RU2767895C1 - Optical-surgical device for detection and recognition of neurovascular structures in the volume of biological tissue - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to optical-surgical devices for detecting and recognizing neurovascular structures in the volume of biological tissue. The device includes a housing with movable and fixed jaws fixed therein, a branch spreading unit and a fiber optic unit. The optical fiber unit includes a radiation source in the form of at least one optical fiber for supplying an optical signal for probing a biological tissue and a radiation receiver in the form of at least one optical fiber for receiving a return signal, made with the possibility of biological tissue spectroscopy. The radiation source and receiver are located in the jaws. The fiber optic unit and jaws are made with the possibility of subsurface contact probing of biological tissue with optical radiation of at least two wavelengths by the method for reflective diffusion spectroscopy. Radiation sources are placed on the working end on one of the branches, and receivers - on the working end on one of the remaining branches. The sources are combined into at least two groups located along separate non-coincident semi-axes directed away from the receiver. Each group of sources consists of at least two subgroups, each of which is designed to provide a signal at least two wavelengths. The sources of each subgroup are located at a distance of no more than 1 mm from each other. In working condition for probing biological tissue with divorced branches, the distance from each subgroup of sources to the corresponding receiver is at least 5 mm.

EFFECT: providing the possibility of probing biological tissue to a maximum depth of at least 5 mm with the identification of neurovascular structures and the possibility of changing the probing depth in the diagnostic process with small dimensions of the opto-surgical device.

12 cl, 11 dwg

Description

The technical field to which the invention belongs

The invention relates to the field of medicine, medical equipment and medical technology, and in particular to devices for diagnostics, incl. intraoperative and surgical manipulations, and is designed to detect and recognize local inhomogeneities that differ in optical properties from the surrounding biological tissues in the study area. It is possible to use the device for various types of surgery or invasive manipulations, as well as for probing through intact skin. In particular, the invention can be used in neurosurgery to detect and recognize neurovascular structures, main arterial and venous vessels and nerves, in the volume of biological tissue during operations to remove a brain tumor, including the endoscopic transnasal method.

State of the art

The task of detecting and recognizing neurovascular structures is especially relevant in neurosurgery when performing operations to remove neoplasms. The problem of the current methods of resection of skull base tumors by the endoscopic transnasal method lies in the complexity of the operation itself. Pathological tissue is removed with endoscopic instruments through the sinuses piecewise, several millimeters each. During the operation, there is a high risk of damage to neurovascular structures located in the volume of the tumor tissue. Damage to the cranial nerve leads to the loss of functionality of the muscles associated with the injured nerve, the loss of important physiological functions, and a significant deterioration in the quality of life; damage to an arterial vessel - to an instant lethal outcome.

To minimize damage to the main arteries during surgery, as well as to increase the degree of radical resection of the tumor tissue, special neurosurgical sensors are used for intraoperative Doppler ultrasound (USDG) [Sharipov O. I. et al. Experience in the use of intraoperative Doppler ultrasound in endoscopic transsphenoidal surgery // Journal "Issues of Neurosurgery" named after N.N. Burdenko. - 2016. - T. 80. - No. 2. - S. 15-20]. Ultrasound devices, ultrasound devices and sensors provide information about the presence of a vessel in the volume of biological tissue by the speed and direction of blood flow in the vessel. To scan the surgical field, a combined device with a movable working part is used, which makes it possible to locate vessels in different directions. The presence of an arterial vessel, its depth relative to the surface of the tumor is assessed by the monitor in the M-mode window (M-Mode). The disadvantage of such a device is the difficulty of using a separate USDG sensor in skull base neurosurgery with transnasal access due to the significant size of the USDG sensor compared to the size of any used neurosurgical instruments for manipulation and the small area of the operation. The ultrasound probe is not functionally compatible with surgical instruments. The disadvantage of the ultrasound sensor is also the difficulty of detecting nerve structures in the tissue volume. Device for ultrasound imaging of nerves and blood vessels presented in [Smistad E., Johansen K.F., Iversen D.H., Reinertsen I. Highlighting nerves and blood vessels for ultrasound-guided axillary nerve block procedures using neural networks // J. Med. Image. 2018. V. 5. N 4. P. 044004.], is not intended for a small surgical field with limited access, for example, endonasal neurosurgery. The identification of these structures is carried out by analyzing the resulting images that are difficult to interpret.

For intraoperative identification of cranial nerves, it is known to use trigger electromyography devices (t-EMG, t-EMG) and spontaneous electromyography (free run EMG, f-EMG) [Parthasarathy D. Thirumala, Santhosh Kumar Mohanraj, Miguel Habeych, Kelley Wichman, Yue Fang Chang , Paul Gardner, Carl Snyderman, Donald J. Crammond, Jeffrey Balzer. Value of Free-Run Electromyographic Monitoring of Extraocular Cranial Nerves during Expanded Endonasal Surgery (EES) of t7he Skull Base. Journal of Neurological Surgery Reports. 2013;74:R1. http://dx.doi.org/10.1055/s-0033-1346975; Shkarubo A.N. et al. Neurophysiological identification of cranial nerves in endoscopic endonasal surgery of tumors of the skull base // Journal "Neurosurgery Issues" named after N.N. Burdenko. - 2016. - T. 80. - No. 3. - S. 35-49.]. Neurophysiological identification of cranial nerves several times reduces the frequency of their damage, and as a result, improves the quality of life of patients. However, t-EMG only identifies motor and mixed nerves. The main disadvantages of t-EMG devices also include a wide area of current propagation through electrically conductive tissues, which can lead to excitation of distant nerve structures and a false response to stimulation, and the need to register the response with additional measuring instruments outside the area of nerve localization. A modern alternative to electrical nerve stimulation is optical infrared (IR) stimulation [Infrared neural stimulation of human spinal nerve roots in vivo / J. M. Cayce, J. D. Wells, J. D. Malphrus et al. // Neurophotonics. 2015. - 2(1). - R. 015007; Pulsed laser versus electrical energy for peripheral nerve stimulation / J. Wells, P. Konrad, C. Kao et al. // Journal of Neuroscience Methods. 2007. - 163(2). - P. 326-337.], which does not require direct contact of the device with the stimulated nerve and has a local effect. However, a significant limitation of such devices is the possibility of detecting the nerve only when it is located superficially and the need to use additional means to record the response of the stimulated nerve. Technical means of optical reflectance spectroscopy [Balthasar A., Desjardins A. E., M. van der Voort, et al. Optical Detection of Peripheral Nerves: An in Vivo Human Study // Regional anesthesia and pain medicine, 2012, Vol. 37, No.3, p. 277-82.] allow intraoperative differentiation of tissues by composition, for example, by the concentration of hemoglobin and lipids, however, they are not applicable to the analysis of deep tissue layers and are used to identify only superficially located nerves.

Surgical instruments widely used in clinical practice for manipulations with biological tissues, tumor removal, including transnasal access, do not allow intraoperative diagnostics of biological tissues, detection and recognition of local inhomogeneities in the volume of biological tissue, for example, neurovascular structures [Semyonov G.M. Modern surgical instruments. [Electronic resource], accessed 05.05.2021 https://www.litres.ru/gennadiy-semenov/sovremennye-hirurgicheskie-instrumenty/chitat-onlayn/]. Practical and functional are devices that combine the functions of surgical instruments and diagnostic devices.

An analogue of the claimed device is a clamping device based on two movable branches for detecting a nerve in the volume of tissue examined between the branches by the optical method when transilluminated in a wide band of 350-550 nm, or at individual frequencies, for example, 405 nm or 488 nm, or reflected from the clamped tissue radiation [WO 2018/229771 A1]. The radiation source in this device is located on at least one branch, and the radiation receiver on at least one of the branches. When the absence of a nerve is established, the clamped volume of tissue is bitten out with the same device. The tissue is not bitten out when a nerve is found in it. There are options for using different radiation sources: LEDs, lasers, white light sources, and various receivers - from photodiodes to CCD matrices. There is an implementation of the device with the possibility of docking it with an endoscope and/or a laparoscope. Both mechanical dissection and tissue removal, and dissection using ultrasonic or electrical energy are possible. The main disadvantage of this device is the inability to detect a blood vessel - arterial or venous, in the volume of biological tissue sandwiched between the branches and its identification.

