Dual expanding spinal implant, system, and method of use

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of U.S. patent application Ser. No. 17/331,058, titled DUAL WEDGE EXPANDABLE IMPLANT, SYSTEM AND METHOD OF USE, filed May 26, 2021 which is a continuation in part of U.S. patent application Ser. No. 17/123,889, titled EXPANDABLE INTER-BODY DEVICE, SYSTEM, AND METHOD, filed Dec. 16, 2020 which claims priority to and incorporates by reference co-related international patent applications, PCT/IB2020/000942, titled Expandable Inter-Body Device, System, and Method, filed Nov. 5, 2020; and PCT/IB2020/000953, titled Expandable Inter-Body Device, System, and Method, filed Nov. 5, 2020. The contents of each are hereby incorporated in their entireties. This application also incorporates the entire contents of U.S. Pat. No. 10,238,503 filed Nov. 1, 2016 and U.S. Pat. No. 10,610,376 filed Oct. 16, 2015.

FIELD

The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a surgical device that includes an expandable spinal implant, systems for implanting and manipulating the expandable spinal implant, and a method for treating a human spine. In some embodiments, disclosed implants may be used in a transforaminal lumbar interbody fusion (TLIF) procedure and other embodiments may be used in an anterior cervical discectomy and fusion (ACDF) procedure although other uses in other areas of the spine or for other orthopedic applications are also contemplated.

BACKGROUND

Spinal disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor, and fracture may result from factors including trauma, disease and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including pain, nerve damage, and partial or complete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercise can be effective; however, they may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes fusion, fixation, correction, discectomy, laminectomy and implantable prosthetics. As part of these surgical treatments, spinal constructs, such as, for example, bone fasteners, spinal rods and interbody devices can be used to provide stability to a treated region. For example, during surgical treatment, interbody devices may be introduced to a space between adjacent vertebral bodies (the interbody space) to properly space the vertebral bodies and provide a receptacle for bone growth promoting materials (BGM), e.g., bone graft and/or synthetic materials.

Mechanically operated interbody implants may be used to align and/or realign a patient's spine during a medical procedure. Conventional implants designed for the Thoracic and Lumbar region of the spine often include top and bottom endplates and a mechanical means to separate the top and bottom endplates. The mechanical mechanisms to separate the top and bottom endplates are often cumbersome and require a large footprint that is often unsuitable for TLIF type surgeries and/or ACDF type surgeries of the spine.

SUMMARY

The techniques of this disclosure generally relate, for example, to highly adjustable interbody devices that are expandable to selectively increase and decrease a spacing distance between superior and inferior endplates of the interbody device at either or both of a proximal end and/or a distal end of the implant.

In one aspect, an expandable implant movable between a contracted position and an expanded position, is disclosed. The implant may include, an expandable body extending from a proximal end to a distal end in a proximal-to-distal direction, extending from a first lateral side to a second lateral side in a widthwise direction, and extending from a superior end to an inferior end in a vertical direction, for example. In various embodiments, the expandable body may be defined by a superior endplate and an inferior endplate opposite the superior endplate, for example. In various embodiments, the superior endplate may include a first outside surface and a first inside surface opposite the first outside surface, the first inside surface may include first proximal ramps and first distal ramps disposed opposite the first proximal ramps, for example. In various embodiments, the inferior endplate may include a second outside surface and a second inside surface opposite the second outside surface, the second inside surface may include second proximal ramps and second distal ramps disposed opposite the second proximal ramps, for example. In various embodiments, a support frame may be coupled to the superior endplate and the inferior endplate, the support frame may have a proximal screw guide and a distal screw guide opposite the proximal screw guide, for example. In various embodiments, a proximal set screw rotatably supported by the proximal screw guide and a distal set screw rotatably supported by the distal screw guide may be provided, for example. In various embodiments, a proximal wedge may include first superior ramped surfaces and first inferior ramped surfaces, the proximal wedge may be coupled to the proximal set screw; and a distal wedge may include second superior ramped surfaces and second inferior ramped surfaces, the distal wedge may be coupled to the distal set screw, for example. In various embodiments, in a contracted position the proximal wedge and the distal wedge are disposed in a medial position of the body, for example. Additionally, in some embodiments, in a first expanded position a spacing between the superior and inferior endplates at the proximal side is greater than a spacing between the superior and inferior endplates at the proximal side in the contracted position, in the first expanded position the proximal wedge may contact the first superior ramped surfaces and the first inferior ramped surfaces and is disposed proximate the proximal side, for example. Additionally, in some embodiments, in a second expanded position a spacing between the superior and inferior endplates at the distal side is greater than a spacing between the superior and inferior endplates at the distal side in the contracted position, in the second expanded position the distal wedge may contact the first and second proximal ramps and is disposed proximate the proximal side with respect to the medial position, for example.

In another aspect, a spinal implant system is disclosed. The spinal implant system may include an expandable implant movable between a contracted position and an expanded position. The implant may include, an expandable body extending from a proximal end to a distal end in a proximal-to-distal direction, extending from a first lateral side to a second lateral side in a widthwise direction, and extending from a superior end to an inferior end in a vertical direction, for example. In various embodiments, the expandable body may be defined by a superior endplate and an inferior endplate opposite the superior endplate, for example. In various embodiments, the superior endplate may include a first outside surface and a first inside surface opposite the first outside surface, the first inside surface may include first proximal ramps and first distal ramps disposed opposite the first proximal ramps, for example. In various embodiments, the inferior endplate may include a second outside surface and a second inside surface opposite the second outside surface, the second inside surface may include second proximal ramps and second distal ramps disposed opposite the second proximal ramps, for example. In various embodiments, a support frame may be coupled to the superior endplate and the inferior endplate, the support frame may have a proximal screw guide and a distal screw guide opposite the proximal screw guide, for example. In various embodiments, a proximal set screw rotatably supported by the proximal screw guide and a distal set screw rotatably supported by the distal screw guide may be provided, for example. In various embodiments, a proximal wedge may include first superior ramped surfaces and first inferior ramped surfaces, the proximal wedge may be coupled to the proximal set screw; and a distal wedge may include second superior ramped surfaces and second inferior ramped surfaces, the distal wedge may be coupled to the distal set screw, for example.

