WO2023173704A1 - Instrument de fixation, son procédé de fabrication et dispositif de fixation médical - Google Patents

Instrument de fixation, son procédé de fabrication et dispositif de fixation médical Download PDF

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Publication number
WO2023173704A1
WO2023173704A1 PCT/CN2022/118109 CN2022118109W WO2023173704A1 WO 2023173704 A1 WO2023173704 A1 WO 2023173704A1 CN 2022118109 W CN2022118109 W CN 2022118109W WO 2023173704 A1 WO2023173704 A1 WO 2023173704A1
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WO
WIPO (PCT)
Prior art keywords
rope
knot
ring
loop
segment
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Application number
PCT/CN2022/118109
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English (en)
Chinese (zh)
Inventor
葛立
张凤羽
霍红亚
王远强
赖卫国
Original Assignee
上海利格泰生物科技有限公司
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Application filed by 上海利格泰生物科技有限公司 filed Critical 上海利格泰生物科技有限公司
Publication of WO2023173704A1 publication Critical patent/WO2023173704A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone

Definitions

  • the present invention relates to the field of medical devices, and in particular to a fixation device, a manufacturing method thereof and a medical fixation device.
  • the loop titanium plate fixation method is a surgical method for ligament and tendon reconstruction. This method does not require additional incisions on the lateral condyle.
  • the built-in titanium plate with loops can be used to firmly fix the upper end of the ligament graft without bone fragments at both ends in the femoral bone canal. This method is currently using the semitendinosus tendon, gracilis tendon, etc. A relatively mature and effective method for ACL reconstruction without bone graft.
  • the coil in the titanium band loop plate that is, the loop ring
  • the fixation effect is not good, and the titanium plate with loops often moves, which can easily cause ligament scratches, loosening and other adverse reactions, affecting the healing effect.
  • the metal material of the titanium plate with loops can cause bone damage due to wear and tear on the bone during long-term activities at the contact surface with the bone. It can also easily cause various types of inflammation and infection, endangering your health.
  • the poor fit between the looped titanium plate and the bone causes the sutures fixed on the looped titanium plate to shake in the bone canal, which increases the wear of the sutures and affects the service life of the sutures.
  • tissue attachment devices including screws, suture rivets, etc. can also result in weak fixation.
  • the purpose of the present invention is to provide a fixation device, a manufacturing method thereof, and a medical fixation device, which can improve the fixation effect of tissues and bones, reduce wear and tear on tissues and bones, and increase the service life of the fixation device.
  • the fixation device provided by the present invention is formed by braiding a rope, and includes: a ring part, the ring part includes a wire loop, the wire loop is used to pass through the target tissue; and the knot part, the knot part Connected to the ring part, the knot part is used to abut with the bone; the adjustment part is connected to the ring part, the adjustment part is used to adjust the size of the wire loop, during use Tighten the wire loop to fix the target tissue and the bone.
  • the beneficial effect of the fixation device provided by the present invention is that: the rope is woven to form the ring part, the knot part and the adjustment part, and the size of the wire loop of the ring part is adjusted through the adjustment part, so that the knot part The part fixes the target tissue and the bone. Because the knot formed by weaving the rope can produce a certain deformation according to the surface shape of the bone when it comes into contact with the bone, so as to reduce the gap and increase the contact area, thereby reducing the gap and increasing the contact area.
  • the knot formed by braiding ropes has a certain degree of flexibility, which can effectively reduce the wear and tear on bones; replacing the metal titanium plate with the knot formed by braiding ropes can also This prevents the wire from wearing out in the pores of the metal titanium plate and increases the service life of the fixed instrument.
  • the knot portion includes a knot loop and a coil wound around the knot loop.
  • the beneficial effect is that the contact area between the knot and the bone is increased through the knotted loop and the coil wound around the knotted loop.
  • the knot is an "o"-shaped knot
  • the coil includes a first coil wound around the "o"-shaped knot. Its beneficial effect is to help increase the contact area between the knot and the bone and increase the fixation strength.
  • the knot is an "8"-shaped knot
  • the coil includes a second coil wound around one of the "8"-shaped knots and another coil wound around the "8"-shaped knot.
