BG113167A - Universal system for stereotactic guidance in neurosurgical interventions for ventriculopuncture and a method for implementation of the system thereof - Google Patents

Abstract

The present invention relates to a universal system for stereotactic guidance in neurosurgical interventions for puncturing the ventricles of the brain (ventriculopuncture), as well as to a method for stereotactic guidance in neurosurgical interventions for ventriculopuncture and drainage for craniocerebral diseases and other craniocerebral diseases. pressure, by means of the universal system according to claim 1.

Description

UNIVERSAL STEREOTACTIC GUIDANCE SYSTEM FOR NEUROSURGICAL INTERVENTIONS FOR VENTRICULOPUNCTURE AND METHOD OF STEREOTACTIC GUIDANCE USING THE SYSTEM

FIELD OF ENGINEERING

[00011] The present patent application belongs to the field of systems for stereotactic guidance in neurosurgical interventions for puncturing the cerebral ventricles (ventriculopuncture) and essentially represents a universal system for stereotactic guidance in neurosurgical interventions for puncturing the cerebral ventricles (ventriculopuncture). The present invention also relates to a method for stereotactic guidance in neurosurgical interventions for ventriculopuncture and drainage in the context of craniocerebral trauma and other diseases requiring measurement of intracranial pressure, by means of the universal system.

PRIOR STATE OF THE ART |0002| Ventriculopuncture is used in a wide range of neurosurgical diseases, such as the treatment of craniocerebral trauma, brain tumors and hemorrhages, and others in which measurement of intracranial pressure is necessary. The novelty of a universal stereotactic guidance system is the possibility to take into account the individual anatomical features of the specific patient with a precise three-dimensional orientation and, based on this, to give an individualized, precise localization of the entry point for ventriculopuncture. precise direction of penetration of the catheter to the cerebral ventricles with precise angulation in the coronary, sagittal and axial planes, security, repeatability and reliability of the intervention.

|0003| There are a large number of technical solutions that aim to solve the problem of precise positioning of catheters in the ventricular system:

|0004| Patent US5891157A entitled "Apparatus for Stereotactic Surgical Procedures" discloses a stereotactic navigation system for guiding a medical instrument that includes a stereotactic frame for guiding the medical instrument during neurosurgical intervention. The system contains a device for recording data on the patient and the location of the frame on his head; a device for tracking the position of the medical instrument relative to the stereotactic frame on the patient's head; a controller for receiving and processing data and a display for received images.

|0005| In patent US4613324A it is entitled "Method and device for guiding a catheter in the ventricular system of the human brain". The method involves positioning the device on the foramen of the skull, cutting and coagulating the dura mater, guiding and inserting a catheter into the ventricular system. The device indicates the direction of entry of the catheter into the ventricular system through a guide fixed on the external cranial surface. The guide is positioned so as to ensure the entry of the catheter at an angle of 90 degrees to the imaginary plane tangential to the cranial surface in the area of the bore.

|0006| In patent US5569267A it is entitled "Method and device for parieto-occipital placement of ventricular catheters" and discloses the device which is a C-shaped clamp with a front-fixing and rear-guiding part. Once fixed to the skull, the device provides precise guidance of the catheter through the posterior guide cannula to the posterior (occipital) horn of the ventricular system.

[0007] Patent US7925328B2 is entitled "Surgical navigation systems including reference and localization frames" and discloses a method and device for performing stereotactic surgery using a stereotactic navigation system. The method and apparatus uses a stereotactic head frame that has arrays of transmission coils attached to it. to allow automatic registration as well as tracking of an instrument with respect to the stereotactic head frame.

|0008] The above solutions, as well as a number of others, seek to precisely position the patient's head in absolute coordinates (most often relative to the operating table) and then guide and orient the instrument again in absolute coordinates relative to the thus positioned head. These systems are usually bulky, multi-component, require complex binding and rigid positioning in preoperative imaging, and their application is too difficult and time-consuming for an often urgent intervention such as ventriculopuncture. Another part of the devices have a simplified structure and application, but do not take into account the specific shape and dimensions of the patient's head and do not provide a sufficiently good accuracy of the procedure and of directing the catheters to the ventricular system. With most systems, the problem of moving from pre-operative, non-sterile measurements to the sterile environment and applying (reproducing) the measurements made in a sterile environment is not easily and unambiguously solved.

