CN115094552A - Lifting wire and preparation method thereof - Google Patents
Lifting wire and preparation method thereof Download PDFInfo
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- CN115094552A CN115094552A CN202210692369.8A CN202210692369A CN115094552A CN 115094552 A CN115094552 A CN 115094552A CN 202210692369 A CN202210692369 A CN 202210692369A CN 115094552 A CN115094552 A CN 115094552A
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- polyethylene glycol
- gas
- barb
- wire
- lifting
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Images
Classifications
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- D—TEXTILES; PAPER
- D02—YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
- D02G—CRIMPING OR CURLING FIBRES, FILAMENTS, THREADS, OR YARNS; YARNS OR THREADS
- D02G3/00—Yarns or threads, e.g. fancy yarns; Processes or apparatus for the production thereof, not otherwise provided for
- D02G3/02—Yarns or threads characterised by the material or by the materials from which they are made
- D02G3/04—Blended or other yarns or threads containing components made from different materials
- D02G3/045—Blended or other yarns or threads containing components made from different materials all components being made from artificial or synthetic material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0059—Cosmetic or alloplastic implants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/041—Mixtures of macromolecular compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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- D—TEXTILES; PAPER
- D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
- D01F—CHEMICAL FEATURES IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS; APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OF CARBON FILAMENTS
- D01F8/00—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof
- D01F8/04—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof from synthetic polymers
- D01F8/14—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof from synthetic polymers with at least one polyester as constituent
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- D—TEXTILES; PAPER
- D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
- D01F—CHEMICAL FEATURES IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS; APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OF CARBON FILAMENTS
- D01F8/00—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof
- D01F8/04—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof from synthetic polymers
- D01F8/16—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof from synthetic polymers with at least one other macromolecular compound obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds as constituent
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- D—TEXTILES; PAPER
- D02—YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
- D02G—CRIMPING OR CURLING FIBRES, FILAMENTS, THREADS, OR YARNS; YARNS OR THREADS
- D02G3/00—Yarns or threads, e.g. fancy yarns; Processes or apparatus for the production thereof, not otherwise provided for
- D02G3/22—Yarns or threads characterised by constructional features, e.g. blending, filament/fibre
- D02G3/38—Threads in which fibres, filaments, or yarns are wound with other yarns or filaments, e.g. wrap yarns, i.e. strands of filaments or staple fibres are wrapped by a helically wound binder yarn
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- D—TEXTILES; PAPER
- D02—YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
- D02G—CRIMPING OR CURLING FIBRES, FILAMENTS, THREADS, OR YARNS; YARNS OR THREADS
- D02G3/00—Yarns or threads, e.g. fancy yarns; Processes or apparatus for the production thereof, not otherwise provided for
- D02G3/44—Yarns or threads characterised by the purpose for which they are designed
- D02G3/448—Yarns or threads for use in medical applications
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- D—TEXTILES; PAPER
- D02—YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
- D02J—FINISHING OR DRESSING OF FILAMENTS, YARNS, THREADS, CORDS, ROPES OR THE LIKE
- D02J3/00—Modifying the surface
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- D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
- D10B2331/00—Fibres made from polymers obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polycondensation products
- D10B2331/04—Fibres made from polymers obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polycondensation products polyesters, e.g. polyethylene terephthalate [PET]
Abstract
The invention relates to a medical device, in particular to a lifting wire and a preparation method thereof. The pulling line comprises a pulling line body and barbs; one end of the barb is a connecting part and is fixed on the lifting line body; the other end of the barb is an extension end; the cross-sectional area of the extension end is larger than that of the connection portion. The end part area of the extending end of the barb arranged on the lifting line is larger than the cross section area of the connecting part, so that the lifting area can be increased, the lifting force is increased, the larger contact surface between the barb and the tissue is favorable for reducing pain, and the compliance of a patient is improved.
Description
Technical Field
The invention relates to a medical device, in particular to a lifting wire and a preparation method thereof.
Background
The embedded line is a special cosmetic lifting line implanted in the skin to stimulate the skin to proliferate collagen, thereby achieving the purpose of improving the loose state of the skin. The traditional wrinkle and skin removing surgery generally utilizes the surgery to perform subcutaneous peeling, redundant skin excision and then suture and lift, thereby achieving the treatment effect; the embedding thread is implanted to a part needing to be lifted by utilizing an absorbable thread (mainly comprising a small bell thread, Meidi plastic, minova and the like), and the phenomena of wrinkles, looseness and the like are improved by lifting the thread body. Compared with other existing non-operative wrinkle removal technologies such as a thermal magic tape and an ultrasonic scalpel, the embedded line side is heavy and anti-aging, can act on an epidermal layer and a dermal layer, and has an effect immediately after the embedded line side is finished.
The lifting line can be divided into smooth line, spiral line, sawtooth line and the like according to different line types, wherein the smooth line mainly plays a role in filling, whitening, spot lightening and the like, and the sawtooth line mainly plays a role in lifting and reshaping.
