WO2011055396A1 - Élément modulaire pour des systèmes de stabilisation dynamique des vertèbres - Google Patents

Élément modulaire pour des systèmes de stabilisation dynamique des vertèbres Download PDF

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Publication number
WO2011055396A1
WO2011055396A1 PCT/IT2009/000500 IT2009000500W WO2011055396A1 WO 2011055396 A1 WO2011055396 A1 WO 2011055396A1 IT 2009000500 W IT2009000500 W IT 2009000500W WO 2011055396 A1 WO2011055396 A1 WO 2011055396A1
Authority
WO
WIPO (PCT)
Prior art keywords
modular element
notches
modular
joining
vertebra
Prior art date
Application number
PCT/IT2009/000500
Other languages
English (en)
Inventor
Paolo Guerra
Giuseppe Sala
Franco Ronchi
Original Assignee
Sintea Plustek S.R.L.
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 Sintea Plustek S.R.L. filed Critical Sintea Plustek S.R.L.
Priority to PCT/IT2009/000500 priority Critical patent/WO2011055396A1/fr
Publication of WO2011055396A1 publication Critical patent/WO2011055396A1/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
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7026—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form
    • 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
    • A61B17/7049—Connectors, not bearing on the vertebrae, for linking longitudinal elements together
    • A61B17/705—Connectors, not bearing on the vertebrae, for linking longitudinal elements together for linking adjacent ends of longitudinal elements

