Fixing device, manufacturing method thereof and medical fixing device
Technical Field
The invention relates to the field of medical equipment, in particular to a fixing instrument, a manufacturing method thereof and a medical fixing device.
Background
Complete or partial separation of ligaments, tendons, shoulder or other soft tissues from bone is a common injury, particularly in athletes and the elderly. When subjected to violence, resulting in non-physiological activity, the ligament is pulled beyond its tolerance, i.e. damage or even tissue separation occurs. Surgical intervention is often required, especially when the tissue is completely separated from its associated bone.
The belt loop titanium plate fixing method is an operation method for ligament and tendon reconstruction. The method can firmly fix the upper ends of the ligament grafts without bone pieces at the two ends in the femoral side bone canal by using a built-in belt loop titanium plate without adding a lateral condyle side incision, and is a mature and effective method in the prior art of reconstructing ACL by using the grafts without bone pieces such as semitendinous tendon, gracilis tendon and the like.
In the ligament reconstruction operation process of the knee joint of the human body, a coil in a titanium plate with a loop, namely a loop, is mainly utilized to form crisscross with a ligament graft and is tensioned. In clinical use, the fixing effect is poor, the movement of the belt loop titanium plate often occurs, and the adverse reactions such as ligament scratch, looseness and the like are easy to cause, so that the healing effect is influenced. The metal material of the belt loop titanium plate has no neglect on the bone injury effect caused by the abrasion injury of the bone in the long-term movement of the contact surface with the bone, and various inflammation infections are easy to cause, thus endangering the health.
Meanwhile, the poor anastomosis degree between the belt loop titanium plate and the bone causes that the suture fixed on the belt loop titanium plate shakes in the bone canal to a certain extent, so that the abrasion to the suture is increased, and the service life of the suture is influenced.
Other tissue attachment devices currently in common use, including screws, suture rivets, and the like, can also result in poor fixation.
Accordingly, there is a need to develop a new type of fixation device, a method of manufacturing the same, and a medical fixation device, which avoid the above-mentioned problems of the prior art.
Disclosure of Invention
The invention aims to provide a fixing device, a manufacturing method thereof and a medical fixing device, which can improve the fixing effect of tissues and bones, reduce the abrasion to the tissues and bones and prolong the service life of the fixing device.
To achieve the above object, the present invention provides a fixing device formed by braiding a string, comprising: a loop portion comprising a wire loop for passage of a target tissue; a knot portion connected to the loop portion, the knot portion configured to abut against bone; the adjusting part is connected with the ring part and used for adjusting the size of the wire loop, and the wire loop is tightened to fix the target tissue with the bone in the use process.
The fixing device provided by the invention has the beneficial effects that: the rope-shaped object is braided to form the ring part, the knot part and the adjusting part, the size of a wire loop of the ring part is adjusted through the adjusting part, so that the knot part fixes target tissues and bones, and the knot part formed by braiding the rope-shaped object can generate certain deformation along with the surface shape of the bones when contacting with the bones, so that the gap is reduced, the contact area is increased, and the fixing effect of the tissues and the bones is further improved; the knot formed by braiding the rope-shaped objects has certain flexibility, so that abrasion to bones can be effectively reduced; the knot part formed by braiding the rope-shaped object replaces the metal titanium plate, so that abrasion of the wire in the hole of the metal titanium plate is avoided, and the service life of the fixing apparatus is prolonged.
Optionally, the junction part includes a junction ring and a coil wound around the junction ring. The beneficial effects are that: the contact area between the junction and the bone is increased by the junction ring and the coil wound on the junction ring.
Optionally, the junction ring is an o-shaped junction ring, and the coil includes a first coil wound around the o-shaped junction ring. The beneficial effects are that: the contact area between the junction and the bone is increased, and the fixation strength is increased.
Optionally, the junction ring is an "8" shaped junction ring, and the coil includes a second coil wound around one of the "8" shaped junction rings and a third coil wound around the other of the "8" shaped junction rings. The beneficial effects are that: the 8-shaped knot ring is beneficial to further increasing the contact area between the knot part and the bone and increasing the fixing strength.
Optionally, the number of windings of the first coil is greater than or equal to 3 and less than or equal to 15. The beneficial effects are that: the coil spacing is reduced, the contact area between the junction and the bone is increased, and the fixation strength is increased.
