WO2023146132A1

WO2023146132A1 - Pull-type one-sided cortical bone fixing anchor

Info

Publication number: WO2023146132A1
Application number: PCT/KR2022/020475
Authority: WO
Inventors: 유대희; 조정호; 정상현
Original assignee: 주식회사 에어스
Priority date: 2022-01-26
Filing date: 2022-12-15
Publication date: 2023-08-03
Also published as: KR20230115154A

Abstract

The present invention relates to a pull-type one-sided cortical bone fixing anchor configured to be fixed to a cortical bone as a pull-type anchor and minimize damage to a human body. The pull-type one-sided cortical bone fixing anchor according to an embodiment of the present invention may be configured to include an anchor sleeve in which a header unit inserted into a cortical bone and expanding by external force to be fixed to the cortical bone is provided at a lower end thereof and an anchor pin configured to be inserted into the anchor sleeve and generate external force to expand the header unit at the time of pulling.

Description

Pull-type single cortical bone fixation anchor

The present invention relates to a single cortical bone fixing anchor inserted into and fixed to one cortical bone, and more particularly, to a pull-type single cortical bone fixing anchor fixed to a cortical bone as a pull type and configured to minimize damage to the body. .

In general, in the case of spinal surgery or fracture treatment, treatment or treatment is performed using a fixation device that is inserted into the bone and fixed according to the treatment or treatment method. As an example of the fixing device, Korean Patent No. 10-1178488 discloses a 'device for fixing bones', and Korean Patent No. 10-1813525 discloses a 'pedicle screw having a four-line thread'. there is.

However, the bone fixation devices as described above are provided with a screw thread on the outer surface for fixation, and are rotated through the screw thread and fixed to the bone. There is a problem in that it damages the bone and generates heat around it in the process of inserting or releasing it into the bone, which acts as a factor that increases the procedure or treatment time.

The present invention is proposed to solve the above-described problems, and is formed in an anchor structure to prevent damage to the patient's body and heat generation in fixing cortical bone, thereby reducing operation or treatment time and enabling transplantation, removal, and correction. One object is to provide an anchor for easy fixation of one cortical bone.

In order to solve the above problems, a pull-type one-side cortical bone fixing anchor according to an embodiment of the present invention is inserted into a cortical bone, expands by an external force, and has a header portion fixed to the cortical bone, which is provided at the lower end and inserted into the anchor sleeve, It may be configured to include an anchor pin configured to generate an external force that expands the header portion when pulled.

Here, the header portion of the anchor sleeve is configured such that the header portion body is equally divided into a plurality of parts by a plurality of incisions to expand and deform by an external force, and the anchor pin is wider than the hollow portion of the anchor sleeve through which the anchor pin passes. A pin header forming an area may be provided so that when the anchor pin is pulled upward in a state where the pin header is positioned below the header portion of the anchor sleeve, the pin header is positioned inside the anchor sleeve and the header portion body is expanded. there is.

In addition, an expansion range enlargement hole for expanding an expansion range of the header unit may be formed at an end of each of the plurality of incisions in the longitudinal direction.

In addition, the anchor sleeve hollow part forms an inclined surface on the side so that the lower side of the header part forms a diameter of the upper and lower beams, and the pin header forms an inclined surface on the side so as to form a diameter of the upper and lower beams. An inclined surface having an inclination angle greater than an inclination angle of the inclination surface of the anchor sleeve hollow part is formed on the side, so that the inclination surface of the pin header moves along the inclination surface of the anchor sleeve hollow part, thereby extending the header portion.

In addition, the expansion range of the header portion may be adjusted by differently forming a difference between an inclination angle of the inclination surface of the hollow portion of the anchor sleeve and an inclination angle of the inclination surface of the pin header.

In addition, the header portion may be configured to be separated from and coupled to the anchor sleeve and may be used interchangeably.

In addition, the pull-type one-side cortical bone fixing anchor further includes a pull nut coupled to an upper end of the anchor pin to control pulling of the anchor pin, and the anchor pin and the pull nut may be screwed together.

Meanwhile, the pull-type one-side cortical bone fixing anchor may further include a buffer member provided at the lower end of the anchor sleeve on the outer circumferential surface of the header portion to buffer a gap between the anchor sleeve and the cortical bone.

