WO2016157852A1 - Fastener of surgical cable, and manufacturing method thereof - Google Patents

Fastener of surgical cable, and manufacturing method thereof Download PDF

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Publication number
WO2016157852A1
WO2016157852A1 PCT/JP2016/001719 JP2016001719W WO2016157852A1 WO 2016157852 A1 WO2016157852 A1 WO 2016157852A1 JP 2016001719 W JP2016001719 W JP 2016001719W WO 2016157852 A1 WO2016157852 A1 WO 2016157852A1
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WO
WIPO (PCT)
Prior art keywords
surgical cable
hole
main body
fastener
surgical
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Application number
PCT/JP2016/001719
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French (fr)
Japanese (ja)
Inventor
橋本　勝
Original Assignee
株式会社ＡｉｍｅｄｉｃＭＭＴ
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Filing date
Publication date
Application filed by 株式会社ＡｉｍｅｄｉｃＭＭＴ filed Critical 株式会社ＡｉｍｅｄｉｃＭＭＴ
Priority to JP2017509276A priority Critical patent/JP6513791B2/en
Publication of WO2016157852A1 publication Critical patent/WO2016157852A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin

Definitions

  • the present invention relates to a surgical cable fastener, and more particularly, to a fastener for fastening both ends of a surgical cable to each other in an internal fixation operation using a surgical cable, and a method for manufacturing the same.
  • a surgical treatment method for fractures is known in which a fractured part is directly fixed in the body using a metal pin, screw, plate, rod, wire, cable or the like.
  • a surgical cable (cable for internal fixation) is wound around a fractured part and tensioned, and then both ends of the surgical cable are fastened together using a fastener to fix the fractured part.
  • a through hole is formed in the main body of the fastener, and after passing through both ends of the surgical cable through the through hole, the main body is caulked and deformed (plastic deformation) to crush the through hole. Secure the surgical cable by caulking.
  • Patent Document 1 describes a sleeve having a head portion in which a cable fixing hole for fixing a surgical cable is formed and a piercing portion to be inserted into a bone.
  • Surgical cable fasteners are foreign substances embedded in the body, and may cause symptoms such as inflammation, pain, and hemorrhage by stimulating living tissue, so it is desirable to make them as small as possible.
  • the size of the fastener is reduced, the length of the through-hole formed in the fastener is also shortened. Therefore, the outer peripheral surface of the surgical cable inserted and fixed in the through-hole and the inner surface of the through-hole of the fastener There is a risk that the surgical cable is slipped and displaced in the axial direction of the through hole due to insufficient frictional force therebetween.
  • the fastener is downsized. As in the case where the surgical cable is inserted, the frictional force between the outer peripheral surface of the surgical cable that is inserted and fixed in the through hole of the main body portion of the fastener and the inner surface of the through hole of the fastener is insufficient. May slip and displace with respect to the fastener.
  • the present invention provides a fastener and a method of manufacturing the same that can prevent a surgical cable that is inserted into a through hole of a body portion of the fastener and fixed by caulking from sliding with respect to the fastener.
  • the issue is to provide.
  • one aspect of the present invention is a fastener (10) for fastening both ends of a surgical cable to each other, and a through hole (18) through which the surgical cable can be inserted.
  • an unevenness (19) is formed.
  • the surgical cable caulked and fixed to the main body portion of the fastener, the axial displacement of the through-hole, that is, the slip displacement with respect to the fastener, the unevenness formed on the inner surface of the through-hole and the surgical It can restrain by the frictional force which arises between the outer peripheral surfaces of a cable. Therefore, the surgical cable can be firmly fixed to the main body of the fastener.
  • the two through holes (18) are preferably formed substantially in parallel. According to this aspect, one end of the surgical cable is fixed in one through hole (18A), and the other end of the surgical cable is fixed in the other through hole (18B).
  • the surgical cable can be more reliably fixed as compared with the case where both ends of the surgical cable are fixed in the through hole. That is, the surgical cable can be more firmly fixed as compared with the case where there is only one through hole.
  • the surgical cable insertion operation and fastening operation at the time of internal fixation surgery are facilitated.
  • the unevenness formed on the inner surface of the through hole is a female screw (19) formed in a spiral shape along the axial direction of the through hole (18).
  • the unevenness can be easily realized by a simple method.
  • the female screw formed in this way extends in a direction intersecting with the axial direction of the through hole, the sliding displacement of the surgical cable in the axial direction of the through hole can be effectively restrained. .
  • the unevenness formed on the inner surface of the through hole includes a clockwise female screw portion (19R) having a female screw groove formed in a clockwise direction along the axial direction of the through hole (18), and a through hole. It is preferable to include a counterclockwise female thread portion (19L) having a female thread groove formed in a counterclockwise spiral shape along the axial direction.
  • the protrusion (19a) constituting the unevenness is extended so as to be orthogonal to the axial direction of the through hole, and the sliding displacement of the surgical cable in the axial direction of the through hole is effectively restrained. be able to.
  • the top of the thread of the female screw is flat. According to this aspect, since the tip portion of the screw thread is not sharp, there is no possibility that the outer peripheral surface of the surgical cable inserted through the through hole is damaged by the screw thread of the female screw.
  • the surgical cable fastener (10) according to the present invention may further include an insertion portion (14) protruding from the bottom surface of the main body portion (12). According to this aspect, the fastener of the present invention can be used for pin-cable internal fixation surgery.
  • the surgical cable fastener (10) may further include a grip portion (16) protruding from the upper surface of the main body portion (12).
  • a grip portion (16) protruding from the upper surface of the main body portion (12).
  • 1 aspect of this invention is a manufacturing method of the fastener (10) for mutually fastening the both ends of a surgical cable, Comprising: For fixing the said surgical cable Forming a through hole (18) through which the surgical cable can be inserted in the main body portion so that the main body portion (12) can be caulked and deformed; and an anti-slip of the surgical cable on the inner surface of the through hole. And a step of forming irregularities (19) for the purpose.
  • the slide displacement in the axial direction of the through hole of the surgical cable that is caulked and fixed to the main body that is, the slide displacement with respect to the fastener, the unevenness formed on the inner surface of the through hole and the outer periphery of the surgical cable.
  • the fastener which can be restrained by the frictional force generated between the surfaces can be easily manufactured.
  • the step of forming the unevenness (19) it is preferable to form a female screw (19) on the inner surface of the through hole (18) using a tap.
  • the internal thread can be easily and easily formed on the inner surface of the through hole.
  • the step of forming the unevenness (19) includes the step of forming a female screw groove having a clockwise spiral shape along the axial direction of the through hole (18) using the first tap, and the second step. And forming a female screw groove having a counterclockwise spiral shape along the axial direction of the through hole.
  • corrugation can be extended so as to be orthogonal to the axial direction of a through-hole. Thereby, the fastener which can restrain effectively the sliding displacement of the axial direction of a through-hole of a surgical cable can be manufactured easily.
  • the surgical cable fastener since the concave and convex portions are formed on the inner surface of the through hole of the main body portion, the surgical cable inserted into the through hole of the main body portion and fixed by caulking is provided on the main body portion. It is possible to prevent the sliding displacement with respect to. As a result, it is possible to stably maintain the tension of the surgical cable wound around the fractured part or the like in the internal fixation operation. Moreover, according to the manufacturing method of the fastener for surgical cables by this invention, the fastener of the said structure can be manufactured easily.
  • FIG. 1 is an overall perspective view of a surgical cable fastener according to the present invention
  • FIG. The principal part expansion perspective view of FIG. FIG. 3 is a cross-sectional view taken along line III-III in FIG. 2, where (A) is a single threaded female thread, (B) is a double threaded female thread, (C) is a female thread with a trapezoidal thread, and (D) is a single-bladed sawtooth. The internal female screw is shown.
  • FIG. 1 (A) Longitudinal sectional view of the through hole, (B) Horizontal sectional view of the through hole, (C) Development view of the through hole, and (D) Front view of the main body when the female screw around both ends of the single line is formed (A) Longitudinal sectional view of the through hole, (B) Horizontal sectional view of the through hole, (C) Development view of the through hole, and (D) Front view of the main body when two female threads around both sides are formed
  • the fastener 10 of the present invention includes a main body portion 12 in which two through holes 18 ⁇ / b> A and 18 ⁇ / b> B into which a surgical cable 20 (see FIG. 6) can be inserted, and a bottom surface of the main body portion 12.
  • a pin-shaped insertion portion 14 that protrudes vertically and a bar-shaped grip portion 16 that protrudes vertically on the upper surface of the main body portion 12 are provided.
  • the insertion portion 14 and the grip portion 16 are provided so as to extend on the same straight line with the main body portion 12 interposed therebetween.
  • the fastener 10 is made of a material having high biocompatibility such as stainless steel and titanium alloy.
  • a material having high biocompatibility such as stainless steel and titanium alloy.
  • surgical stainless steel of ISO standard 5832-1 which is generally used for medical devices, may be used.
  • the fastener 10 is used together with a surgical cable 20 (an internal fixation cable) for an internal fixation operation for directly fixing a fractured part inside the body.
  • the fastener 10 of the present invention can be applied to various uses other than the internal fixation operation of a fractured part, and may be used, for example, for fixing a biological tissue or a surgical instrument.
  • the surgical cable 20 a flexible cable formed by twisting a plurality of strands made of a material having high biocompatibility such as stainless steel or a polymer material is used.
  • the surgical cable 20 is not limited to a stranded wire, and may be a single wire such as a piano wire or a mild steel wire.
  • the surgical cable 20 is fixed to the inner surface of the through hole 18 of the main body portion 12 by caulking and deforming the main body portion 12 of the fastener 10 so that the surgical cable 20 is fixed in the left and right directions of the main body portion 12. It is preferable that the plastic deformation occurs when pressure is applied from the radial direction of the through-hole 18.
  • the main body portion 12 of the fastener 10 is a portion for fixing both ends of the surgical cable 20 so as to fasten the both ends of the surgical cable 20 to each other.
  • the main body 12 is formed in a substantially rectangular parallelepiped shape, and the bottom surface and the top surface are formed in a substantially rectangular shape.
  • the shape of the main body portion 12 is not particularly limited, but it is desirable that the left and right side surfaces are formed in a flat rectangular shape so that the body portion 12 can be easily grasped with forceps during internal fixation surgery.
  • angular part of the main-body part 12 is chamfered suitably.
  • the main body 12 has two through holes 18A and 18B (hereinafter, simply referred to as through holes 18) through which the surgical cable 20 can be inserted.
  • the through holes 18 have the same cross-sectional shape and the same hole diameter (inner diameter), and are arranged in parallel to each other at a predetermined interval. Specifically, the through holes 18 are provided side by side in a direction parallel to the top surface and the bottom surface of the main body 12.
  • the through-hole 18 is formed in a straight line and has a circular cross-sectional shape.
  • the inner diameter of the through hole 18 is formed to be slightly larger than the outer diameter of the surgical cable 20. For example, if the outer diameter of the surgical cable 20 is 1.2 mm, the inner diameter of the through hole 18 is 1. It is formed to about 3 mm.
  • the cross-sectional shape and size of the through hole 18 are not particularly limited, and the surgical cable 20 can be inserted, and when the main body portion 12 is deformed by caulking, the surgical cable 20 is crimped and fixed. Any shape and size that can be formed can be formed into various shapes and sizes such as an ellipse and a polygon.
  • the through holes 18 have the same cross-sectional shape and size as each other, but the cross-sectional shape and size of the through holes 18 can be inserted through the surgical cable 20. And as long as it can be crushed at the time of caulking deformation of main part 12 and surgical cable 20 can be fixed, it may differ from each other.
  • the main body 12 is configured to be caulked and deformed so that the through-hole 18 is crushed when the left and right side surfaces are sandwiched with forceps or the like and pressed strongly. That is, the main body 12 is configured to have a rigidity that can be caulked and deformed.
  • the caulking deformation so that the through-hole 18 is crushed means that the main body portion 12 is plastically deformed and the cross-sectional shape of the through-hole 18 is deformed from a circular shape to an elliptical shape.
