Soft tissue repair device

Abstract

The present invention discloses a soft tissue repair device, comprising an anchor and a connecting wire, wherein the anchor comprises an outer part and an inner part, the proximal end face of the outer part is provided with an axial hollow, the outer part comprises two distal threading holes arranged at the distal end and two proximal threading holes arranged at the proximal end, the inner part is provided with an axial through hole, the inner part extends into the hollow from the proximal end of the outer part, the connecting wire is pre-set in the outer part and the inner part through the proximal threading hole, the distal threading hole and the through hole, the connecting wire forms a connecting ring on the proximal outer side of the inner part, and as the two ends of the connecting wire are tightened, the inner part moves toward the distal end in the outer part and clamps with the outer part. The present invention only requires passing the soft tissue through the connecting wire, and does not require suturing, thereby simplifying the operation steps of the operation.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a soft tissue repair device used for connecting and fixing bones and soft tissues in orthopedic surgery. Background Art

[0002] In recent years, complete or incomplete separation of ligaments, tendons or other soft tissues from the bones associated with them in the body has become a relatively common injury; or after ligament repair and reconstruction surgery, during the patient's initial recovery process, due to insufficient fixation between the soft tissue and the bone, relative slippage of the soft tissue or loosening or even falling off of the implanted fixation device will delay or inhibit proper healing.

[0003] Currently, arthroscopic surgery is the main method of repair. There are two repair methods. One is fixation with U-shaped nails (door-shaped nails). This type of implant is used for soft tissue fixation. After the soft tissue (such as the anterior cruciate ligament) is embedded in the middle of the "pillars" on both sides of the nail body, a special tool is used to knock the "pillars" into the bone surface to an appropriate depth, and the soft tissue to be fixed is pressed by the end "crossbeam" to complete the fixation. This fixation method is accompanied by certain disadvantages: after the implant is completed, the tail end of the implant protrudes from the bone surface, causing irritation of other surrounding soft tissues or discomfort in the front of the patient's knee. Some patients experience pain in the front of the knee when squatting or kneeling; the implant has a large lateral span, and the additional trauma caused by the surgical incision during implantation is large. Another fixation method is fixation with a wire anchor. The general steps for using a wire anchor for soft tissue fixation are: after the anchor body is implanted into the bone surface, a suture needle or a special thread-passing tool is used to pass the suture through the soft tissue to be fixed, and the two free ends of the same suture are knotted to complete the fixation. This fixation method also has some disadvantages: the operation process is cumbersome and time-consuming; the suturing and knotting processes must be done manually by the surgeon; the suture diameter is small, and there is a possibility of cutting soft tissue. Summary of the invention

[0004] In order to solve the above technical problems, the present invention provides a soft tissue repair device.

[0005] A soft tissue repair device comprises an anchor and a connecting wire, wherein the anchor comprises an outer part and an inner part, the proximal end face of the outer part is provided with an axial hollow, the outer part comprises two distal threading holes arranged at the distal end and two proximal threading holes arranged at the proximal end, the inner part is provided with an axial through hole, the inner part extends into the hollow from the proximal end of the outer part, the connecting wire is pre-set in the outer part and the inner part through the proximal threading hole, the distal threading hole and the through hole, the connecting wire forms a connecting ring on the proximal outer side of the inner part, and as the two ends of the connecting wire are tightened, the inner part moves toward the distal end in the outer part and clamps with the outer part.

[0006] Preferably, the outer portion of the outer component is cylindrical, the distal threading holes are symmetrically arranged on the distal end surface of the outer component, and the axis of the distal threading holes is parallel to the axis of the outer component.

[0007] Preferably, the proximal threading hole is symmetrically arranged on the outer wall of the outer component close to the proximal side of the distal threading hole, and the axis of the proximal threading hole is perpendicular to the axis of the outer component.

[0008] Preferably, the above technical solution has an intermediate component on the distal end face of the outer component, and the intermediate component is located between the two distal threading holes. After the outer component and the inner component are clamped, the distal end face of the inner component fits with the proximal end face of the intermediate component.

