WO2022121229A1

WO2022121229A1 - Cryolipolysis treatment assembly and device

Info

Publication number: WO2022121229A1
Application number: PCT/CN2021/092513
Authority: WO
Inventors: 杨云; 黄楚波; 刘倩; 杨力
Original assignee: 上海微创惟美医疗科技(集团)有限公司
Priority date: 2020-12-10
Filing date: 2021-05-08
Publication date: 2022-06-16
Also published as: CN112220551A; CN112220551B

Abstract

A cryolipolysis treatment assembly and device, the cryolipolysis treatment assembly comprises a treatment unit (100), an antifreeze agent, an isolation film (300), and signal acquisition units (200); the treatment unit (100) is used for receiving a cooling quantity provided by an external mechanism, and transferring the cooling quantity to a target area for cryolipolysis; the antifreeze agent is applied to the target area, the isolation film (300) covers the antifreeze agent; a plurality of through holes are disposed on the isolation film (300); the signal acquisition units (200) are disposed on the treatment unit (100); when the treatment unit (100) is positioned on the isolation film (300), the antifreeze agent partially overflows from the through holes to come into contact with the treatment unit (100); and at the same time, contact ends (210) penetrate the isolation film (300) by means of the through holes to touch skin in the target area so as to collect a target signal, and the target signal is used to determine whether the skin in the target area is frozen. In the cryolipolysis treatment assembly, the signal acquisition units (200) can be in contact with the skin in the target area so as to directly and promptly monitor the skin temperature in the area to avoid delays and prevent frostbite.

Description

A kind of cryolipolysis treatment component and device

technical field

The invention relates to the technical field of medical devices, in particular to a cryolipolysis treatment component and a device.

Background technique

The mechanism of obesity is that energy intake exceeds energy expenditure, resulting in excessive accumulation of body fat and excess body weight. The accumulation of local fat in the body will not only destroy people's appearance and athletic ability, but even significantly increase health risks, causing cardiovascular and cerebrovascular diseases, diabetes, high blood pressure and certain cancers. Therefore, it is necessary to take some measures to control or eliminate excessive fat. Fat.

Existing fat reduction techniques include traumatic fat reduction and non-traumatic fat reduction, of which traumatic fat reduction includes liposuction, and non-invasive fat reduction includes laser lipolysis, ultrasonic lipolysis, radio frequency lipolysis, and cryo-lipolysis. Compared with traumatic fat loss, non-traumatic fat loss is more favored by beauty lovers. Among them, cryo-lipolysis utilizes the feature that human fat-rich cells are less tolerant to low temperature than non-lipid-rich cells. On the surface of the skin, the temperature of the subcutaneous fat layer is lowered to the point where the fat cells trigger programmed death, which is then excreted out of the body with the body's metabolism to achieve the purpose of fat loss.

In the process of cryolipolysis, the safety of skin tissue is a priority. In order to reduce the risk of skin tissue freezing, in the prior art, antifreeze or antifreeze film is applied to the skin surface during cryo-lipolysis treatment, and a monitoring system is set on the cryo-lipolysis device. However, this monitoring system is different from the There is a barrier layer between the skin, and the temperature of the skin surface cannot be directly monitored. When the skin surface freezes, the corresponding temperature parameters need to be identified through the barrier layer, and adjustment measures can be taken, which will cause a delay of more than 10s in adjustment, which is very likely to cause irreversible damage to the skin tissue.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a cryo-lipolysis treatment component and device, which can directly monitor the temperature of the skin surface when using the cryo-lipolysis treatment component for cryo-lipolysis treatment, eliminate adjustment delay, and improve the safety of treatment , to avoid skin damage.

In order to achieve the above object, the present invention provides a cryo-lipolysis treatment assembly, comprising a treatment unit, an antifreeze agent, an isolation membrane and a signal acquisition unit; wherein, the treatment unit is used for receiving the cooling energy provided by an external organization, and The cold energy is transferred to the target area for freezing and lipolysis; the antifreeze agent is used to coat the skin of the target area; the isolation film is covered on the antifreeze agent, and a plurality of a through hole; the signal acquisition unit is arranged on the treatment unit;

The cryo-lipolysis treatment assembly is configured such that when the treatment unit is positioned on the isolation membrane, the antifreeze partially overflows from the through hole to contact the treatment unit, while the signal acquisition unit The isolation membrane penetrates through the through hole and is in contact with the skin of the target area, so as to collect a target signal of the skin, and the target signal is used to determine whether the skin of the target area is frozen.

