Compendium of Health Telematics Projects 94-98 (Draft)
Home Documents Compendium HT Projects 94-98 Updated: Aug 26, 1998 

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EASI

European applications in surgical interventions

Project code: HC 1012
Project value: 2985.0 KECU
EC contribution: 1800.0 KECU
Number of partners: 6
Number of countries: 4
Duration:36 months
Starting date: Jan 1, 96
              
Contact: Frans A. Gerritsen
Philips Medical Systems Nederland B.V.
Easy Vision / EasyGuide Advanced Development
P.O. Box 10.000
5680 DA Best
The Netherlands

Tel: +31-40-27.62.381
Fax: +31-40-27.63.816
E-mail: frans.gerritsen@best.ms.philips.com
Web Site: www2.echo.lu/telematics/health/easi.html

Overview

The EASI project uses health telematics to increase the resources available to the inter-disciplinary tasks of Image-Guided Therapy. Advanced methods for multi-modality image segmentation, registration and visualisation for pre-operative surgical planning and intra-operative surgical support are developed. By combining pre-operative image data and intra-operative localisation, the project helps to improve effectiveness and quality of clinical interventions while reducing patient risks and overall cost of treatment. This is applied for two clinical application areas: neurosurgery and vascular surgery.

The EASI-demonstrators help surgeons to locate anatomical structures on the basis of patient images acquired before and/or during surgery. This guidance facilitates minimally-invasive surgery, and potentially improves accuracy and speed, and reduces risks.

Guidance occurs through an optical localiser which measures the position of surgical tools. Once the patient and the pre-operative images have been correlated, the surgical tools can be overlaid on patient images in real-time, showing the surgeon the position and orientation of the tools in relation to the patient's anatomy and pathology.

Purpose and objectives

The EASI (European Applications in Surgical Interventions) project uses health telematics to increase the resources available to the interdisciplinary tasks of Image-Guided Therapy, involving surgery, radiology, interventional radiology, and imaging science professionals in the hospital. Based on available results (from the 3rd Framework’s AIM-projects COVIRA and CAMI), advanced methods for multi-modality image segmentation, registration and visualisation in the context of pre-operative surgical planning will be extended and validated towards image-guided surgery. Two representative application areas are addressed: Neurosurgery, where the initial life cycle phases have already been covered and many image-processing methods are at hand from COVIRA, and the challenging area of Vascular Surgery for treatment of abdominal aorta aneurysms (inserting a vessel prosthesis to avoid rupturing), where there is intra-operative organ motion with respect to the situation reflected in the pre-operatively acquired 3D images.

The following simplified usage scenario applies. The lesion is visualised in 3 dimensions (3D) in its spatial relationship to its anatomical environment (nerves, vessels, organs). A thorough and efficient pre-operative surgical plan is made (based on pre-operative 3D MR, CT and DSA images), transferred to the operating room and onto the patient via registration tools. During surgery, this plan needs to be checked and, if necessary, updated using intra-operative information. This is done by using localiser/motion tracking principles and extending them to include real-time imaging for position verification and/or updating of the plan. Updates of the surgical plan are especially relevant to reduce patient risks and to improve the quality of the intervention when changes have occurred compared to the pre-operative situation, either because of re-oriented anatomy, or as a result of surgery itself.

The project will thus help to improve effectiveness and quality of clinical interventions while reducing patient risks and overall cost of treatment. This goal is reached via added- value services and systems with tools which enhance the capabilities of the relevant clinical healthcare professionals (task HC 2.3). Telematics services are developed and integrated to provide health professionals with an optimal working environment (task HC 2.1) to bridge the gap between radiological diagnosis and new approaches to therapy. At the same time, the project develops and validates advanced techniques to combine 3D imaging technologies, virtual environments and advanced intra-operative navigation tools in therapy planning, quality improvement and minimally invasive surgery (task HC 2.8).

User Needs to be Addressed — Neurosurgery

The EASI project develops, validates and demonstrates the use of image guidance with both open and frameless stereotactic procedures. New ways of doing this are also evaluated.
Open intra-cranial neurosurgical approaches conventionally suffer from limited accuracy of localisation and navigation but are more patient-friendly prior to the operation. Stereotactic frame based procedures are accurate but logistically awkward. They require calculation time from the surgeon, and are patient-unfriendly during pre-operative imaging. Also, no real-time feedback is given during introduction of instruments. Present navigation systems allow for better planning and guidance in open neuro-surgery, but are hampered by intra-operative changes to the brain, and lack the accuracy and mechanical guidance of a stereo-tactic frame.

User Needs to be Addressed — Vascular surgery

An abdominal aorta aneurysm (AAA) is a life threatening dilation of the main artery, occurring mainly in men at older age. Elective or emergency surgery nowadays implies a completely open approach which is not without risk. Recently a minimal invasive approach “Transfemoral Endovascular Aneurysm Management” (TEAM) was designed as an alternative to open surgery. Because of the minimally invasive approach, X-ray imaging is required to guide the procedure. This implies that the surgeon has lost perception of the third dimension, as well as his touch and feel during surgery.

The EASI project develops, validates and demonstrates a safe and effective TEAM procedure using pre-operative and intra-operative image guidance. Pre-operative simulation of both graft and surgery will help to predict surgery outcome and contribute to education of trainees in this new technique. The following user needs are addressed: extensive pre-operative (3D) imaging to define the surgical plan, simulation of procedure to see whether the procedure will be successful, intra-operative execution of the plan with intra-operative 2D X-ray imaging, and a possible didactic application.

