WO2007087469A1 - Spinal anchor assemblies having extended receivers - Google Patents

Spinal anchor assemblies having extended receivers Download PDF

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Publication number
WO2007087469A1
WO2007087469A1 PCT/US2007/060364 US2007060364W WO2007087469A1 WO 2007087469 A1 WO2007087469 A1 WO 2007087469A1 US 2007060364 W US2007060364 W US 2007060364W WO 2007087469 A1 WO2007087469 A1 WO 2007087469A1
Authority
WO
WIPO (PCT)
Prior art keywords
anchor
connecting member
arms
implantation
extended
Prior art date
Application number
PCT/US2007/060364
Other languages
French (fr)
Inventor
John D. Pond Jr.
Anthony J. Melkent
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
Application filed by Warsaw Orthopedic, Inc. filed Critical Warsaw Orthopedic, Inc.
Priority to JP2008552522A priority Critical patent/JP2009524496A/en
Priority to EP07710054.3A priority patent/EP1981420B1/en
Priority to AU2007208177A priority patent/AU2007208177A1/en
Publication of WO2007087469A1 publication Critical patent/WO2007087469A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7037Screws 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7074Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7083Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
    • A61B17/7085Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements for insertion of a longitudinal element down one or more hollow screw or hook extensions, i.e. at least a part of the element within an extension has a component of movement parallel to the extension's axis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7074Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7091Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for applying, tightening or removing longitudinal element-to-bone anchor locking elements, e.g. caps, set screws, nuts or wedges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7011Longitudinal element being non-straight, e.g. curved, angled or branched
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032Screws or hooks with U-shaped head or back through which longitudinal rods pass
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter

Definitions

  • Orthopedic- devices such as spinal tods, plates, tethers, staples and other devices can be secured along the spinal column between one or more vertebral levels io stabilize the one or more vertebra! levels. While sitrgieai procedures along the spinal column for placement of such devices are becoming less invasive, the decrease in space available in the approach to the surgical site and at the surgical site for handling and manipulating of the devices increases the difficulty in maneuvering, maintaining and finally positioning of the devices during the procedure. Furthermore, the small and intricate parts comiuoaly associated with such orthopedic devices can increase the difficulty of the installation procedure. Accordingly, systems and devices which facilitate placement of orthopedic devices along the spinal column are desirable.
  • a connecting member is movable along the guide portion from a location outside the patient to the implantation portion m Lhe patient, where the connecting member is secured to the anchor assembly with an. engaging member.
  • the guide portion is formed as a single unit with but separable from the implantation portion to provide a. modified low-profile anchor assembly after implantation of the connecting member.
  • Fig. 1 is an elevation view a system for positioning a connecting member along the spinal column in a minimally invasive procedure.
  • Fig. 2 is s sectional view of an extended .receiver comprising a portion of the system of Fig 1 .
  • Fig. 3 is a sectional view of a modified extended receiver and anchor of an anchor assembly comprising a portion of the system of Pig. 1.
  • Fig. 4 is an elevation view of the system of Fig. .1 with a connecting member positioned in the extended receivers of the anchor assemblies.
  • Fig, S is a plan view of the arrangement of Fig. 4.
  • Fig. 6 is an elevation view of the system of Fig. I with a connecting member positioned in the implam&lion portions of the extended receivers of the anchor assemblies,
  • Fig. 7 is a perspective showing engaging .members for positioning in the extended receivers to secure the connecting member in the implantation portions of the anchor assemblies.
  • Fig, 8 is a perspective of a portion of the system showing one of the engaging members positioned in one of the extended receivers to secure the connecting member in the implantation portions of the anchor assemblies.
  • Fig. 9 is the view of Fig. 8 showing the engaging member engaged to the implantation portion of the extended receiver to secure the connecting member therein.
  • Fig. 10 is the view of Fig, 9 showing a proximal break-off portion of the engaging member removed upon application of sufficient force thereto.
  • Fig. 1 1 is the view of FIg. 10 with one of the arms of the extended receiver separated from the implantation portion at a break-off region therebetween..
  • Fig. 12 is the view of Fig. 11 with the other arm of the extended receiver separated from the implantation, portion at. a second break-off region therebetween.
  • a system 40 for positioning a connecting member .100 adjacent the spinal column in a minimally invasive surgical procedure is shown.
  • system 40 Is particularly suited for minimally invasive surgical procedures, it is not restricted to such.
  • syster ⁇ .40 provides at bast a pair of anchors assemblies 45 Including extended receivers 50 mounted fo anchors 120 engaged to the spinal column. The extended receivers 50 extend proximaily from the anchors 120, and guide the placement of a connecting member 1 00 from a position remote from the spinal column to a position adjacent the spinal column.
  • the extended receivers 50 are configured so that when the connecting .member .100.is adjacent the spinal column, connecting member 100 extends between the at ieast a pair of anchors 120, The connecting member 100 can be secured to the anchor assemblies 45 and provide stabilization of the spinal column segment to which the anchors 120 are attached.
  • the extended receivers 50 can be modified without invasivdy accessing the patient's body after positioning of connecting member 1 00 to provide the anchor assemblies with, a configuration suitable for postoperative implantation, lti one embodiment, each of the at least a pair of extended receivers 50 includes a distal implantation portion 52 adjacent the respective anchor 120 for receiving the connecting member 100 in an implantation position to stabilize one or more vertebral levels.
  • a proximal guide portion 54 extends from opposite sides of the implantation portion 52 for guiding the connecting member 100 from a location outside the patient to its implantation location ⁇ n the implantation portion 52 adjacent fee anchors 120.
  • the guide portion 54 defines a channel therethrough that opens along opposite sides of ⁇ he extended receiver S0 r and extends from the proximal end of the extended receiver 50 to the implantation portion 52.
  • gi ⁇ de portion 54 is formed as a single unit with implantation portion 52 portion at a break-off segment therebetween. The break- off segment provides a separation location between the implantation portion 52 and the guide portion 54 so that when sufficient force is applied to guide portion 54 it can. be removed to modify the extended receiver 50 to an implantation configuration.
  • the at least a pair of anchor assemblies 45 includes three anchor assemblies 45.
  • the connecting member 100 is an elongated rod and the anchors 120 are bone screws.
  • the bone screws can be & multi-axial type screw positioned m the implantation portion 52 of extended receiver 50 s ⁇ that the receiver and bone screw are pivotal relative to one another, in another embodiment; the bone screws axe tion- pivotal or fixed relative to the receiver.
  • Connecting member 100 can be received ⁇ .a, cm, or about die implantation, portion 52 of extended receiver 50 for engagement thereto.
  • the connecting member 100 car* be rigid, vsemt-rigid, flexible, elastic, non-compression load bearing, or of other suitable form for extending between and stabilizing adjacent portions of the spina] column when secured thereto.
