CN113827545A - Antifreeze injection preparation assisting in frozen fat dissolution, liquid guide device, kit and frozen fat dissolution system - Google Patents
Antifreeze injection preparation assisting in frozen fat dissolution, liquid guide device, kit and frozen fat dissolution systemDownload PDFInfo
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- 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
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- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
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- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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- A—HUMAN NECESSITIES
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- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0061—Methods for using microneedles
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Abstract
Description
Technical Field
The invention relates to the technical field of frozen fat dissolving, in particular to an antifreeze injection preparation, a liquid guide device, a kit and a frozen fat dissolving system for assisting frozen fat dissolving.
Background
Frozen fat dissolving, also called frozen fat reduction, utilizes the characteristic that human fat-rich cells are more sensitive to low temperature than other non-fat-rich cells, and sends frozen fat to a designated fat reduction part through a non-invasive device, so that fat cells in the area are subjected to apoptosis under the action of cold stimulation and then are discharged through the metabolism of the organism, thereby achieving the purpose of fat reduction. Compared with other non-invasive fat reduction technologies, frozen fat dissolving is the most effective non-invasive fat reduction method, and the average fat reduction rate can reach 25%.
However, the mode of removing heat in subcutaneous tissues by freezing and fat dissolving is single, and skin tissues are challenged by lower temperature while the temperature of adipose tissues is reduced in the mode of transdermal cooling, so that the risk of skin frostbite is easy to occur, and no method capable of well preventing skin frostbite exists at present. Therefore, how to prevent skin frostbite in the process of freezing and dissolving fat becomes an important problem to be solved urgently by the freezing and dissolving fat equipment.
Disclosure of Invention
In view of the above, there is a need for an antifreeze injection preparation, a catheter, a kit and a frozen fat dissolving system for assisting frozen fat dissolving. The antifreeze injection preparation, the liquid guide device, the kit and the frozen fat dissolving system for assisting frozen fat dissolving can ensure the fat dissolving effect and simultaneously avoid the skin frostbite phenomenon.
An antifreeze injection for assisting in freezing and dissolving fat is provided, wherein the freezing point of the antifreeze injection is lower than-10 ℃, the viscosity of the antifreeze injection is 1-1000 cps at 20-40 ℃, and the pH is 6.5-7.5.
In one embodiment, the antifreeze injection formulation comprises an antifreeze agent selected from one or more of glycerol, propylene glycol, ethylene glycol, butylene glycol, polyethylene glycol, sucrose, trehalose, and dextran.
In one embodiment, the antifreeze injection preparation further comprises one or more of a humectant, a protein and a vitamin.
In one embodiment, the humectant is hyaluronic acid with the relative molecular mass of 2000D-10000D; and/or
The protein is human albumin; and/or
The vitamin is vitamin E.
A liquid guide device comprises a first substrate and a liquid guide part arranged on the first substrate, wherein the liquid guide part comprises a coating film and the antifreeze liquid injection preparation coated in the coating film.
In one embodiment, the liquid guiding portion is in a convex shape gradually reduced from one end close to the first substrate to one end far away from the first substrate.
In one embodiment, the number of the liquid guide parts is multiple, each liquid guide part is in a cone shape, the height of each liquid guide part is 1.5-2 mm, and the diameter of the bottom surface is 50-200 μm; the interval between two adjacent liquid guide parts is 500-1000 μm; the amount of the antifreeze injection preparation filled in each drainage part is 2 mu L/mm3～3μL/mm3。
In one embodiment, the biodegradable film is made of a material selected from the group consisting of: one or more of polylactic acid, maltose polymer, polyhydroxy acid, pharmaceutical gelatin, and starch.
The antifreeze solution injection preparation and the liquid guide device are applied to the preparation of a frozen fat dissolving kit or a frozen fat dissolving system.
A frozen fat dissolving kit comprises the antifreeze injection or the liquid guide.
In one embodiment, the frozen fat dissolving kit comprises the antifreeze injection preparation; and
the microneedle injector is provided with an introducing head, the introducing head comprises a second substrate and microneedles arranged on the second substrate in an array mode, the microneedles are hollow tubes, and the microneedles are provided with injection through holes.
In one embodiment, the introduction head further includes a regulating portion disposed on the second substrate, and the regulating portion is configured to regulate a length of the microneedle extending out of the second substrate.
In one embodiment, one end of the microneedle, which is far away from the substrate, is a closed end, and the through hole is opened in the side wall of the microneedle; and/or
The through hole is arranged at the end part of the microneedle, which is far away from the substrate.
A frozen lipolysis system comprising; injection device and frozen fat dissolving device
The injection device is used for introducing the antifreeze injection preparation into the pretreatment area;
the frozen fat dissolving device is used for carrying out frozen fat dissolving treatment on the pretreatment area introduced with the antifreeze injection preparation.
