WO2020211527A1 - 一种缝合线、缝合装置及其应用 - Google Patents

一种缝合线、缝合装置及其应用 Download PDF

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Publication number
WO2020211527A1
WO2020211527A1 PCT/CN2020/076355 CN2020076355W WO2020211527A1 WO 2020211527 A1 WO2020211527 A1 WO 2020211527A1 CN 2020076355 W CN2020076355 W CN 2020076355W WO 2020211527 A1 WO2020211527 A1 WO 2020211527A1
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WO
WIPO (PCT)
Prior art keywords
cam
elongated body
suture
tissue
suture thread
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PCT/CN2020/076355
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English (en)
French (fr)
Inventor
杨瑞
晏伟
夏佩佩
魏征
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童妍(上海)医疗器械有限公司
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Publication of WO2020211527A1 publication Critical patent/WO2020211527A1/zh

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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

Definitions

  • the application belongs to the field of medical devices, and relates to a suture thread, a suture device and applications thereof.
  • 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.
  • US5425747 and US5584859 propose a medical suture with a barbed structure.
  • This kind of "barbed" suture is widely used in medical cosmetic surgery.
  • this type of suture is punctured and buried in the subcutaneous tissue, the direction of the barb opening is opposite to the puncture direction, and the barb is half-closed under the pressure of the tissue State: After the puncture is completed, when the main thread of the suture thread tends to fall off, the barbs have a meshing effect on the tissue, and multiple barbs work together to produce huge resistance to prevent the suture thread from falling off.
  • US7582105 proposes an improved instrument for tissue suture, which is particularly advantageous in plastic surgery.
  • a suture thread with a directional cam-type device is provided.
  • the cam-type device can be manufactured into a one-way or two-way structure to play the role of meshing tissue.
  • Nodules are tied before and after the silk thread passing through the cam-type device.
  • Multiple cam-type devices and nodules are arranged in succession, one knot and one cam are arranged in sequence, and one more nodule is placed before and after the first cam and the last cam to define the convexity.
  • the purpose of this application is to provide a suture thread, a suture device and its application.
  • the suture thread can stably fix the cam on the suture thread and prevent the suture thread from piercing into the tissue and the cam and the cam start to engage the tissue.
  • the relative slippage of the silk thread can avoid the problems of cam deviation and uneven force.
  • One of the objectives of the present application is to provide a suture thread comprising: an elongated body including a first free end and a second free end; a first cam assembly and a second cam sleeved on the elongated body
  • the first cam assembly and the second cam assembly each include at least one cam;
  • the cam includes a small end and a large end, and the cross-sectional area of the small end of the cam is smaller than the cross-sectional area of the large end of the cam;
  • the direction of the small end of the cam faces the direction of the first free end of the elongated body, and the direction of the small end of the cam of the second cam assembly faces the direction of the second free end of the elongated body;
  • the cam outer wall is provided with at least one engagement reinforcement part.
  • the suture thread in the present application includes an elongated body, a first cam component and a second cam component. It can be sutured in both directions during stitching, and the suture thread can lift at the final puncture position, thereby achieving better Beauty effect.
  • the cross-sectional area of the small end in the present application is smaller than the cross-sectional area of the large end of the cam.
  • the angle between the engagement reinforcing member and the outer wall surface of the cam is ⁇ , 10° ⁇ 45°.
  • the engagement reinforcement member is a needle.
  • the engagement reinforcement member is a plurality of cone thorns.
  • the engagement strengthening member is preferably a cone thorn in the shape of an oblique vertebra, the cone tip of the cone thorn faces outward, and the bottom surface of the cone thorn is in contact with the cam wall, wherein the angle between the engagement strengthening member and the outer wall surface of the cam is the oblique vertebra
  • the angle ⁇ formed by the line formed by the conical tip of the body and the center of the bottom surface of the oblique vertebrae and the outer wall surface of the cam for example, if the engagement strengthening member is a regular oblique vertebra, the included angle is the central axis of the engagement strengthening member and The angle formed by the outer wall of the cam.
  • the big end of the cam has a tooth-like structure.
  • the large end of the cam has a tooth-like structure, which can further increase the engagement performance between the suture thread and the tissue, and cooperate with the engagement strengthening member to further increase the engagement ability between the suture thread and the tissue, and further prevent the cam from falling off. Therefore, the suture can be firmly and precisely fixed in the tissue, and the pulling effect of the suture on the tissue can be avoided due to the loss of the cam.
  • the tooth-like structure includes at least 3 teeth.
  • the tooth structure includes at least 3 teeth, the meshing ability of the cam and the tissue will be better.
  • the wall thickness of the cam is 0.1-0.9mm thickest, such as 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, etc., preferably 0.3 mm.
  • the wall thickness of the cam is at least 0.05-0.2mm, such as 0.05mm, 0.08mm, 0.1mm, 0.12mm, 0.15mm, 0.18mm, 0.2mm, etc., preferably 0.09mm.
  • the cross-sectional area of the small end in the present application is smaller than the cross-sectional area of the large end of the cam.
  • the large end can have a better meshing effect on the tissue; there is a space between the large end and the small end of the cam in the present application, and the wall thickness It refers to the thickness of the cam wall enclosing the space.
  • the wall thickness of the cam decreases from the small end to the large end.
  • the large end with the smaller wall thickness is easy to tightly engage the tissue, which can prevent the cam from falling off and affect the lifting of the tissue. Pull effect.
  • the shape of the hollow portion of the cam is a trumpet shape with a hollow portion.
  • the appearance of the trumpet shape in this application conforms to the standard of a generalized trumpet shape, that is, a structure whose cross-sectional area gradually increases through a straight line or a curve from the small end to the large end, and the curve includes a concave curve and a convex curve.
  • the cam may also include a straight section, the cross-sectional area of both ends of the straight section is the same, and may be cylindrical, and the cross-sectional area of the straight section is less than or equal to the cross-sectional area of the trumpet-shaped small end.
  • the straight section is preferably formed as a whole with the elongated body to minimize the slight relative slippage of the cam and the wire.
  • the cross-sectional area of the small end or the straight section is small, and the cross-sectional area of the large end is larger.