Optionally, the treatment unit includes a contact surface, the contact surface is used to transfer the cold energy to the target area, and a loading part is provided on the contact surface; the signal acquisition unit is arranged on the The loading part includes a contact end; the contact end is used for penetrating the isolation membrane for contacting with the skin of the target area.

Optionally, the signal acquisition unit includes an integrated ultrasonic transceiver, and the ultrasonic transceiver has the contact end; and/or the signal acquisition unit includes an optical transceiver, and the optical transceiver has the contact and/or, the signal acquisition unit includes an electrode, and the electrode has the contact end.

Optionally, when the signal acquisition unit includes an electrode, the loading part includes a loading hole, the electrode is installed at the loading hole, and an insulation is provided between the electrode and the hole wall of the loading hole Floor.

Optionally, the material of the insulating layer includes any one of ceramic insulating material, 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 includes electrodes, and the resistivity of the antifreeze agent is 200 kΩ·cm to 1000 kΩ·cm.

Optionally, the resistivity of the antifreeze is 300 kΩ·cm to 500 kΩ·cm.

Optionally, the antifreeze includes osmotic protective agent, non-penetrating protective agent, distilled water, thickener and amphoteric surfactant.

Optionally, the permeability protecting agent includes at least one of glycerol, dimethyl sulfoxide, ethylene glycol, and propylene glycol; and/or,

The impermeable protective agent includes at least one of sucrose, fructose, trehalose, dextran, and hydroxyethyl starch; and/or,

The thickener includes at least one of hydroxyethyl cellulose, hydroxymethyl cellulose, and sodium alginate.

Optionally, the contact end is flush with the outer surface of the isolation membrane or protrudes from the isolation membrane.

Optionally, the number of the signal collection units is multiple, and the contact end of each of the signal collection units penetrates through the isolation membrane from one of the through holes.

Optionally, the through holes are arranged on the isolation membrane in an array.

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 include a first through hole and a second through hole; one of the second through holes is used for all the signal acquisition units of at least two of the signal acquisition units. The contact end penetrates.

Optionally, it is characterized in that the area of the isolation film is larger than the area of the target region.

Optionally, the treatment unit is further provided with a negative pressure channel 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 also provides a cryo-lipolysis treatment device, comprising the cryo-lipolysis treatment component as described in any one of the preceding items, a cold source and a host; the cold source is used to provide cooling to the treatment unit. The host is connected in communication with the signal acquisition unit and the cold source, and is configured to determine whether the skin of the target area is frozen according to the target signal collected by the signal acquisition unit, and then adjust the cold source. The source of cooling provided to the treatment unit.

Optionally, a negative pressure cavity is further provided on the treatment unit, and the cryo-lipolysis treatment device further includes a suction source for communicating with the negative pressure cavity to generate a suction source in the negative pressure cavity. negative pressure.

Compared with the prior art, the cryo-lipolysis treatment assembly and device of the present invention have the following advantages: the aforementioned cryo-lipolysis treatment assembly includes a treatment unit, an antifreeze agent, an isolation membrane and a signal acquisition unit; wherein, the treatment unit is used for Receive the cold energy provided by an external agency, and transfer the cold energy to the target area for cryo-lipolysis; the antifreeze agent is used to coat the skin of the target area; the isolation film covers the antifreeze and the isolation membrane is provided with a plurality of through holes; the signal acquisition unit is provided on the treatment unit; the cryolipolysis treatment assembly is configured to be configured when the treatment unit is positioned on the isolation membrane When the antifreeze partially overflows from the through hole to contact the treatment unit, and at the same time, the signal acquisition unit penetrates the isolation membrane from the through hole and contacts the skin of the target area, The target signal of the skin is collected, and the target signal is used to determine whether the skin of the target area is frozen. The signal acquisition unit can be in contact with the skin of the target area during the process of freezing and lipolysis, so as to directly collect the target signal, timely feedback the temperature state, avoid delay, and help improve the safety of the cryo-lipolysis treatment.

