HRP20121063A2 - Localization tile and set for fixing her - Google Patents

Abstract

The present invention relates to a localization plate (1.0) and a set for its repetitive insertion and removal from a patient. The fixation can be done by screwing (4.0) directly onto the patient's bone (5.0) or gluing it to the skin. The localization plate (1.0) has three holes; two holes (1.5, 1.6) for repetitive positioning of the localization plate and a through hole (1.4) for the passage of the threaded screw body (4.3) for attachment to the bone (5.0). The plate has at least three markers (1.2), each of said markers (1.2) having centrally circular holes (1.3) positioned perpendicular to the common plane of all markers (1.2) which serves for accurate optical localization. All the joints of the center of the circular bore (1.3) of each of the markers (1.2) with them closest to the adjacent center of the circular bore (1.3) form a set of parallel or vertical lines, consisting of at least one parallel and at least one vertical line. The localization pad (1.0) is used when specifying the vision system (7.0, 8.0) to assist the surgeon in performing the surgery.

Description

Field of invention

The subject of the invention relates to a localization plate and a set for fixing it. The field of the invention relates to diagnosis, surgery, identification; especially for accessories used for surgery and diagnostics; more precisely as an accessory for stereotactic surgery.

Technical problem

In neurosurgery, the procedure of surgical operations using neuronavigation has been used for a long time, in which a special system monitors the movement and position of surgical instruments, the image of which is linked to the preoperative or intraoperative image, and enables the neurosurgeon to precisely manage the surgical procedure. For such a way of working, markers clearly visible on diagnostic recordings were required; e.g. with CT (computed tomography), MRI (magnetic resonance imaging) or PET (positron emission tomography) scans, but also on surgical instruments during work in the operating theater that were identified in the room for example by infrared radiation.

The first technical problem that is solved by the present invention relates to the repetitive placement of a marker system in the form of a localization plate on the patient's bone, especially on the bones of the head and spine.

The second technical problem that is solved by the present invention is the solution of the first technical problem by a minimally invasive method without compromising repeatability.

The third technical problem that is solved by the subject invention relates to a system that additionally performs optical correction of the positioning of the external vision system.

The fourth technical problem solved by the present invention is the use of a localization plate in conjunction with stereotactic frames for neurosurgical operations.

State of the art

The prior art is extremely rich in both patent and non-patent literature. Solving the problem of visual localization of instrumentation in relation to the patient was approached more seriously in the early 90s of the 20th century, see e.g. Bucholtz et al., "Intraoperative Localization using a three dimensional optical digitizer", Proceedings of Clinical Application of Modern Imaging technology , SPIE 189: 312-322, 1993. Said document teaches a stereotactic highly precise approach to a surgical site within a patient's skull. The mentioned system uses infrared optical localizers to indicate positions on some of the diagnostic images such as CT, MRI or PET. The importance of this work is that it reveals a way how the relative position of the surgical instrument in relation to the patient's head is determined by computer using data from the marker ring on the patient's head. This document only defines the scope of the subject invention.

Document US 6,273,896 (Franck I. J. et al.) filed in 1998 teaches a stereotactic frame that can be repetitively placed on a patient's head, using two screws driven into the patient's skull bone and a washer that provides a plane of attachment of the stereotactic frame. The stereotactic frame is equipped with markers that enable diagnostic imaging and subsequent positioning of surgical instruments relative to the patient's head. Unlike the cited state-of-the-art document, the subject invention is used with the help of only one screw, without a backing plate and in a way that does not compromise the repeatability of the position of the marker marks. The cited document also represents the closest state-of-the-art document with regard to the performance of the localization plate according to the subject invention. This sterotactic framework appears in various versions of the vision systems of later documents, more or less by the same group of authors:

- US 6,282,437; "Body-mounted sensing system for stereotactic...";

- US 6,298,262; "Instrument guidance for stereotactic surgery";

- US 6,351,662; "Movable arm locator for stereotactic surgery";

- US 6,529,765; "Instrumented and actuated guidance fixture..."; and

- US 6,546,277; "Instrument guidance system for spinal and other...".

