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
  • A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass
  • A61B17/7034—Screws or hooks with U-shaped head or back through which longitudinal rods pass characterised by a lateral opening
• • 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
• • 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

Definitions

• the present invention concerns bone anchors, particularly useful for engagement in the vertebrae.
• the invention contemplates a bone screw assembly that allows loading of an elongated rod or other member extending along the spine from the side, while enabling adjustment of the rod substantially in a plane.
• a bendable rod is disposed longitudinally along the length of the spine or vertebral column.
• the rod may be 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 the 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.
• one such fixation element is a hook that is configured to engage the laminae of the vertebra.
• Another very prevalent fixation element is a spinal screw which can be threaded into various aspects of the vertebral bone.
• the rod is situated on one or opposite sides of the spine or spinous processes.
• a plurality of bone screws are threaded into a portion of several vertebral bodies, for example into the pedicles of these vertebrae.
• the rod(s) are connected or affixed to these plurality of bone screws to apply corrective and stabilizing forces to the spine.
• TSRH® Spinal System sold by Medtronic Sofamor Danek, Inc.
• the TSRH® 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 that is parallel to the plane of the spinal rod.
• variable angle screw Details of this variable angle screw can be found in U.S. Pat. No. 5,261,909 to Sutterlin et al., owned by the Assignee of the present invention.
• One goal achieved by the TSRH® 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 TSRH® System also allows the surgeon to easily engage a bent spinal rod to each of the fixation elements for final tightening.
• the fixation elements are the 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 CD® 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 to Cotrel.
• One benefit of this feature of the CD® System is that the fixation element is positioned directly beneath the elongated rod. This helps reduce the overall bulkiness of the implant construct and minimizes the trauma to surrounding tissue.
• vertebral anchors have channels for an elongated rod or other member that open upward, i.e. directly away from the bone to which the anchor is attached.
• the convenience of such a structure is clear, as the anchor can be first placed in the bone, then the rod can be essentially lain on top of it, within the channel.
• a surgeon may wish to use anchors to translate the vertebral body to the rod. This translation will typically involve horizontal as well as vertical components.
• Side loading implants, along with their associated instruments, can simplify the execution of this type of maneuver. Use of such implants can present less interference from lateral tissue, the potential to pre-load the locking components prior to inserting the anchor and also innovative means of provisionally capturing the rod prior to final tightening.
• FIG. 1 is a side view of an embodiment of a side-loading sagitally-adjustable bone anchor.
• FIG. 2 is a side view of the embodiment shown in FIG. 1, rotated ninety degrees with respect to FIG. 1.
• FIG. 3 is a side view of the embodiment shown in FIG. 1, rotated 180 degrees with respect to FIG. 1.
• FIG. 4 is cross-sectional view of the embodiment shown in FIG. 1, taken along the lines 4 — 4 in FIG. 3 and viewed in the direction of the arrows.
• FIG. 5 is a side view of a portion of the embodiment shown in FIG. 1.
• FIG. 6 is a side view of the portion shown in FIG. 5, rotated ninety degrees with respect to FIG. 5.
• FIG. 7 is a cross-sectional view taken along the lines 7 — 7 in FIG. 6 and viewed in the direction of the arrows.
• FIG. 8 is a side view of the portion shown in FIG. 5, rotated 180 degrees with respect to FIG. 5.
• FIG. 9 is a cross-sectional view taken along the lines 9 — 9 in FIG. 8 and viewed in the direction of the arrows.
• FIG. 10 is a top view of an embodiment of an internal piece useable in the apparatus shown in FIG. 1.
• FIG. 1 1 is a side view of the embodiment shown in FIG. 10.
• FIG. 12 is a rear view of the embodiment shown in FIG. 10.
• FIG. 13 is a front view of the embodiment shown in FIG. 10.
• FIG. 14 is a top view of an embodiment of a clip useable in the apparatus shown in FIG. 1.
• FIG. 15 is a side view of the embodiment shown in FIG. 14.
• FIG. 16 is a top view of another embodiment of a clip useable in the apparatus shown in FIG. 1. DESCRIPTION OF A PREFERRED EMBODIMENT
• Bone screw 20 may be made for attachment to vertebrae, such as cervical, thoracic, lumbar and or sacral bone structures, or other bones or tissues. Similarly, aspects of bone screw 20 described herein can be included in vertebral hooks, bone clamps, and other orthopedic implant devices.
• Screw 20 in the embodiment shown in FIG. 1, includes a shaft 22, a receiving portion 24, and an internal piece 26.
