WO2022022159A1 - 一种冷冻溶脂治疗组件、装置及防冻剂 - Google Patents

一种冷冻溶脂治疗组件、装置及防冻剂 Download PDF

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Publication number
WO2022022159A1
WO2022022159A1 PCT/CN2021/101091 CN2021101091W WO2022022159A1 WO 2022022159 A1 WO2022022159 A1 WO 2022022159A1 CN 2021101091 W CN2021101091 W CN 2021101091W WO 2022022159 A1 WO2022022159 A1 WO 2022022159A1
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Prior art keywords
antifreeze
film
holes
negative pressure
cryo
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PCT/CN2021/101091
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English (en)
French (fr)
Inventor
杨云
黄楚波
王凯丽
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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 WO2022022159A1 publication Critical patent/WO2022022159A1/zh

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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
    • A61B18/0218—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques with open-end cryogenic probe, e.g. for spraying fluid directly on tissue or via a tissue-contacting porous tip
    • 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
    • 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
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • 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

Definitions

  • the present invention relates to the technical field of medical devices, in particular to a medical device based on refrigeration technology and components thereof, and an antifreeze used in the medical field.
  • 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.
  • the present invention provides a cryo-lipolysis treatment component, comprising:
  • the treatment unit is used to receive the cold energy provided by the external mechanism, and transfer the cold energy to the target area for cryo-lipolysis; the treatment unit is also provided with a negative pressure channel, and the negative pressure channel is used for connected with an external suction mechanism to generate negative pressure in the negative pressure channel;
  • the viscosity of the antifreeze is not less than 5000cp;
  • the cryo-lipolysis treatment assembly is configured such that when the treatment unit is positioned on the first membrane and negative pressure is generated in the negative pressure cavity, the first membrane is adsorbed on the treatment unit, and simultaneously The antifreeze partially overflows from the first through hole to contact the treatment unit.
  • the first film includes a first array area and a second array area, and the second array area is arranged around the first array area;
  • the first through hole includes a plurality of first sub-through holes and a plurality of second sub-through holes, the plurality of first sub-through holes are evenly distributed on the first array area, and the plurality of second sub-through holes are The through holes are evenly distributed on the second array area;
  • the distribution density of the first sub-through holes is greater than the distribution density of the second sub-through holes, and/or the diameter of the first sub-through holes is smaller than the diameter of the second sub-through holes.
  • the diameters of the plurality of first through holes are equal, and the plurality of first through holes are evenly distributed on the first film.
  • the area of the first film is greater than the area of the target area, and the distance between the edge of the first film and the edge of the target area is greater than or equal to 5 cm.
  • the thickness of the first film is 30 ⁇ m-100 ⁇ m, and the diameter of the first through holes is 2 mm-5 mm; and/or, the distance between two adjacent first through holes is 1 mm -5mm.
  • the first film is an elastic plastic film
  • the material of the first film is any one of polyethylene, polyurethane, polyester resin, polyvinyl chloride and ethylene-vinyl acetate copolymer.
  • the treatment unit includes a body and a second membrane disposed on the body, the body includes a vacuum handle and a contour fitting head, and one end of the vacuum handle is used to communicate with the suction mechanism and the freezing device.
  • the source is connected, and the other end is connected with the profile adapter head; the profile adapter head is used for contacting with the first film and part of the antifreeze;
  • the second film is disposed between the vacuum handle and the contour fitting head and is configured to deform when subjected to a stretching force and to remain deformed after the stretching force is removed;
  • a sealing ring is further included, which is arranged between the vacuum handle and the contour fitting head, and the second film is fixedly connected with the sealing ring.
  • the second film is Parafilm.
  • the viscosity of the antifreeze is 5000cp-10000cp, and the freezing point is less than or equal to -15°C.
  • the antifreeze includes the following components: propylene glycol, distilled water, hydroxyethyl cellulose, soluble sugar and lecithin.
  • the pH of the antifreeze is 6.5-7.5.
  • the present invention also provides a cryo-lipolysis treatment device, comprising the cryo-lipolysis treatment component and a host as described in any preceding item; the host includes a suction mechanism and a freezing source; the suction mechanism The freezing source is connected to the treatment unit and is used for providing cold energy to the treatment unit.
  • the present invention also provides an antifreeze, the viscosity of the antifreeze is not less than 5000cp.
  • the viscosity of the antifreeze is 5000cp-10000cp, and the freezing point is less than or equal to -15°C.
  • the antifreeze includes the following components: propylene glycol, distilled water, hydroxyethyl cellulose, soluble sugar and lecithin.
  • the antifreeze includes 40%-61% propylene glycol, 36%-57% distilled water, 1%-2% hydroxyethyl cellulose, 0.5%-1% soluble Sugar and 0.5%-2% lecithin.
  • the pH of the antifreeze is 6.5-7.5.
  • cryolipolysis treatment component Compared with the prior art, the cryolipolysis treatment component, device and antifreeze of the present invention have the following advantages:
  • the treatment unit When using the cryo-lipolysis treatment assembly for cryo-lipolysis, the treatment unit is positioned on the first membrane, and then the external suction mechanism is turned on to generate negative pressure in the negative pressure channel, so that As soon as the first film is adsorbed on the treatment unit, at the same time, since a plurality of first through holes are opened on the first film, the first through holes are used as negative pressure channels to prevent freezing on the skin. Both the agent and the skin can be adsorbed, on the one hand, the risk of the treatment unit falling off is avoided, on the other hand, the antifreeze agent is closely attached to the first film, so that the air bubbles between the two are discharged, and the heat conduction efficiency is improved.
  • the treatment unit includes a body and a second membrane
  • the body includes a vacuum handle and a contour adapter head
  • one end of the vacuum handle is used for connecting with the suction mechanism and the freezing source, and the other end is connected with the a profile fitting head is connected
  • the profile fitting head is used for contact with the first membrane and part of the antifreeze
  • the second membrane is disposed between the vacuum handle and the profile fitting head, and
  • the second film is configured to deform when subjected to a tensile force, and maintain the deformation after the tensile force is removed
  • the treatment unit is configured to be adsorbed on the second film under the action of negative pressure.
  • a second through hole communicated with the negative pressure channel is opened on the second film.
  • a second membrane is provided to reduce direct contact of the antifreeze with the vacuum handle of the treatment unit, facilitating cleaning of the vacuum handle.
  • the viscosity of the antifreeze is greater than or equal to 5000cp, preferably 5000cp-10000cp.
  • the antifreeze further includes a pH buffer for maintaining the pH of the antifreeze at 6.5-7.5 (pH at normal temperature). The antifreeze can effectively reduce the freezing point of the skin, and has better activation on the skin surface to avoid flowing and gathering on the skin surface.
