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WO2025093995A1 - Adjustable spinal screw assembly - Google Patents

Adjustable spinal screw assembly Download PDF

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Publication number
WO2025093995A1
WO2025093995A1 PCT/IB2024/060409 IB2024060409W WO2025093995A1 WO 2025093995 A1 WO2025093995 A1 WO 2025093995A1 IB 2024060409 W IB2024060409 W IB 2024060409W WO 2025093995 A1 WO2025093995 A1 WO 2025093995A1
Authority
WO
WIPO (PCT)
Prior art keywords
opening
screw
connector
crown
connector body
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/IB2024/060409
Other languages
French (fr)
Inventor
William Allen REZACH
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Warsaw Orthopedic Inc
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
Publication of WO2025093995A1 publication Critical patent/WO2025093995A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • 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 or setting implements
    • 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, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped

Definitions

  • the present disclosure relates to a spinal screw assembly that supports a spinal rod for use in a spinal procedure.
  • spinal disorders such as degenerative disc disease, disc herniations, scoliosis or other curvature abnormalities, and fractures
  • implants may be used to preserve motion between vertebral members.
  • Surgical treatment typically involves the use of longitudinal members, such as spinal rods.
  • Spinal rods may be attached to the exterior of two or more vertebral members to assist with the treatment of a spinal disorder.
  • Spinal rods may provide a stable, rigid column that helps bones to fuse, and may redirect stresses over a wider area away from a damaged or defective region.
  • rigid spinal rods may help in spinal alignment.
  • an adjustable spinal screw assembly includes a screw, a connector body, a crown, and an eccentric base connector.
  • the screw has a threaded body that defines a screw axis and has an at least partially rounded head.
  • the connector body has a base opening, at least two side walls extending from the base opening, and a middle portion therebetween. The at least two side walls are spaced apart to form a support recess opening defining a central axis.
  • the crown is positioned in the middle portion of the connector body.
  • the crown has an end sized to receive the at least partially rounded head of the screw.
  • the eccentric base connector is disposed in the base opening.
  • the eccentric base connector has a first opening sized to receive the at least partially rounded head of the screw and a second opening sized to receive the crown. The first opening is eccentrically positioned on the eccentric base connector.
  • an adjustable spinal screw assembly includes a screw, a connector body, a crown, and an eccentric base.
  • the screw has a threaded body that defines a screw axis and has an at least partially rounded head.
  • the connector body has a base opening, at least two side walls extending from the base opening, and a middle portion therebetween. The at least two side walls are spaced apart to form a support recess opening defining a central axis.
  • the base opening, the middle portion, and the support recess opening are concentric.
  • the crown is positioned in the middle portion of the connector body.
  • the crown has an end sized to receive the at least partially rounded head of the screw.
  • the eccentric base connector is disposed in the base opening.
  • the eccentric base connector has a first opening sized to receive the at least partially rounded head of the screw and a second opening sized to receive the crown.
  • the first opening and the support recess opening are nonconcentric.
  • the method also includes moving the connector body in a downward direction until the at least partially rounded head of the screw is received in a first opening of the eccentric bas connector.
  • the method also includes rotating the connector body relative to the screw.
  • the method also includes moving the crown in a downward direction onto the at least partially rounded head of the screw until the at least partially rounded head is received in a first end of the crown.
  • FIG. 1A illustrates a perspective view of the spinal screw assembly, according to some aspects of the present disclosure.
  • FIG. IB illustrates a perspective view of the spinal screw assembly of FIG. 1A rotated in a first transversal direction.
  • FIG. 1C illustrates a perspective view of the spinal screw assembly of FIG. 1A rotated in a second transversal direction.
  • FIG. 2A illustrates a front view of the spinal screw assembly of FIG. 1 A offset in a first direction.
  • FIG. 2B illustrates a front view of the spinal screw assembly of FIG. 1A offset in a second direction.
  • FIG. 3 illustrates a front exploded view of the spinal screw assembly of FIG. 1A.
  • FIG. 4 illustrates a top view of the spinal screw assembly of FIG. 1A.
  • FIG. 5 illustrates a perspective view of the connector body of the spinal screw assembly of FIG. 1A.
  • FIG. 6 illustrates a section view of the connector body of FIG. 5 taken along the line 6—6.
  • FIG. 7 illustrates a perspective view of the eccentric base of the spinal screw assembly of FIG. 1A.
  • FIG. 8 illustrates a top view of the eccentric base of FIG. 7.
  • FIG. 9 illustrates a side view of the eccentric base of FIG. 7.
  • FIG. 10 illustrates a section view of the eccentric base of FIG. 7 taken along the line 10—10.
  • FIG. 11 illustrates a side view of the eccentric base of FIG. 7 coupled to a crown in the unlocked position.
  • FIG. 12 illustrates a section view of the eccentric base and the crown of FIG. 11 taken along the line 12—12.
  • FIG. 13 illustrates a side perspective view of the eccentric base of FIG. 7 coupled to a crown in the locked position.
  • FIG. 14 illustrates a section view of the eccentric base and the crown of the FIG. 13 perspective view taken along the line 14—14.
  • FIG. 15 illustrates a partial section view of the spinal screw assembly of FIG. 2A in the unlocked position taken along the line 15—15.
  • FIG. 16 illustrates a partial section view of the spinal screw assembly of FIG. 2B in the locked position taken along the line 16—16.
  • FIG. 17 illustrates a method of installing a spinal screw assembly, according to some aspects of the present disclosure.
  • FIG. 18 illustrates a method of manufacturing a spinal screw assembly, according to some aspects of the present disclosure.
  • the components of the spinal screw assembly 10 described herein can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone material.
  • biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone material.
  • materials include, but are not limited to, a titanium alloy (e.g., Ti-6A1-4V), pure titanium, cobalt-chromium (CoCr), and polyether ether ketone (PEEK).
  • a rod is used to align vertebrates of the spine.
  • the rod is connected to the vertebrates or other anatomical structures by a spinal screw assembly having a connector body and a screw.
  • the screw is inserted into the vertebrates and is manipulated to correct the spine.
  • the connector body supports at least one end of the rod, and the other end of the rod may be connected to a second spinal screw assembly to align the spine.
  • the screw in the spinal screw assembly may be semi-rigid in the sagittal plane but may be able to flex in the coronal plane to ease the placement of the rods and spinal screw assemblies during the spinal procedures. Additionally, in complex spinal procedures, the vertebrates may be deformed or rotated.
  • FIGS. 1A-1C a spinal screw assembly 10 is illustrated according to some aspects of the present disclosure.
  • the spinal screw assembly 10 can support a rod 14 that might extend along the length of at least a portion of a spine.
  • the spinal screw assembly 10 includes a screw 18 that is inserted into the spine and a connector body 22 that connects the rod 14 to the screw 18.
  • the spinal screw assembly 10 is multi-axial in all positions.
  • the spinal screw assembly 10 may pivot about the connector body 22 in a conical direction.
  • FIGS. IB and 1C illustrate the spinal screw assembly 10 flexed in the coronal plane in a first direction and flexed in a second, opposite direction.
  • FIGS. 1A-1C depict the spinal screw 10 in three different axial positions, additional multi-axial positions are contemplated.
  • FIGS. 2A and 2B illustrate the spinal screw assembly 10 translated in a first medial direction and translated in a second medial direction.
  • the screw 18 is offset from the connector body 22. More specifically, a central axis 62 of the connector body 22 is offset from a screw axis 50 of the screw 18. The offset amount can be adjusted such that the spinal screw assembly 10 is an adjustable spinal screw assembly.
  • the screw 18 includes a first end 36 having a pointed tip that is inserted into the spine during a spinal procedure.
  • FIG. 3 illustrates additional detail of the spinal screw assembly 10.
  • the spinal screw assembly 10 includes the screw 18, the connector body 22, a crown 26, and an eccentric base connector 30.
  • the screw 18 includes the first end 36, a second end 40, and a body 44 extending between the first end 36 and the second end 40.
  • the pointed tip of the first end 36 is inserted into the spine during a spinal procedure.
  • the second end 40 defines an at least partially rounded head.
  • the second end 40 is received in the connector body 22.
  • the body 44 is a threaded body and defines the screw axis 50 (FIG. 2A).
  • the screw 18 can be formed from Ti-6al-4V, though other biologically acceptable materials are also contemplated.
  • FIG. 4 depicts an exemplary top view of the spinal screw assembly 10, such as the spinal screw assembly illustrated in FIG. 1A to 3, including showing the offset between the screw axis 50 and the central axis 62.
  • FIGS. 5-6 illustrate the connector body 22.
  • the connector body 22 connects the rod 14 (FIGS. 1A to 1C) to the screw 18 (FIGS. 1A to 3).
  • the connector body 22 can be formed from CoCr, though other biologically acceptable materials are also contemplated.
