WO2023238865A1 - Device for in-vivo implantation - Google Patents

Device for in-vivo implantation Download PDF

Info

Publication number
WO2023238865A1
WO2023238865A1 PCT/JP2023/021015 JP2023021015W WO2023238865A1 WO 2023238865 A1 WO2023238865 A1 WO 2023238865A1 JP 2023021015 W JP2023021015 W JP 2023021015W WO 2023238865 A1 WO2023238865 A1 WO 2023238865A1
Authority
WO
WIPO (PCT)
Prior art keywords
tooth
contact surface
degrees
vivo
lateral direction
Prior art date
Application number
PCT/JP2023/021015
Other languages
French (fr)
Japanese (ja)
Inventor
満 清水
Original Assignee
ＨＯＹＡ Ｔｅｃｈｎｏｓｕｒｇｉｃａｌ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ＨＯＹＡ Ｔｅｃｈｎｏｓｕｒｇｉｃａｌ株式会社 filed Critical ＨＯＹＡ Ｔｅｃｈｎｏｓｕｒｇｉｃａｌ株式会社
Publication of WO2023238865A1 publication Critical patent/WO2023238865A1/en

Links

Images

Classifications

    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs

Definitions

  • the present invention relates to an in-vivo implantation device that is inserted between opposing bones.
  • the implantable device since it has a cavity formed in the center so as to pass through the upper surface and the lower surface, the implantable device can be placed between opposing bones. It was difficult to securely fix it between the two. A bone growth promoting substance can be placed in the cavity, but the larger the cavity, the smaller the contact area with the bone, and the lower the fixation force of the in-vivo implantable device.
  • An object of the present invention is to solve the problems of the conventional techniques described above, and to create a material that can be firmly fixed between bones even if it has cavities or holes that reduce the contact surface with bones.
  • the purpose is to provide devices for implantation in the body.
  • the present invention provides an in-vivo implantable device to be inserted between opposing bones, including a first contact surface that contacts one bone, and a second contact surface that is formed back to back with the first contact surface. and a hole penetrating from the first contact surface to the second contact surface.
  • At least one of the contact surface and the second contact surface is provided with a plurality of first teeth arranged along the longitudinal direction of the main body on one side of the hole, and , a plurality of second teeth are provided on the other side so as to be arranged along the longitudinal direction, and a width direction in which the first teeth extend and a width direction in which the second teeth extend. is inclined with respect to a lateral direction that is an in-plane direction of the first contact surface or the second contact surface and a direction perpendicular to the longitudinal direction.
  • the main body portion has one end in the longitudinal direction formed in a wedge shape, and the first tooth and the second tooth are provided so as to be inclined so that the hole side is closer to the one end. It may be.
  • the first tooth and the second tooth may be provided so as to have an inclination of 10 degrees or more and 25 degrees or less with respect to the lateral direction.
  • the first tooth and the second tooth may be provided so as to have an inclination of 10 degrees or more and 20 degrees or less with respect to the lateral direction.
  • the first tooth and the second tooth may be provided so as to have an inclination of 7.5 degrees or more and 17.5 degrees or less with respect to the lateral direction.
  • the first tooth and the second tooth may be provided so as to have an inclination of 15 degrees with respect to the lateral direction.
  • the first contact surface or the second contact surface is provided such that the third tooth extending in the lateral direction is adjacent to the first tooth and the second tooth, The distance between the third tooth, the first tooth, and the second tooth may be larger at a position
  • an in-vivo implantation device that can be sufficiently firmly fixed between bones even if it has a cavity or hole that reduces the contact surface with bones.
  • FIG. 1 shows a perspective view of an in-vivo implantation device according to an embodiment of the present invention.
  • a schematic diagram showing a state in which an in-vivo implantation device is inserted between vertebrae is shown.
  • FIG. 2 shows a top view of the in-vivo implantation device.
  • FIG. 2 shows a side view of the in-vivo implantation device.
  • FIG. 6 shows a hexagonal view of an in-vivo implantation device in which the angle of the first tooth and the second tooth with respect to the lateral direction is 15°.
  • FIG. 6 is a hexagonal view in which only characteristic tooth portions of the in-vivo implantable device are shown in solid lines, in which the angle of the first tooth and the second tooth with respect to the lateral direction is 15°.
  • Figure 2 schematically shows a longitudinal pull-out test.
  • a lateral pull-out test is schematically shown.
  • 1 shows a top view and a side view of a conventional in-vivo implantable device.
  • the hexagonal view of the in-vivo implantation device according to a modification in which the angle of the first tooth and the second tooth with respect to the lateral direction is 10° is shown.
  • the hexagonal view of the in-vivo implantation device according to a modified example in which the angle of the first tooth and the second tooth with respect to the lateral direction is 20° is shown.
  • FIG. 1 shows a perspective view of an in-vivo implantable device according to an embodiment of the present invention
  • FIG. 2 shows a schematic diagram showing how the in-vivo implantable device is inserted between vertebrae.
  • FIG. 3 shows a top view of the in-vivo implantable device
  • FIG. 4 shows a side view of the in-vivo implantable device
  • FIG. 5 shows the relationship between the first tooth and the second tooth in the lateral direction.
  • FIG. 6 shows a hexagonal view of an in-vivo implantable device in which the angle is 15°
  • FIG. A hexagonal view showing only the typical tooth portions with solid lines is shown.
  • the in-vivo implantation device 100 is formed into a substantially rectangular parallelepiped and has a first abutting surface 21 and a second abutting surface 22, which face each other in the vertebrae.
  • This is a spinal implant for interposing a first abutting surface 21 and a second abutting surface 22 between bones so that they are in contact with the bones and are sandwiched therebetween.
  • the in-vivo implantation device 100 has an elongated frame (main body portion) 10 and a base material 20 that is a fusion portion.
  • the frame 10 and the base material 20 are integrally molded using titanium or a titanium alloy, and are manufactured using a 3D printer.
  • the frame 10 is formed solid, has a shape in which two side walls 11 and 12, a rear wall 13, and a front wall 14 are combined into a rectangular shape, and a base material 20 is formed inside. .
  • the base material 20 is exposed from the first contact surface 21 and the second contact surface 22 (see FIG. 1).
  • the base material 20 is provided in a substantially rectangular shape so that its outer periphery is covered by the front wall 14, side walls 11, 12, and rear wall 13 of the frame 10.
  • the base material 20 is made of the same material as the frame 10 and is integrally formed into a net shape.
  • the pair of side walls 11 and 12 are each formed to have a flat surface and are positioned to face each other. As shown in FIG. 4, these side walls 11 and 12 have an opening 11a having an oval shape extending in the longitudinal direction L from the front wall 14 side to the rear wall 13 side so as to be located in the center of the longitudinal direction L. , 12a are formed.
  • a flat rear wall 13 is located at the rear of the side walls 11 and 12. This rear wall 13 may be formed with a screw hole for attaching an instrument 101 (see FIG. 2).
  • a front wall 14 provided at the front of the side walls 11 and 12 is formed in a wedge shape protruding in the longitudinal direction L.
  • the first contact surface 21 and the second contact surface 22 have a plurality of first teeth 1 on one side with the hole 23 interposed therebetween along the longitudinal direction L of the frame 10.
  • a plurality of second teeth 2 are provided so as to be arranged along the longitudinal direction L on the other side.
  • the width direction T1 in which the first tooth 1 extends from the hole 23 toward the side wall 11 is in the in-plane direction of the first contact surface 21 and in the lateral direction W, which is a direction perpendicular to the longitudinal direction L. It is tilted by an angle ⁇ 1.
  • the width direction T2 in which the second tooth 2 extends from the hole 23 toward the side wall 12 is the in-plane direction of the second contact surface 22 and the lateral direction perpendicular to the longitudinal direction L. It is inclined at an angle ⁇ 2 with respect to the direction W.
  • the angle ⁇ 1 of the first tooth 1 and the angle ⁇ 2 of the second tooth 2 are the same in magnitude.
  • These first teeth 1 and second teeth 2 are provided so as to be inclined so that the closer to the hole 23 the closer the front wall 14 is.
  • the angle ⁇ 1 of the first tooth 1 and the angle ⁇ 2 of the second tooth 2 are 15°.
  • the in-vivo implant device 100 preferably has an overall width in the lateral direction W (see FIG. 1) of 6 mm or more and 12 mm or less, and preferably 7 mm or more and 11 mm or less. is more preferable, more preferably 8 mm or more and 10 mm or less, and in this embodiment, the overall width in the lateral direction W is 9 mm.