Closest to the claimed solution is an opto-surgical device, a detailed description of which is given in [US Patent No. 9,925,008 B2]. This device relates to surgical forceps having components for treating and/or monitoring the tissue to be treated. In particular, these are surgical forceps for open and endoscopic operations based on light energy for connection (soldering, coagulation) and separation of tissues (cutting, biting out) and / or for diagnosing tissue properties. In this endoscopic surgical device, for surgical manipulations of connection and separation, laser radiation energy at wavelengths strongly absorbed by biological tissues is used. Diagnostics of biological tissues is also performed on the basis of radiation of wavelengths that are weakly absorbed by biological tissues, for example, in the near infrared region. The range of applied wavelengths is from 200 nm to 1100 nm. The device consists of a body and an end assembly based on two jaws functionally connected to the body. Each jaw has a tissue contact surface. By moving at least one jaw, their spaced or closed positions are ensured. In the second position, the jaws form a cavity inside between them to collect and hold the tissue, for example, when separating (cutting) the latter. The device solves the problem of reducing the number of simultaneously used tools/devices in the operating field, and allows you to do without additional tools. There are options for implementing the device with battery power, regulators for turning on / off the laser energy supply of the required wavelength, with a stopper or rack, with levers like scissors for manipulating jaws. There are different options for the supply of radiation to the tissue, fiber optic, with reflective or refractive elements, different options for the design of the jaws for diagnosing the state and composition of the biological tissue located between them. Variants of the device with different emitters are possible: white light sources, lasers, laser diodes, with lenses or fibers for supplying radiation to the tissue, with different wavelengths, with different switching modes (simultaneously or alternately), different numbers, different locations in the jaws. Device variants with different receivers are possible: from lenses, optical fibers to photodetectors (photodiodes, CCD matrices, etc.) - in different numbers and arrangements for measuring the optical properties of tissues. Receiver options for RF measurements are available. Options for the prototype device include a wide variety of spectroscopic measurements, including Raman spectroscopy for assessing the quality of crosslinking and identifying specific tissue types and their composition (collagen, proteins, water, etc.), measuring optical properties such as reflection and transmission, optical coherence tomography for tissue imaging. Diagnostics includes determining the composition of biological tissue (water saturation, blood supply, pathological changes, etc.), while it is possible to select the irradiation mode, energy level to achieve the desired surgical (therapeutic) effect. For the prototype, optical control of the distance between the branches is possible to ensure a certain thickness of the tissue captured for manipulations, so that the thickness is greater than the depth of penetration of optical radiation into the tissue, and the radiation is completely absorbed. Constructive solutions are possible for determining the spectral characteristics of tissue in transmission, for reflection, in different positions, at different wavelengths, for measuring temperature along a tissue sample between the jaws, for determining the position of the device relative to biological tissue by the signal reflected from the tissue, constructive solutions with the implementation of optical connections between branches, for postoperative visualization of tissues and analysis of the state of the tissue before and / or after surgical procedures. The device is controlled manually with the formation of control signals supplied to the controller, which synchronizes the operation of all sources and receivers. A variant of the implementation of the device is possible, in which the numerical values of important parameters, for example, the thickness of the captured tissue, are displayed on the screen in the form of numerical values, and/or an audible signal is given when the parameters deviate from the permissible values.

The main disadvantages of this device are the following:

- a small diagnosable volume of biological tissue clamped between the branches and a small depth of examination (no more than 3 mm for device options compatible with transnasal access); in addition, small volumes of tissue are also available for optical coherence tomography, which is used for tissue imaging;

- the inability to increase the depth of probing of biological tissue and in advance (before direct surgical procedures) to obtain information about neurovascular structures that are located deeper and damage to which is highly undesirable during the operation;

- poorly controlled or uncontrolled compression force of the branches, which is dangerous by possible spasm of the main arteries, which is especially critical for brain tissues in neurosurgery;

- the inability to implement time-resolved spectroscopy on small volumes of tissue between the branches, and, consequently, the impossibility of obtaining quantitative estimates of such optical parameters as absorption and transport scattering coefficients at different wavelengths, and conducting a quantitative analysis of the composition and structure of the studied volume of biological tissue with necessary accuracy and necessary spatial resolution;

- the absence of quantitative estimates of the dynamics of blood flow in vessels of different calibers, from microcirculatory to main, in the studied volume of tissue.

In addition, as follows from the literature data and the description of the closest solution to the claimed device (prototype), comprehensive information about the composition and structure of biological tissue is provided by spectroscopic methods, both broadband and in a narrow spectral range, and at individual wavelengths. A problematic situation arises when it is necessary to ensure the small dimensions of a diagnostic device with a characteristic transverse dimension of no more than 6 mm, for example, for transnasal access, and to carry out diagnostics to the maximum possible depth from the surface of the tissue volume under study, while providing the necessary spatial resolution/sensitivity for detection and recognition of neurovascular inclusions in the tissue volume. The coordinated (optimal) values of the specified parameters (device dimensions, probing depth, and sensitivity/resolution) are determined by the size and depth of neurovascular structures, the optical properties of nerves, arterial and venous vessels, and surrounding tissues, and the mutual arrangement of these structures in the studied tissue volume.

Devices for diagnosing the volume of tissue clamped between the jaws (with its subsequent biting out / dissection in the absence of vital structures, nerves and blood vessels) are designed for differential analysis of individual types of tissues according to relative optical, spectral characteristics at different wavelengths, integrally determined over the entire thickness of the clamped tissue volume, imaging characteristics, etc. These devices do not provide the desired maximum probing depth of at least 5 mm, taking only deformable surface layers of tissue into the fold between the jaws. In addition, these devices will capture a different volume of tissue between the jaws with significantly different viscoelastic properties of the tissue under study, which will lead to diagnostic errors, and with relatively hard/dense tissues, to the impossibility of deep probing or the impossibility of diagnosing at all. The solution presented in US Patent No. 9,925,008 provides a controlled gripping volume of tissue, but does not provide control of the squeezing force of the tissue volume between the branches, which can significantly distort the diagnostic result, for example, in the presence of a venous vessel, with loose, easily crushed tumor tissue, or vice versa with dense hard tissue.

The technical problem is the development of a device without the disadvantages listed above and designed to detect and recognize neurovascular structures in the volume of biological tissue, incl. for intraoperative, as well as for surgical procedures.

Disclosure of invention

The technical result of the invention is to provide the possibility of probing biological tissue to a maximum depth of at least 5 mm with the identification of neurovascular structures - obtaining reliable data on the presence of nerves, large and small arteries and veins in the volume of biological tissue, and the possibility of changing the probing depth in the diagnostic process at small dimensions of the opto-surgical device.

In addition, the invention in one of its embodiments makes it possible to control the pressing force of the jaws to the studied volume of biological tissue, which makes it possible to evaluate the viscoelastic properties of the tissue and the features of blood flow fluctuations in the studied volume, to eliminate motor artifacts in informative optical signals. This allows the identification of neurovascular structures in the volume of different tissues without reducing the recognition efficiency, which ensures reliable controlled contact of the device with the biological tissue under study during the diagnostic process.

The claimed device is universal, can have a different size range, various design options from manual to automated, can be used for both open neurosurgical operations and closed access or endoscopic, including transnasal, as well as for other types of surgical intervention , in plastic and reconstructive surgery and, in addition, to determine and recognize neurovascular structures through intact skin, for example, during venipuncture or location of peripheral nerves, as well as to detect and recognize local heterogeneities that differ in optical properties from the surrounding biological tissues in the study area , for example, pathological tissues, and can also have different controls: with manual, automated, automatic, - and with various options for automated or automatic control systems.

