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WO2023199903A1 - Bague de réglage d'angle d'inclinaison de vis à plaque de fixation et système de fixation de plaque de fixation l'utilisant - Google Patents

Bague de réglage d'angle d'inclinaison de vis à plaque de fixation et système de fixation de plaque de fixation l'utilisant Download PDF

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Publication number
WO2023199903A1
WO2023199903A1 PCT/JP2023/014653 JP2023014653W WO2023199903A1 WO 2023199903 A1 WO2023199903 A1 WO 2023199903A1 JP 2023014653 W JP2023014653 W JP 2023014653W WO 2023199903 A1 WO2023199903 A1 WO 2023199903A1
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WO
WIPO (PCT)
Prior art keywords
ring
screw
hole
leg
plate
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2023/014653
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English (en)
Japanese (ja)
Inventor
ザッタ，ダニエル
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nipro Corp
Original Assignee
Nipro Corp
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 Nipro Corp filed Critical Nipro Corp
Priority to JP2024514963A priority Critical patent/JPWO2023199903A1/ja
Publication of WO2023199903A1 publication Critical patent/WO2023199903A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor

Definitions

  • the present invention provides a screw inclination angle adjustment ring for a fixation plate that can tilt screws for fixing a fixation plate for internal fixation such as a radial plate to a bone at a desired angle with respect to the fixation plate, and fixation of the fixation plate using the same. It's about systems.
  • a fixation plate is known that straddles the fracture and fixes the radius. There is.
  • Patent Document 1 discloses that a spherical ring-shaped bearing 117 is tiltably fitted into a hole 115 of a plate 111 so that a screw 116 can be tilted in a desired direction. are doing.
  • This bearing 117 has a female threaded part 121 formed on the entire inner surface of the hole 115 to be screwed into the male threaded part 120 of the screw 116, and four slits 124 extending downward from the upper end of the bearing 117 at intervals in the circumferential direction. has been done.
  • FIG. 10B when the male threaded portion 120 of the screw 116 is screwed into the female threaded portion 121, the upper portion of the bearing 117 can expand outward in the radial direction.
  • an object of the present invention is to solve the above-mentioned problems and to provide a fixing plate screw inclination angle adjusting ring and a fixing plate fixing system that can reliably prevent a decrease in fixing force.
  • the present invention is configured as follows.
  • the present invention has a spherical outer surface, has a hole through which a screw can be inserted, and is tiltably fitted into a fitting hole of a fixation plate to be fixed to a bone.
  • the inner surface of the hole has a female thread part into which the male thread part of the head of the screw is screwed, and a plurality of leg parts branched from the middle part to the lower part by slits extending from the lower edge to the middle part.
  • a screw inclination angle adjustment ring for a fixing plate which has an engagement protrusion on the inner surface of the hole of the leg that can come into contact with the engagement protrusion below the head of the screw,
  • the male threaded portion of the head of the screw is screwed into the female threaded portion of the inner surface of the hole in the upper portion, thereby fixing the screw and the ring;
  • the engagement protrusion below the head of the screw comes into contact with the engagement protrusion on the inner surface of the hole of the leg, and the leg is pushed outward in the radial direction of the ring. is pressed against the inner surface of the fitting hole of the fixing plate, and the ring and the fixing plate are fixed.
  • the male threaded part of the screw and the female threaded part of the ring are screwed together at the upper part of the ring to exert a fixing force between the screw and the ring.
  • the engagement protrusions on the leg portions of the ring are engaged with each other to push the leg portions outward, thereby exerting a fixing force between the ring and the plate. Therefore, two types of fixing force can be exerted separately and independently, and a decrease in fixing force can be reliably prevented.
  • FIG. 1 is a perspective view of a ring of a fixation plate fixation system according to a first embodiment of the present invention.
  • FIG. 2A is a front view of the screw of the fixation plate fixation system of the first embodiment of the present invention.
  • Figure 2B is an enlarged view of the vicinity of the screw head.
  • Figure 2C is an enlarged perspective view of the vicinity of the screw head.
  • Figure 2D is a perspective view of the screw
  • FIG. 3 is a perspective view of the fixing plate of the fixing plate fixing system of the first embodiment of the present invention.
  • Figure 4A is a front view of the ring.
  • FIG. 4B is a longitudinal cross-sectional view of the ring.
  • FIG. 5 is a perspective view of the fixing system of the fixing plate according to the first embodiment of the present invention.
  • FIG. 6A is a longitudinal cross-sectional view of the screw and ring when the screw begins to be screwed into the ring.
  • Figure 6B is a front view of the screw and ring when the screw is fully screwed into the ring.
  • FIG. 7A is a plan view of the fixing plate fixing system of the first embodiment of the present invention.
  • FIG. 7B is an enlarged cross-sectional view of the fixation plate and ring of the fixation system of FIG.
  • FIG. 8A is an enlarged cross-sectional view of the fixing plate and ring in the fixing system of FIG. 7A when the lower part of the ring is inclined in the direction A of FIG. 7A with respect to the axial direction of the fitting hole of the fixing plate.
  • FIG. 8B is an enlarged cross-sectional view of the fixing plate and ring in the fixing system of FIG. 7A when the lower part of the ring is inclined in the B direction of FIG. 7A with respect to the axial direction of the fitting hole of the fixing plate.
  • FIG. 8C is an enlarged sectional view of the fixing plate and ring in the fixing system of FIG.
  • FIG. 8D is an enlarged sectional view of the fixing plate and ring in the fixing system of FIG. 7A when the lower part of the ring is inclined in the direction D of FIG. 7A with respect to the axial direction of the fitting hole of the fixing plate.
  • FIG. 8E is an enlarged sectional view of the fixing plate and ring in the fixing system of FIG. 7A when the lower part of the ring is inclined in the A direction and C direction of FIG. 7A with respect to the axial direction of the fitting hole of the fixing plate.
  • FIG. 8D is an enlarged sectional view of the fixing plate and ring in the fixing system of FIG. 7A when the lower part of the ring is inclined in the direction D of FIG. 7A with respect to the axial direction of the fitting hole of the fixing plate.
  • FIG. 8E is an enlarged sectional view of the fixing plate and ring in the fixing system of FIG. 7A when the lower part of the ring is inclined in the A direction and C direction of FIG. 7A with respect to the axial direction of the fitting
