WO1998040025A1

WO1998040025A1 - Method and device for registering and retrieving at least one site in an operating area

Info

Publication number: WO1998040025A1
Application number: PCT/EP1998/001335
Authority: WO
Inventors: Jürgen PENSEL
Original assignee: Leica Mikroskopie Systeme Ag
Priority date: 1997-03-07
Filing date: 1998-03-06
Publication date: 1998-09-17
Also published as: JP2001515383A; EP0966235A1

Abstract

The invention relates to a method and a device for registering and retrieving at least one site (1) in an observation field, for example an operating area (2), especially for biopsies, and provides a useful method for marking tissue samples.

Description

Method and device for registering and retrieving at least one location in an operating area

The invention relates to a method and a device according to the preambles of independent claims 1, 2 and 7.

In the course of oncological operations, there is often the need to take tissue samples for a tissue examination. The result of the tissue examination often influences the progress of the operation. For this reason, attempts are made to obtain the result of such tissue examinations as quickly as possible in order to be able to take measures depending on the result of the tissue examinations, if possible with an open surgical wound.

As a rule, such tissue samples (biopsies) are taken at several points - if necessary according to a previously defined scheme. The individual pieces of tissue are then brought to the examination in marked containers. The result of the examination comes back to the operator coded with the markings of the associated containers. On the basis of handwritten records, the latter can usually reconstruct from which points in the surgical wound he took the corresponding biopsies. However, the exact reconstruction is indispensable for a possibly necessary targeted post-resection.

This procedure is - since it depends on the memory ability of the surgeon and on the human recording of the removal Spelling supports - poor. For safety reasons, too much healthy tissue is often removed. In addition, it takes some time and at least an assistant to make the labels and records.

The invention has for its object to find a new - computer-assisted - method, or to provide a corresponding device with which the process of marking, assigning and retrieving biopsy sites in an operation wound is to be facilitated.

A biopsy positioning sensor detects the points at which a biopsy is taken in the three-dimensional operation area and stores a reference point in a three-dimensional, virtual image that can be fed to the operator by means of a display. The three-dimensional image is coupled to the operation field via customary, computer-aided stereo-tactical measures in such a way that viewing the virtual image in the correct position is made visible, superimposed on the actual image of the operation field. The surgeon thus recognizes those places where he has previously taken the tissue samples. A designation or coding of these locations, which is associated with the coding of the tissue samples, also leads to an error-free detection of the assigned tissue parts.

The coding can consist of numbers, letters or symbols.

Although methods are already known in which spatial position information is recorded, these recordings serve a different purpose. You are according to that State of the art also coupled with spatial, EDP-acquired and reproduced images of the operating field.

Such a known method is described in DE 37 17 871 C2. This is about a method for reproducible visual representation of the position of an instrument during a surgical intervention, which is carried out using layer images of a body part stored in a memory of a data processing system and displayed on an output device, the position of the instrument also being shown in FIG is stored in the memory so that the position of the instrument in the room together with the image can be retrieved from the memory at a later time.

The task on which this known method is based consists, inter alia, in recording the course of the operation and thus in documenting the result of the operation, and in using this documentation as teaching aids during training and for expert purposes. However, this known method does not offer a satisfactory solution in the sense of the object of the present invention, because firstly in conventional stereotactic interventions there is not always an image of the operation area stored in a memory, and secondly in practice this image can also differ from reality. This is particularly so because the image is not updated before the operation by means of conventional x-rays or computed tomography images. Because of the operation itself, it regularly happens that the area of operation or the part of the tissue to be operated changes. For example, surrounding tissue fills the section from which a tumor was removed. If one were to use the known method for the new task according to the invention, this could lead to the fact that in the stored image with the "superimposed" position data of the instrument, apparent realities are given which do not correspond to reality.

The method according to the invention therefore fundamentally dispenses with the use of stored pre-operative image data for the purpose of later localization of certain points - e.g. Biopsy sites - in the operating area; it relies much more on the biopsy in a virtual three-dimensional recording plane

To represent positions, i.e. without direct coupling with a stored image of the operation area. A coupling, which may be helpful for the surgeon, with the actual image of the operation area only results from the superimposition of the image of the virtual plane reflected by the display over the operation field viewed through the microscope or the like.

