A lifting line

Abstract

The present invention provides a lifting wire, which includes a slender and flexible wire body and a first tissue engaging component and a second tissue engaging component arranged on the wire body. The first tissue engaging component and the second tissue engaging component both include a plurality of tissue engaging elements, the tissue engaging elements have a small end and a large end arranged relatively, the small ends of the tissue engaging elements of the first tissue engaging component are all facing the first free end of the wire body, the small ends of the tissue engaging elements of the second tissue engaging component are all facing the second free end of the wire body, the tissue engaging element has a wall body extending 360° along the circumferential direction, and part of the wall body is recessed inwardly along the radial direction of the tissue engaging element to form a guide wall. By setting the guide wall, it is beneficial to guide the body tissue into the inner cavity of the tissue engaging element, improve the engagement performance of the tissue engaging element, and thus improve the lifting performance of the lifting wire.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a lifting wire. Background Art

[0002] Age and environmental factors can cause the soft tissue and bone volume of the human face to shrink, the ligaments to gradually relax, and the superficial muscle fascia system to gradually sag. The relaxation of the cheek fat pads and the effect of gravity will cause the surface tissue of the face to sag, lose elasticity, increase wrinkles, and deepen grooves.

[0003] With the progress and development of society, people's demand for beauty is gradually increasing, especially the demand for facial rejuvenation, which has a growing trend year by year. At present, improving and maintaining facial rejuvenation is to introduce special lifting threads made of bioabsorbable materials into the superficial soft tissue through a minimally invasive surgery, and the loose facial soft tissue is lifted and restored through the excellent lifting and mechanical balancing effects of the lifting threads.

[0004] CN103251433A discloses a suture, comprising a slender flexible body and a plurality of tissue engaging elements. The slender flexible body is a multi-strand braided or woven structure, having a first end and a second end. Each tissue engaging element is defined by a hole passing through it, and is arranged on the slender flexible body through the hole. A plurality of knots are arranged on the slender flexible body, each knot is larger than the hole, and the knots hold the continuously arranged tissue engaging elements on the slender flexible body. The tissue engaging element is defined by a narrow end and an open end, and the open features of the open end and the inside of the tissue engaging element cooperate to provide tissue engaging characteristics, so that after the suture is implanted, it can support and fix the tissue, thereby achieving the effect of lifting and shaping the face.

[0005] However, after the knot is set, the stress of the elongated flexible body at the knot will increase, causing the elongated flexible body to deform and break at the knot. In particular, when the elongated flexible body is made of degradable materials, the elongated flexible body is easily degraded at the knot during the sterilization process, which reduces the overall strength of the elongated flexible body, resulting in the product being unable to meet the use requirements after the sterilization is completed. In addition, it cannot be ensured that the tissue can enter the interior of the tissue engaging element through the open end, that is, the interior of the tissue engaging element may not provide engaging characteristics, thereby greatly reducing the pulling ability of the suture. Summary of the invention

[0006] In order to solve at least one of the above-mentioned technical problems, the purpose of the present invention is to provide a pulling wire that can guide body tissue into the inner cavity of a tissue engaging element, ensure the engagement of the body tissue with the inner cavity, improve the engagement performance of the tissue engaging element, and thus improve the pulling ability of the pulling wire on the body tissue.

[0007] To achieve this object, the present invention adopts the following technical solutions:

[0008] A lifting wire, the lifting wire comprising a slender and flexible wire body and a first tissue engaging component and a second tissue engaging component arranged on the wire body, the wire body having a first free end and a second free end arranged opposite to each other, the first tissue engaging component and the second tissue engaging component both comprising a plurality of tissue engaging elements, the tissue engaging elements having a small end and a large end arranged opposite to each other, the outer diameter of the small end being smaller than the outer diameter of the large end, the small ends of the tissue engaging elements of the first tissue engaging component both facing the first free end, the small ends of the tissue engaging elements of the second tissue engaging component both facing the second free end, the tissue engaging element having a wall body extending 360° along the circumferential direction, the wall body enclosing a hollow structure with both ends penetrating, so that the small end has a first through hole, the large end has a second through hole, and an inner cavity is formed in the tissue engaging element, and part of the wall body is recessed radially inwardly along the tissue engaging element to form a guide wall.

[0009] In one embodiment, the guide wall extends at an angle of ≤180° in the circumferential direction.

[0010] In one embodiment, a portion of the wall protrudes radially outward from the tissue engaging element to form a compensation wall.

[0011] In one embodiment, the guide wall extends at an angle of 180° in the circumferential direction, the compensation wall extends at an angle of 180° in the circumferential direction, and the guide wall and the compensation wall together constitute the wall body.

[0012] In one embodiment, protrusions and / or grooves are arranged on the inner surface of the wall.

[0013] In one embodiment, the height of the protrusion is 0.01 mm-0.5 mm, and the depth of the groove is 0.01 mm-0.5 mm.

[0014] In one embodiment, a plurality of annular protrusions are provided on the inner surface of the wall at intervals along the axial direction of the tissue engaging element.

[0015] In one embodiment, the outer surface of the wall is configured to be smooth.

[0016] In one embodiment, the axial length of the tissue engaging element is 0.5 mm-4 mm, the outer diameter of the small end is 0.05 mm-1.2 mm, and the outer diameter of the large end is 0.2 mm-1.5 mm.

