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Intraoperative catheter based and image guided nuclide and electronic radiation therapy

Goal: The title says it all!

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Axel Boese
added a research item
PurposeSurgery, chemo- and/or external radiation therapy are the standard therapy options for the treatment of laryngeal cancer. Trans-oral access for the surgery reduces traumata and hospitalization time. A new trend in treatment is organ-preserving surgery. To avoid regrowth of cancer, this type of surgery can be combined with radiation therapy. Since external radiation includes healthy tissue surrounding the cancerous zone, a local and direct intraoral radiation delivery would be beneficial.MethodsA general concept for a trans-oral radiation system was designed, based on clinical need identification with a medical user. A miniaturized X-ray tube was used as the radiation source for the intraoperative radiation delivery. To reduce dose distribution on healthy areas, the X-ray source was collimated by a newly designed adjustable shielding system as part of the housing. For direct optical visualization of the radiation zone, a miniature flexible endoscope was integrated into the system. The endoscopic light cone and the field of view were aligned with the zone of the collimated radiation. The intraoperative radiation system was mounted on a semi-automatic medical holder that was combined with a frontal actuator for rotational and translational movement using piezoelectric motors to provide precise placement.ResultsThe entire technical set-up was tested in a simulated environment. The shielding of the X-ray source was verified by performing conventional detector-based dose measurements. The delivered dose was estimated by an ionization chamber. The adjustment of the radiation zone was performed by a manual controlling mechanism integrated into the hand piece of the device. An endoscopic fibre was also added to offer visualization and illumination of the radiation zone. The combination of the radiation system with the semi-automatic holder and actuator offered precise and stable positioning of the device in range of micrometres and will allow for future combination with a radiation planning system.ConclusionsThe presented system was designed for radiation therapy of the oral cavity and the larynx. This first set-up tried to cover all clinical aspects that are necessary for a later use in surgery. The miniaturized X-ray tube offers the size and the power for intraoperative radiation therapy. The adjustable shielding system in combination with the holder and actuator provides a precise placement. The visualization of radiation zone allows a targeting and observation of the radiation zone.
Michael Friebe
added a research item
Recent advances in endoscopy have led to new technologies with significant optical imaging improvements. Since its development a few years ago, narrow-band imaging (NBI) has already been proved useful
Michael Friebe
added 2 research items
Dargestellt und beschrieben ist ein Stent (1) zum Einführen in menschliche Körperhöhlen, insbesondere in Blutgefäße, mit einem proximalen Einführanfang (2) und einem distalen Einführende (3) mit einem hülsenförmigen Stentkörper (4) aus biokompatiblem Material und mit einem im Inneren des Stentkörpers (4) vorgesehenen Stützdraht (5) als Stützkörper, wobei der Stützdraht (5) im Aufspannzustand des Stents (1) innenseitig spiralförmig am Stentkörper (4) anliegt, wobei der Stentkörper (4) in einem komprimierten Zustand des Stents zusammengelegt ist und in einem Aufspannzustand expandierbar ist. Erfindungsgemäß ist vorgesehen, daß der Stützdraht (5) mit seinem proximalen Ende im Bereich des proximalen Einführanfangs (2) am Stentkörper (4) befestigt ist und mit seinem distalen Ende im komprimierten Zustand aus dem distalen Einführende (3) des Stentkörpers (4) herausgeführt ist, daß der Stützdraht (5) als formhaltender Federdraht ausgebildet ist, der im komprimierten Zustand zumindest im Bereich des Stentkörpers (4) vorgespannt ist und der bei Einfederung in die Spiralform eine Expansion des zusammengelegten Stentkörpers (4) bis in den Aufspannzustand bewirkt.
