WO2007011407A1 - Systeme de vis a os a liaison universelle - Google Patents

Systeme de vis a os a liaison universelle Download PDF

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Publication number
WO2007011407A1
WO2007011407A1 PCT/US2005/039283 US2005039283W WO2007011407A1 WO 2007011407 A1 WO2007011407 A1 WO 2007011407A1 US 2005039283 W US2005039283 W US 2005039283W WO 2007011407 A1 WO2007011407 A1 WO 2007011407A1
Authority
WO
WIPO (PCT)
Prior art keywords
bone
receiver
head
bone anchor
assembly
Prior art date
Application number
PCT/US2005/039283
Other languages
English (en)
Inventor
Dong Myung Jeon
Patrick Dennis Moore
Original Assignee
Dong Myung Jeon
Patrick Dennis Moore
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 Dong Myung Jeon, Patrick Dennis Moore filed Critical Dong Myung Jeon
Publication of WO2007011407A1 publication Critical patent/WO2007011407A1/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
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7038—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other to a different extent in different directions, e.g. within one plane only
    • 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
    • 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
    • A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass

Definitions

  • the present invention relates to devices and implants used in osteosynthesis and other orthopedic surgical procedures such as devices for use in spinal surgery, and, in particular, to an posterior pedicle screw, connector/rod assembly which is implantable within a patient for stabilization of the spine.
  • the present invention contemplates a top loading bone anchor assembly capable of achieving multiple angular, as well as multiple spherical axial orientations with respect to an elongated member extending along bone tissue.
  • an elongated member such as a bendable rod is disposed longitudinally along a length of the bone(s).
  • the rod is preferably bent to correspond to the normal curvature of the spine in the particular region being instrumented.
  • the rod can be bent to form a normal kyphotic curvature for the thoracic region of the spine, or a lordotic curvature for the lumbar region.
  • the rod is engaged to various vertebrae along a length of the spinal column by way of a number of fixation elements.
  • fixation elements can be provided which are configured to engage specific portions of the vertebra and other bones.
  • one such fixation element is a hook that is configured to engage the laminae of the vertebra.
  • Another very prevalent fixation element is a screw that can be threaded into various parts of the vertebrae or other bones.
  • the rod is situated on opposite sides of the spine or spinous processes.
  • a plurality of bone screws are threaded into a portion of several vertebral bodies, very frequently into the pedicles of these vertebrae.
  • the rods are affixed to these plurality of bone screws to apply corrective and stabilizing forces to the spine.
  • a rod-type spinal fixation system includes elongated rods and a variety of hooks, screws and bolts all configured to create a segmental construct throughout the spine.
  • the spinal rod is connected to the various vertebral fixation elements by way of an eyebolt.
  • the fixation elements are engaged to the spinal rod laterally adjacent to the rod.
  • a variable angle screw is engaged to the spinal rod by way of an eyebolt. The variable angle screw allows pivoting of the bone screw in a single plane parallel to the plane of the spinal rod. Details of this variable angle screw can be found hi U.S. Pat. No. 5,261,909 to Sutterlin et al.
  • One goal achieved by the system is that the surgeon can apply vertebral fixation elements, such as a spinal hook or a bone screw, to the spine in appropriate anatomic positions.
  • the system also allows the surgeon to easily engage a bent spinal rod to each of the fixation elements for final tightening.
  • fixation elements for engagement between an elongated rod and the spine.
  • the fixation elements themselves include a body that defines a slot within which the spinal rod is received.
  • the slot includes a threaded bore into which a threaded plug is engaged to clamp the rod within the body of the fixation element.
  • the system includes hooks and bone screws with this "open-back" configuration. Details of this technology can be found in U.S. Pat. No. 5,005,562.
  • fixation elements of the system are capable only of pivoting about the spinal rod to achieve variable angular positions relative to the rod. While this limited range of relative angular positioning is acceptable for many spinal pathologies, many other cases require more creative orientation of a bone screw, for instance, relative to a spinal rod. Certain aspects of this problem are addressed by the variable angle screw of the system, as discussed in the '909 Patent. However, there is a need for a bone screw that is capable of angular orientation in multiple planes relative to the spinal rod as well as multiple spherical head orientations.
  • the bone screw axis is capable of various three dimensional orientations with respect to the spinal rod as well as three dimensional spherical axis orientation to the receiving (head) element of the devices axial orientation of the bone engaging screw member.
