WO2020253256A1 - 一种单向提拉埋植线、提拉装置及使用其的整形方法 - Google Patents

一种单向提拉埋植线、提拉装置及使用其的整形方法 Download PDF

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Publication number
WO2020253256A1
WO2020253256A1 PCT/CN2020/076357 CN2020076357W WO2020253256A1 WO 2020253256 A1 WO2020253256 A1 WO 2020253256A1 CN 2020076357 W CN2020076357 W CN 2020076357W WO 2020253256 A1 WO2020253256 A1 WO 2020253256A1
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WIPO (PCT)
Prior art keywords
pulling
cam body
lifting
line
wire
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2020/076357
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English (en)
French (fr)
Inventor
晏伟
夏佩佩
魏征
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tongyan Shanghai Medical Equipment Co Ltd
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Tongyan Shanghai Medical Equipment Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tongyan Shanghai Medical Equipment Co Ltd filed Critical Tongyan Shanghai Medical Equipment Co Ltd
Priority to EP20826661.9A priority Critical patent/EP3915516B1/en
Priority to KR1020217037955A priority patent/KR102665937B1/ko
Priority to JP2021553851A priority patent/JP2022524195A/ja
Publication of WO2020253256A1 publication Critical patent/WO2020253256A1/zh
Priority to US17/470,822 priority patent/US20220000471A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • 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
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00747—Dermatology
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00792—Plastic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00893—Material properties pharmaceutically effective
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0448—Additional elements on or within the anchor
    • A61B2017/0451—Cams or wedges holding the suture by friction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0461—Means for attaching and blocking the suture in the suture anchor with features cooperating with special features on the suture, e.g. protrusions on the suture
    • A61B2017/0462—One way system, i.e. also tensioning the suture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0496—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A61B2017/06176—Sutures with protrusions, e.g. barbs
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Definitions

  • the application belongs to the technical field of medical devices, and relates to a unidirectional pulling implantation line, a pulling device, and a shaping method using the same.
  • the soft tissue and bone volume of the human face will shrink, ligaments begin to relax, the superficial muscle fascia system gradually droops, the zygomatic and cheek fat pads relax and the effect of gravity, the facial surface tissues show sagging, Decrease in elasticity, increase in wrinkles, and deepen groove formation. And with the increase of age, hormone levels in the body change, collagen loss and facial gland atrophy and other factors together make the face show undesirable changes in characteristics-aging.
  • the silk thread is made of biodegradable and absorbable materials with good biocompatibility. After a period of time, while the silk thread is degraded and absorbed by the facial tissue, it can stimulate the regeneration of collagen in the subcutaneous tissue to form a new Support ligaments and elastic fibers, make facial skin thicker and prevent skin aging.
  • CN207804289U discloses a new type of beauty lifting wire, comprising a pulling wire and needles connected at both ends; two sets of lifting pieces are symmetrically arranged on the pulling wire, and the lifting pieces are horn-shaped; the pulling wire connects the two groups of lifting pieces, and the two groups of lifting pieces are symmetrically distributed On both sides of the middle section of the cable, and the small heads of each group of lifting members are facing the needles of the same side of the cable, the inner side of the small heads of the lifting members is provided with a non-slip knot, the size of the non-slip knot is larger than the inner hole diameter of the small head.
  • the purpose of this application is to provide a unidirectional lifting implant line, a lifting device and a shaping method using the same.
  • the unidirectional lifting implant line has a large lifting force and a lifting time. Long, simple operation, no obvious surgical marks on the visible part of the back of the operation.
  • the present application provides a unidirectional lifting implantation line.
  • the unidirectional lifting implantation line includes a pulling wire and at least one cam body sleeved on the pulling wire.
  • the two ends of the pulling wire are divided into a pulling end and a free end, and the free end is provided with an anchor point structure for fixing the pulling wire.
  • the two sides of the cam body are divided into a large end surface and a small end surface, and the large end surfaces of the cam body all face the free end of the traction line.
  • the lifting end and the free end are terms created by the inventor.
  • the lifting end refers to the end where the pulling wire enters the skin tissue first after the one-way lifting implant thread penetrates the skin tissue and is named the lifting end.
  • the lifting end can realize the lifting and wrinkle removal effect on the skin tissue;
  • the free end refers to the end that remains outside the skin tissue after the one-way lifting implant thread penetrates the skin tissue and is named the free end.
  • the anchor point structure at the free end is used to fix the skin tissue to prevent the one-way pulling implant thread from slipping into the tissue.
  • the large end surface and the small end surface are distinguished by the size of the cross-sectional area.
  • the cam body used in this application is a non-equal diameter cylindrical structure, the end with the smaller cross-sectional area is named the small end surface, and the end with the larger cross-sectional area is named the large end surface.
  • the present application improves the traditional two-way lifting method into a one-way lifting method by setting an anchor point structure. While ensuring that the implanted thread does not slide into the skin tissue completely, the pulling force is improved and the pulling time is shortened. .
  • the traction line is provided with 4-24 cam bodies, for example, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, or 24.
  • the cam bodies are equidistantly distributed on the traction line.
  • the distance between two adjacent cam bodies is 2.5-15mm, for example 2.5mm, 3mm, 3.5mm, 4mm, 4.5mm, 5mm, 5.5mm, 6mm, 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, 9.5mm, 10mm, 10.5mm, 11mm, 11.5mm, 12mm, 12.5mm, 13mm, 13.5mm, 14mm, 14.5mm or 15mm, more preferably, between two adjacent cam bodies The spacing is 5.5mm.
  • the cam body is unequal-distance gradient distribution on the traction line.
  • Those skilled in the art need to select an appropriate gradient distribution law according to the patient's physical condition and the need for plastic surgery.
  • the anchor point structure is a hollow knot or a buckle.
  • the function of the anchor point structure is to jam the one-way lifting implant line to prevent the one-way lifting and embedding line from slipping and completely sliding into the skin tissue, causing the operation to fail.
  • the conventional lifting implant thread is mostly a two-way lifting operation. The problem is that on the one hand, it needs to be pierced at a symmetrical position on the face, so acupuncture wounds must be formed at visible positions on the face, resulting in surgical marks after the operation.
  • part of the cam body in the two-way lifting implant line is used to hold the skin tissue, and the remaining part of the cam body is really used to achieve the lifting effect, while the individual cam body
  • the number is closely related to the pulling force and the pulling time. The more the number of cam bodies, the greater the pulling force and the shorter the pulling time. Therefore, under the premise of using the same number of cam bodies, the two-way pulling effect is less Obviously inferior to the lifting effect of one-way lifting. Therefore, the present application simply improves the structure of the existing two-way lifting and embedding line.
  • An anchor point structure is added at the pulling end of the pulling line, and the anchor point structure is used to replace the two-way lifting and embedding line used for clamping.
  • the part of the cam body that tightens the skin tissue ensures that the pulling implant thread will not completely slip into the skin tissue, while increasing the pulling force and shortening the pulling time.
  • the hollow knot refers to the opposite way of knotting with the slip knot.
  • the difference is that the knot state of the hollow knot and the slip knot is different after the thread is straightened. After the hollow knot is straightened, the slip knot is locked and formed Dead knot; and after the thread is straightened, the slip knot is unwrapped and the knot disappears.
  • this application does not specifically limit and describe it in detail. After the thread is straightened, the knot is locked and the knot is formed. Knotting methods can be used in this application, and all fall within the scope of disclosure and protection of this application.
  • the buckle structure refers to a clamping component that can move in one direction.
  • it can include a one-way barb structure provided on the traction line and a one-way lock in cooperation with the barb structure. After the chuck, the chuck and the barb structure are locked, the entire buckle structure can only move forward but not backward.
  • the buckle structure provided in the present application is not in the structure or material itself, but in the role and function it can play. Therefore, an anchor point structure of any shape that can achieve the above technical effects Both can be used in this application, and all fall within the scope of disclosure and protection of this application.
  • the cross-sectional area of the small end surface of the cam body is smaller than the cross-sectional area of the large end surface.
  • the cross-sectional area of the small end surface of the cam body in this application is smaller than the cross-sectional area of the large end surface.
  • the pulling wire is a single-strand wire or a multi-strand wire.
  • the cam body has a tapered structure.
  • the cam body has a solid cone structure.
  • the cam body and the traction wire are integrally formed, and further preferably, the cam body and the traction wire are integrally formed by a hot press injection molding process.
  • the cam body has a tapered structure penetrating in the axial direction.
  • the wall thickness of the cam body gradually decreases.
  • the wall thickness at the small end surface of the cam body is 0.1-0.9mm, for example, it can be 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm or 0.9mm, It is preferably 0.3 mm.
  • the wall thickness at the large end surface of the cam body is 0.05 to 0.2 mm, for example, it can be 0.05 mm, 0.08 mm, 0.1 mm, 0.12 mm, 0.15 mm, 0.18 mm or 0.2 mm, preferably 0.09 mm.
  • the cam body and the pulling wire are fixed by an adhesive.
  • the cam body and the pulling wire are fixed by heat sealing.
  • a limiting member is provided between adjacent cam bodies to limit the relative positions of the cam bodies.
  • the function of the limiter is: on the one hand, it ensures the stability of the traction line and the cam body to avoid relative slippage. On the other hand, when the cam body enters the skin tissue, once the cam position is fixed, the traction line can also be positioned The corresponding position plays a better lifting effect.
  • the limiting member is a wire knot.
  • the limiter described in this application is not limited to any structure, form or shape, and any component that can function as a limiter can be used in this application.
  • a more preferred limit method is: A certain distance is knotted by itself to block the cam body and prevent the cam body from slipping on the traction line. However, in this application, the distance between adjacent stoppers is greater than the length of the cam body in the axial direction. Therefore, the cam body is still A small amount of slip can be carried out between adjacent limit pieces, but it will not completely slip off the traction line.