In one embodiment, the injection device is a microneedle injector or the above-mentioned liquid guide.
In one embodiment, the injection device is a microneedle injector, the microneedle injector comprises a second substrate and microneedles arranged on the second substrate in an array manner, the microneedles are hollow tubes, and the microneedles are provided with injection through holes.
A frozen fat dissolving method comprises the following steps:
introducing the antifreeze injection into a pretreatment region;
and performing frozen fat dissolving treatment on the pretreatment area introduced with the antifreeze injection preparation.
In one embodiment, in the step of introducing the antifreeze injection preparation, the introduced amount of the antifreeze injection preparation is 2 μ L/mm3～3μL/mm3The introduction rate is 10 to 25 mu L/min.
In one embodiment, the step of introducing the antifreeze solution injection preparation is performed by using an injection device, the injection device is the liquid guide device or a microneedle injector, the microneedle injector comprises a second substrate and microneedles arranged on the second substrate in an array manner, the microneedles are hollow tubes, and the microneedles are provided with injection through holes.
Has the advantages that:
the antifreeze solution injection can effectively reduce the skin freezing point, and can be directly introduced into the skin inner layer due to the injection preparation, so that the antifreeze solution injection can be spontaneously dispersed in the extracellular fluid of the dermis layer and the epidermis layer and is permeated and transferred with the intracellular part, when a frozen fat dissolving device is adopted for treatment, the skin freezing point can be further reduced, the fat dissolving effect is ensured, and the skin frostbite phenomenon is avoided.
Compared with a smearing agent, on one hand, the antifreeze injection overcomes the defect of limited penetration depth caused by the barrier effect of the stratum corneum, fully ensures that the antifreeze injection can be uniformly distributed in the skin layer of an area to be treated, reduces the freezing point of extracellular interstitial fluid and the intracellular water content at the same time, thereby reducing the freezing point of the whole skin layer and effectively avoiding the problem that the skin is frostbitten or equipment is failed due to skin freezing; on the other hand, the operation difficulty or complexity is reduced, and the problem of poor treatment effect caused by uneven artificial smearing is avoided.
In addition, after the skin layer is protected by directly introducing the antifreeze injection preparation, even deeper adipose tissues (now in the range of 1 cm) can be destroyed by lower treatment temperature than in the prior art, and the actual fat reduction rate and the user satisfaction are improved.
Drawings
FIG. 1 is a schematic view of an injection device according to an embodiment of the present invention;
FIG. 2 is a schematic view of an injection device according to another embodiment of the present invention;
FIG. 3 is a schematic view of an injection device according to another embodiment of the present invention;
FIG. 4 is a schematic view of a frozen fat dissolving device according to an embodiment of the present invention.
Detailed Description
In order that the invention may be more fully understood, a more particular description of the invention will now be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
According to the antifreeze injection preparation for assisting in freezing and dissolving fat, the freezing point of the antifreeze injection preparation is lower than-10 ℃, the viscosity of the antifreeze injection preparation is 1-1000 cps at 20-40 ℃, and the pH is 6.5-7.5.
In the research and development process of researchers, it is found that if the antifreeze or the antifreeze gel is directly coated by the coating agent or attached to the adsorption material and then placed on the skin by a loading method, the antifreeze or the antifreeze gel is difficult to truly prevent the skin from being frostbitten. The reason for this is that the fact whether the above method can actually work is mainly based on the permeability of the antifreeze in the skin, but due to the barrier effect of the stratum corneum of the skin, the antifreeze is difficult to completely permeate into the skin layer and reach the dermis layer, which is the layer with the highest water content in the skin layer and is most easily frostbitten. Even if the antifreeze with higher permeability is adopted, or the skin freezing point is reduced by methods such as removing the cuticle, massaging, ultrasonic stimulation and the like, the effect is not ideal, and the phenomena of skin frostbite, equipment failure and the like caused by skin freezing and the like can still occur for a high frequency; if the temperature of the treatment device is directly raised to avoid freezing of the skin, this method can seriously affect the fat-reducing effect.
Therefore, the research and development personnel of the invention innovatively adopt the antifreeze injection preparation to directly introduce the antifreeze injection preparation into the inner layer of the skin, so that the antifreeze injection preparation can be spontaneously dispersed in the extracellular fluid of the dermis layer and the epidermis layer and is permeated and transferred with the intracellular part, and when a frozen fat dissolving device is adopted for treatment, the antifreeze point of the skin can be effectively reduced, and the phenomenon of skin frostbite can be avoided. Compared with a smearing agent, the antifreeze injection is adopted, so that on one hand, the defect of limited penetration depth caused by the barrier effect of the stratum corneum is overcome, the antifreeze injection can be fully and uniformly distributed in the skin layer of an area to be treated, the intracellular water content is reduced while the freezing point of extracellular interstitial fluid is reduced, the freezing point of the whole skin layer is reduced, and the problems that the skin is frostbitten or the equipment is broken down due to skin freezing can be effectively avoided; on the other hand, the operation difficulty or complexity is reduced, and the problem of poor treatment effect caused by uneven artificial smearing is avoided. Furthermore, after the skin layer is protected by the antifreeze injection preparation, even deeper fat tissue (now in the range of 1 cm) can be destroyed by lower treatment temperature than in the prior art, and the actual fat reduction rate and customer satisfaction are improved.
