CH702637A1 - Pre-bent biocompatible plastic rod for surgical stabilization of spinal column of patient, is bent in supply condition along longitudinal axis by thermal plasticity after annealing process and by injection molding process - Google Patents

Pre-bent biocompatible plastic rod for surgical stabilization of spinal column of patient, is bent in supply condition along longitudinal axis by thermal plasticity after annealing process and by injection molding process Download PDF

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Publication number
CH702637A1
CH702637A1 CH00133/10A CH1332010A CH702637A1 CH 702637 A1 CH702637 A1 CH 702637A1 CH 00133/10 A CH00133/10 A CH 00133/10A CH 1332010 A CH1332010 A CH 1332010A CH 702637 A1 CH702637 A1 CH 702637A1
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CH
Switzerland
Prior art keywords
bent
plastic rod
longitudinal axis
injection molding
patient
Prior art date
Application number
CH00133/10A
Other languages
German (de)
Inventor
Stefan Freudiger
Rolf Diener
Original Assignee
Spinesave Ag
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 Spinesave Ag filed Critical Spinesave Ag
Priority to CH00133/10A priority Critical patent/CH702637A1/en
Publication of CH702637A1 publication Critical patent/CH702637A1/en

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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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7011Longitudinal element being non-straight, e.g. curved, angled or branched
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing

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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)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

The biocompatible plastic rod (1) is bent in a supply condition along its longitudinal axis by thermal plasticity after an annealing process and by an injection molding process. The plastic rod is provided in a rehydrated condition and manufactured from polycarbonate urethane. The plastic rod of higher shore harnesses is heated in an operating room to transform into a bent form.

Description

[0001] Mit der vorliegenden Erfindung wird ein elastischer Verbindungsstab entsprechend Patentanspruch eins in vorgekrümmter Form bereitgestellt. Elastische Verbindungsstäbe werden typischerweise mit Pedikelschrauben zur dynamischen Stabilisierung von Wirbelsäulen verwendet. With the present invention, an elastic connecting rod according to claim one is provided in pre-curved shape. Elastic connecting rods are typically used with pedicle screws for dynamic stabilization of spinal columns.

[0002] Je nach Morphologie des Patienten und Lage der dynamischen Stabilisierung können Verbindungsstäbe nicht immer geradlinig verlaufen. Verbindungsstäbe müssen daher, entsprechend der vorliegenden Krümmung der Wirbelsäule, ihrerseits gekrümmt werden. Depending on the morphology of the patient and the location of the dynamic stabilization connecting rods may not always be straight. Connecting rods must therefore, in turn, be curved according to the present curvature of the spine.

[0003] Bei Fusionseingriffen werden in der Regel Metallstäbe verwendet, welche im Operationssaal mithilfe von Apparaturen plastisch gekrümmt werden. In fusion surgery usually metal rods are used, which are plastically curved in the operating room using equipment.

[0004] Elastische Kunststoffstäbe können bei geringen Shore-Härten leicht in die erforderliche Krümmung gebracht werden. Bei höheren Shore-Härten lassen sich solche Kunststoffstäbe bei Raumtemperatur aber keiner grösseren Formänderung mehr unterziehen. Elastic plastic rods can be easily brought into the required curvature at low Shore hardnesses. At higher Shore hardnesses, such plastic rods can no longer undergo any major change in shape at room temperature.

[0005] Der Stand der Technik nennt hierzu erst ansatzweise Methoden. Diese werden im Folgenden erläutert und es werden ihre Nachteile gegenüber der vorliegenden Erfindung hervorgehoben. The prior art calls for this only rudimentary methods. These will be explained below and their disadvantages compared with the present invention will be emphasized.

[0006] Die Erfindung gemäss Patentschrift US 5 415 661 zeigt weit über die anatomische Wirbelsäulenkrümmung hinausgehende stark gekrümmte Stäbe aus Faserverbundwerkstoffen. Die starke Krümmung hat nicht die Aufgabe der Anatomie zu folgen, sondern den faserverstärkten Kunstoffstäben zusätzliche Elastizität zu geben. Die starke Krümmung benötigt einen hohen Platzbedarf und kann bei angrenzendem Gewebe zu unerwünschten Interferenzen führen. The invention according to patent US 5,415,661 shows far beyond the anatomical spine curvature beyond highly curved rods made of fiber composites. The strong curvature does not have the task of following the anatomy, but to give the fiber-reinforced plastic rods additional elasticity. The high curvature requires a large amount of space and can lead to unwanted interference with adjacent tissue.

