JP2013046716A - Spacer fixing tool and spacer with the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a spacer fixing tool capable of easily and reliably performing an operation of fixing a spacer in a bone, and to provide the spacer with the spacer fixing tool capable of easily performing an operation for securing a gap between the bones.SOLUTION: The spacer fixing tool is used to fix the spacer to the bone, while inserting the spacer in the gap between the bones. The spacer fixing tool has a plurality of threads, and a rod-shaped binding member for bundling and fastening between at least one end of the plurality of threads with each other. At least one of the plurality of threads is fastened detachably from the binding member, when necessary.

Description

  The present invention relates to a spacer fixing tool used when fixing a spacer to a bone, and a spacer including the spacer fixing tool.

  As a treatment for cervical spondylotic myelopathy, posterior longitudinal ligament ossification, yellow ligament ossification, intervertebral disc herniation and the like, a median longitudinal split cervical vertebral laminoplasty is performed.

  In midline longitudinal split laminoplasty, the midline (center) of the vertebral arch or spinous process is cut, and the vertebral arches on both sides are opened like hinges with the midline as the boundary. To enlarge. At this time, a spacer is inserted into a gap opened by cutting a vertebral arch or spinous process.

  For example, a spacer having a substantially trapezoidal shape in plan view is used by being inserted into the gap such that the narrow portion is on the spinal canal (vertebral foramen) side.

  In order to prevent the spacer from detaching from the vertebral arch or spinous process, a suture thread is inserted into the through-hole formed in the vertebral arch or spinous process and the through-hole formed in the spacer, and the spacer is tightened. (See, for example, Japanese Patent Laid-Open No. 2007-082826 (Patent Document 1)). The spacer is usually fixed using a plurality of sutures, but the operation of inserting the plurality of sutures through the through holes is extremely complicated, and improvement is desired.

  Japanese Patent Application Laid-Open No. 2011-136092 (Patent Document 2) discloses at least one suture made of a biocompatible material, and at least one suture thread provided on the suture thread and having a higher rigidity than the suture thread. And a bone graft suturing tool, wherein the hard portion is composed of a surgical needle. According to Patent Document 2, a soft suture can be easily guided and passed through a through hole in a bone filling material or an autologous bone with the hard portion at the top, It is described that the insertion property can be maintained even after the suture is softened by passing it through.

  Utility Model Registration No. 3069906 (Patent Document 3) discloses a suture with a surgical needle in which a surgical needle is fixedly attached to both ends of a suture formed by arranging a plurality of threads of the same length. As a means for attaching and attaching the surgical needle to the suture thread, the plurality of ends are collectively inserted into a thread attachment hole provided in the base portion of the needle toward the axial direction, and press-fit. Cite how to do.

However, since the bone grafting suturing device and the surgical needle-attached suture described in Patent Documents 2 and 3 are obtained by fixing and attaching the surgical needle to the suture, a plurality of sutures can be easily separated. Can not do it. Therefore, for example, in the median longitudinal split-type laminoplasty, when the spacer is tied and fixed with a suture thread inserted through the through hole, the suture thread is cut with scissors or the like near the surgical needle, An operation of separating a plurality of sutures is required. It is very complicated to perform such an operation during the operation, and if the separated surgical needle is lost, it is difficult to find this part and there is a risk of leaving it in the patient's body.

JP 2007-082826 JP 2011-136092 Utility Model Registration No. 3069906

  An object of the present invention is to provide a spacer fixing tool that can easily and reliably perform an operation of fixing a spacer to a bone, and a spacer with a spacer fixing tool that can easily perform an operation of securing a gap between bones. There is.

As a result of diligent research in view of the above object, the present inventors have adjusted the fixing strength of the binding member in a spacer fixing tool formed by bundling ends of a plurality of sutures and fixing them with a rod-like binding member. Or by providing a cut in at least one of the plurality of threads, it can be easily inserted into the through holes provided in the bone and the spacer, and the suture can be easily separated from the binding member. The inventors have found that the operation of fixing the spacer after the process can be easily performed, and have arrived at the present invention.