  • the overall width is within such a preferable range, the in-vivo implantable device 100 can be fixed sufficiently firmly between bones.
  • the in-vivo implant device 100 preferably has an overall length in the longitudinal direction L (see FIG. 1) of 17 mm or more and 29 mm or less, and preferably 19 mm or more and 27 mm or less. More preferably, the length is 21 mm or more and 25 mm or less, and in this embodiment, the overall length in the longitudinal direction L is 23 mm. When the length is within such a preferable range, the in-vivo implantable device 100 can be fixed sufficiently firmly between bones.
  • the heights of the plurality of first teeth 1 and the plurality of second teeth 2 are equal to the height of the first contact surface 21 and the second contact surface 21 in the height direction H (see FIG. 1). It is preferably 0.2 mm or more and 0.8 mm or less, more preferably 0.3 mm or more and 0.7 mm or less, and even more preferably 0.4 mm or more and 0.6 mm or less, based on the contact surface 22. In this embodiment, this height is 0.5 mm. When the height is within such a preferable range, the in-vivo implantable device 100 can be fixed sufficiently firmly between bones.
  • the plurality of first teeth 1 and the plurality of second teeth 2 each have a distance (tooth pitch) from the apex of one tooth to the apex of the adjacent tooth in the longitudinal direction L (see FIG. 1). It is preferably 1.0 mm or more and 3.0 mm or less. This pitch is more preferably 1.5 mm or more and 2.3 mm or less, and even more preferably 1.8 mm or more and 2.0 mm or less. In this embodiment, this pitch is 1.9 mm. When the distance is within such a preferable range, the in-vivo implantable device 100 can be fixed sufficiently firmly between the bones.
  • the in-vivo implant device 100 has a width of the first tooth 1 and the second tooth 2 in the lateral direction W (see FIG. 1) of 1.6 mm or more. It is preferably .4 mm or less, more preferably 1.7 mm or more and 2.3 mm or less, even more preferably 1.8 mm or more and 2.2 mm or less, and 1.9 mm or more and 2.1 mm or less. is even more preferable, and in this embodiment, it is 2.0 mm.
  • the in-vivo implantation device 100 has the advantage that even if the width of the first tooth 1 and the second tooth 2 in the lateral direction W is within such a range, the first tooth 1 and the second tooth 2 Because the teeth 2 are angled as described above, it is possible to secure the tooth 2 sufficiently firmly between the bones.
  • the width of the hole 23 in the lateral direction W is preferably 4.2 mm or more and 5.8 mm or less. , more preferably 4.4 mm or more and 5.6 mm or less, further preferably 4.6 mm or more and 5.4 mm or less, even more preferably 4.8 mm or more and 5.2 mm or less, and this embodiment , it is 5.0 mm.
  • the first tooth 1 and the second tooth 2 have the above-mentioned shape. Due to the angularity, etc., it is possible to secure the bones sufficiently firmly between the bones.
  • the length of the hole 23 in the longitudinal direction L is preferably 8 mm or more and 16 mm or less, and 9 mm or more. It is more preferably 15 mm or less, even more preferably 10 mm or more and 14 mm or less, even more preferably 11 mm or more and 13 mm or less, and in this embodiment, it is 12 mm.
  • the length of the hole 23 in the longitudinal direction L refers to the longest portion.
  • the first tooth 1 and the second tooth 2 have the above-described structure. Due to such an angle, etc., it is possible to fix the bones sufficiently firmly between the bones.
  • the in-vivo implantable device 100 As shown in FIG. 3, on the rear wall 13 side of the first tooth 1 and the second tooth 2, there is a third tooth 3 extending in the lateral direction W. They are provided on the first contact surface 21 and the second contact surface 22 so as to be adjacent to each other. The distance between the third tooth 3, the first tooth 1, and the second tooth 2 increases as the position approaches the hole 23. This allows the in-vivo implantable device 100 to be fixed sufficiently firmly between the devices.
  • FIG. 7 schematically shows a longitudinal pull-out test
  • FIG. 8 schematically shows a transverse pull-out test.
  • the pullout test in the longitudinal direction L as shown in FIG.
  • the maximum load (N) was measured.
  • "Solid rigid polyurethane foam 15 pcf" material: polyurethane foam, Grade 15 based on ASTM F1839) manufactured by Soborn Corporation was used as the simulated bone, and the in-vivo implantation device 100 pcf was used with a pressing load of 100 N.
  • the upper simulated bone was pressed in the direction shown by arrow A so as to sandwich it.
  • the shaft 32 passed through the opening 11a of the side wall 11 and the opening 12a of the side wall 12 is pulled out with a wire 33 in the longitudinal direction L as shown by arrow B.
  • the drawing speed is 10 mm/min.
  • the angles ⁇ 1 and ⁇ 2 of the first tooth 1 and the second tooth 2 tilted with respect to the lateral direction W are the same, and the angles ⁇ 1 and ⁇ 2 are set to 0 degrees, 5 degrees, and 10 degrees.
  • the average maximum pullout load (N) was measured when the load was changed to 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, and 40 degrees.
  • Conventional products are indicated as "conventional" in the table below. The structure of the conventional product is shown in Figure 9.
  • the device 100 for implantation in a living body has a T-shaped member 34 in which a vertical bar 34a and a horizontal bar 34b are integrally assembled in a T-shape. 12 opening 12a (see FIG. 4), the horizontal bar 34b is brought into contact with the side wall 12 from the outside, and the T-shaped member 34 is pulled out in the lateral direction W as shown by arrow C with a wire 35.
  • the drawing speed at this time was 10 mm/min.
  • the angles ⁇ 1 and ⁇ 2 of the first tooth 1 and the second tooth 2 tilted with respect to the lateral direction W are the same, and the angles ⁇ 1 and ⁇ 2 are set to 0 degrees, 5 degrees, and 10 degrees.
  • the average maximum pullout load (N) was measured when the load was changed to 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, and 40 degrees.
  • the angles ⁇ 1 and ⁇ 2 of the first tooth 1 and the second tooth 2 with respect to the lateral direction W are preferably 10 degrees or more and 25 degrees or less, more preferably 10 degrees or more and 20 degrees or less. More preferably, it is 7.5 degrees or more and 17.5 degrees or less, and in particular, it is found that 15 degrees is the most preferable because the pull-out load becomes significantly large.
  • the conventional product has a smaller hole than the in-vivo implantation device 100 of this embodiment, and the teeth are larger than the in-vivo implantation device 100 of this embodiment, so at the same tooth angle of 0 degrees, In both the longitudinal direction L and the lateral direction W, the average maximum pullout load (N) was greater than that of the in-vivo implantable device 100 of this embodiment.
  • conventional products have small pores, they cannot be filled with a large amount or large porous material like the in-vivo implant device 100 of this embodiment, and the pores are relatively large.
  • the contact surface is relatively small, the problem of the present invention of exerting a sufficient fixing force against the bone cannot be solved.
  • the in-vivo implant device 100 has a first abutting surface 21 that abuts one bone positioned to sandwich the in-vivo implant device 100;
  • An elongated frame 10 having second contact surfaces 22 formed back to back and contacting the other bone, and a hole 23 penetrating from the first contact surface 21 to the second contact surface 22.
  • At least one of the first contact surface 21 and the second contact surface 22 has a plurality of first teeth 1 on one side with the hole 23 interposed therebetween along the longitudinal direction L of the frame 10.
  • a plurality of second teeth 2 are provided so as to be arranged along the longitudinal direction L, and a plurality of second teeth 2 are provided so as to be arranged along the longitudinal direction L, and the first teeth 1 extend in the width direction T1 and
  • the width direction T2 in which the second tooth 2 extends is an in-plane direction of the first abutting surface 21 or the second abutting surface 22, and is inclined with respect to the lateral direction W.
  • the in-vivo implantation device 100 has a cavity or a hole that reduces the contact surface with the bone so that the first tooth 1 and the second tooth 2 are difficult to displace relative to the bone. can also be fixed sufficiently firmly between the bones.
  • the present invention has been described above using embodiments, the present invention is not limited thereto.
  • an in-vivo implantation device is described in which the angle of the first tooth and the second tooth with respect to the lateral direction is 15 degrees, but the present invention is not limited to this.
  • the device has the same dimensions as the in-vivo implant device 100 according to the above embodiment, and the first tooth and the second tooth are inclined with respect to the lateral direction, for example, as shown in FIG. , the angle of the first tooth and the second tooth with respect to the lateral direction may be 10°, or as shown in FIG. 11, the angle of the first tooth and the second tooth with respect to the lateral direction may be 20°. It's okay.