In another aspect, and in various embodiments, in a contracted position the proximal wedge and the distal wedge are disposed in a medial position of the body, for example. Additionally, in some embodiments, in a first expanded position a spacing between the superior and inferior endplates at the proximal side is greater than a spacing between the superior and inferior endplates at the proximal side in the contracted position, in the first expanded position the proximal wedge may contact the first superior ramped surfaces and the first inferior ramped surfaces and is disposed proximate the proximal side, for example. Additionally, in some embodiments, in a second expanded position a spacing between the superior and inferior endplates at the distal side is greater than a spacing between the superior and inferior endplates at the distal side in the contracted position, in the second expanded position the distal wedge may contact the first and second proximal ramps and is disposed proximate the proximal side with respect to the medial position, for example. Additionally, in various embodiments, the support frame may further include a plurality of engagement prongs extending towards the proximal end in the proximal-to-distal direction, for example. Additionally, the system may include an insertion tool extending in a longitudinal direction from a proximal end to a distal end thereof, and the insertion tool may include a plurality of engagement arms that may have a size and shape corresponding to the plurality of engagement prongs, for example.

In another aspect, an expandable and contractable spinal implant is disclosed. The implant may include an expandable body extending from a proximal end to a distal end in a proximal-to-distal direction, extending from a first lateral side to a second lateral side in a widthwise direction, and extending from a superior end to an inferior end in a vertical direction, the expandable body may be defined by a superior endplate and an inferior endplate opposite the superior endplate, for example. In various embodiments, the expandable body may include a beveled hook portion at a distal end thereof. In various embodiments, the superior endplate may include a first outside surface and a first inside surface opposite the first outside surface, the first inside surface may include first proximal ramps and first distal ramps disposed opposite the first proximal ramps, for example. In various embodiments, the inferior endplate may include a second outside surface and a second inside surface opposite the second outside surface, the second inside surface may include second proximal ramps and second distal ramps disposed opposite the second proximal ramps, for example. In various embodiments, a support frame may be coupled to the superior endplate and the inferior endplate, the support frame may have a proximal screw guide and a distal screw guide opposite the proximal screw guide, for example. Additionally, the proximal screw guide may define a first rotation axis and the distal screw guide may define a second rotation axis, the first and second rotation axes may extend in the proximal-to-distal direction, for example. In various embodiments, a proximal set screw rotatably supported by the proximal screw guide and a distal set screw rotatably supported by the distal screw guide may be provided. In various embodiments, a proximal wedge may be to the proximal set screw and may include first superior ramped surfaces and first inferior ramped surfaces, and a distal wedge may be coupled to the distal set screw and may include second superior ramped surfaces and second inferior ramped surfaces, for example. In various embodiments, the proximal wedge may be coupled to the proximal set screw and movable toward and away from the proximal end in the proximal-to-distal direction by rotation of the proximal set screw along the first rotation axis, the distal wedge may be coupled to the distal set screw and movable toward and away the distal end in the proximal-to-distal direction by rotation of the distal set screw along the second rotation axis, for example. Additionally, in various embodiments, the proximal wedge and distal wedge may be configured to simultaneously distract the superior and inferior endplates in a parallel manner upon simultaneous rotation of both the proximal set screw and distal set screw in a first direction and simultaneously contract the superior and inferior endplates in a parallel manner upon simultaneous rotation of both the proximal set screw and distal set screw in a second direction opposite the first direction, for example.

In another aspect, and in various embodiments, the proximal set screw may be configured to urge the proximal wedge towards the proximal end in the proximal-to-distal direction upon independent rotation of the proximal set screw in the first direction, thereby distracting the superior and inferior endplates at the proximal end, for example. In various embodiments, the distal set screw may be configured to urge the distal wedge towards the distal end in the proximal-to-distal direction upon independent rotation of the distal set screw in the first direction, thereby distracting the superior and inferior endplates at the distal end.

The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a front perspective view of an expandable implant.

FIG. 2 is an alternate front perspective view of an expandable implant.

FIG. 3 is a top down view of an expandable implant.

FIG. 4 is a front perspective view of an expandable implant.

FIG. 5 is an alternate front perspective view of an expandable implant.

FIG. 6 is an exploded parts view of an expandable implant.

FIG. 7 is an interior view of a superior endplate.

FIG. 8 is an alternate view of a superior endplate.

FIG. 9 is an interior view of an inferior endplate.

FIG. 10 is an alternate view of an inferior endplate.

FIG. 11 is a front perspective view of an expandable implant showing various example curvature profiles.

FIG. 12 is a side view of an inferior portion of expandable implant.

FIG. 13 is a rear perspective view of an expandable implant.

FIG. 14 is a rear perspective view of an expandable implant in a first expanded configuration.

FIG. 15 is a rear perspective view of an expandable implant in the first expanded configuration.

FIG. 16 is an alternate rear perspective view of an expandable implant in a second expanded configuration.

FIG. 17 is a side view of a cross section cut of an expandable implant in a contracted configuration.

FIG. 18 is a perspective view of a cross section cut of an expandable implant in an expanded configuration.

FIG. 19 is a perspective view of a cross section cut of an expandable implant in an expanded configuration.

FIG. 20A is a top down view of a disc space and an expandable spinal implant in a first position.

FIG. 20B is a top down view of a disc space and an expandable spinal implant in a first position.

FIG. 21 is a perspective view of an inserter tool for use with disclosed expandable implants.

FIG. 22 is a perspective view of an inserter tool for use with disclosed expandable implants.

FIG. 23 is a perspective view of an inserter tool for use with disclosed expandable implants.

FIG. 24A is a perspective view of an inserter tool for use with disclosed expandable implants.

FIG. 24B is a perspective view of a distal region of an inserter tool for use with disclosed expandable implants.

FIG. 25 is a perspective view of an inserter tool coupled to an expandable implant.

FIG. 26 is a perspective view of an inserter tool and a driver tool for use with disclosed expandable implants.

FIG. 27 is a perspective view of a drive tool for use with disclosed expandable implants.

