WO2020047269A1 - Système polyaxial perfectionné et procédure chirurgicale - Google Patents

Système polyaxial perfectionné et procédure chirurgicale Download PDF

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Publication number
WO2020047269A1
WO2020047269A1 PCT/US2019/048833 US2019048833W WO2020047269A1 WO 2020047269 A1 WO2020047269 A1 WO 2020047269A1 US 2019048833 W US2019048833 W US 2019048833W WO 2020047269 A1 WO2020047269 A1 WO 2020047269A1
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WO
WIPO (PCT)
Prior art keywords
rod
spinal implant
locking
bearing
spinal
Prior art date
Application number
PCT/US2019/048833
Other languages
English (en)
Inventor
Marc Evan Richelsoph
Original Assignee
Marc Evan Richelsoph
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 Marc Evan Richelsoph filed Critical Marc Evan Richelsoph
Publication of WO2020047269A1 publication Critical patent/WO2020047269A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A61B17/7008—Longitudinal elements, e.g. rods with a cross-section which varies along its length with parts of, or attached to, the longitudinal elements, bearing against an outside of the screw or hook heads, e.g. nuts on threaded rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/704—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other the longitudinal element passing through a ball-joint in the screw head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter

Definitions

  • the present invention relates to spinal implant systems and surgical procedures for insertion of spinal implants.
  • the lumbar spine consists of multiple vertebrae that in a healthy spine are flexibly held within a general S curve. Each vertebra is a different size and different geometry.
  • the pedicles on each vertebra which are posts that extend from the vertebral body, vary in angle and distance apart from one vertebral body to the next. Therefore, each polyaxial screw sits at a different angle and height when inserted to the same depth into the pedicles.
  • a rod can be contoured or bent to meet the openings or saddles in the polyaxial screw, this is extremely difficult to do well. If the rod is not bent perfectly, one or more polyaxial screw saddles or openings will be below the rod in a multilevel construct. Securing the rod by normal set screws or other locking means will pull the polyaxial screw up to meet the rod, either distorting the spinal anatomy or weakening the bone interface. In certain situations, such as scoliosis, this can be a benefit to aid in realigning the spine. However, in general, it is preferred to have an ideal fit.
  • a key element of spinal surgery is the need for compression or distraction.
  • This allows a surgeon to compress vertebral bodies against an interbody, bone graft, or distract to allow an interbody or bone graft into the intervertebral space or restore proper disc height to remove pressure off of nerves.
  • Large compressor and distractor instruments are bulky, and do not provide accurate compression and distraction or tactile feedback. While a unique compressor and distractor instrument for a polyaxial plate-based system is described in Richelsoph et al., US Pat. Nos. 9,044,273 and 9,526,531, for a polyaxial screw system, a different and novel approach is needed to allow for a reduced polyaxial body size.
  • US Pat. No. 8,535,352 to Altarac, et al. discloses a spinal alignment system for interconnecting vertebral bodies that includes a bone screw polyaxially connected to a seat, the seat including a top opening, a first rod receiving portion and a second rod receiving portion, a first rod channel and a second rod channel.
  • the system is implanted into a first vertebral body.
  • a first rod is introduced to the seat through the top opening in a first orientation and connected to the first rod receiving portion.
  • a second rod is introduced to the seat through the top opening in a first orientation and connected to the second rod receiving portion.
  • the first and second rods are each moved into a second orientation such that the rods project through the first and second rod channels, respectively.
  • Altarac, et al. is very inefficient energy-wise due to the top opening of the seat. When the rods are inserted and any set screw is tightened, this will splay the arms of the seat. Alterac tries to compensate by using a set screw and bayonet concept, but this does not eliminate splaying and reduces the amount of contact area of the rods the set screw can apply load to. This will compromise the integrity of the implant body and not provide sufficient locking.
  • the design of Altarac, et al. further cannot work with compression and distraction procedures that treat more than two levels of the spine, or easily change out rods or implants in these two-level procedures.
  • the present invention provides for a spinal implant including a body operatively attached to a bone screw for attachment to a spine, wherein the body and bone screw are a single piece, a rod assembly comprising a rod within a rod retainer, and a locking nut received within a top portion of the body and exerting compressive force to lock the rod retainer against a spinal rod at a desired position.
  • the present invention also provides for a spinal implant assembly, including multiple spinal implants interconnected through rod assemblies.
  • the present invention provides for a method of using the spinal implant above, by inserting the spinal implant at a bone structure of a spine, receiving at least one rod into at least one bearing, and tightening the locking nut thereby exerting force against the bearings, and locking the position of the bearings.
  • the present invention provides for a spinal implant including a body having a bone screw for attachment to a spine, a module including at least one rod retainer retained within the module, a first locking screw rotatably attached to the module, a rod assembly received within at least one rod retainer, and a second locking screw received within a top portion of the body and exerting compressive force to lock the rod retainer against a spinal rod at a desired position.
  • the present invention provides for a spinal implant including a body having an opening to receive at least one axial bearing, at least one axial bearing for receiving a rod retainer within to provide polyaxial motion, a bone screw for attachment to a spine, at least one spinal rod, and a locking mechanism to lock said rod retainer against a spinal rod at a desired position.
  • the present invention provides for a spinal impla nt including a body including an insert for receiving bearings and receiving a bone screw for attachment to a spine, the insert having a wedge formed directly therein, a rod assembly comprising a rod within a rod retainer, and a locking mechanism to lock the rod retainer against a spinal rod at a desired position.
  • the present invention also provides for a method of using the spinal implant above, by inserting the spinal implant at a bone structure of a spine, receiving at least one rod into at least one bearing, tightening the locking nut thereby exerting force against the bearings, and driving inserts away from a center of the body with a wedge, moving bearings into seats, compressing at least one rod, and locking the position of the bearings.
  • the present invention further provides for a spinal implant including two rod receivers, whereby one rod receiver is open to receive a spinal rod and the second rod receiver is closed with a removable plug.
