RU2714192C1 - Device for skin separation of face from underlying tissues - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to aesthetic medicine, surgical cosmetology and plastic surgery, and is applicable for face and neck surgeries, for removing previously installed cosmetic threads, for separating adhesions. Device comprises: i) an external device for remote control of movement of the implanted microdevice, comprising light signal sensors configured to receive light signals from the implanted microdevice underneath the skin, sensors for changing the characteristics of the magnetic field emitted by the working portion of the implanted microdevice, and electromagnetic signal inductors configured to act on the working portion of the implanted microdevice to change the direction of movement thereof; ii) an elongated micro device implantable under the skin, comprising a working portion with a retractable cutting element fixed in a groove on the front portion of the micro-device, sensors of parameters of living tissues and sensors of linear and angular movement of the implanted microdevice located in the direction of movement of the implanted microdevice - on the front-top surface of the working part. Upper part of the working part is made of a magnetic material capable of bending in accordance with the shape of the surface of the underlying tissues and with the possibility of interaction with sensors of changes of magnetic field parameters of the remote control device located outside the body. Lower part of working part comprises: a) microelectrical drive with power supply, connected to sensors of parameters of living tissues and movement by means of microcircuit, b) the microcontroller functionally by means of microcircuits connected: to sensors of parameters of live tissues and movement of the implanted microdevice, with a magnetoactive element in the upper part of the working part of the implanted microdevice, with a retractable cutting element, with a microelectrical drive. Body of the implanted micro-device has height suitable for mechanical separation of face skin from underlying tissues.

EFFECT: use of the device provides atraumatic separation of facial and neck tissues – skin from subcutaneous fat when placing a micro-device subcutaneously, in various areas of face and neck in the process of directed, controlled movement of micro-device, which does not require implantation of another tissue separation device in other required places.

11 cl, 1 ex

Description

The invention relates to aesthetic medicine, surgical cosmetology and plastic surgery and may find application in operations on the face and neck, to remove previously installed cosmetic threads, separation of adhesions, etc.

Existing cosmetic therapeutic and surgical measures do not give satisfactory results. Patients are beginning to pay more and more attention to plastic surgery, which is faced with the task of correcting deep wrinkles of the skin that cannot be eliminated with circular face plastic surgery.

A known method of eliminating wrinkles (M. A. Sulamanidze, D. Salti, M. Machett, R. Rene, G. N. Mikhailov. Elimination of facial wrinkles by subcutaneous soft tissue dissection // Annals of plastic, reconstructive and aesthetic surgery. - 3, 4. - 1999. - pp. 29-36), which consists in the dissection of the fibrous jumpers using a wire scalpel. After preliminary marking is applied to the skin in the wrinkle area, a needle is punctured at one of the poles of the wrinkle with a needle, immersing it at the required depth in subcutaneous fat (TFA). Then, under the control of a finger, it is advanced along the perimeter of the detachment zone until the contour is bent. At this point, the needle is brought to the surface of the skin. Together with it stretches a wire fixed in her ear. Through the same hole, the needle is again inserted under the skin and in the same fiber layer it moves further to the next bend of the contour, i.e. each subsequent injection is performed at the site of the previous injection. Thus, wire fringes the entire intended area of the skin with the withdrawal of the needle into the very first hole of the skin. Then, with soft sawing, the soft tissues are stratified, bringing it to the surface of the skin, separating the skin-fat flap from the underlying tissues. After wrinkling, a cold isotonic sodium chloride solution is introduced into the created cavity for hemostasis until a pink liquid appears, then a pressure bandage and an ice pack are applied. This procedure is carried out within 2-4 days. Formacryl polyacrylamide gel is injected into the created cavities in the amount necessary to level contour deformation.

The disadvantages of this method is the trauma due to the need for at least 4 needle punctures, the duration of the postoperative period, i.e. hemostasis for 2-4 days, reoperation for the introduction of polyacrylamide gel Formacryl.

There is also a method for reducing wrinkles (David S. Orentreich. - Subcutaneous Incisionless (Subcision) Surgery for the Correction of Depressed Scars and Wrinkles. - Dermatol Surg. - 1995; 21; 543-549), the essence of which is to cut the fibrous jumpers of the wrinkles with a needle with three faces, which is introduced to the required depth of the pancreas through a puncture in one of the poles of the wrinkle. Previously, markings are applied to the skin in the area of wrinkles. The needle makes translational movements in various directions. Blood is poured from the damaged vessels. The resulting blood clot fills the cavity and helps to smooth out the unfavorable fold for a period of 6 to 12 months. However, this method is quite traumatic, there is a risk of bleeding, postoperative results are short-lived.

Thus, during cosmetic procedures, in the work of plastic surgeons it is often required to separate some soft tissues of the patient from others, separating them with the least trauma and without increasing the time of the operation.

A device for separating and exfoliating soft tissues (RU 32988 U1, 10/10/2003, Sergienko EN), consisting of branches and a handle, in which the cutting part of the device is made in the form of two branches of a trihedral shape, the inner (non-working) edges of the branches is known polished and tightly in contact with each other to the place of articulation for 8 cm, the outer (working) edges of the branches are sharpened, the distal ends of both branches are flattened and in closed form represent a platform with a diameter of 5 mm, the handle is made in the form of two semicircular joints dyaschihsya handles, one of which screw is rigidly attached steel plate S-shape 3 mm wide serving damper.

However, this device relates to traumatic surgical instruments that cannot provide the minimal trauma that is required during cosmetic surgery on the face and neck.

The surgical retractor, which consists of a working part made in the form of a hook represented by blunt teeth, and a handle with a total length of 110 mm and a working part width of 5 mm, does not provide low trauma. The working part of the hook is represented by 2 blunt teeth with a width of 1 mm and is located at an angle of 10 ° to the handle, and the handle is made in the form of a ring 30 × 25 mm in size (BY patent on ПМ No. 8460 dated 02.11.2011. Bogdan V.G., Skoda P .V., Avdievich A.D., Tovstov D.A.).

Known surgical retractor for mobilization of the stem and perforating saphenous veins, which allow operations from mini-access, observing the principle of least trauma, without skin incision (RU 167389 U1, SSTU named after Gagarin Yu.A., 10.01.2017). A retractor for mobilization of stem and perforating saphenous veins contains a hook, a rod and a handle. The hook is made in the form of an open ring with a pointed distal part in the form of a tip co-directed with the axis of the rod at an acute angle and bending inward to the center. The device is designed to reduce the invasiveness of surgery when mobilizing the stem and perforating saphenous veins, to facilitate the approach to the location of the veins in the interest of cosmetic wounds. The retractor is injected through a puncture of the skin, ultrasound control is used to determine the position of the vein.

However, the large dimensions of the device (length 60-80 mm, designed for veins, the depth of which is 3-5 cm, the diameter of the shaft up to 2 cm) do not allow using it in cosmetic operations in the face and neck.

Known surgical instrument for dissecting trabeculae (RU 2536104 C2, Sviridov SV, 12/20/2014), made in the form of a rod of round, elliptical or oval shape in cross section with a handle. The end of the rod is made curved in a horizontal plane to the left or right along a logarithmic curve with an angle of divergence from the longitudinal axis of the rectilinear portion of the rod at 5-10 ° angular and ends with a ball head with a beard, the cut of which is sharpened. On the curved section of the rod, a comb is made of a number of grooves of the shaped profile located inside the bend arc. The edges of the grooves are sharpened. The handle is made curly with recesses for covering, holding and fixing the position of the tool in space with the right or left hand. The tool allows you to get a long-lasting cosmetic effect by smoothing the skin surface in the area of cellulite fossa, reducing the thickness of the fat layer in the subcutaneous space, and also due to the completeness of liposuction.

In this case, surgical steel, for example, 03X16H15M3, AISI316L or others, corrosion-resistant and compatible with the environment of the surgical field (blood, lymph, etc.) materials, as well as pure inactive metals, for example, can be used as the core material tantalum, titanium and alloys, for example, nitinol. The material of the handle can be an inert polymer or plastic, conveniently molded during processing and chemically inert, as well as resistant to sterilizing environments and conditions, for example, styracryl, nylon, lavsan, fluoroplastic, etc. To increase and maintain cutting ability A wear-resistant coating may be applied to sharpened cutting edges of grooves-traps - titanium nitrides, zirconium, chromium, molybdenum, hafnium, tantalum, titanium carbonitride, titanium intermetallic compounds with aluminum, corundum, diamond-like rytiya with subsequent laser sharpening.

However, the dimensions of this tool for separating trabeculae do not allow its full use in plastic surgery in the face and neck, where thinner tools of small sizes are required.

A standard tool for performing operations on liposuction is known - a cannula, which is a tubular rod with a number of holes at the working end. However, in all cases, during liposuction, the opening in the cannula is clogged with scraps of trabeculae - strands of connective tissue between the muscles and skin (the so-called mezra). This significantly complicates the process, increases its duration, adversely affects the quality and depth of liposuction, namely, the degree of removal of adipose tissue. At the same time, the volume of the potential or permissible build-up of the fat layer can be significantly reduced, for example, by the thickness of the fat layer, by its height between the muscles and the dermis, and, in addition, to help level the skin surface in the area of the surgical field, namely by reducing the depth of the cellulite pits, or even doubling their number - by dissecting trabeculae.