FIG. 28A is an enlarged view of a proximal end of an inserter tool in an unlocked position.

FIG. 28B is an enlarged view of a proximal end of an inserter tool in a locked position.

FIG. 29 is a cross section cut showing a drive tool operably engaged with an expandable implant.

FIG. 30 is a cross section cut showing a drive tool operably engaged with an expandable implant.

FIG. 31 is a perspective view of an alternate drive tool for use with disclosed expandable implants.

FIG. 32 is a cross section cut of the alternate drive tool of FIG. 31 engaged with an expandable implant.

FIG. 33 is a reference drawing showing the human spine of which various disclosed implant embodiments may be installed in.

FIG. 34 is a reference drawing showing various planes and reference directions of which the various disclosed implant embodiments may move in or act in.

DETAILED DESCRIPTION

Embodiments of the present disclosure relate generally, for example, to spinal stabilization systems, and more particularly, to surgical instruments for use with spinal stabilization systems. Embodiments of the devices and methods are described below with reference to the Figures.

The following discussion omits or only briefly describes certain components, features and functionality related to medical implants, installation tools, and associated surgical techniques, which are apparent to those of ordinary skill in the art. It is noted that various embodiments are described in detail with reference to the drawings, in which like reference numerals represent like parts and assemblies throughout the several views, where possible. Reference to various embodiments does not limit the scope of the claims appended hereto because the embodiments are examples of the inventive concepts described herein. Additionally, any example(s) set forth in this specification are intended to be non-limiting and set forth some of the many possible embodiments applicable to the appended claims. Further, particular features described herein can be used in combination with other described features in each of the various possible combinations and permutations unless the context or other statements clearly indicate otherwise.

Terms such as “same,” “equal,” “planar,” “coplanar,” “parallel,” “perpendicular,” etc. as used herein are intended to encompass a meaning of exactly the same while also including variations that may occur, for example, due to manufacturing processes. The term “substantially” may be used herein to emphasize this meaning, particularly when the described embodiment has the same or nearly the same functionality or characteristic, unless the context or other statements clearly indicate otherwise.

Referring generally to FIGS. 1-6 various views of an expandable implant 100 are illustrated. For example, FIGS. 1-2 and 4-5 are various perspective views of an expandable implant 100, FIG. 3 is a top down view of an expandable implant 100 showing various axes and points of reference, and FIG. 6 is an exploded parts view of an expandable implant 100. As illustrated, expandable implant 100 may include a proximal end 100p, a distal end 100d, and first and second lateral sides 100l. The proximal end 100p may include an adjustment aperture 101 and an engagement cutout 103 for use with various surgical tools disclosed in FIGS. 21-32. In various embodiments, engagement cutout 103 may be defined by a superior engagement cutout 103s and an inferior engagement cutout 103i, for example. As shown in FIG. 3, implant 100 may extend in a proximal-to-distal direction from the proximal end 100p to the distal end 100d though axis P-D through the center of the moving mechanism of implant 100, for example. Implant 100 may extend in a widthwise direction from the first lateral side 100l to the second lateral side 100l through a widthwise axis W-W through the center of the moving mechanism of implant 100, for example. Axis P-D may be perpendicular and/or substantially perpendicular to the widthwise axis B-B.

In various embodiments, implant 100 may include tip portion 104 including a superior endplate 10 hooked portion 11 and an inferior endplate 20 hooked portion 21. In various embodiments, tip portion 104 may extend in a transverse and/or diagonal orientation with respect to the widthwise direction W-W and/or proximal-to-distal P-D direction, for example. As seen in FIG. 1, when implant 100 is in the collapsed position, the tip portion 104 is beveled. For example, hooked portion 11 and hooked portion 21 slope towards one another towards the tip portion 104. At least one advantage of a beveled surface at the tip portion may be easier initial insertion within a disc space. Another advantage may be an increased surface area, enabling implant 100 to withstand greater loads during implant expansion, and to create lordosis, for example. As will be explained in greater detail below with reference to FIGS. 20A and 20B, the tip portion 104 may be configured for insertion of the implant 100 into a disc space between an upper vertebral body and a lower vertebral body, to hook around the vertebral foramen VF in a multitude of viable positions, thereby avoiding interference with the neural elements, particularly the spinal cord, located in the vertebral foramen VF, for example. Additionally, in various embodiments, superior endplate 10 may include a lateral aperture 16 and inferior endplate 20 may include a lateral aperture 26 (see FIGS. 5, 15, and 16) for facilitating a fusion process as will be explained in further detail below in conjunction with FIG. 32.

In various embodiments, superior endplate 10 may include a first slot 13 and a second slot 14 on opposite lateral ends thereof, for example. Similarly, inferior endplate 20 may include a third slot 23 and a fourth slot 24 on opposite lateral ends thereof, for example. Slots 13, 14, 23, 24 may be used to constrain a support frame 30 (see FIG. 6) within the interior of the superior and inferior endplates 10, 20. In some embodiments, support frame 30 may be a relatively long extended and approximately rectangular shaped frame extending in the proximal-to-distal direction P-D. In some embodiments, support frame 30 may be a relatively short and approximately square shaped frame.

FIG. 6 is an example exploded parts views of an expandable implant 100. Consistent with the disclosure herein, the superior and inferior endplates 10, 20 may be movable with respect to one another in the vertical direction and also may be inclinable, e.g., capable of distraction and lordosis and even kyphotic adjustments. The superior endplate 10 and inferior endplate 20 may be operably engaged and/or coupled with one another by a support frame 30, for example. Support frame 30 may include a first post 34 and a second post 33 on each lateral side surface of support frame 30. For example, first post 34 may be an elongate cylindrical post extending in the widthwise direction W-W from support frame and second post 33 may be a relatively shorter elongate cylindrical post extending in the widthwise direction W-W, for example. Additionally, in some embodiments, post 34 and post 33 may have an inclined end cap having a planar end surface approximating the shape of an oval (at least in a head on view from the side). Similarly, the other lateral side of support frame 30 may also include a first post 34 and a second post 33. In some embodiments, the posts 34, 33 on opposite lateral ends may be transposed. For example, on a first lateral end, post 34 may be above post 33 and on the other lateral end post 33 may be above post 34. This arrangement may facilitate the symmetrical transference of forces throughout implant 100, for example. Additionally, posts 34 may extend through slotted apertures 14, 24 of superior and inferior endplates 10, 20, for example. Similarly, posts 33 may extend through slotted apertures 13, 23 of superior and inferior endplates 10, 20, for example. In various embodiments, support frame 30 may include a lateral aperture 35 adjacent posts 33, 34 on at least one lateral side surface thereof, for example. In the example embodiment, a single lateral aperture 35 is disposed on a single lateral side surface of support frame 30 for facilitating a direction of flow of a bone growth promoting material which will be explained in further detail below.