  • the connector body 22 is generally U-shaped in the illustrated embodiment.
  • the connector body 22 may include a base 34, a middle portion 38, a first side wall 42, and a second side wall 46.
  • the base 34 includes a base opening 52 that is sized to receive the eccentric base connector 30.
  • the middle portion 38 is positioned between the base 34 and the first and second side walls 42, 46.
  • the middle portion 38 includes a middle opening 54 that is at least sized to fit the crown 26 (see FIG. 3).
  • the middle opening 54 has a diameter that is greater than the diameter of the crown 26.
  • the middle opening 54 has a diameter that allows crown 26 and eccentric base connector 30 to rotate 360 degrees.
  • the first side wall 42 and the second side wall 46 extend upwardly from the base 34.
  • the first and second side walls 42, 46 are spaced apart to form a central opening 58 (e.g., a support recess opening).
  • the central opening 58 is sized to receive a threaded fastener to secure the rod 14 to the connector body 22.
  • the central opening 58 defines a central axis 62.
  • the middle opening 54 is situated between the base opening 52 and the central opening 58.
  • the middle opening 54 is contiguous with both the base opening 52 and the central opening 58, and the middle opening 54 is continuous with both the base opening 52 and the central opening 58.
  • the base opening 52, the middle opening 54, and the central opening 58 are concentric openings and the central axis 62 extends through the center of the base opening 52, the middle opening 54, and the central opening 58.
  • the base opening 52 has a larger diameter than the middle opening 54 and the central opening 58
  • the middle opening 54 has a larger diameter than the central opening 58.
  • Each of the side walls 42, 46 includes an inner surface 66 and an outer surface 70 (e.g., the outer periphery). Together, the first side wall 42 and the second side wall 46 define a threaded interface 68.
  • the inner surface 66 of the first side wall 42 defines a first portion of the threaded interface 68 and the inner surface 66 of the second side wall 46 defines a second portion of the threaded interface 68.
  • the threaded interface 68 may engage the threaded fastener to secure the rod 14 to the spinal screw assembly 10.
  • FIGS. 7-10 illustrate the eccentric base connector 30 first introduced in FIG. 3.
  • the eccentric base connector 30 supports the crown 26 and the screw 18.
  • the eccentric base connector 30 is disposed in the base opening 52 of the connector body 22.
  • the eccentric base connector 30 has a circular shape and has a central axis 94.
  • the central axis 94 is coaxial with the central axis 62 (FIGS. 2A-2B) of the connector body 22.
  • the eccentric base connector 30 can be formed from Ti-6A1-4V, though other biologically acceptable materials may also be used.
  • the eccentric base connector 30 includes a first end 84 and a second end 88.
  • the first end 84 includes a first opening 86 (see, e.g., FIG. 9), and the second end 88 includes a second opening 90.
  • the first opening 86 is configured to receive the first end 74 (see FIG. 3) of the crown 26.
  • the second opening 90 is configured to receive the second end 78 (see FIG. 3) of the crown 26.
  • the first opening 86 is continuous and concentric with the second opening 90.
  • the first opening 86 and the second opening 90 define an opening axis 98 (see FIGS. 7 and 8).
  • the first opening 86 and the second opening 90 are eccentrically positioned on the eccentric base connector 30.
  • the central axis 94 of the connector body 22 is parallel but not colinear with the opening axis 98 of the first opening 86 and the second opening 90 where the opening axis 98 is offset from the central axis 94.
  • the first opening 86 and the second opening 90 are also offset from the base opening 52, the middle opening 54, and the central opening [0045]
  • the first opening 86 includes a first groove 102 and the second opening 90 includes a second groove 106.
  • a middle groove 110 is positioned between the first groove 102 and the second groove 106.
  • the middle groove 110 has a larger diameter than the first groove 102 and the second groove 106.
  • the first groove 102 and the second groove 106 have different diameters.
  • the first groove 102 may be equivalent to the second groove 106.
  • a first retaining ring 114 is positioned in the first groove 102.
  • the first retaining ring 114 is moveable between the first groove 102 and the middle groove 110.
  • the first retaining ring 114 is made of flexible material that is able to contract and expand.
  • the first retaining ring 114 is in a natural state.
  • the first retaining ring 114 can expand radially.
  • the second end 40 (see FIG. 15) of the screw 18 engages the first retaining ring 114 to move the first retaining ring 114 between the first groove 102 and the middle groove 110.
  • the first retaining ring 114 limits the axial movement of the screw 18, such as in a downward direction.
  • the first retaining ring 114 is a C-ring.
  • the first retaining ring 114 may be an O-ring.
  • a second retaining ring 118 (see FIG. 12) is positioned in the second groove 106.
  • the second retaining ring 118 is moveable between the second groove 106 and the middle groove 110.
  • the second retaining ring 118 is made of flexible material that is able to contract and expand.
  • the second retaining ring 118 is in a contracted state.
  • the second retaining ring 118 expands into its natural shape.
  • the first end 74 of the crown 26 engages the second retaining ring 118 to move the second retaining ring 118 between the second groove 106 and the middle groove 110.
  • the second retaining ring 118 limits the axial movement of the crown 26, such as in a downward direction.
  • the second retaining ring 118 is a C-ring.
  • the second retaining ring 118 may be an O-ring.
  • the crown 26 is depicted supported by the eccentric base connector 30 in the connector body 22.
  • the crown 26 may be positioned in the middle opening 54 of the middle portion 58 of connector body 22 (see FIG. 15).
  • the crown 26 may include a first end 74 and a second end 78.
  • the first end 74 includes an opening 82 that is sized to receive the second end 40 (see FIGS. 3 and 15) of the screw 18.
  • the second end 78 has a flat surface which supports the rod 14 (FIG. 1A).
  • the crown 26 can be formed from pure titanium, though other biologically acceptable materials may also be used.
  • FIGS. 11-14 the crown 26 is shown being received in the second opening 90 of the eccentric base connector 30.
  • the crown 26 is moveable between an up-position (see FIGS. 11 to 12) and a down-position (see FIGS. 13 to 14).
  • a majority of the crown 26 extends above the second end 88 of the eccentric base connector 30 and the first end 74 of the crown 26 is positioned above the second groove 106.
  • the majority of the crown 26 is positioned in the second opening 90 of the eccentric base connector 30 and the first end 74 of the crown 26 is positioned adjacent the second groove 106.
  • the crown 26 When the crown 26 is in the up position, there may be a weld 122 (FIG. 15) between the crown 26 and the eccentric base connector 30.
  • the weld 122 may be a spot weld that secures the crown 26 to the eccentric base connector 30.
  • the weld 122 prevents the second retaining ring 118 from accidentally entering the middle groove 110.
  • the weld 122 is a breakable weld which breaks when a predetermined amount of force is applied to the crown 26 in the downward direction and breaks as the crown 26 moves in the downward direction.
  • the force to break the weld 122 may be between approximately 200 N to 500 N.
  • the spinal screw assembly 10 may include multiple welds 122 where the number of welds 122 between the crown 26 and the eccentric base connector 30 is dependent on the desired breaking force.
  • the spinal screw assembly 10 may further include a lockring 126 positioned between eccentric base connector 30 and the base 34 of the connector body 22.
  • the lockring 126 may be secured (e.g., welded) to the connector body 22 such that the lockring 126 and the connector body 22 can co-rotate.
  • the lockring 126 is positioned in the connector body 22 such that it engages a flange 130 of the eccentric base connector 30.
  • the flange 130 is positioned on the second end 88 of the eccentric base connector 30.
  • the lockring 126 limits the axial movement of the eccentric base connector 30. More specifically, the lockring 126 limits the axial movement of the eccentric base connector 30 in the downward direction.
  • FIG. 15 illustrates the spinal screw assembly 10 (see FIGS. 1A to 3) in the unlocked position and with the screw 18 being received in the eccentric base connector 30.
  • the crown 26 In the unlocked position, the crown 26 is in the up position.
  • the weld 122 secures the crown 26 to the eccentric base connector 30.
  • the second end 40 of the screw 18 is engaged with the first retaining ring 114 such that the axial movement of the screw 18 is limited.
  • the connector body 22 and lockring 126 are rotatable relative to (e.g., about) the screw 18, the eccentric base connector 30, and the crown 26.
  • FIG. 16 illustrates the spinal screw assembly 10 (see FIGS. 1A to 3) in the locked position.
  • the crown 26 In the locked position, the crown 26 is in the down-position and the weld 122 (see FIG. 15) between the crown 26 and the eccentric base connector 30 is broken.
  • the second end 40 of the screw 18 is received in the opening 82 of the crown 26.
  • the connector body 22 and lockring 126 are rotatable relative to the screw 18, the eccentric base connector 30, and the crown 26.