  • the inner surface of the through hole 18 is provided with irregularities for preventing the surgical cable 20 from slipping.
  • irregularities are formed on the inner surface of the through hole 18, when the surgical cable 20 is caulked and fixed to the main body portion 12 by caulking and deforming the main body portion 12, the inner surface of the through hole 18 and the surgical cable 20.
  • the frictional force between the outer peripheral surface and the outer peripheral surface can be increased.
  • the sliding displacement of the surgical cable 20 in the axial direction of the through hole 18, that is, the sliding displacement with respect to the main body portion 12 can be restricted by the frictional force increased by the unevenness.
  • the surgical cable 20 can be firmly fixed to the main body 12.
  • the unevenness is realized by forming the female screw 19 on the inner surface of the through hole 18.
  • a method for forming the female screw 19 will be described. First, a through hole 18 as a pilot hole is formed in the main body portion 12 using a core drill. Next, using a tap, a screw is cut on the inner surface of the through hole 18 (preparation hole) to form an internal thread 19.
  • the inner diameter of the through hole 18 (preparation hole) is 1.3 mm
  • a tap having an outer diameter of 1.4 mm and a valley diameter of 1.3 mm is used, a female screw 19 having a shape as shown in FIGS. Can be formed.
  • FIG. 3 (A) shows a case where a single thread type female thread 19 is formed using a single thread type tap
  • FIG. 3 (B) shows a double thread type tap using a double thread type tap.
  • the case where the internal thread 19 is formed is shown.
  • the female screw 19 can be formed in a spiral shape along the axial direction of the through hole 18. Since the female screw 19 formed in this way extends in a direction intersecting the axial direction of the through hole 18, it effectively restrains the sliding displacement of the surgical cable 20 in the axial direction of the through hole 18. Can do.
  • the thread may damage the outer peripheral surface of the surgical cable 20 inserted through the through-hole 18, and possibly cut off.
  • a tap having a valley diameter smaller than the inner diameter of the through hole 18 (preparation hole) may be used.
  • the internal diameter of the internal thread 19 becomes larger than the valley diameter of the external thread of the tap, and as a result, the thread of the internal thread 19 can be formed in a trapezoidal shape.
  • the inner diameter of the through-hole 18 is 1.3 mm
  • the thread is trapezoidal as shown in FIG. Can be formed.
  • the material of the main body portion 12 is plastically deformed and flows, so the shape, valley diameter, pitch, etc. of the female screw 19 (that is, the male screw of the tap) are set in consideration thereof. There is a need to.
  • the shape of the female screw 19 formed on the inner surface of the through hole 18 may be various other shapes.
  • the flank forming the thread may be a single-blade serrated female screw 19 having flank angles different from each other like a set of a substantially vertical surface and an inclined surface.
  • the shape of the female screw 19 is not limited to the triangular screw shape as described above, and may be various shapes such as, for example, a square screw shape or a shape having different flank angles forming a screw thread.
  • 3A to 3D are all counterclockwise spirals (inclined in the direction of screwing by turning the male screw that matches the tap or female screw 19 counterclockwise). It is made into a shape.
  • the female screw 19 is formed using a tap after the through-hole 18 is formed.
  • the female screw 19 is formed simultaneously with the formation of the through-hole 18 using a drill or the like having protrusions formed on the side portions. May be.
  • the internal thread 19 is formed using a tap, but the internal thread 19 may be formed using another tool or the like.
  • a clockwise tap is used to cut a screw on the inner surface of the through-hole 18 to form a clockwise female screw portion 19R having a female screw groove formed in a clockwise direction, and to the left.
  • Each of these taps is used to cut a screw on the inner surface of the through hole 18 to form a counterclockwise female thread portion 19L having a female thread groove formed in a counterclockwise spiral shape.
  • FIG. 4 shows an example in which a clockwise female thread portion 19R and a counterclockwise female thread portion 19L are formed using a single thread screw type tap
  • FIG. 5 shows a clockwise female thread portion using a double thread type tap.
  • An example in which 19R and a counterclockwise female thread portion 19L are formed is shown. Note that either the clockwise female screw portion 19R or the counterclockwise female screw portion 19L may be formed first.
  • FIG. 4A and 5B shows a longitudinal sectional view of the through hole 18 (an AA sectional view of (D) corresponding to the III-III section of FIG. 2), and (B) shows the through hole.
  • 18 is a horizontal sectional view (BB sectional view of (D))
  • C is a developed view of the through hole 18
  • D is a front view of the main body 12 (viewed by arrow D in (A)).
  • Figure). 4 and 5 both show the tip of the thread as in the case of using a tap with an outer diameter of 1.4 mm and a valley diameter of 1.3 mm when the inner diameter of the through-hole 18 (bottom hole) is 1.3 mm. An example in which the part is pointed is shown.
  • the screw thread has a shape in which a part in the circumferential direction is cut, and forms a protrusion 19 a orthogonal to the axial direction of the through hole 18.
  • the thread is cut at the top and bottom of the through-hole 18 to halve the height, and the thread is maintained at the left and right of the through-hole 18 to form the protrusion 19a. Therefore, when the main body 12 is caulked from the left-right direction, the inserted surgical cable 20 is deformed so as to meander by the protrusion 19a, and generates a large frictional force as an axial force of the through hole 18. Thereby, the sliding displacement of the axial direction of the through-hole 18 of the surgical cable 20 is restrained effectively.
  • the screw thread formed earlier is fixed by the tap used later.
  • the portion is shaved to form a ridge 19 a that is orthogonal to the axial direction of the through-hole 18. Specifically, the height of the thread is maintained at the top, bottom, left, and right of the through hole 18, and the thread is cut between them to halve the height.
  • the ridge 19a is formed by maintaining. Since the left and right screw threads are formed at the same position in the axial direction of the through hole 18, when the main body portion 12 is caulked from the left and right directions, the inserted surgical cable 20 has the same pitch as the pitch of the screw threads.
  • a large frictional force is generated as a force in the axial direction of the through hole 18 by being sandwiched and deformed by the plurality of formed protrusions 19a. Thereby, the sliding displacement of the axial direction of the through-hole 18 of the surgical cable 20 is restrained effectively.
  • the clockwise female thread portion 19R and the counterclockwise female thread portion 19L shown in FIGS. 4 and 5 are pointed at the tip of the thread like the female thread 19 in FIGS. 3 (A) and 3 (B).
  • the thread may be formed in a trapezoidal shape as shown in FIG. 3 (C), or may be formed in a single-blade sawtooth shape as shown in FIG. 3 (D). 4 and 5 may be formed at different positions in the circumferential direction.
  • the unevenness is realized by forming the female screw 19 on the inner surface of the through hole 18.
  • the unevenness may be realized using other methods.
  • the unevenness may be formed using an etching technique. In that case, when the surgical cable 20 is caulked and fixed in the through-hole 18, the unevenness has a shape, pattern, or pattern that can increase the frictional force between the inner surface of the through-hole 18 and the outer peripheral surface of the surgical cable 20. It is good to form with a pattern.
  • the unevenness may be formed using, for example, a sand blast technique or a 3D printer technique.
  • the insertion part 14 is formed in a pin shape with a circular cross section, and has a diameter of about 2 mm.
  • the insertion portion 14 is configured integrally with the main body portion 12, and the proximal end of the insertion portion 14 extends vertically from the bottom surface of the main body portion 12.
  • the tip of the insertion portion 14 is a pointed tip shape portion 14A formed by double chamfering and V-shaped processing so that it can be easily inserted into a bone.
  • the shape and the number of insertion parts 14 are not limited.
  • the shape of the insertion portion 14 is not limited to a pin shape, and may be a spike shape, for example.
  • the number of insertion parts 14 may be two or four, for example.
  • the grip portion 16 is used for various operations during internal fixation surgery, for example, an operation for inserting the insertion portion 14 into a bone, an operation for passing the surgical cable 20 through the through hole 18 of the main body portion 12, or the main body portion 12. It is a portion that can be gripped by forceps, a grasping tool, a surgical instrument (for example, a drill), an operator's hand, or the like during operations such as caulking and fixing the surgical cable 20. For this reason, the grip part 16 has a chamfered part 26A on its side surface so that it can be easily grasped with forceps or the like.
  • the grip portion 16 is not required after the insertion portion 14 is inserted into the bone and the surgical cable 20 is fixed to the main body portion 12, so that the grip portion 16 can be removed from the main body portion 12 and removed.
  • the main body 12 is fixed to the main body 12 so as to be separable.
  • the connecting portion 26 ⁇ / b> B of the grip portion 16 with the main body portion 12 is tapered so as to be easily separated from the main body portion 12.
  • the fasteners 10A to 10G are fixed to predetermined portions of the bone 100 of the fracture part.
  • the fasteners 10A to 10G are fixed to seven locations of the bone 100.
  • the fasteners 10A to 10G are fixed by inserting the insertion portion 14 into the bone 100. As shown in the drawing, almost the entire insertion portion 14 is inserted into the bone 100. Note that the number of fasteners 10 and the insertion position of the insertion portion 14 are appropriately selected so that the fixation of the fractured portion is optimal.
  • the surgical cable 20 is passed through the through-hole 18A of the main body 12 of the fastener 10 fixed to the bone 100.
  • This operation is performed by grasping one end of the surgical cable 20 with tweezers or forceps and passing the thread through the needle hole. This operation is performed in the order of 10B, 10B, 10C, 10D, 10E, 10F, and 10G from the fastener 10A.
  • the distal end portion of the surgical cable 20 that has passed through the through hole 18A of the fastener 10G is passed through the through hole 18B of the main body portion 12 of the fasteners 10A and 10B.
  • the surgical cable 20 can be formed into an annular shape by passing the surgical cable 20 through the main body 12 of the fasteners 10A and 10B twice. Thereby, the surgical cable 20 is wound around the fracture part.
  • both ends of the surgical cable 20 are clamped with forceps or the like and tensioned, and the surgical cable 20 is tensioned.
  • the left and right side surfaces of each body portion 12 of the fasteners 10A and 10B through which the surgical cable 20 is passed twice are sandwiched with forceps and are strongly pressed and deformed. Accordingly, the through holes 18A and 18B are crushed and deformed, and the surgical cable 20 is also plastically deformed.
  • the grip portion 16 of each fastener 10 is bent and separated at the connecting portion 16 ⁇ / b> B and removed from the main body portion 24. Thereafter, the internal fixation operation is completed by performing suturing or the like. In addition, the excess part of the edge part of the surgical cable 20 is cut and removed.
  • the inner surface of the through hole 18 of the main body portion 12 is provided with irregularities for preventing the surgical cable 20 from slipping in the longitudinal direction. Since the frictional force between the surgical cable 20 and the surgical cable 20 can be increased, there is no possibility that the surgical cable 20 inserted through the through hole 18 and fixed to the main body portion 12 is slid and displaced with respect to the main body portion 12. . Therefore, the surgical cable 20 can be firmly fixed to the main body portion 12. As a result, the tension of the surgical cable 20 can be stably maintained, so that the bone of the fracture can be stably fixed.
  • the fasteners 10C to 10G are simply used to insert and support the surgical cable 20, so the surgical cable 20 is not fixed to the fasteners 10C to 10G.
  • the surgical cable 20 may be caulked and fixed to any or all of the main body portions 12 of the fasteners 10C to 10G. In that case, the tension of the surgical cable 20 can be stably maintained between the fasteners to which the surgical cable 20 is fixed. Therefore, even when the fixing of the surgical cable 20 in the fasteners 10A and 10B is loosened or damaged, the tension of the surgical cable 20 is stably maintained between the fasteners to which the surgical cable 20 is fixed. The Therefore, the tension of the surgical cable 20 can be held more reliably.
  • the fastener 10 of the present invention is configured to include the insertion portion 14, but the fastener 10 of the present invention may not include the insertion portion 14.
  • the fastener 10 of the present invention is configured to include the grip portion 16, but the fastener 10 of the present invention may not include the grip portion 16.