[0007] Die Erfindung gemäss Patentschrift EP 0 786 235 B1 verwendet vorgekrümmte Metallstäbe und setzt sich die Aufgabe, diese im Schraubenkopf ohne Begradigung zu klemmen. Hierbei beschränken sich Metallstäbe auf die Aufgabe, die versorgten Wirbelkörper derart stark zu stabilisieren, dass diese knöchern zusammenwachsen (fusionieren) können. The invention according to patent EP 0 786 235 B1 uses pre-curved metal rods and sets itself the task of clamping them in the screw head without straightening. In this case, metal bars are limited to the task of stabilizing the supplied vertebral bodies so strongly that these bones can grow together (fuse).

[0008] Die Erfindung gemäss Patentanmeldung WO 2004/096 066 A2 schlägt ein krümmbares Lumen vor, welches nach dem Einsetzen in die Wirbelsäule durch eine Vielzahl metallener Stäbchen gefüllt wird. Die mit diesem Verfahren erzielte Krümmung muss als aufwendig bezeichnet werden. The invention according to patent application WO 2004/096 066 A2 proposes a curvable lumen, which is filled by a plurality of metallic rods after insertion into the spinal column. The curvature achieved with this method must be described as expensive.

[0009] Die Erfindung gemäss Patentanmeldung US 2007/0 035 795 A1 zeigt zwar gekrümmte Rohrsegmente, welche jedoch nicht die Aufgabe der dynamischen Stabilisierung von Wirbelsäulensegmenten haben, sondern einen Ersatz der Facettengelenke sicherstellen sollen. Although the invention according to patent application US 2007/0 035 795 A1 shows curved pipe segments, which do not have the task of dynamic stabilization of spinal segments, but to ensure a replacement of the facet joints.

[0010] Die im Folgenden beschriebene Erfindung stellt sich demnach die Aufgabe, einen biokompatiblen Kunststoffstab derart vorgekrümmt anzubieten, dass dieser ohne aufwendige Manipulation in eine Wirbelsäule eingelegt werden kann, auch wenn die zugehörigen Aufnahmen der Pedikelschrauben nicht geradlinig verlaufen. The invention described below therefore has the task of providing a biocompatible plastic rod precurved in such a way that it can be inserted into a spine without complicated manipulation, even if the associated receptacles of the pedicle screws do not run in a straight line.

[0011] Kunststoffstäbe höherer Shore-Härten müssen im Operationssaal erwärmt werden, um in eine vorgegebene Krümmung überführt zu werden. Um solche Erwärmungsprozesse möglichst zu umgehen, stellt sich die vorliegende Erfindung die Aufgabe, Kunststoffstäbe in typische Krümmungen vorzukrümmen. Plastic rods higher Shore hardnesses must be heated in the operating room to be transferred to a predetermined curvature. In order to circumvent such heating processes as far as possible, the present invention has the object vorzukrümmen plastic rods in typical curvatures.

[0012] Eine erste Lösung dieser Aufgabe zeichnet sich dadurch aus, dass drei spezielle Kunststoffeigenschaften kombiniert zur Anwendung gelangen, nämlich (1) die Temperung, um für die Krümmung die grösstmögliche Elastizität zu erzielen, (2) die Thermoplastizität, um die erzielte Krümmung nach Abkühlung zu erhalten und (3) die Rehydration, um eine anschliessende nachteilige Versteifung durch Austrocknung zu vermeiden. A first solution to this problem is characterized by the fact that three special plastic properties are used in combination, namely (1) the heat treatment in order to achieve the greatest possible elasticity for the curvature, (2) the thermoplasticity to the curvature obtained To obtain cooling and (3) the rehydration, in order to avoid a subsequent adverse stiffening by dehydration.

Claims (7)