  • the spinal screw assembly 10 allows the connector body 22 to rotate relative to the screw 18. More specifically, the connector body 22 and the lockring 126 are rotatable relative to the screw 18, the crown 26, and the eccentric base connector 30. The connector body 22 is able to rotate 360 degrees around the screw 18, the crown 26, and the eccentric base connector 30. The connector body 22 is able to rotate relative to the screw 18 before and after the spinal screw assembly 10 is in the locked position. The rotation of the connector body 22 relative to the screw 18 allows for an adjustable offset amount between the connector body 22 and the screw 18. The rotation also allows a portion of the crown 26 to be accessible or for the entire crown 26 to be accessible.
  • the spinal screw assembly 10 is an offset spinals screw assembly 10 wherein the connector body 22 is offset from the screw 18 in the medial plane. More specifically, the central axis 62 of the connector body 22 is offset from the screw axis 50 of the screw 18. The central axis 62 can be offset from the screw axis 50 in a first direction in the medial plane and in a second direction in the medial plane.
  • the spinal screw assembly 10 may have an offset amount between central axis 62 and the screw axis 50 that is between 0 mm and about 2 mm. In some embodiments, the offset amount may be between about 0.5 mm and about 1.5 mm. In some embodiments, the offset amount is at least 1 mm. In some embodiments, the offset amount may be no greater than 1.5 mm. As discussed above, the offset amount may be adjusted by rotating the connector body 22 relative to the screw 18 and the eccentric base connector 30.
  • an exemplary method 200 of installing the present spinal screw assembly 10 is described.
  • the user may place or position the connector body 22 on the second end 40 of the screw 18.
  • the user may align the first opening 86 (FIG. 10) of the eccentric base connector 30 with the second end 40 of the screw 18 such that the screw 18 is received in the first opening 86 of the eccentric base connector 30.
  • the user may also place the connector body 22 on the second end 40 of the screw 18 such that central axis 62 (FIG. 15) of the central opening 58 is offset from the screw axis 50 (FIG. 15).
  • the user may move the connector body 22 in a downward direction (e.g., toward the first end 36 of the screw 18). Moving the connector body 22 in the downward direction causes the second end 40 of the screw 18 to engage with the first retaining ring 114. As the connector body 22 moves downward, the second end 40 of the screw 18 pushes the first retaining ring 114 into the middle groove 110 (FIG. 10) of the eccentric base connector 30. The first retaining ring 114 expands in the middle groove 110. The connector body 22 may be moved in the downward direction until second end 40 of the screw 18 is received in the first opening 86 (FIG. 10) of the eccentric base connector 30.
  • the user may move the connector body 22 in the upward direction after step 220.
  • Moving the connector body 22 in the upward direction causes the second end 40 of the screw 18 to push the first retaining ring 114 back into the first groove 102 (FIG. 10).
  • the first retaining ring 114 contracts to fit the first groove 102 and limits the axial movement of the connector body 22 relative to the screw 18. More specifically, the first retaining ring 114 limits the upward movement of the connector body 22.
  • the user may rotate the connector body 22. More specifically, the user may rotate the connector body 22 relative to the screw 18 and the crown 26. The user may rotate the connector body 22 to align the connector body 22, and more specifically the entire spinal screw assembly 10, with other spine screw assemblies. The user may rotate the connector body 22 to achieve the desired offset amount.
  • the user may move the crown 26 in the downward direction. More specifically, the user may use a tool to push the crown 26 downward. Moving the crown 26 in the downward direction includes breaking the weld 122 (FIG. 15) between the eccentric base connector 30 and the crown 26. Moving the crown 26 in the downward direction causes the first end 74 of the crown 26 to engage with the second retaining ring 118. As the crown 26 is moved downward, the crown 26 moves the second retaining ring 118 from the second groove 106 to the middle groove 110. The second retaining ring 118 expands to fit the middle groove 110. The user may move the crown 26 is the downward direction until the second end 40 of the screw 18 is received in the first opening 86 of the crown 26. The user may move the crown 26 in the downward direction until the weld 122 breaks indicating the crown 26 is in the down position (FIG. 14).
  • an exemplary method 300 of manufacturing the present spinal screw assembly 10 is described.
  • the user may insert the crown 26 into the eccentric base connector 30. More specifically, the first end 74 of the crown 26 may be inserted into the second opening 90 (FIG. 10) of the eccentric base connector 30.
  • the user may apply a weld between the eccentric base connector 30 and the crown 26.
  • the user may apply the spot weld 122 (FIG. 15) between the eccentric base connector 30 and the crown 26 to secure the crown 26 to the eccentric base connector 30.
  • the user may apply multiple spot welds 122 between the eccentric base connector 30 and the crown 26.
  • the user may insert the eccentric base connector 30 into the connector body 22. More specifically, the user may insert the eccentric base connector 30 into the base opening 52 of the connector body 22. When the eccentric base connector 30 is being inserted into the connector body 22, the connector body 22 may be positioned upside down such that the middle portion 38 limits the axial movement of the eccentric base connector 30.
  • the user may insert the lockring 126 into the connector body 22. More specifically, the lockring 126 may be inserted into the base opening 52 of the connector body 22 between the base 34 and the eccentric base connector 30. The lockring 126 may be inserted such that the lockring 126 engages with the flange 130 of the eccentric base connector 30.
  • the user may apply a weld between the lockring 126 and the connector body 22. More specifically, the user may apply a weld seam between the lockring 126 and the connector body 22 to secure the lockring 126 to the connector body 22 and prevent or limit the axial movement of the eccentric base connector 30 in the connector body 22.
  • the method 200 and the method 300 may include more operational steps or fewer operational steps. In some embodiments, the operational steps in the method 200 and the method 300 may occur in a different sequence then the sequence that the operational steps are presented in in this disclosure. In some embodiments, the operational steps in the method 200 and the method 300 may occur simultaneously or concurrently.
  • Example 1 An adjustable spinal screw assembly comprising: a screw having a threaded body defining a screw axis and an at least partially rounded head; a connector body having a base opening, at least two side walls extending from the base opening, and a middle portion therebetween, the at least two side walls being spaced apart to form a support recess opening defining a central axis; a crown positioned in the middle portion of the connector body, the crown having an end sized to receive the at least partially rounded head of the screw; and an eccentric base connector disposed in the base opening, the eccentric base connector having a first opening sized to receive the at least partially rounded head of the screw and a second opening sized to receive the crown, the first opening being eccentrically positioned on the eccentric base connector.
  • Example 2 The adjustable spinal screw assembly of Example 1, wherein the connector body is rotatable relative to the screw, the crown, and the eccentric base connector.
  • Example 3 The adjustable spinal screw assembly of Example 1, wherein the screw axis is offset from the central axis when the screw is received in the eccentric base connector.
  • Example 4 The adjustable spinal screw assembly of Example 3, wherein the screw axis is offset at least 1 mm from the central axis.
  • Example 5 The adjustable spinal screw assembly of Example 4, wherein the screw axis is offset up to 1.5 mm from the central axis.
  • Example 6 The adjustable spinal screw assembly of Example 1, wherein the base opening, the support recess opening, and the middle portion are concentric.
  • Example 7 The adjustable spinal screw assembly of Example 1, wherein the first opening and the second opening are concentric.
  • Example 8 The adjustable spinal screw assembly of Example 1, further comprising a lockring positioned between the eccentric base connector and the base opening of the connector body.
  • Example 9 The adjustable spinal screw assembly of Example 8, wherein the lockring is welded to the base opening of the connector body.
  • Example 10 The adjustable spinal screw assembly of Example 8, wherein the lockring is rotatable about the eccentric base connector.
  • Example 11 An adjustable spinal screw assembly comprising: a screw having a threaded body defining a screw axis and an at least partially rounded head; a connector body having a base opening, at least two side walls extending from the base opening, and a middle portion therebetween, the at least two side walls being spaced apart to form a support recess opening defining a central axis, wherein the base opening, the middle portion, and the support recess opening are concentric; a crown positioned in the middle portion of the connector body, the crown having an end sized to receive the at least partially rounded head of the screw; and an eccentric base connector disposed in the base opening, the eccentric base connector having a first opening sized to receive the at least partially rounded head of the screw and a second opening sized to receive the crown, wherein the first opening and the support recess opening are nonconcentric.
  • Example 12 The adjustable spinal screw assembly of Example 11, wherein the central axis of the support recess opening is offset from the screw axis.
  • Example 13 The adjustable spinal screw assembly of Example 11, wherein the screw axis is offset up to 1.5 mm from the central axis.
  • Example 14 The adjustable spinal screw assembly of Example 11, wherein the screw axis is offset at least 1 mm from the central axis.
  • Example 15 The adjustable spinal screw assembly of Example 11, wherein the connector body is rotatable about the screw, the crown, and the eccentric base connector.