  • the present application optionally adds other engagement reinforcement components to the cam body to help enhance the engagement between the cam body and the skin tissue.
  • the engagement reinforcement member is an oblique cone thorn covering the outer surface of the cam, the cone tip of the cone thorn faces outward, the bottom surface of the cone thorn is in contact with the cam wall, the line connecting the cone tip and the center of the bottom surface and the cam
  • the included angle formed by the outer wall surface is denoted as ⁇ .
  • the value range of the included angle ⁇ is 10° ⁇ 45°.
  • the meshing reinforcement component and the tissue have better meshing ability.
  • ⁇ 10° the opening of the meshing reinforcement component is too small, and it is in a closed state after entering the tissue, even if the suture starts to fall off due to the reverse force. It is also difficult for the engagement reinforcement component to automatically open and engage the tissue; when ⁇ >45°, the engagement reinforcement component opens too much, and the engagement reinforcement component is prone to produce greater resistance when entering the tissue, which may cause tissue damage.
  • the engagement reinforcement member may also be a tooth-shaped structure provided on the large end surface of the cam body.
  • the tooth-like structure with no less than 3 teeth can further increase the engagement strength between the one-way lifting implant thread and the skin tissue, and the taper on the outer surface of the cam can further increase the engagement between the one-way lifting implant thread and the tissue At the same time, it can also effectively prevent the cam body from falling off, so that the one-way lifting implant line can be firmly and precisely fixed inside the skin tissue to avoid the lifting effect on the tissue due to the cam falling off.
  • the cam body and the pulling wire are made of degradable materials.
  • the degradable material includes synthetic degradable polymer materials and/or natural degradable polymer materials.
  • the synthetic degradable polymer material includes polylactic acid, L-polylactic acid, DL-polylactic acid, polyglycolide copolymer, polycaprolactone, polypentyl hydroxybutyrate, polyacetyl glutamate Any one or a combination of at least two of acid, polyorthoester, polyoxyethylene/polybutene copolymer, and polylactide-cocaprolactone copolymer.
  • the natural degradable polymer material includes any one or a combination of at least two of collagen, gelatin, chitosan, hyaluronic acid, sodium alginate and agarose.
  • the traction wire and/or the surface of the cam body is loaded with medicine.
  • the drug is selected from one or a combination of at least two of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, opioids or analgesic adjuvants.
  • the present application provides a lifting device, which includes a needle tubular conveying part, a holding handle, and the unidirectional lifting implant thread according to the first aspect, the needle tubular conveying part It includes a fixed end and an open end, and the fixed end is fixed with the grip handle.
  • the pulling wire pulling end of the unidirectional pulling implant thread passes through the inside of the needle tubular conveying part through the open end of the needle tubular conveying part.
  • the open end of the needle tube conveying part is provided with a cam body position adjustment part, and the cam body position adjustment part is used to readjust the cam when the needle tube conveying part is withdrawn from the skin tissue. Return the body to the preset position or straighten and tighten the one-way lifting implant line.
  • the relative position of the cam body is limited by the limiting effect of the limiting element to prevent slippage, it can still make a small slip between adjacent limiting elements. Therefore, When the needle tube conveying part penetrates the skin tissue, the relative position of the cam body in the skin tissue cannot be fully ensured. The possible result is that before the needle tube conveying part penetrates the skin tissue, the cam bodies are still limited by the stopper. Keep the equidistant position distribution under the action of the position, but as the needle tube conveying part penetrates the skin, the cam body will slip slightly between the adjacent stoppers under the action of friction with the puncture port. As a result, the distance and positional relationship of the cam body entering the skin tissue are shifted.
  • the present application is provided with a cam body position adjustment component at the open end.
  • the cam body on the one-way lifting implantation line will pass through the cam body position adjustment part one by one. Under the action of friction or resistance between the cam body position adjustment part and the cam body, the cam body will return to the position of the limiter or the cam body. The body maintains the same or regular spacing along with the extension of the traction line.
  • the cam body position adjustment component is a blocking baffle at the open end, and the blocking baffle is fixed inside the needle-shaped conveying part.
  • the present application does not specifically limit the shape of the blocking baffle, and any blocking baffle of any structure that can provide friction or resistance to the cam body and urge the cam body to return to the position of the limiting member can be used in this application.
  • the locking baffle is fixed to the inside of the needle-like conveying part along the radial direction of the needle-like conveying part or fixed to the inside of the needle-like conveying part along the axial direction of the needle-like conveying part.
  • the cam body has elasticity, so that after the cam body position adjustment component applies friction or resistance to the cam body, the cam body can smoothly pass through the open end of the needle-shaped conveying part, which facilitates the withdrawal of the needle-shaped conveying part.
  • the blocking baffle is made of soft plastic material.
  • the soft plastic material can prevent the cam body from being damaged when it is in frictional contact with the blocking baffle, which affects the subsequent lifting operation.
  • the soft plastic material is any one or at least two of silicone rubber, polyurethane (PU), polypropylene (HDPE), high density polyethylene (PTFE) and polytetrafluoroethylene (PTFE) combination.
  • PU polyurethane
  • HDPE polypropylene
  • PTFE high density polyethylene
  • PTFE polytetrafluoroethylene
  • the open end of the needle-like conveying part adopts a necking structure that is concave in the radial direction of the needle-like conveying part, and the necking structure is used to withdraw from the needle-like conveying part. Re-adjust the cam body to return to the preset position or straighten and tighten the one-way lifting implant line when skin tissue is being used.
  • the design concept of the necking structure is similar to the above-mentioned cam body position adjustment component.
  • the purpose to be achieved is to readjust the position relationship of the cam body.
  • the cam body is contracted one by one.
  • the present application provides a shaping method for lifting by using the unidirectional pulling device described in the second aspect, and the shaping method includes:
  • the lifting device pierces the skin tissue, presses and fixes the pulling end of the pulling wire of the one-way pulling implant thread through the skin tissue, and at the same time withdraws the needle tube conveying part, the one-way pulling implant thread stays in the skin tissue ;
  • the anchor point structure fixes the one-way pulling implant line to prevent the one-way pulling implant line from completely sliding into the skin tissue, and adjust the pulling force by adjusting the pulling force of the pulling end of the one-way pulling implant line to achieve lifting wrinkle.
  • the said shaping method further includes the step of installing a unidirectional pulling implant line before step (I).
  • the installation process includes: tightening the one-way lifting implantation wire, passing the pulling end of the pulling wire through the inside of the needle tubular conveying part through the threading tool, passing through the open end of the needle tubular conveying part, and passing out After retaining the excess traction line.
  • step (I) the septal skin tissue is pressed to fix the excess pulling line after passing out, so as to fix the unidirectional pulling implant line.
  • the cam body position adjustment component and/or the necking structure re-adjust the cam body to the preset position or straighten and tighten the one-way lifting Embedding line.
  • the cam body position adjustment component plays the role of straightening and tightening the unidirectional lifting implantation wire;
  • the body and the traction line are fixed by the way of limit parts, then the cam body can still make a small slip between the adjacent limit parts.
  • the cam body position adjustment component can play the role of re-adjusting the cam body to return to the preset position And the function of straightening and tightening the one-way lifting implantation line.
  • the preset position is the clamping position between the large end surface of the cam body and the limiting member.
  • the shaping method further includes: fixing the one-way pulling implant line after step (II) is completed.
  • the fixing method is: the free end of the pulling wire of the implanted wire is pulled one-way and fixed to the puncture entrance by knotting with the skin tissue.
  • step (I) and step (II) are used to embed multiple sets of unidirectional pulling implant lines at the same puncture entrance, and the free ends of the pulling wires of the multiple sets of unidirectional pulling implant lines are knotted or Multiple groups are tied to each other and fixed at the puncture entrance.
  • the unidirectional lifting implant thread provided in this application realizes the fixation of the unidirectional lifting implant thread and the skin tissue by setting the anchor point structure, and prevents the unidirectional lifting implant thread from sliding into the skin tissue completely;
  • the present application also provides a lifting device, which realizes the readjustment of the position of the cam body during the needle withdrawal process by providing a cam position adjustment component or a necking structure at the open end of the needle tube conveying part to maintain the cam body
  • the relative position does not slip when entering the skin tissue, and at the same time it has a straightening and tightening effect on the one-way lifting implant thread, preventing it from entanglement after entering the skin tissue, resulting in uneven force during the lifting process. Affect the lifting effect.
  • FIG. 1 is a schematic structural diagram of a lifting device provided by a specific embodiment of this application, in which the enlarged area shows the installation position of the unidirectional lifting implant line;
  • Fig. 2 is a schematic structural diagram of a unidirectional pulling implant line provided by a specific embodiment of the application, in which the traction line and the cam body are fixed by a limiting member;
  • FIG. 3 is a schematic structural diagram of a unidirectional pulling implant line provided by a specific embodiment of this application, in which the pulling line and the cam body are integrally formed;
  • Fig. 4 is a schematic structural diagram of a lifting device (excluding a unidirectional lifting implant line) provided by a specific embodiment of the application, in which the enlarged area shows the structure of the open end and the blocking baffle.
  • 1- one-way pulling implantation line 11-traction line; 12-cam body; 2-needle tubular conveying part; 21-embedding thread through exit; 22-cam body position adjustment component; 3-holding handle .
  • the present application provides a one-way lifting implantation line 1.
  • the unidirectional lifting implantation line 1 is shown in Figures 2 and 3, and includes a pulling line 11 and sleeves At least one cam body 12 on the pulling wire 11.
  • the two ends of the pulling line 11 are divided into a pulling end and a free end.