  • system 40 includes a first anchor assembly 45a engaged to vertebra Vl and having a first extended receiver 50a, a second anchor assembly 45b engaged to vertebra V2 having a second extended receiver 50b, a*id a third anchor assembly 45c engaged to vertebra V3 and having a. third extended receiver 50c.
  • Extended receivers 50a, 50b, and 50c axe engaged to respective ones of a first anchor 120a, a second anchor 120b and a third anchor 120c. which are engageable to respective ones of three adjacent vertebrae Vl, V2, V3, shown diagrammatica ⁇ y In Fig.
  • Extended receivers 50a, 50b, SOc extend proxitnally from the respective anchors 1.20a, 120b, 1.20c through the tissue along the spinal column such that their proximal ends project from or are adjacent the skin level S of the patient for access by the surgeon.
  • Extended receivers 50a, 50b, and.50c- define a mmi ⁇ nally invasive path for delivery of connecting member 100 through the skin and tissue of the patient to the anchors engaged to the vertebrae.
  • the minimally invasive path reduces and/or minimizes the tissue retraction and dissection required to accommodate delivery of connecting member 1.00 to the implantation location along the spinal column where it provides the desired external stabilization of one or more vertebral levels.
  • Extended receiver 50 includes a lower or distal implantation portion 52 and an upper or proximal guide portion 54 extending along a central axis 51 .
  • Guide portion 54 includes a pair of arms 55, 57 formed as a single unit with but removable from implantation portion 52 at break-off regions 56. 58, respectively.
  • Receiver $0 defines a general U-sfiape with a channel 62 extending therethrough transversely to central axis 51.
  • a lower through-hole 64 extends along central axis 51 and opens at the bottom or distal end of implantation portion 52, In one embodiment, hole 64 is substantially perpendicular to channel 62.
  • Implantation portion 52 forms a saddle that bouses anchor 120 and. receives the connecting member 100 therethrough in an orthogonal or transverse orientation t ⁇ central axis 51 and in arc orientation generally parallel with the spinal coiumrt.
  • Implantation portion 52 includes a pair of opposite side members 66, 6S sized and spaced to accommodate elongate member 100 therein .
  • Arms 55, 5? form an extension of respective ones of the side members 66, 68, and are singularly formed therewith at the respective break-off region 56, 58.
  • Anns 55, 57 include a length extending proximally from side members 66, 68 so that the proximal ends of arms 55, 57 are located outside the patient when anchor 120 is engaged to the spinal column, in. one embodiment, this length is at least 30 millimeters. In another embodiment, the length of arms 55 ⁇ 57 is at least 50 millimeters.
  • side members 66, 68 each include an internal thread profile 67, 69 that threadingly engages an engaging member 90 (as described below).
  • Hole 64 is sized and shaped to receive and support anchor 120 therethrough. Near the bottom of implantation portico 52 ? hole 64 is narrowed by a wail portion 70. Below wall portion 70, hole 64 opens outwardly by virtue of a. wall portion 72. Wall portion 72 allows anchor 120 to be positioned in any of an infinite number of angular positions relative to implantation portion 52 by reducing interference of the lower portion of implantation portion 52 with a shank portion ⁇ 24 of anchor 120, while a head portion 122 of anchor 120 is supported on wall portion 70.
  • anchor 120 is formed as a single unit with receiver 50 and extends along axis 51 ⁇ i a uniaxial arrangement.
  • anchor 120 is captured in receiver 50 with a split-ring washer, collar, or other suitable retaining member,
  • anchor 120 is pivotal in single plane, or in a predetermined number of planes, relative to receiver 50.
  • implantation portion 52 includes an inner groove 74.
  • groove 74 extends about side members 66, 6S and around hole 64.
  • Groove 74 is configured to accommodate snap ring 76 in a compressed condition.
  • Groove 74 can have a height tiiat is, in one form, greater than a thickness of snap ring 76.
  • Snap ring 76 can retain a crown 78 in implantation portion 52 about the proximal side of head 122 of anchor 120.
  • Connecting member 100 is seated against crown 7S when secured in implantation portion 52 with engaging member 90. In one embodiment, seating of crown 78 locks anchor .S 20 in position relative to extended receiver 50.
  • crown 78 and/or head 122 can include engagement structures that engage one another to provide the locked arrangement.
  • at least some motion between the connecting member and anchor 120 is maintained by crown 78 when, connecting member is secured in implantation portion 52.
  • crown 78 can be omitted and that, the connecting member 100 is seated directly against head 122 of anchor 120,
  • Fig. 3 further shows a modified anchor assembly 45' where amis 53, 57 have been severed at break-off regions 56, 58, forming modified break-off regions 56', 58".
  • Arms 55. 57 are removed after placement of connecting member 100 into implantation portion 52 and securement of engaging member 90 with internal threads 67, 69 of side members 66, 68.
  • arms 55, 57 can each include an internal thread profile 80, 82, respectively, that is threadhigly engageable by engaging member 90 m it passes therethrough.
  • the threaded engagement between arms 55. 57 and engaging member 90 provides a mechanical advantage m forcing connecting member 100 into implantation portion 52.
  • connecting member 100 is posif.io.oed through the aligned chaanels 62 of extended receivers 5Oa, 5Ob, 50c.
  • connecting member 100 fits within and maintains the channels 62 in alignment when it is positioned therebetween.
  • one or more of the extenders 50a, 501?, 50c can be pivoted toward and/or away from She others as may be desired to facilitate placement of connecting member 100 therein.
  • Connecting member 100 is moved below the skin level S and toward the spinal column until it is positioned in or adjacent implantation portions 52 of extended receivers 50, as shown in Fig. 6.
  • engaging members 90a, 90b, 90c are provided for positioning through respective ones of the extended recovers 50a, 50b, 50c.
  • Engaging members 90 can. be in the form of a set screw having a distal externally threaded portion 92 and a proximal tool- engaging portion.94.
  • Tool engaging portion 94 can be configured to break- off from distal portion 92 upon application of a sufficient .force.
  • Engaging members 90a, 90b, 90c can be secured to the respective implantation portions 52 of extended receivers 50 to secure connecting element 100 to the anchor assemblies 45.
  • engaging member 90a is shown m threaded engagement with the internal threads along arms 55, 57 of guide portion 54 of extended receiver 50a.
  • connecting member 100 is not full seated or positioned in implantation portion 52 of any one or more of the extended receivers
  • the respective engaging member 90 can act. on the connecting member and reduce or force it into position into the implantation portion 52.
  • the .internal threads along arms 55, 57 provide a mechanical advantage in advancing the connecting member into the implanted position by bringing the vertebrae into alignment along connecting .member IQO.
  • engaging member 90a contacts connecting member 100 as engaging member 90 is threadingly advanced into engagement with the internal threads along side members 66, 68 of implantation portion 52.