  • FIG. l is a view of a screw body
  • FIG. 2 is a view of a lock nut
  • FIG. 3 is a view of a load distributing plate
  • FIG. 4 is a view of a load distributing plate and locking nut
  • FIG. 5 is a view of a screw assembly
  • FIG. 6 is a view of a screw assembly with rod receivers and rods
  • FIG. 7 is an iso view of a locked assembly
  • FIG. 8 is a top iso view of a locked assembly
  • FIG. 9 is a view of a screw body assembly
  • FIG. 10 is a view of a screw body
  • FIG. 11 is a view of a screw body with instrument attachment
  • FIG. 12 is a section view of a screw body
  • FIG. 13 is a view of a spinal rod with rod retainers
  • FIG. 14 is a view of a spinal module
  • FIG. 15 is exploded view of a spinal module assembly
  • FIG. 16 is a section view of spinal module body
  • FIG. 17 is an iso view of an insert
  • FIG. 18 is a section view of an insert
  • FIG. 19 is an iso view of a rod retainer
  • FIG. 20 is a section view of a rod retainer
  • FIG. 21 is an iso view of a wedge component
  • FIG. 22 is an side view of a set screw
  • FIG. 23 is a section view of a set screw
  • FIG. 24 is a section view of a module assembly
  • FIG. 25 is a partial exploded view of a module and screw assembly
  • FIG. 26 is a view of a locked module and screw assembly
  • FIG. 27 is a view of a locked module and polyaxial screw assembly
  • FIG. 28 is an exploded view of a module and polyaxial screw assembly
  • FIG. 29 is a section view of a polyaxial screw assembly
  • FIG. 30 is an iso view of an insert
  • FIG. 31 is a top iso view of an insert
  • FIG. 32 is an iso view of a module assembly
  • FIG. 33 is a top iso view of a module assembly
  • FIG. 34 is a view of a monoaxial screw body
  • FIG. 35 is an iso view of a monoaxial screw body and module assembly
  • FIG. 36 is a side view of multiple screw body and module assemblies
  • FIG. 37 is an iso view of collet and wedge assembly
  • FIG. 38 is an iso view of collet and wedge assembly with spinal rods
  • FIG. 39 is a view of a polyaxial screw assembly and screw
  • FIG. 40 is a view of a polyaxial screw assembly with body and screw
  • FIG. 41 is an iso view of a lock nut
  • FIG. 42 is a side view of lock nut
  • FIG. 43 is a top iso view of a transverse connector and module
  • FIG. 44 is a top view of a transverse connector and module
  • FIG. 45 is a view of a screw body variation and collet
  • FIG. 46 is a view of a collet assembly
  • FIG. 47 is an exploded view of a collet assembly
  • FIG. 48 is an iso view of a monoaxial screw body and bearing assembly
  • FIG. 49 is an view of an axial bearing and rod retainer
  • FIG. 50 is a side iso view of rod retainer
  • FIG. 51 is a side iso view of an axial bearing
  • FIG. 52 is an iso view of an axial bearing and rod retainer variation
  • FIG. 53 is a section view of a variation of a body
  • FIG. 54 is a side view of a variation of a body with single set screw
  • FIG. 55 is a partially exploded view of an assembly
  • FIG. 56 is an exploded view of an assembly
  • FIG. 57 is a side iso view of load distributing plate;
  • FIG. 58 is a view of a screw body and assembly;
  • FIG. 59 is an exploded view of an assembly
  • FIG. 60 is a side view of an insert
  • FIG. 61 is an exploded partial section view of an insert
  • FIG. 62 is a view of a body
  • FIG. 63 is a view of a body, locknut, and dual insert assembly.
  • the invention provides a new implant system for adjusting to the anatomy of the spine and connecting two or more vertebral bodies securely that overcomes the mentioned disadvantages of the heretofore-known devices and methods of this genera l type and that provide such features by substantially departing from the conventional concepts and designs of the prior art, and in so doing allow simpler and more accurate connection of multiple spinal implants while providing a small overall size leading to less trauma to soft tissue.
  • the present invention provides for a spinal implant including a body having an insert received within a bottom portion of the body, the insert receiving a bone screw at a bottom portion for attachment to a spine, a rod assembly received within a rod slot on a side portion of the body wherein the rod slot does not extend through a top surface of the body, and a locking nut received within a top portion of the body and interlocking with a top portion of the insert.
  • the present invention also provides for a spinal implant assembly, including multiple spinal implants interconnected through rod assemblies, further described below.
  • One of the advantages of the present invention is that the body that is not split or extended through a top surface of the body (i.e.
  • the present invention generally provides for a spinal implant, including a partially flexible body with an opening for receiving a bone screw, a receiver for accepting a rod that pivots independently of the body, and a locking mechanism that compresses the partially flexible body against the at least one receiver to lock the assembly.
  • Relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions.
  • the terms "comprises,” “comprising,” or any other variation thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
  • An element proceeded by "comprises ... a" does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.
  • the advantages of the implant shown by general assembly are significant in the ability to allow for angulation of at least one rod without the need for a polyaxial screw interface.
  • the height of the assembly is extremely low, allowing for easier placement, and for pediatric deformity, reducing soft tissue issues often a problem with normal polyaxial screws.
  • the screw is always accessible through the locknut, allowing the screw to be moved up and down in the pedicle as needed to adjust assembly height. With two bearings adjustable within a large range and the ability to adjust assembly height, the surgeon has new tools at his disposal to treat complex pediatric deformity.
  • Figures 1 through 12 show an embodiment that incorporates the spherical bearing or bearings of the previous embodiments.
  • the body and bone screw are now one piece. This eliminates the body and screw head interface of previous embodiments and creates a rigid structure. While the bone screw portion could be made separately and attached to the body portion by mechanical or welding techniques, it would be preferred to machine the component from one single piece of material.
  • Body component 120 consists of a main body 120a having a lower surface 120b, upper surface 120c, and a bone screw threaded portion 120d for insertion into bone.
  • the bone screw has a tip 120e which can be provided with a cutting flute 120q to help start and cut threads in bone during insertion.
  • a neck portion 120f transitions the bone screw portion 120d to head portion 120a.
  • the upper threaded portion 120g of body 120 is an extension of threads 120h and is broken away after locking the assembly.
  • a notch 120r creates a stress riser to allow the upper threaded portion to be broken away at the desired location.
  • the body is shown here rounded 120j at the bottom to reduce impingement with bone and soft tissue, and can be a variety of shapes, as will be seen in the following figures.
  • Body 120 has two side faces 120U and 120V into which openings reach to seats 120k are created by machining.
  • Seats 120K are spherical and machining them in the desired location creates the opening.
  • a chamfer or radius 120m breaks a sharp edge where the sphere breaks through faces 120U and 120V.
  • this edge can be broken by a cylinder or a cylinder and chamfer combination.
  • a tapered, cylindrical, or combination of both extends up from the spherical seat and out of body 120.
  • This extension forms wall 120h. It is preferred that this feature be angled outward relative to the centerline of body 120.
  • the spherical seat 120K is connected to a cylinder and the cylinder is rotated about the spherical center away from the center line of the body. By rotating the taper or cylinder outward, the sphere can enter the seat while leaving material across the top of body 120 at the approximate location of breakoff tabs 120r. This creates an extremely rigid structure as well as a place for an optional central access threaded hole, which will be described further in Figure 8 and Figure 12.
