DE102012205193A1 - Method for testing of medical devices and processes using test object, involves examining simulation of treated structure by stereolithographic printing process, exposing simulation to medical device, and applying proposed treatment process - Google Patents
Method for testing of medical devices and processes using test object, involves examining simulation of treated structure by stereolithographic printing process, exposing simulation to medical device, and applying proposed treatment process Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
- A61B6/58—Testing, adjusting or calibrating thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
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- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B1/00—Comparing elements, i.e. elements for effecting comparison directly or indirectly between a desired value and existing or anticipated values
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0033—Features or image-related aspects of imaging apparatus, e.g. for MRI, optical tomography or impedance tomography apparatus; Arrangements of imaging apparatus in a room
- A61B5/0037—Performing a preliminary scan, e.g. a prescan for identifying a region of interest
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
- A61B5/055—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
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- G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
- G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
- G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
- G09B23/286—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine for scanning or photography techniques, e.g. X-rays, ultrasonics
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- G—PHYSICS
- G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
- G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
- G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
- G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
- G09B23/30—Anatomical models
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Abstract
Description
Die Erfindung betrifft ein Verfahren zum Test von medizinischen Geräten und Methoden mit Hilfe eines Testobjekts. The invention relates to a method for testing medical devices and methods with the aid of a test object.
Alle Systeme und Einrichtungen haben ein gewisses Fehlerrisiko. Das Risiko steigt mit der Größe und Komplexität eines Systems, insbesondere mit der Größe und Komplexität von Software, die in Steuerungssystemen und -einrichtungen Verwendung finden. All systems and equipment have a certain risk of error. The risk increases with the size and complexity of a system, especially with the size and complexity of software used in control systems and devices.
Es existieren bspw. bereits einige Ansätze zur Verbesserung der Sicherheit von Softwareintensiven Systemen, wie bspw. Formale Verifikation, Statische Analyse, Dynamische Analyse und Manual Review. Solche Systeme durchlaufen sowieso immer eine Reihe von Tests bevor sie zu Produkten werden, es gibt aber auch internationale Standards und Normen für sicherheitskritische Software und Systeme die einzuhalten sind. Durch das Testen wird das Vertrauen in die Funktionalität und die Sicherheit des Produkts erhöht. For example, there are already some approaches to improving the security of software intensive systems, such as. Formal Verification, Static Analysis, Dynamic Analysis and Manual Review. Such systems always undergo a series of tests before they become products, but there are also international standards and standards for safety-critical software and systems to be adhered to. Testing increases confidence in the functionality and safety of the product.
Bei medizinischen Systemen ist die Patientensicherheit immer von höchstem Belang – dies gebietet allein schon der vor mindestens 1500 Jahren formulierte Eid des Hypokrates. Deshalb müssen diese Systeme und Behandlungsmethoden besonders gut und ausgiebig getestet werden, bevor sie beim Patienten zum Einsatz kommen. In medical systems, patient safety is always of the utmost importance - this is dictated by the oath of Hypocrates formulated at least 1500 years ago. Therefore, these systems and methods of treatment must be particularly well and extensively tested before they are used on the patient.
Die der Erfindung zu Grunde liegende Aufgabe besteht nun darin, ein Verfahren zum Test von medizinischen Geräten und Methoden anzugeben, bei dem die Qualität, die Quantität und die Genauigkeit der Testfälle und damit die Sicherheit der Patienten bei gleichen Kosten erhöht wird. The object underlying the invention is now to specify a method for testing medical devices and methods in which the quality, the quantity and the accuracy of the test cases and thus the safety of the patients is increased at the same cost.
Diese Aufgabe wird durch die Merkmale des Patentanspruchs 1 erfindungsgemäß gelöst. Die weiteren Ansprüche betreffen bevorzugte Ausgestaltungen der Erfindung. This object is achieved by the features of claim 1 according to the invention. The further claims relate to preferred embodiments of the invention.