There are prerequisites for the development and use of tools for dissecting trabeculae, based on the features of the anatomical structure and connection of the skin and subcutaneous tissues.

So, it is known for ligamentotom - a surgical instrument for dissecting ligaments and tendons, made in the form of a stepwise curved rod with a handle; the end of the rod is made in the form of a plate with a wedge-shaped cleft, the edges of which are sharpened (RU 2012252 C1, Volkovets NN, IPC A61B 17/32, 05/15/1994). The disadvantage of this tool is the limited scope - only in the open surgical field.

Known subcutaneous electric knife (RU 17847 from 05/10/2001), consisting of a generator, active and passive electrodes. The active electrode is represented by a needle coated with a special laser spraying that protects the skin from damage, and the tip of the needle is free before this spraying. When the generator is turned on by successive turns of the needle to the sides along the perimeter of the designated zone, the skin is peeled off from the underlying tissues and at the same time the fibrous bridge connecting the skin to the muscles is cut off. Damaged blood vessels are directly coagulated by a subcutaneous electrocutaneous knife (hemostasis) during cutting. If necessary, to level contour deformation and create a barrier to the formation of a new wrinkle, the required amount of a non-absorbable gel substance indifferent to the body is introduced into the created reservoir between the skin and fiber. These operations relate to liquid gel dermatensia (RU 2189180 C1, 09.20.2002, Tverskaya GMA).

Such operations are bloodless, atraumatic, as they inject the needles in one place, simultaneously with the dissection of tissues, coagulation of damaged blood vessels is performed. This shortens the postoperative period, gives a lasting cosmetic result.

In this case, magnetoactive elastomers (MAEs) are known - a new type of magnetically controlled materials whose properties change reversibly under the influence of a magnetic field. This material belongs to the class of Smart materials. (Stepanov G.V. et al. Magnetically active polymer with magnetically solid filler // Bulletin of PNIPU, 2013, Mechanics, No. 4, pp. 106-137).

One of its properties is the magnetorheological effect, i.e. dependence of viscoelastic properties on the magnetic field. A detailed study of the material revealed a number of useful properties in it, in addition to the magnetorheological effect: magneto-deformation effect, magnetostrictive effect, shape memory effect (pseudo-plasticity effect), magnetoresistive effect, magneto-piezoresistive effect (super-additive change in electrical conductivity under the influence of magnetic field and mechanical pressure). Parameters such as dielectric constant and magnetic susceptibility also change under the influence of a magnetic field. The diverse properties of the material are determined by the processes of dipole-dipole interaction between the magnetized particles of the magnetic filler, as well as the processes of reversible movement (structuring) or rotation of anisotropic particles of the filler inside the polymer matrix. The fields of application of the material are effective passive and active controlled damping devices, sensors of magnetic field, acceleration, pressure, deformation, as well as biology - cell technology.

This material is often called a “magnetorheological elastomer”, as well as magnetic gel, magnetoelastic, ferrogel, magnetically active, magnetically controlled elastomer.

It is based on an elastic polymer matrix and magnetic filler.

The first widely studied property is the magnetorheological effect. The material is patented and researched by the American firms Ford and Lord Corporation. The second interesting property is the magnetodeformation effect (deformation in an inhomogeneous magnetic field) and the magnetostrictive effect (deformation in a uniform magnetic field).

These material properties are used in the construction of active and passive damping devices, actuators, micromotors. An interesting effect is the shape memory effect, which manifests itself if the material is placed in a uniform magnetic field: elastic rubber becomes plastic, like clay or clay. Under the influence of external mechanical force, it takes on a new form. After turning off the magnetic field, the original shape is restored. It was shown that in the region of small deformations, the elasticity and viscosity of a material in a magnetic field of 300 mT can increase by a factor of 100 and 400.

Thus, the material is interesting both from the point of practical application and from the point of view of scientific research on the nature of the interaction of magnetic particles inside the polymer matrix.

MAE is obtained on the basis of powders of magnetic fillers — soft magnetic iron and magnetically hard — neodymium-boron iron in a siloxane polymer matrix. Production methods are described in the mentioned publication: G. Stepanov et al. Magnetically active polymer with magnetically solid filler // Bulletin of PNIPU, 2013, Mechanics, No. 4, p. 106-137; as well as in RU 169560 U1, Moscow State University, 03/22/2017.

The main technological stages of obtaining MAE are:

1. Modification of the magnetic filler.

2. The stage of coarse mixing of the magnetic filler and liquid silicone rubber.

3. Fine dispersion on a roll dispersant.

4. Mixing the dispersion with a polymerization catalyst in a turbo mixer.

5. Evacuation of the composition.

6. Processing the mold with a release compound and pouring the composition into molds.

7. Magnetic structuring.

8. Polymerization of the composition in a heating cabinet (microwave heating).

In addition, an important technological stage is the preparation of the surface of the magnetic filler. It is known that the finer the powder, the more difficult it is to evenly distribute it in the polymer matrix. Fine powders are highly agglomerated and, as a rule, have hydrophilic properties. When mixing powders with liquid silicone rubber, it does not penetrate between the particles in the agglomerate, but envelops the agglomerate of many particles. Even the use of dispersing devices, such as roller dispersant and ultrasound, does not completely destroy the units. Aggregates are reduced in size, but still remain.

To reduce the aggregation of powders and impart hydrophobic properties to them, the powder is modified for compatibility with liquid silicone rubber. The powder is treated with a mixture of GKZh-94 (CH ₃ ) ₃ Si-O- [CH ₃ Si (H) -O-] _n- Si (CH ₃ ) ₃ water repellent with silicone oil (PMS) in a hexane solution. For iron powders (2-5 μm), the modifier concentration is 1% by weight of the powder. A mixture of iron powder with a modifier solution is passed through a roller dispersant and dried.

The polymer matrix is a polymer elastic base made of a biostable polymer based on polyacrylate, vinyl polymer or silicone rubber. Preferably, the polymer matrix is made of SIEL grade 2-component silicone rubber manufactured by GNIIHTEOS. The two matrix components are the low molecular weight vinyl component (A): ((CH ₃ ) ₃ SiO (((CH ₃ ) ₂ SiO) a (CH ₃ (H) SiO) _b ) × Si (CH ₃ ) ₃ and the hydride component (B ): (CH ₂ CH) ₃ SiO [CH ₃ SiO] ySi (CHCH ₂ ) ₃ ) are mixed with each other and with a magnetic filler, and then polymerized.

In the presence of a complex platinum catalyst - ((CH ₂ = CH) ₃ SiO [CH ₃ SiO] _y -Si (CH = CH ₂ ) ₃ + Pt-catalyst), their reaction proceeds.

Modification and hydrophobization of the surface of the magnetic filler must be carried out because there are features of the polymerization of rubber. If OH- ions are on the surface of the filler, then side reactions are possible during the polymerization of rubber. In this case, significant defects occur inside the samples.

Each particle is separated from each other and covered with a double layer of silicone molecules. Further, such a modified powder is readily dispersed in liquid silicone rubber.

The technology for producing a product from MAE of a given shape involves pouring a liquid mixture into a mold with subsequent polymerization at a temperature of 100-150 ° C. During heating, delamination of the system is possible, especially if the composition contains large particles of more than 10 microns. To prevent stratification of the composition, structural additives are added that increase the viscosity of the system, such as aerosil and nanomagnetite. It is possible to increase the polymerization rate by increasing the heating rate.

To do this, in the first phase of heating, electromagnetic radiation of the microwave range with a frequency of 2.4 GHz and a given power is used.

For example, it is possible to produce MAE samples in the form of cylinders with a diameter of 25 mm and a height of 2-3 mm with a polydisperse fraction of the magnetic filler (2-70 μm) in an amount of 30 vol. %

Studies have established that the elastic modulus of MAE increases with an increase in the degree of magnetization of the material. Moreover, the elastic modulus in the region of small strains is higher than in the region of large strains. A similar dependence is observed for the viscosity component of the module. The dependence of viscosity on amplitude has a dropping character; also in the region of small strains, the modulus has higher values than in the region of large strains.

The general nature of the dependence does not change with a change in the magnetizing field; with increasing field strength, the numerical values of the parameter increase. In general, there was a slight increase in the loss coefficient with an increase in the strain amplitude and the strength of the magnetizing field.

The dependences of the modules on the magnitude of the magnetizing field are complex. Both parameters increase with increasing value of the magnetizing field. With a general growth of modules from the field, there is a sharp jump in the increase in modules in the range of 1-1.2 T, after which the growth rate slows down. This jump can be explained by the processes of internal structuring of the magnetic filler inside the polymer matrix. In the process of magnetization, the residual magnetization of the filler increases, the dipole-dipole interaction between the particles of the magnetic filler begins, which affects a certain increase in the modules.

Starting from a certain critical value of the residual magnetization, the processes of dipole-dipole interaction increase so much that the particles overcome the elastic forces of the polymer matrix and are attracted to each other, overcoming the elastic forces of the matrix. Internal aggregates appear in the matrix, while the voltage rises sharply, which affects the sharp increase in modules. With further magnetization, the magnetization in the aggregates partially increases, and some particles additionally adjoin the aggregates. It should be noted that in fields of 2 T, the filler approaches the saturation magnetization and its residual magnetization ceases to increase.

