EP3897421A1 - Screw fixing device, fixing kit and fixing method - Google Patents

Screw fixing device, fixing kit and fixing method

Info

Publication number
EP3897421A1
EP3897421A1 EP19842401.2A EP19842401A EP3897421A1 EP 3897421 A1 EP3897421 A1 EP 3897421A1 EP 19842401 A EP19842401 A EP 19842401A EP 3897421 A1 EP3897421 A1 EP 3897421A1
Authority
EP
European Patent Office
Prior art keywords
screws
screw
fact
bone
fixing
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.)
Pending
Application number
EP19842401.2A
Other languages
German (de)
French (fr)
Inventor
Jean-Marie Berger
Pierric Deransart
Christopher R. Chuinard
Thomas BRADLEY EDWARDS
Grant E. GARRIGUES
Armodios M. HATZIDAKIS
Gregory P. Nicholson
Felix BUDDY SAVOIE
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.)
Azurmeds Inc
Original Assignee
Azurmeds Inc
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 Azurmeds Inc filed Critical Azurmeds Inc
Publication of EP3897421A1 publication Critical patent/EP3897421A1/en
Pending legal-status Critical Current

Links

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
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8625—Shanks, i.e. parts contacting bone tissue
    • A61B17/863—Shanks, i.e. parts contacting bone tissue with thread interrupted or changing its form along shank, other than constant taper
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/14—Surgical saws ; Accessories therefor
    • A61B17/15—Guides therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1635—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for grafts, harvesting or transplants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1684—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the shoulder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1778—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the shoulder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8605—Heads, i.e. proximal ends projecting from bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8625—Shanks, i.e. parts contacting bone tissue
    • A61B17/8635—Tips of screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8866—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices for gripping or pushing bones, e.g. approximators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • 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
    • A61F2/30721—Accessories
    • A61F2/30749—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2/40—Joints for shoulders
    • 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
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4601—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
    • 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
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4644—Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material
    • 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
    • A61B2017/564—Methods for bone or joint treatment
    • 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
    • A61B2017/567—Joint mechanisms or joint supports in addition to the natural joints and outside the joint gaps
    • 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
    • A61B2017/568—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B2017/681—Alignment, compression, or distraction mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/105—Modelling of the patient, e.g. for ligaments or bones
    • 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
    • A61F2/28—Bones
    • A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • 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
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4625—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument

Definitions

  • the invention relates to fixation by screws in bones and in particular to adaptations making it possible to optimize this fixation.
  • the fixing device comprising such screws has several drawbacks, among these:
  • a first screw provided at its proximal end with a head for compressing the bone by a straight stop
  • a second screw provided at its distal end with a bone thread having a first helix pitch and at its proximal end with a bone thread having a helix with a pitch smaller than the first pitch propeller.
  • This device is intended for fixation without a bone graft plate in the shoulder for the treatment of pathologies linked to shoulder instability.
  • This device is more particularly intended for fixing the bone graft in the context of a Lartajet procedure.
  • the screw with head is generally placed first, in particular for the reasons mentioned above. In addition, it is usually the screw located in the lowest position that is installed first.
  • At least one of the screws comprises a cannula, that is to say that the screw is formed with a longitudinal through hole,
  • the screw with head comprises:
  • At least one of the screws comprises a conical proximal threaded portion.
  • the two screws comprise a conical proximal threaded portion.
  • the taper of the proximal portion of the two screws has a half angle of about 10 degrees.
  • the proximal part of at least one screw has a smooth portion.
  • the smooth portion is preformed on the screw with head between the head and the threaded proximal portion. This characteristic facilitates the manufacture of the screw by machining.
  • the device comprises the following two screws:
  • a cannula that is to say that the screw is formed with a longitudinal through hole with a diameter between 1 and 2 millimeters
  • a distal threaded portion (at a distance from the head) threaded according to a first pitch and with an outside diameter of between 3 and 5 millimeters;
  • the threads of the distal portions of the screws are double and the threads of the proximal portions are simple.
  • the two screws have a smooth central part separating the proximal portion from the distal portion.
  • the length of the distal threaded portion forms between 46 and 56 percent of the total length of the headless screw and forms between 48 and 58 percent of the total length of the headless screw.
  • the length of the proximal threaded portion is between 5 and 9 millimeters.
  • This length is defined so that the proximal threaded portion is engaged only and only in the graft and in no case in the host bone, this to allow compression.
  • the invention also relates to a fixing kit formed from the device described above, namely that the two screws of different designs are packaged in the same package.
  • the device is remarkable in that it comprises two screws of different designs which are packaged in the same package for the purpose of creating a ready-to-use fixing kit.
  • the kit consists of two screws with a length difference between 0.5 and 5.5 millimeters.
  • kits are delivered non-sterile in a packaging suitable for sterilization by the care establishment.
  • kits are delivered sterile in a packaging suitable for sterilization by gamma ray or x-ray and suitable for aseptic transfer of the device.
  • the fixing kit contains screws which have been selected and / or sized specifically for a patient according to a preoperative planning established on the basis of the patient's preoperative imagery.
  • the invention also relates to a method of fixing a bone graft on a shoulder bone remarkable in that it uses two screws and only two adopting the characteristics described above taken together or not. [74] This process thus applies to a so-called "Latarjet" fixation procedure.
  • the process comprises, before the selection and use of the screws, a preoperative planning comprising the following operations:
  • the preoperative planning method comprises, between the identification and planning operation, an operation for measuring at least one characteristic characteristic of the patient's joint.
  • Figure 1 is an exterior side view of an embodiment of a first of the two screws of the device of the invention
  • Figure 2 is a side view in section of the screw of Figure 1;
  • Figure 3 is an external side view of an embodiment of the second of the two screws of the device of the invention.