  • Example 16 The adjustable spinal screw assembly of Example 11, wherein the first opening is eccentrically positioned on the eccentric base connector.
  • Example 17 The adjustable spinal screw assembly of Example 11, further comprising a lockring positioned between the base opening and the eccentric base connector.
  • Example 18 A method of installing an adjustable spinal screw assembly for use in a spinal procedure, the adjustable spinal screw assembly including, a screw having a threaded body defining a screw axis and an at least partially rounded head, a connector body having a base opening, at least two side walls extending from the base opening, and a middle portion therebetween, the at least two side walls being spaced apart to form a support recess opening defining a central axis, a crown positioned in the middle portion of the connector body, and an eccentric base connector positioned in the base opening, the method including: positioning the connector body on the at least partially rounded head of the screw; moving the connector body in a downward direction until the at least partially rounded head of the screw is received in a first opening of the eccentric base connector; rotating the connector body relative to the screw; and moving the crown in the downward direction onto the at least partially rounded head of the screw until the at least partially rounded head is received in a first end of the crown.
  • Example 19 The method of Example 18, wherein placing the connector body on the at least partially rounded head of the screw includes positioning the connector body such that the central axis of the support recess opening is offset from the screw axis.
  • Example 20 The method of Example 18, further comprising breaking a weld between the crown and the eccentric base connector.
  • Example 21 An adjustable spinal screw assembly (10) comprising: a screw (18) having a threaded body (44) defining a screw axis (50) and an at least partially rounded head (40); a connector body (22) having a base opening (52), at least two side walls (42, 46) extending from the base opening (52), and a middle portion (54) therebetween, the at least two side walls (42, 46) being spaced apart to form a support recess opening (58) defining a central axis (62); a crown (26) positioned in the middle portion (54) of the connector body (22), the crown (26) having an end sized (82) to receive the at least partially rounded head (40) of the screw (18); and an eccentric base connector (30) disposed in the base opening (52), the eccentric base connector (30) having a first opening (86) sized to receive the at least partially rounded head (40) of the screw (18) and a second opening (90) sized to receive the crown (26), the first opening (86) being
  • Example 22 The adjustable spinal screw assembly of Example 21, wherein the connector body (22) is rotatable relative to the screw (18), the crown (26), and the eccentric base connector (30).
  • Example 23 The adjustable spinal screw assembly according to any of the proceeding claims, wherein the connector body (22) can rotate 360 degrees about the screw (18).
  • Example 24 The adjustable spinal screw assembly according to any of the proceeding claims, wherein the screw axis (50) is offset from the central axis (62) when the screw (18) is received in the eccentric base connector (30).
  • Example 25 The adjustable spinal screw assembly according to any of the proceeding claims, wherein the screw axis (50) is offset at least 1 mm from the central axis (62).
  • Example 26 The adjustable spinal screw assembly according to any of the proceeding claims, wherein the screw axis (50) is offset no greater than 1.5 mm from the central axis (62).
  • Example 27 The adjustable spinal screw assembly according to any of the proceeding claims, wherein the base opening (52), the support recess opening (58), and the middle portion (54) are concentric with each other.
  • Example 28 The adjustable spinal screw assembly according to any of the proceeding claims, wherein the first opening (86) and the second opening (90) are concentric with each other.
  • Example 29 The adjustable spinal screw assembly according to any of the proceeding claims, wherein the first opening (86) and the support recess opening (58) are nonconcentric.
  • Example 30 The adjustable spinal screw assembly according to any of the proceeding claims, further comprising a lockring (126) positioned between the eccentric base connector (30) and the base opening (52) of the connector body (22).
  • Example 31 The adjustable spinal screw assembly of claim 30, wherein the lockring (126) is welded to the base opening (52) of the connector body (22).
  • Example 32 The adjustable spinal screw assembly of claim 30 or claim 31, wherein the lockring (126) is rotatable about the eccentric base connector (30).
  • Example 33 A method of installing an adjustable spinal screw assembly (10) for use in a spinal procedure, the adjustable spinal screw assembly (10) including, a screw (18) having a threaded body (44) defining a screw axis (50) and an at least partially rounded head (40), a connector body (22) having a base opening (52), at least two side walls (42, 46) extending from the base opening (52), and a middle portion (54) therebetween, the at least two side walls (42, 46) being spaced apart to form a support recess opening (58) defining a central axis (62), a crown (26) positioned in the middle portion (54) of the connector body (22), and an eccentric base connector (30) positioned in the base opening (52), the method including: positioning the connector body (22) on the at least partially rounded head (40) of the screw (18); moving the connector body (22) in a downward direction until the at least partially rounded head (40) of the screw (18) is received in a first opening (86) of the eccentric base
  • Example 34 The method of Example 33, wherein placing the connector body (22) on the at least partially rounded head (40) of the screw (18) includes placing the connector body (22) such that the central axis (62) of the support recess opening (58) is offset from the screw axis (50).
  • Example 35 The method of Example 33 or Example 34, further comprising breaking a weld (122) between the crown (26) and the eccentric base connector (30).

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Abstract

An adjustable spinal screw assembly includes a screw, a connector body, a crown, and an eccentric base connector. The screw has a threaded body and an at least partially rounded head. The connector body has a base opening, at least two side walls extending from the base opening, and a middle portion therebetween. The at least two side walls are spaced apart to form a support recess opening defining a central axis. The crown is positioned in the middle portion of the connector body. The eccentric base connector is disposed in the base opening. The eccentric base connector has a first opening sized to receive the at least partially rounded head of the screw and a second opening sized to receive the crown. The first opening is eccentrically positioned on the eccentric base connector.

Description

ADJUSTABLE SPINAL SCREW ASSEMBLY
[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/594,668, filed October 31, 2023, the entire content of which is incorporated herein by reference.
TECHNICAL FIELD
[0002] The present disclosure relates to a spinal screw assembly that supports a spinal rod for use in a spinal procedure.
BACKGROUND
[0003] Treatment of spinal disorders, such as degenerative disc disease, disc herniations, scoliosis or other curvature abnormalities, and fractures, often requires surgical treatments. For example, implants may be used to preserve motion between vertebral members.
[0004] Surgical treatment typically involves the use of longitudinal members, such as spinal rods. Spinal rods may be attached to the exterior of two or more vertebral members to assist with the treatment of a spinal disorder. Spinal rods may provide a stable, rigid column that helps bones to fuse, and may redirect stresses over a wider area away from a damaged or defective region. Also, rigid spinal rods may help in spinal alignment.
SUMMARY
[0005] According to one embodiment, an adjustable spinal screw assembly includes a screw, a connector body, a crown, and an eccentric base connector. The screw has a threaded body that defines a screw axis and has an at least partially rounded head. The connector body has a base opening, at least two side walls extending from the base opening, and a middle portion therebetween. The at least two side walls are spaced apart to form a support recess opening defining a central axis. The crown is positioned in the middle portion of the connector body. The crown has an end sized to receive the at least partially rounded head of the screw. The eccentric base connector is disposed in the base opening. The eccentric base connector has a first opening sized to receive the at least partially rounded head of the screw and a second opening sized to receive the crown. The first opening is eccentrically positioned on the eccentric base connector.
[0006] According to another embodiment, an adjustable spinal screw assembly includes a screw, a connector body, a crown, and an eccentric base. The screw has a threaded body that defines a screw axis and has an at least partially rounded head. The connector body has a base opening, at least two side walls extending from the base opening, and a middle portion therebetween. The at least two side walls are spaced apart to form a support recess opening defining a central axis. The base opening, the middle portion, and the support recess opening are concentric. The crown is positioned in the middle portion of the connector body. The crown has an end sized to receive the at least partially rounded head of the screw. The eccentric base connector is disposed in the base opening. The eccentric base connector has a first opening sized to receive the at least partially rounded head of the screw and a second opening sized to receive the crown. The first opening and the support recess opening are nonconcentric.
[0007] According to another embodiment, a method of installing an adjustable spinal screw assembly for use in a spinal procedure is disclosed. The adjustable spinal screw assembly includes a screw, a connector body, a crown, and an eccentric base connector. The screw has a threaded body that defines a screw axis and has an at least partially rounded head. The connector body has a base opening, at least two side walls extending from the base opening, and a middle portion therebetween. The at least two side walls are spaced apart to form a support recess opening defining a central axis. The crown is positioned in the middle portion of the connector body. The eccentric base connector is positioned in the base opening. The method includes positioning the connector body on the at least partially rounded head of the screw. The method also includes moving the connector body in a downward direction until the at least partially rounded head of the screw is received in a first opening of the eccentric bas connector. The method also includes rotating the connector body relative to the screw. The method also includes moving the crown in a downward direction onto the at least partially rounded head of the screw until the at least partially rounded head is received in a first end of the crown. BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The accompanying drawings, which are incorporated in and form a part of the specification, illustrate the embodiments of the invention and together with the written description serve to explain the principles, characteristics, and features of the invention.
