CN220327726U - Kit for detecting a substance in a sample - Google Patents

Kit for detecting a substance in a sample Download PDF

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Publication number
CN220327726U
CN220327726U CN202222721734.1U CN202222721734U CN220327726U CN 220327726 U CN220327726 U CN 220327726U CN 202222721734 U CN202222721734 U CN 202222721734U CN 220327726 U CN220327726 U CN 220327726U
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catabolic
needle
lactic acid
filling
poly
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郑乃诚
明萌
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Individual
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Abstract

The present disclosure relates to a kit. The kit of the present disclosure comprises: the kit body comprises a needle tube and a needle head, wherein the first end of the needle head is arranged on the needle tube; and a catabolic fill line comprising a first segment and a second segment connected to each other, at least a portion of the first segment being located inside the needle and at least a portion of the second segment being located outside the needle, wherein the catabolic fill line is a line made of poly-L-lactic acid. The kit of the present disclosure includes a catabolic fill line, which may be composed of poly-l-lactic acid, which is absorbable, residue-free, and forms lactic acid after metabolism in the human body. The arrangement is such that when the catabolic filling line of the present disclosure is used for filling, not only the catabolic filling line itself can play a role in packing compactness, but also lactic acid after metabolism can still pass through fibroblasts stimulating skin and subcutaneous tissues to reconstruct collagen architecture in a human body by using the fibroblasts.

Description

Kit for detecting a substance in a sample
Technical Field
The disclosure relates to the technical field of medical cosmetic materials, in particular to a kit.
Background
With the development of society and the improvement of living standard, people pursue beauty more and more, and the related technology and materials in the medical and aesthetic field are required more and more. For example, in terms of packing compactness, the population to which attempts are made increases, as does the area where a packing operation is required.
In the related art, the injection of the filling material may cause a certain trauma to human tissues, and there are postoperative side effects, resulting in poor user experience.
Disclosure of Invention
To overcome the problems in the related art, the present disclosure provides a kit.
According to a first aspect of embodiments of the present disclosure, there is provided a kit comprising: the kit body comprises a needle tube and a needle head, wherein the first end of the needle head is arranged on the needle tube; and a catabolic fill line comprising a first segment and a second segment connected to each other, at least a portion of the first segment being located inside the needle and at least a portion of the second segment being located outside the needle, wherein the catabolic fill line is a line made of poly-L-lactic acid.
In one embodiment, the catabolic fill line is 20-80mm in length.
In one embodiment, the needle is 20-50mm in length.
In one embodiment, the length of the needle is 35-40mm; the length of the catabolic filling line positioned inside the needle is 28-33mm, and the length of the catabolic filling line positioned outside the needle is 10-28mm.
In one embodiment, the length of the needle is 22-27mm; the length of the catabolic filling line positioned inside the needle is 15-20mm, and the length of the catabolic filling line positioned outside the needle is 5-20mm.
In one embodiment, the catabolic fill line has a diameter of 90-200 μm.
In an embodiment, the molecular weight of the poly-l-lactic acid of the first section is smaller than the molecular weight of the poly-l-lactic acid of the second section, and a connecting section is arranged between the first section and the second section and is positioned inside the needle.
In one embodiment, the length of the connecting section is 0.5mm-5mm.
In one embodiment, the catabolic fill line has a diameter of 100-120 μm.
In one embodiment, the surface of the catabolic fill line is smooth.
In one embodiment, the kit further comprises a fixing member sleeved on the needle for fixing the catabolic filling line.
In one embodiment, the securing member is located a distance of 5-10mm from a second end of the needle, the second end being disposed opposite the first end.
In an embodiment, the kit further comprises a seal, the kit body and the catabolic fill line being located inside the seal.
According to a second aspect of embodiments of the present disclosure, there is provided a catabolic filling line consisting of poly-l-lactic acid having a molecular weight of 30000Da-150000Da.
In one embodiment, the molecular weight of the poly-L-lactic acid is 30000Da or 60000Da.
In one embodiment, the catabolic filling line has a diameter of 90-200 μm and is used for implantation at the junction of the dermis layer and subcutaneous tissue of a human body.
In one embodiment, the catabolic fill line is colorless or pale white.
In one embodiment, the catabolic fill line has a tensile strength of 25CN-45CN.
In one embodiment, the catabolic fill line has an elongation of 25% -40%.
According to a second aspect of embodiments of the present disclosure, there is provided a method of preparing a catabolic filler wire, the method comprising: dewatering and drying poly-L-lactic acid, spinning, and obtaining catabolic filling yarn after spinning; and stretching the catabolic filling wire and cooling to obtain the catabolic filling wire.
In one embodiment, the spinning is performed after the poly-L-lactic acid is dehydrated and dried, and catabolic filling yarn is obtained after yarn discharging, which comprises the following steps: dewatering and drying poly-L-lactic acid; spinning the dried poly-L-lactic acid at 190-220 ℃ to obtain catabolic filling yarn after yarn discharging.
In one embodiment, the dehydrating and drying the poly-L-lactic acid comprises: and (3) dehydrating and drying the poly-L-lactic acid at the temperature of 65-110 ℃ for 16-24 hours.
In one embodiment, the dehydrating and drying the poly-L-lactic acid comprises: and dehydrating and drying the poly-L-lactic acid by a blast drying box.
In one embodiment, the cooling after stretching the catabolic filling filament to obtain a catabolic filling filament comprises: drawing the catabolic filler filaments into catabolic filler filaments having a diameter of 100-120 μm; cooling and shaping the stretched catabolic filling yarn into a catabolic filling yarn.
In one embodiment, the drawing the catabolic filler filaments into catabolic filler filaments having a diameter of 100-120 μm comprises: the catabolic filling filament is drawn into the catabolic filling filament having a diameter of 100-120 μm at a temperature of 70-85 ℃, wherein the drawing speed is 2-4 times the filament outlet speed.
The present disclosure also provides a catabolic filling line, which is a line composed of poly-L-lactic acid having a molecular weight of 30000Da to 150000Da, the catabolic filling line having a diameter of 90 to 200 μm, for implantation into the dermis layer of a human body.
In one embodiment, the catabolic fill line has a diameter of 100-180 μm.
In one embodiment, the catabolic fill line has a diameter of 100-150 μm.
In one embodiment, the catabolic fill line has a diameter of 110-130 μm.
In one embodiment, the catabolic fill line has a molecular weight of 50000Da to 130000Da.
In one embodiment, the catabolic fill line has a molecular weight of 60000Da to 120000Da.
In one embodiment, the catabolic filling line has a molecular weight of 80000Da to 100000Da.
In one embodiment, the catabolic filling line is a line that is absorbed over 7 months after implantation into the human body.
