Full-suture anchor system and preparation method thereofTechnical Field
The invention belongs to the technical field of tissue repair instruments, and relates to a suture band wire anchor, in particular to a full-suture anchor system and a preparation method thereof.
Background
The suture nail is formed by braiding a plurality of strands of yarns, the shape of the suture nail is nail body shape, flat shape or small tube shape, the inside is hollow or the structure is loose, the suture nail is convenient to penetrate and penetrate out of a suture line, the suture nail is implanted into a prefabricated bone hole, and the suture nail can deform or be spherical by tightening the suture line, so that the suture nail has an anchoring effect.
All currently used full-suture anchors are clamped in the implantation site (typically in the superficial cortical bone) by cinching the suture threaded through the suture anchor so that the suture anchor becomes tied. The suture nail is knitted by a knitting machine, but the assembly of the suture and the suture nail is completed by manual threading, and the efficiency is low. When the U-shaped full-suture anchor nail is implanted, as the suture nail is bent into a U shape and is arranged on the implanter, the diameter is larger than that of the prefabricated hole, the implanter is required to be knocked to knock the suture nail into the prefabricated hole, and the surface of cortical bone can be damaged, even the cortical bone is knocked to be cracked in the process; meanwhile, the suture nail has poor knotting effect and insufficient fixing strength, and the suture nail is easy to fall off. The spherical full-suture anchor is implanted, although knocking is not needed, the suture anchor component is required to be pre-compressed in diameter and is arranged in a hollow tube or other auxiliary instruments, so that the installation is inconvenient, the parts of the handle are more, the operation is inconvenient, and the faults are frequent.
In addition, the existing suture nails are single-layer anchors and are easy to deform, the rigidity of the existing suture nails is insufficient to enter the prefabricated holes, so that the implanter is required to provide larger force for insertion, or the suture nails are firstly received in the hollow tubes or other auxiliary devices and then are assisted to be implanted into the prefabricated holes by the hollow tubes or the other auxiliary devices, the phenomenon that the suture nails are difficult to implant or are blocked in the hollow tubes is easily caused, if the outer diameter of the hollow tubes or the auxiliary devices is considered, the diameter of the prefabricated holes is larger, gaps are reserved between the suture nail assemblies and the prefabricated holes after the hollow tubes or the auxiliary devices are removed, and the fixing strength is reduced.
Disclosure of Invention
The invention aims to provide a full-suture anchor with convenient implantation, small damage and good knotting effect and a preparation method thereof, aiming at the defects of the prior art.
In order to solve the technical problems, the invention adopts the following technical scheme:
A full suture anchor system comprising a suture anchor assembly and an implanter;
the suture nail component is a multilayer structure formed by integrally knitting a suture nail and a suture, the suture is wrapped in the suture nail and provided with two free ends which are positioned outside the suture nail, and the two free ends are positioned at the same end of the suture nail component, so that the suture can freely slide in the suture nail by pulling the free ends;
The implant comprises an implant tube which is a hollow tube for the two free ends of the suture to pass through, and the diameter of the implant tube does not exceed the diameter of the suture nail component.
In the above technical scheme, further, the preparation method of the suture nail assembly is as follows:
Taking a suture as a core wire, wherein one end of the suture is an A end, the other end of the suture is a B end, fixing the A end, using yarns to cross-weave a first layer of suture nails around the core wire to the B end on the surface of the core wire, turning back the B end of the suture along the axis of the outer surface of the suture nails to the A end after reaching a preset suture nail length, using the formed structure together as the core wire, using the yarns to cross-weave a second layer of suture nails on the surface of the suture, and cutting the yarns by using a hot cutting mechanism after reaching the preset suture nail length to obtain a suture nail assembly;
Or after the second layer of suture nails reach the preset suture nail length, continuing to fold the ends A and B of the suture respectively along the axes of the two sides of the outer surface of the suture nail, taking the formed structure as a core wire together, continuing to use yarns to cross-weave the third layer of suture nails on the surface of the suture nail, and continuously carrying out the folding and cross-weaving processes until the suture nail component reaches the required diameter.
Furthermore, the number of the suture lines can be single or multiple, and the number of the suture line nails, the knitting parameters of different layers and the specifications of the used yarns can be different.
Further, the length of the two free ends of the suture in the suture staple assembly should be capable of penetrating into the hollow tube of the implanter tube and out the other end of the hollow tube.
Further, the implant also comprises a handle, one end of the handle is fixedly connected with the implant tube, and a channel is arranged in the handle and communicated with the hollow tube, so that the free end of the suture can smoothly pass through the implant.
Further, the tail of the handle is provided with a slotted hole, and the suture thread can be wound in the slotted hole after penetrating out of the implanter.
Further, the system may further comprise an auxiliary wire disposed at the other end of the suture spike assembly remote from the free end of the suture for bending the suture spike assembly to assist in tying the knot by pulling the auxiliary wire when the suture spike assembly is implanted.
