WO2012089317A1 - Dispositif percutané pour le traitement des fractures vertébrales - Google Patents

Dispositif percutané pour le traitement des fractures vertébrales Download PDF

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Publication number
WO2012089317A1
WO2012089317A1 PCT/EP2011/006441 EP2011006441W WO2012089317A1 WO 2012089317 A1 WO2012089317 A1 WO 2012089317A1 EP 2011006441 W EP2011006441 W EP 2011006441W WO 2012089317 A1 WO2012089317 A1 WO 2012089317A1
Authority
WO
WIPO (PCT)
Prior art keywords
central
constituted
cylindrical body
dilatable
treating spinal
Prior art date
Application number
PCT/EP2011/006441
Other languages
English (en)
Inventor
Andrea Piazzolla
Giuseppe De Giorgi
Original Assignee
Mikai S.P.A.
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 S.P.A. filed Critical Mikai S.P.A.
Publication of WO2012089317A1 publication Critical patent/WO2012089317A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/885Tools for expanding or compacting bones or discs or cavities therein
    • A61B17/8852Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc
    • A61B17/8858Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc laterally or radially expansible

Definitions

  • the present invention relates to a percutaneous device for treating spinal fractures.
  • a conventional device which is particularly adapted for treating osteoporotic compression fractures associated with pathological conditions of the spine caused by aging, is constituted by a sort of small dilatable or expandable metallic scaffold, similar to a stent, which can be inflated with a balloon from the inside of the vertebral body.
  • the device is inserted in the vertebral body percutaneously, by means of a mini-incision which allows the insertion of the instrument.
  • the device can be inserted laterally from either side of the spine and, after correct positioning, can be dilated by means of the balloon, reaching the sustainable height.
  • the stents remain in place, maintaining the created cavity, while the balloons are removed in order to allow the insertion of the cement.
  • Another conventional device is constituted by a titanium implant which is shaped like a jack and is inserted, with a mini-invasive procedure, in the vertebra by means of a transpeduncular approach.
  • the device is provided with a set of adapted instruments for the guided insertion of one or two implants, depending on the anatomical configuration of the fracture and on the degree of reconstruction required.
  • bone cement is injected in the vertebra so as to stabilize the structure and alleviate the pain of the patient.
  • the procedure is typically completed in 20-30 minutes and entails for the patient an immediate relief from pain, allowing his discharge within one or two days.
  • Another type of conventional device is constituted by a lattice-like body made of titanium, which is dilated within the collapsed vertebral body in order to restore the desired height and is subsequently filled with a bone cement that allows its stabilization.
  • Such device is simple to use and the instruments are provided with a color code in order to streamline the surgical procedure, but it has drawbacks.
  • the dilation of the implant is circumferential, with the risk of possible lateral breakthrough.
  • WO2010/100287 and WO2007/028140 disclose widening devices consisting of a tube-shaped main body having elastic sections and which radially expands when the distance between a distal end and a proximal end is reduced.
  • the aim of the present invention is to provide a percutaneous device for treating spinal fractures that overcomes the drawbacks of the cited prior art.
  • an object of the invention is to provide a device that allows to treat different degrees of fracture with a single implant size.
  • Another object of the invention is to provide a device that can be implanted with a procedure that is simple and safe.
  • Another object is to provide a device which, by virtue of its particular constructive characteristics, is capable of giving the greatest assurances of reliability and safety in use.
  • a percutaneous device for treating spinal fractures characterized in that it comprises a substantially cylindrical body, said cylindrical body being pre-cut so as to form a first end portion connected to a second end portion by a central dilatable portion; said central dilatable portion being constituted by two identical members, each of said identical members being constituted by a central body associated with said end portions by means of shaped bars; said bars having ends that are deformable along lines which are all mutually substantially parallel; said central bodies being movable between a closed position and a dilated position on a single vertical plane.
  • Figure 1 is a side view of the device according to the invention, shown in the closed condition;
  • Figure 2 is a longitudinally sectional side view of the device
  • Figure 3 is a side view, similar to Figure 1 , which shows the device in the dilated condition