  • An opening 120w exists between both bearings 86.
  • the locknut 130 has a top surface 130a, lower surface 130b, external diameter 130c, and threaded bore 130d. Grooves for connecting with a driving instrument create walls 130e and bottom wall 130f. A circumferential groove 130g cuts into the lower cylindrical section 130k.
  • a load distributing plate 140 has a top surface 140a, lower edges 140b, a first side 140c, and a second side 140d.
  • Tabs 140f are created by machining part of the plate away, leaving surface 140e. Tabs 140f fit within body 120, and more specifically, 120p. This configuration can of course be changed as long as compression of the bearings 86 can occur.
  • Surface 140g is rounded or shaped to match body 120.
  • Groove 140h is cut into the plate and leaves a ledge 140j and bottom surface 140k.
  • a small blend radius 140m reduces the stress riser at the bottom and top of the groove.
  • the cutout in the middle of the plate 140 creates at least one key 140n and a clearance portion 140p.
  • the key shape is designed to match the taper or cylindrical cutout 120n and the openings in the breakoff tabs 120r. It is important to maintain alignment so that tabs 140f are allowed to move smoothly into the body openings to compress spheres 86 during locking. Spherical seats 140q engage the spheres 86 during locking. A chamfer or radius 140r prevents sharp edges and increases angulation.
  • Locking nut 130 and load distribution plate 140 can be assembled together by engaging ledge 140j in locking nut groove 130g. Once engaged on threads 120c of body 120, the assembly will stay engaged. This allows locking nut 130 to move up and down while forcing load distributing plate 140 to move with it.
  • the assembly generally shown as 900 can be seen in Figure 5, whereby the locknut 130/ load sharing plate 140 assembly are placed over body threads 120c and the locknut 130 turned to engage the threads 120c. It is preferred to peen or otherwise slightly distort the top threads to keep the entire assembly as one piece for insertion in the body 120. This eliminates the need to place the locknut 130 as a separate component. Also this avoids any risk of cross threading.
  • FIG. 6 A shown in Figure 6, the assembly 900 is shown in the unlocked position. This allows the spherical bearings 86 with or without the rods 92 to enter from the sides and slid into seats 120k.
  • Figure 8 shows the central threaded hole of general assembly 900. As per a previous embodiment, this hole allows for access to the back of bearings 86. By engaging the back of the bearings 86, the bearings 86 can be straightened or held in a straight position. For deformity, this can allow for easy curve correction by use of a screwdriver to rotate a set screw to engage the back of the bearings 86 and force the bearings 86 to be straight, and/or provide supplemental locking for rod alignment.
  • Figures 9-11 show embodiment 900 with a different body shape. This is to show that the body 120 can be of any shape that fits the anatomy best.
  • the body 120 is partially spherical in this example.
  • an indentation 120x is provided to allow for an instrument to engage body 120. This allows for screw manipulation as well as an attachment point for a percutaneous guide tube.
  • a guide tube once attached, can pivot in at least one direction to allow the guide tubes to fit in close quarters and not run into each other.
  • a spherical seat 120y is provided for engagement with instrument shaft 150.
  • a chamfer 120z may also be provided to allow for additional angulation and break any sharp edges.
  • Instrument 150 with spherical end 150c, as shown in Figure 11, can then be engaged within seat 120y. With locknut 130 in the unlocked position, the spherical end 150c of instrument 150 is constrained within and can act as a guide for aid in aligning and inserting the implant.
  • Instrument 150 has a bore 150b that extends through the instrument. This allows for a screwdriver to extend through the bore to reach a set screw or align the implant for purposes of insertion. Of course, an external tube could also be used to aid in initial insertion.
  • an instrument such as 150 the screw always remains attached to a guide so that the locking nut can be found and engaged with a locking instrument.
  • Figure 12 shows a section view of general assembly 900. This helps to clarify that the cylinders or tapers that connect to spherical seat 120k are angled, which aids in leaving material and thickness in the middle of body 120. Note that pocket 120w is created such that the back of the bearings 86 are open to being accessed by threads 120t and related set screw. The screw and body are shown cannulated with a thru bore 120zz. This allows the entire implant assembly to be placed over a guide wire.
  • the assembly consists of at least one bearing 86 on one rod 92.
  • The can be connected by a snap ring and groove, a positive feature engaging within a negative feature, bayonet, or other attachment means.
  • the bearings can slide on the rod a set distance. This allows the length of rod and bearing assembly to cover more than one length while allowing for compression and distraction. This can easily be done by providing for a longer groove or feature that allows for sliding while retaining the bearing.
  • the bearing is flexible, it can have a feature that snaps into a groove that is wider than the snap feature, or a groove that snaps over a feature on the rod.
  • the benefits to general embodiment 900 include elimination of a lower spherical seat such as that found in regular polyaxial screws and better energy distribution. By eliminating the seat and moving the polyaxial capability to the rod, the height of the assembly is minimized. In addition, rather than using limited energy to lock three interfaces, there are now only two needed. There is also no risk of head splaying common in polyaxial screws that are top loading, which is also discussed in other embodiments shown herein. Angulation is also significantly increased, as each bearing now has as much angulation as most polyaxial screws. In addition, during scoliosis correction, the screw assembly can directly move the vertebral body. With a polyaxial assembly, the head pivots freely and can be a detriment to ideal correction.
  • the seat in the body be smaller in diameter than the bearing.
  • the load distribution plate and locknut force the bearing into the smaller seat, compressing the bearing around the rod and locking the rod and the bearing into the body and load distribution plate seats.
  • the tolerance stack of each component must be taken into account to be certain that locking can be done under least material conditions (LMC) and maximum material conditions (MMC).
  • the bearings have a surface finish or machined pattern, such as threading, that allows for some deformation to compensate for varying material conditions.
  • the body seat can also be tapered rather than spherical to compress the bearings. With the seat undersized relative to the bearing, there is a preferred lead in or tapered section to allow for the bearing and rod assembly to easily enter the body without interference when general assembly 900 is in the open and unlocked position.
  • breakoff tabs 120r allow the locknut 130 and load distribution plate 140 to be a single assembly with the body 120
  • the locknut 130 and load distribution plate 140 can be supplied as a separate item and placed separately over the breakoff tabs 120r in-vivo.
  • the nut plate assembly can be re-engaged with the remaining body threads.
  • body 120 can also be made without breakoff tabs 120r and the locknut 130 and/or load distribution plate 140 place separately with an instrument.
  • one opening in the body 120 can be left open, preferably with a plug to keep out tissue and debris. This would allow for easy additions as well as later revisions.
