WO2007121128A1 - Methods and devices for the interconnection of bone attachment devices - Google Patents

Methods and devices for the interconnection of bone attachment devices Download PDF

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Publication number
WO2007121128A1
WO2007121128A1 PCT/US2007/066212 US2007066212W WO2007121128A1 WO 2007121128 A1 WO2007121128 A1 WO 2007121128A1 US 2007066212 W US2007066212 W US 2007066212W WO 2007121128 A1 WO2007121128 A1 WO 2007121128A1
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WO
WIPO (PCT)
Prior art keywords
connector
bone attachment
bone
attachment devices
engaging
Prior art date
Application number
PCT/US2007/066212
Other languages
French (fr)
Other versions
WO2007121128B1 (en
Inventor
Marc T. Paul
William B. Null
Tony D. Drewy
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 JP2009505558A priority Critical patent/JP5006926B2/en
Priority to EP07760301A priority patent/EP2004077A1/en
Publication of WO2007121128A1 publication Critical patent/WO2007121128A1/en
Publication of WO2007121128B1 publication Critical patent/WO2007121128B1/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
    • A61B17/7049Connectors, not bearing on the vertebrae, for linking longitudinal elements together
    • A61B17/7052Connectors, not bearing on the vertebrae, for linking longitudinal elements together of variable angle or length
    • 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
    • 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
    • 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
    • A61B17/7004Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A61B17/7007Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
    • 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
    • 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
    • A61B17/7001Screws 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
    • A61B17/7038Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other to a different extent in different directions, e.g. within one plane only
    • 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
    • A61B17/7041Screws or hooks combined with longitudinal elements which do not contact vertebrae with single longitudinal rod offset laterally from single row of screws or hooks
    • 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
    • A61B2017/7073Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant with intervertebral connecting element crossing an imaginary spinal median surface
    • 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

  • the present invention relates to a prosthetic device and a manner of using the same, and more particularly, but not exclusively, relates to the interconnection of components to assemble an orthopedic construct for treatment of a spinal deformity
  • prosthetic implants to address orthopedic injuries and ailments has become commonplace In this arena, it is often desired to decrease the invasiveness of the procedures, improve implant integrity, and provide more positive patient outcomes. Some of these implants depend on interconnection between various system components Unfortunately, current interconnection devices can be limiting in certain applications. Thus, there is a need for additional contributions in this area of technology.
  • One aspect of the present application is a unique prosthesis
  • Other aspects include unique methods, systems, devices, instrumentation, and apparatus involving an orthopedic implantable construct
  • a system that includes a pair of bone attachment devices designed to engage or attach to bone or a bony structure.
  • A! so included is a crosslink device which is structured to form a rigid mechanical connection between the two bone attachment devices and is capable of spanning a range of distances separating the two bone attachment devices and angular orientations between the two bone attachment devices.
  • the ends of the crosslink device include a pivotal connection device that each engage a respective one of the first and second bone attachment devices with an engaging member.
  • a surgical method that includes affixing a first bone attachment device and a second bone attachment device to a corresponding desired skeietai location such as the spine; angularly and translatio ⁇ ally adjusting first and second members of a crosslink device relative to one another: pivotaliy adjusting connectors at the ends of the first and second members of the cross-link device, and securing the connectors to respective ones of the bone attachment devices
  • Still another aspect includes a bone attachment device with a receiver portion, a crosslink device, and an elongate spina! stabilization element such as a rod or plate structured to extend through or about the receiver portion.
  • the crosslink device includes a first member and a second member each having means for pivotaily attaching a connector thereto.
  • the crosslink device further includes means for adjusting the translational and rotational position of the first and second members relative to one another. Also included are means for fixing one of the first and second connectors, the elongate element, and the bone attachment dex'ice together in a rigid construct.
  • Yet another embodiment of the present invention includes 1 attaching two bone attachment devices, each hav ing a receiver portion, to a corresponding desired skeletal location, providing two elongate spinal stabilization elements; and positioning each of the two elongate elements in or on the receiver portion of a different one of the bone attachment devices, spanning distance between the bone attachment devices with a crosslink having an interconnection device for adjustably connecting two bridge members, each bridge member having a connector pivotaily attached thereto at an end thereof opposite the interconnection device; changing the translational and rotational position of the two bridge members relative to one another; changing the planar and angular position of each of the members relative to the bone attachment device, and securins the bridae members to a different one of each of the bone attachment devices and fixing the bone attachment devices, the elongate elements, and the crosslink together in a rigid construct.
  • Fig 1 is a posterior view of a spinal fixation system including a crosslink apparatus relative to the spinal column of a patient.
  • Fig 2 is an exploded assembly view of a crosslink device of the crosslink apparatus of Fig 1.
  • Fig 3 is a cross sectional view of an interconnection device of the crosslink device shewn in Fig 2 when in direction 3—3 of Fig 2
  • Fig 4 is a perspective ⁇ lew of the crosslink device in Fig 2
  • Fig 5 is a side plan view of the crosslink device relative to spinal implant components of the spinal fixation system of Fig 1 , with some features show n in phantom
  • Fig 6 is a perspective assembly view of the crosslink device relative w ith its connection to spinal implant components shown in exploded view
  • Fig 7 is a side plan view of a crosslink de ⁇ ice relative to other embodiment spinal implant components of the spinal fixation system of Hg 1
  • Fig 1 illustrates a posterior spinal fixation system 20 of one embodiment located at a desired skeletal location of a patient More specifically, as depicted in Fig 1, system 20 is affixed to bones B of the spinal column 21 from a posterior approach Bones B include the sac ⁇ srn S and several vertebrae V S ⁇ stem 20 generally includes several bone attachment devices 22 and elongate spinal stabilization elements such as iods 23 structured to selectively interconnect with bone attachment devices 22 In system 20, bone attachment devices 22 are affixed to various locations of the spinal column 21 and interconnected with rods 23 Bone attachment devices 22 may also be interconnected by a crosslink apparatus 24 to provide a stable construct for treating spinal disorders Posterior fixation system 20 may be used for, but is not limited to, treatment of degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and/or a failed previous fusion.
  • FIG 2 is an exploded assembly view of a crosslink device 26 of crosslink apparatus 24 in Fig !
  • Crosslink device 26 includes a first bridging member 28 with a first connector 52 and a second bridging member 40 with a second connector 54.
  • First and second bridging members 28, 40 can be engaged to one another at ends thereof opposite the respective connectors 52. 54 with an adjustable linking/interconnection dev ice 66.
  • Cross-link device 26 can extend between and interconnect respective ones of the first and second bone attachment devices 22 through which rods 23 are positioned.
  • Cross-link device 26 can include linking/interconnection device 66 that allows change of the angular orientation between and the length of first and second bridging members 28, 40, providing adjustability in the positioning of cross-link device 26 between attachment devices 22 to avoid anatomical structures along the spine
  • Crosslink device 26 includes first elongated bridging member 28 having a first end 30 opposite a second end 32 First end 30 includes a first socket 34 defined by a pair of outwardly extending prongs 36 and 37 including apertures 38 and 39 transversely formed therethrough.
  • Crosslink device 26 further includes second elongate bridging member 40 having a first end 42 opposite a second end 44. First end 42 includes a second socket 47 defined by a pair of outwardly extending prongs 48 and 4 Q including apertures 50 and 51 formed transversely therethrough.