  • the third coil of a loop is conducive to further increasing the contact area between the knot and the bone and increasing the fixation strength.
  • the number of winding turns of the first coil is greater than or equal to 3 and less than or equal to 15. Its beneficial effect is to help reduce the distance between coils, increase the contact area between the knot and the bone, and increase the fixation strength.
  • the number of winding turns of the second coil and the third coil is greater than or equal to 3 and less than or equal to 15. Its beneficial effect is to help reduce the distance between coils, increase the contact area between the knot and the bone, and increase the fixation strength.
  • the loop portion is composed of a double wire loop.
  • the beneficial effect is that the double-wire loop is beneficial to increasing the fixing strength compared with the single-wire loop.
  • the double wire loops are parallel to each other.
  • the double wire loops cross each other's centers.
  • the target tissue is human soft tissue, including ligaments, tendons or shoulder blades.
  • the present invention also provides a method for manufacturing the above-mentioned fixation device, which includes the following steps: S1 provides a hollow rope-like object, the rope-like object includes a rope segment, and the rope segment includes a first rope segment and Second rope segment; S2, pass the first rope segment through the first opening on the rope along the direction of the second rope segment, and pass through the second opening on the rope. Out, the bend of the rope forms a central ring; S3 passes the first rope segment through the central ring and tightens the central ring so that the nested part of the rope forms a knotted loop.
  • S4 pass the rope segment through the knot ring and wrap around the knot ring to form a knot
  • S5 pass the first rope segment and the second rope segment through the knot ring in reverse direction, and pass through the knot ring.
  • the part passing through the loop forms an adjustment part, and the other part forms a ring part.
  • the beneficial effect of the method for manufacturing a fixation device provided by the present invention is to manufacture a fixation device.
  • the fixation device is woven from a rope to form the ring portion, the knot portion and the adjustment portion. Adjust the size of the wire loop of the loop so that the knot fixes the target tissue and the bone. Since the knot formed by braiding the rope, when in contact with the bone, it can produce a certain shape according to the surface shape of the bone.
  • the knot formed by the rope-like weaving has a certain degree of flexibility, which can effectively reduce the wear and tear on the bones; with the rope-like
  • the knot formed by fabric weaving replaces the metal titanium plate, which also prevents the thread from wearing in the pores of the metal titanium plate, thereby increasing the service life of the fixed instrument.
  • step S4 includes: winding the first rope segment and the second rope segment together around the knotted ring, and the first rope segment and the second rope segment together form a first coil.
  • winding around the knotted ring includes: winding the first rope segment around a loop of the "8" shaped knotted ring to form a second rope wrapped around the knotted ring.
  • Coil wind the second rope segment around another loop of the "8"-shaped knotted ring to form a third coil wrapped around the knotted ring.
  • step S4 the number of turns that the first rope segment and the second rope segment are wound together on the knotted loop is greater than or equal to 3 and less than or equal to 15.
  • the number of turns of a loop of the "8"-shaped knotted ring of the first rope segment is greater than or equal to 3 and less than or equal to 15, and the second rope segment is wound around the "8"-shaped knot.
  • the number of turns of the other ring is greater than or equal to 3 and less than or equal to 15.
  • step S5 includes: passing the first rope segment and the second rope segment through the knotted loop in parallel.
  • step S5 includes: crossing the first rope segment and the second rope segment and then passing them through the knotted loop.
  • step S5 includes: threading the first rope segment into the second rope segment and then out, and passing through the knot; threading the second rope segment into the first rope Pull it out after the section and pass through the knotted loop.
  • step S5 includes: passing the first rope segment into the second rope segment and then out, and passing it through a loop of the "8" shaped knot; Pass it through the first rope segment, then pass it out, and pass through another loop of the "8" shaped knot ring.
  • the first rope segment is inserted into the second rope segment, it is passed out through a fifth opening, and the fifth opening is located on the second rope segment and close to the knot; After the second rope section penetrates into the first rope section, it passes out from the sixth opening.
  • the sixth opening is located on the first rope section and close to the knot.
