Disclosure of Invention
The invention aims to provide a frozen fat dissolving treatment component and a device, which can directly monitor the temperature of the surface of skin, eliminate regulation delay, improve the safety of treatment and avoid skin injury when the frozen fat dissolving treatment component is used for frozen fat dissolving treatment.
In order to achieve the aim, the invention provides a frozen fat dissolving treatment component which comprises a treatment unit, an antifreeze, an isolation membrane and a signal acquisition unit; the treatment unit is used for receiving cold energy provided by an external mechanism and transmitting the cold energy to a target area for freezing and fat dissolving; the cryoprotectant is for application to the skin of the target area; the isolating film is covered on the antifreezing agent, and a plurality of through holes are formed in the isolating film; the signal acquisition unit is arranged on the treatment unit;
the frozen liposoluble treatment assembly is configured such that when the treatment unit is positioned on the isolation film, the cryoprotectant partially overflows from the through hole to be in contact with the treatment unit, while the signal acquisition unit penetrates the isolation film from the through hole and is in contact with the skin of the target area to acquire a target signal of the skin, the target signal being used for judging whether the skin of the target area is frozen.
Optionally, the treatment unit comprises a contact surface for transferring the cold to the target area, and a loading portion is provided on the contact surface; the signal acquisition unit is arranged on the loading part and comprises a contact end; the contact end is adapted to penetrate the barrier membrane for contact with the skin of the target area.
Optionally, the signal acquisition unit comprises an integral ultrasound transceiver having the contact end; and/or the signal acquisition unit comprises an optical transceiver, and the optical transceiver is provided with the contact end; and/or the signal acquisition unit comprises an electrode, and the electrode is provided with the contact end.
Optionally, when the signal acquisition unit includes an electrode, the loading portion includes a loading hole, the electrode is installed at the loading hole, and an insulating layer is disposed between the electrode and a hole wall of the loading hole.
Optionally, the material of the insulating layer includes any one of a ceramic insulating material, a thermally conductive silicon material, and polyimide.
Optionally, the thickness of the insulating layer is less than or equal to 1 mm; and/or the diameter of the cross section of the electrode is less than or equal to 3 mm.
Optionally, the signal acquisition unit comprises an electrode, and the antifreeze has a resistivity of 200 k Ω · cm to 1000 k Ω · cm.
Optionally, the antifreeze has a resistivity of 300 k Ω -cm to 500 k Ω -cm.
Optionally, the antifreeze agent comprises an osmotic protectant, an impermeable protectant, distilled water, a thickener, and an amphoteric surfactant.
Optionally, the permeability protecting agent comprises at least one of glycerol, dimethyl sulfoxide, ethylene glycol, propylene glycol; and/or the presence of a gas in the gas,
the non-permeability protective agent comprises at least one of sucrose, fructose, trehalose, glucan and hydroxyethyl starch; and/or the presence of a gas in the gas,
the thickener comprises at least one of hydroxyethyl cellulose, hydroxymethyl cellulose and sodium alginate.
Optionally, the contact end is flush with the outer surface of the isolation diaphragm or protrudes from the isolation diaphragm.
Optionally, the number of the signal acquisition units is multiple, and the contact end of each signal acquisition unit penetrates through the isolation film from one through hole.
Optionally, the through holes are arranged in an array on the isolation film.
Optionally, the maximum distance between two adjacent through holes is less than 3 mm.
Optionally, the number of the signal acquisition units is multiple; the through holes comprise a first through hole and a second through hole; and the second through hole is used for the contact ends of at least two signal acquisition units to penetrate through.
Optionally, characterized in that the area of the isolation membrane is larger than the area of the target region.
Optionally, a negative pressure channel is further disposed on the treatment unit, and is used for communicating with an external suction source to generate negative pressure in the negative pressure channel.
