Patent Application
20240272047
The present invention concerns an automated workstation for an operator, and a process, for handling histological samples in the embedding step.
In the field of anatomical pathology, the embedding step of a histological tissue in an embedding material (typically paraffin) is performed after a surgical sample taken from a patient has undergone cutting (“grossing”), formalin fixation and a treatment (“processing”) in which the tissue sample is dehydrated in alcohol and then clarified with xylene, so as to transform the tissue itself from hydrophilic to hydrophobic, in order to proceed with a first impregnation in paraffin.
According to the conventional technique, in the aforementioned grossing step the biological tissue is inserted into a histology cassette, within which it is while it undergoes the aforementioned processing operation, to be then directed towards the subsequent embedding step. An example of a conventional histology cassette is illustrated in
With reference to this figure, the number 1 indicates the assembly of a cassette 2 and a lid 3. In a typical example, the body of the cassette 2, made of plastic material, is in the form of a relatively flat container, with a flat bottom wall 4 and two pairs of opposite walls defining a containment cavity for the histological sample, which can be closed with the lid 3. The bottom wall 4 of the cassette 2 is shaped like a grid, for reasons that will become clear in the following.
According to the conventional process, which is performed entirely manually, before carrying out the embedding procedure an operator separates the lid 3 from the cassette 2, takes the histological sample from the cassette 2 with the aid of a clamp and places it on the bottom of a mould intended to receive the embedding material, and already arranged with a first layer of embedding material (typically paraffin at a temperature sufficient to keep it in a fluid state). The mould can be constituted, for example, of plastic or metallic material and can have a bottom of dimensions which vary according to the sample to be received.
As indicated above, in the conventional procedure, the operator pours a first layer of embedding material on the bottom 6 of a mould 5 and then inserts the histological sample taken from a cassette on the bottom 6 of the mould 5. This step is extremely critical to ensure a high reliability of the examination that is subsequently performed on the sample. In fact, the operator must pay attention to place the histological sample on the bottom of the mould with the most appropriate orientation in order to guarantee the best results in the next microtomy step, in which the sample embedded in a block of embedding material is subjected to the cut.
Once the operator has placed the histological sample on the bottom of the mould 5, orienting it in the most appropriate way, he applies the cassette 2 above the mould 5.
Once this operation has been performed, the operator places the mould 5 containing the histological sample, with the cassette 2 applied above it, under a dispensing tap of embedding material (typically paraffin) maintained at a temperature sufficient to leave it in a fluid state. In this step, the embedding material is poured by gravity into the mould 5, making it pass through the openings of the bottom wall 4 of the cassette. Fluid is poured in sufficient quantity to fill the mould and the containment space of the cassette above the mould.
Once the mould 5 has been filled with embedding material, it is left to cool, by placing it on a cold plate at a temperature usually between −5° C. and −10° C., until the embedding material solidifies. At that point, the solidified body 7 of the embedding material, with the histological sample S embedded therein (
The conventional process described above guarantees a good reliability of the histological examination, as it entrusts the orientation step of the histological sample inside the mould to an operator. This step, as already indicated, is critical for obtaining a good final result and requires the skill of an expert operator who chooses the best orientation of the sample based on the specific features, the shape and the size of the sample and also considering the type of analysis for which it is intended.
At the same time, the traditional, totally manual process involves an intrinsic limit to the productivity of the laboratory.
Another drawback of the fully manual conventional process is that it is subject to a risk of errors which, although small, is not null. Cassette 2 containing each histological sample normally carries an information carrier related to the sample contained therein. This allows the system to preserve a minimum level of traceability of the sample, in the sense of associating the sample with a series of information relating to it, including the identification of the patient, the type of surgical sampling to which it was subjected and the type of test to which it is intended. In a traditional anatomical pathology laboratory, each operator receives on a bench a plurality of cassettes each containing a histological sample and, for each cassette, carries out the above described cycle of operations to embed a histological sample in the embedding material. This way of operating naturally involves the risk of exchanging the samples with each other and of associating a wrong sample to a wrong cassette.
Another drawback of the traditional process lies in the fact that the operator is not physically able to precisely control the quantity of embedding material that is poured into the mould. This may involve the need, after the solidification of the body of embedding material containing the histological sample inside it, to perform a trimming of said body to the predetermined dimensions suitable for its introduction into the microtome, in case the amount of embedding material poured is overflowing. Similarly, an insufficient filling of embedding material within the mould would require a subsequent pouring of the material itself. These operations involve a high waste of time and result in a consequent loss of productivity.