[00091 Based on the above, it is recognized that there is a need to provide a universal stereotactic guidance system with the ability to account for the individual anatomical features of the particular patient with a precise three-dimensional orientation and based on this to give an individualized, accurate localization of the entry point for ventriculopuncture, precise direction of penetration of the catheter to the cerebral ventricles with precise angulation in the coronary, sagittal and axial planes, security, repeatability and reliability of the intervention.

TECHNICAL ESSENCE

[0010] In order to overcome the above-mentioned disadvantages, an innovative universal system for stereotactic guidance in neurosurgical intervention for ventriculopuncture (catheter placement in the frontal horn of the ventricular system) and a method for using the same have now been developed.

[0011] The present invention is based on the idea of significantly improving the accuracy of guiding the surgical instrument (ventricular catheter) by determining the exact location of the entrance hole in the patient's skull and the exact angulation of penetration to reach the ventricular system (frontal horn) of the brain. Through a very easy-to-use mechanism, the device changes its dimensions so that it rests firmly on several nodal points of the patient's skull (root of the nose - nasion and external ear canals) and rests on the head in the area of the intervention site (the entrance hole) , in a manner determined by the individual characteristics and configuration of the skull of the particular patient. A big advantage is that the system works regardless of the positioning and orientation of the patient's head on the surgical table. This was achieved by moving from working in absolute coordinates of finding the inlet point and lead angles and guiding to relative inlet coordinates and angles to nodal and invariant features of the patient's skull, such as the ear line (the line connecting the two ears foramen), longitudinal surface of symmetry (left/right side of the head) and the root of the nose (nasion). An additional advantage of the method and device is the easy and convenient separation of a sterile and non-sterile group of elements and lack of sterilization after each intervention due to the use of part of the system as disposable elements. Another significant advantage is the absence of adjustment elements during the intervention - the different guides have pre-defined angles and only the correct guide has to be selected. This saves time and improves the accuracy of the procedure.

[0012] The aim of the present invention is the creation of an innovative medical guidance system for the world market - a universal system for stereotactic guidance during neurosurgical interventions for ventriculopuncture, increasing the accuracy when placing a catheter for measuring the intracranial pressure in the ventricular system, according to the individual anatomical features of the specific patient. patient.

[0013] The goal was achieved by creating a new device representing a universal system for stereotactic guidance in neurosurgical interventions for ventriculopuncture, which works according to a new method.

|0014| The device consists of: a non-sterile universal stereotactic guidance system with movable joints, which captures the individual anatomical features of the patient's head; sterile replacement platform; a set of sterile replaceable guides that guide the instrument during the intervention itself.

|0015] The device of the universal system for stereotactic guidance in neurosurgical interventions for ventriculopuncture, according to the present disclosure allows rapid and reliable positioning on the patient's head by using three landmarks - the two external auditory canals and the root of the nose (nasion). The device changes its dimensions so that it is positioned stably and fits on the head in the area of the intervention site, in a manner determined by the individual characteristics and configuration of the skull of the particular patient. |0016| When the frame is firmly positioned, readings are made of the indicators from two scales located on the device: one for the distance of the entrance hole from the external auditory passages and the other - for the individual inclination of the skull in the area of the entrance hole. The first scale has three grades - A, B and C and is determined by the position of the centrally located handle (N5 in the drawing). The second scale has five degrees - 0, I. II, III and PP and is determined by the position of a special element named "cradle" (N4 in the drawing).

|0017] On the basis of these two quickly determined scale values, a leading element (guide) is selected from the proposed set of guides. Each guide provides a precise penetration angulation that is based on the readings (A, B and C and 0.1, Π, III and PP) and ensures precise penetration to the frontal horn of the ventricular system.