The technical result is achieved by an opto-surgical device for detecting and recognizing neurovascular structures in the volume of biological tissue, including a body with at least one movable and one fixed jaws fixed in it, or at least two movable jaws, a branch dilution unit, an optical or fiber optic unit, including at least one optical fiber for supplying an optical signal for probing biological tissue - a radiation source, and at least one fiber optic or bundle for receiving a return signal - a radiation receiver, made with the possibility of spectroscopy of biological tissue, while the source and receiver of radiation are located in the branches, according to the invention, the fiber optic unit and branches are made with the possibility of subsurface contact probing of biological tissue with optical radiation of at least two wavelengths (λ _i , i =1 .. K , K ≥2) from the range 650 - 950 nm, reflective diff ultrasound spectroscopy with time resolution to a maximum depth of at least 5 mm, while the branches on the side of the working ends are made with bevels towards the longitudinal axis of the device;

radiation sources are placed on the working end of at least one of the branches, and receivers - on the working end of at least one of the remaining branches;

the sources are grouped into at least two groups located along separate non-coincident semi-axes directed away from the receiver; each group of sources consists of at least two subgroups, each of which is designed to provide a signal at least two wavelengths (λ _i ,i=1..K, K≥2) from the specified range, the sources of each subgroup are located at a distance of no more than 1 mm from each other, and each subgroup is at a certain distance (r _j ,j=1..M,M≥2) from the receiver along the corresponding semi-axis, where K is the number of source wavelengths in each subgroup,M- the number of different distances from subgroups of sources to the corresponding receiver for each separately allocated group of sources of the group; in working condition for probing biological tissue with divorced branches, the distance from each subgroup of sources to the corresponding receiver is at least 5 mm.

Bevels from the side of the working ends of the jaws towards the longitudinal axis of the device can be made at an angle α to the perpendicular drawn to the longitudinal axis of the device with closed jaws, not less than half the average opening angle of the jaws in working condition when probing biological tissue and not more than half of the maximum possible opening angle of the branches.

The device may additionally contain a block for controlling the pressing force of the jaws against the studied biological tissue, including a force sensor built into the body, a block for docking with external positional and/or force control devices.

In addition, the device can be made with the possibility of subsurface contact electrical impedance probing of biological tissue, and equipped with electrodes brought to the working ends of the jaws to enable the implementation of bipolar or tetrapolar modes, at least one channel and at least one frequency from range from 300 Hz to 200 kHz or up to 1 MHz, current strength not more than 0.3 mA and current density that does not cause excitation of nerve and muscle fibers.

The housing preferably contains outer and inner guides (elements), with the possibility of their controlled coaxial movement relative to each other.

The branch dilution unit in one of the embodiments of the invention includes a movable lever movably connected to the body, a fixed body handle, rods rigidly connecting the branches to the movable lever, and a ratchet made with the possibility of fixing the angle of dilution of the branches. The movable arm can be connected to either the inner or outer guide by means of an eye rigidly attached to the respective guide and a roll pin.

The internal guide of the body can be made with a longitudinal internal cavity for the location of optical fibers and optical bundle(s) and rods from the jaws to the movable lever.

The device is made with the possibility of opening the branches to a certain angle and fixing the branches in this position.

For surgical manipulations with biological tissues, the jaws have cutting edges and grooves.

Preferably, the device has a block-modular design, in particular, it is made with the possibility of quick replacement of jaws with an internal guide, a movable lever and a ratchet.

The inventive device provides optimal values for the depth of probing and spatial resolution, which in different implementations ranges from 2 millimeters to several centimeters, in terms of sensitivity due to the possibility of implementing a spectroscopic method of subsurface sounding with a time resolution, which makes it possible to separate the effects of absorption and scattering, and, therefore, to conduct a finer analysis of the composition and structure of the studied volume of biological tissue with the possibility of increasing the depth of probing, allowing you to determine in advance / in advance the presence of an artery and / or nerve trunk of a certain caliber.

A distinctive feature of time-resolved spectroscopy is the model of a “semi-infinite” probed tissue volume, which is necessary and sufficient for the formation of so-called photon density waves, with the possibility of recording backscattered radiation. The claimed device ensures the implementation of this requirement by locating emitters and receivers at the ends of the device, directing irradiation deep into the tissue, and the minimum allowable distance between the subgroups of sources and the receiver is at least 5 mm. The inventive device with a greater probing depth can be combined with the diagnosis of the volume between the branches at the time of biting/dissection.

The inventive device provides a maximum probing depth of at least 5 mm with small dimensions of the device, for example, with a transverse size of the jaws and part of the body placed inside a biological object or in the operating field, not more than 6 mm, suitable for transnasal access in neurosurgery; reliable identification of neurovascular structures in the studied tissue volume; variable probing depth and spatial resolution/sensitivity, for example, to neurovascular structures in the tissue volume. All of the above advantages are realized by the opto-surgical device due to the controlled opening angle of the branches and various options for the location of several subgroups of sources, at least two in each of at least two groups, and at least one receiver for implementing a multi-distance approach to time-resolved spectroscopy , which provides the required depth, volume and spatial resolution.

Brief description of the drawings

The invention is illustrated by illustrative material, where in Fig. 1 shows a longitudinal section of an opto-surgical device (a), a top view of a variant of the working end of a circular section (b), an additional section of the internal guide (c) and a variant of the slider - an element of the rack - in section (d); in fig. Figure 2 shows additional sections of the device: a) a cross section with two guides, b) a cross section of jaws with cutting edges and an internal cavity of a complex profile, c) a longitudinal section of a jaw with a working tip, d) a cross section of the device with a view of the movable lever; in fig. 3 shows a variant of the opto-surgical device with a top-mounted movable handle; in fig. 4 shows the appearance of a variant of the opto-surgical device from opposite sides; in fig. 5 shows options for fastening elements (one-piece (a) and removable (b)) of an opto-surgical device to systems of positioning, position control and/or torque measurements; in fig. 6 shows options for using the device in conjunction with a system of guide elements (a) or when connected to a collaborative robotic arm (b); in fig. Figure 7 shows an embodiment of the working end of a small-sized optical-surgical device with a sector arrangement of the receiver and emitters in a closed state (a), a sectional view of the sector-type working end surface (b) and a device in the biological tissue probing mode with open jaws (c); in fig. Figure 8 shows the design options for the working end of the opto-surgical device, in cross section, when the uniformity of probing is ensured by an increase in the number of point sources (a) and / or receivers (b), the presence of a ruler or matrix of receivers (c) or an increase in the number of sliding jaws (d) , and a variant with built-in electrodes for single-stage electrical impedance probing (e) of the studied volume of biological tissue is presented; in fig. 9 shows individual examples of layouts of groups and subgroups of emitters relative to the receiver at the working end of the opto-surgical device; figure 10 and 11 shows the result of the use of opto-surgical device, in particular, figure 10 - the object of study (a): blood vessels, nerves, soft tissues of the human hand; layout of the device (b) with controlled separation of source fibers from the receiver fiber optic bundle; measuring instruments (c), from left to right: time-resolved spectrometer, robotic mini-manipulator and the working part of the test force-torque installation; figure 11 - the results of the correct detection and recognition of neurovascular structures relative to soft tissues, muscle and skin-fatty, measured by the method of spectroscopy with time-resolved optical parameters with the implementation of the possibility of changing the depth of tissue probing.