  • Figure 4 is a side view in section of the screw of Figure 3;
  • Figure 5 is a sectional view of an assembly of a bone graft to another bone.
  • Figure 6 is a diagram of the main phases of the process leading to the creation of a kit and / or screws according to the invention specific to a patient
  • One embodiment of the device of the invention consists of the two screws shown.
  • the first screw 100 in FIGS. 1 and 2 comprises a head 110 and a rod 120.
  • the head 110 includes an imprint 111 to cooperate with a fitting tool (not shown) allowing the insertion of the screw into the bone.
  • This first screw is preformed with a cannula 130.
  • Rod 120 breaks down into several portions:
  • the second screw 200 of Figures 3 and 4 is formed of a solid headless body which includes
  • the device is used for fixing the bone graft G to a host bone O.
  • the screws are dimensioned so that:
  • the distal threaded portions 124 and 230 only cooperate with the host bone O.
  • the length of the screws 100 and 200 is defined so that the distal threaded portions 124 and 230 of the screws pass through the cortical wall, of the host bone O, opposite the bone graft G.
  • the preoperative imaging of the patient to be operated on is acquired in various ways. For example, x-rays and / or ultrasounds and / or CT images and / or MRI of the shoulder are used.
  • a modeling and identification phase 320 On the basis of the preoperative imaging of the patient to be operated, during a modeling and identification phase 320, at least one segmentation and processing algorithm makes it possible to model the patient's joint, to identify at least one structure anatomical.
  • This phase can include the measurement of at least one characteristic characteristic of the patient's joint.
  • the surgeon performs preoperative planning using a computer interface making it possible to view the modeling of the joint and to carry out at least one of the following operations: size the graft, position the graft on the host bone and position and select the screws constituting the fixing device according to the invention.
  • This method may also include the constitution, manufacture and making available for surgical intervention of a patient-specific fixation kit produced on the basis of the data previously collected and, in particular, the output data from the planning.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Neurology (AREA)
  • Dentistry (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Robotics (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

The invention relates to a screw fixing device for bone, comprising only two screws, characterised in that it comprises: - a first screw provided at the proximal end thereof with a head for compressing the bone by means of a limit stop; - a second screw provided at the distal end thereof with a bone thread section having a first helix pitch and provided at the proximal end thereof with a bone thread section having a helix with a smaller pitch than the first helix pitch.

Description

[1] Description [1] Description
[2] Titre de l'invention : DISPOSITIF DE FIXATION PAR VIS, KIT DE FIXATION ET PROCÉDÉ DE FIXATION [2] Title of the invention: SCREW FIXING DEVICE, FIXING KIT AND FIXING METHOD
[3] DOMAINE D’APPLICATION DE L’INVENTION [3] FIELD OF APPLICATION OF THE INVENTION
[4] L’invention a trait à la fixation par vis dans des os et notamment aux adaptations permettant d’optimiser cette fixation. [4] The invention relates to fixation by screws in bones and in particular to adaptations making it possible to optimize this fixation.
[5] DESCRIPTION DE L’ART ANTÉRIEUR [5] DESCRIPTION OF THE PRIOR ART
[6] Il existe une pluralité de situations où des vis sont introduites à des fins de fixation de portion d’os sur une autre portion d’os. Par exemple, dans le cadre d’une procédure de butée pour le traitement des instabilités de l’épaule, il existe un dispositif de fixation composé de deux vis assurant la fixation d’une greffe d’os (issue de la découpe de la coracoïde, opération dite Latarjet, ou d’autre prélèvement - quart externe de la clavicule, crête iliaque- ou d’allogreffe -tibia distal- ou formé par un bloc de substitut osseux) formant butée sur le bord lésé de la surface glénoïdienne de la scapula. [6] There are a plurality of situations where screws are inserted for the purpose of fixing one portion of bone to another portion of bone. For example, as part of an abutment procedure for the treatment of shoulder instabilities, there is a fixation device composed of two screws ensuring the fixation of a bone graft (resulting from the cutting of the coracoid , operation called Latarjet, or other sample - external quarter of the clavicle, iliac crest- or allograft (distal tibia- or formed by a block of bone substitute) forming a stop on the injured edge of the glenoid surface of the scapula .
[7] Parmi les vis proposées pour ce type de fixation, il existe des vis sans tête et des vis avec tête. Pour les différencier, on considère qu’une vis avec tête est préformée d’une partie proximale saillante, par rapport au fût, lisse venant bloquer l’avancement de la vis dans l’os alors qu’une vis sans tête ne présente pas cette partie saillante lisse de blocage. On appelle portion proximale la portion arrière de vis située à une extrémité de vis et préformée d’un moyen de coopération avec l’outil de pose. La portion distale est la portion avant de vis située à l’autre extrémité et venant en contact en premier avec la pièce à fixer. [7] Among the screws proposed for this type of fixing, there are headless screws and screws with head. To differentiate them, we consider that a screw with head is preformed with a protruding proximal part, relative to the shaft, smooth coming to block the advancement of the screw in the bone whereas a headless screw does not have this smooth locking projection. The rear portion of the screw located at one end of the screw and preformed by means of cooperation with the setting tool is called the proximal portion. The distal portion is the front portion of the screw located at the other end and coming into contact first with the part to be fixed.
[8] Ces vis sont classiquement utilisées pour ce type d’application par paire de vis de mêmes caractéristiques. [8] These screws are conventionally used for this type of application by pair of screws with the same characteristics.
[9] Parmi les vis sans tête, il existe celles décrites dans les documents US4175555, US4463753, US5403136, US6306140 et US10130407. [9] Among the grub screws, there are those described in documents US4175555, US4463753, US5403136, US6306140 and US10130407.