  • FIG. 9A is a longitudinal sectional view of the screw and the ring when the screw is screwed into the ring by a predetermined amount and the engagement protrusion of the screw starts to abut the engagement protrusion of the leg.
  • FIG. 9B is a longitudinal sectional view of the screw and the ring when the screw is further screwed into the ring and the engagement protrusion of the screw comes into pressure contact with the engagement protrusion of the leg and begins to push the leg outward.
  • Figure 9C the screw is completely screwed into the ring, the engagement protrusion of the screw is pressed against the engagement protrusion of the leg, and the leg is pressed against the inner peripheral surface of the fitting hole of the plate, so that the plate and ring are connected.
  • FIG. 10A is a cross-sectional view of a state in which a spherical ring-shaped bearing is tiltably fitted into a hole in a plate so that the screw can be tilted in a desired direction in Patent Document 1.
  • FIG. 10B is a cross-sectional view of a state in which the upper part of the bearing expands outward in the radial direction when the male threaded part of the screw is screwed into the female threaded part in Patent Document 1.
  • the fixing plate fixing system includes a fixing plate screw inclination angle adjustment ring 1, a screw 2, and a fixing plate 3, as shown in FIGS. 1 to 6B.
  • the fixing plate 3 is fixed to the bone with a plurality of screws 2, and as shown in FIG. 3, has a plurality of fitting holes 3a each having a concave spherical inner peripheral surface.
  • the fixing plate 3 has a wide distal region 3g having a plurality of fitting holes 3a, and a proximal region 3h extending from the distal region 3g, forming a T-shaped plate member.
  • proximal region means the region of the fixation plate 3 that is closer to the heart
  • distal region means the region of the fixation plate 3 that is closer to the heart. This refers to an area that is further away from the heart compared to the central area.
  • the fixing plate 3 is made of a thin metal plate made of titanium or its alloy, which is strong, lightweight, and has high biosafety.
  • the material of the fixing plate 3 is not limited to this, and as another example, it may be made of a synthetic resin mixed with long carbon fibers, such as a thermoplastic resin mixed with long carbon fibers, or a composite material thereof.
  • thermoplastic resins are PEEK (polyetheretherketone) or polyetherimide.
  • a specific example of the material of the fixing plate 3 is carbon fiber reinforced polyetheretherketone (CFRPEEK).
  • Other possible combinations of fibers and resins include glass fibers, metal fibers, polyamide fibers, or carbon fibers; examples of resins include epoxy resins, PEEK resins, etc. , or polyetherimide resin.
  • the screw 2 is located between a head 2a, a threaded portion 2b having a smaller diameter than the head 2a and extending from the head 2a, and the head 2a and the threaded portion 2b. It has an engaging protrusion 2f.
  • the outer peripheral surface of the head 2a has a male screw portion 2c for fixing the ring, and the outer peripheral surface of the threaded portion 2b has a male screw screwed into the bone.
  • the engagement protrusion 2f has a smaller diameter than the head 2a and tapers from the head 2a side toward the screw portion 2b side, such as a spherical surface or a conical inclined surface (including a conical straight surface). ).
  • the ring 1 has a spherical outer surface 1a with the center part most protruding, and has a hole 1b into which the screw 2 can be inserted. are doing.
  • the material of the ring 1 is, for example, titanium alloy or carbon fiber reinforced polyetheretherketone (CFRPEEK).
  • CFRPEEK carbon fiber reinforced polyetheretherketone
  • FIG. 7A is a plan view of the fixing system for explaining that the ring 1 can be tilted in any direction, for example, in directions A, B, C, D, etc.
  • FIG. 7B shows the relationship between the fixing plate 3 and the ring 1 when the ring 1 is fitted along the axial direction of the fitting hole 3a of the fixing plate 3 in FIG. 7A and the ring 1 is not inclined with respect to the axial direction x.
  • An enlarged sectional view is shown.
  • 8A to 8E show the lower part 1i of the ring 1 in the A direction, B direction, C direction, and D direction of FIG. 7A in the fixation system of FIG. 7A, respectively, with respect to the axial direction
  • FIG. 3 is an enlarged sectional view of the fixed plate 3 and the ring 1 when tilted in the A direction and the C direction, respectively.
  • the above-mentioned inclination directions are representative examples and are not limited to these directions.
  • the inner surface of the hole in the upper part 1g of the ring 1 has a female threaded part 1c into which the male threaded part 2c of the head 2a of the screw 2 is screwed.
  • the female threaded portion 1c is configured with a double thread screw, for example. Therefore, the male threaded portion 2c of the head 2a of the screw 2 is screwed into the female threaded portion 1c on the inner surface of the hole of the upper portion 1g, thereby fixing the screw 2 and the ring 1.
  • double thread screws fixing force can be obtained with less fastening operation.
  • a plurality of slits 1d extending in the axial direction of the ring hole from the lower edge to the intermediate portion 1h are provided at intervals in the circumferential direction (for example, at equal intervals).
  • the width dimension of each slit 1d is, for example, constant.
  • the lower part 1i is branched at these slits 1d, so that it has a plurality of leg parts 1e that can be bent outward in the radial direction.
  • the leg portion 1e has at least three legs. In FIG. 1, there are 12 slits 1d and 12 legs 1e, but in practice, the number of legs 1e is about 10 to 14.
  • each leg 1e has an engagement protrusion 1f that can come into contact with the engagement protrusion 2f below the head 2a of the screw 2.
  • the engagement protrusion 1f may have a spherical surface or a conical inclined surface (including a conical straight surface) that becomes tapered from the intermediate portion 1h side toward the lower end of the lower portion 1i, similar to the engagement convex portion 2f. ).
  • the outer surface of the engagement protrusion 1f is the spherical surface of the lower part 1i of the ring 1. Therefore, as shown in FIGS.
  • each leg 1e is pushed out so as to expand radially outward in the radial direction of each ring 1, and the spherical outer surface of each leg portion 1e is pressed against the inner surface of the spherical fitting hole of the fixing plate 3, so that each ring 1 is inserted into the fixing plate 3.
  • Each ring 1 and the fixing plate 3 are fixed in an inclined state relative to each other.
  • a part of the outer surface 1a of the ring 1 has flat portions 1k spaced apart by 180 degrees around the hole axis and corresponding to the flat portions 3k on the inner surface of the fitting hole 3a of the plate 3.
  • a flat portion 3k having a width slightly smaller than the flat portion 1k of the ring 1 presses and holds the ring 1.
  • the flat portion 1k is a spherical surface having a smaller radius than the radius of the spherical surface in the area other than the flat portion 1k, and means a portion that looks like a flat portion.