In order to achieve the above object, the present invention further provides a frozen liposoluble therapeutic device, including the frozen liposoluble therapeutic component, a cold source and a host machine as described in any one of the above items; the cold source is used for providing cold energy for the treatment unit; the host is in communication connection with the signal acquisition unit and the cold source and is configured to judge whether the skin of the target area is frozen according to the target signal acquired by the signal acquisition unit, so as to adjust the cold quantity provided by the cold source to the treatment unit.
Optionally, a negative pressure channel is further disposed on the treatment unit, and the frozen fat dissolving treatment device further includes a suction source for communicating with the negative pressure channel to generate negative pressure in the negative pressure channel.
Compared with the prior art, the frozen fat dissolving treatment assembly and the device have the advantages that: the frozen fat dissolving treatment component comprises a treatment unit, an antifreeze, an isolation membrane and a signal acquisition unit; the treatment unit is used for receiving cold energy provided by an external mechanism and transmitting the cold energy to a target area for freezing and fat dissolving; the cryoprotectant is for application to the skin of the target area; the isolating film is covered on the antifreezing agent, and a plurality of through holes are formed in the isolating film; the signal acquisition unit is arranged on the treatment unit; the frozen liposoluble treatment assembly is configured such that when the treatment unit is positioned on the isolation film, the cryoprotectant partially overflows from the through hole to be in contact with the treatment unit, while the signal acquisition unit penetrates the isolation film from the through hole and is in contact with the skin of the target area to acquire a target signal of the skin, the target signal being used for judging whether the skin of the target area is frozen. The signal acquisition unit can contact with the skin in the target area in the process of freezing and fat dissolving so as to directly acquire the target signal and feed back the temperature state in time, thereby avoiding delay and being beneficial to improving the safety of freezing and fat dissolving treatment.
Detailed Description
The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the present invention, and the components related to the present invention are only shown in the drawings rather than drawn according to the number, shape and size of the components in actual implementation, and the type, quantity and proportion of the components in actual implementation may be changed freely, and the layout of the components may be more complicated.
Furthermore, each of the embodiments described below has one or more technical features, and thus, the use of the technical features of any one embodiment does not necessarily mean that all of the technical features of any one embodiment are implemented at the same time or that only some or all of the technical features of different embodiments are implemented separately. In other words, those skilled in the art can selectively implement some or all of the features of any embodiment or combinations of some or all of the features of multiple embodiments according to the disclosure of the present invention and according to design specifications or implementation requirements, thereby increasing the flexibility in implementing the invention.
As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural forms "a plurality" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
The invention aims to provide a frozen fat dissolving treatment assembly, which comprises a treatment unit and a signal acquisition unit; the treatment unit is used for receiving cold energy provided by an external mechanism and transmitting the cold energy to a target area for freezing and fat dissolving; the cryoprotectant is for application to the skin of the target area; the isolating film is covered on the antifreezing agent, and a plurality of through holes are formed in the isolating film; the signal acquisition unit is arranged on the treatment unit; the frozen liposoluble treatment assembly is configured such that when the treatment unit is positioned on the isolation film, the cryoprotectant partially overflows from the through hole to be in contact with the treatment unit, while the signal acquisition unit penetrates the isolation film from the through hole and is in contact with the skin of the target area to acquire a target signal of the skin, the target signal being used for judging whether the skin of the target area is frozen. In this freezing fat dissolving treatment subassembly, signal acquisition unit can with the skin contact of target area monitors the target signal on skin surface in time, feeds back temperature information, avoids postponing, then external mechanism can be in time according to the cold volume supply of skin surface's temperature regulation, reduces the probability that the frostbite takes place, improves the safety in utilization.
The other purpose of the present invention is to provide a frozen fat dissolving treatment device, which comprises the frozen fat dissolving treatment component, a cold source and a host. Wherein the cold source is used for providing cold for the treatment unit. The host is in communication connection with the signal acquisition unit and the cold source, and is configured to judge whether the skin of the target area is frozen according to the target signal acquired by the signal acquisition unit, and further adjust the cold quantity provided by the cold source to the treatment unit.
To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention. The same or similar reference numbers in the drawings identify the same or similar elements.