[0009] Preferably, the outer wall of the outer component is provided with a wire groove corresponding to the proximal threading hole, and the wire groove penetrates the outer wall of the outer component toward the proximal end along the axial direction of the outer component.

[0010] Preferably, in the above technical solution, the width of the wire groove is greater than or equal to the aperture of the proximal threading hole.

[0011] Preferably, in the above technical solution, the cross section of the wire groove is arc-shaped or rectangular.

[0012] Preferably, the above technical solution is provided with a protrusion at the distal end of the inner component, and the protrusion is used to clamp with the proximal threading hole.

[0013] Preferably, the above technical solution is characterized in that an arc structure is provided on the outside of the proximal threading hole.

[0014] Preferably, in the above technical solution, the hollow cross-section of the outer component is circular or elliptical, and the cross-sectional shape of the inner component is adapted to the cross-sectional shape of the hollow.

[0015] The advantages and positive effects of the present invention are as follows: the present invention provides a soft tissue repair device, in which connecting wires are pre-set in the inner and outer parts of the anchor, and when in use, the soft tissue is passed through the connecting ring located at the proximal end of the inner part, and after the anchor is implanted, the connecting belt is tightened and then tied into a knot; since the anchor is entirely embedded below the bone surface after implantation, the patient will not experience problems such as kneeling pain after implantation of a door-type nail; since the anchor only needs to pass the soft tissue through the connecting wire and no suturing is required, the surgical operation steps are simplified; since the soft tissue can be pressed to fit the bone surface by the thicker suture or the thickened structure in the suture belt, cutting of the soft tissue can be avoided, and the surface of the soft tissue can be effectively protected from damage; the present invention can be fixed without knotting, and can also be knotted to enhance the fixing effect, providing a variety of options for complex situations during surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 is a schematic structural diagram of a soft tissue repair device provided by an embodiment of the present invention;

[0017] Figure 2 is a schematic structural diagram of an inner component provided by an embodiment of the present invention;

[0018] Figure 3 is a schematic structural diagram of an outer component provided by an embodiment of the present invention;

[0019] Figure 4 It is a schematic structural diagram of a soft tissue repair device provided by an embodiment of the present invention without connecting wires.

[0020] Among them: 1. outer part; 2. inner part; 3. wire belt; 4. threaded structure; 5. hollow; 6. through hole; 7. connecting ring; 8. middle part; 9. wire groove; 10. protrusion; 11. arc structure; 12. first proximal threading hole; 13. second proximal threading hole; 14. first distal threading hole; 15. second distal threading hole. DETAILED DESCRIPTION

[0021] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments may be combined with each other.

[0022] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and the like are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second", and the like may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "multiple" means two or more.

[0023] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood by specific circumstances.

[0024] The present invention will be described in detail below with reference to the accompanying drawings and in conjunction with embodiments.

[0025] This embodiment provides a soft tissue repair device, such as Figure 1-4 As shown, it includes an anchor and a connecting wire. The connecting wire is a suture or a wire band 3. In this embodiment, the connecting wire is a high-strength suture or a high-strength wire band commonly used in orthopedics, with different wire diameter specifications to meet different needs. The middle part of the high-strength wire band is thickened, and the high-strength suture is locally reduced in diameter. Since soft tissues such as ligaments or tendons can be pressed to fit the bone surface by the thicker suture or the thick structure of the wire band 3, the soft tissue is avoided from being cut, and the surface of the soft tissue can be effectively protected from being damaged. The anchor includes an outer part 1 and an inner part 2. The outer wall of the outer part 1 includes a threaded structure 4 or an annular inverted tooth structure distributed along the axial direction, so that the outer part 1 can be smoothly installed in the bone at the corresponding position where the soft tissue is fixed. If the outer part 1 adopts a threaded structure 4, the outer part 1 needs to be implanted and fixed by screwing in with a screwdriver; if the outer part 1 adopts an annular inverted tooth structure distributed along the axial direction, the outer part 1 needs to be implanted and fixed by driving in. The drawings of this embodiment only show the thread structure 4, which is screwed into the preset hole at the corresponding fixed position on the bone surface. The thread structure 4 in the drawings is only for schematic illustration. The actual processing of the thread is based on ensuring that it is screwed into the bone channel without loosening. The form and pitch can be combined in a variety of ways. The thread structure 4 and the annular inverted tooth structure belong to the existing structure of connecting the anchor screw with the bone channel, and will not be repeated here.