Thus, magnetically rigid filler MAE exhibits an increase in viscoelasticity after magnetization and is able to work as an effective working fluid in passive and semi-active damping devices without magnetization systems. It should be noted that the effects of changes in the viscoelastic properties in such a material are lower than in composites with a soft magnetic filler.

Dilution of the magnetic material FeNdB with non-magnetic iron oxide α-Fe203 leads to an increase in the distance between magnetized particles, a decrease in the demagnetizing factor, and, accordingly, an increase in the measured coercive force of the material. Comparison of two samples with a rigid matrix confirms the classical position: a sample with a low concentration of magnetic filler has a higher coercive force.

The effect of “dilution” is most clearly seen when measuring the properties of pressed tablets with a bunch of epoxy resin. Samples with an elastic matrix exhibit the opposite effect. The coercive force of the sample with an elastic matrix is the smallest. This indicates that during the magnetization reversal of the sample, the particles of the magnetically rigid filler are inverted mechanically inside the polymer matrix. This mechanism of magnetization and magnetization reversal is a unique property of this MAE.

The dielectric constant of the magnetic elastomer changes under the influence of an external magnetic field up to 150% in the case of FeNdB filler and up to 80% for Fe filler. The field dependence of the dynamic dielectric constant is essentially nonlinear.

Significant anisotropy of the dynamic dielectric constant of the MAE with respect to the relative orientation of the constant magnetic field and the alternating electric field is observed. The magnitude of the effect reaches a significant value (more than 150%) and depends on the type of magnetic filler MAE and the direction of the applied field. For a sample consisting of a polymer matrix without magnetic particles, a change in dielectric constant under the action of an external magnetic field was not found within the error.

By analyzing the behavior of the material and the totality of properties, we can conclude that, in addition to the dipole – dipole interaction between particles, the processes of reversible movement of magnetic particles inside the polymer matrix under the influence of a magnetic field occur. That is, particles of a magnetic filler under the influence of a magnetic field and dipole-dipole interaction form chain-like structures inside the polymer matrix in the direction of the magnetic field. If a magnetically rigid filler, for example, FeNdB powder, is used as a magnetic filler, the processes of rotation of the magnetic filler inside the polymer matrix are observed.

The well-known properties of MAE are used in the manufacture of magnetic fillings, for which the liquid polymer composition is rolled using a squeegee on the surface of a fluoroplastic plate to a predetermined thickness. To carry out the polymerization process, the plate is placed in an oven at a temperature of 100-150 ° C for 30-60 minutes. A magnetic seal of the required size is cut out on the surface of the plate and removed (GV Stepanov, D.Yu. Borin, E.Yu. Kramarenko, VV Bogdanov, DA Semerenko, and PA Storozhenko. Magnetoactive Elastomer Based on Magnetically Hard Filler: Synthesis and Study of Viscoelastic and Damping Properties. Polymer Science, Ser. A, 2014, Vol. 56, No. 5, pp. 603-613; S. Abramchuk, E. Kramarenko, G. Stepanov, LV Nikitin, G. Filipcsei, AR Khokhlov, and M Zrinyi, Novel Highly Elastic Magnetic Materials for Dampers and Seals: Part I. Preparation and Characterization of the elastic materials. Polym. Adv. Technol. 18, 883-890 (2007); GV Stepanov, SS Abramchuk, DA Grishin, LV Nikitin , E. Yu. Kramarenko, and AR Khokhlov, Effect of a homogeneous magnetic field on the viscoelastic behavior of magnetic elastomers. Polymer 48, 488 (2007)). The outside is coated with a biocompatible silicone elastomer.

Since any magnetized body or magnetic inhomogeneity can be considered as a magnetic dipole or their combination and undergo force action due to an external magnetic field, the possibility of using magnetic fields as a tool to control the movement and orientation of these objects, in particular, is of great practical importance. for medical applications.

Foreign bodies with a magnetization are deliberately introduced into the human body to perform various tasks. Control of them using an external magnetic field allows the patient to carry out various diagnostic and / or therapeutic procedures without serious consequences.

Known technical solutions for creating a magnetic field controlled endoscopic capsules, when magnetic control is carried out using an external magnetic field created by both electromagnets and permanent magnet systems. For example, such complexes for conducting a fully controlled capsule endoscopic examination are disclosed in US 20070221233 A1, publ. 09/27/2007, US20100268026 A1, publ. October 21, 2010, US 20110054255 A1, publ. 03.03.2011, US 20110184235 A1, publ. 07/28/2011.

The main disadvantages of existing systems are the inability to manipulate the endoscopic capsule in the gastrointestinal tract with 6 degrees of freedom, including movement throughout the gastrointestinal tract, significant dimensions and weight of the unit.

A known configuration of a magnetic control system using a single permanent magnet that allows you to reorient the capsule in the stomach (Arthur W Mahoney and Jake J Abbott: 5-DOF Manipulation of a Magnetic Capsule in Fluid using a Single Permanent Magnet: Proof-of-Concept for Stomach Endoscopy. In Hamlyn Symp. Med. Robot., Pages 114-115, 2013).

In the known solution, a robotic “arm” is used, a manipulator that moves one magnet. Both linear displacements and the rotation of the magnet are realized due to rotations in the joints of the “arm”. The use of a single magnet allows you to control the orientation of the magnet of the endoscopic capsule, however, the magnetic force is always directed towards the magnet manipulator. Moreover, there are "dead zones" and inconvenient directions in the workspace.

Known manipulator of an endoscopic magnetically controlled capsule (KR 100540758 B1, publ. 10.01.2006), which allows you to move and stop the endoscopic capsule in the patient's body. The manipulator has 5 degrees of freedom, two rotational of which are realized due to two nodes of rotation, and three linear (transverse, longitudinal and vertical directions) - due to nodes of linear movements. The device has two permanent magnets, each of which is fixed in a clamp on both sides of the patient, made with the possibility of rotation and movement in the vertical and longitudinal planes. The clamp is mounted on a rail mounted on a vertical bed, while the linear movement of the permanent magnet in the transverse plane occurs due to the movement of the bed along the base.

The disadvantages of this manipulator are that the distance between the endoscopic capsule and the external permanent magnet is manually controlled, so there is a risk of operator damage to the body walls when the capsule and magnet are at a small distance from each other. In addition, the use of two magnets located on opposite sides of the patient does not allow to create all possible field configurations necessary for effective control of the capsule. This manipulator has low accuracy and poor reproducibility.

Existing magnetic systems that control the movement of a foreign object with magnetization in the patient’s body have insufficient accuracy of tool movement and manipulation capabilities in a limited space, and therefore there are “dead zones” and it is impossible to create a system of any predetermined configuration at any point in the working space magnetic field, including the magnitude and direction of the field, the values of all components of the magnetic field gradient.

It is also known a device for controlling the movement of an object having a magnetization and located inside the patient’s body (RU 2667880, Tishin AM et al., Pharmag LLC, https://findpatent.ru/patent/266/2667880.html) and containing at least 4 sources of constant magnetic field located in the region of space surrounding the patient’s body. Moreover, each of the sources has 5 degrees of freedom and is configured to automatically control its spatial position and angular orientation using feedback and taking into account the position and orientation of the object inside the patient. As an object, (a) an endoscopic capsule, a medical microrobot, a drug solution with magnetic nanoparticles, a micro or nano-needle, a sensor or a stimulator can be used.

The source of the constant magnetic field can be made in the form of at least one permanent magnet, an electromagnet or an electromagnet with a core, in the form of a system comprising an electromagnet and at least one permanent magnet.

The device can be made in such a way that each source of a constant magnetic field is installed in the manipulator, mounted on a single common base. The configuration of the manipulator can be performed on the basis of the spatial mechanism of the parallel structure. The manipulator can be made in the form of a tripod, which consists of three linear drives and provides 3 degrees of freedom for the controlled coordinate movement of the rotation drive, which is installed at the end point of the linear drives. Moreover, the rotation drive is arranged to fix the source of constant magnetic field and provides 2 angular degrees of freedom for the controlled adjustment of the rotation angles of the source of constant magnetic field.

Using feedback to move sources of a constant magnetic field, taking into account the position and orientation of the object, determined using one of the known methods for tracking the position of the object and its orientation in real time, allows you to increase the accuracy of control and positioning of the object by this manipulator.

This effect is also used in our invention.

To provide feedback when moving an implantable device under the skin of the device with the microcontroller of the implanted device, as well as to provide information about the surrounding tissues to an external remote control device, several types of sensors must be present both on the implantable device and on the external remote control device.

Thus, spectrophotometry (SPS) of biological tissues in the red and near infrared (K-NIR) wavelength ranges is known, which is a set of methods for photometric measurements of optical radiation fluxes from radiation sources or after its interaction with samples depending on the wavelength.

Among the most widely used in clinical practice SPS methods, SPS is known with deep probing of biological tissue and registration of backscattered radiation; An example is optical tissue oximetry, which is used to determine the degree of oxygen hemoglobin oxygenation in working muscle tissue, in the brain of newborns with pathology or in adults in the process of active brain activity. In this method, radiation scattered in the opposite direction is recorded. The physical basis of the SPS methods is the interaction of light photons with biological tissue.