Abstract

The purpose of the present invention is to provide a device for in-vivo implantation that can be secured with sufficient firmness between bones, even if there is a cavity or hole that reduces the contact surface with the bones.　This device 100 for in-vivo implantation, which is sandwiched between two opposing bones, comprises an elongated main body part 10 having a first contact surface 21 brought into contact with one bone, a second contact surface formed back-to-back with the first contact surface 21 and brought into contact with the other bone, and a hole portion 23 penetrating from the first contact surface 21 to the second contact surface, wherein at least one among the first contact surface 21 and the second contact surface is provided such that a plurality of first teeth 1 are arranged along a longitudinal direction L of the main body part 10 on one side across the hole portion 23, a plurality of second teeth 2 are provided so as to be arranged along the longitudinal direction L on the other side, and a width direction T1 in which the first teeth 1 extend and a width direction T2 in which the second teeth 2 extend are the in-plane direction of the first contact surface 21 or the second contact surface, and are inclined relative to a lateral direction W, which is a direction perpendicular to the longitudinal direction L.

Description

生体内埋込用器具In-vivo implantation devices
　本発明は、対向する骨どうしの間に挟むための生体内埋込用器具に関する。 The present invention relates to an in-vivo implantation device that is inserted between opposing bones.
　従来、対向する骨どうしの間に挟むための生体内埋込用器具が知られている。この種の生体内埋込用器具は、骨から出てくる組織が多孔性の材料に侵入して結合することにより、骨に固定されていた。このため、有意な量の多孔性の材料を利用するがコスト効率は変わらず、生体内埋込用器具に要求される強度を維持する改良された生体内埋込用器具が提案されている（例えば、特許文献１参照）。 Conventionally, in-vivo implantation devices that are inserted between opposing bones have been known. This type of in-vivo implantable device was fixed to the bone by the tissue emerging from the bone penetrating and bonding to a porous material. For this reason, improved bioimplantable devices have been proposed that utilize significant amounts of porous material but remain cost-effective and maintain the strength required for bioimplantable devices ( For example, see Patent Document 1).
特開２０１６－１３５２４３号公報Japanese Patent Application Publication No. 2016-135243
　しかしながら、上記従来の技術による生体内埋込用器具では、上面部と下面部を通るように中央部に形成された空洞を有していることから、生体内埋込用器具を対向する骨どうしの間に強固に固定することは困難であった。空洞に骨成長促進物質を設置することができるが、空洞が大きくなるほど骨との接触面積が小さくなり、生体内埋込用器具の固定力は低下することとなる。 However, in the conventional implantable device described above, since it has a cavity formed in the center so as to pass through the upper surface and the lower surface, the implantable device can be placed between opposing bones. It was difficult to securely fix it between the two. A bone growth promoting substance can be placed in the cavity, but the larger the cavity, the smaller the contact area with the bone, and the lower the fixation force of the in-vivo implantable device.
　本発明の目的は、上述した従来の技術が有する課題を解消し、骨と接触面を小さくする空洞ないし孔を有していても、骨どうしの間に充分に強固に固定することのできる生体内埋込用器具を提供することを目的とする。 An object of the present invention is to solve the problems of the conventional techniques described above, and to create a material that can be firmly fixed between bones even if it has cavities or holes that reduce the contact surface with bones. The purpose is to provide devices for implantation in the body.
　本発明は、対向する骨どうしの間に挟むための生体内埋込用器具において、一方の骨に当接する第１の当接面と、前記第１の当接面と背中合わせに形成されて他方の骨に当接する第２の当接面と、前記第１の当接面から前記第２の当接面にかけて貫通する孔部と、を有する細長形状の本体部を備え、前記第１の当接面及び前記第２の当接面の少なくとも一方は、前記孔部を挟んだ一方の側に複数の第１の歯が前記本体部の長手方向に沿って配列するように設けられているとともに、他方の側に複数の第２の歯が前記長手方向に沿って配列するように設けられており、前記第１の歯が延在する幅方向及び前記第２の歯が延在する幅方向は、前記第１の当接面または前記第２の当接面の面内方向であるとともに前記長手方向に垂直な方向である横方向に対して傾いていることを特徴とする。 The present invention provides an in-vivo implantable device to be inserted between opposing bones, including a first contact surface that contacts one bone, and a second contact surface that is formed back to back with the first contact surface. and a hole penetrating from the first contact surface to the second contact surface. At least one of the contact surface and the second contact surface is provided with a plurality of first teeth arranged along the longitudinal direction of the main body on one side of the hole, and , a plurality of second teeth are provided on the other side so as to be arranged along the longitudinal direction, and a width direction in which the first teeth extend and a width direction in which the second teeth extend. is inclined with respect to a lateral direction that is an in-plane direction of the first contact surface or the second contact surface and a direction perpendicular to the longitudinal direction.
　この場合において、前記本体部は、前記長手方向の一端がくさび形状に形成されており、前記第１の歯及び前記第２の歯は、前記孔部側が前記一端に近くなるように傾いて設けられていてもよい。前記第１の歯及び前記第２の歯は、前記横方向に対して１０度以上２５度以下の傾きを有するように設けられていてもよい。前記第１の歯及び前記第２の歯は、前記横方向に対して１０度以上２０度以下の傾きを有するように設けられていてもよい。前記第１の歯及び前記第２の歯は、前記横方向に対して７．５度以上１７．５度以下の傾きを有するように設けられていてもよい。前記第１の歯及び前記第２の歯は、前記横方向に対して１５度の傾きを有するように設けられていてもよい。前記第１の当接面または前記第２の当接面は、前記横方向に延在する第３の歯が前記第１の歯及び前記第２の歯と隣り合うように設けられており、前記第３の歯と前記第１の歯及び前記第２の歯との間隔は、前記孔部に近い位置ほど大きくなっていていてもよい。 In this case, the main body portion has one end in the longitudinal direction formed in a wedge shape, and the first tooth and the second tooth are provided so as to be inclined so that the hole side is closer to the one end. It may be. The first tooth and the second tooth may be provided so as to have an inclination of 10 degrees or more and 25 degrees or less with respect to the lateral direction. The first tooth and the second tooth may be provided so as to have an inclination of 10 degrees or more and 20 degrees or less with respect to the lateral direction. The first tooth and the second tooth may be provided so as to have an inclination of 7.5 degrees or more and 17.5 degrees or less with respect to the lateral direction. The first tooth and the second tooth may be provided so as to have an inclination of 15 degrees with respect to the lateral direction. The first contact surface or the second contact surface is provided such that the third tooth extending in the lateral direction is adjacent to the first tooth and the second tooth, The distance between the third tooth, the first tooth, and the second tooth may be larger at a position closer to the hole.
　本発明では、骨と接触面を小さくする空洞ないし孔を有していても、骨どうしの間に充分に強固に固定することのできる生体内埋込用器具を提供することができる。 According to the present invention, it is possible to provide an in-vivo implantation device that can be sufficiently firmly fixed between bones even if it has a cavity or hole that reduces the contact surface with bones.
本発明の一実施形態に係る生体内埋込用器具を示す斜視図を示す。FIG. 1 shows a perspective view of an in-vivo implantation device according to an embodiment of the present invention. 生体内埋込用器具を脊椎間に挿入している様子を示す模式図を示す。A schematic diagram showing a state in which an in-vivo implantation device is inserted between vertebrae is shown. 生体内埋込用器具の上面図を示す。FIG. 2 shows a top view of the in-vivo implantation device. 生体内埋込用器具の側面図を示す。FIG. 2 shows a side view of the in-vivo implantation device. 横方向に対する第１の歯及び第２の歯の角度が１５°である生体内埋込用器具の六面図を示す。FIG. 6 shows a hexagonal view of an in-vivo implantation device in which the angle of the first tooth and the second tooth with respect to the lateral direction is 15°. 横方向に対する第１の歯及び第２の歯の角度が１５°である生体内埋込用器具の特徴的な歯の部分のみを実線で示した六面図を示す。FIG. 6 is a hexagonal view in which only characteristic tooth portions of the in-vivo implantable device are shown in solid lines, in which the angle of the first tooth and the second tooth with respect to the lateral direction is 15°. 長手方向の引き抜き試験を模式的に示す。Figure 2 schematically shows a longitudinal pull-out test. 横方向の引き抜き試験を模式的に示す。A lateral pull-out test is schematically shown. 従来の生体内埋込用器具の上面図及び側面図を示す。1 shows a top view and a side view of a conventional in-vivo implantable device. 横方向に対する第１の歯及び第２の歯の角度が１０°である変形例に係る生体内埋込用器具の六面図を示す。The hexagonal view of the in-vivo implantation device according to a modification in which the angle of the first tooth and the second tooth with respect to the lateral direction is 10° is shown. 横方向に対する第１の歯及び第２の歯の角度が２０°である変形例に係る生体内埋込用器具の六面図を示す。The hexagonal view of the in-vivo implantation device according to a modified example in which the angle of the first tooth and the second tooth with respect to the lateral direction is 20° is shown.