[0017] In one embodiment, the outer diameter of the large end is 2-4 times the outer diameter of the small end.

[0018] In one embodiment, the wall thickness of the wall body at the small end is 0.05 mm-0.6 mm, and the wall thickness of the wall body at the large end is 0.02 mm-0.5 mm.

[0019] In one embodiment, along the direction from the small end to the large end, the wall thickness of the wall body is uniformly arranged, or the wall thickness of the wall body gradually decreases.

[0020] In one embodiment, the tissue engaging element is produced by injection molding or heat expansion.

[0021] In one embodiment, the thread body is a single thread, or the thread body is a braided or woven structure formed by multiple threads.

[0022] In one embodiment, the length of the wire is 50 mm-500 mm, and the outer diameter of the wire is 0.02 mm-1.08 mm.

[0023] In one embodiment, the thread body and the tissue engaging element are both made of degradable materials.

[0024] In one embodiment, the degradable material includes any one of polylactic acid, polyglycolic acid, polycaprolactone, polydioxanone and lactide-co-glycolide, or a combination of at least two thereof.

[0025] In one embodiment, the thread and the tissue engaging element are both made of polylactic acid, or the thread and the tissue engaging element are both made of lactide-co-glycolide, or one of the thread and the tissue engaging element is made of polylactic acid and the other is made of lactide-co-glycolide.

[0026] In one embodiment, the polylactic acid is L-polylactic acid, and the mass ratio of lactide to glycolide in the lactide-glycolide copolymer is (70-90):(10-30).

[0027] In one embodiment, the first tissue engaging component and the second tissue engaging component are symmetrically distributed on both sides of the midpoint of the wire.

[0028] In one embodiment, a distance H between the first tissue engaging component and the second tissue engaging component is 5 mm-50 mm.

[0029] In one embodiment, the number N1 of tissue engaging elements of the first tissue engaging assembly is 2-20, and the number N2 of tissue engaging elements of the second tissue engaging assembly is 2-20.

[0030] In one embodiment, N1 is equal to N2.

[0031] In one embodiment, the tissue engaging elements of the first tissue engaging component are distributed at equal intervals, and the interval h1 is 3 mm-10 mm, and the tissue engaging elements of the second tissue engaging component are distributed at equal intervals, and the interval h2 is 3 mm-10 mm.

[0032] In one embodiment, said h1 is equal to said h2.

[0033] In one embodiment, the tissue engaging element is slidably disposed on the wire body, and the first tissue engaging component and the second tissue engaging component each include a plurality of limiting members, so that both ends of each tissue engaging element are provided with the limiting members for limiting.

[0034] In one embodiment, the limiting member is a hollow knot arranged on the wire body.

[0035] In one embodiment, the initial diameter of the hollow knot is 0.05 mm-2 mm.

[0036] In one embodiment, the lifting thread further includes an introduction needle having a connecting end and a puncture end that are relatively arranged. There are two introduction needles, and the two introduction needles are respectively arranged on the first free end and the second free end through their respective connecting ends.

[0037] In one embodiment, the connection end is opened, the first free end and the second free end are respectively inserted into the corresponding openings, and then the first free end and the second free end are connected to the corresponding introduction needle by crimping.

[0038] In one embodiment, the introduction needle is an elongated needle and is made of metal.

[0039] In one embodiment, the length of the introduction needle is 50 mm-250 mm, and the outer diameter of the introduction needle is 0.2 mm-1.4 mm.

[0040] In one embodiment, the lifting wire is sterilized by ethylene oxide or electron beam.

[0041] In one embodiment, the lifting wire is sterilized after being pre-frozen, for example, the lifting wire is pre-frozen and then sterilized by a low-energy electron beam.

[0042] In one embodiment, a low temperature environment is used during the sterilization process, for example, low temperature ethylene oxide sterilization is used.

[0043] In one embodiment, the lifting line is sealed and packaged in an aluminum foil bag, and a desiccant and / or an oxygen absorbent is placed in the bag.

[0044] In one embodiment, the lifting thread is stored at room temperature, or the lifting thread is refrigerated, for example, refrigerated at 0°C-8°C, or the lifting thread is frozen, for example, frozen at (-25°C)-(-15°C).

[0045] Compared with the prior art, the present invention has the following beneficial effects:

[0046] The present invention sets part of the wall of the tissue engaging element as a guide wall through the design of the tissue engaging element in the lifting line, so that the inner surface of the guide wall constitutes a guide surface, which is conducive to guiding the body tissue into the inner cavity, and improves the probability of the body tissue engaging with the inner cavity. In addition, the line body is easily offset relative to the guide wall, which increases the openness of the second through hole, and even if the body tissue is large, it can smoothly enter the inner cavity and engage with the inner cavity. In addition, the outer surface of the guide wall constitutes a support surface, which can be supported on the body tissue, thereby preventing the tissue engaging element from sliding in the direction opposite to the lifting direction, ensuring the lifting effect of the tissue engaging element on the body tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figure 1A It is a schematic structural diagram of the pulling line of the present invention.

[0048] Figure 1B for Figure 1A Schematic diagram of the structure of the pulling line after the hollow knot is tightened.

[0049] Figure 1C for Figure 1A The structure diagram of the lifting line shown is when the line body is in a straightened state.