In one embodiment, the catabolic fill line is a line after dehydration drying and stretching of the poly-L-lactic acid.
The technical scheme provided by the embodiment of the disclosure can comprise the following beneficial effects: the kit disclosed by the disclosure comprises a catabolic filling line, wherein the catabolic filling line consists of poly-L-lactic acid, is absorbable, has no residue and is formed into lactic acid after metabolism in a human body. The arrangement is that when the catabolic filling line is used for filling, not only the catabolic filling line can play a role in filling and tightening, but also lactic acid after metabolism can still pass through fibroblasts for stimulating skin and subcutaneous tissues so as to reconstruct collagen frameworks in a human body by utilizing the fibroblasts, and further the filling and tightening effect of the catabolic filling line can be exerted for a long time and continuously.
The catabolic filling line is partially arranged inside the needle, and the other part of the catabolic filling line is arranged outside the needle, so that the catabolic filling line can be operated by an operator conveniently, and the experience of a user can be improved.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the disclosure and together with the description, serve to explain the principles of the disclosure.
Fig. 1 is a schematic structural diagram of an catabolic filler line, according to an exemplary embodiment.
FIG. 2 is a schematic view showing a state of use of a catabolic filler wire according to an exemplary embodiment.
FIG. 3 is a flow chart illustrating a method of preparing catabolic filler wires, according to an exemplary embodiment.
FIG. 4 is a flow chart illustrating a method of preparing catabolic filler wires, according to an exemplary embodiment.
FIG. 5 is a flow chart illustrating a method of preparing catabolic filler wires, according to an exemplary embodiment.
FIG. 6 is a flow chart illustrating a method of preparing catabolic filler wires according to an exemplary embodiment.
FIG. 7 is a flow chart illustrating a method of preparing catabolic filler wires, according to an exemplary embodiment.
Fig. 8 is a flow chart illustrating a method of preparing a kit according to an exemplary embodiment.
Fig. 9 is a flow chart illustrating a method of preparing a kit according to an exemplary embodiment.
Detailed Description
Reference will now be made in detail to exemplary embodiments, examples of which are illustrated in the accompanying drawings. When the following description refers to the accompanying drawings, the same numbers in different drawings refer to the same or similar elements, unless otherwise indicated. The implementations described in the following exemplary examples are not representative of all implementations consistent with the present disclosure. Rather, they are merely examples of apparatus and methods consistent with some aspects of the present disclosure as detailed in the accompanying claims.
With the development of society and the improvement of living standard, people pursue beauty more and more, and the related technology and materials in the medical and aesthetic field are required more and more. For example, in terms of packing compactness, the population to which attempts are made increases, as does the area where a packing operation is required.
In the related art, the catabolic filling line may cause a certain trauma to human tissues, and have postoperative side effects, resulting in poor user experience.
To overcome the problems in the related art, the present disclosure provides a kit.
A kit provided according to the present disclosure, comprising: the kit body comprises a needle tube and a needle head, wherein the first end of the needle head is arranged on the needle tube; and a catabolic fill line, a portion of the catabolic fill line being located inside the needle and another portion of the catabolic fill line being located outside the needle, wherein the catabolic fill line is a line made of poly-L-lactic acid.
The catabolic fill line of the present disclosure may include first and second segments connected to one another, at least a portion of the first segment being located inside the needle and at least a portion of the second segment being located outside the needle.
The kit of the present disclosure includes a catabolic fill line, which may be composed of poly-l-lactic acid, which is absorbable, residue-free, and forms lactic acid after metabolism in the human body. The arrangement is that when the catabolic filling line is used for filling, not only the catabolic filling line can play a role in filling and tightening, but also lactic acid after metabolism can still pass through fibroblasts for stimulating skin and subcutaneous tissues so as to reconstruct collagen frameworks in a human body by utilizing the fibroblasts, and further the filling and tightening effect of the catabolic filling line can be exerted for a long time and continuously. The catabolic filling line is partially arranged inside the needle, and the other part of the catabolic filling line is arranged outside the needle, so that the catabolic filling line can be operated by an operator conveniently, and the experience of a user can be improved.
Fig. 1 is a schematic structural diagram of an catabolic filler line, according to an exemplary embodiment. FIG. 2 is a schematic view showing a state of use of a catabolic filler wire according to an exemplary embodiment.
As shown in fig. 1 and 2, the kit 10 of the present disclosure may include a kit body and a catabolic fill line 200. The kit body may include needle cannula 300 and needle 100. One end of needle 100 may be mounted to needle cannula 300. For example, one end of needle 100 may be inserted into the interior of needle cannula 300. Needle cannula 300 and needle 100 may be in communication with each other, and a piston, a piston shaft, and a piston handle may be disposed inside needle cannula 300 to complete the injection of kit 10. Alternatively, a core rod may be provided inside needle cannula 300, and the injection of cartridge 10 may be accomplished by pushing or pulling the core rod.
In one embodiment, the catabolic fill line 200 may be 20-80mm in length. For example, in an embodiment, the length of catabolic fill line 200 may be 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, 50mm, 55mm, 60mm, 65mm, 70mm, 75mm, or 80mm.
In one embodiment, needle 100 is 20-50mm in length. For example, in embodiments, the length of needle 100 may be 20mm, 25mm, 30mm, 35mm, 38mm, 40mm, 45mm, or 50mm.
As shown in fig. 1 and 2, a portion of catabolic fill line 200 may be located inside needle 100 and another portion may be located outside needle 100. Such an arrangement may facilitate the physician's operation, i.e., during use, without having to push the catabolic filling line out of a portion and then inject it, but rather directly. The operation of doctors is convenient, and the possibility of pollution in the using process can be reduced. In particular, if the operation steps are more cumbersome, the greater the possibility of contamination.
In one embodiment, the length of the needle 100 may be 35-40mm, the length of the catabolic fill wire 200 inside the needle 100 may be 28-33mm, and the length of the catabolic fill wire 200 outside the needle 100 may be 10-28mm. For example, in one embodiment, the length of the needle 100 may be 38mm, the length of the catabolic fill wire 200 inside the needle 100 may be 30mm, and the length of the catabolic fill wire 200 outside the needle 100 may be 25mm.
In one embodiment, the length of the needle 100 may be 22-27mm, the length of the catabolic fill wire 200 inside the needle 100 may be 5-20mm, and the length of the catabolic fill wire 200 outside the needle 100 may be 15-20mm. For example, in one embodiment, the length of needle 100 may be 25mm, the length of catabolic fill wire 200 inside needle 100 is 18mm, and the length of catabolic fill wire 200 outside needle 100 is 18mm.
