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WO2007121095A1 - Articulations multi-axiales non bloquantes pour implants vertébraux - Google Patents

Articulations multi-axiales non bloquantes pour implants vertébraux Download PDF

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Publication number
WO2007121095A1
WO2007121095A1 PCT/US2007/065960 US2007065960W WO2007121095A1 WO 2007121095 A1 WO2007121095 A1 WO 2007121095A1 US 2007065960 W US2007065960 W US 2007065960W WO 2007121095 A1 WO2007121095 A1 WO 2007121095A1
Authority
WO
WIPO (PCT)
Prior art keywords
anchor
connector
head
channel
wear
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.)
Ceased
Application number
PCT/US2007/065960
Other languages
English (en)
Inventor
Eric S. Heinz
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.)
Warsaw Orthopedic Inc
Original Assignee
Warsaw Orthopedic Inc
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 US11/403,351 external-priority patent/US8366776B2/en
Application filed by Warsaw Orthopedic Inc filed Critical Warsaw Orthopedic Inc
Priority to PCT/US2007/065960 priority Critical patent/WO2007121095A1/fr
Publication of WO2007121095A1 publication Critical patent/WO2007121095A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • 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 or setting implements
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • 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 or setting implements
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032Screws or hooks with U-shaped head or back through which longitudinal rods pass