  • FIG. 1 is a schematic diagram of the cryo-lipolysis treatment component provided by the present invention according to an embodiment of the present invention during fat-dissolving in a target area;
  • FIG. 3 is a schematic structural diagram of a treatment unit of a cryolipolysis treatment component provided by the present invention according to an embodiment
  • FIG. 4 is a schematic structural diagram of a first film of a cryolipolysis treatment component provided by the present invention according to an embodiment
  • FIG. 5 is a schematic structural diagram of the first film of the cryolipolysis treatment component provided by the present invention according to another embodiment
  • 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.
  • the core idea of the present invention is to provide a cryo-lipolysis treatment component, the cryo-lipolysis treatment component includes a treatment unit, an antifreeze agent and a first film.
  • the treatment unit is used to receive the cold energy provided by an external mechanism, and transfer the cold energy to the target area of the human body for cryo-lipolysis;
  • the treatment unit is also provided with a negative pressure channel, and the negative pressure channel is provided on the treatment unit.
  • the pressure channel is used for connecting with an external suction mechanism to generate negative pressure in the negative pressure channel.
  • the antifreeze is used for coating on the target area, and the viscosity of the antifreeze is not less than 5000cp.
  • the first film is used to cover the antifreeze, and the first film is provided with a plurality of first through holes.
  • the cryo-lipolysis treatment assembly is configured so that when the treatment unit is positioned on the first membrane and negative pressure is generated in the negative pressure cavity, the first membrane is adsorbed on the treatment unit, and simultaneously The antifreeze partially overflows from the first through hole to contact the treatment unit.
  • the treatment unit can be firmly adsorbed on the target area to avoid falling off.
  • the antifreeze is in close contact with the first film, and there are no air bubbles between them, thereby enhancing heat conduction.
  • part of the antifreeze is squeezed and overflows from the first through hole to contact the treatment unit, which reduces the interfacial tension of the antifreeze on the side close to the skin, and also increases the distance of the antifreeze away from the skin.
  • the wetting tension on one side can reduce the fluidity of the antifreeze, combined with the antifreeze with a viscosity of not less than 5000cp, so that the antifreeze will not be affected by the negative pressure and flow on the skin surface, thereby avoiding the localization of the target area.
  • the skin surface is not covered with antifreeze, reducing the probability of frostbite events.
  • Fig. 1 shows a schematic diagram of the cryo-lipolysis treatment component provided by the embodiment of the present invention performing fat-dissolving in a target area of the human body
  • Fig. 2 shows the cryo-lipolysis treatment device provided by the embodiment of the present invention performing fat-dissolving in the target area of the human body The overall schematic diagram of lipolysis.
  • the cryo-lipolysis treatment assembly includes a treatment unit 100 , an antifreeze agent 200 and a first film 300 .
  • the treatment unit 100 is used for receiving externally provided cooling energy and transferring the cooling energy to the target area for cryo-lipolysis.
  • the treatment unit 100 is also provided with a negative pressure channel (not shown in the figure), and the negative pressure channel is used for connecting with an external suction mechanism to generate negative pressure in the negative pressure channel.
  • the antifreeze 200 is used for coating on the target area, and the viscosity of the antifreeze 200 is not less than 5000cp.
  • the first film 300 is used to cover the antifreeze 200 to facilitate the penetration of the antifreeze 200 , and a plurality of first through holes 310 are provided on the first film 300 .
  • a layer of antifreeze 200 is applied on the target area of the patient's body, and the amount of the antifreeze is usually about 20ml.
  • the first film 300 is covered on the antifreeze 200 , and care should be taken to smooth the first film 300 when covering, so as to remove air bubbles between the first film 300 and the antifreeze 200 as much as possible.
  • the treatment unit 100 is placed on the first membrane 300, and the suction mechanism is turned on, so as to generate a negative pressure in the negative pressure channel to adsorb the first membrane 300 to the treatment unit 100 on.
  • the first film 300 is also provided with a first through hole 310, the first through hole 310 is used as a negative pressure channel, so that the antifreeze 200 and the skin of the target area are both adsorbed by negative pressure and face the negative pressure.
  • the treatment unit 100 moves or has a tendency to move towards the treatment unit 100 . In this way, not only can the treatment unit 100 be firmly positioned in the target area to avoid falling off, but also the air bubbles between the antifreeze 200 and the first film 300 can be discharged to make the two closely contact, which is beneficial to Improve heat conduction and improve treatment effect.
  • the antifreeze 200 is squeezed to partially overflow from the first through hole 310 and contact the treatment unit 100, so as to reduce the interfacial tension of the antifreeze 200 near the skin and increase the The effect of the wetting tension on the side of the antifreeze away from the skin is increased, thereby reducing the fluidity of the antifreeze 200 .
  • the antifreeze 200 when the antifreeze 200 with a viscosity of more than 5000 cp is used, the antifreeze 200 can be effectively prevented from flowing on the skin surface due to the influence of negative pressure, and the local skin of the target area caused by the flow and accumulation of the antifreeze 200 can be avoided.
  • Antifreeze 200 covers the situation, reduces the probability of frostbite accidents, and improves the safety of treatment.
  • the high-viscosity antifreeze 200 also has strong adhesion to the skin of the target area, which enhances the thermal contact between the treatment unit 100 and the skin, and further improves the heat conduction efficiency.
  • the shape of the first film 300 may be the same as or different from the shape of the target area, but the area of the first film 300 should be larger than that of the target area, so that the first film 300 can completely cover the coating Antifreeze 200 in the target area.
  • the distance between the edge of the first film 300 and the edge of the target area can be greater than or equal to 5 cm, so as to prevent the first film 300 from shifting under the suction of negative pressure and deviating from the target area, reducing Risk of frostbite in the target area.
  • the treatment unit 100 in this embodiment may include a main body 110 , and the main body 110 may have the same structure as the treatment unit of the cryolipolysis treatment device in the prior art.
  • the body 110 includes a vacuum handle 111 and a contour fitting head 112 .
  • One end of the vacuum handle 111 is used to connect with the suction device and the freezing source of the host 20, and the other end is detachably connected to the contour adapter head 112 by means of snaps or threads, and preferably the vacuum
  • a sealing ring (not shown in FIG. 2 and FIG. 3 ) is also provided at the connection between the handle 111 and the profile fitting head 112 to improve the sealing performance and reduce leakage.
  • the middle area of the contour fitting head 112 is closer to the vacuum exhaust port of the vacuum handle 111 .
  • the reason for this arrangement is that the first array area is closer to the vacuum exhaust port, so that the antifreeze 200 in the first array area is easier to be evacuated by negative pressure. Therefore, the arrangement density and aperture in the first array area are higher.
  • the small first sub-through hole 311 helps to prevent this part of the antifreeze 200 from flowing to the vacuum exhaust port.
  • the large number of first sub-through holes 311 in the first array region also helps to disperse the pressure, so that the treatment unit 100 can be more closely attached to the target region, and the heat conduction efficiency is improved.