  • Figure 4 is a perspective view of the device according to the invention, shown in the closed condition
  • Figure 5 is a perspective view of the device in the dilated condition with a stabilization screw
  • Figure 6 is a perspective view of the device of the preceding figure, taken from the opposite side;
  • Figure 7 is a perspective view of a dedicated instrument for applying the device according to the present invention.
  • Figure 8 is a schematic view showing the insertion of the device prior to its expansion
  • Figure 9 is a view, similar to the preceding one, showing the step of expanding the device.
  • the device according to the invention comprises a substantially cylindrical body, which is pre-cut so as to form a first end portion 2 which is connected to a second end portion 3 by means of a dilatable or expandable central portion.
  • the dilatable central portion is constituted by two identical members, each of which is constituted by a central body 4 which is associated with the end portions 2 and 3 by means of two shaped bars: an inner bar 5 and an outer bar 6.
  • the ends of the bars 5 and 6 can bend, with respect to the end portions 2 and 3 and to the central body 4, along lines which are all mutually substantially parallel, so that the two central bodies 4 dilate on a single vertical plane.
  • the second portion 3 includes an internal thread 7 which is adapted to accommodate the end of a screw 8, the head 9 of which engages the first portion 2 of the device.
  • the pre-cut cylindrical body is preferably made of titanium alloy and has a diameter, in the dilated position, that is approximately three times its diameter in the closed position.
  • the inlet diameter is approximately 5 mm, while the central portion expands, within the soma, up to approximately 17 mm.
  • the device is inserted within the vertebral body 10 and is then dilated by means of a dedicated instrument 11.
  • the extent of the expansion is decided in the intraoperative period, depending on the degree of kyphotization of the vertebra.
  • the instrument 1 1 also allows to remove the device in the intraoperative period, by virtue of the collapse of the device, which again assumes the initial cylindrical shape by means of the extension of the structure.
  • the device is provided in two embodiments: standard and screw-in.
  • the space created in the bone is filled with cement (PMMA).
  • stabilization is performed not by injecting cement but by virtue of the screw 8, which is fixed to the second portion 3, i.e., the distal end, of the device 1.
  • the device according to the present invention allows, by means of a percutaneous operating technique, to treat even old osteoporotic and traumatic spinal fractures.
  • the device which is provided in a single size, can dilate to the height required to restore the vertebral collapse; the operator can block the dilation once the image intensifier, by means of an X-ray, confirms a satisfactory result.
  • An important advantage of the present invention is constituted by the possibility to easily remove the device in the intraoperative period, making it return to its closed configuration by means of a dedicated instrument.
  • the device according to the present invention has a dilation in a substantially vertical direction, without any lateral or circumferential dilation, avoiding the risk of lateral breakthrough.
  • the device according to the present invention allows to choose the desired degree of dilation or expansion in the intraoperative period without forcing the surgeon to decide beforehand which type of implant to use, as in the case of traditional devices.
  • the device according to the present invention may also be removed in the intraoperative period.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Un dispositif percutané pour le traitement des fractures vertébrales, selon l'invention, se compose d'un corps substantiellement cylindrique, prédécoupé de sorte à former une première portion d'extrémité connectée à une seconde portion d'extrémité par une portion dilatable centrale ; la portion dilatable centrale est constituée de deux éléments identiques, chacun étant constitué d'un corps central associé aux portions d'extrémité par le biais de barres de forme spécifique ; les barres comportent des extrémités déformables le long d'axes tous mutuellement et substantiellement parallèles ; les corps centraux peuvent être déplacés entre une position fermée et une position dilatée le long d'un plan vertical unique.
PCT/EP2011/006441 2010-12-29 2011-12-20 Dispositif percutané pour le traitement des fractures vertébrales WO2012089317A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITGE2010A000144A IT1403237B1 (it) 2010-12-29 2010-12-29 Dispositivo percutaneo per il trattamento delle fratture vertebrali
ITGE2010A000144 2010-12-29

Publications (1)

Publication Number Publication Date
WO2012089317A1 true WO2012089317A1 (fr) 2012-07-05

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2011/006441 WO2012089317A1 (fr) 2010-12-29 2011-12-20 Dispositif percutané pour le traitement des fractures vertébrales