  • the size relationship of the dimensions is [Radius (1) of fitting hole 3a of plate 3] > [Radius (2) of 2/3 of the entire circumference of ring 1 (portion other than the flat part of ring 1)] > [Ring 1 Radius of flat part 1k of plate 3 (3) > [Width of flat part 3k of inner surface of fitting hole of plate 3 (4)], It becomes. Due to the size relationship of radius (1)>radius (2), the ring 1 freely moves and expands within the fitting hole 3a, and is fixed by pressure contact. Due to the size relationship of radius (3)>width (4), a part of the ring 1 is press-fitted into the fitting hole 3a of the plate 3 and its area is small, so it can move freely within the fitting hole 3a and retain the holding force. be.
  • the surface of the flat portion 3k of the fitting hole 3a has a diameter that is crimped to the ring 1. This surface maintains the orientation of the ring 1 at a desired angle. Further, since the ring 1 can change the angle steplessly due to its spherical structure, the axial direction x of the ring 1 can be adjusted to the optimal direction along the joint surface according to the patient's joint shape. Further, the flat part 1k of the ring 1 is aligned with the flat part 3k of the plate 3, and the ring 1 on the outer surface of the spherical surface is fitted into the fitting hole of the recessed spherical surface and is locked with a click feeling.
  • the ring 1 has two or more flat portions 1k that engage with the flat portions 3k of the fitting hole 3a of the plate 3 and are snapped into place, and are held within the fitting hole 3a of the plate 3. It can be tilted in any direction with respect to the axial direction of the fitting hole 3a of the plate 3.
  • the circumferential dimension of each of the flat portions 1k and 3k is at least 1 ⁇ 3 of the entire circumference of the respective peripheral surface.
  • the flat portions 1k and 3k refer to portions where only a portion of the outer surface of the ring 1 is flat, or portions where only a portion of the inner peripheral surface of the fitting hole 3a of the plate 3 is flat.
  • the flat portion 3k on the plate side is made to be slightly larger than the ring side, and the flat portions 1k, 3k are formed over the entire axial length of the ring 1 and the entire thickness of the plate 3.
  • the slit 1d is provided in an area that is 1/3 or more of the total length of the outer surface 1a along the axial direction of the hole 1b of the ring 1 and does not have the female threaded portion 1c up to the intermediate portion 1h.
  • “having it in an area without the female threaded part 1c” means having it only in the area without the female threaded part 1c, and having it in an area without the female threaded part 1c and having part of the slit 1d in the area where the female threaded part 1c exists. This also includes cases where it is included in the section.
  • the reason why the slit 1d is arranged in an area that is 1/3 or more of the total length of the outer surface 1a along the axial direction of the hole 1b of the ring 1 and does not have the female threaded portion 1c up to the intermediate portion 1h is because there is no female threaded portion 1c. This is to make the leg portion 1e of the region spread smoothly. Since the female threaded portion 1c ends at the position where the ring diameter is maximum, the female threaded portion 1c itself does not widen and does not affect the fastening force between the ring 1 and the screw 2.
  • the reason why the engagement convex portion 2f of the screw 2 and the engagement protrusion 1f of the leg portion 1e are provided is to ensure that the leg portion 1e spreads reliably by surface contact. That is, when the slit 1d begins to open, the engaging convex portion 2f of the screw 2 and the engaging protrusion 1f of the leg portion 1e are in surface contact, and each leg portion 1e is designed to open uniformly.
  • the load point is at the tip of the leg 1e at the beginning of opening, and as the screw 2 is screwed in, it moves to the middle of the leg 1e, reducing the moment applied from the screw 2 to the leg 1e. The risk of damage to part 1e is reduced.
  • the ring 1 is pushed into the fitting hole 3a of the plate 3 in advance and fitted so as to be tiltable.
  • a cylindrical drill guide is inserted into the hole 1b of the ring 1, and the drill guide is inserted in the desired direction with respect to the axial direction of the fitting hole 3a of the plate 3. tilt to.
  • the drill is then inserted into the angled drill guide to drill a hole in the bone.
  • the threaded portion 2b of the screw 2 is inserted into the hole 1b of the ring 1, passed through, and inserted into the bone hole formed by the drill, and the screw 2 is inserted with the tool. Turn with to start screwing.
  • each leg 1e is located at a position where the inclination angle of the inclined surface 1m of the lower end of each leg 1e in the initial position that is not pushed outward is an angle ⁇ 1 with respect to the ring axis direction x. . In this state, the outer surface of each leg portion 1e is not in contact with the inner surface of the fitting hole 3a of the plate 3.
  • each leg 1e is located at a position where the inclination angle of the inclined surface 1m at the lower end of each leg 1e is an angle ⁇ 2 (however, ⁇ 2> ⁇ 1) with respect to the ring axis direction x, and each leg The outer surface of 1e has started to come into contact with the inner surface of the fitting hole of plate 3.
  • each leg 1e is located at a position where the inclination angle of the inclined surface 1m at the lower end of each leg 1e is an angle ⁇ 3 (however, ⁇ 3> ⁇ 2) with respect to the ring axis direction x, and each leg The outer surface of 1e is in pressure contact with the inner surface of the fitting hole of the plate 3.
  • the fixing plate 3 is fixed to the bone together with the ring 1 by the screws 2.
  • the male threaded portion 2c of the screw 2 and the female threaded portion 1c of the ring 1 are screwed together at the upper portion 1g of the ring 1 to exert a fixing force between the screw 2 and the ring 1.
  • the engagement protrusion 2f of the screw 2 and the engagement protrusion 1f of the leg 1e of the ring 1 engage with each other at the lower part 1i of the ring 1, pushing the leg 1e outward and creating a fixing force between the ring 1 and the plate 3. can be demonstrated. Therefore, two types of fixing force can be exerted separately and independently, and a decrease in fixing force can be reliably prevented.
  • a radial bone plate is used as an example, but the present invention is applicable not only to the radius but also to fixation members such as plates or intramedullary nails for various parts such as the femur or tibia. be.
  • fixation plate screw inclination angle adjustment ring and fixation plate fixation system are useful because they can reliably prevent a decrease in fixation force when fixing the fixation plate to a bone with screws.
  • Screw inclination angle adjustment ring 1a Outer surface 1b Hole 1c
  • Female thread part 1d
  • Slit 1e
  • Leg part 1f
  • Engagement protrusion 1g
  • Upper part 1h
  • Intermediate part 1i
  • Lower part 1k
  • Flat part 1m
  • Lower end slope 2 Screw 2a
  • Head 2b Thread part 2c
  • Male thread part 2f Convex portion 3
  • Fixed plate 3a Fitting hole 3g Distal region 3h Proximal region 3k Flat portion x Axial direction of fitting hole

