Testing and/or setting device for a photodynamic diagnosis...

Surgery – Endoscope – Having imaging and illumination means

Reexamination Certificate

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C434S267000, C073S865900, C600S160000

Reexamination Certificate

active

06361490

ABSTRACT:

DESCRIPTION
1. Field of the Invention
The present invention relates to a device for testing and/or adjusting a PDD or PDT system and/or for training on such a system.
2. Prior Art
Systems for photodynamic diagnosis (PDD) and/or photodynamic therapy (PDT) are employed in medicine in many ways and forms. Just by way of example ophthalmologic, endoscopic or neuro-surgical applications should be mentioned here.
The photodynamic diagnosis and therapy serves, for instance, to detect or treat malignant and also benign degenerations. To this end, photosensitising substances are administered which collect specifically in the tissue to be analysed and which fluoresce in response to illumination with stimulating light (photodynamic diagnosis) or, respectively, produce a photo-toxic effect when the photosensitising substance is administered in high doses and a high intensity of illumination is provided, which effect destroys the degenerated tissue (photodynamic therapy). Endogenous fluorescent substance can also be used for photodynamic diagnosis. Then so-called auto-fluoresceins are involved.
The range of wavelength of the stimulating light includes shorter wavelengths than the range in which fluorescent light occurs.
In the known PDD or PDT systems the problem is involved that the fluorescence, which characterises the tissue and which is induced by the administered photosensitising substance and by the application of stimulating light, can be detected only “in vivo”. This means that presently the known PDD or PDT systems can be completely tested or verified in their entirety only under “in vivo” conditions.
Moreover, at present training or education on PDD or PDT systems can be provided only “in vivo” as well. This involves the inevitable acceptance of either a comparatively high burden on the patients part or insufficient training with the consequence that malignant tissue or carcinomas, respectively, are possibly not detected.
The present invention is therefore based on the problem of providing a device which is suitable for “ex vivo” testing of PDD or PDT systems and/or training on such systems.
An inventive solution to this problem is defined in Patent claim
1
. Improvements of the invention are the subject matters of claims
2
et seq.
BRIEF DESCRIPTION OF THE INVENTION
In accordance with the invention a device is provided for testing and/or adjusting a PDD or PDT system and/or for training on such a system, which comprises a target reflecting the light from the illuminating system of the PDD or PDT system, and at least one light source emitting the light within the wavelength range of the fluorescent spectrum of the respective photosensitising substance.
The inventive device hence allows for both testing of the illuminating system and the imaging unit of the PDD or PDT system. It is possible, in particular, that the manufacturer of such a system checks such a system for functional integrity, inclusive of fluorescence detection, prior to delivery of the system to a customer. The system can also be employed to adjust the individual components and specifically to check the adjustment of a possibly envisaged filter system.
Above all, however, the inventive device permits the training of physicians for the application of such systems, enabling the doctors to convince themselves of the unobjectionable condition of the used PDD system in the event of a negative result.
Within the general framework of the basic inventive idea, the most different embodiments are conceivable:
It is possible, for instance, that the target includes several light sources so that the light emitted within the wavelength range of the fluorescent spectrum of the respective photosensitising substance comes from a “larger area”. Specifically in an approach to offer certain patterns to the trainee on such a PDD or PDT system for recognition, it is possible to control the light sources selectively in such a manner that they emit light in the form of definable patterns. Additionally or alternatively the size of the light-emitting area of the light sources may be varied.
Furthermore, the light sources may present emission surfaces of different sizes, which may be used, inter alia, to detect an extension of fluorescent areas which is just still detectable by the examining person. Hence the limits of resolution can be determined.
For adjustment of the system it is moreover preferable that the target includes at least one sensor which detects the intensity of the illuminating light and produces an output signal which is applied to a controller which controls the intensity of the light emitted by the light source or sources. In order to convey to the trainee on such a PDD or PDT system an “idea” of the mode of operation of such a system it is moreover expedient that the at least one sensor detects the intensity of the illuminating light only within that wavelength range by which the respectively employed photosensitiser is stimulated. It is furthermore possible that the controller controls the light source(s) of the target in such a way that these light sources emit light at a reduced brightness, as the time increases, thus simulating the decay of the efficiency of the fluorescent marker.
In a number of PDD or PDT systems the illuminating unit emits not only light within the wave range by which the photosensitiser is stimulated but also in other wavelength ranges so that the irradiated tissue may be additionally illuminated. In an alternative, a further light source or additional light sources may be provided which emit illuminating light in addition to the stimulating light. In such PDD or PDT systems it is preferable that a filter system is provided which blocks the stimulating light which is directly reflected on the tissue zone or the target, so that it is easier for the examining person to detect the fluorescent radiation against the “background” of the irradiated light.
This filter system may be configured, in particular, in correspondence with a design proposed by Karl Storz GmbH & Co. in such a way that the filter system matches the degree of net transmittance of the illuminating system with the fluorescent spectrum of stimulation of the respective photosensitiser and the degree of net transmittance of the imaging unit with the fluorescent spectrum of the respective photosensitiser in such a way that the two degrees of net transmittance will noticeably overlap only within a comparatively narrow wavelength range. This small wavelength range may be selected in particular in such a manner that the light reflected therein will furnish a sufficient “background illumination” for the fluorescent light so that the examining person will be able to “recognise” the illuminated tissue area independently of the fluorescent light.
The visual detectability of the fluorescent radiation can be further enhanced by the provision that the intensity and/or extension of the wavelength range of the light serving merely for illumination may be adjusted. This adjustment can be performed, for instance, by the measure that a light source is used which can be tuned in terms of wavelengths or that a tunable filter system is disposed ahead of the light source with a fixed emission spectrum.
The transmission graph of this filter system may be adjustable like the transmission graph of the filter system of the imaging unit
The use of filters in the imaging unit may furthermore be utilised in the following manner:
Particularly in cases where light of a further wavelength range is coupled in additionally to the stimulating light, which serves for background illumination for the range from which fluorescent light is emitted, a differentiation by colour with higher contrast can be obtained by an appropriate selection of the filters or by adjustment of the filter wavelengths.
The inventive device can hence also be employed for detecting the optical colour differentiation between the fluorescent effect and the background light. Moreover, users of a PDD system can utilise the inventive device for the purpose to adjust the system to that respective colou

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