[0050] Figure 2A 1 is a cross-sectional view of a tissue engaging element of the present invention having uniform wall thickness (the outer diameter gradually increases through a straight line).

[0051] Figure 2B 2 is a cross-sectional view of another tissue engaging element of the present invention having uniform wall thickness (the outer diameter gradually increases through a convex curve).

[0052] Figure 2C Also provided is a cross-sectional view of a tissue engaging element of the present invention having a uniform wall thickness (with the outer diameter gradually increasing through a concave curve).

[0053] Figure 3A1 is a cross-sectional view of a tissue engaging element of the present invention having a gradually decreasing wall thickness (the outer diameter gradually increases through a straight line).

[0054] Figure 3B 2 is a cross-sectional view of another tissue engaging element of the present invention having a gradually decreasing wall thickness (the outer diameter gradually increases through a convex curve).

[0055] Figure 3C Still another cross-sectional view of a tissue engaging element of the present invention having a tapering wall thickness (with an outer diameter increasing gradually through a concave curve).

[0056] Figure 4 2 is a cross-sectional view of a tissue engaging element provided with annular protrusions according to the present invention.

[0057] Figure 5A Schematic diagram of the lifting of a tissue engaging element of the present invention.

[0058] Figure 5B FIG. 4 is a schematic diagram of another tissue engaging element of the present invention being lifted.

[0059] Figure 5C Still another schematic diagram of lifting a tissue engaging element of the present invention is shown.

[0060] Fig. 6A for Figure 5A Schematic diagram of the tissue engaging element after being squeezed by body tissue.

[0061] Figure 6B for Figure 5B Schematic diagram of the tissue engaging element after being squeezed by body tissue.

[0062] Reference numerals:

[0063] Wire body 1, first free end 11, second free end 12, tissue engaging element 21, small end 211, large end 212, wall body 213, first through hole 214, second through hole 215, inner cavity 216, annular protrusion 217, guide wall 218, compensation wall 219, limiter 22, first end limiter 221, second end limiter 222, introduction needle 3, connecting end 31, puncture end 32. DETAILED DESCRIPTION

[0064] The technical solution of the present invention is further described below by means of specific implementation methods. It should be understood by those skilled in the art that the specific implementation methods are only used to help understand the present invention and should not be regarded as specific limitations of the present invention.

[0065] See also Figure 1A-Figure 1CThe present invention provides a lifting wire, comprising a slender and flexible wire body 1 and a first tissue engaging component and a second tissue engaging component arranged on the wire body 1. The wire body 1 has a first free end 11 and a second free end 12 arranged opposite to each other. The first tissue engaging component and the second tissue engaging component both include a plurality of tissue engaging elements 21. The tissue engaging element 21 has a small end 211 and a large end 212 arranged opposite to each other, and the outer diameter of the small end 211 is smaller than the outer diameter of the large end 212. The small ends 211 of the tissue engaging elements 21 of the first tissue engaging component are all facing the first free end 11, and the small ends 211 of the tissue engaging elements 21 of the second tissue engaging component are all facing the second free end 12.

[0066] During implantation, the first free end 11 first punctures into the body tissue at a pre-confirmed puncture point through an auxiliary tool and moves in the body tissue along a first preset direction. The tissue engaging elements 21 of the first tissue engaging assembly, driven by the first free end 11, puncture into the body tissue in the order of first the small end 211 and then the large end 212, and move along the first preset direction. Then, the second free end 12 punctures into the body tissue at the same puncture point through an auxiliary tool and moves in the body tissue along a second preset direction opposite to the first preset direction. The tissue engaging elements 21 of the second tissue engaging assembly, driven by the second free end 12, puncture into the body tissue in the order of first the small end 211 and then the large end 212, and move along the second preset direction. The order of first the small end 211 and then the large end 212 can facilitate the tissue engaging element 21 to enter the body tissue and minimize the damage to the body tissue. After the implantation is completed, the auxiliary tool is removed, and one of the two groups of tissue engagement components plays an anchoring role, which can prevent the lifting wire from slipping in the body tissue, and the large end 212 of the tissue engagement element 21 of the other group of the two tissue engagement components is engaged with the body tissue. Specifically, the large end 212 hooks the body tissue, which plays a role in lifting, supporting and fixing the body tissue. Therefore, through the pulling force and tension caused by the lifting wire of the present invention after implantation, the loose skin and tissues of the face, chin, neck, chest, abdomen, buttocks and vagina can be lifted, shaped, and wrinkled, which plays a role in beauty and repair.

[0067] It should be noted that after the first free end 11 and the second free end 12 penetrate into the body tissue, they can remain in the body tissue, or they can penetrate out of the body tissue after moving to a preset position, which is determined by the auxiliary tool actually used. In addition, one of the two groups of tissue engagement components can play an anchoring role, so the first free end 11 and the second free end 12 do not need to be anchored to the lifting wire by tying a knot or setting an anchor.

