The present invention generally relates to a specimen receptacle system for an imaging apparatus for imaging ex-vivo tissue specimens.
In the field of ex-vivo tissue specimen analysis, an important issue is the evaluation of resection accuracy. After resecting for example tumorous tissues, the surgical margins of the resected tissues need to be assessed in order to be able to decide whether more tissue has to be resected or not since tumorous tissues need to be removed as completely as possible. Thereto, the resected tissues need to have a sufficient margin of tumour free tissues. Such an evaluation of resection accuracy may be done by a histopathologist. However, the presence or stand-by of a histopathologist during an operation may be relatively expensive and may be logistically relatively difficult to achieve. At the same time, the histopathological evaluation may be a relatively time-consuming process and may be difficult to realize intraoperatively. Therefore, such a histopathological evaluation is rarely performed intraoperatively, resulting in an undesirable scheduling of additional subsequent surgeries in case of post-surgical detection of tumorous margins in the resected tissues.
It is known to use one or more imaging techniques in the evaluation of resection accuracy of ex-vivo tissue specimen, which imaging techniques can visualize tumorous tissue. A CT imaging module can for example detect differences in tissue densities in a tissue specimen and provide morphological information on the imaged tissue specimen, distinguishing tumorous tissue from healthy tissue. However, the contrast between tumorous and healthy tissue is often limited in CT images. A PET imaging module can detect the distribution of a positron-emitting radiotracer, administered to a patient before imaging, in the body of said patient. As some radiotracers are taken up in tumorous tissue with high specificity, a PET imaging module can for example provide images of tumorous tissue with a relatively high accuracy. Unfortunately, PET images may not provide detailed morphological information. Combining images made by a CT imaging module and by a PET imaging module can therefore be very advantageous in clinical imaging, in particular in margin assessment of a resected tissue specimen.
An important issue in margin assessment of a resected tissue specimen is the ex-vivo orientation of the tissue specimen with respect to a body of which the tissue has been resected. Different techniques are in use to define the orientation of the tissue specimen. The surgeon can for example indicate an anterior, posterior, superior or inferior side of the tissue specimen by using specific wires or colour paints indicative of said side or by using labelled markers or clips. An orientation of the specimen can for example be prescribed by a provider of a specimen container for an imaging apparatus. However, such a prescription is prone to human manipulation and/or handling errors and can lead to an erroneous margin assessment with respect to the original orientation of the tissue specimen in the body.
It is therefore an aim of the present invention to solve or at least alleviate one or more of the above-mentioned problems. In particular, the invention aims at providing a specimen receptacle system for an imaging apparatus for imaging ex-vivo tissue specimens which allows relative flexibility in an orientation of the resected specimen while minimizing a risk of potential handling errors.
To this aim, according to a first aspect of the invention, there is provided a specimen receptacle system for an imaging apparatus for imaging ex-vivo tissue specimens. In particular, the specimen receptacle system comprises a specimen receptacle having a bottom and an upstanding wall. The specimen receptacle system further comprises an additional bottom plate which is attachable to the bottom of the specimen receptacle. The additional bottom plate can for example be attached to the bottom of the specimen receptacle in a permanent manner, for example by gluing or in any other suitable way. Alternatively, the additional bottom plate may be removably attachable to the bottom of the specimen receptacle. The additional bottom plate is configured to receive the ex-vivo tissue specimen in an orientation which may be chosen by the user. The additional bottom plate includes at least two distinctive orientation markers configured to indicate at least two substantially transverse anatomical directions, which are assignable to said at least two distinctive orientation markers depending on the orientation of the ex-vivo tissue specimen on the additional bottom plate chosen by the user. The at least two orientation markers can for example include at least two distinctive symbols, for example at least two among a star, a square, a disk, a polygon, a cross or whatever other symbol, as will be clear to the person skilled in the art. Said at least two orientation markers are preferably placed along a periphery of the additional bottom plate, such that said markers can remain visible when the ex-vivo tissue specimen is placed on the additional bottom plate. Contrary to prior art specimen receptacle systems, the ex-vivo tissue specimen can be placed on the additional bottom plate in an orientation chosen by the user instead of being imposed by the manufacturer of the specimen receptacle system. In determining an optimal orientation for the ex-vivo tissue specimen in the specimen container, the user can for example take into account stability of the positioning of the ex-vivo tissue specimen and/or particularities of the tissue specimen needing to be imaged. It is however preferred that the user chooses an orientation for the ex-vivo tissue specimen such that an anatomical direction of the ex-vivo tissue specimen corresponds to one of the at least two distinctive orientation markers. The choice for an orientation of the ex-vivo tissue specimen on the additional bottom plate is therefore preferably not entirely random but chosen among a number of potential orientations, the number of potential orientations depending on the number of distinctive orientation markers on the additional bottom plate. The user can then, in function of the chosen orientation of the ex-vivo tissue specimen, assign a significance, in particular an anatomical direction, to the orientation markers. In other words, the two distinctive orientation markers allow assignation of at least two substantially transverse anatomical directions to said at least two distinctive orientation markers depending on the orientation of the ex-vivo tissue specimen chosen by the user. A first symbol can be assigned a first anatomical direction or orientation, for example ‘posterior’, and a second symbol can be assigned a second anatomical direction or orientation which is substantially transverse to the first direction, for example ‘superior’ or ‘inferior’ or ‘left’ or ‘right’. By assigning at least two transverse anatomical directions, any orientation within one of the three anatomical planes, the sagittal or longitudinal plane, the transverse plane, and the coronal or frontal plane, can be defined. The assignation of at least two substantially transverse anatomical directions to said at least two distinctive orientation markers may be different at every use of the specimen receptacle. In this way, manipulation of ex-vivo tissue specimens can be simplified allowing more flexibility, and manipulation errors can be avoided, or at least be decreased.