However, further developments are also within the scope of the invention, which also use pre-operative image data sets, but not for the purpose of storing the geographic information about the biopsy sampling points, but only for the previously used purpose of stereotactically guiding an operator in the operation of a tumor or Like after the operation of the tumor, however, this image data - as already mentioned above - become relatively meaningless, since in many cases there is a tissue shift. If, on the other hand, tissue samples are taken at randomly selected locations after the tissue shift and these locations are recorded in the virtual image plane and these recordings are superimposed by the microscope after the evaluation of the tissue samples in the image of the operating field, this offers the surgeon a rapid and reliable Assistance to Find the areas where he took the biopsy. Various advantages result from the effect according to the invention, which are particularly advantageously reflected in further developments of the invention:

For example, labeling of the container in which the corresponding tissue sample is subsequently stored can be made automatically by marking a biopsy point in the virtual plane. Such a labeled container allows the pathologist to prepare a report that reaches the surgeon as quickly as possible. Based on the registration number (marking) of this piece of tissue that appears in the report, the surgeon can immediately find the appropriate location in the operating area by calling up the virtual location of the tissue removal with its registration number (marking).

Apart from quickly finding your way around the operating area, this leads to a certain learning effect, since the surgeon recognizes exactly from which area he took the corresponding biopsy and can therefore draw conclusions about any changes in his surgical technique. It is easier for him to view the corresponding area at the same time using an operating microscope or endoscope.

According to another embodiment of the invention, the automatic recording of certain points in a virtual plane can of course also be used to update existing and stored images of the operation area. For example, after appropriate image data processing, a large number of points lying along a natural envelope surface can cause a tissue shift that may have occurred in a previously recorded image to be corrected by using the latter envelope area is compared with the envelope surface that was previously virtually inscribed in a CT or MRI or similar image during the operation and after which a tumor was removed. If the two enveloping surfaces do not coincide, a tissue shift has obviously occurred, which can be used by suitable known computer measures for the purpose of updating the stored image.

A further development of the invention is particularly preferred: the same or a similar coding can, according to the invention, be used automatically for marking biopsy containers (adhesive labels, EAN code, etc.).

However, the invention also deals with the further development or more advantageous application of the PDD method ("PDD": Photo Dynamic Diagnostic). The method of photodynamic diagnosis allows a diagnostic statement to be made by introducing and illuminating fluorescent substances in the tissue. These substances - e.g. Hpd (Photofrin II) or aminovulinic acid (ALA) - brought into the blood circulation or from there into the tissue, so that these substances get into the cell circulation, where they accumulate and concentrate in particular in metabolically active tissues (e.g. tumor tissues). Prototypes of such PDD systems had already been developed between 1982 and 1990 and are now being used in a wide variety of areas, such as in skin diagnostics, but also inside organs, e.g. in the diagnosis of bladder cancer, for use. The doctor sees the tumor much better under the special lighting.

In the optimal case, such PDD arrangements can be coupled with PDT (Photo-Dynamic Therapy), in that certain light frequencies force certain tumor markers to react in situ, which can destroy the tissue enriched with the markers - and thus the tumor.

Where this is not possible, or also because of fundamental considerations of pathology, it would be useful for the doctor to access the affected tissue repeatedly, or at least later, or at least to the region of the affected tissue. In principle, all requirements apply that have already been mentioned in the introduction to the description.

The new idea of the invention is now based on the further task of, in particular, recording the location of tumors or the like made visible by PDD and of indicating this location to an operator at will (i.e. also after the enrichment has subsided and after the special lighting has gone out).

According to the invention, "tumor mapping" is carried out to achieve this object, in that the areas marked by fluorescence and thereby made visible are optoelectronically recorded and locally assigned to the rest of the image.

This allocation and storage of the location information is carried out as in the methods described above.

The advantage is obvious: Before the tumor is removed, the doctor can mirror the local information into his surgical microscope so that he can still see the areas that are not visible to the naked eye - without special lighting. For example, the tumor is outlined by the computer by fluorescence. This outline will later be reflected to the surgeon if necessary. It is therefore basically a two-dimensional process. Within the scope of the invention, however, a three-dimensional variant should also be included:

In X-ray technology, methods are known for marking tumors in a CT and making them visible by, as in the case of PDD, introducing certain substances into the cell cycle. One example is the scintigram. With the help of a CT, such locations can be recorded three-dimensionally. According to the invention, the three-dimensional locations can be graphically described using an image computer. This graphical representation can then - like in the two-dimensional method - be mirrored in three-dimensionally to the surgeon without having to also have the entire three-dimensional CT superimposed on it. It is crucial that the location of the - possibly exclusively - of interest (tumor) is brought optoelectronically in relation to other reference points, so that a reproduction of this information leads the surgeon to the right place.