  • the shape of the hollow part is an inner horn shape
  • the length of the inner horn shape in the direction of the elongated body is m
  • the length of the cam in the direction of the elongated body is s, where 1/4s ⁇ m ⁇ s.
  • the straight section also includes a hollow inner cylinder (also referred to as an inner straight section), the length of the inner straight section along the elongated body is l, and the cam runs along the elongated body direction.
  • the length is s, where 1/3s ⁇ l ⁇ 2/3s.
  • the length of s is 1.5-3mm, such as 1.5mm, 1.8mm, 2mm, 2.2mm, 2.5mm, 2.8mm, 3mm, etc., preferably 2.5mm, that is, the length of l is 0.8-1.6mm, such as 0.8 mm, 0.9mm, 1.0mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, etc.
  • the shape of the hollow part is a trumpet shape (referred to as an inner horn in this application), and the hollow part also includes a straight section (referred to as an inner straight section in this application), and the inner straight section is a cylinder.
  • Body shape in order to ensure that the slender body is directly stressed on the inner straight section after the puncture is completed, and to avoid the slender body from being linearly stressed on the circumferential structure of the large and small end sections.
  • the length of the inner straight section is l and the cam is thin along the
  • the length of the long main body direction is s, 1/3s ⁇ l ⁇ 2/3s; when the length of the inner straight section l ⁇ 1/3s, the relieving effect of the inner straight section on the linear force is not obvious; If the length of the straight section l>2/3s, the proportion of the inner straight section to the length of the cam is too high, which will affect the engagement of the cam on the tissue.
  • the horn angle of the horn in the hollow portion is ⁇ , where 20° ⁇ 120°.
  • This application controls the horn angle of the horn-shaped opening section of the hollow part to adjust the distance of the straight section in the hollow part, thereby better controlling the meshing effect.
  • the horn angle ⁇ 20° the opening of the opening section is smaller and larger.
  • the difference between the diameter of the small end and the small end is small.
  • the large end cannot closely engage the tissue, and the cam slips off easily, causing the lifting operation to fail;
  • ⁇ >120° the opening of the opening section is larger, the big end If the diameter is too large, it will bear greater resistance during the process of implanting the tissue, and it is easy to strain the tissue.
  • first cam assembly and the second cam assembly are symmetrically distributed on both sides of the midpoint of the elongated body.
  • the number of cams of the first cam assembly and the second cam assembly are the same.
  • the distance between adjacent cams in the first cam assembly and the second cam assembly is the same.
  • the number of cams of the first cam assembly is four.
  • the distance between adjacent cams in the first cam assembly is 3-10mm, for example, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, etc.
  • the number of cams of the second cam assembly is four.
  • the distance between adjacent cams in the second cam assembly is 3-10mm, for example, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, etc.
  • the cam and the elongated body are restricted by a restricting member.
  • the limiting member is a knot.
  • the diameter of the knot in the direction perpendicular to the length of the elongated body is larger than the aperture of the small end of the cam.
  • the cam and the elongated body are fixed by heat sealing.
  • the cam and the slender body are restricted by the stopper.
  • the stability of the slender body and the cam can be ensured to avoid relative slippage.
  • the slender body can also be positioned to a fixed position, which has a better lifting effect.
  • the elongated body is a single thread.
  • the elongated body and the cam assembly are both degradable materials.
  • the degradable materials include synthetic degradable polymer materials and/or natural degradable polymer materials.
  • the synthetic degradable polymer materials include polylactic acid, L-polylactic acid, DL-polylactic acid, polyglycolide copolymer, polycaprolactone, polypentyl hydroxybutyrate, polyacetyl Any one or a combination of at least two of glutamic 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 second objective of the present application is to provide a suture device comprising the suture thread described in the first objective and metal needle bodies located at both ends of the suture thread.
  • the suture device in the present application can perform two-way suture when the tissue is sutured, and can play a lifting effect after the suture is completed, thereby achieving a better cosmetic or therapeutic effect.
  • the suture device in this application is suitable for wound closure, tissue tightening, tissue support, suspension and fixation processes.
  • the third purpose of this application is to provide an application of the suture device as described in the second purpose in tissue suturing.
  • the cam and tissue in the suture in this application have good meshing ability, which can stably and precisely fix the suture on the tissue.
  • the cam can be stably fixed on the suture to prevent the suture from puncturing into the tissue and starting the cam
  • the cam and the silk thread have a relatively large relative slip phenomenon, so as to avoid the problems of cam deviation and uneven force; when the suture device is sutured in the soft tissue, the suture thread is pulled at the final puncture position , It can avoid the problems of cam deviation that can not be lifted and uneven force on the cam.
  • Figure 1 is a schematic view of the suture thread in the embodiment
  • Figure 2 is a front view of the cam assembly in the embodiment
  • Figure 3 is a front view of the cam in the cam assembly in Figure 2;
  • Figure 4 is a perspective view of the cam structure in Embodiment 1;
  • Figure 5 is another perspective view of the cam structure in embodiment 1;
  • Figure 6 is a perspective view of the cam structure in Embodiment 2.
  • Figure 7 is another perspective view of the cam structure in Embodiment 2.
  • Figure 8 is a perspective view of the cam structure in Embodiment 3.
  • Figure 9 is another perspective view of the cam structure in Embodiment 3.
  • Figure 10 is a perspective view of the cam structure in Embodiment 4.
  • Figure 11 is another perspective view of the cam structure in embodiment 4.
  • 1 is the elongated body
  • 2 is the first free end
  • 3 is the second free end
  • 4 is the first cam assembly
  • 5 is the second cam assembly
  • 6 is the cam
  • 7 is the small end
  • 8 is the big end
  • 9 is a meshing reinforcement member
  • 10 is a tooth structure.
  • the suture thread includes an elongated body 1, wherein the elongated body 1 includes a first free end 2 and a second free end 3;
  • the first cam assembly 4 and the second cam assembly 5 on the elongated body 1, wherein the first cam assembly 4 and the second cam assembly 5 each include at least one cam 6; and in conjunction with Figure 3, the cam 6 includes a small end 7 and a large The cross-sectional area of the small end 7 of the cam 6 is smaller than the cross-sectional area of the large end 8 of the cam 6;
  • the small end 7 of the cam of the first cam assembly 4 faces the direction of the first free end 2 of the elongated body 1, and the second cam
  • the direction of the small end 7 of the cam of the assembly 5 faces the direction of the second free end 3 of the elongated body 1;
  • the outer wall of the cam 6 is provided with an engaging reinforcement member 9 along the direction of the small end 7 to the large end 8 of the cam 6
  • the elongated body is preferably a single-strand thread.