  • Screws of this type of angular orientation in multiple planes relative to the spinal rod have been referred to as poly-axial or multi-axial bone screws.
  • no screw systems have employed both angular orientation in multiple planes relative to the spinal rod and three dimensional spherical axis orientation to the receiving (head) element of the devices axial orientation of the bone engaging screw member.
  • a bone screw which includes a spherical projection on the top of the bone screw.
  • An externally threaded receiver member supports the bone screw and a spinal rod on top of the spherical projection.
  • An outer nut is tightened onto the receiver member to press the spinal rod against the spherical projection to accommodate various angular orientations of the bone screw relative to the rod. While this particular approach utilizes a minimum of components, the security of the fixation of the bone screw to the rod is lacking. In other words, the engagement or fixation between the small spherical projection on the bone screw and the spinal rod is readily disrupted when the instrumentation is subjected to the high loads of the spine, particularly in the lumbar region.
  • a spherical headed bone screw is supported within separate halves of a receiver member. The bottom of the halves are held together by a retaining ring. The top of the receiver halves are compressed about the bone screw by nuts threaded onto a threaded spinal rod.
  • Harms et al. in U.S. Pat. No., 5,207,678, a receiver member is flexibly connected about a partially spherical head of a bone screw. Conical nuts on opposite sides of the receiver member are threaded onto a threaded rod passing through the receiver.
  • the receiver member flexibly compresses around the head of the bone screw to clamp the bone screw in its variable angular position.
  • the spinal rod must be threaded in order to accept the compression nuts. It is known that threading rods can tend to weaken the rods in the face of severe spinal loads.
  • the design of the bone screws in the '458 and '678 Patents require a multiplicity of parts and are fairly complicated to achieve complete fixation of the bone screw.
  • a further approach illustrated in U.S. Pat. No. 5,797,911 to Sherman et al. is to provide a U-shaped holder through the top of which a bone fastener topped with a crown member is loaded.
  • the holder accommodates a rod in a channel above the crown member and a compression member above the rod.
  • the compression member presses on the rod and crown member to lock the fastener against the holder in any of a number of angles in three dimensions with respect to the rod.
  • This approach has proven to be quite effective in addressing the above-identified problems. However, it does not permit bottom-loading of the fastener. Additionally, the holder is somewhat bulky in order to accommodate the other structural components.
  • a bone fixation assembly in one embodiment, includes a receiver member defining an upper opening portion and a lower shaft portion creating an "U-shape" geometry, a channel configured to receive the elongated member (rod) and communicating with said upper opening portion and said lower shaft portion, and internal threaded portion located at the top outside surface of the posts; and
  • a bone-engaging anchor having a lower portion configured to engage a bone and a head having a width, said width of said head fashioned in the shape of an upside/down "U” creating a closed loop, said head being movably disposed over and around said one upper receiver posts and located at the bottom of the "U" shape;
  • a compression retaining member defining an aperture smaller than said outside width of said receiving member posts, said retaining member at least partially housed in said top portion of said receiver member and positioned over said elongated member and tightened during utilization. Forces transmitted during tightening are imparted on the bone anchor member, and the lower surface ' of the receiving member to anchor all said components in any angular and/or axial configuration within design parameters.
  • FIG. 1 is a side elevational view of one embodiment of the multi-axial bone screw anchor assembly of the present invention.
  • FIG. 2 is an exploded view of the embodiment of the invention depicted in FIG. 1.
  • FIG. 3 a is a side elevational view of an embodiment of the receiver member of the embodiment of the invention illustrated in FIG. 2.
  • FIG. 3 b is a front elevational view of the embodiment of the receiver member illustrated in FIG. 3a.
  • FIG. 3c is a sectional view, taken along the lines 3c-3c in FIG. 3a, and viewed in the direction of the arrows, of the embodiment of the receiver member illustrated in FIG. 3a.
  • FIG. 3d is a sectional view, taken along the lines 3d— 3d of FIG. 3b and viewed in the direction of the arrows, of the embodiment of the receiver member illustrated in FIG. 3 a.
  • FIG. 4a is a side elevational view of an embodiment of a bone anchor used in the embodiment of the invention illustrated in FIG. 2.
  • FIG. 4b is a sectional view, taken along the lines 4b ⁇ 4b of FIG. 4a and viewed in the direction of the arrows, of the embodiment of the bone anchor illustrated in FIG. 4a.
  • FIG. 4c is a magnified view of one embodiment of the head of the embodiment of the bone anchor illustrated in FIG. 4a.