Description of drawings

The accompanying drawings are used for better understanding of the present invention and do not constitute an improper limitation of the present invention.

FIG. 1 is a schematic structural diagram of a cryo-lipolysis treatment assembly provided by an embodiment of the present invention, in which only a treatment head and a signal acquisition unit are shown.

FIG. 2 is a cross-sectional view of a cryolipolysis treatment assembly provided by the present invention according to an embodiment, and the signal acquisition unit in the figure is an electrode.

FIG. 3 is a schematic diagram of the cryo-lipolysis treatment device according to an embodiment of the present invention performing fat-dissolving in a target area of the human body.

FIG. 4 is a schematic structural diagram of the isolation membrane of the cryolipolysis treatment component according to an embodiment of the present invention.

FIG. 5 is a schematic structural diagram of the isolation membrane of the cryolipolysis treatment component provided by another embodiment of the present invention.

FIG. 6 is a schematic structural diagram of an isolation membrane of a cryolipolysis treatment component provided by a further embodiment of the present invention.

FIG. 7 is a schematic structural diagram of the isolation membrane of the cryolipolysis treatment component according to another embodiment of the present invention.

[reference numerals are explained below]:

100-treatment unit; 110-contact surface, 111-loading part; 121-insulation layer; 200-signal acquisition unit; 210-contact terminal; 300-isolation membrane; 310-through hole; 311-first through hole, 312- The second through hole; 20-host.

Detailed ways

The embodiments of the present invention are described below through specific specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the drawings provided in this embodiment are only to illustrate the basic concept of the present invention in a schematic way, so the drawings only show the components related to the present invention rather than the number, shape and the number of components in actual implementation. For dimension drawing, the type, quantity and proportion of each component can be changed at will in actual implementation, and the component layout may also be more complicated.

In addition, each embodiment of the following description has one or more technical features, but this does not mean that the person using the present invention must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately. One or all of the technical features of the . In other words, under the premise of possible implementation, those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or The combination of some or all of the technical features in the multiple embodiments is selectively implemented, thereby increasing the flexibility of the implementation of the present invention.

As used in this specification, the singular forms "a," "an," and "the" include plural referents, and the plural forms "a plurality" include two or more 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 "installed", "connected", "connected" shall be To be understood in a broad sense, for example, it may be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected, or indirectly connected through an intermediate medium, and it can be the internal communication between two elements or the interaction relationship between the two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

One of the objectives of the present invention is to provide a cryo-lipolysis treatment component, including a treatment unit and a signal acquisition unit; wherein, the treatment unit is used for receiving cold energy provided by an external organization, and delivering the cold energy to a target area to performing cryo-lipolysis; the anti-freezing agent is used to coat the skin of the target area; the isolation film is covered on the anti-freezing agent, and a plurality of through holes are arranged on the isolation film; the signal acquisition a unit is disposed on the treatment unit; the cryolipolysis treatment assembly is configured such that when the treatment unit is positioned on the isolation membrane, the antifreeze partially overflows from the through hole to interact with the treatment At the same time, the signal acquisition unit penetrates the isolation membrane from the through hole and contacts the skin of the target area to collect the target signal of the skin, and the target signal is used to judge the target area. Whether the skin freezes. In the cryo-lipolysis treatment assembly, the signal acquisition unit can contact the skin of the target area, monitor the target signal on the skin surface in time, and feed back temperature information to avoid delay, and then the external mechanism can timely respond to the skin The temperature of the surface adjusts the supply of cold energy, reduces the probability of frostbite, and improves the safety of use.

Another object of the present invention is to provide a cryo-lipolysis treatment device, which includes the cryo-lipolysis treatment component, a cold source and a host. Wherein, the cold source is used to provide cold energy for the treatment unit. The host is connected in communication with the signal acquisition unit and the cold source, and is configured to determine whether the skin of the target area is frozen according to the target signal collected by the signal acquisition unit, and can further adjust the The cooling power provided by the cooling source to the treatment unit.

In order to make the objects, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that, the accompanying drawings are all in a very simplified form and in inaccurate scales, and are only used to facilitate and clearly assist the purpose of explaining the embodiments of the present invention. The same or similar reference numbers in the drawings represent the same or similar parts.