In addition, one or more friction pattern protrusions of a vertical-horizontal grid pattern type, an oblique line grid pattern type, a dot pattern type, and a wavy line-straight line mixed pattern type may be formed on an outer surface of the header part.

In addition, in the pull-type cortical bone fixing anchor, a belt insertion groove is formed across the anchor sleeve and the pull nut to form a length along the circumference, and a fixing belt is inserted into the belt insertion groove and then bound to the anchor sleeve. The pull nut may be configured to be secured by a fixing belt.

The pull-type one-side cortical bone fixation anchor according to an embodiment of the present invention prevents heat generation because there is no rotation of the screw thread compared to the conventional method of fixing to the cortical bone using screw thread rotation, and minimizes the risk of surgery by minimizing damage to the body. It can reduce and help the patient recover.

In addition, since it is a structure in which one cortical bone is fractured, it is possible to correct rotational deformation even after inserting a metal nail into the intramedullary cavity, and accurate correction may be possible.

On the other hand, the pull-type one-side cortical bone fixation anchor according to an embodiment of the present invention is not limited to the above-mentioned effects according to the embodiment of the present invention, and may further include all effects predictable from the specification and drawings. .

1 is a perspective view of a pull-type single cortical bone fixing anchor according to an embodiment of the present invention.

FIG. 2 is an exploded perspective view of the pull-type one cortical bone anchor of FIG. 1;

3A, 3B, and 3C are enlarged views illustrating various shapes of the header part among the pull-type one-sided cortical bone fixing anchors of FIG. 1 .

4A and 4B are diagrams showing various types of the expansion range magnifying sphere of FIG. 3 as examples.

5A and 5B are diagrams illustrating the use of the pull-type single cortical bone fixing anchor of FIG. 1 .

6A and 6B are enlarged views showing a portion near a cortical bone in the exemplary view of FIG. 5 .

7 is a perspective view of a dedicated applicator for a pull-type single cortical bone fixing anchor according to an embodiment of the present invention.

8 is a cross-sectional view of the exclusive applicator of FIG. 7 .

FIG. 9 is a view showing a state in which a pull-type single cortical bone fixing anchor is mounted on the exclusive applicator of FIG. 7 .

10 is a cross-sectional view of FIG. 9 .

11 is a view showing the configuration and operation of a buffer member provided according to an embodiment of the present invention.

12a, 12b, 12c, and 12d are views showing various examples of friction pattern protrusions provided according to an embodiment of the present invention.

13A and 13B are diagrams showing examples of friction improving screw threads provided according to an embodiment of the present invention.

14 is a view showing the configuration and operation of a fixing belt provided according to an embodiment of the present invention.

Hereinafter, the description of the present invention with reference to the drawings is not limited to specific embodiments, and various transformations may be applied and various embodiments may be applied. In addition, the content described below should be understood to include all conversions, equivalents, or substitutes included in the spirit and scope of the present invention.

In the following description, terms such as first and second are terms used to describe various components, and are not limited in meaning per se, and are used only for the purpose of distinguishing one component from another.

Like reference numbers used throughout this specification indicate like elements.

Singular expressions used in the present invention include plural expressions unless the context clearly dictates otherwise. In addition, terms such as "include", "include" or "have" described below are intended to designate that features, numbers, steps, operations, components, parts, or combinations thereof described in the specification exist. should be construed, and understood not to preclude the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

Hereinafter, a pull-type single cortical bone fixing anchor according to an embodiment of the present invention will be described in detail with reference to the accompanying drawings for an embodiment of the present invention.

1 is a perspective view of a pull-type cortical bone fixing anchor on one side according to an embodiment of the present invention, FIG. 2 is an exploded perspective view of the pull-type cortical bone fixing anchor on one side of FIG. 1, and FIGS. 3a, 3b, and 3c are the pull-type anchor of FIG. 1 It is an exemplary diagram showing various shapes of the header part among cortical bone fixation anchors on one side in an enlarged manner.

4A and 4B are diagrams showing various forms of the extension scope of FIGS. 3A, 3B, and 3C as examples, and FIGS. 5A and 5B are diagrams illustrating the use of the pull-type one-side cortical bone fixing anchor of FIG. 1 . , FIGS. 6A and 6B are enlarged views showing a portion near the cortical bone in the exemplary view of FIG. 5 .