Fig. 1 shows a schematic structural diagram of a cryo-liposuction treatment assembly according to an embodiment of the present invention. Referring to fig. 1, the frozen liposoluble therapeutic assembly includes a therapeutic unit 100, a cryoprotectant, an isolation membrane 300 (not shown in fig. 1, see fig. 4 to 7), and a signal acquisition unit 200. The treatment unit 100 is used for receiving cold energy provided by an external mechanism and transmitting the cold energy to a target area of a human body to carry out frozen fat dissolving. The cryoprotectant is for application to the skin of the target area; the isolating film is covered on the antifreezing agent, and a plurality of through holes are formed in the isolating film; the signal acquisition unit 200 is disposed on the treatment unit 100. The frozen liposoluble therapeutic component is configured such that when the therapeutic unit 100 is positioned on the isolation film, the cryoprotectant partially overflows from the through hole to be in contact with the therapeutic unit 100, while the signal collecting unit penetrates the isolation film from the through hole and is in contact with the skin of the target region to collect a target signal for determining whether the skin of the target region is frozen. The signal acquisition unit 200 of the frozen liposoluble therapeutic assembly provided by this embodiment can contact with the skin of the target area and timely acquire the target signal capable of reflecting the temperature state of the skin of the area, thereby avoiding delay. Here, the contact of the signal collection unit 200 with the skin of the target area includes both the direct contact of the signal collection unit 200 with the skin of the target area without any material obstruction, and the case where a liquid film exists between the signal collection unit 200 and the skin of the target area (i.e., the case where a cryoprotectant is applied to the skin of the target area, and a liquid film formed by the cryoprotectant exists between the signal collection unit and the skin of the target area), and the thickness of the liquid film is extremely small, so that the transmission delay of the target signal due to the thickness of the liquid film is negligible.
In more detail, referring to fig. 2, the treatment unit 100 comprises a contact surface 110, the contact surface 110 being adapted to deliver the cold to the target area. The contact surface 110 is provided with a loading portion 111. The signal collecting unit 200 is disposed on the loading part 111 and includes a contact end 210. The contact end 210 is adapted to penetrate the barrier membrane to contact the skin of the target area. It should be understood that the contact end 210 is exposed to the outside of the treatment unit 100, which means that the contact end 210 is not shielded and exposed to the air environment. Optionally, the contact end 210 is flush with or protrudes from the outer surface of the isolation diaphragm.
Fig. 3 is a schematic diagram illustrating a frozen liposuction treatment device according to an embodiment of the present invention for liposuction of a target region of a human body. Referring to fig. 3, the apparatus for frozen lipolysis therapy includes the frozen lipolysis therapy component, a cold source (not shown) and a main machine 20. Wherein the cold source is used for providing cold to the therapy unit 100. The host 20 is in communication connection with the signal acquisition unit 200 and the cold source, and is configured to determine whether the skin of the target area is frozen according to the target signal acquired by the signal acquisition unit 200, so as to adjust the cold amount provided by the cold source to the treatment unit 100.
In the embodiment of the present invention, the signal acquisition unit 200 monitors the temperature change of the skin of the target area in time, so that the host 20 can know the state of the skin of the target area in time (i.e. whether the skin is frozen), and can further adjust the cold quantity, reduce the probability of frostbite of the skin of the target area, and improve the safety of the frozen fat dissolving treatment device. Preferably, the number of the signal acquisition units 200 is plural.