Document EP-B-1952778 (Goldbach G.) teaches a technical solution for a laser-tracked marker used for calibration and testing the calibration accuracy of a vision localization system. The marker consists of round retroreflectors that are used to measure the position with the help of a laser, and markers that are searched for by vision or some other system. The invention also enables the calibration of other localization systems. This document only defines the scope of the subject invention.

Document EP-B-0997109 (Bucholz D. R.) teaches a system for determining the position of a surgical probe or some other surgical instrument, with respect to a desired part of the patient's body, for example, the head, spine, etc. The surgical instrument and reference markers are located with the help of sound sensors or , in an alternative version, with the help of infrared sensors. The system interacts with a frame that is attached to the patient's head bone in at least two points. This document only defines the scope of the subject invention.

As for the localization plates and their use with sterotactic frames, we find document FR2814667 (LOMBARD BERTRAND) in the state of the art. This document teaches a rigid stereotactic frame that attaches to the nasal bone and auditory canals where the markers are fixedly located within the stereotactic frame and are interchangeable with respect to the desired diagnosis to be performed on the patient. In contrast to the mentioned technical solution, the solution according to the subject invention enables the use of a localization plate attached to a similar stereotactic device with exactly the same functionality as shown in the cited state of the art.

The essence of invention

The subject of the invention relates to a localization plate for registering (connecting) the coordinate systems of the robot and the patient, as well as specifying the vision system during surgery. The localization plate enables repeated insertion and removal from the patient and consists of a body and at least three markers. The mentioned markers form an optical contrast to guide the external vision system.

In one technical solution, the localization plate is fixed and positioned on the patient's bone with only one screw. Such a localization plate has three holes; two holes are used for repetitive centering of the plate and a through hole for the passage of the threaded part of the screw used to fasten it to the bone.

Each of the mentioned markers has an additional centrally placed circular hole, placed perpendicular to the common plane of all markers, which serves for accurate optical localization. All connectors of the centers of the circular holes, of each of the markers with the center of the circular hole closest to them, form a set of parallel or vertical lines that consist of at least one parallel and at least one vertical line.

The invention also relates to a set for fixing the localization plate, which consists of a screw, nuts and a key. The screw has two protrusions that interact with the holes on the localization plate and are intended for the exact positioning of the localization plate on said screw. The thread of the screw passes through the through hole of the localization plate, with which said localization plate is tightened with a nut against the support plate. The screw on the lower side of the plate rest has a waist, the length of which is chosen according to the place of installation, depending on the thickness of the patient's soft tissue, and whose lower part of the waist is made in the form of a thread that twists into the bone. The nut has a bottom side made in the form of a ball calotte. The key serves to twist and turn the screw into the patient's bone.

The set for fixing the localization plate has a nut additionally equipped with a spike for optical measurement of the positioning error, as well as marker marks in the form of shallow grooves placed at a previously defined distance that determine the unit dimension during optical reading.

The set for fixing the localization plate by gluing it directly to the patient's skin, consists of an adhesive based on collodion preparations, as well as a preparation for removing the plate based on alcohol.

The localization plate according to the invention can also be used in conjunction with stereotactic frames.

Brief description of the drawing

The accompanying drawings are included in the description and illustrate one of the possible solutions of the invention.

Figures 1A, 1B and 1C show a localization plate, Figure 1A is a top view of the markers, Figure 1B shows a section A-A indicated by the line-point in Figure 1A, and Figure 1C is a three-dimensional view of the same embodiment of the localization plate.

Drawings 2A, 2B and 2C show a localization plate equipped with a screw and nut with a spike for fixing and positioning the plate, drawing 2A is a top view of the markers, drawing 2B shows a section B-B indicated by the line-point in drawing 2A, and drawing 1C is a three-dimensional view of the same design localization tiles.