  • FIG. 7 shows an embodiment in which the fastener 10 is not provided with the insertion portion 14 and the grip portion 16, that is, an embodiment in which the fastener 10 is configured to include only the main body portion 12.
  • the fastener 10 shown in FIG. 7 is used to fasten both ends of the surgical cable 20 to each other in order to wrap the surgical cable 20 around a fracture or the like.
  • the two through holes 18A and 18B are formed in parallel with a predetermined interval therebetween, but are continuous with each other in the width direction (hole diameter direction) without a predetermined interval. It may be formed. For example, as shown in FIG. 8, you may form so that a part of circular cross section of through-hole 18A, 18B may mutually overlap. In this way, when the two through holes 18 are formed so as to be continuous with each other in the hole diameter direction and have a cross-sectional shape of 8 in shape, the deformation of the through holes 18 when the body portion 12 is caulked and deformed is prevented. Since the inner diameter of the through hole 18 and the surgical cable 20 can be brought into closer contact with each other, the surgical cable 20 can be more firmly fixed.
  • the two through holes 18A and 18B are formed side by side in a direction parallel to the top surface and the bottom surface of the main body portion 12, but the formation positions of the through holes 18A and 18B are: Any position that can be crushed when the main body 12 is deformed by caulking and can be fixed by caulking the surgical cable 20 can be arbitrarily changed.
  • the through holes 18 ⁇ / b> A and 18 ⁇ / b> B may be formed so as to be shifted from each other in a direction orthogonal to the upper surface and the bottom surface of the main body 12.
  • the two through holes 18A and 18B are formed in the main body portion 12, but only one through hole 18 may be formed in the main body portion 12.
  • the shape and size of the through-hole 18 can pass the surgical cable 20 in a double manner, and can be crushed when the body 12 is caulked and deformed to fix the surgical cable 20 by caulking. It must be in shape and size.
  • the size of one through-hole 18 formed in the main body 12 is as follows. In the main body part 12 to be caulked and deformed, the cross-sectional shape of the through hole 18 may be collapsed at the time of caulking deformation and the surgical cable 20 can be fixed.

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  • Heart & Thoracic Surgery (AREA)
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Abstract

In order to provide a fastener that can prevent slip displacement of a surgical cable relative to the main body of said fastener, the surgical cable is inserted into a through-hole in the main body of the fastener and is affixed to said main body by crimping. The inner surface of through-holes (18A, 18B) in the main body (12) of the fastener (10) is formed to be uneven (have an internal threading 19) for preventing the surgical cable from slipping. The frictional force generated between the uneven inner surface and the outer peripheral surface of the surgical cable constrains slip displacement of the surgical cable, affixed by crimping to the main body portion (12) of the fastener (10), in the axial direction of the through-hole (18), that is, constrains slip displacement relative to the main body (12). Consequently, it becomes possible to securely fix the surgical cable to the main body (12) of the fastener (10).

Description

外科用ケーブルの締結器及びその製造方法Surgical cable fastener and method of manufacturing the same
　本発明は、外科用ケーブルの締結器に関し、より詳細には、外科用ケーブルを使用する方式の内固定手術において、外科用ケーブルの両端部を互いに締結するための締結器及びその製造方法に関する。 The present invention relates to a surgical cable fastener, and more particularly, to a fastener for fastening both ends of a surgical cable to each other in an internal fixation operation using a surgical cable, and a method for manufacturing the same.
　骨折の外科的治療方法として、金属製のピン、スクリュー、プレート、ロッド、ワイヤ、ケーブル等の固定具を使用して、骨折部を体内で直接固定する内固定手術が知られている。内固定手術の手法の１つとして、外科用ケーブル（体内固定用ケーブル）を骨折部に巻き付けて緊張した後、締結器を使用して外科用ケーブルの両端部を互いに締結して骨折部を固定する方法がある。締結器の本体部には貫通孔が形成されており、貫通孔に外科用ケーブルの両端部を通した後、本体部をかしめ変形（塑性変形）させて貫通孔を潰すことにより、本体部に外科用ケーブルをかしめ固定する。 </ RTI> As a surgical treatment method for fractures, internal fixation surgery is known in which a fractured part is directly fixed in the body using a metal pin, screw, plate, rod, wire, cable or the like. As one of the internal fixation surgery methods, a surgical cable (cable for internal fixation) is wound around a fractured part and tensioned, and then both ends of the surgical cable are fastened together using a fastener to fix the fractured part. There is a way to do it. A through hole is formed in the main body of the fastener, and after passing through both ends of the surgical cable through the through hole, the main body is caulked and deformed (plastic deformation) to crush the through hole. Secure the surgical cable by caulking.
　このような締結器としては、例えば、本願出願人による特許文献１に記載されたものがある。特許文献１には、外科用ケーブルを固定するためのケーブル固定孔が形成された頭部と、骨に刺入される刺入部とを有するスリーブが記載されている。 As such a fastener, for example, there is one described in Patent Document 1 by the present applicant. Patent Document 1 describes a sleeve having a head portion in which a cable fixing hole for fixing a surgical cable is formed and a piercing portion to be inserted into a bone.
特許第３７３８１８３号Japanese Patent No. 3738183
　外科用ケーブルの締結器は、体内に埋入される異物であり、生体組織を刺激して炎症、疼痛、出血等の症状を引き起こす虞があるため、できるだけ小型化することが望ましい。しかし、締結器を小型化すると、締結器に形成された貫通孔の長さも短くなるため、貫通孔に挿通してかしめ固定された外科用ケーブルの外周面と締結器の貫通孔の内面との間の摩擦力が不足し、外科用ケーブルが貫通孔の軸方向に滑り変位する虞がある。外科用ケーブルが貫通孔の軸方向に、すなわち締結器に対して滑り変位すると、骨折部等に巻き付けられた外科用ケーブルが緩んで緊張力が低下するため、骨折部等の固定力が低下する。 Surgical cable fasteners are foreign substances embedded in the body, and may cause symptoms such as inflammation, pain, and hemorrhage by stimulating living tissue, so it is desirable to make them as small as possible. However, when the size of the fastener is reduced, the length of the through-hole formed in the fastener is also shortened. Therefore, the outer peripheral surface of the surgical cable inserted and fixed in the through-hole and the inner surface of the through-hole of the fastener There is a risk that the surgical cable is slipped and displaced in the axial direction of the through hole due to insufficient frictional force therebetween. When the surgical cable is slid and displaced in the axial direction of the through hole, that is, with respect to the fastener, the surgical cable wound around the fractured part is loosened and the tension is reduced, so that the fixing force of the fractured part is reduced. .
　また、締結器を小型化しない場合でも、外科用ケーブルの素材や、外科用ケーブルを構成する素線の本数等に起因して外科用ケーブルの外周面が滑り易い場合は、締結器を小型化した場合と同様に、締結器の本体部の貫通孔に挿通してかしめ固定された外科用ケーブルの外周面と締結器の貫通孔の内面との間の摩擦力が不足して、外科用ケーブルが締結器に対して滑り変位する虞が生じる。 Even if the fastener is not downsized, if the outer peripheral surface of the surgical cable is slippery due to the material of the surgical cable or the number of strands constituting the surgical cable, the fastener is downsized. As in the case where the surgical cable is inserted, the frictional force between the outer peripheral surface of the surgical cable that is inserted and fixed in the through hole of the main body portion of the fastener and the inner surface of the through hole of the fastener is insufficient. May slip and displace with respect to the fastener.
　本発明は、上記の問題点を鑑み、締結器の本体部の貫通孔に挿通してかしめ固定された外科用ケーブルが締結器に対して滑り変位することを防止できる締結器及びその製造方法を提供することを課題とする。 In view of the above-described problems, the present invention provides a fastener and a method of manufacturing the same that can prevent a surgical cable that is inserted into a through hole of a body portion of the fastener and fixed by caulking from sliding with respect to the fastener. The issue is to provide.
　上記課題を解決するために、本発明の一態様は、外科用ケーブルの両端部を互いに締結するための締結器（１０）であって、前記外科用ケーブルを挿通可能な貫通孔（１８）が形成され、かつ前記貫通孔に挿通された前記外科用ケーブルを固定するべくかしめ変形可能な本体部（１２）を含み、前記本体部の前記貫通孔の内面に、前記外科用ケーブルの滑り止めのための凹凸（１９）が形成されていることを特徴とする。 In order to solve the above-mentioned problems, one aspect of the present invention is a fastener (10) for fastening both ends of a surgical cable to each other, and a through hole (18) through which the surgical cable can be inserted. A body portion (12) that can be crimped to fix the surgical cable formed and inserted through the through-hole, and an inner surface of the through-hole of the body portion is configured to prevent slippage of the surgical cable. For this purpose, an unevenness (19) is formed.
　この態様によれば、締結器の本体部にかしめ固定された外科用ケーブルの、貫通孔の軸方向の滑り変位、すなわち締結器に対する滑り変位を、貫通孔の内面に形成された凹凸と外科用ケーブルの外周面との間に生じる摩擦力によって拘束することができる。したがって、締結器の本体部に外科用ケーブルを強固に固定することが可能となる。 According to this aspect, the surgical cable caulked and fixed to the main body portion of the fastener, the axial displacement of the through-hole, that is, the slip displacement with respect to the fastener, the unevenness formed on the inner surface of the through-hole and the surgical It can restrain by the frictional force which arises between the outer peripheral surfaces of a cable. Therefore, the surgical cable can be firmly fixed to the main body of the fastener.
　前記貫通孔（１８）は、略平行に２つ形成することが好ましい。この態様によれば、一方の貫通孔（１８Ａ）において外科用ケーブルの一方の端部が固定され、他方の貫通孔（１８Ｂ）において外科用ケーブルの他方の端部が固定されるので、１つの貫通孔において外科用ケーブルの両端部が固定される場合と比べて、外科用ケーブルをより確実に固定することができる。すなわち、貫通孔が１つだけの場合と比べて、外科用ケーブルをより強固に固定することができる。また、各貫通孔に、外科用ケーブルの各端部がそれぞれ挿通されるので、内固定手術時の外科用ケーブルの挿通作業及び締結作業が容易になる。 The two through holes (18) are preferably formed substantially in parallel. According to this aspect, one end of the surgical cable is fixed in one through hole (18A), and the other end of the surgical cable is fixed in the other through hole (18B). The surgical cable can be more reliably fixed as compared with the case where both ends of the surgical cable are fixed in the through hole. That is, the surgical cable can be more firmly fixed as compared with the case where there is only one through hole. In addition, since each end of the surgical cable is inserted into each through hole, the surgical cable insertion operation and fastening operation at the time of internal fixation surgery are facilitated.
　前記貫通孔の前記内面に形成された前記凹凸は、貫通孔（１８）の軸方向に沿って螺旋状に形成された雌ねじ（１９）であることが好ましい。この態様によれば、前記凹凸を簡便な方法で容易に実現することができる。また、このように形成された雌ねじは、貫通孔の軸方向に対して交差する方向に延びているので、外科用ケーブルの、貫通孔の軸方向の滑り変位を効果的に拘束することができる。 It is preferable that the unevenness formed on the inner surface of the through hole is a female screw (19) formed in a spiral shape along the axial direction of the through hole (18). According to this aspect, the unevenness can be easily realized by a simple method. Moreover, since the female screw formed in this way extends in a direction intersecting with the axial direction of the through hole, the sliding displacement of the surgical cable in the axial direction of the through hole can be effectively restrained. .
　前記貫通孔の前記内面に形成された前記凹凸は、貫通孔（１８）の軸方向に沿って右回りの螺旋状に形成された雌ねじ溝を有する右回り雌ねじ部（１９Ｒ）と、貫通孔の軸方向に沿って左回りの螺旋状に形成された雌ねじ溝を有する左回り雌ねじ部（１９Ｌ）とを含むことが好ましい。この態様によれば、凹凸を構成する突条（１９ａ）を、貫通孔の軸方向に直交するように延在させ、外科用ケーブルの、貫通孔の軸方向の滑り変位を効果的に拘束することができる。 The unevenness formed on the inner surface of the through hole includes a clockwise female screw portion (19R) having a female screw groove formed in a clockwise direction along the axial direction of the through hole (18), and a through hole. It is preferable to include a counterclockwise female thread portion (19L) having a female thread groove formed in a counterclockwise spiral shape along the axial direction. According to this aspect, the protrusion (19a) constituting the unevenness is extended so as to be orthogonal to the axial direction of the through hole, and the sliding displacement of the surgical cable in the axial direction of the through hole is effectively restrained. be able to.