From the material point of view, the current mainstream material of the facial lifting wire is an absorbable material, and mainly comprises materials such as PDO, PPDO and the like. In recent years, with the continuous and deep research and the gradual progress of material science, more and more degradable materials are applied to the facial pulling string, such as poly (glycolide-co-lactide) (PGLA), poly (lactic-co-lactide) (PLLA), poly (caprolactone) (PCL), poly (lactic-co-caprolactone) (PLA-PCL), and the like. PPDO and PLA are mainly used in the aspect of selecting raw materials of the lifting wire, but the materials are easily absorbed by organism tissues, the degradation period is short, the filling effect is that the material temporarily occupies the body volume, and causes limited local host tissue reaction (limited regenerated fibrous nature), the long-term filling and collagen regeneration induction effects are difficult to maintain, the degradation period of the PCL material is long, and the change of the molecular weight can also control the degradation time.
The processing of the pull-up line cone body or the barb mainly comprises the technologies of injection molding, coining and cutting. Cutting is mainly based on injection molding and stamping at present because the structure of the thread main body needs to be damaged and the mechanical performance is reduced.
CN206745401U provides a facial lifting wire, which is made by injection molding a cone on the wire body, and adding three barbs (120 °) at the end of the cone increases the lifting effect, but the cross-sectional area is too large due to the three barbs, so the implanted wire is painful and has a large wound when moving in vivo. CN107468291A adopts integrative injection moulding to add the barb on the online body, but carries and to carry the effect weak, and the outside point makes foreign matter feel and painful sense strengthen.
Disclosure of Invention
The present invention is directed to solving at least one of the above problems.
The invention firstly provides a lifting wire, the cross section area of the extending end of the barb arranged on the lifting wire is larger than that of the connecting part, so that the lifting area can be increased, the lifting force is increased, the larger contact surface between the lifting wire and the tissue is favorable for reducing pain, and the compliance of a patient is improved.
A pull cord comprising: lifting the wire body; and a barb; one end of the barb is a connecting part and is fixed on the lifting line body; the other end of the barb is an extending end; the cross-sectional area of the extension end is larger than that of the connection portion.
According to the embodiment of the invention, the barbs can be distributed on the same radial plane of the pull-up line body, and also can be spirally distributed on different radial planes of the pull-up line body.
According to the embodiment of the invention, the barbs are distributed annularly along the radial plane of the pull wire body; preferably the gaps between the barbs on the ring are 2-5 mm.
According to an embodiment of the invention, the number of barbs on the radial plane of the pull wire body is at least 1, such as 1-10, in particular such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10.
According to an embodiment of the invention, the pull wire body is a helix formed by a helix of at least 3 filaments. The number of filaments is at least 3, such as 3-10, or 3-6, such as 3, 4, 5, 6, 7, 8, 9, 10.
According to an embodiment of the invention, the monofilament 101 is a spiral spun thread.
According to the embodiment of the invention, the number of barbs on the radial plane of the pulling line body is the same as that of monofilaments forming the pulling line body. Thus, the situation that the impression is not firm due to the connection of barbs to gaps among monofilaments can be avoided; and the tensile strength of the silk threads can be ensured to be the same in the lifting and pulling process, the situation that part of the silk threads are bent and deformed is avoided, and the silk threads are uniformly compacted and stretched.
According to the embodiment of the invention, the lifting wire body is a spiral line formed by 3 monofilaments in a spiral manner; the number of barbs on the radial plane of the pulling line body is 3, and the included angle between the barbs is 120 degrees. 3 barbs are uniformly distributed on the radial plane of the pulling line body, and the pulling line has a better pulling effect compared with a single barb.
According to the embodiment of the invention, the included angle between the outer side inclined edge of the barb and the pulling line body is 45-60 degrees. Therefore, the lifting effect can be further improved, and the barbs are not easy to bend and deform.
According to an embodiment of the invention, the barbs are conical or approximately conical. Fixed on the pulling-up line body by the vertex of the cone (as a connecting part).
According to an embodiment of the invention, the ratio of the cross-sectional area of the extension end to the cross-sectional area of the connection portion is (4-9: 1, e.g. 4:1, 5:1, 6:1, 7:1, 8:1, 9: 1. It has been found that the cross-sectional area of the connecting portion is too small and the barbs tend to fall off the pull cord body. The cross section area of the connecting part can be appropriate within the proportion range, the barb is not easy to fall off while the lifting effect is met, and the cross section area of the extending end is not too large, so that the wound is larger.
According to an embodiment of the invention, the diameter of the pull wire body is 0.4-1.0mm, such as 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm and 1.0 mm.
According to the embodiment of the invention, the cross-sectional diameter of the connecting part of the barb is 0.2-0.5 times of that of the pull wire body. For example, 0.2 times, 0.3 times, 0.4 times, 0.5 times. Therefore, the barbs are not easy to fall off from the pulling line main body, the connection strength is high, the line main body structure is damaged greatly, and the mechanical strength is reduced.
According to an embodiment of the present invention, the length of the barb is 0.5 to 1 times the diameter of the cross section of the body of the pull wire. For example, 0.5 times, 0.6 times, 0.7 times, 0.8 times, 0.9 times, 1 time. If the barbs are too short, the lifting effect is not obvious; too long gives a barb structure with poor mechanical properties and is easily broken. Within the range, the lifting effect and the mechanical property of the barb structure can be ensured.