Drawings 3A, 3B, 3C and 3D show nuts for fixing the localization plate and optical (re)positioning, drawing 3A shows a nut with a spike and a partial section, drawing 3B a three-dimensional view of the same design of the nut, drawing 3C shows a nut without a clamping spike with a partial section and a drawing of a 3D spatial representation of the clamping nut.

Figures 4A, 4B and 4C show a screw for screwing into the patient's bone and attachment and positioning of the localization plate, Figure 4A shows a view and plan view of the screw, Figure 4B a side view of the screw, and Figure 4C a perspective view of the same screw.

Drawings 5A and 5B show the completed connection of the placed and secured localization plate to the patient's bone, as well as the key. Figure 5A shows the invasive fixation of the localization plate with a screw screwed into the bone, and Figure 5B shows a key for twisting and turning the subject screw into the patient's bone.

Drawings 6A and 6B show the localization plate positioned by means of a screw on the skull bone - calvaria, clamped with a nut with a spike intended for the process of testing the accuracy of reproducibility of placing the localization plate, drawing 6A shows the placed and fixed skull bone - calvaria on the supporting plate, and drawing 6B a section A-A of the mentioned elements along the dotted line shown in drawing 6A.

Figure 7 shows an optical system consisting of a camera and a laser for positioning the localization plate.

Drawing 8 shows CT images of the localization plate placed on the human skull, and the exact positioning of the marker holes on the localization plate, with the determination of their coordinates in all three planes by a special software program.

Drawing 9 is a photograph of a localization plate with glued "fiducial" markers.

Figure 10 shows a multi-plane reconstruction of an MRI scan with visible "fiducal" markers.

Figure 11 shows an MRI scan with fiducial markers visible.

Figure 12 shows an MRI image with a marked TI point of interest within the patient's brain.

Drawing 13 shows a diagrammatic protocol for testing the accuracy of marker positions on the localization plate when removing and re-installing the localization plate on a screw screwed into the skull bone - the calvaria.

Detailed description of the invention

None of the localization systems with markers listed in the state of the art enables a simple and safe connection, i.e. reading the coordinate points of the target locations in the patient's head and the coordinate system of the neurosurgical robot, while being connected by only one connecting point to the patient's bone, or joining is done by gluing.

The localization system, which consists of a localization plate and a set for fixing it, solves all the technical problems listed earlier.

Drawings 1A, 1B and 1C show the localization plate (1.0) according to the present invention. The localization plate (1.0) consists of a body (1.1) on which there are places for accepting marker inserts (1.2), holes for screw threads (1.4) and holes for shoots - pins (1.5, 1.6). The shape of the localization plate (1.0) can be arbitrary, but in practice, shapes are used that have the smallest mass, while maintaining the given technical function. An example is the stylized triangle shape shown in Figure 1A.

The technical role of marker inserts (1.2) is multiple. The primary role is that the mentioned marker inserts (1.2) are visible in the diagnostic recordings; eg CT scans, see figure 8, MRI and PET. The secondary role of the marker inserts (1.2) is to enable positioning with the external vision system using the holes (1.3) in the marker insert (1.2).

What characterizes the localization plate (1.0) according to the present invention is the mutual relationship between the centers of the holes (1.3) made in each of the marker inserts (1.2). It should be mentioned that the marker inserts (1.2) are nested in the body (1.1) of the localization plate (1.0) coplanar; in such a way that their upper surfaces are flush with the upper surface of the body (1.1) of the localization plate (1.0) as can be seen in drawing 1B showing a section A-A along the dash-dot line shown in drawing 1A. The marker inserts (1.2) are distributed on the board so that all connectors of the center of the circular holes (1.3) of each of the markers (1.2) with the nearest neighboring center of the circular holes (1.3) form a set of mutually parallel or vertical lines consisting of at least one parallel and at least one vertical line. The optimal number of marker inserts (1.2) that enables sufficient positioning reliability is 3 or 4, as shown in the minimal variant in drawings 1A, 1B and 1C.