  • bridging members 28 and 40 between respective first ends 30 and 42 and second ends 32 and 44 include an arcuate configuration so that in the operative, implanted position bridging members 28 and 40 are convexly curved away from the spinal column to provide clearance over anatomical structures
  • members 28 and 40 may be more or less arcuate and may even be straight.
  • First and second sockets 34, 47 are each sized and structured to receive first connector 52 and second connector 54 therein, respectively
  • Each of first connector 52 and second connector 54 includes a body 56 and a branch 58 extending from body 56 wherein branch 58 is appropriately sized relative to first socket 34 and second socket 47 and is structured for insertion therein
  • Branch 58 further includes an aperture 62 extending transversely therethrough such that when connectors 52 and 54 are inserted into sockets 34 and 4 ⁇ t respectively, aperture 62 of branch 58 aligns with apertures 38, 39 and 50, 51
  • a fulcrum 64 shown in the form of pin may be inserted through aperture 3 S of prong 36, through aperture 62, and through aperture 39 of prong 37 to photally interconnect connector 52 with socket 34 Similarly, when proper!) aligned, connector 54 may be photally inter connected to socket 4? by inserting fulcrum 64 through aperture 50 of prong 48. through aperture 62, and then through aperture 51 of prong 49
  • fulcrum 64 may be in the form of a bolt or screw Fulcrum 64 can also be press fit welded or otherwise secured to one or both of the prongs of the respecthe socket Fulcrum 64 may also be a standard bolt and nut combination oi any othei device known to those skilled in the art capable of permitting pivotal movement thereabout It is also contemplated that the arrangement between the branch and socket could be reversed so that one or both of connectors 52. 54 defines a socket and the respective adjacent end of bridging member 28, 40 defines * a blanch pi ⁇ otaliy coupled in. the socket
  • crosslink de ⁇ ice 26 in Fig 4 there is illustrated the directions of pivotal movement of connectors 52 and 54 about fulcrum 64 Connectors 52 and 54 ma) pivoi freelv in an upwaid or downward direction as indicated by respective Directional Arrows D and E While connectors 52 and 54 are illustrated as being substantial!) ui the same plane, it is intended that their planar relationship will shift when crosslink de ⁇ ice 26 is attached to bone attachment devices 22 ha ⁇ ing different eievational locations within the body and having different angular orientations i dative to one anothei and relative to the connectors 52. 54 The absHt ⁇ to adjust the angular orientation of the ends of bridging members 28, 40 with connectors 52, 54 facilitates attachment of crosslink device 26 between bone attachment devices with an infinite number of relative locations and angular orientations between the bone attachment devices
  • bod) 56 of connectors 52 and 54 includes an apeiture 60 therethrough to facilitate engagement with bone attachment devices 22 of Fig I
  • body 56 does not an aperture 60 that is completely enclosed
  • an open collar with a slot is defined by each body 56 of connectors 52 and 54 in lieu of the enclosed aperture 60
  • the structures of connectors 52 and 54 have a different means for engaging the respective bone attachment devices 22.
  • the shape and size of bridging members 28 and 40 can differ from that depicted as desired for a particular application.
  • the connectors 52, 54 can abut against the ends of the respective receiver portions 90, or may include a cavity to at least partially receive the respective receiver portion 90 therein. It should be further understood that connectors 52, 54 may rotate around the bone attachment device 22 until finally secured thereto with an engaging member. The rotational adjustability of the connectors 52, 54 and thus bridging members 28, 40 with respect to the hone attachment devices further facilitates adjustment in the angular orientation and length of the bridging members 28, 40 relative to one another
  • Crosslink device 26 further includes an adjustable linking/interconnection device t>6 ha ⁇ ing a stem t>8, a fastener 70, and a sleeve 72 defining a passageway 74
  • a detailed cross sectional view of interconnection device 66 is provided in Fig. 3 that corresponds to the section line ⁇ 3 presented in Fig 2.
  • Sleeve 72 is positioned opposite stem 68 5 which extends away therefrom
  • Bridging member 40 is structured for r ⁇ ta table engagement with stem 68 and bridging member 28 is structured for transiationai and rotatabie engagement within passageway 74 of sleeve 72.
  • Second end portion 44 of bridging member 40 includes end portion 45 that defines a passage 46 therethrough.
  • stem 68 of device 66 extends through passage 46.
  • passage 46 can alternatively be defined as a fork, slot, shim, collar, or blade ⁇ just to name a few possibilities) that receives stem 68 instead of the enclosed structure of passage 46.
  • bridging member 40 can be moved through a range of rotational positions about axis Rl, as represented by the rotational motion arrow A.
  • Bridging member 28 includes second end 32 opposite first end 30 that defines an end portion 33 that extends through passageway 74 of sleeve 72. and has a range of translations! motion along axis T as represented by range segment B in Fig 4 Furthermore, passageway 74 and end portion 33 are sized and shaped to facilitate a range of rotational positions about axis R.2 relative to passageway 74 and sleeve 72 as represented by rotational motion arrow C in Fig 4. After extending stem 68 through passage 46 and end portion 33 through passageway 74 and determining selected positioning relative to axes Hf , R2. and T, fastener 70 including an aperture 76 with internal threading 78 is engaged with threading 80 on stem &S.
  • bridging members 28 and 40 become fixed relative to one another as fastener 70 is tightened on stem 68 to bear against a side of end portion 33 opposite the side in contact with end portion 45. it should be appreciated that before final tightening, refinements can he made in the relative positioning.
  • a bridging construct is provided that spans between a pair of bone attachment devices 22 with a selected rotational configuration relative to axes R l and R2 (and ranges A and C) and a selected translational configuration relative to axis T along range segment B.
  • axes RJ and R2 are approximately orthogonal to one another, bridging members 28, 40 can be angularly adjusted relative to one another about axis RI .
  • the angular orientation of connectors 52, 54 relative to another can be adjusted by rotation of bridging member 28 about axis 112.
  • axis ill is parallel to the view plane, but axis R2 is perpendicular thereto, being represented by cross hairs.
  • Translation axis T is parallel to axis R2, as best shown in Fig 4.
  • Crosslink apparatus 24 includes crosslink device 2(> and a pair of bone attachment devices in the form of bone screw 82 and hone screw 84.
  • Bone screws 82 and 84 can each have an elongated shaft or stem 86 with a helical threaded portion 88.
  • Stem 86 is staictured to threading ⁇ y engage a passageway prepared in one or more bones or bony structures in a standard manner, and can be provided with cutting flutes or other structure for self-tapping and/or self-drilling capabilities.
  • Stem 86 can also he cannul ⁇ ted to receive a guidewire to facilitate placement and may further include fenestrations or other openings for placement of bone growth material.
  • Bone screw 82 and bone screw 84 each have a head or a receiver portion 90 defining a receiving channel *34 between upright arms 92.
  • Arms 92 can include an internal threading 98.
  • head 90 includes a receiving channel 94 but does not include threading c >8.