It is understood that the antifreeze injection preparation of the present invention does not generate toxic irritation or has less toxic irritation, and can be used as an implantable medical agent after being approved by the relevant departments, for example, agents with toxic and irritation such as dimethyl sulfoxide, acetamide, etc., are understood to be excluded from the scope of alternative agents. Further, the antifreeze injection preparation comprises an antifreeze, preferably: one or more of glycerol, propylene glycol, ethylene glycol, butylene glycol, polyethylene glycol, sucrose, trehalose, and dextran. The agent has excellent biocompatibility, and can directly reduce the freezing point of aqueous solution in a skin layer or change the concentration of interstitial fluid of skin cells, thereby reducing the risk of freezing injury of the skin layer during low-temperature treatment.
The concentration of the antifreeze injection preparation of the present invention is not particularly limited, and the concentration may be controlled within the above range by merely controlling the freezing point, viscosity, and pH, and may be adjusted according to the requirements of specific reagents and frozen fat dissolving equipment, and all of them are understood to be within the scope of the present invention. It is understood that the solvent in the antifreeze solution injection preparation is acceptable solvent in the injection preparation, such as water and the like.
Further, the viscosity of the antifreeze injection is 1 to 1000cps at the temperature of between 20 and 40 ℃; furthermore, the viscosity of the antifreeze injection is 1-100 cps. Furthermore, the antifreeze injection comprises 25 to 30 percent (w/w) of glycerol solution; furthermore, the antifreeze injection comprises 40 to 45 percent (w/w) of propylene glycol solution; furthermore, the antifreeze injection comprises 40-45% (w/w) of propylene glycol solution and sucrose, wherein the mass percentage of the sucrose in the antifreeze injection is 0.2-0.5%; furthermore, the antifreeze injection preparation comprises 5-10% (w/w) of glycerol solution, 12-20% (w/w) of polyethylene glycol solution and trehalose, wherein the mass percentage of the trehalose in the antifreeze injection preparation is 0.1-0.2%, and the antifreeze injection preparation has a better antifreeze effect and less damage to cells.
Furthermore, the antifreeze injection preparation can also comprise one or more of a humectant, protein and vitamin, so as to enhance the nourishing effect of the antifreeze injection preparation on skin, protect skin tissues more effectively, and prevent or avoid the phenomena of dehydration, dryness, pigmentation, skin relaxation and the like of skin layers in or after treatment. Among them, the kind of the humectant is not particularly limited, and hyaluronic acid having a molecular weight of 2000D to 10000D is preferable, human albumin is preferable as the protein, and vitamin E is preferable as the vitamin.
As shown in FIGS. 1 to 3, the present invention also provides an injection device 10 for introducing the antifreeze injection preparation described above into a pretreatment area.
In an embodiment, as shown in fig. 1 to 2, the injection device is a microneedle injector, wherein themicroneedle injector 10a includes anintroduction head 100, theintroduction head 100 includes asecond substrate 110a andmicroneedles 121 arranged on thesecond substrate 110a in an array, themicroneedles 121 are hollow tubes, and themicroneedles 121 are provided with injection throughholes 1211. By introducing the antifreeze injection preparation by using themicroneedle 121, the antifreeze injection preparation can be efficiently introduced into a predetermined site, the uniformity of the distribution of the antifreeze injection preparation in the skin can be improved, and frostbite caused by lack of the antifreeze injection preparation in a local region can be avoided. In addition, themicro needles 121 have small wound, are convenient for users to use, and have high comfort.
Further, the total length of themicroneedles 121 is 1.5mm to 2mm, the diameter (inner diameter) of the microneedles is 200 μm to 500 μm, and the distance between two adjacent microneedles is about 500 μm to 1000 μm.
Further, an injection throughhole 1211 is opened at an end portion away from thesubstrate 110 a; further, the injection throughholes 1211 are opened at an end portion away from thesecond substrate 110a, and the ends of themicro needles 1211 are tapered to facilitate introduction of the coolant into a desired portion.