  • connecting element 100 is firmly seated m implantation portion 52 and sufficient torque applied to proximal portion 94 to sever it from distal portion 5)2, providing a modified engaging member 90a" .
  • engaging member 90a' can be recessed into Implantation portion 52 so that it engages the threades along side members 66, 6S.
  • ar ⁇ 57 has been separated from implantation portion 52 by applying sufficient torque, twisting, be ⁇ dhig or shearing forces to the proximal end of arm 57 to sever it at break-off, region 58 at side member 68.
  • Fig. 10 connecting element 100 is firmly seated m implantation portion 52 and sufficient torque applied to proximal portion 94 to sever it from distal portion 5)2, providing a modified engaging member 90a" .
  • engaging member 90a' can be recessed into Implantation portion 52 so that it engages the threades along side members 66, 6S.
  • ar ⁇ 57 has been separated from implantation portion 52 by applying sufficient torque,
  • arm 55 has been separated from implantation portion 52 by applying sufficient, removal force at the proximal end of arm 55 to sever it at break-off region 56 a.
  • side member 66, Arms 55, 57 include sufficient, rigidity along their length to transmit, the removal force applied to the proximal end to the respective break-off region with out twisting, deforming or severing at a location proximal of the break-off region. This allows the minimally invasive access to be maintained without tissue retraction to access arms 55, 57 at locations within the patient to apply the removal force.
  • Connecting member i00 is thus secured tor post-operative implantation to a modified anchor assembly 45a' having a suitably low profile for post-operative implantation.
  • the other anchors assemblies 45b, 45c can be similarly modified after securement of connecting member 100 therein to provide a low profile for system 40 extending from the spinal column.
  • Break-off regions 56, 58 provide an area of reduced wall thickness adjacent the distal end of the respective arm 55, 57 that extends between the arm 55, 57 and the respective side member 66. 68. Break-off regions 56, 58 can be located between the internal thread profiles defined by side members 66, 6S s.nd the adjacent arm 55, 57. In the illustrated embodiment, the outer surface of each of the break-ofF regions 56, 58 forms a concave depression or recess that extends completely about arm 55, 57 and the respective adjacent side member 6( ⁇ 68.
  • Each of the arms $5, 57 Is joined to the respective side member 66, 68 with a break-off region having a wall thickness thai is reduced comparatively fco an adjacent wall thickness of the respective arm and the respective side member.
  • Other embodiments contemplate other techniques for reducing the wall thickness to provide a break-off region, such as by providing perforations or undercuts between the arms 55, 57 and the respective adjacent side member 66. 68.
  • the break-off regions provide a separation location that is generally uniform and substantially free of sharp of jagged edges after separatum of the respective arms 55, 57.
  • Other embodiments contemplate a break -off region that is in a thread-free-zone.
  • ⁇ t may also be desirable to provide a desired alignment between vertebrae by reducing the connecting member into the implantation portion of the extended receivers of the anchor assemblies.
  • the vertebrae may be misaligned as a result of spondylolisthesis, anatomical differences between the vertebrae, or some other condition.
  • the engaging members 90 can be employed to provide a mechanical advantage to seat the connecting member in the implantation, portions as the engaging members are thread! ngly advanced along the arms 55, 57 and into the side members 66, 68.
  • System 40 may employ various instruments to facilitate selection of the connecting member, placement of the connecting member through the extenders and to the anchors, securetnent of the connecting member to the anchors, and manipulation of the vertebrae and/or anchors to a desired position or condition.
  • a driver can be provided that is positionable through any one of the extended receivers to engage the anchor to the vertebra.
  • a driver ibr positioning the engaging member through the extended receiver and into engagement with the implantation portion can also be provided.
  • a counter-torque device such as a wrench or handle arm, can be secured to any one of the extended receivers to hold the extended receiver in position relative to the anchor attached thereto as torque is applied to seat the engaging member into contact with the connecting member in the implantation portion of the extender receiver.
  • Compressors and distract ⁇ rs can also be provided to facilitate: application of a compressive or distraction force between anchors before- final attachment of the connecting member to each anchor.
  • Calipers can be provided to .measure a distance between the outermost extended receivers for sizing of the length of the coaneetmg .member to be positioned between the- anchors.
  • a holding instrument can be provided that is adapted to grasp and hold the connecting member placed between the extenders, mid can be employed to facilitate moving dis connecting member distal iy along the extenders toward and into the anchors.
  • A. reduction instrument can be provided that is positionabis along or about the extender receiver to provide a mechanScal. advantage for reduction of the connecting member Into one or more of the implantation poriiojis of the extended receivers.
  • connecting members examples include rods, wires, tethers, strands, cables, hands, plates, and struts.
  • the connecting member may include one component, or may include two or more components.
  • coRtteetmg xnember is shown i ⁇ i Fig, 1 , and includes connecting member 100 having a « elongated rod-shaped body 102.
  • Body 102 extends along a longitudinal axis .101 between a first end 104 and an opposite second end 106.
  • Body 102 is curved about a radius formed by longitudinal axis Wl .
  • Ends 104, 106 include generally the same size and shape,, although such is not required.
  • body 102 is linear, a combination of linear and curved segments, a combination of linear segments angled relative to one another, or a combination of segments having differing curvatures.
  • Body 102 has a uniform cross-section along its length, which can be circular as shown.
  • connecting member is an elongated rod made from a metal alloy such as titanium.
  • Other materials are also contemplated, including resorbable materials, non-resorbable materia!, polymers, elastomers, ceramics, other metals m ⁇ metal alloys, shape memory materials, bone and bone substitute material ; , composites, and combinations of materials.
  • Eacli of the anchor assemblies can be attached to the respective vertebra using any one of a number of techniques.
  • a procedure contemplates m incision over the target locationoa of the spinal column, and that the skin and tissue are sequentially dilated to provide a minimally invasive pathway for anchor assembly insertion and engagement to each vertebra.
  • a cannulated outer needle with ati inner stylet can first be inserted to the targeted regions of the vertebrae, such as the pedicle is a posterior procedure, and aligned to provide the desired trajectory into the pedicle. Alignment can be monitored and checked with any viewing system, including radiographic, fluoroscopic, microscopic, endoscopic, loupes, naked eye, or any other suitable viewing system, or instrument. After the eannulated needle and stylet are inserted into the vertebra, the inner stylet Is withdrawn with the cannulated outer needle remaining engaged to the vertebra. A gui.dewire Is positioned through the cannula led outer needle and engaged in ihe vertebra.
  • the outer needle is then withdrawn so that the guidewire remains in place.
  • the tissue around the guidewire is sequentially dilated with a number of tubular dilators of increasing diameter.
  • the guidewire and inner dilators are removed and the last inserted dilator provides a protected pathway to the pedicle or other targeted portion of the vertebra.
