BIOLOGY TISSUE RENEWAL FACILITY

Description

[0001] The invention relates to a device for biological tissue regeneration according to the preamble of claim 1.

[0002] The invention is applicable in medicine and surgery, including cosmetic surgery. Thus, the invention is suitable, for example, for the treatment of trophic and slow-healing ulcers, pressure ulcers, burns, scars, etc. Another area of ​​application is the rejuvenation of biological tissues, including skin, in various locations. The method provided by the device is based on the transfer of non-mechanical energy, in particular acoustic wave energy, into the biological tissues of the human body. The invention relates to various embodiments of a device that generates the wave energy required to carry out the method.

[0003] For example, a skin rejuvenation procedure using ablation or vaporization of the epidermis with a CO2-carbon dioxide laser beam with 10.6 µm wavelengths or an Er:YAG laser beam with 2.94 µm wavelengths (Palomar 2940 Fractional Laser, Deka SmartXide DOT, Candela CO2RE) [1] is known. In this case, the healing effect is based on vaporization in the epidermis with minimal thermal damage to the deeper skin layers. This does not lead to complete destruction of all skin layers and stimulates new cell growth. The disadvantages of this known procedure are its high degree of trauma, a long rehabilitation period, and the presence of a wound surface. This results in a high risk of infection, pain both during treatment and during the regeneration period, a risk of pigmentation changes, and the formation of scar tissue.Furthermore, the procedure is not suitable for use on movable body parts, such as the neck, eyelids, etc., because the healing process of the wound surface requires immobility of the treatment area.

[0004] A non-invasive photorejuvenation method is also known from the state of the art. In this method, radiation penetrates deep into the skin and causes damage to collagen fibers, subsequently stimulating the formation of new collagen (Palomar 1540 Fractional Laser, Candela GentleMAX, Candela Smoothbeam) [2]. This method offers the possibility of treating virtually any area of ​​the skin. The disadvantages of the method are a low healing effect and unsatisfactory cosmetic results. The amount of collagen synthesized is insufficient to achieve the desired rejuvenation effect. A rejuvenation effect is understood as an observed reduction in wrinkle size. After this procedure, skin tone is improved due to enhanced capillary circulation, and a temporary cutaneous edema is induced, creating a provisional wrinkle reduction effect.

[0005] Skin rejuvenation procedures using non-invasive ultrasound irradiation are known from the prior art [3, 4, 5]. These procedures allow for the treatment of various skin areas within predefined treatment zones. A drawback of these procedures is that the tissues are stressed by the ultrasound wavefront. Consequently, not only the predefined zone is treated, but the surrounding tissues are also affected. This leads to an enlargement of the tissue damage zone and delays rehabilitation.

[0006] The closest prior art to the method according to the invention is a method of microablative photorejuvenation of the skin [6]. The essence of this method is that the skin is irradiated with a laser. This irradiation does not involve a broad laser beam but rather numerous microbundles. Each of the microbundles causes either coagulation and vaporization or ablation of the skin micro-areas, depending on the spectral and temporal characteristics of the radiation used. The microbundles can have a diameter of 1 to several hundred micrometers and be spaced several hundred micrometers apart from each other. The healing effect of this method is based on the assumption that the removed or destroyed tissues are replaced by new cells. After several treatments, it should be possible to replace all the skin in the treated area with new skin.When a microcoagulation effect of the skin is achieved using glasses with an ER laser (laser device "fraxel", wavelength 1.54 µm), the heat decomposition of the skin cells occurs without vaporization. If radiation is used that can cause both vaporization and coagulation of the skin cells (e.g., CO2 gas laser radiation, wavelength 10.64 µm), microchannels of vaporized tissue with a surrounding coagulation zone are formed. If ER laser radiation (with a wavelength of 2.94 µm) is used, tissue vaporization in the form of microchannels occurs without coagulation of the surrounding tissue. This known method has the following drawbacks: The depth of micro-injuries at which a rejuvenating effect can be achieved is limited by the depth of coagulation or ablation. Consequently, it is not possible to perform rejuvenation deep within the skin (dermis) and subcutaneous tissue (hypodermis). Due to the shallow depth of the micro-injuries, it is not possible to achieve intensive tissue regeneration during the treatment of trophic and purulent wounds, etc.; that is, the procedure is unsuitable when deep tissue renewal is required. This procedure is invasive, which increases the risk of infection at the treated surface. As a result of the tissue removal, contact occurs between living tissue and the surrounding tissue. This can cause the growth of fibrous tissue instead of complete renewal of the isomorphic tissue.Treatments performed using microablative methods are painful and therefore require the use of an anesthetic.