|0018| The special element labeled "cradle" (N4 in the drawing) has a shape and dimensions identical to a sterile replacement platform. After the stable positioning of the universal frame, the exact position of the cradle is marked with a surgical marker on the patient's skin. These benchmarks will serve to position the sterile replacement platform during the intervention itself. This ensures a transition from pre-operative, non-sterile measurement to the sterile conditions required for any neurosurgical intervention.

|0019| During the intervention, the selected guide is attached to a special replacement sterile platform. This replacement sterile platform has geometry, contact surfaces to the head and marking surfaces completely identical to the "cradle" tracks of the universal stereotactic guidance system. After access through the soft tissue and cranial bone is achieved by the surgeon, he places the replacement platform in a location completely identical to that of the universal stereotactic guidance system "cradle" along the universal stereotactic guidance system marker lines previously made. In the special bed of the replacement platform, the one chosen from the set of sterile replaceable guides that corresponds to the indicators reported by the universal stereotactic frame (A, B and C and 0, I, Π, III and PP) is placed and fixed. In this way, the maximally accurate positioning and orientation of the intracranial pressure measurement and ventriculopuncture catheter is achieved in the required direction, after which it is introduced and penetrated to the necessary depth to reach the frontal horn of the ventricular system.

|0020] The five main steps of the method can be described as follows:

|0021 ] Placement of the universal stereotactic guidance system on the patient's head and stable fixation in both ear canals, the root of the nose and the "cradle" position corresponding to the curvature of the head. Marking the position of the "cradle" on the skin with a surgical marker.

(0022 ] In this arrangement of the universal stereotactic guidance system reading is done on two scales - one for the distance of the ear line, which is read in three degrees - A. B and C and one for the inclination of the local surface of the skull in the area of penetration in five grades - 0.1, Π, III and PP;

|00231 On the basis of these two determined values, a guide (guide, guiding element) is selected from a set of sterile guides, which will be used in the following stages of the intervention, quickly and easily.

[0024] The following steps are carried out in sterile conditions, during the intervention itself. A replacement sterile platform is placed in a place identical to the "cradle" and previously marked in step 1. This also identifies the exact place where the skin incision and the drilling of the skull (trepanation hole) will take place.

[0025] In the last step, the selected sterile guide is placed and fixed in the special bed of the replacement platform. The guide provides the necessary direction (angulation) of penetration in the axial, coronal and sagittal planes. The sterile platform and the inserted special sterile guide ensure the precise guidance of the catheter during its penetration into the ventricular system.

[0026| The special disposable guides are developed in a set of 3x5 or a total of 15 combinations with a unique spatial orientation determined by the different correction angles in the antero-posterior direction (coronal plane) and medio-lateral direction (sagittal plane). The choice of a specific guide depends on the indications of the universal system for stereotactic guidance on both scales - for the distance of the ear line that is read (A, B and C) and for the inclination of the local surface of the skull in the penetration area (0.1, II, III and PP);

BRIEF DESCRIPTION OF THE ATTACHED FIGURES |0027|

Figure I. Represents a schematic representation of the positioning of a universal system according to the present disclosure

Figure 2 shows a universal system according to the present disclosure in cross-section along the line S1-S1, presenting a clear view of the position of the constituent elements.

Figure 3 shows a close-up view of the universal system, as shown in a cross-section along the S2-S2 line. head size. Figure 5 shows the universal system according to the present disclosure in an exploded view.

Figure 5.1 presents a perspective view of the handle 5

Figure 5.2 presents a view of the main body (1) with visibility of the cup-shaped bed (bed) and the retainer of the universal system, according to the disclosure.