  • the single-strand thread has a smaller diameter and better toughness, which is convenient for suture of human tissues.
  • the diameter, toughness, number of layers and other specific conditions of the thread are determined by those skilled in the art.
  • the elongated body, the first cam component and the second cam component are all biodegradable materials, and the biodegradable materials that can be used include polylactic acid, L-polylactic acid, DL-polylactic acid, polyglycolide Copolymer, polycaprolactone, polypentyl hydroxybutyrate, polyacetylglutamic acid, polyorthoester, polyoxyethylene/polybutene copolymer, polylactide co-caprolactone copolymer, collagen, gelatin, chitosan Any one or a combination of at least two of sugar, hyaluronic acid, sodium alginate and agarose, which material is specifically selected, can be adjusted by those skilled in the art according to actual needs; in this embodiment, the suture thread is after the suture is completed It is left inside the human body, and the biodegradable materials can be degraded in the human body without side effects on the human body.
  • the number of cams in the first cam assembly and the second cam assembly is at least 1, preferably 4, and the number of cams can be adjusted by those skilled in the art according to actual needs; the first cam assembly and the second cam The distance between adjacent cams in the assembly is 3-10mm, the specific settings can be adjusted by those skilled in the art according to actual needs, and the first cam assembly and the second cam assembly are symmetrically distributed on both sides of the midpoint of the elongated body, which is convenient for When suturing, the suture enters the tissue and the cam achieves a better meshing effect.
  • the cam includes a small end and a large end.
  • the end with a small cross-sectional area is called the small end, and the end with a large cross-sectional area is called the big end.
  • the small end of the first cam assembly faces the first free end of the elongated body.
  • the small end of the second cam component faces the second free end of the slender body, which is convenient for the two-way puncture process, the small end of the cam component faces the free end of the slender body, which is convenient for puncture and does not cause tissue damage. Large damage; the cross-sectional area of the small end of the cam is smaller than the cross-sectional area of the large end, and the cross-sectional area of the small end and the large end can be adjusted by those skilled in the art according to actual needs.
  • the included angle between the engagement strengthening member and the outer wall surface of the cam is ⁇ , where the included angle ⁇ between the engagement strengthening member and the outer wall surface of the cam is the cone tip of the oblique cone and The line formed by the center of the bottom surface of the oblique vertebral body and the outer wall surface of the cam.
  • the included angle is the angle formed by the central axis of the engagement strengthening member and the outer wall surface of the cam.
  • the specific ⁇ value selection can be adjusted by those skilled in the art according to actual needs; when ⁇ 10°, the opening of the mesh reinforcement component Too small, it is in a closed state after entering the tissue, even if the suture thread starts to fall off under the force, it is difficult for the engagement reinforcement component to automatically open and engage the tissue; when ⁇ >45°, the engagement reinforcement component opens too much, when entering the tissue Engagement reinforcement parts are prone to produce greater resistance, which may cause tissue damage.
  • the engagement reinforcement member is a plurality of cone thorns, which are used to penetrate into the tissue and engage with the tissue.
  • the engagement reinforcement member is a cone thorn in the shape of an oblique vertebra.
  • the specific engagement reinforcement member is selected and the engagement reinforcement member is in the cam
  • the density setting of the outer wall surface can be adjusted by those skilled in the art according to actual needs.
  • the big end of the cam has a tooth-like structure.
  • the tooth-like structure contains at least 3 teeth, which can further increase the engagement performance between the suture thread and the tissue, and cooperate with the engagement strengthening component to further increase the suture thread and tissue engagement performance.
  • the meshing ability can further prevent the cam from falling off, so that the suture can be firmly and precisely fixed in the tissue, and avoiding the pulling effect of the suture on the tissue due to the cam falling off.
  • the number of tooth structures can be selected by those skilled in the art. Adjust according to actual needs.
  • the shape of the cam is a hollow flared shape, that is, the cross-sectional area of the cam from the small end 7 to the large end 8 gradually increases through a straight line.
  • the outer wall surface of the cam The engagement reinforcement member 9 is provided.
  • the shape of the engagement reinforcement member 9 is an oblique cone, and the angle between the central axis of the engagement reinforcement member 9 and the outer wall surface of the cam is 45°, and the cam is large.
  • One side of the end is a tooth-like structure 10, and the number of tooth-like structures 10 is nine.
  • the shape of the cam is a hollow trumpet shape, that is, the cross-sectional area of the cam from the small end 7 to the large end 8 gradually increases through a straight line, and the outer wall surface of the cam is provided
  • an engagement strengthening member 9 the shape of the engagement strengthening member 9 is an oblique cone, facing the small end 7 to the big end 8, the angle between the engagement strengthening member 9 and the outer wall of the cam is 30°, and the big end side of the cam is
  • the number of tooth-like structures 10 is four.
  • the cross-sectional area of the cam gradually increases from the small end to the large end, it is easy to enter the inside of the tissue and can reduce the damage to the tissue.
  • the angle of the tooth tip of the tooth structure on the big end of the cam is an acute angle, which has a strong meshing ability when meshing tissues.
  • the engagement strengthening component on the cam opens the engagement tissue under the action of force, thereby achieving a better engagement effect.
  • the shape of the cam is a hollow trumpet shape, that is, the cam is a structure in which the cross-sectional area from the small end 7 to the large end 8 gradually increases through the convex curve, and the outer wall of the cam
  • a meshing reinforcement member 9 is provided.
  • the shape of the meshing reinforcement member 9 is an oblique cone, facing the small end 7 to the large end 8.
  • the engagement reinforcement member 9 and the cam outer wall are tangent at the intersection with the central axis of the engagement reinforcement member 9
  • the formed angle is 10°
  • the large end side of the cam is the tooth-like structure 10, and the number of the tooth-like structures 10 is 5.
