives of Facial Plastic Surgery
IssueVolume 12, No. 3, May-June 2010, page 186
Title"Computer-Assisted Design and Manufacture of Implants in the Late Reconstruction of Extensive Orbital Fractures ."
AuthorsO. Lieger, R. Richards, M. Liu and T. Lloyd
AbstractIntroduction

To evaluate the use of computer-assisted designed and manufactured (CAD/CAM) orbital wall and floor implants for late reconstruction of extensive orbital fractures.

Methods

We performed a retrospective data review on 29 patients treated for extensive orbital fractures from January 1, 1997, through December 31, 2007, at the University College London Hospitals. The use of a CAD/CAM technique based on cross-sectional computed tomographic scans, generating an accurate stereolithographic model, enabled surgeons and technicians to plan and create the best dimension and position of the implant. Sheet titanium was then pressed to shape from a design outlined on a counterdie of the new reconstructed model.

Results

Twenty-nine patients with late enophthalmos due to complex orbital fractures underwent successful reconstruction surgery. Enophthalmos was corrected in all patients. Diplopia was improved in 14 patients, and extraocular movement was improved in 13.

Conclusions

The CAD/CAM implants represent a financially viable method for secondary reconstruction of the orbit. This method enables the surgeon to plan the operation in detail, facilitates the surgical procedure, and can help to improve the outcome.




PublicationBritish Journal of Oral and Maxillofacial Surgery
IssueVolume 46, Issue 7, October 2008, page e35
Title"Orbital floor and cranioplasty repair with press-formed titanium implants; a means to assess the technical reproducibility of computer planning, fabrication and surgery."
AuthorsV. Sauret-Jackson, R. Richards and A. Dawood
AbstractIntroduction

The successful production of accurate titanium implants for the reconstruction of craniofacial and maxillofacial bony defects from Computer Tomography (CT) scan data and computer assisted design and manufacturing methods is now commonplace, but little data exists to demonstrate the technical precision of this approach to orbital repair.

This paper demonstrates how the planned and achieved result may be compared and evaluated at the time of manufacture and subsequently, postoperatively.

Method

The orbital defect was assessed on an interactive display showing simultaneously the patients sagittal, coronal and transverse CT cross-sections and 3D reconstruction. A mirror-image of the undamaged orbit was created to 'virtually' repair the defect.

A rapid prototype stereo lithographic model of the repaired defect was fabricated and used to cold-press a titanium form, which was further refined to create the finished implant. A notch in the implant vertically above the infraorbital nerve was added to help the surgeon to position the implant. The implants were developed in conformance with Medical Devices regulations for customised implants.

Before a distribution of the finished implant the stereo lithographic modal was scanned in a Cone Beam Computer Tomography Scanner with the implant in place. A similar postoperative scan of the patient was also taken of the repaired defect with implant in place.

Result

Co-registration of these scans enabled an assessment of the accuracy of the implant manufacturing process, and the correlation between planned and achieved surgical result.

Conclusion

This work shows the design and the anatomical landmarks well-suited for accurate positioning of the implant in theatre.






Click to view the July 2008 British Association of Oral and Maxillofacial Surgeons presentation in Acrobat (pdf) format.

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