  • the anchor assembly can then be positioned through the dilated pathway and engaged to the vertebra. The procedure is then repeated to position the desired number of anchor assemblies, whether it. be two, three or four or more. Incisions can be made between die adjacent anchor assemblies to provide a pathway for insertion of the connecting member.
  • the connecting member can be inserted axially into one of the extended receivers and then manipulated below the skin aad musculature by rotating it to extend between the anchor assemblies, avoiding incisions through the skin and musculature between the anchor assemblies.
  • the anchor assemblies are inserted percutaneousty without sequential dilation.
  • the guidewire is positioned as discussed above, and the anchor can be cammlated for positioning over the guidewire.
  • the anchor and extended receivers are assembled and then positioned together over the guidewire, which guides the anchor assembly to the pedicle or other targeted portion of the vertebra.
  • a cammlated driver tool is positioned over the guidewire and. through the extended receiver to engage the head of the anchor and drive it into the vertebra.
  • a pathway to the target location is prepared as discussed above.
  • the guidewire and any dilators are removed.
  • a cannula or other suitable retractor may remain in the incision to provide a protected pathway to the target location, although direct .insertion through a micro-incision is also contemplated.
  • An anchor driver is inserted through the extended receiver and engaged to the head of the anchor.
  • the anchor driver can maintain the anchor in rigid alignment with the axis of the extended receiver if the anchor assembly is multi-axial.
  • the anchor and extended receiver are inserted percutaneously to the target location of the vertebra, such as the pedicle. Insertion and alignment of the anchor assembly may be .monitored fluoroscopically or with any suitable surgical navigation system.
  • the anchor is then engaged to the vertebra at the target location with the extended receiver extending proximally therefrom through the skin level of the patient.
  • Anchor assembly insertion and engagement Is repeated for each vertebra along the instrumented levels.
  • placement of the anchor assemblies can be conducted through a micro-indsion, through a retracted opening formed in the tissue approaching the targeted location on the vertebra, or through a tubular member providrng a protected passageway to one or more of the adjacent vertebrae, 3t is also contemplated that nerve monitoring can be performed through the extended receivers to gujde placement of the anchors in the appropriate locations in the vertebrae.
  • the anchor assemblies are engaged to pedicles of the respective vertebrae. Each pedicle can be drilled and, if. necessary' or desired, tapped to receive a threaded screw portion of the anchor assembly.
  • Formation and tapping of the holes in the pedicles can be monitored with an electrical stimulus applied through a guidewire, tap, probe, or anchor driver prior to and during anchor assembly insertion. Response of the patient can be monitored to determine that anchor placement does not impinge upon arty nerves.
  • the giridewire, tap, probe, driver or other instrument can be placed through a sleeve or dilator made from plastic material to provide a non-conductive insulator,
  • an electrical signal is applied through the anchor assembly to guide placement of the anchor into the vertebrae without impinging on neural structures.
  • the extended receivers can be insulated with a protective, non-conductive coating, sleeve or other layer to prevent the current from straying.

Abstract

There are provided systems (40) and methods for positioning a connecting member (100) adjacent the spinal column that include one or more anchor assemblies (45) having an anchor (120) engageable to bony structure and an extended receiver (50) having a guide portion (54) and an implantation portion (52). A connecting member (100) is movable along the guide portion (54) from a location outside the patient to the implantation portion (52) in the patient, where the connecting member (100) is secured to the anchor assembly (45) with an engaging member (90). The guide portion (54) is formed as a single unit with but separable from the implantation portion (52) to provide a modified low-profile anchor assembly (45) after implantation of the connecting member (100).

Description

SPINAL ANCHOR ASSEMBLIES HAVING EXTENDED RECEIVERS
BACKGROUND
Orthopedic- devices such as spinal tods, plates, tethers, staples and other devices can be secured along the spinal column between one or more vertebral levels io stabilize the one or more vertebra! levels. While sitrgieai procedures along the spinal column for placement of such devices are becoming less invasive, the decrease in space available in the approach to the surgical site and at the surgical site for handling and manipulating of the devices increases the difficulty in maneuvering, maintaining and finally positioning of the devices during the procedure. Furthermore, the small and intricate parts comiuoaly associated with such orthopedic devices can increase the difficulty of the installation procedure. Accordingly, systems and devices which facilitate placement of orthopedic devices along the spinal column are desirable. SUMMARY
There are provided systems and methods for positioning a connecting member adjacent the spiaal column that, include at least two anchor assemblies having an anchor engageabie to bony structure and an extended receiver having a guide portion and an. implantation portion.. A connecting member is movable along the guide portion from a location outside the patient to the implantation portion m Lhe patient, where the connecting member is secured to the anchor assembly with an. engaging member. The guide portion is formed as a single unit with but separable from the implantation portion to provide a. modified low-profile anchor assembly after implantation of the connecting member.
These and other aspects will be apparent from the following description of the illustrated embodiments.
BSXEF 0ESCR«»T1ON OF THE FIGURES
Fig. 1 is an elevation view a system for positioning a connecting member along the spinal column in a minimally invasive procedure.
Fig. 2 is s sectional view of an extended .receiver comprising a portion of the system of Fig 1 .
Fig. 3 is a sectional view of a modified extended receiver and anchor of an anchor assembly comprising a portion of the system of Pig. 1. Fig. 4 is an elevation view of the system of Fig. .1 with a connecting member positioned in the extended receivers of the anchor assemblies.
Fig, S is a plan view of the arrangement of Fig. 4.
Fig. 6 is an elevation view of the system of Fig. I with a connecting member positioned in the implam&lion portions of the extended receivers of the anchor assemblies,
Fig. 7 is a perspective showing engaging .members for positioning in the extended receivers to secure the connecting member in the implantation portions of the anchor assemblies.
Fig, 8 is a perspective of a portion of the system showing one of the engaging members positioned in one of the extended receivers to secure the connecting member in the implantation portions of the anchor assemblies.
Fig. 9 is the view of Fig. 8 showing the engaging member engaged to the implantation portion of the extended receiver to secure the connecting member therein.
Fig. 10 is the view of Fig, 9 showing a proximal break-off portion of the engaging member removed upon application of sufficient force thereto.
Fig. 1 1 is the view of FIg. 10 with one of the arms of the extended receiver separated from the implantation portion at a break-off region therebetween..
Fig. 12 is the view of Fig. 11 with the other arm of the extended receiver separated from the implantation, portion at. a second break-off region therebetween.
.DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
For the purposes of promoting art understanding of the principles of the ia.veo.tioa, reference will now be made to the embodiments illustrated in the drawings and. specific language will be used Io describe the same, ϊt will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any such alterations and further modifications in the illustrated devices and described methods, and a.ny such further applications of the principles of the invention as illustrated herein are contemplated as would normally occur to one skilled in the art to which the invention relates.