  • the arrangement density of the first sub-through holes 311 is greater than the arrangement density of the second sub-through holes 312 , and the diameter of the first sub-through holes 311 is the same as the second sub-through hole 312 . , or the diameter of the first sub-through holes 311 is smaller than the diameter of the second sub-through holes 312 and the arrangement density of the first sub-through holes 311 is equal to the arrangement density of the second sub-through holes 312 Similar effects can also be achieved.
  • the diameters of the first sub-through holes 311 and the second sub-through holes 312 are selected in the range of 2 mm to 5 mm, preferably, the diameter of the first sub-through holes 311 is about 3 mm.
  • the diameter of the second through holes 312 is 5 mm.
  • the distance between two adjacent first sub-through holes 311 is about 1 mm-5 mm, preferably 1 mm-2 mm.
  • the distance between two adjacent second through-holes 312 is about 1mm-5mm, preferably 1mm-2mm.
  • the first through holes 310 on the first thin film 300 may also adopt other distribution methods, for example, in an alternative embodiment, as shown in FIG.
  • the diameters of the through holes 310 are equal, and a plurality of the first through holes 310 are evenly distributed on the first film 300 .
  • the diameter of the first through holes 310 is 2mm-5mm, such as 2mm, 3mm, 4mm, 5mm, etc., and the distance between two adjacent first through holes 310 is 1mm-5mm.
  • the first film 300 is an elastic plastic film to avoid tearing damage under the action of negative pressure.
  • the material of the first film 300 is selected from any one of PE (polyethylene), PU (polyurethane), PET (polyester resin), PVC (polyvinyl chloride) and EVA (ethylene-vinyl acetate copolymer).
  • the thickness of the first film 300 may be 30 ⁇ m-100 ⁇ m.
  • the viscosity of the antifreeze 200 used in the embodiment of the present invention is greater than or equal to 5000cp, preferably 5000cp-10000cp.
  • the antifreeze includes propylene glycol, distilled water, hydroxyethyl cellulose, soluble sugar, lecithin.
  • the consumption of propylene glycol in the antifreeze agent is 40%-61%
  • the consumption of distilled water is 36%-57%
  • the consumption of hydroxyethyl cellulose is 1%-2%
  • the consumption of soluble sugar is 0.5%.
  • %-1% the dosage of lecithin is 0.5%-2%.
  • the consumption of propylene glycol is 49%
  • the consumption of distilled water is 48%
  • the consumption of hydroxyethyl cellulose is 1%
  • the consumption of soluble sugar is 1%
  • the consumption of lecithin is 1%.
  • the antifreeze agent further includes a pH buffer for maintaining the pH of the antifreeze agent at 6.5-7.5 (pH at normal temperature). The antifreeze can effectively reduce the freezing point of the skin, and has better activation on the skin surface to avoid flowing and gathering on the skin surface.
  • the preparation method of the antifreeze is as follows: propylene glycol, distilled water, hydroxyethyl cellulose, soluble sugar and lecithin are weighed according to the proportions, and each component is added into a reaction vessel. Add pH buffer to the reaction vessel to adjust the pH to 6.5-7.5. The material in the reaction vessel was stirred at 37° C. until the viscosity of the liquid substance in the reaction vessel reached a predetermined value (ie, any value between 5000cp-10000cp).
  • a mechanical stirring device can be used to stir the reaction material, the stirring speed is 120r/min, and the stirring time is at least 4h.
  • the treatment unit 100 further includes a second film 120 , the second film 120 is detachably disposed on the vacuum handle 111 on the main body 110 , and is located between the vacuum handle 111 and the vacuum handle 111 .
  • the contours fit between the heads 112 .
  • the side of the vacuum handle 111 facing the contour adapting head 112 has a contact surface, and the second film 120 covers the contact surface.
  • the second film 120 is configured to deform when subjected to a stretching force, and maintain the deformation after the stretching force is removed, that is, the second film 120 has a smaller restoring force after the deformation.
  • the second film 120 is firstly disposed between the vacuum handle 111 and the contour adapter head 112, then the treatment unit 100 is connected to the main unit 20, and the The suction mechanism generates negative pressure in the vacuum handle 111 (a part of the negative pressure cavity), under the action of the negative pressure, the second film 120 is stretched and deformed and adsorbed on the vacuum handle 111.
  • a needle or other mechanism is used to open a second through hole 121 on the second film 120 to serve as a negative pressure channel.
  • the adsorption force received by the second film 120 becomes smaller, but since the deformation recovery ability of the second film 120 is extremely small, it maintains the deformation generated when the second film 120 is adsorbed by negative pressure, so the second film 120 is still Adhere closely to the contact surface of the vacuum handle 111 .
  • the material of the second film 120 may be Parafilm.
  • the edge of the second film 120 is connected to the sealing ring 113 .
  • the advantage of this arrangement is that when the vacuum handle 111 and the contour adapter head 112 are assembled, the Putting the second film 120 on the vacuum handle 111 is convenient for use.
  • the sealing ring 113 and the second film 120 may be integrally formed by injection molding, and may also be integrally connected by bonding, crimping, crimping or any other suitable manner.
  • the cryo-lipolysis treatment device provided by the embodiment of the present invention includes the aforementioned cryo-lipolysis treatment component and the host 20 , the host 20 includes a suction device and a freezing source, and the suction The device communicates with the negative pressure channel of the treatment unit 100 to generate negative pressure in the negative pressure channel; the freezing source is connected to the treatment unit 100 to provide cooling to the treatment unit 100 .
  • This embodiment does not limit the connection between the host 20 and the treatment unit 100.
  • the host 20 and the treatment unit 100 are fixedly connected (that is, the two are integrated into one structure), or they may be detachably connected (that is, the two are split structures).
  • this embodiment does not limit the number of the treatment units 100, that is, at least one of the treatment units 100 can be connected to each of the host 20 at the same time, such as one, two, three, etc., so as to It is used to perform cryolipolysis on multiple target areas of the patient at the same time.
  • the embodiment of the present invention also provides an antifreeze, the viscosity of the antifreeze is not less than 5000cp.
  • the viscosity of the antifreeze is 5000cp-10000cp, and the freezing point is less than or equal to -15°C.
  • the antifreeze includes propylene glycol, distilled water, hydroxyethyl cellulose, soluble sugar, lecithin and other components, further, the antifreeze also includes a pH buffer to maintain the pH of the antifreeze at within the range of 6.5-7.5.
  • the amount of propylene glycol is 40%-61%, the amount of distilled water is 36%-57%, the amount of hydroxyethyl cellulose is 1%-2%, the amount of soluble sugar is 1%-2% by weight percentage.
  • the dosage is 0.5%-1%, and the dosage of lecithin is 0.5%-2%.
  • the amount of propylene glycol is 49%, the amount of distilled water is 48%, the amount of hydroxyethyl cellulose is 1%, the amount of soluble sugar is 1%, and the amount of lecithin is 1%.