Positions in the drawings are indicated:

1 - branches, inside which fibers (29) and a bundle / bundles (30) pass and in a certain order (in groups and subgroups) exit at the working ends of the branches (the working end of the opto-surgical instrument (Fig. 2, b, c, fig. 6a, b and Fig. 7);

2 - internal guide of the body, moving (to an allowable distance) inside the outer guide (4);

3 - rods - rigid, non-deformable rods, pushing and spreading branches (1) by acting on the movable lever (5) and moving it relative to the fixed handle (11), controlled and fixed with the help of a rack, represented by elements: (9) - a plate with ledges and recesses (44) (or teeth), (10) - a ledge with a slot (cavity) in which the plate (9) is located, and (12) - a slider that moves up / down in the through hole in (10) and it can be a stop-lock for expanding the jaws at a certain angle when inserted into the recess (44) on the plate (9) of the rack (Fig. 1 and Fig. 2);

4 - outer guide of the housing, having: a cavity for the movable guide (2), an eye (13) with a slot (in the case of the upper attachment of the movable lever (5), as in Fig. 3) and holes for inserting the movable lever (5), a ledge in the form of a fixed handle (11), on which a fixed protrusion (10) is made, having a cavity in the form of a guide for the plate (9) of the rack (35) (Fig. 1, Fig. 2, Fig. 3, Fig. 4); an embodiment of the invention is possible, in which there is a longitudinal mounting ledge (19) for fixing the opto-surgical device in positioning support systems (systems of guide elements of the type (22)) and in automated systems of position-force control (such as collaborative robotic manipulators (26) (Fig. 5));

5 - movable lever that controls the branches (1), to which the branches are attached using rods (3), the upper end of which is allowed to rotate around the axis of the cylindrical pin (14), and the lower end of the lever (5) moves in the same plane relative to the fixed handle ( 11) the outer guide (4) of the housing (34), and to which the inner plate (9) of the rack is hinged (Fig. 1, Fig. 2, d, Fig. 3);

6 - a screw that fixes the relative position of the guides (2 and 4) of the body, internal to external, and protects the force sensor (7) from accidental impacts when the opto-surgical device is not used in the measurement (diagnostic) mode, but is moved (entered into operating field / output from the operating field) or provided (for this device) surgical procedures (Fig. 1 - 4);

7 - force sensor (for example, a miniature strain gauge with a diameter of not more than 15 mm) registers the pressing force in the measurement mode, when the screw (6) is loosened manually and does not fix the mutual fixed position of the inner (2) and outer (4) body guides, while the guide (2) moves relative to (4) and presses on the sensitive area of the force sensor (Fig. 1, Fig. 3 - 5),

8 - arbitrarily grouped optical fibers of sources (all can be combined with a single braid to be placed in the cavity of the inner (2) guide of the housing) and a separately passing fiber-optic bundle / bundles of the receiver (at least one) (Fig. 1 - 3); at the exit from the body (34) through the provided holes (18) (Fig. 4), all fibers and bundles can be combined with a single braid, with their subsequent separation at the opposite end in the form of standard connectors for connection to a spectrometer, made with the possibility of forming a probing optical radiation for time-resolved diffusion spectroscopy, for example, as described in RU 2736307 and reception of radiation scattered in the studied biological tissue in the opposite direction;

9 - inner plate of the rack (35) with notches / stops / teeth for setting the position of the movable lever (5) relative to the fixed handle (11) of the outer guide (4) of the body (34) and setting the required opening angle of the jaws (1), which determines the distance between groups of emitter fibers (29) (Fig. 7 a) and bundle/bundles of receivers (30) (Fig. 7 a), and, therefore, determining the probed depth, probed tissue volume and spatial resolution;

10 - protrusion of the fixed handle (11) of the outer guide (4) of the body (34), formed by radial generators, rigidly permanently fastened to the handle (11) and having an internal cavity for free movement of the plate (9) of the rack (35), plate ( 9) is hinged on the lever (5) (figure 1, a);

11 - fixed handle of the outer guide (4) of the housing (34), relative to which the movable lever (5) is moved by hand and its position is fixed by means of a ratchet (elements (9), (10) and (12)) (fig. 1, a, figure 4);

12 - a flat slider that fixes the opening of the ratchet in a certain position with the help of recesses (44) (grooves / ledges / teeth) in the plate (9) of the ratchet (35) (Fig. 1a, d) and fixes the opening of the branches (1) to a certain angle, from zero (jaws for insertion into the operating field are closed) through an intermediate one (s) to ensure the necessary position of the emitter fibers relative to the receiving tourniquet(s), to the maximum opening angle of the jaws for the maximum probing depth possible with this design of an optical-surgical instrument the studied biological tissue (with certain dimensional ratios of the entire device under the conditions of a surgical operation: from neurosurgical ones with transnasal access to abdominal ones with open access to the wound);

13 - ears (Fig.1, a and Fig. 2, d), rigidly connected with the inner guide (2), with the lower attachment of the movable lever (5) to them using a cylindrical pin (14) or an eyelet with a slot (as a monolithic part of the outer guide (4) of the housing or rigidly permanently connected to (4)) for inserting the movable lever (5) and its movable connection using a cylindrical pin (14) (Fig. 3);

14 - a cylindrical pin for the movable fastening of the lever (5), fixed in the ear (lugs) with removable fasteners (17);

15 - a flat spring (Fig. 1, a) (spring plates (Fig. 4)), providing breeding of the movable lever (5) and the fixed handle (11);

16 - standard connector (Fig. 4) and connecting wires of the force sensor (7) for connecting it to the signal recording unit during measurements;

17 - removable fasteners for fixing the cylindrical pin (14), in the ears / eye (13) (figure 4),

18 - body openings (for example, side ones) in the outer (4) and inner (2) guides of the body of the opto-surgical device (Fig. 4) for the output of the fiber optic cable (with source fibers and receiver bundles) and wires for connecting electrodes, if electrical impedance is provided probing of the studied biological tissue at the same time or separately from optical probing;

19 - longitudinal protrusion of the outer guide (4) of the housing (Fig. 5, a) for fixing the opto-surgical device in positioning support systems, for example, in the form of a system of guides (22) (Fig. 6, a) with a number of degrees of freedom of at least four (then the force sensor (7) and the screw (6) are used in the same way as in the manual mode of using an opto-surgical device) or for fixing in automated systems of position-force control, for example, such as a collaborative robot-manipulator (26) (Fig. 6b), then the screw (6) is always in a position that fixes the inner (2) and outer (4) guides motionless relative to each other, both when inserting the instrument, and in the diagnostic measurement mode, and during surgical manipulations, i.e. to. instead of the force sensor (7), the readings of the torque sensor (27) of the cobot (26) are used (Fig. 6b);

20 - fastening element-protrusion (Fig. 5, b), which is inserted into the outer guide (4) of the housing instead of the force sensor (7) and fixed with a fastening screw (21) if the opto-surgical device is used only together with an automated system position-force control, for example, the type of a collaborative robot-manipulator (26) (abbreviated as a cobot) or any other version of an automated system for positioning and manipulating the device;

21 - fixing screw for fixing the fastening element-protrusion (20) on the outer guide (4) of the body of the opto-surgical device (figure 5, b);

22 - a system of guide elements with the number of degrees of freedom of at least 4 to support the positioning of the opto-surgical device (Fig. 6a);

23 - attachment point of the opto-surgical device (25) to the system (22) of guide elements (Fig. 6a);

24 - attachment point of the opto-surgical device (25) to the automated position-force control system, for example, of the cobot type (26) (Fig. 6, b);

25 - opto-surgical device, connecting wires (16) of the force sensor (7) and fiber optic cable are not displayed (Fig. 6, a, b);

26 - collaborative robot-manipulator with 6 degrees of freedom (Fig. 6, b) as a variant of the automated system of position-force control and manipulation of the opto-surgical device;

27 - torque sensor;

28 - movable platform (two- or three-coordinate) (Fig. 6, b) for moving the position / position-force control system or an automated system;

29 - optical fibers of sources of probing radiation (emitters) (Fig. 7, b, Fig. 8);

30 - fiber optic bundle of the receiver of radiation backscattered in the studied biological tissue (Fig. 7, b, Fig. 8),

31 - electrodes on the working end of the opto-surgical device (Fig. 8e);

32 - studied biological tissue (Fig. 7, c),

33 - axial cylinder of the branches (1) relative to which the branches (1) are rotated and opened at a certain angle, which is presented in the layout of the device with the ears (13) down and with the lower fastening of the movable lever (5) (Fig.1, a) ;

34 - housing of the opto-surgical device, consisting of internal (2) and external (4) guides (Fig. 1, a, Fig. 3);

35 - rack, formed by elements (9), (10) and (12) (Fig. 1, a);

36 - cutting edges of branches for surgical procedures (Fig. 2, a);

37 - working fiber optic tip of the branches/working end (Fig. 1, a, Fig. 2, b);

38 - holes for optical fibers or a fiber optic bundle in the working tip (37) of the jaws (1) (Fig. 2, b) for bringing sources / receivers to the working end;

39 - openings in the material of the branches for optical fibers or bundles (figure 2, a) and directing them into the cavity of the inner guide (2) of the housing (34);

40 - internal cavity with closed branches (figure 2, a), formed by the grooves of the branches for filling with biological tissue during surgical procedures;

41 - groove in the outer guide (4) of the body (34) for assembling the device and prompt replacement, if necessary, of the jaws (1) with rods (3), the inner guide (2) and the movable lever (5) (Fig. 2, c );

42 - cavity inside the protrusion (10) of the fixed handle (11) for the plate (9) of the rack (35) (Fig. 1, a);

43 - swivel plate (9) ratchet with a movable lever (5) (Fig.1. a).