Documents US 2015/198509 A1 and JP 6 383 625 B2 describe a system and a process for automatically carrying out the embedding operation of a histological sample in an embedding material. According to this proposal, the histological sample is arranged inside a support, of the dedicated type, which is in turn arranged within a cassette, also of the dedicated type. The support locks the histological tissue in place, exerting a specific compression action on the tissue itself, in order to maintain a sample orientation that is set during the previous grossing step. Still according to this known proposal, at least three different types of supports for the sample are provided, which can be chosen according to the size of the sample. The support, with the sample inserted therein, is positioned inside a cassette, which in the case of this known solution makes the functions of the mould of the conventional process. The cassettes, with inside them the supports containing the samples, are then placed inside an apparatus which automatically performs the embedding operation.
The aforementioned prior art is not free from drawbacks. First of all, the preparation of the histological sample within a support which is then positioned inside the cassette can involve the application of an excessive pressure on the sample, so that during the subsequent cutting operation, in microtomy, it can occur that the material constituting the support sticks to the sample or leaves a footprint on the sample, contaminating it, or in any case making necessary subsequent operations of cleaning and separation between the actual organic tissue and the material that adhered to the tissue, with consequent loss of time for the operator. In other cases, it may occur that the compression of the tissue within the support is not sufficient to prevent the sample from moving inside the support, losing the orientation it was given and also with the risk of falling out of the cassette, in particular during the processing step in which the cassettes containing the samples undergo various passages through the different reagents of the process. But the main drawback of the aforementioned known system is that the process carried out within the embedding workstation is completely “closed”, in the sense that it does not allow any type of check in progress on the operations that are performed within the workstation. This can result in an error (for example, an incorrect association of a sample with the identification information of the sample) being detected too late, i.e. when a sample embedded in an embedding material has already arrived to the microtomy station in order to be cut. The same drawback exists when, for example, it occurs that the sample in a cassette has been lost, or that it is badly oriented and therefore unsuitable for cutting, or even when it is found that the same support embeds two non-homogeneous samples. In the case of a badly oriented sample, the diagnosis can certainly be compromised. If, on the other hand, a sample is lost, an investigation must be started to recover it with the consequent need to block the system, with significant drawbacks from the point of view of productivity.
The main object of the present invention is to solve the drawbacks of the known solutions.
In particular, an object of the present invention is to provide an automated workstation and a process for the embedding of a histological sample in an embedding material which on the one hand keeps a high degree of reliability as regards the orientation of the histological sample during the embedding operation and the preservation of this orientation during the entire operation, but which on the other hand allows to significantly increase productivity compared to the conventional totally manual process, also standardizing its execution.
Another important object of the present invention is to provide an automated workstation and a process for embedding a histological sample in an embedding material which achieves a very high degree of safety against the risk of errors both as it concerns the correct association of a histological sample with information relating to its identification, and as it concerns the control of the presence and correct positioning of the histological sample during the whole embedding process.
Another object of the present invention is to provide an automated workstation and a process for embedding a histological sample in an embedding material which are completely “open” in the sense of allowing a verification check and, if necessary, a correction intervention during the entire execution of the embedding process.
A further object of the invention is to provide an automated workstation and a process for embedding a histological sample in an embedding material which allow an extremely precise control of the amount of embedding material that is dispensed within the mould and the associated cassette also according to the volume, different from case to case, filled by the histological sample to be embedded, with the consequent possibility of avoiding waste of time due to subsequent trimming operations of the solidified body of the embedding material.
A further object of the invention is to provide an automated workstation and a process for the embedding of an organic sample in an embedding material which have a high degree of flexibility, in the sense of being able to operate with cassettes and moulds of any known type used in the conventional manual process, without requiring the preparation of dedicated cassettes or moulds.
A still further object of the invention is that of realizing all the aforementioned goals with relatively simple means and with small dimensions and low cost.
In order to achieve one or more of the aforementioned objects, the invention relates to an automated workstation for an operator, for embedding histological samples with embedding material, comprising:
According to a further feature of the invention, the workstation further comprises a second handling device, to pick up from the transfer device each mould and the associated cassette, which are filled with embedding material, and to deposit them at said cooling area and, preferably, also a third handling device, which can be constituted by the second handling device or by a further handling device, configured and programmed to pick up a cassette and the solidified body of embedding material adhering thereto, together with the associated mould, after they have been cooled at said cooling area, and to feed them at first to a station for detachment of each mould from the solidified body adhering to the cassette and thereafter to an output area of the workstation which is configured for delivering the cassettes, with the associated solidified bodies in which the histological samples are embedded, to a transport system.