Further, as shown in fig. 2, there are a plurality of injection throughholes 1211, one end of the micro-needle 121 away from thesecond substrate 110a is a closed end, and the injection throughholes 1211 are opened on the side wall of the micro-needle 121, so as to improve the uniformity of spreading the antifreeze injection and improve the treatment effect. Further, the diameter of the injection throughhole 1211 opened on the sidewall is 50 μm to 200 μm, and a distance between two adjacent injection through holes is about 200 μm to 500 μm.
Further, as shown in fig. 1, theintroduction head 100 further includes a regulatingportion 130 disposed on thesecond substrate 110a for regulating the length of the microneedle protruding from thesecond substrate 110a so as to control the introduction site of the antifreeze injection preparation. Before the antifreeze injection preparation is introduced, the thickness of the skin layer of the treatment part is determined by means of ultrasound, CT and the like, then the regulatingpart 130 on the introducinghead 100 is regulated and controlled to preset the length of themicroneedle 121 inserted into the skin layer, so that the length of the part of themicroneedle 121 extending out of thesecond substrate 110a is just close to or equal to the thickness of the measured skin layer, and the treatment effect is improved.
Further, themicroneedle injector 10a further includes: aninjection tube 200 for containing the antifreeze injection preparation A and apush rod 300 for pushing the antifreeze injection preparation A, wherein theinjection tube 200 is inosculated with thesecond base 110a of the leading-inhead 100, so that the antifreeze injection preparation A in theinjection tube 200 enters themicroneedle 121 of the leading-inhead 100 under the action of thepush rod 300.
It can be understood that theintroducer head 100 and theinjection tube 200 cooperate with each other to form a closed cavity for containing the antifreeze injection preparation a, and the antifreeze injection preparation a can be introduced into themicroneedle 121 by the action of thepush rod 300. The connection between theintroducer head 100 and thesyringe 200 is not particularly limited, and a detachable connection such as a snap lock or a screw connection is preferably used to facilitate replacement of the introducer head. For example: the threads can be arranged on the periphery of thesubstrate 110a, the threads matched with the threads on the periphery of thesecond substrate 110a are arranged on the inner wall of one end of theinjection tube 200, and the leading-inhead 100 and theinjection tube 200 can be connected and detached by rotating, so that the operation difficulty is reduced, and the leading-inhead 100 is convenient to replace. The mode of disposing theplunger 300 is not particularly limited, and as shown in fig. 1 and 2, theplunger 300 may include astopper 310 and apusher 320, thestopper 310 being inserted into thesyringe 200, the periphery of thestopper 310 contacting the inner wall of thesyringe 200 and forming a cavity for containing the antifreeze injection preparation a together with theintroducer 100; the pushingpart 320 is connected with the blockingpart 310 to control the blockingpart 310 to slide along the inner wall of theinjection tube 200, thereby controlling the input and output of the antifreeze injection preparation A.
In one embodiment, as shown in fig. 3, the injection device is aliquid guide 10b, theliquid guide 10b includes afirst substrate 110b and aliquid guide 120 disposed on thefirst substrate 110b, theliquid guide 120 includes acoating film 122 and an antifreeze injection preparation a coated in thecoating film 122; wherein thecoating film 122 is a biodegradable film, the freezing point of the antifreeze injection A is lower than-10 ℃, the viscosity of the antifreeze injection A is 1-1000 cps at 20-40 ℃, and the pH value is 6.5-7.5.
Further, theliquid guiding part 120 is in a convex shape gradually tapering from one end close to thefirst base 110b to one end far away from thefirst base 110b, and guides the liquid
Thus, after theliquid guide 10b is injected into the pretreatment area, theouter seal film 122 is automatically degraded to release the coated antifreeze injection preparation a, so that the antifreeze injection preparation can be introduced into the pretreatment area and skin damage can be reduced.
The antifreeze injection preparation is as described above, and is not described herein again.
Further, the antifreeze injection preparation comprises an antifreeze, preferably: one or more of glycerol, propylene glycol, ethylene glycol, butylene glycol, polyethylene glycol, sucrose, trehalose, and dextran.
Further, the material forming the biodegradable film is selected from: polylactic acid (preferably in an amount greater than 90% starch), maltose polymer, polyhydroxy acid, pharmaceutical gelatin, and starch.
Further, the method for preparing theliquid guide 10b comprises the following steps: the degradable material is made into a film with a desired shape, then an antifreeze injection preparation is injected to form theliquid guide part 120, and then theliquid guide part 120 is integrated on thefirst substrate 110b by means of mold thermal injection. It will be appreciated that, during the hot injection molding process using the mold, the injection hole generated when the antifreeze injection preparation is injected is fused with thefirst substrate 110b, and thus a sealed film can be formed.