[0007] US Patent 5,725,482 describes a method for focusing vibrational energy onto a target volume within a surrounding, adjacent medium. It transfers high-intensity energy from low-level energy sources to the target volume. Several standing compression waves are generated in the medium along corresponding longitudinal axes between opposing pairs of coordinated transducers. The target volume is located at the common intersection of the axes of the standing compression waves. The opposing pairs of transducers are spaced apart at a distance equal to an integer multiple of half the wavelength of the corresponding standing wave. The phase angle of each standing compression wave is adjusted so that each wave reaches its maximum intensity (amplitude) within the target volume at the point where it intersects with the other standing waves.The multiple overlapping standing waves interfere constructively in the target volume, thereby giving the target volume a more intense vibrational energy than the surrounding medium.

[0008] US 2005 / 0085748 A1 describes a device and a method for using ultrasound enriched with microbubbles, thrombolytic drugs, or other active substances for clot dissolution, wherein at least one ultrasound transducer generates a plurality of acoustic signals, and time, amplitude, phase, and frequency modulation of the signals enables a more uniform power output with fewer gaps in the ultrasound field. The interference patterns from one or more transducers are continuously shifted in position. A phased array of transducers can generate a beam that is swept across the area to be treated. In another embodiment, an array of transducers can generate ultrasound with a range of slightly varying frequencies to produce an interference pattern that sweeps in and out through the tissue to be treated.A single array can be used to create both effects simultaneously or separately.

[0009] The object of the invention is to develop a device for non-invasive biological tissue regeneration, restoring the performance characteristics, properties, and structures of the tissues. This is achieved by creating micro-injuries in predefined zones of the biological tissues, thereby enabling subsequent natural regeneration of the respective biological tissues in these zones. Micro-injuries (micro-destructions) must be created in the biological tissue without forming microchannels that come into contact with an aggressive environment. This is made possible by completely preventing the growth of fibrous tissue. Such an action should allow the creation of micro-injuries with subsequent regeneration of both surface and deep-lying biological tissue of any type and location.Furthermore, the application of the device is intended to ensure a reduction in pain sensations and a risk of infection compared to other methods known from the prior art, including microablative methods.

[0010] The problem is solved by the features of claim 1.

[0011] The stated problem is solved by means of the device according to the invention for biological tissue regeneration, restoring the performance characteristics, properties, and structures of these tissues. When applied, micro-injury areas are created in predetermined regions of the biological tissues, allowing for subsequent natural regeneration. For this purpose, the tissues are subjected to a mechanical injury of a predetermined severity by generating at least one interference zone of acoustic waves in predetermined regions. The acoustic waves originate from two sources and propagate through the tissues to be regenerated.

[0012] In general, the device according to the invention generates strong, phase-in-phase acoustic waves on the surface of tissue requiring rejuvenation or of a higher-lying tissue. These phase-in-phase acoustic waves have target properties (design characteristics), in particular a target power. Specifically, varying the power of the acoustic waves makes it possible to adjust the predetermined depth of the micro-injury areas accordingly. By utilizing interference of the interacting acoustic waves, the dimensions can be reduced and the localization determined in all directions of the tissue's micro-injury area. This allows for a significant increase in the efficiency of the directional effect and a reduction in rehabilitation time. The tissue micro-injury according to the inventive method is non-thermal in nature.For this reason, neither vaporization nor coagulation occurs when the biological tissues are exposed to the acoustic waves. Furthermore, the acoustic waves are capable of penetrating biological tissues to a certain depth without forming any channels (this depth is determined by the properties of the acoustic waves). Thus, the contact between living tissues and oxygen is not prolonged as a result of this exposure. This reduces the risk of fibrous tissue growth and suggests that this is a genuine, rather than merely visually observed, biological renewal / rejuvenation of the tissues. The energy of the acoustic waves increases in the interference zones at a predetermined location. Under the influence of the acoustic wave energy, areas of damaged, but not destroyed, tissue are formed in these zones.The regeneration of biological tissues can occur not only as a result of complete destruction of tissue cells but also through partial injury. This allows for biological tissue renewal in areas with a predetermined location. Since there is no complete destruction of the deep-lying cells of the biological tissues, the rehabilitation period can be significantly shortened. Pain from the injury is also considerably reduced because the injured area is smaller, the degree of injury can be predetermined, and there is no heat exposure.