[10] Le dispositif de fixation comprenant de telles vis présente plusieurs inconvénients, parmi ceux-ci : [10] The fixing device comprising such screws has several drawbacks, among these:
[11] - La complexité de la révision (c’est-à-dire de retirer la fixation) du fait de la difficulté d’identifier la portion proximale de la vis et de la difficulté d’insérer l’outil de pose dans le moyen de coopération (enfouissement du moyen de coopération dans l’os) ; [11] - The complexity of the revision (ie removing the attachment) due to the difficulty of identifying the proximal portion of the screw and the difficulty of inserting the tool laying in the cooperation means (burial of the cooperation means in the bone);
[12] - Pour obtenir une compression adéquate, un risque de mauvais positionnement de la vis (saillie de la vis en avant de la greffe ou en arrière de la scapula) avec en conséquence : [12] - To obtain adequate compression, a risk of incorrect positioning of the screw (protrusion of the screw in front of the graft or behind the scapula) with consequently:
[13] - Risque de léser les structures anatomiques (muscle, nerf) ; [13] - Risk of damaging anatomical structures (muscle, nerve);
[14] - Risque de perte de la fixation de la greffe si une des vis traverse la greffe ; [14] - Risk of loss of graft fixation if one of the screws crosses the graft;
[15] - Pour obtenir un positionnement adéquat de la vis, un risque de compression insuffisante ou excessive (car elle dépend de la qualité osseuse et de l’enfoncement de la vis) avec en conséquence : [15] - To obtain an adequate positioning of the screw, a risk of insufficient or excessive compression (because it depends on the bone quality and the depression of the screw) with consequently:
[16] - Risque de perte de la fixation de la greffe et de mobilisation de la greffe en cas de compression insuffisante ; [16] - Risk of loss of graft fixation and mobilization of the graft in the event of insufficient compression;
- Risque de fracture de la greffe en cas de surcompression. - Risk of graft fracture in the event of overcompression.
[17] Parmi les vis avec tête, il existe celles décrites dans les documents suivants : [17] Among the screws with head, there are those described in the following documents:
US4537185, US5334204, US5925048, US6565573, US7637929 et US8900279. US4537185, US5334204, US5925048, US6565573, US7637929 and US8900279.
[18] Le dispositif comprenant de telles vis présente des inconvénients, parmi ceux- ci : [18] The device comprising such screws has drawbacks, among these:
[19] - Avec des têtes partiellement ou totalement enfouies dans la greffe (tête hémisphérique) : [19] - With heads partially or totally buried in the graft (hemispherical head):
[20] - Un risque de fracture de la greffe (section d’os trop faible entre les deux têtes de vis ou section d’os trop faible entre la tête de vis et l’extrémité de la greffe) ; [20] - A risk of graft fracture (too small a section of bone between the two screw heads or too low a section of bone between the screw head and the end of the graft);
[21] - La complexité de la révision du fait de la difficulté d’identifier la tête de vis et de la difficulté d’insérer l’outil de pose dans le moyen de coopération (enfouissement du moyen de coopération dans l’os). [21] - The complexity of the revision due to the difficulty of identifying the screw head and the difficulty of inserting the setting tool into the cooperation means (burial of the cooperation means in the bone).
[22] - Avec des têtes partiellement ou totalement saillante de la greffe (tête plate ou bombée) : [22] - With heads partially or totally projecting from the graft (flat or domed head):
[23] - Un risque d’irritation des tissus mous (muscles, ligaments, nerfs, ...) par frottement sur la tête de vis. [24] - Un risque de conflit entre les deux têtes de vis (en effet le diamètre des têtes de vis dicte l’entraxe qui peut s’avérer trop important par rapport la taille de la greffe d’os surtout en cas de petite greffe) avec en conséquence : [23] - A risk of irritation of the soft tissues (muscles, ligaments, nerves, ...) by friction on the head of the screw. [24] - A risk of conflict between the two screw heads (in fact the diameter of the screw heads dictates the distance between centers which can prove to be too large in relation to the size of the bone graft, especially in the case of a small graft ) with consequently:
[25] - Risque de fracture de la greffe (section d’os trop faible entre la tête de la deuxième vis et l’extrémité de la greffe) ; [25] - Risk of graft fracture (too small a section of bone between the head of the second screw and the end of the graft);
[26] - Risque de compression insuffisante au niveau de la seconde vis (chevauchement des têtes de vis) ; [26] - Risk of insufficient compression at the level of the second screw (overlapping of the screw heads);
[27] - Risque de malposition de la première vis (lors de la compression de la seconde vis, déplacement de la première vis pouvant générer une perte de la fixation de la vis et/ou un endommagement de la greffe) ; [27] - Risk of malposition of the first screw (during compression of the second screw, displacement of the first screw which can generate a loss of the fixation of the screw and / or damage to the graft);
[28] BRÈVE DESCRIPTION DE L’INVENTION [28] BRIEF DESCRIPTION OF THE INVENTION
[29] Ce que constatant, la demanderesse a mené des recherches visant à proposer un dispositif de fixation alternative résolvant les inconvénients de l’art antérieur. [29] Finding this, the plaintiff has conducted research aimed at proposing an alternative fixing device which overcomes the drawbacks of the prior art.
[30] Ces recherches ont abouti à la conception d‘un dispositif de fixation par vis pour os comprenant deux vis et seulement deux, remarquable en ce qu’il comprend : [30] This research led to the design of a bone screw fixation device comprising two screws and only two, remarkable in that it includes:
[31] - Une première vis pourvue à son extrémité proximale d’une tête pour comprimer l’os par une butée franche ; [31] - A first screw provided at its proximal end with a head for compressing the bone by a straight stop;
[32] - Une seconde vis pourvue à son extrémité distale d’un filetage à os présentant un premier pas d’hélice et à son extrémité proximale d’un filetage à os présentant une hélice d’un pas inférieur que le premier pas d’hélice. [32] - A second screw provided at its distal end with a bone thread having a first helix pitch and at its proximal end with a bone thread having a helix with a pitch smaller than the first pitch propeller.