That is, the first spacer fixing tool of the present invention used to fix the spacer to the bone with the spacer inserted in the gap between the bones,
Multiple threads,
A rod-like binding member that binds and fixes at least one end of the plurality of yarns; and
At least one of the plurality of yarns is fixed to be separable from the binding member when necessary.

  The force required for separating the yarn and the binding member is preferably 1 to 10 N in terms of tensile strength.

With the spacer inserted in the gap between the bones, the second spacer fixing tool of the present invention used to fix the spacer to the bone,
Multiple threads,
A rod-like binding member that binds and fixes at least one end of the plurality of yarns; and
At least one of the plurality of yarns is provided with a cut so that it can be easily cut when necessary.

  The force required for cutting and separating the yarn at the cut portion is preferably 1 to 10 N in terms of tensile strength.

It is preferable that the plurality of yarns are fixed by being pressed and attached to a base portion of the binding member while being inserted into an attachment hole provided in the axial direction.

  It is preferable that both ends of the plurality of yarns are bundled and fixed by the binding member.

  The length of the binding member is preferably 8 to 35 mm. The thickness of the binding member is preferably 0.8 to 2 mm.

  The end of the binding member is preferably chamfered.

  The binding member is preferably made of stainless steel.

The plurality of yarns are preferably made of a polymer material or a metal material.

The plurality of yarns preferably have different colors from each other.

The plurality of yarns preferably include yarns having different lengths.

The spacer with a spacer fixing tool of the present invention is a spacer having a through hole that is inserted into a gap between bones, and is characterized in that the spacer fixing tool is inserted into the through hole.

Preferably, the spacer is for cutting the vertebral arch or the vertebral arch and spinous process and inserting it into the open gap.

  The spacer fixing tool of the present invention comprises a plurality of threads and rod-like binding members, and is configured to be separable from the rod-like binding members, so that a plurality of holes are provided in the through holes provided in the bone and the spacer. The thread can be easily inserted, and a plurality of threads can be easily separated after being inserted, and the operation of fixing the spacer and securing the gap between the bones can be easily and reliably performed.

It is a schematic diagram which shows an example of the spacer fixing tool of this invention. It is a schematic diagram which shows the method of forming the adhering part of a binding member and a thread | yarn of the spacer fixing member of this invention. It is a schematic diagram which shows the example of the crimping machine for adhering a thread | yarn to a binding member. It is a schematic diagram which shows the cross section of the press part formed with the crimping machine. It is a schematic diagram which shows the example of a structure of a press part. It is a schematic diagram which shows another example of the spacer fixing tool of this invention. It is a perspective view which shows an example of the spacer with a spacer fixing tool of this invention. It is a schematic diagram for demonstrating a median longitudinal split-type expansion laminoplasty. It is another schematic diagram for demonstrating a median longitudinal split-type expansion laminoplasty. FIG. 10 is still another schematic diagram for explaining a median longitudinal split-type laminoplasty. FIG. 10 is still another schematic diagram for explaining a median longitudinal split-type laminoplasty. It is a perspective view for demonstrating the method to fix a spacer.

[1] Median longitudinal split-type laminoplasty The spacer fixing tool or spacer with a spacer fixing tool of the present invention is used, for example, in a median vertical split-type laminoplasty. The median longitudinal split type laminoplasty will be described with reference to FIGS. 8 to 11, the upper side is the dorsal side, and the lower side is the ventral side.

  As shown in FIG. 8, the vertebra 100 includes a vertebral body 110, a vertebral arch 120 that extends behind the vertebral body 110 (upper side in FIG. 8) and forms a spinal canal (vertebral foramen) 140, And a spinous process 130 protruding backward from the central portion.