　前記雌ねじのねじ山の頂が平坦状であることが好ましい。この態様によれば、ねじ山の先端部分が尖っていないので、貫通孔に挿通された外科用ケーブルの外周面を雌ねじのねじ山によって傷つける虞がない。 It is preferable that the top of the thread of the female screw is flat. According to this aspect, since the tip portion of the screw thread is not sharp, there is no possibility that the outer peripheral surface of the surgical cable inserted through the through hole is damaged by the screw thread of the female screw.
　本発明による外科用ケーブルの締結器（１０）は、前記本体部（１２）の底面に突設された刺入部（１４）をさらに含むことができる。この態様によれば、本発明の締結器をピン・ケーブル方式の内固定手術に使用することができる。 The surgical cable fastener (10) according to the present invention may further include an insertion portion (14) protruding from the bottom surface of the main body portion (12). According to this aspect, the fastener of the present invention can be used for pin-cable internal fixation surgery.
　また、本発明による外科用ケーブルの締結器（１０）は、前記本体部（１２）の上面に突設されたグリップ部（１６）をさらに含むことができる。この態様によれば、グリップ部を鉗子や把持具等で把持することにより、内固定手術の際の様々な作業、例えば、刺入部を骨に刺入する作業、本体部の貫通孔に外科用ケーブルを通す作業、または本体部に外科用ケーブルをかしめ固定する作業等を容易にかつ作業性よく行うことができる。 In addition, the surgical cable fastener (10) according to the present invention may further include a grip portion (16) protruding from the upper surface of the main body portion (12). According to this aspect, by gripping the grip portion with forceps, a gripping tool, etc., various operations during the internal fixation operation, for example, the operation of inserting the insertion portion into the bone, the surgical operation in the through hole of the main body portion The operation of passing the cable for use or the operation of caulking and fixing the surgical cable to the main body can be performed easily and with good workability.
　また、上記課題を解決するために、本発明の一態様は、外科用ケーブルの両端部を互いに締結するための締結器（１０）の製造方法であって、前記外科用ケーブルを固定するための本体部（１２）をかしめ変形可能にすべく、前記本体部に前記外科用ケーブルを挿通可能な貫通孔（１８）を形成する工程と、前記貫通孔の内面に、前記外科用ケーブルの滑り止めのための凹凸（１９）を形成する工程とを含むことを特徴とする。 Moreover, in order to solve the said subject, 1 aspect of this invention is a manufacturing method of the fastener (10) for mutually fastening the both ends of a surgical cable, Comprising: For fixing the said surgical cable Forming a through hole (18) through which the surgical cable can be inserted in the main body portion so that the main body portion (12) can be caulked and deformed; and an anti-slip of the surgical cable on the inner surface of the through hole. And a step of forming irregularities (19) for the purpose.
　この態様によれば、本体部にかしめ固定された外科用ケーブルの、貫通孔の軸方向の滑り変位、すなわち締結器に対する滑り変位を、貫通孔の内面に形成された凹凸と外科用ケーブルの外周面との間に生じる摩擦力によって拘束できる締結器を容易に製造することができる。 According to this aspect, the slide displacement in the axial direction of the through hole of the surgical cable that is caulked and fixed to the main body, that is, the slide displacement with respect to the fastener, the unevenness formed on the inner surface of the through hole and the outer periphery of the surgical cable. The fastener which can be restrained by the frictional force generated between the surfaces can be easily manufactured.
　前記凹凸（１９）を形成する工程では、タップを使用して前記貫通孔（１８）の内面に雌ねじ（１９）を形成することが好ましい。この態様によれば、貫通孔の内面に雌ねじを簡単かつ容易に形成することができる。 In the step of forming the unevenness (19), it is preferable to form a female screw (19) on the inner surface of the through hole (18) using a tap. According to this aspect, the internal thread can be easily and easily formed on the inner surface of the through hole.
　或いは、前記凹凸（１９）を形成する工程は、第１のタップを使用して前記貫通孔（１８）の軸方向に沿って右回りの螺旋状を呈する雌ねじ溝を形成する工程と、第２のタップを使用して前記貫通孔の軸方向に沿って左回りの螺旋状を呈する雌ねじ溝を形成する工程とを含むことが好ましい。この態様によれば、凹凸を構成する凸部を、貫通孔の軸方向に直交するように延在させることができる。これにより、外科用ケーブルの、貫通孔の軸方向の滑り変位を効果的に拘束できる締結器を容易に製造することができる。 Alternatively, the step of forming the unevenness (19) includes the step of forming a female screw groove having a clockwise spiral shape along the axial direction of the through hole (18) using the first tap, and the second step. And forming a female screw groove having a counterclockwise spiral shape along the axial direction of the through hole. According to this aspect, the convex part which comprises an unevenness | corrugation can be extended so as to be orthogonal to the axial direction of a through-hole. Thereby, the fastener which can restrain effectively the sliding displacement of the axial direction of a through-hole of a surgical cable can be manufactured easily.
　本発明による外科用ケーブルの締結器によれば、本体部の貫通孔の内面に凹凸が形成されていることにより、本体部の貫通孔に挿通してかしめ固定された外科用ケーブルが、本体部に対して滑り変位することを防止することができる。その結果、内固定手術において骨折部等に巻き付けられた外科用ケーブルの緊張力を安定的に維持することができる。また、本発明による外科用ケーブルの締結器の製造方法によれば、上記構成の締結器を容易に製造することができる。 According to the surgical cable fastener according to the present invention, since the concave and convex portions are formed on the inner surface of the through hole of the main body portion, the surgical cable inserted into the through hole of the main body portion and fixed by caulking is provided on the main body portion. It is possible to prevent the sliding displacement with respect to. As a result, it is possible to stably maintain the tension of the surgical cable wound around the fractured part or the like in the internal fixation operation. Moreover, according to the manufacturing method of the fastener for surgical cables by this invention, the fastener of the said structure can be manufactured easily.
本発明による外科用ケーブルの締結器の全体斜視図。1 is an overall perspective view of a surgical cable fastener according to the present invention; FIG. 図１の要部拡大斜視図。The principal part expansion perspective view of FIG. 図２のＩＩＩ－ＩＩＩ線断面図であり、（Ａ）は一条ねじ型の雌ねじ、（Ｂ）は二条ねじ型の雌ねじ、（Ｃ）はねじ山が台形状の雌ねじ、（Ｄ）は片刃鋸歯状の雌ねじを示す。FIG. 3 is a cross-sectional view taken along line III-III in FIG. 2, where (A) is a single threaded female thread, (B) is a double threaded female thread, (C) is a female thread with a trapezoidal thread, and (D) is a single-bladed sawtooth. The internal female screw is shown. 一条の両回りの雌ねじが形成された場合の（Ａ）貫通孔の縦断面図、（Ｂ）貫通孔の水平断面図、（Ｃ）貫通孔の展開図、（Ｄ）本体部の正面図(A) Longitudinal sectional view of the through hole, (B) Horizontal sectional view of the through hole, (C) Development view of the through hole, and (D) Front view of the main body when the female screw around both ends of the single line is formed 二条の両回りの雌ねじが形成された場合の（Ａ）貫通孔の縦断面図、（Ｂ）貫通孔の水平断面図、（Ｃ）貫通孔の展開図、（Ｄ）本体部の正面図(A) Longitudinal sectional view of the through hole, (B) Horizontal sectional view of the through hole, (C) Development view of the through hole, and (D) Front view of the main body when two female threads around both sides are formed 本発明による外科用ケーブルの締結器を外科用ケーブルと共に使用して、ヒトの骨折した膝関節部を内固定手術した例を示す図。The figure which shows the example which used the fastener of the surgical cable by this invention with the surgical cable, and performed internal fixation operation | movement of the knee joint part which fractured the human. 本発明による外科用ケーブルの締結器の変形例を示す図であり、締結器が本体部だけを備えて構成された例を示す。It is a figure which shows the modification of the fastener of the surgical cable by this invention, and shows the example by which the fastener was provided only with the main-body part. 本発明による外科用ケーブルの締結器の変形例を示す図であり、２つの貫通孔を８の字状に形成した例を示す。It is a figure which shows the modification of the fastener of the surgical cable by this invention, and shows the example which formed two through-holes in 8 character shape.
　以下、本発明による外科用ケーブルの締結器（以降、単に「締結器」と称する）の実施形態を、図面を参照して説明する。 Hereinafter, an embodiment of a surgical cable fastener according to the present invention (hereinafter, simply referred to as a “fastener”) will be described with reference to the drawings.
　図１に示すように、本発明の締結器１０は、外科用ケーブル２０（図６参照）を挿通可能な２つの貫通孔１８Ａ、１８Ｂが形成された本体部１２と、本体部１２の底面に垂直に突設されたピン状の刺入部１４と、本体部１２の上面に垂直に突設された棒状のグリップ部１６とを備えて構成されている。刺入部１４とグリップ部１６は、本体部１２を挟んで同一直線上に延在するように設けられている。 As shown in FIG. 1, the fastener 10 of the present invention includes a main body portion 12 in which two through holes 18 </ b> A and 18 </ b> B into which a surgical cable 20 (see FIG. 6) can be inserted, and a bottom surface of the main body portion 12. A pin-shaped insertion portion 14 that protrudes vertically and a bar-shaped grip portion 16 that protrudes vertically on the upper surface of the main body portion 12 are provided. The insertion portion 14 and the grip portion 16 are provided so as to extend on the same straight line with the main body portion 12 interposed therebetween.
　締結器１０は、例えばステンレス鋼やチタン合金等の生体適合性が高い材料から作製される。例えば、医療器具に一般的に使用されるＩＳＯ規格５８３２－１のサージカルステンレスを用いるとよい。この締結器１０は、外科用ケーブル２０（体内固定用ケーブル）と共に、骨折部を体内で直接固定する内固定手術に使用される。なお、本発明の締結器１０は、骨折部の内固定手術以外にも様々な用途に適用可能であり、例えば、生体組織または外科用器具等の固定に用いてもよい。 The fastener 10 is made of a material having high biocompatibility such as stainless steel and titanium alloy. For example, surgical stainless steel of ISO standard 5832-1, which is generally used for medical devices, may be used. The fastener 10 is used together with a surgical cable 20 (an internal fixation cable) for an internal fixation operation for directly fixing a fractured part inside the body. The fastener 10 of the present invention can be applied to various uses other than the internal fixation operation of a fractured part, and may be used, for example, for fixing a biological tissue or a surgical instrument.
　外科用ケーブル２０は、例えばステンレス鋼や高分子材料等の生体適合性が高い材料からなる素線を複数本撚り合わせて構成した、可撓性を有するものが用いられる。なお、外科用ケーブル２０としては、撚り線のものに限らず、例えばピアノ線や軟鋼線等の単線のものであってもよい。また、外科用ケーブル２０は、締結器１０の本体部１２をかしめ変形させたときに、本体部１２の貫通孔１８の内面に密着してかしめ固定されるように、本体部１２の左右両側方向（すなわち、貫通孔１８の径方向）から圧力を加えたときに塑性変形するものであることが好ましい。 As the surgical cable 20, a flexible cable formed by twisting a plurality of strands made of a material having high biocompatibility such as stainless steel or a polymer material is used. Note that the surgical cable 20 is not limited to a stranded wire, and may be a single wire such as a piano wire or a mild steel wire. In addition, the surgical cable 20 is fixed to the inner surface of the through hole 18 of the main body portion 12 by caulking and deforming the main body portion 12 of the fastener 10 so that the surgical cable 20 is fixed in the left and right directions of the main body portion 12. It is preferable that the plastic deformation occurs when pressure is applied from the radial direction of the through-hole 18.