Implementation of the invention

The device contains the following main building blocks: jaws for diagnostics and surgical manipulations; branch dilution block at a certain fixed angle; optical or fiber-optic unit for the implementation of time-resolved spectroscopy and sounding to a certain depth; pressing force control unit or position-force control according to a given algorithm in manual and/or automated modes; docking unit with external devices of position-force control.

It is possible to implement a device with a block for conducting electrical impedance diagnostics.

The block requirements are as follows.

Branches (1) have the smallest dimensions in the closed state, for example, with a maximum transverse dimension of not more than 6 mm, which is important for introduction into the surgical field through a small access, for example, transnasally, and in the open state for optical diagnostics, they provide certain distances between subgroups fiber optics of sources and a fiber optic bundle of a receiver in a fiber optic block, for example, more than 0 mm and up to 20 mm for transnasal neurosurgery and / or other operations with a small operating field and narrow access to the field, or, preferably, various intervals from 0 mm to two lengths of jaws with a permissible jaw opening angle of 180 degrees and with the structurally provided possibility of performing time-resolved spectroscopy in such a maximum open state or at large opening angles of more than 120 degrees. The inventive device provides different fixed opening angles of the branches, for example, from 20 degrees to 60 degrees in transnasal neurosurgery and / or other operations with a small operating field and narrow access to the field, or, preferably, various intervals in the range of more than 0 degrees and up to 180 degrees, which provide different probing depths and must correspond to the size of the surgical field and different options for access to the studied volume of biological tissue, and different design options. To ensure reliable contact of the device with the biological tissue under study, without air gaps, the working ends of the jaws are made with bevels towards the longitudinal axis of the device, forming an angle with the perpendicular to the longitudinal axis of the branch, preferably not less than half the average opening angle of jaws used in working condition at probing biological tissue and not more than half of the maximum opening angle of the branches. Beveled ends of the jaws can be made in the form of separate tips (37), providing for the output of optical fibers and bundles and fixedly connected to the jaws, for example, with glue. Or the branches themselves have working ends beveled at the required angle. The number of branches must be at least two in order to implement time-resolved diffusion spectroscopy and achieve the technical result of the device. To increase the uniformity of probing of the studied volume of biological tissue, the use of more than two jaws can be provided. To increase the versatility of the device, the possibility of prompt replacement of the jaws during a surgical operation (intraoperatively) can be implemented to meet the requirements of intraoperative diagnostics and surgical intervention. The working ends and jaws can have a different cross-sectional contour profile to ensure the necessary uniformity of probing the studied volume of biological tissue and the required spatial resolution/sensitivity and/or the ability to perform the required surgical procedures.

The branch dilution unit provides a certain fixed angle of opening of the branches, probing depth and spatial resolution. In some versions of the device, the jaw extension unit includes a fixed body handle (11) and a movable lever (5), the movement of which and fixation in a certain position are regulated by a spring element (for example, a flat spring (15)) and a ratchet (35), a plate (9 ) which is pivotally (43) connected to the lever (5), as well as rigid rods connecting the branches with the movable lever and pushing the branches under the action of the lever. The plate (9) of the rack (35) moves in the inner cavity of the protrusion (10) of the handle (11) and is fixed by the slider (12) in the recesses (44) of the plate (9). The branch dilution unit may also have another design solution that implements the functions listed above.

An optical fiber or optical block provides the supply of optical probing radiation to the biological tissue under study and the registration of backscattered radiation, for example, with fibers and bundles of the required number and relative position built into the working ends (37) of the jaws (1), depending on the required depth of probing, the required spatial resolution and necessary sensitivity to neurovascular inclusions in the studied volume of biological tissue. To ensure the safety of optical fibers and bundles, they are passed from the working ends (37) through special cavities (39) in the branches (1) and further into the cavity of the internal guide (2) of the body (34) of the device, and are also removed from the body through special holes (18 ) in the inner (2) and outer (4) guides, coordinated to form a through, non-overlapping, hole in the body (34) of the device.

The block for controlling the position and/or pressing force based on a force sensor and/or a torque sensor ensures the uniformity of measurements, reproducibility of results, and diagnostic efficiency, since allows you to register the pressing force of the jaws to the biological tissue, ensure reliable contact of the device with the biological tissue under study during diagnostics, eliminate motion artifacts in informative optical signals and control mobility, for example, blood flow dynamics, in the volume of biological tissue under study. To ensure the above functions, the force sensor (7) is preferably located between the inner (2) and outer (4) guides of the housing (34) of the device. To prevent the force sensor (7) from falling out of the housing during intraoperative diagnostics and surgical procedures, fixation of the force sensor (7) inside the outer guide (4) of the housing can be provided, one-piece, for example, by gluing, or detachable, for example, using a plate - cover or stop plate for the hole in the housing (34) (in the outer rail (4)), through which the load cell (7) is inserted/removed, which is attached to the housing (outer rail), for example, with a screw/screws. Alternatively, it is possible to place a flat spring (spring plate) between the force sensor (7) and the guide (4), while the spring is permanently attached to the guide (4).

The block for controlling the position and/or pressing force, or position-force control, can be made in a mechanized, automated or manual version using force-torque, force, angle and other types of sensors that allow determining the position and/or pressing force of the opto-surgical device to studied biological tissue. The mechanized version involves the use of a tripod position control unit and / or a set of guides (22) for precise guidance (required positioning) of the opto-surgical device (25) at the point of interest, and to control the pressing force, the use of a force sensor (7) built into the device or force sensor (torque sensor) built into the mount (23) of the guide, to which the device (25) is fixedly attached. As an automated position control system, for example, a robotic manipulator (collaborative robot (26)) can be used, with which the device (25) is fixedly connected through the mount (24) and into which the force-torque sensor (27) is built. An external additional positioning of the cobot (26) can be provided, for example, using a movable table / platform (28), two- or three-axis. Also, an external computer vision system can be additionally used, which is programmatically connected to the positional control of the cobot (26) and includes at least one video camera. In the manual version, the position and/or force sensors are part of the opto-surgical device, the position of which is controlled by the device operator based on intraoperative video surveillance and/or sensor readings.

The docking block can be formed by fasteners of type (19) or (20, 21) for connecting the opto-surgical device with positioning / position-force control systems of type (22), (26) or another design for guiding, controlling and monitoring the position of the device in space and in relation to the studied volume of biological tissue.