Definitions

  • the human spine serves many functions.
  • the vertebral members of the spinal column protect the spinal cord.
  • mov ⁇ abk facet joists and resilient discs disposed between the vertebral members permit motion between individual vertebral members, Tbe spssa.
  • column also supports other portions of the huiftsa body, When viewed from a posterior or anterior direction, the vertebral members are generally a ⁇ g ⁇ ed, although the width of the vertebral members generally increases from the cervical region to the lumbar region.
  • the spins is curved U) absorb leads and maintain the balance, of the upper body.
  • Abnormal curvatures may occur in some patients, For example, kyphosis may describe an exaggerated posterior curvature ia the thoracic region. Lordosis may describe an exaggerated anterior curvature of the ktsbar region. Scoliosis may describe an abnormal lateral curvature.
  • one iechmqac to correct abnormal spinal curvatures Ls to insert interbody implants ⁇ faat include a desired correction angle between vertebral bodies in the spine.
  • the correction angle may be in the coronal plane or ihe sagittal plane. It h certainly possible to merude implants that provide both coronal and sagittal correction of multiplanar defects.
  • a single interbody implant may provide a desired angular correction in the coronal plaae aud a separate desired angular correction in the sagittal piaae.
  • An implant with this configuration provides a compound correction that is the vector combination of the two corrections.
  • Illustrative embodiments disclosed herein are directed to a connector thai pivotally connects a vertebral anchor to a longitudinal member.
  • the connector body may be directly or indirectly attached to the anchor.
  • the connector body may include a channel and a cavity that are aligned along a common axis.
  • the channel is generally sized to receive the longitudinal member
  • the connector may have an associated fastener that mates with the channel to maintain the longitudinal member in the channel.
  • the cavity may be positioned on an opposite side of the body from the channel while being aligned with the channel.
  • the cavity may include a narrow opening that extends into an enlarged receiving area.
  • the receiving area may be isolated from the channel, in one embodiment, an intermediate section defines a boundary between the receiving area and the channel.
  • the receiving area may be sized to accommodate an enlarged head of the anchor.
  • the narrow opening may be sized to retain the head within the receiving area.
  • the receiving area may be further sized to allow the anchor to freely pivot about the common axis, even when the fastener mates with the receiver.
  • the connector may also include a wear member positioned within the cavity. The wear member may form its own receiving area that h isolated from the channel and sized to accommodate the head of the anchor.
  • Figures 1 A and IB are perspective views of an assembly according to one or more embodiments comprising a longitudinal member attached to the spine;
  • Figures 2A and 2B are perspective views of a pivoting head coupled to an anchor member according to one embodiment
  • Figure 3 is a side section view of a pivoting head coupled to an anchor member and securing a longitudinal member according to one embodiment
  • Figure 4 is a perspective view of an anchor member for use with a pivoting head according to one embodiment
  • Figure 5 is a perspective view of a wear member for use with a pivoting head according to one embodiment
  • Figure 6 is a side view, including a partial section view, of an assembled anchor member and wear member for use with a pivoting head according to one embodiment
  • Figure 7 is a side section view of a pivoting head with an anchor member and wear member inserted therein according to one embodiment.
  • Figure 8 is a side section view of an assembled pivoting head with an anchor member and wear member constrained therein according to one embodiment
  • Figures C >A and Q B are top section views of a pivoting head with an anchor member and wear member inserted therein according to different embodiments;
  • Figure 10 is a side section view of an assembled pivoting head with an anchor member and wear member constrained therein according to one embodiment.
  • Figure 1 1 is a perspective view of a wear member for use with a pivoting head according to one embodiment
  • Figure 12 is a side section view of an unassembled anchor member and wear member for use with a pivoting head according to one embodiment
  • Fi gures 13 A and 13B are side section views of an assembled anchor member and wear member for use with a pivoting head according to one embodiment
  • Figures 14A and 14B are side section views showing a technique for assembling a pivoting head with an anchor member and wear member constrained therein according to one embodiment
  • Figure 15 is a side section view of an assembled pivoting head with an anchor member and wear member constrained therein according to one embodiment
  • Figure 16 is a side section view of an assembled pivoting head with an anchor member and wear member constrained therein according to one embodiment
  • FIGS. IA and IB show another type of longitudinal member 15 that is secured between the sacrum S and a vertebral member V (e.g., LS)
  • the longitudinal member 15 is a flexible member, such as a resin or polymer compound.
  • Some flexible non-metallic longitudinal members 15 are constructed from materials such as PEEK and UFiMWPF ' , Other types of flexible longitudinal members ! 5 may comprise braided metallic structures.
  • the longitudinal member 15 is rigid or semi-rigid and may be constructed from metals, including for example stainless steels, cobalt-chrome, titanium, and shape memory alloys Further, the longitudinal member 15 may be straight, curved, or comprise one or more curved portions along its length.
  • the longitudinal member ! 5 is secured to the vertebral member V with one embodiment of a non-locking, pivoting head 10 in accordance with the teachings provided herein. In the embodiment shown, the longitudinal member 15 is secured to a saddle 16 within the pivoting head 10 with a securing member 12.
  • the securing member 12 shown in Figures IA and IB features a snap-off driving member 14