1. Kunststoffstab (1) für die chirurgische Versorgung der Wirbelsäule, dadurch gekennzeichnet, dass seine Längsachse im Lieferzustand nicht geradlinig, sondern gekrümmt verläuft.1. plastic rod (1) for the surgical care of the spine, characterized in that its longitudinal axis in the delivery state is not rectilinear, but curved. 2. Kunststoffstab nach Anspruch 1, dadurch gekennzeichnet, dass die Krümmung durch Thermoplastizität erreicht wird.2. Plastic rod according to claim 1, characterized in that the curvature is achieved by thermoplasticity. 3. Kunststoffstab nach Anspruch 2, dadurch gekennzeichnet, dass die Krümmung durch Thermoplastizität nach Temperung erreicht wird.3. Plastic rod according to claim 2, characterized in that the curvature is achieved by thermoplasticity after annealing. 4. Kunststoffstab nach Anspruch 1, dadurch gekennzeichnet, dass die Krümmung durch Spritzguss in gebogener Form erreicht wird.4. Plastic rod according to claim 1, characterized in that the curvature is achieved by injection molding in a curved shape. 5. Kunststoffstab nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass zusätzlich zu der Krümmung auch eine Verdrehung nach links (4) oder rechts (5) überlagert ist.5. plastic rod according to one of claims 1 to 4, characterized in that in addition to the curvature and a rotation to the left (4) or right (5) is superimposed. 6. Kunststoffstab nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass der Kunststoffstab in rehydriertem Zustand geliefert wird.6. Plastic rod according to one of claims 1 to 5, characterized in that the plastic rod is supplied in rehydrated state. 7. Kunststoffstab nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, dass der Kunststoffstab aus Polycarbonateurethane gefertigt ist.7. Plastic rod according to one of claims 1 to 6, characterized in that the plastic rod is made of polycarbonate urethanes.
CH00133/10A 2010-02-04 2010-02-04 Pre-bent biocompatible plastic rod for surgical stabilization of spinal column of patient, is bent in supply condition along longitudinal axis by thermal plasticity after annealing process and by injection molding process CH702637A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CH00133/10A CH702637A1 (en) 2010-02-04 2010-02-04 Pre-bent biocompatible plastic rod for surgical stabilization of spinal column of patient, is bent in supply condition along longitudinal axis by thermal plasticity after annealing process and by injection molding process

Applications Claiming Priority (1)

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CH00133/10A CH702637A1 (en) 2010-02-04 2010-02-04 Pre-bent biocompatible plastic rod for surgical stabilization of spinal column of patient, is bent in supply condition along longitudinal axis by thermal plasticity after annealing process and by injection molding process

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150173799A1 (en) * 2012-07-05 2015-06-25 Spinesave Ag Elastic rod having different degrees of stiffness for the surgical treatment of the spine

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0470660A1 (en) * 1990-08-07 1992-02-12 Acromed B.V. Apparatus for the correction of scoliosis
US5415661A (en) * 1993-03-24 1995-05-16 University Of Miami Implantable spinal assist device
WO2005030281A2 (en) * 2003-09-26 2005-04-07 Societe Hexabio 4 Al Du Doyen Brus Biocompatible elastomer material for mould prosthesises implantable in a human body
US20070162007A1 (en) * 2004-08-13 2007-07-12 Mazor Surgical Technologies, Ltd. Minimally invasive spinal fusion
US20070191832A1 (en) * 2006-01-27 2007-08-16 Sdgi Holdings, Inc. Vertebral rods and methods of use
FR2902991A1 (en) * 2006-06-29 2008-01-04 Frederic Fortin Posterior dynamic stabilization device for vertebral column, has one-piece unit forming viscoelastic core and made of elastomer material which is biocompatible with human body, where unit takes form of helical coil with shock-absorbing pads
WO2008027860A2 (en) * 2006-08-31 2008-03-06 Warsaw Orthopedic, Inc. Polymer rods for spinal applications
US20080177388A1 (en) * 2007-01-18 2008-07-24 Warsaw Orthopedic, Inc. Variable Stiffness Support Members

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0470660A1 (en) * 1990-08-07 1992-02-12 Acromed B.V. Apparatus for the correction of scoliosis
US5415661A (en) * 1993-03-24 1995-05-16 University Of Miami Implantable spinal assist device
WO2005030281A2 (en) * 2003-09-26 2005-04-07 Societe Hexabio 4 Al Du Doyen Brus Biocompatible elastomer material for mould prosthesises implantable in a human body
US20070162007A1 (en) * 2004-08-13 2007-07-12 Mazor Surgical Technologies, Ltd. Minimally invasive spinal fusion
US20070191832A1 (en) * 2006-01-27 2007-08-16 Sdgi Holdings, Inc. Vertebral rods and methods of use
FR2902991A1 (en) * 2006-06-29 2008-01-04 Frederic Fortin Posterior dynamic stabilization device for vertebral column, has one-piece unit forming viscoelastic core and made of elastomer material which is biocompatible with human body, where unit takes form of helical coil with shock-absorbing pads
WO2008027860A2 (en) * 2006-08-31 2008-03-06 Warsaw Orthopedic, Inc. Polymer rods for spinal applications
US20080177388A1 (en) * 2007-01-18 2008-07-24 Warsaw Orthopedic, Inc. Variable Stiffness Support Members

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150173799A1 (en) * 2012-07-05 2015-06-25 Spinesave Ag Elastic rod having different degrees of stiffness for the surgical treatment of the spine
US10695097B2 (en) * 2012-07-05 2020-06-30 Spinesave Ag Elastic rod having different degrees of stiffness for the surgical treatment of the spine

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