Further, eachliquid guide portion 120 is zigzag; further, each liquid guidingportion 120 is a cone; further, each liquid guide part has a height of 1.5 to 2mm, a bottom surface diameter of 50 to 200 μm, an interval between two adjacentliquid guide parts 120 is 500 to 1000 μm, and the antifreeze injection preparation is filled in eachliquid guide part 120 in an amount of 2 μ L/mm3～3μL/mm3。
It is understood that the material of the first substrate is not particularly limited, and an existing polymer film may be used, and thefirst substrate 110b may be a degradable material or a non-degradable material, and is not particularly limited herein. In addition, the shape and thickness of thefirst substrate 110b are not particularly limited, and it is preferable that the first substrate is a thin film having a thickness of 600 to 1000 μm for easy preparation.
The invention also provides application of the antifreeze injection preparation in preparation of a frozen fat dissolving kit or a frozen fat dissolving system. The invention also provides application of the injection device in preparation of a frozen fat dissolving kit or a frozen fat dissolving system. The antifreeze injection preparation and the injection device are as described above, and are not described in detail herein.
The invention also provides a frozen fat dissolving kit which comprises the antifreeze injection preparation or the liquid guide device. The invention also provides a frozen fat dissolving kit which comprises the antifreeze injection and the liquid guide device. Further, the frozen fat dissolving kit comprises the antifreeze solution injection preparation and also comprises a microneedle injector. The antifreeze injection preparation and the injection device (the liquid guide, the microneedle injector) are as described above, and are not described herein again.
The kit is prepared from the antifreeze injection and the injection device, so that an operator can conveniently use the kit in cooperation with a freezing and fat dissolving instrument. It is understood that the antifreeze solution injection preparation can be prepared into an injection preparation for direct use, and corresponding raw materials and solvents can also be placed in a kit and prepared before use, which is understood to be within the protection scope of the present invention. In addition, the quantity of the antifreeze injection preparation, the microneedle injector or the liquid guider in the kit is not particularly limited, and may be set according to actual conditions, which is not to be construed as a limitation to the present invention, for example, an introduction head having different microneedle arrangements or microneedle pore sizes may be configured to facilitate replacement according to actual conditions. And the kit can also comprise an agent for enhancing heat conduction (such as nano particles), an anesthetic (such as lidocaine), a skin repair product (such as skin cream), medical alcohol, an instruction for use and the like, so as to be convenient for a user to use.
The invention also provides a frozen fat dissolving system, which comprises an injection device 10 and a frozenfat dissolving device 20; an injection device 10 for introducing the antifreeze injection preparation into the pretreatment area; the frozenfat dissolving device 20 is used for performing frozen fat dissolving treatment on the pretreatment region into which the antifreeze injection preparation is introduced. Further, the injection device 10 is the injection device described above. The antifreeze injection preparation and the injection device are as described above, and are not described in detail herein.
The frozen fat dissolving device can adopt the existing frozen fat dissolving device, in one embodiment, as shown in fig. 4, the frozenfat dissolving device 20 comprises amain body 21, atreatment head 22 and apipeline 23 for connecting the main body and the treatment head, wherein the connection mode between themain body 21 and thepipeline 23 and the connection mode between thepipeline 23 and thetreatment head 22 are not particularly limited, the main body and the pipeline can be connected in an integrated mode, or the main body and the treatment head can be connected in a split mode, the purpose of fat reduction can be achieved by injecting the refrigerant into a pretreatment area firstly and then fixing the treatment head to the pretreatment area, and the energy for removing the heat of a fat layer is generated by the main body or the treatment head.
The invention also provides another frozen fat dissolving system which comprises a frozen fat dissolving kit and a frozen fat dissolving device, wherein the frozen fat dissolving kit and the frozen fat dissolving device are as described above and are not described in detail herein.
The invention also provides a method for freezing and dissolving fat, which comprises the following steps:
s101: introducing the antifreeze injection into a pretreatment region;
the antifreeze injection preparation is as described above, and is not described in detail herein.
Further, the antifreeze injection preparation is introduced by using the injection device. The specific introduction method may be selected according to the kind of the injection device.
In an embodiment, the injection device is amicroneedle injector 10a (specifically, as described above) as shown in fig. 1 and fig. 2, and the step S101 may include the following steps: theintroduction head 100 containing themicroneedles 121 is connected to theinjection tube 200 filled with the antifreeze injection preparation a, the length of the microneedles is adjusted, themicroneedles 121 are inserted (preferably, vertically inserted) into the pretreatment area, thepush rod 300 is slowly pushed to slowly introduce the antifreeze injection preparation a into the pretreatment area, and then the regulating and controllingpart 130 is adjusted to slowly withdraw themicroneedles 121. Further, the amount of antifreeze injection introduced was 2. mu.L/mm3～3μL/mm3The introduction rate is 10 to 25 mu L/min.
