Two-way self-locking full-suture anchor fixing deviceTechnical Field
The invention relates to a medical instrument, in particular to a two-way self-locking full-suture anchor fixing device.
Background
In recent years, the technology of a wire anchor using titanium alloy, PEEK and polylactic acid materials as materials is widely used for repairing injuries at the joint of soft tissues and bone tissues, such as: rotator cuff injury, labrum injury, proximal femur tendon injury, anterior and posterior labrum injury on the shoulder joint, collateral ulnar ligament injury reconstruction, distal biceps brachii tendon injury, inter-navicular ligament repair, triangular fibrocartilage repair, extensor tendon injury repair, and the like. The hard anchor is screwed on bone tissue near the fixing part, the preloaded suture on the anchor passes through the soft tissue to be repaired, and the soft tissue is fixed in contact with the surface of the bone tissue by binding and tightening the suture, so that the physical repair of the damaged tissue is completed.
As hard material anchor technology is increasingly applied, hard material anchors are known to suffer from a number of drawbacks: the titanium alloy metal anchor is easy to generate inflammation due to rejection reaction after being implanted, so that bone dissolution occurs at the implantation position, the anchor is caused to be loosened and shifted, and the fixation is caused to fail. The PLA absorbable anchor can be degraded and broken too early after being implanted, the fixation firmness is reduced due to secondary anchor displacement, and the degradation product can cause problems such as synovitis, osteolysis and the like. Although the anchor with the wire made of PEEK solves the problems of easy loosening, displacement and the like after the implantation of the anchor made of the PEEK, also solves the problems of rupture or premature degradation after the implantation of the anchor made of absorbable materials, the problem that the fixation firmness is reduced due to secondary displacement, synovitis and osteolysis are easily caused by degradation products, but the problems of larger bone canal at the implantation position of the anchor, larger bone removal amount, easy occurrence of fracture or bone rupture and the like still exist. In addition, once the hard anchor is detached from the bone canal after implantation, the hard anchor can cause damage to nearby joint tissues and bone surfaces; the repair of the hard anchors is not only very difficult but also causes great pain to the patient.
In order to solve the problems of hard anchors, full suture anchor products have emerged. The anchor portion of the product is made of a material that can be used to make a suture. Has the following advantages: the shape of the soft material anchor can be changed at will, the required bone path is small during fixation, and the bone removal amount is small; the bone canal can be slightly enlarged during repair and replaced by a hard anchor; even if the soft full-suture anchor is pulled out of the bone canal after being implanted, the soft full-suture anchor can not damage the surrounding joints and the bone surface.
Currently, common products on the market areRC(ConMed)，FiberTakTM (Arthrex), juggerKnot (Biomet) is characterized by anchors typically made of 5# PET or UHMWPE suture, preloaded suture passed through the interior of the anchor, the anchor being placed in a neutral position on the inserter head, and in use, the inserter drives the anchor to a designated position in the bone canal, and then the inserter is removed, pulling the loaded suture by hand to retract the anchor and expand against the bone canal wall, thereby completing the fixation.
However, when the product is implanted, the anchor can freely change shape in the bone canal, the expected ideal shape state may not be achieved, the friction force formed by the extrusion of the anchor and the bone canal is small, and the extraction force is reduced. In addition, such products require deeper bone tunnels to achieve the desired shape, and if the tunnels are too short or if too great a tension is applied to the preloaded suture during release, this can easily result in the anchor not forming the desired shape pulling out or moving toward the cortical bone on the tunnel surface, resulting in failure to fix.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a bidirectional self-locking full-suture anchor fixing device.
The invention provides a bidirectional self-locking full-suture anchor fixing device, which comprises an anchor, a coil and an inserter;
the coil is connected with the inserter;
the anchor is a suture anchor, and the coil comprises a preloaded suture;
the preloaded suture passes through the suture anchor.
Preferably, the preloaded suture passes through the suture anchor in a radial direction from the proximal side of the suture anchor, then both ends of the preloaded suture extend towards the distal end of the suture anchor, respectively penetrate into the suture anchor from the distal side of the suture anchor, then extend in an axial direction of the suture anchor, and pass out from the proximal end of the suture anchor.
Preferably, the suture anchor is provided with an aperture in an axial direction;
the preloaded suture extends along the aperture out of the proximal face of the suture anchor.
Preferably, the linear direction passing through the intersection of the preloaded suture and the distal outer side of the suture anchor is parallel or staggered with respect to the linear direction passing through the intersection of the preloaded suture and the proximal outer side of the suture anchor.