According to a further preferred feature, said working area is equipped with a monitor for displaying the information contained in the information carrier of the cassette located at the working area to the operator.
In a further embodiment, the working area is provided with a mould feeding system, for feeding moulds to the working area and, preferably, said mould feeding system is controlled by said electronic controller in such a way as to select, on the basis of the information contained in the information carrier of the cassette located at the working area and after detection of the size of the histological sample which is within the cassette, a mould of a type suitable for the histological sample to be processed and to feed this mould to the working area.
Still in a further embodiment, the workstation comprises an automatic transport system for retrieval of the moulds after their detachment from the respective solidified body of embedding material and from the associated cassette, and for feeding the retrieved moulds, through a cleaning station, back to the working area.
The present invention also relates to the process which is carried out by means of the automated workstation described above.
Thanks to the above indicated features, the workstation according to the invention allows to obtain a series of relevant advantages.
First of all, productivity is drastically increased compared to the case of the conventional process, since the entire cycle of operations that precedes and follows the step of placing and orientating the sample within the mould is carried out in a totally automated way.
At the same time, an operator can manually perform the step of placing and orienting the histological sample within the mould, which ensures greater reliability on the correct orientation of the sample and on the maintenance of such correct orientation during the process, which, as it has been seen, constitutes a critical factor for obtaining an optimal result in the following analysis of the sample.
Furthermore, the workstation according to the invention allows a drastic reduction, if not a total elimination, of the risk of errors, due to the fact that it is arranged to feed the working area of the operator one cassette at a time, in an automated way, when a signal indicating the conclusion of the cycle of operations carried out in the working area on a previous cassette has been detected.
A further important advantage of the workstation according to the invention lies in the fact that it is totally “open” in the sense that it allows traceability of each histological sample during the entire cycle of operations to which it is subjected, with the possibility of checking at all times the association of a specific sample with the information that identify it, and of checking the correct performance of operations and intervene during the work to correct any detected abnormality.
A further relevant advantage of the invention lies in the fact that it allows a precise control of the quantity of embedding material that is poured into each mould, linked to the volume occupied by the histological sample, which gives the possibility of obtaining, with the solidification of the embedding material, a body without excess portions which therefore does not require any shaping or trimming.
A further advantage of the workstation according to the invention is that of being able to adapt to the use with any cassette or mould of a known type, as well as to the interfacing with any known device able to perform the previous processing step.
Further characteristics and advantages of the invention will be clear from the following description with reference to the attached drawings, provided purely by way of non-limiting example, in which:
In a particularly preferred embodiment, automated transport systems are provided upstream and downstream of the workstation 8 according to the invention. The transport system 10 which is arranged upstream feeds cassettes containing histological samples to be analyzed, while a transport system 11 arranged downstream of the workstation feeds histological samples, each embedded in a body of embedding material, to the next station of an automated sample processing line.
Returning to
An advantageous feature of the workstation according to the invention is that it is able to operate, in a totally flexible way, with any known type of cassette.
Furthermore, as will be evident from the following description, in the process and in the workstation according to the invention, the advantage of continuous traceability of each processed sample is achieved, which allows the sample to be associated with the identification information relating thereto throughout all the course of operations performed at the workstation.
For this purpose, an information carrier is provided on the body of the cassette 2 which carries information associated with the histological sample contained in the cassette. In a preferred example (see
The information contained in the code C may include patient identification information, information related for example to the number of samples inserted within the same cassette, information related to the previous processing steps which the sample underwent, information related to the nature of the sample, macroscopic images of the sample and any further information that may be useful to an operator who manually performs, in a working area W downstream of the input area A (
An electronic controller E (only schematically indicated in
The cassettes 2, suitably closed with the respective lid 3, which are received in the input area A are picked up by a handling device 12 of any known type and deposited in an accumulation area 13 which, if necessary, can be provided with a system to keep the cassettes in a desired temperature range.
In the illustrated example, the handling device 12 consists of a robot of any known type having a gripping head 12A movable along three axes X, Y, Z orthogonal to each other. In the example shown in
In a preferred example an optical detection device 18 of any known type, able to detect the code C carried by each cassette 2 so as to allow the electronic controller E to trace the cassette during its entire path through the workstation, can be associated to the input area A or to the handling device 12. In the example of
The workstation is preferably equipped with a monitor M on which the electronic controller E displays the information related to the cassette which is from time to time in the working area W.