Michael Friebe
added 2 research items
Dargestellt und beschrieben ist eine Kathetereinrichtung (1) für perkutane Eingriffe, insbesondere für Injektionen, Biopsien oder dergleichen, mit einem Außenkatheter (2) und einem Werkzeug für den Eingriff, insbesondere einer Injektionsnadel (3), einer Biopsiezange, Elektroden oder dergleichen, am proximalen Ende (4) der Kathetereinrichtung, wobei das Werkzeug in einem Zuführzustand im Außenkatheter (2) aufgenommen und die Werkzeugspitze des Werkzeugs in dem Zuführzustand im Außenkatheter (2) versenkt oder mit dem proximalen Ende des Außenkatheters (2) ausgefluchtet ist, wobei das Werkzeug relativ zum Außenkatheter (2) derart bewegbar ist, daß zumindest die Werkzeugspitze in einem Eingriffszustand über das proximale Ende des Außenkatheters (2) übersteht, wobei ein Anschlag (5) zur Eingriffstiefenbegrenzung des Werkzeugs beim Eingriff vorgesehen ist, wobei der Anschlag (5) eine Mehrzahl von im Zuführzustand innerhalb des Außenkatheters (2) angeordneten Federschenkeln (6) als Anschlagmittel aufweist, wobei die Federschenkel (6) beim Ausfahren des Werkzeugs ausfedern und sich nach außen hin öffnen, wobei die Federschenkel (6) im ausgefahrenen Eingriffszustand in radialer Richtung über den Außenkatheter (2) überstehen und wobei jeder Federschenkel (6) an seinem proximalen Ende wenigstens eine Anschlagfläche (7) zur Anlage gegen ein Körpergewebe im Eingriffszustand aufweist. Erfindungsgemäß ist vorgesehen, daß die Anschlagfläche (7) nach außen gewölbt ist.
Dargestellt und beschrieben ist eine Kathetereinrichtung (1) für perkutane Eingriffe, insbesondere für Injektionen, Biopsien oder dergleichen, mit einem Außenkatheter (2) und einem Werkzeug für den Eingriff, insbesondere einer Injektionsnadel (4), einer Biopsiezange, Elektroden oder dergleichen, am proximalen Ende der Kathetereinrichtung (1), wobei das Werkzeug in einem Zuführzustand im Außenkatheter (2) aufgenommen und die Werkzeugspitze des Werkzeugs in dem Zuführzustand im Außenkatheter (2) versenkt oder mit dem proximalen Ende (6) des Außenkatheters (2) ausgefluchtet ist, wobei das Werkzeug relativ zum Außenkatheter (2) derart bewegbar ist, dass zumindest die Werkzeugspitze in einem Eingriffszustand über das proximale Ende (6) des Außenkatheters (2) übersteht und wobei ein Begrenzungselement (7) zur Eingriffstiefenbegrenzung des Werkzeugs beim Eingriff vorgesehen ist. Erfindungsgemäß ist vorgesehen, dass das Begrenzungselement (7) im Zuführzustand eine nicht-expandierte Grundform aufweist und dass das Begrenzungselement (7) durch Stauchen von der Grundform in eine expandierte Begrenzungsform im Eingriffszustand überführbar ist, wobei beim Stauchen eine relative Längenänderung des Begrenzungselementes (7) bewirkt wird und wobei das Begrenzungselement (7) beim Stauchen in radialer Richtung nach außen hin und/oder in proximaler Richtung expandiert und wenigstens eine in radialer und/oder proximaler Richtung über den Außenkatheter (2) überstehende Begrenzungsfläche (9) ...
Michael Friebe
added a research item
Radiotherapy is applied to tumors and surrounding tissue to destroy affected cells within a designated area. Usually the therapeutic ionizing radiation is delivered by external beam radiation (EBRT) or brachytherapy. External beam radiation damages healthy tissue, while brachytherapy is sometimes difficult to apply to deeper seated tumors. Low-energy, low-weight miniaturized X-ray tubes could be used in a portable setup to deliver therapeutic radiation minimally invasive to deeper seated tumors using a suited applicator. The applicator is designed as a conical lead shield with 2mm wall thickness to minimize radiation exposure of the sources environment and fits to the shape of the radiation exit window of the source. A collimation whole with 5mm diameter at the tip of the lead cone is used to attach a hollow, cylindrical stainless steel needle with 5mm outer and 4mm inner diameter, filled with air. The needle is inserted into the patient’s body and navigated to the tumor via image guidance and placed according to the treatment plan. The maximum volume of the treated tumor is approximately 250mm³ with mentioned needle dimensions. The needle diameter can be changed to adjust the treatment volume. The dose rate can also be adjusted through the acceleration voltage and beam current setting of the source (40-60kV and 50-200µA). Dose rates measured at 10cm distance in air from the source head range from 104-450mGy per minute. This translates to radiation doses of up to 13.5Gy in 30 minutes to the tumor surface. Tumors too close to critical radiation sensitive structures or greater than 8mm diameter should not be considered. Since the energy of the X-ray radiation source is relatively low the shielding effort in the treatment room is almost negligible. Such a system could be a low-budget option for an ambulatory setup for radiotherapy and could potentially be applied intraoperatively.