The following is a more detailed description of the claimed invention, which does not limit its essence. The specialist understands that the invention has various options for its implementation, and a detailed description of individual options for its implementation is purely explanatory, demonstrating the possibility of achieving the claimed technical result. The claimed device may be subject to various changes and modifications, understandable to a specialist based on reading this description. Such changes do not limit the scope of claims. For example:

- various versions of the body are possible with a different number of components (not only internal and external guides), different shapes and lengths of the guides of the body and its other possible elements, providing, for example, deviations of the jaws at certain angles to the left / right and / or up / down;

- the number, length, shape of the branches, as well as the shape of the beveled working end of the branches can change, they can have additional components, for example, moving forward from the jaws for surgical procedures, the branches can have a composite shape with a fold relative to the longitudinal axis without damaging the inside fiber optics and bundles;

- the jaw dilution unit can have different design options, the type and number of components that ensure the necessary functioning of the jaws and the performance of the declared function of branch dilution at fixed angles, it can be with manual, electronic or remote automatic and / or automated control;

- a fiber optic unit can have different options for grouping and number of subgroups, groups of (contact) sources and receivers of radiation backscattered in the tissue, contact with biological tissue can be carried out directly through optical fibers and bundles, or through additional refractive and / or reflective optical elements such as lenses, prisms, etc. or systems of optical elements, various options for the formation of bundles for various options for output from the device case;

- the number of wavelengths of radiation probing biological tissue, the shape of fiber optic bundles can be changed, different photodetectors can be directly built into the jaws, including rulers and photodetector matrices.

The device contains jaws (1), which are attached to one end of the inner guide (2), coaxially inserted into the outer guide (4) of the body (34) ( Fig.1, Fig. 2, Fig. 3 ). The relative position of the outer (4) and inner (2) rails can be fixed with a screw (6). A force sensor (7) is located between the end surfaces of the outer (4) and inner (2) guides on the fixed lever (11) mounting side. Branches (1) with the help of rods made, for example, in the form of rods (3) are attached to the movable lever (5), for example, with the help of a cylindrical pin (14) at both ends of which there are mounting stops (17). The movable lever is fixed between the lugs (13), rigidly connected to the inner guide (2) of the housing ( Fig.1 ). A variant of execution ( Fig. 3 ) is possible with the upper fastening of the movable lever (5) with a cylindrical pin (14) in the slot of the lug (13) of the outer guide (4), which allows attachment of more than two movable jaws. Branches may have a common axis of rotation (33) located perpendicular to the axis of the guides (2) and (4) of the body (34) ( figure 1, a ).

The optical fibers of the emitters (29) and the fiber-optic bundle/bundles of the receiver (30) are built into the working tips (37) of the jaws, pass in the cavities (39) of the jaws and in the cavity of the internal guide (2) of the body (34) in the form of randomly grouped bundles (8) ( Fig.1, Fig. 2, Fig. 3 ) along the rods (3) and exit the opto-surgical device through holes (18) in the inner (2) and outer (4) guides ( Fig. 4 ). The outer (4) and inner (2) guides of the housing (34) of the opto-surgical device can have different cross-sectional profiles, from round (as shown in Fig. 1-4 ), round-square to rectangular-elongated or complex, including different in length of the outer and inner guides, but the same at the junction of the latter. The working tips (37) of the jaws (1) have an inclined profile (working end) relative to the longitudinal axis of the device to ensure better contact with the biological tissue during the diagnostic process. The required inclination is determined by the jaw opening angles used, and the angle of the jaw end line with the perpendicular to the longitudinal axis of the jaw is not less than half of the average jaw opening angle used in probing biological tissue and not more than half of the maximum jaw opening angle of more than 0 degrees and up to 120 degrees.

In particular, the bevels of the working ends of the jaws towards the longitudinal axis of the device, forming an angle (α) with the perpendicular to the longitudinal axis of the jaws in the closed state, are determined by, for example, at least half of the average opening angle (β _cf ) of the jaws from possible fixed working opening angles (β _i , i =1.. m ) used in a specific version of the device for probing biological tissue, and not more than half of the maximum opening angle (β _max ) of the jaws allowed in working condition for probing:

;

.

;

.

With admissible jaw opening angles of more than 120 degrees and up to 180 degrees, the jaws have a special design with the location of the optical part (optical fibers, bundles and/or other optical elements) inside the jaws and/or on an additional internal bevel.

The device has a ratchet (35) formed by a protrusion (10) fastened to a fixed handle (11) of the outer guide (4) of the housing ( figure 1, figure 2, figure 3 ), a plate (9) inserted inside the protrusion with notches ( 44) and ledges, as well as a flat slider (12) moving up/down in the through hole of the protrusion (10) to ensure and fix the required opening angle of the jaws (1). The plate (9) is hinged to the movable lever (5).

Spring elements can be fixed between the movable lever (5) and the fixed handle (11), for example, in the form of a flat spring (15) of any design ( Fig. 1, Fig. 4 ).

A miniature force sensor (7), for example, a load cell with a diameter of not more than 15 mm, can be connected to the data recording unit board through a standard connector (16) and using connecting wires.

The outer guide (4) of the housing (34) has a groove at the bottom (41) almost along the entire length of the guide to the fixed handle (11) (as in Fig. 1, a) to enable assembly and disassembly of the device, and prompt replacement of jaws with an internal guide and movable lever.

It is also possible to implement the invention when the outer guide (4) of the housing has a longitudinal protrusion (19) ( Fig. 5, a ) or the device has an additional fastener (20) inserted instead of the force sensor into the outer guide (4) and fixed with fixing screw (21) ( Fig. 5b ). Elements (19) and (20) serve to interface the device with external positioning, position control and/or torque measurement systems, as, for example, shown in FIG. 5, where through the longitudinal protrusion (19) the opto-surgical device (25) is connected through the mount (23) to the system (22) of guide elements ( Fig. 6, a ) with the number of degrees of freedom of at least 4. Inserted fastener (20 ) allows connection of the device (25) through the mount (24) to the force-torque sensor (27) connected to the collaborative robot-manipulator (26) (cobot) with six degrees of freedom ( Fig. 6b ). The cobot (26) is fixed on a movable two/three-axis platform (28), if necessary.

One of the simplest designs of the working end of a fiber-optic sensor ( Fig. 7, a, b ) is a sector version with one receiver and eight sources ( Fig. 7, b ), which implements two linear variants of the minimum configuration - two distances from the receiver (30 ) to subgroups of emitters (29) and two wavelengths from the red and near infrared (NIR) range in each subgroup. In the closed state, the sensor has the minimum dimensions for insertion into the surgical field ( Fig. 7, a ), in working condition with divorced jaws ( Fig. 7, c ) provides the necessary probing depth of the studied volume of biological tissue (32). The range of probing depths is determined by the range of distances ( r _j , j =1.. M , M ≥2) from subgroups of emitters to the receiver ( Fig. 9 ) and the range of fixed jaw opening angles from minimum to maximum. Each group of emitters consists of at least two subgroups, each of which contains emitters of at least two wavelengths from the specified range of values, located at a distance of no more than 1 mm from each other, and each subgroup - at a certain distance ( r _j , j =1..M, M≥2) from the receiver along the corresponding semi-axis, which provides the specified probing depth in each direction along the semi-axis.

More complex designs of the working end of the fiber optic sensor are shown in Fig. 8, where the sounding uniformity is ensured by an increase in the number of sources ( Fig. 8, a ) and/or receivers ( Fig. 8, b ), the presence of a line of receivers ( Fig. 8, c ) or an increase in the number of sliding jaws ( Fig. 8, d ) . The design variant of the opto-surgical device shown in Fig. 3 allows for two to four moving jaws or more.

Close-to-square cross-sectional shape of the jaws (1) and the internal guide (2) of the body of the opto-surgical device provides the most dense arrangement of the elements of optical probing of biological tissue, optical fibers of sources and receivers ( Fig. 8, a-c ). It is also possible to place electrodes (31) ( Fig. 8, e ) on the working end of the device for conducting electrical impedance probing in conjunction with optical probing [Bioimpedance analysis of human body composition / D.V. Nikolaev, A.V. Smirnov, I.G. Bobrinskaya, S.G. Rudnev. - M.: Nauka, 2009. - 392 p.]. In FIG. 8(e) the electrode assembly is represented by four external current electrodes and four internal potential electrodes forming two tetrapolar measuring channels.