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne une bague de réglage d'angle d'inclinaison de vis de plaque de fixation et un système de fixation de plaque de fixation qui peuvent empêcher de manière fiable une réduction de la force de fixation. Cette bague présente une surface externe sphérique (1a) et un trou interne (1b) à travers lequel une vis (2) peut être insérée, et est ajustée de manière inclinable à l'intérieur d'un trou d'ajustement (3a) d'une plaque de fixation (3) pour être fixée à un os. La surface interne du trou dans une partie supérieure (1g) de la bague présente une partie de filetage femelle (1c) à laquelle est vissée une partie de filetage mâle (2c) d'une partie de tête (2a) de la vis. Une région allant d'une partie centrale (1h) à une partie inférieure (1i) de la bague comporte une pluralité de parties pattes (1e) séparées par des fentes (1d) s'étendant du bord inférieur à la partie intermédiaire. La surface interne du trou dans les parties pattes comporte des saillies de mise en prise (1f) qui peuvent venir en butée contre des parties de saillie de mise en prise (2f) de la vis qui sont situées sous la partie de tête.
PCT/JP2023/014653 2022-04-12 2023-04-11 Bague de réglage d'angle d'inclinaison de vis à plaque de fixation et système de fixation de plaque de fixation l'utilisant Ceased WO2023199903A1 (fr)

