EP1474053A1 - Systeme polyaxial posterieur pour la colonne vertebrale - Google Patents

Systeme polyaxial posterieur pour la colonne vertebrale

Info

Publication number
EP1474053A1
EP1474053A1 EP03739733A EP03739733A EP1474053A1 EP 1474053 A1 EP1474053 A1 EP 1474053A1 EP 03739733 A EP03739733 A EP 03739733A EP 03739733 A EP03739733 A EP 03739733A EP 1474053 A1 EP1474053 A1 EP 1474053A1
Authority
EP
European Patent Office
Prior art keywords
set forth
rod
recess
head
bushing
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.)
Withdrawn
Application number
EP03739733A
Other languages
German (de)
English (en)
Inventor
Moti Altarac
Philip A. Mellinger
Alex Vaccaro
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.)
Cross Medical Products LLC
Original Assignee
Cross Medical Products LLC
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
Priority claimed from US10/361,195 external-priority patent/US7163538B2/en
Priority claimed from US10/360,145 external-priority patent/US20040006342A1/en
Application filed by Cross Medical Products LLC filed Critical Cross Medical Products LLC
Publication of EP1474053A1 publication Critical patent/EP1474053A1/fr
Withdrawn legal-status Critical Current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
    • A61B17/70—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
    • A61B17/701—Longitudinal elements with a non-circular, e.g. rectangular, cross-section
    • 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
    • A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A61B17/7007—Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
    • 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
    • A61B17/56—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
    • A61B17/7041—Screws or hooks combined with longitudinal elements which do not contact vertebrae with single longitudinal rod offset laterally from single row of screws or hooks
    • 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