It is noted that the present disclosure is not limited thereto, and the specific kit 10, needle 100, catabolic fill line 200, and the length of catabolic fill line 200 outside and inside needle 100 are not limited to the above embodiments, and may be variously adjusted depending on the site for injection.
As shown in fig. 1 and 2, the catabolic fill line 200 provided by the present disclosure may be composed of poly-l-lactic acid, i.e., the constituent of the catabolic fill line of the present disclosure is one hundred percent poly-l-lactic acid.
In recent years, a great deal of medical literature has elucidated that lactic acid is a very important factor for human body to regulate and activate fibroblasts in skin and soft tissues, which in turn play a major role in reconstructing the supporting structure of skin and subcutaneous tissue, the collagen microarchitecture. Thus, the catabolic filling line of the present disclosure also has the effect of stimulating collagen production when metabolized to lactic acid after being implanted into a human body. In contrast, the catabolic filling line of the related art does not have an effect of stimulating collagen production because lactic acid is not produced during the metabolic process.
Therefore, after the catabolic filling line disclosed by the invention is implanted into a human body, besides the effect of filling compactness, lactic acid can be uniformly diffused and distributed to skin and soft tissues to further trigger reconstruction of an autologous collagen structure after lactic acid is generated by metabolism, so that the effect of autologous filling is achieved. That is, lactic acid stimulates collagen production in the human body, and these produced collagens can play a role of filling.
In the present disclosure, the molecular weight of poly-L-lactic acid may be 30000Da to 150000Da. For example, in one embodiment, the molecular weight of poly-L-lactic acid may be 30000Da. In one embodiment, the molecular weight of poly-L-lactic acid may be 60000Da.
In the present disclosure, the catabolic stuffer line may have a tensile strength of 2.0-4.0cN/dtex (25 CN-45 CN).
According to the above, the catabolic filling line of the present disclosure is composed of poly-L-lactic acid, and after being injected into a human body, is metabolized into lactic acid by poly-L-lactic acid, and the fibroblast is stimulated with lactic acid to generate collagen, so that a tightening effect can be achieved. In this case, the requirement for the tensile strength of the catabolic filling line can be reduced, so that the process difficulty can be reduced, the catabolic filling line composed of poly-L-lactic acid can be produced more easily, and the production efficiency of the catabolic filling line can be improved.
In the present disclosure, reducing the tensile strength of catabolic fill lines may avoid creating excessive stretching forces at locations (e.g., periocular, neck, face, etc.) that may cause damage to human tissue at those locations. On the other hand, reducing the tensile strength can avoid the catabolic filling lines from pulling tissues at these sites, which would lead to relaxation of the tissues after metabolism of the catabolic filling lines, reducing the duration of the effect of the catabolic filling lines composed of poly-L-lactic acid.
It is also noted that in the present disclosure, the length of needle 100, the length of catabolic fill wire 200 inside needle 100, the length of catabolic fill wire 200 outside needle 100, etc. are set for catabolic fill wires of lower tensile strength as employed in the present disclosure. That is, the arrangement can be matched with the tensile strength of the catabolic filling line, and the catabolic filling line can be conveniently injected without being damaged.
The catabolic fill wire of the present disclosure may include first and second segments connected to one another, at least a portion of the first segment being located inside the needle and at least a portion of the second segment being located outside the needle.
poly-L-lactic acid is degraded into lactic acid in human tissues, and lactic acid is a key step for renewing skin and subcutaneous tissues of a human body by stimulating ciliated cells in the tissues to reconstruct collagen microarchitecture. Therefore, poly-L-lactic acid is not a direct active ingredient when acting in the human body. How much effect poly-L-lactic acid can exert is related to the total amount of lactic acid it can degrade. The molecular weight of poly-L-lactic acid affects the degradation rate, and the smaller the molecular weight, the faster the degradation rate, and vice versa.
The rate of release of lactic acid can be controlled by controlling the molecular weight, so that the polylactic acid with the same weight, i.e. the same final total effect, but smaller molecular weight has a high short-time effect but a short effect release time. The molecular weight is high, the short-term effect is lower, but the maintenance time is long. In the present disclosure, the catabolic filling line is provided in two sections, i.e., a first section and a second section, and the first section and the second section adopt different molecular weights from each other, and such a setting can control to realize the effect that some line sections (first section or second section) play a role of quick release effect in the early stage and some line sections (second section or first section) play a role of slow release effect for a long time.
It is noted that the present disclosure is not limited to including a first segment and a second segment, and in some cases, may include more segments, and the molecular weights of the segments may be different from each other.
In the present disclosure, at least a portion of the first section may be located inside the needle and at least a portion of the second section may be located outside the needle. For example, in some embodiments, the first section may be entirely internal to the needle, the second section may be external to the needle, and the second section may be external to the needle. In such embodiments, the molecular weight of the poly-l-lactic acid of the first stage may be less than the molecular weight of the poly-l-lactic acid of the second stage.
By the arrangement, due to the fact that the molecular weight of the poly-L-lactic acid in the second section is large, catabolic filling lines outside the needle head can be prevented from being catalyzed by factors such as water vapor in the air, and therefore breakage of part of line bodies during operation can be avoided.
In the present disclosure, the second section may be located outside the needle, further comprising a fold back of the needle tip, e.g. the location of the second end of the needle. During operation, the needle tip (the second end of the needle) first contacts the skin and pierces the skin, so that the needle tip is subjected to a relatively large force. The second section with larger molecular weight of poly-L-lactic acid is arranged at the needle point, so that the breakage of the thread body when the needle point enters the skin can be avoided.
The line body with larger molecular weight has longer degradation speed under the same environmental condition. On the contrary, the molecular weight is small, and the in vivo degradation time is short. In general, even if the environment is dried, a small amount of moisture is unavoidably contained in the air and is present in the finished package when the product is packaged, and if the wire is embrittled, the wire may be broken during operation, and particularly, the probability of occurrence of the needle point wire is higher. Therefore, the needle tip can be placed at the needle tip reverse folding position, the probability of breakage of the needle tip when the needle tip is placed into the skin is reduced, meanwhile, the small-component rapid degradation in the needle body can be realized, the postoperative effect is rapid, the large-molecular-weight needle is delayed and the effect is continuously released, and the effects of the needle tip and the needle tip are combined.
In the present disclosure, a connecting section may be provided between the first section and the second section, and the connecting section may be located at a second end of the needle, the second end being disposed opposite to the first end.