Referring to Fig. 1 there is shown a system 40 for positioning a connecting member .100 adjacent the spinal column in a minimally invasive surgical procedure. Although system 40 Is particularly suited for minimally invasive surgical procedures, it is not restricted to such. Furthermore, although its use and application is described with regard to spinal surgery, applications In surgeries other than spina! surgery are also contemplated. ϊn one form, systerø.40 provides at bast a pair of anchors assemblies 45 Including extended receivers 50 mounted fo anchors 120 engaged to the spinal column. The extended receivers 50 extend proximaily from the anchors 120, and guide the placement of a connecting member 1 00 from a position remote from the spinal column to a position adjacent the spinal column. The extended receivers 50 are configured so that when the connecting .member .100.is adjacent the spinal column, connecting member 100 extends between the at ieast a pair of anchors 120, The connecting member 100 can be secured to the anchor assemblies 45 and provide stabilization of the spinal column segment to which the anchors 120 are attached. The extended receivers 50 can be modified without invasivdy accessing the patient's body after positioning of connecting member 1 00 to provide the anchor assemblies with, a configuration suitable for postoperative implantation, lti one embodiment, each of the at least a pair of extended receivers 50 includes a distal implantation portion 52 adjacent the respective anchor 120 for receiving the connecting member 100 in an implantation position to stabilize one or more vertebral levels. A proximal guide portion 54 extends from opposite sides of the implantation portion 52 for guiding the connecting member 100 from a location outside the patient to its implantation location ϊn the implantation portion 52 adjacent fee anchors 120. The guide portion 54 defines a channel therethrough that opens along opposite sides of ϊhe extended receiver S0r and extends from the proximal end of the extended receiver 50 to the implantation portion 52. In another embodiment, giύde portion 54 is formed as a single unit with implantation portion 52 portion at a break-off segment therebetween. The break- off segment provides a separation location between the implantation portion 52 and the guide portion 54 so that when sufficient force is applied to guide portion 54 it can. be removed to modify the extended receiver 50 to an implantation configuration. In another embodiment, the at least a pair of anchor assemblies 45 includes three anchor assemblies 45.
In one embodiment, the connecting member 100 is an elongated rod and the anchors 120 are bone screws. The bone screws can be & multi-axial type screw positioned m the implantation portion 52 of extended receiver 50 sα that the receiver and bone screw are pivotal relative to one another, in another embodiment; the bone screws axe tion- pivotal or fixed relative to the receiver. Connecting member 100 can be received ϊ.a, cm, or about die implantation, portion 52 of extended receiver 50 for engagement thereto. The connecting member 100 car* be rigid, vsemt-rigid, flexible, elastic, non-compression load bearing, or of other suitable form for extending between and stabilizing adjacent portions of the spina] column when secured thereto.
In Fig. .1 , system 40 includes a first anchor assembly 45a engaged to vertebra Vl and having a first extended receiver 50a, a second anchor assembly 45b engaged to vertebra V2 having a second extended receiver 50b, a*id a third anchor assembly 45c engaged to vertebra V3 and having a. third extended receiver 50c. Extended receivers 50a, 50b, and 50c axe engaged to respective ones of a first anchor 120a, a second anchor 120b and a third anchor 120c. which are engageable to respective ones of three adjacent vertebrae Vl, V2, V3, shown diagrammaticaϋy In Fig. L It should be understood;, however, that the system aad techniques discussed herein may employ only two extended receivers and two anchors, or three or more extended receivers and anchors. Extended receivers 50a, 50b, SOc extend proxitnally from the respective anchors 1.20a, 120b, 1.20c through the tissue along the spinal column such that their proximal ends project from or are adjacent the skin level S of the patient for access by the surgeon. Extended receivers 50a, 50b, and.50c- define a mmiϊnally invasive path for delivery of connecting member 100 through the skin and tissue of the patient to the anchors engaged to the vertebrae. The minimally invasive path reduces and/or minimizes the tissue retraction and dissection required to accommodate delivery of connecting member 1.00 to the implantation location along the spinal column where it provides the desired external stabilization of one or more vertebral levels.
Referring now to Fig. 2, there is shown one embodiment of an extended receiver 50. Extended receiver 50 includes a lower or distal implantation portion 52 and an upper or proximal guide portion 54 extending along a central axis 51 . Guide portion 54 includes a pair of arms 55, 57 formed as a single unit with but removable from implantation portion 52 at break-off regions 56. 58, respectively. Receiver $0 defines a general U-sfiape with a channel 62 extending therethrough transversely to central axis 51. A lower through-hole 64 extends along central axis 51 and opens at the bottom or distal end of implantation portion 52, In one embodiment, hole 64 is substantially perpendicular to channel 62.
Implantation portion 52 forms a saddle that bouses anchor 120 and. receives the connecting member 100 therethrough in an orthogonal or transverse orientation tα central axis 51 and in arc orientation generally parallel with the spinal coiumrt. Implantation portion 52 includes a pair of opposite side members 66, 6S sized and spaced to accommodate elongate member 100 therein . Arms 55, 5? form an extension of respective ones of the side members 66, 68, and are singularly formed therewith at the respective break-off region 56, 58. Anns 55, 57 include a length extending proximally from side members 66, 68 so that the proximal ends of arms 55, 57 are located outside the patient when anchor 120 is engaged to the spinal column, in. one embodiment, this length is at least 30 millimeters. In another embodiment, the length of arms 55^ 57 is at least 50 millimeters.
As further shown in Fig, 3, side members 66, 68 each include an internal thread profile 67, 69 that threadingly engages an engaging member 90 (as described below). Hole 64 is sized and shaped to receive and support anchor 120 therethrough. Near the bottom of implantation portico 52? hole 64 is narrowed by a wail portion 70. Below wall portion 70, hole 64 opens outwardly by virtue of a. wall portion 72. Wall portion 72 allows anchor 120 to be positioned in any of an infinite number of angular positions relative to implantation portion 52 by reducing interference of the lower portion of implantation portion 52 with a shank portion Ϊ24 of anchor 120, while a head portion 122 of anchor 120 is supported on wall portion 70.
Other embodiments contemplate other engagement relationships between, the anchor 120 aaid receiver 50. fo one embodiment, anchor 120 is formed as a single unit with receiver 50 and extends along axis 51 ύi a uniaxial arrangement. In another embodiment, anchor 120 is captured in receiver 50 with a split-ring washer, collar, or other suitable retaining member, In siiil other embodiments, anchor 120 is pivotal in single plane, or in a predetermined number of planes, relative to receiver 50.