• Shaft 22 is an elongated piece having one or more threads 30 on at least a portion, e.g. a relatively lower portion.
• Thread 30 may be a cancellous thread, of a configuration suited to implantation into a vertebra or similar bone. Thread 30 may be self-tapping or intermittent, or may have more than one crest winding about shaft 22, or of other appropriate configurations.
• a neck 32 at a relatively upper portion of shaft 22 is provided. Neck 32 may be above thread 30, or may also include thread(s) or a threaded portion. In an embodiment in which shaft 22 is integrally joined to receiving portion 24, as by unitary formation or construction or by solid attachment, neck 32 is attached to receiving portion 24.
• receiving portion 24 is substantially C-shaped, having an upper leg 40, a lower leg 42, and an intermediate portion 44 joining them.
• Upper leg 40 has a threaded aperture 46 into which a set screw 48 can be threaded.
• Aperture 46 may have a longitudinal axis that is perpendicular to upper leg 40, or such axis may be angled with respect to upper leg 40, e.g. toward intermediate portion 44.
• Lower leg 42 may connect to shaft 22.
• shaft 22 is integrally joined to receiving portion 24.
• shaft 22 may be attached in a particular embodiment to receiving portion 24 at a relatively forward portion of lower leg 42.
• Shaft 22 may also be attached to receiving portion 24 at other parts of receiving portion 24.
• shaft 22 could be attached at a central portion of leg 42, i.e. an area approximately equidistant from intermediate portion 44 and a front or opening portion of receiving portion 24.
• Shaft 22 could also be attached to leg 42 at a rearward portion, i.e. an area relatively close to or at intermediate portion 44.
• Intermediate portion 44 joins legs 40 and 42. Taken together, legs 40 and 42 and intermediate portion 44 form substantially a C-shape, with a channel 52 substantially to one side of intermediate portion 44 and having a mouth 54 between legs 40 and 42. In a particular embodiment, mouth 54 is somewhat wider than the breadth of channel 52 further within receiving portion 24. For example, as shown in FIGS. 2 and 6, channel 52 may taper substantially uniformly from mouth 54 toward intermediate portion 44.
• receiving portion 24 further includes a cavity 56 in lower leg 42 and intermediate portion 44.
• Cavity 56 is relatively shallow in an area or hollow 58 substantially corresponding to lower leg 42.
• Cavity 56 may be substantially cylindrical and relatively deep in an area or hole 60 into or through intermediate portion 44.
• at least a part of cavity 56 in the area 60 in intermediate portion 44 may have a substantially hour-glass shape (e.g. somewhat wider at upper and lower ends than at an area between the upper and lower ends).
• a rim or flange 61 extends at least partially around area 60 of cavity 56 in a position relatively distant from channel 52 to assist in retaining internal piece 26, as will be described further below.
• Rim or flange 61 may extend around substantially the entire circumference of area 60 of cavity 56, or may extend around somewhat less than that circumference.
• receiving portion 24 is provided with one or more ridges 62.
• Ridges 62 are provided to engage the underside of internal piece 26 when screw 20 is locked.
• ridges 62 are positioned substantially perpendicular to the direction of a rod in channel 52. It will be seen that ridges 62 could be positioned substantially parallel or obliquely to such a rod, could be positioned substantially in a chevron-type formation, or in any other way to help lock internal piece 26 and receiving portion 24 against movement with respect to each other.
• splines or other engaging structure can be provided on both the internal piece 26 (e.g. on its external surface 67) and on the receiving portion 24 in the area 58 of cavity 56.
• Internal piece 26 includes a rounded seat portion 63 and a post portion 64.
• Seat portion 63 has an internal curved surface 66, an external curved surface 67, and a substantially flat front surface 68.
• Internal surface 66 in a particular embodiment, has a substantially cylindrical shape which can have a radius the same as or similar to that of a rod to be used with screw 20.
• Internal surface 66 and front surface 68 may come together in an edge 70.
• the total arc of internal surface 66, from post portion 64 to edge 70 is less than 180 degrees, and may be about 120 degrees.
• other embodiments of internal piece 26 may have an internal surface including an arc equal to or somewhat greater than 180 degrees. In such a case, a rod having substantially the same diameter as such an internal surface may form a snap-fit or interference fit with such internal surface. A rod of substantially smaller diameter than such an internal surface would, of course, fit without interference.
• Post portion 64 extends from one end of seat portion 63.
• post portion 64 and seat portion 63 are substantially in the same plane.