In the present disclosure, the connecting segment may be located inside the needle. The connecting section is a position for connecting two sections of line bodies with different molecular weights of poly-L-lactic acid, and compared with the line bodies at other positions of catabolic filling line, the connecting section is possibly coarser and is arranged in the needle head, so that the pain felt by a user during operation can be reduced, the use feeling of the user is improved,
the connection between polylactic acid wires with different molecular weights is optimal for end-to-end connection. In order to minimize pain when the needle and the thread are placed in the skin, two threads of different molecular weights are not used side by side so as to avoid increasing pain due to increasing the thread diameter. In addition, the design can hide the joint end of the two wire bodies in the needle body, so that the friction between the joint part and the skin, which is increased due to relatively rough joint part, is avoided.
In the present disclosure, the length of the connection section may be 0.5mm-5mm. For example, in one embodiment, the length of the connecting section may be 1mm-3mm. In the present disclosure, the connection segment may employ a medical bio-glue, for example, an a-cyanoacrylate, or other medical bio-glue such as a SUP-SDBS compound may be employed.
In the present disclosure, the various different molecular weight segments can be joined by using different molecular weight (10000-130 kDa) L-polylactic acid segments, two or more different molecular weight segments, and medical bio-glue at the head and tail, in this case a-cyanoacrylate, or other medical bio-glue such as SUP-SDBS complex.
In exemplary embodiments of the present disclosure, the catabolic filling line may have a diameter of 90-200 μm, and the catabolic filling line may be used to implant an interface of a dermis layer and subcutaneous tissue of a human body. Because the catabolic filling line of the present disclosure has a relatively thin diameter, it is possible to avoid seeing the catabolic filling line at the surface of the skin when implanted at the junction of the dermis layer and the subcutaneous tissue. In particular, if the diameter of the catabolic filling line exceeds this range, the catabolic filling line may be directly seen from the skin surface of the user, which results in a reduced aesthetic effect and does not meet the customer's requirements.
In addition, the catabolic filling wire has a smaller diameter, has smaller stimulation to human tissues in the implantation process, and has no obvious foreign body sensation generated by a user.
In particular, the catabolic fill wire of the present disclosure is relatively thin in diameter and thus may be implanted at the interface of the dermis layer and subcutaneous tissue. The fibroblast exists mainly in the dermis layer, so that the catabolic filling line is implanted at the junction of the dermis layer and subcutaneous tissue, and the metabolized lactic acid can be used for stimulating the fibroblast to generate collagen, so that the filling effect can be better achieved.
In the present disclosure, the catabolic fill line is of a relatively thin diameter, and thus, in the case of implantation into the dermis layer, the contours of the catabolic fill line are not visible or touched on the skin surface of the user.
In addition, since the catabolic filling lines of the present application are relatively thin, and the content of poly-L-lactic acid contained in a unit area of a human body is relatively small after implantation into the human body, effective doses can be evenly distributed over the whole face, for example, different doses of catabolic filling lines can be injected at different positions of the whole face. If the diameter of the thread exceeds the range of the present application, there may be cases where scars are generated due to problems such as local overdose, uneven dose distribution, or ineffective metabolites (PDO, PPDO thread), or inability to change skin, or excessive local stimulation.
In the present disclosure, the catabolic fill line may be colorless or pale, such that it may be avoided to see the catabolic fill line at the surface of the skin. In particular, if the catabolic filling lines are darker in color, the catabolic filling lines may be directly seen from the skin surface of the user, which results in a reduced aesthetic effect and may not meet the customer's requirements.
In exemplary embodiments of the present disclosure, the surface of the catabolic fill line may be smooth. With such an arrangement, the frictional force between the catabolic filling line and the human tissue is reduced when performing filling compaction, so that the catabolic filling line is more easily injected into the human body. In the injection process, pain generated by the user is reduced, and the use experience of the user is improved. In addition, after entering the human body, the injury of the human body can not be caused, the pain of the user can not be increased, the use experience of the user is improved, and the problem of subsequent postoperative side effects does not exist.
Specifically, after the smooth catabolic filling line is injected into a human body, the catabolic filling line exists in the human body for a certain period of time, and starts along with the tissues in the human body along with the activities, expressions and the like of the human body. In this case, the smooth catabolic filling line does not exert a pulling action on the tissues of the human body, and thus the user does not feel pain due to the pulling action, avoiding affecting the user's daily life.
Polylactic acid is metabolized in the human body to form lactic acid, and lactic acid itself exists in the human body. The catabolism filling line of the present disclosure is composed of poly-L-lactic acid at one hundred percent, that is, the catabolism filling line of the present disclosure can be completely metabolized into lactic acid after being implanted into a human body, and finally can be metabolized into carbon dioxide and water, thereby realizing zero residue in the human body and improving the safety of the product of the present disclosure.
For example, the catabolic filling lines of the present disclosure may be metabolically absorbed by the human body within a period of about 6 months or less or about 7 months after implantation into the human body. Specific absorption time the present disclosure is not particularly limited, and in actual cases, the metabolic absorption time of the catabolic filling line may vary depending on the diameter of the catabolic filling line, the implantation length, the implantation site, and the like.
By combining the above, the catabolism filling line composed of the poly-L-lactic acid can be used for filling a human body to achieve the effect of tightening, and meanwhile, lactic acid generated by the metabolism of the poly-L-lactic acid is used for stimulating fibroblasts to generate collagen, so that the effect of tightening is further improved. In addition, the generated collagen can also play a role in filling. By the arrangement, the damage of catabolic filling lines to human bodies is reduced, and the effects of tightening and filling can be achieved. And with metabolism of the catabolic filling line, the filling tightening effect of the catabolic filling line can be exerted permanently and continuously.
In view of the above, it can be seen that the kit of the present disclosure is convenient to use. The catabolic filling line is arranged in the needle head, can be directly injected without adding normal saline or water for injection, lidocaine injection and the like, not only saves a large amount of time required by re-dissolution (certain dosage forms require re-dissolution for the previous day and six hours at the minimum), but also reduces medicament pollution possibly caused in the process of re-dissolution.
The kit of the present disclosure presets an accurate injection quantity. As the trocars continuously penetrate the treated area, the catabolic fill lines remaining in the target tissue have a volume, i.e., a "fixed dose" of polylactic acid, with the needle in each trocar having a width. Therefore, in a certain area range, only the catabolic filling line below a certain safe dose can be placed, so that the side effect that local injection dose is too high due to poor control during liquid polylactic acid injection can be eliminated.
Specifically, different kits can be specifically prepared according to different injection sites, injection areas and the like, and in the operation process, a doctor only needs to inject a plurality of kits respectively according to the calculated dosage, so that the operation can be completed. The problems of various non-normative and uncertain problems existing in manual calculation and operation can be avoided.