  • the free end is provided with an anchor point structure for fixing the pulling line 11, and the anchor point structure may be a hollow knot or a buckle.
  • the two sides of the cam body 12 are divided into a large end surface and a small end surface, and the large end surface of the cam body 12 faces the free end of the traction wire 11.
  • the cam bodies 12 are equidistantly distributed or unequal-distance gradient distribution on the traction line 11; the distance between two adjacent cam bodies 12 is 2.5-15mm, and the traction line 11 is sleeved with 4-24 cam bodies 12. Those skilled in the art can adjust the matching relationship between the distance between adjacent cam bodies 12 and the number of cam bodies 12 according to the patient's physical condition and the desired lifting effect.
  • the cam body 12 has a tapered structure, and optionally includes a cone (flat-headed cone) and a pyramid (flat-headed pyramid).
  • the cam body 12 may be a solid cone structure or a tapered structure penetrating axially.
  • the fixing method of the cam body 12 and the pulling wire 11 is as shown in FIG. 3, and the unidirectional lifting implant wire 1 is manufactured by a hot-pressing injection integral molding process.
  • the cam body 12 adopts a conical structure penetrating in the axial direction the wall thickness of the cam body 12 gradually decreases along the direction from the small end surface to the large end surface, and the fixing method of the cam body 12 and the traction line 11 can optionally adopt an adhesive , Heat-sealing or fixing of the limiting member, a preferred technical solution is shown in Fig. 2, in which the traction wire 11 itself is knotted to achieve the limiting and fixing effect of the cam body 12.
  • the cam body 12 and the pulling wire 11 are made of degradable materials, which do not need to be taken out after the operation. They are degraded in the body and have no toxic side effects to the human body.
  • the degradable materials used include synthetic biodegradable polymer materials and/or natural biodegradable materials. Degrade polymer materials.
  • the synthetic degradable polymer material is selected from polylactic acid, L-polylactic acid, DL-polylactic acid, polyglycolide copolymer, polycaprolactone, polypentyl hydroxybutyrate, polyacetylglutamic acid, Any one or a combination of at least two of polyorthoesters, polyoxyethylene/polybutene copolymers and polylactide cocaprolactone copolymers, the natural degradable polymer material is selected from collagen, gelatin, chitosan Any one or a combination of at least two of, hyaluronic acid, sodium alginate and agarose.
  • the surface of the traction wire 11 and/or the cam body 12 is also loaded with drugs, which can be selected as one or a combination of at least two of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, opioids, or analgesic adjuvants ,
  • drugs which can be selected as one or a combination of at least two of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, opioids, or analgesic adjuvants .
  • the medicine can be loaded on the pulling wire 11 or the surface of the cam body 12 alone, or it can be loaded on the pulling wire 11 and the surface of the cam body 12.
  • the present application provides a lifting device as shown in FIG. 1, which includes a needle-shaped conveying portion 2, a gripping handle 3, and the unidirectional lifting implant line 1 provided in the above specific embodiment.
  • the needle-shaped conveying part 2 includes a fixed end and an open end, the fixed end is fixed with the grip handle 3; the open end is provided with an implant thread through outlet 21 (for detailed structure, please refer to the partial enlarged view in Fig. 1, which is shown in the partial enlarged area The structure diagram of the single-line lifting implant line and the state of the unidirectional lifting implant line 1 when it passes through the implant line through exit 21).
  • the pulling end of the pulling wire 11 of the unidirectional pulling implanting wire 1 passes through the implanting wire through exit 21 through the inside of the needle-shaped conveying part 2.
  • the “passing out” and “passing in” here refer to the positional relationship and state during installation, and do not refer to installation actions and methods.
  • a cam body position adjustment component 22 is provided at the implant thread through outlet 21 for re-adjusting the cam body 12 to return to a preset position when the needle tube conveying part 2 is withdrawn from the skin tissue.
  • an optional cam body position adjustment component 22 is a blocking baffle located at the embedding line through exit 21 (the specific structure and position relationship of the blocking baffle can be referred to the partial area enlarged view in FIG. 4)
  • the material of the blocking baffle is a soft plastic material, which can optionally include any one or a combination of at least two of silicone rubber, PU, PP, HDPE and PTFE.
  • a constricted structure that is concave in the radial direction of the needle-shaped conveying part 2 can also be designed at the open end of the needle-shaped conveying part 2 to withdraw from the needle-shaped conveying part 2.
  • the cam body 12 is readjusted to return to the preset position.
  • the present application provides a shaping method using the aforementioned lifting device for lifting, and the shaping method includes:
  • the threading is performed before the operation. Specifically, the threading process includes: tightening the one-way lifting implant thread 1, and threading the pulling end of the pulling thread 11 through the grip part of the pulling device through the needle tubular conveying part 2 through the threading tool.
  • the inside of the implanted thread is passed through the implanted thread through the exit 21. After passing through, the excess traction thread 11 is retained, and the excess traction thread 11 is bent.
  • the excess traction thread 11 is used to facilitate the separation of the surgeon when the needle is removed during the operation.
  • the skin tissue is pressed to fix the unidirectional lifting implant thread 1 to prevent the unidirectional lifting implant thread 1 from being withdrawn along with the needle tubular conveying part 2 during the needle withdrawal process.
  • the "pierce in” and “pierce out” mentioned here refer to the installation actions and methods, and do not specifically refer to the installation state and positional relationship.
  • the surgery includes:
  • the lifting device is pierced into the skin tissue, and the implant thread is pulled in one direction.
  • the cross-sectional area of the cam gradually increases from the small end to the large end, it is convenient to enter the tissue and can reduce the damage to the tissue.
  • Fix the pulling end of the pulling wire 11 of the one-way pulling implant thread 1 that is, the extra pulling wire 11 reserved during the threading before the operation), and at the same time slowly withdraw the needle tube conveying part 2;
  • the one-way lifting implant thread 1 stays inside the skin tissue. Because the one-way lifting implant thread 1 is a biodegradable material, it can be degraded in human tissues, so it will not cause toxic side effects to the human body.
  • steps (I) and (II) to achieve multiple groups of one-way lifting implant lines 1 implanted at the same puncture entrance.
  • multiple groups of one-way lifting implants The free ends of the traction line 11 of the thread 1 are knotted in pairs or multiple groups of mutual knots and fixed at the puncture entrance. While reducing the puncture entrance, it can achieve the lifting effect of multiple parts and prevent the patient from showing obvious surgical marks or Scars that are difficult to recover.
  • This embodiment provides a unidirectional lifting implantation line 1, including a pulling line 11 and four cam bodies 12 sleeved on the pulling line 11, each cam body 12 is equidistantly distributed on the pulling line 11, The distance between two adjacent cam bodies 12 is 15 mm, and the thread knot formed between the adjacent cam bodies 12 by the knotting of the pulling wire 11 itself defines the relative position between the adjacent cam bodies 12.
  • the two ends of the pulling wire 11 are divided into a pulling end and a free end.
  • the free end is provided with a hollow knot for fixing the pulling wire 11.
  • By tying the hollow knot at the pulling end it replaces the two-way pulling implanted wire used for clamping
  • the part of the cam body 12 that tightens the skin tissue ensures that the pulling implant thread will not completely slip into the skin tissue, while increasing the pulling force and shortening the pulling time.
  • the two sides of the cam body 12 are divided into a large end surface and a small end surface.
  • the large end surface faces the free end of the pulling wire 11, and naturally, the small end surface faces the pulling end of the pulling wire 11.
  • the cam body 12 is a conical structure penetrating in the axial direction.
  • the wall thickness at the small end surface is 0.9mm, and the wall thickness at the large section is 0.2mm.
  • the wall thickness of the cam body 12 Gradually reduce, that is, uniformly reduce from 0.9mm to 0.2mm.
  • Both the cam body 12 and the pulling wire 11 are made of degradable materials, which can be self-degraded in the skin tissue without taking them out after the operation.
  • the surfaces of the cam body 12 and the pulling wire 11 are both loaded with non-steroidal anti-inflammatory drugs.
  • This embodiment also provides a lifting device, which includes a needle tubular conveying part 2, a holding handle 3, and the above-mentioned unidirectional pulling implantation thread 1, wherein the needle tubular conveying part 2 includes a fixed end and an open end, and the fixed end It is fixed with the grip handle 3; the opening end is provided with an implant thread through exit 21, and the pulling end of the pulling line 11 of the one-way pulling implant thread 1 is passed through the implant thread through exit 21 through the inside of the needle tubular conveying part 2.
  • a lifting device which includes a needle tubular conveying part 2, a holding handle 3, and the above-mentioned unidirectional pulling implantation thread 1, wherein the needle tubular conveying part 2 includes a fixed end and an open end, and the fixed end It is fixed with the grip handle 3; the opening end is provided with an implant thread through exit 21, and the pulling end of the pulling line 11 of the one-way pulling implant thread 1 is passed through the implant thread through exit 21 through the inside of the needle tubular conveying part 2.
  • a blocking baffle made of silicone rubber is provided at the implant thread exit 21, which is used to re-adjust the cam body 12 to return to the preset position and straighten and tighten the unidirectional lifting when the needle-shaped conveying part 2 is withdrawn from the skin tissue
  • the blocking baffle is fixed inside the needle-shaped conveying part 2 along the radial direction of the needle-shaped conveying part 2.
  • the blocking baffle provided at the implant thread through the exit 21 exerts friction on the cam body 12.
  • the cam body 12 is re-adjusted to the thread knot, causing the large cross-section of the cam body 12 to jam the stopper, ensuring that the relative position of each cam body 12 entering the skin tissue does not shift, so that the skin tissue is in the cam body Under the pulling action of 12, the force is evenly received; on the other hand, under the action of applying friction to the cam body 12, the unidirectional pulling implant thread 1 is straightened and tightened to prevent it from being entangled after entering the skin tissue , Resulting in uneven force in the lifting process, affecting the lifting effect.
