ps i— patient specific implants. derived from ct data for...

PSI—Patient Specific Implants.Derived from CT data for excellentreconstructive results.

Better anatomic fit

Reduced operating time

Satisfying aesthetic results

Synthes CMF PSI—Patient Specific Implants

PSI—Patient Specific Implants

Intended for the replacement of bony voids in the cranial/ craniofacial skeleton.

Features– Better anatomic fit versus conventional fixation/reconstruction methods

– Reduced operating time compared to traditional reconstruction methods that require extensive contouring

– Satisfying aesthetic results for surgeon and patient

– Suitable materials for definitive treatment

– Impact- and fracture-resistant for optimal protection of underlying structures

– Autoclavable—withstands repeated sterilization

Synthes Patient Specific Implants are derived from 1 mm sliceDICOM uncompressed CT data, which is obtained from thehospital radiology department.

Synthes CMF

Medical imaging software is used to visualize the CT data,and to create an anatomically correct skull model and animplant model.

Surgeons have a choice of two biocompatible materials: – PEEK Optima-LT (polyetheretherketone) or

– Commercially pure (CP) titanium

Synthes will fabricate one nonsterile implant for shipment to the surgeon, after receipt of purchase order and design approval.

Synthes plates and screws are used to attach the Patient Specific Implant to the native bone.


PSI—Patient Specific Implants continued

Applications

Synthes CMF

Synthes Patient Specific Implants can be designed to fit voids in the cranial and craniofacial skeleton.

Depending on the size(length, width, and height)of the implant required, Synthes may design a singleor multi-piece implant.Multi-piece implants allowthe surgeon greater flexibility when treatinglarger defects.

Multi-piece implants may be joined together using Synthes standard cranial andcraniofacial fixation systems.

Cranial Applications

Craniofacial Applications Onlay Applications

1-piece 3-piece

3-piece 1-piece

2-piece onlay 2-piece onlay

1-piece onlay 1-piece onlay

1-piece

2-piece 3-piece 1-piece

2-piece 2-piece

Choice of Material

PEEK Optima-LT (Polyetheretherketone)

– Engineered for strength, stability and biocompatibility

– Radiolucent (minimal MRI artifact)

– Bone-like strength

– Surgeon can determine plate and screw placement during surgery

– Lightweight


– Can be used with Synthes cranial and craniofacial fixation systems

– Implant is 3.0 mm thick (nominal)

– If modifications of a PEEK implant are required (e.g. drainage, monitoring devices), they can be performed in the OR with standard instruments


PEEK Mechanical Properties

Cortical Bone PEEK

Modulus of Elasticity (stiffness) (GPa) 8–24 3.6–4.1

Yield Strength (MPa) 115 113

Notes regarding the use of PEEK Patient Specific Implants:PEEK patient specific implants require minimal (if any) modification. For minor fitmodifications, it is suggested that the surgeon modify the patient bone ratherthan modifying the PEEK patient specific implant. PEEK patient specific implantscan be modified with a high speed burr, if needed. It is suggested that the PEEK implants be modified and rinsed in sterile saline solution away from the implant/surgical site, to ensure that particulate debris does not infiltrate the surgical site after any modifications.

Standard plates and self-tapping or self-drilling screws can be used to attach thePEEK patient specific implant to the patient. Screw holes, regardless of screwsize and type, must be predrilled away from the surgical site.

Titanium (commercially pure, implant grade)

– Ultra-high strength

– Radiopaque

– Excellent biocompatibility


– Requires the use of Synthes Low Profile Neuro or MatrixNEURO plate and screw fixation systems

– Requires the use of Titanium Low Profile Neuro Machine Screws (488.066) for attachment of the plates to the implant (see Figure 1)

– Titanium implant is 2.5 mm thick (nominal)

Synthes CMF

Titanium Mechanical Properties

Cortical Bone Titanium

Modulus of Elasticity (stiffness) (GPa) 8–24 103

Yield Strength (MPa) 115 230 (minimum)

Notes regarding the use of Titanium Patient Specific Implants: Titanium patient specific implants cannot be modified. If there are any minor fit modifications required, the surgeon must modify the patient’s bone.