[33] La différence de pas entre les filetages distal et proximal de la seconde vis permet d’obtenir la compression souhaitée. [33] The difference in pitch between the distal and proximal threads of the second screw allows the desired compression to be obtained.
[34] Ce dispositif est destiné à la fixation sans plaque de greffon d’os dans l’épaule à des fins de traitement des pathologies liées à l’instabilité de l’épaule. [34] This device is intended for fixation without a bone graft plate in the shoulder for the treatment of pathologies linked to shoulder instability.
[35] Ce dispositif est plus particulièrement destiné à la fixation du greffon d’os dans le cadre d’une procédure Lartajet. [35] This device is more particularly intended for fixing the bone graft in the context of a Lartajet procedure.
[36] Cette caractéristique est particulièrement avantageuse en ce que l’utilisation combinée d’une vis avec tête et d’une vis sans tête garantit : [37] - La position optimale des deux vis indépendantes de la taille et de la forme de la greffe ; [36] This characteristic is particularly advantageous in that the combined use of a head screw and a headless screw guarantees: [37] - The optimal position of the two screws, independent of the size and shape of the graft;
[38] - Une compression optimale de la greffe obtenue par l’appui sur la greffe de la vis avec tête et par la différence de pas entre le filet distal et le filet proximal de la vis sans tête ; [38] - Optimal compression of the graft obtained by pressing on the graft of the head screw and by the difference in pitch between the distal thread and the proximal thread of the headless screw;
[39] - L’absence de risque de conflit entre les deux portions proximales des vis l’une étant enfouie dans la greffe et l’autre étant en saillit de la greffe ; [39] - The absence of risk of conflict between the two proximal portions of the screws, one being buried in the graft and the other being protruding from the graft;
[40] - Une maîtrise du risque de fracture de la greffe puisque la première compression est donnée par la vis avec tête. Le risque d’exercer une compression excessive avec la vis sans tête est donc diminué. [40] - Control of the risk of graft fracture since the first compression is given by the screw with head. The risk of excessive compression with the grub screw is therefore reduced.
[41] La vis avec tête est généralement placée en premier pour notamment les raisons évoquées ci-dessus. De plus, c’est généralement la vis située dans la position la plus basse qui est installée en premier. [41] The screw with head is generally placed first, in particular for the reasons mentioned above. In addition, it is usually the screw located in the lowest position that is installed first.
[42] Selon une autre caractéristique particulièrement avantageuse de l’invention, au moins une des vis comprend une canule c’est-à-dire que la vis est ménagée d’un trou longitudinal traversant, [42] According to another particularly advantageous characteristic of the invention, at least one of the screws comprises a cannula, that is to say that the screw is formed with a longitudinal through hole,
[43] Selon une autre caractéristique particulièrement avantageuse de l’invention, la vis avec tête comprend : [43] According to another particularly advantageous characteristic of the invention, the screw with head comprises:
[44] - une portion filetée distale (à distance de la tête) filetée selon un premier pas, [44] - a distal threaded portion (at a distance from the head) threaded according to a first step,
[45] - une portion filetée proximale (proche de la tête) filetée selon un deuxième pas inférieur au premier pas. [45] - a proximal threaded portion (close to the head) threaded in a second step less than the first step.
[46] Selon une autre caractéristique particulièrement avantageuse, au moins une des vis comprend une portion filetée proximale conique. [46] According to another particularly advantageous characteristic, at least one of the screws comprises a conical proximal threaded portion.
[47] Selon une autre caractéristique particulièrement avantageuse, les deux vis comprennent une portion filetée proximale conique. [47] According to another particularly advantageous characteristic, the two screws comprise a conical proximal threaded portion.
[48] Selon une autre caractéristique particulièrement avantageuse de l’invention, la conicité de la portion proximale des deux vis présente un demi-angle d’environ 10 degrés. [48] According to another particularly advantageous characteristic of the invention, the taper of the proximal portion of the two screws has a half angle of about 10 degrees.
[49] Selon une autre caractéristique particulièrement avantageuse de l’invention, la partie proximale d’au moins une vis comporte une portion lisse. [50] Selon une autre caractéristique particulièrement avantageuse de l’invention, la portion lisse est préformée sur la vis avec tête entre la tête et la portion proximale filetée. Cette caractéristique facilite la fabrication de la vis par usinage. [49] According to another particularly advantageous characteristic of the invention, the proximal part of at least one screw has a smooth portion. [50] According to another particularly advantageous characteristic of the invention, the smooth portion is preformed on the screw with head between the head and the threaded proximal portion. This characteristic facilitates the manufacture of the screw by machining.