The length of the barb refers to the distance between the connecting part of the barb and the extending end.
In some embodiments, the pull wire body is a helix formed by a helix of 3 filaments; the number of the barbs on the radial plane of the pulling line body is 3, and the included angle between the barbs is 120 degrees; the included angle between the inclined edge at the outer side of the barb and the lifting line body is 45-60 degrees; the diameter of the cross section of the barb connecting part is 0.2-0.5 times of that of the lifting wire body; the length of the barb is 0.5 to 1 time of the diameter of the cross section of the lifting wire body; the ratio of the cross-sectional area of the extending end to the cross-sectional area of the connecting part is (4-9): 1.
According to the embodiment of the invention, the material of the pull-up line body is selected from one or a combination of more of Polycaprolactone (PCL), polyethylene glycol (PEG) and a copolymer of polycaprolactone and polyethylene glycol (PCL-PEG).
In some embodiments, the material of the pull-up cord body is a mixture of polycaprolactone and polyethylene glycol; among them, it is preferable that the polyethylene glycol content in the mixture is 5 wt% to 20 wt%, for example, 5 wt%, 6 wt%, 7 wt%, 8 wt%, 9 wt%, 10 wt%, 11 wt%, 12 wt%, 13 wt%, 14 wt%, 15 wt%, 16 wt%, 17 wt%, 18 wt%, 19 wt%, 20 wt%. If the content of the polyethylene glycol exceeds 20 wt%, the mechanical tension of the wire body is too small and the wire body is fragile; if the content of polyethylene glycol is less than 5 wt%, the linear body is too less hydrophilic.
In some embodiments, the material of the pull-up cord body is a mixture of polycaprolactone and polyethylene glycol; of these, the polycaprolactone content in the mixture is preferably from 80% to 95% by weight, for example 95%, 94%, 93%, 92%, 91%, 90%, 89%, 88%, 87%, 86%, 85%, 84%, 83%, 82%, 81%, 80%.
In some embodiments, the weight ratio of polyethylene glycol to polycaprolactone in the mixture is (5-20):
(95-80)。
the mixture of polycaprolactone and polyethylene glycol in the invention refers to a physical mixture of polycaprolactone and polyethylene glycol, i.e. a polymer which is not a mixture of polycaprolactone and polyethylene glycol.
The inventor surprisingly found that the PEG and PCL are physically mixed (non-polymerized) without high temperature, so that the firm connection between the barbs and the helical line can be further strengthened at the temperature of less than or equal to 50 ℃. Compared with the prior cross-linking mixing (or copolymerization) method, the method can greatly reduce the melting point and facilitate the subsequent impression of the barbs.
According to an embodiment of the invention, the melting point of the body of the pulling wire is 55-60 ℃, such as 55 ℃ and 58 ℃ and 60 ℃.
According to the embodiment of the present invention, the molecular weight (weight average molecular weight, the same applies hereinafter) of the polycaprolactone is 10 to 25 ten thousand, for example 18 to 25 ten thousand, specifically, 10 ten thousand, 15 ten thousand, 18 ten thousand, 20 ten thousand, 22 ten thousand, 25 ten thousand.
According to the embodiment of the invention, the molecular weight (weight average molecular weight, the same applies hereinafter) of the polyethylene glycol is 4000-10000, such as 6000-10000, specifically 4000, 5000, 6000, 8000, 9000 and 10000.
According to the embodiment of the invention, the molecular weight of the copolymer of polycaprolactone and polyethylene glycol (PCL-PEG) is 10-25 ten thousand. Wherein, the molecular weight of the PCL is 10-25 ten thousand, such as 10 ten thousand, 15 ten thousand, 20 ten thousand and 25 ten thousand; the molecular weight of PEG is 4000-10000, such as 4000, 5000, 6000, 8000, 9000, 10000.
Researches find that the degradation time of the pulling wire can be prolonged by selecting the materials with the molecular weight range. In addition, the molecular weight of PEG in the range is favorable for improving the hydrophilicity of the pulling line.
According to an embodiment of the invention, the material of the pull-up cord body is made into oriented monofilament threads by electrospinning.
According to the embodiment of the invention, the oriented monofilament yarns are woven into a spiral line, namely the pulling yarn body.
According to an embodiment of the invention, the barbs are fixed on the lift wire body by coining.
According to an embodiment of the invention, the material of the barb is the same as the material of the pull wire body.
The invention also provides a preparation method of the pull-up wire, which comprises the following steps:
1) preparing the material for preparing the pull wire body into blended electrospinning liquid; preparing oriented monofilament yarns by electrostatic spinning;
2) weaving the oriented monofilament into a spiral line as a body of the lifting wire;
3) and impressing barbs on the spiral line.
In some embodiments, the solvent of the blended electrospinning solution may be selected from dichloromethane, chloroform, DMF, hexafluoroisopropanol, DMSO, ethyl acetate, and the like.