1 to 6, the present invention is a fixed anchor inserted into one cortical bone (CB) suitable for fracture surgery, in particular, minimally invasive fracture surgery, including an anchor sleeve 10 and an anchor pin 20, and an anchor pin. After inserting (20) into the anchor sleeve (10), pull the anchor pin (20) within the anchor sleeve (10) to fix it within the cortical bone (CB) formed on the surface layer of the bone (B). it's about

Here, the anchor sleeve 10 is provided with a header portion 11 at the lower end, the header portion 11 is inserted into the cortical bone CB, expanded by an external force and fixed to the cortical bone CB, and the anchor pin 20 When pulled while being inserted into the anchor sleeve 10, it may be configured to generate an external force that expands the header portion 11.

The structure of the present invention as described above has an advantage in that it can be easily fixed and released, and can minimize bone damage to a patient in comparison to a structure that has been inserted into and fixed to a bone using a rotation of a screw thread in the related art.

There may be several structures for expanding and fixing the header portion 11 of the anchor sleeve 10 inserted into the cortical bone CB using the anchor pin 20, but in the present invention, it is simpler and easier to use , In order to further minimize bone damage to the patient, the header portion 11 may include a header portion body 11-1 and an incision portion 11-2, and the anchor pin 20 may include a pin body ( 21) and a pin header 22.

Specifically, the header body 11-1 is preferably, but not limited to, a cylindrical shape and may be provided with a smaller diameter than the diameter of the anchor sleeve 10 at the lower end of the anchor sleeve 10, and the cutout 11- 2) may form a length along the plane from the center of the lower end surface of the header body 11-1 toward the upper end surface of the header body 11-1. At this time, a plurality of cutouts 11-2 may be provided to form lengths in directions symmetrical to each other, and may be configured to equally divide the header body 11-1 into a plurality of parts.

The pin body 21 of the anchor pin 20 is preferably, but not limited to, formed in a cylindrical shape and may be configured to be inserted through the anchor sleeve 10. To this end, the anchor sleeve 10 is an anchor pin ( 20) may be formed from the upper end to the lower end of the header body 11-1. That is, the center of the plurality of cutouts 11-2 may be connected to the hollow part 12.

The pin header 22 may be provided at the lower end of the pin body 21 . Here, the pin header 22 may form a larger area than the hollow part 12 of the anchor sleeve 10 . Accordingly, when inserted into the hollow portion 12 of the anchor sleeve 10, the weakly rigid portion may be deformed by the pin header 22.

In the present invention, the header body 11-1 is cut so that the header body 11-1 is evenly divided according to the configuration of the above-described cutout 11-2, so that the rigidity is lowered and the expansion deformation is easily performed by external force. Therefore, the header part 11 is deformed by inserting the pin header 22 into an external force body that expands the header part 11 and inserting it into the divided header part body 11-1.

More specifically, when the anchor pin 20 is pulled upward in a state where the pin header 22 is located on the lower side of the header portion 11 of the anchor sleeve 10, the pin header 22 is located inside the anchor sleeve 10 It is configured so that the header body 11-1 is extended. Here, when the pin body 21 is inserted into the anchor sleeve 10, the pin body 21 is preferably formed longer than the anchor sleeve 10 so that both the top of the pin body 21 and the pin header 22 protrude. do.

On the other hand, each cutout 11-2 may form an extension range enlargement 11-3 at an end in the longitudinal direction, that is, an end located at an upper end. The expansion range expansion sphere 11-3 is configured to further increase the expansion range of the header part 11 formed only by the cutout 11-2, and the cutout ( 11-2) is formed of a circular sphere having a wider diameter than the width, a circular sphere of relatively small diameter as shown in FIG. 4a, or a long hole-shaped sphere forming a length laterally as shown in FIG. 4b. Expansion range can be expanded.

In addition, the hollow part 12 located on the lower side of the header part 11 in the hollow part of the anchor sleeve (hereinafter referred to as 'anchor sleeve hollow part') forms an inclined surface 12a on the side so as to form the diameter of the upper and lower beams. And, the pin header 22 is also configured to form an inclined surface 22a on the side to form a diameter of the upper and lower beams, so that the pin header 22 is configured to form the upper and lower beams of the anchor sleeve 10 when the pin body 21 is pulled. It may be configured to be inserted into the hollow portion 12 forming the diameter.