  • the distance from the first opening to the second opening is equal to the distance from the third opening to the fourth opening.
  • the beneficial effect is that the two rings of the "8" shaped knotted ring are of the same size.
  • the fourth opening is adjacent to the second opening.
  • the present invention also provides a medical fixation device, including the above-mentioned fixation instrument,
  • Figure 1 is a schematic structural diagram of a fixation device in a first embodiment of the present invention
  • Figure 2 is a schematic structural diagram of a fixation device in a second embodiment of the present invention.
  • Figure 3 is a schematic diagram of step S1 of the manufacturing method of the fixation device in the first embodiment of the present invention
  • Figure 4 is a schematic diagram of step S2 of the manufacturing method of the fixation device in the first embodiment of the present invention
  • Figure 5 is a schematic diagram of the first rope segment passing through the central ring in step S3 of the manufacturing method of the fixation device in the first embodiment of the present invention
  • Figure 6 is a schematic diagram of tightening the central ring in step S3 of the manufacturing method of the fixation device in the first embodiment of the present invention
  • Figure 7 is a schematic diagram of forming a knot ring in step S3 of the manufacturing method of a fixation device in the first embodiment of the present invention.
  • Figure 8 is a schematic diagram of steps S4 and S5 of the manufacturing method of the fixation device in the first embodiment of the present invention.
  • Figure 9 shows the manufacturing method of the fixation device in the second embodiment of the present invention.
  • the second rope segment is reversely inserted through the third opening on the rope and then passed out through the fourth opening on the rope.
  • Figure 10 is a schematic diagram of the "8"-shaped knotted ring formed by the manufacturing method of the fixation device in the second embodiment of the present invention.
  • Figure 11 is a schematic diagram of step S4 of the manufacturing method of a fixation device in the second embodiment of the present invention.
  • Figure 12 is a schematic diagram of step S5 of the manufacturing method of the fixation device in the second embodiment of the present invention.
  • Figure 14 is a schematic structural diagram of double wire loops crossing each other's centers in an embodiment of the present invention.
  • embodiments of the present invention provide a fixation device.
  • Figure 1 is a schematic structural diagram of a fixation device in a first embodiment of the present invention.
  • the fixation device includes a ring portion 1, and the ring portion 1 is composed of a double wire loop.
  • the double wire loop includes a first wire loop 11 and a second wire loop 12. ;
  • the target tissue passes through the center of the first wire loop 11 and the second wire loop 12.
  • the target tissue can be a ligament and is covered by the first wire loop 11 and the second wire loop.
  • 12 is pulled to the bone to be fixed;
  • the knot part 2 is connected to the ring part 1, and the knot part 2 is used to abut with the bone;
  • the adjustment part 3, the adjustment part 3 It includes a first end 31 and a second end 32.
  • the first end 31 and the second end 32 are respectively connected to the first wire loop 11 and the second wire loop 12.
  • the knot 2 is a coil wound around the "o"-shaped knot ring 51 or the "8"-shaped knot ring 52, and passes through the knot. 2. Realize the fixation effect of the titanium plate in the existing technology, and achieve better fixation effect than titanium plate fixation, reduce bone wear, and increase the service life of the fixation device.
  • the knotted loops include “o”-shaped knotted loops 51 or “8”-shaped knotted loops 52, but the shape of the knotted loops of the present invention is not limited to this.
  • the knot is an “o”-shaped knot 51
  • the coil includes a first coil 61 wound around the “o”-shaped knot 51 .
  • the knot is an "8"-shaped knot 52
  • the second coil 62 is wound around a ring of the "8"-shaped knot 52
  • the knot 2 It also includes a third coil 63 wound around another loop in the "8"-shaped knotted ring 52; the second coil 62 is wound in a manner that it repeatedly passes through the center of one loop of the "8"-shaped knotted loop 52.
  • the third coil 63 is wound around the "8"-shaped knot in a manner that it repeatedly passes through the center of another loop of the "8"-shaped knot loop 52. Ring 52 on the rope.
  • the number of winding turns of the first coil 61 is 3, 5, 8, 10 or 15.