Definitions

  • the present invention relates, in its more general aspect, to a modular system for the dynamic stabilization of spinal vertebra.
  • the invention likewise relates to a modular element for the production of the abovementioned system.
  • the invention is intended in particular for the field of orthopaedic surgery and neurosurgery wherein there is the need for providing dynamic support for two or more vertebra of the spinal column following injury, lesions or malformations or in all those cases wherein there is a discontinuity in the biomechanical behaviour of the spinal column.
  • the following description is given with specific reference to this field of application with the purpose of simplifying disclosure thereof.
  • stabilization that is to say connect them by means of a subcutaneous device to each of the spinal vertebra involved in the stabilization.
  • a spinal stabilization device is for example known and described in the patent application USA n° 2007/0093814 and wherein a support rod is provided, connected to some spinal vertebra by means of conventional anchorage means with screw attachment, for example of the pedicle screw type.
  • This rod has an elongated cylindrical shape and is made in titanium nickel alloy, in steel or in titanium.
  • peripheral grooves are provided, extending longitudinally, which substantially increase the slimness of the rod to allow it to respond better to flexural stresses.
  • peripheral and alternating notches are instead provided on diametrically opposite sides in relation to the rod axis.
  • the depth of the notches is smaller than the radius of the circular section of the rod. In this case too the solution was provided to improve the flexural response of this type of support rod.
  • the flexible modular elements are obtained by means of a cylindrical body wherein a helical continuous notch is formed peripherally, while the joining elements are smooth bars inserted in corresponding end housings of the flexible modular elements and connected thereto by means of pins or attachment screws inserted radially at the ends of the flexible modular elements to block in position the joining elements.
  • this solution has some disadvantages, the first of which is due to the fact that the system obtained with the composition of the abovementioned modular elements is flexible but axially incompressible.
  • the flexibility provided by the helical notch is even so high for the type of application that only a few expensive semi-rigid materials are suitable for being used to make these modular elements.
  • the proposed solution at the basis of the present invention is that of using as flexible modular element a tubular sleeve body wherein a plurality of slots or through notches are formed transverse to the axis of the sleeve.
  • a modular element for systems for dynamic stabilization of vertebra of the spinal column of the type comprising at least one flexible body having opposite ends which can be connected to respective joining elements to form rod-shaped structure to be associated with at least two spinal vertebra to be stabilized, characterised in that said body is of the tubular sleeve type comprising in at least one of its central sections a plurality of through notches formed on at least one transverse attitude plane to provide axial and flexural yielding for said body.
  • the tubular sleeve body is made with an organic polymer, for example polyaryletherketone or PAEK.
  • the opposite ends of the tubular sleeve body are shaped internally to hold by a quick fit a corresponding end of one of said joining elements.
  • the notches are angularly distanced one from the other in a regular fashion and the notches of the same attitude plane are angularly staggered in relation to the notches formed in an attitude plane axially adjacent to the previous one.
  • the modular element 1 can be filled internally with a synthetic material, soft or spongy and biocompatible, which occupies all the free space in the central hole of the sleeve and in the notches.
  • the modular element 1 can be covered by a sheath or by a membrane in synthetic material, again to avoid permeation in the notches of connective tissue.
  • a system for the dynamic stabilization of spinal vertebra having a rod- shaped structure obtained from the combination of a modular element of the abovementioned type and of two opposite joining elements each having a stem, a shaped end in order to be connected with quick fit to a corresponding end of the modular element and an annular edge between stem and end.
  • Figure 1 shows a perspective and schematic view of a modular element for producing, according to the invention, dynamic spinal vertebra stabilization systems
  • Figure 2 is a front view of the element of Figure 1;
  • Figure 3 is a view from above of the element of Figure 1 ;
  • Figure 4 is a perspective and schematic view of a joining element connected to the modular element of Figure 1 to form a system of dynamic stabilization of spinal vertebra according to the present invention
  • Figure 5 is a perspective and schematic view of another joining element which can be connected to the modular element of Figure 1 to form a system of dynamic stabilization of spinal vertebra according to the present invention
  • Figure 6 is a perspective and schematic view of a system of dynamic stabilization of spinal vertebra made in accordance with the present invention with the combination of a modular element of Figure 1 and of two joining elements of Figure 4;
  • Figure 7 is a perspective and schematic view of another system of dynamic stabilization of spinal vertebra made in accordance with the present invention with the combination of two modular elements of Figure 1, of two joining elements of Figure 4 and of a joining element of Figure 5;
  • Figure 8 shows a perspective and schematic view of a system of dynamic stabilization according to the invention applied to a pair of spinal vertebra. Detailed description
  • 1 denotes overall a modular element realised in accordance with the present invention for systems 10 of dynamic stabilization of vertebra of the spinal column.
  • the modular element 1 is intended to be connected to other elements of the same structure by means of joining elements 15 and 18 which are to be described in greater detail herein below.
  • the modular element 1 essentially comprises a tubular sleeve body 2 with circular section and axis X-X, having diameter "d" of about 1 1 mm.
  • the diameter d can be identified as the maximum overall dimension transverse to the axis X-X of the modular element 1.
  • Other diameters can also be adopted if necessary, preferably for example in the range of values comprised between 9 mm and 12 mm.
  • the sleeve 2 has an axial extension "h" which varies according to the applications.
  • the sleeve 2 can be made in a plurality of diverse sizes d and h, at least three different tubular sleeves 2 are provided to facilitate the work of the surgeon.
  • the tubular sleeve 2 has perimeter wall 4 of predetermined thickness "s".
  • the thickness s of the perimeter wall 4 can have or otherwise a ratio of proportionality with the diameter or transverse overall dimension d.
  • the tubular sleeve 2 in its various axial extensions, is made with an organic polymeric material or in any case with a biocompatible material.
  • the organic polymer can be for example of the type commercially known as polyaryletherketone or PAEK.
  • This material can be extruded for example with a densit of 1.9 g/cm 3 , or in any case with a density compatible with the type of application, and has excellent resistance to high temperatures, to attacks by chemical products and to impact.
  • This material is moreover thermoplastic and biocompatible.
  • the modular element 1 can be made in biocompatible metal material.
  • the sleeve 2 has opposite ends 6 and 7 intended to be connected to other elements of the system 10, more particularly to the joining elements 15 and/ or 18 to form a composite system 10 and to be associated with at least two spinal vertebra to be stabilized, as shown in Figures 6 and 7.
  • Figure 8 shows an example of application of a system 10 of the present invention to a pair of spinal vertebra.
