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WO2024062361A1 - Dispositif de fixation externe pour fractures osseuses - Google Patents

Dispositif de fixation externe pour fractures osseuses Download PDF

Info

Publication number
WO2024062361A1
WO2024062361A1 PCT/IB2023/059218 IB2023059218W WO2024062361A1 WO 2024062361 A1 WO2024062361 A1 WO 2024062361A1 IB 2023059218 W IB2023059218 W IB 2023059218W WO 2024062361 A1 WO2024062361 A1 WO 2024062361A1
Authority
WO
WIPO (PCT)
Prior art keywords
connection
fixer
axis
designed
bone
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/IB2023/059218
Other languages
English (en)
Inventor
Egidio SERRA
Giuseppe MACCAGNANO
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.)
MIKAI SpA
Original Assignee
MIKAI SpA
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 MIKAI SpA filed Critical MIKAI SpA
Publication of WO2024062361A1 publication Critical patent/WO2024062361A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/60Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements for external osteosynthesis, e.g. distractors, contractors
    • A61B17/62Ring frames, i.e. devices extending around the bones to be positioned
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/60Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements for external osteosynthesis, e.g. distractors, contractors
    • A61B17/66Alignment, compression or distraction mechanisms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/60Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64Devices extending alongside the bones to be positioned
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/60Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64Devices extending alongside the bones to be positioned
    • A61B17/6491Devices extending alongside the bones to be positioned allowing small-scale motion of bone ends