In the drawings:
[0009] FIG. 1A illustrates a perspective view of the spinal screw assembly, according to some aspects of the present disclosure.
[0010] FIG. IB illustrates a perspective view of the spinal screw assembly of FIG. 1A rotated in a first transversal direction.
[0011] FIG. 1C illustrates a perspective view of the spinal screw assembly of FIG. 1A rotated in a second transversal direction.
[0012] FIG. 2A illustrates a front view of the spinal screw assembly of FIG. 1 A offset in a first direction.
[0013] FIG. 2B illustrates a front view of the spinal screw assembly of FIG. 1A offset in a second direction.
[0014] FIG. 3 illustrates a front exploded view of the spinal screw assembly of FIG. 1A.
[0015] FIG. 4 illustrates a top view of the spinal screw assembly of FIG. 1A.
[0016] FIG. 5 illustrates a perspective view of the connector body of the spinal screw assembly of FIG. 1A.
[0017] FIG. 6 illustrates a section view of the connector body of FIG. 5 taken along the line 6—6.
[0018] FIG. 7 illustrates a perspective view of the eccentric base of the spinal screw assembly of FIG. 1A.
[0019] FIG. 8 illustrates a top view of the eccentric base of FIG. 7. [0020] FIG. 9 illustrates a side view of the eccentric base of FIG. 7.
[0021] FIG. 10 illustrates a section view of the eccentric base of FIG. 7 taken along the line 10—10.
[0022] FIG. 11 illustrates a side view of the eccentric base of FIG. 7 coupled to a crown in the unlocked position.
[0023] FIG. 12 illustrates a section view of the eccentric base and the crown of FIG. 11 taken along the line 12—12.
[0024] FIG. 13 illustrates a side perspective view of the eccentric base of FIG. 7 coupled to a crown in the locked position.
[0025] FIG. 14 illustrates a section view of the eccentric base and the crown of the FIG. 13 perspective view taken along the line 14—14.
[0026] FIG. 15 illustrates a partial section view of the spinal screw assembly of FIG. 2A in the unlocked position taken along the line 15—15.
[0027] FIG. 16 illustrates a partial section view of the spinal screw assembly of FIG. 2B in the locked position taken along the line 16—16.
[0028] FIG. 17 illustrates a method of installing a spinal screw assembly, according to some aspects of the present disclosure.
[0029] FIG. 18 illustrates a method of manufacturing a spinal screw assembly, according to some aspects of the present disclosure.
DETAILED DESCRIPTION
[0030] The following description of the depicted embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. Before any embodiments of the disclosure are explained in detail, it is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or of being carried out in various ways.
[0031] Embodiments of the presently disclosed system are described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. In the following description, well- known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.
[0032] Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. Use of “including” and “comprising” and “having” and variations thereof as used herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless specified or limited otherwise, the terms “mounted,” “connected,” “supported,” and “coupled” and variations thereof are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings.
[0033] The components of the spinal screw assembly 10 described herein can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone material. Examples of such materials include, but are not limited to, a titanium alloy (e.g., Ti-6A1-4V), pure titanium, cobalt-chromium (CoCr), and polyether ether ketone (PEEK).
[0034] In spinal procedures, a rod is used to align vertebrates of the spine. The rod is connected to the vertebrates or other anatomical structures by a spinal screw assembly having a connector body and a screw. The screw is inserted into the vertebrates and is manipulated to correct the spine. The connector body supports at least one end of the rod, and the other end of the rod may be connected to a second spinal screw assembly to align the spine. The screw in the spinal screw assembly may be semi-rigid in the sagittal plane but may be able to flex in the coronal plane to ease the placement of the rods and spinal screw assemblies during the spinal procedures. Additionally, in complex spinal procedures, the vertebrates may be deformed or rotated. The deformed vertebrates may cause the surgeon to make a tradeoff between being able to place the spinal screw assembly in a preferred orientation, being able to obtain the desired correction, and being able to place the rods due to the alignment. A spinal screw assembly that is able to translate in the in medial or lateral direction can be desirable to minimize the surgeon having to make tradeoffs. The disclosed embodiment of the spinal screw assembly 10 is able to translate in the medial or lateral direction.
[0035] Referring to FIGS. 1A-1C, a spinal screw assembly 10 is illustrated according to some aspects of the present disclosure. The spinal screw assembly 10 can support a rod 14 that might extend along the length of at least a portion of a spine. The spinal screw assembly 10 includes a screw 18 that is inserted into the spine and a connector body 22 that connects the rod 14 to the screw 18. As shown in FIGS. 1A-1C, the spinal screw assembly 10 is multi-axial in all positions. The spinal screw assembly 10 may pivot about the connector body 22 in a conical direction. FIGS. IB and 1C illustrate the spinal screw assembly 10 flexed in the coronal plane in a first direction and flexed in a second, opposite direction. Although the FIGS. 1A-1C depict the spinal screw 10 in three different axial positions, additional multi-axial positions are contemplated.
[0036] FIGS. 2A and 2B illustrate the spinal screw assembly 10 translated in a first medial direction and translated in a second medial direction. As explained in more detail below, when the spinal screw assembly 10 is translated in the medial direction, the screw 18 is offset from the connector body 22. More specifically, a central axis 62 of the connector body 22 is offset from a screw axis 50 of the screw 18. The offset amount can be adjusted such that the spinal screw assembly 10 is an adjustable spinal screw assembly. The screw 18 includes a first end 36 having a pointed tip that is inserted into the spine during a spinal procedure.
[0037] FIG. 3 illustrates additional detail of the spinal screw assembly 10. The spinal screw assembly 10 includes the screw 18, the connector body 22, a crown 26, and an eccentric base connector 30. The screw 18 includes the first end 36, a second end 40, and a body 44 extending between the first end 36 and the second end 40. The pointed tip of the first end 36 is inserted into the spine during a spinal procedure. The second end 40 defines an at least partially rounded head. The second end 40 is received in the connector body 22. The body 44 is a threaded body and defines the screw axis 50 (FIG. 2A). The screw 18 can be formed from Ti-6al-4V, though other biologically acceptable materials are also contemplated.
[0038] FIG. 4 depicts an exemplary top view of the spinal screw assembly 10, such as the spinal screw assembly illustrated in FIG. 1A to 3, including showing the offset between the screw axis 50 and the central axis 62.
[0039] FIGS. 5-6 illustrate the connector body 22. The connector body 22 connects the rod 14 (FIGS. 1A to 1C) to the screw 18 (FIGS. 1A to 3). The connector body 22 can be formed from CoCr, though other biologically acceptable materials are also contemplated. The connector body 22 is generally U-shaped in the illustrated embodiment. The connector body 22 may include a base 34, a middle portion 38, a first side wall 42, and a second side wall 46.
[0040] The base 34 includes a base opening 52 that is sized to receive the eccentric base connector 30. The middle portion 38 is positioned between the base 34 and the first and second side walls 42, 46. The middle portion 38 includes a middle opening 54 that is at least sized to fit the crown 26 (see FIG. 3). In the illustrated embodiment, the middle opening 54 has a diameter that is greater than the diameter of the crown 26. The middle opening 54 has a diameter that allows crown 26 and eccentric base connector 30 to rotate 360 degrees. The first side wall 42 and the second side wall 46 extend upwardly from the base 34. The first and second side walls 42, 46 are spaced apart to form a central opening 58 (e.g., a support recess opening). The central opening 58 is sized to receive a threaded fastener to secure the rod 14 to the connector body 22. The central opening 58 defines a central axis 62.
[0041] With continued reference to FIGS. 5-6, the middle opening 54 is situated between the base opening 52 and the central opening 58. The middle opening 54 is contiguous with both the base opening 52 and the central opening 58, and the middle opening 54 is continuous with both the base opening 52 and the central opening 58. The base opening 52, the middle opening 54, and the central opening 58 are concentric openings and the central axis 62 extends through the center of the base opening 52, the middle opening 54, and the central opening 58. In the illustrated embodiment, the base opening 52 has a larger diameter than the middle opening 54 and the central opening 58, and the middle opening 54 has a larger diameter than the central opening 58.
[0042] Each of the side walls 42, 46 includes an inner surface 66 and an outer surface 70 (e.g., the outer periphery). Together, the first side wall 42 and the second side wall 46 define a threaded interface 68. The inner surface 66 of the first side wall 42 defines a first portion of the threaded interface 68 and the inner surface 66 of the second side wall 46 defines a second portion of the threaded interface 68. The threaded interface 68 may engage the threaded fastener to secure the rod 14 to the spinal screw assembly 10.