In some embodiments, the blended electrospinning liquid is made by physically mixing polycaprolactone, polyethylene glycol, and a solvent; wherein the polyethylene glycol content is preferably 5 wt% to 20 wt% based on the total weight of polycaprolactone and polyethylene glycol. In some embodiments, the weight ratio of polyethylene glycol to polycaprolactone is (5-20) to (95-80).
In some embodiments, the blended electrospinning liquid contains 10-15 wt% polycaprolactone, and 1-2 wt% polyethylene glycol.
In some embodiments, the magnetic field strength is 10000-50000 gauss when the magnetic field is applied in the direction perpendicular to the direction of the electric field during electrospinning.
In some embodiments, step 2) weaves the oriented monofilament thread into a spiral by a braiding machine.
In some embodiments, step 3) is 3D imprinting.
In particular, the barbs may be embossed on the periphery of the helix (the body of the puller wire) using a suitable die using an embossing press. Specifically, the imprinting temperature is 25-60 deg.C, such as 25 deg.C, 30 deg.C, 35 deg.C, 40 deg.C, 45 deg.C, 50 deg.C, 55 deg.C, 60 deg.C.
Specifically, the barbs are formed by adopting an imprinting mold with barbs, softening a line body at an imprinting temperature and imprinting.
Compared with the common fused monofilament, the embedded wire main body formed by spirally weaving the monofilament woven by electrostatic spinning and at least three strands of monofilaments HAs higher porosity, the porous structure is favorable for gel filling (HA, collagen and silk fibroin hydrogel can be used for loading lidocaine, antibiotics and the like to relieve surgical pain and inflammation), and in addition, the monofilament prepared by electrostatic spinning HAs orientation and can increase the axial tensile strength of the wire. The degradation rate is changed by controlling the molecular weight of the PCL, the melting temperature of the PCL is reduced by adding PEG, the implementation of an imprinting process is facilitated, and the regeneration and aggregation of regenerated collagen after implantation are improved due to the hydrophilicity.
The embodiment of the invention prepares a novel lifting line structure by a method combining electrostatic spinning and 3D imprinting, and is suitable for parts such as the face, the lower jaw and the like. Firstly, preparing thinner oriented monofilaments by an electrostatic spinning technology, increasing the axial stretching force of the monofilaments, and enabling the monofilaments prepared by electrostatic spinning to have oriented gaps so as to be beneficial to adsorption and oriented release of drugs; secondly, three monofilaments are spirally woven into a spiral line, and a high porosity structure is provided among the monofilaments to further strengthen axial stretching force; and thirdly, pressing the line body onto the cone by adopting a 3D imprinting technology to achieve the purpose of enhancing the lifting effect.
The invention also comprises the pulling wire prepared by the method.
The invention has at least one of the following technical effects:
1) the spiral pulling wire adopts an electrostatic spinning technology to prepare oriented monofilaments, the monofilaments are woven into a spiral line, high traction performance is provided, porosity can be further improved, and the high porosity provides a support for filling of gel (HA, collagen and silk fibroin hydrogel, the hydrogel can be loaded with lidocaine, antibiotics and the like to relieve operation pain and diminish inflammation) and migration of cells.
2) The barb (cone) adopts 3D impression technology, and intensity is higher, and 120 distribution mode guarantees to have the higher cross-sectional area that reduces when carrying the effect, and the wound is littleer during the operation.
3) The blunt surface lifting surface with the barb (cone) structure can increase the lifting area, thereby increasing the lifting force, and the larger contact surface between the blunt surface lifting surface and tissues is favorable for reducing pain and improving the compliance of patients.
4) The degradation rate is controlled by the change of the molecular weight of the polymer, the hydrophilic PEG component simplifies the process and can also promote the regeneration and aggregation of the regenerated collagen in vivo.
Drawings
Fig. 1 and 2: the drawing line structure of this embodiment is schematically illustrated.
FIG. 3: electron micrograph of electrospun oriented monofilament prepared in example 1.
FIG. 4: electron micrograph of electrospun oriented monofilament prepared in comparative example 4.
FIG. 5: electron micrograph of electrospun oriented monofilament prepared in comparative example 5.
FIG. 6: electron micrograph of electrospun oriented monofilament prepared in comparative example 6.
Detailed Description
The following examples are intended to illustrate the invention, but are not intended to limit the scope of the invention. The examples do not show the specific techniques or conditions, according to the technical or conditions described in the literature in the field, or according to the product specifications. The reagents or instruments used are conventional products available from regular distributors, not indicated by the manufacturer.
Key terms and technical abbreviations referred to herein
PCL: polycaprolactone
PEG: polyethylene glycol
PPDO: poly (p-dioxanone)
PGA: polyhydroxyacetic acid
PLA: polylactic acid
PLGA: polylactic-co-glycolic acid
HA: hyaluronic acid
As shown in fig. 1 and 2, the present embodiment provides a pulling wire including: the pull wire body 100, the barb 200; one end of the barb 200 is a connecting part 202 fixed on the pulling line body 100; the other end of the barb 200 is an extension end 201; the cross-sectional area of the extension end 201 is larger than that of the connection portion 202.