  • the driving member H is integrally formed with the securing member 12 and allows a surgeon to drive the securing member 12 into contact with the longitudinal member 15 to achieve a certain installation torque Above that torque, the driving member 14 will snap off, separating from the securing member 12. In this manner, the securing member 12 may provide the desired clamping force to secure the longitudinal member 15.
  • Figure 1 A shows a first orientation for the pivoting head i0 identified by the centerline labeled X.
  • Figure I B shows a second position representing a different spatial relationship between the sacrum S and the vertebra V As compared to Figure I A. the vertebra V in Figure 1 B exhibits some amount of angular and torsional displacement relative to the sacrum S. Consequently, the pivoting head 10 is illustrated in a second orientation identified by the centerline labeled Y The pivoting head 10 may provide some or all of this rotation
  • the illustrations provided in Figures IA and IB show the pivoting head 10 as part of a spina! implant that is coupled between a vertebral body V and a sacrum S.
  • pivoting head 10 may be used in constructs that are coupled to vertebral bodies V alone
  • a vertebral implant may be construed to mean implants that are coupled to any or all portions of a spine, including the sac ⁇ sffh vertebral bodies, and the skull.
  • FIGS 2A and 2B illustrate perspective views of the illustrative embodiment of the pivoting head 10 coupled to an anchor member 18.
  • a head 32 of the anchor member 18 is pivotally coupled to a base portion 34 of the pivoting head 10.
  • the anchor member 18 comprises threads for insertion into a vertebral member V as shown in Figure 1
  • the anchor member 18 is a pedicle screw
  • the exemplary saddle 16 is comprised of opposed upright portions forming a U-shaped channel within which a longitudinal member 15 is placed
  • a seating surface 24 forms the bottom of the U-shaped channel ⁇ n one embodiment, the seating surface 24 is curved to substantial!) match the radius of a longitudinal member 15 that is positioned within the saddle S 6
  • An aperture 26 within the seating surface provides access to a driving feature used to insert the anchor member 18 into a member V
  • the pivoting head 10 is shown substantially aligned with the anchor member ! 8 along the eenterhne labeled X
  • the anchor member 18 is shown pivoted relative to the pivoting head 10 That is, the photing head 10 is shown still aligned with the centerUne labeled X while the anchor member 18 is shown aligned with the center! ine labeled Y
  • the pivoted displacement of the pivoting head 10 relative to the anchor membei 1 S ed in Figure 2B is provided by an articulation mechanism that is more clearly ⁇ isibte in the section view provided in Figure 3
  • Figure 3 shows a section view of the pivoting head 10 holding a different type of longitudinal member 28 in this embodiment, the longitudinal member 28 is a spinal rod
  • the spinal rod 28 is scouted within the saddle 16 with a seeming member 12
  • the securing member 12 is an external! ⁇ ' threaded set screw, though other types of securing members such as externally threaded caps and nuts may be used
  • an articulation mechanism 40 is disposed below the saddle 16 and generally aligned with the central axis X
  • the articulation mechanism 40 comprises an enlarged head 32 of the anchor member 18 that is pivotally coupled to a wear member 30 within the base portion 34 of the piv oting head 10 Since the enlarged head 32 is configured to pivot within the wear member 30, the wcai mcnibei 30 and the outer surface of the enlarged head 32 may be constructed of a wear resistant material
  • Some suitable examples mav include hardened metals, titanium carbide, cobalt chrome, polymers, and ceramics
  • a wear resistant laver ma ⁇ be coated onto the enlarged head 32 and the wear member 30
  • the wear member 30 may be integrally formed into or form a part of the base portion 34
  • the wear member 30 ma ⁇ be bonded to the base portion 34 using a biocompatible adhesive such as PMMA or other known adhesh es
  • the part of the base portion 34 m contact with the enlarged head 32 may be coated with a wear resistant layer Coating processes that include, for example, vapor deposition, dip coating, diffusion bonding, and electron beam welding may be used to coat the above indicated materials onto a similar 01 dissimilar substrate
  • Diffusion bonding is a soli d-siate joining process capable of joining a wide range of metal and ceramic combinations
  • the process ma ⁇ be applied o ⁇ er a variety of durations, applied pressure, bonding temperature, and method of heat application
  • the bonding is typically formed in the solid phase and ma> be carried out in vacuum or a protective atrn ⁇ sphe
  • the articulation mechanism 40 is spatially and functionally isolated from the clamping forces that are applied between the securing member 12, the rod 28. and the seating surface 24 (see Figures 2A 5 2B) That is, since the compression forces applied b> the securing member 12 arc not transmitted to the articulation mechanism 40, the anchor member 18 freely rotates about the central axis X In one embodiment, there is no interference between the enlarged head 32 and the wear member 30 This type of fit may minimize the sliding friction that impedes the motion of the anchor member 18 relative to the wear member 30
  • Figure 4 shows a perspectne view of the enlarged head 32 of the exemplary anchor member 18
  • the enlarged head 32 is substantial!) spherical to allow multi-axial pivoting of the anchor member 18 relative to the pivoting head 10
  • the enlarged head 32 has other shapes to allow motion in fewer directions
  • a disc-shaped enlarged head 32 may provide motion within a desired plane fhe enlarged head 32 ma> also include a driving feature 42 that allows a surgeon to attach the anchor member 18 to a vertebra V
  • a hex recess dri ⁇ ing feature 42 is shown
  • Other types of dm ing features 42 may be appropriate, including for example, slotted, star, Torx. and cross-shaped features
  • the driving feature 42 ma ⁇ be accessed through the aperture 26 shown in Figures 2 ⁇ . 2B, and 3
  • Figure 5 shows a perspeeth e view of a wear member 30 according to one embodiment
  • the wear member 30 is cylindrically shaped and includes an outer surface 44 and an inner surface 46 extending between a top surface 50 and a bottom surface 52
  • the inner surface 46 is constructed to match the shape of the enlarged head 32 Df the threaded anchor member 18