  • deceiving channel 94 can fours a channel structured to passively secure rod 23 in receiver portion c >0 without additional securing means for those embodiments including iod 23
  • Bottom portion % can be concavel> cuived and form a portion of a circle to receh e the rod in form fitting engagement therein
  • Other embodiments contemplate that the rod is positioned against a head of a bone screw, or against a cap or crown adjacent a head of a bone screw in receiver portion 90
  • bone screw 82 and bone screw 84 are made of medical grade stainless steel but other embodiments ma> be composed of, but are not limited to. titanium, a titanium alloy or other metallic alloy, and'' or a nonmetaliic composition
  • Bone attachment devices 22 may be, but are not limited to, multi-axial, poly-axial, u ⁇ i ⁇ a ⁇ ial.
  • bone attachment devices 22 may include one or more hooks to engage an adjacent bom structure such as a pedicle, lamina, spinous process, transverse process, or other bom structure suitable engaged with a spinal hook
  • a m ⁇ lti ⁇ a ⁇ ial laminar hook form of device 22 can be used in place of screw 82 and/or screw 84
  • device 22 can include a bone attachment structure in the form of a staple, bone plate, interbod) fusion device, interbody spacer, spinal anchor, intravertebra! fusion de ⁇ ice, bone clamp, or other anchor
  • rod 23 may be solid oi hollow along some or all of its length and/or raa ⁇ be of homogenous or heterogeneous composition
  • Rod 23 can be rigid, or be flexible or include one or more flexible portions to permit at least limited spinal motion
  • Rod 23 may be substituted with any suitable spinal stabilization element positionable along the spinal column, including plates, tethers, wires, cables, cords, inflatable devices, expandable devices, and formed in place devices, for example
  • the embodiment illustrated in Fig 5 further includes two engaging members 100 and 101 structured to secure crosslink device 26 to bone screws 82 and 84. respectively, or other bone attachment de ⁇ ices
  • Engaging members 100 and 101 each include a longitudinal threaded stem 102, 102 " , respectiv ely, opposite a head 104 Head 104 of each of engaging members 100, 101 includes a tool engagement cavity 106
  • Tool engagement cavity 106 ma be but is not limited to, a hex or alien wench configuration
  • tool engagement may be provided b> a differently shaped structure for engagement by an appropriate assembly tool oi may be absent
  • engaging members 100 and 101 include a frangible, break-away portion which is engaged by a iool to rotate engaging members 100 and 101 into receiver portion 90 until a threshold torque level is reached, at which point the break-away portion fractures, separating from the remaining portions of engaging members 100, 101 at a predetermined location
  • FIG 5 illustrates bone screw 82 ha ⁇ ing rod 23 positioned in recm er portion 1 K)
  • receiver portion 90 and rod 23 may differ in size in relation to one another and ' or other components of system 20
  • engaging member 100 is engaged in receiver portion 90
  • the end of threaded stem 102 can bear against rod 23 and force rod 23 against bottom portion % or other structure in receiver portion 90, securing rod 23 with crosslink device 26 and bone screw 82 in a rigid construct
  • engaging member 101 is shown not complete! ⁇ engaged with receiver portion 90 of bone screw 84 in order to aid in the depiction of threading 98 1 (owevcr, stem 102' includes a length extending from head 104 such that its distal end stops at location 91 in receiver portion 00 At location 91 , the distal end of stem 102 ' remains spaced from rod 23 in receiver portion W In this configuration, rod 23 is free to axiaih translate and move relative to bone SCJCW 84 ami cioss-link ice 26 while cross-link device 26 and bone screw 84 are rigidly coupled to one another It is further contemplated the engaging members 100, 101 may be employed in either or both of bone screws 82, S4 or other bone attachment de ⁇ ice 22
  • one or both of the connectors 52, 54 may include a structure that contacts the respective adjacent rod 23 when engaging member 10! vuth s,tem 102' is engaged io a bone attachment device 22 Accordingly, when engaging member 101 is tightened, it remains spaced from rod 23 in receiver portion 90. while connector 52. 54 includes a recess to receive receiver portion W. or includes a structure extending distalh therefrom toward rod 23 that contacts and securely engages rod 23 to receiver portion vo of the bone attachment device
  • FIG. 5 shows the top or proximal end of C X> of the receiver portions 90 of bone screw 82 and bone screw 84 in different elev ational planes
  • Crosslink device 26 is able to fittingly engage v ⁇ ith proximal ends 99 of the receiver portions 90 or other staieture of the bone attachment device 22 even if at different clevatiosial planes and different angular orientations because connectors 52 and 54 phot about iulcrum t>4 While not shown, it should be understood that the elevational differences between the proximal ends 99 of bone attachment devices may be greater, smallei, or even the same in alternative embodiments
  • Fig 6 is a perspective assembly view of crosslink apparatus 24 wherein like numerals refer to like features previously described
  • a coupler 107 is utilized
  • Coupler 107 has first end 108 opposite a second end !00 and includes a longitudinal threaded stem 1 10 with an internally threaded portion 1 12
  • the first end 108 is further defined by a tool cooperation portion 1 14
  • Longitudinal threaded stem 1 10 of coupler 107 is structured to engage threading 98 when coupler 107 is rotated into receiver portion 90 of bone screws 82 and 84
  • the embodiment of Fig 6 includes one or more rod(s) 23 through the respective receiver portions 90 of bone scicws 82, 84
  • Rod(s) 23 is/are placed into rod receiving channel 94 and coupler 107 is engaged with threading 98 such that second end 109 bears against rod(s) 23 to create a rigid engagement between receiver portion 90 and rod 23
  • Internally threaded portion 1 12 is structured to engage, for example, threaded stem ⁇ 02 of engaging membei 100 when engaging member 100 is insetted through kittuie 60 of an adjacent one of the connectors 52 and 54
  • coupler 107 is tightened in receiver portion Q G and engaging member 100 is tightened in internally threaded portion 1 12 crosslink dev ice 26 is locked in a rigid construct with bone screws 82 and 84 or other bone attachment devices 22 While bone screw 82 and bone screw S4 are both shown using coupler ! 07.
  • coupler 107 may be absent from one or both of bone seiew 82 and bone screw 84 Ii is further contemplated that coupler 107 ma ⁇ be used in alternative bone attachment devices 22 not illustrated in Fig 6
  • FIG. 1 An alternative embodiment of crosslink apparatus 24 is shown in a side plan in Fig 7 xs here certain hidden features are shown in phantom and where like numerals icfer to like features previous!) described
  • Connector 52 of crosslink device 26 is shown connected to a bone attachment device 22 in the form of a laminar hook 1 16
  • Laminar hook 1 16 includes a hook portion 1 18 structured to engage bone or a bom surface and a proximal head or receiver portion 124
  • Receiver portion 124 further includes a receiving channel 126 formed by a pair of uptight arms 122 having internal threading 127 disposed therein
  • An engaging member, such as engaging member 100. can be passed through, aperture 60 and engaged with threading 127 to create a rigid construct between connector 52 and laminar hook 1 1o and a rod or other elongate element positioned in receiving channel 126
  • Connector 54 is shown connected to a bone attachment dev ice 22 in the form of bone anchor 128 including a distal bone engaging portion 130 opposite a pro ⁇ imally extending post 132
  • a coupler clamp 134 including a receiver portion 136
  • the receiver portion 136 is a post engagement portion 138 including an aperture 141 through which post 132 extends
  • Coupler clamp 134 further includes a rod interface washer 138 and a post interface washer 140 Disposed on the side of washer 138 and washer 140 facing each other are a set of intzigi taring teeth 142 lmerdigi taring teeth 142 are structured to allow lockable positioning of washer 138 and washer 140 such that the angular orientation of rod 23 relative to bone anchor 128 may be altered
  • engaging member 100 is passed through aperture 60 and fulh engaged with a threaded aperture 144 disposed near receiver portion 136
  • interdigitating teeth 142 become locked as rod 23 is forced to bias
  • crosslink apparatus 24 is free from both engaging members 100, KH and/or apertures 60 in connectors 52, 54.