　以下、図面を参照して、本発明の好適な実施の形態について説明する。
　図１は、本発明の一実施形態に係る生体内埋込用器具を示す斜視図を示し、図２は、生体内埋込用器具を脊椎間に挿入している様子を示す模式図を示し、図３は、生体内埋込用器具の上面図を示し、図４は、生体内埋込用器具の側面図を示し、図５は、横方向に対する第１の歯及び第２の歯の角度が１５°である生体内埋込用器具の六面図を示し、図６は、横方向に対する第１の歯及び第２の歯の角度が１５°である生体内埋込用器具の特徴的な歯の部分のみを実線で示した六面図を示す。 Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings.
FIG. 1 shows a perspective view of an in-vivo implantable device according to an embodiment of the present invention, and FIG. 2 shows a schematic diagram showing how the in-vivo implantable device is inserted between vertebrae. , FIG. 3 shows a top view of the in-vivo implantable device, FIG. 4 shows a side view of the in-vivo implantable device, and FIG. 5 shows the relationship between the first tooth and the second tooth in the lateral direction. FIG. 6 shows a hexagonal view of an in-vivo implantable device in which the angle is 15°, and FIG. A hexagonal view showing only the typical tooth portions with solid lines is shown.
　本実施形態に係る生体内埋込用器具１００は、図１に示すように、略直方体に形成されて第１の当接面２１及び第２の当接面２２を有し、脊椎において対向する骨どうしの間で第１の当接面２１及び第２の当接面２２を骨に接触させて挟まれるように介在させるための脊椎インプラントである。生体内埋込用器具１００を脊椎間に挿入する際には、図２に示すように、例えば、専用の器具１０１が固定され、生体内埋込用器具１００が脊椎間の所望の位置に配置された状態で器具１０１を外すようになっている。 As shown in FIG. 1, the in-vivo implantation device 100 according to the present embodiment is formed into a substantially rectangular parallelepiped and has a first abutting surface 21 and a second abutting surface 22, which face each other in the vertebrae. This is a spinal implant for interposing a first abutting surface 21 and a second abutting surface 22 between bones so that they are in contact with the bones and are sandwiched therebetween. When inserting the in-vivo implantable device 100 between the vertebrae, as shown in FIG. The instrument 101 is removed in this state.
　生体内埋込用器具１００は、図３に示すように、細長形状のフレーム（本体部）１０と癒合部である基材２０とを有している。フレーム１０及び基材２０は、チタンまたはチタン合金を用いて一体で成形されており、３Ｄプリンタを用いて製造される。 As shown in FIG. 3, the in-vivo implantation device 100 has an elongated frame (main body portion) 10 and a base material 20 that is a fusion portion. The frame 10 and the base material 20 are integrally molded using titanium or a titanium alloy, and are manufactured using a 3D printer.
　フレーム１０は、中実に形成されており、２つの側壁１１，１２と、後壁１３と、前壁１４とが矩形に組み合わされた形状を有して、内部に基材２０が形成されている。 The frame 10 is formed solid, has a shape in which two side walls 11 and 12, a rear wall 13, and a front wall 14 are combined into a rectangular shape, and a base material 20 is formed inside. .
　基材２０は、第１の当接面２１及び第２の当接面２２（図１参照）から露出して。基材２０は、外周がフレーム１０の前壁１４、側壁１１，１２、及び後壁１３で覆われるように略矩形に設けられている。基材２０は、フレーム１０と同一材料かつ一体で網状に成形されている。 The base material 20 is exposed from the first contact surface 21 and the second contact surface 22 (see FIG. 1). The base material 20 is provided in a substantially rectangular shape so that its outer periphery is covered by the front wall 14, side walls 11, 12, and rear wall 13 of the frame 10. The base material 20 is made of the same material as the frame 10 and is integrally formed into a net shape.
　一対の側壁１１，１２は、それぞれ平坦な面を有するように形成されており、互いに対向するように位置している。これら側壁１１，１２は、図４に示すように、長手方向Ｌの中央に位置するように、前壁１４側から後壁１３側に向けて長手方向Ｌに延びる長円形状を有する開口部１１ａ，１２ａが形成されている。 The pair of side walls 11 and 12 are each formed to have a flat surface and are positioned to face each other. As shown in FIG. 4, these side walls 11 and 12 have an opening 11a having an oval shape extending in the longitudinal direction L from the front wall 14 side to the rear wall 13 side so as to be located in the center of the longitudinal direction L. , 12a are formed.
　側壁１１，１２の後部には、平坦に形成された後壁１３が位置している。この後壁１３は、器具１０１（図２参照）を取り付けるためのねじ穴が形成されていてもよい。 A flat rear wall 13 is located at the rear of the side walls 11 and 12. This rear wall 13 may be formed with a screw hole for attaching an instrument 101 (see FIG. 2).
　側壁１１，１２の前部に設けられた前壁１４は、長手方向Ｌに突出したくさび形に形成されている。 A front wall 14 provided at the front of the side walls 11 and 12 is formed in a wedge shape protruding in the longitudinal direction L.
　第１の当接面２１及び第２の当接面２２は、図３に示すように、孔部２３を挟んだ一方の側に複数の第１の歯１がフレーム１０の長手方向Ｌに沿って配列するように設けられているとともに、他方の側に複数の第２の歯２が長手方向Ｌに沿って配列するように設けられている。第１の歯１が孔部２３から側壁１１に向けて延在する幅方向Ｔ１は、第１の当接面２１の面内方向であるとともに長手方向Ｌに垂直な方向である横方向Ｗに対して角度θ１だけ傾いている。同様に、第２の歯２が孔部２３から側壁１２に向けて延在する幅方向Ｔ２は、第２の当接面２２の面内方向であるとともに長手方向Ｌに垂直な方向である横方向Ｗに対して角度θ２だけ傾いている。本実施形態では、第１の歯１の角度θ１と第２の歯２の角度θ２との大きさが同じになっている。これら第１の歯１及び第２の歯２は、孔部２３側ほど前壁１４に近くなるように傾いて設けられている。なお、本実施形態では、第１の歯１の角度θ１と第２の歯２の角度θ２とは１５°となっている。 As shown in FIG. 3, the first contact surface 21 and the second contact surface 22 have a plurality of first teeth 1 on one side with the hole 23 interposed therebetween along the longitudinal direction L of the frame 10. A plurality of second teeth 2 are provided so as to be arranged along the longitudinal direction L on the other side. The width direction T1 in which the first tooth 1 extends from the hole 23 toward the side wall 11 is in the in-plane direction of the first contact surface 21 and in the lateral direction W, which is a direction perpendicular to the longitudinal direction L. It is tilted by an angle θ1. Similarly, the width direction T2 in which the second tooth 2 extends from the hole 23 toward the side wall 12 is the in-plane direction of the second contact surface 22 and the lateral direction perpendicular to the longitudinal direction L. It is inclined at an angle θ2 with respect to the direction W. In this embodiment, the angle θ1 of the first tooth 1 and the angle θ2 of the second tooth 2 are the same in magnitude. These first teeth 1 and second teeth 2 are provided so as to be inclined so that the closer to the hole 23 the closer the front wall 14 is. In addition, in this embodiment, the angle θ1 of the first tooth 1 and the angle θ2 of the second tooth 2 are 15°.
　本実施形態に係る生体内埋込用器具１００は、図５に示すように、横方向Ｗ（図１参照）の全体幅が６ｍｍ以上１２ｍｍ以下であることが好ましく、７ｍｍ以上１１ｍｍ以下であることがより好ましく、８ｍｍ以上１０ｍｍ以下であることがさらに好ましく、本実施形態において、横方向Ｗの全体幅は９ｍｍである。上記全体幅がそのような好ましい範囲内であることにより、生体内埋込用器具１００は、骨どうしの間に充分に強固に固定されることが可能になる。 As shown in FIG. 5, the in-vivo implant device 100 according to the present embodiment preferably has an overall width in the lateral direction W (see FIG. 1) of 6 mm or more and 12 mm or less, and preferably 7 mm or more and 11 mm or less. is more preferable, more preferably 8 mm or more and 10 mm or less, and in this embodiment, the overall width in the lateral direction W is 9 mm. When the overall width is within such a preferable range, the in-vivo implantable device 100 can be fixed sufficiently firmly between bones.
　本実施形態に係る生体内埋込用器具１００は、図５に示すように、長手方向Ｌ（図１参照）の全体長さが１７ｍｍ以上２９ｍｍ以下であることが好ましく、１９ｍｍ以上２７ｍｍ以下であることがより好ましく、２１ｍｍ以上２５ｍｍ以下であることがさらに好ましく、本実施形態において、長手方向Ｌの全体長さは２３ｍｍである。上記長さがそのような好ましい範囲内であることにより、生体内埋込用器具１００は、骨どうしの間に充分に強固に固定されることが可能になる。 As shown in FIG. 5, the in-vivo implant device 100 according to the present embodiment preferably has an overall length in the longitudinal direction L (see FIG. 1) of 17 mm or more and 29 mm or less, and preferably 19 mm or more and 27 mm or less. More preferably, the length is 21 mm or more and 25 mm or less, and in this embodiment, the overall length in the longitudinal direction L is 23 mm. When the length is within such a preferable range, the in-vivo implantable device 100 can be fixed sufficiently firmly between bones.