Support frame 30 may include a plurality of engagement prongs 32 or post like structures extending towards proximal end 100p. In the example illustration, four engagement prongs 32 are symmetrically distributed at respective corners of a proximal end of support frame 30. However, other embodiments may include more or less engagement prongs 32, for example, 1, 2, 3, 5, 6, etc. Engagement prongs 32 may be used to couple implant 100 to an inserter tool 200, as will be explained in further detail below. For example, an inserter tool 200 may grasp the outside of the engagement prongs 32. In various embodiments, the outside surfaces of engagement prongs 32 may form right angles at four corners such that a generally square or rectangular shape is formed. Additionally, in various embodiments, the inside surfaces of engagement prongs 32 may include a thread pattern. For example, the four engagement prongs 32 may define a thread pattern for supporting a set screw 40 and such thread pattern may be discontinuous between respective prongs 32 and pick back up at the next respective prong 32 such that set screw 40 may be rotatably supported therein by a discontinuous thread pattern. Support frame 30 may include a proximal screw guide 31p and a distal screw guide 31d. The proximal and distal screw guides 31p, 31d may each be defined by a circular aperture having an internal circumferential surface including a thread pattern and define a rotation axis extending through a center of the thread pattern, respectively. In some embodiments, the thread patterns may be reversed and in other embodiments they may be the same. The proximal screw guide 31p may rotatably support a proximal set screw 40 and the distal screw guide 31d may rotatably support a distal set screw 50, for example. The proximal set screw 40 may include a thread pattern 41 extending along a portion of the outside circumferential surface thereof and a drive engagement surface 43 extending along a portion of the inside circumferential surface thereof. A remaining portion of the outside circumferential surface thereof may be defined by a diameter that is less than a diameter of the portion of set screw 40 having thread pattern 41, for example. For example, a smooth circumferential surface 44 that is inset towards an axial centerline of set screw 40 and with respect to thread pattern 41. For example still, one end of set screw 40 may include a thread pattern 41 and the other end may include an inset circumferential surface 44 having at least one flange 42 on an end thereof. In some embodiments, an upper flange 42 and a lower flange 42 are provided, and in other embodiments the flange 42 extends all the way around the end of circumferential surface 44 as an annular ring, for example. Similarly, the distal set screw 50 may include a thread pattern 51 extending along a portion of the outside circumferential surface thereof and a drive engagement surface 53 extending along a portion of the inside circumferential surface thereof. A remaining portion of the outside circumferential surface thereof may be defined by a diameter that is less than a diameter of the portion of set screw 50 having thread pattern 51, for example. For example, a smooth circumferential surface 54 that is inset towards an axial centerline of set screw 50 with respect to thread pattern 51. For example still, one end of set screw 50 may include a thread pattern 51 and the other end may include an inset circumferential surface 54 having at least one flange 52 extending from an end thereof. In some embodiments, an upper and lower flange 52 are provided, and in other embodiments the flange 52 extends all the way around the end of circumferential surface 54 as an annular ring. In various embodiments, set screws 40 and 50 may be the same, similar, different, and/or substantially similar.

Implant 100 may include a proximal wedge structure 60 and a distal wedge structure 70, for example. Proximal wedge structure 60 may be coupled to proximal set screw 40 and distal wedge structure 70 may be coupled to distal set screw 50, for example. Proximal wedge 60 may include an aperture 61 having a size and shape corresponding to circumferential surface 44. For example, set screw 40 may be coupled to proximal wedge 60 by disposing the circumferential surface 44 within aperture 61 such that flange(s) 42 extend through aperture 61 and securely couple the proximal wedge 60 with proximal set screw 40 such that proximal set screw 40 may rotate within aperture 61. Additionally, flange 42 may permit axial translation of forces, for example by pushing and/or pulling. Proximal wedge 60 may further include a pair of superior ramped surfaces 63 and a pair of inferior ramped surfaces 64. Superior ramped surfaces 63 may be disposed on opposite lateral ends of proximal wedge 60 from one another and inferior ramped surface 64 may be disposed on opposite lateral ends of proximal wedge 60 from one another, for example. Similarly, distal wedge structure 70 may include an aperture 71 having a size and shape corresponding to circumferential surface 54 of distal set screw 50. For example, set screw 50 may be coupled to distal wedge 70 by disposing the circumferential surface 54 within aperture 71 such that flanges 52 extend through aperture 71 and securely couple the distal wedge 70 with distal set screw 50 such that distal set screw 50 may rotate within aperture 71 and permit axial translation of forces. Distal wedge 70 may further include a pair of superior ramped surfaces 73 and a pair of inferior ramped surfaces 74. Superior ramped surfaces 73 may be disposed on opposite lateral ends of distal wedge 70 from one another and inferior ramped surfaces 74 may be disposed on opposite lateral ends of distal wedge 70 from one another. In various embodiments, proximal wedge 60 and distal wedge 70 may be the same, similar, different, and or substantially the same. Additionally, in various embodiments, the angle of inclination and length of proximal ramps 63, 64 may be different on each end to provide for a different magnitude of expansion and/or kyphotic expansion. Similarly, the angle of inclination and length of distal ramps 73,74 may be different on each end to provide for a different magnitude of expansion and/or kyphotic expansion.