  • the number of winding turns of the second coil 62 and the third coil 63 is 3, 5, 8, 10 or 15.
  • the number of winding turns of the second coil 62 and the third coil 63 is 8.
  • Figure 13 is a schematic structural diagram of two parallel loops in an embodiment of the present invention.
  • Figure 14 is a schematic structural diagram of double wire loops crossing each other's centers in an embodiment of the present invention.
  • the ring part 1 is composed of a double wire loop.
  • the loop part 1 includes the first wire loop 11 and the second wire loop 12 .
  • the double wire loops are parallel to each other.
  • the first wire loop 11 and the second wire loop 12 are parallel to each other and do not pass through each other's centers.
  • the double wire loops cross each other's centers. Specifically, the first wire loop 11 passes through the center of the second wire loop 12, or the second wire loop 12 passes through the center of the first wire loop 11 .
  • the fixation device is used to fix soft tissues of the human body, including but not limited to ligaments and tendons.
  • Figure 3 is a schematic diagram of step S1 of the manufacturing method of a fixed device in the first embodiment of the present invention
  • Figure 4 is a schematic diagram of step S2 of the manufacturing method of a fixed device in the first embodiment of the present invention
  • Figure 5 is a schematic diagram of the first method of manufacturing a fixed device of the present invention.
  • FIG. 1 A schematic view of the first rope segment passing through the central ring in step S3 of the manufacturing method of the fixation device in the embodiment;
  • Figure 6 is a schematic view of tightening the central ring in step S3 of the manufacturing method of the fixation device in the first embodiment of the present invention;
  • Figure 7 It is a schematic diagram of forming a knot ring in step S3 of the manufacturing method of a fixation device in the first embodiment of the present invention;
  • Figure 8 is a schematic diagram of steps S4 and S5 of the manufacturing method of a fixation device in the first embodiment of the present invention.
  • An embodiment of the present invention also provides a method for manufacturing a fixation device, including the following steps S1 to S5.
  • S2 inserts the first rope section 41 from the first opening on the rope along the direction of the second rope section 42, that is, the direction A in the figure, and passes it through the rope.
  • the second opening on the rope goes out, and the bend of the rope forms a central ring.
  • S3 passes the first rope section 41 through the central ring and tightens the central ring so that the nested part of the rope forms an "o" shaped knot.
  • Ring 51
  • the rope segment is passed through the “o”-shaped knot ring 51 in the same direction and wound around the “o”-shaped knot ring 51 to form the knot portion 2 .
  • step S4 includes: winding the first rope section 41 and the second rope section 42 together around the "o" shaped knot 51, the first rope section 41 and the second rope segment 42 together form the first coil 61 .
  • Figure 9 shows the manufacturing method of the fixation device in the second embodiment of the present invention.
  • the second rope segment is reversely inserted through the third opening on the rope and then passed out through the fourth opening on the rope.
  • Figure 10 is a schematic diagram of the manufacturing method of the fixation device in the second embodiment of the present invention forming an "8" shaped knot ring;
  • Figure 11 is a schematic diagram of step S4 of the manufacturing method of the fixation device in the second embodiment of the present invention;
  • Figure 12 is a schematic diagram of step S5 of the manufacturing method of the fixation device in the second embodiment of the present invention.
  • steps S3 and S4 also include: reversing the second rope section 42, that is, direction B in the figure, from the third opening on the rope. Pass it in, and then pass it out through the fourth opening on the rope, and tighten the second rope section 42 so that the nested part of the rope forms an "8" shaped knot loop 52 .
  • step S4 the winding around the knotted ring includes: winding the first rope segment 41 around a loop of the "8" shaped knotted ring 52, so as to Form a second coil 62 wrapped around the "8"-shaped knot loop 52; wrap the second rope segment 42 around another loop of the "8"-shaped knot loop 52 to form a loop around the "8"-shaped knot loop 52.
  • the third coil 63 of the knot loop 52 is connected.
  • step S4 the number of turns that the first rope segment 41 and the second rope segment 42 are wound together on the knotted ring is 3, 5, 8, 10 or 15.