  • the outer surface 44 may be configured as desired to fit within the base portion 34 of the pivoting head 10 as shown in
  • the outer surface 44 is substantially cylindrical
  • the exemplary wear member 30 also includes a gap 48
  • the gap 48 in the present embodiment ma> be used to spread open the wear member 30 by an amount sufficient to sup the wear member 30 over the enlarged head 32 of the anchor member ! 8
  • the ⁇ ear member 30 is shown installed on the enlarged head 32 in Figure 6
  • Figure 6 also shows relevant dimensions of the wear member 30 and the enlarged head 32
  • Dimension L represents a width of the enlarged head 32 at its widest point
  • Dimensions M and N lespectiveSy represent an interior width at the top 50 and bottom 52 of the wear member 30
  • dimension L is larger than both ⁇ j and N ⁇ hus, the gap 48 allows the enlarged head 32 to fit within the wear member 30 as shown in Figure 6
  • Figure 7 shows the assembled wear member 30 and anchor member S 8 inserted into the base portion 34 ⁇ f the oting head 10
  • the anchor member 18 and wear member 30 are retained within the base portion 34 by deforming the lower lip 56 in the direction of the arrow labeled F
  • the deforming step may be performed using a variety of techniques, including but not limited to mechanical pressing, swaging, and orbital forming
  • Orbital forming (or orbital forging) is a cold metal forming process during which the workpiece (the base portion 34 in this case) is transformed between upper and lower dies I he process features one or the other of these dies orbiting relative to the other with a compression force applied theicbetween Due to this orbiting motion over the workpiece, the resultant localized forces can achieve a high degree of deformation at a relatively low compression force level
  • the fully assembled pivoting head 10 is illustrated in Figure 8 In this figure, the lower lip 56 of the base portion 34 is formed to constrain the wear member 30 and the anchor member 18
  • Figures 4 M and 9LJ show section ⁇ iews according to the section line IX-IX shown in Figure 8
  • Figure 9 A shows one embodiment where the enlarged head 32 and wear member 30 are substantially spherical as previously described
  • the pivoting head 10 may phot about a plurality of axes, including axes A, B, C " , and E) as shown in Figure 9A
  • Figure 9B shows an alternative embodiment where the enlarged head 132 and wear member 130 are substantial!) disc-shaped
  • this configuration may allow pivoting motion about axis B, but not other axes, including axis A
  • Figure 10 show s an alternative embodiment of the pivoting head I Oa
  • the section view shown in Figuie 10 is similar to Figure 8 and shows an alternaih e technique for retaining the w ear member 30 and anchor member 18 within the base portion 34a
  • a snap ring 58 is in&ened into the bottom of the base portion 34a beneath the wear member 30 The snap ring 58 may effectively retain the wear member 30 and anchor member 18 within the head 10a
  • Figure 11 shoves an alternative configuration of the wear member 30a
  • the outer and inner surfaces 44a, 46a The w ear member 30a also includes a gap 48a as with the previous embodiment shown in Figure 5 I ⁇ owevcr. gap 48a does not extend from the bottom surface 52a to the top surface 50a In this embodiment, the top surface 50a of the wear member 30a is substantial!) continuous
  • the gap 48a is * illustrated as an arc. though other shapes r ⁇ a ⁇ be used
  • the gap 48a is sized to be wider than at least a top portion of the anchor menibei 18, just beneath the enlarged head 32, so that the anchor member 18 may be installed into the wear member 30a as shown in Figures J 2.
  • Figure 12 shows a side cross-section view of the exemplary anchor member I S and wear member 30a in Figure 12.
  • the anchor member ! 8 and the wear member 30a are unassembled
  • the anchor member 18 is rotated (relative to the wear member 30a) in the direction of the arrow labeled R
  • the enlarged head 32 of the rotated anchoi member 18 is inserted into the wear member 30a A3 so, w ith the anchor member 18 rotated as shown, a stem portion 54 of the anchor member 18 just beneath the enlarged head 32 is inserted into the gap 48a
  • the enlarged head 32 is inserted past the bottom surface 52a at point T
  • the anchor member 18 can be rotated back in the direction of the anow labeled U and towards the orientation shown in Figure I3B
  • Figures J4A and I 4B show an alternative embodiment of the pivoting head 10b where the anchor member 18 is inserted into the base portion 34b and wear member 30a in a manner similar to thai depicted in Figures 13 A and DR That is, to insert the anchor member 18 into the base portion 34b, the anchor member 18 is rotated approximately to the position shown in Figure J4A Then, the enlarged head 32 of the rotated anchor member S 8 is inserted into the wear member 30a ⁇ f the same time, the stem portion 54 is inserted into the gap 4Sa and a gap ! 48a in the base portion 34b Once inserted in this manner, the anchor member 18 can be rotated back in the direction of the arrow labeled U and towards the orientation shown in Figure 14B
  • an anchoi mcmbei 18 thai comprises threads for insertion into a vertebra) member Y
  • the pivoting head 10 may be incorporated on other t ⁇ pes of bone screws
  • different types of screws may be used to attach longitudinal members 15 to the sacrum S or to other parts of a vertebral member V I hese include, for example, anterior and lateral portions of a vertebral body
  • the pivoting head 10 may be implemented on other t> pes of anchoring members tor example.
  • Figure 15 shows a pivoting head 10 incorporated onto a hook -type anchor member 1 18
  • the pivoting head 10 is incorporated onto another type of threaded anchor member 218 that is inserted into a plate 220 instead of a bony member
  • Spatial K relative terms such as “under “ , '”below “upper”, and the like, ate used for ease of description to explain the positioning of one element relative to a second element These terms are intended to encompass different orientations of the device in addition to different orientations than those depicted in the figures f urther, terms such as “firsf . "second”, and the IiLe, are also used to describe ⁇ arious elements, regions, sections, etc and are also not intended to be limiting Like terms iefer to like elements throughout the description