[0068] The lifting line also includes an introduction needle 3. The introduction needle 3 has a connecting end 31 and a puncture end 32 that are relatively arranged. There are two introduction needles 3, and the two introduction needles 3 are respectively arranged on the first free end 11 and the second free end 12 of the thread body 1 through the corresponding connecting ends 31. Specifically, the connecting end 31 of the introduction needle 3 is opened, and the first free end 11 and the second free end 12 are respectively inserted into the corresponding openings, and then the first free end 11 and the second free end 12 are connected to the corresponding introduction needle 3 by crimping. In addition, the introduction needle 3 is a slender needle body and is made of metal, preferably stainless steel. The introduction needle 3 can be a hollow structure or a solid structure. The length of the introduction needle 3 is 50mm-250mm. The outer diameter of the introduction needle 3 is 0.2mm-1.4mm.

[0069] The introduction needle 3 is used as the auxiliary tool described above. Specifically, 1) the puncture point, the first preset direction, the second preset direction, the first exit point corresponding to the first preset direction, and the second exit point corresponding to the second preset direction are marked on the area to be lifted (for example, the cheek area); 2) the introduction needle 3 corresponding to the first free end 11 is inserted through the puncture point to the required depth, and moves along the first preset direction in the body tissue to the first exit point and then passes out of the skin; 3) by means of traction, the first tissue engagement component enters the body tissue under the drive of the first free end 11 and moves along the first preset direction; 4) the first tissue engagement component After being in place, the first free end 11 is cut off and the corresponding introduction needle 3 is removed; 5) The introduction needle 3 corresponding to the second free end 12 is inserted through the same puncture point to the required depth, and moves along the second preset direction in the body tissue to the second exit point and then passes through the skin; 6) By means of traction, the second tissue engagement component enters the body tissue and moves along the second preset direction under the drive of the second free end 12; 7) After the second tissue engagement component is in place, it is cut off at the second free end 12 and the corresponding introduction needle 3 is removed; 8) Use your fingers to gently press the soft tissue to fine-tune the implantation state of the lifting thread.

[0070] The thread body 1 and the tissue engaging element 21 are both made of degradable materials. Therefore, the lifting thread of the present invention can be degraded in situ and then excreted from the body or absorbed by the body, and can stimulate the body to produce collagen, reshape, tighten the skin, increase skin elasticity, and improve texture.

[0071] The degradable material includes any one of polylactic acid, polyglycolic acid, polycaprolactone, polydioxanone and lactide-glycolide copolymer, or a combination of at least two thereof.

[0072] The material of the wire body 1 and the material of the tissue engaging element 21 may be the same or different.

[0073] In one embodiment, the thread 1 and the tissue engaging element 21 are both made of polylactic acid; in another embodiment, the thread 1 and the tissue engaging element 21 are both made of lactide-glycolide copolymer; in yet another embodiment, one of the thread 1 and the tissue engaging element 21 is made of polylactic acid and the other is made of lactide-glycolide copolymer, that is, the thread 1 is made of polylactic acid and the tissue engaging element 21 is made of lactide-glycolide copolymer, or the thread 1 is made of lactide-glycolide copolymer and the tissue engaging element 21 is made of polylactic acid.

[0074] Compared with other degradable materials, polylactic acid and lactide-co-glycolide have a slower degradation rate, so they can achieve a long-lasting effect. Among them, polylactic acid can be L-polylactic acid, and in lactide-co-glycolide, the mass ratio of lactide to glycolide is (70-90):(10-30), for example, 70:30, 80:20, 82:18, 90:10, but not limited to the listed values, other values ​​not listed in the range are also applicable.

[0075] The wire body 1 can be a single wire, or a braided or woven structure formed by multiple wires. The braided or woven structure is conducive to the growth of body tissues and entering the gaps between the wires, thereby increasing the stability of the lifting wire in the body tissues after implantation, preventing the lifting wire from sliding and shifting arbitrarily, and helping to enhance the lifting, supporting, and fixing effects of the lifting wire on the body tissues.

[0076] The length of the wire body 1 is 50mm-500mm. The outer diameter of the wire body 1 is 0.02mm-1.08mm. The lifting wire of the present invention is mainly used for lifting the face. The force required for facial tissue to overcome gravity is 1N, and the muscle pulling force required for making facial expressions is 3N-5N. Therefore, the wire body 1 needs to have a certain tensile strength to be able to withstand the resistance of body tissue during implantation, and to be able to withstand the lifting force of lifting the face after implantation. Therefore, the outer diameter of the wire body 1 cannot be too small, otherwise, the tensile strength is too low and it is not easy to operate. However, the outer diameter of the wire body 1 cannot be too large. When the outer diameter of the wire body 1 is too large, the damaged channel in the body tissue will be too large after the lifting wire is implanted, which is not conducive to the repair of the body tissue, and will also affect the lifting effect of the tissue engaging element 21 on the body tissue.

[0077] The first tissue engaging component and the second tissue engaging component are symmetrically distributed on both sides of the midpoint of the thread body 1 .

[0078] The spacing H between the first tissue engaging component and the second tissue engaging component is 5 mm to 50 mm.

[0079] The number N1 of tissue engaging elements 21 of the first tissue engaging assembly is 2-20.

[0080] The number N2 of tissue engaging elements 21 of the second tissue engaging assembly is 2-20.

[0081] In this embodiment, N1 is equal to N2. It is understandable that in other embodiments not shown, N1 and N2 may be different.