Die Erfindung betrifft im Wesentlichen Verfahren zum Test von medizinischen Geräten und Behandlungsmethoden, wie bspw. CT oder MRT, bei dem zunächst eine Nachbildung einer betreffenden zu untersuchenden/behandelnden Struktur durch ein stereolithographisches Druckverfahren mit variabler Dichte erzeugt wird, wobei die Nachbildung hinsichtlich mindestens einer Eigenschaft ein möglichst genaues Abbild der zu untersuchenden Struktur darstellt, und bei dem diese Nachbildung dann dem medizinischen Gerät bzw. der geplanten Behandlungsmethode ausgesetzt und anschließend zur Analyse herangezogen wird. Diese Erfindung erhöht die Patientensicherheit durch Erhöhung der Qualität, der Quantität und der Genauigkeit von Testfällen während der Entwicklung von Strahlungsgeräten aber auch später durch realitätsnahe Vorabüberprüfung einer geplanten konkreten Behandlung mit diesen Geräten. The invention relates generally to methods of testing medical devices and treatment methods, such as CT or MRI, in which a replica of a subject structure to be examined / processed is first produced by a variable density stereolithographic printing process, the replica being at least one property represents as accurate as possible an image of the structure to be examined, and in which this replica is then exposed to the medical device or the planned treatment method and then used for analysis. This invention enhances patient safety by increasing the quality, quantity, and accuracy of test cases during the development of radiation devices, but also later by providing close-to-reality pre-examination of a planned, concrete treatment with these devices.
Nachfolgend wird die Erfindung anhand eines in der Zeichnung dargestellten Ausführungsbeispiels näher erläutert. Hierbei ist eine Nachbildung T einer betreffenden zu untersuchenden/behandelnde Struktur eines Patienten gezeigt, die durch ein stereolithographisches Druckverfahren mit variabler Dichte erzeugt wurde und gerade einer geplanten medizinischen Behandlungsmethode R anstelle dieses Patienten ausgesetzt wird. Darüber hinaus ist exemplarisch eine oberste Schicht L der Nachbildung T dargestellt, die aus einzelnen Punktbereichen einer Druck/Aufbausubstanz P gebildet wird, die mindestens eine Eigenschaft des betreffenden menschlichen Gewebes nachbildet. The invention will be explained in more detail with reference to an embodiment shown in the drawing. Here, a replica T of a subject to be examined / treated structure of a patient is shown, which was generated by a stereolithographic printing method with variable density and is currently being exposed to a planned medical treatment method R instead of this patient. In addition, an uppermost layer L of the replica T is shown by way of example, which is formed from individual dot areas of a printing / building substance P which simulates at least one property of the relevant human tissue.
Während der Entwicklung von modernen medizinischen Geräten, wie computerassistierten Schichtenaufzeichnungsgeräten, bspw. Computertomographen, oder Teilchentherapiegeräten werden für das Testen eine Reihe von bestimmten Testobjekten mit ganz bestimmten möglichst exakt definierten Eigenschaften und räumlichen Verteilungen benötigt, um die Qualität und Sicherheit dieser Geräte zu gewährleisten. During the development of modern medical devices, such as computer-assisted slice recorders, such as computed tomography or particle therapy devices, testing requires a number of specific test objects with very specific and precisely defined properties and spatial distributions to ensure the quality and safety of these devices.
Darüber hinaus sollen bestimmte Methoden zur Diagnoseunterstützung oder Behandlungsmethoden vorab, möglichst ohne Belastung des Patienten, unter möglichst realistischen Bedingungen durchgeführt und überprüft werden. In addition, certain methods for diagnostic support or treatment methods should be carried out and checked in advance, if possible without burdening the patient, under the most realistic conditions possible.
Soll bspw. ein bestimmter Bereich eines Patienten analysiert oder behandelt werden, so wird zunächst eine exakte Nachbildung der betreffenden Strukturen erstellt. Diese Nachbildung wird dann der geplanten Methode ausgesetzt und dann anschließend zur Auswertung herangezogen. Auf diese Weise kann praktisch durch das jeweils anzuwendende Gerät selbst das Funktionieren der Untersuchung oder Behandlung vorab verifiziert werden, ohne dass der Patient hierzu tatsächlich selbst einer Strahlung ausgesetzt wird. If, for example, a particular area of a patient is to be analyzed or treated, an exact replica of the structures concerned is initially created. This replica is then exposed to the planned method and then used for evaluation. In this way, the functioning of the examination or treatment can in practice be verified in advance by the device to be used in each case, without the patient actually being exposed to radiation for this purpose.