[0013] The surface area of ​​the sources of the in-phase acoustic waves is preferably in the range between 10 nm² and 10 µm². All zero points (centers / epicenters) of the acoustic waves are advantageously arranged at equal distances from each other. These distances are chosen in the range between 10 µm and 1 cm.

[0014] Using the device according to the invention, the mechanical injury zones of the tissues are advantageously formed below the surface of the tissue that is in contact with the environment, without increasing the contact area between the living tissues and the aggressive media. Thus, according to the invention, a device is provided by means of which micro-injury zones can be created without having to increase the contact area between the living tissues and the environment. This significantly reduces the risk of infection during rehabilitation compared to known methods.

[0015] The minimum power of the generated acoustic waves is chosen such that: the power of a single wave emanating from a center / epicenter (zero point) is insufficient to mechanically damage / destroy the biological tissues to be exposed; the total power achieved through interference of waves emanating from secondary centers is sufficient to mechanically damage the biological tissues to be exposed with a predetermined degree of severity.

[0016] The erythema that develops after application to the skin surface can be used to visually check that the effect has been sufficient.

[0017] Frequency is another property of acoustic waves, the alteration of which can vary the effect on biological tissue. Thus, by selecting the frequency of the acoustic waves according to the natural frequency of the respective biological tissues, it becomes possible to selectively regenerate specific biological tissues by achieving resonance with the aforementioned frequencies. Therefore, such a frequency of the acoustic wave is chosen from the range of advantageous device configurations according to the natural frequency of the biological tissue requiring rejuvenation, ensuring a selective effect on that specific tissue.

[0018] In advantageous configurations of the device, the degree of mechanical injury is selected from a range between two levels: that of disruption of cell membrane integrity and that of complete destruction of the cells of the biological tissue requiring rejuvenation. This allows the intervention to stimulate the regeneration of biological tissues both with and without the destruction of all (intact) cells within these tissues. A renewal / rejuvenation effect can even be achieved with partial damage to the cells of the biological tissues.

[0019] In other advantageous configurations, the acoustic waves are generated in the form of directional acoustic waves. This also makes it possible to locate and optimize the formation of micro-injury zones.

[0020] The stated problem is also solved by means of the embodiment of a device for carrying out the above-described inventive method for biological tissue regeneration. This device enables the restoration of the performance characteristics, properties, and structures of tissues. The device includes a radiation source and a means for generating numerous centers / epicenters of acoustic waves on the surface of the biological tissues requiring regeneration or the higher-lying tissues.

[0021] In an initial configuration of the device, the task is accomplished by using an ultrasound source as the radiation source. The ultrasound source has a means of generating numerous centers / epicenters of equally spaced acoustic waves on the surface of the biological tissues requiring renewal or the higher-lying tissues.

[0022] In the first and second configurations of the device, it is advantageous that the distance between the centers / epicenters of the acoustic waves is in the range between 10 µm and 1 cm.

[0023] The above-mentioned advantages, as well as all other advantages of the device according to the invention for biological tissue renewal and restoration of the performance characteristics, properties and structures of the tissues, and the advantages of the embodiments of the corresponding device, are discussed in detail below using an example of possible advantageous embodiments and with reference to the figures with respective reference numerals.

[0024] However, these variations are not limited to the cases described here. They show: Fig. 1 is an overview image of the formation of micro-injury areas of cells in biological tissue according to one of the possible embodiments, Fig. 2 is an overview image of the formation of micro-injury areas of cells in biological tissue according to a second embodiment, Fig. 3 is an overview image of the formation of micro-injury areas of cells in biological tissue according to a third embodiment, and Fig. 4 is a schematic representation of the device according to the third embodiment.