  • the preparation method of described antifreeze is as follows: take each component material (i.e. propylene glycol, distilled water, hydroxyethyl cellulose, soluble sugar and lecithin) by proportioning; all components are added in the container to form mixture; the pH of the mixture is adjusted is 6.5-7.5; the mixture is stirred for 4h-6h until the viscosity of the mixture reaches 5000cp-10000cp.
  • the mixture is stirred by means of mechanical stirring, and the speed of mechanical stirring is 120 r/min.

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Abstract

本发明提供了一种冷冻溶脂治疗组件、装置及防冻剂，所述冷冻溶脂治疗组件包括：治疗单元，用于与目标区域热交换以进行冷冻溶脂；所述治疗单元设置有负压腔道，所述负压腔道用于与外部的抽吸机构连接，以在所述负压腔道内产生负压；防冻剂，用于涂覆在所述目标区域，所述防冻剂的黏度不小于5000cp；第一薄膜，用于覆盖在所述防冻剂上，且所述第一薄膜上设置有第一通孔；所述冷冻溶脂治疗组件被配置为当所述治疗单元定位于所述第一薄膜上，且所述负压腔道内产生负压时，所述第一薄膜吸附在所述治疗单元上，同时所述防冻剂部分地从所述第一通孔溢出而与所述治疗单元接触。该冷冻溶脂治疗组件的冷冻效果好，且避免了防冻剂到处流淌，提高使用体验感。

Description

一种冷冻溶脂治疗组件、装置及防冻剂 技术领域
本发明涉及医疗器械技术领域，具体涉及基于致冷技术的医疗装置及其组件，以及用于医疗领域的防冻剂。
背景技术
肥胖的发生机制是因为能量摄入超过能量消耗，导致体内脂肪过度蓄积和体重超标。身体局部脂肪的堆积不仅会破坏人的外貌和运动能力，甚至会显著增加健康风险，引起心脑血管疾病、糖尿病、高血压和某些癌症，因此有必要采取一些手段来控制或消除过多的脂肪。
现有的减脂技术包括有创伤减脂和无创伤减脂，其中有创伤减脂包括抽脂，无创伤减脂包括激光溶脂、超声溶脂、射频溶脂、冷冻溶脂等。相比于有创伤减脂，无创伤减脂更受爱美者的青睐，其中冷冻溶脂利用人体富脂细胞比非富脂细胞对低温的耐受性差的特性，通过将冷量持续作用于皮肤表面，使皮下脂肪层的温度降低至脂肪细胞触发程序性死亡，之后随人体代谢排出体外以达到减脂目的。
在进行冷冻溶脂时，需要在皮肤表面涂抹防冻液或防冻膜，以避免溶脂过程中用于进行热交换的治疗手柄与皮肤表面热接触不良，或者低温造成皮肤组织发生冻结事件。现有技术中的一种处理方法是在皮肤表面涂抹防冻剂，再用薄膜覆盖在防冻剂上以加速防冻剂的渗透。该方式一方面容易出现治疗头真空失效或滑动脱落的风险，另一方面在治疗头的负压下薄膜与防冻剂不能充分粘合而使得两者之间存在气泡，影响热传导，降低溶脂效果。现有技术中的另一种处理方法是提供一种预加载防冻剂的吸附材料或联结装置，在溶脂前将该吸附材料或联结装置施加在目标区域的皮肤上，并定位在治疗头附件，然后治疗头吸附并进行冷冻溶脂。该方法存在的缺点在于当吸附材料上承载的防冻剂较多时，防冻剂无法完全被吸附材料固定，其覆盖在皮肤表面时，防冻剂滴答乱流，降低使用者的体验感。
发明内容
本发明的目的在于提供一种冷冻溶脂治疗组件、装置及防冻剂，其可使冷冻剂均匀分布于目标区域的皮肤表面，一方面避免冷冻剂流动而导致皮肤表面出现未被冷冻剂覆盖的区域，另一方面还可排出冷冻剂中的气泡，改善热传导效率。
为实现上述目的，本发明提供了一种冷冻溶脂治疗组件，包括：
治疗单元，用于接受外部机构提供的冷量，并将所述冷量传递至目标区域以进行冷冻溶脂；所述治疗单元上还设置有负压腔道，所述负压腔道用于与外部的抽吸机构连接，以在所述负压腔道内产生负压；
防冻剂，用于涂覆在所述目标区域，所述防冻剂的黏度不小于5000cp；
第一薄膜，用于覆盖在所述防冻剂上，且所述第一薄膜上设置有多个第一通孔；
所述冷冻溶脂治疗组件被配置为当所述治疗单元定位于所述第一薄膜上，且所述负压腔道内产生负压时，所述第一薄膜吸附在所述治疗单元上，同时所述防冻剂部分地从所述第一通孔溢出而与所述治疗单元接触。
可选地，所述第一薄膜包括第一阵列区和第二阵列区，所述第二阵列区环绕所述第一阵列区设置；
所述第一通孔包括多个第一子通孔和多个第二子通孔，多个所述第一子通孔均布在所述第一阵列区上，多个所述第二子通孔均布在所述第二阵列区上；
所述第一子通孔的分布密度大于所述第二子通孔的分布密度，和/或，所述第一子通孔的孔径小于所述第二子通孔的孔径。
可选地，多个所述第一通孔的孔径相等，且多个所述第一通孔均匀地分布在所述第一薄膜上。
可选地，所述第一薄膜的面积大于所述目标区域的面积，且所述第一薄膜的边缘与所述目标区域的边缘的距离大于或等于5cm。
可选地，所述第一薄膜的厚度为30μm-100μm，且所述第一通孔的孔径为2mm-5mm；和/或，相邻两个所述第一通孔之间的距离为1mm-5mm。
可选地，所述第一薄膜为弹性塑料膜，所述第一薄膜的材料为聚乙烯、 聚氨酯、涤纶树脂、聚氯乙烯及乙烯-乙酸乙烯共聚物中的任一种。
可选地，所述治疗单元包括本体和设置在所述本体上的第二薄膜，所述本体包括真空手柄和轮廓适配头，所述真空手柄的一端用于与所述抽吸机构及冷冻源连接，另一端与所述轮廓适配头连接；所述轮廓适配头用于与所述第一薄膜及部分所述防冻剂接触；
所述第二薄膜设置在所述真空手柄与轮廓适配头之间，且被配置为在受到拉伸力时发生形变，并在取消拉伸力后保持形变；
所述治疗单元被配置为当所述第二薄膜在负压的作用下吸附在所述真空手柄上之后，在所述第二薄膜上开设与所述负压腔道相连通的多个第二通孔。
可选地，还包括密封圈，设置在所述真空手柄与所述轮廓适配头之间，且所述第二薄膜与所述密封圈固定连接。
可选地，所述第二薄膜为Parafilm封口膜。
可选地，所述防冻剂的黏度为5000cp-10000cp，冰点小于或等于-15℃。
可选地，所述防冻剂包括如下组分：丙二醇、蒸馏水、羟乙基纤维素、可溶性糖及卵磷脂。
可选地，以重量百分数计，所述防冻剂中包括40％-61％的丙二醇、36％-57％的蒸馏水、1％-2％的羟乙基纤维素、0.5％-1％的可溶性糖及0.5％-2％的卵磷脂。