  • various means for connecting crosslink device 26 with bone attachment devices 22 are included.
  • the means may include, but are not limited to, snap rings, nuts, pins, compression fits, snap fits, clamps, adhesives, and fusions.
  • engaging members 100, 101 are shown with externally threaded stems.
  • Other embodiments contemplate engaging members 100, 101 with other structures for engaging receiver portion 32, including twist locks, snap fits, interference fits, slide-fits, clamps, expansion fits, and internally threaded stems, for example.
  • the connecting means change the corresponding structure of connector 52 and connector 54 will change In embodiments including rod 23 the manner in which rod 23 is secured to one or both of bone attachment devices 22 w ⁇ i also change.
  • cross-link apparatus 24 can be composed of medical grade stainless steel.
  • Other embodiments may be composed of, but are not limited to, titanium, a titanium alloy or other metallic alloy, and/or a nonrnetallie composition

Abstract

A pair of bone attachment devices (22) and a crosslink device (26) for a spinal fixation system (20) or other implant arrangement is provided that extends between and engages the bone attachment devices (22) with engaging members (100, 101). The bone attachment devices (22) include a receiver portion (90) and the crosslink device (26) includes a pair of elongated bridging members (28, 40) each having a pivotally attached connector (52, 54) for connecting to the bone attachment devices (22) at various planar elevations. An interconnection device (66) situated between the connectors (52, 54) receives the members (28, 40) and allows translational and rotational adjustment of the members (28, 40) relative to one another.

Description

METHODS AND BEVlCES FOR THE INTERCONNECTION OF BONE
ATTACH 3Vl ENT DEVICES
BACKGROUND
The present invention relates to a prosthetic device and a manner of using the same, and more particularly, but not exclusively, relates to the interconnection of components to assemble an orthopedic construct for treatment of a spinal deformity
The use of prosthetic implants to address orthopedic injuries and ailments has become commonplace In this arena, it is often desired to decrease the invasiveness of the procedures, improve implant integrity, and provide more positive patient outcomes. Some of these implants depend on interconnection between various system components Unfortunately, current interconnection devices can be limiting in certain applications. Thus, there is a need for additional contributions in this area of technology.
SUMMARY
One aspect of the present application is a unique prosthesis Other aspects include unique methods, systems, devices, instrumentation, and apparatus involving an orthopedic implantable construct
In one aspect there is a system that includes a pair of bone attachment devices designed to engage or attach to bone or a bony structure. A! so included is a crosslink device which is structured to form a rigid mechanical connection between the two bone attachment devices and is capable of spanning a range of distances separating the two bone attachment devices and angular orientations between the two bone attachment devices. The ends of the crosslink device include a pivotal connection device that each engage a respective one of the first and second bone attachment devices with an engaging member.
In a further aspect, there is provided a surgical method that includes affixing a first bone attachment device and a second bone attachment device to a corresponding desired skeietai location such as the spine; angularly and translatioπally adjusting first and second members of a crosslink device relative to one another: pivotaliy adjusting connectors at the ends of the first and second members of the cross-link device, and securing the connectors to respective ones of the bone attachment devices
Still another aspect includes a bone attachment device with a receiver portion, a crosslink device, and an elongate spina! stabilization element such as a rod or plate structured to extend through or about the receiver portion. The crosslink device includes a first member and a second member each having means for pivotaily attaching a connector thereto. The crosslink device further includes means for adjusting the translational and rotational position of the first and second members relative to one another. Also included are means for fixing one of the first and second connectors, the elongate element, and the bone attachment dex'ice together in a rigid construct.
Yet another embodiment of the present invention includes1 attaching two bone attachment devices, each hav ing a receiver portion, to a corresponding desired skeletal location, providing two elongate spinal stabilization elements; and positioning each of the two elongate elements in or on the receiver portion of a different one of the bone attachment devices, spanning distance between the bone attachment devices with a crosslink having an interconnection device for adjustably connecting two bridge members, each bridge member having a connector pivotaily attached thereto at an end thereof opposite the interconnection device; changing the translational and rotational position of the two bridge members relative to one another; changing the planar and angular position of each of the members relative to the bone attachment device, and securins the bridae members to a different one of each of the bone attachment devices and fixing the bone attachment devices, the elongate elements, and the crosslink together in a rigid construct.
Further embodiments, forms, features, aspects, benefits, objects, and advantages of the present application shall become apparent from the detailed description and figures provided herewith
BRIEF DESCRIPTION OF THE DRAWINGS
Fig 1 is a posterior view of a spinal fixation system including a crosslink apparatus relative to the spinal column of a patient.
Fig 2 is an exploded assembly view of a crosslink device of the crosslink apparatus of Fig 1. Fig 3 is a cross sectional view of an interconnection device of the crosslink device shewn in Fig 2 when
Figure imgf000004_0001
in direction 3—3 of Fig 2
Fig 4 is a perspective \ lew of the crosslink device in Fig 2
Fig 5 is a side plan view of the crosslink device relative to spinal implant components of the spinal fixation system of Fig 1 , with some features show n in phantom
Fig 6 is a perspective assembly view of the crosslink device relative w ith its connection to spinal implant components shown in exploded view
Fig 7 is a side plan view of a crosslink de\ ice relative to other embodiment spinal implant components of the spinal fixation system of Hg 1
DETAILED DESCRIPTION OF SELECTED EMBODIMENTS
For the purpose of promoting an understanding of the principles of the i mention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same It will nevertheless be understood that no limitation of the scope of the invention is thereby intended Any alterations and further modifications in the described embodiments, and an> further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates
The present inxention provides unique orthopedic prosthesis, s\ stems, methods of use and manufacture, deuces, instruments, and kits incorporated herein b\ reference in its entiret) is H S Patent Application Serial No ! 1 /401,822. filed on April K). 2006, entitled "CROSSLINK INTERCONNECTION OF BONE ATTACHM CNT DEVICES"
Fig 1 illustrates a posterior spinal fixation system 20 of one embodiment located at a desired skeletal location of a patient More specifically, as depicted in Fig 1, system 20 is affixed to bones B of the spinal column 21 from a posterior approach Bones B include the sacαsrn S and several vertebrae V S\ stem 20 generally includes several bone attachment devices 22 and elongate spinal stabilization elements such as iods 23 structured to selectively interconnect with bone attachment devices 22 In system 20, bone attachment devices 22 are affixed to various locations of the spinal column 21 and interconnected with rods 23 Bone attachment devices 22 may also be interconnected by a crosslink apparatus 24 to provide a stable construct for treating spinal disorders Posterior fixation system 20 may be used for, but is not limited to, treatment of degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and/or a failed previous fusion.