Here, the inclination angle β of the inclination surface of the pin header 22 based on the vertical line VL is formed to form a greater inclination angle than the inclination angle α of the inclination surface of the anchor sleeve hollow part 12, so that the pin header 22 The inclined surface 22a of the anchor sleeve may be configured to expand the header portion 11 while moving along the inclined surface 12a of the hollow portion 12 .

If the difference between the inclination angle α of the anchor sleeve hollow part 12 and the inclination angle β of the pin header 22 is formed differently using the above principle, the extension range of the header part 11 can be adjusted. may be

For example, if the difference between the inclination angle α of the anchor sleeve hollow portion 12 and the inclination angle β of the pin header 22 is reduced, the expansion range of the header portion 11 can be narrowed. If the difference is large, the extension range of the header part 11 can be made wider.

Since the adjustment of the expansion range of the header part 11 as described above is directly related to the fixing force for the cortical bone CB, it can be useful for setting the fixing force for the cortical bone CB.

On the other hand, although not shown in the drawings, the header portion 11 may be configured to be separated and coupled from the anchor sleeve 10 so that it can be replaced and used, thereby improving hygiene.

At this time, in order to separate and combine the header part 11, the header part body 11-1 and the anchor sleeve 10 may be screwed together, or, on the other hand, an unspecified fixing device may be provided.

In addition, the pull-type single cortical bone fixing anchor according to an embodiment of the present invention may further include a pull nut 30 for fine adjustment and adjustment convenience of the anchor pin 20 .

The pull nut 30 is coupled to the upper end of the anchor pin 20, that is, a portion exposed upward of the anchor sleeve 10 when the anchor pin 20 is inserted into the anchor sleeve 10, and thus the anchor pin 20 It can be configured to adjust the pulling of.

Specifically, the anchor pin 20 and the full nut 30 may be screwed to each other by forming threads, and the full nut 30 rotates according to the direction of the thread by a tool or manpower while the anchor pin It can be moved in the upward direction of (20) or in the downward direction. At this time, while the anchor pin 20 continues to move downward, it can no longer be moved at the top of the anchor sleeve 10 and stops. If it continues to rotate in this state, the anchor pin 20 rotates along the screw thread and pulls upward. will lose Using this, the operator can more precisely adjust the anchor pin 20 and conveniently adjust the anchor pin 20 .

The shape of the full nut 30 is not limited, but may preferably be a polygonal shape, and may be used for the use of the exclusive applicator 100 together with the mechanism fastening part 35 formed at the top of the anchor sleeve 10. may be

7 is a perspective view of a dedicated applicator for a pull-type single cortical bone fixation anchor according to an embodiment of the present invention, FIG. 8 is a cross-sectional view of the dedicated applicator of FIG. 7, and FIG. 9 is a pull-type single cortical bone fixation anchor in the dedicated applicator of FIG. is a view showing a mounted state, and FIG. 10 is a cross-sectional view of FIG. 9 .

7 to 10, the mechanism fastening part 35 may be provided in a polygonal shape at the top of the anchor sleeve 10, and the full nut 30 is the top of the anchor pin 20, that is, the anchor pin ( 20) may be provided in a polygonal shape at a portion exposed to the upper side of the anchor sleeve 10 when inserted into the anchor sleeve 10. Here, the polygonal shape may preferably be a hexagon, but is not necessarily limited thereto.

The applicator 100 dedicated to mechanically adjusting the pull-type cortical bone fixing anchor on one side of the present invention can be fixed to the instrument fastening part 35 and the pull nut 30 provided in a polygonal shape, specifically, the instrument fastening part ( 35), the body portion 101 of the dedicated applicator 100 may be fixed, and the handle portion 102 of the dedicated applicator 100 may be fixed to the full nut 30.

The dedicated applicator 100 may include a body portion 101 and a handle portion 102, and may further include a gripping portion 103 extending from the body portion 101 for convenience of handling and gripping. It can be.

Specifically, the body portion 101 may be formed with a sleeve fastening groove 101a having a shape corresponding to the surface of the mechanism fastening portion 35 to the inside of the lower end to fix the mechanism fastening portion 35, and the handle portion ( 102 may have a nut fastening groove 102a having a shape corresponding to the surface of the pull nut 30 formed inside the lower end to fix the pull nut 30 .