It will be understood by those skilled in the art that the "target area" refers to a region of the human body where liposoluble treatment is desired, such as the abdomen, legs, etc. The "target signal" is determined according to the type of the signal collecting unit 200, for example, when the signal collecting unit 200 includes an integrated ultrasonic transceiver having the contact end 210 and contacting the skin of the target area to emit ultrasonic waves, which are reflected differently before and after freezing, so that the target signal may include the ultrasonic waves reflected by the skin of the target area. For another example, when the signal acquisition unit 200 includes an integrated optical transceiver, the optical transceiver has the contact end 210, contacts with the skin of the target area, and emits the detection light, and after the skin of the target area is frozen, the optical property of the skin of the target area is changed accordingly, which may be embodied in enhanced scattering, so that the target signal may include the scattered light of the skin of the target area. As another example, when the signal acquisition unit 200 comprises an electrode, the electrode has the contact end 210 to contact the skin of the target area, and the bio-impedance of the skin of the target area can be used as the target signal. The inventor researches and discovers that the change of the biological impedance of the target area is not obvious before and after the skin of the target area is frozen, but the impedance change rate is changed greatly, so the host 20 processes the biological impedance after receiving the biological impedance to obtain the impedance change rate, judges whether the skin is frozen according to the impedance change rate, and improves the sensitivity.
Referring back to fig. 2, when the signal acquisition unit 200 includes an electrode, the electrode may be a columnar structure, and the diameter of the cross section thereof is less than or equal to 3 mm. The "diameter" referred to herein means, when the cross section of the electrode is circular, the diameter of the circle, and when the cross section of the electrode is non-circular, the diameter of the circumscribed circle of the non-circle. The electrode has good electrical and thermal conductivity, and in order to avoid local supercooling or overheating of the skin tissue in the region in contact with the electrode, the material of the electrode is preferably the same as the material of the contact surface 110, for example, an aluminum alloy.
Further, a part of the plurality of electrodes serves as an anode terminal, and the other part serves as a cathode terminal. When the bio-impedance is acquired, current flows from the anode end, flows through the skin of the target area and then flows into the cathode end. This procedure requires that no current transfer is possible between the electrode and the treatment unit 100, i.e. that an insulation treatment is required between the electrode and the treatment unit 100. Specifically, referring to fig. 3, the loading portion 111 includes a loading hole, the electrode is mounted in the loading hole, and an insulating layer 121 is disposed between the electrode and a wall of the loading hole. The material of the insulating layer 121 needs to have good thermal conductivity, low temperature resistance, and the like, and alternative materials include, but are not limited to, ceramic insulating materials, thermally conductive silicon materials, polyimide, and the like. The thickness of the insulating layer 121 should not exceed 1mm, and the thinner the better.
In general, the temperature distributions of different regions of the contact surface 110 are not completely the same, and when the liposolution treatment is performed, the skin at a position corresponding to the region with the lowest temperature on the contact surface 110 on the target region is most likely to freeze, and therefore, it is preferable to install the loading portion 111 in the region with the lowest temperature on the contact surface 110 to mount the signal acquisition unit 200. In some embodiments, the heat sink is cooled by a semiconductor, and the temperature of the region of the contact surface 110 corresponding to the central position of the semiconductor cooling plate is the lowest. In other embodiments, the cold source provides cold to the treatment unit 100 via the cryogenic fluid, and a fluid channel is provided in the treatment unit 100 for the cryogenic fluid to flow through, and the area of the contact surface 110 corresponding to the inlet of the fluid channel is the lowest temperature area. In addition, the "lowest temperature" may be a temperature range.
Further, the freezing point of the antifreeze used in this embodiment may be less than or equal to-15 ℃. In this manner, the therapy unit 100 transmits the cold to the cryoprotectant, from which it is transmitted to the skin of the target area, and then into the subcutaneous lipid-rich cells, causing the lipid-rich cells to programmed die at low temperatures.
The amount of the antifreeze is generally 10ml to 30ml, preferably 15ml to 20 ml. The viscosity (normal temperature) of the antifreeze used in the embodiment is 3000cp-10000cp, preferably 5000cp-8000cp, the fluidity of the antifreeze on skin is relatively low, so that the antifreeze can be prevented from flowing around in the process of freezing and dissolving fat, and the experience of a patient is improved. When the signal acquisition unit 200 comprises electrodes, the cryoprotectant should have a suitable resistivity, too high, reducing the sensitivity of the electrode to the response of the biological impedance of the skin of the target area; the resistance is too low and the current flows directly through the cryoprotectant and not through the skin of the target area, and the bio-impedance of the skin of the target area cannot be obtained. In this example, the specific resistance of the antifreeze should be 200 k.OMEGA.cm to 1000 k.OMEGA.cm, preferably 300 k.OMEGA.cm to 800 k.OMEGA.cm.
