WO2016043676A1 - Vis pédiculaire à système d'avertissement - Google Patents

Vis pédiculaire à système d'avertissement Download PDF

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Publication number
WO2016043676A1
WO2016043676A1 PCT/TR2015/000170 TR2015000170W WO2016043676A1 WO 2016043676 A1 WO2016043676 A1 WO 2016043676A1 TR 2015000170 W TR2015000170 W TR 2015000170W WO 2016043676 A1 WO2016043676 A1 WO 2016043676A1
Authority
WO
WIPO (PCT)
Prior art keywords
pedicle screw
conductive end
electrical charge
connection point
warning
Prior art date
Application number
PCT/TR2015/000170
Other languages
English (en)
Inventor
Sezgin YILMAZ
Original Assignee
Efmed Kesi̇ci̇ Takimlar Hirdavat Tibbi̇ Aletler Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
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 Efmed Kesi̇ci̇ Takimlar Hirdavat Tibbi̇ Aletler Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ filed Critical Efmed Kesi̇ci̇ Takimlar Hirdavat Tibbi̇ Aletler Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
Publication of WO2016043676A1 publication Critical patent/WO2016043676A1/fr

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
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • 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
    • A61B17/1613—Component parts
    • A61B17/1626—Control means; Display units
    • 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
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped
    • 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
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7092—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for checking pedicle hole has correct depth or has an intact wall
    • 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
    • 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
    • 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
    • A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated

Definitions

  • the present invention relates to a pedicle screw with warning system which is inserted into vertebra in spinal operations and gives audio and visual information to the surgeon about the place where it is situated inside the vertebra during surgical operation.
  • pedicle screw A screw or screws called as pedicle screw is or are fixed to the vertebra in most of these operations performed. These operations are performed entirely by means of surgical intervention. The surgeon determines the place where the screw will be fixed and then inserts the screw into vertebra by screwing after it passes through the pedicle. It is of prime importance that the pedicle screw is inserted to right place inside vertebra, it only corresponds to bone during placement and does not contact any tissue or muscle except bone during this surgical intervention. Performing all this surgical intervention in the best and correct way depends on experience and skill of the surgeon.
  • Inserting the screw exactly into the right part of the bone and contacting it with no tissue except the bone during operation depends on experience of the surgeon. The more experienced the surgeon is, the more successfully and correctly the operation is performed. There is no system which automatically measures how correctly the pedicle screw, which is inserted into the bone of the patient, is placed; whether it corresponds to any tissue except the bone during spinal operations and gives the surgeon warning in the event of an undesirable condition. These conditions directly affect success rate in these types of operations. Operations performed by experienced surgeons are more successful, possibility of making a mistake is higher for surgeons who have received education recently or have the deficiency of imaging device.
  • An objective of the present invention is to realize a pedicle screw which has a warning system that gives audio, light and visual warning to the surgeon about the tissue where s/he is located while fitting it into the bone.
  • Another objective of the present invention is to realize a pedicle screw which has a warning system that can recognize the tissue where it is located according to its resistance.
  • Another objective of the present invention is to realize a pedicle screw which has a warning system that guides the surgeon during spinal operations.
  • Figure 1 is a schematic view of the pedicle screw with warning system.
  • Figure 2 is a cross-sectional view of the pedicle screw with warning system.
  • Figure 3 is a schematic view of the pedicle screw with warning system.
  • the pedicle screw (1) which is inserted into the vertebrae in spinal operations and gives warning by measuring in what type of tissue the surgeon proceeds during the operation essentially comprises:
  • the outer body (2) is located on the outermost surface of the inventive pedicle screw (1).
  • the outer body (2) is preferably coated with threads which will enable insertion into bone.
  • the head (21 ) is located on the upper part of the body (2).
  • the pedicle screw (1) is moved in a forward and backward direction inside the bone upon being rotated by means of a tightening apparatus placed inside the slot. Tightening and rotating the pedicle screw (1) is carried out by means of the slot located on the head (21).
  • the user enables the screw (1) to proceed inside the bone by tightening the head (21) through tightening gun or manually.
  • the head (21) part is preferably protruding and circular.
  • the head (21) can be formed such that it can be angled independently of the body (2).
  • the body (2) has electrical conductivity and on the body (2), there is at least one connection point (22) where the preferred electrical charge (+ or -) can be connected on the body (2).
  • the body (2) is charged with the electrical charge that it receives over the connection point (22).
  • the body (2) is charged with positive (+) or negative (-) electrical charge.
  • Interior of the body (2) has a hollow structure and inner surface of the body (2) is coated with insulation material.
  • an insulation layer (3) is formed in the inner surface of the body (2).
  • the insulation layer (3) is preferably made of a material having no electrical conductivity and it provides electrical insulation. Different materials can be used as insulation layer (3).
  • the insulation layer (3) made of insulation materials.
  • the insulation layer (3) and the conductive end (4) are located in the gap existing in the inner surface of the body (2).
  • the conductive end (4) can be along the whole body (2) and it can also be shorter than the body (2). In a preferred embodiment of the invention, the conductive end (4) is along the whole body (2).
  • the conductive end (4) has conductive characteristic. On the conductive end (4), there is at least one connection point (41) where the preferred electrical charge (+ or -) can be connected. In a preferred embodiment of the invention, the conductive end (4) is charged with positive (+) or negative (-) electrical charge. The conductive end (4) is charged with electrical charge (+ and -) in the pole received from the connection point (41).
  • the battery (5) provides electrical charge for the body (2) and the conductive end
  • connection point (22) located on the body (2) and the connection point (41) located on the conductive end (4) are connected to the poles of the battery
  • the battery (5) charges the connection points (22, 41) such that one of them is (+) and the other is (-) when it is activated.
  • control box (6) there is at least one control box (6).
  • the control box (6) is located in the head (21) on the body (2).
  • the control box (6) is located independently of the screw (1).
  • the battery (5) is preferably located inside the control box (6).
  • the control box (6) is preferably fixed onto the pedicle screw (1) by the connection member (7).
  • the connection member (7) is in the form of lug, clips, welding, etc.
  • warning indicator (8) there is at least one warning indicator (8) on the control box (6).
  • the warning indicator (8) gives audio, light and visual warning.
  • the warning indicator (8) operates according to the electrical resistance measured by the body (2) and the conductive end (4). When the electrical resistance read from the body (2) and the conductive end (4) differs by the electrical resistance measured in the bone, the warning indicator (8) is automatically activated and it gives audio, light and visual warning to the surgeon.
  • the battery (S) is connected to the body (2) and the conductive end (4) by means of the connection points (22, 41).
  • the battery (5), the body (2) and the conductive end (4) are charged with electrical charge in preferred pole.
  • the body (2) and the conductive end (4) are inserted into the bone.
  • an electrical charge is read between the body (2) and the conductive end (4).
  • the electrical charge read is transmitted to the control box (6) continuously.
  • the pedicle screw (1) is being inserted into the bone, it measures an electrical charge according to the tissue where the body (2) and the conductive end (4) contact.
  • the control box (6) finds out that there is a change in the resistance value read, it automatically operates the warning indicator (8).
  • the warning indicator (8) is automatically activated by determining whether there is any change of tissue inside the bone where the pedicle screw (1) is inserted, in other words whether the screw (1) proceeds inside the bone or on another tissue, during surgical operation according to the resistance value.
  • there are resistance values of different tissues such as bone, muscle, vessel, nerve membrane inside the control box (6).
  • the control box (6) is adapted such that it will keep resistance values in thereof.
  • the control box (6) is adapted such that it will send signal to the warning indicator (8) automatically when any change occurs in the resistance values during surgical intervention.
  • the control box (6) is adapted such that it will detect on which tissue an operation is performed at which resistance at that moment according to the value that it receives from the body (2) and the conductive end (4) continuously from the moment it is activated.
  • the control box (6) continuously reads a resistance information during surgical operation and controls operation of the warning indicator (8).
  • the warning indicator (8) is adapted such that it will give audio, light or visual warning.