[0043] FIGS. 7-10 illustrate the eccentric base connector 30 first introduced in FIG. 3. The eccentric base connector 30 supports the crown 26 and the screw 18. The eccentric base connector 30 is disposed in the base opening 52 of the connector body 22. In the illustrated embodiment, the eccentric base connector 30 has a circular shape and has a central axis 94. The central axis 94 is coaxial with the central axis 62 (FIGS. 2A-2B) of the connector body 22. The eccentric base connector 30 can be formed from Ti-6A1-4V, though other biologically acceptable materials may also be used.
[0044] The eccentric base connector 30 includes a first end 84 and a second end 88. The first end 84 includes a first opening 86 (see, e.g., FIG. 9), and the second end 88 includes a second opening 90. The first opening 86 is configured to receive the first end 74 (see FIG. 3) of the crown 26. The second opening 90 is configured to receive the second end 78 (see FIG. 3) of the crown 26. The first opening 86 is continuous and concentric with the second opening 90. The first opening 86 and the second opening 90 define an opening axis 98 (see FIGS. 7 and 8). The first opening 86 and the second opening 90 are eccentrically positioned on the eccentric base connector 30. More specifically, the central axis 94 of the connector body 22 is parallel but not colinear with the opening axis 98 of the first opening 86 and the second opening 90 where the opening axis 98 is offset from the central axis 94. The first opening 86 and the second opening 90 are also offset from the base opening 52, the middle opening 54, and the central opening
Figure imgf000009_0001
[0045] Referring to FIGS. 10 and 12, the first opening 86 includes a first groove 102 and the second opening 90 includes a second groove 106. A middle groove 110 is positioned between the first groove 102 and the second groove 106. The middle groove 110 has a larger diameter than the first groove 102 and the second groove 106. In the illustrated embodiment, the first groove 102 and the second groove 106 have different diameters. In some embodiments, the first groove 102 may be equivalent to the second groove 106.
[0046] A first retaining ring 114 is positioned in the first groove 102. The first retaining ring 114 is moveable between the first groove 102 and the middle groove 110. The first retaining ring 114 is made of flexible material that is able to contract and expand. When the first retaining ring 114 is positioned in the first groove 102, the first retaining ring 114 is in a natural state. When the first retaining ring 114 is positioned in the middle groove 110, the first retaining ring 114 can expand radially. The second end 40 (see FIG. 15) of the screw 18 (FIG. 2A) engages the first retaining ring 114 to move the first retaining ring 114 between the first groove 102 and the middle groove 110. When the first retaining ring 114 is received in the first groove 102, the first retaining ring 114 limits the axial movement of the screw 18, such as in a downward direction. In the illustrated embodiment, the first retaining ring 114 is a C-ring. In some embodiments, the first retaining ring 114 may be an O-ring.
[0047] A second retaining ring 118 (see FIG. 12) is positioned in the second groove 106. The second retaining ring 118 is moveable between the second groove 106 and the middle groove 110. The second retaining ring 118 is made of flexible material that is able to contract and expand. When the second retaining ring 118 is positioned in the second groove 106, the second retaining ring 118 is in a contracted state. When the second retaining ring 118 is positioned in the middle groove 110, the second retaining ring 118 expands into its natural shape. The first end 74 of the crown 26 engages the second retaining ring 118 to move the second retaining ring 118 between the second groove 106 and the middle groove 110. When the second retaining ring 118 is received in the second groove 106, the second retaining ring 118 limits the axial movement of the crown 26, such as in a downward direction. In the illustrated embodiment, the second retaining ring 118 is a C-ring. In some embodiments, the second retaining ring 118 may be an O-ring.
[0048] With continued reference to FIG. 12, the crown 26 is depicted supported by the eccentric base connector 30 in the connector body 22. The crown 26 may be positioned in the middle opening 54 of the middle portion 58 of connector body 22 (see FIG. 15). The crown 26 may include a first end 74 and a second end 78. The first end 74 includes an opening 82 that is sized to receive the second end 40 (see FIGS. 3 and 15) of the screw 18. The second end 78 has a flat surface which supports the rod 14 (FIG. 1A). The crown 26 can be formed from pure titanium, though other biologically acceptable materials may also be used.
[0049] Turning now to FIGS. 11-14, the crown 26 is shown being received in the second opening 90 of the eccentric base connector 30. The crown 26 is moveable between an up-position (see FIGS. 11 to 12) and a down-position (see FIGS. 13 to 14). In the up position, a majority of the crown 26 extends above the second end 88 of the eccentric base connector 30 and the first end 74 of the crown 26 is positioned above the second groove 106. In the down-position, the majority of the crown 26 is positioned in the second opening 90 of the eccentric base connector 30 and the first end 74 of the crown 26 is positioned adjacent the second groove 106.
[0050] When the crown 26 is in the up position, there may be a weld 122 (FIG. 15) between the crown 26 and the eccentric base connector 30. The weld 122 may be a spot weld that secures the crown 26 to the eccentric base connector 30. The weld 122 prevents the second retaining ring 118 from accidentally entering the middle groove 110. The weld 122 is a breakable weld which breaks when a predetermined amount of force is applied to the crown 26 in the downward direction and breaks as the crown 26 moves in the downward direction. The force to break the weld 122 may be between approximately 200 N to 500 N. The spinal screw assembly 10 may include multiple welds 122 where the number of welds 122 between the crown 26 and the eccentric base connector 30 is dependent on the desired breaking force. [0051] Turning to FIG. 15, the spinal screw assembly 10 (see FIGS. 1A to 3) may further include a lockring 126 positioned between eccentric base connector 30 and the base 34 of the connector body 22. The lockring 126 may be secured (e.g., welded) to the connector body 22 such that the lockring 126 and the connector body 22 can co-rotate. The lockring 126 is positioned in the connector body 22 such that it engages a flange 130 of the eccentric base connector 30. The flange 130 is positioned on the second end 88 of the eccentric base connector 30. The lockring 126 limits the axial movement of the eccentric base connector 30. More specifically, the lockring 126 limits the axial movement of the eccentric base connector 30 in the downward direction.
[0052] FIG. 15 illustrates the spinal screw assembly 10 (see FIGS. 1A to 3) in the unlocked position and with the screw 18 being received in the eccentric base connector 30. In the unlocked position, the crown 26 is in the up position. The weld 122 secures the crown 26 to the eccentric base connector 30. The second end 40 of the screw 18 is engaged with the first retaining ring 114 such that the axial movement of the screw 18 is limited. The connector body 22 and lockring 126 are rotatable relative to (e.g., about) the screw 18, the eccentric base connector 30, and the crown 26.
[0053] FIG. 16 illustrates the spinal screw assembly 10 (see FIGS. 1A to 3) in the locked position. In the locked position, the crown 26 is in the down-position and the weld 122 (see FIG. 15) between the crown 26 and the eccentric base connector 30 is broken. The second end 40 of the screw 18 is received in the opening 82 of the crown 26. The connector body 22 and lockring 126 are rotatable relative to the screw 18, the eccentric base connector 30, and the crown 26.
[0054] The spinal screw assembly 10 allows the connector body 22 to rotate relative to the screw 18. More specifically, the connector body 22 and the lockring 126 are rotatable relative to the screw 18, the crown 26, and the eccentric base connector 30. The connector body 22 is able to rotate 360 degrees around the screw 18, the crown 26, and the eccentric base connector 30. The connector body 22 is able to rotate relative to the screw 18 before and after the spinal screw assembly 10 is in the locked position. The rotation of the connector body 22 relative to the screw 18 allows for an adjustable offset amount between the connector body 22 and the screw 18. The rotation also allows a portion of the crown 26 to be accessible or for the entire crown 26 to be accessible.
[0055] As mentioned above and illustrated in FIGS. 2A-2B, 4, and 15-16, the spinal screw assembly 10 is an offset spinals screw assembly 10 wherein the connector body 22 is offset from the screw 18 in the medial plane. More specifically, the central axis 62 of the connector body 22 is offset from the screw axis 50 of the screw 18. The central axis 62 can be offset from the screw axis 50 in a first direction in the medial plane and in a second direction in the medial plane. The spinal screw assembly 10 may have an offset amount between central axis 62 and the screw axis 50 that is between 0 mm and about 2 mm. In some embodiments, the offset amount may be between about 0.5 mm and about 1.5 mm. In some embodiments, the offset amount is at least 1 mm. In some embodiments, the offset amount may be no greater than 1.5 mm. As discussed above, the offset amount may be adjusted by rotating the connector body 22 relative to the screw 18 and the eccentric base connector 30.
[0056] In some embodiments, there may be some rotational positions of the connector body 22 that allow the central axis 62 to be aligned with the screw axis 50. In these rotational positions (not shown), the connector body 22 is not offset from the screw 18 in medial plane. However, in these positions, the connector body 22 is offset from the screw 18 in the sagittal plane.