  • FIG. 5a is a top view of the retaining member.
  • FIG. 5b is a side elevational view of the retaining member.
  • FIG. 6 is an enlarged sectional view of the embodiment of the present invention illustrated in FIG. 1.
  • assembly 20 includes a receiver member 30, a bone anchor 50.
  • the assembly 20 of the present invention is designed for use with an elongated member R (FIG. 6) such as a spinal rod, bar or other orthopedic construct, as further described below.
  • Receiver member 30 defines an upper opening portion 31a and a lower shaft portion 31b, which in the illustrated embodiment form a single opening 32 extending through receiver member 30 from an upper aperture 33 in top end 34 to a lower closed loop 35 in bottom end 36. Lower closed loop portion 31b of opening 32.
  • upper and lower closed loop portions 3 Ia, 3 Ib can have a variety of configurations, such as each having one or more sections of differing diameter.
  • Opening 32 is partially surrounded by a chamfered or rounded edge 40a at top end 34 of receiver member 30.
  • Receiver member 30 in the illustrated embodiment includes a pair of upright branches 42, 43 through which opening 32 extends. Branches 42, 43 further define a U-shaped channel 45 transverse to opening 32 that communicates with upper portion 31a and lower portion 3 Ib of opening 32, and that accommodates an elongated member R (FIG. 6).
  • internal threads 44 are formed in branches 42, 43, internal thread 44 in a specific embodiment is a modified acme buttress thread.
  • FIGS. 4a-4c an embodiment of a bone anchor 50 used in the present invention is shown.
  • the illustrated bone anchor 50 is a bone screw.
  • Bone anchor 50 includes an anchorage portion 52 and a head portion 54.
  • Anchorage portion 52 includes at least one thread 56, which may be a cancellous self-tapping thread.
  • Head portion 54 forms part of a sphere/loop in the illustrated embodiment, though alternative curvate and other configurations may be employed.
  • Head 54 in one particular embodiment includes a series of ridges/lines 58 for improving purchase with the interface of receiver member 30 (described below).
  • Head 54 may have alternative friction- increasing surface configuration(s) such as roughening or knurling.
  • bone anchor 50 could be a bone-engaging hook rather than a screw.
  • anchorage portion 52 would be configured with a hook rather than an elongated section with thread 56.
  • Head 54 of bone anchor 50 is shaped and sized to fit over and around either post of the receiver member 30. Specifically, head 54 has a "U-shaped” geometry that being movably disposed over and around said one upper receiver posts and located at the bottom of the "U" shape portion 70.
  • assembly 20 is assembled as follows: bone anchor 50, is inserted over and around either post of the receiver member 30 substantially in one step as shown in (Fig. 2).
  • Bone anchor member 50 remains slideably and rotatably positioned in lower shaft 3 Ib of opening 32 and retained in that location of receiving member 30, and bone anchor 50 remains multi-axially moveable with respect to receiving member 30.
  • assembly 20 is assembled (as described above) prior to use in a surgical procedure.
  • bone anchor 50 of assembly 20 is threaded into an appropriately prepared hole in a bone (not shown). It will be understood that in alternative embodiments of the invention, for example where bone anchor 50 is a bone hook, drilling a hole in bone and threading the anchor therein may not be necessary.
  • an appropriate screwing tool is threaded onto the external threads of the receiving member 30, thus locking the assembly co-axially into one solid assembly, and is used to "drive" the bone anchor 50 therefore, threaded into the bone.
  • the appropriate screwing tool is then removed.
  • receiver member 30 is positioned so that opening 32 forms a desired angle with bone anchor 50, as depicted in FIG. 1.
  • the angle theta. between bone anchor 50 and opening 32 can be any value up to 90 degrees in any direction (180 degrees total angulation) .
  • the maximum angle of bone anchor 50 relative to opening 32 can be changed in two ways, for example by angling bone anchor 50 to its maximum off axis in association with maximum rotation of the receiver member 30 component.
  • receiver member 30 may be angled as the surgeon desires with respect to bone anchor 50.
  • An elongated member R such as a spinal rod, connector, or other orthopedic surgical implant is coupled with assembly 20. Elongated member R is placed in channel 45 of receiver member 30, and contacts outer surface 50 of bone anchor member 70.
  • a compression member 120 such as a skirted nut, skirted set-screw or similar device, is threaded into/onto threads 44 of receiver member 30 and down onto elongated member R.
  • Compression member 120 in one embodiment, is a skirted set- screw having external threads and a "skirt" to slide over the receiver member 30 and a print 124 for applying torque.
  • compression member 120 could be an internally- threaded nut.
  • assembly 20 can be assembled during the surgical procedure.
  • Preferred materials for the present invention include stainless steel and titanium. It will be recognized that any sturdy biocompatible material may be used to accomplish the osteosynthesis and other orthopedic surgical goals of the present invention.