The hole for the screw thread (1.4) has the function of allowing the unhindered passage of the thread (4.3) of the screw (4.0), while the holes for the studs - pins (1.5, 1.6) enable the exact positioning of the localization plate (1.0) on the cylindrical studs - pins (4.1, 4.2) ) screw (4.0).

Cylindrical projections - pins (4.1, 4.2) do not necessarily have the same diameters, but it is important that they have identical diameters with the holes (1.5, 1.6), to form a sliding joint. It is most favorable that the localization plate has at least two holes for studs - pins, and the screw (4.0) has an equivalent number of cylindrical studs - pins, drawings 2A, 2B and 2C. Of course, technical designs that have either a larger number of protrusions - pins or, for example, a system of corresponding grooves and protrusions performed on a screw (4.0) or localization plate (1.0), can also serve to achieve the same technical effect. A practical check, as will be seen later, shows that the double pin-hole system enables high repeatability of the procedures of removing and placing the localization plate (1.0) on the screw (4.0).

Drawings 4A, 4B and 4C show the screw (4.0) according to the present invention. The screw (4.0) consists of the screw body - the waist (4.4) in the extension of which there is a thread (4.5). The middle part of the screw (4.0) has a flat circular support plate (4.6) placed vertically on the body of the screw-waist (4.4) whose bisector corresponds to the bisector of the body of the screw-waist (4.4) and the thread (4.5). The upper part of the screw (4.0) is made as a cylindrical part with a thread (4.3) also in the bisector of the body of the screw - the waist (4.4) and the flat circular supports of the plate (4.6). Cylindrical protrusions of pins (4.1, 4.2) are firmly placed on the flat circular support plate (4.6), perpendicular to the surface of said circular flat support plate (4.6).

The technical role of the screw body - the waist (4.4) is intended to pass through the soft part of the tissue (5.1), drawing 5A, and their length is determined by the thickness of the soft part of the tissue (5.1). The thread (4.5) located in the continuation of the screw body (5.1) is intended for screwing into the bone (5.0) of the patient. The shape of the thread, whether it is cylindrical or conical, with a normal, small thread, the profile of the teeth of the thread for wood or for sheet metal serves the same purpose and represents only the operational solution of the production, drawings 4A, 4B, and 4C..

The purpose of the flat circular support of the plate (4.6) is to achieve parallelism of the localization plate (1.0) which rests on the upper flat surface of the plate (4.6), and that cylindrical projections - pins (4.1, 4.2) are vertically placed and fixed on its upper surface. The mentioned cylindrical protrusions - pins (4.1, 4.2) do not necessarily have the same diameters, but it is important that they have identical diameters with the holes (1.5, 1.6) on the localization plate (1.0), and that they form a sliding connection with it.

The threaded cylindrical part (4.3) placed on the upper side in the bisector of the screw (1.4) has the function of fixing the localization plate (1.0) to the screw (4.0) using nuts (2.0 or 3.0). The type of thread, i.e. the shape of the teeth on the threaded cylindrical part (4.3), has no influence on the clamping of the localization plate (1.0) on the screw (4.0), although a normal or small metric thread or Whitworth thread is preferred.

Drawing 5B shows a key (6.0) whose lower working part is shaped to encompass the screw (4.0) and to rest on the cylindrical projections - pins (4.1, 4.2) in order to transmit the twisting moment to the screw (4.0) via them. The handle on the upper part of the wrench (6.0) enables the twisting torque to be achieved with its arm.

Drawings 3A, 3B, 3C, and 3D show nuts (2.0, 3.0) for clamping the localization plate (1.0) to the screw (4.0). A nut with a spike (2.0) in addition to the corresponding female thread according to the type of thread on the cylindrical part with a thread (4.3), which ensures the twisting function, also has a spike (2.2) with two marker marks (2.1) in the form of shallowly cut annular grooves with a precisely determined distance . On the nut there is a notched nut ring - rim (2.3). The spherically rounded lower part of the nut (2.4) is in contact with the localization plate (1.0).