Definitions

  • the invention relates to an implant for the spine.
  • the invention relates to a construct based on a rod which is held in a posterior relation to the spine using a multi-component bone anchor that includes multiple joints in order to achieve multiple degrees of freedom that can when desired be locked in a particular axial alignment.
  • the invention relates to a plate and locking cap assembly that is provided in a pre-assembled state to span several vertebrae.
  • Constructs have been designed for some time for implantation in the spine which generally include a series of bone fasteners, such as hooks or screws, that are secured to the vertebrae, and which are used to hold stabilizer means such as a rod or plate that spans several vertebrae for stabilization, fixation, and/or for alignment of the vertebrae.
  • bone fasteners such as hooks or screws
  • a spinal rod assembly typically includes two sets of rods that are fixed to adjacent vertebrae on either side of the spinous process to span a section of spine.
  • the bone anchors may include a number of fixation means, such as screws or hooks, which are used for fixation to the spine, and anchor means, such as rod anchors that includes means to secure the rod to the fixation means.
  • fixation means such as screws or hooks
  • anchor means such as rod anchors that includes means to secure the rod to the fixation means.
  • these component parts are a single integral unit, while other systems utilize a number of assembled components such as for the anchor portion of the assembly.
  • the constructs need to be relatively easy to assemble, to be safe for the area of implantation, to provide for flexibility of use to accommodate a number of different indications for implantation and for variations in individuals who require their use, to be strong, yet minimally invasive and low profile, to be useful for manipulation, as well as for the maintenance of the desired alignment of the spine.
  • the present invention provides a multi-component bone anchor for use primarily with a rod in any area of the spine.
  • the anchor includes multiple joints in order to provide many degrees of freedom by providing two selectively variable axes of alignment for the fixation assembly which can however, be easily locked to form a solid (i.e. fixed) point of fixation in the bone.
  • the invention has a bone screw with a concavely rounded interior surface formed within a cage (i.e. a compressible open recess having a series of resilient prongs) that receives the convexly rounded exterior surface of a post member, preferably to form a ball and socket, or more preferably a partial ball and socket type cooperation to define the first variable axis of rotation.
  • a locking cap cooperates with a screw rod connector to form the second point of rotation for the second axis.
  • the inwardly curving inner surface of the locking cap is preferably slightly smaller (i.e.
  • a locking nut is screwed onto the post to cause locking of both the locking cap in the screw rod connector and of the cage in the locking cap as the post is drawn upward.
  • a single locking step causes both axes of rotation to become fixed to make the construct more rigid in the bone.
  • the system includes a bone screw having a pronged cage that retains the rounded and preferably hemi-spherical head of a post member.
  • the bottom of the post head has a concave recess or dimple that engages a resilient spindle member captured in a recess at the bottom of the cage.
  • the spindle member biases the post member upward against the inside of the restraining prongs of the cage.
  • the post head has an upper rounded camming surface that urges the prongs outward to allow the post to be snap fit into place in the cage for assembly and also as a locking mechanism .
  • the interior surface of the cage is slightly smaller than the outer diameter of the post head to ensure a fit which can be locked in place by compression by the downward action of the locking cap.
  • the outer surface of the cage prongs collectively taper outwardly along the vertical axis of the screw to form a camming surface with the tapered (i.e. conical or curved ) interior recess of the locking cap.
  • the locking cap interior surface has a slight corresponding taper to cause the cage to be biased inward and downward against the top surface of the post head engagement member as the post is screwed upward in relation to the locking cap.
  • the locking cap has a slotted bushing that engages an elongated slot in a screw rod connector, which may also have an interior curve which mates with an exterior curve of the bushing to allow movement transverse to the rod axis as well as optionally at a variable angle.
  • the screw rod connector includes a channel or recess for the rod which allows it to be offset from the point of fixation. The amount of offset is determined by the position of the locking cap in the rod connector slot.
  • a locking nut has a bottom portion along a through bore with interior threads and a tapered exterior surface which increases in diameter towards the top. The top portion is a slightly larger head which includes an exterior hex driving surface, such as a hexagon shape.
  • the interior threads of the hex headed locking nut engage the exterior threads on the post head, upward of the post engagement member.
  • the taper biases the slotted bushing of the locking cap outward to lock it into place within the rod-connector slot.
  • the post engagement member is drawn upward and locked into position against the prongs of the screw cage, which are in turn captured between the engagement member and the interior recess of the locking cap.
  • the top portion of the post also has an external hex in order to allow the system to be tightened by turning the nut relative to the post while the post is held in a fixed position. In some cases, the surgeon may even decide to refrain from tightly locking the nut against the post member in order to retain some of the play of the fixation assembly which still acts as a tether and to accept some of the loading of the rod.
  • the proposed product is unique in allowing multiple degrees of freedom prior to tightening.
  • the angle of the post can be varied about a first center of rotation with respect to the screw.
  • the angle of the screw can be varied about a second center of rotation with respect to the locking cap which is secured in the slot in the screw-rod connector.
  • the location of the locking cap in the slot of the screw-rod connector can also be varied.
  • a plate is used in place of the rod as the longitudinal stabilizer.
  • the plate includes slotted apertures that each includes a locking cap which fits down over the post and onto the exterior surface of the screw. The caps are press fit from the bottom into the plate.
  • the locking nut includes a flanged area, or a washer that fits over the top of the locking cap and abuts the top surface of the plate in the vicinity of the flange.
  • These degrees of freedom include one or more of a variable angle for the bone screw relative to the rod axis, a variable angle for the bone screw connector relative to the rod axis, a variable amount of offset relative to the rod axis, and a variable height of the screw rod connector through the amount of tightening.