• Post portion 64 is substantially rectangular in cross-section, with two substantially smooth flat side surfaces 72 and substantially smooth curved top and bottom surfaces 74.
• a groove 76 is provided in at least one of the surfaces 72 or 74 of post portion 64, and in a particular embodiment a plane including groove 76 is substantially perpendicular to post portion 64.
• Internal piece 26 is inserted into cavity 56 of receiving portion 24 so that post portion 64 is within area 60 of cavity 56, and seat portion 63 is at least partially within area 58 of cavity 56. When this insertion is complete, internal piece 26 can rotate with respect to receiving portion 24 about post portion 64. Seat portion 63 generally rotates in a plane that is dictated by the placement of screw 20. For example, if screw 20 is attached to a vertebra, internal piece 26 can rotate so that seat portion is in a generally sagittal plane. As another example, if screw 20 is used with a lateral connector, such that screw 20 is about 90 degrees left or right from a rod or vertebral column, internal piece 26 can rotate so that seat portion is in a generally coronal plane.
• internal piece 26 may rotate in a complete circle with respect to receiving portion 24, unless seat portion 63 interferes with upper leg 40 or another part of receiving portion 24.
• area 58 of cavity 56 is of an hour-glass shape
• the possible amount of rotation of internal piece 26 with respect to receiving portion 24 is limited, as the sides of the hour-glass portion of cavity 56 will engage one or both of surfaces 72 after internal piece 26 and receiving portion 24 are rotated with respect to each other through a certain angle.
• Curved surfaces 74 of post portion 64 do not interfere with similarly curved boundaries of hour-glass portion of cavity 56.
• a ring clip 80 may be provided.
• Clip 80 is a substantially circular C-shaped member with an inner diameter 82, an outer diameter 84, and a gap 86.
• a similar clip 80' with a gap 86' may include an internal extension part 88'.
• Clip 80 may be elastically deformable by widening or narrowing gap 86 to a degree greater than exists in the normal, unstressed state of clip 80.
• clip 80 is placed so that at least a part of clip 80, e.g. inner diameter 82 and possibly more, within groove 76 of post portion 64.
• Clip 80' could be placed so that at least a portion, e.g. some or all of extension part 88', is within groove 76.
• clip 80 is around post portion 64, post portion 64 cannot be withdrawn from cavity 56 of receiving portion 24 due to interference between clip 80 and rim or flange 61.
• Clip 80 does not interfere with rotational movement of internal piece 26 with respect to receiving portion 24.
• other methods of retaining internal piece 26 in receiving portion 24 can be used, such as peening post portion 62 within cavity 56.
• Set screw 48 includes external threads adapted for engagement with threaded aperture 46.
• set screw 48 includes an imprint 89 in or on a top surface adapted for engagement with a tool for tightening and/or loosening set screw 48.
• Imprint 89 may be internal, e.g. a hexagonal or hexalobed opening, or may be external, e.g. a hexagonal head. It will be seen that an internal print may be preferred as it may add nothing or a smaller amount to the overall height or profile of screw 20.
• Set screw 48 may further include a curved, pointed, conical or other surface 49 at the bottom. Such a surface engages a rod within receiving portion 24 as further described below.
• Set screw 48 may be placed at least partially within threaded aperture 46 such that none or a very small amount of set screw 48 extends into channel 52. Alternatively, set screw may be left out of aperture 46 until a rod is inserted into receiving portion 24, and may then be inserted into aperture 46 and against the rod, as is further described below.
• receiving portion 24 may further include one or more indentations 90 for receiving a gripping or positioning tool.
• Indentations 90 are shown in one embodiment on either side of receiving portion 24, in an area in or adjacent to upper leg 40 and intermediate portion 44. It will be seen that indentations 90 could be in any part of receiving portion 24.
• Indentations 90 in the illustrated embodiment have an entry portion 92 and a holding portion 94.
• Holding portion 94 has a rounded or part circular portion 96 having a corner 98.
• a holding or gripping tool (not shown) having one or more rounded or circular protrusions at or adjacent to the end(s) of such a tool may be used.
• Such protrusion(s) may be inserted at entry portion(s) 92 and curved, angled or hooked around corner 98 into circular portion 96. In this manner, such a tool can be used to hold, position, manipulate or otherwise work on or with screw 20.
• a surgeon first prepares the surgical site as is generally known in the art, for example by making an open, minimally-invasive or other incision in the skin and subdermal tissues to obtain access to the desired surgical site:
• spinal surgery will be described as a principal example of the use of the above-described embodiments.