The beneficial effects of the invention are as follows:
The suture nail component in the full-suture anchor system adopts a unique method of integrally knitting the suture nail and the suture, does not need manual threading, and can be rapidly manufactured into the suture nail components with different sizes and specifications through the selection of parameters such as the number of the suture nails, the knitting layers of the suture nail, the linear density of yarns and the like (the knitting parameters of each layer of the suture nail can be different), and can be applied to various different operation positions.
Meanwhile, the whole suture nail component has a multi-layer structure and a unique weaving mode, so that the suture nail component has more excellent implantable performance, the rigidity of the suture nail is enhanced, the suture nail can be smoothly pushed into the prefabricated bone hole only by using a corresponding implanter, knocking is not needed, the diameter of the required prefabricated bone hole is smaller than that of the conventional scheme, and the damage to cortical bone is smaller. On the other hand, compared with the existing suture anchor, under the condition of the same diameter before tying, the suture nail assembly is formed by knitting a plurality of layers of folded binding yarns in the suture, so that the diameter after tying is larger and stronger. Thus, the suture staple assembly of the present invention has greater fixation strength.
In addition, the suture nail can better realize spherical knot formation after suture is tightened, and the double-layer or multi-layer structure of the suture nail can effectively increase the friction resistance among fibers, so that the knotted suture nail component is not easy to restore to the original shape, and the greater fixing strength can be maintained.
Drawings
FIG. 1 is a schematic representation of a method of braiding a suture staple assembly according to the present invention;
FIG. 2 is a schematic view of the installation of the suture staple assembly and the implanter of the present invention;
FIG. 3 is a schematic illustration of the effect of the full-suture anchor of the present invention (double-layered suture anchor cinched to a ball after cinching the suture);
FIG. 4 is a schematic structural view of the full suture anchor of comparative example 1;
Fig. 5 is a schematic structural view of the full suture anchor of comparative example 2.
In the figure: 1. suture nail component 2, implantation device tube 3, handle 4, suture 5, auxiliary line 6, preformed bone hole.
Detailed Description
Other advantages and effects of the present invention will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present invention with reference to specific examples. The invention may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present invention. It should be noted that the following embodiments and features in the embodiments may be combined with each other without conflict.
It should be noted that, for the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention are clearly and completely described below, and it is obvious that the described embodiments are some embodiments of the present invention, but not all embodiments.
The full suture anchor system of the present invention comprises a suture anchor assembly and an implanter;
the suture nail component is a multilayer structure formed by integrally knitting a suture nail and a suture, the suture is wrapped in the suture nail and provided with two free ends which are positioned outside the suture nail, and the two free ends are positioned at the same end of the suture nail component, so that the suture can freely slide in the suture nail by pulling the free ends;
The implant comprises an implant tube which is a hollow tube for the two free ends of the suture to pass through, and the diameter of the implant tube does not exceed the diameter of the suture nail component.
The suture nail component adopts a unique multi-fold braiding mode to form a multi-layer structure, as shown in figure 1, and the specific braiding process is as follows:
Taking a suture as a core wire, wherein one end of the suture is an A end, the other end of the suture is a B end, fixing the A end, using yarns to cross-weave a first layer of suture nails around the core wire to the B end on the surface of the core wire, turning back the B end of the suture along the axis of the outer surface of the suture nails to the A end after reaching a preset suture nail length, using the formed structure together as the core wire, using the yarns to cross-weave a second layer of suture nails on the surface of the suture, and cutting the yarns by using a hot cutting mechanism after reaching the preset suture nail length to obtain a suture nail assembly;
Or after the second layer of suture nails reach the preset suture nail length, continuing to fold the ends A and B of the suture respectively along the axes of the two sides of the outer surface of the suture nail, taking the formed structure as a core wire together, continuing to use yarns to cross-weave the third layer of suture nails on the surface of the suture nail, and continuously carrying out the folding and cross-weaving processes until the suture nail component reaches the required diameter.
Due to the adoption of the unique multi-turn multi-layer braiding process, compared with the suture nail obtained by yarns with the same layer number, the method can effectively enhance the rigidity of the suture nail, and meanwhile, the diameter after knotting is larger, and the fixing strength is larger.
Examples
Integrally knitting a multi-layered suture nail assembly with a suture through a suture nail: the method comprises the steps of adopting an 8-spindle or 16-spindle braiding machine, taking a single (or a plurality of) suture thread as a core thread, fixing one end, braiding a first layer of suture nails around the core thread in a crossing manner, turning back one free end of the suture thread to be used as the core thread together with the obtained suture nails after reaching the preset suture nail length (generally 15mm-30 mm), and continuously braiding a second layer of suture nails on the outer side of the suture thread in the opposite direction to form a suture nail with a double-layer structure (as shown in figure 1), or continuously turning back the free end of the suture thread to be used as the core thread together and braiding on the outer side of the suture nail until the suture nail component reaches the required diameter. The yarn is cut off by a hot cutting mechanism, so that the two ends of the suture nail are firm and cannot be loosened. Meanwhile, the suture can slide freely in the suture nail, so that the suture nail assembly is completed.
Different numbers of core wires, the number of layers of the suture nails, the yarn linear density, the knitting angle and the knitting density are selected to make the suture nails with different specifications and various assembly combinations, thereby being applicable to different operation positions.