Fig. 1 shows a schematic structural diagram of a cryolipolysis treatment component provided by an embodiment of the present invention. Please refer to FIG. 1 , the cryo-lipolysis treatment assembly includes a treatment unit 100 , an antifreeze agent, an isolation membrane 300 (not shown in FIG. 1 , please refer to FIGS. 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 transferring the cold energy to the target area of the human body for cryo-lipolysis. The antifreeze agent is used to coat the skin of the target area; the isolation film is covered on the antifreeze agent, and a plurality of through holes are arranged on the isolation film; the signal acquisition unit 200 is arranged in the on the treatment unit 100. The cryo-lipolysis treatment assembly is configured such that when the treatment unit 100 is positioned on the isolation membrane, the antifreeze partially overflows from the through hole to contact the treatment unit 100 while the signal The acquisition unit penetrates through the isolation membrane from the through hole, and contacts with the skin of the target area to collect a target signal, where the target signal is used to determine whether the skin of the target area is frozen. The signal acquisition unit 200 of the cryolipolysis treatment assembly provided in this embodiment can contact the skin of the target area, and collect the target signal that can reflect the skin temperature state of the area in time to avoid delay. Here, the contact between the signal acquisition unit 200 and the skin of the target area includes not only the direct contact between the signal acquisition unit 200 and the skin of the target area without any material barrier, but also the direct contact between the signal acquisition unit 200 and the skin of the target area. When there is a liquid film between the skin of the target area (that is, when antifreeze is applied on the skin of the target area, at this time, there is a liquid film formed by the antifreeze between the signal acquisition unit and the skin of the target area), the liquid film The thickness of the liquid film is very small, so the transfer delay of the target signal caused by the thickness of the liquid film is negligible.

In more detail, please refer to FIG. 2 , the treatment unit 100 includes a contact surface 110 for transferring the cooling energy to the target area. The contact surface 110 is provided with a loading portion 111 . The signal acquisition unit 200 is disposed on the loading part 111 and includes a contact end 210 . The contact end 210 is used to penetrate the isolation membrane to contact the skin of the target area. It should be understood that the exposure of the contact end 210 to the outside of the treatment unit 100 means that the contact end 210 is not shielded and exposed to the air environment. Optionally, the contact end 210 is flush with the outer surface of the isolation membrane or protrudes from the isolation membrane.

Fig. 3 shows a schematic diagram of the cryo-lipolysis treatment device according to an embodiment of the present invention performing fat-dissolving in a target area of the human body. Please refer to FIG. 3 , the cryo-lipolysis treatment device includes the cryo-lipolysis treatment component, a cold source (not shown in the figure) and a host 20 . Wherein, the cold source is used to provide cold energy to the treatment unit 100 . The host 20 is connected in communication 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 collected by the signal acquisition unit 200, and then adjust the target area. The cooling power provided by the cooling source to the treatment unit 100.

In this embodiment of the present invention, the signal acquisition unit 200 monitors the temperature change of the skin in the target area in time, so that the host 20 can timely know the state of the skin in the target area (that is, whether freezing occurs), and The amount of cooling can be further adjusted to reduce the probability of frostbite on the skin of the target area, and to improve the safety of the cryolipolysis treatment device. Preferably, the number of the signal acquisition units 200 is multiple.

Those skilled in the art should understand that the "target area" refers to the part in the human body that needs to be treated with fat dissolving, such as abdomen, legs and the like. The "target signal" is determined according to the type of the signal acquisition unit 200. For example, when the signal acquisition unit 200 includes an integrated ultrasonic transceiver, the ultrasonic transceiver has the contact end 210 and is connected with the contact end 210. The skin of the target area contacts to emit ultrasonic waves, and the skin of the target area reflects the ultrasonic waves differently before and after freezing, so the target signal may include 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 and is in contact with the skin of the target area and emits detection light. After the skin in the area is frozen, the optical properties of the skin in the area are correspondingly changed, which may be embodied in the enhancement of scattering, and the target signal may include the scattered light of the skin in the target area. For another example, when the signal acquisition unit 200 includes an electrode, the electrode has the contact end 210 to be in contact with the skin of the target area. At this time, the bioimpedance of the skin of the target area can be used as the target signal. The inventor's research found that before and after the skin of the target area is frozen, the bioimpedance of the area does not change significantly, but the impedance change rate has a large change, so the host 20 performs the bioimpedance measurement after receiving the bioimpedance. Process to obtain the impedance change rate, and judge whether the skin is frozen according to the impedance change rate, so as to improve the sensitivity.