Fig 2 is an exploded assembly view of a crosslink device 26 of crosslink apparatus 24 in Fig ! , Crosslink device 26 includes a first bridging member 28 with a first connector 52 and a second bridging member 40 with a second connector 54. First and second bridging members 28, 40 can be engaged to one another at ends thereof opposite the respective connectors 52. 54 with an adjustable linking/interconnection dev ice 66. Cross-link device 26 can extend between and interconnect respective ones of the first and second bone attachment devices 22 through which rods 23 are positioned. Cross-link device 26 can include linking/interconnection device 66 that allows change of the angular orientation between and the length of first and second bridging members 28, 40, providing adjustability in the positioning of cross-link device 26 between attachment devices 22 to avoid anatomical structures along the spine
Crosslink device 26 includes first elongated bridging member 28 having a first end 30 opposite a second end 32 First end 30 includes a first socket 34 defined by a pair of outwardly extending prongs 36 and 37 including apertures 38 and 39 transversely formed therethrough. Crosslink device 26 further includes second elongate bridging member 40 having a first end 42 opposite a second end 44. First end 42 includes a second socket 47 defined by a pair of outwardly extending prongs 48 and 4 Q including apertures 50 and 51 formed transversely therethrough. As depicted, bridging members 28 and 40 between respective first ends 30 and 42 and second ends 32 and 44 include an arcuate configuration so that in the operative, implanted position bridging members 28 and 40 are convexly curved away from the spinal column to provide clearance over anatomical structures In alternative embodiments members 28 and 40 may be more or less arcuate and may even be straight.
First and second sockets 34, 47 are each sized and structured to receive first connector 52 and second connector 54 therein, respectively Each of first connector 52 and second connector 54 includes a body 56 and a branch 58 extending from body 56 wherein branch 58 is appropriately sized relative to first socket 34 and second socket 47 and is structured for insertion therein Branch 58 further includes an aperture 62 extending transversely therethrough such that when connectors 52 and 54 are inserted into sockets 34 and 4~t respectively, aperture 62 of branch 58 aligns with apertures 38, 39 and 50, 51 When aligned appropriately, a fulcrum 64 shown in the form of pin may be inserted through aperture 3 S of prong 36, through aperture 62, and through aperture 39 of prong 37 to photally interconnect connector 52 with socket 34 Similarly, when proper!) aligned, connector 54 may be photally inter connected to socket 4? by inserting fulcrum 64 through aperture 50 of prong 48. through aperture 62, and then through aperture 51 of prong 49
It is contemplated that am of apertures 38, 39, 50. and 51 may include threading therein, such that fulcrum 64 may be in the form of a bolt or screw Fulcrum 64 can also be press fit welded or otherwise secured to one or both of the prongs of the respecthe socket Fulcrum 64 may also be a standard bolt and nut combination oi any othei device known to those skilled in the art capable of permitting pivotal movement thereabout It is also contemplated that the arrangement between the branch and socket could be reversed so that one or both of connectors 52. 54 defines a socket and the respective adjacent end of bridging member 28, 40 defines* a blanch pi\ otaliy coupled in. the socket
Referring to the side plan view of crosslink de\ice 26 in Fig 4, there is illustrated the directions of pivotal movement of connectors 52 and 54 about fulcrum 64 Connectors 52 and 54 ma) pivoi freelv in an upwaid or downward direction as indicated by respective Directional Arrows D and E While connectors 52 and 54 are illustrated as being substantial!) ui the same plane, it is intended that their planar relationship will shift when crosslink de\ ice 26 is attached to bone attachment devices 22 ha\ ing different eievational locations within the body and having different angular orientations i dative to one anothei and relative to the connectors 52. 54 The absHt\ to adjust the angular orientation of the ends of bridging members 28, 40 with connectors 52, 54 facilitates attachment of crosslink device 26 between bone attachment devices with an infinite number of relative locations and angular orientations between the bone attachment devices
In one embodiment, bod) 56 of connectors 52 and 54 includes an apeiture 60 therethrough to facilitate engagement with bone attachment devices 22 of Fig I In alternative embodiments (not shown) body 56 does not an aperture 60 that is completely enclosed In one such variation, an open collar with a slot is defined by each body 56 of connectors 52 and 54 in lieu of the enclosed aperture 60 In another foim, the structures of connectors 52 and 54 have a different means for engaging the respective bone attachment devices 22. Correspondingly, the shape and size of bridging members 28 and 40 can differ from that depicted as desired for a particular application.
For example, the connectors 52, 54 can abut against the ends of the respective receiver portions 90, or may include a cavity to at least partially receive the respective receiver portion 90 therein. It should be further understood that connectors 52, 54 may rotate around the bone attachment device 22 until finally secured thereto with an engaging member. The rotational adjustability of the connectors 52, 54 and thus bridging members 28, 40 with respect to the hone attachment devices further facilitates adjustment in the angular orientation and length of the bridging members 28, 40 relative to one another
Crosslink device 26 further includes an adjustable linking/interconnection device t>6 ha\ ing a stem t>8, a fastener 70, and a sleeve 72 defining a passageway 74 A detailed cross sectional view of interconnection device 66 is provided in Fig. 3 that corresponds to the section line }~~3 presented in Fig 2. Sleeve 72 is positioned opposite stem 685 which extends away therefrom Bridging member 40 is structured for rυta table engagement with stem 68 and bridging member 28 is structured for transiationai and rotatabie engagement within passageway 74 of sleeve 72. Second end portion 44 of bridging member 40 includes end portion 45 that defines a passage 46 therethrough.
When assembled together as shown in Figs. 1 and 3-7. stem 68 of device 66 extends through passage 46. As in the case of aperture (>0, passage 46 can alternatively be defined as a fork, slot, shim, collar, or blade {just to name a few possibilities) that receives stem 68 instead of the enclosed structure of passage 46. Referring to Fig. 4, bridging member 40 can be moved through a range of rotational positions about axis Rl, as represented by the rotational motion arrow A.
Bridging member 28 includes second end 32 opposite first end 30 that defines an end portion 33 that extends through passageway 74 of sleeve 72. and has a range of translations! motion along axis T as represented by range segment B in Fig 4 Furthermore, passageway 74 and end portion 33 are sized and shaped to facilitate a range of rotational positions about axis R.2 relative to passageway 74 and sleeve 72 as represented by rotational motion arrow C in Fig 4. After extending stem 68 through passage 46 and end portion 33 through passageway 74 and determining selected positioning relative to axes Hf , R2. and T, fastener 70 including an aperture 76 with internal threading 78 is engaged with threading 80 on stem &S. As fastener 70 is turned, sleeve 72 brings end portion 33 into contact with end portion 45. forming a bearing relationship therebetween that resists movement therebetween. Correspondingly, bridging members 28 and 40 become fixed relative to one another as fastener 70 is tightened on stem 68 to bear against a side of end portion 33 opposite the side in contact with end portion 45. it should be appreciated that before final tightening, refinements can he made in the relative positioning. Once fastener 70 is finally tightened a bridging construct is provided that spans between a pair of bone attachment devices 22 with a selected rotational configuration relative to axes R l and R2 (and ranges A and C) and a selected translational configuration relative to axis T along range segment B. It should be appreciated that axes RJ and R2 are approximately orthogonal to one another, bridging members 28, 40 can be angularly adjusted relative to one another about axis RI . The angular orientation of connectors 52, 54 relative to another can be adjusted by rotation of bridging member 28 about axis 112. In Fig. 3, axis ill is parallel to the view plane, but axis R2 is perpendicular thereto, being represented by cross hairs. Translation axis T is parallel to axis R2, as best shown in Fig 4.