[0057] Referring to FIGS. 3 and 17, an exemplary method 200 of installing the present spinal screw assembly 10 is described. For example, once the first end 36 of the screw 18 is secured to the spine, at operational step 210, the user may place or position the connector body 22 on the second end 40 of the screw 18. The user may align the first opening 86 (FIG. 10) of the eccentric base connector 30 with the second end 40 of the screw 18 such that the screw 18 is received in the first opening 86 of the eccentric base connector 30. The user may also place the connector body 22 on the second end 40 of the screw 18 such that central axis 62 (FIG. 15) of the central opening 58 is offset from the screw axis 50 (FIG. 15). [0058] At step 220, the user may move the connector body 22 in a downward direction (e.g., toward the first end 36 of the screw 18). Moving the connector body 22 in the downward direction causes the second end 40 of the screw 18 to engage with the first retaining ring 114. As the connector body 22 moves downward, the second end 40 of the screw 18 pushes the first retaining ring 114 into the middle groove 110 (FIG. 10) of the eccentric base connector 30. The first retaining ring 114 expands in the middle groove 110. The connector body 22 may be moved in the downward direction until second end 40 of the screw 18 is received in the first opening 86 (FIG. 10) of the eccentric base connector 30.
[0059] In some aspects, the user may move the connector body 22 in the upward direction after step 220. Moving the connector body 22 in the upward direction causes the second end 40 of the screw 18 to push the first retaining ring 114 back into the first groove 102 (FIG. 10). When the first retaining ring 114 is returned to the first groove 102, the first retaining ring 114 contracts to fit the first groove 102 and limits the axial movement of the connector body 22 relative to the screw 18. More specifically, the first retaining ring 114 limits the upward movement of the connector body 22.
[0060] At step 230, the user may rotate the connector body 22. More specifically, the user may rotate the connector body 22 relative to the screw 18 and the crown 26. The user may rotate the connector body 22 to align the connector body 22, and more specifically the entire spinal screw assembly 10, with other spine screw assemblies. The user may rotate the connector body 22 to achieve the desired offset amount.
[0061] At step 240, the user may move the crown 26 in the downward direction. More specifically, the user may use a tool to push the crown 26 downward. Moving the crown 26 in the downward direction includes breaking the weld 122 (FIG. 15) between the eccentric base connector 30 and the crown 26. Moving the crown 26 in the downward direction causes the first end 74 of the crown 26 to engage with the second retaining ring 118. As the crown 26 is moved downward, the crown 26 moves the second retaining ring 118 from the second groove 106 to the middle groove 110. The second retaining ring 118 expands to fit the middle groove 110. The user may move the crown 26 is the downward direction until the second end 40 of the screw 18 is received in the first opening 86 of the crown 26. The user may move the crown 26 in the downward direction until the weld 122 breaks indicating the crown 26 is in the down position (FIG. 14).
[0062] Referring to FIGS. 3 and 18, an exemplary method 300 of manufacturing the present spinal screw assembly 10 is described. For example, at operational step 310, the user may insert the crown 26 into the eccentric base connector 30. More specifically, the first end 74 of the crown 26 may be inserted into the second opening 90 (FIG. 10) of the eccentric base connector 30.
[0063] At step 320, the user may apply a weld between the eccentric base connector 30 and the crown 26. The user may apply the spot weld 122 (FIG. 15) between the eccentric base connector 30 and the crown 26 to secure the crown 26 to the eccentric base connector 30. In some embodiments, the user may apply multiple spot welds 122 between the eccentric base connector 30 and the crown 26.
[0064] At step 330, the user may insert the eccentric base connector 30 into the connector body 22. More specifically, the user may insert the eccentric base connector 30 into the base opening 52 of the connector body 22. When the eccentric base connector 30 is being inserted into the connector body 22, the connector body 22 may be positioned upside down such that the middle portion 38 limits the axial movement of the eccentric base connector 30.
[0065] At step 340, the user may insert the lockring 126 into the connector body 22. More specifically, the lockring 126 may be inserted into the base opening 52 of the connector body 22 between the base 34 and the eccentric base connector 30. The lockring 126 may be inserted such that the lockring 126 engages with the flange 130 of the eccentric base connector 30.
[0066] At step 350, the user may apply a weld between the lockring 126 and the connector body 22. More specifically, the user may apply a weld seam between the lockring 126 and the connector body 22 to secure the lockring 126 to the connector body 22 and prevent or limit the axial movement of the eccentric base connector 30 in the connector body 22. [0067] In some embodiments, the method 200 and the method 300 may include more operational steps or fewer operational steps. In some embodiments, the operational steps in the method 200 and the method 300 may occur in a different sequence then the sequence that the operational steps are presented in in this disclosure. In some embodiments, the operational steps in the method 200 and the method 300 may occur simultaneously or concurrently.
[0068] As various modifications could be made to the exemplary embodiments, as described above with reference to the corresponding illustrations, without departing from the scope of the invention, it is intended that all matter contained in the foregoing description and shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the invention should not be limited by any of the above-described exemplary embodiments but should be defined only in accordance with the claims and their equivalents.
[0069] The following examples are a non-limiting list of clauses in accordance with one or more techniques of this disclosure.
[0070] Example 1. An adjustable spinal screw assembly comprising: a screw having a threaded body defining a screw axis and an at least partially rounded head; a connector body having a base opening, at least two side walls extending from the base opening, and a middle portion therebetween, the at least two side walls being spaced apart to form a support recess opening defining a central axis; a crown positioned in the middle portion of the connector body, the crown having an end sized to receive the at least partially rounded head of the screw; and an eccentric base connector disposed in the base opening, the eccentric base connector having a first opening sized to receive the at least partially rounded head of the screw and a second opening sized to receive the crown, the first opening being eccentrically positioned on the eccentric base connector.
[0071] Example 2. The adjustable spinal screw assembly of Example 1, wherein the connector body is rotatable relative to the screw, the crown, and the eccentric base connector. [0072] Example 3. The adjustable spinal screw assembly of Example 1, wherein the screw axis is offset from the central axis when the screw is received in the eccentric base connector.
[0073] Example 4. The adjustable spinal screw assembly of Example 3, wherein the screw axis is offset at least 1 mm from the central axis.
[0074] Example 5. The adjustable spinal screw assembly of Example 4, wherein the screw axis is offset up to 1.5 mm from the central axis.
[0075] Example 6. The adjustable spinal screw assembly of Example 1, wherein the base opening, the support recess opening, and the middle portion are concentric.
[0076] Example 7. The adjustable spinal screw assembly of Example 1, wherein the first opening and the second opening are concentric.
[0077] Example 8. The adjustable spinal screw assembly of Example 1, further comprising a lockring positioned between the eccentric base connector and the base opening of the connector body.
[0078] Example 9. The adjustable spinal screw assembly of Example 8, wherein the lockring is welded to the base opening of the connector body.
[0079] Example 10. The adjustable spinal screw assembly of Example 8, wherein the lockring is rotatable about the eccentric base connector.
[0080] Example 11. An adjustable spinal screw assembly comprising: a screw having a threaded body defining a screw axis and an at least partially rounded head; a connector body having a base opening, at least two side walls extending from the base opening, and a middle portion therebetween, the at least two side walls being spaced apart to form a support recess opening defining a central axis, wherein the base opening, the middle portion, and the support recess opening are concentric; a crown positioned in the middle portion of the connector body, the crown having an end sized to receive the at least partially rounded head of the screw; and an eccentric base connector disposed in the base opening, the eccentric base connector having a first opening sized to receive the at least partially rounded head of the screw and a second opening sized to receive the crown, wherein the first opening and the support recess opening are nonconcentric.
[0081] Example 12. The adjustable spinal screw assembly of Example 11, wherein the central axis of the support recess opening is offset from the screw axis.
[0082] Example 13. The adjustable spinal screw assembly of Example 11, wherein the screw axis is offset up to 1.5 mm from the central axis.
[0083] Example 14. The adjustable spinal screw assembly of Example 11, wherein the screw axis is offset at least 1 mm from the central axis.
[0084] Example 15. The adjustable spinal screw assembly of Example 11, wherein the connector body is rotatable about the screw, the crown, and the eccentric base connector.
[0085] Example 16. The adjustable spinal screw assembly of Example 11, wherein the first opening is eccentrically positioned on the eccentric base connector.
[0086] Example 17. The adjustable spinal screw assembly of Example 11, further comprising a lockring positioned between the base opening and the eccentric base connector.
[0087] Example 18. A method of installing an adjustable spinal screw assembly for use in a spinal procedure, the adjustable spinal screw assembly including, a screw having a threaded body defining a screw axis and an at least partially rounded head, a connector body having a base opening, at least two side walls extending from the base opening, and a middle portion therebetween, the at least two side walls being spaced apart to form a support recess opening defining a central axis, a crown positioned in the middle portion of the connector body, and an eccentric base connector positioned in the base opening, the method including: positioning the connector body on the at least partially rounded head of the screw; moving the connector body in a downward direction until the at least partially rounded head of the screw is received in a first opening of the eccentric base connector; rotating the connector body relative to the screw; and moving the crown in the downward direction onto the at least partially rounded head of the screw until the at least partially rounded head is received in a first end of the crown.