Please refer back to FIG. 2 , when the signal acquisition unit 200 includes electrodes, the electrodes may be columnar structures, and the diameter of the cross-section of the electrodes is less than or equal to 3 mm. The "diameter" mentioned here means that when the cross-section of the electrode is circular, the diameter refers to the diameter of the circle, and when the cross-section of the electrode is non-circular, the The diameter refers to the diameter of the non-circular circumscribed circle. The electrode has good electrical and thermal conductivity. In order to avoid local overcooling or overheating of the skin tissue in the area in contact with the electrode, the electrode material is preferably the same as that of the contact surface 110 , such as aluminum alloy.

Further, a part of the plurality of electrodes is used as an anode terminal, and the other part is used as a cathode terminal. During acquisition of the bioimpedance, current flows from the anode end through the skin of the target area and then into the cathode end. This process requires no current transfer between the electrodes and the treatment unit 100 , that is, insulation treatment between the electrodes and the treatment unit 100 is required. Specifically, please refer to FIG. 3 , the loading part 111 includes a loading hole, the electrode is installed in the loading hole, and an insulating layer 121 is disposed between the electrode and the hole wall of the loading hole. The material of the insulating layer 121 needs to have good thermal conductivity, low temperature resistance and other properties, and optional 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 1 mm, and the thinner the better.

Generally, the temperature distributions of different regions of the contact surface 110 are not exactly the same. When performing lipolysis treatment, the skin at the position on the target region corresponding to the region with the lowest temperature on the contact surface 110 has the highest temperature. Freezing easily occurs. Therefore, it is preferable to install the signal acquisition unit 200 by disposing the loading portion 111 in the region where the temperature of the contact surface 110 is the lowest. In some embodiments, the cooling source is refrigerated by a semi-conductor, so the temperature of the area of the contact surface 110 corresponding to the central position of the semi-conductor cooling sheet is the lowest. In other embodiments, the cold source provides cold energy to the treatment unit 100 through a low-temperature fluid, then the treatment unit 100 is provided with a flow channel for the low-temperature fluid to circulate, and the contact surface 110 corresponds to the flow channel The region of the inlet is the region with the lowest temperature. In addition, the "minimum 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°C. In this way, the treatment unit 100 transmits the cold energy to the antifreeze, and then the antifreeze transmits it to the skin of the target area, and then enters the subcutaneous lipid-rich cells, so that the lipid-rich cells are Programmed death at hypothermia.

The dosage of the antifreeze is generally 10ml-30ml, preferably 15ml-20ml. The viscosity (normal temperature) of the antifreeze used in this example is 3000cp-10000cp, preferably 5000cp-8000cp, the antifreeze of this viscosity has relatively low fluidity on the skin, which can avoid the process of freezing and fat-dissolving. It flows around and enhances the patient's experience. When the signal acquisition unit 200 includes an electrode, the antifreeze should have a suitable resistivity, and if the resistivity is too large, the response sensitivity of the electrode to the bioimpedance of the skin of the target area is reduced; if the resistance is too small, the current The bioimpedance of the skin of the target area cannot be obtained by flowing the antifreeze directly without passing through the skin of the target area. In this embodiment, the resistivity of the antifreeze should be 200kΩ·cm˜1000kΩ·cm, preferably 300kΩ·cm˜800kΩ·cm.