Referring now to Fig 5, there is shown crosslink apparatus 24 of Fig. I with certain hidden features in phantom Crosslink apparatus 24 includes crosslink device 2(> and a pair of bone attachment devices in the form of bone screw 82 and hone screw 84. Bone screws 82 and 84, respectively, can each have an elongated shaft or stem 86 with a helical threaded portion 88. Stem 86 is staictured to threadingϊy engage a passageway prepared in one or more bones or bony structures in a standard manner, and can be provided with cutting flutes or other structure for self-tapping and/or self-drilling capabilities. Stem 86 can also he cannulαted to receive a guidewire to facilitate placement and may further include fenestrations or other openings for placement of bone growth material.
Bone screw 82 and bone screw 84 each have a head or a receiver portion 90 defining a receiving channel *34 between upright arms 92. Arms 92 can include an internal threading 98. In alternative embodiments not shown, head 90 includes a receiving channel 94 but does not include threading c>8. or may include external threading in addition to or alternatively to threading 98 deceiving channel 94 can fours a channel structured to passively secure rod 23 in receiver portion c>0 without additional securing means for those embodiments including iod 23 Bottom portion % can be concavel> cuived and form a portion of a circle to receh e the rod in form fitting engagement therein Other embodiments contemplate that the rod is positioned against a head of a bone screw, or against a cap or crown adjacent a head of a bone screw in receiver portion 90
In one form bone screw 82 and bone screw 84 are made of medical grade stainless steel but other embodiments ma> be composed of, but are not limited to. titanium, a titanium alloy or other metallic alloy, and'' or a nonmetaliic composition Bone attachment devices 22 may be, but are not limited to, multi-axial, poly-axial, uπi~a\ial. uπi-pianai bone screws where stem 86 and receh er portion 90 are movable relathe to one another in one movable form, stem 86 and receiver portion 90 are engaged together with a "ball and joint" or swhel type of coupling that permits relative movement therebetween during at least some stages of assembly In yet another form, bone attachment devices 22 may include one or more hooks to engage an adjacent bom structure such as a pedicle, lamina, spinous process, transverse process, or other bom structure suitable engaged with a spinal hook For instance, a mυlti~a\ial laminar hook form of device 22 can be used in place of screw 82 and/or screw 84 In still other embodiments, device 22 can include a bone attachment structure in the form of a staple, bone plate, interbod) fusion device, interbody spacer, spinal anchor, intravertebra! fusion de\ ice, bone clamp, or other anchor
In addition, rod 23 may be solid oi hollow along some or all of its length and/or raa\ be of homogenous or heterogeneous composition Rod 23 can be rigid, or be flexible or include one or more flexible portions to permit at least limited spinal motion Rod 23 may be substituted with any suitable spinal stabilization element positionable along the spinal column, including plates, tethers, wires, cables, cords, inflatable devices, expandable devices, and formed in place devices, for example
The embodiment illustrated in Fig 5 further includes two engaging members 100 and 101 structured to secure crosslink device 26 to bone screws 82 and 84. respectively, or other bone attachment de\ ices Engaging members 100 and 101 each include a longitudinal threaded stem 102, 102", respectiv ely, opposite a head 104 Head 104 of each of engaging members 100, 101 includes a tool engagement cavity 106 Tool engagement cavity 106 ma) be but is not limited to, a hex or alien wench configuration In alternative embodiments, tool engagement may be provided b> a differently shaped structure for engagement by an appropriate assembly tool oi may be absent Indeed, in one alternative, engaging members 100 and 101 include a frangible, break-away portion which is engaged by a iool to rotate engaging members 100 and 101 into receiver portion 90 until a threshold torque level is reached, at which point the break-away portion fractures, separating from the remaining portions of engaging members 100, 101 at a predetermined location
Longitudinal threaded stem 102. 102" of each of engaging members 100. 101 passes through the respectk e aperture 60 of corresponding connectors 52 and 54 to engage threading 98 of the respective receh er portion 90 Once threaded therein and tightened, head 104 of each engaging member 100 and 101 bears against the corresponding connector 52 or 54 to secure the respective bridging members 28 and 40 to the respective t occi vet portions 90 ft should be appreciated that head 104 is sized and shaped to contact connector 52 or 54 in a bearing relationship including where it forms a material boundary for the corresponding aperture 60 It should be further understood that connector 52 and 54 mav rotate around the bone attachment device 22 until engaging members 100 and 101 are fully tightened to allow adjustment in the orientation of bridging members 28, 40
Fig 5 illustrates bone screw 82 ha\ ing rod 23 positioned in recm er portion 1K) Ia \arious embodiments of this application receiver portion 90 and rod 23 may differ in size in relation to one another and'or other components of system 20 As engaging member 100 is engaged in receiver portion 90, the end of threaded stem 102 can bear against rod 23 and force rod 23 against bottom portion % or other structure in receiver portion 90, securing rod 23 with crosslink device 26 and bone screw 82 in a rigid construct
In Fig 5 engaging member 101 is shown not complete!} engaged with receiver portion 90 of bone screw 84 in order to aid in the depiction of threading 98 1 (owevcr, stem 102' includes a length extending from head 104 such that its distal end stops at location 91 in receiver portion 00 At location 91 , the distal end of stem 102' remains spaced from rod 23 in receiver portion W In this configuration, rod 23 is free to axiaih translate and move relative to bone SCJCW 84 ami cioss-link
Figure imgf000010_0001
ice 26 while cross-link device 26 and bone screw 84 are rigidly coupled to one another It is further contemplated the engaging members 100, 101 may be employed in either or both of bone screws 82, S4 or other bone attachment de\ ice 22
In an alternative embodiment not shown, one or both of the connectors 52, 54 may include a structure that contacts the respective adjacent rod 23 when engaging member 10! vuth s,tem 102' is engaged io a bone attachment device 22 Accordingly, when engaging member 101 is tightened, it remains spaced from rod 23 in receiver portion 90. while connector 52. 54 includes a recess to receive receiver portion W. or includes a structure extending distalh therefrom toward rod 23 that contacts and securely engages rod 23 to receiver portion vo of the bone attachment device
It should be fuπher understood that the embodiment ϋlustrated in Fig 5 shows the top or proximal end of CX> of the receiver portions 90 of bone screw 82 and bone screw 84 in different elev ational planes Crosslink device 26 is able to fittingly engage v\ ith proximal ends 99 of the receiver portions 90 or other staieture of the bone attachment device 22 even if at different clevatiosial planes and different angular orientations because connectors 52 and 54 phot about iulcrum t>4 While not shown, it should be understood that the elevational differences between the proximal ends 99 of bone attachment devices may be greater, smallei, or even the same in alternative embodiments
Fig 6 is a perspective assembly view of crosslink apparatus 24 wherein like numerals refer to like features previously described In this embodiment a coupler 107 is utilized Coupler 107 has first end 108 opposite a second end !00 and includes a longitudinal threaded stem 1 10 with an internally threaded portion 1 12 The first end 108 is further defined by a tool cooperation portion 1 14 Longitudinal threaded stem 1 10 of coupler 107 is structured to engage threading 98 when coupler 107 is rotated into receiver portion 90 of bone screws 82 and 84 While not shown, it is contemplated that the embodiment of Fig 6 includes one or more rod(s) 23 through the respective receiver portions 90 of bone scicws 82, 84 Rod(s) 23 is/are placed into rod receiving channel 94 and coupler 107 is engaged with threading 98 such that second end 109 bears against rod(s) 23 to create a rigid engagement between receiver portion 90 and rod 23
Internally threaded portion 1 12 is structured to engage, for example, threaded stem ϊ 02 of engaging membei 100 when engaging member 100 is insetted through apoituie 60 of an adjacent one of the connectors 52 and 54 Once coupler 107 is tightened in receiver portion QG and engaging member 100 is tightened in internally threaded portion 1 12 crosslink dev ice 26 is locked in a rigid construct with bone screws 82 and 84 or other bone attachment devices 22 While bone screw 82 and bone screw S4 are both shown using coupler ! 07. it should be understood that in alternativ e embodiments coupler 107 may be absent from one or both of bone seiew 82 and bone screw 84 Ii is further contemplated that coupler 107 ma\ be used in alternative bone attachment devices 22 not illustrated in Fig 6