[51] Selon une autre caractéristique particulièrement avantageuse de l’invention, le dispositif comprend les deux vis suivantes : [51] According to another particularly advantageous characteristic of the invention, the device comprises the following two screws:
[52] - Une première vis avec tête [52] - A first screw with head
[53] incluant [53] including
[54] une canule c’est-à-dire que la vis est ménagée d’un trou longitudinal traversant de diamètre compris entre 1 et 2 millimètres, [54] a cannula, that is to say that the screw is formed with a longitudinal through hole with a diameter between 1 and 2 millimeters,
[55] une tête de diamètre compris entre 6 et 9 millimètres et d’épaisseur au centre comprise entre 1 et 3 millimètres, [55] a head with a diameter between 6 and 9 millimeters and a thickness at the center between 1 and 3 millimeters,
[56] une portion filetée distale (à distance de la tête) filetée selon un premier pas et de diamètre extérieur compris entre 3 et 5 millimètres ; [56] a distal threaded portion (at a distance from the head) threaded according to a first pitch and with an outside diameter of between 3 and 5 millimeters;
[57] une portion filetée proximale (proche de la tête) conique filetée selon un deuxième pas inférieur au premier pas ; [57] a proximal threaded portion (close to the head) conical threaded in a second step less than the first step;
[58] - une deuxième vis sans tête [58] - a second grub screw
[59] incluant [59] including
[60] une portion filetée distale filetée selon un premier pas et de diamètre extérieure compris entre 3 et 5 millimètres, [60] a distal threaded portion threaded according to a first pitch and with an outside diameter of between 3 and 5 millimeters,
[61] une portion filetée proximale conique filetée selon un deuxième pas inférieur au premier pas. [61] a conical proximal threaded portion threaded in a second step less than the first step.
[62] Selon un mode de réalisation préféré mais non limitatif, les filetages des portions distales des vis sont doubles et les filetages des portions proximales sont simples. [62] According to a preferred but nonlimiting embodiment, the threads of the distal portions of the screws are double and the threads of the proximal portions are simple.
[63] Selon une autre caractéristique particulièrement avantageuse de l’invention, les deux vis ont une partie médiane lisse séparant la portion proximale de la portion distale. [63] According to another particularly advantageous characteristic of the invention, the two screws have a smooth central part separating the proximal portion from the distal portion.
[64] Selon une autre caractéristique particulièrement avantageuse de l’invention, la longueur de la portion filetée distale forme entre 46 et 56 pourcents de la longueur totale de la vis avec tête et forme entre 48 et 58 pourcents de la longueur totale de la vis sans tête. [64] According to another particularly advantageous characteristic of the invention, the length of the distal threaded portion forms between 46 and 56 percent of the total length of the headless screw and forms between 48 and 58 percent of the total length of the headless screw.
[65] Cette proportion est définie de sorte que la portion filetée distale soit bien engagée seulement et uniquement dans l’os hôte et en aucun cas dans la greffe, ceci pour permettre la compression. [65] This proportion is defined so that the distal threaded portion is engaged only and only in the host bone and in no case in the graft, this to allow compression.
[66] Selon une autre caractéristique particulièrement avantageuse de l’invention, la longueur de la portion filetée proximale est comprise entre 5 et 9 millimètres. [66] According to another particularly advantageous characteristic of the invention, the length of the proximal threaded portion is between 5 and 9 millimeters.
[67] Cette longueur est définie de sorte que la portion filetée proximale soit bien engagée seulement et uniquement dans la greffe et en aucun cas dans l’os hôte, ceci pour permettre la compression. [67] This length is defined so that the proximal threaded portion is engaged only and only in the graft and in no case in the host bone, this to allow compression.
[68] L’invention concerne également un kit de fixation formé du dispositif décrit ci- dessus à savoir que les deux vis de conceptions différentes sont conditionnées dans un même emballage. Ainsi, selon une autre caractéristique particulièrement avantageuse, le dispositif est remarquable en ce qu’il comprend deux vis de conceptions différentes qui sont conditionnées dans un même emballage à des fins de création d‘un kit de fixation prêt à l’emploi. [68] The invention also relates to a fixing kit formed from the device described above, namely that the two screws of different designs are packaged in the same package. Thus, according to another particularly advantageous characteristic, the device is remarkable in that it comprises two screws of different designs which are packaged in the same package for the purpose of creating a ready-to-use fixing kit.
[69] Selon un mode de réalisation particulièrement avantageux de l’invention, le kit est constitué de deux vis avec une différence de longueur comprise entre 0,5 et 5,5 millimètres. [69] According to a particularly advantageous embodiment of the invention, the kit consists of two screws with a length difference between 0.5 and 5.5 millimeters.
[70] Selon un mode de réalisation, les kits sont livrés non stériles dans un conditionnement adapté à la stérilisation par l'établissement de soins. [70] According to one embodiment, the kits are delivered non-sterile in a packaging suitable for sterilization by the care establishment.
[71] Selon un autre mode de réalisation, les kits sont livrés stériles dans un conditionnement adapté à la stérilisation par rayon gamma ou rayon x et adapté à un transfert aseptique du dispositif. [71] According to another embodiment, the kits are delivered sterile in a packaging suitable for sterilization by gamma ray or x-ray and suitable for aseptic transfer of the device.
[72] Selon une autre caractéristique particulièrement avantageuse, le kit de fixation contient des vis qui ont été sélectionnées et/ou dimensionnées spécifiquement pour un patient selon une planification préopératoire établie sur la base de l’imagerie préopératoire du patient. [72] According to another particularly advantageous characteristic, the fixing kit contains screws which have been selected and / or sized specifically for a patient according to a preoperative planning established on the basis of the patient's preoperative imagery.
[73] L’invention concerne également un procédé de fixation d’une greffe d’os sur un os d’épaule remarquable en ce qu’il utilise deux vis et seulement deux adoptant les caractéristiques décrites ci-dessus prises ensemble ou non. [74] Ce procédé s’applique ainsi à une procédure de fixation dite « Latarjet ». [73] The invention also relates to a method of fixing a bone graft on a shoulder bone remarkable in that it uses two screws and only two adopting the characteristics described above taken together or not. [74] This process thus applies to a so-called "Latarjet" fixation procedure.