Titanium patient specific implants require the use of Synthes Low Profile Neuro or MatrixNEURO fixation systems (plates and screws).

The surgeon must preselect the location of Synthes plates and machine screwholes during the implant design review process.

The implant will be provided with threaded screw holes. The Titanium Low Profile Neuro Machine Screws (488.066) are required for attachment of the Low Profile Neuro or MatrixNEURO plates to the titanium implant.

Titanium PSI Implant

Bone Screw

Bone

Figure 1

Plate

1.6 mm Titanium Machine Screw(488.066)

Ordering Process

1Surgeon sends patient to radiology to be scanned according to Synthes CT Scanning Protocol.

Synthes CT Scanning Protocol can be obtained from a Synthes Sales Consultant or at http://products.synthes.com.

2The completed Request for Quote (RFQ) form and the CT scan (according to the CT Scanning Protocol) are both sent together to:Synthes CMFAttn: Patient Specific Implant Department1301 Goshen ParkwayWest Chester, PA 19380

CT scan and RFQ can be sent overnight via Synthes PSI prepaid mailers.

Notes– Scans must be less than four months old. Films will not be accepted.

– Patient’s CT scan and any additional patient informationwill be used solely for the production of a Patient SpecificImplant. All patient information will be kept confidential.

– The data can be sent either by mail (express) or fax.


CT Scanning ProtocolSynthes Patient Specific Implants

This document describes the guidelines for a CT scan that is taken for the purpose of ordering a Patient Specific Implant from Synthes. Notice: Patient Specific Implants are intended for the replacement of bony voids in the cranial/craniofacial skeleton.

Matrix 512 x 512Slice Thickness 1.0 mmFeed per Rotation 1.0 mmReconstructed Slice Increment 1.0 mmReconstructed Algorithm Bone or High ResolutionGantry Tilt 0ºAccepted Media CD or MODSynthes only accepts uncompressed DICOM data. Note on Disc: Scanner type, date of scan, patient name and number, surgeon,hospital, contact number.

Scanning Instructions

– Ensure scanner is DICOM compliant. Refer to supported scanner list below.

– Scans must be less than four months old.– Data must be on CD or Magnetic Optical Disk (MOD) only.

Films will not be accepted.– Scan all slices of the study in the same direction.– Align the patient in a way that prevents as many artifacts

as possible in the resulting images. It is advised not to use a gantry tilt because data may be of inferior quality.

– Scan with the same slice spacing; the slice spacing must be less than or equal to the slice thickness. The slice thickness should be between 0.625 mm and 1.25 mm.

– Reconstruct the images with a 512 x 512 matrix.– Only the axial images are required.– All slices must have the same field of view, the same

reconstruction center, and the same table height.– Send the images (DICOM slices) to the surgeon.

Siemens Somatom PlusSiemens Somatom HiQSiemens Somatom DRHSiemens Somatom ARSiemens Somation 4 Plus, Volume ZoomSiemens Somatom 4ARSiemens Magnetom (MR Scanner)Siemens Somatom BalanceSiemens Somatom AR StarSiemens Magnetom (MR)Siemens Magnetom ExpertSiemens Emotion DuoSiemens GBS IIIToshiba MEC AsteionToshiba MEC AquilionToshiba AquilionToshibaToshiba Xvision/EX

Toshiba XPress/SX, GX, HS1Philips EasyvisionPhilips Tomoscan 60/TX, TXPhilips Tomoscan CX, CX/S, CX/QPhilips Tomoscan LX, LX/C, SRPhilips Medical Systems AVE1Philips Medical Systems 6000Hitachi W950, W2000, MRP 7000Hitachi 7000, AVEU, LX, THitachi CT95, CT20GE Hilight AdvantageGE AdvantageGE HispeedGE Sigma (MR)GE LightSpeed QX/iGE HiSpeed RP, CT/I, AdvantageGEMS Jupiter, Zeus, ZeusRPGEMS Genesus_Zeus, Genesus_Signa