[0082] The tissue engaging elements 21 of the first tissue engaging component are distributed at equal intervals, and the interval h1 is 3mm-10mm, preferably 5mm or 8mm. h1 cannot be too large. When h1>10mm, the number of tissue engaging elements 21 in the area to be lifted is too small, which may easily cause uneven lifting; h1 cannot be too small. When h1<3mm, too little body tissue enters between two adjacent tissue engaging elements 21, and the tissue engaging elements 21 may easily slip off, and the lifting of the body tissue may not be achieved.

[0083] The tissue engaging elements 21 of the second tissue engaging assembly are distributed at equal intervals, and the interval h2 is 3mm-10mm, preferably 5mm or 8mm. h2 cannot be too large. When h2>10mm, the number of tissue engaging elements 21 in the area to be lifted is too small, which may easily cause uneven lifting; h2 cannot be too small. When h2<3mm, too little body tissue enters between two adjacent tissue engaging elements 21, and the tissue engaging elements 21 may easily slip off, and the lifting of the body tissue may not be achieved.

[0084] In this embodiment, h1 is equal to h2. It is understandable that in other embodiments not shown, h1 and h2 may be different.

[0085] Please combine Figure 2A-2C as well as Figures 3A-3C The outer contour of the tissue engaging element 21 is trumpet-shaped, and along the direction from the small end 211 to the large end 212, the outer diameter of the tissue engaging element 21 gradually increases through a straight line, a concave curve or a convex curve.

[0086] The axial length of the tissue engaging element 21 is 0.5 mm to 4 mm. The length of the tissue engaging element 21 cannot be too short, otherwise it cannot be processed; the length of the tissue engaging element 21 cannot be too long, otherwise, in the area to be lifted, the number of tissue engaging elements 21 is too small, resulting in poor lifting effect.

[0087] The outer diameter of the small end 211 is 0.05 mm to 1.2 mm. The outer diameter of the small end 211 cannot be too large, otherwise it is difficult to pass through the puncture hole. In addition, the small end 211 needs to be arranged in coordination with the wire body 1, so it cannot be too small.

[0088] The outer diameter of the big end 212 is 0.2mm-1.5mm. The passage of the tissue engaging element 21 in the body tissue cannot be too large, otherwise it will affect the recovery of the body tissue. Based on this, the outer diameter of the big end 212 cannot be too large. In addition, if the outer diameter of the big end 212 is too large, a protrusion will be formed on the skin surface, affecting the appearance. However, the outer diameter of the big end 212 cannot be too small. If the outer diameter of the big end 212 is too small, the big end 212 cannot mesh with the body tissue well and cannot play a lifting effect.

[0089] In one embodiment, the outer diameter of the large end 212 is 2-4 times the outer diameter of the small end 211 .

[0090] Please continue reading Figure 2A-2C as well as Figures 3A-3C The tissue engaging element 21 has a wall body 213 extending 360° in the circumferential direction. The wall body 213 has an inner surface and an outer surface. The wall body 213 encloses a hollow structure with both ends penetrating, so that the small end 211 has a first through hole 214, the large end 212 has a second through hole 215, and an inner cavity 216 is formed in the tissue engaging element 21.

[0091] The aperture of the first through hole 214 is smaller than the aperture of the second through hole 215, and the aperture of the first through hole 214 matches the outer diameter of the wire body 1, that is, the aperture of the first through hole 214 is equal to or slightly larger than the outer diameter of the wire body 1, and the aperture of the first through hole 214 is 0.02mm-1.1mm. In this way, the tissue engaging element 21 can be passed through the wire body 1, and after the lifting wire is implanted, the second through hole 215 and the inner cavity 216 have an open feature, so that the inner cavity 216 can cooperate with the large end 212 to engage with the body tissue.

[0092] As described above, the tissue engaging element 21 is inserted into the thread body 1, and the small end 211 needs to bear the linear cutting force of the thread body 1. Therefore, the wall thickness of the wall body 213 at the small end 211 cannot be too small, otherwise, the tissue engaging element 21 is easily cut by the thread body 1, thereby affecting the use. In addition, in order to facilitate puncture, the outer diameter of the small end 211 cannot be too large. When the aperture of the first through hole 214 is determined according to the outer diameter of the thread body 1, the outer diameter of the small end 211 depends on the wall thickness of the wall body 213 at the small end 211. Therefore, the wall thickness of the wall body 213 at the small end 211 cannot be too large. The wall thickness of the wall body 213 at the small end 211 is 0.05mm-0.6mm.

[0093] After the small end 211 of the tissue engagement element 21 punctures into the body tissue, the large end 212 also needs to enter the body tissue through the puncture port, and after the implantation is completed, the large end 212 needs to engage with the body tissue to play the role of lifting, supporting and fixing the body tissue. Therefore, the wall thickness of the wall 213 at the large end 212 cannot be too large, otherwise, the large end 212 is difficult to pass through the puncture port. The wall thickness of the wall 213 at the large end 212 can be designed to be smaller, so that the large end 212 can be deformed when squeezed at the puncture port (when the squeezing force is reduced or removed, the deformation can be restored), which is convenient for entering the body tissue and can achieve a smaller wound surface entering the body tissue. The wound surface is small, which is conducive to shortening the recovery time, and it is also more beautiful after recovery. In addition, after entering, the large end 212 with a certain deformation performance is easy to engage with the body tissue. However, the wall thickness of the wall body 213 at the large end 212 cannot be too small, otherwise, after the large end 212 enters the body tissue, it is difficult to provide sufficient radial support force, and thus it is impossible to provide a pulling force to the body tissue. In addition, if the wall thickness 213 of the wall body 213 at the large end 212 is too small, when pulling, the large end 212 will form a large pressure on the body tissue, which may cut the body tissue. The wall thickness of the wall body 213 at the large end 212 is 0.02mm-0.5mm.