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JP2024514963A JPWO2023199903A1 (fr) 2022-04-12 2023-04-11

Applications Claiming Priority (2)

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US202263330064P 2022-04-12 2022-04-12
US63/330,064 2022-04-12

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100256686A1 (en) * 2009-04-06 2010-10-07 Lanx, Inc. Bone plate assemblies with backout protection and visual indicator
JP2011510754A (ja) * 2008-01-30 2011-04-07 イービーアイ，リミテッド ライアビリティ カンパニー 骨プレーティングシステム
WO2011085272A1 (fr) * 2010-01-08 2011-07-14 Biomet Manufacturing Corp. Vis de blocage à angle variable
US20130317554A1 (en) * 2012-05-23 2013-11-28 Thomas Purcell Locking mechanism for an implantable medical device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011510754A (ja) * 2008-01-30 2011-04-07 イービーアイ，リミテッド ライアビリティ カンパニー 骨プレーティングシステム
US20100256686A1 (en) * 2009-04-06 2010-10-07 Lanx, Inc. Bone plate assemblies with backout protection and visual indicator
WO2011085272A1 (fr) * 2010-01-08 2011-07-14 Biomet Manufacturing Corp. Vis de blocage à angle variable
US20130317554A1 (en) * 2012-05-23 2013-11-28 Thomas Purcell Locking mechanism for an implantable medical device

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