In the particular illustrated embodiment of implantation portion 52, implantation portion 52 includes an inner groove 74. As illustrated., groove 74 extends about side members 66, 6S and around hole 64. Groove 74 is configured to accommodate snap ring 76 in a compressed condition. Groove 74 can have a height tiiat is, in one form, greater than a thickness of snap ring 76. Snap ring 76 can retain a crown 78 in implantation portion 52 about the proximal side of head 122 of anchor 120. Connecting member 100 is seated against crown 7S when secured in implantation portion 52 with engaging member 90. In one embodiment, seating of crown 78 locks anchor .S 20 in position relative to extended receiver 50. In such an embodiment, crown 78 and/or head 122 can include engagement structures that engage one another to provide the locked arrangement. In a further embodiment, at least some motion between the connecting member and anchor 120 is maintained by crown 78 when, connecting member is secured in implantation portion 52. Still other embodiments contemplate that crown 78 can be omitted and that, the connecting member 100 is seated directly against head 122 of anchor 120,
Fig. 3 further shows a modified anchor assembly 45' where amis 53, 57 have been severed at break-off regions 56, 58, forming modified break-off regions 56', 58". Arms 55. 57 are removed after placement of connecting member 100 into implantation portion 52 and securement of engaging member 90 with internal threads 67, 69 of side members 66, 68. As shown in Fig. 2, arms 55, 57 can each include an internal thread profile 80, 82, respectively, that is threadhigly engageable by engaging member 90 m it passes therethrough. The threaded engagement between arms 55. 57 and engaging member 90 provides a mechanical advantage m forcing connecting member 100 into implantation portion 52. When engaging member 90 is advanced distally into engagement with side members 66, 68, the connecting member 100 is firmly seated against crown 78, and engaging member 90 is secured to side members 66, 68
Referring now to Figs. 4-12. various steps for implanting connecting member 100 and securing it along the spinal column in a minimally invasive surgical procedure employing system 40 will be discussed. In Fig. 4, coaaecting member 100 is posif.io.oed through the aligned chaanels 62 of extended receivers 5Oa, 5Ob, 50c. As shown in Fig. 5, connecting member 100 fits within and maintains the channels 62 in alignment when it is positioned therebetween. For extenders having multi-axial capabilities, one or more of the extenders 50a, 501?, 50c can be pivoted toward and/or away from She others as may be desired to facilitate placement of connecting member 100 therein. Connecting member 100 is moved below the skin level S and toward the spinal column until it is positioned in or adjacent implantation portions 52 of extended receivers 50, as shown in Fig. 6.
In Fig, 7 engaging members 90a, 90b, 90c are provided for positioning through respective ones of the extended recovers 50a, 50b, 50c. Engaging members 90 can. be in the form of a set screw having a distal externally threaded portion 92 and a proximal tool- engaging portion.94. Tool engaging portion 94 can be configured to break- off from distal portion 92 upon application of a sufficient .force. Engaging members 90a, 90b, 90c can be secured to the respective implantation portions 52 of extended receivers 50 to secure connecting element 100 to the anchor assemblies 45. ϊn Fig. 8, engaging member 90a is shown m threaded engagement with the internal threads along arms 55, 57 of guide portion 54 of extended receiver 50a. In instances wherein connecting member 100 is not full seated or positioned in implantation portion 52 of any one or more of the extended receivers, the respective engaging member 90 can act. on the connecting member and reduce or force it into position into the implantation portion 52. The .internal threads along arms 55, 57 provide a mechanical advantage in advancing the connecting member into the implanted position by bringing the vertebrae into alignment along connecting .member IQO. As shown in Fig. 9, engaging member 90a contacts connecting member 100 as engaging member 90 is threadingly advanced into engagement with the internal threads along side members 66, 68 of implantation portion 52.
In Fig. 10 connecting element 100 is firmly seated m implantation portion 52 and sufficient torque applied to proximal portion 94 to sever it from distal portion 5)2, providing a modified engaging member 90a" . In this implanted position, engaging member 90a' can be recessed into Implantation portion 52 so that it engages the threades along side members 66, 6S. In Fig. 1 1 , arøα 57 has been separated from implantation portion 52 by applying sufficient torque, twisting, beπdhig or shearing forces to the proximal end of arm 57 to sever it at break-off, region 58 at side member 68. In Fig. 12, arm 55 has been separated from implantation portion 52 by applying sufficient, removal force at the proximal end of arm 55 to sever it at break-off region 56 a.t side member 66, Arms 55, 57 include sufficient, rigidity along their length to transmit, the removal force applied to the proximal end to the respective break-off region with out twisting, deforming or severing at a location proximal of the break-off region. This allows the minimally invasive access to be maintained without tissue retraction to access arms 55, 57 at locations within the patient to apply the removal force. Connecting member i00 is thus secured tor post-operative implantation to a modified anchor assembly 45a' having a suitably low profile for post-operative implantation. The other anchors assemblies 45b, 45c can be similarly modified after securement of connecting member 100 therein to provide a low profile for system 40 extending from the spinal column.
Break-off regions 56, 58 provide an area of reduced wall thickness adjacent the distal end of the respective arm 55, 57 that extends between the arm 55, 57 and the respective side member 66. 68. Break-off regions 56, 58 can be located between the internal thread profiles defined by side members 66, 6S s.nd the adjacent arm 55, 57. In the illustrated embodiment, the outer surface of each of the break-ofF regions 56, 58 forms a concave depression or recess that extends completely about arm 55, 57 and the respective adjacent side member 6(\ 68. Each of the arms $5, 57 Is joined to the respective side member 66, 68 with a break-off region having a wall thickness thai is reduced comparatively fco an adjacent wall thickness of the respective arm and the respective side member. Other embodiments contemplate other techniques for reducing the wall thickness to provide a break-off region, such as by providing perforations or undercuts between the arms 55, 57 and the respective adjacent side member 66. 68. In any event, the break-off regions provide a separation location that is generally uniform and substantially free of sharp of jagged edges after separatum of the respective arms 55, 57. Other embodiments contemplate a break -off region that is in a thread-free-zone. ϊt may also be desirable to provide a desired alignment between vertebrae by reducing the connecting member into the implantation portion of the extended receivers of the anchor assemblies. For example, the vertebrae may be misaligned as a result of spondylolisthesis, anatomical differences between the vertebrae, or some other condition. Also, there may be slight misalignments between the receiver members that make manually positioning the connecting member into each of the receiver members difficult. In such situations, the engaging members 90 can be employed to provide a mechanical advantage to seat the connecting member in the implantation, portions as the engaging members are thread! ngly advanced along the arms 55, 57 and into the side members 66, 68.