[0094] Along the direction from the small end 211 to the large end 212, the wall thickness of the wall body 213 can be set uniformly or gradually reduced. When any of the two methods is selected to set the wall thickness of the wall body 213, the inner cavity 214 is all trumpet-shaped. As described above, when the large end 212 is engaged with the body tissue, the second through hole 215 and the open features of the inner cavity 216 allow the body tissue to enter and be embedded in the inner cavity 216, that is, the inner cavity 216 can also play a role in engaging with the body tissue. The more body tissue enters the inner cavity 216, the stronger the engagement effect of the inner cavity 216 on the body tissue, and the stronger the pulling force of the tissue engagement element 21 on the body tissue. Based on this, it is necessary to improve the openness of the second through hole 215, that is, to increase the aperture of the second through hole 215, which can facilitate the body tissue to enter the inner cavity 216. Therefore, preferably, the wall thickness of the wall 213 gradually decreases from the small end 211 to the large end 212, so that the second through hole 215 can obtain a larger aperture.

[0095] In addition, the surface area and / or friction of the inner surface of the wall body 213 can be increased, that is, the surface area and / or friction of the surface of the inner cavity 216 can be increased to improve the meshing effect of the inner cavity 216. Specifically, protrusions and / or grooves are provided on the inner surface of the wall body 213. The protrusions can increase the surface area and friction of the surface of the inner cavity 216, but the height of the protrusions cannot be too large, otherwise it will affect the volume of the inner cavity 216, thereby affecting the entry of body tissue into the inner cavity 216. The height of the protrusions is 0.01mm-0.5mm. Similarly, the grooves can increase the surface area and friction of the surface of the inner cavity 216, but the depth of the grooves cannot be too large, otherwise it will affect the strength of the wall body 213. The depth of the grooves is 0.01mm-0.5mm. Figure 4 As shown, in this embodiment, a plurality of annular protrusions 217 are arranged on the inner surface of the wall 213 at intervals along the axial direction of the tissue engaging element 21.

[0096] Different from the inner surface of the wall body 213, the outer surface of the wall body 213 can be set to be smooth, so that no uncomfortable tingling sensation will be generated when the lifting thread is implanted.

[0097] The connection between the small end 211 and the wall 213 can be chamfered to reduce the resistance of the small end 211 when it penetrates, so as to facilitate passing through the puncture hole. In this way, the contact surface between the small end 211 and the body tissue can be reduced during puncture, and it can also play a guiding role after contacting the body tissue, so that the small end 211 can smoothly enter the body tissue. The range of the chamfer is 100°-170°.

[0098] In order to facilitate the tissue engaging element 21 to enter the body tissue, a slit can be set on the wall 213 along the direction from the small end 211 to the large end 212, so that the slit can produce yield at the puncture hole, so that the tissue engaging element 21 can pass through the puncture hole smoothly. Alternatively, the wall 213 can be set in a spiral structure around the central axis of the tissue engaging element 21, which can also play a role in reducing the implantation resistance.

[0099] See also Figure 5A-Figure 5C , the tissue engaging element 21 can be set as a non-rotating body. Specifically, part of the wall 213 of the tissue engaging element 21 is recessed inwardly along the radial direction of the tissue engaging element 21 to form a guide wall 218. The inner surface of the guide wall 218 is a guide surface and constitutes a part of the surface of the inner cavity 216, which is conducive to guiding the body tissue into the inner cavity 216 and improving the probability of the body tissue engaging with the inner cavity 216. In addition, the outer surface of the guide wall 218 is a support surface, which is an arc-shaped surface recessed inwardly along the radial direction of the tissue engaging element 21, which can be supported on the body tissue to prevent the tissue engaging element 21 from rotating in the direction opposite to the pulling direction ( Figure 5A-Figure 5C Slide in the opposite direction of the arrow. Figure 6A-6BWhen the tissue engaging element 21 is a rotating body, the probability of the body tissue entering the inner cavity 216 from all directions is equal, so the wire body 1 is not easy to be offset, that is, generally speaking, the axis of the wire body 1 coincides with the central axis of the tissue engaging element 21. In this way, the openness of the second through hole 215 will be affected by the wire body 1, and when the volume of the body tissue is large, it is difficult to enter the inner cavity 216. By setting the tissue engaging element 21 as a non-rotating body, the body tissue preferentially enters the inner cavity 216 through the inner surface of the guide wall 218, so that the wire body 1 is offset, the openness of the second through hole 215 is increased, which is conducive to the body tissue entering the inner cavity 216 and improves the engagement performance of the tissue engaging element 21.