  • This embodiment provides a one-way pulling implantation line 1, including a pulling line 11 and 14 cam bodies 12 sleeved on the pulling line 11, and each cam body 12 is equidistantly distributed on the pulling line 11.
  • the distance between two adjacent cam bodies 12 is 5.5 mm, and the cam body 12 and the pulling wire 11 are fixedly bonded with an adhesive.
  • the two ends of the pulling wire 11 are divided into a pulling end and a free end.
  • the free end is provided with a buckle for fixing the pulling wire 11.
  • the buckle structure includes a unidirectional barb structure and a barb structure provided on the pulling wire 11 The structure cooperates with each other to form a one-way locking chuck. After the chuck and the barb structure are locked, the entire buckle structure can only be forward but not backward.
  • the buckle structure replaces the two-way lifting embedding line used for clamping
  • the part of the cam body 12 that tightens the skin tissue ensures that the pulling implant thread will not completely slip into the skin tissue, while increasing the pulling force and shortening the pulling time.
  • the two sides of the cam body 12 are divided into a large end surface and a small end surface.
  • the large end surface faces the free end of the pulling wire 11, and naturally, the small end surface faces the pulling end of the pulling wire 11.
  • the cam body 12 is a tapered structure penetrating in the axial direction.
  • the wall thickness at the small end surface is 0.1 mm, and the wall thickness at the large section is 0.05 mm.
  • the wall thickness of the cam body 12 Gradually reduce, that is, uniformly reduce from 0.1mm to 0.05mm.
  • Both the cam body 12 and the pulling wire 11 are made of degradable materials, which can be self-degraded in the skin tissue without taking them out after the operation.
  • the surfaces of the cam body 12 and the pulling wire 11 are both loaded with steroid anti-inflammatory drugs.
  • This embodiment also provides a lifting device, which includes a needle tubular conveying part 2, a holding handle 3, and the above-mentioned unidirectional pulling implantation thread 1, wherein the needle tubular conveying part 2 includes a fixed end and an open end, and the fixed end It is fixed with the grip handle 3; the opening end is provided with an implant thread through exit 21, and the pulling end of the pulling line 11 of the one-way pulling implant thread 1 is passed through the implant thread through exit 21 through the inside of the needle tubular conveying part 2.
  • a lifting device which includes a needle tubular conveying part 2, a holding handle 3, and the above-mentioned unidirectional pulling implantation thread 1, wherein the needle tubular conveying part 2 includes a fixed end and an open end, and the fixed end It is fixed with the grip handle 3; the opening end is provided with an implant thread through exit 21, and the pulling end of the pulling line 11 of the one-way pulling implant thread 1 is passed through the implant thread through exit 21 through the inside of the needle tubular conveying part 2.
  • the open end of the needle-shaped delivery part 2 near the implant thread through-outlet 21 is designed as a narrowing structure that is concave in the radial direction of the needle-shaped delivery part 2 for straightening and retracting the needle-like delivery part 2 when the skin tissue is withdrawn. Tightly pull the implant thread 1 in one direction to prevent it from being entangled in the skin tissue, and the blocking baffle is fixed inside the needle tubular conveying part 2 along the axial direction of the needle tubular conveying part 2.
  • the necking structure exerts friction on the cam body 12, thereby straightening and tightening the one-way lifting Embedding thread 1, prevent it from entanglement after entering the skin tissue, resulting in uneven force during the lifting process and affecting the lifting effect.
  • This embodiment provides a unidirectional lifting implantation line 1, including a pulling line 11 and ten cam bodies 12 sleeved on the pulling line 11, and each cam body 12 is equidistantly distributed on the pulling line 11.
  • the distance between two adjacent cam bodies 12 is 5.5 mm, and the cam body 12 and the pulling wire 11 are fixed by heat sealing.
  • the two ends of the pulling wire 11 are divided into a pulling end and a free end.
  • the free end is provided with a hollow knot for fixing the pulling wire 11.
  • By tying the hollow knot at the pulling end it replaces the two-way pulling implanted wire used for clamping
  • the part of the cam body 12 that tightens the skin tissue ensures that the pulling implant thread will not completely slip into the skin tissue, while increasing the pulling force and shortening the pulling time.
  • the two sides of the cam body 12 are divided into a large end surface and a small end surface.
  • the large end surface faces the free end of the pulling wire 11, and naturally, the small end surface faces the pulling end of the pulling wire 11.
  • the cam body 12 is a tapered structure penetrating in the axial direction.
  • the wall thickness at the small end surface is 0.3mm, and the wall thickness at the large section is 0.09mm.
  • the wall thickness of the cam body 12 Gradually reduce, that is, uniformly reduce from 0.3mm to 0.09mm.
  • Both the cam body 12 and the pulling wire 11 are made of degradable materials, which can be self-degraded in the skin tissue without taking them out after the operation.
  • the surfaces of the cam body 12 and the pulling wire 11 are both loaded with opioids.
  • This embodiment also provides a lifting device, which includes a needle tubular conveying part 2, a holding handle 3, and the above-mentioned unidirectional pulling implantation thread 1, wherein the needle tubular conveying part 2 includes a fixed end and an open end, and the fixed end It is fixed with the grip handle 3; the opening end is provided with an implant thread through exit 21, and the pulling end of the pulling line 11 of the one-way pulling implant thread 1 is passed through the implant thread through exit 21 through the inside of the needle tubular conveying part 2.
  • a lifting device which includes a needle tubular conveying part 2, a holding handle 3, and the above-mentioned unidirectional pulling implantation thread 1, wherein the needle tubular conveying part 2 includes a fixed end and an open end, and the fixed end It is fixed with the grip handle 3; the opening end is provided with an implant thread through exit 21, and the pulling end of the pulling line 11 of the one-way pulling implant thread 1 is passed through the implant thread through exit 21 through the inside of the needle tubular conveying part 2.
  • the embedding line through exit 21 is provided with a blocking baffle made of HDPE material, and at the same time, the open end of the needle tube conveying part 2 is designed to shrink inwardly in the radial direction of the needle tube conveying part 2 near the implant line through exit 21.
  • the opening structure, the blocking baffle and the necking structure are used to straighten and tighten the single-thread lifting implant line when the needle-tube conveying part 2 is withdrawn from the skin tissue to prevent it from being entangled inside the skin tissue.
  • the axial direction of the needle-shaped conveying part 2 is fixed inside the needle-shaped conveying part 2.
  • the retaining baffle provided at the implant thread exit 21 and the necking structure designed at the open end give The cam body 12 exerts friction to straighten and tighten the one-way lifting implant thread 1 to prevent it from being entangled after entering the skin tissue, resulting in uneven force in the lifting process and affecting the lifting effect.