　複数の第１の歯１及び複数の第２の歯２の高さは、図６に示すように、高さ方向Ｈ（図１参照）において、第１の当接面２１及び第２の当接面２２を基準として０．２ｍｍ以上０．８ｍｍ以下であることが好ましく、０．３ｍｍ以上０．７ｍｍ以下であることがより好ましく、０．４ｍｍ以上０．６ｍｍ以下であることがさらに好ましい。本実施形態において、この高さは０．５ｍｍである。上記高さがそのような好ましい範囲内であることにより、生体内埋込用器具１００は、骨どうしの間に充分に強固に固定されることが可能になる。 As shown in FIG. 6, the heights of the plurality of first teeth 1 and the plurality of second teeth 2 are equal to the height of the first contact surface 21 and the second contact surface 21 in the height direction H (see FIG. 1). It is preferably 0.2 mm or more and 0.8 mm or less, more preferably 0.3 mm or more and 0.7 mm or less, and even more preferably 0.4 mm or more and 0.6 mm or less, based on the contact surface 22. In this embodiment, this height is 0.5 mm. When the height is within such a preferable range, the in-vivo implantable device 100 can be fixed sufficiently firmly between bones.
　複数の第１の歯１及び複数の第２の歯２は、長手方向Ｌ（図１参照）において、それぞれ、ある歯の頂点からそれに隣接する歯の頂点までの距離（歯のピッチ）が、１．０ｍｍ以上３．０ｍｍ以下であることが好ましい。このピッチは１．５ｍｍ以上２．３ｍｍ以下であることがより好ましく、１．８ｍｍ以上２．０ｍｍ以下であることがさらに好ましい。本実施形態において、このピッチは、１．９ｍｍである。上記間隔がそのような好ましい範囲内であることにより、生体内埋込用器具１００は、骨どうしの間に充分に強固に固定されることが可能になる。 The plurality of first teeth 1 and the plurality of second teeth 2 each have a distance (tooth pitch) from the apex of one tooth to the apex of the adjacent tooth in the longitudinal direction L (see FIG. 1). It is preferably 1.0 mm or more and 3.0 mm or less. This pitch is more preferably 1.5 mm or more and 2.3 mm or less, and even more preferably 1.8 mm or more and 2.0 mm or less. In this embodiment, this pitch is 1.9 mm. When the distance is within such a preferable range, the in-vivo implantable device 100 can be fixed sufficiently firmly between the bones.
　本実施形態に係る生体内埋込用器具１００は、図５に示すように、横方向Ｗ（図１参照）における第１の歯１及び第２の歯２の幅が、１．６ｍｍ以上２．４ｍｍ以下であることが好ましく、１．７ｍｍ以上２．３ｍｍ以下であることがより好ましく、１．８ｍｍ以上２．２ｍｍ以下であることがさらに好ましく、１．９ｍｍ以上２．１ｍｍ以下であることがさらにより好ましく、本実施形態においては２．０ｍｍである。本実施形態に係る生体内埋込用器具１００は、第１の歯１及び第２の歯２の横方向Ｗにおける幅がそのような範囲内であっても、第１の歯１及び第２の歯２に上述したような角度が付けられていること等によって、骨どうしの間に充分に強固に固定されることが可能になる。 As shown in FIG. 5, the in-vivo implant device 100 according to the present embodiment has a width of the first tooth 1 and the second tooth 2 in the lateral direction W (see FIG. 1) of 1.6 mm or more. It is preferably .4 mm or less, more preferably 1.7 mm or more and 2.3 mm or less, even more preferably 1.8 mm or more and 2.2 mm or less, and 1.9 mm or more and 2.1 mm or less. is even more preferable, and in this embodiment, it is 2.0 mm. The in-vivo implantation device 100 according to the present embodiment has the advantage that even if the width of the first tooth 1 and the second tooth 2 in the lateral direction W is within such a range, the first tooth 1 and the second tooth 2 Because the teeth 2 are angled as described above, it is possible to secure the tooth 2 sufficiently firmly between the bones.
　本実施形態に係る生体内埋込用器具１００は、図５に示すように、横方向Ｗ（図１参照）における孔部２３の幅が、４．２ｍｍ以上５．８ｍｍ以下であることが好ましく、４．４ｍｍ以上５．６ｍｍ以下であることがより好ましく、４．６ｍｍ以上５．４ｍｍ以下であることがさらに好ましく、４．８ｍｍ以上５．２ｍｍ以下であることがさらにより好ましく、本実施形態において、５．０ｍｍである。本実施形態に係る生体内埋込用器具１００は、横方向Ｗにおける孔部２３の幅がそのような範囲内であっても、第１の歯１及び第２の歯２に上述したような角度が付けられていること等によって、骨どうしの間に充分に強固に固定されることが可能になる。 In the in-vivo implant device 100 according to the present embodiment, as shown in FIG. 5, the width of the hole 23 in the lateral direction W (see FIG. 1) is preferably 4.2 mm or more and 5.8 mm or less. , more preferably 4.4 mm or more and 5.6 mm or less, further preferably 4.6 mm or more and 5.4 mm or less, even more preferably 4.8 mm or more and 5.2 mm or less, and this embodiment , it is 5.0 mm. In the in-vivo implantation device 100 according to the present embodiment, even if the width of the hole 23 in the lateral direction W is within such a range, the first tooth 1 and the second tooth 2 have the above-mentioned shape. Due to the angularity, etc., it is possible to secure the bones sufficiently firmly between the bones.
　本実施形態に係る生体内埋込用器具１００は、図５に示すように、長手方向Ｌ（図１参照）における孔部２３の長さが、８ｍｍ以上１６ｍｍ以下であることが好ましく、９ｍｍ以上１５ｍｍ以下であることがより好ましく、１０ｍｍ以上１４ｍｍ以下であることがさらに好ましく、１１ｍｍ以上１３ｍｍ以下であることがさらにより好ましく、本実施形態において、１２ｍｍである。なお、長手方向Ｌにおける孔部２３の長さは、最長部分を指すものとする。本実施形態に係る生体内埋込用器具１００は、上記孔部２３の長手方向Ｌにおける長さがそのような範囲内であっても、第１の歯１及び第２の歯２に上述したような角度が付けられていること等によって、骨どうしの間に充分に強固に固定されることが可能になる。 In the in-vivo implant device 100 according to the present embodiment, as shown in FIG. 5, the length of the hole 23 in the longitudinal direction L (see FIG. 1) is preferably 8 mm or more and 16 mm or less, and 9 mm or more. It is more preferably 15 mm or less, even more preferably 10 mm or more and 14 mm or less, even more preferably 11 mm or more and 13 mm or less, and in this embodiment, it is 12 mm. Note that the length of the hole 23 in the longitudinal direction L refers to the longest portion. In the in-vivo implantation device 100 according to the present embodiment, even if the length of the hole 23 in the longitudinal direction L is within such a range, the first tooth 1 and the second tooth 2 have the above-described structure. Due to such an angle, etc., it is possible to fix the bones sufficiently firmly between the bones.
　第１の歯１及び第２の歯２の後壁１３側には、図３に示すように、横方向Ｗに延在する第３の歯３が第１の歯１及び第２の歯２と隣り合うように第１の当接面２１上及び第２の当接面２２上に設けられている。第３の歯３と第１の歯１及び第２の歯２との間隔は、孔部２３に近い位置ほど大きくなっている。これにより、生体内埋込用器具１００は、どうしの間に充分に強固に固定されることが可能になる。 As shown in FIG. 3, on the rear wall 13 side of the first tooth 1 and the second tooth 2, there is a third tooth 3 extending in the lateral direction W. They are provided on the first contact surface 21 and the second contact surface 22 so as to be adjacent to each other. The distance between the third tooth 3, the first tooth 1, and the second tooth 2 increases as the position approaches the hole 23. This allows the in-vivo implantable device 100 to be fixed sufficiently firmly between the devices.
　図７は、長手方向の引き抜き試験を模式的に示し、図８は、横方向の引き抜き試験を模式的に示す。
　長手方向Ｌの引き抜き試験は、図７に示すように、一対の模擬骨３０，３１の間に生体内埋込用器具１００を挟み、生体内埋込用器具１００を長手方向Ｌに引き抜くときの最大荷重（Ｎ）を測定した。この試験において、模擬骨としては、ソーボーン社製の「Ｓｏｌｉｄ　ｒｉｇｉｄｐｏｌｙｕｒｅｔｈａｎｅ　ｆｏａｍ　１５　ｐｃｆ」（材質はポリウレタンフォーム、ＡＳＴＭ　Ｆ１８３９に準拠するＧｒａｄｅ　１５）を用いており、押付荷重１００Ｎで生体内埋込用器具１００を挟むように上側の模擬骨を矢印Ａで示す方向に押し付けた。生体内埋込用器具１００は、側壁１１の開口部１１ａと側壁１２の開口部１２ａを通って渡された軸３２をワイヤ３３で長手方向Ｌに矢印Ｂで示すように引き抜いており、このときの引抜速度は１０ｍｍ／ｍｉｎである。 FIG. 7 schematically shows a longitudinal pull-out test, and FIG. 8 schematically shows a transverse pull-out test.
In the pullout test in the longitudinal direction L, as shown in FIG. The maximum load (N) was measured. In this test, "Solid rigid polyurethane foam 15 pcf" (material: polyurethane foam, Grade 15 based on ASTM F1839) manufactured by Soborn Corporation was used as the simulated bone, and the in-vivo implantation device 100 pcf was used with a pressing load of 100 N. The upper simulated bone was pressed in the direction shown by arrow A so as to sandwich it. In the in-vivo implantation device 100, the shaft 32 passed through the opening 11a of the side wall 11 and the opening 12a of the side wall 12 is pulled out with a wire 33 in the longitudinal direction L as shown by arrow B. The drawing speed is 10 mm/min.
　長手方向Ｌの引き抜き試験では、第１の歯１及び第２の歯２の横方向Ｗに対して傾いた角度θ１，θ２をそれぞれ同じ大きさとし、角度θ１，θ２を０度、５度、１０度、１５度、２０度、２５度、３０度、３５度、４０度と変化させたときの平均引抜最大荷重（Ｎ）について測定している。歯の角度が０度であり、孔部が本実施形態の生体内埋込用器具１００よりも小さい（従って、歯の幅は本実施形態の生体内埋込用器具１００よりも大きい）従来品についても同様の試験を行った。従来品は下記表において「従来」と表記する。従来品の構造は図９に示す。 In the pull-out test in the longitudinal direction L, the angles θ1 and θ2 of the first tooth 1 and the second tooth 2 tilted with respect to the lateral direction W are the same, and the angles θ1 and θ2 are set to 0 degrees, 5 degrees, and 10 degrees. The average maximum pullout load (N) was measured when the load was changed to 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, and 40 degrees. A conventional product in which the tooth angle is 0 degrees and the hole is smaller than the in-vivo implant device 100 of this embodiment (therefore, the tooth width is larger than the in-vivo implant device 100 of this embodiment) A similar test was also conducted for Conventional products are indicated as "conventional" in the table below. The structure of the conventional product is shown in Figure 9.
　長手方向Ｌの引き抜き試験の測定結果は、表１に示すようになった。なお、この表において、角度θ１，θ２が１５度のものだけ５回測定し、それ以外の角度θ１，θ２では４回測定した。 The measurement results of the pull-out test in the longitudinal direction L are shown in Table 1. In this table, only the angles θ1 and θ2 of 15 degrees were measured five times, and the other angles θ1 and θ2 were measured four times.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