　締結器１０の本体部１２は、外科用ケーブル２０の両端部を互いに締結するべく、外科用ケーブル２０の両端部を固定するための部分である。本体部１２は、略直方体状に形成されており、底面及び上面は略矩形状に形成されている。本体部１２の形状は特に限定されるものではないが、内固定手術の際に鉗子等で把持し易いように、左右両側面が平坦な矩形状に形成されていることが望ましい。また、生体組織への刺激を避けるために、本体部１２の角は適宜面取りされることが好ましい。 The main body portion 12 of the fastener 10 is a portion for fixing both ends of the surgical cable 20 so as to fasten the both ends of the surgical cable 20 to each other. The main body 12 is formed in a substantially rectangular parallelepiped shape, and the bottom surface and the top surface are formed in a substantially rectangular shape. The shape of the main body portion 12 is not particularly limited, but it is desirable that the left and right side surfaces are formed in a flat rectangular shape so that the body portion 12 can be easily grasped with forceps during internal fixation surgery. Moreover, in order to avoid irritation | stimulation to a biological tissue, it is preferable that the corner | angular part of the main-body part 12 is chamfered suitably.
　本体部１２は、外科用ケーブル２０を挿通可能な２つの貫通孔１８Ａ、１８Ｂ（以降、総称するときは、単に貫通孔１８と称する）を有している。貫通孔１８は、互いに同一の横断面形状及び孔径（内径）を有しており、互いに所定の間隔を隔てて互いに平行に配置されている。具体的には、貫通孔１８は、本体部１２の上面及び底面に対して平行な方向に、左右に並んで設けられている。貫通孔１８は、直線状に形成されており、円形の横断面形状を有している。また、貫通孔１８の内径は、外科用ケーブル２０の外径よりも少し大きく形成されており、例えば、外科用ケーブル２０の外径が１．２ｍｍであれば、貫通孔１８の内径は１．３ｍｍ程度に形成されている。 The main body 12 has two through holes 18A and 18B (hereinafter, simply referred to as through holes 18) through which the surgical cable 20 can be inserted. The through holes 18 have the same cross-sectional shape and the same hole diameter (inner diameter), and are arranged in parallel to each other at a predetermined interval. Specifically, the through holes 18 are provided side by side in a direction parallel to the top surface and the bottom surface of the main body 12. The through-hole 18 is formed in a straight line and has a circular cross-sectional shape. Further, the inner diameter of the through hole 18 is formed to be slightly larger than the outer diameter of the surgical cable 20. For example, if the outer diameter of the surgical cable 20 is 1.2 mm, the inner diameter of the through hole 18 is 1. It is formed to about 3 mm.
　なお、貫通孔１８の横断面形状及び大きさは特に限定されず、外科用ケーブル２０を挿通することができ、かつ本体部１２をかしめ変形させたときに潰れて外科用ケーブル２０をかしめ固定することができる形状及び大きさであれば、楕円形や多角形等の様々な形状及び大きさに形成することができる。また、本実施形態では、貫通孔１８は、互いに同一の横断面形状及び大きさを有しているが、貫通孔１８の横断面形状及び大きさは、外科用ケーブル２０を挿通可能であり、かつ本体部１２のかしめ変形時に潰れて外科用ケーブル２０を固定可能であれば、互いに異なっていてもよい。 In addition, the cross-sectional shape and size of the through hole 18 are not particularly limited, and the surgical cable 20 can be inserted, and when the main body portion 12 is deformed by caulking, the surgical cable 20 is crimped and fixed. Any shape and size that can be formed can be formed into various shapes and sizes such as an ellipse and a polygon. In the present embodiment, the through holes 18 have the same cross-sectional shape and size as each other, but the cross-sectional shape and size of the through holes 18 can be inserted through the surgical cable 20. And as long as it can be crushed at the time of caulking deformation of main part 12 and surgical cable 20 can be fixed, it may differ from each other.
　本体部１２は、その左右両側面を鉗子等で挟んで強く押圧されたときに、貫通孔１８が潰れるようにかしめ変形するように構成されている。すなわち、本体部１２は、かしめ変形可能な程度の剛性を有して構成されている。ここで、貫通孔１８が潰れるようにかしめ変形するとは、本体部１２が塑性変形して、貫通孔１８の横断面形状が円形から楕円形に変形することをいう。本体部１２をかしめ変形させることにより、貫通孔１８に挿通した外科用ケーブル２０を本体部１２にかしめ固定することができる。 The main body 12 is configured to be caulked and deformed so that the through-hole 18 is crushed when the left and right side surfaces are sandwiched with forceps or the like and pressed strongly. That is, the main body 12 is configured to have a rigidity that can be caulked and deformed. Here, the caulking deformation so that the through-hole 18 is crushed means that the main body portion 12 is plastically deformed and the cross-sectional shape of the through-hole 18 is deformed from a circular shape to an elliptical shape. By caulking and deforming the main body 12, the surgical cable 20 inserted through the through hole 18 can be caulked and fixed to the main body 12.
　貫通孔１８の内面には、外科用ケーブル２０の滑り止めのための凹凸が形成されている。このように、貫通孔１８の内面に凹凸が形成されると、本体部１２をかしめ変形させて外科用ケーブル２０を本体部１２にかしめ固定したときに、貫通孔１８の内面と外科用ケーブル２０の外周面との間の摩擦力を高めることができる。そして、前記凹凸により高められた摩擦力によって、外科用ケーブル２０の、貫通孔１８の軸方向の滑り変位、すなわち本体部１２に対する滑り変位を拘束することができる。その結果、本体部１２に外科用ケーブル２０を強固に固定することができる。 The inner surface of the through hole 18 is provided with irregularities for preventing the surgical cable 20 from slipping. As described above, when irregularities are formed on the inner surface of the through hole 18, when the surgical cable 20 is caulked and fixed to the main body portion 12 by caulking and deforming the main body portion 12, the inner surface of the through hole 18 and the surgical cable 20. The frictional force between the outer peripheral surface and the outer peripheral surface can be increased. Then, the sliding displacement of the surgical cable 20 in the axial direction of the through hole 18, that is, the sliding displacement with respect to the main body portion 12 can be restricted by the frictional force increased by the unevenness. As a result, the surgical cable 20 can be firmly fixed to the main body 12.
　本実施形態では、貫通孔１８の内面に雌ねじ１９を形成することにより、前記凹凸を実現した。雌ねじ１９の形成方法について説明すると、まず、コアドリルを使用して、本体部１２に、下穴としての貫通孔１８を形成する。次いで、タップを使用して、貫通孔１８（下穴）の内面にねじを切って雌ねじ１９を形成する。貫通孔１８（下穴）の内径が１．３ｍｍの場合、外径１．４ｍｍ、谷径１．３ｍｍのタップを使用すると、図３（Ａ）、（Ｂ）に示すような形状の雌ねじ１９を形成することができる。図３（Ａ）は、一条ねじタイプのタップを使用して、一条ねじ型の雌ねじ１９を形成した場合を示し、図３（Ｂ）は二条ねじタイプのタップを使用して、二条ねじ型の雌ねじ１９を形成した場合を示す。このようにして、雌ねじ１９を貫通孔１８の軸方向に沿って螺旋状に形成することができる。このように形成された雌ねじ１９は、貫通孔１８の軸方向に対して交差する方向に延びているので、外科用ケーブル２０の、貫通孔１８の軸方向の滑り変位を効果的に拘束することができる。 In the present embodiment, the unevenness is realized by forming the female screw 19 on the inner surface of the through hole 18. A method for forming the female screw 19 will be described. First, a through hole 18 as a pilot hole is formed in the main body portion 12 using a core drill. Next, using a tap, a screw is cut on the inner surface of the through hole 18 (preparation hole) to form an internal thread 19. When the inner diameter of the through hole 18 (preparation hole) is 1.3 mm, when a tap having an outer diameter of 1.4 mm and a valley diameter of 1.3 mm is used, a female screw 19 having a shape as shown in FIGS. Can be formed. FIG. 3 (A) shows a case where a single thread type female thread 19 is formed using a single thread type tap, and FIG. 3 (B) shows a double thread type tap using a double thread type tap. The case where the internal thread 19 is formed is shown. In this manner, the female screw 19 can be formed in a spiral shape along the axial direction of the through hole 18. Since the female screw 19 formed in this way extends in a direction intersecting the axial direction of the through hole 18, it effectively restrains the sliding displacement of the surgical cable 20 in the axial direction of the through hole 18. Can do.
　貫通孔１８の内面に形成された雌ねじ１９のねじ山の先端部分が尖っていると、貫通孔１８に挿通された外科用ケーブル２０の外周面をねじ山が傷つけ、場合によっては切断する虞があるので、雌ねじ１９のねじ山の頂が平坦な面を有するように構成することが望ましい。つまり、雌ねじ１９のねじ山が平坦状になるように、ねじ山を台形状に形成することが好ましい。そのためには、貫通孔１８（下穴）の内径よりも小さい谷径を有するタップを使用するとよい。このようなタップを使用して雌ねじ１９を形成すると、雌ねじ１９の内径が、タップの雄ねじの谷径よりも大きくなるので、結果として、雌ねじ１９のねじ山を台形状に形成することができる。例えば、貫通孔１８（下穴）の内径が１．３ｍｍの場合、外径１．４ｍｍ、谷径１．２５ｍｍのタップを使用すると、図３（Ｃ）に示すような、ねじ山が台形状の雌ねじ１９を形成することができる。なお、タップでねじを切った際に、本体部１２の材料が塑性変形して流れるので、雌ねじ１９（すなわち、タップの雄ねじ）の形状、谷径、ピッチ等は、そのことを考慮して設定する必要がある。 If the tip of the thread of the female screw 19 formed on the inner surface of the through-hole 18 is sharp, the thread may damage the outer peripheral surface of the surgical cable 20 inserted through the through-hole 18, and possibly cut off. For this reason, it is desirable to configure the female thread 19 so that the top of the thread has a flat surface. That is, it is preferable that the thread is formed in a trapezoidal shape so that the thread of the female screw 19 is flat. For this purpose, a tap having a valley diameter smaller than the inner diameter of the through hole 18 (preparation hole) may be used. When the internal thread 19 is formed using such a tap, the internal diameter of the internal thread 19 becomes larger than the valley diameter of the external thread of the tap, and as a result, the thread of the internal thread 19 can be formed in a trapezoidal shape. For example, when the inner diameter of the through-hole 18 (preparation hole) is 1.3 mm, if a tap having an outer diameter of 1.4 mm and a valley diameter of 1.25 mm is used, the thread is trapezoidal as shown in FIG. Can be formed. When the screw is cut with the tap, the material of the main body portion 12 is plastically deformed and flows, so the shape, valley diameter, pitch, etc. of the female screw 19 (that is, the male screw of the tap) are set in consideration thereof. There is a need to.
　貫通孔１８の内面に形成される雌ねじ１９の形状は、他にも様々な形状のものが考えられる。例えば、図３（Ｄ）に示すような、ねじ山を形成するフランクが略垂直面と傾斜面との組のように互いに異なるフランク角を有する片刃鋸歯状の雌ねじ１９であってもよい。雌ねじ１９を片刃鋸歯状に形成すると、外科用ケーブル２０が貫通孔１８の軸方向に滑り変位するときに、外科用ケーブル２０の外周面が略垂直面に当接して抵抗を受けることとなる。したがって、外科用ケーブル２０がねじ山の略垂直面側と当接する方向（図中の左方向）の摩擦力を高めることができるので、その方向への外科用ケーブル２０の滑り変位を抑制することができる。また、雌ねじ１９の形状は、上記のような三角ねじ状に限らず、例えば角ねじ状のものや、ねじ山を形成するフランク角が互いに異なるもの等の様々な形状であってもよい。 The shape of the female screw 19 formed on the inner surface of the through hole 18 may be various other shapes. For example, as shown in FIG. 3 (D), the flank forming the thread may be a single-blade serrated female screw 19 having flank angles different from each other like a set of a substantially vertical surface and an inclined surface. When the female screw 19 is formed in a single-tooth sawtooth shape, when the surgical cable 20 is slid in the axial direction of the through hole 18, the outer peripheral surface of the surgical cable 20 comes into contact with the substantially vertical surface and receives resistance. Therefore, since the frictional force in the direction in which the surgical cable 20 abuts on the substantially vertical surface side of the screw thread (left direction in the figure) can be increased, the sliding displacement of the surgical cable 20 in that direction is suppressed. Can do. The shape of the female screw 19 is not limited to the triangular screw shape as described above, and may be various shapes such as, for example, a square screw shape or a shape having different flank angles forming a screw thread.