Referring generally to FIGS. 7-8, there are various interior views of an interior portion of a superior endplate 10 and referring generally to FIGS. 9-10, there are various views of an interior portion of an inferior endplate 20. In various embodiments, the proximal wedge 60 and distal wedge 70 may act against various surfaces of superior and inferior endplates 10, 20 to expand, contract, and incline implant 100 in various positions. For example, superior endplate 10 may include a pair of proximal ramps 18 that are disposed proximate the proximal end of superior endplate 10 and are inclined from a medial position of superior endplate 10 towards the proximal end 100p of implant 100, for example. In the disclosed embodiment, a first proximal ramp 18 and a second proximal ramp 18 are disposed on opposite sides of superior engagement cutout 103s. Additionally, superior endplate 10 may include a pair of distal ramps 19 that are disposed proximate the distal end of superior endplate 10 and are inclined from a medial position of superior endplate 10 towards the distal end 100d of implant 100. Additionally, in at least some embodiments, a pair of lower distal catches 19a may be disposed adjacent to distal ramps 19, respectively, and be positioned towards the outside lateral surface of superior endplate 10. Additionally, the pair of lower distal catches 19a may extend farther in a vertical direction than the remaining portions of superior endplate 10 and be generally inclined in the same, similar, and or substantially similar direction as distal ramps 19. In some embodiments, lower distal catches 19a may be referred to as guidewalls. Additionally, in some embodiments the combination of a ramp 19 and a catch 19a may be referred to as a channel in which a corresponding portion of a wedge is disposed within.

Similarly, inferior endplate 20 may include a pair of proximal ramps 28 that are disposed proximate the proximal end of inferior endplate 20 and are inclined from a medial position of inferior endplate 20 towards the proximal end 100p of implant 100, for example. In the disclosed embodiment, a first proximal ramp 28 and a second proximal ramp 28 are disposed on opposite sides of inferior engagement cutout 103i. Additionally, inferior endplate 20 may include a pair of distal ramps 29 that are disposed proximate the distal end of inferior endplate 20 and are inclined from a medial position of inferior endplate 20 towards the distal end 100d of implant 100. Additionally, in at least some embodiments, a pair of upper distal catches 29a may be disposed adjacent to distal ramps 29, respectively, and be positioned towards the outside lateral surface of inferior endplate 20. Additionally, the pair of upper distal catches 29a may extend farther in a vertical direction than the remaining portions of inferior endplate 20 and be generally inclined in the same, similar, and or substantially similar direction as distal ramps 29. Furthermore, in some embodiments the combination of a ramp 29 and a catch 29a may be referred to as a channel in which a corresponding portion of a wedge is disposed within.

As will be explained in more detail below, superior ramped surfaces 63 of proximal wedge 60 may directly contact and act against proximal ramps 18 of superior endplate 10 and inferior ramped surfaces 64 of proximal wedge 60 may directly contact and act against proximal ramps 28 of inferior endplate 20. As will also be explained in more detail below, superior ramped surfaces 73 of distal wedge 70 may directly contact and act against distal ramps 19 of superior endplate 10 and inferior ramped surfaces 74 of distal wedge 70 may directly contact and act against distal ramps 29 of inferior endplate 20.

Referring generally to FIGS. 11-19, there are various perspective views of an expandable implant 100 in a contracted position and in various expanded configurations. In various embodiments, the superior endplate 10 and inferior endplate 20 may optionally include fixation surfaces such as scallops 10s and/or teeth or surface roughened textures (not illustrated) for facilitating fixation of implant 100. As shown in FIG. 11, superior endplate 10 is bi-concave. For example, superior endplate 10 is concave in the proximal-to-distal direction P-D along curved line 10-P-D and superior endplate 10 is concave in the widthwise direction W-W along curved line 10-W-W, for example. This arrangement may be advantageous for mating with the concavity of a lower surface of a superior endplate of an adjacent vertebrae (not illustrated), for example. Other embodiments may have substantially planar upper surfaces and/or be concave in only one of the proximal-to-distal direction P-D and widthwise direction W-W. For example, superior endplate 10 may be uni-convex. Additionally, inferior endplate 20 may have any of the same concavity relationships as explained above with respect to superior endplate 10, for example.

FIG. 12 illustrates an embodiment where the superior endplate 10 and inferior endplate 20 are inclined in the proximal-to-distal direction P-D. For example, a height between endplates at the proximal end 100p may be less than a height between endplates at the distal end 100d such that in a collapsed position the relationship between the superior endplate 10 and inferior endplate 20 may be understood as a kyphotic relationship, for example. Additionally, tip portion 104 may be understood to have a tapered leading tip which may facilitate insertion of implant 100 between two collapsed vertebrae, for example. For example, as shown best in FIG. 13.

FIG. 13 illustrates an example configuration of implant 100 in a contracted position and FIG. 17 illustrates a cross section of an example configuration of implant 100 in a contracted position. FIGS. 14-15 and FIG. 18 each illustrate an example configuration of implant 100 in an expanded configuration where the distal end 100d is expanded relative to the contracted position. In FIG. 14 and FIG. 15, it is illustrated that the distal wedge 70 has moved towards the distal end 100d of implant 100 in the proximal-to-distal direction P-D, for example. Distal wedge 70 may have moved towards the distal end 100d from a medial position due to distal set screw 50 being rotated within distal screw guide 31d such that distal set screw 50 is linearly translated towards distal end 100d of implant 100. In doing so, distal set screw 50 pushes distal wedge 70 towards distal end 100d. Due to the inclination of superior ramps 73 and inferior ramps 74, the superior and inferior endplates 10, 20 are pushed apart at the distal end 100d. For example, superior ramps 73 may slide along distal ramps 19 of superior endplate 10 and inferior ramps 74 may slide along distal ramps 29 of inferior endplate 20. In this way, set screw 50 linearly translates distal wedge 70 such that superior and inferior ramps 74, 73 act against the superior and inferior endplates 10, 20 to urge them apart from one another at the distal end 100p of implant 100. Additionally, as shown in FIG. 18, lower distal catches 19a may also serve as an extended ramp portion that facilitates maintaining the distal wedge 70 moving in a proximal-to-distal direction, i.e., lower distal catches 19a may constrain distal wedge 70 such that it does not slide off track during expansion and/or contraction. In various embodiments, superior endplate 10 may include a first ramp extension 15d and inferior endplate 20 may include a second ramp extension 25d. Ramp extensions 15d and 25d may be positioned on an interior of endplates 10, 20, respectively, at a distal end such that they may allow implant 100 to further expand. In some embodiments, ramp extensions 15d and 25d may include a stop block or protrusion to prevent implant 100 from over expanding. For example, ramp extensions 15d, 25d prevent distal wedge 70 from moving too far in the distal direction. Those with skill in the art will appreciate that the particular location of ramp extensions 15d, 25d may be positioned to lengthen and/or shorten the corresponding ramps as needed.