The additional bottom plate can advantageously be made of foam. Foam can be substantially invisible to X-rays. As a result, an X-ray image of a tissue specimen on foam will give an impression of a floating tissue specimen which can simplify automated image treatment since there is a clear border of the specimen avoiding artefacts in the image. Moreover, an additional bottom plate in foam can provide several practical advantages in use for receiving ex-vivo tissue specimens. Foam can at least partly absorb body fluids of the ex-vivo tissue. Additionally, foam can allow relatively easy fixation of the ex-vivo tissue specimen on the additional bottom plate, for example by pinning the specimen into the foam or fixating the specimen in any other way known to the person skilled in the art. Foam can for example be closed cell foam, such as for example polyethylene (PE) or ethyl vinyl acetate (EVA), which is relatively robust and can for example allow writing on the foam. The foam is preferably white foam or a foam in any light colour. White or a light colour enhances visibility of colours when paint is used on the foam for markings or indicators.
The specimen receptacle can preferably include an inwardly protruding edge. The additional bottom plate may include a corresponding recess configured to receive said protruding edge of the specimen receptacle. In this way, the additional bottom plate can be inserted into the specimen receptacle in a single way only. As a result, the orientation markers on the additional bottom plate can always be oriented similarly with respect to the specimen receptacle. The inwardly protruding edge can protrude from the bottom of the specimen receptacle or from the upstanding wall of the specimen receptacle or from both the upstanding wall and the bottom of the specimen receptacle. The protruding edge and the recess can have any suitable shape as long as the shapes are corresponding shapes such that the protruding edge can engage the recess in only one way. Alternatively, the specimen receptacle may include a recess or an outwardly protruding edge, and the additional bottom plate may include a corresponding protruding edge fitting into said recess of the specimen receptacle.
The additional bottom plate can preferably include at least four distinctive orientation markers configured to indicate at least four anatomical directions of which at least two anatomical directions are substantially transverse to each other. More preferably, every two adjacent orientation markers can be configured to indicate substantially transverse anatomical directions. The at least four distinctive orientation markers can for example be assigned to four anatomical directions within one of the three anatomical planes. Even if an orientation can already be defined by two transverse directions, at least four distinctive orientation markers can help in defining an orientation of an ex-vivo tissue specimen beyond doubt, for example when the ex-vivo tissue specimen partly covers one or more of the orientation markers. Moreover, at least four distinctive orientation markers can increase a number of potential orientations for the ex-vivo tissue specimen. Even if the user can choose a most optimal orientation for the ex-vivo tissue specimen, the choice for said orientation is not entirely random. It is still preferred to position and orient the ex-vivo tissue on the additional bottom plate of the specimen receptacle in such a way that one anatomical direction of the ex-vivo tissue specimen corresponds to one of the at least two or more distinctive orientation markers. Four distinctive orientation markers, of which every two adjacent orientation markers are configured to indicate substantially transverse anatomical directions, can for example provide 24 preferred potential orientations for the ex-vivo tissue specimen on the additional bottom plate. Every additional set of four orientation markers, of which every two adjacent orientation markers are configured to indicate substantially transverse anatomical directions, can multiply said number of preferred potential orientations for the ex-vivo tissue specimen on the additional bottom plate. Such an additional set of four orientation markers may for example be rotated over for example 30° or 45° with respect to a first set of four distinctive orientation markers. It will be understood by the person skilled in the art that the at least four orientation markers are at least four distinctive orientation markers, for example at least four different symbols. Such orientation markers may differ in shape, or in colour, or both in shape and in colour.