GE Prospeed, Cytec, CT PaceGE Prospeed PlusGE Cytec 3000iGE9800GE CT/IYokogawa Medical Systems FormatElscint Exel 2400Elscint CT TwinElscint EliteElscint OmniProElscint Twin FlashPicker PQ 2000, PQ 5000, 6000Picker UltraZPicker MxTwinPicker MX8000Picker Sys9049Picker International Polaris 1.0TPicker International PQS

© 2007 Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 1/10 J7844-E

DICOM Compliant Scanners

Contact: Patient Specific Implants Help Desk at (610) 719-6777, or by e-mail at [email protected]

Use the following scan parameters or the closest approximation possible:

Request for QuoteSynthes Patient Specific Implants

Notice: Patient Specific Implants are intended for the replacement of bony voids in the cranial/craniofacial skeleton.

Please send:1. Completed “Request for Quote” form2. CT Scan/Optical Disc from radiology

(with scanner type, date of scan, patient name/number on disc)

Mail to:Synthes CMFAttn: Patient Specific Implant Department1301 Goshen Parkway West Chester, PA 19380

© 2007 Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 1/10 J7770-E

Shipping Information

*Denotes required fields

Contact: Patient Specific Implants Help Desk at (610) 719-6777, or by e-mail at [email protected]

This Patient Specific Implant will be supplied with the understanding that the surgeon will make the sole determination for its use and application.

Surgeon name*

Hospital contact/Title to receive implant*

Mailing address*

City State Zip code

Office number* Office fax*

E-mail address*

Secondary contact name

Secondary number Secondary e-mail

Approximate defect location and shape (please draw/annotate defect)

Billing Information

Hospital name*

Purchasing contact

Purchasing office number E-mail

Synthes account #* Account on credit hold?*

Implant Information

Synthes suggests that surgery not be scheduled until Synthes receives the PO and the surgeon completes design validation.

Patient name*

Planned surgery date Patient ID number* Scan date*

Implant material (choose one):* � PEEK � Titanium

Design validation method (choose one):* � Skull model � CAD images via e-mail

Description of defect*

Surgeon and Shipping Information:Patient Specific Implants and skull models must be shipped directly to surgeon; no P.O. boxes. Please indicateexact name and location for model andimplant to be shipped.

3Synthes designs the implant and provides a quote to the customer.

The computer images and/or skull model will be sent to the surgeon for review and approval.

Note: If the CT data cannot be reconstructed into a 3-D format, Synthes will request a modified scan. If the defectis not clearly defined, Synthes will contact the surgeon toverify the margins of the defect. In both instances, additionaltime will be needed.

Most defects have borders which are clearly defined on theCT scan, and a quotation can be prepared upon receipt ofthe scan and the RFQ form.

Partially resorbed bone within the defect area (highlightedred), removal of existing implants, unclear defects and resections are some situations which will require consultationwith the surgeon to define the implant configuration beforethe quotation process can begin.

Synthes CMF

Ordering Process continued

4Review and approval of the design can be done in one of two ways:1. A skull model and an implant model are shipped to the surgeon, or

2. Computer images of the defect, the implant and the implant fitted into the defect are sent electronically to the surgeon.

5Surgeon approves the design.

Prompt approval of the design is required for the implant to be manufactured in a timely fashion. If changes are required at this stage, the model will be modified, reviewedand ap proved by the surgeon again. This will delay the startof implant manufacture.

6When the purchase order and design approval are received,Synthes starts manu facturing the implant. After manufac-turing, one nonsterile implant will be shipped overnight tothe surgeon.


1 2

Ordering Process Overview

Synthes CMF

No

Start

3 Business Days

Depends

on customer

follow-up

4 Business Days

Overnight shipment to customer

No

Yes

No

Feedback to the customer

No order will be placed

Receipt ofRFQ, CT Scan*

by PSI Department

Initial design of the implant

Quote and implantdesign to the customer

Finalize the design for manufacturing

Manufacturing

Re-design ofthe implant

Verificationof the request

Design approved

Receipt of purchase

order

Yes

Yes

+ 2 days

*Following Synthes CT Scanning Protocol

Synthes CMF1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185 www.synthes.com

© 2004 Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 1/10 J5245-F

ps i— patient specific implants. derived from ct data for...

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