Country Status (2)

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IT (1) IT1403237B1 (fr)
WO (1) WO2012089317A1 (fr)

Cited By (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014097306A (ja) * 2012-11-13 2014-05-29 Chang Gung Univ 骨を強化する装置と前記装置を搭載するための器具
US9295562B2 (en) 2008-01-17 2016-03-29 DePuy Synthes Products, Inc. Expandable intervertebral implant and associated method of manufacturing the same
US9320615B2 (en) 2010-06-29 2016-04-26 DePuy Synthes Products, Inc. Distractible intervertebral implant
US9402737B2 (en) 2007-06-26 2016-08-02 DePuy Synthes Products, Inc. Highly lordosed fusion cage
US9414934B2 (en) 2008-04-05 2016-08-16 DePuy Synthes Products, Inc. Expandable intervertebral implant
US9526620B2 (en) 2009-03-30 2016-12-27 DePuy Synthes Products, Inc. Zero profile spinal fusion cage
US9561117B2 (en) 2012-07-26 2017-02-07 DePuy Synthes Products, Inc. Expandable implant
US9717601B2 (en) 2013-02-28 2017-08-01 DePuy Synthes Products, Inc. Expandable intervertebral implant, system, kit and method
US9724207B2 (en) 2003-02-14 2017-08-08 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US9750552B2 (en) 2009-07-06 2017-09-05 DePuy Synthes Products, Inc. Expandable fixation assemblies
US9833334B2 (en) 2010-06-24 2017-12-05 DePuy Synthes Products, Inc. Enhanced cage insertion assembly
US9913727B2 (en) 2015-07-02 2018-03-13 Medos International Sarl Expandable implant
US9949769B2 (en) 2004-03-06 2018-04-24 DePuy Synthes Products, Inc. Dynamized interspinal implant
US9993349B2 (en) 2002-06-27 2018-06-12 DePuy Synthes Products, Inc. Intervertebral disc
US10390963B2 (en) 2006-12-07 2019-08-27 DePuy Synthes Products, Inc. Intervertebral implant
US10398563B2 (en) 2017-05-08 2019-09-03 Medos International Sarl Expandable cage
US10433974B2 (en) 2003-06-30 2019-10-08 DePuy Synthes Products, Inc. Intervertebral implant with conformable endplate
US10500062B2 (en) 2009-12-10 2019-12-10 DePuy Synthes Products, Inc. Bellows-like expandable interbody fusion cage
US10537436B2 (en) 2016-11-01 2020-01-21 DePuy Synthes Products, Inc. Curved expandable cage
US10888433B2 (en) 2016-12-14 2021-01-12 DePuy Synthes Products, Inc. Intervertebral implant inserter and related methods
US10940016B2 (en) 2017-07-05 2021-03-09 Medos International Sarl Expandable intervertebral fusion cage
US10973650B2 (en) 2015-12-30 2021-04-13 Nuvasive, Inc. Lordotic expandable fusion implant
US11234833B2 (en) 2015-05-12 2022-02-01 Nuvasive, Inc. Expandable lordosis intervertebral implants
US11273047B2 (en) 2017-12-18 2022-03-15 Nuvasive, Inc. Expandable implant device
US11344424B2 (en) 2017-06-14 2022-05-31 Medos International Sarl Expandable intervertebral implant and related methods
US11426290B2 (en) 2015-03-06 2022-08-30 DePuy Synthes Products, Inc. Expandable intervertebral implant, system, kit and method
US11426286B2 (en) 2020-03-06 2022-08-30 Eit Emerging Implant Technologies Gmbh Expandable intervertebral implant
US11446156B2 (en) 2018-10-25 2022-09-20 Medos International Sarl Expandable intervertebral implant, inserter instrument, and related methods
US11452607B2 (en) 2010-10-11 2022-09-27 DePuy Synthes Products, Inc. Expandable interspinous process spacer implant
US11497619B2 (en) 2013-03-07 2022-11-15 DePuy Synthes Products, Inc. Intervertebral implant
US11510788B2 (en) 2016-06-28 2022-11-29 Eit Emerging Implant Technologies Gmbh Expandable, angularly adjustable intervertebral cages
US11596523B2 (en) 2016-06-28 2023-03-07 Eit Emerging Implant Technologies Gmbh Expandable and angularly adjustable articulating intervertebral cages
US11679000B2 (en) 2013-05-22 2023-06-20 Nuvasive, Inc. Expandable fusion implant and related methods
US11752009B2 (en) 2021-04-06 2023-09-12 Medos International Sarl Expandable intervertebral fusion cage
US11850160B2 (en) 2021-03-26 2023-12-26 Medos International Sarl Expandable lordotic intervertebral fusion cage
US11911287B2 (en) 2010-06-24 2024-02-27 DePuy Synthes Products, Inc. Lateral spondylolisthesis reduction cage
US12023255B2 (en) 2023-03-13 2024-07-02 DePuy Synthes Products, Inc. Expandable inter vertebral implant