  • the ability to adjust angulation of the rods via a central access port is novel and provides further advantages.
  • the spine can be straightened in at least one plane, eliminating complex instrumentation and possibly providing a better result in a more incremental and gentle manner.
  • each implant can be adjusted one at a time, gently pulling the spine back into position.
  • the present invention therefore provides for a method of using the above spinal implant, by inserting the spinal implant at a bone structure of a spine, receiving at least one rod into at least one bearing, and tightening the locking nut thereby exerting force against the bearings, and locking the position of the bearings.
  • FIG. 14 through 24 general embodiment 1000 is shown.
  • This embodiment consists of a body component 160 having an upper surface 160a, a secondary surface 160b, a lower surface 160e, a first face 160c, and a second face 160d.
  • a recess 160h in body 160 leaves two higher surfaces 160f and 160g. It is preferred that the lower surfaces of 160f and 160g be rounded to avoid tissue impingement.
  • Features 160f and 160g in this embodiment extend all the way around the body to the back 160j, creating a uniform groove around the sides.
  • Retained within body 160 is at least one bearing 164, and preferably two.
  • Bearings 164 which are similar to the other bearings shown herein, but numbered here for clarity, have a spherical or partially spherical face 164a, a bore 164b, a front edge 164c, and at least one slot 164d.
  • a set screw 162 has a top surface 162a, external threads 162d, and external threads 162c. This fits within threads within a portion of the body 160.
  • a second locking screw 165 is free to rotate while preferably attached to the body 160 and is shown in more detail in later figures. As an assembly, the unit shown in Figure 14 is called a module.
  • FIG. 15 details the components of the module.
  • the body 160 has a round extension 160q extending from face 160b. Threads 160g extend partially into the body from surface 160a. These threads match external threads 162c of set screw 162.
  • Bearings 164 have a back edge 164f that face inwards towards the body 160 during assembly. While the bearings 164 can be sym metrical, they can have additional features that make the back of the bearing 164 different from the front.
  • Inserts 166 have a cylindrical outer surface 166a, a front face 166b, a back face 166c, and a slot 166e. In this embodiment, a groove 166d is cut into the top of insert 166.
  • the central pin 170 has a top surface 170, end 170b, a flat main section 170c, a ta pered section having tapered faces 170e and 170f extending from flat main section 170c to flat face 170g.
  • Section 170h is tapered from flat section 170c to end 170b.
  • the taper angles of section 170h and 170e/170f should preferably be equal.
  • This pin 170 can be of any shape capable of functioning, including rectangular, square or round.
  • Figure 16 shows a section view of body 160.
  • a radius is preferred between cylindrical section 160q and face 160b to avoid any stress risers.
  • an opening 160n in the bottom of the body allows for pin 170 to pass through the bottom to allow the pin to move deeper through the assembly. This hole may not be necessary in certain applications.
  • I nternal features of the body 160 include two spherical seats 160k, a central bore 160n, and chamfers 160m transitioning from bore 160n to spherical seats 160k.
  • the bore 160n is larger in diameter than the diameter of the spherical seat 160k.
  • Figures 17 and 18 show details of insert 166.
  • the insert 166 has a front face 166b, back face 166c, a bore 166p, and a spherical or partially spherical seat 166n.
  • a groove 166d is cut into back face 166c, creating edges 166h and 166j.
  • a chamfer or blend radii 166g is provided to allow the pin wedge faces to engage face 166d without catching a sharp edge.
  • Groove 166d can also be a single taper that matches or closely matches the taper angle of the pin tapered surfaces.
  • Radiused surface 166k also allows the pin to contact a smooth section of the insert 166, while radiused edge 166f avoids a sharp edge and makes insert 166 easier to insert in body 160.
  • bearing 164 can have additional features.
  • Bearing 164 has a surface 164a with grooves or a pattern machined into the surface, an internal bore 164 that extends partially through the sphere, and a smaller bore 164f that extends from back surface 164e, creating lip 164g.
  • a cylindrical extension 164h extends from the bearing. The edge of the cylinder 164h and face 164c is radiused or chamfered 164j on the inner edge.
  • Pin 170 is shown in Figure 21 in a rectangular shape. Sides 170m and 170n can be generally flat to fit within groove 166d in the inserts as well as to keep alignment of the inserts relative to the pin.
  • the round section 170k can also be grooved to have a retaining feature or ring to engage a feature in set screw 162. This allows the set screw to be attached to pin 170 while allowing the set screw to freely turn.
  • Figures 22 and 23 show set screw 162.
  • Driving feature 162d is shown as a pentalobe in Figure 23 in previous Figures. It can be any driving feature sufficient to take the torque required to lock the assembly. During machining, it is usual to drill a hole to create an initial opening to broach the driving feature. Doing so creates a chamfered feature 162g at the bottom of the hole.
  • a bore 162e extends at least partially into the set screw to allow pin section 170a to fit within.
  • the pin 170 and set screw 162 can be attached by a retaining ring and corresponding grooves, a swage of the top 170a of 170k, or other approaches.
  • Figure 24 shows the assembly or complete module 1000.
  • the inserts 164 are slotted to allow them to be compressed to fit through the openings in body 160 through faces 160c and 160d.
  • Bearings 164 are also compressible and inserted after the inserts 166. When fully inserted, the center of bearing 164 sits within bore 160n. As bore 160n is equal or larger than the bearing diameter, the bearing 164 can freely turn in the space provided and bore 164b is open and not com pressed such that it can accept a rod.
  • Pin 170 is placed such that pin fits within groove 166d on both 166 inserts. This can be done first before placing set screw 162, or the pin 170 can be attached to the set screw 162 first, as discussed above, and then inserted as an assembly.
  • the module 1000 is complete and ready to accept spinal rods.
  • the rods can be round or other shapes, such as rectangular or square and the opening in bearings 164 designed to match.
  • the threaded hole 160g is large enough to accept insert 164, then the insert can be inserted into the threaded hole and no slot 166e would be needed.
  • pin 170 acts as a wedge, driving inserts 166 away from the center and toward faces 160c and 160d of the body.
  • This in turn moves bearings 164 in the same direction, driving the bearings into seats 160k.
  • the bearings 164 With rods in the bearings 164, the bearings 164 are compressed into the seats while being compressed against the rod, providing positive locking of the rod and bearing at various angles.
  • This mechanism has numerous advantages and can be used in a variety of ways. As will also be seen, it is not necessary to use a spinal rod in both bearings 164, but one can be plugged to allow the addition of a spinal rod at a later date.