  • the ends 6 and 7 of the sleeve 2 have a respective lowered circular housing 16, 17 constituting an inlet for an initial section 21 of the sleeve 2 shaped internally for coupling with one of the joining elements 15 or 18.
  • the initial section 21 can be shaped with teeth or ridges to encourage joining with quick fit to a corresponding end of the joining elements 15 or 18.
  • the initial section 21 involves nut threading for a threaded coupling with a corresponding threaded end of the joining elements 15 or 18.
  • the joining elements 15 comprise a stem 1 1, having comparable length to that of the tubular sleeve 2, and a shaped end 19 for quick fit form coupling with one of the ends 6, 7 of the tubular sleeve 2.
  • annular edge 22 which defines the shaped or threaded portion of the end 19.
  • the free end of the element 15 opposite the end 19 is provided with an embedded housing 23 with hexagonal section for the insertion of an Allen key for manoeuvre shown in the drawings.-
  • the structure of the joining element 15 is substantially that of a screw with plain shank 1 1 and threaded head 19, with an annular edge 22 between shank 1 1 and head 19.
  • the joining element 15 can be made with the same organic polymeric material with which the modular element 1 is made.
  • the joining element 15 can be made with a biocompatible and non-osteoconductive metal alloy or a metal, for example titanium.
  • the joining element 15 is in any case rigid.
  • the end 19 of the joining element 15 is intended to couple in threaded engagement with the initial section 21 at the end 6 or 7 of the tubular sleeve 2 up to the point wherein the annular edge 22 is held completely in the lowered housing 16 or 17 of the corresponding end 6 or 7.
  • the structure of the joining element 18 is substantially similar to that of the joining element 15 with the difference that there is a stem 25 defined by two opposite annular edges 31, 32 which separate the stem 25 from respective shaped or perimetrally threaded ends 28, 29.
  • Embedded housings 26 with hexagonal section are also provided in the joining element 18, in both the ends 28 and 29, for the use of an Allen key which can facilitate tightening in the form or threaded coupling between a joining element 18 and a modular element 1.
  • This particular joining element 18 is used to connect one to the other two modular elements 1 , as clearly shown in Figure 7.
  • This joining element 18 is also made with the same material used to make the joining element 15.
  • Figure 6 shows an example of a system 10 of dynamic stabilization of spinal vertebra made in accordance with the present invention with rod- shaped structure obtained from the combination of a modular element 1 and of two joining elements 15.
  • Figure 7 shows an example of a system 10 of dynamic stabilization of spinal vertebra made in accordance with the present invention and with a rod-shaped structure wherein at least two modular elements 1 with tubular sleeve 2 are connected and joined one to the other by a joining element 18, inserted between two sleeves 2, and have at the ends of the system two joining elements 15.
  • a joining element 18 inserted between two sleeves 2
  • the tubular sleeve 2 is involved, in at least one of its central sections 9, by a plurality of through notches 12 or cuts formed on at least one attitude plane transverse to the axis X-X of the sleeve 2.
  • the notches 12 are substantially slots which traverse completely the perimeter wall 4 of the tubular sleeve 2.
  • the notches 12 are formed on attitude planes transverse to the axis X-X and, preferably, are orthogonal to the axis.
  • the notches 12 are formed on multiple attitude planes parallel one to the other in a predetermined distanced relation. It should also be noted that in the plurality of attitude planes of the notches 12 there may also be some that are not parallel one to the other. Herein below more specific reference will be made to the attitude planes parallel one to the other only so as to simplify the disclosure of the invention.
  • the notches are preferably distanced axially by a few millimetres, that is to say that there is a distance of a few millimetres between one attitude plane and that immediately adjacent in an axial direction, for example these attitude planes are distant in a range from 1 to 4 millimetres.
  • the notches 12 can be angularly distanced one from the other in a regular fashion.
  • these notches 12 can extend angularly on the same attitude plane by circumference arcs regular one in relation to the other.
  • the notches 12 on the same plane can be in an equal or odd number but in any case extend for a predetermined angular section slightly less than 360° /number of notches, in such a way that there is at least one section 27 of perimeter wall 4 of the sleeve 2 which maintains the continuity of the wall 4 between one notch 12 and that immediately and radially adjacent.
  • the notches 12 of the same plane are preferably angularly staggered in relation to the notches formed in an attitude plane of the notches parallel to the previous one and axially adjacent.
  • notches 12 formed on attitude planes alternating one with the other correspond in number and arrangement.
  • the section 27 of perimeter wall 4 which separates a notch 12 from a notch 12 angularly adjacent on the same attitude plane is situated substantially at the centre of the circumference arc subtended by a notch 12 formed on an attitude plane immediately above and below.
  • the modular element 1 can be internally filled with a synthetic material, soft or spongy and biocompatible, which occupies all the free space in the central hole of the sleeve 2 and in the notches 12. This avoids the possible penetration or proliferation of connective or subcutaneous tissue in the curves of the system 10 during the entire period of implanting.
  • the modular element 1 can be covered by a sheath or by a membrane in synthetic material, again to avoid permeation in the notches of connective tissue.
  • the particular configuration of the sleeve element 2 confers dual axial and flexural yielding to the modular element 1 of the present invention.
  • the modular element 1 thus has axial yielding. At the same time the configuration of the modular element 1 allows a predetermined elasticity to be guaranteed in relation to flexural stresses.
  • organic polymeric material in the structure of the modular element 1 gives it special usefulness for the field of application for which it is intended, this material being totally biocompatible and non- osteoconductive.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Neurology (AREA)
  • Surgery (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)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un élément modulaire (1) pour des systèmes (10) de stabilisation dynamique de vertèbres de la colonne vertébrale, du type comprenant au moins un corps flexible ayant des extrémités opposées (6, 7) qui peuvent être reliées à des éléments de jonction respectifs (15, 18) pour former une structure en forme de barre à associer à au moins deux vertèbres à stabiliser. Cet élément modulaire comporte un corps manchon tubulaire (2) et comprend, dans au moins une de ses parties centrales (9), une pluralité d'encoches traversantes (12) formées sur au moins un plan transversal à l'axe (X-X) du manchon (2). De manière avantageuse, un tel élément modulaire permet d'obtenir un système (10) de stabilisation dynamique des vertèbres au moyen d'une structure en forme de barre obtenue de la combinaison d'au moins un élément modulaire (1) et de deux éléments de jonction (15) ayant chacun : une tige (11), une extrémité façonnée (19) pour l'adaptation rapide aux extrémités correspondantes dudit élément modulaire (1) et un bord annulaire (22) entre la tige (11) et l'extrémité (19).
PCT/IT2009/000500 2009-11-09 2009-11-09 Élément modulaire pour des systèmes de stabilisation dynamique des vertèbres WO2011055396A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IT2009/000500 WO2011055396A1 (fr) 2009-11-09 2009-11-09 Élément modulaire pour des systèmes de stabilisation dynamique des vertèbres