　横方向Ｗの引き抜き試験は、図８に示すように、一対の模擬骨３０，３１の間に生体内埋込用器具１００を挟み、生体内埋込用器具１００を横方向Ｗに引き抜くときの最大荷重（Ｎ）を測定した。この試験は、引き抜き方向を前方ではなく後方にする等の変更をした以外は、基本的にＡＳＴＭ　Ｆ－０４．２５．０２．０２に基づいて行った。この試験において、模擬骨としては、ソーボーン社製の「Ｓｏｌｉｄ　ｒｉｇｉｄｐｏｌｙｕｒｅｔｈａｎｅ　ｆｏａｍ　１５　ｐｃｆ」（材質はポリウレタンフォーム、ＡＳＴＭ　Ｆ１８３９に準拠するＧｒａｄｅ　１５）を用いており、押付荷重１００Ｎで生体内埋込用器具１００を挟むように上側の模擬骨を矢印Ａで示す方向に押し付けた。生体内埋込用器具１００は、縦棒３４ａと横棒３４ｂとが一体でＴ字形状に組まれたＴ字部材３４の縦棒３４ａ部分を側壁１１の開口部１１ａ（図４参照）と側壁１２の開口部１２ａ（図４参照）とを通し、横棒３４ｂ部分を側壁１２に外側から当接させ、Ｔ字部材３４をワイヤ３５で横方向Ｗに矢印Ｃで示すように引き抜いており、このときの引抜速度は１０ｍｍ／ｍｉｎである。 In the pullout test in the lateral direction W, as shown in FIG. The maximum load (N) was measured. This test was basically conducted based on ASTM F-04.25.02.02, with the exception of changes such as changing the pulling direction to the rear instead of the front. In this test, "Solid rigid polyurethane foam 15 pcf" (material: polyurethane foam, Grade 15 in accordance with ASTM F1839) manufactured by Soborn was used as the simulated bone, and the in-vivo implantation device 100 was used with a pressing load of 100 N. The upper simulated bone was pressed in the direction shown by arrow A so as to sandwich it. The device 100 for implantation in a living body has a T-shaped member 34 in which a vertical bar 34a and a horizontal bar 34b are integrally assembled in a T-shape. 12 opening 12a (see FIG. 4), the horizontal bar 34b is brought into contact with the side wall 12 from the outside, and the T-shaped member 34 is pulled out in the lateral direction W as shown by arrow C with a wire 35. The drawing speed at this time was 10 mm/min.
　横方向Ｗの引き抜き試験でも、第１の歯１及び第２の歯２の横方向Ｗに対して傾いた角度θ１，θ２をそれぞれ同じ大きさとし、角度θ１，θ２を０度、５度、１０度、１５度、２０度、２５度、３０度、３５度、４０度と変化させたときの平均引抜最大荷重（Ｎ）について測定している。 In the pullout test in the lateral direction W, the angles θ1 and θ2 of the first tooth 1 and the second tooth 2 tilted with respect to the lateral direction W are the same, and the angles θ1 and θ2 are set to 0 degrees, 5 degrees, and 10 degrees. The average maximum pullout load (N) was measured when the load was changed to 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, and 40 degrees.
　横方向Ｗの引き抜き試験の測定結果は、表２に示すようになった。なお、この表において、全ての角度θ１，θ２について４回測定した。 The measurement results of the pull-out test in the lateral direction W are shown in Table 2. In this table, all angles θ1 and θ2 were measured four times.
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000002
　表１及び表２から、第１の歯１及び第２の歯２の横方向Ｗに対する角度θ１，θ２は、１０度以上２５度以下であることが好ましく、より好ましくは１０度以上２０度以下、さらに好ましくは７．５度以上１７．５度以下であり、特に１５度とすると引抜荷重が大幅に大きくなり最も好ましいことが分かる。 From Tables 1 and 2, the angles θ1 and θ2 of the first tooth 1 and the second tooth 2 with respect to the lateral direction W are preferably 10 degrees or more and 25 degrees or less, more preferably 10 degrees or more and 20 degrees or less. More preferably, it is 7.5 degrees or more and 17.5 degrees or less, and in particular, it is found that 15 degrees is the most preferable because the pull-out load becomes significantly large.
　従来品は、本実施形態の生体内埋込用器具１００よりも孔部が小さく、歯が本実施形態の生体内埋込用器具１００よりも大きいため、歯の角度が同じ０度においては、長手方向Ｌ及び横方向Ｗのいずれにおいても、本実施形態の生体内埋込用器具１００よりも大きい平均引抜最大荷重（Ｎ）を発揮した。しかし、従来品は、孔部が小さいため、そもそも、本実施形態の生体内埋込用器具１００のように多量又は大きい多孔性の材料を充填することはできないものであり、比較的大きい孔部を有し（接触面が比較的小さい）ながら骨に対して充分な固定力を発揮するという本発明の課題を解決し得るものではない。 The conventional product has a smaller hole than the in-vivo implantation device 100 of this embodiment, and the teeth are larger than the in-vivo implantation device 100 of this embodiment, so at the same tooth angle of 0 degrees, In both the longitudinal direction L and the lateral direction W, the average maximum pullout load (N) was greater than that of the in-vivo implantable device 100 of this embodiment. However, since conventional products have small pores, they cannot be filled with a large amount or large porous material like the in-vivo implant device 100 of this embodiment, and the pores are relatively large. Although the contact surface is relatively small, the problem of the present invention of exerting a sufficient fixing force against the bone cannot be solved.
　本実施形態に係る生体内埋込用器具１００は、生体内埋込用器具１００を挟み込むように位置する一方の骨に当接する第１の当接面２１と、第１の当接面２１と背中合わせに形成されて他方の骨に当接する第２の当接面２２と、第１の当接面２１から第２の当接面２２にかけて貫通する孔部２３と、を有する細長形状のフレーム１０を備え、第１の当接面２１及び第２の当接面２２の少なくとも一方は、孔部２３を挟んだ一方の側に複数の第１の歯１がフレーム１０の長手方向Ｌに沿って配列するように設けられているとともに、他方の側に複数の第２の歯２が長手方向Ｌに沿って配列するように設けられており、第１の歯１が延在する幅方向Ｔ１及び第２の歯２が延在する幅方向Ｔ２は、第１の当接面２１または第２の当接面２２の面内方向であるとともに横方向Ｗに対して傾いている。これにより、生体内埋込用器具１００は、第１の歯１及び第２の歯２が骨に対して位置ずれし難くなるため、骨と接触面を小さくする空洞ないし孔を有していても、骨どうしの間に充分に強固に固定されることができる。 The in-vivo implant device 100 according to the present embodiment has a first abutting surface 21 that abuts one bone positioned to sandwich the in-vivo implant device 100; An elongated frame 10 having second contact surfaces 22 formed back to back and contacting the other bone, and a hole 23 penetrating from the first contact surface 21 to the second contact surface 22. At least one of the first contact surface 21 and the second contact surface 22 has a plurality of first teeth 1 on one side with the hole 23 interposed therebetween along the longitudinal direction L of the frame 10. A plurality of second teeth 2 are provided so as to be arranged along the longitudinal direction L, and a plurality of second teeth 2 are provided so as to be arranged along the longitudinal direction L, and the first teeth 1 extend in the width direction T1 and The width direction T2 in which the second tooth 2 extends is an in-plane direction of the first abutting surface 21 or the second abutting surface 22, and is inclined with respect to the lateral direction W. As a result, the in-vivo implantation device 100 has a cavity or a hole that reduces the contact surface with the bone so that the first tooth 1 and the second tooth 2 are difficult to displace relative to the bone. can also be fixed sufficiently firmly between the bones.
　以上、実施形態を用いて本発明を説明したが、本発明はこれに限定されるものではない。例えば、上記実施形態では、横方向に対する第１の歯及び第２の歯の角度が１５°である生体内埋込用器具について説明しているが、これに限定されない。上記実施形態に係る生体内埋込用器具１００と同程度の寸法を有し、第１の歯と第２の歯とが横方向に対して傾いていれば、例えば、図１０に示すように、横方向に対する第１の歯及び第２の歯の角度が１０°であったり、図１１に示すように、横方向に対する第１の歯及び第２の歯の角度が２０°であったりしてもよい。 Although the present invention has been described above using embodiments, the present invention is not limited thereto. For example, in the above embodiment, an in-vivo implantation device is described in which the angle of the first tooth and the second tooth with respect to the lateral direction is 15 degrees, but the present invention is not limited to this. If the device has the same dimensions as the in-vivo implant device 100 according to the above embodiment, and the first tooth and the second tooth are inclined with respect to the lateral direction, for example, as shown in FIG. , the angle of the first tooth and the second tooth with respect to the lateral direction may be 10°, or as shown in FIG. 11, the angle of the first tooth and the second tooth with respect to the lateral direction may be 20°. It's okay.
　　Ｗ…横方向
　　Ｌ…長手方向
　　Ｔ１…幅方向
　　Ｔ２…幅方向
　　１…第１の歯
　　２…第２の歯
　　３…第３の歯
　　１０…フレーム（本体部）
　　１１…側壁
　　１１ａ…開口部
　　１２…側壁
　　１２ａ…開口部
　　１３…後壁
　　１４…前壁
　　２０…基材
　　２１…第１の当接面
　　２２…第２の当接面
　　２３…孔部
　　３０…模擬骨
　　３１…模擬骨
　　３２…軸
　　３３…ワイヤ
　　３４…Ｔ字部材
　　３４ａ…縦棒
　　３４ｂ…横棒
　　３５…ワイヤ
　　１００…生体内埋込用器具
　　１０１…器具
  W... Lateral direction L... Longitudinal direction T1... Width direction T2... Width direction 1... First tooth 2... Second tooth 3... Third tooth 10... Frame (body part)
DESCRIPTION OF SYMBOLS 11... Side wall 11a... Opening part 12... Side wall 12a... Opening part 13... Rear wall 14... Front wall 20... Base material 21... First contact surface 22... Second contact surface 23... Hole part 30... Simulated bone 31... Simulated bone 32... Shaft 33... Wire 34... T-shaped member 34a... Vertical bar 34b... Horizontal bar 35... Wire 100... In-vivo implantation instrument 101... Instrument

