Expandable intervertebral implant and method

Abstract

An apparatus includes a core having a proximal end and a distal end and defining a first internal thread. A drive screw includes a first end and a second end. The first end includes a first external thread. The second end includes a second external thread that engages the first internal thread. A first body includes a second internal thread that engages the first external thread. A second body is coupled to the drive screw. A first plate is coupled to the core and the first body. The first plate includes a first vertebral engagement surface. A second plate is coupled to the core and includes a second vertebral engagement surface. The drive screw is configured to rotate relative to the core to simultaneously pivot the first plate relative to the core and change a distance between the first vertebral engagement surface and the second vertebral engagement surface.

Description

Technical Field

[0001] This disclosure generally relates to medical devices, systems, and methods for treating musculoskeletal disorders, and more specifically to expandable intervertebral implantation systems and methods for treating the spine. Background Technology

[0002] Spinal disorders, such as degenerative disc disease, herniated discs, osteoporosis, vertebral lordosis, spinal stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and fractures, can be caused by factors including trauma, disease, and degenerative conditions resulting from injury and aging. Spinal disorders typically lead to symptoms including pain, nerve damage, and partial or complete loss of mobility. For example, after a disc collapse, severe pain and discomfort can occur due to the pressure exerted on the nerves and spine.

[0003] Non-surgical treatments, such as medication, rehabilitation, and exercise, may be effective; however, they may not relieve the symptoms associated with these conditions. Surgical treatments for these spinal conditions include fusion, fixation, discectomy, laminectomy, and implantable prostheses. These treatments may utilize intervertebral implants. This disclosure describes improvements to these prior art techniques. Summary of the Invention

[0004] In one embodiment, according to the principles of this disclosure, a device for spaced vertebral members includes a core extending along a longitudinal axis between opposing proximal and distal ends. The core defines a first internal thread. A drive screw includes opposing first and second ends. The first end includes a first external thread. The second end includes a second external thread. The second external thread engages with the first internal thread. A first body includes the second internal thread. The first body is coupled to the first end such that the first external thread engages the second internal thread. A second body is coupled to the drive screw. A first plate is coupled to the core and the first body. The first plate includes a first vertebral engagement surface. A second plate is coupled to the core. The second plate includes a second vertebral engagement surface. The drive screw is configured to rotate relative to the core to simultaneously pivot the first plate relative to the core and change the distance between the first and second vertebral engagement surfaces.

[0005] In one embodiment, according to the principles of this disclosure, a device for spaced vertebral members includes a core extending along a longitudinal axis between opposing proximal and distal ends. The core defines a first internal thread. A drive screw includes opposing first and second ends. The first end includes a first external thread. The second end includes a second external thread. The second external thread engages with the first internal thread. A first body includes the second internal thread. The first body is coupled to the first end such that the first external thread engages the second internal thread. A second body is coupled to the drive screw. A first plate is coupled to the core and the first body. The first plate includes a first vertebral engagement surface. A second plate is coupled to the core. The second plate includes a second vertebral engagement surface. The drive screw is configured to rotate relative to the core to simultaneously pivot the first plate relative to the core and change the distance between the first and second vertebral engagement surfaces. The first body includes a first inclined surface. The first plate includes a second inclined surface. The second inclined surface is configured to slide along the first inclined surface to pivot the first plate relative to the core. The second plate includes a plurality of first inclined surfaces. The second body includes a plurality of second inclined surfaces. The second inclined surface is configured to slide along the first inclined surface to change the distance between the first vertebral joint surface and the second vertebral joint surface.

[0006] In one embodiment, according to the principles of this disclosure, a device for spaced vertebral members includes a core extending along a longitudinal axis between opposing proximal and distal ends. The core defines a first internal thread. A drive screw includes opposing first and second ends. The first end includes a first external thread. The second end includes a second external thread. The second external thread engages with the first internal thread. A first body includes the second internal thread. The first body is coupled to the first end such that the first external thread engages the second internal thread. A second body is coupled to the drive screw. A first plate is coupled to the core and the first body. The first plate includes a first vertebral engagement surface. A second plate is coupled to the core. The second plate includes a second vertebral engagement surface. Rotation of the drive screw relative to the core in a first direction moves the device from a first configuration to a second configuration, in which the vertebral surfaces extend parallel to the longitudinal axis and are spaced apart from each other by a first distance, and in the second configuration, the first vertebral surfaces extend at an acute angle relative to the longitudinal axis and are spaced apart from each other by an increased second distance. Attached Figure Description

[0007] This disclosure will become more readily apparent from the specific description accompanying the following figures, in which:

[0008] Figure 1 This is a side view of an embodiment of an implant based on the principles of this disclosure;

[0009] Figure 2 yes Figure 1 A side sectional view of the implant shown;

[0010] Figure 3 yes Figure 1 A side sectional view of the implant shown;

[0011] Figure 4 yes Figure 1 Partial dashed perspective view of the implant shown;

[0012] Figure 5 yes Figure 1 A top view of the implant shown; and

[0013] Figure 6 yes Figure 1 Top view of the implant shown. Detailed Implementation

[0014] Exemplary embodiments of the expandable intervertebral implant system and related methods of use disclosed herein are discussed in relation to medical devices for treating musculoskeletal disorders, and more specifically in relation to expandable intervertebral implant systems and related methods for treating the spine. It is anticipated that the implant system can provide, for example, fusion, decompression, restoration of sagittal balance, and resistance to subduction into tissues, such as the surface of the vertebral endplate.

