WO2022121229A1 - Ensemble et dispositif de traitement par cryolipolyse - Google Patents

Ensemble et dispositif de traitement par cryolipolyse Download PDF

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Publication number
WO2022121229A1
WO2022121229A1 PCT/CN2021/092513 CN2021092513W WO2022121229A1 WO 2022121229 A1 WO2022121229 A1 WO 2022121229A1 CN 2021092513 W CN2021092513 W CN 2021092513W WO 2022121229 A1 WO2022121229 A1 WO 2022121229A1
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Prior art keywords
signal acquisition
treatment
cryo
skin
target area
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PCT/CN2021/092513
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English (en)
Chinese (zh)
Inventor
杨云
黄楚波
刘倩
杨力
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上海微创惟美医疗科技(集团)有限公司
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Publication of WO2022121229A1 publication Critical patent/WO2022121229A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B18/0206—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques ultrasonic, e.g. for destroying tissue or enhancing freezing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452—Skin
    • A61B2018/00458—Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
    • A61B2018/00464—Subcutaneous fat, e.g. liposuction, lipolysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00904—Automatic detection of target tissue

Definitions

  • the invention relates to the technical field of medical devices, in particular to a cryolipolysis treatment component and a device.
  • 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.
  • traumatic fat reduction includes liposuction
  • non-invasive fat reduction includes laser lipolysis, ultrasonic lipolysis, radio frequency lipolysis, and cryo-lipolysis.
  • cryo-lipolysis utilizes the feature that human fat-rich cells are less tolerant to low temperature than non-lipid-rich cells.
  • 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.
  • the safety of skin tissue is a priority.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the material of the insulating layer includes any one of ceramic insulating material, thermally conductive silicon material and polyimide.
  • 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 signal acquisition unit includes electrodes, and the resistivity of the antifreeze agent is 200 k ⁇ cm to 1000 k ⁇ cm.
  • the resistivity of the antifreeze is 300 k ⁇ cm to 500 k ⁇ cm.
  • the antifreeze includes osmotic protective agent, non-penetrating protective agent, distilled water, thickener and amphoteric surfactant.
  • 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.
  • the contact end is flush with the outer surface of the isolation membrane or protrudes from the isolation membrane.
  • 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.
  • the through holes are arranged on the isolation membrane in an array.
  • the maximum distance between two adjacent through holes is less than 3 mm.
  • 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.
  • the area of the isolation film is larger than the area of the target region.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Fig. 1 shows a schematic structural diagram of a cryolipolysis treatment component provided by an embodiment of the present invention.
  • 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.
  • 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.
  • the 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.
  • 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.
  • the cryo-lipolysis treatment device includes the cryo-lipolysis treatment component, a cold source (not shown in the figure) and a host 20 .
  • 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.
  • 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.
  • the number of the signal acquisition units 200 is multiple.
  • 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.
  • the optical transceiver 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.
  • the signal acquisition unit 200 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.
  • 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.
  • the electrode material is preferably the same as that of the contact surface 110 , such as aluminum alloy.
  • 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.
  • the temperature distributions of different regions of the contact surface 110 are not exactly the same.
  • 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.
  • 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.
  • 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.
  • the "minimum temperature" may be a temperature range.
  • the freezing point of the antifreeze used in this embodiment may be less than or equal to -15°C.
  • 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.
  • 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.
  • the resistivity of the antifreeze should be 200k ⁇ cm ⁇ 1000k ⁇ cm, preferably 300k ⁇ cm ⁇ 800k ⁇ cm.
  • the antifreeze includes osmotic protective agent, non-penetrating protective agent, distilled water, thickener and amphoteric surfactant.
  • 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.
  • 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.
  • 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.
  • the isolation film 300 is used to cover the antifreeze.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the material of the isolation film 300 should be non-adsorbing to the antifreeze, and may have elasticity, and be a transparent material.
  • PET polyethylene terephthalate
  • PU polyurethane
  • PE polyethylene
  • PVC polyvinyl chloride
  • EVA ethylene vinyl acetate
  • 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 ⁇ m ⁇ 150 ⁇ m, 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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
  • the diameter of the second through hole 312 Set according to the distribution of the signal acquisition unit 200 .
  • 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.
  • 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.
  • 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.

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  • Thermotherapy And Cooling Therapy Devices (AREA)

Abstract

La présente invention concerne un ensemble et un dispositif de traitement par cryolipolyse, l'ensemble de traitement par cryolipolyse comprenant une unité de traitement (100), un agent antigel, un film d'isolation (300) et des unités d'acquisition de signaux (200); l'unité de traitement (100) est utilisée pour recevoir une quantité de refroidissement fournie par un mécanisme externe, et transférer la quantité de refroidissement à une zone cible pour la cryolipolyse; l'agent antigel est appliqué à la zone cible, le film d'isolation (300) recouvre l'agent antigel; une pluralité de trous traversants sont disposés sur le film d'isolation (300); les unités d'acquisition de signaux (200) sont disposées sur l'unité de traitement (100); lorsque l'unité de traitement (100) est positionnée sur le film d'isolation (300), l'agent antigel déborde partiellement des trous traversants pour venir en contact avec l'unité de traitement (100); et en même temps, des extrémités de contact (210) pénètrent dans le film d'isolation (300) par les trous traversants pour entrer en contact avec la peau dans la zone cible de façon à collecter un signal cible, et le signal cible est utilisé pour déterminer si la peau dans la zone cible est gelée. Dans l'ensemble de traitement par cryolipolyse, les unités d'acquisition de signaux (200) peuvent être en contact avec la peau dans la zone cible de façon à surveiller directement et rapidement la température de la peau dans la zone pour éviter les retards et prévenir les engelures.
PCT/CN2021/092513 2020-12-10 2021-05-08 Ensemble et dispositif de traitement par cryolipolyse WO2022121229A1 (fr)

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CN112674812A (zh) * 2021-02-24 2021-04-20 贵阳德漫多医疗科技有限公司 一种用于治疗皮肤病变的微创手术系统

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