Claims (7)

  1. 　対向する骨どうしの間に挟むための生体内埋込用器具において、
    　一方の骨に当接する第１の当接面と、
    　前記第１の当接面と背中合わせに形成されて他方の骨に当接する第２の当接面と、
    　前記第１の当接面から前記第２の当接面にかけて貫通する孔部と、
    を有する細長形状の本体部を備え、
    　前記第１の当接面及び前記第２の当接面の少なくとも一方は、前記孔部を挟んだ一方の側に複数の第１の歯が前記本体部の長手方向に沿って配列するように設けられているとともに、他方の側に複数の第２の歯が前記長手方向に沿って配列するように設けられており、
    　前記第１の歯が延在する幅方向及び前記第２の歯が延在する幅方向は、前記第１の当接面または前記第２の当接面の面内方向であるとともに前記長手方向に垂直な方向である横方向に対して傾いていることを特徴とする、生体内埋込用器具。     In an in-vivo implantable device to be inserted between opposing bones,
    a first contact surface that contacts one bone;
    a second abutting surface formed back to back with the first abutting surface and abutting the other bone;
    a hole penetrating from the first contact surface to the second contact surface;
    comprising an elongated main body having a
    At least one of the first contact surface and the second contact surface is configured such that a plurality of first teeth are arranged along the longitudinal direction of the main body on one side of the hole. and a plurality of second teeth are provided on the other side so as to be arranged along the longitudinal direction,
    The width direction in which the first teeth extend and the width direction in which the second teeth extend are in-plane directions of the first contact surface or the second contact surface and the longitudinal direction. An in-vivo implantation device characterized by being inclined with respect to the lateral direction, which is a direction perpendicular to the .
  2. 　請求項１に記載の生体内埋込用器具において、
    　前記本体部は、前記長手方向の一端がくさび形状に形成されており、
    　前記第１の歯及び前記第２の歯は、前記孔部側が前記一端に近くなるように傾いて設けられたことを特徴とする、生体内埋込用器具。     The in-vivo implantable device according to claim 1,
    The main body portion has one end in the longitudinal direction formed in a wedge shape,
    The device for implantation in a living body, wherein the first tooth and the second tooth are provided at an angle so that the hole side is closer to the one end.
  3. 　請求項２に記載の生体内埋込用器具において、
    　前記第１の歯及び前記第２の歯は、前記横方向に対して１０度以上２５度以下の傾きを有するように設けられたことを特徴とする、生体内埋込用器具。     The in-vivo implantable device according to claim 2,
    An instrument for implantation in a living body, wherein the first tooth and the second tooth are provided at an inclination of 10 degrees or more and 25 degrees or less with respect to the lateral direction.
  4. 　請求項３に記載の生体内埋込用器具において、
    　前記第１の歯及び前記第２の歯は、前記横方向に対して１０度以上２０度以下の傾きを有するように設けられたことを特徴とする、生体内埋込用器具。     The in-vivo implantable device according to claim 3,
    The device for implantation in a living body, wherein the first tooth and the second tooth are provided with an inclination of 10 degrees or more and 20 degrees or less with respect to the lateral direction.
  5. 　請求項４に記載の生体内埋込用器具において、
    　前記第１の歯及び前記第２の歯は、前記横方向に対して７．５度以上１７．５度以下の傾きを有するように設けられたことを特徴とする、生体内埋込用器具。     The in-vivo implantable device according to claim 4,
    An in-vivo implantation device, characterized in that the first tooth and the second tooth are provided with an inclination of 7.5 degrees or more and 17.5 degrees or less with respect to the lateral direction. .
  6. 　請求項５に記載の生体内埋込用器具において、
    　前記第１の歯及び前記第２の歯は、前記横方向に対して１５度の傾きを有するように設けられたことを特徴とする、生体内埋込用器具。     The in-vivo implantable device according to claim 5,
    The device for implantation in a living body, wherein the first tooth and the second tooth are provided at an angle of 15 degrees with respect to the lateral direction.
  7. 　請求項１乃至６のいずれか１項に記載の生体内埋込用器具において、
    　前記第１の当接面または前記第２の当接面は、前記横方向に延在する第３の歯が前記第１の歯及び前記第２の歯と隣り合うように設けられており、前記第３の歯と前記第１の歯及び前記第２の歯との間隔は、前記孔部に近い位置ほど大きくなっていることを特徴とする、生体内埋込用器具。
          The in-vivo implantable device according to any one of claims 1 to 6,
    The first contact surface or the second contact surface is provided such that the third tooth extending in the lateral direction is adjacent to the first tooth and the second tooth, An instrument for implantation in a living body, characterized in that a distance between the third tooth, the first tooth, and the second tooth increases as the position approaches the hole.
PCT/JP2023/021015 2022-06-06 2023-06-06 Device for in-vivo implantation WO2023238865A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2022-091463 2022-06-06
JP2022091463A JP7200425B1 (en) 2022-06-06 2022-06-06 Implantable device