In one embodiment, the injection device is theliquid guide 10b (as described above) in fig. 3, and the step S101 may include the following steps: theliquid guide part 120 in the injection device is inserted into the pretreatment area through external force, and the injection device is placed for a period of time, the sealingfilm 122 formed by the degradable material is spontaneously degraded, and the coated antifreeze solution injection preparation A is released and flows out.
In one embodiment, the pretreatment area is the dermis layer;
in one embodiment, the pre-treated region is a skin layer of ex vivo tissue; in one embodiment, the pre-treated region is a dermal layer of ex vivo tissue;
in one embodiment, the pretreatment area is a skin layer of in vivo tissue; in one embodiment, the pretreatment area is a dermal layer of the body tissue.
And S102, treating the pretreatment area introduced with the anti-freezing liquid injection preparation by using a freezing fat dissolving device.
The processing in step S012 may be performed according to the specific type of the frozen fat dissolving device used, and is not particularly limited herein. The treatment head of the frozen liposoluble device is usually placed in a pretreatment area, and the device is started and treated at a preset temperature for a preset time. In one embodiment, the treatment temperature is between-20 ℃ and-10 ℃.
The freezing and fat dissolving method leads the antifreeze injection preparation into the pretreatment area directly, fully ensures that the antifreeze injection preparation can be uniformly distributed in the skin layer of the pretreatment area, obviously lowers the freezing point of the skin layer, and completely avoids the phenomena of frostbite of the skin, equipment failure caused by skin freezing and the like. In addition, the frozen fat dissolving method can damage deeper adipose tissues by adopting lower treatment temperature than that in the prior art, and effectively improves the actual fat reducing rate. The freezing fat dissolving method is simple to operate, special operation skills are not needed, and the application range can be effectively improved.
The present invention will be described below with reference to examples.
Example 1
Antifreeze injection preparation: 25 to 30 percent (w/w) of glycerol solution is prepared, 0.05g of hyaluronic acid with the molecular weight of 2000D to 10000D, 0.1ml of human albumin and 0.5 percent of vitamin E are added, the pH is adjusted to be within the range of 6.5 to 7.5, and the viscosity is adjusted to be within the range of about 10 to 500cps, so that the antifreeze injection preparation of the embodiment 1 is prepared.
An injection device: the injection device of the present embodiment is a microneedle injector 10a illustrated in fig. 1, specifically: the anti-freezing solution injection preparation A comprises an introduction head 100, an injection tube 200 and a push rod 300, wherein the injection tube 200 is in a hollow tube shape, the injection tube 200 is in threaded connection with the introduction head 100, the push rod 300 comprises a blocking part 310 and a pushing part 320, the blocking part 310 is embedded in the injection tube 200, the periphery of the blocking part 310 is in contact with the inner wall of the injection tube 200, a cavity for containing an anti-freezing solution injection preparation A is formed together with the introduction head 100, the introduction head 100 comprises a second substrate 110a and microneedles 121 arranged on the second substrate 110a in an array mode, the microneedles are hollow tubes provided with injection through holes (not shown), the injection through holes are formed in the end parts far away from the second substrate 110a, the total length of the microneedles 121 is 2mm, the diameter of the microneedles 121 is 250 μm, the distance between two adjacent microneedles 121 is about 800 μm, and a regulating part 130 is arranged on the second substrate 110a of the introduction head 100 to regulate the length of the microneedles 121 extending out of the second substrate 110 a.
The freezing fat dissolving method comprises the following steps:
(1) packaging the antifreeze solution injection preparation into theinjection tube 200 of the injection device 10;
(2) adjusting a regulatingpart 130 on the introducinghead 100, and pre-adjusting the length of the micro-needle 121 of the introducinghead 100 to ensure that the length of the micro-needle 121 exposed out of the introducing head is close to or equal to the thickness of the measured skin layer;
(3) the leading-inhead 100 is connected with theinjection tube 200, so that the upper end surface of the leading-inhead 100 is completely attached to the lower end surface of theinjection tube 200, no gap is ensured between the leading-inhead 100 and the injection tube, and the problems of insufficient injection amount or excessive injection amount of the antifreeze injection and the like are avoided;
(4) vertically inserting the microneedle injection device prepared in the step (3) into the pretreatment region, and enabling the lower end face of the leading-inhead 100 to be tightly attached to the skin surface of the pretreatment region of the treatment region;
(5) holding the injection tube by a hand, controlling thepush rod 300 by a thumb to enable the antifreeze solution injection A to slowly enter a skin layer, ensuring that the leading-in speed of the antifreeze solution injection A is 10-25 mu L/min, and simultaneously adjusting the regulatingpart 130 by the other hand to control the length of themicroneedle 121 to enable themicroneedle 121 inserted into the pretreatment area to gradually withdraw outwards until all the microneedles are withdrawn;
(6) the treatment head of the frozen fat dissolving device is placed in a pretreatment area for treatment.