[0026] Specifically, the outer component 1 includes a threading hole structure, which is divided into a proximal threading hole and a distal threading hole. The proximal end face of the outer component 1 is provided with an axial hollow 5. The outer component 1 includes two distal threading holes arranged at the distal end and two proximal threading holes arranged at the proximal end. The inner component 2 is provided with an axial through hole 6. The inner component 2 extends into the hollow 5 from the proximal end of the outer component 1. The connecting wire is pre-set in the outer component 1 and the inner component 2 through the proximal threading hole, the distal threading hole and the through hole 6. The connecting wire forms a connecting ring 7 on the proximal outer side of the inner component 2. As the two ends of the connecting wire are tightened, the inner component 2 moves toward the distal end in the outer component 1 and clamps with the outer component 1. The outer component 1 and the inner component 2 clamp and fix the connecting wire.

[0027] Specifically, the distal threading holes include a first distal threading hole 14 and a second distal threading hole 15 , and the proximal threading holes include a first proximal threading hole 12 and a second proximal threading hole 13 . The direction of the connecting wire is as follows: (1) one end of the connecting wire enters the first proximal threading hole 12 on one side; (2) it passes through the first distal threading hole 14 on the same side as the first proximal threading hole 12 in the previous step and then passes out of the outer component 1; (3) it passes through the second distal threading hole 15 on the opposite side; (4) it enters the through hole 6 of the inner component 2, is appropriately stretched and then the connecting wire is reversely passed through the through hole 6 to form a connecting ring 7 on the proximal outer side of the inner component 2; (5) after passing through the first distal threading hole 14 on the same side, i.e., step (2), it passes through the second distal threading hole 15 on the opposite side, i.e., step (3), and then passes out from the second proximal threading hole 13 on the opposite side until it reaches the position of the other end of the connecting wire, thereby burying one end of the connecting wire and the other end of the connecting wire in the anchor installation handle. This winding method can prevent loosening.

[0028] Specifically, the outer part 1 is cylindrical in shape, and the distal threading hole is symmetrically arranged on the distal end surface of the outer part 1. In order to ensure that the suture or thread band 3 can pass smoothly and can move relatively easily, the axis of the distal threading hole is parallel to the axis of the outer part 1.

[0029] Specifically, the proximal threading holes are symmetrically arranged on the outer wall of the outer component 1 near the proximal side of the distal threading holes, and the proximal threading holes are semicircular or approximately semicircular in shape, and are arranged at the same height relative to the outer component 1, and are symmetrical about the central axis of the outer component 1. In order to ensure that the suture or thread band 3 passes through smoothly and can move relatively easily, the axis of the proximal threading hole is perpendicular to the axis of the outer component 1.

[0030] Specifically, an intermediate component 8 is provided on the distal end surface of the outer component 1, and the intermediate component 8 is located between the two distal threading holes. After the outer component 1 is clamped with the inner component 2, the distal end surface of the inner component 2 fits with the proximal end surface of the intermediate component 8. The intermediate component 8 can prevent the inner component 2 from sinking further, and can also form a fitting surface with the distal end of the inner component 2 to compress the connecting line passing through the two surfaces.

[0031] Furthermore, the outer wall of the outer component 1 is provided with a wire groove 9 corresponding to the proximal threading hole, and the wire groove 9 penetrates the outer wall of the outer component 1 proximally along the axial direction of the outer component 1. Optionally, the width of the wire groove 9 is greater than or equal to the aperture of the proximal threading hole. The depth of the wire groove 9 is preferably such that the suture or line tape 3 can slide relatively when it is located thereon. The wire groove 9 must ensure that the suture or line tape 3 passing through can slide smoothly. The wire groove 9 can be processed into an arc shape or a rectangle according to the shape of the matching suture or line tape 3.

[0032] Furthermore, no matter how the outer component 1 is implanted (screwed in or driven in), a preset hole needs to be drilled in advance at the corresponding fixed position on the bone surface. The outer component 1 is provided with a variety of size structures to adapt to different preset hole diameters, so as to better match different bone conditions and adapt to different populations.