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IT2009/000500 WO2011055396A1 (fr) 2009-11-09 2009-11-09 Élément modulaire pour des systèmes de stabilisation dynamique des vertèbres

Publications (1)

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WO2011055396A1 true WO2011055396A1 (fr) 2011-05-12

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Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0677277A2 (fr) * 1994-03-18 1995-10-18 Patrice Moreau Ensemble prothétique rachidien
FR2728158A1 (fr) * 1994-12-14 1996-06-21 Elberg Jean Francois Modelisation d'une prothese notamment intervertebrale
FR2774581A1 (fr) * 1998-02-10 1999-08-13 Dimso Sa Stabilisateur interepineux a fixer a des apophyses epineuses de deux vertebres
US20050261686A1 (en) 2004-05-14 2005-11-24 Paul Kamaljit S Spinal support, stabilization
US20070016190A1 (en) * 2005-07-14 2007-01-18 Medical Device Concepts Llc Dynamic spinal stabilization system
US20070088359A1 (en) 2005-02-07 2007-04-19 Woods Richard W Universal dynamic spine stabilization device and method of use
US20070093814A1 (en) 2005-10-11 2007-04-26 Callahan Ronald Ii Dynamic spinal stabilization systems
US20070093904A1 (en) * 2005-10-26 2007-04-26 Lutz Biedermann Implant with one piece swivel joint
US20070203446A1 (en) 2006-01-24 2007-08-30 Lutz Biedermann Connecting rod with external flexible element
US20080033435A1 (en) * 2001-12-07 2008-02-07 Armin Studer Damping element and device for stabilization of adjacent vertebral bodies
US20090088803A1 (en) * 2007-10-01 2009-04-02 Warsaw Orthopedic, Inc. Flexible members for correcting spinal deformities
US20090093846A1 (en) * 2007-10-04 2009-04-09 Zimmer Spine Inc. Pre-Curved Flexible Member For Providing Dynamic Stability To A Spine

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0677277A2 (fr) * 1994-03-18 1995-10-18 Patrice Moreau Ensemble prothétique rachidien
FR2728158A1 (fr) * 1994-12-14 1996-06-21 Elberg Jean Francois Modelisation d'une prothese notamment intervertebrale
FR2774581A1 (fr) * 1998-02-10 1999-08-13 Dimso Sa Stabilisateur interepineux a fixer a des apophyses epineuses de deux vertebres
US20080033435A1 (en) * 2001-12-07 2008-02-07 Armin Studer Damping element and device for stabilization of adjacent vertebral bodies
US20050261686A1 (en) 2004-05-14 2005-11-24 Paul Kamaljit S Spinal support, stabilization
US20070088359A1 (en) 2005-02-07 2007-04-19 Woods Richard W Universal dynamic spine stabilization device and method of use
US20070016190A1 (en) * 2005-07-14 2007-01-18 Medical Device Concepts Llc Dynamic spinal stabilization system
US20070093814A1 (en) 2005-10-11 2007-04-26 Callahan Ronald Ii Dynamic spinal stabilization systems
US20070093904A1 (en) * 2005-10-26 2007-04-26 Lutz Biedermann Implant with one piece swivel joint
US20070203446A1 (en) 2006-01-24 2007-08-30 Lutz Biedermann Connecting rod with external flexible element
US20090088803A1 (en) * 2007-10-01 2009-04-02 Warsaw Orthopedic, Inc. Flexible members for correcting spinal deformities
US20090093846A1 (en) * 2007-10-04 2009-04-09 Zimmer Spine Inc. Pre-Curved Flexible Member For Providing Dynamic Stability To A Spine

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