The specimen receptacle preferably is at least partly transparent. In particular, the upstanding wall of the specimen receptacle can be transparent. More preferably, the entire specimen receptacle is transparent. The specimen receptacle is preferably transparent to different ranges of wavelengths, in particular, to X-rays. It is preferred to have a specimen receptacle which is additionally transparent to visible light such that visual inspection of the ex-vivo tissue is possible. The specimen receptacle can for example be made of a transparent plastic, such as acrylic or styrene acrylonitrile. The specimen receptacle may for example be made by injection moulding.
It is preferred that the specimen receptacle is substantially cylindrical. Such a shape can optimize a surface area of the bottom of the specimen receptacle with respect to a surface area of the upstanding wall. Alternatively, other shapes are possible as well. The upstanding wall may preferably be high enough to provide a lateral support to the ex-vivo tissue specimen. At the same time, the upstanding wall can preferably be not too high such as not to hinder insertion of the ex-vivo tissue specimen into the receptacle. A height of the upstanding wall can for example be included in a range of more or less 3 cm to more or less 10 cm, more preferably around 4 cm to more or less 7 cm, for example around 5 cm. A diameter or analogous width of the specimen receptacle can preferably correspond to a field-of-view of an imaging apparatus in which the specimen receptacle system can be used. A diameter of the specimen receptacle may for example be comprised in a range of more or less 9 cm to more or less 12 cm, for example be around 10.5 cm. Depending on the type of ex-vivo specimens to be imaged, dimensions of the specimen receptacle may be adapted.
An upper side of the specimen receptacle may preferably be open. An open top or upper side can allow use of a top-down camera, for example in an imaging apparatus. A top-down view or preferably image of the ex-vivo specimen in the specimen receptacle can allow a joint view on both the ex-vivo tissue specimen and on the at least two orientation markers of the additional bottom plate. Such a view can allow an automated determination of the orientation of the ex-vivo tissue specimen based on a preliminary assignment of the orientation markers to an anatomical direction. Alternatively, the specimen receptacle may include an openable upper side, for example a lid, which my advantageously be transparent to X-rays and preferably also to visible light.
An upper edge of the upstanding wall may advantageously include a visual indicator such as a notch. Such a notch or any other visual indicator may help in lining up the specimen receptacle system in an imaging apparatus, in particular with respect to a rotational orientation since the specimen receptacle system may preferably be insertable in an imaging apparatus in only one orientation.
The specimen receptacle system may further comprise a platform on which the bottom of the receptacle is releasably fixable. Fixation of the specimen receptacle on such a dedicated platform can ensure a stable positioning of the specimen receptacle, and thus of the ex-vivo tissue specimen, during the procedure of imaging the ex-vivo tissue specimen. Said platform may be integrated into a dedicated imaging apparatus or may be configured to be mountable into existing imaging apparatuses, for example by retrofitting such imaging apparatuses.
The specimen receptacle and/or the platform may be configured to allow a releasable fixating of the specimen receptacle on the platform in a single orientation only. This single orientation fixation may be obtained in many different ways. As an example, one of the bottoms of the receptacle and the platform can include at least one, preferably a plurality of, outwardly protruding edge configured to be received in a corresponding recess in the other of the bottom of the receptacle and the platform. A bottom of the specimen receptacle, in particular a periphery of the bottom, can for example include outwardly, preferably downwardly, protruding edges. To improve stability of the specimen receptacle when not fixated on the platform, it is preferred to include at least three edges, for example four edges, which can be like supporting edges on which the specimen receptacle can stand. The platform can then include corresponding recesses configured to receive the edges protruding from the bottom of the specimen receptacle. Alternatively, the bottom of the receptacle can include at least one recess configured to receive an edge upwardly protruding from the platform. In both cases, the protruding edges and corresponding recesses can only allow one way of fixating the specimen receptacle on the platform such that an orientation of the orientation markers with respect to the platform is known and always the same.
Said at least one outwardly protruding edge, either downwardly protruding from the specimen receptacle or upwardly protruding from the platform, can advantageously include a bevelled edge. A bevelled edge can guide insertion of said at least one edge into a corresponding recess, thus facilitating the manipulating of the specimen receptacle. Ends or sides or both of said at least one edge may be bevelled.