In some methods of operation, it may be advantageous to determine a target range of expansion and position a stop block or protrusion as explained above in a position where a surgeon may fully expand the implant 100 with the confidence that the fully expanded position is the target expansion range. For example still, a plurality of implants 100 may be manufactured, each with a different maximum and/or target expansion range in the form of a stop block or surface at different positions along the corresponding ramp, and an end user such as a surgeon may select one of the plurality of implants 100 corresponding to the target expansion range for a particular patient's target alignment and/or corrective procedure. In some embodiments, welding, swagging, adhesive such as epoxy, etc. may be disposed around an end portion of set screws 40, 50 to stop the advancement of set screws 40, 50 at a predetermined range. Similarly, in some embodiments, welding, swagging, adhesive's such as epoxy, etc. may be disposed around an end portion of the threaded portion of support body 30 to stop the advancement of set screws 40, 50 at a predetermined range. For example, an epoxy may be disposed within the threaded portions of engagement prongs 32 at the proximal end to stop the advancement of set screw 40 at a predetermined distance corresponding to the target expansion range.

With reference to FIGS. 16 and 19, it is illustrated that the proximal wedge 60 has moved towards the proximal end 100p of implant 100 in the proximal-to-distal direction P-D, for example. Although not visible in FIG. 16, proximal wedge 60 may have moved towards the proximal end 100p from a medial position due to proximal set screw 40 being rotated within proximal screw guide 31p such that proximal set screw 40 is linearly translated towards proximal end 100p of implant 100 (for example, compare a position of set screw 40 in FIG. 15 to that of FIG. 16). In doing so, proximal set screw 40 pushes proximal wedge 60 towards proximal end 100p. Due to the inclination of superior ramps 63 and inferior ramps 64, the superior and inferior endplates 10, 20 are pushed apart at the proximal end 100p. For example, superior ramps 63 may slide along proximal ramps 18 of superior endplate 10 and inferior ramps 64 may slide along proximal ramps 28 of inferior endplate 20. In this way, set screw 40 linearly translates proximal wedge 60 such that superior and inferior ramps 64, 63 act against the superior and inferior endplates 10, 20 to urge them apart from one another at the proximal end 100p of implant 100.

In various embodiments, implant 100 may be distracted in a parallel manner where the superior and inferior endplates 10, 20 are substantially parallel to one another and/or a height between superior and inferior endplates 10, 20 is about the same at the proximal end 100p and distal end 100d of implant 100, for example. The distal end 100d of implant 100 may be expanded due to distal wedge 70 moving towards the distal end 100d of implant 100 in the proximal-to-distal direction P-D, for example. Distal wedge 70 may move towards the distal end 100d from a medial position due to distal set screw 50 being rotated within distal screw guide 31d such that distal set screw 50 is linearly translated towards distal end 100d of implant 100. In doing so, distal set screw 50 may push distal wedge 70 towards distal end 100d. Due to the inclination of superior ramps 73 and inferior ramps 74, the superior and inferior endplates 10, 20 are pushed apart at the distal end 100d. For example, superior ramps 74 may slide along distal ramps 19 of superior endplate 10 and inferior ramps 73 may slide along distal ramps 29 of inferior endplate 20. In this way, set screw 50 linearly translates distal wedge 70 such that superior and inferior ramps 74, 73 act against the superior and inferior endplates 10, 20 to urge them apart from one another at the distal end 100d of implant 100.

Referring generally to FIGS. 17-19, various cross section views of an expandable implant 100 in a contracted configuration and an expanded configuration are shown. As shown in FIG. 17, implant 100 is in a contracted position and each of the proximal wedge 60 and distal wedge 70 are in a medial position. Furthermore, posts 34, 33 of support frame 30 are engaged with the superior and inferior endplates 10, 20 by extending through slots 14, 23, respectively. As shown in FIG. 18, posts 34, 33 of support frame 30 have changed a relative position within slots 14, 23 (relative to FIG. 17) to accommodate the increase in height at the proximal end 100p. For example, posts 34, 33 may be fixed to support frame 30 and the superior and inferior endplates 10, 20 may have expanded relative to support frame 30 and therefore posts 34, 33 are shown in a different position relative to slots 14, 23. In FIG. 18, proximal wedge 60 may have moved towards the proximal end 100p due to proximal set screw 40 being rotated and thereby pushing proximal wedge 60 towards proximal end 100p, for example. Additionally, superior ramps 63 and inferior ramps 64, may act against the superior and inferior endplates 10, 20 to push them apart. For example, superior ramps 63 may slide along proximal ramps 18 of superior endplate 10 and inferior ramps 64 may slide along proximal ramps 28 of inferior endplate 20. In this way, set screw 40 linearly translates proximal wedge 60 towards proximal end 100p such that superior and inferior ramps 63, 64 act against the superior and inferior endplates 10, 20 to urge them apart from one another. Additionally, in some embodiment's lower proximal catches 18a of superior endplate 10 may be provided at the proximal end of superior endplate 10. Lower proximal catches 18a may act as a catch surface such that when set screw 40 is rotated in the opposite direction a lower surface of superior ramps 63 may push against lower proximal catches 18a to facilitate closing of the implant 100, for example. Additionally, in some embodiments the combination of a ramp 18 and a catch 18a may be referred to as a channel in which a corresponding portion of a wedge is disposed within. Furthermore, in some embodiment's upper proximal catches 28a of inferior endplate 20 may be provided at the proximal end of inferior endplate 20. Upper proximal catches 28a may act as a catch surface such that when set screw 40 is rotated in the opposite direction an upper surface of inferior ramps 64 may push against upper proximal catches 28a to facilitate closing of the implant 100, for example. Additionally, in some embodiments the combination of a ramp 28 and a catch 28a may be referred to as a channel in which a corresponding portion of a wedge is disposed within.