The nut (3.0) of the corresponding female thread according to the type of thread on the cylindrical part with the thread (4.3) which ensures the twisting function is without a spike, with a knurled nut ring - rim (3.1) and a spherically rounded lower part of the nut (3.2).

The spike (2.2) of the nut (2.0) is intended for optical measurement of the positioning error, as well as the marker marks (2.1) on it, made in the form of shallow notched grooves, placed at a previously defined distance, which determine the unit dimension during optical reading. The knurled nut ring - rim (2.3) with its roughness is intended for manual twisting and tightening of the nut.

The spherically rounded lower part of the nut (2.4) with its spherical shape eliminates the influence of the nut in the tightening process on the parallel placement of the localization plate (1.0) in relation to the upper surface of the flat circular support of the plate (4.6).

The purpose of the nut (3.0) without the spike is exclusively to tighten the localization plate (1.0) with the screw (4.0). The knurled nut ring - rim (3.1) with its roughness is intended for manual twisting and tightening of the nut. The spherically rounded lower part of the nut (3.2) with its spherical shape in the tightening process eliminates the influence of the nut on the parallel placement of the localization plate (1.0) in relation to the upper surface of the flat circular support of the plate (4.6).

The set that will be used in practice with the localization plate (1.0) depends on the method of attachment. The set for invasive fixation will consist of a screw (4.0), a nut (3.0) and (2.0) as well as a tightening key (6.0).

The set for non-invasive fixing will consist of an adhesive based on collodion preparations, as well as an alcohol-based tile remover.

I. The procedure for experimentally checking the repeatability of placement of the localization plate on the skull bone by an invasive procedure

In order to determine the repeatability of the subject invention, an examination of the exact position of the marker (1.2) on the localization plate (1.0) attached to one screw (4.0) screwed into the bone (5.0) of the skull was carried out, drawing 6A and 6B.

Reproducibility means performing the following procedure:

placed localization plates (1.0) on a screw (4.0) - twisted into the bone of the skull, the so-called "calvary" (9.0) - manual fastening of the localization plate (1.0) with a nut (2.0),

measurement of the exact position of the marker (1.2),

removing and reinstalling and tightening on the same screw (4.0), and

checking the identity of the marker position (1.2) with the previous reading, i.e. establishing the deviation.

I.1 Measurement protocol

In order to obtain accurate data, a test protocol was determined. The order of the procedure and the work phase are shown in a flow diagram (drawing 13), and the following definitions are used:

The bone (5.0) is the upper part of the skull - the calvaria (9.0), without the soft part of the skin and subcutaneous tissue (5.1).

The calvaria (9.0) should be fixed on the bottom side (along the edge) to a rigid base, i.e. the stand (10.0).

The stand (10.0) with an attached part of the skull bone - calvaria (9.0) is fastened to the work table with screws.

A hole of the appropriate diameter (1.9 mm or 2 mm) is drilled with a drill.

The screw (4.0) is placed in the drilled hole and screwed to the end of the thread, with the key (6.0).

A localization plate (1.0) is placed on the screw (4.0). The two cylindrical pins (4.1, 4.2) on the flat circular plate (4.6) of the screw (4.0) fit into the corresponding holes for the pins (1.5, 1.6) on the localization plate (1,0). A nut (2.0) is tightened on the screw (4.0). While screwing the nut (2.0), hold the localization plate (1.0) with your fingers to prevent the screw (4.0) from turning and changing its orientation.

The procedure of localization of the plate with the robot is carried out in such a way as to record the position and orientation of the localization plate (1.0) with 6 coordinates [x(mm), y(mm), z(mm), α(º), β(º), γ (º)], see drawing 7.