From an optical point of view, biological tissues, including biological fluids: blood, lymph, etc., can be divided into two large classes:

1) highly scattering (optically cloudy), such as skin, brain, vessel wall, blood, sclera, the optical properties of which are described by a multiple scattering model;

2) weakly scattering (transparent), such as the cornea and lens of the eye, the optical properties of which are described in the model of single (or multiple) scattering.

Biological tissues are optically heterogeneous, are highly scattering and absorbing media with an average refractive index greater than that of air. At the bioobject-air interface, part of the radiation is reflected, the so-called Fresnel reflection, and the rest penetrates into the biological tissue. Due to multiple scattering and absorption, the radiation decays exponentially as it propagates through biological tissue. Volume scattering is the cause of the propagation of a significant proportion of radiation in the opposite direction, backscattering.

The absorbed light is converted into heat, re-emitted in the form of fluorescence, and is also spent on photobiochemical reactions. The absorption spectrum is determined by the type of dominant absorption centers, as well as the water content in the biological tissue. In the ultraviolet (UV, λ <390 nm) and infrared (IR) (λ> 1 μm) spectral regions, absorption by proteins and water is high, respectively, therefore, the contribution of scattering is relatively small, and light penetrates into the biological tissue superficially - only a few cell layers. For short waves of the visible region, the penetration depth of a typical biological tissue is 0.5, 2.5 mm; both absorption and scattering take place; about 15-40% of the incident radiation is reflected. In the wavelength region of 0.6.0.9 μm, scattering prevails over absorption, therefore, the depth of light penetration increases to 8.2 mm. Also, the intensity of radiation reflected and scattered backward by biological tissue increases significantly, up to 35-70% of the incident. In the green region of the spectrum of 500-570 nm, hemoglobin absorption of blood dominates.

The absorption of scattered light by skin pigments gives quantitative information on the concentration of bilirubin, melanin, water, oxygen saturation of hemoglobin, the content of drugs and other absorbers in the tissue and blood, which is the basis of a number of diagnostic methods. Significant penetration of visible and near infrared light through the skin into the human body in the wavelength region of the so-called “therapeutic window” (650-900 nm) is the basis of a number of phototherapy and optical diagnostics (SPS) methods. Hard tissues such as ribs and cranial box, as well as whole blood show a relatively good transmission in the visible and near infrared region of the spectrum.

Chromophores of biological tissues - substances responsible for the absorption of radiation, can be divided into those that exhibit oxygen-dependent absorption (oxy- and deoxyhemoglobin, myoglobin and cytochrome oxidase), and those whose absorption does not change significantly during clinical measurements in vivo (water, melanin , bilirubin, adipose tissue).

The main contribution to the total absorption coefficient in the red and near-IR spectral regions is made by the hemoglobin and water fractions. The contribution of the remaining chromophores ranges from a fraction of a percent for bilirubin and up to 10% for cytochrome oxidase and skin melanin. The correctness of taking into account the contribution of these chromophores to the total absorption coefficient determines the component of the methodological error of the SPS methods, which is taken into account differently in different SPS methods and their instrument implementations.

Four independent macroscopic parameters characterize the propagation of radiation in the tissue: scattering anisotropy parameter (g), absorption coefficient (m _a ), scattering coefficient (m _s ), and refractive index (n). These parameters, in fact, carry information about both biochemical properties and morphological, structural and functional features of the tissue, i.e. allow you to determine its type.

The dominant factors affecting the scattering properties of biological tissues are the size, shape and density of scattering centers, as well as differences in refractive indices. Scattering in biological tissues mainly occurs on cells, cellular organelles and macromolecules, such as proteins. The size of mammalian cells is in the range of 2-30 μm, and the cell organelles vary significantly in shape and size (from 5 nm to 7 μm). Proteins are more often regarded as "spheres" with a diameter of less than 7 nm.

The variability of the refractive index in biological tissues is also great. Lipids (n "1.46) and proteins (n" 1.51) have relatively high refractive indices, while intercellular fluid has a lower refractive index (n "1.35) (https://megapredmet.ru/ 1-73329.html).

Fluorescence spectroscopy (FSS) is based on probing a biological object with radiation in the visible region of the spectrum to excite endogenous and exogenous fluorescent skin biomarkers (NADH, flavins, lipofuscins, porphyrins, etc.) and to record fluorescence spectra. This method allows you to register and analyze in vivo the content in tissues and organs of substances that determine the metabolism and viability of cells and tissues. Many biomarkers are characterized by close or overlapping absorption and fluorescence regions; as a result, radiation emerging from the tissue has a complex spectral composition. The signal is a superposition of the fluorescence spectra of various natural components of biological tissue, such as collagen, elastin, nicotinamide (NADH), etc., having different fluorescence intensities at different wavelengths. To register fluorescence, diagnostic systems contain small-sized fiber-optic spectrum analyzers that allow recording and quantitatively measuring the intensities of the back-scattered tissue (source) radiation and fluorescence radiation as a function of wavelength, i.e. determine the spectral power density of the secondary radiation from biological tissue.

To excite fluorescence in tissues in vivo, as a rule, low-power (power P <10 mW) cw lasers of a selected wavelength or narrow-band LED emitters are used. This is the cheapest constructive solution that allows the use of fiber optic probes for transporting radiation to and from biological tissue. The LAKK-M diagnostic complex, for example, contains several such laser and LED radiation sources at wavelengths λ = 365, 450, 532 and 635 nm. The radiation from the lasers is delivered to the surface of the biological tissue through the light guide, which is one of the veins (usually central) of a multicore optical fiber probe, which contains, in addition to the light, a set of receiving optical fibers, through which secondary radiation (scattered, fluorescence) detected from the biological tissue is formed in diagnostic volume of biological tissue delivered to a polychromator. Inside the polychromator, the radiation passes through a threshold cut-off optical filter, which attenuates the initial radiation at a laser generation wavelength of about 1000 times, and is decomposed into a spectrum by a dispersing element — a diffraction grating. Further, this entire spectrum is recorded by a linear photodetector, converted into an electrical signal proportionally to the spectral power density incident on the photodetector, the electrical signal is amplified by an amplifier, and fed through a standard interface to a computer for further processing.

Thanks to the multi-element matrix photodetector and polychromator, the entire spectrum of secondary radiation, including the fluorescence spectrum, can be immediately observed on a computer screen in real time.

Fluorescence diagnostics makes it possible to evaluate the fluorescence emission intensity of nicotinamides, flavins, lipofuscin, porphyrins, and other enzymes. To assess fluorescence, in particular, the coefficient of fluorescence contrast of biological tissue is used, which is determined by the formula: Kf = 1 + (If - Il) / (If + Il), where If is the maximum (peak) of intensity in the fluorescence line of the enzyme; Il is the maximum in peak intensity in the excitation line.

Sensors based on the above physical effects of SPS, FSS can be used in the device we offer.

However, in this case, the choice of the sensor can be significantly affected by the fact that the proposed device should be extremely small.

At the same time, developments are underway in the world to create spectrometric sensors and methods for using THz-frequency radiation for medical and biological problems. This is due, first of all, to the fact that in this range lie the strongest absorption lines of many substances (for example, water, ammonia, alcohols). Moreover, in the terahertz range are the vibration frequencies of large groups of atoms forming a molecule and the vibrations of hydrogen bonds of many organic substances of interest to biology and medicine (proteins, DNA molecules). They are very sensitive to the geometric shape of the molecule, its environment and play an important role in biochemical reactions.

Sensors implementing the method of terahertz spectroscopy are based on the phenomenon of absorption by groups of atoms of a test object of electromagnetic radiation in the terahertz range. When the radiation energy is absorbed, molecular vibrations are excited, since molecules absorb only those energy quanta whose frequencies correspond to the frequencies of stretching, deformation, and vibrational vibrations of the molecules. The ability of terahertz sensors to identify certain classes of substances is based on the resonance phenomenon of the so-called torsional vibrations of molecules of organic substances. The use of terahertz spectroscopy allows remote identification of explosives and drugs, which is an advantage, since it is not always possible to identify them by other methods.

A positive feature of the terahertz spectroscopy method is that the absorption bands of the same type of vibration of the atomic group of various substances are located in a certain range of the spectrum (for example, 3720-3550 cm ^-1 - the range of stretching vibrations of -OH groups; 3050-2850 cm ^-1 - groups —CH, —CH ₂ , —CH _{3 of} organic substances). The exact position of the maximum absorption band of the atomic group within this range indicates the nature of the substance (for example, a maximum of 3710 cm ^-1 indicates the presence of —OH groups, and a maximum of 3030 cm ^-1 indicates the presence of = CH groups of aromatic structures). Thus, the rich spectrum of vibrational and rotational transitions in organic substances and compounds in the terahertz range allows one to determine their presence and identification with high accuracy and, therefore, terahertz spectroscopy can be used to analyze mixtures and identify pure substances or their mixtures by comparative analysis of the spectra feedback.

Currently, the issue of developing ultra-small spectrometers and spectrometric sensors is relevant worldwide. The miniaturization of the sizes of THz spectrometers is an important task of both technological and commercial applications in general.