A fundamental feature of the present invention lies in the fact that the working area W where the operator works receives only one cassette at a time. As will be seen in more detail below, only when the cycle of operations that must be performed in the working area W on a specific cassette is over, the system enables the feed to the working area W of a new cassette. When the signal indicating the completion of the cycle of operations performed on the cassette located in the working area W is received by the electronic controller E, this last controls the handling device 12 to pick up a specific cassette from the accumulation area 13 and feed it to the working area W.
As will also be described in more detail below, the electronic controller E is configured and programmed to perform a selection (“sorting”) of the cassette that must be fed from time to time to the working area W on the basis of the information associated with each cassette, which are detected by means of the optical detection device 18′ located at the input area A.
Preferably, after the feeding of the cassette to the working area W, the dimensions and hence the volume occupied by the histological sample contained in the cassette 2 are detected, according to any known measuring or scanning device. Still with reference to
In particular, the aforementioned mould 5 can be manually chosen by the operator with an appropriate size based on the volume of the histological sample previously detected. On the other hand, according to a preferred solution, the mould 5 can be supplied to the operator automatically, again on the basis of the detected volume of the histological sample, as well as already pre-filled with paraffin in an automated way by the dispensing device 14 according to the size of the bottom 6 of the mould 5 itself.
Once the operation of repositioning the histological sample in the mould has been performed, the operator applies the cassette 2 over the mould 5 and places the group thus obtained on a transfer device 15, which will be described in more detail below as well as all the following steps, with reference to
The transfer device 15 carries the mould 5 containing the histological sample, with the body of the cassette 2 applied above it, to an embedding material dispensing device 16. In the station 16, the mould and the cassette associated with it are filled with embedding material (typically paraffin) maintained in a fluid state. As will also be described in detail below, the dispensing of embedding material is carried out in a controlled and precise way, since a sensor device is associated with the dispensing device 16 to detect the level of the embedding material within the cassette, assisted by an algorithm able to calibrate the dispensing on the basis of a series of parameters known to the electronic controller E from the previous step.
Before or after the dispensing device 16 a detection station 18 is provided, able to detect the information associated with the code C carried by the cassette 2.
Again with reference to
Finally, the workstation 8 comprises a system for picking up the moulds from the cooling area B, after the time necessary to obtain the solidification of the embedding material carried by each mould has elapsed.
As will also be described in detail below, the workstation comprises a device for detachment of the cooled moulds 5 from the respective cassettes 2, with the solidified embedding material which remains associated with each cassette 2. A transport device provides to feed at the output of the workstation or in an accumulation area the cassettes 2 with associated the bodies of embedding material within which the histological samples are embedded.
When the electronic controller E receives a signal indicating the completion of the cycle of operations on the cassette which was in the working area W, it enables the feeding to the working area W of a new cassette. In this condition, the handling device 12 brings its gripping head 12A to a predetermined position, to pick up a given cassette 2.
As already indicated above, the electronic controller is configured and programmed to carry out a selection operation (“sorting”) of the cassettes 2 so as to feed the cassettes one at a time from the accumulation area 13 to the working area W according to a predetermined sequence, on the basis of the information associated with each cassette (which in this example are detected by means of the optical detection device 18′ described above). Therefore, in the aforementioned example, this sorting operation is performed before the intervention of the operator in the working area W.
The criteria followed by the electronic controller to define the most appropriate sequence can be of various types and can be based, for example, both on the information associated with the cassettes and on the need to homogeneously distribute the work to the microtomy stations arranged downstream of the workstation. Basically it is therefore possible to organize and distribute the histological samples to the subsequent processing stations both on the basis of the nature of the analyses to be performed and on the basis of the organizational needs of the laboratory.