The localization of the plate (1.0) is performed 10 times consecutively without removing the localization plate (1.0) from the screw (4.0) in order to establish the repeatability error of the robot and the localization measuring system consisting of the camera (7.0) and the laser (8.0). This error is later incorporated into the statistical model.

With the second robot, visual guidance of the robot is performed and 3 correction distances are recorded, i.e. translations along the axis of the localization plate (1.0) [x(mm), y(mm), z(mm)].

The nut (2.0) is unscrewed from the screw and the localization plate (1.0) is removed. When unscrewing the nut (2.0), the localization plate (1.0) is adhered to, so that the orientation of the screw does not change.

The examiner repeats the procedure from points e), f), h) and i) 30 times and records all measurements in order to obtain a sufficient statistical sample for analysis.

The second examiner repeats the same procedure 30 times and records the results.

The orientation of the tile (1.0) is localized in step f). The position of the plate (1.0) is localized in two independent measurements - step f) and g). All collected data is processed statistically.

The maximum positioning error (Euclidean distance) of the robot tool tip is calculated. The error calculation refers to the scatter of common surgical locations resulting from the reproducibility of the position and orientation of the localization plate (1.0).

I.2 Measurement results

Tables 1 to 4 show measurements of the identity of the tile position, i.e. all spatial coordinates and angles of rotation - x, y, z, α, β and γ.

Tables 1 and 2 show measurements in which the localization plate (1.0) was repositioned on the screw (4.0) 30 times by two independent measurers.

The symbols used in the tables represent:

AVG - mean error value;

SD - standard deviation, i

MAX - maximum error

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Tables 3 and 4 show the repeatability measurements of the robotic measuring system, the localization plate (1.0) was firmly fixed on the calvaria (9.0) and the measurement was performed 30 times.

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Table 5 shows the coordinates of the points (T0, T1, ..., T5) that represent the simulated areas of the operative intervention. Spatial error was then added to these points due to the difference in the spatial position of the localization plate (1.0) with the markers (1.2) established by the measurements in tables 1 to 4.

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Tables 6 to 9 show measurements of spatial (Euclidean) deviation.

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I.3 Conclusion based on reproducibility measurement

The measurement results show that the disassembly and assembly of the localization plate (1.0) with markers (1.2) and one screw (4.0) does not affect the change in the position and orientation of the localization plate (1.0) and that the dispersion of values maintains the same range.

The total impact of errors caused by measurement and/or repositioning of the localization tile (1.0) was examined by calculating spatial transformations. At six simulated points (T0, T1, ..., T5) of the surgical procedure in the area of the patient's brain, the localization and/or repositioning error and its, or their, spatial transformation are superimposed. Calculating spatial transformations describes the impact of localization and/or repositioning errors on spatial deviations in operating points.

It can be seen that the errors are very similar with the fixed localization tile (1.0), tables 3 and 4, as well as with the repositioned one, tables 1 and 2.

Tables 6 to 9 show that the statistical values of Euclidean distances/errors from imaginary points never exceed 0.3 mm, which is significantly more accurate than common surgical standards.

II. Measuring the stability of the position of the glued localization plate (1.0) with markers in real conditions - non-invasive method (drawings 9 to 12)

Since it is a matter of directly gluing the localization plate (1.0) to the skin, drawing 10, and not fixing it with a screw (4.0) to the bone (5.0), two images of the patient were used for the measurement, which were performed using the magnetic resonance technique - MRI, at a distance of approximately 1 hour, the first at 17:19 and the second at 18:15, see tables 10, 11, 13 and 14.

Gluing includes the following procedures:

The localization plate (1.0) with markers (1.2) is glued using the Collodion surgical glue; COLLODIUM, 4% solution in ethanol and diethyl ether (e.g. Caesar & Loretz GmbH, product no. 7193), on the patient's head, as shown in the 3D reconstruction image, drawing 10. The mentioned type of glue is used in the prior art as an adhesive for closing small wounds and superficial surgical procedures.