  First, as shown in FIG. 9, the spinous process 130 is cut along the midline 200 using an air drill or the like, and the vertebral arch 120 is divided into two to form cut portions 130a and 130b. Further, grooves 121a and 121b are formed on the outer side of the root portion of the vertebral arch 120 using an air drill or the like. The grooves 121a and 121b have a depth enough to cut only the outer plate and not the inner plate. The portions where the grooves 121a and 121b are formed are hinge portions (hinges) 122a and 122b.

  Next, as shown in FIG. 10, the cut portions 130a and 130b are rotated about the hinge portions 122a and 122b, so that the cut portions of the spinous processes 130 are expanded and a gap 150 is formed. Here, the inner side surface facing the gap 150 between the cutting portions 130a and 130b is shaped as necessary.

  Next, through holes 131a and 131b are formed in the cutting portions 130a and 130b. After that, as shown in FIG. 11, a substantially trapezoidal spacer S is inserted into the gap 150 in plan view. Thus, an enlarged vertebral arch 160 is formed by the spinous process 130 of the patient and the spacer S.

  During or after the operation, the spacer fixing tool 1 of the present invention is inserted into the through holes 131a and 131b of the spinous process 130 and the through hole S1 of the spacer S. Then, as will be described later, the first yarn 10a and the second yarn 10b are pulled out from the binding member 11 of the spacer fixing tool 1, and the first yarn 10a and the second yarn 10b separated into two pieces are used, The spacer S is fixed to the cutting parts 130a and 130b.

  As the spacer S, those composed of bioceramics such as alumina, zirconia, calcium phosphate compound, etc. are preferably used. A porosity of 70% or less (particularly 30 to 50%) is suitable.

[2] Spacer fixing tool
(1) First Mode As shown in FIG. 1, the first mode of the spacer fixing tool 1 is a rod-like shape for binding a plurality of yarns 10 each having a diameter D and at least one end of the plurality of yarns 10. And at least one of the plurality of yarns is fixed so as to be separable from the binding member when necessary. In the example shown in FIG. 1, the binding members 11 and 11 are fixed to both ends of the first yarn 10a and the second yarn 10b, respectively.

  For example, as shown in FIG. 2 (a), the plurality of yarns 10 are fixed to the binding member 11 by attaching the plurality of yarns 10 (see FIG. 2) to the mounting holes 11c provided in the base portion 11b of the binding member 11 in the axial direction. Then, the end portions of the first yarn 10a and the second yarn 10b) are inserted together, and as shown in FIG. 2 (b), the end portion of the bundling member 11 is inserted from the outer peripheral portion with pliers and caulking machines. It is performed by pressing using an instrument such as. At this time, the pressing portion 12 is formed by adjusting the pressing strength so that at least one of the plurality of yarns 10 can be easily pulled out and separated from the binding member 11.

  The fixing by pressing is preferably performed using a caulking machine 20 as shown in FIG. 3 (a), for example. The caulking machine 20 includes a pedestal portion 22 having a groove 21 having a semicircular cross section, and a movable portion 23 for applying a pressing force to the binding member 11 placed in the groove 21. The movable part 23 can be driven in the direction of the arrow F at a speed and pressure of 2 mm to press the binding member 11. Note that the thickness of the movable portion 23 (in the direction perpendicular to the plane of FIG. 3) is as thin as about 0.5 to 3 mm, and the binding member can be pressed pinpointed. The caulking machine 20 shown in FIG. 3 (a) applies the pressing force to the bundling member 11 in which the first thread 10a and the second thread 10b are inserted into the mounting hole 11c, so that the first caulking machine 20 has an appropriate strength. The first yarn 10a and the second yarn 10b can be fixed to the binding member 11. FIG. 4A shows a cross-sectional shape of the pressing portion 12 after pressing at this time.

  As shown in FIG. 3 (b), the protruding portion 24 may be provided on the movable portion 23 of the caulking machine 20. The protruding portion 24 is provided in a direction along a semicircular groove 21 provided in the pedestal portion 22, and when the pressing force is applied to the binding member 11, the binding member 11 is cross-sectioned. The shape is deformed to be a heart shape. FIG. 4B shows a cross-sectional shape of the pressing portion 12 after pressing at this time.