[75] Selon une autre caractéristique particulièrement avantageuse, le procédé comprend préalablement à la sélection et à l’utilisation des vis, une planification préopératoire comportant les opérations suivantes : [75] According to another particularly advantageous characteristic, the process comprises, before the selection and use of the screws, a preoperative planning comprising the following operations:
[76] - Collecte d’une imagerie préopératoire de l’épaule du patient par [76] - Collection of preoperative imaging of the patient's shoulder by
radiographie et/ou échographie et/ou image scanner et/ou IRM de l’épaule, x-ray and / or ultrasound and / or CT scan and / or MRI of the shoulder,
[77] - Modélisation de l’articulation, [77] - Modeling of the joint,
[78] - Identification d’au moins une structure anatomique, [78] - Identification of at least one anatomical structure,
[79] - Planification préopératoire de au moins une des éléments suivant : [79] - Preoperative planning of at least one of the following:
dimensionnement de la greffe, positionnement de la greffe, positionnement des vis, graft sizing, graft positioning, screw positioning,
[80] Selon une autre caractéristique particulièrement avantageuse, le procédé de planification préopératoire comporte entre l’opération d’identification et de planification, une opération de mesure d’au moins une caractéristique propre de l’articulation du patient. [80] According to another particularly advantageous characteristic, the preoperative planning method comprises, between the identification and planning operation, an operation for measuring at least one characteristic characteristic of the patient's joint.
[81] Les concepts fondamentaux de l’invention venant d’être exposés ci-dessus dans leur forme la plus élémentaire, d’autres détails et caractéristiques ressortiront plus clairement à la lecture de la description qui suit et en regard des dessins annexés, donnant à titre d’exemple non limitatif, un mode de réalisation de l’invention. [81] The fundamental concepts of the invention having just been exposed above in their most basic form, other details and characteristics will emerge more clearly on reading the description which follows and with reference to the appended drawings, giving by way of nonlimiting example, an embodiment of the invention.
[82] BRÈVE DESCRIPTION DES DESSINS [82] BRIEF DESCRIPTION OF THE DRAWINGS
[83] La figure 1 est une vue extérieure de côté d’un mode de réalisation d’une première des deux vis du dispositif de l’invention ; [83] Figure 1 is an exterior side view of an embodiment of a first of the two screws of the device of the invention;
[84] La figure 2 est une vue de côté en coupe de la vis de la figure 1 ; [84] Figure 2 is a side view in section of the screw of Figure 1;
[85] La figure 3 est une vue extérieure de côté d’un mode de réalisation de la deuxième des deux vis du dispositif de l’invention ; [85] Figure 3 is an external side view of an embodiment of the second of the two screws of the device of the invention;
[86] La figure 4 est une vue de côté en coupe de la vis de la figure 3 ; [86] Figure 4 is a side view in section of the screw of Figure 3;
[87] La figure 5 est une vue en coupe d’un assemblage d’une greffe d’os à un autre os. [88] La figure 6 est un schéma des phases principales du processus aboutissant à la création d’un kit et/ou de vis selon l’invention spécifiques à un patient [87] Figure 5 is a sectional view of an assembly of a bone graft to another bone. [88] Figure 6 is a diagram of the main phases of the process leading to the creation of a kit and / or screws according to the invention specific to a patient
[89] DESCRIPTION D’UN MODE PRÉFÉRÉ DE RÉALISATION [89] DESCRIPTION OF A PREFERRED EMBODIMENT
[90] Un mode de réalisation du dispositif de l’invention est constitué par les deux vis illustrées. [90] One embodiment of the device of the invention consists of the two screws shown.
[91] La première vis 100 des figures 1 et 2 comprend une tête 110 et une tige 120. [91] The first screw 100 in FIGS. 1 and 2 comprises a head 110 and a rod 120.
La tête 110 comprend une empreinte 111 pour coopérer avec un outil (non illustré) de pose permettant l’insertion de la vis dans l’os. Cette première vis est préformée d’une canule 130. The head 110 includes an imprint 111 to cooperate with a fitting tool (not shown) allowing the insertion of the screw into the bone. This first screw is preformed with a cannula 130.
[92] La tige 120 se décompose en plusieurs portions : [92] Rod 120 breaks down into several portions:
[93] - Une portion proximale lisse 121 disposée sous la tête 110, [93] - A smooth proximal portion 121 disposed under the head 110,
[94] - Une portion filetée proximale conique 122 présentant un pas donné (simple filet), [94] - A conical proximal threaded portion 122 having a given pitch (single thread),
[95] - Une portion médiane lisse 123, [95] - A smooth middle portion 123,
[96] - Une portion filetée distale 124 présentant un pas supérieur (double filetage) au pas de la portion proximale 122. [96] - A distal threaded portion 124 having a pitch greater (double threading) than the pitch of the proximal portion 122.
[97] La deuxième vis 200 des figures 3 et 4 est formé d’un corps plein sans tête qui comprend [97] The second screw 200 of Figures 3 and 4 is formed of a solid headless body which includes
[98] - Une portion filetée proximale conique 210 présentant un pas donné (simple filet) et une empreinte 211 pour coopérer avec un outil de pose, [98] - A conical proximal threaded portion 210 having a given pitch (simple thread) and an imprint 211 to cooperate with a fitting tool,
[99] - Une portion médiane lisse 220, [99] - A smooth middle portion 220,
[100] - Une portion filetée distale 230 présentant un pas supérieur (double filetage) au pas de la portion proximale 210. [100] - A distal threaded portion 230 having a pitch greater (double threading) than the pitch of the proximal portion 210.