[0025] Fig. 1The figure shows an overview of the formation of micro-injury zones in cells within biological tissue according to one of the possible configurations. Here, acoustic waves 1 propagate from corresponding centers / epicenters (zero points) 2 on a surface 3 of biological tissue 4 into the interior of the biological tissue 4. The power of each acoustic wave 1 is chosen such that it is insufficient to mechanically destroy any components of the biological tissue 4 being treated. The micro-injury zones will only form in the interference zones 5 (shown in dark in the figure) of the acoustic waves 1 originating from the adjacent centers / epicenters 2.

[0026] Fig. 2Figure 1 shows an overview of the formation of micro-injury zones in cells within biological tissue according to a second of the possible configurations. Here, the acoustic waves 1 propagate from the corresponding centers / epicenters 2 on the surface 3 of the biological tissue 4 into the interior of the biological tissue 4. The power of each acoustic wave 1 is selected such that it will form mechanical destruction zones 6 of the biological tissue 4 to be treated next to the respective center / epicenter 2 (complete destruction of the surface tissue) and micro-injury zones (areas with local injuries) in the interference zones 5 of the acoustic waves 1 originating from the adjacent centers / epicenters 2. The mechanical destruction zones 6 and the interference zones 5 are marked in dark in the figure.

[0027] Fig. 3Figure 1 shows an overview of the formation of micro-injury areas in cells within biological tissue according to a third of the possible configurations. Here, acoustic waves 1 propagate from the respective centers / epicenters 2 on the surface 3 of the biological tissue 4 into the interior of the biological tissue 4. To form the micro-injury areas in the deeper tissues, the acoustic waves are generated in the form of directional acoustic waves 7. The micro-injury areas form in the interference zones 8 of all two directional acoustic waves 7 from the corresponding adjacent centers / epicenters 2. The interference zones 8 are marked in dark in the figure.

[0028] Fig. 4Figure 1 shows a schematic representation of the setup of an embodiment not belonging to the invention. Here, the radiation source is designed in the form of a laser radiation source 9. The means for forming numerous centers / epicenters of the acoustic waves on the surface of the biological tissue requiring renewal or the higher-lying tissues includes a light splitter 10 and an optical system 13. The light splitter 10 divides the output laser beam 11 into as many laser beams 12 as are required to achieve the predetermined distribution. The optical system 13 brings the laser beams 12 generated by the light splitter 10 together at angles required to obtain a predetermined spatial beam intensity distribution 14 by means of multi-beam interference.

[0029] The registered device functions as follows: The acoustic waves 1 (7) with predetermined properties (power, frequency) are generated using one of the embodiments of the device according to the invention for biological tissue regeneration with restoration of the performance characteristics, properties and structures of the tissues. Each acoustic wave 1 (7) begins to propagate from the respective center / epicenter 2 into the interior of the biological tissue 4.

[0030] For example, the minimum power of acoustic wave 1 is sufficient in the design according to Fig. 1The propagation of wave 1 is not intended to mechanically destroy any components of the treatable biological tissue 4. Therefore, it is not accompanied by any destruction of the biological tissue 4. However, the interference with the acoustic waves 1 originating from the neighboring centers / epicenters 2 allows the overall power of the acoustic wave 1 to be increased locally until these power values ​​are sufficient to form areas of mechanical injury of a specific degree in the biological tissue 4 within these interference zones 5. These areas will then spread from the surface 3 into the interior of the tissue and represent zones of uneven micro-injury (of a predetermined degree) to the cells in the biological tissue 4.

[0031] Such tissue injury does not require an increase in the contact area between the living tissues and the aggressive environment, thus minimizing the growth of fibrous tissue.

[0032] If the power of the acoustic waves 1 increases, such power values ​​can be achieved according to the design as follows. Fig. 2This will be achieved, where each individual acoustic wave 1 is capable of causing independent tissue destruction. The process of impact will then change slightly and will proceed as follows: The waves 1 originate from each center / epicenter 2 and penetrate into the interior of the biological tissue 4. They cause mechanical destruction (zones 6 of mechanical destruction) until the power values ​​of these waves fall below their threshold values. The further propagation of the waves 1 into the interior of the biological tissue 4 is not accompanied by any tissue degradation except in the interference zones 5 of the waves 1, which originate from the neighboring centers / epicenters 2. Thus, the injury area consists of a complete destruction zone of the surface tissue (zones 6 of mechanical destruction) and areas with local injuries (interference zones 5).