The mounting hole 11c can be formed by laser processing or the like. The mounting hole 11c only needs to have an inner diameter and a depth that allow the plurality of yarns 10 to be inserted and can be fixed with a separable strength when necessary. For example, two yarns having a diameter of about 0.2 to 0.8 mm When used, the mounting hole 11c may have an inner diameter of about 0.5 to 1.8 mm and a depth of about 2 to 4 mm.

The pressing strength is appropriately adjusted according to the material and thickness of the bundling member 11, the size of the attachment hole 11c, the thickness and material of the thread, the shape of the pressing portion 12, and the like, and the optimum condition is selected. For example, when a binding hole 11c having a diameter of 1 mm is formed in a binding member 11 made of stainless steel having a diameter of 1.2 mm and two polyester yarns having a diameter of 0.4 mm are fixed, by pressing with a force of 200 to 500 g, At least one of the plurality of yarns 10 can be easily pulled out and separated from the binding member 11, and the yarn can be fixed with a strength that does not separate by the impact during the transfer of the suture and the handling level during the operation.

Usually, when fixing the binding member 11 and the thread 10, it is possible to prevent the thread 10 from coming off from the binding member 11 by pressing strongly over the entire outer peripheral surface of the binding member end. In the present invention, as described above, the end of the binding member 11 is pressed with a predetermined loose pressing force and pinpoint, and the cross-sectional shape of the binding member 11 is made into a semicircular shape or a heart shape, thereby binding The thread 10 is adjusted so as to come out from the member 11 with an appropriate force.

  The force (separation strength) required for separating the first yarn 10a and / or the second yarn 10b from the binding member 11 is preferably about 1 to 10 N in terms of tensile strength, and is preferably 1.2 to 5 N 2 is more preferable, and about 1.5 to 3.5 N is most preferable. For the separation strength, the binding member 11 of the spacer fixing tool 1 and an arbitrary thread (here, the thread 10a) are respectively set on a strength measuring machine (“EZ-Test” manufactured by Shimadzu Corporation), and the binding member 11 The yarn 10a and the bundling member 11 are pulled in the opposite directions at a speed of 5 mm / min along the axial direction, and evaluated by the maximum value of the tensile strength until the yarn 10a is separated from the bundling member 11. To do.

  If the tensile strength of the fixing portion between the binding member 11 and the threads 10a, 10b is set within the above range, the threads 10a, 10b can be easily separated from the binding member 11, and the suture thread It does not separate due to impact during transfer or handling during operation. Therefore, the operation of fixing the spacer S to the cutting portions 130a and 130b can be performed in a shorter time, and the problem that the yarns 10a and 10b are separated from the binding member 11 before use can be prevented.

As shown in FIG. 5 (a), the fixing portion of the binding member 11 and the yarns 10a, 10b is provided with a pressing portion 12 only on the base portion 11b of the binding member 11, so that the yarns 10a, 10b are needed. Although both may be configured to be pulled out, as shown in FIG. 5 (b), as shown in FIG. 5 (b), the pressing portions 12a, 12b are respectively provided at two locations: a base portion 11b of the bundling member 11 and a location at a fixed distance from the base portion 11b. 12b may be provided, and the yarns 10a and 10b may be fixed by the pressing portion 12a, and only the yarn 10b may be fixed by the pressing portion 12b.

  When the pressing portions 12a and 12b are provided at two locations on the binding member 11, the pressing portion 12a provided on the base portion 11b is similar to the pressing portion 12 shown in FIG. And / or formed with a relatively low pressing force (for example, about 200 to 500 g) so that the second yarn 10b can be easily pulled out and separated, while the pressing portion 12b prevents the yarn 10b from coming off easily. The yarn 10b is firmly fixed so that it does not easily come off from the binding member 11, and only the yarn 10a is easily pulled out and separated from the binding member 11 by forming with a high pressing force (for example, about 2000 g). A spacer fixing tool can be obtained. The pressing portion 12b is preferably formed by pressing the entire binding member 11 uniformly from all directions while rotating the binding member 11.