[101] Comme illustré sur le dessin de la figure 5, le dispositif est utilisé pour la fixation du greffon d’os G sur un os hôte O. Comme illustrées, les vis sont dimensionnées de sorte que : [101] As illustrated in the drawing in FIG. 5, the device is used for fixing the bone graft G to a host bone O. As illustrated, the screws are dimensioned so that:
[102] - les portions filetées proximales 122 et 210 ne coopèrent qu’avec le greffon G ; [102] - the proximal threaded portions 122 and 210 cooperate only with graft G;
[103] - les portions filetés distales 124 et 230 ne coopèrent qu’avec l’os hôte O. [104] De plus, la longueur des vis 100 et 200 est définie de sorte que les portions filetées distales 124 et 230 des vis traversent la paroi corticale, de l’os hôte O, opposé au greffon d’os G. [103] - the distal threaded portions 124 and 230 only cooperate with the host bone O. [104] In addition, the length of the screws 100 and 200 is defined so that the distal threaded portions 124 and 230 of the screws pass through the cortical wall, of the host bone O, opposite the bone graft G.
[105] En préalable à l’intervention chirurgicale, durant la phase de collecte de données 310, l’imagerie préopératoire du patient à opérer est acquise de diverses manières. À titre d’exemple, des radiographiques et/ou échographies et/ou images scanner et/ou IRM de l’épaule sont utilisées. [105] Prior to the surgical intervention, during the data collection phase 310, the preoperative imaging of the patient to be operated on is acquired in various ways. For example, x-rays and / or ultrasounds and / or CT images and / or MRI of the shoulder are used.
[106] Sur la base de l’imagerie préopératoire du patient à opérer, durant une phase de modélisation et identification 320, au moins un algorithme de segmentation et de traitement permet de modéliser l’articulation du patient, d’identifier au moins une structure anatomique. Cette phase peut comporter la mesure de au moins une caractéristique propre de l’articulation du patient. [106] On the basis of the preoperative imaging of the patient to be operated, during a modeling and identification phase 320, at least one segmentation and processing algorithm makes it possible to model the patient's joint, to identify at least one structure anatomical. This phase can include the measurement of at least one characteristic characteristic of the patient's joint.
[107] Durant la phase de planification 330, le chirurgien réalise une planification préopératoire au moyen d’une interface informatique permettant de visualiser la modélisation de l’articulation et de réaliser au moins une des opérations suivantes : dimensionner la greffe, positionner la greffe sur l’os hôte et positionner et sélectionner les vis constitutives du dispositif de fixation selon l’invention. [107] During the planning phase 330, the surgeon performs preoperative planning using a computer interface making it possible to view the modeling of the joint and to carry out at least one of the following operations: size the graft, position the graft on the host bone and position and select the screws constituting the fixing device according to the invention.
[108] Ce procédé peut comporter en outre la constitution, fabrication et mise à disposition pour l’intervention chirurgicale d’un kit de fixation spécifique au patient réalisé sur la base des données précédemment collectées et, en particulier, des données de sortie de la planification. [108] This method may also include the constitution, manufacture and making available for surgical intervention of a patient-specific fixation kit produced on the basis of the data previously collected and, in particular, the output data from the planning.
[109] On comprend que le dispositif qui vient d’être ci-dessus décrit et représenté, l’a été en vue d’une divulgation plutôt que d’une limitation. Bien entendu, divers aménagements, modifications et améliorations pourront être apportés à l’exemple ci-dessus, sans pour autant sortir du cadre de l’invention. [109] It is understood that the device which has just been described and shown above, was for the purpose of disclosure rather than limitation. Of course, various arrangements, modifications and improvements could be made to the above example, without going beyond the ambit of the invention.

Claims

Revendications Claims
[Revendication 1] 11. Dispositif de fixation par vis pour os comprenant deux vis et seulement deux , CARACTÉRISÉ PAR LE FAIT QU’il comprend : [Claim 1] 11. Device for fixing by screw for bone comprising two screws and only two, CHARACTERIZED BY THE FACT THAT it includes:
- Une première vis pourvue à son extrémité proximale d’une tête pour comprimer l’os par une butée franche ; - A first screw provided at its proximal end with a head to compress the bone by a straight stop;
- Une seconde vis pourvue à son extrémité distale d’un filetage à os présentant un premier pas d’hélice et à son extrémité proximale d’un filetage à os présentant une hélice d’un pas inférieur que le premier pas d’hélice. - A second screw provided at its distal end with a bone thread having a first helix pitch and at its proximal end with a bone thread having a helix with a pitch smaller than the first helix pitch.
[Revendication 2] 2. Dispositif de fixation selon la revendication 1 , [Claim 2] 2. Fastening device according to claim 1,
CARACTÉRISÉ PAR LE FAIT QUE la vis avec tête comprend : CHARACTERIZED BY THE FACT THAT the screw with head includes:
une portion filetée distale filetée selon un premier pas, a distal threaded portion threaded according to a first step,
une portion filetée proximale filetée selon un deuxième pas inférieur au premier pas. a proximal threaded portion threaded according to a second step less than the first step.
[Revendication 3] 3. Dispositif de fixation selon les revendications 1 et 2, [Claim 3] 3. Fastening device according to claims 1 and 2,
CARACTÉRISÉ PAR LE FAIT QUE au moins une des vis comprend une portion filetée proximale conique. CHARACTERIZED BY THE FACT THAT at least one of the screws includes a conical proximal threaded portion.
[Revendication 4] 4. Dispositif de fixation selon les revendications 1 et 2, [Claim 4] 4. Fastening device according to claims 1 and 2,
CARACTÉRISÉ PAR LE FAIT QUE les deux vis comprennent une portion filetée proximale conique. CHARACTERIZED BY THE FACT THAT the two screws include a conical proximal threaded portion.
[Revendication 5] 5. Dispositif de fixation selon les revendications 2 à 4, [Claim 5] 5. A fixing device according to claims 2 to 4,
CARACTÉRISÉ PAR LE FAIT QUE la conicité de la portion proximale des deux vis présente un demi-angle d’environ 10 degrés. CHARACTERIZED BY THE FACT THAT the taper of the proximal portion of the two screws has a half angle of about 10 degrees.