The kit disclosed by the invention has simpler and more accurate components. The liquid young needle must be added with thickener (such as CMC), freeze-dried excipient (mannitol), and lidocaine anesthetic in the course of preparation, which increases drug allergy or irritation. The method can completely remove all additives, only contains high-purity L-polylactic acid, and completely gets rid of the possibility of side effects caused by non-main components. Furthermore, the traditional re-dissolved young needle is a swirling liquid, and the needle is settled after standing for a certain time (some dosage forms are as short as twenty seconds), so that the injection of the same amount of liquid medicine is a common problem of different dosages. The thread body of the present application contains only a fixed amount of polylactic acid, and can completely and precisely control the amount of polylactic acid to be placed per unit tissue volume.
In exemplary embodiments of the present disclosure, the catabolic fill line may have a diameter R of 100-120 μm. The present disclosure is not limited thereto and various choices may be made as needed during actual use.
In the present disclosure, the catabolic filling line may be applied to various parts of the human body, for example, the face, torso, buttocks, or the like. Specifically, catabolic fill lines of different diameters may be selected depending on the application to different sites. For example, catabolic fill lines for the face may be relatively thin, about 90um, about 100um, about 110um, or about 120 um. Catabolic filling lines for application to the buttocks may be relatively thick in diameter, for example, about 150um, about 160um, about 170um, about 180um, about 190um, or about 200 um. As shown in fig. 2, during actual use, the catabolic fill-line 200 may be implanted using a kit, for example, by pushing the needle 300 of the kit, and pushing the catabolic fill-line 200 out of the needle 100. The catabolic fill line 200, which is located outside of the kit, may be secured by a fixture 400.
In the present disclosure, the fixing member 400 may be foam or silica gel, or may be made of foam or silica gel. In one embodiment, the securing member 400 may be a foam silicone sponge.
In the present disclosure, a securing member 400 may be sleeved over the needle 100 for securing the catabolic fill wire 200. For example, a notch may be provided in the fixture 400 such that the catabolic fill wire 200 may be wrapped around the fixture 400. The catabolic filling line 200 is fixed by the fixing member 400, so that the catabolic filling line 200 can be more stably arranged, and the length of the catabolic filling line positioned inside and outside the needle 100 is unchanged, thus further ensuring the accuracy of a doctor in the injection process.
In the present disclosure, the distance L of the mount 400 from the second end of the needle 100 may be 5-10mm, for example, in one embodiment, the distance L may be 10mm. In the present disclosure, the distance L is set within this range, and it is possible to prevent the fixture 400 from affecting the subsequent injection while the fixture 400 fixes the catabolic filling line 200.
In the present disclosure, the second end of needle 100 is disposed opposite the first end, i.e., the injection end of needle 100 may be the second end. The second end of the needle 100 may be beveled to facilitate injection.
In an embodiment, the kit 10 may further include a seal (not shown), and both the kit body and the catabolic fill line 100 may be located inside the seal. For example, the seal may be made of any material that can be adapted for use in a sterilization process, and may be plastic or rubber in particular. The seal may be at least partially transparent or opaque. The transparent seal facilitates the viewing of the interior kit body and needle etc.
The sealing element can be used after the kit is sterilized in advance and then packaged, and the kit can be used after being disassembled when in use, and physiological saline or water for injection, lidocaine injection and the like do not need to be added before injection, so that a large amount of time for reconstitution (certain dosage forms require one day before reconstitution and six hours at minimum) is saved, and the medicament pollution possibly caused in the process of reconstitution is reduced.
In the present disclosure, the exterior of the needle 100 may also be provided with a needle protecting cover for protecting the needle 100 from external contamination and also preventing the needle 100 from stabbing others.
According to the setting of the needle tube, the smooth catabolic filling line is designed to be reversely folded and preset inside and outside the needle tube through the inclined plane of the needle tip, an operator only needs to detach the sterile inner package and the needle sleeve, local anesthesia is not required to be injected, the needle tube can be directly and simultaneously pierced and pulled out by the superfine needle (30G-25G), the operation is finished, and the operation can be finished after about 2-5 seconds of placing the needle tube into the needle tube.
According to the design of the present disclosure (complete set of wires and flexible fine needles), the operator can repeatedly receive the treatment for an unlimited number of times with only a simple training when the patient has a need. The traditional operation type method is completely abandoned, and a large number of thorns are used for hooking, so that the discomfort and the side effects after operation caused by the traction of soft tissues by mechanical force are avoided.
The design of the present disclosure, in particular, can be divided into two sections: the front section is the slender flexible needle head of the present disclosure, and when penetrating needle line, the distal receptor of the sensory nerve network can be triggered along the bottom layer of dermis to cause the contraction of innumerable erector hair muscles, so that the skin is instantly contracted, and the contraction effect is three-dimensional volume reduction formed by the combination of the contraction of XY axes of innumerable different facets, so that the principle similar to that of curtain pulling is greatly improved by means of unidirectional linear involvement (the experimental skin length is unchanged) of soft tissues compared with the traditional buried line. The uniform skin contraction caused by this physiological stimulus may last for about three to five weeks.
The back end of the design mainly relies on the polylactic acid of the line body to degrade after about the second to three weeks, and the nano-sized lactic acid is separated out and diffused to the periphery, including dermis and subcutaneous tissue, activates self fibroblasts, starts to metabolize aging tissues, rebuilds younger collagen microarchitecture and secretes autologous hyaluronic acid, and builds blood vessels, nerve endings, immune cells, fat cells and the like which can promote other normal and healthy newborns, thus building a fully functional, healthy and compact younger tissue. Compared with the traditional mode of mechanical and uniaxial pulling by means of materials such as coarser and harder PDO without physiological functions, the traditional pulling mode has the advantages that skin texture is not assisted, continuous mechanical force pulling is carried out, skin and soft tissue fibers are broken for a long time, irreversible damage is caused, the external appearance is further aged, and therefore the acceptance of patients is extremely low. The arrangement of the second disclosure can improve the use experience of the patient.
Taking 30 subjects using the catabolic filling line of the present disclosure as an example, taking 30 subjects using an implant line having barbs with a diameter greater than the diameter of the catabolic filling line of the present application as a comparative example, the following several aspects of the test were performed on the examples and comparative examples:
1. in terms of satisfaction, the number of subjects willing to receive a second operation after half a year to one year at the same price was examined. In actual use, the effect of such an injection procedure is typically maintained for a period of time, not for life, and thus the subject is often required to perform multiple injections. Also, whether or not the subject receives the injection again at the same price for a certain period of time is an important index for evaluating the satisfaction of the subject with the first operation.
In the examples, 25 subjects received the second run at the same price after half a year to one year, while in the comparative examples, only 1 subject received the second run at the same price after half a year to one year. It can be seen that the satisfaction of the subject with the present product is significantly higher than with other implant lines.