[0088] Example 19. The method of Example 18, wherein placing the connector body on the at least partially rounded head of the screw includes positioning the connector body such that the central axis of the support recess opening is offset from the screw axis.
[0089] Example 20. The method of Example 18, further comprising breaking a weld between the crown and the eccentric base connector.
[0090] Example 21. An adjustable spinal screw assembly (10) comprising: a screw (18) having a threaded body (44) defining a screw axis (50) and an at least partially rounded head (40); a connector body (22) having a base opening (52), at least two side walls (42, 46) extending from the base opening (52), and a middle portion (54) therebetween, the at least two side walls (42, 46) being spaced apart to form a support recess opening (58) defining a central axis (62); a crown (26) positioned in the middle portion (54) of the connector body (22), the crown (26) having an end sized (82) to receive the at least partially rounded head (40) of the screw (18); and an eccentric base connector (30) disposed in the base opening (52), the eccentric base connector (30) having a first opening (86) sized to receive the at least partially rounded head (40) of the screw (18) and a second opening (90) sized to receive the crown (26), the first opening (86) being eccentrically positioned on the eccentric base connector (30).
[0091] Example 22. The adjustable spinal screw assembly of Example 21, wherein the connector body (22) is rotatable relative to the screw (18), the crown (26), and the eccentric base connector (30).
[0092] Example 23. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the connector body (22) can rotate 360 degrees about the screw (18).
[0093] Example 24. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the screw axis (50) is offset from the central axis (62) when the screw (18) is received in the eccentric base connector (30). [0094] Example 25. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the screw axis (50) is offset at least 1 mm from the central axis (62).
[0095] Example 26. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the screw axis (50) is offset no greater than 1.5 mm from the central axis (62).
[0096] Example 27. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the base opening (52), the support recess opening (58), and the middle portion (54) are concentric with each other.
[0097] Example 28. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the first opening (86) and the second opening (90) are concentric with each other.
[0098] Example 29. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the first opening (86) and the support recess opening (58) are nonconcentric.
[0099] Example 30. The adjustable spinal screw assembly according to any of the proceeding claims, further comprising a lockring (126) positioned between the eccentric base connector (30) and the base opening (52) of the connector body (22).
[00100] Example 31. The adjustable spinal screw assembly of claim 30, wherein the lockring (126) is welded to the base opening (52) of the connector body (22).
[00101] Example 32. The adjustable spinal screw assembly of claim 30 or claim 31, wherein the lockring (126) is rotatable about the eccentric base connector (30).
[00102] Example 33. A method of installing an adjustable spinal screw assembly (10) for use in a spinal procedure, the adjustable spinal screw assembly (10) including, a screw (18) having a threaded body (44) defining a screw axis (50) and an at least partially rounded head (40), a connector body (22) having a base opening (52), at least two side walls (42, 46) extending from the base opening (52), and a middle portion (54) therebetween, the at least two side walls (42, 46) being spaced apart to form a support recess opening (58) defining a central axis (62), a crown (26) positioned in the middle portion (54) of the connector body (22), and an eccentric base connector (30) positioned in the base opening (52), the method including: positioning the connector body (22) on the at least partially rounded head (40) of the screw (18); moving the connector body (22) in a downward direction until the at least partially rounded head (40) of the screw (18) is received in a first opening (86) of the eccentric base connector (30); rotating the connector body (22) relative to the screw (18); and moving the crown (26) in the downward direction onto the at least partially rounded head (40) of the screw (18) until the at least partially rounded head (40) is received in a first end of the crown (26).
[00103] Example 34. The method of Example 33, wherein placing the connector body (22) on the at least partially rounded head (40) of the screw (18) includes placing the connector body (22) such that the central axis (62) of the support recess opening (58) is offset from the screw axis (50).
[00104] Example 35. The method of Example 33 or Example 34, further comprising breaking a weld (122) between the crown (26) and the eccentric base connector (30).

Claims

What is claimed is:
1. An adjustable spinal screw assembly (10) comprising: a screw (18) having a threaded body (44) defining a screw axis (50) and an at least partially rounded head (40); a connector body (22) having a base opening (52), at least two side walls (42, 46) extending from the base opening (52), and a middle portion (54) therebetween, the at least two side walls (42, 46) being spaced apart to form a support recess opening (58) defining a central axis (62); a crown (26) positioned in the middle portion (54) of the connector body (22), the crown (26) having an end sized (82) to receive the at least partially rounded head (40) of the screw (18); and an eccentric base connector (30) disposed in the base opening (52), the eccentric base connector (30) having a first opening (86) sized to receive the at least partially rounded head (40) of the screw (18) and a second opening (90) sized to receive the crown (26), the first opening (86) being eccentrically positioned on the eccentric base connector (30).
2. The adjustable spinal screw assembly of claim 1, wherein the connector body (22) is rotatable relative to the screw (18), the crown (26), and the eccentric base connector (30).
3. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the connector body (22) can rotate 360 degrees about the screw (18).
4. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the screw axis (50) is offset from the central axis (62) when the screw (18) is received in the eccentric base connector (30).
5. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the screw axis (50) is offset at least 1 mm from the central axis (62).
6. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the screw axis (50) is offset no greater than 1.5 mm from the central axis (62).
7. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the base opening (52), the support recess opening (58), and the middle portion (54) are concentric with each other.
8. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the first opening (86) and the second opening (90) are concentric with each other.
9. The adjustable spinal screw assembly according to any of the proceeding claims, wherein the first opening (86) and the support recess opening (58) are nonconcentric.
10. The adjustable spinal screw assembly according to any of the proceeding claims, further comprising a lockring (126) positioned between the eccentric base connector (30) and the base opening (52) of the connector body (22).
11. The adjustable spinal screw assembly of claim 10, wherein the lockring (126) is welded to the base opening (52) of the connector body (22).
12. The adjustable spinal screw assembly of claim 10 or claim 11, wherein the lockring (126) is rotatable about the eccentric base connector (30).
13. A method of installing an adjustable spinal screw assembly (10) for use in a spinal procedure, the adjustable spinal screw assembly (10) including, a screw (18) having a threaded body (44) defining a screw axis (50) and an at least partially rounded head (40), a connector body (22) having a base opening (52), at least two side walls (42, 46) extending from the base opening (52), and a middle portion (54) therebetween, the at least two side walls (42, 46) being spaced apart to form a support recess opening (58) defining a central axis (62), a crown (26) positioned in the middle portion (54) of the connector body (22), and an eccentric base connector (30) positioned in the base opening (52), the method including: positioning the connector body (22) on the at least partially rounded head (40) of the screw (18); moving the connector body (22) in a downward direction until the at least partially rounded head (40) of the screw (18) is received in a first opening (86) of the eccentric base connector (30); rotating the connector body (22) relative to the screw (18); and moving the crown (26) in the downward direction onto the at least partially rounded head (40) of the screw (18) until the at least partially rounded head (40) is received in a first end of the crown (26).
14. The method of claim 13, wherein placing the connector body (22) on the at least partially rounded head (40) of the screw (18) includes placing the connector body (22) such that the central axis (62) of the support recess opening (58) is offset from the screw axis (50).
15. The method of claim 13 or claim 14, further comprising breaking a weld (122) between the crown (26) and the eccentric base connector (30).
PCT/IB2024/060409 2023-10-31 2024-10-23 Adjustable spinal screw assembly Pending WO2025093995A1 (en)

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US63/594,668 2023-10-31

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120016425A1 (en) * 2009-11-09 2012-01-19 Ebi, Llc Multiplanar bone anchor system
US20150182261A1 (en) * 2013-12-31 2015-07-02 Blackstone Medical, Inc. Translational pedicle screw systems
US20170290608A1 (en) * 2016-01-22 2017-10-12 Spinal Usa, Inc. Spinal fixation systems and methods
US20190105081A1 (en) * 2017-10-10 2019-04-11 Spine Wave, Inc. Translational posterior cervical polyaxial screw

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120016425A1 (en) * 2009-11-09 2012-01-19 Ebi, Llc Multiplanar bone anchor system
US20150182261A1 (en) * 2013-12-31 2015-07-02 Blackstone Medical, Inc. Translational pedicle screw systems
US20170290608A1 (en) * 2016-01-22 2017-10-12 Spinal Usa, Inc. Spinal fixation systems and methods
US20190105081A1 (en) * 2017-10-10 2019-04-11 Spine Wave, Inc. Translational posterior cervical polyaxial screw

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