[Revendication 6] 6. Dispositif de fixation selon l’une quelconque des revendications précédentes, CARACTÉRISÉ PAR LE FAIT QUE la portion filetée distale des deux vis forme entre 46 et 58 pourcents de la longueur totale. [Claim 6] 6. Fastening device according to any one of the preceding claims, CHARACTERIZED BY THE FACT THAT the distal threaded portion of the two screws forms between 46 and 58 percent of the total length.
[Revendication 7] 7. Dispositif de fixation selon l’une quelconque des revendications précédentes, CARACTÉRISÉ PAR LE FAIT QUE les deux vis ont une partie médiane lisse séparant la portion proximale de la portion distale. [Claim 7] 7. A fixing device according to any one of the preceding claims, CHARACTERIZED BY THE FACT THAT the two screws have a smooth central part separating the proximal portion from the distal portion.
[Revendication 8] 8. Dispositif de fixation selon l’une quelconque des revendications précédentes, CARACTÉRISÉ PAR LE FAIT QU’au moins une des vis comprend une canule c’est-à-dire que la vis est ménagée d’un trou longitudinal traversant. [Claim 8] 8. Fastening device according to any one of the preceding claims, CHARACTERIZED BY THE FACT THAT at least one screws includes a cannula that is to say that the screw is formed with a longitudinal through hole.
[Revendication 9] 9. Dispositif de fixation selon l’une quelconque des revendications précédentes, CARACTÉRISÉ PAR LE FAIT QUE la partie proximale d’au moins une vis comporte une portion lisse. [Claim 9] 9. Fastening device according to any one of the preceding claims, CHARACTERIZED BY THE FACT THAT the proximal part of at least one screw has a smooth portion.
[Revendication 10] 10. Dispositif de fixation selon l’une quelconque des revendications précédentes, CARACTÉRISÉ PAR LE FAIT QUE la partie filetée distale d’au moins une vis comporte une double filetage. [Claim 10] 10. Fastening device according to any one of the preceding claims, CHARACTERIZED BY THE FACT THAT the distal threaded part of at least one screw has a double thread.
[Revendication 11] 11. Dispositif de fixation selon l’une quelconque des revendications précédentes, CARACTÉRISÉ PAR LE FAIT QUE la différence de longueur totale entre les deux vis est comprise entre 0,5 et 5,5 millimètres. [Claim 11] 11. Fastening device according to any one of the preceding claims, CHARACTERIZED BY THE FACT THAT the difference in total length between the two screws is between 0.5 and 5.5 millimeters.
[Revendication 12] 12. Kit de fixation formé du dispositif selon l’une quelconque des revendications précédentes, CARACTÉRISÉ PAR LE FAIT QU’il contient lesdites vis qui ont été préalablement stérilisées. [Claim 12] 12. Fixing kit formed from the device according to any one of the preceding claims, CHARACTERIZED BY THE FACT that it contains said screws which have been previously sterilized.
[Revendication 13] 13. Kit de fixation formé du dispositif selon l’une quelconque des revendications précédentes, CARACTÉRISÉ PAR LE FAIT QU’il contient les vis préalablement sélectionnées et/ou fabriquées sur la base d’une planification préopératoire. [Claim 13] 13. Fixing kit formed from the device according to any one of the preceding claims, CHARACTERIZED BY THE FACT that it contains the screws previously selected and / or manufactured on the basis of a preoperative planning.
[Revendication 14] 14. Procédé de fixation d’une greffe d’os sur un os d’épaule, CARACTÉRISÉ EN CE QU’il utilise deux vis et seulement deux où chaque vis a une conception différente selon l’une quelconque des revendications 1 à 12. [Claim 14] 14. Method for attaching a bone graft to a shoulder bone, CHARACTERIZED IN THAT it uses two screws and only two where each screw has a different design according to any one of claims 1 at 12.
[Revendication 15] 15. Procédé de fixation selon la revendication 14, [Claim 15] 15. Method of fixing according to claim 14,
CARACTÉRISÉ EN CE QU’il comprend préalablement à la sélection et à l’utilisation des vis, une planification préopératoire comportant les opérations suivantes : CHARACTERIZED IN THAT it includes, prior to the selection and use of the screws, a preoperative planning comprising the following operations:
- Collecte d’une imagerie préopératoire de l’épaule du patient par - Collection of preoperative imaging of the patient's shoulder by
radiographie et/ou échographie et/ou image scanner et/ou IRM de l’épaule, x-ray and / or ultrasound and / or CT scan and / or MRI of the shoulder,
- Modélisation de l’articulation, - Modeling of the joint,
- Identification d’au moins une structure anatomique, - Identification of at least one anatomical structure,
- Planification préopératoire de au moins une des opérations suivantes : - Preoperative planning of at least one of the following operations:
dimensionner la greffe, positionner la greffe sur l’os hôte et positionner les visj size the graft, position the graft on the host bone and position the screws
EP19842401.2A 2018-12-21 2019-12-20 Screw fixing device, fixing kit and fixing method Pending EP3897421A1 (en)

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US11291487B2 (en) 2022-04-05
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EP3897410A2 (en) 2021-10-27
US20220346849A1 (en) 2022-11-03
FR3090314A1 (en) 2020-06-26
FR3090314B1 (en) 2022-10-07
US20200197030A1 (en) 2020-06-25
WO2020129019A3 (en) 2020-08-13
US11406435B2 (en) 2022-08-09
US20220211421A1 (en) 2022-07-07
WO2020129014A1 (en) 2020-06-25

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