Figure 6 is a perspective view of the sterile platform and guide (7)

Figure 7 shows the sterile platform and guide (7) in working mode

Figure 8 shows a top view of the universal system according to the disclosure at a stage before the guide (7) is inserted and when the guide (7) is inserted

PREFERRED EMBODIMENT OF THE UNIVERSAL SYSTEM AND METHOD ACCORDING TO THE DISCLOSURE |0028] With reference to the accompanying drawings, a particular embodiment of the universal system and method of the disclosure will now be disclosed in which a neurosurgical intervention for ventriculopuncture in the treatment of brain injuries and for measurement of intracranial pressure.

[0029] By means of the universal system, according to the present disclosure, a new method of stereotactic targeting is also provided, which utilizes the characteristic well-known and widely used landmarks of the anatomy of the human head. These are the line formed by the ear canals of the left - L and right - R ear of the person - or the so-called "ear line" and the nasal point - N located at the bridge of the nose. The T point, which can be located in the left or right hemisphere of the head, is the target of the intervention. Achieving the goal is carried out through a point of intervention - t.O lying on the surface of the head on the same side relative to the sagittal plane from which t.T is (Fig. 1).

[00301 In the preferred embodiment, the stereotactic targeting method considers the coordinates of points 0 and T forming the spatial line OT. The projection of this line in the sagittal plane -S is determined by point T and the ear line, as in this projection point L and. R match and a common point is formed. Thus, the intervention point point 0 must lie on the line determined by the common point of the ear line L = R and the target point T (Fig. 1). In the sagittal plane, the location of point 0 can be unambiguously determined by the length of the arc HL characterizing the curvature of the frontal bone, the central angle β formed by the lines LN = RN and LO = RO and the linear dimension H in the direction of the line LO = R0. Thus, the coordinates of point T can be found, as a point lying on the line LO = RO and distant from point О at a distance h. The other projection of the spatial line OT is located in a plane - Θ perpendicular to the sagittal plane S and coinciding with the line LO = RO. There, for intervention in the right hemisphere of the head, point T lies on a straight line composed of the displacement of the point DR at a distance DR relative to the sagittal plane - S and the displacement of the point SR at a distance SR in the direction of the line of the ear canals LR. Respectively, for the left hemisphere of the head, the offsets are at distances DL and SL. Thus, the coordinates of the intervention point 0 and the target point T are precisely and unambiguously defined (Fig. 1).

[0031| The universal system for stereotactic guidance in neurosurgical interventions for ventriculopuncture, in one exemplary embodiment, consists of a main body I (fig. 5), to which, through specially shaped openings 1.1, a rotatable arm 2 is mounted through the axes 2.1 formed therein, to the main body 1 are mounted movably along their length along an arcuate trajectory with movable elements "clamp 3, assembled twice on the left and on the right (fig. 5). on one side of the bracket 3, along the side edge, a toothed rack 3.1 with teeth is formed, and at the opposite end, special brackets 3.2 are transversely located for insertion into the patient's ear opening. To the main body 1, in the specially shaped holes 1.1, a swing 4 is mounted, which can be rotated around the holes 4.1 and around the axes 2.1 of the arm 2, fixed precisely on the same axis of the hole 1.1. A handle 5 is attached to the main body 1 with gear teeth 5.1 formed on its front face with a channel 5.2 formed below it, and radial recesses are also formed at the bottom of the channel. The handle 5 is connected to the main body 1 when the two identical clamps 3 are located in the innermost part of the main body 1, in which the teeth of the gear wheel 5.1 of the handle 5 are uniquely engaged with the teeth of the gear rack 3.1 of the clamps 3. The mounting of the handle 5 to the main body 1 is carried out by means of elastic elements 1.2 of a specially shaped cup-shaped bed 1.6 and do not allow reverse disassembly of the handle 5 by falling and locking in the channel 5.2 (fig. 5.2). For the clear rotation of the handle 5, engaged through the teeth of the gear wheel 5.1 bilaterally with the teeth of the rack 3.1 of the clamps 3, and at the bottom of the channel 5.2 are formed radial concave areas, in which falls and holds a retainer 1.4 of the main body 1 formed radially movable in the cup-shaped bed 1.6 (Fig. 5.2).