Hierzu wird durch einen 3-dimensionalen bzw. stereolithographischen Druck mit variabler Dichte ein nahezu willkürliches Modell des gewünschten Untersuchungs/Behandlungsbereiches als Testobjekt erzeugt. For this purpose, a nearly arbitrary model of the desired examination / treatment area as a test object is generated by a 3-dimensional or stereolithographic pressure with variable density.
Aus MIT News
Die einzelnen Schichten eines 3D-Druckes werden typischerweise durch Klebesubstanzen zwischen den Schichten sowie durch chemische Reaktion oder durch thermisches Verschmelzen mit der jeweils darunterliegenden Schicht gebildet. The individual layers of a 3D print are typically formed by adhesive substances between the layers as well as by chemical reaction or by thermal fusion with the respectively underlying layer.
Bei der Erfindung soll die Dichte nicht auf die physikalische Dichte, also auf den Quotienten aus Masse durch Volumen, beschränkt, sondern auch die Durchlässigkeit von Licht oder Strahlung oder Partikel bzw. Elementarteilchen des betreffenden Materials darunter verstanden werden. Die unterschiedlichen Gewebe von lebenden Organismen haben z. B. eine unterschiedliche Dichte oder Transparenz bezüglich Strahlung. Um eine genaue Nachbildung zum Testen von Aufzeichnungs- oder Behandlungsgeräten zu schaffen, muss entsprechend der gewünschten Messung ein schichtenweiser Einbau von Bereichen mit unterschiedlichen Dichten bewirkt werden.In the invention, the density is not limited to the physical density, that is, the quotient of mass by volume, but also the permeability of light or radiation or particles or elementary particles of the material in question are understood. The different tissues of living organisms have z. B. a different density or transparency with respect to radiation. In order to provide an accurate replica for testing recording or treatment equipment, a layered incorporation of regions of different densities must be effected in accordance with the desired measurement.
Die unterschiedlichen Dichten können hierbei prinzipiell durch Verwendung unterschiedlicher Druck/Aufbausubstanzen und/oder unterschiedlicher Mischungsverhältnisse dieser unterschiedlichen Druck/Aufbausubstanzen und/oder durch unterschiedlich dichtes Aufbringen einer oder mehrer solcher Substanzen erzeugt werden.The different densities can in principle be generated by using different pressure / build-up substances and / or different mixing ratios of these different pressure / build-up substances and / or by different densely applying one or more of such substances.
Die Verwendung von photographischen, z.B. strahlungsempfindlichen, Emulsionen oder Bestandteilen in einem 3D-Drucker ermöglicht in den physikalischen Gewebenachbauten Strahlendosiswerte auf Molekülebene zu erfassen, zu messen, zu untersuchen und zu archivieren.The use of photographic, e.g. radiation-sensitive, emulsions or components in a 3D printer allows to record, measure, analyze and archive radiation dose values at the molecular level in physical tissue replicas.
Solche Objekte sind sehr wertvoll beim Testen der Treffgenauigkeit, der Präzision und der örtlichen Dosisverteilung. Sie stellen eine stabile Aufzeichnung für eine spätere Analyse und einen Beweis für korrekt durchgeführte Behandlungen sowie eine korrekte Systemfunktion dar.Such objects are very valuable in testing accuracy, precision and local dose distribution. They provide a stable record for later analysis and proof of correct treatments as well as correct system function.
Durch die Verwendung von strahlungsempfindlichen Bestandteilen in den Druck/Aufbausubstanzen der stereolithographischen Drucker werden Detektoren zur Aufzeichnung der Bahnen von energiereichen Teilchen gebildet.Through the use of radiation-sensitive constituents in the printing / building substances of the stereolithographic printers detectors for recording the orbits of high-energy particles are formed.
Durch die Verwendung von Bestandteilen in den Druck/Aufbausubstanzen der stereolithographischen Drucker mit gleichen Transparenz oder Dichte wie biologisches Gewebe werden sehr realitätsnahe 3D-Modelle zur Aufzeichnung der Bahnen von energiereichen Teilchen für die Teilchen-Therapie gebildet. By using constituents in the printing / building substances of stereolithographic printers with the same transparency or density as biological tissue, very realistic 3D models are formed for recording the orbits of energetic particles for particle therapy.