Here, the handle part 102 may be configured such that a lower end having a nut fastening groove 102a is inserted into the body part 101 and rotated inside the body part 101, and when rotating, the connected pull nut 30 It is possible to adjust the elevation or descent of the anchor pin 20 by rotating.

On the other hand, the handle part 102 is not limited in its shape, but may be provided in a 'T' shape to facilitate gripping or manipulation, and the gripping part 103 will be configured to be detachable from the body part 101. can

The pull-type one-side cortical bone fixing anchor according to the embodiment of the present invention configured as described above prevents heat generation because there is no rotation of the screw thread in the cortical bone, compared to the conventional method of fixing to the cortical bone using the rotation of the screw thread, and prevents damage to the body. It can reduce the risk factors of surgery by minimizing it and help the patient's recovery.

On the other hand, referring to FIGS. 11 to 14, the pull-type cortical bone fixation anchor according to an embodiment of the present invention includes a buffer member 40, a friction pattern protrusion 50, a friction improving screw thread 55, or a fixing belt 60 ).

Referring to FIG. 11 , the buffer member 40 may be provided at the lower end of the anchor sleeve 10 on the outer circumferential surface of the header portion 11 . That is, the buffer member 40 may be inserted into the header portion 11 and positioned at the lower end of the anchor sleeve 10 . At this time, the buffer member 40 is formed of rubber or silicon material and can act as a buffer between the surfaces, and through this, the buffer member 40 is attached to the anchor sleeve 10 and the cortical bone during treatment with the fixed anchor of the present invention. By buffering between the CBs, it is possible to prevent the anchor sleeve 10 from rubbing and damaging the cortical bone CB.

On the other hand, the buffer member 40 may form a groove (not shown) in the header portion 11 so as not to be easily separated from the header portion 11 and insert it, and form an outer circumferential surface having the same diameter as the outer circumferential surface of the anchor sleeve 10. Thus, damage to the cortical bone CB due to the lower surface of the anchor sleeve 10 can be prevented as much as possible.

Referring to FIG. 12 , a friction pattern protrusion 50 may be formed on an outer surface of the header part 11 . Specifically, the friction pattern protrusion 50 is a vertical-horizontal lattice pattern in which vertical and horizontal lines are arranged to cross each other as shown in FIG. 12A, or a pattern is formed in which diagonal lines in different directions are intersected as shown in FIG. 12B. It may also be an oblique grid pattern type.

In addition, the friction pattern protrusions 50 may be a dot pattern type having only dot protrusions as shown in FIG. 12c, or a wavy line-straight mixed pattern type in which a pattern is formed by mixing wavy lines and straight lines as shown in FIG. 12d.

Here, the mixture of the wavy line and the straight line is formed in FIG. 12D, the wavy line forms a length from the upper side to the lower side, and the straight line is formed in the horizontal direction between the wavy lines, but is not limited thereto, and the wavy line forms a length laterally, Straight lines may be formed in a vertical direction between wavy lines, and various types of changes may be possible.

The friction pattern protrusions 50 as described above may be mixed with each other or configured individually, and when the header part 11 is expanded by the anchor pin 20, to increase the fixing force with the cortical bone CB. can be configured. At this time, shear force may be formed in various directions according to the pattern, so that the fixing force may be high.

Meanwhile, as shown in FIGS. 13A and 13B , the header portion 11 may have a friction improving screw thread 55 formed on the outer surface. 13A and 13B are diagrams showing examples of friction improving screw threads provided according to an embodiment of the present invention.

Referring to FIG. 13 , the friction improving screw thread 55 is to improve the fixing force when the header part 11 is expanded, and is different from the screw thread inserted by rotation for fixing of conventional bone fixation devices. As shown in the drawing, the friction improving screw thread 55 is preferably formed only up to a partial height of the header portion 11 to which the header portion 11 extends, but is not necessarily limited, and although not shown in the drawing, the header portion 11 ) may be formed throughout.

Referring to FIG. 14, in configuring the pull nut 30 according to the present invention, a belt insertion groove 65 is formed along the circumference of the anchor sleeve 10 and the pull nut 30, respectively. can In addition, both ends may be bound to the belt insertion groove 65 after the fixing belt 60 is inserted. Here, the fixing belt 60 can tighten the belt insertion groove 65 formed across the anchor sleeve 10 and the full nut 30 when both ends are coupled, and the anchor sleeve 10 and the anchor pin 20 ) can be performed.