[0032] The action of the universal system for stereotactic guidance in neurosurgical interventions for ventriculopuncture, according to the present disclosure for applying the developed method is as follows:

|0033| First preparatory stage - a universal stereotactic guidance system is placed on the patient's head, the special consoles 3.2 of the clamps 3 are placed in the patient's ear holes, and the arm 2 is rotated by its axis 2.1 around the opening 1.1 of the main body 1 and so on , that the specially shaped "omega" end of shoulder 2 is positioned exactly at the root of the nose (nasion) and is positioned stably in the nasal bridge. By turning the handle 5, the left and right clamps 3 are moved simultaneously and symmetrically, until the cradle 4 is firmly and firmly established on the surface of the patient's cranial box, contacting through four convexly shaped elements 4.1 to 4.4 (fig. 3 and fig. 8) with the surface of the head. When achieving a stable position of the universal system, it is necessary to read the angular position of the handle 5 marked with A, B and C according to which letter is closest to the intended marker 1.5 of the main body 1. The angular position is also read of the cradle 4 relative to the main body 1, which is carried out by reading through a specially shaped window 4.8 in the cradle 4, taking into account the visible symbol groups 1.3 marked with 0,1, І, Ш and ПП and marked on an arc-shaped surface around the specially shaped opening 1.1 (fig. 8).

[0034| Marker lines should be applied to the patient's skin using the contour of the convex shaped element 4.4 and the centering V-shaped channel 4.5 to accurately indicate the location of the cradle 4 on the surface of the patient's head. In this way, the individual features of the patient's head are removed and the position of the cradle is marked unambiguously and precisely. These marker lines will serve to position the sterile replacement platform in subsequent stages.

[0035] According to the determined values of the angular position of the handle 5 - A, B or C according to which letter is closest to the marker 1.5 of the main body 1 and the reading through a specially designed window 4.8 in the cradle 4 reading the visible symbol groups 1.3 formed on an arc-shaped surface around the specially shaped opening 1.1 of 0,1, II, Ill or PP according to a special table it is determined which of the available in the set of replaceable guides should be selected for the correct patient (preferably 5x3=15 guides with different angulations, but it is possible and set is another scope).

|0036| The second working stage is during the surgical intervention itself and takes place in sterile conditions. This necessitates the use of sterile single-use items. Along the marked marker lines delineating the cradle of the universal stereotactic guidance system, a substitute sterile platform 6 is placed with an attached preselected guide 7 from the set (Fig. 6), which guides the instrument during the intervention itself. Each guide 7 is protected from incorrect installation by a specially designed contact surface on a sterile platform - bed 6.7 (fig. 6) which prevents incorrect placement and fixing of the guide 7 and, respectively, of the guide hole - 7.1. Depending on whether one works on the left or the right (in the left or right hemisphere, respectively), different, unambiguously marked guides are used. Both sterile elements, the platform 6 and the uniquely attached element - the guide 7, are destroyed after use. The universal stereotactic guidance system (Fig. 7 and Fig. 8) can be sterilized and reused.

Claims (6)