In a further embodiment, the above described system for feeding moulds 5 to the working area W can be of the automatic type, i.e. controlled by the electronic controller E so as to select, on the basis of the detection of the volume of the histological sample S which occurs precisely in this step, by means of the aforementioned known measuring or scanning device (not shown), a mould 5 having a bottom 6 whose size is suitable for the histological sample S to be treated and to feed it directly to the working area W, relieving the operator from the task of having to choose it manually. In particular, the choice of a suitable mould 5 can be made easier by the reading, by such automatic system, of an information carrier F (see
On the bottom 6 of the mould 5 is then deposited, by means of the dispensing device 14 (
At this point, the operator places the histological sample on the bottom 6, orienting it in the most appropriate way. The orientation is chosen by the operator on the basis of the information provided to him via the monitor M by the electronic controller E relating to the nature of the sample, possibly with the help of macroscopic photographs of the sample, considering the operations to which the sample must be subjected. In particular, the orientation will be chosen in such a way that the cutting operation performed at the microtome downstream of the workstation allows to obtain sections of the sample that are optimal for following analyses.
As can be seen the orientation operation, in the workstation according to the invention, is left to the operator, as it is critical for obtaining the best results of subsequent laboratory analyses. At the same time, the total automation of the operations that precede and follow the manual positioning and orientation of the sample allows to drastically increase the productivity of the laboratory. As already indicated, to these advantages are added further advantages already discussed above, related to the traceability of the sample through the entire path in the workstation and to the possibility of obtaining an extremely precise dosing of the embedding material, so as to avoid trimming operations of the final solidified body of the embedding material containing the histological sample.
With reference again to
The transfer device 15 stops a support 15A in a position ready to receive a new group G (
In an example, the electronic controller E is programmed to enable the feeding to the working area W of a new cassette by the handling device 12, when it receives, from the detection station 18 downstream of the working area W, a signal which indicates the detection by the latter of the code C of the cassette, coming from the working area W, which is located in front of the detection station 18, and which acts as a signal of completion of the cycle of operations on the cassette itself in the working area W. Naturally, the enable signal to the feeding of a new cassette in the working area W could be obtained in any other way, or be activated by the operator itself, without prejudice to the principle of feeding the cassettes to the working area W one at a time.
Basically, it is achieved a total control, till the last drop, of the volume of embedding material dispensed by both the dispensing devices 14 and 16, calibrating everything according to the volume of the histological sample S to be embedded and therefore to the dimensions of the bottom 6 of the mould 5 that receives it. Essentially, the accuracy in dispensing the correct amount of embedding material is ensured by the combination of two controls, one on the appropriate volume of embedding material to be dispensed, the other on the reaching of the predetermined level of embedding material, both within the mould 5 (for the first layer of embedding material) and within the associated cassette 2 (for the embedding material P).
Returning to
Naturally, both the configuration of the handling devices 12 and 20 and the configuration of the transfer device 15 could vary widely. As an alternative to the examples used, it is therefore possible to adopt handling and transfer devices of any other known type.
Following the aforementioned detachment, the mould 5 falls into a pit 22 where it is retrieved by an automatic transport system for retrieval of the moulds, while the solidified body of the embedding material remains adhered to the body of the respective cassette 2. In the illustrated example, the gripping head 20A of the handling device 20 temporarily places the group G on a horizontal support wall 21A, after which it releases the group G. The head 20A is rotated around a vertical axis to carry a gripping device 23, which always belongs to the head 20A, to engage the upper surface of the solidified body of embedding material P belonging to the group G. By means of the gripping device 23, the head 20A brings the group G above the pit 22, between two brackets 24 carried by the supporting wall 21A at the two sides of an opening 25 of the wall 21A. The two brackets 24 have upper edges folded horizontally. When the gripping device 23 has brought the group G above the opening 25 and between the two brackets 24, the detachment of the mould can already occur naturally by gravity, but if necessary the gripping device 23 moves slightly upwards the group G in such a way that the opposite edges of the mould 5 are held by the folded edges of the brackets 24, which causes the mould 5 to fall into the pit 22 passing through the opening 25, while the group G constituted by the solidified body 7 of embedding material P with the cassette 2 associated therewith remains joined to the gripping device 23 (
The detached moulds 5 which are received in the pit 22 can be retrieved by an automatic transport system, unless they are of the disposable type. The automatic transport system can feed the moulds through a cleaning station, to remove the residues of the embedding material, and then convey them back to the feeding system of the moulds 5 to the working area W.
Naturally, the principle of the invention remaining the same, the details of construction and the embodiments may vary widely with respect to those described and illustrated purely by way of example, without thereby departing from the scope of the present invention, as defined in the attached claims. For example, it is not excluded that the orientation of the sample within the mould is also performed using an automated system.
| Number | Date | Country | Kind |
|---|---|---|---|
| 102021000013757 | May 2021 | IT | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2022/054847 | 5/24/2022 | WO |