Through this, the fixing belt 60 can prevent the pull nut 30 from rising apart from the anchor sleeve 10 by the resistance of the cortical bone CB or bone B in the belt insertion groove 65. As a result, the adjustment of the pull nut 30 is more accurate and easy, and the fixation force to the cortical bone of the present invention can be improved.

Although the embodiments of the present invention have been described with reference to the accompanying drawings, those skilled in the art can implement them in other specific forms without changing the technical spirit or essential features of the present invention. you will be able to understand Therefore, the embodiments described above are illustrative in all respects and are not restrictive.

[Description of code]

10: anchor sleeve

11: header part

11-1: Header body

11-2: incision

11-3: Expansion range expansion sphere

12: hollow part

12a: slope

20: anchor pin

21: pin body

22: pin header

22a: slope

30: full nut

35: mechanism fastening part

40: buffer member

50: friction pattern protrusion

55: friction enhancing thread

60: fixed belt

65: belt insertion groove

100: exclusive applicator

101: body part

101a: sleeve fastening groove

102: handle part

102a: nut fastening groove

103: gripping part

VL: vertical line

CB: cortical bone

B: bone

Claims

An anchor sleeve provided at the lower end of a header inserted into the cortical bone and expanded by an external force to be fixed to the cortical bone; and

A pull-type one-sided cortical bone fixing anchor comprising an anchor pin inserted into the anchor sleeve and configured to generate an external force that expands the header portion when pulled.
According to claim 1,

The header portion of the anchor sleeve,

The header body is divided equally into a plurality of parts by a plurality of incisions and is configured to be expanded and deformed by an external force.

The anchor pin,

A pin header forming a larger area than the hollow anchor sleeve through which the anchor pin passes,

When the anchor pin is pulled upward while the pin header is located on the lower side of the header portion of the anchor sleeve, the pin header is located inside the anchor sleeve and the header portion body is expanded.
According to claim 2,

The plurality of incisions,

A pull-type one-sided cortical bone fixing anchor, characterized in that an expansion range expansion sphere for expanding the expansion range of the header portion is formed at each longitudinal end.
According to claim 2,

The anchor sleeve hollow part,

An inclined surface is formed on the side so that the lower side of the header part has a diameter of the upper and lower beams,

The pin header,

An inclined surface is formed on the side to form the diameter of the upper and lower beams, and an inclined surface is formed on the side to form an inclination angle greater than the inclination angle of the inclination angle of the inclination surface of the hollow part of the anchor sleeve based on the vertical line,

A pull-type one-side cortical bone fixing anchor, characterized in that the inclined surface of the pin header expands the header portion while moving along the inclined surface of the hollow portion of the anchor sleeve.
According to claim 4,

A pull-type one-sided cortical bone fixing anchor, characterized in that the extension range of the header can be adjusted by differently forming the difference between the inclination angle of the inclination surface of the anchor sleeve hollow and the inclination angle of the inclination surface of the pin header.
According to claim 1,

The header part,

A pull-type one-side cortical bone fixation anchor, characterized in that it is configured to be separated and combined from the anchor sleeve and can be used interchangeably.
According to claim 1,

Further comprising a pull nut coupled to the upper end of the anchor pin to control the pulling of the anchor pin,

The anchor pin and the pull nut are pull-type one-sided cortical bone fixation anchors, characterized in that they are screwed together.
According to claim 1,

The pull-type one-side cortical bone fixing anchor further comprising a buffer member provided at the lower end of the anchor sleeve on the outer circumferential surface of the header portion to buffer a gap between the anchor sleeve and the cortical bone.
According to claim 1,

The header part,

A pull-type one-side cortical bone fixation anchor characterized in that one or more friction pattern protrusions of vertical-horizontal grid pattern type, oblique grid pattern type, dot pattern type, and wavy line-straight mixed pattern type are formed on the outer surface.
According to claim 7,

A belt insertion groove forming a length along the circumference is formed across the anchor sleeve and the pull nut, respectively,

A pull-type one-side cortical bone fixation anchor, characterized in that the fixation belt is inserted into the belt insertion groove and then bound, and the anchor sleeve and the pull nut are fixed by the fixation belt.