In a further development of this invention, for example, even a computer-controlled surgical tool could take the necessary actions.

A combination of the types of image capture or playback processes described above for better orientation is also within the scope of the invention.

Reference numbers list

Location observation field, operation area, operation field observation device (surgical microscope / endoscope) instrument instrument data, position data acquisition unit memory data input unit display reference coordinate system code; 1 1 a-11d marker; 12a-12e: places operator switch viewing beam path marking generator transmitter or sensor sensor, possibly also several sensors for different functions data output unit (printer) biopsy forceps display control viewing area 22a, 22b, 22b '(spatial, 3-D) scanner MRI, CT -, X-ray, video images / also diagnostic data generator video camera memory tumor filling area

Figure description

The invention is explained in more detail with the aid of a schematically illustrated exemplary embodiment. The same components have the same reference symbols, the same components have the same reference symbols with different indices. The invention is not restricted by the figures, they merely show one of the practical application possibilities within the scope of the invention.

FIG. 1 shows a microscope 3, which is located by means of transmitters or sensors 17 in its spatial position relative to a reference coordinate system 10 by a position data acquisition unit 6.

The sensor or sensors 18 monitor the setting of the optics of the microscope 3 to determine the field of view of the microscope, its magnification and the position of the focal plane. Sensors 17 and 18 together enable the position data acquisition unit 6 to determine the spatial position of the operating area 2 seen through the microscope.

The position data acquisition unit 6 also monitors the position of an instrument 4 or its instrument tip 5 with respect to the coordinate system 10. The location 1, which lies in the operating area 2 and was indicated by the instrument tip 5, is in this way in its spatial position with respect to the coordinate system 10 definable.

According to the invention, a code 11 is assigned to the location, the spatial position information and the code 11 being stored in a memory 7. In the figures, locally different codes are designated 11 a-1 1 d. Of course, other - for example mechanical - position monitoring devices can also be provided within the scope of the invention in order to determine the position of the operation area, of the operation microscope 3 or of its observation beam path 15 or of the instrument tip 5.

In the event of a change in the position of the microscope 3 in relation to the operating area 2, the position information about the location 1 in the memory 7 is changed such that an optical representation of the location 1 by a marker 12 appears on a display 9 such that an operator 13 can make the marking 12 recognizes as a virtual image at the true location 1. The display 9 is faded into the microscope beam path in a manner known per se. In the figures, different markings are shown differentiated with 12a-12e.

The marker 12 is generated by a marker generator 16, which is designed as a microprocessor or computer and is programmable via a data input unit 8. In addition to the assignment of the marking 12, this structure also enables a marking 12 to be designated by means of code 11, so that both the marking and its name appear on the display 9. In this way, by entering the code 11 in the data input unit 8, an operator 13 can cause the display 12 - in relation to the coordinate system 10 - the marking 12 with the code 1 1, which is visible to the operator 13 through the microscope, the true location 1 appears overlaid. The data input unit can also be voice-controlled or eye-controlled, for example. It can also have a scanner 23 or the like, which can be used to paint over an object on which the code 11 is written. As an example, the specified codes are indicated with "AB" and a corresponding location number. A display controller 21 is connected upstream of the display 9, which enables additional image information to be displayed. mations overlay the viewing beam path 15. For example, as is known per se, this can be diagnostic data obtained before the intervention by means of MRI, CT or X-ray or the like (symbolically represented by 24). However, it can also be video images that were recorded by a - symbolically represented - video camera 25, which has already stored the image of the operating area 2 in a memory 26 at any time.

Since the area of operation 2 can change in the course of an operation, diagnostic data made earlier at a later point in time no longer correspond to the actual area of operation in the correct position. Especially when taking biopsies, the position data obtained earlier from previous diagnostic procedures therefore no longer offer any help. In contrast, the recording and playback of images of the operation area 2 - e.g. recorded during the extraction of a biopsy at location 1 and reproduced at the time of consciously visiting this location 1 - may be helpful according to the invention at a later time.