Optionally, the antifreeze includes osmotic protective agent, non-penetrating protective agent, distilled water, thickener and amphoteric surfactant. Wherein, the permeability protecting agent includes at least one of glycerol, dimethyl sulfoxide, ethylene glycol, and propylene glycol. The non-osmotic protective agent can be dissolved in distilled water but cannot enter cells, which is used to keep the antifreeze in a supercooled state, so as to reduce the concentration of lipolysis in the skin tissue at a specific temperature, and play a role in protecting the skin . Optional impermeable protective agents include, but are not limited to, at least one of saccharides, such as sucrose, fructose, trehalose, dextran, and hydroxyethyl starch. The thickener includes at least one of hydroxyethyl cellulose, hydroxymethyl cellulose, and sodium alginate. For example, by weight percentage, the antifreeze includes 40%-61% propylene glycol, 36%-57% distilled water, 1%-2% hydroxyethyl cellulose, 0.5%-1% soluble fructose, 0.5%-1% soluble fructose, 0.5% % to 2% of lecithin. Or, by weight percentage, the antifreeze includes 45%-60% glycerin, 30%-40% propylene glycol, 8%-10% distilled water, 1%-2% hydroxyethyl cellulose and 0.5% ~2% lecithin. Further, the antifreeze also includes a pH adjuster to adjust the pH of the antifreeze to 6.5-7.5.

As mentioned above, the isolation film 300 is used to cover the antifreeze. As shown in FIG. 4 to FIG. 7 , the isolation film 300 is provided with a plurality of through holes 310 for the antifreeze agent and the contact end 210 to pass through. This arrangement, on the one hand, can reduce the interfacial tension of the antifreeze on the side close to the skin, and increase the wetting tension on the side of the antifreeze away from the skin, thereby further reducing the fluidity of the antifreeze on the skin surface, effectively preventing the The flow of the antifreeze on the surface of the skin avoids the situation that the skin of a part of the target area is not covered by the antifreeze due to flow accumulation, and further reduces the probability of frostbite events. On the other hand, the antifreeze comes into contact with the contact surface 110 of the treatment unit 100 after overflowing from the through hole, which improves the thermal contact and heat conduction between the contact surface 110 and the skin of the target area uniformity.

Preferably, the treatment unit 100 can also be provided with a negative pressure channel, and the negative pressure channel is used to connect with an external suction source, so as to generate negative pressure in the negative pressure channel for adsorbing the target. area of skin. Here, the through hole 310 is also used as a gas channel to transmit negative pressure, realize the negative pressure adsorption to the skin of the target area, improve the heat conduction efficiency, and when the negative pressure adsorption treatment is performed, the flow of the gas improves all the The uniformity of the temperature distribution of the contact surface 110.

The shape of the isolation film 300 in this embodiment may be the same as or different from the shape of the target area, but the area of the isolation film 300 should be larger than the area of the target area, so that the isolation film 300 can be completely Cover the antifreeze applied to the target area. Preferably, the distance between the edge of the isolation film 300 and the edge of the target area can be greater than or equal to 5 cm, to avoid displacement and deviation from the target area during the process of freezing and fat-dissolving, especially under negative pressure adsorption. , reducing the risk of frostbite in the target area.

In this embodiment, the material of the isolation film 300 should be non-adsorbing to the antifreeze, and may have elasticity, and be a transparent material. For example, PET (polyethylene terephthalate) film, PU (polyurethane) film, PE (polyethylene) film, PVC (polyvinyl chloride) film, EVA (ethylene vinyl acetate) film etc. Preferably, the isolation film is made of EVA film, and the EVA film material has better adhesion, which can better limit the fluidity of the antifreeze during the treatment process, and can prevent the treatment unit 100 from loosening and moving. bit.

The thickness of the isolation film 300 is about 30 μm˜150 μm, and the distribution, shape, size, density, etc. of the through holes 310 thereon are determined according to the shape, size, and distribution of the contact end 210 of the signal acquisition unit 200 , In order to ensure that all the contact ends 210 of the signal acquisition units 200 can penetrate through the corresponding through holes 310 to contact the skin of the target area.