Durch die Verwendung von Bestandteilen in den Druck/Aufbausubstanzen der stereolithographischen Drucker, die das gleiche Emissionsverhalten wie biologisches Gewebe im starken Magnetfeld aufweisen, werden 3D-Modelle für die Entwicklung und den Test von Kernspintomographen gebildet. Through the use of constituents in the printing / building substances of the stereolithographic printers, which have the same emission behavior as biological tissue in the strong magnetic field, 3D models for the development and testing of magnetic resonance tomographs are formed.
Hierdurch sind genaue Nachbildungen für den Test von medizinischen Geräten durch automatisierte Herstellverfahren kostengünstig erzeugbar. As a result, accurate replicas for the test of medical devices by automated manufacturing processes can be produced inexpensively.
ZITATE ENTHALTEN IN DER BESCHREIBUNG QUOTES INCLUDE IN THE DESCRIPTION
Diese Liste der vom Anmelder aufgeführten Dokumente wurde automatisiert erzeugt und ist ausschließlich zur besseren Information des Lesers aufgenommen. Die Liste ist nicht Bestandteil der deutschen Patent- bzw. Gebrauchsmusteranmeldung. Das DPMA übernimmt keinerlei Haftung für etwaige Fehler oder Auslassungen.This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.
Zitierte Nicht-PatentliteraturCited non-patent literature
- http://web.mit.edu/newsoffice/2011/3d-printing-0914.html [0013] http://web.mit.edu/newsoffice/2011/3d-printing-0914.html [0013]
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| DE201210205193 DE102012205193A1 (en) | 2012-03-30 | 2012-03-30 | Method for testing of medical devices and processes using test object, involves examining simulation of treated structure by stereolithographic printing process, exposing simulation to medical device, and applying proposed treatment process |
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| DE201210205193 DE102012205193A1 (en) | 2012-03-30 | 2012-03-30 | Method for testing of medical devices and processes using test object, involves examining simulation of treated structure by stereolithographic printing process, exposing simulation to medical device, and applying proposed treatment process |
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| DE102012205193A1 true DE102012205193A1 (en) | 2013-10-02 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3135199A1 (en) * | 2015-08-13 | 2017-03-01 | Paul Jahnke | Model and system for use in an imaging technique |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030122544A1 (en) * | 1995-04-14 | 2003-07-03 | University Of Rochester | Thin film phantoms and phantom systems |
| US20060253761A1 (en) * | 2005-04-04 | 2006-11-09 | Christopher Sakezles | Method of making tissue simulating analog materials and models made from same |
| US20100021029A1 (en) * | 2008-02-22 | 2010-01-28 | Pearlstein Robert D | Systems and methods for characterizing spatial distortion in 3d imaging systems |
| US20100202001A1 (en) * | 2007-07-16 | 2010-08-12 | Miller Michael A | Anatomically realistic three dimensional phantoms for medical imaging |
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- 2012-03-30 DE DE201210205193 patent/DE102012205193A1/en not_active Ceased
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030122544A1 (en) * | 1995-04-14 | 2003-07-03 | University Of Rochester | Thin film phantoms and phantom systems |
| US20060253761A1 (en) * | 2005-04-04 | 2006-11-09 | Christopher Sakezles | Method of making tissue simulating analog materials and models made from same |
| US20100202001A1 (en) * | 2007-07-16 | 2010-08-12 | Miller Michael A | Anatomically realistic three dimensional phantoms for medical imaging |
| US20100021029A1 (en) * | 2008-02-22 | 2010-01-28 | Pearlstein Robert D | Systems and methods for characterizing spatial distortion in 3d imaging systems |
Non-Patent Citations (1)
| Title |
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| http://web.mit.edu/newsoffice/2011/3d-printing-0914.html |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3135199A1 (en) * | 2015-08-13 | 2017-03-01 | Paul Jahnke | Model and system for use in an imaging technique |
| US9924919B2 (en) | 2015-08-13 | 2018-03-27 | Paul Jahnke | Model and system for use in an imaging technique |
| US10182786B2 (en) | 2015-08-13 | 2019-01-22 | Paul Jahnke | Model and system for use in an imaging technique |
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