A variant of the device, made with the possibility of performing surgical manipulations with biological tissues, has cutting side edges (36) of the jaws (1) and an internal cavity (40) of a complex profile inside each jaw in the section with cutting edges, where cavities (39) are provided for removing optical fibers sources and receiver harness from the working tip (37) into the cavity of the inner guide (2) ( Fig. 2b, c ).

Optical-surgical device allows to detect and recognize neurovascular structures, main arterial and venous vessels and nerves in the volume of biological tissue, including tumor. The method of such detection and recognition is described in more detail in the description of the patent for the invention RU 2736307.

The device works as follows.

In the initial state, the inner guide (2) is manually fixed in the outer guide (4) by means of a screw (6). The movable lever (5) is manually compressed towards the fixed lever (11), while the plate (9) of the ratchet slides inside the protrusion (10) on the fixed lever (11) and the jaws (1) are tightly closed. The device has minimal dimensions and can be inserted into the operating cavity. In the presence of expanding spring elements in the device, for example, a flat spring (15), the closed position of the branches is held manually ( Fig. 1, 4 ) or with the help of an appropriate recess of the type (44) on the plate (9) of the rack ( Fig. 2, b ) , into which the slider (12) is inserted.

To carry out optical measurements according to the method described in patent RU 2736307, having removed the slider (12), if it was fixed, manually or using a flat spring (15) remove the movable lever (5) from the fixed handle (11), while the branches diverge (one). The desired angle of divergence of the jaws (1) is fixed with a slider (12) in the corresponding recess (44) of the plate (9) of the rack (35). By manually turning the screw (6), the non-fixed mutual position of the inner (2) and outer (4) guides of the body of the opto-surgical device is ensured, which makes it possible to control the pressing force of the device to the biological tissue and changes in the pressing force.

In working condition, for optical sounding, the jaws (1) are moved to a certain angle ( Fig. 1, 3 ), corresponding to a set of certain distances between the subgroups of sources (29) and the receiver / receivers (30), implemented on the working end (41) of the device ( Fig.7, Fig. 8, Fig. 2c ). Breeding is carried out manually using rods (3), a movable lever (5) and a rack (35) with a slider (12), which is raised and lowered with one finger in the through hole (45) of the protrusion (10) of the fixed handle (11). Shown in FIG. 1 and FIG. 3 versions of the device make it possible to provide one intermediate opening of the branches (1) along the recess (44) between the ledges of the plate (9) of the rack (35), into which the slider (12) is lowered. The number of possible opening angles and probing depths is changed by making additional recesses (44) on the plate (9) of the rack, into which the slider (12) is lowered, and is determined by the relationship between the values of the “source-receiver” distances at the working end of the device and a certain opening angle of the jaws (1), which corresponds to the number of the recess (44) on the plate (9) of the rack (35).

Mechanical contact and interaction of the device with the biological tissue under study is controlled using a built-in between the inner (2) and outer (4) guides of the force sensor (7), which is connected via a standard connector (16) with wires to the registration unit board and/or to a computer for further processing. The signals from the force sensor (7), recorded during manual manipulation of the device, are used to control the force of pressing the device to the studied biological tissue, to eliminate motor artifacts from simultaneously recorded and processed optical signals. As a force sensor (7), a miniature strain gauge with a diameter of not more than 15 mm can be used [Miniature strain gauges. [Electronic resource] Access mode: https://tokves.ru/miniatyurnyie-datchiki.html?yclid=1960109841313981044].

The proposed opto-surgical device can have different overall dimensions, the outer (4) and inner (2) guides of the body (34) can have different cross-sectional profiles, from round, round-square to rectangular-elongated or complex, including those differing in length external and internal guides, but identical at the junction of the latter. The most suitable size and shape of the device is determined by the size of the surgical field and the method of access to it, from skull base neurosurgery with transnasal access to abdominal operations, as well as the properties of the studied volume of biological tissue, its size and uniformity in composition and structure, and, therefore, in terms of optical properties. For example, with a tumor diameter of 6 cm, the distances r _j are preferably from 6 mm to 12 mm, which determines the opening angles of the branches with their known length, cross-sectional size, shape and size of the working end.

It is possible to quickly replace the working end of the device together with the movable lever (5) and connecting cables (3) in order to best match the opto-surgical device to the task being solved with its help.

If it is necessary to use a system (22) of guide elements ( Fig. 6, a ) with at least 4 degrees of freedom (to improve the positioning accuracy and direction of the device, reduce the load on the hand during manipulations and reduce the amplitude of motor artifacts in informative optical signals), the outer the guide (4) of the device body is made with a longitudinal protrusion (19) ( Fig. 5, a ), with which the device is inserted into the mount (23) ( Fig. 6, a ).

It is possible to implement the device with an additional fastener (20), which is inserted into the outer guide (4) instead of the force sensor and fixed with a fastening screw (21) ( Fig. 5b ). The inserted fastener (20) allows the device (25) to be connected through the attachment assembly (24) to the force-torque sensor (27) connected to the collaborative robot-manipulator (26) (cobot) with six degrees of freedom ( Fig. 6, b ) [Catalogue industrial robots. Desktop mini-robots [Electronic resource] Access mode: http://robotforum.ru/promyishlennyie-robotyi.html; force sensors. ForceKit by Weiss-Robotics. [Electronic resource] Access mode: http://ant-company.ru/catalog/forcesensor/forcekit/]. The cobot (26) is fixed on a movable, at least two-coordinate platform (28). The cobot (26) and the platform (28) are connected to the controller and controlled using special software in accordance with the method described in RU 2736307.

The sharp cutting edges (36) and the internal cavity (40) of the jaws ( Fig. 2b, c ) make it possible to carry out individual surgical manipulations with biological tissues along with the performance of a diagnostic procedure.

The electrode assemblies built into the jaws ( Fig. 7, e ) allow, simultaneously with the optical one, electrical impedance local probing of the studied volume of biological tissue by a bipolar or tetrapolar method [Bioimpedance analysis of the composition of the human body / D.V. Nikolaev, A.V. Smirnov, I.G. Bobrinskaya, S.G. Rudnev. - M.: Nauka, 2009. - 392 p.].

The permissible range of jaw opening angles is determined by the design of the fiber optic sensor with the required access to the operating field, taking into account the size of the operating space. The opening angle determines the size of the probed volume of biological tissue.

Distributed rather than point sources with uniform illumination of the studied volume do not provide spatial resolution and spatial sensitivity to neurovascular structures in the studied volume.

Spatial resolution and sensitivity, which can provide the proposed optical-surgical device for the detection and recognition of neurovascular structures, are determined by the size of the minimum required volume of biological tissue to implement the spectroscopic method with time resolution [Optical biomedical diagnostics. In 2 vols. T. 1 / Per. from English. ed. V.V. Tuchina. - M.: Fizmatlit, 2007. - 560 p. Chapter 3, Chapter 7], corresponding to the distance from the emitters to the receiver of at least 5 mm, and the number of measurement channels of the spectrometer used with the opto-surgical device.

To test the feasibility of the proposed opto-surgical device and its functionality for detecting and recognizing neurovascular structures, a mock-up was made ( Fig. 10b ) based on a surgical instrument with controlled and fixed in the desired position dilution of the working ends, to which rods imitating individual jaws of the device. The rods were manufactured at the Research and Development Center for Fiber Optic Devices. The working end of one rod contains the end of the optical fibers of the emitters, located in a sector, as shown in Fig.7, b. The working end of the other rod contains the end of the receiver's fiber optic bundle. The object of the study was the inner region of the human hand, parts of the palm, wrist and forearm ( Fig. 10a ). The approximate localization of the main veins, arteries, and nerve trunks is known from the anatomical atlas; before testing the device layout, the localization of neurovascular structures was refined by ultrasound imaging. To measure the optical parameters, absorption coefficients (μ _a ) and transport scattering (μ _s '), an OxiplexTS time-resolved spectrometer with phase modulation approach (ISS, Inc., USA) was used ( Fig. 10 c ) [ISS website . [Electronic resource] Access mode: http://iss.com/biomedical/instruments/oxiplexTS.html]. For position-force control, a desktop manipulator of the “UFACTORY uArm Swift Pro” type was used [Roboarm “UFACTORY uArm Swift Pro”. [Electronic resource] Access mode: https://top3dshop.ru/robots/uarm-swift-pro.html], with force and distance sensors and a computer vision system, and an Instron 8801 power plant was used ( Fig. 10b ) .