Preferably, the inserter comprises a boom and a handle;
the main rod comprises a rod head part and a rod body part;
the handle, the rod body part and the rod head part are connected in sequence;
any one or any multiple of the three parts of the handle, the shaft part and the club head part is provided with an opening;
the preloaded suture passes through the aperture.
Preferably, the handle, the shaft part and the club head part are all provided with openings, and a plurality of the openings are mutually communicated;
the preloaded suture extends through a plurality of the apertures.
Preferably, the near end of the handle is provided with a wire clamping groove and a wire winding groove;
the preloaded suture passes through the wire clamping groove and is coiled on the wire winding groove.
Preferably, the head portion is provided with an anchor fixing groove;
the anchor fixation slot is at least capable of contacting a suture anchor.
Preferably, the inserter further comprises a pull wire rod;
the pull rod directs a preloaded suture through the inserter along an aperture.
Preferably, the proximal end of the handle is also provided with a tie ring;
the ends of the preloaded suture are secured to the tie ring.
Compared with the prior art, the invention has the following beneficial effects:
1. the invention can realize bidirectional self-locking, so that the suture anchor nail can reach the expected shape quickly, and the deployment is simple and quick;
2. the invention reduces the displacement required for deploying the suture anchor to reach the expected shape, thereby reducing the dependence on the depth of the bone canal;
3. the invention reduces the displacement required when deploying suture anchors, increases the strength of bearing tensile force, and reduces the possibility of pulling out the anchors when deploying.
4. The invention has compact and reasonable structure and simple and convenient operation.
Drawings
Other features, objects and advantages of the present invention will become more apparent upon reading of the detailed description of non-limiting embodiments, given with reference to the accompanying drawings in which:
FIG. 1 is a schematic illustration of a first attachment of a preloaded suture to a suture anchor;
FIG. 2 is a schematic illustration of a second attachment of a preloaded suture to a suture anchor;
FIG. 3 is a perspective view of an inserter;
FIG. 4 is an enlarged perspective view of the distal end of the inserter;
FIG. 5 is a perspective view of the handle at one viewing angle;
FIG. 6 is a perspective view of the handle at another viewing angle;
FIG. 7 is a schematic diagram of the principle of operation of the pull rod;
fig. 8 is a schematic diagram of the operation of the present invention.
The figure shows:
suture anchor 1 handle 32
Preloaded suture 2 wire winding slot 321
Inserter 3 card slot 322
Main rod 31 and stay rod 33
Anchor fixing groove 311
Detailed Description
The present invention will be described in detail with reference to specific examples. The following examples will assist those skilled in the art in further understanding the present invention, but are not intended to limit the invention in any way. 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.
The invention provides a bidirectional self-locking full-suture anchor fixing device which comprises an anchor, a coil and an inserter. In the embodiment, the anchor is a suture anchor 1, which is made of a section of 10# suture, the suture is hollow knitting, the length of the suture is 2cm, the weft density is 30-50 meshes, and the suture material is PET or UHMWPE. The coil comprises a preloaded suture 2, the preloaded suture 2 adopts a No. 2 suture and is made of UHMWPE, and the coil can also comprise 2 or more preloaded sutures 2 according to the required strength in use. The inserter 3 comprises a main rod 31 and a handle 32, the handle 32 is formed by processing ABS plastic, a winding groove 321 and a clamping groove 322 are formed in the tail of the handle, a metal part of the inserter 3 is made of 304 stainless steel, the main rod 31 is formed by connecting a rod body part and a rod head part, and an anchor fixing groove 311 is formed in the rod head part. The materials and specifications of the components shown in the examples are only one possible solution for implementing the present invention, which is protected but not limited to the above-mentioned materials and specifications, for example, the suture anchor 1 may be made of 9# or other specification suture; preloaded suture 2 may also be 1#, 3# or otherwise; the metal part of the inserter 3 may also be made of 316 stainless steel.
The preloaded suture 2 is connected with the suture anchor 1 by a certain winding mode, and in the embodiment, the connection of the preloaded suture 2 and the suture anchor is completed according to the following steps:
1) The preloaded suture 2 penetrates from the side surface position of 5mm of the upper top end of the suture anchor 1 along the radial direction and then passes out, and two intersection points of the preloaded suture 2 and the outer side surface of the suture anchor 1 are respectively marked as A, B;
2) Two wire ends of the preloaded suture 2 respectively penetrate from the side surface position of the suture anchor 1, which is 5mm away from the lower top end, and reach into the center hole of the suture anchor 1, and two intersection points of the preloaded suture 2 and the outer side surface of the suture anchor 1 are respectively marked as C, D; as shown in fig. 1, C, D are respectively located directly below A, B;
3) The preloaded suture 2 passes through the central hole of the suture anchor 1 and then passes out, and when the preloaded suture passes out, two line ends are distributed at the two sides of the upper penetrating line.