"Fiducial" markers (11.0), which are already used in clinical practice, are glued to the localization plate (1.0) at the positions of markers (1.2) with holes (1.3) that are visible on CT images but not visible on MRI. , drawing 9, for MRI scans. A total of 3 "fiducial" markers (11.0) marked FM1, FM2, FM3 were used.

Two independent measurers localized the spatial positions of FM1, FM2 and FM3 in the coordinate system of the MRI image reconstruction, figure 11. An arbitrary stationary point of interest TI inside the patient's brain was also localized, figure 12.

Measurements were made of the mutual distance of each of the 3 "fiducial" markers (11.0) in relation to the TI point.

II.1 Measurement results of the glued localization plate (1.0) with "fiducial" markers (11.0) and interpretation of the results

The coordinates of the "fiducial" marker points (11.0) and the TI point are shown in tables 10 to 15. Tables 10 and 11 show the readings of the first meter, while Tables 13 and 14 show the readings of the second meter. Tables 12 and 15 show comparative measurements and differences in spatial distances of point TI in relation to each "fiducial" marker (11.0) [TI-FM1, TI-FM2, TI-FM3] for each measurer. The maximum measured distance difference for different magnetic resonance imaging - MR, in the case of both meters, is 0.45 mm.

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The established deviation of the results of the non-invasive fastening method when the plate is not rigid, i.e. attached to the patient's bone (5.0) with a screw (4.0), but glued to the patient's skin is acceptable. The surgical glue allows limited movement of the localization plate, which was established by measuring the position of the "fiducial" marker (11.0).

The acceptability of the non-invasive procedure of gluing the localization plate (1.0) stems from the knowledge that in a time of approximately 1 hour there was no unacceptable displacement of the localization plate (1.0), and that time is sufficient for recording and the start of the surgical procedure. The non-invasive method reduces the patient's trauma and facilitates the manipulation of the preoperative preparation.

III. Application in conjunction with stereotactic frames

The localization plate (1.0) according to the present invention can also be used in conjunction with stereotactic frames, preferably with adapters that are placed on the patient's head non-invasively.

It is clear to one of ordinary skill in the art that the screw (4.0) of the localization plate (1.0) may be attached to the stereotaxic frame and not to the patient's bone. The localization plate (1.0) can be easily used for example with the stereotactic frame previously described in the prior art as FR2814667. In this mode of use, the repeatability depends on the basic repeatability of placing/removing the stereotactic frame.

IV – Positioning of the localization plate with an external vision system

For the identification of spatial coordinates and the orientation of the localization plate (1.0), a developed measuring system is used, which gives results by cross-section of laser distance measurement and planar measurements obtained by the camera. The measurement system calculates the result in three steps. The first step is to search the workspace with the aim of finding the localization tile (1.0). Then, with the help of two-dimensional translational displacements, the robotic arm is positioned over the localization tile (1.0) with the region of interest in the center of the field of view to ensure the highest accuracy of the system. The second step is to measure distances and spatial angles. This measurement is performed with the aim of aligning the camera (7.0) and the laser (8.0) with the spatial plane in which the localization tile (1.0) lies. To determine spatial angles in the first step, it is necessary to determine the distance of the localization plate (1.0) from the laser (8.0). It is then necessary to reduce this distance to a previously defined value by iterative movements of the robotic arm. The procedure is iteratively repeated in order to reduce the error of the exact positioning of the robotic arm as much as possible. After that, movements in the direction of the x-axis and y-axis are performed along the edge of the localization tile (1.0) in order to determine how much the distance deviation is at the edge points. The dimensions of the localization plate (1.0), the displacements of the robot arm and the laser measurement values (8.0) are known parameters. By means of trigonometric transformations of these data, the angles of rotation around the x-axis and the y-axis are obtained. After this part of the procedure, all the necessary data were obtained to align the robot arm with the plane of the localization plate (1.0). The spatial angle of rotation about the z-axis is calculated by measuring it using a vision system with a camera (7.0). When the vision system sends feedback about the angle of the z axis, all the spatial angles and distances of the tile are known, and this procedure uniquely performs the spatial localization of the tile. Based on the spatial correlation between the coordinates of the operative point and the points of interest on the localization plate obtained by CT scans, the position of the operative point in robotic coordinates is brought into relation.