  • a monoaxial screw 172 is provided having a top surface 172a, tip 172b, bone threads 172c, external main section 172d, blend radius 172e, a first face 172f and second opposite face 172g.
  • An opening 172h with a radius 172j matches the module external dimensions with sufficient dimensions to allow the module to enter and seat within.
  • the module can be inserted with or without the rods in place until locking screw 165 contacts the top of threads 172k in monoaxial screw 172.
  • locking screw 165 is turned to engage the module within screw body 172. Once engaged and the rods inserted, the assembly can be locked. Locking screw 165 is tightened to a much lower load than a normal polyaxial screw, which avoids splaying of the arms of screw 172. Locking of set screw 162 locks the rod angulation and rod position.
  • FIGS 27 through 31 show how the module can be effectively used in a polyaxial screw.
  • a screw body 180 has a top surface 180a, bottom surface 180b, an external surface 180c, a chamfered or radiused section 180e, a threaded portion 180f, and a U-shaped slot 180g.
  • the module 160 fits within this slot.
  • a bone screw 1, with tip lb, threads If, neck le, and spherical head lc is also present.
  • Bone screw 1 also has a driving feature Id extending from top surface la.
  • Rods 4 with a cylindrical surface 4a are shown in the bearings 164, although they can be placed before or after insertion of the module in screw body 180.
  • Screw body 180 also contains an internal tapered section 180k extending from bottom surface 180b and pocket 180r.
  • Bone Screw Retainer 182 has an upper surface 182a, lower surface 182b, spherical seat 182g, a tapered or partially tapered external surface 182c and a cylindrical extension 182f.
  • the Bone Screw Retainer also has a central bore to allow a screw driver to fit through to access the bone screw driving feature Id.
  • FIG. 28 clarifies the polyaxial assembly.
  • the Bone Screw Retainer 182 has at least one slot 182d that allows the Bone Screw Retainer 182 to be compressed to fit within screw body 180 through the bore in face 180b. Once inserted, the Bone Screw Retainer 182 re-expands and stays in position. Recess 180r allows the Bone Screw Retainer 182 enough room to allow it to move up and expand outward to allow bone screw head lc to seat within spherical seat 182g.
  • the Bone Screw Retainer 182 has a hinge slot 182d and preferably some smaller slots 182m to allow increased flexibility and enhanced locking. Cylinder 182f creates a step 182j where it meets section 182k.
  • bone screw 1 is placed in the bone and the head 180, which includes the Bone Screw Retainer 182, is snapped over bone screw head lc.
  • Rods 4 can be inserted into the module or they can be inserted after placement.
  • the module with or without rod 4 or rods 4 is then inserted into head 180.
  • locking screw 165 is tightened, the bottom of the module pushes down on the Bone Screw Retainer 182, forcing taper 182c to be compressed against bone screw head lc, locking the module and angulation of head 180 relative to the bone screw.
  • the rods 4 can then be adjusted and then locked by turning set screw 162.
  • FIGS 32 and 33 show the module with additional features. While the internal mechanism is the same, the module has features to increase rigidity of the bone screw body, should it be necessary.
  • Body 161 has a top surface 161a, first face 161c, second face 161d, a groove 161h, lower face 161e, edges 161f and 161g, an extension 161m, preferably tapered leading to a cylindrical portion 161n.
  • two openings 160P can be cut through the top of the body that allow the arms of the U- shaped seat in a screw body to fit within.
  • a locking nut retention feature can be provided by providing a recess 161t, a lip 161r, and a flexible tab 160s to grab features on the lock nut to hold it in position so it is retained with the module.
  • a face 161q is created when machining the pocket for the locking nut.
  • Locking nut 163 has a top surface 163a, side surface 163b and internal driving feature 163c
  • Figure 34 shows a bone screw 184 and saddle with the top geometry to fit within openings 160p on module 161.
  • the bone screw 184 has a top surface 184a, a bone screw tip 184b, external surface 184d, which is radiused 184e or tapered at the bottom, and a neck portion 184f.
  • the bone screw 184 is threaded 184c with an appropriate thread for spinal fixation.
  • the upper portion of the saddle has a recess 184g that is small enough to fit within 161P of body 161. Threads 184h extend downward from top 184a and cut into sidewalls 184j.
  • the bottom of the saddle is preferably radiused 184k to maximize material and avoid stress risers.
  • the sides of the saddle 184m and 184n are cut to fit the recess in module 161, between edges 161f and 161g.
  • this geometry can apply to other embodiments herein.
  • a recess 184p can be provided to allow for clearance of pin 170 should it pass through opening 160n in body 160.
  • Figure 35 shoes an assembly with module 161 and bone screw and saddle 184.
  • the threads from locking nut 163 engage the threads 184h in the bone screw and saddle to lock the module 161 in position.
  • Set screw 162 is then tightened to lock rods 186 and bearing positions.
  • the rods 186 have ends 186a, a surface 186bm and features, such as grooves, teeth, or proud rings 186c to allow for better retention within the bearings.
  • the rods 186 can be inserted within the bearings 164 and retained therein while also allowing for compression and distraction without dislodging the rod 186.
  • Figure 36 shows how multiple assemblies can be connected by rods. While shown in a straight line, the bearings 164 allow for significant angulation and the assemblies can be connected at various angles. The key advantage as that each segment is independent, allowing long rods to be broken down into short segments. This allows a surgeon to start with a single level construct and add on levels as needed at the time of surgery or later at the time of revision. To add on later, it is preferred that the bearings 164 not in use be plugged to keep soft tissue and bone from blocking the opening(s). Plug 190 is designed to fit within the bearing 164 and block the opening. As an example, plug 190 has a first end 190a, a groove 190b, and a cylindrical portion 190c.
  • Groove 190b allows for easy grabbing and pulling of the plug.
  • the plug also fills the bore of the bearing, such that the bearing, even without a rod, can act as part of the locking of the assembly. As the assembly requires that pin 170 push against inserts 166, this provides balance without a rod and proper distribution of the locking loads.
  • FIGs 37 and 38 show a different variation of insert 166.
  • this embodiment has collets 167 that allow bearings 164 to fit within.
  • Collets 167 have a first face 167a back face 167b, a spherical or partially spherical seat 167c, a slot 167d, smaller optional slots 167e, a tapered surface 167f, and a cylindrical section 167g.
  • a groove 167h allows the pin and wedge of 170 to fit within.
  • Bearings 164 snap into collet 167 and the rods 4 slide into the bearings.
  • Body 160 or 161 would then have internal tapers instead of spherical seats 160k.
  • the wedging feature of pin 170 drives the collets outwards, compressing taper 167f, which compresses spherical seat 167 against bearing 164 and against rod 4, locking the assembly.