  • the cross-sectional area of the horn from the small end to the large end gradually increases through the form of a convex curve, which can further reduce the difficulty of entering the tissue, thereby further reducing the damage to the tissue, and the cam is in When entering the tissue, it is in a closed state under the action of force, and will not cause damage to the tissue during suturing.
  • the rope is lifted, and the cam structure starts to receive reverse force.
  • the tooth structure on the big end of the cam It has a strong meshing ability with the tissue, and the meshing strengthening member on the cam opens the meshing tissue under the action of force, so as to achieve a better meshing effect.
  • the shape of the cam is a triangular cone with a hollow part, and the cross-sectional area from the small end to the large end is gradually increased in a straight line.
  • the outer wall surface of the cam is provided with an engagement reinforcement member 9 ,
  • the shape of the engaging reinforcement member 9 is an oblique cone, and the angle between the engaging reinforcement member 9 and the outer wall surface of the cam is 25° in the direction of the small end 7 to the large end 8.
  • the wall thickness refers to the thickness of the cam wall surrounding the space.
  • the wall thickness of the small end and the big end of the cam can be the same or different.
  • the wall thickness of the small end of the cam is greater than the wall thickness of the large end, and the large end with lower wall thickness is easy to tightly engage the tissue, which can prevent the cam from falling off, thereby affecting the lifting effect of the suture on the tissue;
  • the wall thickness of the cam The thickest thickness is 0.1-0.9mm, the thickness of the cam wall is the thinnest 0.05-0.2mm, how to set the thickest thickness and the thinnest thickness of the cam wall 10 can be adjusted according to actual needs by those skilled in the art, preferably the cam contains a hollow Part of the trumpet and a straight section, the diameter and cross-sectional area of the straight section and the small end of the trumpet are equal, and the cross-sectional area of the trumpet from the small end to the large end gradually increases in the
  • the length of the inner straight section along the elongated body 1 is l
  • the length of the cam along the elongated body 1 is s
  • l satisfies 1/3s ⁇ l ⁇ 2/ 3s, when l ⁇ 1/3s, the relieving effect of the inner straight section on the linear force is not obvious
  • when l>2/3s the proportion of the inner straight section in the length of the cam is too high, which affects the cam’s organization Meshing effect
  • the cross-sectional area of the inner horn from the small end to the large end is gradually increased by a straight line or a curve.
  • the curve includes a concave curve and a convex curve.
  • the big end cannot be closely engaged with the tissue, and the phenomenon of cam sliding is easy to occur, which causes the lifting operation to fail; when ⁇ >120°, the opening If the opening of the segment is larger, the diameter of the large end is too large, and the resistance is greater during the implantation process, and the tissue is easily strained.