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Abstract

一种单向提拉埋植线（1）和提拉装置。单向提拉埋植线（1）包括牵引线（11）和套设在牵引线（11）上的至少一个凸轮体（12）。牵引线（11）两端分为提拉端和自由端，自由端设置有用于固定牵引线（11）的锚点结构。凸轮体（12）两侧分为大端面和小端面，凸轮体（12）的大端面均朝向牵引线（11）的自由端。该单向提拉埋植线（1）通过设置锚点结构实现了单向提拉埋植线（1）与皮肤组织的暂时固定，防止单向提拉埋植线（1）完全滑入皮肤组织。同时，通过在针管状输送部（2）的开口端设置凸轮体位置调整部件（22）或缩口结构，该提拉装置实现了在撤针过程中，对凸轮体（12）位置的重新调整，保持凸轮体（12）在进入皮肤组织时的相对位置不发生严重偏移。

Description

一种单向提拉埋植线、提拉装置及使用其的整形方法 技术领域
本申请属于医疗器械技术领域，涉及一种单向提拉埋植线、提拉装置及使用其的整形方法。
背景技术
由于年龄、环境等因素会导致人体脸部软组织和骨骼容量萎缩，韧带开始松弛，浅表肌肉筋膜系统逐渐下垂，颧颊脂肪垫的松弛加之重力的作用，脸部表面组织表现出松垂、弹性减退、皱纹增加、沟槽形成加深等表现。且随着年龄的增加，体内激素水平发生改变，胶原蛋白流失以及脸部腺体萎缩等因素共同使脸部表现出不良的特性变化-衰老。
随着社会的进步和发展，人们对美的需求也在逐渐增加，尤其对脸部的年轻化需求，且有逐年增长的趋势，目前提高和保持脸部年轻化是通过一种微创手术将特制的由可吸收生物材料制备丝线导入浅层软组织中，通过丝线优良的提拉和力学平均分配作用将松弛的脸部软组织提拉复位。
可对脸部不同部位进行针对性地提拉，直接作用到松弛性皮肤。另外，制备丝线的材料为具有良好生物相容性的生物可降解、可吸收性材料，经过一段时间，丝线在被脸部组织降解吸收的同时，能刺激皮下组织胶原蛋白的再生，形成新生的支持韧带和弹力纤维，使得脸部皮肤变厚预防皮肤老化。
CN207804289U公开了一种新型美容提拉线，包括拉线及其两端连接的针头；拉线上对称设置两组提升件，提升件为喇叭形；拉线将两组提升件串起，两组提升件对称分布在拉线中段的两侧，且每组提升件的小头均朝向与其同侧的拉线的针头，提升件的小头内侧设置防滑结，防滑结的尺寸大于小头的内孔 直径。
虽然市场上常规采用的提拉除皱产品繁多，功能齐全，但多为双向提拉埋植线，在使用过程中通常需要在脸部可见处穿入后对称植入提拉，形成创口，影响患者脸部美观。
发明内容
针对现有技术存在的不足，本申请的目的在于提供一种单向提拉埋植线、提拉装置及使用其的整形方法，该单向提拉埋植线具备提拉力大，提拉时间长，手术操作简单，手术后面部可见部位无明显手术痕迹等优点。
为达此目的，本申请采用以下技术方案：
第一方面，本申请提供了一种单向提拉埋植线，所述的单向提拉埋植线包括牵引线和套设在所述牵引线上的至少一个凸轮体。
所述的牵引线两端分为提拉端和自由端，所述自由端设置有用于固定牵引线的锚点结构。
所述的凸轮体两侧分为大端面和小端面，所述凸轮体的大端面均朝向牵引线的自由端。
其中，提拉端和自由端为发明人自行创设术语，提拉端是指在单向提拉埋植线刺入皮肤组织后，牵引线随即首先进入皮肤组织的一端命名为提拉端，借由该提拉端可实现对皮肤组织的提拉除皱作用；自由端是指在单向提拉埋植线刺入皮肤组织后，留在皮肤组织外部的一端命名为自由端，术后，自由端的锚点结构用于与皮肤组织固定，防止单向提拉埋植线滑入组织内部。
大端面和小端面以截面积大小作为区分标准，本申请采用的凸轮体为非等径柱体结构，截面积较小的一端命名为小端面，截面积较大的一端命名为大端面。
本申请通过设置锚点结构将传统的双向提拉方式改进为单向提拉方式，在保证提拉埋植线不至于完全滑入皮肤组织内部的同时，提高了提拉力，缩短了提拉时间。
作为本申请一种优选的技术方案，所述的牵引线上套设有4～24个凸轮体，例如可以是4个、5个、6个、7个、8个、9个、10个、11个、12个、13个、14个、15个、16个、17个、18个、19个、20个、21个、22个、23个或24个。
优选地，所述的凸轮体在牵引线上等距分布。
优选地，相邻的两个凸轮体之间的间距为2.5～15mm，例如可以是2.5mm、3mm、3.5mm、4mm、4.5mm、5mm、5.5mm、6mm、6.5mm、7mm、7.5mm、8mm、8.5mm、9mm、9.5mm、10mm、10.5mm、11mm、11.5mm、12mm、12.5mm、13mm、13.5mm、14mm、14.5mm或15mm，进一步优选地，相邻的两个凸轮体之间的间距为5.5mm。
凸轮体的个数与相邻凸轮体的间距之间存在一定的匹配关系，本领域的技术人员需要结合患者的身体状况和整形提拉需求进行适当调整。
优选地，所述的凸轮体在牵引线上不等距梯度分布。本领域技术人员需要根据患者的身体状况和整形提拉需求选择合适的梯度分布规律。
优选地，所述的锚点结构为空心结或卡扣。锚点结构的作用在于卡住单向提拉埋植线，防止单向提拉埋直线发生滑移，完全滑入皮肤组织内部，导致手术失败。另外，常规的提拉埋植线多为双向提拉操作方式，其问题在于：一方面，需要在面部对称位置刺入，从而务必需要在面部可见位置形成针刺创口，导致术后产生手术痕迹，影响患者的面部美观；另一方面，双向提拉埋植线中一部分凸轮体用于承担卡紧皮肤组织的作用，剩余部分的凸轮体才真正用于实 现提拉作用，而凸轮体的个数与提拉力和提拉时间密切相关，凸轮体个数越多，提拉力越大，提拉时间越短，因此，在采用相同个数凸轮体的前提下，双向提拉的提拉效果则明显劣于单向提拉的提拉效果。故此，本申请对现有的双向提拉埋植线的结构进行了简单改进，在牵引线的提拉端增加了锚点结构，通过锚点结构代替了双向提拉埋植线中用于卡紧皮肤组织的部分凸轮体，在保证提拉埋植线不至于完全滑入皮肤组织内部的同时，提高了提拉力，缩短了提拉时间。
需要予以解释说明的是，空心结和卡扣并非并领域技术人员公知的打结方式或常规零部件，具体地：
在本申请中，空心结是指与活结相反的打结方式，区别在于，拉直丝线后空心结与活结的绳结状态不同，空心结在拉直丝线后，活结锁死，形成死结；而活结在拉直丝线后，活结解套，绳结消失，对于具体的打结方法，本申请并未进行特殊限定和详细说明，在拉直丝线后使得绳结锁死形成死结的任意打结方法均可用于本申请中，也均落入本申请的公开范围和保护范围之内。
在本申请中，卡扣结构指的是一种可单向移动的卡紧部件，特别地，可以包括在牵引线上设置的单向倒刺结构和与倒刺结构相互配合形成单向锁死的卡头，卡头与倒刺结构锁死后，整个卡扣结构只能向前移动不能向后移动。本领域的技术人员也应了解的是，本申请提供的卡扣结构不在于结构或材质本身，而在于其所能发挥的作用和功能，因此，可实现上述技术效果的任意形状的锚点结构均可用于本申请中，也均落入本申请的公开范围和保护范围之内。
优选地，所述凸轮体小端面的截面积小于大端面的截面积。本申请中凸轮体小端面的截面积小于大端面的截面积，在凸轮体进入皮肤组织后，大端面对组织能够起到较好的啮合效果；凸轮的壁厚沿小端面至大端面方向逐渐减小，其中壁厚较小的大端面易紧密啮合组织，可以避免凸轮脱落，从而增强对皮肤 组织的提拉效果。
优选地，所述的牵引线为单股丝线或多股丝线。
作为本申请一种优选的技术方案，所述的凸轮体为锥形结构。
优选地，所述的凸轮体为实心锥形结构。
优选地，所述的凸轮体与所述牵引线一体成型，进一步优选地，所述的凸轮体与所述牵引线采用热压注塑工艺一体成型。
作为本申请一种优选的技术方案，所述的凸轮体为沿轴向贯通的锥形结构。
优选地，沿所述凸轮体的小端面至大端面方向，所述的凸轮体的壁厚逐渐减小。
优选地，所述的凸轮体小端面处的壁厚为0.1～0.9mm，例如可以是0.1mm、0.2mm、0.3mm、0.4mm、0.5mm、0.6mm、0.7mm、0.8mm或0.9mm，优选0.3mm。
优选地，所述的凸轮体大端面处的壁厚为0.05～0.2mm，例如可以是0.05mm、0.08mm、0.1mm、0.12mm、0.15mm、0.18mm或0.2mm，优选为0.09mm。
优选地，所述的凸轮体与所述牵引线通过粘结剂固定。
优选地，所述的凸轮体与所述牵引线通过热封固定。
优选地，相邻的凸轮体之间设置限位件用于限定凸轮体的相对位置。限位件的作用在于：一方面，保证牵引线和凸轮体的稳定性，避免出现相对滑移，另一方面，当凸轮体进入皮肤组织后，一旦凸轮的位置固定，牵引线也能定位到相应位置，起到较好的提拉作用。
优选地，所述的限位件为丝线结。本申请所述的限位件不限于任何结构、形式和样态，可起到限位定位作用的任何部件均可用于本申请中，此外，更优选的限位方式为：将牵引线每隔一段距离自身打结，用于卡住凸轮体，防止凸轮体在牵引线上滑移，但在本申请中，相邻限位件的间距大于凸轮体沿轴向的 长度，因此，凸轮体仍可在相邻限位件之间进行小幅度的滑移，但不至于从牵引线上完全滑落。