Example 2
Antifreeze injection preparation: preparing 40 to 45 percent (w/w) propylene glycol solution, adding 0.2 to 0.5 percent of sucrose, 0.05g of hyaluronic acid with the molecular weight of 2000D to 10000D, 0.1ml of human albumin and 0.5 percent of vitamin E, adjusting the pH to be within the range of 6.5 to 7.5 and the viscosity to be within the range of 400 to 1000cps to obtain the antifreeze injection preparation of the embodiment 2
An injection device: the injection device of the present embodiment is a microneedle injector 10a illustrated in fig. 2, specifically: the anti-freezing injection device comprises an introducing head 100, an injection tube 200 and a push rod 300, wherein the injection tube 200 is in a hollow tube shape, the injection tube 200 is in threaded connection with the introducing head 100, the push rod 300 comprises a blocking part 310 and a pushing part 320, the blocking part 310 is embedded into the injection tube 200, the periphery of the blocking part 310 is in contact with the inner wall of the injection tube 200, a cavity for containing an anti-freezing injection preparation A is formed together with the introducing head 100, the introducing head 100 comprises a second substrate 110a and microneedles 121 arranged on the second substrate 110a in an array mode, the microneedles are hollow tubes provided with injection through holes 1211, the injection through holes 1211 are arranged on the side walls, the aperture of the injection through holes 1211 on the side walls is 100 micrometers, the distance between every two adjacent injection through holes 1211 is 300 micrometers, the total length of the microneedles 121 is 2mm, the diameter of the microneedles 121 is 250 micrometers, the distance between every two adjacent microneedles 121 is 800 micrometers, and a regulating part (not shown in the figure) is arranged on the second substrate 110a of the introducing head 100, to regulate the length of the microneedles 121 protruding from the second substrate 110 a.
The freezing fat dissolving method comprises the following steps:
(1) the antifreeze solution injection preparation is packaged in theinjection tube 200 of the injection device 10;
(2) adjusting a regulatingpart 130 on the introducinghead 100, and pre-adjusting the length of the micro-needle 121 of the introducinghead 100 to ensure that the length of the micro-needle 121 exposed out of the introducing head is close to or equal to the thickness of the measured skin layer;
(3) the leading-inhead 100 is connected with theinjection tube 200, so that the upper end surface of the leading-inhead 100 is completely attached to the lower end surface of theinjection tube 200, no gap is ensured between the leading-inhead 100 and the injection tube, and the problems of insufficient injection amount or excessive injection amount of the antifreeze injection and the like are avoided;
(4) vertically inserting the microneedle injection device prepared in the step (3) into a pretreatment area, slowly adjusting apush rod 300 to ensure that the introduction rate of the antifreeze injection is 10-25 mu L/min, and injecting the antifreeze injection in aninjection tube 200 into a skin layer through a porous microneedle, wherein when the introduction amount of the antifreeze injection is about 2 mu L/mm3～3μL/mm3When the injection is stopped, the micro-needle is pulled out to ensure that the lower end surface of the leading-in head is tightly attached to the pretreatment areaA skin surface of the area;
(5) the treatment head of the frozen fat dissolving device is placed in a pretreatment area for treatment.
Example 3
Antifreeze injection preparation: preparing 5-10% (w/w) of glycerol, 12-20% (w/w) of polyethylene glycol solution, adding 0.1-0.2% of trehalose, 0.05g of hyaluronic acid with the molecular weight of 2000D-10000D, 0.1ml of human albumin and 0.5% of vitamin E, adjusting the pH to be within the range of 6.5-7.5 and the viscosity to be within the range of 100-1000 cps to prepare the antifreeze injection preparation of the embodiment 3;
an injection device: theliquid guide apparatus 10b shown in fig. 3 is prepared by the following steps: aconical sealing film 122 is made of gelatin, the length of the sealingfilm 122 is about 1.8mm, the diameter of the bottom surface is about 100 mu m, and then the antifreeze injection A is poured into the sealingfilm 122 to form aliquid guide part 120; integrating theliquid guide part 120 on thefirst substrate 110b with a thickness of about 600-1000 μm by means of mold thermal injection;
the freezing fat dissolving method comprises the following steps:
(1) placing the liquid guide part 120 (i.e. theconical sealing film 122 coated with the antifreeze injection preparation A) in a pretreatment area, pressing by hand into the skin layer, wherein the film degrades spontaneously within 3-5min, and the coated antifreeze injection preparation flows out into the skin layer;
(2) after thesealing film 122 is completely dissolved, thefirst substrate 110b is removed and the treatment is started by placing the treatment head in this area.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (19)
1. An antifreeze injection for assisting in freezing and dissolving fat is characterized in that the antifreeze injection has a freezing point lower than-10 ℃, a viscosity of 1-1000 cps and a pH value of 6.5-7.5 at 20-40 ℃.