  • the slender body, the first cam assembly, and the second cam assembly can be restricted by a stopper to prevent the cam assembly and the wire from sliding relative to each other, thereby causing the cam to deviate and affecting the engagement of human tissue and the cam Effect;
  • the limiter can be a knot or other degradable limiter materials, at least ensure that there are limiters on both sides of each cam, then the number of limiters is at least two more than the number of cams It is convenient to fix the cam better;
  • the cross-sectional area of the stopper perpendicular to the elongated main body is larger than the aperture of the small end of the cam to prevent the stopper from passing through the cam and affect the effect of the stop;
  • the stopper specifically chooses knot or Other degradable limiting materials, or the specific value of their diameter, can be adjusted by those skilled in the art according to actual needs; in this embodiment, when the hollow structure of the cam is trumpet-shaped, it is preferable that the elongated body and the cam pass through The heat sealing is fixed
  • This embodiment also provides a suture device, which includes the above-mentioned suture thread and metal needle bodies located at both ends of the suture thread.
  • metal needle bodies are provided at both ends of the suture thread, which can be used for two-way suture during suture. After the suture is completed, the elongated body can be lifted to achieve a better lifting effect, thereby being used for tissue suture.

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Abstract

本申请提供了一种缝合线、缝合装置及其应用；所述缝合线包括：细长主体，包括第一自由端和第二自由端；套设在细长主体上的第一凸轮组件和第二凸轮组件，所述第一凸轮组件和第二凸轮组件均包括至少一个凸轮；所述凸轮包括小端和大端，所述凸轮小端的截面积小于凸轮大端的截面积；所述第一凸轮组件的凸轮的小端方向朝向细长主体的第一自由端方向，所述第二凸轮组件的凸轮的小端方向朝向细长主体的第二自由端方向；所述凸轮外壁面设置有至少一个啮合加强部件；所述缝合线在穿入组织后凸轮能够与组织保持较好的啮合关系。

Description

一种缝合线、缝合装置及其应用 技术领域
本申请属于医疗器械领域，涉及一种缝合线、缝合装置及其应用。
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。
US5425747和US5584859中提出了一种倒刺结构的医用缝合线。这种“倒刺”结构的缝合线被广泛应用到医疗美容外科手术中，这类缝合线在穿刺埋入皮下组织时，倒刺开口方向和穿刺方向相反，倒刺受到组织的压迫处于半闭合状态，穿刺结束后，在缝合线主线有脱落倾向时，倒刺对组织具有啮合作用，且多个倒刺协同作用，产生巨大的阻力防止缝合线脱落。
US7582105中提出了一种以组织缝合为目的的改进器械，在整形手术过程中特别有利。提供了一种带有定向凸轮式装置的缝合线，该凸轮式装置可制造成单向或双向的结构起到啮合组织的作用，在穿过凸轮式装置的丝线前后打上结节，在丝线上连续布置多个凸轮式装置和结节，一结一凸轮依次布置，在第一个凸轮和最后一个凸轮前后多打一个结节来限定凸。
虽然含有倒刺结构的医用缝合线在一定程度上对松弛皮肤起到提拉作用，但含有凸轮式装置缝合线的凸轮对组织的啮合作用明显优于倒刺结构，且凸轮对皮肤的刺激和作用时间也优于倒刺结构。但由于缝合线凸轮不可避免会在组织中啮合能力不强，产生和丝线发生相对滑移的现象。
因此，提供一种避免在穿刺进入组织后凸轮和组织啮合效果好的缝合线非常有必要。
发明内容
本申请的目的在于提供一种缝合线、缝合装置及其应用，所述缝合线能将凸轮稳定的固定在缝合线上，防止缝合线在穿刺进入组织和凸轮开始啮合组织过程中出现的凸轮和丝线发生相对滑移现象，从而避免出现凸轮偏移以及受力不均的问题，且缝合线在穿入组织后凸轮能够与组织保持较好的啮合关系；缝合装置在进行软组织缝合时，缝合线在最终穿刺位置提拉时，能够避免出现与组织啮合效果较差导致无法提拉的问题。
为达到此申请目的，本申请采用以下技术方案：
本申请的目的之一在于提供一种缝合线，所述缝合线包括：细长主体，包括第一自由端和第二自由端；套设在细长主体上的第一凸轮组件和第二凸轮组件，所述第一凸轮组件和第二凸轮组件均包括至少一个凸轮；所述凸轮包括小端和大端，所述凸轮小端的截面积小于凸轮大端的截面积；所述第一凸轮组件 的凸轮的小端方向朝向细长主体的第一自由端方向，所述第二凸轮组件的凸轮的小端方向朝向细长主体的第二自由端方向；所述凸轮外壁面设置有至少一个啮合加强部件。