本申请对凸轮体可选地附加其他啮合加强部件，有助于增强凸轮体与皮肤组织的啮合作用。
示例性地，所述的啮合加强部件为覆盖凸轮体外表面的斜椎状的锥刺，锥刺的锥尖朝外，锥刺的底面与凸轮壁接触，锥尖与底面中心的连线和凸轮外壁面所形成的夹角记为α，优选地，夹角α的取值范围为10°≤α≤45°。在此范围内，则啮合加强部件和组织具有较好的啮合能力，当α＜10°，啮合加强部件的张口偏小，进入组织后处于闭合状态，即使缝合线反向开始受力脱落时，啮合加强部件也难以自动张开并啮合组织；当α＞45°，啮合加强部件张口过大，在进入组织时啮合加强部件易产生较大阻力，可能会造成组织损伤。
示例性地，所述的啮合加强部件还可以是设置于凸轮体大端面的齿状结构。通过设置不少于3个齿的齿状结构能进一步增加单向提拉埋植线与皮肤组织的啮合强度，配合凸轮体外表面的锥刺，进一步增加单向提拉埋植线与组织的啮合能力，同时，也可以有效防止凸轮体脱落，从而能够将单向提拉埋植线稳固精密的固定在皮肤组织内部，避免因凸轮脱落影响对组织的提拉作用。
作为本申请一种优选的技术方案，所述的凸轮体和牵引线为可降解材料。
优选地，所述的可降解材料包括合成类可降解高分子材料和/或天然可降解高分子材料。
优选地，所述的合成类可降解高分子材料包括聚乳酸、L-聚乳酸、DL-聚乳酸、聚乙丙交酯共聚物、聚己内酯、聚羟基丁酸戊酯、聚乙酰谷氨酸、聚正酯、聚氧化乙烯/聚丁烯共聚物和聚丙交酯共己内酯共聚物中的任意一种或至少两种的组合。
优选地，所述的天然可降解高分子材料包括胶原、明胶、壳聚糖、透明质酸、海藻酸钠和琼脂糖中的任意一种或至少两种的组合。
优选地，所述的牵引线和/或凸轮体表面负载有药物。
优选地，所述的药物选自非甾体类抗炎药、类固醇类抗炎药物、阿片类药物或镇痛辅助药中的一种或至少两种的组合。
第二方面，本申请提供了一种提拉装置，所述的提拉装置包括针管状输送部、握持手柄和第一方面所述的单向提拉埋植线，所述针管状输送部包括固定端和开口端，所述固定端与握持手柄相固定。
所述的单向提拉埋植线的牵引线提拉端经针管状输送部的内部由针管状输送部的开口端穿出。
作为本申请一种优选的技术方案，所述的针管状输送部开口端设置有凸轮体位置调整部件，所述的凸轮体位置调整部件用于在针管状输送部撤出皮肤组织时重新调整凸轮体回归预设位置或拉直收紧单向提拉埋植线。
如上所述，在本申请中，凸轮体虽然在限位件的限位作用下限定了其相对位置不至于滑脱，但仍可在相邻限位件之间做小幅度滑移，因此，在针管状输送部刺入皮肤组织时，无法完全确保凸轮体在皮肤组织内的相对位置，可能出现的结果是，在针管状输送部刺入皮肤组织前，各凸轮体仍在限位件的限位作用下保持等距位置分布，但随着针管状输送部刺入皮肤时，凸轮体在与刺入口的摩擦作用下，导致凸轮体在相邻的限位件之间发生小幅度滑移，从而造成进入皮肤组织的凸轮体的间距及位置关系出现偏移，在提拉牵引线自由端时，皮肤组织在位置关系不规律的凸轮体的拉扯作用下受力不均匀，最终影响提拉效果。因此，本申请在开口端设置了凸轮体位置调整部件，在撤回针管状输送部的过程中，由于单向提拉埋植线被术者隔着皮肤组织固定无法移动，因此随着 撤回过程的进行，单向提拉埋植线上的凸轮体会逐个经过凸轮体位置调整部件，在凸轮体位置调整部件与凸轮体之间的摩擦或阻力作用下，凸轮体重回限位件所处位置或者凸轮体随着牵引线的伸展保持相同或有规律的间距，位置重调后的凸轮体随即进入皮肤组织，则很难发生滑移，最终保证了在进入人体皮肤组织后每个凸轮体的相对位置。优选地，所述的凸轮体位置调整部件为位于开口端的卡位挡板，所述的卡位挡板固定于针管状输送部的内部。本申请对于卡位挡板的形状不作特殊限定，可以给凸轮体提供摩擦或阻力作用，促使凸轮体回归限位件所处位置的任意结构的卡位挡板均可用于本申请中。
优选地，所述的卡位挡板沿针管状输送部的径向固定于针管状输送部的内部或沿针管状输送部的轴向固定于针管状输送部的内部。
优选地，所述凸轮体具有弹性，使得凸轮体位置调整部件对凸轮体施加摩擦力或阻力后凸轮体又能顺利通过针管状输送部开口端，方便撤回针管状输送部。
优选地，所述的卡位挡板为软性塑胶材料。软性塑料材料可以防止凸轮体在与卡位挡板摩擦接触时造成损伤，影响后续提拉操作。
优选地，所述的软性塑胶材料为硅橡胶、聚氨酯(PU)、聚丙烯(HDPE)、高密度聚乙烯(PTFE)和聚四氟乙烯(PTFE)中的任意一种或至少两种的组合。
作为本申请一种优选的技术方案，所述的针管状输送部的开口端采用沿针管状输送部径向内凹的缩口结构，所述的缩口结构用于在针管状输送部撤出皮肤组织时重新调整凸轮体回归预设位置或拉直收紧单向提拉埋植线。
同样地，缩口结构的设计理念与上述凸轮体位置调整部件相似，所要达到的目的均是重新调整凸轮体的位置关系，在针管状输送部撤出皮肤组织的过程中，凸轮体逐个经过缩口结构，缩口结构与凸轮体之间产生摩擦作用，从而将 凸轮体重新调至预设位置，使得凸轮体的大断面卡住限位件，从而保证各凸轮体的相对位置关系不偏移。因此，本领域的技术人员应理解的是，可实现上述技术效果的其他结构或额外增加的零部件均可用于本申请中，并落入本申请的保护范围和公开范围之内。
第三方面，本申请提供了一种采用第二方面所述的单向提拉装置进行提拉的整形方法，所述的整形方法包括：
(Ⅰ)提拉装置刺入皮肤组织，隔皮肤组织按压固定单向提拉埋植线的牵引线提拉端，同时撤出针管状输送部，单向提拉埋植线留在皮肤组织内部；
(Ⅱ)锚点结构固定单向提拉埋植线，防止单向提拉埋植线完全滑入皮肤组织，通过单向提拉埋植线的牵引线提拉端调整提拉力实现提拉除皱。
作为本申请一种优选的技术方案，所述的整形方法在步骤(Ⅰ)之前还包括安装单向提拉埋植线的步骤。
优选地，所述的安装过程包括：拉紧单向提拉埋植线，通过引线工具将牵引线提拉端经过针管状输送部的内部，从针管状输送部的开口端穿出，穿出后保留多余的牵引线。
优选地，步骤(Ⅰ)中隔皮肤组织按压固定穿出后多余的牵引线从而固定单向提拉埋植线。
优选地，步骤(Ⅱ)中在针管状输送部撤出皮肤组织的过程中，凸轮体位置调整部件和/或缩口结构将凸轮体重新调整至预设位置或拉直收紧单向提拉埋植线。具体而言，当凸轮体与牵引线采用一体成型工艺制造或使用粘合剂、热封等固定方式固定，凸轮体位置调整部件发挥拉直收紧单向提拉埋植线的作用；当凸轮体与牵引线采用限位件的方式固定，则凸轮体仍可在相邻限位件之间做小幅度滑移，此时凸轮体位置调整部件可以发挥重新调整凸轮体回归预设位置 的作用以及拉直收紧单向提拉埋植线的作用。
优选地，所述的预设位置为凸轮体大端面与限位件卡紧处。
优选地，所述的整形方法还包括：在步骤(Ⅱ)结束后对单向提拉埋植线进行固定。
优选地，所述的固定方式为：单向提拉埋植线的牵引线自由端与皮肤组织打结固定在刺入口。
优选地，采用步骤(Ⅰ)和步骤(Ⅱ)在同一刺入口埋植多组单向提拉埋植线，并将多组单向提拉埋植线的牵引线自由端两两打结或多组相互打结固定在刺入口。
本申请所述的数值范围不仅包括上述例举的点值，还包括没有例举出的上述数值范围之间的任意的点值，限于篇幅及出于简明的考虑，本申请不再穷尽列举所述范围包括的具体点值。
与现有技术相比，本申请的有益效果为：
(1)本申请提供的单向提拉埋植线通过设置锚点结构实现了单向提拉埋植线与皮肤组织的固定，防止单向提拉埋植线完全滑入皮肤组织；
(2)本申请还提供了一种提拉装置，通过在针管状输送部开口端设置凸轮位置调整部件或缩口结构实现了在撤针过程中，对凸轮体位置的重新调整，保持凸轮体在进入皮肤组织时的相对位置不发生滑移，同时对单向提拉埋植线起到了拉直收紧的作用，防止其在进入皮肤组织后发生缠绕，导致提拉过程受力不均，影响提拉效果。
附图说明
图1为本申请一个具体实施方式提供的提拉装置的结构示意图，其中，放大区域显示了单向提拉埋植线的安装位置；
图2为本申请一个具体实施方式提供的单向提拉埋植线的结构示意图，其中，牵引线与凸轮体采用限位件的方式固定；
图3为本申请一个具体实施方式提供的单向提拉埋植线的结构示意图，其中，牵引线与凸轮体采用一体成型；
图4为本申请一个具体实施方式提供的提拉装置(不含单向提拉埋植线)的结构示意图，其中，放大区域显示了开口端和卡位挡板的结构。
其中，1-单向提拉埋植线；11-牵引线；12-凸轮体；2-针管状输送部；21-埋植线穿出口；22-凸轮体位置调整部件；3-握持手柄。
具体实施方式
下面结合附图并通过具体实施方式来进一步说明本申请的技术方案。
在一个具体实施方式中，本申请提供了一种单向提拉埋植线1，所述的单向提拉埋植线1如图2和图3所示，包括牵引线11和套设在所述牵引线11上的至少一个凸轮体12。牵引线11两端分为提拉端和自由端，其中，自由端设置有用于固定牵引线11的锚点结构，锚点结构可选为空心结或卡扣。凸轮体12两侧分为大端面和小端面，凸轮体12的大端面均朝向牵引线11的自由端。