  As shown in FIG. 12, in the above-mentioned median longitudinal split laminoplasty, as shown in FIG. 12, (a) the spacer fixing tool 1 is inserted into the through holes 131a, 131b and S1, and (b) the spacer S is cut into the spinous processes 130. (C) After the first yarn 10a and the second yarn 10b are pulled out from the binding member 11, the first yarn 10a and the second yarn fixed by the binding member 11 are aligned. 10b is separated, and (d) the spacer S is cut by the first thread 10a and the second thread 10b so that the spacer S and the cut portions 130a and 130b of the spinous process 130 are tightened. It can be firmly and quickly fixed to the portions 130a and 130b. A method of using the spacer fixing tool 1 will be described in detail later.

(A) Bundling member The length of the bundling member 11 is not particularly limited, but is preferably about 8 to 35 mm, and more preferably about 10 to 30 mm. By setting the length of the bundling member 11 within the above range, the bundling member 11 can be reliably held with a finger or the like. Moreover, if it is the said range, the length of the bundling member 11 is not too long, and insertion operation of the spacer fixing member 1 to the through holes 131a and 131b and the through hole S1 can be easily performed.

  The thickness of the bundling member 11 is not particularly limited, but is preferably about 0.8 to 2 mm, and more preferably about 1 to 1.5 mm. The thickness of the bundling member 11 is preferably set as appropriate by through holes formed in bones or spacers.

  The binding member 11 is preferably made of a material having excellent corrosion resistance such as stainless steel, titanium, titanium alloy and the like.

  The binding member 11 is formed in the through-holes 131a and 131b formed in the spinous processes 130 and the through-hole S1 formed in the spacer S (see FIGS. 10 and 11) in the above-described median longitudinal split-type laminoplasty. In order to facilitate insertion of the spacer fixing tool 1, it is preferable to chamfer the tip end portion 11a and process it into a smooth shape (spherical shape in FIG. 2). The tip portion 11a may have a conical shape or the like.

  By providing the binding member 11 at both ends of the spacer fixing tool 1, when the spacer fixing tool 1 is inserted into the through holes 131a, 131b and S1, an operation of inserting from any end side can be performed. .

(B) Yarn The yarn 10 is not particularly limited, but is preferably mainly composed of a polymer material. The yarn is preferably made of a material having biocompatibility. It may be made of a metal material such as titanium.

  Polymer materials include polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer (EVA) and other polyolefins, cyclic polyolefins, modified polyolefins, polyvinyl chloride, polyvinylidene chloride, polystyrene, polyamide, polyimide Polyamideimide, polycarbonate, poly- (4-methylpentene-1), ionomer, acrylic resin, polymethyl methacrylate, acrylonitrile-butadiene-styrene copolymer (ABS resin), acrylonitrile-styrene copolymer (AS resin) , Butadiene-styrene copolymer, polyoxymethylene, polyvinyl alcohol (PVA), ethylene-vinyl alcohol copolymer (EVOH), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polycyclohexane terephthalate (PCT), etc. Polyester, polyether, polyetherketone (PEK), polyetheretherketone (PEEK), polyetherimide, polyacetal (POM), polyphenylene oxide, modified polyphenylene oxide, polysulfone, polyethersulfone, polyphenylene sulfide, polyarylate, fragrance Group polyester (liquid crystal polymer), polytetrafluoroethylene, polyvinylidene fluoride, fluororesin, and the like, and these may be used in combination.

  Among these, polyester is preferable. By using polyester, relatively high flexibility can be imparted to each of the yarns 10a and 10b, and the operation of fixing the spacer S is facilitated.

  The yarn 10 may be composed of a monofilament yarn or a multifilament yarn. Here, the monofilament yarn refers to a single fiber that does not have a long continuous connection portion, and the multifilament yarn refers to a single fiber that is formed by twisting a plurality of monofilaments together. Say that.