An alternative embodiment of crosslink apparatus 24 is shown in a side plan
Figure imgf000012_0001
in Fig 7 xs here certain hidden features are shown in phantom and where like numerals icfer to like features previous!) described Connector 52 of crosslink device 26 is shown connected to a bone attachment device 22 in the form of a laminar hook 1 16 Laminar hook 1 16 includes a hook portion 1 18 structured to engage bone or a bom surface and a proximal head or receiver portion 124 Receiver portion 124 further includes a receiving channel 126 formed by a pair of uptight arms 122 having internal threading 127 disposed therein An engaging member, such as engaging member 100. can be passed through, aperture 60 and engaged with threading 127 to create a rigid construct between connector 52 and laminar hook 1 1o and a rod or other elongate element positioned in receiving channel 126
Opposite hood i 16, another embodiment bone attachment device is shown Connector 54 is shown connected to a bone attachment dev ice 22 in the form of bone anchor 128 including a distal bone engaging portion 130 opposite a pro\imally extending post 132 Engaged about post 132 is a coupler clamp 134 including a receiver portion 136 Opposite the receiver portion 136 is a post engagement portion 138 including an aperture 141 through which post 132 extends Coupler clamp 134 further includes a rod interface washer 138 and a post interface washer 140 Disposed on the side of washer 138 and washer 140 facing each other are a set of inteidigi taring teeth 142 lmerdigi taring teeth 142 are structured to allow lockable positioning of washer 138 and washer 140 such that the angular orientation of rod 23 relative to bone anchor 128 may be altered However, once engaging member 100 is passed through aperture 60 and fulh engaged with a threaded aperture 144 disposed near receiver portion 136, interdigitating teeth 142 become locked as rod 23 is forced to bias the washers 138, 140 into contact with one another This occurs as threaded stem 102 presses against rod 23 forcing washers 138 and 140 together and pulling aperture 141 tight against post 132 to create a rigid construct between connector 54, rod 23, and bone anchor 128 Bone attachment devices 22 including bone anchor 128 and other forms are commercially available, for example, under the trade name TSR.H-3D® spinal systems.
In alternative embodiments crosslink apparatus 24 is free from both engaging members 100, KH and/or apertures 60 in connectors 52, 54. In these embodiments various means for connecting crosslink device 26 with bone attachment devices 22 are included. The means may include, but are not limited to, snap rings, nuts, pins, compression fits, snap fits, clamps, adhesives, and fusions. For example, engaging members 100, 101 are shown with externally threaded stems. Other embodiments contemplate engaging members 100, 101 with other structures for engaging receiver portion 32, including twist locks, snap fits, interference fits, slide-fits, clamps, expansion fits, and internally threaded stems, for example. As the connecting means change the corresponding structure of connector 52 and connector 54 will change In embodiments including rod 23 the manner in which rod 23 is secured to one or both of bone attachment devices 22 wθi also change.
The components of cross-link apparatus 24 can be composed of medical grade stainless steel. Other embodiments may be composed of, but are not limited to, titanium, a titanium alloy or other metallic alloy, and/or a nonrnetallie composition
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered illustrative and not restrictive in character, it being understood that only selected embodiments have been shown and described and that al! changes, equivalents, and modifications that come within the scope of the inventions described herein or defined by the following claims are desired to be protected. Any experiments, experimental examples, or experimental results provided herein are intended to be illustrative of the present invention and should not be construed to limit or restrict the invention scope Further, any theory, mechanism of operation, proof, or finding stated herein is meant to further enhance understanding of the present invention and is not intended to limit the present invention in any way to such theory, mechanism of operation, proof, or finding In reading the claims, words such as "a", "an" "at least on", and "at least a portion" are not intended Io limit the claims to only one item unless specifically stated to the contrary Further, when the language "at least a portion" and/ or "a portion" is used, the claims may include a portion and/or the entire item unless specifically stated to the contrary.

Claims

What is claimed is
! An apparatus, comprising two hone attachment deuces structured to anchor to bone, a crosslink device structured to interconnect the two bone attachments devices and adjustably span a distance separating the two bone attachment devices, the crosslink device including a first member including a first end portion and an opposite first connector including a bodv structured to engage a first one of the bone attachment devices and the first connector being pivotal reiaih e to the first member, a second member including a second end portion and an opposite second connector including a bodv structured to engage a second one of the bone attachment devices and the second connector being pivotal relative to the second member. an interconnection de\ice positioned between the first end portion and the second end portion to interconnect the first member and the second member together, and two engaging members, a first one of the engaging members being structured to engage the first connector and the first bone attachment dev ice when the first connector is aligned with the first one of the bone attachment devices to secure the first member thereto, and a second one of the engaging members being structured to engage the second connector and the second bone attachment de\ ice when the second connector is aligned with the second one of the bone attachment devices to secure the second member thereto
2 I he apparatus of claim 1 wherein at least one of the bone attachment devices includes a proximal receiver portion, the receiver portion including an internal threading and the engaging member engaging the reeeh er portion includes a threaded stem threadinglv, engaging the internal threading along the receiver portion
3 The apparatus of claim 2 wherein the engaging member engaging the receiver portion engages the respectiv e one of the first and second connectors to the receiver portion of the at least one bone attachment dcv ice 4 The apparatus of claim 1 wherein the bone attachment devices each include a bone engaging portion in the foim of a bone screw and a proximal receh er for engagement bv the engaging member, wherein the proximal receiver is pivotal re!ati\e to the bone screw
5 The apparatus of claim 1, wheieiπ one of the first member and the first connector includes a branch and the other of the in st member and the first connector includes a socket, the branch and socket being pϊvotalH coupled to one another, and one of the second member and the second connector includes a branch and the other of the second member and the second connector includes a socket, the branch and socket being photallv coupled to one another
6 The apparatus of claim 5 wherein each of the fust member and the second member includes a longitudinal axis and wherein each of the sockets includes an aperture therethrough, the aperture being transverse to the longitudinal axis of the first member and the second member
7 The apparatus of claim d wherein each of the fust connector and the second connector includes a longitudinal axis and wherein each of the branches includes an aperture therethrough, the aperture being transverse to the longitudinal axis of an adjacent one of the first connector and the second connector
S The apparatus of claim 7 further comprising a first pin and a second pin each structured to extend through the aperture of a respecth e one of the first connector and the second connector to couple the branch to the socket and pivotal!) secure the respectiv e first and second connector with the respective first and second member
9 The apparatus of claim 8 wherein the first pin and the second pin each permits pivotal rotation of the respective one of the first and second connectors relative to the respective first and second member
10 The apparatus of claim I wherein at least one of the two bone attachment
Figure imgf000016_0001
is a bone anchor including a distal bone engaging portion, a post extending proximally from the bone engaging portion, and a coupler clampingly engaged about the post
1 1 The apparatus of claim 1 wherein the interconnection device further includes a connector body defining a passageway to recehe the first member with an adjustable range of translations! and first rotational positions relative to the passageway and a stem to engage the second member with an adjustable range of second rotational positions relative to the stem and a fastener structured to fix the first member in the passageway at one of the transnational positions and one of the first rotational positions and to fix the second member relative to the stem at one of the second rotational positions when engaged to the stem.