Further, the barbs 200 may be distributed in the same plane (radially) of the pull-up cord body 100 or may be distributed in a spiral shape in different planes of the pull-up cord body 100.
Further, the barbs 200 are distributed annularly along the radial plane of the pull wire body 100; preferably the gaps between the barbs 200 on the ring are 2-5 mm.
Further, the number of barbs 200 on the radial plane of the pull wire body 100 is at least 1, such as 1-10, specifically, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10.
Further, the pull wire body 100 is a spiral line formed by at least 3 monofilaments 101 in a spiral manner. The number of the monofilaments 101 is at least 3, such as 3 to 10, or 3 to 6, such as 3, 4, 5, 6, 7, 8, 9, 10.
Further, the monofilament 101 is a spiral spinning line.
Further, the number of barbs 200 on the radial plane of the pull cord body 100 is the same as the number of monofilaments 101 comprising the pull cord body 100. Thus, the situation that the impression is not firm due to the fact that barbs are connected to gaps among the monofilaments can be avoided; and the tensile strength of the silk threads can be ensured to be the same in the lifting and pulling process, the situation that part of the silk threads are bent and deformed is avoided, and the silk threads are uniformly compacted and stretched.
Further, the pulling wire body 100 is a spiral line formed by 3 monofilaments 101 in a spiral manner; the number of barbs on the radial plane of the pulling line body is 3, and the included angle between the barbs is 120 degrees. 3 barbs are uniformly distributed on the radial plane of the pulling line body, and the pulling line has a better pulling effect compared with a single barb.
Further, the angle between the outer side inclined edge of the barb 200 and the pull wire body 100 is 45-60 degrees. Therefore, the lifting effect can be further improved, and the barbs are not easy to bend and deform.
Further, the barbs 200 are conical or nearly conical. Is fixed to the pulling-up wire body 100 by the apex of the cone as a connecting portion.
Further, the ratio of the cross-sectional area of the extension end 201 to the cross-sectional area of the connection portion 202 is (4-9: 1), for example, 4:1, 5:1, 6:1, 7:1, 8:1, 9: 1. It has been found that the cross-sectional area of the connecting portion is too small and the barbs easily fall off the main body of the pull cord. The cross section area of the connecting part can be appropriate within the proportion range, the barb is not easy to fall off while the lifting effect is met, and the cross section area of the extending end is not too large, so that the wound is larger.
Further, the cross-sectional diameter of the connection part 202 of the barb is 0.2 to 0.5 times the cross-sectional diameter of the pull wire body 100. For example, 0.2 times, 0.3 times, 0.4 times, 0.5 times. Therefore, the barbs are not easy to fall off from the pulling line main body, the connection strength is high, the line main body structure is damaged greatly, and the mechanical strength is reduced.
Further, the length of the barb is 0.5-1 times the diameter of the cross section of the pull wire body 100. For example, 0.5 times, 0.6 times, 0.7 times, 0.8 times, 0.9 times, 1 time. If the barbs are too short, the lifting effect is not obvious; too long results in a barb structure having poor mechanical properties and being easily broken. Within the range, the lifting effect and the mechanical property of the barb structure can be ensured.
The length of the barb of the invention refers to the distance between the connecting part of the barb and the extending end.
In some embodiments, the pull wire body 100 is a helix formed by a helix of 3 monofilaments 101; the number of the barbs 200 on the radial plane of the pull wire body 100 is 3, and the included angle between the barbs 200 is 120 degrees; the inclined edge at the outer side of the barb 200 forms an included angle of 45-60 degrees with the lifting line body 100; the cross-sectional diameter of the connecting part 202 of the barb 200 is 0.2-0.5 times of the cross-sectional diameter of the pull wire body 100; the length of the barb 200 is 0.5 to 1 times of the diameter of the cross section of the pulling wire body 100; the ratio of the cross-sectional area of the extended end 201 to the cross-sectional area of the connection portion 202 is (4-9): 1.
The pull-up wire provided by the embodiment of the invention can regulate and control the degradation period of the pull-up wire according to the molecular weight of the polymer, and solves the problem that the degradation period of the existing beauty pull-up wire in vivo is short; in addition, the cone structure improves the lifting effect, the melting temperature of PCL is reduced by adding PEG, the implementation of a 3D imprinting process is facilitated, and the aggregation of regenerated collagen after implantation is facilitated by adding hydrophilic PEG; the increase of the porosity of the pulling wire is beneficial to gel filling (HA, collagen and silk fibroin hydrogel which can be loaded with lidocaine, antibiotics and the like to relieve the pain of operation and diminish inflammation).
Example 1
This embodiment provides a pulling wire, and its preparation method is as follows:
the method comprises the following steps: preparation of electrospun oriented monofilaments
PCL and PEG are used as starting raw materials, the molecular weight of the PCL is 25 ten thousand, the molecular weight of the PEG is 6000, dichloromethane is used as a solvent, an electrospinning solution containing 15 wt% of the PCL and 1.5 wt% of the PEG (the PCL and the PEG are physically mixed) is prepared, a magnetic field is added in the direction perpendicular to the direction of the electric field, the intensity of the magnetic field is 30000 gauss, and the electrospinning is used for preparing electrospinning oriented monofilaments with the diameter of about 0.28 mm.