  • the construct allows for multiple ranges of movement after assembly, but prior to tightening, where all of theses can be locked by a single locking or tightening mechanism. It is an additional object to provide an additional method of stabilizing the vertebrae in a manner that permits ease of assembly.
  • Figure 1 is end view of the rod anchor assembly in accordance with the present invention.
  • Figure 2 is an exploded assembly view taken 90 degrees from Figure 1 ;
  • Figure 3 is a top view of the assembly of Figure 1 ;
  • Figure 4 is a cross-section of the assembly taken along line 4-4 of Figure 1 ;
  • Figure 5 is a cross-section showing an alternative embodiment of the invention.
  • Figure 6 is a oblique perspective of an alternative embodiment of the screw using a stabilizer plate having preassembled locking caps in the plate;
  • Figure 7 is a side view of the embodiment of Figure 6;
  • Figure 8 is a top view of the embodiment of Figure 7;
  • Figure 9 is a cross-sectional view of the view of Figure 7;
  • Figure 1 0 is a top view of the plate and cap assembly shown in Figure 6;
  • Figure 1 1 is a side perspective view of the plate and cap assembly shown in Figure 1 0. Detailed Description of the Invention
  • the present invention provides a spinal implant assembly including a rod which is preferably not a threaded rod, and which is not shown, but which is held in position relative to the spine by a series of bone anchor assemblies as shown generally at 1 0 in Figure 1 .
  • the bone anchor assembly 1 0 includes a fixation member which comprises a bone screw 1 2 having a threaded lower portion which has a fluted area 1 4 and a suitable thread, such as a cancellous thread 1 6.
  • the top of the bone screw 1 2 includes a receptacle such as a cage 1 8 for a post member 20.
  • the cage comprises a plurality of resilient prongs 21 that are constructed by forming slots 22 in the top of the cage.
  • the prongs terminate to form a circular opening with a small bevel 25 to the top which is slightly smaller in diameter than the diameter of the engagement head 23.
  • These prongs 21 can be deformed outward for the insertion of the engagement head of the screw, or inwardly for a compressive locking of the engagement head in a recess 24 which is shown as a spherical recess that receives the outwardly rounded engagement head 23 of the post member 20.
  • the engagement head is shown as a sphere or in a second embodiment as a modified sphere.
  • the top portion of the sphere of the engagement head 23 may preferably be slightly larger than the inner recess or cavity 24 of the cage.
  • the prongs also collectively have an outer surface 26 that tapers inward toward the central longitudinal axis of the screw and anchor assembly so that the bone screw has a pear type shape.
  • a locking cap 30 has a through bore so that it can be fitted over the post member 20.
  • the lower portion of the locking cap 30 forms a skirt 32 that has an upwardly tapered surface 34 on the inside. This can be a curving surface or a conical surface, but in any case, it is slightly smaller than the outer surface 26 of the prongs so as to enable a compressive contraction of the prongs 21 inward about the head of the engagement member 23.
  • the locking cap includes a bushing 36 that may include a rounded surface 38 which mates with the elongated slot 42 in a flanged area of a screw rod connector 40.
  • the slot may also include a corresponding inner rounded contour to allow the bone anchor assembly to be positioned at a variable angle, as well as at a variable distance of offset from the longitudinal axis of the stabilization rod.
  • the rod is received in a channel 39 and secured in position by means such as a set screw which is received in the threaded recess 44 of the screw rod connector.
  • the bushing 36 of the locking cap also includes a plurality of slots 37 that allow the bushing to be expanded outwardly against the sides of the slots 42 of the screw rod connector so that it may be locked in position.
  • the bone anchor assembly further includes a locking nut 50 having a tapered lower portion 52 and a torque receiving head 54 and an internal threaded throughbore.
  • the lower portion 52 has a terminal bevel 56 that can be received in the terminal beveled opening 58 at the top of the bushing 36.
  • the lower portion also includes a tapered portion 52 having an outer diameter which is slightly larger than the inner diameter of the bore on the inside of the bushing.
  • the post member includes a threaded portion 57 that mates with the internal threads on the locking nut 50.
  • A which corresponds to the angulation of the post engagement head in the cage of the bone screw
  • B which corresponds to the angulation of the locking cap in the slot.
  • both of these angles can be locked by the same locking mechanism .
  • the top of the post has a hexagon shape to allow it to be held during tightening . However, this top can subsequently be sheared off.
  • FIG. 5 is a preferred modification wherein the bottom portion of the engagement head 23 is contoured, to form a hollow recess 70 that is pressed upward by a resilient spindle member 72 which is captured in a cavity 74 in the cage.
  • the post member retains its ability to be variably angled in the cage, but it is biased outward against the cavity of the cage so that it is more apt to stay in a position in the cage before it is tightened (i.e. it is less apt to flop.)
  • a construct generally includes two rods on either side of the spinous process, and a series of bone anchor assemblies implanted in adjacent vertebrae.
  • the assembly may also include other components, such as for example, plates, transverse connectors, cables, and hooks.
  • the implants may be made of suitable implantable biocompatible materials, such as stainless steel and titanium, as well as ceramics, and composite materials.
  • the embodiment shown in Figures 6-1 1 includes many components parts that are substantially similar, if not identical, to those shown in the first five Figures.
  • the assembly 1 1 0 includes at least two, and even three, or more bone screws 1 2 which each have the cage 1 8 that acts as a receptacle for the post member 20.
  • the post includes the ball which is received in the cage, and the post further includes a threaded portion 57 that mates with a hexagonal locking nut 1 50.
  • the locking nut has a flanged area 1 52 which tightens down onto the plate, or alternatively, a separate washer can be provided.
  • the screws are connected by means of a screw connector 1 40 which forms part of the plate assembly 1 20.
  • the plate assembly includes the screw connector, which is a plate having several apertures 1 42 that are longer in length along the longitudinal axis of the plate than the diameter of the bushing 1 36 of the locking cap 1 30. This allows some play in the placement of the cap with respect to the plate. This in turn facilitates assembly onto the posts of the screw assembly.
  • the locking cap includes a skirt 1 32 which functions as previously described. The caps 1 30 are press fit into the slots 1 42 prior to the assembly with the screw, and preferably prior to surgery.