  • Figures 39 and 40 shows that the mechanism of inserts 166 or 167, bearings 164, pin 170, and set screw 162 can be readily adapted to and contained within other shapes.
  • a polyaxial screw allowing for pivot around a screw head is shown.
  • the body 210 is tapered on the outside It has an intermediary top surface 210a, lower surface 210b, tapered surface 210c, at least one long slot 219d to allow body 210 to open enough to accept bone screw 1 screw head lc.
  • Two extensions 210h and 210j allow for an extension of material from surface 210c to allow for proper location of the bearings and internal bearing seats. These extensions have faces 210f and 210g.
  • Body 210 has an upper surface 210a, lower surface 210b, and an optional taper or radius 212d.
  • the internal bore of body 210 is tapered, such that by pulling up on the body, taper 210c is compressed against bone screw head lc, thereby locking the bone screw angle.
  • turning locking screw 165 draws body 212 upwards.
  • locking screw 165 can be eliminated and the body drawn up with in instrument. Final locking of bearings 164 with the rods is done by turning set screw 162.
  • FIG 41 shows more detail of locking screw 165.
  • Locking screw 165 has a top surface 165a, bottom surface 165b, internal bore 165cm external thread 165d, two or more recesses 165e, which create driving edges 165f and 165g.
  • a groove 165h can be provided to accept a snap ring or other feature to allow locking screw 165 to be retained on body 160.
  • Locking screw 169 has a top surface 169a, lower surface 169b, an internal bore 169c, external thread 169d, at least two recesses 169e, which create driving faces 169f and 169g, and external diameter 169h, lip edge 169k, and a groove 189j running above thread 169d below edge 169k. This groove allows a feature on body 161 to hold and retain the locking screw 169 on the body.
  • Figures 43 and 44 show the versatility of the module by adapting the module to a rod to rod connector. Anywhere that polyaxial connection is needed, the module can be adapted.
  • Connector ends 195 are adapted to fit within bearings 164 and fit over rods 4. As the bearings 164 allow for full angular rotation, rods at various angles can be easily connected. Ends 195b can be snapped over the rods, secured with set screws or built in clamps, or any other connection approach.
  • the invention shown in Figures 14-42 provide for a way of eliminating a long rod for spine fixation and replacing it with singular sections that can be attached and added to as needed.
  • the modules can be pre attached to rods, creating a polyaxial connector and inserted into the heads connected to the bone screws as an assembly.
  • the modules can also be implanted by inserting one rod in one side and, placing one module down in a screw head opening, such as 184j, and connecting the rod by pushing into the bearing.
  • the module can come with both bearings open or with one open and the other with a plug, such as 190, to allow for later additions.
  • a single level fusion using two modules can be supplied with two modules having one open bearing each and one plug each.
  • set screw 162 is loosened, the bearing pushed in slightly to loosen it, the plug removed, the rod inserted, and set screw 162 re-tightened.
  • the surfaces of the pin are designed in the shape of a wedge. This allows the mechanics of a simple machine to allow for enhanced loading of both sides (insert and bearing) of the module.
  • the angle of the wedge should be as acute as possible, as the mechanical advantage of a wedge is calculated by dividing the height of the wedge by the wedge width.
  • the maximum load advantage can be gained. This is important, as the bearings must be rigidly locked for most procedures, such as curve correction in pediatric and adult deformity.
  • the internal pin or wedge 170 can be in a different shape.
  • the wedge 406 is now a multi-armed wedge, having top surface 406a, an intermediate flat surface 406b, a cylindrical portion 406d, an external portion 406e, two wedge shaped sections 406f formed with angled faces 406g, and preferably with a central guide piece 406j. While this example shows an internal thread 406c for easy removal of the wedge by inserting a threaded screw or instrument down the middle to push wedge 406 up as it is threaded into wedge 406 or allow wedge 406 to be retained on an instrument, this thread is optional.
  • a groove in 406d can retain a retaining ring that would fit in a groove within locking set screw 401, thus allowing wedge 406 to be able to rotate while allowing wedge 406 to be moved upwards or downwards as set screw 401 is turned.
  • Set screw 401 consists of a top surface 401a, bottom surface 401b, an external thread 401c, and a driving feature 401d to engage the end of an instrument.
  • Wedge 406 fits within body 402.
  • Body 402 consists of an external surface 402a, which can be cylindrical or another shape, a lower surface 402b, and an upper surface 402c.
  • the bone screw 402d is one piece with body 402 and has bone threads 402d and tip 402f. It is also possible to include a polyaxial screw and seat, as shown in previous examples herein, such that the screw can pivot independently of body 402. For this to work, body 402 would be taller and allow the inner assembly to be compressed downward to compress and lock a polyaxial screw seat.
  • Component 404 is a dual taper collet consisting of a central generally cylindrical section 404a, having a first tapered section 404d flaring outward to end 404b, a second tapered section 404c, flaring outward to end 404p, and slots 404e, which allow for the collet to be somewhat flexible. Radii 404f blend the junction between tapers 404b and 404c to cylindrical section 404a to avoid any stress risers. Two spherical or partially spherical seats 404g are machined into each end of dual collet 404. A groove 404j allows for wedge portion 406j to slide within, and flats 404k allow for clearance for the inside of wedge 406.
  • Dual locking rings 408 have an external surface 408a, first face 408b, tapered face 408c, a second face 408d, and an internal tapered surface 408e. While an alignment hole 408g allows for a small pin to be inserted and the locking ring aligned to the dual taper collet via one of slots 404e, this feature can also be machined into the locking ring. In the unlocked position, as shown in Figure 46, the locking rings are towards the center and not engaging the tapers.
  • wedge faces 406g press against faces 408c, driving the locking rings outward, thereby forcing the tapers on the collet and locking rings to engage, thereby compressing the collet tapers inward to compress and lock the spherical bearings 164 in the desired orientation.
  • spinal rods are not shown, but would be placed within the bearing opening 164b, such that compression against the bearing also locks the rod to the bearing simultaneously.
  • the central wedge portion 406j helps to keep the load to each side of the dual collet even. This feature can be removed and the assembly will lock, just not as efficiently.
  • set screw 401 By tightening set screw 401, the set screw exerts force against wedge 406, which in turn forces locking rings 408 to be pushed outwards, creating the locking force necessary to lock the spherical bearings and rods in position. Should only one side need a rod, the other side can use a plug or short piece of rod to keep the bearing opening clean and being filled with debris or tissue.
  • FIG. 48 through 51 a different embodiment generally shown as 450 still allows for two rods to be attached independently, but in a different way.