• the surgeon prepares a hole in the vertebra.
• Screw 20 is then introduced to the surgical site and threaded or otherwise inserted into the hole in the vertebra.
• a holding tool (not shown) with protrusions connected to screw 20 via indentations 90 can be used to hold and either begin to insert or completely insert screw 20 into a hole in the vertebra.
• shaft 22 in the form of a hook blade or other structure
• shaft 22 will be connected to the vertebra, as by hooking it around or otherwise in contact with a pedicle, process or other vertebral part.
• a rod When the anchor 20 is connected to a bone, a rod can be maneuvered to the surgical site, contoured as may be desired, and then inserted into channel 52 of receiving portion 24 via mouth 54.
• the rod is placed in receiving portion 24 until it is adjacent or in contact with seat portion 63 of internal piece 26.
• the rod may be pressed against surface 68 of internal piece 26, which will result in a camming action to push seat portion 63 of internal piece 26 relatively downward so that the rod becomes adjacent to internal surface 66 of seat portion 63.
• the rod and internal piece 26 are rotatable substantially in a plane with respect to receiving portion 24, for example substantially within a sagittal plane relative to the spine. Such rotation is substantially around the axis of post portion 64 of internal piece 26.
• set screw 48 is threaded down through upper leg 40 of receiving portion 24 and into contact with the rod. Screw 48 forces the rod against seat portion 63 of internal piece 26, forcing external surface 67 of internal piece 26 against lower leg 42 of receiving portion 24, e.g. against one or more ridges 62. In an embodiment in which set screw 48 has a curved or conical bottom surface 49, such bottom surface 49 will tend to push the rod in a direction substantially toward intermediate portion 44 and/or lower leg 42 of receiving portion 24. In an embodiment in which set screw 48 has a pointed bottom surface 49, such point(s) may bite into the rod. The rod is then locked with respect to internal piece 26 and receiving portion 24, and internal piece 26 is locked with respect to receiving portion 24.
• Additional screws 20 can be placed in adjacent or relatively distant bone tissue to connect to the same or additional rods.
• other components such as alternative screw or hook apparatus, clamps, connectors, or similar devices can be placed in connection with such rod(s) and such bone tissue(s).
• bone growth materials such as bone morphogenic protein (BMP), demineralized bone matrix (DBM), bone graft, or other substances may also be used in connection with parts of the structures described above so as to repair or correct the patient's physical situation.
• Materials for set screw 48, internal piece 26, ridges 62 and/or the rod can be chosen so that some deformation or penetration of one part with respect to another may occur.
• set screw 48 is provided with one or more points or edges on a bottom surface (e.g. curved or conical surface 49)
• such points or edges can be made of a harder material than the rod so that set screw 48 bites into the rod as set screw 48 is tightened to lock the rod within receiving portion 24.
• internal piece 26 is of a softer material than ridges 62 of receiving portion 24, then ridges 62 may bite into external surface 67 of internal piece 26 on locking the construct.
• screw 20 can be sized for placement at any level of the spine.
• the relative size of the components of the assembly will be modified for the particular vertebra(e) to be instrumented.
• components may be relatively larger for lumbar or sacral placement than those for cervical placement.
• the relative dimensions of post portion 64 of internal piece 26 and area 60 of cavity 56, and/or the relative dimensions of the rod and receiving portion 24, can be chosen to permit greater or lesser degrees of angulation of the rod relative to receiving portion 24.
• the components described above may be formed of stainless steel or other biocompatible materials, such as titanium, certain plastics or ceramics, and materials that permit bone ingrowth.
• shaft 22 could be the blade of a vertebral hook rather than a threaded element.
• an elongated bar can be disposed within the channel of the receiving portion to be clamped between internal piece 26 and set screw 48.
• a rod or longitudinal member can be a part of a lateral connector or other piece used in orthopedic surgery.
• the present invention can be applied equally well to smooth rods or bars, or longitudinal members having various surface features, such as knurling or threading.

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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)
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• Medical Informatics (AREA)
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• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
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• Surgical Instruments (AREA)
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• 2005
  • 2005-12-01 AU AU2005338664A patent/AU2005338664A1/en not_active Abandoned
  • 2005-12-01 WO PCT/US2005/043491 patent/WO2007064324A1/en active Application Filing
  • 2005-12-01 JP JP2008543252A patent/JP2009517174A/ja active Pending
  • 2005-12-01 EP EP05852654A patent/EP1959849A1/de not_active Withdrawn

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