Usually, spectrometric sensors based on the method of impaired total internal reflection are used to record spectra from the surface of a substance (for example, spectrometric sensors of the British company TeraView (www.teraview.com), utility model 92172 “Terahertz scanning probe microscope”, V.V. Gerasimov, B.A. Knyazev, Features of spectroscopy of impaired total internal reflection in the terahertz range // Vestnik NSU, Series: Physics, 2008, vol. 3, No. 4, 97-112). The principle of operation of the known sensors is based on the absorption by the surface layer of the detected substance of electromagnetic radiation energy emerging from the prism of total internal reflection, which is in optical contact with the surface under study. However, such sensors have significant dimensions, significantly exceeding the radiation wavelength.

In most cases, progress in the development of terahertz spectrographs has been associated with time domain spectroscopy (TDS) systems. The TDS system generates and detects a THz signal pulse in the time domain and calculates the spectrum by performing the Fourier transform of the incoming signal. These are technologically sophisticated and quite expensive systems with significant mass-dimensional characteristics. Companies such as Picometrix (USA), TeraView (UK) and Zomega (USA) are developing this line of THz spectrometers.

For example, a Zomega sensor is known for non-destructive testing and implements time-domain spectroscopy (H.-S. Zhang and Albert Redo-Sanchez. Handheld THz Instrumentation // http://spie.org/x86630.xml, CO Lunev , VI Syryamkin. Intelligent Integrated System for the Remote Detection of Explosives // News of Higher Educational Institutions, Physics, T. 56, No. 10/2, 2013).

However, such sensors are quite laborious in production, have significant dimensions, significantly exceeding the radiation wavelength.

A known spectrometric sensor, including a dispersion element made in the form of a concave diffraction grating, an array of radiation receivers located in the corresponding foci of the dispersion element and a recording device (RV CHIMENTI and RJ THOMAS, SPECTROMETERS: Miniature spectrometer designs open new applications potential // laser focus world, 01/05/2013. URL htlp: //www.laserfocusworld.com/articles/print/volume-49/issue-05/features/spectrometers--miniature-spectrometer-designs-open-new-applicati.html; Nano- Stick Spectrometer. URL http: //www.nanoopticdevices.eom/#lspectrometers/clylt).

The principle of operation of such spectrometric sensors is based on the use of the diffraction phenomenon in the Fraunhofer zone, where the distance Z along the optical axis is greater than Z >> d ² / λ, where d is the aperture diameter and λ is the radiation wavelength. However, such spectrometric sensors have significant (in comparison with the radiation wavelength) longitudinal dimensions.

A small-sized spectrometric radiation sensor is known, including an array of dispersion elements made in the form of Fresnel lenses, each of which provides selectivity at a certain frequency, an array of radiation receivers located in the corresponding foci of the dispersion element and a recording device. (Yeonjoon Park et al. Miniaturization of a Fresnel spectrometer, J. Opt. A: Pure Appl. Opt. 10 (2008) 095301 (8pp) doi: 10.1088 / 1464-4258 / 10/9/095301). The principle of operation of this spectrometer is based on the use of the dispersion properties of the Fresnel optics and a line of receivers. The known spectrometric sensor allows to reduce the longitudinal dimensions, since it works in the Fresnel zone. However, its longitudinal dimensions also remain significantly larger than the radiation wavelength, since the principle of construction of the spectrometer fundamentally limits its miniaturization by the focal length F≥2d at a given wavelength λ, i.e. longitudinal dimensions lying in the interval (d << Z << d ² / λ) >> λ.

где: k - коэффициент, равный 1.84, Н - высота кубоида, L - длина стороны кубоида, λ - длина волны падающего волнового фронта, n/n₀ - относительное значение показателя преломления материала кубоида и среды. Авторами известной полезной модели был обнаружен эффект формирования т.н. тераструй (V. Pacheco-Pena, М. Beruete, I.V. Minin, O.V. Minin. Terajets produced by 3D dielectric cuboids // Applied Physics Letters, 105, 084102 (2014); http://dx.doi.org/10.1063/1.4894243) (аналог фотонных наноструй в оптическом диапазоне при падении плоского волнового фронта на сферическую диэлектрическую частицу) при облучении диэлектрических кубоидов, где фокусировка излучения с эффектом сверхразрешения наблюдается на расстояниях 0<Z<(1-3)λ Дисперсионные свойства диэлектрических кубоидов (зависимость длины тераструи, ее положения в пространстве и фокусирующих свойств от значения падающей на кубоид длины волны) применены в качестве основы упомянутого сверхмалого спектрометра с продольными габаритами не более нескольких длин волн (т.е. не более нескольких мм).The task of significantly reducing the longitudinal dimensions of the spectrometric sensor was solved in a utility model disclosed in RU 153680 U1, 07.27.2015, Minin I.V., Minin O.V. This known small-sized spectrometric radiation sensor includes an array of dispersion elements, each of which provides selectivity at a specific frequency, an array of radiation receivers located in the corresponding foci of the dispersion element and a recording device. In this case, the dispersion element is made in the form of dielectric microparticles forming photonic jets. The dielectric microparticles are made in the form of cuboids with sizes determined from the ratio

where: k is a coefficient equal to 1.84, H is the cuboid height, L is the cuboid side length, λ is the wavelength of the incident wave front, n / n ₀ is the relative value of the refractive index of the cuboid material and the medium. The authors of the known utility model have discovered the effect of the formation of the so-called terastruy (V. Pacheco-Pena, M. Beruete, IV Minin, OV Minin. Terajets produced by 3D dielectric cuboids // Applied Physics Letters, 105, 084102 (2014); http://dx.doi.org/10.1063/1.4894243 ) (an analogue of photonic nanojets in the optical range when a plane wave front is incident on a spherical dielectric particle) upon irradiation of dielectric cuboids, where focusing of radiation with the superresolution effect is observed at distances 0 <Z <(1-3) λ , its position in space and focusing properties on the value of the wavelength incident on the cuboid) n namely as the basis of said ultralow spectrometer with longitudinal dimensions of no more than several wavelengths (i.e., no more than several mm).

When terahertz radiation falls on an array of dispersion elements, each of which provides selectivity at a certain frequency and is made in the form of dielectric microparticles forming photonic jets (in particular, cuboids), each element of an array of microparticles forms photonic terastrays (in the terahertz range) whose length Z (λ), in particular, depends on the wavelength of the radiation λ incident on them. In accordance with the dispersion properties of such dielectric microparticles at distances corresponding to the current wavelength, an array of radiation receivers is located, the signals from which enter the recording device. Thus, each channel of a given spectrographic sensor (an element of a microparticle array and a corresponding radiation receiver) is tuned to a specific radiation wavelength corresponding to the spectral band of the substance to be detected and provides selectivity at a specific frequency. The number of an element of an array of microparticles and receivers corresponds to the number of spectral bands to be determined using this sensor (determined by its specific purpose).

This type of sensors can also be used in the device we declare - as sensors located on a device implantable under the skin and designed to determine the parameters of living tissue located along the movement of the device.

There are, inter alia, subcutaneous inputs, such devices that are capable of performing various predetermined manipulations by external control, for example, using various types of energy (light, electric, magnetic), in particular, when using magnetorheological elastomer as an application (for example, described in WO 2019115670 A1, 06/20/2019, Javier Espina Perez, etc.).

Commercially available magnetic stimulants include circular, parabolic, octal (butterfly) and custom designs (Chris HOVEY and Reza Jalinous, The GUIDE TO MAGNETIC STIMULATION, The Magstim Company Ltd, Spring Gardens, Whitland, Carmarthenshire, SA34 0HR, United Kingdom, 2006). Additional embodiments of a magnetic stimulator coil are described, for example, in US 6,179,770; Kent Davy et al. Magnetic stimulation coil and circuit design. IEEE Transactions on Biomedical Engineering, Vol. 47 (No. 11, November 2000): 1493-1499. Many of the problems that are associated with such conventional magnetic stimulants, for example, the complexity of the pulse generator circuit and the problem of overheating, can be largely eliminated by the toroidal design.

Using these coils, waveforms with relatively simple, low-power circuits that are powered by batteries can be obtained. The circuits can be enclosed in a box or attached to the stimulator itself for use as a hand-held device. In any case, the device can only be controlled with the on / off switch and the power knob.

The currents passing through the coils of the magnetic stimulator will saturate its core (for example, a magnetic field of 0.1 to 2 T for the core material Supermendur). This will require approximately 0.5-20 A of the current passing through each coil, usually 2 A, with a voltage on each coil of 10 to 100 volts (US 2013317580 A1, 11/28/2013, Bruce J. Simon, etc.)

Known implantable, including subcutaneous, device (US 2016000548 A1, 01/07/2016, Erez Lieberman Aiden et al. - prototype), functionally connected to an external control device and containing elements that allow you to remotely control the implanted device, in particular for cosmetic goals - to facilitate its movement, expansion, as well as the release of liquid or gas from it, designed to change the contours, shapes of internal tissues, for example, faces. The device may contain elements made telescopic, i.e. able to move out of the device under the action of a signal from an external control element. In an embodiment, the device is an injection device that is sized to allow passage through a channel, for example, a needle, cannula or catheter.

A known device can be placed in the subject’s body in one or more areas, including the face (for example, chin, cheek, jaw, lips, facial fold, forehead, nose), chest (under the pectoral muscle), buttocks (for example, in the gluteus muscle) , legs (e.g., calf, thigh), hands (e.g., biceps, triceps), genital area (e.g. for genital reconstruction), abdomen or heart area. The device may be implanted in the subject’s body to construct or reconstruct one or more parts of the body (for example, after amputation, trauma or burns, scarring, a congenital anomaly, or disease). The device has a wall thickness of from about 1 nm to about 1 cm and, accordingly, a length of from 1 nm to about 10 cm, a volume of from about 10 cm ³ to about 600 cm ³ .