本申请中的缝合线包括细长主体、第一凸轮组件和第二凸轮组件，在进行缝合时能够进行双向缝合，且缝合线在最终穿刺位置能够起到提拉作用，从而起到较好的美容效果。
本申请中小端的截面积小于凸轮大端的截面积，在凸轮组件进入组织后，大端对组织能够起到较好的啮合效果；所述凸轮外壁面设置有啮合加强部件，其中啮合加强部件能够紧密啮合组织，可以避免凸轮脱落。
在本申请中，朝着所述凸轮的小端至大端方向，所述啮合加强部件与所述凸轮外壁面的夹角为α，10°≤α≤45°。
在本申请中，所述啮合加强部件为针状物。
在本申请中，所述啮合加强部件为复数个锥刺。
本申请中，所述啮合加强部件优选为斜椎体形状的锥刺，锥刺的锥尖朝外，锥刺的底面与凸轮壁接触，其中啮合加强部件和凸轮外壁面的夹角为斜椎体的锥尖与斜椎体底面中心形成的的连线和凸轮外壁面所形成的夹角α，示例性的如啮合加强部件为规则的斜椎体，则夹角为啮合加强部件中轴线与凸轮外壁面所形成的夹角。
本申请中，当10°≤α≤45°，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。
在本申请中，所述凸轮的大端一侧为齿状结构。
本申请中，凸轮的大端一侧为齿状结构，能进一步增加缝合线与组织的啮合性能，配合啮合加强部件共同作用，进一步增加缝合线与组织的啮合能力，可以进一步避免凸轮的脱落，从而能够将缝合线稳固精密的固定在组织中，避免因凸轮脱落影响缝合线对组织的提拉作用。
在本申请中，所述齿状结构至少包含3个齿。
本申请中，当齿状结构至少包含3个齿时，凸轮与组织的啮合能力会更好。
在本申请中，所述凸轮的壁厚最厚为0.1-0.9mm，例如0.1mm、0.2mm、0.3mm、0.4mm、0.5mm、0.6mm、0.7mm、0.8mm、0.9mm等，优选0.3mm。
在本申请中，所述凸轮的壁厚最薄为0.05-0.2mm，例如0.05mm、0.08mm、0.1mm、0.12mm、0.15mm、0.18mm、0.2mm等，优选0.09mm。
本申请中小端的截面积小于凸轮大端的截面积，在凸轮组件进入组织后，大端对组织能够起到较好的啮合效果；本申请的凸轮大端和小端之间存在一个空间，壁厚是指围出该空间的凸轮壁的厚度，凸轮的壁厚沿小端至大端方向减小，其中壁厚较小的大端易紧密啮合组织，可以避免凸轮脱落，从而影响对组织的提拉作用。
在本申请中，所述凸轮中空部分的形状为含有中空部分的喇叭形。
本申请喇叭形应理解外观符合广义喇叭形的标准，即从小端至大端截面积经过直线或者曲线逐渐增大的结构，其中曲线包括凹曲线和凸曲线。
所述凸轮还可以包括一段平直段，平直段两端的截面积相同，可为圆柱体状，平直段的截面积小于或等于所述喇叭形小端截面积。平直段优选和细长主体形成一个整体，尽可能减少凸轮和丝线的微小的相对滑移。
所述小端截面积或平直段的截面积较小，而大端截面积较大，当细长主体 带动凸轮组件穿刺组织中时，单个凸轮进入组织的顺序为先小端后大端，便于进入组织，且尽可能减少对组织的损伤，此外还能对组织产生较好的啮合作用。
在本申请中，所述中空部分的形状为内喇叭形，所述内喇叭形沿细长主体方向的长度为m，所述凸轮沿细长主体方向的长度为s，其中1/4s≤m≤s。
在本申请中，所述平直段亦包含一中空内圆柱体(也称为内平直段)，内平直段沿细长主体方向的长度为l，所述凸轮沿细长主体方向的长度为s，其中1/3s≤l≤2/3s。
在本申请中，s的长度为1.5-3mm，例如1.5mm、1.8mm、2mm、2.2mm、2.5mm、2.8mm、3mm等，优选2.5mm，即l的长度为0.8-1.6mm，例如0.8mm、0.9mm、1.0mm、1.1mm、1.2mm、1.3mm、1.4mm、1.5mm、1.6mm等。
在本申请中，中空部分的形状为喇叭形(本申请称为内喇叭形)，所述中空部分还包括平直段(本申请称为内平直段)，所述内平直段为圆柱体形状，为保证穿刺完成后细长主体对内平直段直接受力，避免细长主体对大端段和小端段圆周结构线形受力，内平直段的长度为l，凸轮沿细长主体方向的长度为s，1/3s≤l≤2/3s；当内平直段的长度l＜1/3s，则内平直段对线性受力的缓解作用并不明显；当内平直段的长度l＞2/3s，则内平直段占凸轮长度的比重过高，影响凸轮对组织的啮合作用。
在本申请中，所述中空部分内喇叭形的喇叭角为δ，其中20°≤δ≤120°。
本申请通过控制中空部分喇叭形开口段的喇叭角，从而调整中空部分内平直段的距离，从而更好的控制啮合效果，当喇叭角δ＜20°时，开口段的开口较小，大端和小端直径相差较小，在植入组织后，大端无法紧密啮合组织，易出现凸轮滑落现象，导致提拉手术失败；当δ＞120°，开口段的开口较大，则大端直径过大，在植入组织过程中，承受阻力较大，易拉伤组织。
在本申请中，所述第一凸轮组件和第二凸轮组件对称分布在细长主体中点两侧。
在本申请中，所述第一凸轮组件和第二凸轮组件的凸轮个数相同。
在本申请中，所述第一凸轮组件和第二凸轮组件中相邻凸轮间的距离相同。
在本申请中，所述第一凸轮组件的凸轮个数为4个。
在本申请中，所述第一凸轮组件中相邻凸轮间的距离为3-10mm，例如3mm、4mm、5mm、6mm、7mm、8mm、9mm、10mm等。
在本申请中，所述第二凸轮组件的凸轮个数为4个。
在本申请中，所述第二凸轮组件中相邻凸轮间的距离为3-10mm，例如3mm、4mm、5mm、6mm、7mm、8mm、9mm、10mm等。
在本申请中，所述凸轮与细长主体通过限位件限位。
在本申请中，所述限位件为绳结。
在本申请中，所述绳结在垂直于细长主体长度方向的直径大于凸轮小端的孔径。
在本申请中，所述凸轮与细长主体通过热封固定。
本申请中，凸轮和细长主体通过限位件进行限位，一方面能保证细长主体和凸轮的稳定性，避免出现相对滑移，另一方面在于进入组织后，一旦凸轮的位置固定后，细长主体也能定位到固定位置，起到较好的提拉作用。
在本申请中，所述细长主体为单股丝线。
在本申请中，所述细长主体和凸轮组件均为可降解材料。
在本申请中，所述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。
在本申请中，所述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。
在本申请中，所述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。
本申请的目的之二在于提供一种缝合装置，所述缝合装置包括目的之一所述的缝合线以及位于缝合线两端的金属制针体。
本申请中缝合装置在进行组织缝合时，可以进行双向缝合，在缝合结束后能够起到提拉作用，从而达到较好的美容或治疗效果。
本申请中缝合装置适用于伤口闭合，组织拉紧，组织支撑、悬挂以及固定过程。
本申请的目的之三在于提供一种如目的之二所述的缝合装置在组织缝合中的应用。
相对于现有技术，本申请具有以下有益效果：
本申请中缝合线中凸轮和组织具有较好的啮合能力，能将缝合线稳定精密的固定在组织上，此外能将凸轮稳定的固定在缝合线上，防止缝合线在穿刺进入组织和凸轮开始啮合组织过程中出现的凸轮和丝线发生较大幅度的相对滑移现象，从而避免出现凸轮偏移以及受力不均的问题；缝合装置在进行软组织缝合时，缝合线在最终穿刺位置提拉时，能够避免出现凸轮偏移导致无法提拉以及凸轮受力不均的问题。