Optionally, the number of windings of the second coil and the third coil is greater than or equal to 3 and less than or equal to 15. The beneficial effects are that: the coil spacing is reduced, the contact area between the junction and the bone is increased, and the fixation strength is increased.
Optionally, the loop part is composed of a two-wire loop. The beneficial effects are that: the double wire loop is advantageous for increasing the fixation strength compared to the single wire loop.
Optionally, the two wire loops are parallel to each other.
Optionally, the two loops cross through the centers of each other.
Optionally, the target tissue is a soft tissue of a human body, including a ligament, tendon or shoulder.
In order to achieve the above object, the present invention also provides a method for manufacturing the fixing device, comprising the steps of: s1, providing a hollow rope, wherein the rope comprises a rope portion, and the rope portion comprises a first rope portion and a second rope portion; s2, penetrating the first rope portion from a first opening on the rope-shaped object along the direction of the second rope portion and penetrating out from a second opening on the rope-shaped object, wherein a center ring is formed at the bent part of the rope-shaped object; s3, the first rope portion passes through the center ring, and the center ring is tightened, so that a nesting part of the rope forms a knot ring; s4, the rope part passes through the knot ring and is wound on the knot ring to form a knot part; s5, the first rope portion and the second rope portion reversely penetrate through the knot, the portion penetrating through the knot forms an adjusting portion, and the other portion forms a loop portion.
The manufacturing method of the fixing device provided by the invention has the beneficial effects that: manufacturing a fixing device, wherein the fixing device is formed by braiding a rope-shaped object to form the ring part, the knot part and the adjusting part, the size of a wire loop of the ring part is adjusted through the adjusting part, so that the knot part fixes target tissues and bones, and the knot part formed by braiding the rope-shaped object can generate certain deformation along with the surface shape of the bones when contacting the bones, so that the gap is reduced, the contact area is increased, and the fixing effect of the tissues and the bones is further improved; the knot formed by braiding the rope-shaped objects has certain flexibility, so that abrasion to bones can be effectively reduced; the knot part formed by braiding the rope-shaped object replaces the metal titanium plate, so that abrasion of the wire in the hole of the metal titanium plate is avoided, and the service life of the fixing apparatus is prolonged.
Optionally, the step S4 includes: and winding the first rope portion and the second rope portion together on the knot, wherein the first rope portion and the second rope portion together form a first coil.
Optionally, between step S3 and step S4, further includes: penetrating a second rope portion from a third opening in the rope in the opposite direction of the first rope portion, then penetrating out from a fourth opening in the rope, and tensioning the second rope portion to enable the nesting portion of the rope to form an 8-shaped knot.
Optionally, in step S4, the winding around the junction ring includes: winding said first rope portion around one of said "8" -shaped knot loops to form a second coil around said knot loop; and winding the second rope portion on the other ring of the 8-shaped knot ring to form a third coil wound on the knot ring.
Optionally, in step S4, the number of turns of the first rope portion and the second rope portion wound on the knot together is greater than or equal to 3 and less than or equal to 15.
Optionally, the number of turns of the first rope portion wound on one ring of the 8-shaped knot ring is greater than or equal to 3 and less than or equal to 15, and the number of turns of the second rope portion wound on the other ring of the 8-shaped knot ring is greater than or equal to 3 and less than or equal to 15.
Optionally, the step S5 includes: the first and second rope portions are passed in parallel through the knot.
Optionally, the step S5 includes: crossing the first rope portion and the second rope portion and then passing through the knot.
Optionally, the step S5 includes penetrating the first rope portion into the second rope portion, and then penetrating the first rope portion out of the second rope portion and penetrating the knot; and penetrating the second rope part into the first rope part, and then penetrating out and passing through the knot ring.
Optionally, step S5 includes threading the first rope portion into the second rope portion and then threading the first rope portion out of the second rope portion and threading the first rope portion through one of the "8" -shaped knot loops; the second rope part penetrates into the first rope part and then penetrates out, and penetrates through the other ring of the 8-shaped knot ring.
Optionally, after the first rope portion penetrates into the second rope portion, the first rope portion penetrates out of a fifth opening, and the fifth opening is located on the second rope portion and is close to the knot; the second rope portion penetrates into the first rope portion and then penetrates out of a sixth opening, and the sixth opening is located on the first rope portion and is close to the junction portion.