可选地，所述防冻剂的PH为6.5-7.5。
为实现上述目的，本发明还提供了一种冷冻溶脂治疗装置，包括如前任一项所述的冷冻溶脂治疗组件和主机；所述主机包括抽吸机构和冷冻源；所述抽吸机构用于与所述治疗单元的负压腔道连接，以在所述负压腔道内产生负压；所述冷冻源与所述治疗单元连接，用于向所述治疗单元提供冷量。
为实现上述目的，本发明还提供了一种防冻剂，所述防冻剂的黏度不小于5000cp。
可选地，所述防冻剂的黏度为5000cp-10000cp，冰点小于或等于-15℃。
可选地，所述防冻剂包括如下组分：丙二醇、蒸馏水、羟乙基纤维素、可溶性糖及卵磷脂。
可选地，以重量百分数计，所述防冻剂中包括40％-61％的丙二醇、 36％-57％的蒸馏水、1％-2％的羟乙基纤维素、0.5％-1％的可溶性糖及0.5％-2％的卵磷脂。
可选地，所述防冻剂的PH为6.5-7.5。
与现有技术相比，本发明的冷冻溶脂治疗组件、装置及防冻剂具有如下优点：
第一、前述的冷冻溶脂治疗组件包括治疗单元、防冻剂和第一薄膜，其中所述治疗单元用于接受外部机构提供的冷量，并将冷量传递至目标区域以进行冷冻溶脂，所述治疗单元上设置有负压腔道，所述负压腔道用于与外部的抽吸机构连接，以在所述负压腔道内产生负压；所述防冻剂用于涂覆在所述目标区域，且所述防冻剂的黏度不小于5000cp；所述第一薄膜用于覆盖在所述防冻剂上，且所述第一薄膜上设置有多个第一通孔。在采用所述冷冻溶脂治疗组件进行冷冻溶脂时，将所述治疗单元定位在所述第一薄膜上，然后开启外部的抽吸机构，以使所述负压腔道内产生负压，这样一来所述第一薄膜便被吸附在所述治疗单元上，同时由于所述第一薄膜上开设有多个第一通孔，所述第一通孔作为负压通道，使得皮肤上的防冻剂及皮肤均可被吸附，一方面避免了治疗单元脱落的风险，另一方面使得防冻剂与第一薄膜紧密贴合，使得两者之间的气泡被排出，提高热传导效率，再一方面所述防冻剂被挤压而从所述第一通孔处溢出，并与所述治疗单元接触，使得防冻剂靠近皮肤一侧的界面张力减小，且防冻剂背离皮肤一侧的润湿张力增大，从而降低防冻剂在皮肤表面的流动性，并结合黏度合适的防冻剂可有效阻止防冻剂在皮肤表面流动聚集而出现部分皮肤未被防冻剂覆盖的情形，从而避免发生冻伤事件。
第二、所述治疗单元包括本体和第二薄膜，所述本体包括真空手柄和轮廓适配头，所述真空手柄的一端用于与所述抽吸机构及冷冻源连接，另一端与所述轮廓适配头连接；所述轮廓适配头用于与所述第一薄膜及部分所述防冻剂接触；所述第二薄膜设置在所述真空手柄与所述轮廓适配头之间，且所述第二薄膜被配置为在受到拉伸力时发生形变，而在取消拉伸力后保持形变；所述治疗单元被配置为当所述第二薄膜在负压的作用下吸附在所述真空手柄上之后，在所述第二薄膜上开设与所述负压腔道相连通的第二通孔。设置第 二薄膜以减少防冻剂与治疗单元的真空手柄的直接接触，方便对所述真空手柄进行清洁。
第三、所述防冻剂的黏度大于或等于5000cp，优选为5000cp-10000cp。所述防冻剂还包括PH缓冲剂，用于将所述防冻剂的PH维持在6.5-7.5(常温下的PH)。该防冻剂能够有效降低皮肤的冰点，且其在皮肤表面具有较好的活化性，避免在皮肤表面流淌聚集。
附图说明
附图用于更好地理解本发明，不构成对本发明的不当限定。其中：
图1是本发明根据一实施例所提供的冷冻溶脂治疗组件在目标区域进行溶脂时的示意图；
图2是本发明根据一实施例所提供的冷冻溶脂治疗装置在目标区域进行溶脂时的整体示意图；
图3是本发明根据一实施例所提供的冷冻溶脂治疗组件的治疗单元的结构示意图；
图4是本发明根据一实施例所提供的冷冻溶脂治疗组件的第一薄膜的结构示意图；
图5是本发明根据另一实施例所提供的冷冻溶脂治疗组件的第一薄膜的结构示意图；
图6是本发明根据一实施例所提供的冷冻溶脂治疗组件的第二薄膜与密封圈的连接关系示意图。
[附图标记说明如下]：
100-治疗单元；
110-本体；
111-真空手柄，112-轮廓适配头，113-密封圈；
120-第二薄膜，121-第二通孔；
200-防冻剂；
300-第一薄膜；
310-第一通孔；
311-第一子通孔，312-第二子通孔；
20-主机。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式，本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。需要说明的是，本实施例中所提供的图示仅以示意方式说明本发明的基本构想，遂图式中仅显示与本发明中有关的组件而非按照实际实施时的组件数目、形状及尺寸绘制，其实际实施时各组件的型态、数量及比例可为一种随意的改变，且其组件布局型态也可能更为复杂。
另外，以下说明内容的各个实施例分别具有一或多个技术特征，然此并不意味着使用本发明者必需同时实施任一实施例中的所有技术特征，或仅能分开实施不同实施例中的一部或全部技术特征。换句话说，在实施为可能的前提下，本领域技术人员可依据本发明的公开内容，并视设计规范或实作需求，选择性地实施任一实施例中部分或全部的技术特征，或者选择性地实施多个实施例中部分或全部的技术特征的组合，借此增加本发明实施时的弹性。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，复数形式“多个”包括两个以上的对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，以及术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接。可以是机械连接，也可以是电连接。可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。
本发明的核心思想在于提供一种冷冻溶脂治疗组件，所述冷冻溶脂治疗组件包括治疗单元、防冻剂和第一薄膜。其中，所述治疗单元用于接受外部 机构提供的冷量，并将所述冷量传递至人体的目标区域以进行冷冻溶脂；所述治疗单元上还设置有负压腔道，所述负压腔道用于与外部的抽吸机构连接，以在所述负压腔道内产生负压。所述防冻剂用于涂覆在所述目标区域，且所述防冻剂的黏度不小于5000cp。所述第一薄膜用于覆盖在所述防冻剂上，且所述第一薄膜上设置有多个第一通孔。所述冷冻溶脂治疗组件被配置为当所述治疗单元定位在所述第一薄膜上，且所述负压腔道内产生负压时，所述第一薄膜吸附在所述治疗单元上，同时所述防冻剂部分地从所述第一通孔溢出而与所述治疗单元接触。