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WO2005120400A2 (fr) * 2004-06-09 2005-12-22 Vexim Procedes et dispositif pour la restauration osseuse
WO2007028140A2 (fr) 2005-08-31 2007-03-08 Spineworks Medical, Inc. Dispositifs implantables et methodes de traitement de la deterioration microarchitecturale de tissu osseux
WO2007111979A2 (fr) * 2006-03-24 2007-10-04 Ebi, Llc. Prothèse spinale extensible
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US10238500B2 (en) 2002-06-27 2019-03-26 DePuy Synthes Products, Inc. Intervertebral disc
US9993349B2 (en) 2002-06-27 2018-06-12 DePuy Synthes Products, Inc. Intervertebral disc
US10433971B2 (en) 2003-02-14 2019-10-08 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US9801729B2 (en) 2003-02-14 2017-10-31 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US9925060B2 (en) 2003-02-14 2018-03-27 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10786361B2 (en) 2003-02-14 2020-09-29 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10639164B2 (en) 2003-02-14 2020-05-05 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10583013B2 (en) 2003-02-14 2020-03-10 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
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US10555817B2 (en) 2003-02-14 2020-02-11 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10492918B2 (en) 2003-02-14 2019-12-03 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
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US11096794B2 (en) 2003-02-14 2021-08-24 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
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US10085843B2 (en) 2003-02-14 2018-10-02 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US9724207B2 (en) 2003-02-14 2017-08-08 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
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US11207187B2 (en) 2003-02-14 2021-12-28 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
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US9814589B2 (en) 2003-02-14 2017-11-14 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US9814590B2 (en) 2003-02-14 2017-11-14 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US11432938B2 (en) 2003-02-14 2022-09-06 DePuy Synthes Products, Inc. In-situ intervertebral fusion device and method
US10433974B2 (en) 2003-06-30 2019-10-08 DePuy Synthes Products, Inc. Intervertebral implant with conformable endplate
US11612493B2 (en) 2003-06-30 2023-03-28 DePuy Synthes Products, Inc. Intervertebral implant with conformable endplate
US9949769B2 (en) 2004-03-06 2018-04-24 DePuy Synthes Products, Inc. Dynamized interspinal implant
US10433881B2 (en) 2004-03-06 2019-10-08 DePuy Synthes Products, Inc. Dynamized interspinal implant
US10512489B2 (en) 2004-03-06 2019-12-24 DePuy Synthes Products, Inc. Dynamized interspinal implant
US10398566B2 (en) 2006-12-07 2019-09-03 DePuy Synthes Products, Inc. Intervertebral implant
US11432942B2 (en) 2006-12-07 2022-09-06 DePuy Synthes Products, Inc. Intervertebral implant
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US9895236B2 (en) 2010-06-24 2018-02-20 DePuy Synthes Products, Inc. Enhanced cage insertion assembly
US11654033B2 (en) 2010-06-29 2023-05-23 DePuy Synthes Products, Inc. Distractible intervertebral implant
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US9561117B2 (en) 2012-07-26 2017-02-07 DePuy Synthes Products, Inc. Expandable implant
US10058433B2 (en) 2012-07-26 2018-08-28 DePuy Synthes Products, Inc. Expandable implant
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