Optionally, the hollow rope is a hollow rope woven by threads, and any part of the hollow rope comprises a gap generated by weaving, and the gap is used for penetrating or penetrating the first rope portion or the second rope portion. The beneficial effects are that: the hollow rope formed by braiding the wires is convenient for the penetration and the threading out of the rope end, and an opening for penetration and threading out is not required to be arranged at a specific position.
Optionally, 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 effects are that: the two rings of the 8-shaped junction ring are consistent in size.
Optionally, the fourth opening is adjacent to the second opening.
In order to achieve the above object, the present invention also provides a medical fixing device comprising the above-mentioned fixing instrument,
drawings
FIG. 1 is a schematic view of a fixation instrument according to a first embodiment of the present invention;
FIG. 2 is a schematic view of a fixation instrument according to a second embodiment of the present invention;
FIG. 3 is a schematic view showing a step S1 of a manufacturing method of a fixing device according to a first embodiment of the present invention;
FIG. 4 is a schematic view showing a step S2 of a manufacturing method of a fixing device according to a first embodiment of the present invention;
fig. 5 is a schematic view of a first rope portion passing through a center ring in step S3 of a method of manufacturing a fastening device according to a first embodiment of the present invention;
FIG. 6 is a schematic view showing tightening of the centering ring in step S3 of the method of manufacturing a fastening device according to the first embodiment of the present invention;
FIG. 7 is a schematic view showing a step S3 of the manufacturing method of the fixing device according to the first embodiment of the present invention, in which a knot is formed;
FIG. 8 is a schematic view showing steps S4 and S5 of a method for manufacturing a fastening device according to a first embodiment of the present invention;
FIG. 9 is a schematic illustration of a method of manufacturing a fastening device according to a second embodiment of the invention, whereby a second rope portion is threaded in reverse through a third opening in the rope and then out through a fourth opening in the rope;
FIG. 10 is a schematic view of a method of manufacturing a fastening device according to a second embodiment of the present invention to form an "8" shaped knot ring;
FIG. 11 is a schematic view of a step S4 of a manufacturing method of a fastening device according to a second embodiment of the present invention;
FIG. 12 is a schematic view of a step S5 of a manufacturing method of a fastening device according to a second embodiment of the present invention;
FIG. 13 is a schematic view of a dual-wire loop parallel to each other in an embodiment of the present invention;
FIG. 14 is a schematic view showing the structure of the cross-over of the two loops through the centers of each other in an embodiment of the present invention;
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention. Unless otherwise defined, technical or scientific terms used herein should be given the ordinary meaning as understood by one of ordinary skill in the art to which this invention belongs. As used herein, the word "comprising" and the like means that elements or items preceding the word are included in the element or item listed after the word and equivalents thereof without precluding other elements or items.
The embodiment of the invention provides a fixing device, which solves the problems existing in the prior art.
Fig. 1 is a schematic view showing the structure of a fixing device according to a first embodiment of the present invention.
Fig. 2 is a schematic structural view of a fixing device according to a second embodiment of the present invention.
In some embodiments of the invention, referring to fig. 1 and 2, the fixation device comprises a loop 1, the loop 1 being composed of a two-wire loop comprising a first wire loop 11 and a second wire loop 12; in use, the target tissue passes through the centers of the first wire loop 11 and the second wire loop 12, in particular, the target tissue may be a ligament and is pulled by the first wire loop 11 and the second wire loop 12 to the bone to be fixed therewith; a junction 2, wherein the junction 2 is connected with the ring 1, and the junction 2 is used for abutting against bones; the adjusting part 3, the adjusting part 3 includes a first end 31 and a second end 32, the first end 31 and the second end 32 are respectively connected with the first wire loop 11 and the second wire loop 12, and the first end 31 and the second end 32 are stretched to adjust the sizes of the first wire loop 11 and the second wire loop 12 and fix the target tissue with the bone.
In some embodiments of the present invention, referring to fig. 1 and 2, the knot portion 2 is formed by winding a coil around the o-shaped knot ring 51 or the 8-shaped knot ring 52, and the fixation effect of the titanium plate in the prior art is achieved through the knot portion 2, and the fixation effect is better than that of the titanium plate, the bone abrasion reduction effect is achieved, and the service life of the fixation device is prolonged.
In some embodiments of the present invention, the knot 2 includes a knot ring and a coil wound around the knot ring, the coil being wound around a rope of the knot ring in such a manner as to repeatedly pass through the center of the knot ring.
In some embodiments of the invention, the knot ring comprises an "o" shaped knot ring 51 or an "8" shaped knot ring 52, but the knot ring shape of the invention is not limited thereto.