所述凸轮体12在牵引线11上等距分布或不等距梯度分布；相邻的两个凸轮体12之间的间距为2.5～15mm，牵引线11上套设有4～24个凸轮体12。本领域技术人员对于相邻的凸轮体12之间的间距与凸轮体12的个数之间的配合关系可根据患者的身体状况和期望达到的提拉效果进行调整。
所述的凸轮体12为锥形结构，可选地，包括圆锥(平头圆锥)和棱锥(平头棱锥)，凸轮体12可以为实心锥形结构或沿轴向贯通的锥形结构。
当凸轮体12采用实心锥形结构时，凸轮体12与牵引线11的固定方式如图3所示，采用热压注塑一体成型工艺制造单向提拉埋植线1。当凸轮体12采用 沿轴向贯通的锥形结构时，沿小端面至大端面方向，凸轮体12的壁厚逐渐减小，凸轮体12与牵引线11的固定方式可选地采用粘结剂、热封或限位件固定，一种优选的技术方案如图2所示，通过牵引线11自身打结实现对凸轮体12的限位固定作用。
凸轮体12和牵引线11的材质采用可降解材料，术后无需取出，在体内发生降解，且对人体无毒副作用，所采用的可降解材料包括合成类可降解高分子材料和/或天然可降解高分子材料。其中，合成类可降解高分子材料选自聚乳酸、L-聚乳酸、DL-聚乳酸、聚乙丙交酯共聚物、聚己内酯、聚羟基丁酸戊酯、聚乙酰谷氨酸、聚正酯、聚氧化乙烯/聚丁烯共聚物和聚丙交酯共己内酯共聚物中的任意一种或至少两种的组合，天然可降解高分子材料选自胶原、明胶、壳聚糖、透明质酸、海藻酸钠和琼脂糖中的任意一种或至少两种的组合。
牵引线11和/或凸轮体12表面还负载有药物，可选为非甾体类抗炎药、类固醇类抗炎药物、阿片类药物或镇痛辅助药中的一种或至少两种的组合，药物可单独负载于牵引线11上或凸轮体12表面，也可负载于牵引线11和凸轮体12表面。
在另一个具体实施方式中，本申请提供了一种如图1所示的提拉装置，包括针管状输送部2、握持手柄3和上述具体实施方式提供的单向提拉埋植线1。其中，针管状输送部2包括固定端和开口端，固定端与握持手柄3相固定；开口端开设有埋植线穿出口21(详细结构参见图1中局部放大图，局部放大区域中显示了单线提拉埋植线的结构简图及单向提拉埋植线1由埋植线穿出口21穿出时的状态)。
单向提拉埋植线1的牵引线11提拉端经针管状输送部2的内部由埋植线穿出口21穿出。此处的“穿出”和“穿入”指的是安装时的位置关系及状态，并 非指代安装动作和方法。
埋植线穿出口21处设置有凸轮体位置调整部件22，用于在针管状输送部2撤出皮肤组织时重新调整凸轮体12回归预设位置。具体地，一种可选的凸轮体位置调整部件22为位于埋植线穿出口21处的卡位挡板(卡位挡板的具体结构及位置关系可参见图4中的局部区域放大图)，卡位挡板的材质为软性塑胶材料，可选包括硅橡胶、PU、PP、HDPE和PTFE中的任意一种或至少两种的组合。
此外，若不设置凸轮体位置调整部件22，也可在针管状输送部2的开口端设计一种沿针管状输送部2径向内凹的缩口结构，用于在针管状输送部2撤出皮肤组织时重新调整凸轮体12回归预设位置。
本领域技术人员应理解的是，本申请不限制同时设置凸轮体12位置调整部件22和缩口结构。
在另一个具体实施方式中，本申请提供了一种采用上述提拉装置进行提拉的整形方法，所述的整形方法包括：
术前进行穿线，具体地，穿线过程包括：拉紧单向提拉埋植线1，通过引线工具将牵引线11提拉端由提拉装置的握持部穿入，经针管状输送部2的内部，由埋植线穿出口21穿出，穿出后保留多余的牵引线11，并将多余的牵引线11弯折，多余的牵引线11用于在术中撤针时便于术者隔皮肤组织按压固定单向提拉埋植线1，防止单向提拉埋植线1在撤针过程中随针管状输送部2一同撤出。此处所述的“穿入”和“穿出”表示的是安装动作和方法，而并非特指安装状态和位置关系。
术中包括：
(Ⅰ)将提拉装置刺入皮肤组织，单向提拉埋植线1凸轮由于从小端至大端截面积逐渐增大，便于进入组织内部，且能够减少对组织的损伤，隔皮肤组 织按压固定单向提拉埋植线1的牵引线11提拉端(即在术前穿线时保留的多余的牵引线11)，同时缓慢撤出针管状输送部2；
(Ⅱ)在撤出针管状输送部2的同时，由于牵引线11自由端被术者隔皮肤组织按压固定无法移动，导致针管状输送部2撤出但单向提拉埋植线1仍留在皮肤组织内部；在针管状输送部2撤出皮肤组织的过程中，埋植线穿出口21处设置的凸轮体12位置调整部件22和/或缩口结构将凸轮体12重新调整至限位件处和/或拉直收紧单向提拉埋植线1，致使凸轮体12的大断面卡住限位件，保证进入皮肤组织的每个凸轮体12的相对位置不发生偏移，以便皮肤组织在凸轮体12的提拉作用下均匀受力；
(Ⅲ)在针管状输送部2撤出后，单向提拉埋植线1的大部分留在皮肤组织内部，但单向提拉埋植线1的牵引线11自由端仍留在皮肤组织外部，术者通过提拉牵引线11的自由端调整提拉力实现提拉除皱。
术后，将留在皮肤组织外部的牵引线11自由端与皮肤组织打结固定在刺入口。单向提拉埋植线1留在皮肤组织内部，由于单向提拉埋植线1为可生物降解材料，可在人体组织内降解，因而不会对人体产生毒副作用。
此外，在手术过程中，重复步骤(Ⅰ)和步骤(Ⅱ)，实现在同一刺入口埋植多组单向提拉埋植线1，埋植结束后，将多组单向提拉埋植线1的牵引线11自由端两两打结或多组相互打结固定在刺入口，在减少了刺入口的同时，实现多部位的提拉效果，防止患者在术后出现明显的手术痕迹或难以恢复的疤痕。
实施例1
本实施例提供了一种单向提拉埋植线1，包括牵引线11和套设在所述牵引线11上的4个凸轮体12，各凸轮体12在牵引线11上等距分布，相邻的两个凸轮体12之间的间距为15mm，相邻凸轮体12之间通过牵引线11自身打结形成 的丝线结，限定了相邻凸轮体12之间的相对位置。
牵引线11两端分为提拉端和自由端，自由端设置有用于固定牵引线11的空心结，通过在提拉端打空心结，代替了双向提拉埋植线中用于卡紧皮肤组织的部分凸轮体12，在保证提拉埋植线不至于完全滑入皮肤组织内部的同时，提高了提拉力，缩短了提拉时间。
凸轮体12两侧分为大端面和小端面，大端面均朝向牵引线11的自由端，自然地，小端面均朝向牵引线11的提拉端。凸轮体12为沿轴向贯通的锥形结构，小端面处的壁厚为0.9mm，大断面处的壁厚为0.2mm，沿小端面至大端面方向，所述的凸轮体12的壁厚逐渐减小，即由0.9mm均匀减小至0.2mm。
凸轮体12和牵引线11均采用可降解材料，在术后无需取出，即可在皮肤组织内自行降解。凸轮体12和牵引线11表面均负载有非甾体类抗炎药。
本实施例还提供了一种提拉装置，包括针管状输送部2、握持手柄3和上述单向提拉埋植线1，其中，针管状输送部2包括固定端和开口端，固定端与握持手柄3相固定；开口端开设有埋植线穿出口21，单向提拉埋植线1的牵引线11提拉端经针管状输送部2的内部由埋植线穿出口21穿出。
埋植线穿出口21处设置有硅橡胶材质的卡位挡板，用于在针管状输送部2撤出皮肤组织时重新调整凸轮体12回归至预设位置并拉直收紧单向提拉埋植线1，卡位挡板沿针管状输送部2的径向固定于针管状输送部2内部。
在采用上述提拉装置进行提拉除皱整形手术过程中，随着针管状输送部2撤出皮肤组织，埋植线穿出口21处设置的卡位挡板给凸轮体12施加摩擦作用，一方面，将凸轮体12重新调整至丝线结处，致使凸轮体12的大断面卡住限位件，保证进入皮肤组织的每个凸轮体12的相对位置不发生偏移，以便皮肤组织在凸轮体12的提拉作用下均匀受力；另一方面，在对凸轮体12施加摩擦力的 作用下，拉直并收紧了单向提拉埋植线1，防止其在进入皮肤组织后发生缠绕，导致提拉过程受力不均，影响提拉效果。
实施例2
本实施例提供了一种单向提拉埋植线1，包括牵引线11和套设在所述牵引线11上的14个凸轮体12，各凸轮体12在牵引线11上等距分布，相邻的两个凸轮体12之间的间距为5.5mm，凸轮体12与牵引线11采用粘结剂固定粘结。
牵引线11两端分为提拉端和自由端，自由端设置有用于固定牵引线11的卡扣，具体地，卡扣结构包括在牵引线11上设置的单向倒刺结构和与倒刺结构相互配合形成单向锁死的卡头，卡头与倒刺结构锁死后，整个卡扣结构只能向前不能向后，通过卡扣结构代替了双向提拉埋植线中用于卡紧皮肤组织的部分凸轮体12，在保证提拉埋植线不至于完全滑入皮肤组织内部的同时，提高了提拉力，缩短了提拉时间。
凸轮体12两侧分为大端面和小端面，大端面均朝向牵引线11的自由端，自然地，小端面均朝向牵引线11的提拉端。凸轮体12为沿轴向贯通的锥形结构，小端面处的壁厚为0.1mm，大断面处的壁厚为0.05mm，沿小端面至大端面方向，所述的凸轮体12的壁厚逐渐减小，即由0.1mm均匀减小至0.05mm。
凸轮体12和牵引线11均采用可降解材料，在术后无需取出，即可在皮肤组织内自行降解。凸轮体12和牵引线11表面均负载有类固醇类抗炎药物。
