BG3956U1 - Universal system for stereotactic guidance in neurosurgical interventions for ventriculopuncture - Google Patents

Abstract

The present utility model relates to a universal system for stereotactic guidance in neurosurgical interventions for puncturing the cerebral ventricles (ventriculopuncture) according to claim 1.

Description

(54) UNIVERSAL STEREOTACTIC GUIDANCE SYSTEM FOR NEUROSURGICAL INTERVENTIONS FOR VENTRICULOPUNCTION

Field of technology

The present application for a utility model belongs to the field of stereotactic guidance systems in neurosurgical interventions for puncture of the cerebral ventricles (ventriculopuncture) and is essentially a universal system for stereotactic guidance in neurosurgical interventions for puncture of the cerebral ventricles.

BACKGROUND OF THE INVENTION

Ventriculopuncture is used in a wide range of neurosurgical diseases, such as the treatment of traumatic brain injuries, brain tumors and hemorrhages, and others that require measurement of intracranial pressure. The novelty of a universal system for stereotactic guidance is the ability to take into account the individual anatomical features of the patient with precise three-dimensional orientation and based on this to give individualized, accurate location of the entry point for ventriculopuncture, precise direction of penetration of the catheter to the brain. with precise angulation in coronary, sagittal and axial plan, security, recurrence and reliability of the intervention.

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

U.S. Pat. No. 5,891,157A, entitled "Apparatus for stereotactic surgical procedures", discloses a stereotactic navigation system for guiding a medical instrument, which includes a stereotactic frame for guiding the medical instrument during neurosurgical intervention. The system comprises a device for recording data of 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; controller for receiving and processing data and display for received images.

In patent US4613324A is entitled "Method and device for directing a catheter into the ventricular system of the human brain." The method involves positioning the device at the opening of the skull, cutting and coagulating the dura mater, directing 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 to the outer cranial surface. The guide is positioned to allow the catheter to enter at a 90-degree angle to the imaginary, tangential to the cranial surface in the area of the hole.

U.S. Pat. No. 5,569,267A is entitled "Method and device for parietal-occipital placement of ventricular catheters" and discloses a device which is a C-shaped bracket with an anterior fixation and a posterior guide portion. Once fixed to the skull, the device provides precise guidance of the catheter through the cannula of the posterior, leading part, to the posterior (occipital) horn of the ventricular system.

In patent US7925328B2 is entitled "Surgical navigation systems, including reference and localization frames" and discloses a method and device for performing stereotactic

BG 3956 UI surgery using a stereotactic navigation system. The method and apparatus use a stereotactic frame of the head, which has transmission coil arrays attached to it to allow automatic registration as well as tracking of the instrument with respect to the stereotactic frame of the head.

The above solutions, as well as a number of others, seek to position the patient's head exactly in absolute coordinates (most often relative to the operating table) and then to bring and orient the instrument again in absolute coordinates relative to the head thus positioned. These systems are usually voluminous, multicomponent, require complex binding and fixed rigid positioning in preoperative imaging, and their application is too labor-intensive and time-consuming for an often emergency intervention such as ventriculopuncture. Another part of the devices has a simplified structure and application, but does not take into account the specific shape and size of the patient's head and does not provide good enough accuracy of the procedure and the direction of the catheters to the ventricular system. In most systems, the problem of transition from preoperative, non-sterile measurements to a sterile environment and application (reproduction) of the measurements in a sterile environment is not solved easily and unambiguously.

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

Technical essence of the utility model

To overcome the above shortcomings, now with developed an innovative universal system for stereotactic guidance in neurosurgical intervention for ventriculopuncture (leaving a catheter in the frontal horn of the ventricular system) and a method of using it.

The current utility model is based on the idea of significantly improving the accuracy of the surgical instrument (ventricular catheter) by determining the exact location of the inlet of 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 size so that it steps firmly on several nodal points of the patient's skull (nasal root and external ear canals) and fits on the head in the area of the intervention site (inlet), in a way determined by the individual features 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 is achieved by moving from work to absolute coordinates of the point of entry and angles of guidance and guidance to relative coordinates of the entrance and angles to nodal and fixed elements of the patient's skull, such as the ear line (the line connecting the two ears). hole), longitudinal surface of symmetry (left / right part of the head) and the root of the nose (nasion). An additional advantage of the method and the device is the easy and convenient separation of a sterile and non-sterile group of elements and the lack of

BG 3956 UI sterilization after each intervention due to the use of part of the system as disposable items. Another significant advantage is the lack of adjustment elements during the intervention - the different guides have predefined angles and you only need to choose the right guide. This saves time and improves the accuracy of the procedure.