Results

Demonstrator software promoted into product software.
  • The demonstrator’s software implementation has been taken as a starting point for actual productization (outside of EASI funding) by EasyGuide™/EasyVision engineering groups in future releases of products from Philips Medical Systems. By cooperation of the technical parties involved (consolidating their results in the common software platform resembling the product), a flying start has been made for further exploitation.

    Better understanding of the clinical requirements.

  • The application-specific Clinical Requirements Specifications detail which clinical functionality is essentially needed, for which reasons, for which application scenarios.
  • A living version of the Clinical Requirements, in the form of a working demonstrator. Example implementations such as provided by the demonstrator, are easier to understand (and to comment upon, and to draw conclusions from), than the actual specification.
  • A better understanding of the relative priorities of the clinical requirements which have been implemented. In general, the prioritization of required items after verification/ validation differs (in important details) from the initially indicated prioritization.

    Better understanding of technical feasibility and the work remaining to be done.

  • By implementing the demonstrator and successively refining it in the course of the verification and validation phases, a better understanding has been reached of the technical feasibility of what is clinically required, and of the problems which remain to be solved (i) on the road to productization, and (ii) in future versions of the product – as well as an estimate of the capacities/cost associated with further productization.

    Better understanding of the commercial possibilities.

  • By exposing the demonstrators to a large clinical audience (user group), and by assessing the level of interest expressed by the user group, a better understanding has been achieved of the commercial potential of the application field and of the specific functionality which was developed and validated in the course of the project.

    List of deliverables

      Title Month of delivery Level of Dissemination
    1 EasyScil software development platform to Technical Parties C1, A1, C2, C3, A4 2 Project
    2 Initial Demonstrator Platform to Clinical Users 6 Project
    3 Clinical Assessment of Initial Demonstrator Platform 6 Project
    4 Groundrules for Clinical Evaluation Procedure 6 Project
    5 User Analysis & Initial Version of Clinical Specs 6 Limited
    6 Initial Version of Clinical Evaluation Procedure Specifications 9 Project
    7 Update of Initial Demonstrator Platform 10 Project
    8 Peer review report based on D5, D6, D7 10 Limited
    9 Initial Version of Functional Specs 14 Project
    10 Revised Version of Clinical Evaluation Procedure Specifications 13 Project
    11 Demonstrator 0.1 to Clinical Users 12 Project
    12 Final Version of Clinical Specifications 19 Limited
    13 Initial Version of Clinical Evaluation 19 Project
    14 Initial Version of Technical Specifications 19 Project
    15 Demonstrator 0.5 to Clinical Users 19 Project
    16 Peer review report based on D10, D12, D14 21 Limited
    17 Final Version of Functional Specifications 24 Project
    18 2nd Version of Clinical Evaluation 24 Project
    19 Final Version of Clinical Evaluation Procedure Specifications 24 Public
    20 Demonstrator 1.0 to Clinical Users 24 Project
    21 Final Version of Technical Specifications 30 Project
    22 Demonstrator 1.5 to Clinical Users 30 Project
    23 Peer review report based on D17, D18, D21 32 Limited
    24 Final Version of Clinical Evaluation 36 Limited
    25 Demonstrator 1.9 to Clinical Users 36 Project
    26 Final Confidential Report 36 Limited
    27 Final Public Report 36 Public

    List of participants

    Name: Dr. Ir. Frans A. Gerritsen
    Organisation: EasyGuide Advanced Development
    Address: Philips Medical Systems Nederland B.V.
    Building QP-1105
    P.O. Box 10.000
    NL-5680 DA Best
    Country: The Netherlands
    Tel: +31-40-27.62.381
    Fax: +31-40-27.63.816
    E-mail: frans.gerritsen@best.ms.philips.com

    Name: Prof. Dr. Ir. Paul Suetens
    Organisation: Katholieke Universiteit Leuven
    Address: Laboratory for Medical Imaging Research Radiology
    ESAT Kardinaal Mercierlaan 94
    B-3001 Heverlee
    Country: Belgium
    Tel: +32-16-32.10.66 / +32-16-34.37.46
    Fax: +32-16-32.19.86
    E-mail: paul.suetens@esat.kuleuven.ac.be

    Name: Prof. Dr. D.G.T. Thomas
    Organisation: The National Hospital
    Address: Gough-Cooper Dept. of Neurol. Surgery Institute of Neurology Queen Square WC1N 3BG London
    Country: United Kingdom
    Tel: +44-171-829.8755
    Fax: +44-171-278.7894
    E-mail: j.wadley@ion.ucl.ac.uk

    Name: Dr. Michael H. Kuhn
    Organisation: Technical Systems Hamburg
    Address: Philips Forschungslabor Hamburg P.O. Box 63 05 65 Röntgenstraße 24-26 D-22315 Hamburg
    Country: Germany
    Tel: +49-40-5078.2030
    Fax: +49-40-5078.1977
    E-mail: m.kuhn@pfh.research.philips.com

    Name: Prof. Dr. Bert C. Eikelboom
    Organisation: Utrecht University & University Hospital
    Address: Image Sciences Institute (room E 01.334) Academisch Ziekenhuis Utrecht Heidelberglaan 100 NL - 3584 CX Utrecht
    Country: The Netherlands
    Tel: +31-30-250.69.65
    Fax: +31-30-254.19.44
    E-mail: b.c.eikelboom@chir.azu.nl

    Name: Dr. David J. Hawkes
    Organisation: Guy's Hospital
    Address: Computational Imaging Science Group UMDS Division of Radiology Sciences London Bridge SE1 9RT London
    Country: United Kingdom
    Tel: +44-171-955.2492 (secr. 4531)
    Fax: +44-171-955.4532
    E-mail: d.hawkes@umds.ac.uk

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