In the preferred embodiment C, D need not be located directly below A, B, but may be rotated at an angle, such as 90 degrees or 45 degrees, relative to suture anchor 1. In addition, the length of the suture anchor 1 and the threading position of the preloaded suture 2 may be adjustable, and the preloaded suture 2 may not pass through the side of the suture anchor 1, but may be in contact with the proximal or distal surface of the suture anchor 1. Preferably, the suture anchor 1 may not have a through hole, such as a blind hole or a non-perforated hole, so that the structure can enable the suture anchor to have more material to fill the drilled hole after entering the operation site, thereby increasing the fixing strength, and of course, such a structure has drawbacks, such as the threading process of the preloaded suture 2 becomes more complicated.
In the embodiment, after the preloaded suture 2 is connected with the suture anchor 1, the inserter 3 passes through the middle of the suture anchor 1, the anchor fixing groove 311 butts against the preloaded suture 2 inside the suture anchor 1, the preloaded suture 2 passes through the central hole of the inserter 3, passes out of the opening of the winding groove 321 on the handle 32, winds on the winding groove 321, and the tail end of the preloaded suture 2 is fixed on the clamping groove 322. In a preferred embodiment, as shown in fig. 7, since the central hole in the inserter 3 is relatively long and the difficulty in directly manipulating the preloaded suture 2 through the central hole is also relatively great, a pull rod 33 is also provided, and the pull rod 33 is made of a rigid material capable of penetrating the central hole of the inserter 3. In use, the distal end of the pull rod 33 is extended beyond the distal end face of the inserter 3, the preloaded suture 2 is secured to the pull rod 33, and the pull rod 33 is withdrawn from the proximal end face of the inserter 3, thereby guiding the preloaded suture 2 through the central bore of the inserter 3. The direct attachment of the ends of the preloaded suture 2 to the suture slots 322 may create relative sliding movement, so that in the preferred embodiment, a tie ring may also be provided at the proximal end of the inserter 3 through which the preloaded suture 2 is passed and secured thereto, further increasing the operational stability of the present invention. Preferably, the handle 32, the shaft portion, the head portion, or any one or more of the three components of the inserter 3 are provided with openings, the length of the preloaded suture 2 passing through the openings can be adjusted accordingly, for example, after the preloaded suture 2 is led out from the suture anchor 1, the preloaded suture extends until the proximal end of the shaft portion passes through the handle opening to reach the winding slot 321, and the threading difficulty is reduced accordingly, but the exposed portion of the suture anchor 1 is increased, which is easy to be polluted during operation.
After the suture anchor 1 is sent to the target position by using the inserter 3, the preloaded suture 2 in the clamping groove 322 and the winding groove 321 is released, the inserter 3 is moved out, the preloaded suture 2 is pulled, the four points A, B, C, D are stressed simultaneously, the upper end face of the suture anchor 1 is displaced downwards, the lower end face is displaced upwards, the two ends are contracted and expanded towards the central point simultaneously, the time required for expanding to be in a state of being attached to the bone canal wall is reduced, and quick self-locking is realized. In addition, the displacement of the whole suture anchor 1 outside the bone canal is reduced, so that the requirement on the depth of the bone canal during implantation is reduced, and quick deployment is realized.
Working principle:
1. the insertion site for the suture anchor 1 is prepared using a suitable drill and drill guide, and drilling is performed using a suitable drill.
2. The suture anchor 1, preloaded suture 2, inserter 3 are assembled.
3. The suture anchor 1 is axially aligned with the bore and is then stably inserted into the bore until it is determined by visual inspection that the suture anchor 1 has reached the desired position.
4. The preloaded suture 2 in the clip slot 322 and the wire winding slot 321 is released, the preloaded suture 2 is disengaged from the inserter 3, and the inserter 3 is removed from the suture anchor 1.
5. The preloaded suture 2 is tightly pulled by the balance of both hands, the upper end and the lower end of the suture anchor 1 are contracted towards the center, and the suture anchor 1 is locked in the drilling hole.
The foregoing describes specific embodiments of the present invention. It is to be understood that the invention is not limited to the particular embodiments described above, and that various changes and modifications may be made by one skilled in the art within the scope of the claims without affecting the spirit of the invention.