2. The antifreeze injection formulation of claim 1, wherein said antifreeze injection formulation comprises an antifreeze agent selected from one or more of glycerol, propylene glycol, ethylene glycol, butylene glycol, polyethylene glycol, sucrose, trehalose, and dextran.
3. The antifreeze injection formulation of claim 2, further comprising one or more of a humectant, a protein, and a vitamin.
4. The antifreeze injection according to claim 3, wherein said humectant is hyaluronic acid having a relative molecular mass of 2000D to 10000D; and/or
The protein is human albumin; and/or
The vitamin is vitamin E.
5. A liquid guide device, comprising a first substrate and a liquid guide part arranged on the first substrate, wherein the liquid guide part comprises a coating film and the antifreeze injection preparation according to any one of claims 1 to 4 coated in the coating film; wherein, the coating film is a biodegradable film.
6. The liquid guide device according to claim 5, wherein the liquid guide part is in a convex shape which is gradually reduced from one end close to the first base to one end far away from the first base.
7. The liquid guide device according to claim 6, wherein the liquid guide part is provided in a plurality of numbers, each liquid guide part is a cone, the height of each liquid guide part is 1.5 mm-2 mm, and the diameter of the bottom surface is 50 μm-200 μm; the interval between two adjacent liquid guide parts is 500-1000 μm; the amount of the antifreeze injection preparation filled in each drainage part is 2 mu L/mm3～3μL/mm3。
8. The liquid guide of claim 5, wherein the biodegradable film is made of a material selected from the group consisting of: one or more of polylactic acid, maltose polymer, polyhydroxy acid, pharmaceutical gelatin, and starch.
9. Use of the antifreeze injection preparation of any one of claims 1 to 4 and the liquid guide of any one of claims 5 to 8 in the preparation of a frozen liposoluble kit or in the preparation of a frozen liposoluble system.
10. A frozen liposoluble kit comprising the antifreeze injection preparation according to any one of claims 1 to 4 or the liquid guide according to any one of claims 5 to 8.
11. The frozen liposoluble kit according to claim 10, characterized in that it comprises the antifreeze injection preparation according to any one of claims 1 to 4; and
the microneedle injector is provided with an introducing head, the introducing head comprises a second substrate and microneedles arranged on the second substrate in an array mode, the microneedles are hollow tubes, and the microneedles are provided with injection through holes.
12. The frozen liposuction kit according to claim 11, wherein the introduction head further comprises a regulating part disposed on the second substrate, and the regulating part is configured to regulate a length of the microneedle protruding from the second substrate.
13. A frozen liposuction kit according to claim 12, wherein the end of the microneedle remote from the base is a closed end, and the through hole opens in the side wall of the microneedle; and/or
The through hole is arranged at the end part of the microneedle, which is far away from the substrate.
14. A frozen lipolysis system comprising; an injection device and a freezing and fat dissolving device,
an injection device for introducing the antifreeze injection preparation according to any one of claims 1 to 4 into a pretreatment region;
the frozen fat dissolving device is used for carrying out frozen fat dissolving treatment on the pretreatment area introduced with the antifreeze injection preparation.
15. The frozen liposuction system according to claim 14, wherein the injection device is a microneedle injector or a liquid guide according to any one of claims 5-8.
16. The frozen liposoluble system of claim 15, wherein the injection device is a microneedle injector, the microneedle injector comprises a second substrate and microneedles arranged on the second substrate in an array, the microneedles are hollow tubes, and the microneedles are provided with injection through holes.
17. A frozen fat dissolving method is characterized by comprising the following steps:
introducing the antifreeze injection formulation of any one of claims 1 to 4 into the pretreatment region;
and performing frozen fat dissolving treatment on the pretreatment area introduced with the antifreeze injection preparation.
18. The frozen fat dissolving method as claimed in claim 17, wherein the step of introducing the antifreeze injection preparation comprises injecting the antifreezeThe preparation is introduced in an amount of 2 μ L/mm3～3μL/mm3The introduction rate is 10 to 25 mu L/min.
19. The frozen fat dissolving method according to claim 18, wherein the step of introducing the antifreeze solution injection preparation is performed by using an injection device, the injection device is the liquid guide device or the microneedle injector according to any one of claims 5 to 8, the microneedle injector comprises a second substrate and microneedles arranged on the second substrate in an array manner, the microneedles are hollow tubes, and the microneedles are provided with injection through holes.
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| CN202010578418.6ACN113827545A (en) | 2020-06-23 | 2020-06-23 | Antifreeze injection preparation assisting in frozen fat dissolution, liquid guide device, kit and frozen fat dissolution system |
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