An electron micrograph of the electrospun oriented filaments prepared in this example is shown in fig. 3.
Step two: preparation of helical wire body
Three strands of electrostatic spinning oriented monofilaments are woven into a spiral line, and the diameter of the spiral line is about 0.6mm
Step three: and (3) processing barbs (cones), softening the main body of the lifting wire by an embossing die with the barbs at an embossing temperature, and then embossing and forming.
Preparing a proper mold, preparing three cones at the periphery of the spiral line by using a stamping machine, wherein the stamping temperature is 50 ℃, the included angle between the cones is 120 degrees, the tip (vertex) of each cone is close to the spiral line body, the bottom surface of each cone is far away from the line body, the included angle between the side surface of each cone and the spiral line body is 50 degrees, the diameter of the bottom surface of each cone is 0.5 time of the diameter of the spiral line, the height of each cone is 1 time of the diameter of the spiral line, and the area ratio of the cross section area of the connecting part (the tip of each cone) to the cross section area of the extending end (the bottom surface of each cone) is 1: 4.
Example 2
This embodiment provides a pulling wire, and its preparation method is as follows:
the method comprises the following steps: preparation of electrospun oriented monofilaments
PCL and PEG are used as starting raw materials, the molecular weight of the PCL is 10 ten thousand, the molecular weight of the PEG is 6000, methylene dichloride is used as a solvent, an electrospinning solution containing 10 wt% of the PCL and 2 wt% of the PEG is prepared (the PCL and the PEG are physically mixed), and electrospinning is carried out to prepare an electrospinning oriented monofilament with the diameter of about 0.28 mm.
Step two: preparation of helical wire body
Three strands of electrostatic spinning are woven into a spiral line, and the diameter of the spiral line is about 0.6mm
Step three: and (3) processing barbs (cones), softening the main body of the lifting wire by an embossing die with the barbs at an embossing temperature, and then embossing and forming.
Preparing a proper die, pressing three cone barbs on the periphery of the spiral line by using a pressing machine, wherein the pressing temperature is 50 ℃, the included angle of the cone is 120 degrees, the tip ends of the cone barbs are close to the spiral line body, the round ends are far away from the line body, the inclined edge of the outer side of the cone body and the spiral line body form an included angle of 45 degrees, the diameter of the bottom circle of the cone is 0.2 times of the diameter of the spiral line, and the area ratio of the cross section area of the connecting part (tip end) to the area of the end part (bottom circle) of the extending end of the barb is 1: 4; the height of the cone is 1 times the diameter of the helix.
Example 3
This embodiment provides a pulling wire, and its preparation method is as follows:
the method comprises the following steps: preparation of electrospun oriented monofilaments
The PCL-PEG copolymer is used as a starting material, the molecular weight of the PCL is 25 ten thousand, the molecular weight of the PEG is 4000, dichloromethane is used as a solvent, an electrospinning solution containing 10 wt% of the PCL and 1 wt% of the PEG is prepared (the PCL and the PEG are physically mixed), and the electrospinning is used for preparing the electrospinning oriented monofilaments with the diameter of about 0.28 mm.
Step two: preparation of helical wire body
Three strands of electrostatic spinning are woven into a spiral line, and the diameter of the spiral line is about 0.6mm
Step three: and (3) processing barbs (cones), softening the main body of the lifting wire by an embossing die with the barbs at an embossing temperature, and then embossing and forming.
Preparing a proper die, pressing three cone barbs on the periphery of the spiral line by using a pressing machine, wherein the pressing temperature is 50 ℃, the included angle of the cone is 120 degrees, the tip (vertex) of the cone is close to the spiral line body, the bottom surface of the cone is far away from the line body, the included angle of the inclined edge of the outer side of the cone body and the spiral line body is 60 degrees, the diameter of the bottom surface of the cone is 0.2 time of the diameter of the spiral line, the area ratio of the cross section area of the connecting part (the tip of the cone) to the cross section area of the extending end (the bottom surface of the cone) is 1:9, and the height of the cone is 0.5 time of the diameter of the spiral line.
Example 4
This embodiment provides a pulling wire, and its preparation method is as follows:
the method comprises the following steps: preparation of electrospun oriented monofilaments
PCL and PEG are used as starting raw materials, the molecular weight of the PCL is 25 ten thousand, the molecular weight of the PEG is 10000, dichloromethane is used as a solvent, an electrospinning solution containing 10 wt% of the PCL and 2.0 wt% of the PEG (the PCL and the PEG are physically mixed) is prepared, a magnetic field is added in the direction vertical to the direction of the electric field, the intensity of the magnetic field is 30000 gauss, and the electrospinning is used for preparing an electrospinning oriented monofilament with the diameter of about 0.28 mm.
Step two: preparation of helical wire body
Weaving three strands of electrostatic spinning oriented monofilaments into a spiral line, wherein the diameter of the spiral line is about 0.6mm
Step three: and (3) processing barbs (cones), softening the main body of the lifting wire by an embossing die with the barbs at an embossing temperature, and then embossing and forming.