  • a body 452 has an external surface 452a, a first face 452b, opposite face 452c, a top face 452d, lower face 452e, an attached bone screw 452f with screw tip 452g.
  • Two set screws 454 provide independent locking of each side.
  • the screw screws have a top surface 454a, a driving feature 454b, and threads 454c.
  • Axial bearing 456 allows for rotation in a single plane and consists of a cylindrical outer surface 456a, a first side 456b, a second side 456c, a front face 456d, slots 456e, a radiused and conical opening 456f, a thru hole 456g, which creates a side wall 456h.
  • a spherical seat 456j is machined into the axial bearing 456.
  • Seat 456J can also be non-spherical and include sharp edges or teeth to create mechanical interference. Of course, this component, along with others, can be 3d printed rather than machined.
  • Bearing 460 consists of a front face 460a, a bore 460b, an external partially spherical surface 460c, at least one partial slot 460d and/or through slot 460s, a cylindrical extension 460e on both sides of the bearing, with a chamfered or tapered face 460f, and a back face 460g.
  • a cylindrical extension 460h blends into surface 460c with a radius 460k.
  • bearing 460 when bearing 460 is placed within axial bearing 456, the cylindrical extensions 460e fit within axial bearing holes 456g. This, bearing 460 can only rotate towards faces 456b and 456c, which the axial bearing can rotate around its central axis. This combined motion is multidirectional or polyaxial.
  • the screws When fit within body 452, the screws can compress a locking plate 458 against the axial bearing, which compresses the axial bearing against bearing 460 and a spinal rod within 460b, locking the assembly. While plate 458 may be omitted, plate 458 helps to distribute the load from the set screw more evenly to the bearing assembly.
  • plate 458 and the surface of axial bearing 456 can be splined to create mechanical locking in addition to frictional locking.
  • the surface of bearing 460 can be textured, such as shown with bearing 164.
  • Figure 52 shows a variation of the axial bearing and bearing assembly. Rather than cylindrical extensions 460e from bearing surface 460c, two flats 464f engage two flats 462g in axial bearing 462, which control and restrict rotation of bearing 464 in a similar manner.
  • This version is easier to machine and allows for a more uniform surface texture of bearing 464, which can be similar to bearing 164.
  • Bearing 464 consists of a spherical or partially spherical surface 464a, a front surface 464b, a bore 464c for accepting a rod or plug, a cylindrical or other shape extension 464d, a blend radius 464e, at least one flat 464f, and a blend radius 464g.
  • the axial bearing 462 consists of an external surface 462a that can be smooth or textured, such as splined, a first side 462b, second side 462c, a front face 462d, at least one slot 462e, a conical opening and blend radius 462f, flat 462g, a spherical seat 462h, and external blend radius 462j.
  • Figure 53 shows a section view of body 452.
  • a seat and pocket for at least one axial bearing is machined or formed into the body.
  • a lower surface 452j is contoured to match the axial bearing and lip 452 is rounded 452h and extends higher than the lowest point of surface 452j, to prevent the axial bearing from coming out of the assembly.
  • the pocket has sides 452k and a blend radius 452m to avoid stress risers.
  • a thin web 452q can remain between the axial bearings or be machined away.
  • a blend radius 452n between the screw shank and the base 452e of body 452 reduces stress risers.
  • the bottom seat 452j can be splined or machined as an insert, much like locking plate 458.
  • twin threaded holes 452p are provided to allow for a set screw to lock each side independently. As shown in Figure 54, this twin set screw approach can be replaced by a single threaded hole 452t in body 452. A set screw 470 with a top surface 470a, bottom surface 470b, threads 470c, and driver feature 470d would then be used to lock both sides simultaneously.
  • Figures 55 and 56 generally shown by 450b, show the same basic geometry as 129; however, the monoaxial screw is replaced by a polyaxial screw and cap.
  • the polyaxial screw 499 has a top surface 499a, a threaded portion 499b, a tip 499c, a spherical or partially spherical section 499d, a driving feature 499e, and a chamfer 499f.
  • a cap 498 as a top edge 498a, bottom surface 498b, an external surface 498c, an inner spherical seat 498d, and chamfers or radius cut outs 498e.
  • Figure 57 provides for a general view of locking plate 458.
  • Locking plate 458 has a top surface 458a, a lower surface 458b, a curvate surface 458c, a back edge 458d, a front surface 458e, a first side 458f, a second side 458h, and a front blend radius 458g.
  • Curvate surface 458c and be smooth, textured, or splined to provide different locking conditions for different situations.
  • Figure 58 is a slightly different embodiment where one side of the body has an opening to accept the end of straight spinal without angulation.
  • a long rod construct could end within the body, leaving the angle adjusting opening for a later addition.
  • this could be used in reverse, whereby the angle adjusting end is attached to the end of the spinal construct and the fixed rod opening remains open for later additions.
  • the body 494 has an top face 494a, bottom face 494b, a first face 494b having an opening to accept an axial bearing 456, a second face 494c with an opening 494e to accept a spinal rod or plug, external surface 494j, and a bone screw 494f with top 494g.
  • This embodiment can use two set screws or one, as shown previously, and use a fixed bone screw one piece with body 494 or be polyaxial with a separate bone screw.
  • FIG. 48-58 The embodiments shown in Figures 48-58 have a unique ability. It is possible to lock one plane of motion and leave the other unlocked.
  • the surface area of the axial bearings 456 and 462 is much greater than bearing 460 or 464. Exerting force against the surface will tend to lock the axial bearing more rigidly than the spherical or partially spherical bearing, at least until full force and full locking is achieved.
  • the splines can engage with minimal force exerted against spherical bearing 460 or 464.
  • angulation can be locked in one plane, while the bearing angulation can remain unlocked until full locking force is applied.
  • anterior-posterior angulation of the spinal rods can be locked first.
  • the natural Anterior-Posterior spinal curve can be created first and then the surgeon can focus on the medial-lateral plane. It is possible to alter the configuration and turn the axial bearings ninety degrees and lock the medial-lateral angulation first and then follow by locking the anterior-posterior angulation.
  • the geometry for the assembly would change to maintain top locking but can be done by either rotating the locking features or altering the surface of the axial bearing to be tapered, such as that as it is forced downwards, compression against the axial surface locks the axial surface first and then the spherical bearing, with or without splines.
  • General assembly 700 shows a different embodiment of an alternative way to lock bearing angulation.
  • Figures 59-63 show an insert 702 that has a wedge 702e machined or formed directly into the insert. Looking at insert 702 first, it has a first side 702a and second side 702b, top surface 702d, bottom surface 702c, two extensions 702e that extend outward from faces 702a and 702b, an angular face 702f cut into extensions 702e, and a back face 702g.