According to a further aspect of the invention, there is provided an imaging apparatus system for imaging ex-vivo tissue specimens including a specimen receptacle system the imaging apparatus. Such an image apparatus can provide one or more of the above-mentioned advantages. The image apparatus can for example include a positron emission tomography (PET) imaging module and/or a computed tomography (CT) imaging module. In a very advantageous embodiment, the imaging apparatus may be a single device comprising both a PET imaging module and a CT imaging module. The specimen receptacle system may be configured to receive the ex-vivo tissue specimen for imaging by both the CT imaging module and the PET imaging module.
According to a further aspect of the invention, there is provided a computer-implemented method, a controller and a computer program product for assigning an orientation to an ex-vivo tissue specimen. Such a method, controller and computer program product can provide one or more of the above-mentioned advantages.
In summary, the platform 13 is shaped such that it has a fixed orientation with respect to an imaging apparatus system. The platform 13 and the specimen receptacle are configured to allow only one orientation of the receptacle 1 with respect to the platform 13. The additional bottom plate 5 including the distinctive orientation markers 6 can only be positioned in the specimen receptacle 1 in a single way. The position of the orientation markers 6 can thus be known to the imaging apparatus system and is relatively error-proof. At the same time, the user has a relative freedom in the positioning of the ex-vivo tissue specimen into the specimen receptacle. The user can then be prompted, for example by dedicated software, to assign one of the six anatomical directions to a first of the orientation markers 6. The opposite anatomical direction can then be deduced, which leaves the user to only assign one of the four remaining anatomical directions to a second orientation marker which is on a transverse axis with respect to the first orientation marker. In this way, the other anatomical orientations can be deduced and used by the imaging apparatus system. The present invention can thus provide a specimen receptacle system for an imaging apparatus for imaging ex-vivo tissue specimens which allows relative flexibility in a positioning of the resected specimen while minimizing a risk of potential handling errors.
During surgery, for example during breast surgery, an imaging apparatus, for example a mobile imaging apparatus, may be used to perform ex-vivo tissue specimen imaging. Thereto, a surgeon, or more preferably a nurse, may move the imaging apparatus near the operating table. The surgeon or the nurse may put the excised tissue specimen in the tissue specimen receiving element, such as for example in the present specimen receptacle system in a random orientation. The surgeon, nurse or other operator can then assign an anatomical direction to at least two transverse, and preferably to four of the orientation markers 6 in function of how the tissue specimen is positioned, for example by using dedicated software thereto. The tissue specimen receiving element can then be provided to the imaging apparatus. The imaging apparatus may be shaped such as to correctly position the tissue specimen receiving element in the apparatus. An optical camera, which may be mounted substantially above the tissue specimen receiving element, for example the specimen receptacle system, may now make top view images of the tissue specimen, which may contribute to an automated determination of an orientation of the ex-vivo tissue specimen in the specimen receptacle system. Then the tissue specimen receiving element may be moved to a CT imaging module of the imaging apparatus. The CT imaging module can then perform imaging of the ex-vivo tissue specimen. In a combined PET-CT scanning apparatus, the same tissue specimen receiving element may be moved to a PET imaging module. Then the PET imaging module can perform imaging of the ex-vivo tissue specimen. An image reconstruction module can perform image reconstruction of the CT images and/or of the PET images. Reconstructed 3D PET and/or CT images can then be displayed separately and/or simultaneously on a display for evaluation by the surgeon and/or nurse or by any other medical practitioner, for high precision margin assessment of the ex-vivo tissue specimen, which can preferably be performed intraoperatively.
Although the present invention has been illustrated by reference to specific embodiments, it will be apparent to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied with various changes and modifications without departing from the scope thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. In other words, it is contemplated to cover any and all modifications, variations or equivalents that fall within the scope of the basic underlying principles and whose essential attributes are claimed in this patent application. It will furthermore be understood by the reader of this patent application that the words “comprising” or “comprise” do not exclude other elements or steps, that the words “a” or “an” do not exclude a plurality, and that a single element, such as a computer system, a processor, or another integrated unit may fulfil the functions of several means recited in the claims. Any reference signs in the claims shall not be construed as limiting the respective claims concerned. The terms “first”, “second”, third”, “a”, “b”, “c”, and the like, when used in the description or in the claims are introduced to distinguish between similar elements or steps and are not necessarily describing a sequential or chronological order. Similarly, the terms “top”, “bottom”, “over”, “under”, and the like are introduced for descriptive purposes and not necessarily to denote relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances and embodiments of the invention are capable of operating according to the present invention in other sequences, or in orientations different from the one(s) described or illustrated above.
Number | Date | Country | Kind |
---|---|---|---|
21184424.6 | Jul 2021 | EP | regional |
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/EP2022/065241 | 6/3/2022 | WO |