A known device is placed under the skin to treat imperfections in the skin caused by aging, environmental influences, weight loss, surgery, illness, congenital malformations or for aesthetic improvement (for example, for treating wrinkles, facial scars, acne marks, lines puppets or to enhance various facial features).

The device can be inserted directly into the body of the subject using a needle inserted into the tissue, with direct pressure on the system supporting the device in the body of the subject, while the needle is removed. Or the device is implanted surgically using an incision of integumentary tissues and subsequent suturing.

The device may contain one or more ports with microelectromechanical valves (for example, for a reservoir or cartridge and an adjustable element) and one or more sections. In an embodiment, the valve includes an osmotic valve (for example, allows fluid to be admitted). The control circuit is operatively connected to the valve of the reservoir or cartridge. The filler includes one or more substances that may be in various physical conditions or combinations thereof, including, for example, an inviscid liquid, viscous liquid, gel, powder, balls, flakes, foam, continuous or non-continuous fibers, coils, fiber balls, knitted fibers, woven fabrics, threads, and the like. The filler may be: polyvinylpyrrolidone, silicone oil, vegetable oil, saline, gelatin, collagen, autologous fat, hyaluronic acid, autologous plasma, water, saline, silicone, carbon dioxide or other physiological carriers. For example, a carbon dioxide cartridge can be activated by energy released from a remote control. For example, a radio frequency device may signal a cartridge to emit carbon dioxide in a certain amount (for example, 5 cc over a 12-hour period, etc.). In an embodiment, the remote control is powered by at least one of acoustic energy, radio frequency energy, thermal energy, or light energy.

At the same time, at least one filler for the device includes a polymer or other material that changes state (for example, from liquid to solid or from liquid to gel matrix, etc.) when at least one of the parameters is activated: temperature, hydration, pH, salt concentration, surface tension, specific antigen, specific chemical substance (e.g. protein), light, ultrasound, heat, magnetic force or mechanical elements (e.g. presence of an external membrane or one or more internal co nents).

The filler may be activated using external energy (e.g., laser, ultraviolet, microwave, magnetic field, etc.). The device may use a flow of a substance (eg, gas or liquid) to expand or contract the device. External energy can be used to induce a change in volume, shape, color or tone of the device in vivo.

Thus, this known device is able to separate tissues, including subcutaneously, for cosmetic, plastic purposes, by introducing (releasing) in them certain substances or materials, being able to expand and contract under external, remote control, which controls one or more device motors configured to receive remote signals.

In this case, the external (remote) control can additionally receive and process signals from one or more internal or external sensors of the device, which are functionally connected to the external control. The sensor may be a spatial, temporary, external and / or remote sensor for detecting environmental conditions. For example, the sensor may include an internal sensor for detecting parameters or conditions of the device itself, or parameters or conditions of the body of the subject into which the device is implanted. Examples of internal sensors that can be adapted for use with various embodiments of this device can be found, for example, in application US 2012/0157804.

The device itself can be made of various materials, including a magnetically active elastomer, and therefore, can be controlled from an external console by means of a magnetic field.

However, after implantation, this device is static, does not change its location, but only the size, shape, etc., in the desired place in which it is implanted, but is not able to move under the skin, atraumatically spreading tissues in various places on the face and neck .

This problem is solved in the present invention.

The technical result of the device we developed is to ensure atraumatic separation of the tissues of the face and neck - the skin from the subcutaneous tissue when placing the micro device subcutaneously, and separation is possible in different areas of the face and neck in the process of directed, controlled movement of the micro device, which does not require the implantation of another tissue separation device in other required places. The accuracy of manipulation of subcutaneous tissue separation is ensured by real-time control of the operation of the implantable microdevice. In addition, the risk of reducing complications is provided, due to the fact that the microdevice is implanted only once and solves cosmetological problems in the course of one procedure, in the process of its movement.

For this, a device is proposed for separating facial skin from underlying subcutaneous tissue, comprising:

i) an external device for remote control of the movement of the implantable microdevices containing

light signal sensors configured to receive light signals from an implantable microdevice located under the skin,

sensors for changes in the characteristics of the magnetic field emitted by the working part of the implantable microdevice,

and electromagnetic signal inductors, configured to act on the working part of the implantable microdevices to change the direction of its movement;

ii) an implantable microdevice under the skin of an elongated shape, comprising a working part with a retractable cutting element fixed in a groove on the front of the microdevice,

sensors of parameters of living tissues and sensors of linear and angular displacement of the implantable microdevice located along the direction of movement of the implantable device - on the front-upper surface of the working part,

the upper part of the working part is made of magnetic material capable of bending in accordance with the surface shape of the underlying tissues and with the possibility of interaction with the sensors of changes in the parameters of the magnetic field of the remote control device located outside the body,

the lower part of the working part contains:

a) a microelectric drive with a power source associated with sensors of parameters of living tissues and movement through a microcircuit,

b) the microcontroller functionally by means of integrated circuits:

with sensors of parameters of living tissues and movement of the implantable device,

with a magnetoactive element in the upper part of the working part of the implantable microdevice,

with retractable cutting element

with microelectric drive

while the body of the implantable device has a height suitable for the mechanical separation of facial skin from underlying tissues.

In special cases of its implementation or use, the device may contain:

- means for remote movement of the working part is made in the form of an external remote control with push controls for the cutting element of the working part and is equipped with at least one magnetic material made to interact with at least one magnetic material installed in the working part;

- the surface of the housing with a retractable cutting element, which is equipped with a video camera;

- means for remote movement of the working part, made in the form of an external remote control with pressure control elements of the cutting element of the working part and controlling the video camera and equipped with at least one magnetic material made to interact with at least one magnetic material installed in the working part;

- retractable cutting element made in the form of a circular knife connected to the drive with the possibility of rotation in the horizontal plane of the device;

- retractable cutting element made in the form of a circular saw connected to the drive with the possibility of rotation in the horizontal plane of the device;

- retractable cutting element made in the form of two blades connected to the drive, with the possibility of their oncoming movement;

- an LED made in the form of a label for visually tracking the movement of the device under the skin and installed in the wall of the housing of the working part from the skin side;

- the body of the working part, made in a drop-shaped form, and the front part has a greater height than the back.

The device can be made in the form of a disposable tool;

- turn on the power source, which is connected to the electric drive by a wireless connection and has means for attaching to operating linen or clothes.

The longitudinal size of the device (the optimal size is) does not exceed 0.5-1 cm, including the extendable cutting part of the device, in a volume of not more than 1000 mm ³ (10 × 10 × 10 mm), including the cutting part of the device in the extended state.

The microdevice includes a receiver and an internal control circuit that can receive signals from an external source, such as a remote control or computer or external sensors.

The microdevice contains a microelectric drive (microelectric motor).

The implantable microdevice contains internal sensors that are functionally connected to the receiver and the internal control circuit.

The internal control circuit is functionally connected to other parts of the microdevice. The internal control circuit processes the received signals and informs about it, by means of a microcircuit, other parts of the microdevice, for example, an engine, an electric drive.

The implantable microdevice in its front part contains microsensors (sensors) that allow transmitting information about:

- the properties of the tissue lying in front of the microdevice, for example, about a change in the density of the tissue, its optical properties, the exit of its values outside the specified range. This indicates that in front of the device, for example, tissue of a vessel or nerve, and in this case, the internal circuit of the device allows you to send a signal to the electric drive about the need to stop and change the direction of movement of the microdevice in order to prevent unwanted damage to the tissues. These sensors can be spectrophotometric, can be based on fluorescence spectroscopy, obtaining data on the optical density of the tissue;

- device position - linear and angular displacement sensors, motion / stop sensors, transmitting information to an external device to change the direction of movement.

The implantable microdevice contains:

said sensors of parameters of living tissues lying in front of the microdevice (for example, density, optical properties of the tissue, linear and angular displacement) on the front surface (end) of the microdevice, connected to the power source by means of a microcircuit, and also in the front-upper part of the microdevice - sensor label an infrared signal to track the movement of the microdevice through the skin from the outside;

a power source at the bottom of the device in the form of an appropriate size of the battery or accumulator, by means of a microcircuit connected to the microcontroller and the microelectric drive, moreover, the microcontroller at the bottom of the device provides control of the movement of the device inside the body and is functionally connected (via the microcircuit) to the device’s power supply and the electric drive, providing forward movement of the microdevice forward, as well as with sensors on the front surface of the microdevice;

the microcontroller is made with the possibility of influencing the magnetoactive elastomer from which the working part of the implantable microdevice is made, changing its magnetic field, whereby remotely the sensor of the external control device (outside the body) receives information about the stop of movement of the implanted microdevice and about the need to change the trajectory of its further movement ;

the working part of the implantable device is made of a magnetoactive (magnetorheological) elastomer capable of changing magnetic field parameters in response to external influences (changes in the environment external to the device), for example, through a microcircuit in the form of electric exposure parameters, changed in accordance with changes indicators of implanted microdevice sensors located on its front surface;

the microcontroller also gives an electrical signal to extend the cutting part of the device from its front if the characteristics of the fabric detected by the sensor in front of the device coincide with a given characteristic / range of characteristics (for example, with the density or chemical composition of the pancreas, the density or chemical composition of the solder, connective tissue weight, the range of optical characteristics of the fabric), and an electrical signal to remove the cutting part inside the device;

while the cutting part of the device is made:

or in the form of a circular knife with a diameter of not more than 0.5 cm (not more than the width of the working part of the device) located in the horizontal plane of the working part of the device, with the possibility of rotation in this plane,

or in the form of a disk micropile of similar dimensions, located in the horizontal plane of the working part of the device with the possibility of rotation in this plane,

or in the form of two blades with a width and length of not more than 0.5 cm, with the possibility of oncoming movement of the blades - according to the type of scissors,

while the cutting part is placed inside the implantable device in a horizontal groove from the side of its front surface (end) and connected to the microelectric drive and the microcontroller,

the upper part (half) of the device in the horizontal plane is a magnetoactive elastomer (MAE), and the lower part includes a microcontroller, microcircuits for connecting elements of the device circuit, microelectric drive, power source.