通过在所述防冻剂上覆盖第一薄膜，并在所述第一薄膜上设置第一通孔，使得在进行冷冻溶脂的过程中，利用抽吸机构产生负压，所述第一通孔成为负压通道，一方面使得所述治疗单元牢牢地吸附在目标区域，避免脱落。另一方面使得所述防冻剂与所述第一薄膜紧密接触，两者之间无气泡，增强热传导。再一方面部分所述防冻剂被挤压并从所述第一通孔处溢出而与所述治疗单元接触，减小防冻剂靠近皮肤一侧的界面张力的同时，还增大防冻剂远离皮肤一侧的润湿张力，从而可降低防冻剂的流动性，结合黏性不小于5000cp的防冻剂，使得所述防冻剂不会受负压影响而在皮肤表面流淌，进而避免出现目标区域的局部皮肤表面未被防冻剂覆盖的情形，减少冻伤事件的发生概率。
本发明还提供了一种包括前述冷冻溶脂治疗组件的冷冻溶脂治疗装置，以及一种用于前述冷冻溶脂治疗组件的防冻剂。
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。附图中相同或相似的附图标记代表相同或相似的部件。
图1示出了本发明实施例提供的冷冻溶脂治疗组件在人体的目标区域进行溶脂时的示意图，图2示出了本发明实施例提供的冷冻溶脂治疗装置在人体的目标区域进行溶脂时的整体示意图。
请参考图1，所述冷冻溶脂治疗组件包括治疗单元100、防冻剂200和第一薄膜300。所述治疗单元100用于接受外部提供的冷量，并将所述冷量传递 至目标区域以进行冷冻溶脂。所述治疗单元100上还设置有负压腔道(图中未示出)，所述负压腔道用于与外部的抽吸机构连接，以在所述负压腔道中产生负压。所述防冻剂200用于涂覆在所述目标区域上，且所述防冻剂200的黏度不小于5000cp。所述第一薄膜300用于覆盖在所述防冻剂200上以促进所述防冻剂200的渗透，且所述第一薄膜300上设置有多个第一通孔310。
如图2所示，所述冷冻溶脂治疗组件的所述治疗单元100用于与一主机20连接。所述主机20包括冷冻源(图中未示出)和抽吸机构(图中未示出)，所述冷冻源用于与所述治疗单元100连接，以向所述治疗单元100提供冷量，所述抽吸机构用于与所述治疗单元100的所述负压腔道连通，用于在所述负压腔道内产生负压。
将所述治疗单元100与所述主机20连接后，在患者身体的目标区域上涂覆一层防冻剂200，防冻剂的用量通常可为20ml左右。然后将所述第一薄膜300覆盖在所述防冻剂200上，覆盖时注意抚平所述第一薄膜300，以尽可能地赶走第一薄膜300与所述防冻剂200之间的气泡。之后，将所治疗单元100放置在所述第一薄膜300上，开启所述抽吸机构，以使所述负压腔道内产生负压而将所述第一薄膜300被吸附至所述治疗单元100上。由于所述第一薄膜300上还设置有第一通孔310，该第一通孔310作为负压通道，使得所述防冻剂200及所述目标区域的皮肤皆受到负压吸附而朝向所述治疗单元100移动或具有朝向所述治疗单元100移动的趋势。如此，不仅可使得所述治疗单元100牢固地定位在所述目标区域，避免脱落，还可排出所述防冻剂200与所述第一薄膜300之间的气泡，使两者紧密接触，有利于提高热传导，改善治疗效果。此外，所述防冻剂200受到挤压而部分地从所述第一通孔310处溢出并与所述治疗单元100接触，达到减小所述防冻剂200靠近皮肤一侧的界面张力，并增大所述防冻剂远离皮肤一侧的润湿张力的效果，从而减小所述防冻剂200的流动性。特别地，在采用黏度在5000cp以上的防冻剂200时，可有效防止防冻剂200受负压影响而在皮肤表面流淌，避免出现因所述防冻剂200流动聚集造成的目标区域的局部皮肤未被防冻剂200覆盖情形，降低冻伤事故的发生概率，提高治疗的安全性。另外，高粘度的防冻剂200还与目标区域的皮肤具有较强的粘连性，增强所述治疗单元100与皮肤的热接触， 进一步提高热传导效率。
本领域技术人员可理解，所述防冻剂200的冰点可小于或等于-15°，以将足够低温的冷量传递至目标区域的皮下的富脂细胞，使得富脂细胞在低温下程序性死亡。本领域技术人员还可理解，所述目标区域是指人体中需要进行溶脂治疗的部位，例如腹部、腿部等。
所述第一薄膜300的形状可与所述目标区域的形状相同或不同，但所述第一薄膜300的面积应大于所述目标区域的面积，使得所述第一薄膜300可完全覆盖涂覆在所述目标区域的防冻剂200。较佳地，所述第一薄膜300的边缘与所述目标区域的边缘的距离可大于或等于5cm，避免所述第一薄膜300在负压的吸附下移位而偏离所述目标区域，降低目标区域的冻伤风险。
请继续参考图2并结合图3，本实施例中所述治疗单元100可包括本体110，所述本体110可与现有技术中冷冻溶脂治疗装置的治疗单元的结构相同。具体地，所述本体110包括真空手柄111和轮廓适配头112。所述真空手柄111的一端用于与所述主机20的抽吸装置及冷冻源连接，另一端通过卡扣或螺纹的方式与所述轮廓适配头112可拆卸地连接，且优选所述真空手柄111与所述轮廓适配头112的连接处还设置有密封圈(图2及图3中均未示出)，提高密封性，减少泄露。所述本体110中，所述轮廓适配头112的中间区域更靠近所述真空手柄111的真空排气口。
基于该结构的所述本体110，在一个优选的实施例中，如图4所示，所述第一薄膜300包括第一阵列区(图中未标注)和第二阵列区(图中未标注)，所述第二阵列区环绕所述第一阵列区设置。所述第一通孔310包括第一子通孔311和第二子通孔312，其中所述第一子通孔311均布在所述第一阵列区上，所述第二子通孔312均布在所述第二阵列区上。所述第一子通孔311的分布密度大于所述第二子通孔312的分布密度，且所述第一子通孔311的孔径小于所述第二子通孔312的孔径。这样设置是因为，所述第一阵列区更靠近真空排气口，使得处于第一阵列区处的防冻剂200更容易被负压抽走，因此在第一阵列区设置密度更大、孔径更小的第一子通孔311，有助于阻止这部分的防冻剂200向真空排气口流动。此外，第一阵列区的数量较多的第一子通孔311还有助于分散压力，使得所述治疗单元100与目标区域的贴合更为紧密， 提高热传导效率。在其他实施例中，所述第一子通孔311的设置密度大于所述第二子通孔312的设置密度，且所述第一子通孔311的孔径与所述第二子通孔312的孔径相等，或者所述第一子通孔311的孔径小于所述第二子通孔312的孔径且所述第一子通孔311的设置密度等于所述第二子通孔312的设置密度亦可达到近似的效果。
本实施例中，所述第一子通孔311和所述第二子通孔312的孔径在2mm-5mm范围内选择，优选所述第一子通孔311的孔径约为3mm，所述第二子通孔312的孔径为5mm。相邻两个所述第一子通孔311之间的间距约为1mm-5mm,优选为1mm-2mm。相邻两个所述第二子通孔312之间的间距约为1mm-5mm，优选为1mm-2mm。
本领域技术人员可理解，所述第一薄膜300上的第一通孔310也可采用其他的分布方式，例如在一个替代性的实施例中，如图5所示，多个所述第一通孔310的孔径相等，且多个所述第一通孔310均布在所述第一薄膜300上。可选地，所述第一通孔310的孔径为2mm-5mm，例如2mm、3mm、4mm、5mm等，相邻两个所述第一通孔310之间的间距为1mm-5mm.