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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)

Abstract

L'invention concerne un appareil d'ancrage osseux à liaison universelle à chargement par le dessus. L'appareil comprend un élément de réception supérieur 'en U', un élément d'ancrage et de retenue par compression. L'élément de réception supérieur 'en U' définit deux tiges supérieures et un axe inférieur, pouvant faire partie du 'U', un canal, ainsi qu'une partie filetée interne située au-dessus, sur les tiges. L'ancrage osseux est monté sur et autour de l'une des tiges supérieures de l'élément de réception supérieur 'en U', disposé mobile et situé au niveau de la partie inférieure de l'élément de réception supérieur 'en U', créant une 'liaison' entre l'élément d'ancrage osseux et l'élément de réception supérieur 'en U'.
PCT/US2005/039283 2005-07-18 2005-10-31 Systeme de vis a os a liaison universelle WO2007011407A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US70046805P 2005-07-18 2005-07-18
US60/700,468 2005-07-18

Publications (1)

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WO2007011407A1 true WO2007011407A1 (fr) 2007-01-25

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8419778B2 (en) 2010-01-15 2013-04-16 Ebi, Llc Uniplanar bone anchor system
US8647370B2 (en) 2010-01-15 2014-02-11 Ebi, Llc Uniplanar bone anchor system

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5782833A (en) * 1996-12-20 1998-07-21 Haider; Thomas T. Pedicle screw system for osteosynthesis
US20030149431A1 (en) * 2002-02-01 2003-08-07 Varieur Michael S. Closure system for spinal fixation instrumentation

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5782833A (en) * 1996-12-20 1998-07-21 Haider; Thomas T. Pedicle screw system for osteosynthesis
US20030149431A1 (en) * 2002-02-01 2003-08-07 Varieur Michael S. Closure system for spinal fixation instrumentation

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8419778B2 (en) 2010-01-15 2013-04-16 Ebi, Llc Uniplanar bone anchor system
US8647370B2 (en) 2010-01-15 2014-02-11 Ebi, Llc Uniplanar bone anchor system
US8986356B2 (en) 2010-01-15 2015-03-24 Ebi, Llc Uniplanar bone anchor system
US9211143B2 (en) 2010-01-15 2015-12-15 Ebi, Llc Uniplanar bone anchor system
US9820781B2 (en) 2010-01-15 2017-11-21 Ebi, Llc Uniplanar bone anchor system

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