Referring to FIGS. 4 to 6 , in some embodiments, the number of the through holes 310 is multiple, and the plurality of the through holes 310 are arranged on the isolation film 300 in a matrix. According to the shape of the contact end 210 of the signal acquisition unit 200 , the cross-section of the through hole 310 may be a circle (as shown in FIG. 4 and FIG. 5 ), a square (not shown) or a polygon such as a regular hexagon ( As shown in FIG. 6 , at this time, a plurality of the through holes 310 are arranged in a honeycomb shape). In these embodiments, one of the through holes 310 can only pass through the contact end 210 of the signal acquisition unit 200 , and the diameter of the through hole 310 is the same as the contact end 210 of the signal acquisition unit 200 . diameter to match. In practice, the diameter of the through hole 310 is 4 mm to 5 mm (the circular hole refers to the diameter of the hole, the square hole refers to the maximum side length of the hole, and the hexagonal hole refers to the diameter of the inscribed circle of the hexagon) , preferably 2 mm to 3 mm. In addition, the maximum distance between two adjacent through holes 310 should be less than 3 mm, such as 1 mm˜3 mm, to ensure that all the contact ends 210 of the signal acquisition units 200 can pass through the through holes 310 to While in contact with the skin of the target area, it also has sufficient bearing capacity for the antifreeze. More specifically, when the plurality of through holes 310 are arranged in a parallel matrix, the maximum distance between two adjacent through holes 310 may be 2 mm˜3 mm, and when the plurality of through holes 310 are staggered When arranged in a matrix manner, the maximum distance between two adjacent through holes 310 may be 1 mm˜2 mm. In addition, it should be understood that the number of the through holes 310 is greater than the number of the signal acquisition units 200 , so that some of the through holes 310 pass through the contact end 210 of the signal acquisition unit 200 , and some The through holes 310 serve as overflow passages for antifreeze.

In other embodiments, as shown in FIG. 7 , the through hole 310 includes a first through hole 311 and a second through hole 312 , wherein the first through hole 311 is arranged around the second through hole 312 and is used as a In the overflow channel of the antifreeze, one of the second through holes 312 is used for passing through the contact ends 210 of at least two of the signal acquisition units 200 . In this way, the diameter of the second through hole 312 is larger than that of the first through hole 311 , the diameter of the first through hole 311 may be 2 mm˜5 mm, and the diameter of the second through hole 312 Set according to the distribution of the signal acquisition unit 200 . For example, when the contact surface 110 of the treatment unit 100 has two signal acquisition areas in which signals are arranged in parallel, and a plurality of the signal acquisition units 200 are distributed in the two signal acquisition areas, the isolation Two second through holes 312 may be provided on the membrane 300 , and the shapes and sizes of the two second through holes 312 are designed according to the shape and size of the signal collection area.

Not only this, the isolation membrane 300 is also provided with a plurality of fixing points (not shown in the figure), and the multiple fixing points are used for fixing the isolation membrane 300 to all parts of the treatment unit 100 . on the contact surface 110. That is to say, in use, the isolation film 300 is first positioned on the contact surface 110, and all the contact ends 210 of the signal acquisition units 200 pass through the second through holes, and then The contact surface 110 and the isolation film 300 are connected by fixed points. Adhesives are provided at the fixing points to bond the contact surface 110 and the isolation film 300 . The advantage of this arrangement is that, while ensuring that the contact end 210 of the signal acquisition unit 200 is in effective contact with the skin of the target area, the isolation film 300 is more flat, especially when performing negative pressure adsorption, Avoid wrinkles.

In the technical solution provided by the embodiment of the present invention, the signal acquisition unit is disposed on the contact surface of the treatment unit, and the contact end of the signal acquisition unit is exposed to the outside of the treatment unit, so that the The contact end of the signal acquisition unit can be in contact with the skin of the target area during the cryolipolysis treatment process, and timely collect the target signal that can reflect the temperature state of the skin, so as to avoid the problem of frostbite caused by delay.

Although the present invention is disclosed above, it is not limited thereto. Various modifications and variations can be made in the present invention by those skilled in the art without departing from the spirit and scope of the invention. Thus, provided that these 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 these modifications and variations.

Claims

A cryo-lipolysis treatment assembly, characterized in that it includes a treatment unit, an antifreeze, an isolation membrane, and a signal acquisition unit; wherein, the treatment unit is used for receiving the cooling capacity provided by an external cold source, and converting the cooling capacity Delivered to the target area for cryo-lipolysis; the antifreeze agent is used to coat the skin of the target area; the isolation film is covered on the antifreeze agent, and a plurality of through holes are arranged on the isolation film ; the signal acquisition unit is arranged on the treatment unit;