The layout of the device allows you to reproduce the results stated in RU 2736307, with distances between the sources and the receiver at the working end in the range from 6 mm to 12 mm. The results of detection and recognition of neurovascular structures are shown in Fig. 11. The given examples confirm the feasibility and effectiveness of the proposed device.

Thus, the claimed device eliminates the following disadvantages inherent in the closest solution known from the prior art: limited field of view, small diagnosable volume of biological tissue and shallow depth of study; the inability to controllably change the depth of probing of biological tissue; uncontrolled positioning and/or uncontrolled pressing force of the fiber optic sensor to the surface of the studied volume of biological tissue; uncontrolled clamping of biological tissue at the time of contact probing of the volume under study and, as a result, distortion of the data obtained due to changes in structural and optical parameters; the impossibility of implementing time-resolved spectroscopy and, as a result, carrying out a quantitative analysis of the composition and structure of the studied volume of biological tissue with the required accuracy and the required spatial resolution.

In contrast to the closest solution, the proposed method allows you to controllably change the depth of probing, the value of the studied volume of biological tissue and spatial resolution; control the pressing force and combine the device with robotic complexes; perform time-resolved spectroscopy on controlled tissue volumes, obtain quantitative estimates of such optical parameters as absorption and transport scattering coefficients at different wavelengths, and conduct a quantitative analysis of the composition and structure of the studied volume of biological tissue with the necessary accuracy and the necessary spatial resolution; to obtain quantitative estimates of the dynamics of blood flow in vessels of different calibers, from microcirculatory to main, in the studied volume of tissue.

The claimed device makes it possible to combine the diagnostic functions of the device with individual surgical procedures (separation of tissues and removal of pathological tissues), and also provides the possibility of multi-channel summing up of various probing signals, optical and/or electrical and others, if necessary. The claimed device allows you to change its design due to the block-modular principle of its construction;

Optical-surgical device allows the possibility of sterilization by cold plasma method [Kornev I.I. Modern technologies of low-temperature sterilization of medical devices in medical facilities. [Electronic resource] Access mode: http://www.poliklin.ru/imagearticle/201206/29-31.pdf].

The above distinguishing features of the proposed method lead to the achievement of the following advantages compared to the closest technical solution:

- to increase the efficiency of recognition of neurovascular structures due to the possibility of implementing using the proposed device a method for detecting and recognizing neurovascular structures, presented in RU 2736307, which provides for the acquisition and analysis of a complex of significant parameters (optical, derivative, physiological and shape parameters) in static and, at necessary, in dynamic modes, and obtaining a wider range of criteria that provide the definition, incl. structure type; automated control of the positioning and/or pressing force of the used fiber optic sensor to the surface of the studied volume of biological tissue, which ensures the accounting or absence of non-informative motor artifacts and distortions of optical parameters, ensures the stability and reproducibility of the parameters on which a decision is made based on the relevant criteria; increasing or ensuring uniformity of probing of the studied volume of biological tissue;

- to increase the versatility of the device method due to: a block-modular design principle and the possibility of changing branches, i.e. working end of the device; ensuring greater invariance of the device to the location of neurovascular structures in the studied volume of biological tissue by using at least two groups of emitters of a fiber-optic sensor and analyzing the intensity of backscattered radiation for each source;

- to expand the functionality of the device on a single methodological basis by controlling the possible spasm of arterial vessels of the studied volume of biological tissue or the supplying large artery and the degree of ischemia of the biological tissues they supply with blood using the same device;

- improving the quality of medical care provided due to the reduction or prevention of cases of damage to neurovascular structures and sudden uncontrolled spasm of large arteries due to accidental sharp mechanical impact on them, which are not rare in neurosurgical practice; this method is aimed at effective prevention of such situations.

The proposed method has no restrictions if the spatial resolution and the minimum probed volume are consistent with the characteristic dimensions of the neurovascular structures to be detected and recognized, and the changes in optical parameters that are significant for the detection and recognition of neurovascular structures are at least 2 times greater than the corresponding noise characteristic.

The conducted studies have demonstrated the possibility of carrying out the invention with the achievement of the claimed technical result.

Claims (16)

1. An optical-surgical device for detecting and recognizing neurovascular structures in the volume of biological tissue, including a body with at least one movable and one fixed jaws fixed in it, or at least two movable jaws, a branch dilution unit, optical or a fiber optic unit, including at least one fiber for supplying an optical signal for probing biological tissue - a radiation source, and at least one fiber or fiber optic bundle for receiving a return signal - a radiation receiver, made with the possibility of spectroscopy of biological tissue, while the source and receiver of radiation are located in branches, characterized in that fiber optic unit and branches are made with the possibility of subsurface contact probing of biological tissue with optical radiation of at least two wavelengths (λ _i , i =1.. K , K ≥2) by reflective diffusion spectroscopy with a time resolution to a maximum depth of at least 5 mm, while the jaws on the side of the working ends are made with bevels towards the longitudinal axis of the device, radiation sources are placed on the working end, at least on one of the branches, and receivers - on the working end, at least on one of the remaining branches, the sources are combined into at least two groups located along separate mismatched semi-axes directed away from the receiver; each group of sources consists of at least two subgroups, each of which is designed to deliver a signal at least two wavelengths (λ _i , i =1.. K , K ≥2), and the sources of each subgroup are located from each other at a distance of no more than 1 mm, and each subgroup - at a certain distance ( r _j , j =1.. M , M ≥2) from the receiver along the corresponding semiaxis; in working condition for probing biological tissue with divorced branches, the distance from each subgroup of sources to the corresponding receiver is at least 5 mm. 2. The device according to claim 1, characterized in that the bevels from the side of the working ends of the branches towards the longitudinal axis of the device are made at an angle α to the perpendicular drawn to the longitudinal axis of the device with closed branches, not less than half the average opening angle of the branches in the working state when probing biological tissue and not more than half of the maximum possible opening angle of the jaws. 3. The device according to claim 1, characterized in that it contains a block for controlling the pressing force of the jaws to the studied biological tissue, including a force sensor built into the housing. 4. The device according to claim 1, characterized in that it is equipped with a docking unit with external positional and/or force control devices. 5. The device according to claim 1, characterized in that the housing contains the outer and inner guides, made with the possibility of their adjustable coaxial movement relative to each other. 6. The device according to claim 1, characterized in that the branch dilution unit includes a movable lever movably connected to the body, a fixed body handle, rods rigidly connecting the branches to the movable lever, and a ratchet made with the possibility of fixing the angle of dilution of the branches. 7. The device according to claim 6, characterized in that the movable arm is connected to either the inner or outer guide by means of an eye rigidly attached to the corresponding guide and a cylindrical pin. 8. The device according to claim 5, characterized in that the inner guide is made with a longitudinal inner cavity for the location of optical fibers and optical bundle(s) and rods from the jaws to the handle. 9. The device according to claim 1, characterized in that it is made with the possibility of opening the branches to a certain angle and fixing the branches in this position. 10. The device according to claim 1, characterized in that the jaws have cutting edges and grooves for surgical manipulations with biological tissues. 11. The device according to claim 1, characterized in that it is made with the possibility of subsurface contact electrical impedance probing of biological tissue and is equipped with electrodes brought to the working ends of the jaws to enable the implementation of bipolar or tetrapolar modes, at least one channel and at least at least at one frequency from the range from 300 Hz to 200 kHz or up to 1 MHz, with a current strength of not more than 0.3 mA and a current density that does not cause excitation of nerve and muscle fibers. 12. The device according to claim 6, characterized in that it is made with the possibility of replacing the jaws with an internal guide, a movable lever and a ratchet.

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