　なお、図３（Ａ）～（Ｄ）に示される雌ねじ１９は全て、左回りの（タップや雌ねじ１９に合う雄ねじを左（半時計回り）に回すことで螺進する向きに傾斜する）螺旋状とされている。本実施形態では、雌ねじ１９は、貫通孔１８の形成後にタップを使用して形成したが、側部に突起が形成されたドリル等を使用して、貫通孔１８の形成と同時に形成するようにしてもよい。本実施形態では、また、雌ねじ１９はタップを使用して形成したが、雌ねじ１９は他の工具等を使用して形成してもよい。 3A to 3D are all counterclockwise spirals (inclined in the direction of screwing by turning the male screw that matches the tap or female screw 19 counterclockwise). It is made into a shape. In the present embodiment, the female screw 19 is formed using a tap after the through-hole 18 is formed. However, the female screw 19 is formed simultaneously with the formation of the through-hole 18 using a drill or the like having protrusions formed on the side portions. May be. In this embodiment, the internal thread 19 is formed using a tap, but the internal thread 19 may be formed using another tool or the like.
　図４及び図５は、右回りのタップを使用して貫通孔１８の内面にねじを切り、右回りの螺旋状に形成された雌ねじ溝を有する右回り雌ねじ部１９Ｒを形成し、かつ左回りのタップの両方を使用して貫通孔１８の内面にねじを切り、左回りの螺旋状に形成された雌ねじ溝を有する左回り雌ねじ部１９Ｌを形成した例をそれぞれ示している。図４は、一条ねじタイプのタップを使用して、右回り雌ねじ部１９Ｒ及び左回り雌ねじ部１９Ｌを形成した例を示し、図５は、二条ねじタイプのタップを使用して、右回り雌ねじ部１９Ｒ及び左回り雌ねじ部１９Ｌを形成した例を示している。なお、右回り雌ねじ部１９Ｒ及び左回り雌ねじ部１９Ｌは、どちらを先に形成してもよい。 4 and 5, a clockwise tap is used to cut a screw on the inner surface of the through-hole 18 to form a clockwise female screw portion 19R having a female screw groove formed in a clockwise direction, and to the left. Each of these taps is used to cut a screw on the inner surface of the through hole 18 to form a counterclockwise female thread portion 19L having a female thread groove formed in a counterclockwise spiral shape. FIG. 4 shows an example in which a clockwise female thread portion 19R and a counterclockwise female thread portion 19L are formed using a single thread screw type tap, and FIG. 5 shows a clockwise female thread portion using a double thread type tap. An example in which 19R and a counterclockwise female thread portion 19L are formed is shown. Note that either the clockwise female screw portion 19R or the counterclockwise female screw portion 19L may be formed first.
　図４及び図５のそれぞれにおいて、（Ａ）は貫通孔１８の縦断面図（図２のＩＩＩ－ＩＩＩ断面に相当する（Ｄ）のＡ－Ａ断面図）を示し、（Ｂ）は貫通孔１８の水平断面図（（Ｄ）のＢ－Ｂ断面図）を示し、（Ｃ）は貫通孔１８の展開図を示し、（Ｄ）は本体部１２の正面図（（Ａ）のＤ矢視図）を示している。図４及び図５は共に、貫通孔１８（下穴）の内径が１．３ｍｍの場合に、外径１．４ｍｍ、谷径１．３ｍｍのタップを使用した場合のように、ねじ山の先端部分が尖っている例を示している。 4A and 5B, (A) shows a longitudinal sectional view of the through hole 18 (an AA sectional view of (D) corresponding to the III-III section of FIG. 2), and (B) shows the through hole. 18 is a horizontal sectional view (BB sectional view of (D)), (C) is a developed view of the through hole 18, and (D) is a front view of the main body 12 (viewed by arrow D in (A)). Figure). 4 and 5 both show the tip of the thread as in the case of using a tap with an outer diameter of 1.4 mm and a valley diameter of 1.3 mm when the inner diameter of the through-hole 18 (bottom hole) is 1.3 mm. An example in which the part is pointed is shown.
　図４に示されるように、一条ねじのタップを使用して右回り雌ねじ部１９Ｒ及び左回り雌ねじ部１９Ｌを形成すると、先に形成されたねじ山の一部が、後に使用されるタップにより削られる。これにより、右周りのねじ溝と左回りのねじ溝とが交差する部分が生じるものの、右周り及び左回りのねじ溝は共に完全な形状を有する。一方、ねじ山は、周方向の一部が削られた形状となり、貫通孔１８の軸線方向に直交する突条１９ａを形成する。具体的には、貫通孔１８の上下でねじ山が削られて高さが半分になり、貫通孔１８の左右でねじ山が高さを維持して突条１９ａを形成する。そのため、本体部１２が左右方向からかしめられると、挿通されている外科用ケーブル２０は突条１９ａによって蛇行するように変形し、貫通孔１８の軸方向の力にして大きな摩擦力を発生させる。これにより、外科用ケーブル２０の、貫通孔１８の軸方向の滑り変位が効果的に拘束される。 As shown in FIG. 4, when the clockwise female screw portion 19R and the counterclockwise female screw portion 19L are formed using a single threaded screw tap, a part of the previously formed screw thread is cut by the tap used later. It is done. This produces a portion where the right-hand thread groove and the left-hand thread groove intersect, but both the right-hand thread and the left-hand thread groove have a complete shape. On the other hand, the screw thread has a shape in which a part in the circumferential direction is cut, and forms a protrusion 19 a orthogonal to the axial direction of the through hole 18. Specifically, the thread is cut at the top and bottom of the through-hole 18 to halve the height, and the thread is maintained at the left and right of the through-hole 18 to form the protrusion 19a. Therefore, when the main body 12 is caulked from the left-right direction, the inserted surgical cable 20 is deformed so as to meander by the protrusion 19a, and generates a large frictional force as an axial force of the through hole 18. Thereby, the sliding displacement of the axial direction of the through-hole 18 of the surgical cable 20 is restrained effectively.
　図５に示されるように、二条ねじのタップを使用して右回り雌ねじ部１９Ｒ及び左回り雌ねじ部１９Ｌを形成した場合にも、先に形成されたねじ山は、後に使用されるタップにより一部を削られ、貫通孔１８の軸線方向に直交する突条１９ａを形成する。具体的には、貫通孔１８の上下左右でねじ山が高さを維持し、それらの間でねじ山が削られて高さが半分になり、貫通孔１８の左右でねじ山が高さを維持して突条１９ａを形成する。左右のねじ山は、貫通孔１８の軸方向において同じ位置に形成されるため、本体部１２が左右方向からかしめられると、挿通されている外科用ケーブル２０は、ねじ山のピッチと同じピッチで形成された複数の突条１９ａによって挟み付けられて変形し、貫通孔１８の軸方向の力にして大きな摩擦力を発生させる。これにより、外科用ケーブル２０の、貫通孔１８の軸方向の滑り変位が効果的に拘束される。 As shown in FIG. 5, even when the clockwise female screw portion 19R and the counterclockwise female screw portion 19L are formed by using the double threaded tap, the screw thread formed earlier is fixed by the tap used later. The portion is shaved to form a ridge 19 a that is orthogonal to the axial direction of the through-hole 18. Specifically, the height of the thread is maintained at the top, bottom, left, and right of the through hole 18, and the thread is cut between them to halve the height. The ridge 19a is formed by maintaining. Since the left and right screw threads are formed at the same position in the axial direction of the through hole 18, when the main body portion 12 is caulked from the left and right directions, the inserted surgical cable 20 has the same pitch as the pitch of the screw threads. A large frictional force is generated as a force in the axial direction of the through hole 18 by being sandwiched and deformed by the plurality of formed protrusions 19a. Thereby, the sliding displacement of the axial direction of the through-hole 18 of the surgical cable 20 is restrained effectively.
　図４及び図５に示される右回り雌ねじ部１９Ｒ及び左回り雌ねじ部１９Ｌは、図３（Ａ）や図３（Ｂ）の雌ねじ１９のようにねじ山の先端部分が尖っているが、図３（Ｃ）のようにねじ山が台形状に形成されてもよく、図３（Ｄ）のように片刃鋸歯状に形成されてもよい。また、図４及び図５に示されるねじ山は周方向の異なる位置に形成されてもよい。 The clockwise female thread portion 19R and the counterclockwise female thread portion 19L shown in FIGS. 4 and 5 are pointed at the tip of the thread like the female thread 19 in FIGS. 3 (A) and 3 (B). The thread may be formed in a trapezoidal shape as shown in FIG. 3 (C), or may be formed in a single-blade sawtooth shape as shown in FIG. 3 (D). 4 and 5 may be formed at different positions in the circumferential direction.
　なお、本実施形態では、貫通孔１８の内面に雌ねじ１９を形成することにより、凹凸を実現したが、凹凸は他の方法を用いて実現してもよい。例えば、エッチング技術を使用して、凹凸を形成してもよい。その場合、凹凸は、貫通孔１８において外科用ケーブル２０をかしめ固定した際に、貫通孔１８の内面と外科用ケーブル２０の外周面との間の摩擦力を高めることができる形状、模様、またはパターンで形成するとよい。また、凹凸は、例えばサンドブラスト技術や３Ｄプリンタ技術等を使用して形成してもよい。 In this embodiment, the unevenness is realized by forming the female screw 19 on the inner surface of the through hole 18. However, the unevenness may be realized using other methods. For example, the unevenness may be formed using an etching technique. In that case, when the surgical cable 20 is caulked and fixed in the through-hole 18, the unevenness has a shape, pattern, or pattern that can increase the frictional force between the inner surface of the through-hole 18 and the outer peripheral surface of the surgical cable 20. It is good to form with a pattern. Further, the unevenness may be formed using, for example, a sand blast technique or a 3D printer technique.
　図１に示される刺入部１４は、骨折部の骨に刺入される部分である。刺入部１４は、断面円形のピン状に形成されており、２ｍｍ程度の直径を有している。刺入部１４は、本体部１２と一体的に構成されており、刺入部１４の基端は本体部１２の底面から垂直に延出している。刺入部１４の先端は、骨に刺入し易いように、二面取り加工及びＶ形加工によって尖った槍先形状部１４Ａになっている。なお、刺入部１４の形状や本数は、限定されるものではない。例えば、刺入部１４の形状は、ピン状に限らず、例えばスパイク状であってもよい。また、刺入部１４の本数は、例えば２本または４本であってもよい。 1 is a portion to be inserted into the bone of the fractured portion. The insertion part 14 is formed in a pin shape with a circular cross section, and has a diameter of about 2 mm. The insertion portion 14 is configured integrally with the main body portion 12, and the proximal end of the insertion portion 14 extends vertically from the bottom surface of the main body portion 12. The tip of the insertion portion 14 is a pointed tip shape portion 14A formed by double chamfering and V-shaped processing so that it can be easily inserted into a bone. In addition, the shape and the number of insertion parts 14 are not limited. For example, the shape of the insertion portion 14 is not limited to a pin shape, and may be a spike shape, for example. Moreover, the number of insertion parts 14 may be two or four, for example.
