CN116036367A - Catabolic fill line and method of making same - Google Patents

Catabolic fill line and method of making same Download PDF

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Publication number
CN116036367A
CN116036367A CN202211265258.5A CN202211265258A CN116036367A CN 116036367 A CN116036367 A CN 116036367A CN 202211265258 A CN202211265258 A CN 202211265258A CN 116036367 A CN116036367 A CN 116036367A
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catabolic
filling
lactic acid
poly
line
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郑乃诚
明萌
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/18Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58Materials at least partially resorbable by the body

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Materials For Medical Uses (AREA)

Abstract

The present disclosure relates to catabolic fill lines and methods of making the same. The catabolic filling line provided according to the present disclosure consists of poly-l-lactic acid with a molecular weight of 30000Da-150000Da. The catabolic fill line of the present disclosure is 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.

Description

Catabolic fill line and method of making same
Technical Field
The disclosure relates to the technical field of medical cosmetic materials, in particular to a catabolic filling line and a preparation method thereof.
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 catabolic filling line may cause a certain trauma to human tissues, and have postoperative side effects, resulting in poor user experience.
Disclosure of Invention
To overcome the problems in the related art, the present disclosure provides a catabolic fill line and a method of preparing the same.
According to a first 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 fill line comprises a first segment and a second segment connected to each other, the molecular weight of the poly-l-lactic acid of the first segment being less than the molecular weight of the poly-l-lactic acid of the second segment.
In one embodiment, a connecting section is arranged between the first section and the second section, and the length of the connecting section is 0.5-5mm.
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 diameter of 100-120 μm.
In one embodiment, the surface of the catabolic fill line is smooth.
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 catabolic fill line of the present disclosure is 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.
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.
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 catabolic fill line and a method of preparing the same.
The catabolic filling line provided according to the present disclosure consists of poly-l-lactic acid with a molecular weight of 30000Da-150000Da.
The catabolic fill line of the present disclosure is 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.
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 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 tissues, and that fibroblasts play a major role in reconstructing the supporting structure of skin and subcutaneous tissue, namely 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 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.
The catabolic fill line of the present disclosure may include a first segment and a second segment that are connected to one another.
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, the first segment and the second segment may have a connection segment therebetween, and the connection between the polylactic acid wires of 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 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.
In the present disclosure, the catabolic fill line may have a tensile strength of 2.0-4.0cN/dtex (184-368 MPa). In the present disclosure, the elongation of the catabolic fill line is 25% -40%.
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.
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.
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.
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
Figure BDA0003892872030000131
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
Figure BDA0003892872030000132
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 disclosure 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 (15)

1. A catabolic fill line, comprising poly-l-lactic acid having a molecular weight of 30000Da to 150000Da.
2. The catabolic filling line as recited in claim 1, wherein,
the molecular weight of the poly-L-lactic acid is 30000Da or 60000Da.
3. The catabolic filling line as recited in claim 1, wherein,
the catabolic fill line includes a first segment and a second segment connected to each other, the molecular weight of the poly-L-lactic acid of the first segment being less than the molecular weight of the poly-L-lactic acid of the second segment.
4. The catabolic filling line as recited in claim 3, wherein,
a connecting section is arranged between the first section and the second section, and the length of the connecting section is 0.5-5mm.
5. The catabolic filling line as recited in claim 1, wherein,
the catabolic filling line has a diameter of 90-200 μm and is used for being implanted at the junction of the dermis layer and subcutaneous tissue of a human body.
6. The catabolic filling line as recited in claim 1, wherein,
the catabolic fill line is colorless or pale white.
7. The catabolic filling line as recited in claim 1, wherein,
the surface of the catabolic filling line is smooth.
8. The catabolic filling line as recited in claim 1, wherein,
the catabolic fill line has a tensile strength of 25CN-45CN.
9. The catabolic filling line as recited in claim 3, wherein,
the elongation of the catabolic filling line is 25% -40%.
10. A method of manufacturing a catabolic fill line, the method comprising:
dewatering and drying poly-L-lactic acid, spinning, and obtaining catabolic filling yarn after spinning; and
and (5) stretching the catabolic filling yarn and cooling to obtain the catabolic filling yarn.
11. The method for preparing the catabolic filling line as recited in claim 10, wherein the spinning is performed after the poly-L-lactic acid is dehydrated and dried, and the catabolic filling line is obtained after filament discharging, comprising:
dewatering and drying poly-L-lactic acid;
spinning the dried poly-L-lactic acid at 170-220 ℃ to obtain catabolic filling yarn after yarn discharging.
12. The method of preparing a catabolic filling line as recited in claim 11, wherein the dehydrating and drying 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.
13. The method of preparing a catabolic filling line as recited in claim 12, wherein the dehydrating and drying poly-l-lactic acid comprises:
and dehydrating and drying the poly-L-lactic acid by a blast drying box.
14. The method of manufacturing a catabolic filling line as recited in claim 11, wherein the drawing and cooling the catabolic filling line 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.
15. The method of preparing a catabolic filling wire as recited in claim 14, wherein the drawing the catabolic filling wire into a catabolic filling wire having a diameter of 100-120 μιη 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.
CN202211265258.5A 2022-10-17 2022-10-17 Catabolic fill line and method of making same Pending CN116036367A (en)

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