附图说明
图1是实施方式中缝合线的示意图；
图2为实施方式中凸轮组件的主视图；
图3为图2中凸轮组件中凸轮的主视图；
图4为实施例1中凸轮结构的立体图；
图5为实施例1中凸轮结构的另一个角度的立体图；
图6为实施例2中凸轮结构的立体图；
图7为实施例2中凸轮结构的另一个角度的立体图；
图8为实施例3中凸轮结构的立体图；
图9为实施例3中凸轮结构的另一个角度的立体图；
图10为实施例4中凸轮结构的立体图；
图11为实施例4中凸轮结构的另一个角度的立体图；
其中，1为细长主体，2为第一自由端，3为第二自由端，4为第一凸轮组件，5为第二凸轮组件，6为凸轮，7为小端，8为大端，9为啮合加强部件，10为齿状结构。
具体实施方式
下面通过具体实施方式来进一步说明本申请的技术方案。本领域技术人员应该明了，所述实施例仅仅是帮助理解本申请，不应视为对本申请的具体限制。
本实施方式提供一种缝合线，由图1和图2所示，所述缝合线包括：细长主体1，其中细长主体1包括第一自由端2和第二自由端3；套设在细长主体1上的第一凸轮组件4和第二凸轮组件5，其中第一凸轮组件4和第二凸轮组件5均至少包括一个凸轮6；并结合图3，凸轮6包括小端7和大端8，凸轮6小端7的截面积小于凸轮6大端8的截面积；第一凸轮组件4的凸轮的小端7方向朝向细长主体1的第一自由端2的方向，第二凸轮组件5的凸轮的小端7方向朝向细长主体1的第二自由端3的方向；凸轮6外壁面设置有啮合加强部件9，沿所述凸轮6的小端7至大端8方向，由图3可知，所述啮合加强部件9与所述 凸轮6外壁面的夹角为α，10°≤α≤45°。
本实施方式中细长主体优选为单股丝线，单股丝线具有较小的直径以及较好的韧性，便于进行人体组织缝合，其中丝线的直径、韧性、层数等具体情况本领域技术人员根据实际需要进行调整；细长主体、第一凸轮组件以及第二凸轮组件均为可生物降解材料，可选用的生物降解材料包括聚乳酸、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、聚丙交酯共己内酯共聚物胶原、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，具体选择哪种材料本领域技术人员可根据实际需要进行调整；本实施方式中缝合线在缝合结束后是留在人体内部的，选用可生物降解材料能够在人体内降解，不会对人体生产副作用。
本实施方式中第一凸轮组件和第二凸轮组件中凸轮的个数为至少1个，优选4个，其中凸轮的个数本领域技术人员根据实际需要进行调整；第一凸轮组件和第二凸轮组件中相邻凸轮间的距离为3-10mm，具体设置本领域技术人员可根据实际需要进行调整，且第一凸轮组件和第二凸轮组件对称分布在细长主体中点的两侧，便于在缝合时缝合线进入组织内和凸轮达到较好的啮合效果。
本实施方式中，凸轮包括小端和大端，其中截面积小的一端称为小端，截面积大的一端称为大端，其中第一凸轮组件的小端朝向细长主体的第一自由端，第二凸轮组件的小端朝向细长主体的第二自由端，便于在进行双向穿刺过程中，凸轮组件的小端朝向细长主体的自由端，便于穿刺，也不会对组织造成较大损伤；凸轮小端的截面积小于大端的截面积，其中小端和大端的截面积本领域技术人员可根据实际需要进行调整。
本实施方式中，朝着凸轮小端至大端方向，啮合加强部件与所述凸轮外壁面的夹角为α，其中啮合加强部件和凸轮外壁面的夹角α是斜椎体的锥尖与斜椎体底面中心形成的的连线和凸轮外壁面所形成的，示例性的如啮合加强部件为规则的斜椎体，则夹角为啮合加强部件中轴线与凸轮外壁面所形成的夹角，其中10°≤α≤45°，则啮合加强部件和组织具有较好的啮合能力，具体α值的选择本领域技术人员可根据实际需要进行调整；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。
本实施方式中，啮合加强部件为复数个锥刺，用于刺入组织内部，与组织啮合，优选啮合加强部件为斜椎体形状的锥刺，具体啮合加强部件的选择以及啮合加强部件在凸轮外壁面的密度设置本领域技术人员可根据实际需要进行调整。
本申请中，优选凸轮的大端一侧为齿状结构，齿状结构至少包含3个齿，能进一步增加缝合线与组织的啮合性能，配合啮合加强部件共同作用，进一步增加缝合线与组织的啮合能力，可以进一步避免凸轮的脱落，从而能够将缝合线稳固精密的固定在组织中，避免因凸轮脱落影响缝合线对组织的提拉作用，其中齿状结构个数的选择本领域技术人员可根据实际需要进行调整。
实施例1
本实施例1中，如图4和图5所示，凸轮的形状为中空的喇叭形，即凸轮为从小端7至大端8方向的截面积经过直线逐渐增大的结构，凸轮的外壁表面设置有啮合加强部件9，啮合加强部件9的形状为斜圆锥体，朝着小端7至大端 8方向，啮合加强部件9的中轴线和凸轮外壁面的夹角为45°，且凸轮大端一侧为齿状结构10，齿状结构10的个数为9个。
本实施例中在缝合线刺入组织时，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，且凸轮在进入组织时，在力的作用下处于闭合状态，当穿刺完毕后，提拉绳线，凸轮结构开始反向受力，凸轮大端一侧的齿状结构开始啮合组织，且凸轮上的倒刺在力的作用下也打开啮合组织，从而达到较好的啮合效果。
实施例2
本实施例中，如图6和图7所示，凸轮的形状为中空的喇叭形，即凸轮为从小端7至大端8方向的截面积经过直线逐渐增大的结构，凸轮的外壁表面设置有啮合加强部件9，啮合加强部件9的形状为斜圆锥体，朝着小端7至大端8方向，啮合加强部件9和凸轮外壁面的夹角为30°，且凸轮大端一侧为齿状结构10，齿状结构10的个数为4个。
本实施例中在缝合线刺入组织时，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，且凸轮在进入组织时，在力的作用下处于闭合状态，当穿刺完毕后，提拉绳线，凸轮结构开始反向受力，凸轮大端一侧的齿状结构的齿尖的角度为锐角，在啮合组织时具有较强的啮合能力，且凸轮上的啮合加强部件在力的作用下打开啮合组织，从而达到较好的啮合效果。
实施例3
本实施例中，如图8和图9所示，凸轮的形状为中空的喇叭形，即凸轮为从小端7至大端8方向的截面积经过凸曲线逐渐增大的结构，凸轮的外壁面设 置有啮合加强部件9，啮合加强部件9的形状为斜圆锥体，朝着小端7至大端8方向，啮合加强部件9和凸轮外壁面在和啮合加强部件9中轴线的相交处切线所形成的夹角为10°，且凸轮大端一侧为齿状结构10，齿状结构10的个数为5个。
本实施例中在缝合线进入组织缝合时，喇叭形从小端至大端截面积通过凸曲线的形式逐渐增大，能够进一步降低其进入组织的难度，从而进一步降低对组织的损伤，且凸轮在进入组织时，在力的作用下处于闭合状态，在缝合时不会对组织造成损伤，当穿刺完毕后，提拉绳线，凸轮结构开始反向受力，凸轮大端一侧的齿状结构和组织具有较强的啮合能力，且凸轮上的啮合加强部件在力的作用下打开啮合组织，从而达到较好的啮合效果。
实施例4
本实施例中，如图10和图11所示，凸轮的形状为含有中空部分的三角锥形，从小端至大端的截面积通过直线的方式逐渐增加，凸轮的外壁表面设置有啮合加强部件9，啮合加强部件9的形状为斜圆锥体，朝着小端7至大端8方向，啮合加强部件9和凸轮外壁面的夹角为25°。