可选地，所述第一薄膜300是弹性塑料膜，避免在负压作用下发生撕裂损伤。所述第一薄膜300的材质选自PE(聚乙烯)、PU(聚氨酯)、PET(涤纶树脂)、PVC(聚氯乙烯)及EVA(乙烯-乙酸乙烯共聚物)中的任意一种。所述第一薄膜300的厚度可为30μm-100μm。
进一步地，本发明实施例所使用的防冻剂200的黏度大于或等于5000cp，优选为5000cp-10000cp。在一个示范性的实施例中，所述防冻剂包括丙二醇、蒸馏水、羟乙基纤维素、可溶性糖、卵磷脂。以重量百分数计，所述防冻剂中丙二醇的用量为40％-61％、蒸馏水的用量为36％-57％、羟乙基纤维素的用量为1％-2％、可溶性糖的用量为0.5％-1％、卵磷脂的用量为0.5％-2％。在一个具体的实施例中，丙二醇的用量为49％、蒸馏水的用量为48％、羟乙基纤维素的用量为1％、可溶性糖的用量为1％、卵磷脂的用量为1％。进一步地，所述防冻剂还包括PH缓冲剂，用于将所述防冻剂的PH维持在6.5-7.5(常温下的PH)。该防冻剂能够有效降低皮肤的冰点，且其在皮肤表面具有较好的活化性，避免在皮肤表面流淌聚集。
所述防冻剂的制备方法如下：按照配比称取丙二醇、蒸馏水、羟乙基纤维素、可溶性糖和卵磷脂，并将各组分加入到反应容器中。向反应容器中添加PH缓冲剂，调节PH值为6.5-7.5。在37℃条件下搅拌反应容器内的物料，直至反应容器内的液体物质的黏度达到预定值(即5000cp-10000cp之间的任意值)。本实例中可采用机械搅拌装置对反应物料进行搅拌，搅拌速度为120r/min，搅拌时间至少4h。
进一步地，请参考图3，所述治疗单元100还包括第二薄膜120，所述第二薄膜120可拆卸地设置在所述本体110上的真空手柄111上，并位于所述真空手柄111与所述轮廓适配头112之间。具体来说，所述真空手柄111朝向所述轮廓适配头112的一侧具有一接触面，所述第二薄膜120覆盖在所述接触面上。所述第二薄膜120被配置为在受到拉伸力时发生形变，并在取消拉伸力后保持形变，也即所述第二薄膜120在形变之后的恢复力较小。这样一来，在组装所述治疗单元100时，先将第二薄膜120设置在所述真空手柄111与轮廓适配头112之间，然后将所述治疗单元100与所述主机20连接，开启抽吸机构在所述真空手柄111(所述负压腔道的一部分)中产生负压，在负压的作用下，所述第二薄膜120被拉伸变形并吸附于所述真空手柄111的接触面上，之后再利用针或其他机构在所述第二薄膜120上开设第二通孔121以作为负压通道。此时，所述第二薄膜120受到的吸附力变小，但由于第二薄膜120的形变恢复能力极小，其保持了受到负压吸附时所产生的形变，因而所述第二薄膜120仍紧密地粘附在所述真空手柄111的所述接触面上。最后再将所述轮廓适配头112连接到所述真空手柄111上。通过在所述真空手柄111上设置带有第二通孔121的第二薄膜120，减少所述防冻剂对所述真空手柄111的污染，缩短每次治疗结束后对所述真空手柄111的清洁时间，甚至于，当所述第二通孔121的孔径极小时，每次治疗结束仅需更换所述第二薄膜120，而无需对真空手柄111进行清洁。本实施例中，所述第二薄膜120的材质可为Parafilm封口膜。另外，本领域技术人员可理解，在保证气流可通过的情况下，所述第二通孔121的孔径越小越好，以尽可能地减少防冻剂从所述第二通孔121处渗透而粘附至所述真空手柄111上。
可选地，如图6所示，所述第二薄膜120的边缘与所述密封圈113连接， 这样设置的好处是在组装所述真空手柄111与所述轮廓适配头112时，就可将所述第二薄膜120套装在所述真空手柄111上，方便使用。本实施例中，所述密封圈113与所述第二薄膜120可通过注塑的方式一体成型，也可通过粘接、压接、压装或其他任何合适的方式连接为一体。
进一步地，如图2所示，本发明实施例提供的冷冻溶脂治疗装置包括前述的冷冻溶脂治疗组件和所述主机20，所述主机20包括抽吸装置和冷冻源，所述抽吸装置与所述治疗单元100的负压腔道连通，以在所述负压腔道内产生负压；所述冷冻源与所述治疗单元100，以向所述治疗单元100提供冷量。
本实施例对所述主机20与所述治疗单元100的连接方式不作限定，所述主机20与所述治疗单元100是固定连接(即两者为一体式结构)，也可以是可拆卸地连接(即两者为分体式结构)。此外，本实施例对所述治疗单元100的数量也不作限定，也就是说，每个所述主机20上可同时连接至少一个所述治疗单元100，例如一个、两个、三个等，以便于同时对患者的多个目标区域进行冷冻溶脂。
再进一步地，本发明实施例还提供了一种防冻剂，所述防冻剂的黏度不小于5000cp。优选所述防冻剂的黏度为5000cp-10000cp，冰点小于或等于-15℃。
可选地，所述防冻剂包括丙二醇、蒸馏水、羟乙基纤维素、可溶性糖、卵磷脂等组分，进一步地，所述防冻剂还包括PH缓冲剂以使所述防冻剂的PH维持在6.5-7.5的范围内。
优选地，以重量百分数计，所述防冻剂中，丙二醇的用量为40％-61％、蒸馏水的用量为36％-57％、羟乙基纤维素的用量为1％-2％、可溶性糖的用量为0.5％-1％、卵磷脂的用量为0.5％-2％。更优选地，丙二醇的用量为49％、蒸馏水的用量为48％、羟乙基纤维素的用量为1％、可溶性糖的用量为1％、卵磷脂的用量为1％。