2. In terms of comfort, the catabolic filling lines of the present disclosure are smaller in diameter, i.e., thinner, and achieve uniform dose distribution while reducing the perception of pain during handling, and thus, degradation time. After degradation, the foreign body sensation of the subject is reduced and the comfort is improved.
In an example, only 2 subjects could feel or touch the presence of the wire within three days after receiving the procedure. In the comparative example, 27 subjects still touched the line three months after the operation, 12 subjects still touched the line six months later, and 7 subjects still perceived the line hard block nine months later.
3. In terms of side effects, in the examples, only 2 subjects had a slight bulge in one position of the cheek after surgery due to the change of expression, no pain, and disappeared by themselves without treatment within one week. In the comparative example, there were 6 subjects who had a problem in that a further debridement treatment was necessary because one end of the wire protruded from the skin, and 7 subjects who had a different degree of appearance change in appearance due to protrusion or depression caused by the wire involvement due to the change in expression.
4. In terms of post-operative recovery rate, in the examples, 30 subjects recovered from normal cleansing procedures, cosmetic and skin care application within two days after the procedure. In the examples, 30 subjects had no more sensation of slight swelling after surgery within three days, and no more visible ecchymosis after ten days. In the comparative example, 16 subjects still had a report of swelling, pain or ecchymosis one month after surgery.
Based on the same conception, the present disclosure may provide a method of manufacturing a catabolic filling line for manufacturing the catabolic filling line in the above-described embodiments. FIG. 3 is a flow chart illustrating a method of preparing a catabolic fill line, according to an exemplary embodiment, as shown in FIG. 3, the method of preparing the present disclosure may include the steps of:
s11: and (3) dehydrating and drying the poly-L-lactic acid, spinning, and obtaining the catabolic filling yarn after spinning.
S12: and (5) stretching the catabolic filling yarn and cooling to obtain the catabolic filling yarn.
According to the method, a melt spinning process is adopted, poly-L-lactic acid particles/powder are placed into a melt extruder, and the obtained poly-L-lactic acid compact catabolism filling line is high in strength, uniform and fine in line diameter and smaller in wound caused to tissues through screw melt extrusion and stretching after filament discharge, so that the compact filling effect is better.
In an exemplary embodiment of the present disclosure, fig. 4 is a flowchart illustrating a method of preparing a catabolic filler wire according to an exemplary embodiment, as shown in fig. 4, the method of preparing the present disclosure may include the steps of:
s21: and dehydrating and drying the poly-L-lactic acid.
In the present disclosure, the poly-L-lactic acid may be dehydrated and dried by a forced air drying oven.
S22: spinning the dried poly-L-lactic acid at 170-220 ℃ to obtain catabolic filling yarn after yarn discharging.
In the present disclosure, for example, the poly-L-lactic acid raw material may be dehydrated and dried and then added to a melt spinning machine, and the poly-L-lactic acid fine particles/powder may be placed in a melt extruder to be spun at a melt spinning temperature of 170-220 ℃ using a melt spinning process. Specifically, the filament-discharging mode may be extrusion, for example, screw extrusion. In the present disclosure, the filament discharge may be performed at room temperature.
S23: and (5) stretching the catabolic filling yarn and cooling to obtain the catabolic filling yarn.
In the disclosure, the obtained catabolic filling yarn is cooled to room temperature to obtain the poly-L-lactic acid compact catabolic filling yarn, and the obtained poly-L-lactic acid compact catabolic filling yarn is wound on a coil for standby. However, the present disclosure is not limited thereto and, in some embodiments, the resulting catabolic filler wire may also be placed into a cooling device for cooling. After the metabolism filling wire is prepared, the metabolism filling wire can be wound on a coil for standby, and can be wound on or contained in any component convenient to store, store or use.
In an exemplary embodiment of the present disclosure, fig. 5 is a flowchart illustrating a method of preparing a catabolic filler wire according to an exemplary embodiment, as shown in fig. 5, the method of preparing the present disclosure may include the steps of:
s31: and (3) dehydrating and drying the poly-L-lactic acid at the temperature of 65-110 ℃ for 16-24 hours.
For example, in one embodiment, the temperature of the dehydration drying may be about 75 ℃ and the time of the dehydration drying may be about 16 hours.
S32: spinning the dried poly-L-lactic acid at 170-220 ℃ to obtain catabolic filling yarn after yarn discharging.
S33: and (5) stretching the catabolic filling yarn and cooling to obtain the catabolic filling yarn.
In an exemplary embodiment of the present disclosure, fig. 6 is a flowchart illustrating a method of preparing a catabolic filler wire according to an exemplary embodiment, as shown in fig. 6, the method of preparing the present disclosure may include the steps of:
s41: and (3) dehydrating and drying the poly-L-lactic acid at the temperature of 65-110 ℃ for 16-24 hours.
S42: spinning the dried poly-L-lactic acid at 170-220 ℃ to obtain catabolic filling yarn after yarn discharging.
S43: the catabolic filler filaments are drawn into catabolic filler filaments having a diameter of 100-120 μm.
S44: cooling and shaping the stretched catabolic filling yarn into a catabolic filling yarn.
In an exemplary embodiment of the present disclosure, fig. 7 is a flowchart illustrating a method of preparing a catabolic filler wire according to an exemplary embodiment, as shown in fig. 7, the method of preparing the present disclosure may include the steps of:
s51: and (3) dehydrating and drying the poly-L-lactic acid at the temperature of 65-110 ℃ for 16-24 hours.
S52: spinning the dried poly-L-lactic acid at 170-220 ℃ to obtain catabolic filling yarn after yarn discharging.
S53: drawing a catabolic filler wire into a catabolic filler wire having a diameter of 100-120 μm, comprising: the catabolic filling filament is drawn into a catabolic filling filament having a diameter of 100-120 μm at a temperature of 70-85 ℃, wherein the drawing speed is 2-4 times the filament outlet speed.
S54: cooling and shaping the stretched catabolic filling yarn into a catabolic filling yarn.
The catabolic filling line disclosed by the invention can be used for filling a tightening skin through the action of a line body, and lactic acid in degradation stimulates subcutaneous tissue fibroblasts to restore activity, so that more collagen, elastin and collagen fibers are generated, and the skin is more elastic in the subsequent process; in the process, the molecular structure of the poly-L-lactic acid is gradually degraded and slowly hydrolyzed into lactic acid, the lactic acid as a degradation product is converted into pyruvic acid under the action of lactic acid dehydrogenase, and then enters mitochondria to be thoroughly oxidized and decomposed to generate CO2 and H2O, and the CO 2O is replaced by the new collagen, so that the poly-L-lactic acid has longer-acting and obvious beautifying effect compared with the existing wire carving wire.