[0100] It should be noted that the installation of the guide wall 218 will reduce the volume of the inner cavity 216. Therefore, the angle of the guide wall 218 extending in the circumferential direction is ≤ 180° to prevent the volume of the inner cavity 216 from being too small and unable to accommodate enough body tissues. Figure 5C Part of the wall 213 of the tissue engaging element 21 protrudes outwardly along the radial direction of the tissue engaging element 21 to form a compensation wall 219. The compensation wall 219 is provided to increase the volume of the inner cavity 216. In this way, while it is helpful to guide the body tissue into the inner cavity 216, the inner cavity 216 also has a sufficient volume to accommodate the body tissue. In one embodiment, the guide wall 218 extends at an angle of 180° in the circumferential direction, and the compensation wall 219 also extends at an angle of 180° in the circumferential direction, that is, the guide wall 218 and the compensation wall 219 together constitute the wall 213.

[0101] The tissue engaging element 21 is prepared by injection molding or thermal expansion. In one preferred embodiment, the tissue engaging element 21 is prepared by thermal expansion of a tube, which has a low preparation cost and is convenient for industrial large-scale production and application.

[0102] Please refer again Figure 1A-Figure 1C The tissue engaging element 21 is slidably disposed on the thread body 1, and the first tissue engaging component and the second tissue engaging component both include a plurality of stoppers 22, so that both ends of each tissue engaging element 21 are provided with stoppers 22 for position limiting, and the outer diameter of the stoppers 22 in the direction perpendicular to the length of the thread body 1 is greater than the aperture of the first through hole 214. In this way, each tissue engaging element 21 is limited between two adjacent stoppers 22 corresponding thereto, and can only slide between the two adjacent stoppers 22 corresponding thereto.

[0103] In the first tissue engaging assembly, the number of stoppers 22 is one more than the number of tissue engaging elements 21, that is, the number of stoppers 22 is N1+1. Similarly, in the second tissue engaging assembly, the number of stoppers 22 is one more than the number of tissue engaging elements 21, that is, the number of stoppers 22 is N2+1.

[0104] In the first tissue engagement component, the stopper 22 adjacent to the midpoint of the wire body 1 is the first end stopper 221; in the second tissue engagement component, the stopper 22 adjacent to the midpoint of the wire body 1 is the second end stopper 222; when the wire body 1 is in a straightened state, the distance between the first end stopper 221 and the second end stopper 222 is the distance H between the first tissue engagement component and the second tissue engagement component. In addition, the distances from the first end stopper 221 and the second end stopper 222 to the midpoint of the wire body 1 are equal.

[0105] In addition, when the wire body 1 is in a straight state, the distance between two adjacent limit members 22 in the first tissue engaging component is the distance h1 between two adjacent tissue engaging elements 21; similarly, when the wire body 1 is in a straight state, the distance between two adjacent limit members 22 in the second tissue engaging component is the distance h2 between two adjacent tissue engaging elements 21.

[0106] Specifically, the first tissue engagement component is firstly arranged, and after the first limiting piece 22 is arranged on the wire body 1 at a position close to the first free end 11, the first tissue engagement element 21 is passed through, and then, along the direction away from the first free end 11, the second limiting piece 22 is arranged on the wire body 1 with a spacing h1 from the first limiting piece 22, and the second tissue engagement element 21 is passed through..., and so on, after the N1th limiting piece 22 is arranged and the N1th tissue engagement element 21 is passed through, along the direction away from the first free end 11, the (N1+1)th limiting piece 22 is arranged on the wire body 1 with a spacing h1 from the N1th limiting piece 22, and the arrangement of the first tissue engagement component on the wire body 1 is completed.

[0107] Then, a second tissue engaging component is arranged, which is spaced H from the (N1+1)th limiting piece 22, and the counting is restarted. After the first limiting piece 22 is arranged on the thread body 1, the first tissue engaging element 21 is inserted. Then, along the direction close to the second free end 12, a second limiting piece 22 is arranged on the thread body 1 with a spacing of h2 from the first limiting piece 22, and the second tissue engaging element 21 is inserted… and so on. After the N2th limiting piece 22 is arranged and the N2th tissue engaging element 21 is inserted, along the direction close to the second free end 12, a (N2+1)th limiting piece 22 is arranged on the thread body 1 with a spacing of h2 from the N2th limiting piece 22, and the arrangement of the second tissue engaging component on the thread body 1 is completed.

[0108] It is understandable that in other embodiments not shown, the tissue engaging element 21 may also be fixedly disposed on the thread body 1, for example, by ultrasonic welding, laser welding, heat sealing or bonding. In this case, the stopper 22 is omitted.

[0109] By providing the limiter 22 or fixing the tissue engaging element 21 on the wire body 1, the relative stability of the wire body 1 and the tissue engaging element 21 is ensured, so that after entering the body tissue, the tissue engaging element 1 can play a better lifting role on the body tissue.

[0110] Please continue reading Figure 1A-Figure 1C The limiter 22 is a hollow knot set on the wire body 1. During sterilization, transportation, and storage, the stress at the hollow knot is small, which can ensure the smooth sterilization of the lifting wire, and can extend the shelf life of the lifting wire, and prevent excessive stress from causing the wire body 1 to deform or break at the knot. When in use, the operator pulls the lifting wire at both ends to tighten the hollow knot and reduce the initial diameter of the hollow knot to an implantation diameter suitable for puncture.