Michael Friebe
added a research item
Purpose: Surgery, chemo- and/or external radiation therapy are the standard therapy options for the treatment of laryngeal cancer. Trans-oral access for the surgery reduces traumata and hospitalization time. A new trend in treatment is organ-preserving surgery. To avoid regrowth of cancer, this type of surgery can be combined with radiation therapy. Since external radiation includes healthy tissue surrounding the cancerous zone, a local and direct intraoral radiation delivery would be beneficial. Methods: A general concept for a trans-oral radiation system was designed, based on clinical need identification with a medical user. A miniaturized X-ray tube was used as the radiation source for the intraoperative radiation delivery. To reduce dose distribution on healthy areas, the X-ray source was collimated by a newly designed adjustable shielding system as part of the housing. For direct optical visualization of the radiation zone, a miniature flexible endoscope was integrated into the system. The endoscopic light cone and the field of view were aligned with the zone of the collimated radiation. The intraoperative radiation system was mounted on a semi-automatic medical holder that was combined with a frontal actuator for rotational and translational movement using piezoelectric motors to provide precise placement. Results: The entire technical set-up was tested in a simulated environment. The shielding of the X-ray source was verified by performing conventional detector-based dose measurements. The delivered dose was estimated by an ionization chamber. The adjustment of the radiation zone was performed by a manual controlling mechanism integrated into the hand piece of the device. An endoscopic fibre was also added to offer visualization and illumination of the radiation zone. The combination of the radiation system with the semi-automatic holder and actuator offered precise and stable positioning of the device in range of micrometres and will allow for future combination with a radiation planning system. Conclusions: The presented system was designed for radiation therapy of the oral cavity and the larynx. This first set-up tried to cover all clinical aspects that are necessary for a later use in surgery. The miniaturized X-ray tube offers the size and the power for intraoperative radiation therapy. The adjustable shielding system in combination with the holder and actuator provides a precise placement. The visualization of radiation zone allows a targeting and observation of the radiation zone.
Michael Friebe
added 2 research items
Intraoperative radiation therapy (Low Dose and High Dose nuclear and electronic brachytherapy) is a potential therapy option for local tumours, and oligometastatic cancer treatment. The main benefits are that it can deliver the cell-killing radiation (beta or gamma rays) through small incisions - after surgical treatment or removal - and that it spares healthy tissue of radiation exposure. Radiation protection issues, and accurate dose measurement and quality assurance are the main issues to be resolved. Imaging for placement and therapy verification are essential tools allowing the therapist to accurately determine the tumour location, to place the therapy catheter, and subsequently to quantify and measure the dose delivered and maybe even get a confirmation on the cell killing effects. The talk will give a short overview of some of the current technologies used (Re-188, Y-90, Ir-192, miniature X-ray tubes) and the shortfalls and possible solutions of these therapy approaches particularly when combined with functional (SPECT) and anatomical imaging (US) hybrids and combinations with MRI imaging.
Innovative university based medical technology product development is largely dependent on the availability of external research funding from industry or public / private non-profit institutions. Research by definition is highly speculative and comes with a great risk of failure, which makes it largely unattractive for industry. Government and other non-profit funding agencies require that uncertainty and the reviewers of the programs also like to see a high-tech component and a great amount of scientific complexity. So, there is a clear focus on expensive complexity in current research funding. Especially in the medical technology segment there is a need for innovative tools and devices however, that also enable new minimal invasive radiation therapy therapies. Medical doctors as the users of that technology do appreciate easy to use devices with a low error margin as the final use of the product is on a sensitive living patient. Additionally, the healthcare system has yearly decreasing funds available, developing countries cannot afford the systems made for the developed world, and complexity also requires dedicated support and application staff. The talk will highlight some of the attributes and value propositions that to be developed medical technology devices should have. These may not always be considered scientifically 'cool' from a funding perspective, but that are faster applicable, and more widely useable than the complex and expensive high-tech devices that are often proposed. These features could open new market segments and increase the speed acceptance of new therapies.
Michael Friebe
added a project reference
Michael Friebe
added an update
Michael Friebe
added a project goal
The title says it all!