本实施例中在缝合线刺入组织时，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，且凸轮在进入组织时，在力的作用下处于闭合状态，当穿刺完毕后，提拉绳线，凸轮结构开始反向受力，三角锥形状的凸轮大端的三个角的尖端易啮合住组织结构，且凸轮上的倒刺在力的作用下也打开啮合组织，从而达到较好的啮合效果。
本实施方式中，凸轮大端和小端之间存在一个空间，壁厚是指围出该空间的凸轮壁的厚度，本实施方式中凸轮小端和大端的壁厚可以相同，也可不同， 优选凸轮的小端的壁厚大于大端的壁厚，则壁厚较低的大端容易紧密的啮合组织后，可以避免凸轮的脱落，从而影响缝合线对组织的提拉作用；其中凸轮的壁厚最厚为0.1-0.9mm，凸轮的壁厚最薄为0.05-0.2mm，凸轮壁10的最厚厚度和最薄厚度具体如何设置本领域技术人员可根据实际需要进行调整，优选凸轮为含有中空部分的喇叭形和一段平直段，平直段和喇叭形小端的直径以及截面积相等，喇叭形从小端至大端截面积通过直线或曲线的形式逐渐增大的结构，其中曲线包括凹曲线和凸曲线；喇叭形的壁厚沿小端至大端方向逐渐减小，凸轮的壁厚最厚为0.1-0.9mm，最薄为0.05-0.2mm；中空部分包括内喇叭形，平直段亦包含一中空内圆柱体(内平直段)，内平直段沿细长主体1方向的长度为l，凸轮沿细长主体方向的长度为s，l满足1/3s≤l≤2/3s，当l＜1/3s，则内平直段对线性受力的缓解作用并不明显；当l＞2/3s，则内平直段占凸轮长度的比重过高，影响凸轮对组织的啮合作用；内喇叭形从小端至大端方向截面积也是通过直线或曲线的方式逐渐增大，其中曲线包括凹曲线和凸曲线，内喇叭形小端两侧直线或曲线切线形成的喇叭角δ，δ满足20°≤δ≤120°，通过控制中空部分喇叭形开口段的喇叭角，从而调整中空部分内平直段的距离，从而更好的控制啮合效果，当喇叭角δ＜20°时，开口段的开口较小，大端和小端直径相差较小，在植入组织后，大端无法紧密啮合组织，易出现凸轮滑落现象，导致提拉手术失败；当δ＞120°，开口段的开口较大，则大端直径过大，在植入组织过程中，承受阻力较大，易拉伤组织。
本实施方式中细长主体、第一凸轮组件以及第二凸轮组件可通过限位件进行限位，用于防止凸轮组件和丝线发生相对滑动，从而导致凸轮偏移，影响人体组织和凸轮的啮合效果；其中限位件可以为绳结也可以为其他可降解的限位材料，至少确保每个凸轮的两侧均有限位件，则限位件的个数至少比凸轮的个 数多两个便于更好的固定凸轮；其中限位件垂直于细长主体方向的截面积大于凸轮小端的孔径，避免限位件从凸轮中穿过，影响限位的效果；限位件具体选择绳结或其他可降解的限位材料，亦或其直径的具体选值，本领域技术人员可根据实际需要进行调整；本实施方式中，当凸轮的中空结构为喇叭形时，优选细长主体和凸轮通过热封固定在一起，可进一步避免凸轮与丝线的相对运动从而影响啮合效果。
本实施方式还提供一种缝合装置，所述缝合装置包括上述所述的缝合线以及位于缝合线两端的金属制针体。
本申请中通过在缝合线两端设置金属制针体，在缝合时可进行双向缝合，缝合结束后，提拉细长主体可以达到较好的提拉效果，从而用于组织缝合。
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. 一种缝合线，其包括：
    细长主体(1)，包括第一自由端(2)和第二自由端(3)；
    套设在细长主体(1)上的第一凸轮组件(4)和第二凸轮组件(5)，所述第一凸轮组件(4)和第二凸轮组件(5)均包括至少一个凸轮(6)；
    所述凸轮(6)包括小端(7)和大端(8)，所述凸轮(6)小端(7)的截面积小于凸轮(6)大端(8)的截面积；
    所述第一凸轮组件(4)的凸轮的小端(7)方向朝向细长主体(1)的第一自由端(2)方向，所述第二凸轮组件(5)的凸轮的小端(7)方向朝向细长主体(1)的第二自由端(3)方向；
    所述凸轮(6)外壁面设置有至少一个啮合加强部件(9)。
  2. 根据权利要求1所述的缝合线，其中，朝着所述凸轮(6)的小端(7)至大端(8)方向，所述啮合加强部件(9)与所述凸轮(6)外壁面的夹角为α，10°≤α≤45°。
  3. 根据权利要求2所述的缝合线，其中，所述啮合加强部件(9)为针状物。
  4. 根据权利要求3所述的缝合线，其中，所述啮合加强部件(9)为复数个锥刺。
  5. 根据权利要求1-4中任一项所述的缝合线，其中，所述凸轮(6)的大端(8)一侧为齿状结构(10)；
    优选地，所述齿状结构(10)至少包含3个齿。
  6. 根据权利要求1-5中任一项所述的缝合线，其中，所述凸轮(6)的壁厚最厚为0.1-0.9mm，优选0.3mm；
    优选地，所述凸轮(6)的壁厚最薄为0.05-0.2mm，优选0.09mm。
  7. 根据权利要求1-6中任一项所述的缝合线，其中，所述凸轮(6)的形状为含有中空部分的喇叭形；
    优选地，所述凸轮(6)还包括平直段；
    优选地，所述中空部分的形状为内喇叭形，所述内喇叭形沿细长主体(1)方向的长度为m，所述凸轮(6)沿细长主体(1)方向的长度为s，其中1/4s≤m≤s；
    优选地，所述中空部分还包含内平直段，所述内平直段沿细长主体(1)方向的长度为l，所述凸轮(6)沿细长主体(1)方向的长度为s，其中1/3s≤l≤2/3s；
    优选地，所述内喇叭形的喇叭角为δ，其中20°≤δ≤120°。
  8. 根据权利要求1-7中任一项所述的缝合线，其中，所述第一凸轮组件(4)和第二凸轮组件(5)对称分布在细长主体(1)中点两侧；
    优选地，所述第一凸轮组件(4)和第二凸轮组件(5)的凸轮个数相同；
    优选地，所述第一凸轮组件(4)和第二凸轮组件(5)中相邻凸轮(6)间的距离相同。
  9. 根据权利要求1-8中任一项所述的缝合线，其中，所述第一凸轮组件(4)的凸轮个数为4个；
    优选地，所述第一凸轮组件(4)中相邻凸轮(6)间的距离为3-10mm；
    优选地，所述第二凸轮组件(5)的凸轮个数为4个；
    优选地，所述第二凸轮组件(5)中相邻凸轮(6)间的距离为3-10mm。
  10. 根据权利要求1-9中任一项所述的缝合线，其中，所述凸轮(6)与细长主体(1)通过限位件限位；
    优选地，所述限位件为绳结；
    优选地，所述限位件在垂直于细长主体(1)长度方向的直径大于凸轮(2)小端(7)的孔径。
  11. 根据权利要求1-9中任一项所述的缝合线，其中，所述第一凸轮组件(4)和第二凸轮组件(5)与细长主体(1)通过热封固定。
  12. 根据权利要求1-11中任一项所述的缝合线，其中，所述细长主体(1)为单股丝线。
  13. 根据权利要求1-12中任一项所述的缝合线，其中，所述细长主体(1)和凸轮组件(2)均为可降解材料；
    优选地，所述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。
  14. 一种缝合装置，其包括权利要求1-13中任一项所述的缝合线以及位于缝合线两端的金属制针体。
  15. 根据权利要求14所述的缝合装置在组织缝合中的应用。
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