Industrial applicability

The subject of this invention has undoubted industrial applicability in a faster and simpler way of solving technical problems with smaller lesions per patient who needs such surgical treatment.

List of callsigns

(1.0) localization tile

body

marker insert

hole in marker insert

screw thread hole

hole for the shoot - pin

hole for the shoot - pin

(2.0) nut with spike

(2.1) marker marks

(2.2) spike

(2.3) grooved nut ring - rim

(2.4) spherically rounded lower part of the nut

(3.0) nut

(3.1) grooved nut ring - rim

(3.2) spherically rounded lower part of the nut

(4.0) screw

(4.1) cylindrical shoot - pin

(4.2) cylindrical shoot - pin

(4.3) threaded cylindrical part

(4.4) bolt body - waist

(4.5) thread

(4.6) flat circular tile supports

(5.0) bone

(5.1) soft surface tissue

(6.0) key

(7.0) camera

(8.0) laser

(9.0) calvaria – the upper part of the skull bone

(10.0) stand

(11.0) "fiducial" marker

Claims (5)

1. Localization plate (1.0) for guiding the vision system during surgery (7.0, 8.0), where said plate (1.0) enables repeatable insertion and removal from the patient and which consists of a body (1.1) and at least three markers (1.2) located in on the same plane that are not laid collinearly and fixed and integrated inside the body of the localization plate (1.1), where the mentioned markers (1.2) form an optical contrast for guiding the external vision system (7.0, 8.0), indicated that: - the localization plate (1.0) is fixed and positioned on the patient's bone (5.0) with one screw (4.0), in such a way that the localization plate has three holes; two holes (1.5, 1.6) that serve for repetitive positioning of the plate and a through hole (1.4) for the passage of the threaded screw body (4.0) for attachment to the bone (5.0); - where each of the mentioned markers (1.2) has an additional centrally placed circular hole (1.3) placed perpendicular to the common plane of all markers, which serves for accurate optical localization; and - where all connectors of the centers of the circular holes (1.3) of each of the markers (1.2) with the nearest neighboring center of the circular hole (1.3) form a set of mutually parallel or vertical lines consisting of at least one parallel and at least one vertical line. 2. Set for fixing the localization plate, characterized by the fact that it consists of: - screw (4.0) which has two protrusions (4.1, 4.2) that interact with the holes (1.5, 1.6) on the localization plate (1.0) intended for accurate positioning of the localization plate (1.0) on said screw (4.0); the thread (4.5) of the screw (4.0) that passes through the through hole (1.4) of the localization plate (1.0), with which said localization plate (1.0) is tightened against the supporting plate (4.6); where said screw (4.0) on the lower side of the support of the plate (4.6) has a waist (4.4), the length of which is chosen according to the place of installation, depending on the thickness of the soft tissue (5.1), and whose lower part of the waist (4.4) is made in the form of a thread ( 4.5) which twists into the bone (5.0); - nuts (3.0) with the lower side made in the form of a ball calotte (3.2); and - key (6.0) for twisting and turning the screw (4.0) in the bone (5.0) of the patient. 3. Set for fixing the localization plate according to claim 2, characterized by the fact that the nut (2.0) is additionally equipped with a spike (2.2) for optical measurement of the positioning error, as well as marker marks (2.1) in the form of shallow notched grooves placed at a previously defined distance, which determine the unit dimension during optical reading. 4. A set for fixing the localization plate by gluing it directly to the patient's skin, indicated by the fact that it consists of: an adhesive based on collodion preparations, as well as a preparation for removing the plate based on alcohol. 5. The use of a localization plate, indicated by the fact that it is used in conjunction with stereotactic frames.