  When monofilament yarn is used, there is an advantage that the stiffness of each yarn 10a, 10b becomes strong and the spacer S can be tightened (fixed) more firmly. In addition, since there is no gap between filaments, the risk of infection is reduced. On the other hand, when the multifilament yarn is used, there is an advantage that the flexibility of the yarns 10a and 10b is increased and the spacer S can be tightened more easily and accurately.

  Further, for example, the first yarn 10a can be a monofilament yarn, and the second yarn 10b can be a multifilament yarn. In this case, first, the spacer S can be temporarily fixed with the second multifilament yarn (yarn 10b) and then firmly tightened with the first monofilament yarn (yarn 10a) and tied (mainly fixed). . In this way, the spacer S can be more securely and firmly fixed to the cutting parts 130a and 130b.

  The lengths of the first yarn 10a and the second yarn 10b are not particularly limited, but are preferably about 30 to 100 cm, and more preferably about 50 to 80 cm. In the present embodiment (see FIG. 1), the first yarn 10a and the second yarn 10b have substantially the same length, but may be set to different lengths as necessary.

  It is preferable that the first yarn 10a and the second yarn 10b have substantially the same diameter. The diameter D of each yarn 10a, 10b is not particularly limited, but is preferably about 0.05 to 1 mm, and more preferably 0.2 to 0.8 mm. The diameters of the yarns 10a and 10b may be different depending on the purpose.

  The first yarn 10a and the second yarn 10b are different from each other so that the ends of the different yarns 10a and 10b are not tied together when the spacer is fixed after the binding member 11 is separated. It is preferably colored.

(C) Usage Example of Spacer Fixing Tool A method for fixing the spacer S to the cut portions 130a and 130b of the spinous process 130 using the spacer fixing tool 1 will be described with reference to FIG. FIG. 12 shows a stage between FIG. 10 and FIG. 11 for explaining the median longitudinal split-type laminoplasty.

(i) Hold one binding member 11 of the spacer fixing tool 1 with a finger or the like and insert it into the through hole S1 of the spacer S (not shown). With the spacer fixing tool 1 inserted through the through hole S1 of the spacer S, one binding member 11 of the spacer fixing tool 1 is opened in the through hole 131a in the cutting portion 130a, and the other binding member 11 is opened in the cutting portion 130b. The through hole 131b is inserted (see FIG. 12 (a)).

  At this time, since the binding member 11 has a certain length, it can be reliably gripped and can be reliably operated to be inserted through the through holes 131a, 131b and S1.

(ii) Pull both ends of the spacer fixing tool 1 in the direction of separating and insert the spacer S into the gap 150 (see FIG. 12 (b)).

(iii) The first yarn 10a and the second yarn 10b are pulled out from each binding member 11, and the binding member 11 and each yarn are separated (see FIG. 12 (c)). At this time, since the first yarn 10a and the second yarn 10b are fixed to the binding member 11 with a low tensile strength as described above, the first yarn 10a and the second yarn 10b can be pulled out easily and promptly. The second yarn 10b can be separated. Note that the order of (ii) and (iii) may be reversed.

(iv) The spacer S is tied using the separated first thread 10a, and similarly the spacer S is tied using the second thread 10b. At this time, it is preferable that the first yarn 10a and the second yarn 10b are preliminarily colored in different colors so that different yarns are not mistakenly tied. Thereby, the spacer S can be fixed to the cutting parts 130a and 130b.

(v) The unnecessary portions of the first thread 10a and the second thread 10b are cut to complete the median longitudinal split-type laminoplasty (see FIG. 12 (d)).

Unlike the present invention, for example, when a bone grafting suture tool in which a plurality of threads are firmly fixed to a surgical needle is used, each thread cannot be easily separated. It is necessary to cut the thread and remove the surgical needle to separate the plurality of threads. Such an operation is complicated, and since the surgical needle is thin and small, if the cut surgical needle is lost, it is difficult to find this part and there is a risk of leaving it in the patient's body.