Landscapes

  • 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

L'invention concerne un ensemble de fixation de barres destiné à être implanté dans la colonne vertébrale, comprenant un ensemble d'éléments d'ancrage osseux comportant deux points de pivotement au niveau de la connexion entre le point de fixation et la barre. Par ailleurs, l'écart entre le point de fixation et la barre peut être réglé. L'invention utilise une vis à os comprenant une douille à ergots avec une cavité servant à recevoir la tête d'une tige. La douille peut être serrée autour de la tête à l'aide d'un chapeau de fermeture. Pour ce faire, il suffit de glisser le chapeau autour de la douille compressible et de visser la tête vers le haut, dans la cavité, les filets de la tige entrant en prise avec ceux d'un écrou de blocage au fur et à mesure que la tête est vissée vers le haut. De plus, le chapeau de fermeture comprend une bague de raccordement rainurée pouvant être positionnée dans la fente allongée d'un élément d'assemblage pour barres. Le chapeau de fermeture comprend une partie évasée externe permettant d'écarter la bague de raccordement vers l'extérieur pour la verrouiller dans la fente. Dans un autre mode de réalisation, la tête comprend un espace interne servant à recevoir une mèche ajourée dans une cavité située dans ledit espace, pour limiter le jeu dans l'ensemble avant l'opération de serrage. Dans un autre mode de réalisation, les éléments d'ancrage osseux sont reliés à l'aide d'une plaque comprenant des chapeaux de fermeture pré-assemblés dans la plaque.
EP03739733A 2002-02-13 2003-02-11 Systeme polyaxial posterieur pour la colonne vertebrale Withdrawn EP1474053A1 (fr)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US35699602P 2002-02-13 2002-02-13
US356996P 2002-02-13
US360145 2003-02-07
US10/361,195 US7163538B2 (en) 2002-02-13 2003-02-07 Posterior rod system
US10/360,145 US20040006342A1 (en) 2002-02-13 2003-02-07 Posterior polyaxial plate system for the spine
US361195 2003-02-07
PCT/US2003/004040 WO2003068088A1 (fr) 2002-02-13 2003-02-11 Systeme polyaxial posterieur pour la colonne vertebrale

Publications (1)

Publication Number Publication Date
EP1474053A1 true EP1474053A1 (fr) 2004-11-10

Family

ID=27739171

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03739733A Withdrawn EP1474053A1 (fr) 2002-02-13 2003-02-11 Systeme polyaxial posterieur pour la colonne vertebrale

Country Status (3)

Country Link
EP (1) EP1474053A1 (fr)
AU (1) AU2003210964A1 (fr)
WO (1) WO2003068088A1 (fr)

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