In some embodiments of the invention, referring to fig. 1, the junction ring is an "o" junction ring 51, and the coil includes a first coil 61 wound around the "o" junction ring 51.
In some embodiments of the present invention, referring to fig. 2, the junction ring is an "8" shaped junction ring 52, the second coil 62 is wound around one ring of the "8" shaped junction ring 52, and the junction part 2 further includes a third coil 63 wound around the other ring of the "8" shaped junction ring 52; the second coil 62 is wound around the string of the "8" shaped knot 52 so as to pass repeatedly through the center of one of the loops of the "8" shaped knot 52, and the third coil 63 is wound around the string of the "8" shaped knot 52 so as to pass repeatedly through the center of the other of the loops of the "8" shaped knot 52.
In some embodiments of the present invention, the number of windings of the first coil 61 is 3, 5, 8, 10 or 15.
In some embodiments of the present invention, referring to fig. 1, the number of windings of the first coil 61 is 10.
In some embodiments of the present invention, the number of windings of the second coil 62 and the third coil 63 is 3, 5, 8, 10 or 15.
In some embodiments of the present invention, referring to fig. 2, the number of windings of the second coil 62 and the third coil 63 is 8.
Fig. 13 is a schematic view of a structure in which two loops are parallel to each other in an embodiment of the present invention.
FIG. 14 is a schematic view showing the structure of the cross-over of the two loops passing through the centers of each other in an embodiment of the present invention.
In some embodiments of the present invention, referring to fig. 13 and 14, the loop part 1 is formed of a two-wire loop, and in particular, the loop part 1 includes the first wire loop 11 and the second wire loop 12.
In some embodiments of the present invention, referring to fig. 13, the two wire loops are parallel to each other, and in particular, the first wire loop 11 and the second wire loop 12 are parallel to each other and do not pass through the center of each other.
In some embodiments of the present invention, referring to fig. 14, the double loops cross through the centers of each other, 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.
In some embodiments of the present invention, the length of the double-wire loop is adjustable and a self-locking function is achieved.
In some embodiments of the invention, the fixation instrument is used to fix soft tissues of the human body, including but not limited to ligaments and tendons.
FIG. 3 is a schematic view showing a step S1 of a manufacturing method of a fixing device according to a first embodiment of the present invention; FIG. 4 is a schematic view showing a step S2 of a manufacturing method of a fixing device according to a first embodiment of the present invention; fig. 5 is a schematic view of a first rope portion passing through a center ring in step S3 of a method of manufacturing a fastening device according to a first embodiment of the present invention;
FIG. 6 is a schematic view showing tightening of the centering ring in step S3 of the method of manufacturing a fastening device according to the first embodiment of the present invention; FIG. 7 is a schematic view showing a step S3 of the manufacturing method of the fixing device according to the first embodiment of the present invention, in which a knot is formed; fig. 8 is a schematic diagram showing steps S4 and S5 of a method for manufacturing a fastening device according to a first embodiment of the present invention.
The embodiment of the invention also provides a manufacturing method of the fixing device, which comprises the following steps S1 to S5.
Referring to fig. 3, S1 provides a hollow rope comprising rope portions including a first rope portion 41 and a second rope portion 42, in particular, the first rope portion 41 and the second rope portion 42 are located at both sides of a bend of the rope.
Referring to fig. 4, S2 penetrates the first rope portion 41 from a first opening in the rope and out from a second opening in the rope in the direction of the second rope portion 42, i.e. in the direction of the drawing a, the bend of the rope forming a centre loop.
Referring to fig. 5, 6 and 7, S3 passes the first rope portion 41 through the central loop and tightens the central loop so that the nested portion of the rope forms an "o" shaped knot 51.
Referring to fig. 8, S4 passes the rope portion in the same direction through the o-shaped knot 51 and winds around the o-shaped knot 51 to form a knot 2.
Referring to fig. 8, S5 reverses the first and second rope portions 41 and 42, passes through the "o" shaped knot 51, forms the adjusting portion 3 through a portion of the "o" shaped knot 51, and forms the loop portion 1 through another portion.
In some embodiments of the present invention, referring to fig. 8, step S4 includes: the first rope portion 41 and the second rope portion 42 are wound together around the o-shaped knot 51, and the first rope portion 41 and the second rope portion 42 together form a first coil 61.