　グリップ部１６は、内固定手術の際の様々な作業、例えば、刺入部１４を骨に刺入する作業、本体部１２の貫通孔１８に外科用ケーブル２０を通す作業、または本体部１２に外科用ケーブル２０をかしめ固定する作業等の際に、鉗子、把持具、外科用器具（例えばドリル）、または手術者の手等で掴まれる部分である。このため、グリップ部１６は、その側面に、鉗子等で掴み易いように、面取り部２６Ａを有している。また、グリップ部１６は、刺入部１４を骨に刺入し、本体部１２に外科用ケーブル２０を固定した後は不要になるので、本体部１２から切り離して除去することができるように構成されている。つまり、本体部１２は、本体部１２に分離可能に固定されている。具体的には、グリップ部１６の本体部１２との連結部２６Ｂは、本体部１２から切り離し易いように、テーパ状に細径化されている。このように連結部２６Ｂを細径化することにより、切断具を使用することなく、連結部２６Ｂで折ってグリップ部１６を本体部１２から容易に切り離して除去することができる。 The grip portion 16 is used for various operations during internal fixation surgery, for example, an operation for inserting the insertion portion 14 into a bone, an operation for passing the surgical cable 20 through the through hole 18 of the main body portion 12, or the main body portion 12. It is a portion that can be gripped by forceps, a grasping tool, a surgical instrument (for example, a drill), an operator's hand, or the like during operations such as caulking and fixing the surgical cable 20. For this reason, the grip part 16 has a chamfered part 26A on its side surface so that it can be easily grasped with forceps or the like. The grip portion 16 is not required after the insertion portion 14 is inserted into the bone and the surgical cable 20 is fixed to the main body portion 12, so that the grip portion 16 can be removed from the main body portion 12 and removed. Has been. That is, the main body 12 is fixed to the main body 12 so as to be separable. Specifically, the connecting portion 26 </ b> B of the grip portion 16 with the main body portion 12 is tapered so as to be easily separated from the main body portion 12. By reducing the diameter of the connecting portion 26B in this manner, the grip portion 16 can be easily separated from the main body portion 12 and removed by folding at the connecting portion 26B without using a cutting tool.
　次に、本発明による締結器１０を外科用ケーブル２０と共に使用して、ヒトの骨折した膝関節部を内固定手術した例を、図６を参照して説明する。 Next, an example of using the fastener 10 according to the present invention together with the surgical cable 20 to internally fix the fractured human knee joint will be described with reference to FIG.
　内固定手術の手順を説明すると、まず、骨折部の骨１００の所定箇所にそれぞれ締結器１０Ａ～Ｇを固定する。図６の例では、締結器１０Ａ～Ｇは、骨１００の７箇所に固定される。締結器１０Ａ～Ｇは、その刺入部１４を骨１００に刺入することにより固定される。図示のように、刺入部１４は、そのほぼ全体が骨１００内に挿入される。なお、締結器１０の本数や刺入部１４の刺入位置等は、骨折部の固定が最適になるように適宜選択される。 The procedure of the internal fixation operation will be described. First, the fasteners 10A to 10G are fixed to predetermined portions of the bone 100 of the fracture part. In the example of FIG. 6, the fasteners 10A to 10G are fixed to seven locations of the bone 100. The fasteners 10A to 10G are fixed by inserting the insertion portion 14 into the bone 100. As shown in the drawing, almost the entire insertion portion 14 is inserted into the bone 100. Note that the number of fasteners 10 and the insertion position of the insertion portion 14 are appropriately selected so that the fixation of the fractured portion is optimal.
　次に、骨１００に固定された締結器１０の本体部１２の貫通孔１８Ａに、外科用ケーブル２０を通す。この作業は、外科用ケーブル２０の一方の端部をピンセットや鉗子等で掴んで、針穴に糸を通すようにして行う。この作業を、締結器１０Ａから、１０Ｂ、１０Ｃ、１０Ｄ、１０Ｅ、１０Ｆ、１０Ｇの順に順番に行う。次いで、締結器１０Ｇの貫通孔１８Ａを通した外科用ケーブル２０の先端部を、締結器１０Ａ、１０Ｂの本体部１２の貫通孔１８Ｂに通す。このように、締結器１０Ａ、１０Ｂの本体部１２に外科用ケーブル２０を２重に通すことにより、外科用ケーブル２０を環状にすることができる。これにより、外科用ケーブル２０は骨折部に巻き付けられる。 Next, the surgical cable 20 is passed through the through-hole 18A of the main body 12 of the fastener 10 fixed to the bone 100. This operation is performed by grasping one end of the surgical cable 20 with tweezers or forceps and passing the thread through the needle hole. This operation is performed in the order of 10B, 10B, 10C, 10D, 10E, 10F, and 10G from the fastener 10A. Next, the distal end portion of the surgical cable 20 that has passed through the through hole 18A of the fastener 10G is passed through the through hole 18B of the main body portion 12 of the fasteners 10A and 10B. Thus, the surgical cable 20 can be formed into an annular shape by passing the surgical cable 20 through the main body 12 of the fasteners 10A and 10B twice. Thereby, the surgical cable 20 is wound around the fracture part.
　次に、骨折部に巻き付けられた外科用ケーブル２０を骨折部に所定の圧力を持って密着させるべく、外科用ケーブル２０の両端部をそれぞれ鉗子等で掴んで緊張し、外科用ケーブル２０に張力を加える。この張力印加状態で、外科用ケーブル２０を２重に通した締結器１０Ａ、１０Ｂの各本体部１２の左右両側面を鉗子等で挟んで強く押圧してかしめ変形させる。これにより、貫通孔１８Ａ、１８Ｂは潰れ変形し、また外科用ケーブル２０も塑性変形し、貫通孔１８Ａ、１８Ｂの内面に外科用ケーブル２０の外周面が密着した状態で、貫通孔１８Ａ、１８Ｂにおいて本体部１２に外科用ケーブル２０がかしめ固定される。このようにして、締結器１０によって、外科用ケーブル２０の両端部を、所定の張力を持って互いに締結することができる。 Next, in order to bring the surgical cable 20 wound around the fractured part into close contact with the fractured part with a predetermined pressure, both ends of the surgical cable 20 are clamped with forceps or the like and tensioned, and the surgical cable 20 is tensioned. Add In this tension applied state, the left and right side surfaces of each body portion 12 of the fasteners 10A and 10B through which the surgical cable 20 is passed twice are sandwiched with forceps and are strongly pressed and deformed. Accordingly, the through holes 18A and 18B are crushed and deformed, and the surgical cable 20 is also plastically deformed. In the state where the outer peripheral surface of the surgical cable 20 is in close contact with the inner surfaces of the through holes 18A and 18B, the through holes 18A and 18B The surgical cable 20 is caulked and fixed to the main body 12. In this way, both ends of the surgical cable 20 can be fastened to each other with a predetermined tension by the fastener 10.
　外科用ケーブル２０の両端部の締結後、各締結器１０のグリップ部１６を連結部１６Ｂで折り曲げて切り離し、本体部２４から除去する。その後、縫合等を行うことにより内固定手術は完了する。なお、外科用ケーブル２０の端部の余剰部は、切断して除去される。 After fastening both ends of the surgical cable 20, the grip portion 16 of each fastener 10 is bent and separated at the connecting portion 16 </ b> B and removed from the main body portion 24. Thereafter, the internal fixation operation is completed by performing suturing or the like. In addition, the excess part of the edge part of the surgical cable 20 is cut and removed.
　このような内固定手術では、締結器１０の本体部１２の貫通孔１８の内面と外科用ケーブル２０の外周面との間の摩擦力が不足した場合、締結器１０の本体部１２に固定された外科用ケーブル２０が本体部１２に対して滑り変位する虞がある。外科用ケーブル２０が本体部１２に対して滑り変位すると、外科用ケーブル２０に加えられている張力が緩むため、骨折部の骨を安定して固定することができなくなる。 In such an internal fixation operation, when the frictional force between the inner surface of the through hole 18 of the main body portion 12 of the fastener 10 and the outer peripheral surface of the surgical cable 20 is insufficient, it is fixed to the main body portion 12 of the fastener 10. There is a risk that the surgical cable 20 may slide and displace with respect to the main body 12. When the surgical cable 20 is slid and displaced with respect to the main body portion 12, the tension applied to the surgical cable 20 is loosened, so that the bone of the fracture portion cannot be stably fixed.
　しかし、本発明の締結器１０では、上述したように、本体部１２の貫通孔１８の内面に外科用ケーブル２０の長手方向の滑り止めのための凹凸が形成されており、貫通孔１８の内面と外科用ケーブル２０との間の摩擦力を高めることができるので、貫通孔１８に挿通して本体部１２にかしめ固定された外科用ケーブル２０が本体部１２に対して滑り変位する虞はない。したがって、外科用ケーブル２０を本体部１２に強固に固定することができる。その結果、外科用ケーブル２０の張力を安定的に保持することができるので、骨折部の骨を安定して固定することができる。 However, in the fastener 10 according to the present invention, as described above, the inner surface of the through hole 18 of the main body portion 12 is provided with irregularities for preventing the surgical cable 20 from slipping in the longitudinal direction. Since the frictional force between the surgical cable 20 and the surgical cable 20 can be increased, there is no possibility that the surgical cable 20 inserted through the through hole 18 and fixed to the main body portion 12 is slid and displaced with respect to the main body portion 12. . Therefore, the surgical cable 20 can be firmly fixed to the main body portion 12. As a result, the tension of the surgical cable 20 can be stably maintained, so that the bone of the fracture can be stably fixed.
　なお、上記した内固定手術では、締結器１０Ｃ～１０Ｇは、単に外科用ケーブル２０を挿通支持するために使用されているので、外科用ケーブル２０は締結器１０Ｃ～１０Ｇに固定されていないが、所望に応じて、締結器１０Ｃ～１０Ｇの本体部１２のいずれかまたは全てに外科用ケーブル２０をかしめ固定してもよい。その場合、外科用ケーブル２０が固定された締結器間において、外科用ケーブル２０の張力を安定的に保持することができる。そのため、締結器１０Ａ及び１０Ｂでの外科用ケーブル２０の固定が緩んだまたは損なわれた場合でも、外科用ケーブル２０が固定された締結器間において、外科用ケーブル２０の張力は安定的に保持される。したがって、外科用ケーブル２０の張力をより確実に保持することが可能となる。 In the above-described internal fixation operation, the fasteners 10C to 10G are simply used to insert and support the surgical cable 20, so the surgical cable 20 is not fixed to the fasteners 10C to 10G. If desired, the surgical cable 20 may be caulked and fixed to any or all of the main body portions 12 of the fasteners 10C to 10G. In that case, the tension of the surgical cable 20 can be stably maintained between the fasteners to which the surgical cable 20 is fixed. Therefore, even when the fixing of the surgical cable 20 in the fasteners 10A and 10B is loosened or damaged, the tension of the surgical cable 20 is stably maintained between the fasteners to which the surgical cable 20 is fixed. The Therefore, the tension of the surgical cable 20 can be held more reliably.
　以上、本発明の好適な実施形態について説明したが、本発明は上記実施形態に限定されるものではなく、本発明の趣旨を逸脱しない範囲であれば適宜変更可能である。また、上記実施形態に示した構成要素は必ずしも全てが必須なものではなく、本発明の趣旨を逸脱しない限りにおいて適宜取捨選択することが可能である。 The preferred embodiments of the present invention have been described above, but the present invention is not limited to the above-described embodiments, and can be changed as appropriate without departing from the spirit of the present invention. In addition, all the components shown in the above embodiment are not necessarily essential, and can be appropriately selected without departing from the gist of the present invention.