The purpose of this utility model is to create an innovative for the world market medical guidance system - a universal system for stereotactic guidance in neurosurgical interventions for ventriculopuncture, increasing the accuracy of catheter placement of intracranial pressure in the ventricular system, according to individual individuals.

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

The device consists of: non-sterile universal system for stereotactic guidance is a movable unit that 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.

The device of the universal system for stereotactic guidance in neurosurgical interventions for ventriculopuncture, according to the present disclosure allows fast and reliable placement on the patient's head using three benchmarks - the two external auditory canals and the root of the nose (nasion). The device changes its size so that it is positioned stably and fits on the head in the area of the intervention site, in a way determined by the individual characteristics and configuration of the skull of the particular patient.

When the frame is stably positioned, readings are made from two scales located on the device: one for the distance of the inlet from the external auditory canals and the other for the individual inclination of the skull in the area of the inlet. The first scale has three levels - A, B and C and is determined by the position of the centrally located handle (N5 in the drawing). The second scale has five levels - 0, I, II, III and PP and is determined by the position of a special element called "swing" (N4 in the drawing).

Based on these two quickly determined values of the scales, a leading element (guide) is selected from the proposed set of guides. Each guide provides a well-defined penetration angulation, which is based on the readings (A, B and C and 0, 1, II, III and PP) and ensures precise penetration to the frontal horn of the ventricular system.

The special element marked "swing" (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 swing is marked with a surgical felt-tip pen on the patient's skin. These benchmarks will serve to position the sterile replacement platform during the intervention itself. This ensures a transition from preoperative, non-sterile measurement to the sterile conditions required for any neurosurgical intervention.

BG 3956 UI

During the intervention, the selected guides are attached to a special replacement sterile platform. This replacement sterile platform has a geometry, contact surfaces to the head and marking surfaces completely identical to those of the "swing" of the universal stereotactic guidance system. After being accessed through the soft tissues and skull by the surgeon, he places the replacement platform in place completely identical to that of the “cradle of the universal stereotactic guidance system along the marker lines previously made by the universal stereotactic guidance system. In the special box of the replacement platform is placed and fixed selected from the set of sterile replaceable guides, which corresponds to the indicators read by the universal stereotactic frame (A, B and C and 0,1, II, III and PP). In this way, the most accurate positioning and orientation of the catheter for measuring the intracranial pressure and ventriculopuncture in the required direction is performed, after which it is introduced and penetrates to the required depth to reach the frontal horn of the ventricular system.

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

Placement of the universal system for stereotactic aiming on the patient's head and stable fixation in both ear canals, the root of the nose and the position of the "swing" corresponding to the curvature of the head. Marking the position of the "swing" on the skin with a surgical felt-tip pen.

With this arrangement of the universal system for stereotactic guidance, two scales are read - one for the distance of the ear line, which is read in three degrees - A, B and C and one for the slope of the local surface of the skull in the area of penetration in five degrees. - 0, 1, II, III and PP,

Based on these two values determined quickly and easily, a guide (leading, guiding element) is selected from a set of sterile guides, which will be used in the next stages of the intervention. The next steps are performed under sterile conditions, during the intervention itself. A replacement sterile platform is placed in a place identical to the "swing" and pre-marked in step 1. This identifies the exact place where the skin incision and the skull are punctured (trepanation hole).

In the last step, the selected sterile guide is placed and fixed in a special bed on the replacement platform. The guide provides the necessary direction (angulation) of penetration into the axial, coronary and sagittal plane. The sterile platform and the placed special sterile guide ensure the precise directing of the catheter when it penetrates the ventricular system.

The special disposable guides are developed in a set of 3 x 5 or a total of 15 combinations with a unique spatial orientation determined by the various corrective angles in the anterior-posterior direction (coronary plan) and medio-lateral direction (sagittal plan). The choice of a specific guide depends on the indications of the universal system for stereotactic targeting on both scales - for the distance of the ear line, which is read (A, B and C) and for the slope of the local surface of the skull in the area of penetration (0,1, II , III and PP);

Explanation of the attached figures

Figure 1. Presents a schematic representation of the positioning of a universal system according to the present disclosure;

BG 3956 UI

Figure 2 shows a universal system according to the present disclosure in cross section along the line S1-S1, showing clear visibility of the position of the components;