Based on the same concept, the present disclosure also provides a method for manufacturing a kit, and fig. 8 is a flowchart illustrating a method for manufacturing a kit according to an exemplary embodiment, and as shown in fig. 8, the method for manufacturing the present disclosure may include the steps of:
s61: 50 g of poly-L-lactic acid particles/powder were placed in a drying oven for drying and dewatering for 24H.
S62: drying and adding into a melt spinning machine for spinning.
S63: the melting temperature of the spinning machine is adjusted to 190-220 ℃, spinning is carried out, primary stretching and secondary stretching are adjusted, and the diameter is controlled to be 100-120 mu m.
S64: and (3) cooling and shaping after spinning, and cutting the filaments with the length of 30mm and uniform length.
S65: the polylactic acid thread is threaded into a needle head with the length of 29G-25mm, the length of the thread inside the needle tube is 15mm, a foam fixing sleeve is threaded on the outside, and a needle head protecting sleeve is buckled.
Fig. 9 is a flowchart illustrating a method of preparing a kit according to an exemplary embodiment, as shown in fig. 9, the method of preparing the present disclosure may include the steps of:
s71: 50 g of poly-L-lactic acid particles/powder were placed in a drying oven for drying and dewatering for 24H.
S72: drying and adding into a melt spinning machine for spinning.
S73: the melting temperature of the spinning machine is adjusted to 190-220 ℃, spinning is carried out, primary stretching and secondary stretching are adjusted, and the diameter is controlled to be 100-120 mu m.
S74: and (5) cooling and shaping after spinning, and cutting the yarn with the length of 55mm and uniform length.
S75: the polylactic acid wire is inserted into a needle head with the length of 29G-38mm, the length of the inner wire of the needle tube is 30mm, the length of the outer part of the needle tube is 25mm, a wire body fixing sleeve is inserted outside, and a needle head protective cover is buckled.
According to the actual weighing, the weight per cm length was 0.2353mg per 100um diameter catabolic fill line. Assuming that a standard 38mm long puncture needle is used, the catabolic filling lines are 55mm long and are respectively arranged in the needle heads for 30mm and 25mm outside the needle heads, each puncture needle is equivalent to 1.2942mg of poly-L-lactic acid for injecting into tissues. If 120 puncture needles with the diameter of 38mm are operated on the face in a common state, 155mg of poly-L-lactic acid is equivalent to 1 bottle of freeze-dried powder preparation form produced by the traditional poly-L-lactic acid guangdong brand on the market (the poly-L-lactic acid content of each bottle is 150 mg).
If 200um diameter catabolic filling lines with the same length specification are used for substitution, the same puncture injection quantity of 120 times can reach the injection quantity (cylinder with double pipe diameter, unchanged length and four times volume) of four bottles of traditional child's face needles. Therefore, the total dosage under a certain area can be accurately calculated through different wire diameters, wire lengths and puncture injection needle numbers, the accuracy and uniformity which cannot be achieved by the traditional liquid injection method originally are achieved, the preparation time and the operation time are shortened, the side effect caused by uneven injection dosage is controlled, and the patient acceptance is greatly improved.
Example 1
The embodiment provides a poly-L-lactic acid compact catabolism filling line, wherein the active ingredient of the poly-L-lactic acid compact catabolism filling line is poly-L-lactic acid, the molecular weight of the poly-L-lactic acid is 30000Da, and the diameter of the line is 100-120 mu m.
The preparation method of the poly-L-lactic acid compact catabolism filling line provided by the embodiment comprises the following steps:
placing medical poly-L-lactic acid particles/powder into a drying oven for drying and dewatering for 24 hours at the drying temperature of 16 ℃;
drying, adding into a melt spinning machine for spinning, adjusting the melting temperature of the spinning machine to 190-220 ℃, extruding out the filaments by a screw, controlling the filament outlet temperature to be room temperature, drawing after filament outlet to ensure that the diameter of the obtained filaments is 100-120 mu m, and cooling and shaping. Wherein the spinning temperature can be 200-220 ℃.
The embodiment also provides a kit, taking 1000 samples as examples, comprising:
50g of medical poly-L-lactic acid particles/powder with the molecular weight of 30000 Da;
1000 needles are arranged on the needle handle and the needle, and the inner diameter of the needle tube of the needle is 29G-38mm;
1000 foam balls;
the preparation method of the kit comprises the following steps:
50g of medical poly-L-lactic acid particles/powder are prepared into poly-L-lactic acid compact catabolism filling lines by the preparation method provided by the embodiment, and cut into line segments with the length of 40mm and uniform length;
Penetrating the cut line segments into needle tubes of the needles, wherein each needle corresponds to one line segment; the length of the line segment left in the needle head is 20-25mm;
and sleeving the foam ball on the outer wall of the needle to pinch the part of the line segment outside the needle, and then buckling the needle protective sleeve to obtain the kit.
Example two
The embodiment provides a poly-L-lactic acid compact catabolism filling line and a kit, and the related parameters and the manufacturing method of the poly-L-lactic acid compact catabolism filling line and the kit are basically the same as those of the embodiment one, and the difference is that: the molecular weight of the used medical poly L-lactic acid particles/powder is 40000Da.
Example III
The embodiment provides a poly-L-lactic acid compact catabolism filling line and a kit, and the related parameters and the manufacturing method of the poly-L-lactic acid compact catabolism filling line and the kit are basically the same as those of the embodiment one, and the difference is that: the molecular weight of the used medical poly L-lactic acid particles/powder is 50000Da.
Example IV
The embodiment provides a poly-L-lactic acid compact catabolism filling line and a kit, and the related parameters and the manufacturing method of the poly-L-lactic acid compact catabolism filling line and the kit are basically the same as those of the embodiment one, and the difference is that: the molecular weight of the used medical poly L-lactic acid particles/powder is 60000Da.
Example five
The embodiment provides a poly-L-lactic acid compact catabolism filling line and a kit, and the related parameters and the manufacturing method of the poly-L-lactic acid compact catabolism filling line and the kit are basically the same as those of the embodiment one, and the difference is that: the molecular weight of the used medical poly-L-lactic acid particles/powder is 70000Da.
Example six
The embodiment provides a poly-L-lactic acid compact catabolism filling line and a kit, and the related parameters and the manufacturing method of the poly-L-lactic acid compact catabolism filling line and the kit are basically the same as those of the embodiment one, and the difference is that: the molecular weight of the used medical poly L-lactic acid particles/powder is 80000Da.