[0033] Furthermore, the hollow part 5 of the outer part 1 can be used to accommodate the inner part 2. Optionally, the hollow part 5 is cylindrical and penetrated by a symmetrical plane, and the hollow part 5 can also be elliptical.

[0034] Furthermore, the inner part 2 is a columnar structure, which cooperates with the outer part 1 whose proximal and distal ends of the hollow part 5 are cylindrical, and achieves a small clearance fit with the hollow part 5. The inner part 2 has a pair of protrusions 10 at the distal end, which can be clamped with the proximal threading holes of the outer part 1.

[0035] Furthermore, the structural dimensions of the through hole 6 in the middle of the inner component 2 enable the double-strand suture or thread tape 3 to pass therethrough, and enable the suture or thread tape 3 to move relative to the through hole 6 .

[0036] Furthermore, the outer surface of the inner component 2 is cylindrical and is penetrated by a symmetrical plane. If the hollow part 5 of the outer component 1 is elliptical, the inner component 2 also needs to be elliptical to achieve a better assembly effect.

[0037] Further, the anchor can be made of a variety of materials. In one embodiment, the material can have sufficient physical properties to allow the anchor to be implanted into the bone without damaging the anchor structure. The nature of the material depends on the specific type of anchor. Non-limiting examples of materials that can be used to make the anchor include metals such as titanium, polymers such as polyetheretherketone (PEEK), or combinations thereof. In one embodiment, the anchor can be absorbable, non-absorbable, or a combination thereof.

[0038] Furthermore, the outside of the proximal threading hole is provided with an arc structure 11. The arc structure 11 can prevent the suture or the thread band 3 from being cut during the tightening process, thereby affecting the surgical effect.

[0039] The working process of this embodiment: taking the wire band 3 as an example, the wire band 3 is used to fix the tendon or ligament. One end of the wire band 3 and the other end of the wire band 3 are placed in the installation handle of the anchor (the inner part 2 and the outer part 1) before the anchor is implanted. The direction of the wire band 3 is that one end of the wire band 3 follows the wire groove 9 on one side of the outer part 1 into the first distal threading hole 14 on this side, passes through the first distal threading hole 14 on the same side, bypasses the middle part 8, passes through the second distal threading hole 15 on the opposite side, enters the through hole 6 of the inner part 2, and is appropriately stretched until the thicker part in the middle of the wire band 3 passes through the through hole 6, and then the wire band 3 is reversed through the through hole 6, and after passing through the first distal threading hole 14 on the same side, it passes into the second distal threading hole 15 on the opposite side, and then passes through the second proximal threading hole 13 on the opposite side, passes along the wire groove 9 on the opposite side, until it reaches the position of the other end of the wire band 3.

[0040] The threaded part of the anchor with threaded structure 4 needs to be screwed into the final depth of the bone surface first, and then the connecting ring 7 in the middle of the thicker part of the line band 3 can be passed through the tendon or ligament to be fixed; the connecting ring 7 in the middle of the thicker part of the anchor line band 3 with an annular inverted tooth structure can be passed through the tendon or ligament to be fixed first, or the anchor can be driven into the final depth of the bone surface first.

[0041] When the surgery is performed to the point where it is necessary to fix soft tissues such as tendons or ligaments to the bone surface, the tendons or ligaments to be fixed are passed through the connecting ring 7 of the middle thicker part of the line band 3, and the tendons or ligaments to be fixed are stretched. After ensuring sufficient pre-tightening force, one end of the line band 3 and the other end of the line band 3 are tightened. During the tightening process, the inner part 2 will sink accordingly, and when the protrusion 10 structure at the distal end of the inner part 2 is embedded in the threading hole at the proximal end of the outer part 1, the locking is completed. If the tendons or ligaments to be fixed need to be readjusted, they can be adjusted before the protrusion 10 structure is embedded in the threading hole, and the line band 3 can move again. The middle part 8 can prevent the inner part 2 from sinking further, and can also form a fitting surface with the distal end of the inner part 2, compressing the line band 3 passing between the two surfaces, and completely sinking the inner part 2 into the outer part 1, the tendons or ligaments to be fixed will also be fixed to the bone surface, and the excess line band 3 is cut off to complete the fixation of the soft tissue and the bone surface. In order to enhance the fixing effect between the soft tissue and the bone surface, before cutting off the excess wire band 3 , the two ends of the wire band 3 may be knotted and then the excess wire band 3 may be cut off.