As shown in FIG. 19, posts 34, 33 of support frame 30 have changed a relative position within slots 14, 23 (relative to FIG. 18) to accommodate the increase in height at the distal end 100d. For example, post 34 has moved through slot 14 to a lower position and post 33 has moved to an upper position within slot 23. With reference back to FIG. 17, slots 14, 23 extend in a lateral direction and posts 34, 33 are engaged within slots 14, 23 throughout the full range of expansion (although it may appear that in FIG. 19 slot 14 is open at a bottom end this is due to where the section is taken through, for example). In this way, support frame 30 may remain coupled to implant 100. Additionally, distal wedge 70 may have moved towards the distal end 100d due to distal set screw 50 pushing distal wedge 70 towards distal end 100d. Additionally, superior ramps 74 and inferior ramps 73 may act against the superior and inferior endplates 10, 20 and push them apart at the distal end 100d. For example, set screw 50 linearly translates distal wedge 70 such that superior and inferior ramps 73, 74 act against the superior and inferior endplates 10, 20 to urge them apart from one another at the distal end 100d of implant 100. In some embodiments, upper distal catches 29a of inferior endplate 20 may act as a catch surface such that when set screw 50 is rotated in the opposite direction an upper surface 74a of inferior ramps 74 may push against upper distal catches 29a to facilitate closing of the implant 100, for example. Similarly, lower distal catches 19a of superior endplate 10 may act as a catch surface such that when set screw 50 is rotated in the opposite direction a lower surface 73a of superior ramps 73 may push against lower distal catches 19a to facilitate closing of the implant 100, for example.

Referring generally to FIGS. 20A and 20B, various top down views of a disc space and an expandable spinal implant in a first position (FIG. 20A) and a second position (FIG. 20B) are illustrated. As shown in FIG. 20A, implant 100 may be inserted within the disc space in a first orientation where the tip portion 104 may provide for additional anterior rim engagement. For example, the elongated tip of implant 100 extends in a widthwise direction farther than the width of implant 100 at the proximal end, for example. Additionally, as shown in FIG. 20B, implant 100 may be inserted within the disc space in a second orientation where the tip portion 104 may still provide for additional anterior rim engagement. Accordingly, embodiments in accordance with the principles of this disclosure may be insert within a disc space in a multitude of orientations where tip portion 104 may increase a surface area of implant 100 that may contact and/or support the anterior rim. For example still, tip portion 104 may hook around the vertebral foramen VF in a multitude of viable positions, thereby avoiding interference with the neural elements, particularly the spinal cord, located in the vertebral foramen VF, for example while also supporting the anterior rim. Those with skill in the art will readily appreciate that not all embodiments of implant 100 need have an angled tip portion 104. For example, in some embodiments (not illustrated) implant 100 may extend in a proximal-to-distal direction and have a straight tip portion 104. For example still, implant 100 may extend in a longitudinal direction and in a plan view the left and right sides of implant 100 may be roughly symmetrical, i.e., a longitudinal axis extending in the longitudinal direction may bisect implant 100 into two substantially equal and symmetrical halves. Furthermore, consistent with the disclosure herein, tip portion 104 may be extend for various lengths and at various angles relative to a longitudinal axis of implant 100 as disclosed in U.S. application Ser. No. 15/818,395, the contents of which are incorporated herein by reference in entirety.

Referring generally to FIGS. 21-32 various views of an inserter tool 200 and a drive tool 300 for use with disclosed expandable implants 100 are shown. Inserter tool 200 may extend from a proximal end to distal end and include a hollow outer shaft 201 and a hollow inner shaft 203. The hollow outer shaft 201 may include support walls 207 at a distal end thereof having a size and shape that may be configured to close the flexible tip of shaft 203. For example, seam 203s may enable the distal end of shaft 203 to be compressed together when shaft 203 is insert within outer shaft 201 such that engagement arms 204 are moved closer together. Hollow outer shaft 201 may include a gripping handle 202 extending therefrom and in various embodiments, gripping handle 202 may be a stationary handle or a movable handle (not illustrated), for example. In various embodiments, handle 202 may be disposed in line with the body 201, overlapping with the body 201, on a top portion of handle body 201, and/or offset to one side of body 201. For example still, handle 202 may take such ergonomic preferences of a particular surgeon in mind and be generally adaptable to any of the prior disclosed positions. Additionally, hollow inner shaft 203 may include engagement arms 204 at a distal end thereof, for example. Engagement arms 204 may be used to grip implant 100 at engagement prongs 32, for example (see FIGS. 24A and 24B and FIG. 1). Additionally, engagement arms 204 may have a size and shape generally corresponding to a size and shape of engagement prongs 32. For example, engagement arms 204 may surround (or at least partially surround) engagement prongs 32 and securely grip engagement prongs 32 such that implant 100 may be retained by inserter tool 200 and inserted into a disc space. In various embodiments, engagement arms 204 may have outdents and/or protrusions that engage corresponding grooves and/or recesses of engagement prongs 32 (not illustrated) or vice versa. Inserter tool 200 may include a hollow outer shaft 201 and a hollow inner shaft 203.

As shown in FIG. 22, hollow inner shaft 203 may be inserted within and disposed within hollow outer shaft 201, for example. Hollow inner shaft 203 may include a threaded end 205 at a proximal end thereof. Threaded end 205 may extend beyond the proximal end of hollow outer shaft 201 such that a coupling member 206 having an internal thread pattern corresponding to the threaded end 205 may be attached to a proximal end of hollow inner shaft 203. Once coupling member 206 is sufficiently tightened the hollow outer shaft 201 and hollow inner shaft 203 may be securely coupled. Additionally, as coupling member 206 is rotated, the inner shaft 203 may be pulled deeper within outer shaft 205 such that a compressive force may be applied at the engagement arms 204 via interior surfaces of support walls 207 thereby providing a strong clamping force around engagement prongs 32 of implant 100 (see FIGS. 21-25).