Optionally, the antifreeze agent comprises an osmotic protectant, an impermeable protectant, distilled water, a thickener, and an amphoteric surfactant. Wherein the osmotic protective agent comprises at least one of glycerol, dimethyl sulfoxide, ethylene glycol and propylene glycol. The non-osmotic protective agent is soluble in distilled water but cannot enter cells, and is used for keeping the cryoprotectant in a supercooled state to reduce the concentration of lysolipids in skin tissues at a specific temperature, thereby playing a role in protecting the skin. Optional non-osmotic protectants include, but are not limited to, at least one of sucrose, fructose, trehalose, dextran, hydroxyethyl starch, and the like. The thickener comprises at least one of hydroxyethyl cellulose, hydroxymethyl cellulose and sodium alginate. For example, the antifreeze comprises 40 to 61 percent of propylene glycol, 36 to 57 percent of distilled water, 1 to 2 percent of hydroxyethyl cellulose, 0.5 to 1 percent of soluble fructose and 0.5 to 2 percent of lecithin by weight percentage. Or, the antifreeze comprises, by weight, 45-60% of glycerol, 30-40% of propylene glycol, 8-10% of distilled water, 1-2% of hydroxyethyl cellulose and 0.5-2% of lecithin. Further, the antifreezing agent also comprises a pH regulator, so that the pH of the antifreezing agent is regulated to 6.5-7.5.
As described above, the separation film 300 is used to cover the antifreeze. As shown in fig. 4 to 7, a plurality of through holes 310 for passing the antifreeze and the contact terminals 210 are formed in the separation film 300. According to the arrangement, on one hand, the interfacial tension of the antifreeze on the side close to the skin can be reduced, and the wetting tension of the antifreeze on the side away from the skin can be increased, so that the flowability of the antifreeze on the skin surface is further reduced, the flow of the antifreeze on the skin surface is effectively prevented, the situation that part of the skin of a target area is not covered by the antifreeze due to flow aggregation is avoided, and the probability of frostbite is further reduced. On the other hand, the antifreeze agent overflows from the through hole and then comes into contact with the contact surface 110 of the treatment unit 100, improving the uniformity of thermal contact and conduction between the contact surface 110 and the skin of the target area.
Preferably, the treatment unit 100 may further include a negative pressure channel, and the negative pressure channel is configured to be connected to an external suction source to generate a negative pressure in the negative pressure channel for adsorbing the skin of the target area. Here, the through-holes 310 also serve as gas channels to transmit negative pressure, achieve negative pressure adsorption to the skin of the target region, improve heat conduction efficiency, and improve temperature distribution uniformity of the contact surface 110 by the flow of gas when negative pressure adsorption therapy is performed.
The shape of the isolation film 300 in this embodiment may be the same as or different from that of the target region, but the area of the isolation film 300 should be larger than that of the target region so that the isolation film 300 can completely cover the antifreeze agent coated on the target region. Preferably, the distance between the edge of the isolation membrane 300 and the edge of the target area can be greater than or equal to 5cm, so that the isolation membrane is prevented from being displaced and deviating from the target area in the process of freezing and dissolving fat, particularly under negative pressure adsorption, and the risk of frostbite of the target area is reduced.
In this embodiment, the isolation film 300 should be non-absorbent to the antifreeze, elastic, and transparent. For example, a PET (polyethylene terephthalate) film, a PU (polyurethane) film, a PE (polyethylene) film, a PVC (polyvinyl chloride) film, an EVA (ethylene vinyl acetate) film, and the like. Preferably, the isolation film is made of an EVA film, which has better adhesion, can better limit the fluidity of the anti-freezing agent during the treatment process, and can prevent the treatment unit 100 from loosening and shifting.