[0042] Since the proximal threading hole of the outer component 1 is semicircular or approximately semicircular, after being assembled with the distal protrusion 10 of the inner component 2, it can effectively prevent the inner component 2 from loosening. When the assembly is completed, a "click" sound can be heard, which is convenient for the operator to judge whether it is assembled in place.

[0043] The advantages and positive effects of the present invention are as follows: the present invention provides a soft tissue repair device, in which connecting wires are pre-set in the inner and outer parts of the anchor, and when in use, the soft tissue is passed through the connecting ring located at the proximal end of the inner part, and after the anchor is implanted, the connecting belt is tightened and then tied into a knot; since the anchor is entirely embedded below the bone surface after implantation, the patient will not experience problems such as kneeling pain after implantation of a door-type nail; since the anchor only needs to pass the soft tissue through the connecting wire and no suturing is required, the surgical operation steps are simplified; since the soft tissue can be pressed to fit the bone surface by the thicker suture or the thickened structure in the suture belt, cutting of the soft tissue can be avoided, and the surface of the soft tissue can be effectively protected from damage; the present invention can be fixed without knotting, and can also be knotted to enhance the fixing effect, providing a variety of options for complex situations during surgery.

[0044] The above is a detailed description of an embodiment of the present invention, but the content is only a preferred embodiment of the present invention and cannot be considered to limit the scope of implementation of the present invention. All equivalent changes and improvements made within the scope of the present invention should still fall within the scope of the patent coverage of the present invention.

Claims

1. A soft tissue repair device, characterized in that: The invention comprises an anchor and a connecting wire, wherein the anchor comprises an outer part and an inner part, the proximal end face of the outer part is provided with an axial hollow, the outer part comprises two distal threading holes arranged at the distal end and two proximal threading holes arranged at the proximal end, the inner part is provided with an axial through hole, the inner part extends into the hollow from the proximal end of the outer part, the connecting wire is pre-set in the outer part and the inner part through the proximal threading hole, the distal threading hole and the through hole, the connecting wire forms a connecting ring on the proximal outer side of the inner part, and as the two ends of the connecting wire are tightened, the inner part moves toward the distal end in the outer part and clamps with the outer part; The outer part of the outer component is cylindrical, the distal threading holes are symmetrically arranged on the distal end surface of the outer component, and the axis of the distal threading holes is parallel to the axis of the outer component; An intermediate component is provided on the distal end surface of the outer component, and the intermediate component is located between the two distal threading holes. After the outer component and the inner component are clamped, the distal end surface of the inner component fits with the proximal end surface of the intermediate component; The distal end of the inner component is provided with a protrusion, and the protrusion is used to clamp with the proximal threading hole.

2. The soft tissue repair device according to claim 1, characterized in that: The proximal threading hole is symmetrically arranged on the outer wall of the outer component close to the proximal side of the distal threading hole, and the axis of the proximal threading hole is perpendicular to the axis of the outer component.

3. The soft tissue repair device according to claim 2, characterized in that: The outer wall of the outer component is provided with a wire groove corresponding to the proximal threading hole, and the wire groove penetrates the outer wall of the outer component toward the proximal end along the axial direction of the outer component.

4. The soft tissue repair device according to claim 3, characterized in that: The width of the wire groove is greater than or equal to the aperture of the proximal threading hole.

5. The soft tissue repair device according to claim 3, characterized in that: The cross section of the wire groove is arc-shaped or rectangular.

6. The soft tissue repair device according to claim 1, characterized in that: An arc structure is arranged outside the proximal threading hole.

7. The soft tissue repair device according to claim 1, characterized in that: The hollow cross section of the outer component is circular or elliptical, and the cross section shape of the inner component is adapted to the cross section shape of the hollow.

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