An external, remote control device for the movement of the implantable device may be a keypad containing an infrared signal transceiver to remotely turn on the implantable device, and receiving the signal from the infrared mark on the implanted device is a feedback for the external remote control device.

An external remote control device for an implantable microdevice also has:

power source (e.g. battery, battery),

microcontroller associated with it through a microcircuit,

a magnetic inductance coil emitting an external magnetic field through which the external control device is functionally connected to the implantable device, namely: changes in the predefined parameters of the external magnetic field allow you to influence the changes in the predefined parameters of the MAE of the implanted device, adjusting the features of its movement (stop, start, resumption of movement, direction of turns, etc.),

sensors of magnetic field parameters generated by the MAE, connected to the microcontroller of the external remote control device by means of a microcircuit and giving him information about changes in the parameters of the magnetic field of the MAE.

The power source of the implantable device may be a battery, a fuel cell, an inductive component wireless energy transfer coil or an energy processor capable of collecting energy from body heat or mechanical movement using a thermoelectric or piezoelectric component (see, for example, US 2013/0041235, US 2012/0157804).

For example, a power source may include one or more micro-battery or thin-film batteries (see, for example, US 5,338,625 regarding a thin-film battery and a method for manufacturing it). An implantable microdevice may include one or more power sources that are rechargeable from an external source (see, for example, US 2005/0143787, for a method and system for providing electrical impulses for neuromodulation of a vagus nerve using a rechargeable implanted pulse generator).

The device works as follows.

The implantable microdevice is disposable. After antiseptic treatment of the selected injection site, a superficial cosmetic micro-section of the skin of the face is made, through which the device is inserted under the skin, above the pancreas.

The remote control device is turned on, located at the desired distance from the body surface, above the implantation site of the device, inducing the inclusion of an infrared light signal on the implanted device.

The remote control device in the on state using the activated inductor (after turning on the device) begins to generate a magnetic field that interacts with the MAE of the implanted device.

MAE, changing its own magnetization under the influence of an external magnetic field of a remote device, interacts with a microcontroller through a microcircuit, starting its operation.

The microcontroller sends a signal to turn on the power source of the implanted microdevice, the sensors on the front surface of the device and the microelectric drive, inducing the start of movement of the implanted device under the skin.

In this case, the microcontroller immediately begins to receive signals from motion sensors and parameters of living tissue located on the front surface of the device. At the same time, the microcontroller contains predetermined data on the parameters of living tissue, at which the device can move and extend its cutting element.

If, according to the sensors, these parameters correspond to the set, the microcontroller instructs the implantable device to move forward, while the cutting element receives a signal to extend from the groove of the device and separates the tissues lying in the direction of movement of the implanted microdevice.

If the sensor readings on the parameters of the living tissues in front, change them beyond the boundaries of the specified ranges, the microcontroller, having received this information by means of a microcircuit, gives a signal that the cutting element should slide back into the groove, and the implantable device should stop moving.

At the same time, the motion / stop sensor (linear and angular movement) of the implantable device supplies information through the microcontroller to the MAE, and the characteristics of the magnetic field generated by the MAE change.

As a result, the magnetic field sensors installed on the remote control device capture these changes, transmit this information via a microchip to the microcontroller of the remote external control device, which transmits a change in the parameters of the external magnetic field acting externally on the implanted device and changing the MAE properties of this device. As a result, information about the change in the MAE parameters by means of a microcircuit enters the microcontroller.

The microcontroller, in response, sends a signal to the microelectric drive about the corresponding change in the direction of movement and the resumption of its work (movement and extension of the cutting element). The termination of the implanted device is possible in the place where it started its movement, to reduce the morbidity of the impact. The microdevice is removed from the section and disposed of in the usual way. A cosmetic suture is applied to the incision site.

The infrared mark on the upper surface of the microdevice is designed not only to track the movement of the device, to evaluate its correctness in real time, but also as a sensor that provides information that the implantable device has a charge and is able to move.

Examples of using the device.

We have created four prototypes of microdevices for implantation under the skin of the face.

As an experimental animal model, a pig model can be considered.

Sachs DL, Orringer JS, Voorhees JJ, Fisher GJ. Am J Pathol. 2013 Jan; 182(1): 163-71.).In the process of studying the anatomy of the skin (pigmentation, dermis, adipose tissue, skin appendages), it was found that the density of hair follicles on human skin: ~ 350 / cm ² on the head, ~ 25 / cm ² on the legs and arms and ~ 35 / cm ² on chest and forearms (Distribution of hairs and sweat glands on the bodies of Korean adults: a morphometric study. Hwang K, Baik SHActa Anat (Basel). 1997; 158 (2): 112-20. The lack of significant changes in scalp hair follicle density with advancing age.Sinclair R, Chapman A, Magee J. Br J Dermatol. 2005 Apr; 152 (4): 646-9 .; Eccrine sweat glands are major contributors to reepithelialization of human

Sachs DL, Orringer JS, Voorhees JJ, Fisher GJ. Am J Pathol. 2013 Jan; 182 (1): 163-71.).

Density of hair follicles in a domestic adult pig (~ 10-20 / cm ² ) compared to neonatal pigs (~ 730 / cm ² ) (The comparative histology of porcine and guinea pig skin with respect to iontophoretic drug delivery. Ferry LL, Argentieri G , Lochner DH.Pharm Acta Helv. 1995 Apr; 70 (1): 43-56; Comparative study of hair follicle morphology in eight mammalian species and humans. Mangelsdorf S, Vergou T, Sterry W, Lademann J, Patzelt ASkin Res Technol. 2014 May; 20 (2): 147-54).

The hair follicle, sebaceous and apocrine glands in humans, as in pigs and guinea pigs, are similar. People are unique in that they have millions of sweat glands distributed throughout their hairy skin. Although they are structurally similar and produce similar water-based sweat, these two types of eccrine sweat glands form two different subcategories, depending on their function and characteristics. In pigs, the so-called "eccrine" sweat glands are histologically different (they are branched tubular glands with secretory epithelium) and are found only on the muzzle, lips and carpal organ. On the rest of the skin, pigs have a different type of gland: the “apocrine” sweat glands.

Human skin is highly vascularized compared to mammals. The vascular network of pig skin resembles that of a person by the presence of the lower, middle cutaneous and subepidermal plexus (Radiation effects in swine. I. Vascular supply of the skin and hair. USNRDL-TR-67-141. Forbes PDRes Dev Tech Rep. 1967 Dec 5 ; (): 1-18.), Although the subepidermal vascular plexus is much less dense in porcine than in human skin (Confocal laser scanning microscopy of porcine skin: implications for human wound healing studies.Vardaxis NJ, Brans TA, Boon ME, Kreis RW, Marres LMJ Anat. 1997 May; 190 (Pt 4) (): 601-11).

Pig skin also has less vascular system around the hair follicles and sebaceous glands compared to human skin (THE SKIN OF THE DOMESTIC PIG.MONTAGNA W, YUN JSJ Invest Dermatol. 1964 Jul; 42 (): 11-21.).

Sensory innervation is also more developed in humans than in other mammals (Morphology of cutaneous sensory receptors. Montagna WJ Invest Dermatol. 1977 Jul; 69 (1): 4-7).

At the same time, the skin of pigs and humans looks anatomically close, or at least closer to each other, than the skin of mice, rats or rabbits. In pigs and humans, the epidermis and dermis are cumulatively ~ 1-3 mm thick (The comparative histology of porcine and guinea pig skin with respect to iontophoretic drug delivery. Ferry LL, Argentieri G, Lochner DH. Pharm Acta Helv. 1995 Apr; 70 (1): 43-56.). Hair is rare in both species compared to most other mammals, and their skin connective tissue contains elastic fibers (absent in rodents and rabbits). The epidermis and vascularization are comparable, and both are devoid of pannicular carnosis (with the exception of some residues in several areas) (Function of the panniculus carnosus - a hypothesis. Greenwood JEVet Rec. 2010 Nov 6; 167 (19): 760.).