The cryo-lipolysis treatment assembly is configured such that when the treatment unit is positioned on the isolation membrane, the antifreeze partially overflows from the through hole to contact the treatment unit, while the signal acquisition unit The isolation membrane penetrates through the through hole and is in contact with the skin of the target area, so as to collect a target signal of the skin, and the target signal is used to determine whether the skin of the target area is frozen.
The cryolipolysis treatment assembly according to claim 1, wherein the treatment unit includes a contact surface for transferring the cold energy to the target area, and the contact surface is provided with a contact surface. There is a loading part; the signal acquisition unit is arranged on the loading part and includes a contact end; the contact end is used for penetrating the through hole for contacting with the skin of the target area.
The cryolipolysis treatment assembly according to claim 2, wherein the signal acquisition unit comprises an ultrasonic transceiver, and the ultrasonic transceiver has the contact end; and/or the signal acquisition unit comprises an optical transceiver The optical transceiver has the contact end; and/or the signal acquisition unit includes an electrode, and the electrode has the contact end.
The cryolipolysis treatment assembly according to claim 3, wherein when the signal acquisition unit includes an electrode, the loading part includes a loading hole, the electrode is installed at the loading hole, and the electrode An insulating layer is arranged between it and the hole wall of the loading hole.
The cryo-lipolysis treatment assembly according to claim 4, wherein the material of the insulating layer comprises any one of ceramic insulating material, thermally conductive silicon material and polyimide.
The cryolipolysis treatment assembly according to claim 4, wherein 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.
The cryolipolysis treatment assembly according to claim 2, wherein the signal acquisition unit comprises an electrode, and the resistivity of the antifreeze agent is 200 kΩ·cm to 1000 kΩ·cm.
The cryo-lipolysis treatment assembly according to claim 7, wherein the resistivity of the antifreeze agent is 300 kΩ·cm to 500 kΩ·cm.
The cryo-lipolysis treatment component according to claim 8, wherein the antifreeze agent comprises an osmotic protective agent, an impermeable protective agent, distilled water, a thickening agent and an amphoteric surfactant.
The cryo-lipolysis treatment component according to claim 9, wherein the osmotic protective agent comprises at least one of glycerol, dimethyl sulfoxide, ethylene glycol, and propylene glycol; and/or,

The impermeable protective agent includes at least one of sucrose, fructose, trehalose, dextran, and hydroxyethyl starch; and/or,

The thickener includes at least one of hydroxyethyl cellulose, hydroxymethyl cellulose, and sodium alginate.
The cryolipolysis treatment assembly according to claim 2, wherein the contact end is flush with the outer surface of the isolation membrane or protrudes from the isolation membrane.
The cryo-lipolysis treatment assembly according to claim 2, wherein the number of the signal acquisition units is plural, and the contact end of each of the signal acquisition units penetrates the through hole from one of the through holes. isolation film.
The cryo-lipolysis treatment assembly according to claim 12, wherein the through holes are arranged on the isolation membrane in an array, and the through holes are circular holes, square holes or hexagonal holes.
The cryo-lipolysis treatment assembly according to claim 13, wherein the maximum distance between two adjacent through holes is less than 3 mm.
The cryolipolysis treatment assembly according to claim 2, wherein the number of the signal acquisition units is plural; the through holes include a first through hole and a second through hole; and one of the second through holes The contact ends of at least two of the signal acquisition units pass through.
The cryolipolysis treatment assembly according to any one of claims 2-15, wherein the area of the isolation membrane is larger than the area of the target area.
The cryo-lipolysis treatment assembly according to any one of claims 1-15, wherein the treatment unit is further provided with a negative pressure channel for communicating with an external suction source, so as to Negative pressure is generated in the negative pressure cavity.
A cryo-lipolysis treatment device, characterized in that it comprises the cryo-lipolysis treatment assembly as claimed in any one of claims 1-17, a cold source and a host; the cold source is used to provide cooling to the treatment unit The host is connected in communication with the signal acquisition unit and the cold source, and is configured to determine whether the skin of the target area is frozen according to the target signal collected by the signal acquisition unit, so as to adjust the cold source. The source of cooling provided to the treatment unit.
The cryo-lipolysis treatment device according to claim 18, wherein the treatment unit is further provided with a negative pressure channel, and the cryo-lipolysis treatment device further comprises a suction source for cooperating with the negative pressure The channels communicate to generate negative pressure in the negative pressure channel.