  • a feature 702h allows for clearance based on geometry of body 704. This feature geometry may vary or be absent depending on the geometry of body 704.
  • Body 704 has an external surface 704a, a front face 704b, back face 704c, two openings 704d having a front angular face 704e, a bone screw 704f, and screw tip 704g. I n this example, bone screw 704f is machined in one piece with the remainder of the body. This creates a very low-profile assembly. Of course, it is possible to add in a polyaxial screw and locking mechanism, if preferred.
  • a threaded central stud 704h allows for a single lock nut to lock both sides.
  • a lock nut 706 has a top surface 706a, bottom surface 706b, external surface 706c, slots or driving features 706d, and a blend radius 706e to remove any sharp corners.
  • I nsert 702 has internal features for locking the angulation of spherical bearing 164 and compressing it against a spinal rod held within bore 164b of bearing 164.
  • Surface 704j is a spherically shaped surface that is smaller in diameter than the external surface of bearing 164.
  • a cylindrical opening 702k extending inwards from back 702g is equal to or greater than the external diameter of bearing 164.
  • a transition taper or blend radius allows for a smooth transition between the diameter of spherical surface 702j and cylindrical opening 702k.
  • a front chamfer 702n allows for clearance and angulation of the front of bearing 164. It is preferred that a small cylindrical surface 702p remain between chamfer 702n and spherical surface 702j to allow for easier measuring of the opening diameter and features. Of course, this can be absent, if needed.
  • 702j can be of other shapes or have sharp features to create a mechanical bite into spherical bearing 164.
  • a locking cap 708 has an external surface 708a, a front edge 708bm a back face 708c, and a spherical front face 708d.
  • a cut out 708f can be provided if needed to clear the geometry of the body, in this case central threaded stud 704h.
  • Figure 63 shows the entire assembly generally shown as 700 set up to receive two spinal rods. As the nut is tightened, the inserts are drive inwards, locking the assembly.
  • the present invention also provides for a method of using the spinal implant above, by inserting the spinal implant at a bone structure of a spine, receiving at least one rod into at least one bearing, tightening the locking nut thereby exerting force against the bearings, and driving inserts away from a center of the body with a wedge, moving bearings into seats, compressing at least one rod, and locking the position of the bearings.
  • derotation involves bending a long rod into an approximate proper spinal curve, connecting it to spinal implants, and rotating the rod 90 degrees, thereby acting as a cam to force the spine into alignment. This is effective.
  • derotation involves bending a long rod into an approximate proper spinal curve, connecting it to spinal implants, and rotating the rod 90 degrees, thereby acting as a cam to force the spine into alignment. This is effective.
  • issues First, it is challenging and requires a long incision. Secondly, it induces high amounts of stress on the body during derotation. Third, the instrumentation to accomplish the task is expensive and is not designed to do partial adjustments. Fourth, the surgeon has to commit to longer constructs then might be necessary, thereby fusing vertebrae that might not need to be fused.
  • the ability to add rods one at a time and add in levels or vertebrae as needed changes the treatment option. This allows the surgeon to treat the apex of the curve and straighten it to see what levels actually need to be fused. Additional levels can be added one at a time until the desired result is achieved.
  • one bearing can be left open to provide a simple attachment mechanism to add more implants to at a later surgery. This is often challenging and time consuming with other implant systems, as add on components are necessary or complete removal of implants are required.
  • each level can be adjusted one at a time with simple instrumentation. This eliminates complex instrumentation and possibly providing a better result in a more incremental and gentle manner. Rather than adjust all levels at one, each implant and rod construct can be adjusted one at a time, gently pulling the spine back into position.
  • Ti-6AI-4V ELI bone screws with a machined tooth pattern on the head works well.
  • Other titaniums and titanium alloys can also be used. While stainless steel and other materials, such as polymers, can be used, they are less preferred.
  • Surface roughness on the screw head and/or screw head seat can be applied in a number of ways, including machining, chemical etching, grit blasting, or other means. It is preferable to provide a machined feature on the screw head which creates small grooves around the surface. While this can be done as individual circular grooves, the machined pattern can be run in a helix, effectively creating a shallow thread over the spherical surface. It is preferable to create the surface over the entire spherical area to be certain that rotation of the bone screw head in the insert or collet seat still maintains engagement of the surface roughness pattern regardless of the angulation.
  • the present invention provides for a spinal implant assembly including a first spinal implant having at least one side opening and at least one bearing for receiving a spinal rod to a specific or maximum depth, a second spinal implant having at least one side opening and at least one bearing for receiving a spinal rod to a specific or maximum depth, and a rod that can be inserted through the side opening and bearing of the first spinal implant and connected to the second spinal implant by inserting the rod through the side opening and into the bearing of the second spinal implant.
  • the present invention also provides for a spinal implant assembly including a first spinal implant having two bearings for receiving spinal rods and a second spinal implant having at least one bearing for receiving a spinal rod such that when the first spinal implant and the second spinal implant are implanted, at least one bearing remains open for adding on an additional rod and spinal implant.
  • the present invention also provides for a method of using the spinal implant shown in Figure 25, whereby the bone screw with saddle 172 is inserted into the spine, the module inserted into the saddle, and additional bone screws and modules connected with rods as needed.
  • the present invention also provides for a method for expanding a construct at the time of surgery or a later revision by having an open receiver to accept an additional rod.
  • the present invention also provides for a spinal implant including two rod receivers, whereby one rod receiver is open to receive a spinal rod and the second rod receiver is closed with a removable plug.

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Abstract

L'invention concerne un implant rachidien comprenant un corps fixé de manière fonctionnelle à une vis à os pour une fixation à une colonne vertébrale, le corps et la vis à os étant monobloc, un ensemble tige comportant une tige à l'intérieur d'un dispositif de retenue de tige, et un écrou de blocage reçu à l'intérieur d'une partie supérieure du corps et exerçant une force de compression pour bloquer le dispositif de retenue de tige contre une tige vertébrale à une position souhaitée. L'invention concerne également un ensemble implants rachidiens, comprenant plusieurs implants rachidiens reliés entre eux par l'intermédiaire d'ensembles tiges. L'invention concerne encore des méthodes d'utilisation de cet implant rachidien. Un implant rachidien comprend deux récepteurs de tige, un récepteur de tige étant ouvert pour recevoir une tige rachidienne et le second récepteur de tige étant fermé par un bouchon amovible.
PCT/US2019/048833 2018-08-29 2019-08-29 Système polyaxial perfectionné et procédure chirurgicale WO2020047269A1 (fr)

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