所述防冻剂的制备方法如下：按配比称取各组分物质(即丙二醇、蒸馏水、羟乙基纤维素、可溶性糖及卵磷脂)；将所有组分加入容器中形成混合物；调节混合物的PH为6.5-7.5；搅拌所述混合物4h-6h，直至所述混合物的黏度达到5000cp-10000cp。优选采用机械搅拌的方式来搅拌混合物，机械搅拌的 速度为120r/min。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (19)

  1. 一种冷冻溶脂治疗组件，其特征在于，包括：
    治疗单元，用于接受外部机构提供的冷量，并将所述冷量传递至目标区域以进行冷冻溶脂；所述治疗单元上还设置有负压腔道，所述负压腔道用于与外部的抽吸机构连接，以在所述负压腔道内产生负压；
    防冻剂，用于涂覆在所述目标区域，所述防冻剂的黏度不小于5000cp；
    第一薄膜，用于覆盖在所述防冻剂上，且所述第一薄膜上设置有多个第一通孔；
    所述冷冻溶脂治疗组件被配置为当所述治疗单元定位于所述第一薄膜上，且所述负压腔道内产生负压时，所述第一薄膜吸附在所述治疗单元上，同时所述防冻剂部分地从所述第一通孔溢出而与所述治疗单元接触。
  2. 根据权利要求1所述的冷冻溶脂治疗组件，其特征在于，
    所述第一薄膜包括第一阵列区和第二阵列区，所述第二阵列区环绕所述第一阵列区设置；
    所述第一通孔包括多个第一子通孔和多个第二子通孔，多个所述第一子通孔均布在所述第一阵列区上，多个所述第二子通孔均布在所述第二阵列区上；
    所述第一子通孔的分布密度大于所述第二子通孔的分布密度，和/或，所述第一子通孔的孔径小于所述第二子通孔的孔径。
  3. 根据权利要求1所述的冷冻溶脂治疗组件，其特征在于，多个所述第一通孔的孔径相等，且多个所述第一通孔均匀地分布在所述第一薄膜上。
  4. 根据权利要求1所述的冷冻溶脂治疗组件，其特征在于，所述第一薄膜的面积大于所述目标区域的面积，且所述第一薄膜的边缘与所述目标区域的边缘的距离大于或等于5cm。
  5. 根据权利要求1-4中任一项所述的冷冻溶脂治疗组件，其特征在于，所述第一薄膜的厚度为30μm-100μm，且所述第一通孔的孔径为2mm-5mm；和/或，相邻两个所述第一通孔之间的距离为1mm-5mm。
  6. 根据权利要求1-4中任一项所述的冷冻溶脂治疗组件，其特征在于， 所述第一薄膜为弹性塑料膜，所述第一薄膜的材料为聚乙烯、聚氨酯、涤纶树脂、聚氯乙烯及乙烯-乙酸乙烯共聚物中的任一种。
  7. 根据权利要求1所述的冷冻溶脂治疗组件，其特征在于，所述治疗单元包括本体和设置在所述本体上的第二薄膜，所述本体包括真空手柄和轮廓适配头，所述真空手柄的一端用于与所述抽吸机构及冷冻源连接，另一端与所述轮廓适配头连接；所述轮廓适配头用于与所述第一薄膜及部分所述防冻剂接触；
    所述第二薄膜设置在所述真空手柄与所述轮廓适配头之间，且被配置为在受到拉伸力时发生形变，并在取消拉伸力后保持形变；
    所述治疗单元被配置为当所述第二薄膜在负压的作用下吸附在所述真空手柄上之后，在所述第二薄膜上开设与所述负压腔道相连通的多个第二通孔。
  8. 根据权利要求7所述的冷冻溶脂治疗组件，其特征在于，还包括密封圈，设置在所述真空手柄与所述轮廓适配头之间，且所述第二薄膜与所述密封圈固定连接。
  9. 根据权利要求7所述的冷冻溶脂治疗组件，其特征在于，所述第二薄膜为Parafilm封口膜。
  10. 根据权利要求1所述的冷冻溶脂治疗组件，其特征在于，所述防冻剂的黏度为5000cp-10000cp，冰点小于或等于-15℃。
  11. 根据权利要求10所述的冷冻溶脂治疗组件，其特征在于，所述防冻剂包括如下组分：丙二醇、蒸馏水、羟乙基纤维素、可溶性糖及卵磷脂。
  12. 根据权利要求11所述的冷冻溶脂治疗组件，其特征在于，以重量百分数计，所述防冻剂中包括40％-61％的丙二醇、36％-57％的蒸馏水、1％-2％的羟乙基纤维素、0.5％-1％的可溶性糖及0.5％-2％的卵磷脂。
  13. 根据权利要求10-12中任一项所述的冷冻溶脂治疗组件，其特征在于，所述防冻剂的PH为6.5-7.5。
  14. 一种冷冻溶脂治疗装置，其特征在于，包括如权利要求1-13中任一项所述的冷冻溶脂治疗组件和主机；所述主机包括抽吸机构和冷冻源；所述抽吸机构用于与所述治疗单元的负压腔道连接，以在所述负压腔道内产生负压；所述冷冻源与所述治疗单元连接，用于向所述治疗单元提供冷量。
  15. 一种防冻剂，其特征在于，所述防冻剂的黏度不小于5000cp。
  16. 根据权利要求15所述的防冻剂，其特征在于，所述防冻剂的黏度为5000cp-10000cp，冰点小于或等于-15℃。
  17. 根据权利要求16所述的防冻剂，其特征在于，所述防冻剂包括如下组分：丙二醇、蒸馏水、羟乙基纤维素、可溶性糖及卵磷脂。
  18. 根据权利要求17所述的防冻剂，其特征在于，以重量百分数计，所述防冻剂中包括40％-61％的丙二醇、36％-57％的蒸馏水、1％-2％的羟乙基纤维素、0.5％-1％的可溶性糖及0.5％-2％的卵磷脂。
  19. 根据权利要求15-18任一项所述的防冻剂，其特征在于，所述防冻剂的PH为6.5-7.5。
PCT/CN2021/101091 2020-07-30 2021-06-18 一种冷冻溶脂治疗组件、装置及防冻剂 WO2022022159A1 (zh)

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