Once the coupling member 206 is sufficiently tightened such that engagement arms 204 are secured to engagement prongs 32, a drive tool 300 may be inserted through an aperture of coupling member 206 and into the hollow interior of inner shaft 203 (see FIG. 26). Drive tool 300 may extend in a proximal to distal direction and include a handle 302 at a proximal end and a drive end 301 at a distal end, for example (see FIG. 27). Additionally, drive tool 300 may include a first circumferential channel 303 and a second circumferential channel 304 that may be indented along an outside surface of drive tool 300. In the example, embodiment, a depressible lock 207 of coupling member 206 may selectively engage and disengage with either one of the first circumferential channel 303 and a second circumferential channel 304 to position drive tool 300 at relative axially aligned positions within the interior of hollow interior shaft 203. For example, as shown in FIG. 28A depressible lock 207 is disengaged and as shown in FIG. 28B depressible lock 207 is depressed such that an indent or the like may retain circumferential channels 303 or 304. A relative distance between the first circumferential channel 303 and second circumferential channel 304 may correspond to a distance between the proximal set screw 40 and distal set screw 50, for example, and of course may be adjusted for implants of different lengths.

In this way, toggling between engaging the depressible lock 207 with either one of the first and second circumferential channels 303, 304 may affect whether drive end 301 engages with both the distal set screw 50 and proximal set screw 40 or alternatively just the proximal set screw 40 or just the distal set screw 50, for example. As shown in FIG. 29, the depressible lock 207 may be engaged with the second circumferential channel 304 such that drive end 301 may simultaneously drive both the distal set screw 50 and proximal set screw 40. As shown in FIG. 30, the depressible lock 207 may be engaged with the first circumferential channel 303 (not visible) such that drive end 301 is only engaged with the proximal set screw 40. At least one advantage of this configuration is that an end user such as a surgeon may simultaneously rotate the proximal and distal set screws 40, 50 to cause parallel distraction or rotate only the proximal set screw 40 to cause lordosis, for example.

As illustrated in FIG. 30 and FIG. 31, in at least some embodiments, drive tool 300 may include a necked down portion 305 having a size and shape suitable for only engaging one of the proximal set screw 40 or distal set screw 50 at a time. For example, the necked down portion 305 may have a smaller cross sectional diameter (thickness) than the drive end 301a. This arrangement may be particularly advantageous for engaging only the distal set screw 50 to change a relative height between the superior and inferior endplates 10, 20 at the distal end 100d only, for example. Similarly, this arrangement may be particularly advantageous for engaging only the proximal set screw 40 to change a relative height between the superior and inferior endplates 10, 20 at the proximal end 100p only, for example. Furthermore, when engaging only distal set screw 50, a relative height between the superior and inferior endplates 10, 20 at the distal end 100d may be changed, for example to create kyphosis.

In some embodiments, after implant 100 is expanded into a target configuration suitable for a particular patient, bone graft material (BGM) may be injected into implant 100. For example, flowable bone graft material may be injected under pressure. For example, as shown in FIG. 32, the drive tool 300 may be removed from within the hollow interior of inner shaft 203. Thereafter, bone growth promoting material (BGM) may be injected through the hollow interior of inner shaft 203 and into the interior of implant 100. For example, bone growth promoting material may flow through shaft 203, through set screw 40, through a superior aperture 36 and inferior aperture 37 of support frame 30 (see FIG. 6) and into contact with the endplates of adjacent vertebrae. Additionally, lateral aperture 35 adjacent posts 34, 33 of support frame 30 may allow additional bone growth promoting material to flow out in a lateral direction and into the interior of implant 100 and to surround wedges 60, 70. In this way, the entire interior space of implant 100 may be filled with bone growth promoting material to promote fusion. In some embodiments, flexible curtains (not illustrated) may extend from superior endplate 10 and/or inferior endplate 20 across gaps that may be created between endplates 10, 20 due to expanding the endplates. In some embodiments, a distal most end of distal set screw 50 may also be closed to prevent material from flowing out of distal set screw 50. Additionally, and depending on the type of surgery performed and the various patient anatomy that may contact the implant 100, curtains may not be required, as the patient anatomy would provide a retaining surface to keep material within implant 100. Furthermore, support frame 30 may include a lateral aperture 35 on the lateral side thereof corresponding to the extension direction of tip portion 104 and lateral apertures 16 and 26 of the superior and inferior endplates 10, 20, for example (see also FIGS. 15 and 16). Additionally, in various embodiments, and as explained above, superior endplate 10 may include a lateral aperture 16 (not labeled in FIG. 32) and inferior endplate 20 may include a lateral aperture 26 for allowing BGM material and/or channeling BGM material into the central portion of the disc space away from the anterior rim (see also FIGS. 20A and 20B). For example, BGM material may generally flow in the direction indicated by arrows through implant 100, through lateral aperture 35 of support frame 30, and through lateral apertures 16, 26 of the superior and inferior endplates 10, 20. In this way, BGM may be routed through implant 100 into a central portion of the disc space to facilitate a fusion process due to the lateral apertures 16, 26, 35 all being positioned to allow BGM material to flow into the disc space.

FIG. 33 is a reference drawing showing the human spine of which various disclosed implant embodiments may be installed in. FIG. 34 is a reference drawing showing various planes and reference directions of which the various disclosed implant embodiments may move in or act in with reference to a patient 1.

It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. For example, features, functionality, and components from one embodiment may be combined with another embodiment and vice versa unless the context clearly indicates otherwise. Similarly, features, functionality, and components may be omitted unless the context clearly indicates otherwise. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques).

Unless otherwise specifically defined herein, all terms are to be given their broadest possible interpretation including meanings implied from the specification as well as meanings understood by those skilled in the art and/or as defined in dictionaries, treatises, etc. It must also be noted that, as used in the specification and the appended claims, the singular forms “a.” “an” and “the” include plural referents unless otherwise specified, and that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.