  On the other hand, when the spacer fixing tool 1 of the present invention is used, since the two threads can be easily separated without cutting the thread, the operation is easy and the safety of the operation is improved. Rise.

  In this embodiment, the bundling member 11 is provided at both ends of the thread 10.However, when considering only the ease of operation of inserting the thread 10 into the through holes 131a, 131b and S1, The binding member 11 may be provided only at one end of the yarn 10.

(2) Second Aspect As shown in FIG. 6, the second aspect of the spacer fixing tool 2 of the present invention includes a plurality of yarns 10 (two yarns 10a and 10b in FIG. 6), and a plurality of the plurality of yarns. A bar-like binding member 11 that binds and fixes at least one end of the yarn 10 is provided, and at least one of the plurality of yarns 10 is provided with a notch 13 so that it can be easily cut when necessary. . The notch 13 is provided in a portion of the yarn 10 at a certain distance from the base portion 11b of the binding member 11. In FIG. 6, the second of the first yarn 10a and the second yarn 10b. However, it may be provided on both the first yarn 10a and the second yarn 10b. Further, the cut 13 provided in one thread may be provided at one place or at two or more places.

  In the second embodiment of the spacer fixing tool 2, the plurality of yarns 10 are fixed to the bundling member 11 with a strong pressing force that does not easily separate the yarns 10 and thereby the bundling member 11 and the plurality of the bundling members 11 are fixed. When at least one of the yarns 10 is pulled, the binding member 11 and the plurality of yarns 10 are not separated at the fixing portion, and the yarns 10 are cut at the cuts 13. In order to firmly fix the yarn 10 so as not to easily come off the binding member 11, it is preferable to form the pressing portion 12c with a high pressing force of about 2000 g, for example.

  In order to make the thread 10 easily cut at the portion of the cut 13, the depth and shape of the cut 13 are adjusted, and the force (cutting strength) required for cutting is 1 in tensile strength. It is preferably about ˜10 N, more preferably about 1.2 to 5 N, and most preferably about 1.5 to 3.5 N. The cutting strength can be measured in the same manner as the separation strength measuring method described in the first embodiment of the spacer fixing tool 2.

  As described above, the spacer fixing tool 2 according to the second embodiment includes (a) the point that the thread 10 is provided with the notch 13 and (b) the plurality of the plurality of the plurality of the fixing devices 2 with a strong pressing force that does not easily separate the thread 10. Except for fixing the yarn 10 to the binding member 11, it is the same as the spacer fixing tool 1 in the first embodiment. Therefore, since the requirements other than (a) and (b) are the same as the contents described in the description of the spacer fixing tool 1 in the first aspect, the description is omitted here. However, in the second aspect, the material of the yarn is not suitable for metal, and therefore it is preferably made of a polymer material.

[3] Spacer with spacer fixing tool As shown in FIG. 7, the spacer 1S with spacer fixing tool includes the spacer fixing tool 1 as described in the first and second embodiments described above on the spacer S having a through hole. It is inserted through the through hole.

  The spacer fixing tool 1 is provided to the operator in a state of being inserted through the through hole S1 of the spacer S, for example. The spacer fixing tool 1 may be fixed to the spacer S using a biocompatible material or the like.

  By using a spacer with a spacer fixing tool, the operation of inserting the spacer fixing tool 1 into the through-hole S1 of the spacer S can be omitted at the operation site, so that the operation time can be shortened and the burden on the patient is reduced. Can be reduced.

  As mentioned above, although the spacer fixing tool of this invention and the spacer with a spacer fixing tool were demonstrated based on embodiment of illustration, this invention is not limited to these embodiment, Each structure has the same function. It can be replaced with any that can be exerted, or can be added in any configuration.