System 40 may employ various instruments to facilitate selection of the connecting member, placement of the connecting member through the extenders and to the anchors, securetnent of the connecting member to the anchors, and manipulation of the vertebrae and/or anchors to a desired position or condition. For example,, a driver can be provided that is positionable through any one of the extended receivers to engage the anchor to the vertebra. A driver ibr positioning the engaging member through the extended receiver and into engagement with the implantation portion can also be provided. A counter-torque device such as a wrench or handle arm, can be secured to any one of the extended receivers to hold the extended receiver in position relative to the anchor attached thereto as torque is applied to seat the engaging member into contact with the connecting member in the implantation portion of the extender receiver. Compressors and distractαrs can also be provided to facilitate: application of a compressive or distraction force between anchors before- final attachment of the connecting member to each anchor. Calipers can be provided to .measure a distance between the outermost extended receivers for sizing of the length of the coaneetmg .member to be positioned between the- anchors. A holding instrument can be provided that is adapted to grasp and hold the connecting member placed between the extenders, mid can be employed to facilitate moving dis connecting member distal iy along the extenders toward and into the anchors. A. reduction instrument can be provided that is positionabis along or about the extender receiver to provide a mechanScal. advantage for reduction of the connecting member Into one or more of the implantation poriiojis of the extended receivers.
Examples of suitable connecting members that extend between the anchors include rods, wires, tethers, strands, cables, hands, plates, and struts. The connecting member may include one component, or may include two or more components. One embodiment coRtteetmg xnember is shown iϊi Fig, 1 , and includes connecting member 100 having a« elongated rod-shaped body 102. Body 102 extends along a longitudinal axis .101 between a first end 104 and an opposite second end 106. Body 102 is curved about a radius formed by longitudinal axis Wl . Ends 104, 106 include generally the same size and shape,, although such is not required. Other embodiments contemplate that body 102 is linear, a combination of linear and curved segments, a combination of linear segments angled relative to one another, or a combination of segments having differing curvatures. Body 102 has a uniform cross-section along its length, which can be circular as shown. However, non-uniform cross-sections are also contemplated. In one embodiment, connecting member is an elongated rod made from a metal alloy such as titanium. Other materials are also contemplated, including resorbable materials, non-resorbable materia!, polymers, elastomers, ceramics, other metals mά metal alloys, shape memory materials, bone and bone substitute material;, composites, and combinations of materials.
Eacli of the anchor assemblies can be attached to the respective vertebra using any one of a number of techniques. By way of example and not limitation, one embodiment of a procedure contemplates m incision over the target locatioa of the spinal column, and that the skin and tissue are sequentially dilated to provide a minimally invasive pathway for anchor assembly insertion and engagement to each vertebra.
In another example procedure, a cannulated outer needle with ati inner stylet can first be inserted to the targeted regions of the vertebrae, such as the pedicle is a posterior procedure, and aligned to provide the desired trajectory into the pedicle. Alignment can be monitored and checked with any viewing system, including radiographic, fluoroscopic, microscopic, endoscopic, loupes, naked eye, or any other suitable viewing system, or instrument. After the eannulated needle and stylet are inserted into the vertebra, the inner stylet Is withdrawn with the cannulated outer needle remaining engaged to the vertebra. A gui.dewire Is positioned through the cannula led outer needle and engaged in ihe vertebra. The outer needle is then withdrawn so that the guidewire remains in place. The tissue around the guidewire is sequentially dilated with a number of tubular dilators of increasing diameter. When desired opening size is obtained, the guidewire and inner dilators are removed and the last inserted dilator provides a protected pathway to the pedicle or other targeted portion of the vertebra. The anchor assembly can then be positioned through the dilated pathway and engaged to the vertebra. The procedure is then repeated to position the desired number of anchor assemblies, whether it. be two, three or four or more. Incisions can be made between die adjacent anchor assemblies to provide a pathway for insertion of the connecting member. Alternatively, the connecting member can be inserted axially into one of the extended receivers and then manipulated below the skin aad musculature by rotating it to extend between the anchor assemblies, avoiding incisions through the skin and musculature between the anchor assemblies.
In another embodiment, the anchor assemblies are inserted percutaneousty without sequential dilation. The guidewire is positioned as discussed above, and the anchor can be cammlated for positioning over the guidewire. The anchor and extended receivers are assembled and then positioned together over the guidewire, which guides the anchor assembly to the pedicle or other targeted portion of the vertebra. A cammlated driver tool, is positioned over the guidewire and. through the extended receiver to engage the head of the anchor and drive it into the vertebra.
In another embodiment, a pathway to the target location is prepared as discussed above. The guidewire and any dilators are removed. A cannula or other suitable retractor may remain in the incision to provide a protected pathway to the target location, although direct .insertion through a micro-incision is also contemplated. An anchor driver is inserted through the extended receiver and engaged to the head of the anchor. The anchor driver can maintain the anchor in rigid alignment with the axis of the extended receiver if the anchor assembly is multi-axial. The anchor and extended receiver are inserted percutaneously to the target location of the vertebra, such as the pedicle. Insertion and alignment of the anchor assembly may be .monitored fluoroscopically or with any suitable surgical navigation system. The anchor is then engaged to the vertebra at the target location with the extended receiver extending proximally therefrom through the skin level of the patient. Anchor assembly insertion and engagement Is repeated for each vertebra along the instrumented levels.
Tn any embodiment, placement of the anchor assemblies can be conducted through a micro-indsion, through a retracted opening formed in the tissue approaching the targeted location on the vertebra, or through a tubular member providrng a protected passageway to one or more of the adjacent vertebrae, 3t is also contemplated that nerve monitoring can be performed through the extended receivers to gujde placement of the anchors in the appropriate locations in the vertebrae. In one embodiment, the anchor assemblies are engaged to pedicles of the respective vertebrae. Each pedicle can be drilled and, if. necessary' or desired, tapped to receive a threaded screw portion of the anchor assembly. Formation and tapping of the holes in the pedicles can be monitored with an electrical stimulus applied through a guidewire, tap, probe, or anchor driver prior to and during anchor assembly insertion. Response of the patient can be monitored to determine that anchor placement does not impinge upon arty nerves. The giridewire, tap, probe, driver or other instrument can be placed through a sleeve or dilator made from plastic material to provide a non-conductive insulator, In still a further form, an electrical signal is applied through the anchor assembly to guide placement of the anchor into the vertebrae without impinging on neural structures. The extended receivers can be insulated with a protective, non-conductive coating, sleeve or other layer to prevent the current from straying.
While the invention has been illustrated and described in detail m the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, aad that aϊ! changes and modifications that come within the spirit of the invention are desired to be protected.

Claims

What h claimed is: 1 . A spinal surgical system, comprising: a connecting member including an elongated body having a length sized to extend between at least two vertebrae; and an anchor assembly including a distal anchor engageable to bony structure and an extended receiver extending proxmialiy from and pi votally coupled to said anchor, ssid extended receiver including a distal implantation portion adjacent said anchor sued and shaped to receive said connecting member therein, said extended receiver further including a proximal guide portion including a pair of removable amis extending along a central axis, said arms extending proximaliy from and formed as a single unit with a respective one of a pair of opposite side members of said implantation portion, said amis defining a channel extending therebetween from said implantation portion through proximal ends of said pair of arms, said channel including a thread profile along only a distal portion of said arms, and said channel being sized and shaped to receive said connecting member through said proximal end opening thereof in a transverse orientation to said central axis. 2. The system of claim 1 , wherein each of said amis is joined to said respective side member with a break-off region having a wall thickness reduced comparatively to an adjacent wail thickness of said respective arm and said respective side member.