　例えば、上記実施形態では、本発明の締結器１０は刺入部１４を備えて構成されているが、本発明の締結器１０は刺入部１４を備えていなくてもよい。同様に、上記実施形態では、本発明の締結器１０はグリップ部１６を備えて構成されているが、本発明の締結器１０はグリップ部１６を備えていなくてもよい。締結器１０が刺入部１４及びグリップ部１６を備えていない場合の実施形態、すなわち、締結器１０が本体部１２だけを備えて構成されている場合の実施形態を図７に示す。図７に示す締結器１０は、外科用ケーブル２０を骨折部等に巻き付けるために、外科用ケーブル２０の両端部を互いに締結するのに使用される。 For example, in the above embodiment, the fastener 10 of the present invention is configured to include the insertion portion 14, but the fastener 10 of the present invention may not include the insertion portion 14. Similarly, in the above embodiment, the fastener 10 of the present invention is configured to include the grip portion 16, but the fastener 10 of the present invention may not include the grip portion 16. FIG. 7 shows an embodiment in which the fastener 10 is not provided with the insertion portion 14 and the grip portion 16, that is, an embodiment in which the fastener 10 is configured to include only the main body portion 12. The fastener 10 shown in FIG. 7 is used to fasten both ends of the surgical cable 20 to each other in order to wrap the surgical cable 20 around a fracture or the like.
　また、上記実施形態では、２つの貫通孔１８Ａ、１８Ｂは、互いに所定の間隔を隔てて平行に形成されているが、所定の間隔を隔てずに幅方向（孔径方向）に互いに連続するように形成してもよい。例えば、図８に示すように、貫通孔１８Ａ、１８Ｂの円形横断面の一部が互いに重なるように形成してもよい。このように、２つの貫通孔１８が孔径方向に互い連続し、かつ横断面形状が８の字状になるように形成すると、本体部１２をかしめ変形させたときの貫通孔１８の潰れ変形をより大きくすることができ、それにより、貫通孔１８の内面と外科用ケーブル２０とをより密着させることができるので、外科用ケーブル２０をより強固に固定することができる。 In the above-described embodiment, the two through holes 18A and 18B are formed in parallel with a predetermined interval therebetween, but are continuous with each other in the width direction (hole diameter direction) without a predetermined interval. It may be formed. For example, as shown in FIG. 8, you may form so that a part of circular cross section of through- hole 18A, 18B may mutually overlap. In this way, when the two through holes 18 are formed so as to be continuous with each other in the hole diameter direction and have a cross-sectional shape of 8 in shape, the deformation of the through holes 18 when the body portion 12 is caulked and deformed is prevented. Since the inner diameter of the through hole 18 and the surgical cable 20 can be brought into closer contact with each other, the surgical cable 20 can be more firmly fixed.
　また、上記実施形態では、２つの貫通孔１８Ａ、１８Ｂは、本体部１２の上面及び底面に対して平行な方向に左右に並んで形成されているが、貫通孔１８Ａ、１８Ｂの形成位置は、本体部１２をかしめ変形したときに潰れて外科用ケーブル２０をかしめ固定することができる位置であれば、任意に変更可能である。例えば、貫通孔１８Ａ、１８Ｂは、本体部１２の上面及び底面に対して直交する方向に互いに位置をずらして形成してもよい。 In the above embodiment, the two through holes 18A and 18B are formed side by side in a direction parallel to the top surface and the bottom surface of the main body portion 12, but the formation positions of the through holes 18A and 18B are: Any position that can be crushed when the main body 12 is deformed by caulking and can be fixed by caulking the surgical cable 20 can be arbitrarily changed. For example, the through holes 18 </ b> A and 18 </ b> B may be formed so as to be shifted from each other in a direction orthogonal to the upper surface and the bottom surface of the main body 12.
　また、上記実施形態では、本体部１２に２つの貫通孔１８Ａ、１８Ｂが形成されているが、本体部１２に形成される貫通孔１８は１つだけであってもよい。その場合は、貫通孔１８の形状及び大きさは、外科用ケーブル２０を二重に通すことができ、かつ本体部１２をかしめ変形したときに潰れて外科用ケーブル２０をかしめ固定することができる形状及び大きさである必要がある。なお、図６に示される、外科用ケーブル２０が一度しか通らない位置に使用される締結器１０Ｃ～１０Ｇでは、本体部１２に形成される１つの貫通孔１８の大きさは、外科用ケーブル２０を挿通可能であればよく、かしめ変形される本体部１２において、貫通孔１８の横断面形状がかしめ変形時に潰れて外科用ケーブル２０を固定可能であればよい。 In the above embodiment, the two through holes 18A and 18B are formed in the main body portion 12, but only one through hole 18 may be formed in the main body portion 12. In that case, the shape and size of the through-hole 18 can pass the surgical cable 20 in a double manner, and can be crushed when the body 12 is caulked and deformed to fix the surgical cable 20 by caulking. It must be in shape and size. In the fasteners 10C to 10G used in the position where the surgical cable 20 passes only once as shown in FIG. 6, the size of one through-hole 18 formed in the main body 12 is as follows. In the main body part 12 to be caulked and deformed, the cross-sectional shape of the through hole 18 may be collapsed at the time of caulking deformation and the surgical cable 20 can be fixed.
　１０　　締結器
　１２　　本体部
　１４　　刺入部
　１６　　グリップ部
　１８　　貫通孔
　１９　　雌ねじ（凹凸）
　１９Ｒ　右回り雌ねじ部
　１９Ｌ　左回り雌ねじ部
　１９ａ　突条
　２０　　外科用ケーブル
　１００　骨 DESCRIPTION OF SYMBOLS 10 Fastener 12 Body part 14 Insertion part 16 Grip part 18 Through-hole 19 Female screw (unevenness)
19R Right-handed female thread portion 19L Left-handed female thread portion 19a Projection 20 Surgical cable 100 Bone

Claims (10)

  1. 　外科用ケーブルの両端部を互いに締結するための締結器であって、
    　前記外科用ケーブルを挿通可能な貫通孔が形成され、かつ前記貫通孔に挿通された前記外科用ケーブルを固定するべくかしめ変形可能な本体部を含み、
    　前記本体部の前記貫通孔の内面に、前記外科用ケーブルの滑り止めのための凹凸が形成されていることを特徴とする外科用ケーブルの締結器。     A fastener for fastening both ends of a surgical cable to each other,
    A through-hole through which the surgical cable can be inserted is formed, and a cauldable deformable main body for fixing the surgical cable inserted through the through-hole,
    The surgical cable fastener according to claim 1, wherein unevenness for preventing slipping of the surgical cable is formed on an inner surface of the through hole of the main body.
  2. 　前記貫通孔が略平行に２つ形成されていることを特徴とする請求項１に記載の外科用ケーブルの締結器。 The surgical cable fastener according to claim 1, wherein two through holes are formed substantially in parallel.
  3. 　前記凹凸が、前記貫通孔の軸方向に沿って螺旋状に形成された雌ねじであることを特徴とする請求項１または２に記載の外科用ケーブルの締結器。 The surgical cable fastener according to claim 1 or 2, wherein the irregularities are internal threads formed in a spiral shape along the axial direction of the through hole.
  4. 　前記凹凸が、前記貫通孔の軸方向に沿って右回りの螺旋状に形成された第１雌ねじ溝を有する第１の雌ねじ部と、前記貫通孔の軸方向に沿って左回りの螺旋状に形成された第２雌ねじ溝を有する第２の雌ねじ部とを含むことを特徴とする請求項１または２に記載の外科用ケーブルの締結器。 A first female screw portion having a first female screw groove formed in a clockwise spiral shape along the axial direction of the through hole; and a helical shape counterclockwise along the axial direction of the through hole. The surgical cable fastener according to claim 1 or 2, further comprising a second female screw portion having a formed second female screw groove.
  5. 　前記雌ねじのねじ山の頂が平坦状であることを特徴とする請求項３または請求項４に記載の外科用ケーブルの締結器。 The surgical cable fastener according to claim 3 or 4, wherein the top of the thread of the female screw is flat.
  6. 　前記本体部の底面に突設された刺入部をさらに含むことを特徴とする請求項１ないし５のいずれか一項に記載の外科用ケーブルの締結器。 The surgical cable fastener according to any one of claims 1 to 5, further comprising a piercing portion projecting from the bottom surface of the main body portion.
  7. 　前記本体部の上面に突設されたグリップ部をさらに含むことを特徴とする請求項１ないし６のいずれか一項に記載の外科用ケーブルの締結器。 The surgical cable fastener according to any one of claims 1 to 6, further comprising a grip portion protruding from an upper surface of the main body portion.
  8. 　外科用ケーブルの両端部を互いに締結するための締結器の製造方法であって、
    　前記外科用ケーブルを固定するための本体部をかしめ変形可能にすべく、前記本体部に前記外科用ケーブルを挿通可能な貫通孔を形成する工程と、
    　前記貫通孔の内面に、前記外科用ケーブルの滑り止めのための凹凸を形成する工程と
    を含むことを特徴とする締結器の製造方法。     A method of manufacturing a fastener for fastening both ends of a surgical cable to each other,
    Forming a through-hole through which the surgical cable can be inserted into the main body part so that the main body part for fixing the surgical cable can be caulked and deformed;
    Forming an unevenness for preventing slipping of the surgical cable on the inner surface of the through-hole.
  9. 　前記凹凸を形成する工程では、タップを使用して前記貫通孔の内面に雌ねじを形成することを特徴とする請求項８に記載の締結器の製造方法。 The method for manufacturing a fastener according to claim 8, wherein, in the step of forming the irregularities, a female screw is formed on the inner surface of the through hole using a tap.
  10. 　前記凹凸を形成する工程は、
    　第１のタップを使用して前記貫通孔の軸方向に沿って右回りの螺旋状を呈する第１雌ねじ溝を形成する工程と、
    　第２のタップを使用して前記貫通孔の軸方向に沿って左回りの螺旋状を呈する第２雌ねじ溝を形成する工程と
    を含むことを特徴とする請求項８に記載の締結器の製造方法。     The step of forming the irregularities includes:
    Forming a first female thread groove having a clockwise spiral shape along the axial direction of the through hole using a first tap;
    The manufacturing method of the fastener of Claim 8 including the process of forming the 2nd internal thread groove which exhibits the left-handed spiral shape along the axial direction of the said through-hole using a 2nd tap. Method.
PCT/JP2016/001719 2015-04-01 2016-03-24 Fastener of surgical cable, and manufacturing method thereof WO2016157852A1 (en)

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS51119463U (en) * 1975-03-25 1976-09-28
US5415658A (en) * 1993-12-14 1995-05-16 Pioneer Laboratories, Inc. Surgical cable loop connector
JPH07317721A (en) * 1994-05-30 1995-12-08 Koichi Nagahata Fixing method for terminal of cableway cable and fixng tool for it
EP1346783A2 (en) * 2002-02-27 2003-09-24 Ercos S.p.A. Method for threading inlets formed by drawing, particularly for manufacturing elements of radiators and the like
JP3106970U (en) * 2004-08-02 2005-01-27 株式会社アクセサリーマルタカ Wire clamp and hanging wire using the same
JP2012030241A (en) * 2010-07-29 2012-02-16 Mitsubishi Electric Corp Punching die and method for processing threaded hole using the punching die
US20120215224A1 (en) * 2011-02-17 2012-08-23 Songer Matthew N Cable system for surgical application
JP2015008770A (en) * 2013-06-27 2015-01-19 株式会社アイメディック Surgical cable and surgical bone anchoring unit

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS51119463U (en) * 1975-03-25 1976-09-28
US5415658A (en) * 1993-12-14 1995-05-16 Pioneer Laboratories, Inc. Surgical cable loop connector
JPH07317721A (en) * 1994-05-30 1995-12-08 Koichi Nagahata Fixing method for terminal of cableway cable and fixng tool for it
EP1346783A2 (en) * 2002-02-27 2003-09-24 Ercos S.p.A. Method for threading inlets formed by drawing, particularly for manufacturing elements of radiators and the like
JP3106970U (en) * 2004-08-02 2005-01-27 株式会社アクセサリーマルタカ Wire clamp and hanging wire using the same
JP2012030241A (en) * 2010-07-29 2012-02-16 Mitsubishi Electric Corp Punching die and method for processing threaded hole using the punching die
US20120215224A1 (en) * 2011-02-17 2012-08-23 Songer Matthew N Cable system for surgical application
JP2015008770A (en) * 2013-06-27 2015-01-19 株式会社アイメディック Surgical cable and surgical bone anchoring unit

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