The thickness of the isolation film 300 is about 30 μm to 150 μm, and the distribution, shape, size, density, etc. of the through holes 310 are determined according to the shape, size, distribution of the contact terminals 210 of the signal acquisition units 200, so as to ensure that all the contact terminals 210 of the signal acquisition units 200 can penetrate through the corresponding through holes 310 to contact with the skin of the target area.
Referring to fig. 4 to 6, in some embodiments, the number of the through holes 310 is multiple, and a plurality of the through holes 310 are arranged on the isolation film 300 in a matrix manner. The through holes 310 may be circular (as shown in fig. 4 and 5), square (not shown) or polygonal such as regular hexagon (as shown in fig. 6, in which case a plurality of the through holes 310 are arranged in a honeycomb shape) according to the shape of the contact end 210 of the signal collecting unit 200. In these embodiments, only one of the through holes 310 can be penetrated by the contact end 210 of one of the signal acquisition units 200, and the aperture of the through hole 310 matches the diameter of the contact end 210 of the signal acquisition unit 200. In practice, the diameter of the through hole 310 is 4mm to 5mm (circular hole means the diameter of the hole, square hole means the maximum side length of the hole, hexagonal hole means the diameter of the inscribed circle of the hexagon), and preferably 2mm to 3 mm. In addition, the maximum distance between two adjacent through holes 310 is less than 3mm, for example, 1mm to 3mm, so as to ensure that all the contact terminals 210 of the signal acquisition units 200 can contact the skin of the target area through the through holes 310, and have sufficient bearing capacity for the antifreeze. More specifically, when a plurality of the through-holes 310 are arranged in a parallel matrix, the maximum distance between adjacent two through-holes 310 may be 2mm to 3mm, and when a plurality of the through-holes 310 are arranged in a staggered matrix, the maximum distance between adjacent two through-holes 310 may be 1mm to 2 mm. In addition, it should be understood that the number of the through holes 310 is greater than the number of the signal collection units 200, such that a portion of the through holes 310 are penetrated with the contact terminals 210 of the signal collection units 200, and a portion of the through holes 310 serve as an overflow path for the antifreeze.
In other embodiments, as shown in fig. 7, the through holes 310 include a first through hole 311 and a second through hole 312, wherein the first through hole 311 is disposed around the second through hole 312 and is used as an overflow path for the antifreeze, and one second through hole 312 is used for passing through the contact terminals 210 of at least two signal acquisition units 200. In this way, the aperture of the second through hole 312 is larger than that of the first through hole 311, the aperture of the first through hole 311 may be 2mm to 5mm, and the aperture of the second through hole 312 is set according to the distribution of the signal acquisition units 200. For example, when there are two signal collecting areas on the contact surface 110 of the treatment unit 100, and a plurality of signal collecting units 200 are distributed on the two signal collecting areas, two second through holes 312 may be disposed on the isolation film 300, and the shape and size of the two second through holes 312 are designed according to the shape and size of the signal collecting areas.
In addition to this, the isolation diaphragm 300 is provided with a plurality of fixing points (not shown in the figures) for fixing the isolation diaphragm 300 to the contact surface 110 of the treatment unit 100. That is, in use, the isolation film 300 is first positioned on the contact surface 110, the contact ends 210 of all the signal acquisition units 200 penetrate through the second through holes, and then the contact surface 110 and the isolation film 300 are connected through a fixed point. The fixing point is provided with an adhesive to bond the contact surface 110 and the isolation film 300. This has the advantage that the isolating membrane 300 is more flat, especially when performing negative pressure suction, while ensuring that the contact end 210 of the signal acquisition unit 200 is in effective contact with the skin of the target area, avoiding wrinkles.
In the technical scheme provided by the embodiment of the invention, the signal acquisition unit is arranged on the contact surface of the treatment unit, and the contact end of the signal acquisition unit is exposed outside the treatment unit, so that the contact end of the signal acquisition unit can be contacted with the skin of a target area in the frozen fat dissolving treatment process, a target signal capable of reflecting the temperature state of the skin can be acquired in time, and the problem of frostbite caused by delay is avoided.
Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.