Definitions

  • the present invention concerns an external fixation device for bone fractures .
  • External fixation devices for bone fractures are devices used in orthopaedic surgery to keep in position the fragments at the ends of a fractured bone and at the same time allow consolidation of the fracture , facilitating the circulation and promoting early healing .
  • external fixation devices lock in position screws which are inserted into each of the fragments into which the bone is fractured, maintaining the ends secure and stable while guaranteeing the patient a certain degree of freedom .
  • the known external fixation devices typically comprise a number of sectors having a curved shape , so that they can at least partially surround the limb comprising the bone fractured into two fragments ; each of said sectors is furthermore provided with a plurality of holes having uni form dimensions uni formly distributed along the arc of a circle defined by the sector ; typically, a number of metal wires are connected to said holes ; said wires pass through the bone and are arranged so as to define an angle with variable si ze .
  • the sectors are connected to each other by means of support elements that house a number of preferably clamp-shaped locking elements provided with a through opening and having a locking seat for housing a bone screw, in particular a head end of a bone screw .
  • each bone inj ury can vary considerably according to various parameters such as , for example , the si ze of the patient , the si ze of the fractured bone and the type of inj ury .
  • the external fixation devices of known type have some drawbacks , in particular associated with their rigidity in adapting to the di f ferent characteristics of the patient and his/her bone inj ury, in addition to the fact that the need is increasingly felt to provide external fixation devices that are simple to apply and comfortable for the patient .
  • the obj ect of the present invention is therefore to provide an external fixation device for bone fractures which is free from the drawbacks described above and, in particular, is easy and inexpensive to produce .
  • an external fixation device is provided for bone fractures as claimed by the attached claims .
  • figure 1 is a perspective exploded view of an external fixation device for bone fractures reali zed in accordance with the present invention
  • figure 2 is a perspective view of the device of figure 1
  • figure 3 shows schematically the device of figure 1 applied to a bone fractured into two fragments .
  • the number 1 indicates as a whole an external fixation device for bone fractures .
  • the external fixation device 1 comprises a support unit 2 for resetting a bone fractured into two or more fragments .
  • the external fixation device 1 is advantageously applied to reset a bone fractured close to a j oint .
  • the support unit 2 comprises a fixer 3 , having a curved shape and reduced thickness .
  • the fixer 3 has a substantially semicircular shape so that it can at least partially surround the limb comprising the bone fractured into two fragments .
  • the fixer 3 extends over an arc of a circle that preferably covers 5/ 8 of an entire circle .
  • said extension of the fixer 3 is particularly advantageous as it allows the limb (such as a leg or an arm) to be adequately enveloped without excessively obstructing the limb movements .
  • the fixer 3 is also provided with a plurality of holes 4 or through openings .
  • the holes 4 are uni formly distributed along the arc of a circle defined by the fixer 3 .
  • the fixer 3 typically, to the fixer 3 are connected a number of metal wires 5 that pass through the bone and are arranged so as to define an angle a; preferably, the angle a has a si ze ranging from 15 ° to 25 ° .
  • the metal wires 5 ( two in number ) are connected to substantially diametrically opposite holes 4 .
  • a wire 5a is provided connected to the two holes of the fixer indicated by 4a and 4b and a wire 5b is connected to the two holes indicated by 4c and 4d .
  • the support unit 2 comprises a bearing element 6 which is connected to the fixer 3 by the interposition of a radial connection assembly 7 .
  • the supporting element 6 is intended to allow a number of locking elements BE , of known type , to be locked in a removable manner .
  • the bearing element 6 is intended to allow two clamp-shaped locking elements BE , provided with a through opening and having a locking seat for housing a respective bone screw BS , to be locked in a removable manner .
  • locking elements BE are connected to the fixer 3 in a removable manner .
  • two clamp-shaped locking elements BE are connected in a removable manner to the holes 4 , each of which is in turn connected to a respective locking element BE of the bearing element 6 .
  • the radial connection assembly 7 comprises a connection element 8 provided in turn by means of a threaded pin 9 and a connection plate 10 arranged at one end of the threaded pin 9 .
  • the threaded pin 9 and the connection plate 10 are made in one piece .
  • the connection plate 10 is provided with through slots 11 , having an oblong shape and arranged at the opposite end of the connection plate 10 , on opposite sides with respect to the threaded pin 9 .
  • the threaded pin 9 has a cylindrical symmetry around an axis X .
  • connection plate 10 In use , a flat upper surface of the connection plate 10 is arranged in contact with a flat lower surface of the fixer 3 so as to align the pair of slots 11 with a pair of holes 4 to allow connection of the connection element 8 to the fixer 3 by means of a respective fixing device 12 , preferably obtained by means of a bolt and a nut .
  • connection element 8 is connected to the fixer 3 in a central position; namely, the two holes used to provide the connection with the connection element 8 are indicated by 4e and 4 f and are obtained in a substantially central position of the fixer 3 .
  • the radial connection assembly 7 then comprises a spacer element 13 having a cylindrical symmetry around an axis X and divided into a body 14 and a head 15 having a greater radial thickness than the body 14 .
  • a threaded hole 16 is defined designed to accommodate said threaded pin 9 .
  • the hole 16 has longitudinal dimensions ( along the axis X ) such as to completely accommodate on the inside the threaded pin 9 .
  • the position of the threaded pin 9 inside the hole 16 can be adj usted by rotating the spacer element 13 around the axis X in a clockwise or anticlockwise direction .
  • a number (preferably four ) of locking elements 17 locking the spacer element 13 to the connection element 8 are al so provided, preferably uni formly distributed around the axis X .
  • the radial connection assembly 7 comprises a j oint element 18 provided by a hollow body 19 having a cylindrical symmetry around the axis X .
  • a hole 20 is defined inside the j oint element 18 .
  • the hole 20 has longitudinal dimensions ( along the axis X ) such as to fully accommodate the body 14 on the inside .
  • a number (preferably two ) of locking grub screws 21 locking the spacer element 13 to the j oint element 18 are also provided, preferably uni formly distributed around the axis X .
  • the head 15 is arranged in abutment on an upper end of the j oint element 18 .
  • the j oint element comprises a pin 22 that protrudes radially and is defined by an element with a cylindrical symmetry around an axis Y, orthogonal to the axis X .
  • the pin 22 is intended to provide the coupling with the bearing element 6 .
  • the bearing element 6 is defined by means of two annular elements arranged in a T shape .
  • the bearing element 6 comprises a plate 23 in which an oblong slot 24 is obtained; in particular the slot 24 has an oval shape .
  • the slot 24 has in the longitudinal direction ( along the axis X ) a width that approximates the dimensions of the pin 22 ; the slot 24 accommodates the pin 22 to allow connection with the j oint element 18 by means of a respective fixing device 25 , preferably obtained by means of a washer and a nut .
  • the bearing element 6 comprises a plate 26 in which an oblong slot 27 is obtained; in particular the slot 27 has an oval shape .
  • the equatorial plane of the slot 27 is orthogonal to the equatorial plane of the slot 24 .
  • the slot 27 is designed to accommodate a number (preferably two ) of locking elements , of known type , preferably clamp-shaped and provided with a through opening and having a locking seat to accommodate a bone screw, in particular a head end of a bone screw .
  • the spacer element 13 is rotated around the axis X in a clockwise or anticlockwise direction by varying along the axis X (up or down) the position of the spacer 13 with respect to the connection element 8 .
  • the external fixation device 1 allows simple adj ustment of the relative position o f the spacer 13 with respect to the connection element 8 also allowing micro corrections in the reduction of the bone fracture .