12, The apparatus of claim 1 wherein the first connector and the second connector each define an aperture extending therethrough that is aligned with a receiver portion of the respective bone attachment device
13 The apparatus of claim 12 wherein each of the receiver portions of the bone attachment devices includes a channel and an elongate spinal stabilization element extending through the channel in a transverse orientation to the crosslink device, and each of the two engaging members extends through a respective one of the apertures and engages the aligned receiver portion to secure the elongate element in the receiver portion,
14 Hie apparatus of claim 13 wherein at least one of the receiver portions further comprises a coupler therein, the coupler defining a body with an external portion including threads for engaging the channel and an interior threaded portion for tbieadingly engaging the respective engaging member engaged to the receiver portion.
15 The apparatus of claim 12 wherein at least one of the receiver portions includes a coupler clamp engaged thereto, the coupler clamp including a threaded aperture and wherein at least one of the two engaging members includes a threaded fastener structured to extend through the aperture of the respective connector aligned with the at least one receiver portion to engage the threaded aperture of the coupler clamp and coupie the respective connector to the at least one receiver portion.
16, The apparatus of claim 1 wherein the first member and the second member adjustably attach to the two bone attachment devices over a range of angular orientations of the respective first and second member relative to the respective bone attachment device.
17. A method of using a multiaxial crosslink device comprising. affixing a first and second bone attachment device each to a corresponding desired skeletal location; providing a crosslink device including a first member with a first connector ptvotaily attached thereto and a second member with a second connector pivotally attached thereto, the first member and the second member being interconnected between the first connector and the second connector by an adjustable interconnection device; adjusting the crosslink device with the interconnection device to change translational position and angular orientation of the first member relative to the second [Tt em her; securing the first connector to the first bone attachment device; and securing the second connector to the second bone attachment device, S 8, Hie method of claim 17 wherein the first and second bone attachment devices each include a distal bone engaging portion and a proximal receiver portion, and securing the first connector and securing the second connector includes securing the first and second connectors to the receiver portion of the respective first and second bone attachment devices.
19 The method of claim 1 S further comprising positioning first and second elongate spinal stabilization elements in the receiver portion of respective ones of the first and second bone attachment devices and wherein securing the first and second connectors captures the first and second elongate elements in the respective receiver portions.
20. The method of claim 19 further comprising engaging the elongate spinal stabilization elements in the respective receiver portion with the respective first and second engaging member,
21. The method of claim 18 further comprising positioning first and second elongate spinal stabilization elements in the receiver portion of respective ones of the first and second bone attachment devices and securing the elongate spinal stabilization elements in the receiver portion with a coupler engaged to the receiver portion, and further wherein securing the first and second connectors include engaging respective ones of first and second engaging members to the coupler in the receiver portion of the respective bone attachment device,
22. The method of claim 18, wherein the receiver portion is pivotally and rotationally attached to a bone screw portion of each of the bone attachment devices. 23, The method of claim 17 wherein the desired skeletal location is one or several portions of the spinal column,
24. An apparatus comprising: a first bone attachment device including a receiver portion: a crosslink device including a first elongated member and a second elongated member and means for pivolaily coupling a first connector to an end of the first member, the crosslink device further including means remote from the end for adjustably connecting the first and second members to one another to permit axial and angular translation of the first member and the second member relative to one another; a first elongate spinal stabilization element extending through the receiver portion transversely to at least the first elongated member, and means for fixing the first connector, the first elongate spinal stabilization element, and the first bone attachment device together
25 Hie apparatus of claim 24 wherein the first bone attachment device is selected from the group consisting of: a bone screw, a laminar hook; and a bone anchor including a distal bone screw portion and a post extending proximal Iy from the bone screw portion.
26. The apparatus of claim 24 wherein means for pivotal Iy coupling a first connector to an end of the first member includes a branch extending from one of the connector and the first member and a socket defined by the other of the first member and the first connector, the branch being pivotaϋy coupled in the socket to allow pivoting of the first connector about a pivot axis relative to the first member
27. The apparatus of claim 24, wherein the crosslink device includes means for pivotally coupling a second connector to an end of the second member opposite to the first connector.
28. A method of using a crosslink device comprising attaching two bone attachment devices each to a respective desired location along the spine of a patient, the bone attachment devices each including a receiver portion: positioning each of two elongate spinal stabilization elements in the receiver portion of a different one of the bone attachment devices; providing a crosslink device to span from one of the bone attachment devices to another of the bone attachment devices, the crosslink device including two bridge [ C)
members and an interconnection device adjustably connecting the two bridge members together between the two bone attachment devices, each of the two bridge members including a connector pivotal Iy coupled thereto; adjusting transiational and rotational position of the two bridge members relative to one another with the interconnection device; adjusting the planar and angular position of each of the connectors relative to the bone attachment devices; and securing each respective one of the connectors of the bridge members to a different one of the bone attachment devices to fix the bone attachment devices, the elongate spinal stabilization elements, and the crosslink together in a construct
29 The method of claim 28 wherein each respective one of the bridge members is secured to a different one of the bone attachment devices by positioning a respective one of first and second engaging members through an aperture of the respective connector to engage the respective bone attachment device,
30 The method of claim 29 further comprising engaging a coupler to the receiver portion of each of the bone attachment devices to secure the respective elongate spinal stabilization element in the receiver portion thereof, and wherein the first and second engaging members are engaged to respective ones of the couplers to secure the bridge members to the respective bone attachment device.
31. The method of claim 29 wherein the first and second engaging members each contact the respective elongate spina! stabilization element in the receiver portion when engaged to the respective bone attachment device.
32. The method of claim 2C) wherein the connectors each contact the respective elongate spinal stabilization element when the bridge members are secured to the bone attachment devices
PCT/US2007/066212 2006-04-10 2007-04-09 Methods and devices for the interconnection of bone attachment devices WO2007121128A1 (en)

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WO2007121128B1 (en) 2008-01-24
KR20090007405A (en) 2009-01-16
US20070270808A1 (en) 2007-11-22
CN101426437A (en) 2009-05-06
JP5006926B2 (en) 2012-08-22
EP2004077A1 (en) 2008-12-24
US7837714B2 (en) 2010-11-23
JP2009533173A (en) 2009-09-17

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