Publications (1)

Publication Number Publication Date
WO2023238865A1 true WO2023238865A1 (en) 2023-12-14

Family

ID=84796999

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2023/021015 WO2023238865A1 (en) 2022-06-06 2023-06-06 Device for in-vivo implantation

Country Status (2)

Country Link
JP (1) JP7200425B1 (en)
WO (1) WO2023238865A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003526458A (en) * 2000-03-14 2003-09-09 エスディージーアイ・ホールディングス・インコーポレーテッド Vertebral implant to promote spinal bone fixation
JP2016135243A (en) * 2015-01-14 2016-07-28 ストライカー・ユーロピアン・ホールディングス・Ｉ，リミテッド・ライアビリティ・カンパニー Spinal implant with porous and solid surfaces
JP2022514621A (en) * 2018-12-20 2022-02-14 アディティブ インプランツ インコーポレイテッド Spondylolisthesis system

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003526458A (en) * 2000-03-14 2003-09-09 エスディージーアイ・ホールディングス・インコーポレーテッド Vertebral implant to promote spinal bone fixation
JP2016135243A (en) * 2015-01-14 2016-07-28 ストライカー・ユーロピアン・ホールディングス・Ｉ，リミテッド・ライアビリティ・カンパニー Spinal implant with porous and solid surfaces
JP2022514621A (en) * 2018-12-20 2022-02-14 アディティブ インプランツ インコーポレイテッド Spondylolisthesis system

Also Published As

Publication number Publication date
JP2023178659A (en) 2023-12-18
JP7200425B1 (en) 2023-01-06

Similar Documents

Publication Publication Date Title
US11083589B2 (en) Multi-walled placeholder
US20040127993A1 (en) Spreader implant for placement between vertebrae
US11478286B2 (en) Bone fixation devices
US20040127994A1 (en) Implant for placement between vertebrae
JP4545749B2 (en) Intervertebral implant for lumbosacral joint
JP6669729B2 (en) Independent interbody implant
AU2002225119B2 (en) Intervertebral Implant with Deformable Wedge
US7618456B2 (en) Intervertebral implant
EP2632353B1 (en) Laminoplasty implant, in particular for cervical laminoplasty
US20070010888A1 (en) Intervertebral prosthesis with self-tapping fixing projections
KR20140119797A (en) Surgical staple for insertion into bones
JP2002527196A (en) Strain adjustment fixation cage for spine fixation surgery
BRPI0317820B1 (en) Intervertebral Implant
JP2008532627A (en) Translation plate with spring beam holder
JP2003339726A (en) Spine implant
KR20110067044A (en) Surgical connectors for attaching an elongated member to a bone
WO2023238865A1 (en) Device for in-vivo implantation
CA2568776C (en) Osteosynthesis plate
KR20210100780A (en) Structure of porous spinal implant
CN107157627B (en) Mortise and tenon type thoracolumbar intervertebral fixer
JP6650931B2 (en) Intervertebral implant
CN209826835U (en) Knee joint collateral ligament insertion fixer
JP5654263B2 (en) Spacer
JP5854361B1 (en) Artificial bone spacer
CN213697143U (en) Cervical vertebra fixing device that opens door

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 23819845

Country of ref document: EP

Kind code of ref document: A1