Figure 3 shows a close-up view of the universal system according to the sectional view along the line S2-S2;

Figure 4 shows a top view of the universal system according to the disclosure in the operating position and enlarged visibility views of the swing angular position indicator and the head size zones;

Figure 5 shows the universal system according to the present disclosure in disassembled form,

Figure 5.1 shows a perspective view of handle 5;

Figure 5.2 shows a view of the main body 1 with visibility of the cup-shaped bed and the latch of the universal system according to the disclosure;

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

Figure 7 shows the sterile platform and the guide 7 in operating mode;

Figure 8 shows a top view of the universal system according to the disclosure of a step before placing the guide 7 and with the guide 7 placed;

Example of implementation of the utility model

With reference to the accompanying drawings, a particular embodiment of the universal system of the disclosure and the method by which neurosurgical intervention is performed for ventriculopuncture in the treatment of traumatic brain injury and for measuring intracranial pressure will now be disclosed.

By means of the universal system according to the present disclosure, a new method of stereotactic targeting is provided, which uses the characteristic well-known and widely used benchmarks of human head anatomy. These are the line formed by the ear canals of the left - L and right R human ear - or the so-called "ear line" and the nasal point - N located in the saddle of the nose. Determine the purpose of the intervention point T, which may be located in the left or right hemisphere of the head. Reaching the goal is carried out through a point of intervention - item 0 lying on the surface of the head on the same side relative to the sagittal plane, from which is item T (Figure 1).

In the preferred embodiment, the stereotactic targeting method, the coordinates of points 0 and T forming the spatial line OT are considered. The projection of this line in the sagittal plane S is determined by the point T and the ear line, and in this projection the point L and the point R coincide and a common point is formed. Thus, the intervention point item 0 must lie on the line defined by the common point of the ear line L = R and the target item T (Figure 1). In the sagittal plane, the location of item 0 can be uniquely 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 = R0 and the linear dimension H in the direction of the lines LO - R0 . Thus, the coordinates of the point T can also be found, as a point lying on the line LO = R0 and spaced from the point O by a distance h. The other projection of the spatial line OT is located in a plane perpendicular to the sagittal plane S and coinciding with the line LO = R0. There, for intervention in the right hemisphere of the head, item T lies on a line consisting of the displacement of item 0 at a distance DR relative to the sagittal plane - S and the displacement of item 0 distance SR in the direction of the ear line

BG 3956 UI channels RL 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 (Figure 1).

The universal system for stereotactic guidance in neurosurgical interventions for ventriculopuncture, in one embodiment consists of a main body 1 (figure 5), to which through specially shaped holes 1.1 is mounted with the possibility of rotation arm 2 through the axes formed in it 2.1, to the main body 1 are mounted movably along an arcuate trajectory with movable elements "bracket" 3, assembled twice to the left and right (figure 5), on one side of the bracket 3 along the side edge is formed a toothed rack 3.1 with teeth, and at the opposite end, special brackets 3.2 are placed transversely for placement in the patient's ear canal. To the main body 1 in the specially formed holes 1.1 is mounted movable swivel about holes 4.1 and around the axes 2.1 of the arm 2, swing 4, fixed exactly on the same axis of the hole 1.1. Attached to the main body 1 is a handle 5 with teeth formed on its front forehead on a gear wheel 5.1 with a channel 5.2 formed below it, and radial depressions are formed in the bottom of the channel. The handle 5 is connected to the main body 1 when the two identical brackets 3 are located inwards in the main body 1 in which the teeth of the gear 5.1 of the handle 5 are engaged unambiguously with the teeth of the rack 3.1 of the brackets 3. Mounting the handle 5 to the main body 1 is made by elastic elements 1.2 of a specially shaped cup-shaped bed 1.6 and do not allow disassembly of the handle 5 by falling and locking in the channel 5.2 (figure 5.2). For the clear rotation of the handle 5, engaged by the teeth of the gear 5.1 on both sides with the teeth of the rack 3.1 of the brackets 3, in the bottom of the channel 5.2 are formed radial concave zones in which falls and retains a clamp 1.4 of the main body 1 shaped radially movable in the cup-shaped bed 1.6 (Figure 5.2).