1. A universal system for stereotactic guidance in neurosurgical interventions for ventriculopuncture, characterized by the fact that it consists of a main body 1, to which an arm (2) is mounted through specially shaped holes (1.1), which can be rotated by means of shaped in it axles (2.1), whereby clamps (3) are mounted to the main body (1) movably along their length in an arcuate trajectory. provided on the left and right twice, a toothed rack (3.1) with teeth is formed along the lateral edge of one side of the bracket (3) lengthwise, and special brackets (3.2) are transversely located at the opposite end for insertion into the patient's ear hole , and to the main body (1) in the specially shaped holes (1.1) a swing (4) fixed to the axis of the hole (1.1) is mounted movable and rotatable around the provided holes (4.1) and around the axes (2.1) of the arm (2) . wherein it is connected to the main body (1) by means of elastic elements (1.2) falling and locking in a channel (5.2) of a specially shaped cup-shaped bed (1.6). and a handle (5) with the teeth of a gear wheel (5.1) formed on its front face with a channel (5.2) formed below it, in the bottom of which radial recesses are formed, whereby the teeth of the gear wheel (5.1) from the handle (5) are uniquely engaged with the teeth of the toothed rack (3.1) by the bracket (3), whereby radial concave areas are formed on the bottom of the channel (5.2) to receive and retain a retainer (1.4) provided on the main body (1), shaped radially movable in a cup-shaped bed (1.6). 2. System according to claim 1, characterized in that the cradle (4) is rotatably connected to the main body (1) along an axis (1.1) and is in connection with two convexly shaped elements (4.2) for contact with the head surface of patient for applying marker lines on the patient's skin along the contour of a convex shaped element (4.4) and a centering V-shaped channel (4.5), which is to accurately indicate the location of the cradle (4) on the surface of the patient's head. 3. System according to claim 1, characterized in that the handle (5) is for symmetrical positioning with respect to the mid-sagittal line of the head with the participation of a gear wheel (5.1) and a gear rack (3.1) and for achieving simultaneous and symmetrical displacement on the left and right brackets (3) when the special consoles (3.2) are placed in the ear canals and along the ear line. 4. A method for stereotactic guidance in neurosurgical interventions for ventriculopuncture and drainage in the context of craniocerebral trauma and other diseases requiring measurement of intracranial pressure, by means of a universal system according to claim 1, characterized in that it includes: - determination of the penetration site - entrance trepanation hole and the exact determination of the direction of entry of the catheter to the ventricular system, based on the determination of the individual anatomical parameters of the patient by means of the universal system, according to claim I and the following reference points: the ear line determined by the two external ear canals of the patient as special tips - (3.2) of clamps (3) are placed in the patient's ear openings; the nasal point of the patient's head in the nasal saddle by means of an arm (2) with a specially shaped "omega" end of the arm (2), by rotation about its axis (2.1) relative to an opening (1.1) of the main body (1) and symmetrically along sagittal surface of head symmetry; - by turning the handle (5), the length of the left and right brackets (3) is determined, which remain symmetrically long and reflect the individual distance from the external auditory canal to the midline of the skull; - a cradle (4) is positioned stably on the surface of the patient's cranial box contacting through four convex shaped elements (4.1 to 4.4) with the surface of the head depending on the individual shape of the skull of the specific patient; - after stable positioning of the stereotactic frame, read the angular position of the handle (5), indicated by A. B and C by marker (1.4) from the main body (1) and read the angular position of the cradle (4) in relation to the main body (1), which is carried out through a specially shaped window (4.8) in the cradle (4) on visible symbol groups (1.3), formed on an arcuate surface around an opening (1.1). - after determining an unequivocal choice of a guide (7) from the set of 15 guides, which are fixed to a sterile platform (6) equipped with a shaped surface in the form of a bed (6.7) the section of the surface of the skin of the head along the point of entry for instrument penetration, along the marked marker lines, a replacement sterile platform (6) with an attached pre-selected from a set of preferably 3x5 or another number of guides (7) is placed identically to the left or right of the replacement sterile platform (6), accordingly whether working in the left or right hemisphere. 5. A method according to claim 4, characterized in that the symmetrical positioning with respect to the mid-sagittal line of the head is carried out by the handle (5) by means of a gear wheel (5.1) and a gear rack (3.1), with a simultaneous and symmetrical displacement of the left and right brackets (3) with the special brackets (3.2) placed in the ear canals and along the ear line. 6. Method according to claim 4, characterized in that the guide (7) is protected from incorrect assembly to the replacement sterile platform (6) by a specially shaped contact surface - bed (6.7) and by a specially shaped contact surface of the guide (7 ) only in an unambiguous way, not allowing the misplacement of the guide hole (7.1) to the left or to the right to the substitute sterile platform (6), according to whether the work is done in the left or right hemisphere.