[0111] It should be noted that the initial diameter of the hollow knot needs to be set within an appropriate range, specifically, the initial diameter of the hollow knot is 0.05mm-2mm. When the initial diameter of the hollow knot is too small, a large stress will accumulate at the hollow knot, which will reduce the strength of the wire body 1 and easily break at the hollow knot, which is not conducive to the sterilization, transportation and storage of the lifting line. The initial diameter of the hollow knot should not be too large. During the operator's pulling of the lifting line, the hollow knot is gradually tightened, the position of the hollow knot will be offset, and the spacing between two adjacent tissue engaging elements 21 may increase or decrease, resulting in non-equidistant distribution of the tissue engaging elements 21 of the first tissue engaging component and / or non-equidistant distribution of the tissue engaging elements 21 of the second tissue engaging component, resulting in uneven lifting effect. In order to reduce the impact on the uniformity of lifting, it is necessary to reduce the offset distance of the hollow knot as much as possible, that is, to reduce the initial diameter of the hollow knot as much as possible.

[0112] In order to obtain a hollow knot with an appropriate initial diameter, a standard rod with an appropriate outer diameter is required. The wire body 1 is tied around the standard rod and then gradually tightened until the hollow knot fits the outer surface of the standard rod. The standard rod is removed to complete the setting of a hollow knot with an appropriate initial diameter.

[0113] It is understandable that in other embodiments not shown, other types of limiting members 22 may be provided. For example, a protrusion may be provided on the linear body 1 to serve as the limiting member 22 .

[0114] The lifting thread of the present invention needs to be kept in a sterile state as an implantable product. However, degradable materials will be degraded by radiation, water, oxygen, etc. during the sterilization process. Therefore, it is necessary to adopt a reasonable sterilization method and take certain protective measures to protect the product to the maximum extent. In the present invention, ethylene oxide sterilization is adopted, or electron beam sterilization is adopted. Further, in order to reduce the influence of temperature on the product during the sterilization process, the product is sterilized after pre-freezing, for example, after pre-freezing the product, low-energy electron beam sterilization is adopted, or a low-temperature environment is adopted during the sterilization process, for example, low-temperature ethylene oxide sterilization is adopted. In addition, an aluminum foil bag is used for sealing and packaging, and a desiccant and / or an oxygen absorber are placed. In addition, during transportation and storage, in order to avoid degradation of degradable materials, room temperature storage, or refrigeration, for example, refrigeration at 0°C-8°C, or frozen storage, for example, frozen storage at (-25°C)-(-15°C).

[0115] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0116] In the description of the present invention, "plurality" means two or more.

[0117] In the description of the present invention, "first feature" or "second feature" may include one or more of the features.

[0118] In the description of the present invention, a first feature being “on” or “under” a second feature may include that the first and second features are directly in contact with each other, or may include that the first and second features are not in direct contact with each other but are in contact with each other via another feature therebetween.

[0119] In the description of the present invention, “on”, “over” and “above” a first feature from a second feature includes the first feature being directly above and obliquely above the second feature, or simply means that the first feature is horizontally higher than the second feature.

[0120] In the description of the present invention, the description with reference to the terms "one embodiment", "some embodiments", "illustrative embodiments", "examples", "specific examples", or "some examples" etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example.

[0121] The applicant declares that the above is only a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention shall fall within the protection scope and disclosure scope of the present invention.

Claims

1. A lifting line, characterized in that: The lifting wire comprises a slender and flexible wire body and a first tissue engaging component and a second tissue engaging component arranged on the wire body, the wire body having a first free end and a second free end arranged oppositely, the first tissue engaging component and the second tissue engaging component both comprising a plurality of tissue engaging elements, the tissue engaging elements having a small end and a large end arranged oppositely, the outer diameter of the small end being smaller than the outer diameter of the large end, the small ends of the tissue engaging elements of the first tissue engaging component all facing the first free end, the small ends of the tissue engaging elements of the second tissue engaging component all facing the second free end, the tissue engaging element having a wall body extending 360° along the circumferential direction, the wall body enclosing a hollow structure with two ends passing through, so that the small end has a first through hole, the large end has a second through hole, and an inner cavity is formed in the tissue engaging element, and part of the wall body is recessed inwardly along the radial direction of the tissue engaging element to form a guide wall; A portion of the wall body protrudes outwardly in the radial direction of the tissue engaging element to form a compensation wall, and the guide wall and the compensation wall together constitute the wall body.

2. The lifting wire according to claim 1, characterized in that: The angle at which the guide wall extends in the circumferential direction is ≤180°.

3. The lifting wire according to claim 1, characterized in that: The inner surface of the wall body is provided with protrusions and / or grooves.

4. The lifting wire according to claim 3, further characterized in that: the height of the protrusion is 0.01mm-0.5mm, and the depth of the groove is 0.01mm-0.5mm.

5. The lifting wire according to claim 3, characterized in that: A plurality of annular protrusions are arranged on the inner surface of the wall at intervals along the axial direction of the tissue engaging element.

6. The lifting wire according to claim 1, characterized in that: The tissue engaging element is slidably disposed on the wire body, and the first tissue engaging component and the second tissue engaging component both include a plurality of limiting members, so that both ends of each tissue engaging element are provided with the limiting members for limiting.

7. The lifting wire according to claim 6, characterized in that: The limiting member is a hollow knot arranged on the wire body.

8. The lifting wire according to claim 7, characterized in that: The initial diameter of the hollow knot is 0.05 mm to 2 mm.

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