Preparing a proper mold, preparing three cones at the periphery of the spiral line by using a stamping machine, wherein the stamping temperature is 50 ℃, the included angle between the cones is 120 degrees, the tip (vertex) of each cone is close to the spiral line body, the bottom surface of each cone is far away from the line body, the included angle between the side surface of each cone and the spiral line body is 50 degrees, the diameter of the bottom surface of each cone is 0.5 time of the diameter of the spiral line, the height of each cone is 1 time of the diameter of the spiral line, and the area ratio of the cross section area of the connecting part (the tip of each cone) to the cross section area of the extending end (the bottom surface of each cone) is 1: 4.
Comparative example 1
This comparative example provides a pull wire, which differs from example 1 only in that PCL used in step one has a molecular weight of 5 ten thousand.
Comparative example 2
Compared with the embodiment 1, the lifting wire is different only in the difference of the dies in the third step and the structure of the embossed barbs, the diameter of the bottom surface of the cone in the embodiment 2 is 0.1 time of the diameter of the spiral line, and the height of the cone is 0.3 time of the diameter of the spiral line.
Comparative example 3
This comparative example provides a pull cord which differs from example 1 only in that: the weight ratio of PCL to PEG is 10:1, and the PCL and the PEG are melt-extruded to prepare monofilaments with the same thickness. Wherein the melt spinning speed is 15r/min, the diameter of an extrusion opening is 1mm, the die head temperature is 70 ℃, the feeding temperature is 28 ℃, the first zone temperature is 38 ℃, the second zone temperature is 48 ℃, the third zone temperature is 58 ℃, the extrusion temperature is 70 ℃, the screw pressure is 0.6mp, the water bath cooling temperature is 18 ℃, the filament outlet speed is 30m/min, the secondary drawing is 4 times, and the secondary drawing temperature is 60 ℃.
Comparative example 4
This comparative example provides a pull cord which differs from example 1 only in that: step one, the electrospinning solution contains 15 wt% of PCL and 5 wt% of PEG. And preparing spinning with the same thickness by adopting electrostatic spinning.
An electron micrograph of the electrospun oriented filaments prepared in this comparative example is shown in fig. 4.
Comparative example 5
This comparative example provides a pull cord which differs from example 1 only in that: the first step of electrospinning solution contains 15 wt% of PCL and 0.7 wt% of PEG. And preparing spinning with the same thickness by adopting electrostatic spinning.
An electron micrograph of the electrospun oriented filaments prepared in this comparative example is shown in fig. 5.
Comparative example 6
This comparative example provides a pull cord which differs from example 1 only in that: the molecular weight of PCL used in the first step is 28 ten thousand.
An electron micrograph of the electrospun oriented filaments prepared in this comparative example is shown in fig. 6.
Comparative example 7
This comparative example provides a pull cord, which differs from example 4 only in that: the barb connecting end and the extension end prepared in the third step have the same cross sectional area; wherein the cross-sectional diameter of the barbs is 0.5 times the diameter of the helix.
Comparative example 8
This comparative example provides a pull cord, which differs from example 4 only in that: and thirdly, the ratio of the cross section area of the barb connecting end to the cross section area of the extension end is 4:1, wherein the diameter of the cross section of the barb connecting end is 0.5 times of the diameter of the spiral line.
Experimental example 1: breaking strength and elongation at break
The experimental method comprises the following steps: the breaking strength of example 1 and comparative examples 1 and 4 to 6 was measured using an intelligent electronic tensile machine: the length of the measuring mark is L mm, the stretching speed is 2L mm/min, and the breaking strength and the breaking elongation of the pulling line are recorded.
As a result: the molecular weight is high, the higher the breaking strength of the pulling wire is, the smaller the breaking elongation is, and the pulling wire is not easy to deform while having a higher pulling effect in vivo.
From the results shown in fig. 3, fig. 4-6 and above, it can be seen that PEG accounts for a relatively large amount, the micro-structural filaments of the spinning electron microscope have no orientation, and a plurality of beads are present between the spun filaments, and the breaking strength is relatively small, and the mechanical strength is insufficient; as can be seen from fig. 5, the PEG content is small, the laying is non-oriented, and the mechanical strength is low; as can be seen from FIG. 6, after the molecular weight reaches 28 ten thousand, the viscosity of the electrospinning solution after dissolution is high, the electrospinning microstructure filaments are not smooth and irregular, and the internal pore structure is low, so that the mechanical strength is low.
Experimental example 2: lifting force test
The experimental method comprises the following steps: the pull-wires of example 1 and comparative example 2 were implanted to the same length using 4% sodium alginate and 7% calcium chloride to form a gel, and the intelligent electronic tensile machine was moved at the same rate (100mm/min) before the gel cured, and the maximum force at which the two pull-wires pulled from the gel was recorded.
As a result: the larger the diameter and the longer the height of the bottom circle of the barb cone, the stronger the lifting effect of the barb cone.