  For example, each illustrated spacer fixing tool is composed of two threads, but the spacer fixing tool of the present invention may be composed of three or more threads. In this case, for example, when the spacer is fixed to the bone with two threads and the remaining thread is used to fix the detached spinous process in the original position when the spinous process is separated from the vertebral arch. When the ligament is separated from the spinous process, the separated ligament can be used for fixing to the spinous process.

  In addition, the spacer shown in each embodiment is a spacer used for a gap between bones formed by cutting a vertebral arch and a spinous process, that is, a spinous process spacer, but by cutting a vertebral arch, It may be a spacer used for the gap between the formed bones, that is, a larch spacer. Furthermore, the spacer may be an intervertebral spacer used between vertebral bodies.

1, 2, ... Spacer fixing tool
10 ... Thread
10a ... 1st thread
10b Second thread
11 ... Bundling member 11a ... Tip
11b ・ ・ ・ Base
11c ・ ・ ・ Mounting hole
12 ... Pressing part
20 ... Caulking machine
21 ... Groove
22 ... pedestal
23 ・ ・ ・ Moving part
24 ... ridge
1S ・ ・ ・ Spacer with spacer fixing tool
S ・ ・ ・ Spacer
S1 ... through hole
100 ... vertebra
110 ... vertebral body
120 ...
121a, 121b ... groove
122a, 122b ・ ・ ・ Hinges
130 ・ ・ ・ Spinous process
130a, 130b ... cutting part
131a, 131b ... through hole
140 ... spinal canal
150 ... Gap
160 ... enlarged arch
200: Midline

Claims (15)

A spacer fixing tool used to fix the spacer to the bone in a state where the spacer is inserted into the gap between the bones,
Multiple threads,
A rod-like binding member that binds and fixes at least one end of the plurality of yarns; and
A spacer fixing tool, wherein at least one of the plurality of yarns is fixed separably from the binding member when necessary.   The spacer fixing tool according to claim 1, wherein a force required to separate the yarn and the binding member is 1 to 10 N in terms of tensile strength. A spacer fixing tool used to fix the spacer to the bone in a state where the spacer is inserted into the gap between the bones,
Multiple threads,
A rod-like binding member that binds and fixes at least one end of the plurality of yarns, and at least one of the plurality of yarns is provided with a cut so that it can be easily cut when necessary. A spacer fixing tool.   The spacer fixing tool according to claim 2, wherein a force required for cutting and separating the yarn at the cut portion is 1 to 10 N in tensile strength. The spacer fixing tool according to any one of claims 1 to 4, wherein the plurality of threads are fixed by being pressed and attached in a state of being inserted into an attachment hole provided in an axial direction at a base portion of the binding member. The spacer fixing tool characterized by the above-mentioned.   The spacer fixing tool according to any one of claims 1 to 5, wherein both ends of the plurality of yarns are bound and fixed by the binding member.   The spacer fixing tool according to any one of claims 1 to 6, wherein the binding member has a length of 8 to 35 mm.   The spacer fixing tool according to any one of claims 1 to 7, wherein the binding member has a thickness of 0.8 to 2 mm.   The spacer fixing tool according to any one of claims 1 to 8, wherein an end portion of the binding member is chamfered.   The spacer fixing tool in any one of Claims 1-9 WHEREIN: The said binding member consists of stainless steel, The spacer fixing tool characterized by the above-mentioned.   11. The spacer fixing tool according to claim 1, wherein the plurality of threads are made of a polymer material or a metal material.   12. The spacer fixing tool according to claim 1, wherein the plurality of threads have different colors from each other.   The spacer fixing tool according to any one of claims 1 to 12, wherein the plurality of threads include threads having different lengths. A spacer having a through-hole inserted into a gap between bones,
14. A spacer with a spacer fixing tool, wherein the spacer fixing tool according to any one of claims 1 to 13 is inserted through the through hole.   15. A spacer with a spacer fixing tool according to claim 14, wherein the spacer is for cutting a vertebral arch or a vertebral arch and a spinous process and inserting it into an open gap. Spacer.

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