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (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

Un dispositif de fixation externe (1) pour réinitialiser un os brisé en deux fragments comprenant un élément de fixation (3) ayant une forme incurvée de telle sorte qu'il peut entourer au moins partiellement le membre comprenant l'os brisé en deux fragments ; un élément d'appui (6) conçu pour permettre de verrouiller de manière amovible un certain nombre d'éléments de verrouillage qui présentent un siège de verrouillage pour loger une vis à os ; et un ensemble de liaison radiale (7) interposé entre l'élément de fixation (3) et l'élément d'appui (6) et comprenant un élément de liaison (8) conçu pour créer une liaison avec l'élément de fixation (3), un élément d'articulation (18) conçu pour créer une liaison avec l'élément d'appui (6) et un élément d'espacement (13) interposé entre l'élément de liaison (8) et l'élément d'articulation (18) et pouvant tourner autour d'un premier axe (X) afin de modifier la position de l'élément d'espacement (13) par rapport à l'élément de liaison (8).
PCT/IB2023/059218 2022-09-19 2023-09-18 Dispositif de fixation externe pour fractures osseuses Ceased WO2024062361A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102022000019140 2022-09-19
IT102022000019140A IT202200019140A1 (it) 2022-09-19 2022-09-19 Dispositivo fissatore esterno per fratture ossee

Publications (1)

Publication Number Publication Date
WO2024062361A1 true WO2024062361A1 (fr) 2024-03-28

Family

ID=84362502

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2023/059218 Ceased WO2024062361A1 (fr) 2022-09-19 2023-09-18 Dispositif de fixation externe pour fractures osseuses

Country Status (2)

Country Link
IT (1) IT202200019140A1 (fr)
WO (1) WO2024062361A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009100459A1 (fr) * 2008-02-08 2009-08-13 Texas Scottish Rite Hospital For Children Étai de fixation externe
CN202365897U (zh) * 2011-10-27 2012-08-08 天津市新中医疗器械有限公司 三维空间外固定架
WO2020047334A1 (fr) * 2018-08-29 2020-03-05 Amdt Holdings, Inc. Ensemble entretoise réglable pour systèmes de fixation externes
EP4000545A1 (fr) * 2020-11-24 2022-05-25 Orthofix S.r.l. Système amélioré de fixation externe orthopédique avec rails ou patins amovibles

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009100459A1 (fr) * 2008-02-08 2009-08-13 Texas Scottish Rite Hospital For Children Étai de fixation externe
CN202365897U (zh) * 2011-10-27 2012-08-08 天津市新中医疗器械有限公司 三维空间外固定架
WO2020047334A1 (fr) * 2018-08-29 2020-03-05 Amdt Holdings, Inc. Ensemble entretoise réglable pour systèmes de fixation externes
EP4000545A1 (fr) * 2020-11-24 2022-05-25 Orthofix S.r.l. Système amélioré de fixation externe orthopédique avec rails ou patins amovibles

Also Published As

Publication number Publication date
IT202200019140A1 (it) 2024-03-19

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