Given all the above about the anatomical similarities and differences between human and pig skin, we can say that the pig model is the best model (The pig as a model for human wound healing. Sullivan TP, Eaglstein WH, Davis SC, Mertz PWound Repair Regen. 2001 Mar -Apr; 9 (2): 66-76). The anatomical and functional similarity of the skin of pigs and humans is confirmed by a number of works. So, Fritz P. et al. in 2010, in a process of comparing the passage of hydrophobic substances through the skin of humans and animals (pig and rat), it was determined that pig skin is the most suitable model for this (Comparison of human skin or epidermis models with human and animal skin in in vitro percutaneous absorption. International Journal of Pharmaceutics. Volume 215, Issues 1-2, March 14, 2001, Pages 51-56).

In a 2017 study on allometric scaling of skin thickness, elasticity, viscoelasticity to mass for translating micromedical devices from mice, rats, rabbits, pigs to humans, data were obtained that recommended rabbit skin and pig skin for preclinical trials of medical devices (Jonathan C. J Allometric scaling of skin thickness, elasticity, viscoelasticity to mass for micro-medical device translation: from mice, rats, rabbits, pigs to humans .. Scientific Reports volume 7, Article number: 15885 (2017)).

We conducted experiments on 4 healthy young sexually mature pigs, of both sexes (2 females and 2 males), aged 6-7 months, weighing 70-80.0 kg.

When carrying out the study, we adhered to the "Rules for the work using experimental animals." Pigs were kept under standard conditions in separate vivarium cells with free access to ordinary food and water.

After premedication, all animals were thoroughly shaved. A 10% solution of chloral hydrate in isotonic solution with the addition of 5-10% glucose at the rate of 1 ml / kg was injected into the large ear vein or branches of the vein of the auricle. The depth of anesthesia was easily controlled, since it was advancing “at the tip of the needle” - at the time of administration. Intravenous administration of chloral hydrate provided deep sleep lasting up to 1 hour and anesthesia (Other types of anesthesia can also be used: https://www.activestudy.info/obshhaya-anesteziya-u-svinej/).

Upon reaching anesthesia, microdevices were implanted.

Previously, a month before the test of the microdevice, experimental animals under anesthesia made the following manipulations:

- for two animals cosmetic threads were implanted under the scalp (pigs were previously carefully shaved),

- for two animals, a sclerosant was injected into the vessels under the scalp to stimulate the formation of adhesions (0.5% sodium tetradecyl sulfate was used, which was administered 0.1-0.3 ml at several points on the head subcutaneously. It is also possible to use foam sclerosants as such acceptable doses and concentrations).

After these manipulations, all individuals underwent 5-day broad-spectrum antibiotic therapy. No complications of dermatonecrosis have been reported.

A month later, after the engraftment of the threads and the formation of adhesions (which was established under the supervision of an ultrasound scan), we started testing 4 types of prototypes of the proposed device.

As the basis of the device for separating facial skin from the underlying subcutaneous tissue, in all cases, a device was used containing:

i) an external device for remote control of the movement of the implantable device containing

light signal sensors configured to receive light signals from an implantable microdevice located under the skin,

sensors of changes in the characteristics of the magnetic field emitted by the working part of the implantable device,

and electromagnetic signal inductors, configured to act on the working part of the implantable microdevices to change the direction of its movement;

ii) an implantable microdevice under the skin of an elongated shape, comprising a working part with a retractable cutting element fixed in a groove on the front of the microdevice,

sensors of parameters of living tissues and sensors of linear and angular displacement of the implantable microdevice located along the direction of movement of the implantable microdevice - on the front-upper surface of the working part.

They used suitable sensors capable of detecting changes in the characteristics of the magnetic field emitted by the working part of the implantable microdevices, and suitable inductors of electromagnetic signals on an external device to control the movement of the implantable microdevices.

Like the sensors of parameters of living tissues in front of an implantable microdevice, electromagnetic sensors and signal inductors were devices whose operation is based, respectively, on spectrophotometric analysis, fluorescence spectroscopy, and terahertz interactions.

The upper part of the working part of each microdevice was made of magnetic material capable of bending in accordance with the surface shape of the underlying tissues and with the possibility of interacting with sensors for changing the parameters of the magnetic field of a remote control device located outside the body - MAE.

The lower part of the working part of the implantable microdevices contained:

a) a microelectric drive with a suitable sized power source associated with sensors of parameters of living tissues and movement through a microcircuit,

b) the microcontroller functionally by means of integrated circuits:

with sensors of parameters of living tissues and the movement of an implantable microdevice,

with a magnetoactive element (MAE) in the upper part of the working part of the implantable microdevice,

with retractable cutting element

with microelectric drive.

The body of each implantable microdevice had a height of 0.2 to 0.4 mm, respectively (suitable for mechanically separating the scalp from the underlying tissues).

Retractable cutting elements were presented in microdevices, respectively, with a circular knife, circular saw and in two microdevices - in the form of two blades with the possibility of their oncoming movement.

On one of the devices in the front part, a mini-video camera was mounted, capable of transmitting information to an external device (remote movement) about the state of living tissues lying in front of the implantable microdevice. There were no cameras on the other three microdevices.

The external device in the form of means for remote moving the working part was made in the form of an external remote control with push controls for the cutting element of the working part and provided with magnetic material for interaction with MAE in the working part of the implantable microdevice.

It was possible to use either one means of remote movement of the implantable microdevices (one external remote control could be used for any of the four implantable microdevices), or a specially designed remote control as a means of remote control for each of the implantable microdevices.

One of the remotes had additional controls not only for the cutting element of the working part, but also for controlling the video camera.

Two of the samples of implantable microdevices had an LED in the wall of the body of the working part on the skin side as a mark for visual tracking the movement of this microdevice under the skin.

One of the implantable microdevices had a drop-shaped working part housing, and its front part had a greater height than the back part (0.4 mm versus 0.2 mm).

Devices were used once.

In one of the implantable devices, the power source was connected to the electric drive wirelessly and could be mounted on the leg of the experimental pig using a strap similar to the straps used in the operating rooms to attach cardiovascular sensors to the limbs.

All microdevices after implantation worked in the same way as described above. There were no malfunctions. The time of the operation itself (from skin incision and placement of the implantable device under the skin to the application of cosmetic sutures after its removal) ranged from 10 minutes to 15 minutes.

Antibiotic therapy in the postoperative period was not performed.

Under the control of ultrasound in the experimental animals after the experiment, there were no adhesions and previously introduced cosmetic threads.

Sutures in all animals healed by primary intention, no complications were observed. A month after the experiment, under the control of ultrasound, the absence of adhesions was established, which indicates the achieved effect of both the atraumatic operation of the device and its effectiveness in removing unwanted elements under the skin.

Claims (26)

1. A device for separating facial skin from underlying subcutaneous tissue, comprising: i) an external device for remote control of the movement of the implantable microdevices containing light signal sensors configured to receive light signals from an implantable microdevice located under the skin, sensors for changes in the characteristics of the magnetic field emitted by the working part of the implantable microdevice, and electromagnetic signal inductors, configured to act on the working part of the implantable microdevices to change the direction of its movement; ii) an implantable microdevice under the skin of an elongated shape, comprising a working part with a retractable cutting element fixed in a groove on the front of the microdevice, sensors of parameters of living tissues and sensors of linear and angular displacement of the implantable microdevice located along the direction of movement of the implantable microdevice - on the front-upper surface of the working part, the upper part of the working part is made of magnetic material capable of bending in accordance with the surface shape of the underlying tissues and with the possibility of interaction with the sensors of changes in the parameters of the magnetic field of the remote control device located outside the body, the lower part of the working part contains: a) a microelectric drive with a power source associated with sensors of parameters of living tissues and movement through a microcircuit, b) a microcontroller, functionally by means of integrated circuits: with sensors of parameters of living tissues and the movement of an implantable microdevice, with a magnetoactive element in the upper part of the working part of the implantable microdevice, with retractable cutting element with microelectric drive wherein the body of the implantable microdevice has a height suitable for mechanically separating facial skin from underlying tissues. 2. The device according to p. 1, characterized in that the means for remote movement of the working part is made in the form of an external remote control with push controls for the cutting element of the working part and is equipped with at least one magnetic material made to interact with at least one magnetic material installed in the working part of the implantable microdevices. 3. The device according to claim 1, characterized in that the surface of the housing with a retractable cutting element is equipped with a video camera. 4. The device according to p. 3, characterized in that the means of remote movement of the working part is made in the form of an external remote control with push controls for cutting the working part and controlling the video camera and is equipped with at least one magnetic material made to interact with at least one magnetic material installed in the working part. 5. The device according to claim 1, characterized in that the retractable cutting element is made in the form of a circular knife connected to the drive with the possibility of rotation in the horizontal plane of the microdevice. 6. The device according to p. 1, characterized in that the retractable cutting element is made in the form of a circular saw connected to the drive with the possibility of rotation in the horizontal plane of the microdevice. 7. The device according to p. 1, characterized in that the retractable cutting element is made in the form of two blades connected to the drive, with the possibility of their oncoming movement. 8. The device according to claim 1, characterized in that an additional LED is installed in the wall of the housing of the working part on the skin side, made in the form of a mark for visual tracking the movement of the microdevice under the skin. 9. The device according to p. 1, characterized in that the housing of the working part is made in a drop-shaped form, and the front part has a greater height than the back. 10. The device according to p. 1, characterized in that the microdevice is disposable. 11. The device according to p. 1, characterized in that the power source is connected to the electric drive by a wireless connection and has means for attaching to operating linen or clothes.