  • step S4 the total number of turns of the first rope section 41 and the second rope section 42 is wound around the "o"-shaped knot ring 51. is 10.
  • step S4 the number of turns of a loop of the "8"-shaped knot ring 52 of the first rope segment 41 is 3, 5, 8, 10 or 15, and the number of turns of the first rope segment 41 is 3, 5, 8, 10 or 15.
  • the number of turns of the second rope segment 42 wound around the other loop of the "8" shaped knot loop 52 is 3, 5, 8, 10 or 15.
  • step S4 the number of turns of a loop of the "8"-shaped knot ring 52 of the first rope segment 41 is 8, and the second rope segment is wound The number of turns of the segment 42 wound around the other loop of the "8" shaped knot loop 52 is 8.
  • step S5 includes: passing the first rope section 41 and the second rope section 42 through the knotted loop in parallel, so that the double wire loops are parallel to each other.
  • step S5 includes: crossing the first rope section 41 and the second rope section 42 and then passing them through the knotted loop, so that the double wire loops cross each other. center of.
  • step S5 includes: passing the first rope section 41 into the second rope section 42 and then out, and passing through the "o"-shaped knot ring 51; The two rope segments 42 pass through the first rope segment 41 and then pass out, and pass through the "o" shaped knot 51 .
  • step S5 includes: passing the first rope section 41 into the second rope section 42 and then out, and passing through a loop of the "8" shaped knot ring 52;
  • the second rope section 42 penetrates into the first rope section 41 and then passes out, and passes through another loop of the “8” shaped knot ring 52 .
  • the first rope section 41 after the first rope section 41 penetrates into the second rope section 42, it passes through a fifth opening, and the fifth opening is located on the second rope section 42 and close to the The knot part 2; after the second rope section 42 penetrates into the first rope section 41, it passes out from the sixth opening, and the sixth opening is located on the first rope section 41 and close to the knot.
  • the hollow rope-like object is a hollow rope braided by threads, and any part of the hollow rope includes a gap created by the braiding, and the gap is used for the first rope segment or the The second rope segment passes in or out.
  • the distance from the first opening to the second opening is equal to the distance from the third opening to the fourth opening.
  • the two "8" shaped knot rings formed in this way The ring size is consistent, so that the size of both sides of the knot 2 formed based on the "8" shaped knot ring is even.
  • the fourth opening is adjacent to the second opening.
  • An embodiment of the present invention also provides a medical fixation device, including the above fixation instrument.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Rheumatology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un instrument de fixation, qui est formé par des matériaux de type fil tissé et comprend : une partie d'anneau, qui comprend un anneau de fil pour qu'un tissu cible passe à travers ; une partie de nœud, qui est reliée à la partie d'anneau, la partie de nœud étant utilisée pour venir en butée contre un os ; et une partie de réglage, qui est reliée à la partie d'anneau pour ajuster la taille de l'anneau de fil. Pendant l'utilisation, le tissu cible est fixé à l'os, et la partie de nœud formée par les matériaux de type fil tissé peut produire une certaine déformation conjointement avec la forme de surface de l'os lorsqu'elle est en contact avec l'os, de façon à réduire l'espace, à augmenter la zone de contact et à améliorer ainsi l'effet de fixation entre le tissu et l'os. La présente invention concerne en outre un procédé de fabrication de l'instrument de fixation, et un dispositif de fixation médical.
PCT/CN2022/118109 2022-03-16 2022-09-09 Instrument de fixation, son procédé de fabrication et dispositif de fixation médical WO2023173704A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202210260254.1A CN114652379B (zh) 2022-03-16 2022-03-16 固定器械及其制造方法和医用固定装置
CN202210260254.1 2022-03-16

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CN114652379B (zh) * 2022-03-16 2023-09-05 上海利格泰生物科技股份有限公司 固定器械及其制造方法和医用固定装置

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CN109890303A (zh) * 2016-11-03 2019-06-14 史密夫和内修有限公司 具有软锚固植入物的组织修复组件和系统
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CN113853170A (zh) * 2019-06-14 2021-12-28 史密夫和内修有限公司 软锚固组织修复组件和系统
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