Experimental example 3: breaking strength and elongation at break
The porosity of both threads was measured and the breaking strength of example 1 and comparative example 3 was determined using an intelligent electronic tensile machine: the measuring gauge had a length of L mm and a drawing rate of 2L mm/min, and the breaking strength and elongation at break of the lift wire were recorded.
As a result: the monofilament prepared by electrostatic spinning has orientation, so that the breaking strength of the pulling wire is increased, the mechanical property is higher, the porosity is high, and the filling of gel and the migration and aggregation of cells are facilitated.
Experimental example 4: breaking strength, breaking elongation and lifting force test
The experimental method was the same as in experimental examples 2 and 3.
And (4) conclusion: as can be seen from the above table, when the areas of the extension end and the connection section are the same, the difference of the lifting force is not great, but the breaking strength of the thread main body is reduced; when the area of the extension end is smaller than that of the connecting section, the lifting force is too small, and the face stretching effect is weakened.
Although the invention has been described in detail hereinabove with respect to a general description and specific embodiments thereof, it will be apparent to those skilled in the art that modifications or improvements may be made thereto based on the invention. Accordingly, it is intended that all such modifications and alterations be included within the scope of this invention as defined in the appended claims.
Claims (10)
1. A pull cord, comprising:
lifting the wire body; and
a barb;
one end of the barb is a connecting part and is fixed on the lifting line body;
the other end of the barb is an extension end; the cross-sectional area of the extension end is larger than that of the connection portion.
2. The pull-cord of claim 1, wherein the barbs are distributed in the same radial plane of the pull-cord body; or the pulling wire body is spirally distributed on different radial planes of the pulling wire body; preferably the gaps between the barbs on the ring are 2-5 mm.
3. The puller wire according to claim 1 or 2, wherein the puller wire body is a helix formed by a helix of at least 3 filaments; optionally, the number of filaments is at least 3-10, or 3-6.
4. A puller wire as in any of claims 1-3, wherein the number of barbs in a radial plane of the puller wire body is the same as the number of monofilaments comprising the puller wire body.
5. The puller wire according to any one of claims 1-4, wherein the ratio of the cross-sectional area of the extended end to the cross-sectional area of the connecting portion is (4-9): 1; and/or the presence of a gas in the gas,
the diameter of the cross section of the barb connecting part is 0.2-0.5 times of that of the lifting wire body; and/or the presence of a gas in the gas,
the length of the barb is 0.5 to 1 time of the diameter of the cross section of the lifting wire body; and/or the presence of a gas in the gas,
the included angle of the barbs is 120 degrees; and/or the presence of a gas in the gas,
the included angle between the inclined edge at the outer side of the barb and the lifting line body is 45-60 degrees.
6. The pulling thread according to any one of claims 1 to 5, wherein the material of the pulling thread body is selected from one or a combination of polycaprolactone, polyethylene glycol, and a copolymer of polycaprolactone and polyethylene glycol;
optionally, the material of the pull line body is a mixture of polycaprolactone and polyethylene glycol; wherein, the content of the polyethylene glycol in the mixture is preferably 5 to 20 weight percent; preferably, the mixture of polycaprolactone and polyethylene glycol refers to a physical mixture of the two;
optionally, the polycaprolactone has a molecular weight of 10-25 ten thousand;
optionally, the molecular weight of the polyethylene glycol is 4000-10000;
optionally, the molecular weight of the copolymer of polycaprolactone and polyethylene glycol is 10-25 ten thousand; among them, PCL having a molecular weight of 10 to 25 ten thousand is preferable; preferably, the PEG molecular weight is 4000-10000.
7. The method for producing a pulling wire according to any one of claims 1 to 6, comprising:
1) preparing the material for preparing the pull wire body into blended electrospinning liquid; preparing oriented monofilament yarns by electrostatic spinning;
2) weaving the oriented monofilament thread into a spiral line as a body of the lifting wire;
3) and impressing barbs on the spiral line.
8. The method for preparing the pulling-wire according to claim 7, wherein the solvent of the blended electrospinning solution is selected from dichloromethane, chloroform, DMF, hexafluoroisopropanol, DMSO, ethyl acetate; and or (b) a,
the blended electrospinning liquid is prepared by physically mixing polycaprolactone, polyethylene glycol and a solvent; wherein, based on the total weight of the polycaprolactone and the polyethylene glycol, the content of the polyethylene glycol is preferably 5 wt% -20 wt%; optionally, the weight ratio of polyethylene glycol to polycaprolactone is (5-20) to (95-80); and/or the presence of a gas in the gas,
the blended electrospinning solution contains 10-15 wt% of polycaprolactone and 1-2 wt% of polyethylene glycol.
9. The method for preparing a pulling wire as defined in claim 7 or 8, wherein a magnetic field is applied in a direction perpendicular to the direction of the electric field during electrospinning, and the magnetic field strength is 10000- & 50000 gauss; and/or the presence of a gas in the gas,
step 2) weaving the oriented monofilament yarns into spiral lines by a weaving machine; and/or the presence of a gas in the gas,
the temperature of the embossing is 25-60 ℃.
10. A lift wire produced by the method of any one of claims 7 to 9.
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