The operation of the universal system for stereotactic guidance in neurosurgical interventions for ventriculopuncture, according to the present disclosure for the application of the developed method is as follows:

First preparatory stage - a universal system for stereotactic guidance is placed on the patient's head, as special brackets 3.2 of the brackets 3 are placed in the patient's ear openings, and the arm 2 rotates through its axis 2.1 around the opening 1.1 of the main body 1 and so on that a specially shaped "omega" end of the shoulder 2 is positioned exactly at the root of the nose (nasion) and is positioned firmly in the nasal saddle. By rotating the handle 5, the left and right brackets 3 are moved simultaneously and symmetrically, until the cradle 4 is firmly and firmly fixed on the surface of the patient's skull, contacting the surface by means of four convexly shaped elements 4.1 to 4.4 (Figure 3 and Figure 8). on the head. When achieving a stable position of the universal system, it is necessary to take into account the angular position of the handle 5 marked with A, B and C according to which letter is closest to the provided marker 1.5 of the main body 1. The angular position is taken into account of the swing 4 in relation to the main body 1, which is realized by reading through a specially shaped window 4.8 in the swing 4 taking into account the visible symbol groups 1.3

BG 3956 UI marked with 0, 1, II, III and PP and marked on an arcuate surface around the specially shaped opening 1.1 (Figure 8).

Marking lines should be applied to the patient's skin using the contour of the convexly shaped element 4.4 and the centering V-shaped channel 4.5 to accurately mark 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 taken and the position of the cradle is marked unambiguously and precisely. These marker lines will be used to position the sterile replacement platform in the following steps.

According to the determined values of the angular position of the handle 5 - A, B or C, depending on which letter is closest to the marker 1.5 from the main body 1 and the reading through a specially shaped window 4.8 in the swing 4 taking into account the visible symbol groups 1.3 formed on an arcuate surface around the specially formed hole 1.1 of 0, 1, II, III or II according to a special table it is determined which of the available in the set of replaceable guides to be chosen for the correct patient (preferably 5x3 15 guides with different angulations, but a set with another scope).

The second working stage is during the surgery itself and takes place in sterile conditions. This requires the use of sterile disposable items. On the applied marker lines outlining the cradle of the universal system for stereotactic guidance, there is a replacement sterile platform 6 - with a pre-selected guide 7 (figure 6) connected, which guides the instrument during the intervention. Each guide 7 is protected from incorrect installation by a specially formed contact surface of a sterile platform - bed 6.7 (figure 6), which does not allow incorrect placement and fixing of the guide 7 and respectively - of the guide hole - 7.1. Depending on whether you are working left or right (respectively in the left or right hemisphere), different, uniquely marked guides are used. Both sterile elements - the platform 6 and the uniquely connected element - the guide 7, are destroyed after use. The universal stereotactic guidance system (Figure 7 and Figure 8) can be sterilized and reused.

Claims (3)

Claims Universal system for stereotactic guidance in neurosurgical interventions for ventriculopunctures, characterized in that it consists of a main body (1), to which a arm (2) is mounted by means of specially shaped holes (1.1), which is rotatable by means of axes (2.1) formed therein, in which brackets (3) are provided movably along the main body (1) movably along their length in an arcuate trajectory, provided twice to the left and right, along the side edge of one side of the bracket (3) a toothed rack (3.1) is formed along the teeth, and at the opposite end brackets (3.2) are placed transversely for placement in the patient's ear canal, and to the main body (1) in the specially shaped holes (1.1) is mounted movably rotating about provided openings (4.1) and around the axles (2.1) of the arm (2), a swing (4) attached to the axis of the opening (1.1), whereby the main body (1) is connected by elastic elements (1.2) falling and locking in channel (5.2) of a special shape but a cup-shaped bed (1.6), and a handle (5) with teeth formed on its front forehead on a gear wheel (5.1) with a channel formed below it (5.2), in the bottom of which radial depressions are formed, whereby the teeth of the gear wheel 5.1) from the handle (5) are engaged unambiguously with the teeth of the toothed rack (3.1) from the bracket (3), where at the bottom of the channel (5.2) are formed radial concave zones, for receiving and holding a retainer (1.4) provided on the main body (1) formed radially movable in a cup-shaped bed (1.6). System according to claim 1, characterized in that the swing (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 surface of the head of patient to apply marker lines on the patient's skin along the contour of a convexly shaped element (4.4) and a centering V-shaped channel (4.5), which is to accurately mark the location of the swing (4) on the surface of the patient's head. System according to claim 1, characterized in that the handle (5) is for symmetrical position with respect to the median, sagittal line of the head with the participation of a gear (5.1) and a toothed rack (3.1) and for achieving simultaneous and symmetrical displacement of the the left and right brackets (3) when the brackets (3.2) are placed in the ear canals and along the ear line.