Of course, there are also possibilities within the scope of the invention to also record the marker 12 from the memory 7 when recording video in the memory 26. An operator has with this

Training variant the possibility, when looking again at a location 1, for example when the operating microscope 3 is pivoted, to display the image in which he sees what the area in question looked like at the time of the biopsy. It is thus possible for the surgeon to carry out an optical follow-up check in order to improve safety as to whether the virtual location with the marking 12 that has been converted and converted from the memory 7 as a result of a change in position of the surgical microscope 3 actually corresponds to the true location 1. If tissue shifts have resulted from the operation that no longer allow the earlier diagnostic data to be displayed in the correct position, the method according to the invention can also be used to update these diagnostic data.

Figures 3a-3c indicate this possibility according to the invention. The image of a spatial area 22b was created, for example, from a diagnostic data generator 24 and shows a tumor 27. In order to improve the usability of the diagnostic data, the tumor 27 was clarified optically in terms of computer technology at its boundary with an envelope surface 28 according to FIG. 3b. The surface 22b 'differs from the surface 22b by additional computational processing. After the tumor has been removed, the surgeon takes biopsies at defined locations 1 of the tumor bed, locations 12a-e being recorded and later being shown in a spatial area 22a according to FIG. 3c. Theoretically, these locations should now coincide with locations on the enveloping surface 28. If this is not the case and if a tissue shift can be calculated, the diagnostic data can be converted on the basis of the determined tissue shift in accordance with the spatial surface 22b so that they correspond to an update, without the patient having to undergo the diagnostic recordings again.

FIG. 2 symbolically indicates the various spatial surfaces 22 which are not limited at the top and which, as shown on the display 9, can be superimposed on the viewing beam path 15 of the microscope 3.

The practical marking of tissue samples or the like is also within the scope of the invention, in that the marking generator 16 is followed by a data output unit 19 - for example a printer - which prints the code 11 immediately after its generation; at- for example, immediately onto a container into which the tissue sample is then placed.

Confusion and human errors are significantly reduced by this measure according to the invention.

Of course, the invention can be expanded: it is conceivable to connect an automatic tissue sample analysis station. According to a further inventive concept, this enables the automatic display of a marking 12 on the display 9 as a function of a positive or negative finding of the corresponding tissue sample. The operator 13 is thus guided in real-time during his biopsy procedure.

For example and advantageously, “in-situ” analyzes (optical biopsy) can also be carried out, which provide the surgeon with the necessary information within a very short period of time while the surgical wound is still open.

The diagnostic image data mentioned in the claims comprise at least data which are obtained, for example, by the following imaging methods: X-ray, CT, MRI, scintigram, etc.

Claims

claims

1. Method for registering and retrieving at least one location (1) in a field of view (2) under a viewing device (3) using an instrument (4) with an instrument tip (5), a spatial position data acquisition unit (6) with a memory (7), a data input unit (8) and a display (9), the field of view (2) being kept in relation to a reference coordinate system (10), the position of the viewing device (3) relative to the reference coordinate system known and / or monitored and the position data acquisition unit (6) acquires the position of the instrument tip (5) relative to the reference coordinate system (10), characterized in that, at the command of the user (13), the respective location (1) that the instrument tip (5) in this Assumes moment, is recorded by the spatial position data acquisition unit (6) and stored in the memory (7), whereupon this location (1) is requested by the user (13) ch a marker or as a video display is indicated or displayed, and this representation is superimposed on the beam path of the viewing device (3) so that the user (13) a virtual marker (12) or the video image of the location in the real operation area ( 2) sees.

2. Method for registering and retrieving at least one location (1) in an operation area (2) under a viewing device (3) during an operation, biopsy etc. using an instrument (4) with an instrument tip (5), a spatial one Position data acquisition unit (6) with a memory (7), a data input unit (8) and a display (9), the operating area (2) being kept in relation to a reference coordinate system (10), the position of the viewing device (3) is known and / or monitored relative to the reference coordinate system (10) and the position data acquisition unit (6) detects the position of the instrument tip (5) relative to the reference coordinate system (10), characterized in that the respective one at the command of the operator (13) Place (1) that the

Instrument tip (5) takes at this moment, recorded by the spatial position data acquisition unit (6) and stored in the memory (7) by assigning a code (1 1), the code (11) being made perceptible, at the request of the operator (13) this code (1 1) is entered into the data input unit (8), whereupon a three-dimensional marking (12) is shown on the display (9) at the location (1) assigned to the code (11), and this representation of the viewing device (3) is placed upstream, so that the surgeon (13) sees the virtual marker (12) in the real operation area (2).