Example seven
The embodiment provides a poly-L-lactic acid compact catabolism filling line and a kit, and the related parameters and the manufacturing method of the poly-L-lactic acid compact catabolism filling line and the kit are basically the same as those of the embodiment one, and the difference is that: the molecular weight of the used medical poly L-lactic acid particles/powder is 90000Da.
Example eight
The embodiment provides a poly-L-lactic acid compact catabolism filling line and a kit, and the related parameters and the manufacturing method of the poly-L-lactic acid compact catabolism filling line and the kit are basically the same as those of the embodiment one, and the difference is that: the molecular weight of the poly-L-lactic acid particles/powder used for medical use was 100kDa.
Example nine
The embodiment provides a poly-L-lactic acid compact catabolism filling line and a kit, and the related parameters and the manufacturing method of the poly-L-lactic acid compact catabolism filling line and the kit are basically the same as those of the embodiment one, and the difference is that: the molecular weight of the poly-L-lactic acid particles/powder used for medical use was 110kDa.
Examples ten
The embodiment provides a poly-L-lactic acid compact catabolism filling line and a kit, and the related parameters and the manufacturing method of the poly-L-lactic acid compact catabolism filling line and the kit are basically the same as those of the embodiment one, and the difference is that: the molecular weight of the poly-L-lactic acid particles/powder used for medical use was 130kDa.
Example eleven
The embodiment provides a poly-L-lactic acid compact catabolism filling line and a kit, and the related parameters and the manufacturing method of the poly-L-lactic acid compact catabolism filling line and the kit are basically the same as those of the embodiment one, and the difference is that: the molecular weight of the poly-L-lactic acid particles/powder used for medical use was 150kDa.
The poly-L-lactic acid compact catabolic filling lines provided in examples one to nine were each subjected to mechanical property testing, and the results are shown in Table 1 below.
Table 1 shows the mechanical properties of the poly-L-lactic acid compact catabolic filling lines provided in examples one to nine at a hot plate temperature of 70℃and a hot plate temperature of 90 ℃in comparison
Table 2 shows the mechanical properties of the poly-L-lactic acid compact catabolic filling lines provided in examples one to nine at a hot plate temperature of 80℃and a hot plate temperature of 120 ℃in comparison
The catabolic filling line disclosed by the invention has the advantages of small side effect, good filling effect and the like, and also has excellent tensile strength and shear strength. Such tensile and shear strengths allow for a wider range of applicable conditions for catabolic fill lines of the present disclosure, with better use, given that there may be some cutting, pulling actions during subsequent use.
It is to be understood that, in order to achieve the above-described functions, the catabolic filling line provided in the embodiments of the present disclosure includes corresponding hardware structures and/or software modules for performing the respective functions. The disclosed embodiments may be implemented in hardware or a combination of hardware and computer software, in combination with the various example elements and algorithm steps disclosed in the embodiments of the disclosure. Whether a function is implemented as hardware or computer software driven hardware depends upon the particular application and design constraints imposed on the solution. Those skilled in the art may implement the described functionality using different approaches for each particular application, but such implementation is not to be considered as beyond the scope of the embodiments of the present disclosure.
It is understood that the term "plurality" in this disclosure means two or more, and other adjectives are similar thereto. "and/or", describes an association relationship of an association object, and indicates that there may be three relationships, for example, a and/or B, and may indicate: a exists alone, A and B exist together, and B exists alone. The character "/" generally indicates that the context-dependent object is an "or" relationship. The singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.
It is further understood that the terms "first," "second," and the like are used to describe various information, but such information should not be limited to these terms. These terms are only used to distinguish one type of information from another and do not denote a particular order or importance. Indeed, the expressions "first", "second", etc. may be used entirely interchangeably. For example, first information may also be referred to as second information, and similarly, second information may also be referred to as first information, without departing from the scope of the present disclosure.
It will be further understood that the terms "center," "longitudinal," "transverse," "front," "rear," "upper," "lower," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, as used herein, refer to an orientation or positional relationship based on that shown in the drawings, merely for convenience in describing the present embodiments and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operate in a particular orientation.
It will be further understood that "connected" includes both direct connection where no other member is present and indirect connection where other element is present, unless specifically stated otherwise.
It will be further understood that although operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous.
Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the concepts disclosed herein. This application is intended to cover any adaptations, uses, or adaptations of the disclosure following, in general, the principles of the disclosure and including such departures from the present disclosure as come within known or customary practice within the art to which the disclosure pertains. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the disclosure being indicated by the following claims.
It is to be understood that the present disclosure is not limited to the precise arrangements and instrumentalities shown in the drawings, and that various modifications and changes may be effected without departing from the scope thereof. The scope of the present disclosure is limited only by the appended claims.

Claims (12)

1. A kit, comprising:
the kit body comprises a needle tube and a needle head, wherein the first end of the needle head is arranged on the needle tube; and
catabolic fill-line comprising a first segment and a second segment connected to each other, at least part of the first segment being located inside the needle and at least part of the second segment being located outside the needle,
wherein the catabolic filling line is a line made of poly-L-lactic acid.
2. The kit according to claim 1, wherein,
the catabolic filling line has a length of 20-80mm.
3. The kit according to claim 2, wherein,
the length of the needle head is 20-50mm.
4. The kit according to claim 3, wherein,
the length of the needle head is 35-40mm;
the length of the catabolic filling line positioned inside the needle is 28-33mm, and the length of the catabolic filling line positioned outside the needle is 10-28mm.
5. The kit according to claim 3, wherein,
the length of the needle head is 22-27mm;
the length of the catabolic filling line positioned inside the needle is 15-20mm, and the length of the catabolic filling line positioned outside the needle is 5-20mm.
6. The kit according to claim 3, wherein,
the catabolic filling line has a diameter of 90-200 μm.
7. The kit according to claim 1, wherein,
the molecular weight of the poly-L-lactic acid in the first section is smaller than that of the poly-L-lactic acid in the second section, a connecting section is arranged between the first section and the second section, and the connecting section is positioned in the needle head.
8. The kit of claim 7, wherein the length of the connecting segment is 0.5-5mm.
9. The kit according to claim 3, wherein,
the surface of the catabolic filling line is smooth.
10. The kit according to any one of claim 1 to 9, wherein,
the kit further comprises a fixing piece, wherein the fixing piece is sleeved on the needle head and used for fixing the catabolic filling line.
11. The kit according to claim 10, wherein,
the distance between the fixing piece and the second end of the needle head is 5-10mm, and the second end is opposite to the first end.
12. The kit according to any one of claim 1 to 9, wherein,
The kit further comprises a seal, the kit body and the catabolic fill line being located inside the seal.
CN202222721734.1U 2022-10-17 2022-10-17 Kit for detecting a substance in a sample Active CN220327726U (en)

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