The core wire and the knitting yarn can be made of the same material (such as ultra-high molecular weight polyethylene), can be made of different materials (such as polyethylene terephthalate is selected as the yarn, ultra-high molecular weight polyethylene is selected as the core wire), and can be made of common polymer materials such as nylon and polypropylene.
Composition of the implanter and installation of the suture staple assembly: as shown in fig. 2, the implanter consists of a handle and an implanter tube, the implanter tube is a hollow tube, the aperture is smaller than the diameter of the suture nail component, a channel is arranged in the handle and communicated with the hollow tube, the diameters of the channel and the hollow tube are the same, the channel is used for threading out a suture, and a slotted hole for binding the suture is arranged on the handle; the suture nail component is arranged on the implanter, and two free ends of the suture thread can be wound on the slotted hole of the handle after passing through the implanter tube and the handle in sequence.
In addition, the system includes an auxiliary wire for bending the suture staple assembly into a knot by pulling the auxiliary wire after implantation of the suture staple assembly. The auxiliary line is arranged at the other end of the suture nail component far away from the free end of the suture, can directly penetrate through the end, and directly expose the two ends of the auxiliary line outside, or can also penetrate into the implanter and penetrate out from the handle end, and the auxiliary line is distinguished from the suture by adopting different colors or materials if the auxiliary line penetrates into the implanter together.
Implantation of the suture staple assembly procedure: the method comprises the steps of firstly drilling a preformed bone hole at a preset position, penetrating an auxiliary wire at the insertion end of a suture nail component, only slightly larger than the outer diameter of the suture nail component, holding a handle to push the suture nail component into the preformed bone hole together with the auxiliary wire (if the two ends of the auxiliary wire do not penetrate into an implanter but are exposed, the two ends of the auxiliary wire are exposed out of the preformed bone hole), unwinding a wound suture on the handle, pulling the auxiliary wire to enable the suture nail component to deflect in the preformed bone hole, simultaneously pulling two sutures until the suture nail component is pulled, and then tightening the suture nail component into balls and clamping the balls in the preformed bone hole under the limit of an implanter tube (shown in figure 3), and then withdrawing the auxiliary wire and the implanter, and simultaneously pulling the sutures at the two ends to tighten backwards, thereby anchoring the suture nail.
Comparative example 1
This comparative example is a full suture anchor of the prior art, having a construction as shown in fig. 4, comprising two sutures, a flat suture nail. Two sutures are combined with flat suture nails in a penetrating manner to form a suture nail assembly. When in implantation, the suture nail is bent into a U shape and is arranged on the implantation device with the forked end part, then the implantation device is knocked to knock the suture nail into the prefabricated hole, and the suture nail is tightened into a knot by tightening the tail end of the suture.
Comparative example 2
This comparative example is a full suture anchor (soft anchor) of the prior art, which is constructed as shown in fig. 5, and comprises a single suture, a cylindrical suture anchor. The suture is combined with the cylindrical suture nail in a penetrating and penetrating manner to form a suture nail assembly. In implantation, the soft anchors are loaded into a dedicated delivery system including an insertion tube and a soft anchor pusher, which is introduced into the preformed hole using the insertion tube. The insertion tube is then withdrawn and the suture staples are cinched into knots by cinching the suture ends.
Test of fixing Strength
Under the same conditions (using a 20PCF polyurethane block), the full suture anchor of this example was compared to the set strength test values of comparative examples 1 and 2, and the results are shown in table 1:
TABLE 1
As can be seen from table 1, under the same conditions (using 20PCF polyurethane block, diameter of suture nail, diameter of preformed bone hole), since the suture nail of comparative example 1 is bent into a U shape together with the diameter of the fork-shaped end of the implanter (as shown in fig. 4), the implantation size thereof is larger than the diameter of the preformed bone hole, so that the suture nail is knocked into the preformed bone hole by the implanter, the diameter of the preformed bone hole after the suture nail is actually knocked in becomes large or there is a cortical bone fracture, and thus the fixation strength of the suture anchor in bone is reduced; comparative example 2 since the soft anchor was sleeved with an insertion tube (as shown in fig. 5), a gap remained between the implanted suture nail and the hole after the insertion tube was withdrawn from the preformed hole, and its fixation strength was also lowered. In summary, the staple assembly of the present embodiment therefore has greater fixation strength.
Size measurement after full suture anchor knot (or ball) formation
Under the same conditions (using a 20PCF polyurethane block), the full suture anchor of this example was compared to the measurements after tying of comparative examples 1 and 2, the results are shown in table 2:
TABLE 2
As can be seen from Table 2, the double-layered suture staple assemblies of the present embodiments have a greater knot size and thus have a higher fixation strength. The schematic diagram of the knot is shown in figure 3.
The foregoing description of the preferred embodiments of the invention is provided merely to facilitate the understanding of the invention and is not intended to limit the invention. It should be noted that variations and modifications could be made by those skilled in the art without departing from the inventive concept. These are all within the scope of the present invention.