3. The method according to claim 1 or 2, wherein the viewing device (3) comprises transmitters or sensors (17), characterized in that the transmitters or sensors (17) for detecting the position of the viewing device (3) or its viewing beam path

(15) relative to the reference coordinate system (10) or to the observation field or to the operation field (2) are detected by the position data acquisition unit (6), and that when the position of the observation device (3) changes or when a position or setting is or change in function of the viewing beam path (15), the representation of the marking (12) on the display (9) is changed by a marking generator (16) in such a way that the virtual marking (12) for the operator (13) - optionally together with the code (1 1) - appears in the correct position and size.

4. The method according to claim 1, 2 or 3, wherein the position data acquisition unit (6) is assigned a data output unit (19), characterized in that one or the position data corresponding to the acquired position data (11) directly via the data output unit (19) - e.g. on

Printer - is output to identify substances removed from the field of view or the area of operation (2).

5. The method according to any one of the preceding claims, characterized in that transmitters or sensors (17) are rigidly assigned to the field of view or the operating area (2), the relative positions of which to the reference coordinate system (10) are monitored by the position data acquisition unit (6) or be registered in order to track the representation of the virtual marking (12) on the display (9) in the event of a changed relative position.

6. The method according to any one of the preceding claims, with a superimposition of previously obtained spatial diagnostic image data in the viewing beam path (15), characterized in that these diagnostic image data are updated computationally based on the arbitrarily obtained position data by correcting spatial surface data written in the diagnostic image data are with real surface data, which are created by scanning with the instrument tip (5), whereupon the diagnostic image data are shown together with the markings (12) in the display (9).

7. Device for performing a method according to one of the preceding claims, with a viewing device (3) and a viewing beam path (15), an instrument (4) with a detectable instrument tip (5), a spatial position data acquisition unit (6) for acquiring the spatial position of the instrument tip (5) relative to a reference coordinate system (10), a memory (7) for storing spatial position data in connection with one, the code (11) assigned to the respective position data, a data input unit (8) and a display (9), the image of which can be superimposed on the viewing beam path (15), characterized in that the position data acquisition unit (6) and / or the instrument (4 ) is associated with a switch (14), the voluntary actuation of which triggers the position data acquisition unit (6), and that the position data acquisition unit (6) comprises a software or computer-controlled marker generator (16) which creates a virtual marker (12) which codes in position Memory (7) can be stored and, on code-linked request on the display (9), in the correct position with respect to the reference coordinate system (10) can be displayed.

8. The device according to claim 7, characterized in that the viewing device is a sensor-marked surgical microscope or endoscope (3), and that preferably for

Position detection of the viewing beam path (15) sensors (18) are provided, which are coupled to the position detection unit and also capture the optical (magnification) data of the image seen through the microscope or endoscope (3) and feed them to the marking generator (16).

9. The device according to claim 7 or 8, characterized in that the position data acquisition unit (6) is assigned a data output unit (19) - in particular a printer - which, for each arbitrary position data acquisition, has the code (1 1) assigned to this position. outputs or prints.

10. Device according to one of claims 7 to 9, characterized in that the instrument tip (5) comprises a biopsy forceps (20), the closing movement of which is coupled to the switch (14).

11. The device according to one of claims 7 to 10, characterized in that the display (9) is controlled by a display controller (21) which allows the superimposition of three-dimensional viewing surfaces (22) in the viewing beam path (15), the Viewing areas comprise at least one of the following areas: an area (22a) which represents at least one — preferably all — marking (s) (12), optionally together with the associated codes (11); an area (22b) which contains at least one diagnostic data image of the

Operating area (2), optionally with additionally inscribed virtual line or area information - preferably updated in a position-data-controlled manner; an area (22c) which represents at least one spatial video recording of the operation area (2) at a point in time which is before its visible display - but after the diagnosis data has been generated, in which case the viewing device (3) has at least one video camera (25 ) assigned.

12. The method according to any one of claims 1 to 6, characterized in that for the optimal detection of features of interest in the field of view or in the operating field (2) this is enriched with photoactive substances, and during the observation and Location registration by means of excitation light to make the photoactive substances visible.

13. The method according to any one of claims 1 to 6 or 12, characterized in that the observation field or operation field (2) three-dimensional markings, which are created using 3-D non-optical data obtained in advance, are superimposed.

14. The method according to claim 13, characterized in that the 3-D data are three-dimensional MRI or CT X-ray or computer scintigram data.