本实施例还提供了一种提拉装置，包括针管状输送部2、握持手柄3和上述单向提拉埋植线1，其中，针管状输送部2包括固定端和开口端，固定端与握持手柄3相固定；开口端开设有埋植线穿出口21，单向提拉埋植线1的牵引线11提拉端经针管状输送部2的内部由埋植线穿出口21穿出。
针管状输送部2的开口端靠近埋植线穿出口21处设计成沿针管状输送部2 径向内凹的缩口结构，用于在针管状输送部2撤出皮肤组织时拉直并收紧单向提拉埋植线1，防止其在皮肤组织内部发生缠绕，卡位挡板沿针管状输送部2的轴向固定于针管状输送部2内部。
在采用上述提拉装置进行提拉除皱整形手术过程中，随着针管状输送部2撤出皮肤组织，缩口结构给凸轮体12施加摩擦作用，从而拉直并收紧单向提拉埋植线1，防止其在进入皮肤组织后发生缠绕，导致提拉过程受力不均，影响提拉效果。
实施例3
本实施例提供了一种单向提拉埋植线1，包括牵引线11和套设在所述牵引线11上的10个凸轮体12，各凸轮体12在牵引线11上等距分布，相邻的两个凸轮体12之间的间距为5.5mm，凸轮体12与牵引线11通过热封固定。
牵引线11两端分为提拉端和自由端，自由端设置有用于固定牵引线11的空心结，通过在提拉端打空心结，代替了双向提拉埋植线中用于卡紧皮肤组织的部分凸轮体12，在保证提拉埋植线不至于完全滑入皮肤组织内部的同时，提高了提拉力，缩短了提拉时间。
凸轮体12两侧分为大端面和小端面，大端面均朝向牵引线11的自由端，自然地，小端面均朝向牵引线11的提拉端。凸轮体12为沿轴向贯通的锥形结构，小端面处的壁厚为0.3mm，大断面处的壁厚为0.09mm，沿小端面至大端面方向，所述的凸轮体12的壁厚逐渐减小，即由0.3mm均匀减小至0.09mm。
凸轮体12和牵引线11均采用可降解材料，在术后无需取出，即可在皮肤组织内自行降解。凸轮体12和牵引线11表面均负载有阿片类药物。
本实施例还提供了一种提拉装置，包括针管状输送部2、握持手柄3和上述单向提拉埋植线1，其中，针管状输送部2包括固定端和开口端，固定端与握持 手柄3相固定；开口端开设有埋植线穿出口21，单向提拉埋植线1的牵引线11提拉端经针管状输送部2的内部由埋植线穿出口21穿出。
埋植线穿出口21处设置有HDPE材质的卡位挡板，同时，在针管状输送部2的开口端靠近埋植线穿出口21处设计成沿针管状输送部2径向内凹的缩口结构，卡位挡板和缩口结构用于在针管状输送部2撤出皮肤组织时拉直并收紧单线提拉埋植线，防止其在皮肤组织内部发生缠绕，卡位挡板沿针管状输送部2的轴向固定于针管状输送部2内部。
在采用上述提拉装置进行提拉除皱整形手术过程中，随着针管状输送部2撤出皮肤组织，埋植线穿出口21处设置的卡位挡板和开口端设计的缩口结构给凸轮体12施加摩擦作用，从而拉直并收紧单向提拉埋植线1，防止其在进入皮肤组织后发生缠绕，导致提拉过程受力不均，影响提拉效果。
申请人声明，以上所述仅为本申请的具体实施方式，但本申请的保护范围并不局限于此，所属技术领域的技术人员应该明了，任何属于本技术领域的技术人员在本申请揭露的技术范围内，可轻易想到的变化或替换，均落在本申请的保护范围和公开范围之内。

Claims (15)

  1. 一种单向提拉埋植线，其包括牵引线和套设在所述牵引线上的至少一个凸轮体；
    所述的牵引线两端分为提拉端和自由端，所述自由端设置有用于固定牵引线的锚点结构；
    所述的凸轮体两侧分为大端面和小端面，所述凸轮体的大端面均朝向牵引线的自由端。
  2. 根据权利要求1所述的单向提拉埋植线，其中，所述的牵引线上套设有4～24个凸轮体。
  3. 根据权利要求2所述的单向提拉埋植线，其中，所述的凸轮体在牵引线上等距分布；
    优选地，相邻的两个凸轮体之间的间距为2.5～15mm，进一步优选地，相邻的两个凸轮体之间的间距为5.5mm。
  4. 根据权利要求2所述的单向提拉埋植线，其中，所述的凸轮体在牵引线上不等距梯度分布。
  5. 根据权利要求1-4中任一项所述的单向提拉埋植线，其中，所述的锚点结构为空心结或卡扣；
    优选地，所述的凸轮体小端面的截面积小于大端面的截面积；
    优选地，所述的牵引线为单股丝线或多股丝线。
  6. 根据权利要求1-5中任一项所述的单向提拉埋植线，其中，所述的凸轮体为锥形结构；
    优选地，所述的凸轮体为实心锥形结构。
  7. 根据权利要求1-6中任一项所述的单向提拉埋植线，其中，所述的凸轮体与所述牵引线一体成型，进一步优选地，所述的凸轮体与所述牵引线采用热 压注塑工艺一体成型。
  8. 根据权利要求1-7中任一项所述的单向提拉埋植线，其中，所述的凸轮体为沿轴向贯通的锥形结构；
    优选地，沿所述凸轮体的小端面至大端面方向，所述的凸轮体的壁厚逐渐减小；
    优选地，所述的凸轮体小端面处的壁厚为0.1～0.9mm，优选0.3mm；
    优选地，所述的凸轮体大端面处的壁厚为0.05～0.2mm，优选为0.09mm；
    优选地，所述的凸轮体与所述牵引线通过粘结剂固定；
    优选地，所述的凸轮体与所述牵引线通过热封固定；
    优选地，相邻的凸轮体之间设置限位件用于限定凸轮体的相对位置；
    优选地，所述的限位件为丝线结。
  9. 根据权利要求1-8中任一项所述的单向提拉埋植线，其中，所述的凸轮体和牵引线为可降解材料；
    优选地，所述的可降解材料包括合成类可降解高分子材料和/或天然可降解高分子材料；
    优选地，所述的合成类可降解高分子材料包括聚乳酸、L-聚乳酸、DL-聚乳酸、聚乙丙交酯共聚物、聚己内酯、聚羟基丁酸戊酯、聚乙酰谷氨酸、聚正酯、聚氧化乙烯/聚丁烯共聚物和聚丙交酯共己内酯共聚物中的任意一种或至少两种的组合；
    优选地，所述的天然可降解高分子材料包括胶原、明胶、壳聚糖、透明质酸、海藻酸钠和琼脂糖中的任意一种或至少两种的组合。
  10. 根据权利要求1-9中任一项所述的单向提拉埋植线，其中，所述的牵引线和/或凸轮体表面负载有药物；
    优选地，所述的药物选自非甾体类抗炎药、类固醇类抗炎药物、阿片类药物和镇痛辅助药中的一种或至少两种的组合。
  11. 一种提拉装置，其包括针管状输送部、握持手柄和权利要求1-10中任一项所述的单向提拉埋植线，
    所述的针管状输送部包括固定端和开口端，所述固定端与握持手柄相固定；
    所述的单向提拉埋植线的牵引线提拉端经针管状输送部的内部由针管状输送部的开口端穿出。
  12. 根据权利要求11所述的提拉装置，其中，所述的针管状输送部开口端设置有凸轮体位置调整部件，所述的凸轮体位置调整部件用于在针管状输送部撤出皮肤组织时重新调整凸轮体回归预设位置或拉直收紧单向提拉埋植线；
    优选地，所述的凸轮体位置调整部件为位于开口端的卡位挡板，所述的卡位挡板固定于针管状输送部的内部；
    优选地，所述的卡位挡板沿针管状输送部的径向固定于针管状输送部的内部或沿针管状输送部的轴向固定于针管状输送部的内部；
    优选地，所述的卡位挡板为软性塑胶材料；
    优选地，所述的软性塑胶材料为硅橡胶、聚氨酯、聚丙烯、高密度聚乙烯和聚四氟乙烯中的任意一种或至少两种的组合。
  13. 根据权利要求11或12所述的提拉装置，其中，所述的针管状输送部的开口端采用沿针管状输送部径向内凹的缩口结构，所述的缩口结构用于在针管状输送部撤出皮肤组织时重新调整凸轮体回归预设位置或拉直收紧单向提拉埋植线。
  14. 一种采用权利要求11-13中任一项所述的提拉装置进行提拉的整形方法，其包括：
    (Ⅰ)针管状输送部刺入皮肤组织，隔皮肤组织按压固定单向提拉埋植线的牵引线提拉端，同时撤出针管状输送部，单向提拉埋植线留在皮肤组织内部；和
    (Ⅱ)锚点结构固定单向提拉埋植线，防止单向提拉埋植线完全滑入皮肤组织，通过单向提拉埋植线的牵引线提拉端调整提拉力实现提拉除皱。
  15. 根据权利要14所述的整形方法，其中，所述的整形方法在步骤(Ⅰ)之前还包括安装单向提拉埋植线的步骤；
    优选地，所述的安装过程包括：拉紧单向提拉埋植线，通过引线工具将牵引线提拉端经过针管状输送部的内部，从针管状输送部的开口端穿出，穿出后保留多余的牵引线；
    优选地，步骤(Ⅰ)中隔皮肤组织按压固定穿出后多余的牵引线从而固定单向提拉埋植线；
    优选地，步骤(Ⅱ)中在针管状输送部撤出皮肤组织的过程中，凸轮体位置调整部件和/或缩口结构将凸轮体重新调整至预设位置或拉直收紧单向提拉埋植线；
    优选地，所述的预设位置为凸轮体大端面与限位件卡紧处；
    优选地，所述的整形方法还包括：在步骤(Ⅱ)结束后对单向提拉埋植线进行固定；
    优选地，所述的固定方式为：单向提拉埋植线的牵引线自由端与皮肤组织打结固定在刺入口；
    优选地，采用步骤(Ⅰ)和步骤(Ⅱ)在同一刺入口埋植多组单向提拉埋植线，并将多组单向提拉埋植线的牵引线自由端两两打结或多组相互打结固定在刺入口。
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