Landscapes

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

Abstract

La présente invention concerne une vis pédiculaire (1) qui est insérée dans des os au cours d'opérations rachidiennes et qui émet un avertissement en mesurant dans quel type de tissu intervient le chirurgien au cours de ladite opération, qui est essentiellement caractérisée en ce qu'elle comprend : au moins un corps externe (2); au moins une couche d'isolation (3) qui est située sur le corps externe (2) et offre une isolation électrique; au moins une extrémité conductrice (4) qui est située à l'intérieur du corps (2) et qui a une charge électrique au niveau d'un pôle préféré.
PCT/TR2015/000170 2014-09-16 2015-04-22 Vis pédiculaire à système d'avertissement WO2016043676A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2014/10861 2014-09-16
TR201410861 2014-09-16

Publications (1)

Publication Number Publication Date
WO2016043676A1 true WO2016043676A1 (fr) 2016-03-24

Family

ID=53267547

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2015/000170 WO2016043676A1 (fr) 2014-09-16 2015-04-22 Vis pédiculaire à système d'avertissement

Country Status (1)

Country Link
WO (1) WO2016043676A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040243207A1 (en) * 2003-05-30 2004-12-02 Olson Donald R. Medical implant systems
US20050059972A1 (en) * 2003-09-16 2005-03-17 Spineco, Inc., An Ohio Corporation Bone anchor prosthesis and system
FR2874497A1 (fr) * 2004-08-25 2006-03-03 Spinevision Sa Implant comprenant une ou plusieurs electrodes et instrument de pose associe
US20080125637A1 (en) * 2006-09-21 2008-05-29 Wyatt Drake Geist Implant equipped for nerve location and method of use
US20090125072A1 (en) * 2007-11-13 2009-05-14 Neubardt Seth L Surgical bone screw construction
US20100106198A1 (en) * 2008-10-23 2010-04-29 Warsaw Orthopedic, Inc Nerve stimulating bone screw

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040243207A1 (en) * 2003-05-30 2004-12-02 Olson Donald R. Medical implant systems
US20050059972A1 (en) * 2003-09-16 2005-03-17 Spineco, Inc., An Ohio Corporation Bone anchor prosthesis and system
FR2874497A1 (fr) * 2004-08-25 2006-03-03 Spinevision Sa Implant comprenant une ou plusieurs electrodes et instrument de pose associe
US20080125637A1 (en) * 2006-09-21 2008-05-29 Wyatt Drake Geist Implant equipped for nerve location and method of use
US20090125072A1 (en) * 2007-11-13 2009-05-14 Neubardt Seth L Surgical bone screw construction
US20100106198A1 (en) * 2008-10-23 2010-04-29 Warsaw Orthopedic, Inc Nerve stimulating bone screw

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