[0033] The visually observed effect will manifest itself in this case as the formation of a so-called "frost" on the surface being treated. The "frost" effect refers to areas of mechanically damaged tissue. Varying the power of the acoustic wave also allows for variation in the depth of these micro-injuries.

[0034] Acoustic directional waves 7 can be generated using the device according to the invention. In this case, the interference of the acoustic waves 7 will only occur deep within the biological tissues, without damaging the surface layers. The areas of mechanical micro-injury will arise in the interference zones 8.

[0035] Tissue regeneration after using the device according to the invention will proceed faster compared to the prototype, because even with the second embodiment (see Fig. 2Only surface tissues (zones 6 of mechanical destruction) will experience complete mechanical destruction. Cells located deep within the tissue will not be completely destroyed, but only damaged (interference zones 5). In all other configurations, including any configurations not discussed in detail here, there is no complete destruction of any biological tissues whatsoever.

[0036] The device according to the invention for biological tissue renewal can also have various configurations.

[0037] The device, according to its first configuration, can have a powerful ultrasound source as its radiation source. A contact surface can be used as a "generator" of the centers / epicenters 2 of the acoustic waves 1 (7). The contact surface is designed in the form of an ordered set of needles. The needles are arranged at a predetermined distance from each other (the needle spacing is in the range between 10 µm and 1 cm) and contact the surface 3 of the biological tissue 4 over areas of 10 nm² to 10 µm².

[0038] The overview plan is Fig. 4The wide laser beam 11 generated by the laser source 9 is incident on a light splitter 10. The light splitter 10 divides the laser beam 11 into several laser beams 12. This quantity of laser beams 12 is required to achieve a predetermined distribution. The optical system 13 brings the laser beams 12 generated by the light splitter 10 together at angles required to achieve a predetermined spatial beam intensity distribution 14 by means of multi-beam interference.

[0039] The devices according to the invention for the renewal / rejuvenation of biological tissues are known in medical practice. Nevertheless, the above description, including the examples which illustrate some non-exhaustive embodiments of the invention, demonstrates that the method and the device according to the invention make it possible to achieve new and unexpected technical results. This is primarily due to the fact that the renewal effect of various biological tissues located at different depths can be achieved by creating micro-injury zones without thermal influence, i.e., without evaporation or coagulation of any overlying tissues. Thus, tissue regeneration occurs without any growth of fibrous cells. Consequently, actual, and not merely visually observed, rejuvenation takes place. Sources of information

[0040] 1. B. Yeremeyev, K. Kalaydzyan. Laser against wrinkles. Electronic Almanac. "Cosmetics and Medicine". [Electronic Information Resource] - April 6, 2012 - http: / / daniel.ru / cm / arc / r403.htm. 2. Palomar Rejuvenation. Website of the RO-DEN Health Center / Epicenter [Electronic Information Resource] - May 4, 2012 - http: / / www.roden.by / cosmetology / palomar-omolojenie / . 3. US Patent Application 2011 / 0218464 A1, published September 8, 2011. 4. US Patent Application 2012 / 0016239 A1, published January 19, 2012. 5. Patent application US 2012 / 0053458 A1, published on March 1, 2012. 6. Patent US 6,997,923 B2, published on October 31, 2002.

Claims

1. A device for the biological renewal of skin tissue with restoration of the performance characteristics, properties and structures of tissues, having an ultrasound source and a means for forming numerous epicenters (2) of acoustic, non-thermal, in-phase waves (1) on the surface (3) of the skin in need of renewal, these epicentres (2) being equidistant from one another, and the means being designed to emit the waves from the epicentres in a semicircle in order to provide an interference area for the waves , characterized in that the distance between the epicentres (2) of the acoustic waves (1) is in the range between 10 µm and 1 cm and the area of the sources of the in-phase acoustic waves at the means is in the range between 10 nm2 and 10 µm2.