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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

L'invention porte sur un implant vertébral destiné à être utilisé pour établir des courbures rachidiennes désirées et comprenant des corps séparés. Chaque corps peut comprendre un angle associé entre ses surfaces inférieure et supérieure. De plus, les corps d'implant peuvent être empilés de sorte que les angles associés soient orientés selon différents plans anatomiques. Les corps d'implant peuvent être fixés les uns aux autres par un connecteur et peuvent être utilisés soit indépendamment, soit ensemble pour réaliser une courbure rachidienne désirée. Chaque corps d'implant peut comprendre des dispositifs d'assemblage des os qui s'étendent vers l'extérieur depuis les surfaces supérieure et inférieure du corps d'implant. Les corps d'implants peuvent comporter des évidements qui sont situés de façon à correspondre aux parties saillantes d'assemblage des os dans d'autres corps d'implant pour permettre le contact entre les surfaces inférieure et supérieure des corps d'implant respectifs.
PCT/US2007/065960 2006-04-13 2007-04-04 Articulations multi-axiales non bloquantes pour implants vertébraux Ceased WO2007121095A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2007/065960 WO2007121095A1 (fr) 2006-04-13 2007-04-04 Articulations multi-axiales non bloquantes pour implants vertébraux

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11/403,351 US8366776B2 (en) 2006-04-13 2006-04-13 Vertebral implants having predetermined angular correction and method of use
US11/403,351 2006-04-13
PCT/US2007/065960 WO2007121095A1 (fr) 2006-04-13 2007-04-04 Articulations multi-axiales non bloquantes pour implants vertébraux

Publications (1)

Publication Number Publication Date
WO2007121095A1 true WO2007121095A1 (fr) 2007-10-25

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4304011A (en) * 1980-08-25 1981-12-08 Whelan Iii Edward J Semi-constrained metacarpophalangeal prosthesis
US6146421A (en) * 1997-08-04 2000-11-14 Gordon, Maya, Roberts And Thomas, Number 1, Llc Multiple axis intervertebral prosthesis
US20040049272A1 (en) * 1999-10-22 2004-03-11 Archus Orthopedics, Inc. Facet arthroplasty devices and methods
US20050277919A1 (en) * 2004-05-28 2005-12-15 Depuy Spine, Inc. Anchoring systems and methods for correcting spinal deformities
WO2007087562A1 (fr) * 2006-01-27 2007-08-02 Warsaw Orthopedic, Inc. Joints multiaxiaux non bloquants dans un implant vertébral et procédés d'utilisation

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4304011A (en) * 1980-08-25 1981-12-08 Whelan Iii Edward J Semi-constrained metacarpophalangeal prosthesis
US6146421A (en) * 1997-08-04 2000-11-14 Gordon, Maya, Roberts And Thomas, Number 1, Llc Multiple axis intervertebral prosthesis
US20040049272A1 (en) * 1999-10-22 2004-03-11 Archus Orthopedics, Inc. Facet arthroplasty devices and methods
US20050277919A1 (en) * 2004-05-28 2005-12-15 Depuy Spine, Inc. Anchoring systems and methods for correcting spinal deformities
WO2007087562A1 (fr) * 2006-01-27 2007-08-02 Warsaw Orthopedic, Inc. Joints multiaxiaux non bloquants dans un implant vertébral et procédés d'utilisation

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