FIG. 9 is a schematic illustration of a method of manufacturing a fastening device according to a second embodiment of the invention, whereby a second rope portion is threaded in reverse through a third opening in the rope and then out through a fourth opening in the rope; FIG. 10 is a schematic view of a method of manufacturing a fastening device according to a second embodiment of the present invention to form an "8" shaped knot ring; FIG. 11 is a schematic view of a step S4 of a manufacturing method of a fastening device according to a second embodiment of the present invention; fig. 12 is a schematic diagram of a step S5 of a manufacturing method of a fastening device according to a second embodiment of the present invention.
In some embodiments of the present invention, referring to fig. 9 and 10, between step S3 and step S4 further includes: the second rope portion 42 is reversed, i.e. in the direction shown at B, penetrating from the third opening in the rope and then penetrating from the fourth opening in the rope and tightening the second rope portion 42, causing the nested portion of the rope to form an "8" shaped knot 52.
In some embodiments of the present invention, referring to fig. 11, in step S4, the winding around the junction ring includes: winding the first rope portion 41 around one of the loops of the "8" shaped knot 52 to form a second coil 62 around the "8" shaped knot 52; the second rope portion 42 is wound around the other loop of the "8" shaped knot 52 to form a third coil 63 wound around the "8" shaped knot 52.
In some embodiments of the present invention, in step S4, the first rope portion 41 and the second rope portion 42 are wound around the knot together for 3, 5, 8, 10 or 15 turns.
In some embodiments of the present invention, referring to fig. 8, in step S4, the number of turns of the first rope portion 41 and the second rope portion 42 wound together around the o-shaped knot 51 is 10.
In some embodiments of the present invention, in step S4, the number of turns of the first rope portion 41 wound around one of the "8" shaped knot 52 is 3, 5, 8, 10 or 15, and the number of turns of the second rope portion 42 wound around the other of the "8" shaped knot 52 is 3, 5, 8, 10 or 15.
In some embodiments of the present invention, referring to fig. 12, in step S4, the number of turns of the first rope portion 41 wound around one of the "8" shaped knot rings 52 is 8, and the number of turns of the second rope portion 42 wound around the other of the "8" shaped knot rings 52 is 8.
In some embodiments of the present invention, referring to fig. 13, step S5 includes: the first and second rope portions 41, 42 are passed in parallel through the knot loops, so that the bifilar loops are parallel to each other.
In some embodiments of the present invention, referring to fig. 14, step S5 includes: the first and second rope portions 41 and 42 are crossed and then passed through the knot so that the double loops cross through the centers of each other.
In some embodiments of the present invention, step S5 includes threading the first rope portion 41 into the second rope portion 42 and then threading out through the o-shaped knot 51; the second rope portion 42 is threaded into the first rope portion 41 and then threaded out and through the o-shaped knot 51.
In some embodiments of the present invention, step S5 comprises threading the first rope portion 41 into the second rope portion 42 and then out through one of the "8" shaped knot loops 52; the second rope portion 42 is threaded into the first rope portion 41 and then threaded out and through the other of the "8" -shaped knot loops 52.
In some embodiments of the present invention, after the first rope portion 41 penetrates into the second rope portion 42, the first rope portion is penetrated out from a fifth opening, and the fifth opening is located on the second rope portion 42 and is close to the knot 2; the second rope portion 42 penetrates into the first rope portion 41 and then passes out of a sixth opening located on the first rope portion 41 and close to the knot 2.
In some embodiments of the invention, the hollow rope is a wire-braided hollow rope, and any place of the hollow rope comprises a slit generated by braiding, wherein the slit is used for penetrating or penetrating the first rope portion or the second rope portion.
In some embodiments of the present invention, the distance from the first opening to the second opening is equal to the distance from the third opening to the fourth opening, so that the two loops of the "8" shaped knot loop formed in this way are identical in size, and the two sides of the knot portion 2 formed based on the "8" shaped knot loop are uniform in size.
In some embodiments of the invention, the fourth opening is adjacent to the second opening.
The embodiment of the invention also provides a medical fixing device which comprises the fixing instrument.
While embodiments of the present invention have been described in detail hereinabove, it will be apparent to those skilled in the art that various modifications and variations can be made to these embodiments. It is to be understood that such modifications and variations are within the scope and spirit of the present invention as set forth in the following claims. Moreover, the invention described herein is capable of other embodiments and of being practiced or of being carried out in various ways.