3. The system of claim 1 , wherein each of said side members defines aai internal thread profile along said implantation portion and each of said arms defines an internal thread profile adjacent a distal end thereof that forms an extension of the thread profile of said side members.
4. The system of claim 3, wherein each of said arms is joined to said respective side member at a break-off region between said internal thread profile of said side members aad said internal thread profile of said arms.
5. The system of claim 1 , wherein said anchor includes a head pivotally captured in said implantation portion of said extended receiver, said anchor further including a shaft extending through a distal opening through said implantation portion for engaging the bony structure,
6. Tlie system of claim 5, further comprising a crown positioned about said head of said anchor In said implantation portion.
7. The system of dairø 6, further comprising a second anchor assembly including a second distal anchor engageable to a second vertebra and a second extended receiver extending proximalty from am! pivotal relative to said second anchor, said second extended receiver including a distal implantation portion adjacent said second anchor sixed and shaped to receive said connecting memfrer therein, said second extended receiver further including a proximal guide portion including a pair of removable arms extending along a central axis proximally from and formed as a single unit with a respective one of a pair of opposite side members of said implantation portion, said arms defining a channel extending therebetween from said implantation portion through proximal ends of said pair of arms, said channel being sized and shaped, to receive said connecting member through said proximal, end opening thereof hi a transverse orientation to said central axis.
8. The system of claim 7, wherein, for each of said extended receivers, each of said side members defines &n internal thread profile along said implantation portion and each of said arras of said respective extended receiver defines an internal thread profile adjacent a distal end thereof that forms an extension of the thread profile of said side members, and further comprising: first and second engaging members oositionabϊe in. a respective one of said extended receivers to secure said connecting member in said implantation portion, thereof, each of said engaging members including an externally threaded portion threadingly engageable with said interna! thread profiles along s&ϊd arms and said side members of said respective extended receiver.
9. The system of claim 7, wherein said connecting member includes a length sized to extend between at least three vertebrae and further comprising a third anchor assembly including a third distai anchor engageable to a third vertebra and a third extended receiver extending proximally from and pivotal relative to said third anchor, said third extended receiver including a distal implantation portion adjacent said third anchor sized and shaped to receive said connecting member therein, smd third extended receiver further including a proximal guide portion including a pair of removable arms extending along a centra! axis proxπtiaHy from and formed as a single unit with a respective one of a pair of opposite side members of said implantation portion, said arrøs defining a channel extending therebetween from said implantation portion through proximal ends of said pair of arms, said channel being sized and shaped to receive said connecting member through said proximal end opening thereof in a transverse orientation to said central axis.
1.0. The system of claim 1 , wherein each of said arms includes a Length extending from said respective side .member that is at least 30 millimeters.
"1 .1. An anchor assembly for securing an elongate connecting member along the spinal, column, comprising: a distal anchor for engaging bony structure aid an extended receiver extending prøximaliy from said anchor, said extended receiver including a distal implantation portion adjacent said anchor, said implantation portion being sized and shaped to receive the connecting member therein, said extended receiver further including a guide portion extending proximally from said implantation portion along a central axis, wherein said implantation portion includes opposite side members and said guide portion includes opposite amis defining a chaaael therebetween, and said opposite arms each include a distal end formed as a single unit with a respective one of said side members at a break-off region, said break-off region providing a separation location for separation of said arms from said respective side member upon application of a threshold force to said arms, said separation location providing a recessed surface Interrupting an internal thread profile extending along said arms and said side members,
.12. The assembly of claim 1 1 , wherein said channel extends through and opens at proximal ends of said arms. 13, The assembly of claim 12, wherein said channel is sized and shaped to receive said connecting member through said proximal end opening thereof in a transverse orientation to said central axis.
Ϊ4. The assembly of claim 1 1 » wherein each of said break-off regions includes a wall thickness reduced comparatively to an adjacent wall thickness of said respective arm and said respective side member. 15. The assembly of claim 1 1, wherein said recessed surface extends completely about said aim and said side member. 16. The assembly of claim I I, further comprising an engaging member positionable in said extended receiver, said engaging member including an externally threaded portion threadingly engageable with said internal thread profiles along said arms and said side members. 17. An anchor assembly for securing an elongate connecting member along the spinal column, comprising: a distal anchor and an. extended receiver exte.odi.og proxlmally from said anchor, said extended receiver including a distal implantation portion adjacent said anchor, said extended receiver further including a guide portion extending proxlmally from said implantation portion along a central axis;, wherein said implantation portion includes opposite side members and said guide portion includes opposite anus each defining a channel therebetween for receiving the connecting member therethrough, wherein each of said side members defines an internal thread profile along said implantation portion and each of said arms defines an internal thread profile adjacent a distal end thereof along only a portion of a length of said arm, said internal thread profile forming an extension of the thread profile of said, side members, wherein each of said anus is joined to said respective side member as a single unit therewith at a reduced thickness region between said internal thread profiles of said arm and said side member, said reduced thickness region defining a separation location for separation of said arm from said respective side member upon application of a threshold force to said arm. 1 8. The assembly of claim 1 1, wherein said anchor is pivotatty coupled to said extended receiver.
Ϊ9. A method for securing a connecting element along a spinal column, comprising: engaging a first anchor assembly to a first varlebrΑ and a second, anchor assembly to a second vertebra, the first and second, anchor assemblies each including an extended receiver extending proximaHy from the respective first and second vertebrae- through the skin of the patient; positioning an elongate connecting member through the extended receivers in an orientation generally parallel to the spinal column; guiding the connecting member along proximal guide portions of the extended receivers and into distal implantation portions of the extended receivers; securing the connecting member in the implantation portions with engaging members positioned into respective ones of the extended receivers in engagement with the implantation portion thereof; and removing the guide portions by applying force to each of the guide portions, the force severing the guide part'toxis from the. respective implantation portion at a break-off region where the guide portion is formed as a single unit with the implantation portion.
20. The method of claim 19, wherein the guide portions each include a pair of arms and the i Replantation portions each include a pair of side members, said pair of amis being formed at a distal end thereof as a single unit with a respective one of said side members. 21. The method of claim 20, wherein securing the connecting member Includes threading! y advancing the engaging member along an. internal thread profile that extends only along a portion of a length of the guide portion atid the implantation portion of the respective extended receiver. 22. The method of claim 19, further comprising pivoting the extended receiver of at least one of the anchor assemblies to a desired position relative to an anchor engaged. to the respective vertebra.
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