[0015] In some embodiments, the expandable interbody implant of the system disclosed herein is used to achieve implant geometry that is otherwise impossible or difficult to insert with minimal morbidity. The expandable interbody implant allows expansion in two ways. One component increases the total height of the implant (parallel expansion), while another component manipulates the angle of the implant while the first component increases the total height of the implant.

[0016] In some embodiments, both parallel and angular expansion are infinitely adjustable (within a specified range). In some embodiments, the implant is configured to cover all clinically required size combinations (angle and height) with a single implant. In some embodiments, the implant is backfilled with a bone graft.

[0017] It is foreseeable that, since any combination of height and angle of the implant is available, the implant provides the ability to closely match the geometry of the patient's intervertebral disc. Because only one or a few implants of different sizes are needed to match any intervertebral disc geometry, manufacturing costs can be significantly reduced, thereby streamlining production and logistics. The number of instruments required for implant placement is also reduced. Due to the capabilities of the implants disclosed herein, the system of this disclosure also prevents the need for trial or incorrect selection, which will also reduce traditional surgical steps.

[0018] In some embodiments, the expandable interbody implant of the system disclosed herein includes a single screw to allow for an increase in graft volume as the device expands. The implant includes a left-hand thread engaging the screw to allow the first portion to advance faster than the second portion.

[0019] It is foreseeable that this disclosure can be used to treat spinal conditions such as degenerative disc disease, herniated disc, osteoporosis, vertebral lordosis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and fractures. This disclosure is also considered for other bone and bone-related applications, including those related to diagnosis and treatment. Further consideration has been given to the fact that the disclosed expandable intervertebral implant can be used alternatively in surgical procedures performed on patients in a prone or supine position, and / or with various surgical approaches to the spine, including anterior, posterior, posterior midline, midline, lateral, posterolateral, and / or anterolateral approaches, as well as in other body regions. The expandable intervertebral implant of this disclosure can also be used alternatively in surgical procedures treating the lumbar, cervical, thoracic, and pelvic regions of the spine. The expandable intervertebral implant and methods of this disclosure can also be used in animals, bone models, and other non-living substrates, for example, for training, testing, and demonstration.

[0020] This disclosure can be more readily understood by referring to the following detailed description of the accompanying drawings, which form a part of this disclosure. It should be understood that this disclosure is not limited to the specific apparatus, methods, conditions, or parameters described and / or shown herein, and the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to limit the claimed disclosure. Furthermore, as used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and unless the context clearly indicates otherwise, references to a particular numerical value include at least that particular value. A range may be expressed herein as from “about” or “approximately” one particular value and / or to “about” or “approximately” another particular value. In expressing this range, another embodiment includes from one particular value and / or to another particular value. Similarly, when a numerical value is expressed as an approximation using the antecedent “about,” it should be understood that the particular value forms another embodiment. It should also be understood that all spatial references, such as horizontal, vertical, top, upper, lower, bottom, outside, inside, end (indicating position and location), left and right, rear, front, etc., are for illustrative purposes only and may vary within the scope of this disclosure. For example, the references “above” and “below” are relative and are used only in the context of other references, and are not necessarily “upper” and “lower”.

[0021] Furthermore, as used in the specification and including the appended claims, “treatment” for a disease or condition refers to a procedure undertaken to attempt to alleviate the signs or symptoms of the disease or condition, which may include the administration of one or more medications to a patient. Relief may occur before or after the signs or symptoms of the disease or condition appear. Thus, treatment includes prevention or avoidance of the disease or adverse condition (e.g., preventing the disease from occurring in patients who may be susceptible to the disease but have not yet been diagnosed with it). Furthermore, treatment does not require complete relief of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment may include suppressing the disease, such as halting its progression, or alleviating the disease, such as causing disease regression. For example, treatment may include reducing acute or chronic inflammation; relieving pain; mitigating and inducing the regrowth of new ligaments, bones, and other tissues; as an adjunct to surgery; and / or any reparative surgical procedure. Furthermore, as used in the specification and including the appended claims, unless otherwise specifically indicated, the term “tissue” includes soft tissue, ligaments, tendons, cartilage, and / or bone.

[0022] The following discussion includes a description of expandable interbody implants based on the principles of this disclosure and related methods of using the expandable interbody implants. Alternative embodiments are also disclosed. Exemplary embodiments of this disclosure will now be described in detail with reference to the accompanying drawings. Turning now to... Figures 1 to 6 The diagram shows the components of an interbody implantation system 300 according to the principles of this disclosure.

[0023] Components of System 300 may be made of biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone materials and / or composites thereof, depending on the specific application and / or preference of the practicing physician. For example, components of System 300 may be made individually or collectively of materials such as stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, stainless steel alloys, and superelastic metal alloys (e.g., nickel-titanium alloys, such as GUM manufactured by Toyota Material Incorporated of Japan). Superelastic plastics and metals), ceramics and their composites (such as calcium phosphate (e.g., SKELITE manufactured by Biologix) TMThermoplastics (e.g., polyaryletherketone (PAEK), including polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and polyetherketone (PEK)), carbon-PEEK composites, PEEK-BaSO4 polymer rubber, polyethylene terephthalate (PET), fabrics, silicone, polyurethane, silicone-polyurethane copolymers, polymer rubber, polyolefin rubber, hydrogels, semi-rigid and rigid materials, elastomers, rubber, thermoplastic elastomers, thermosetting elastomers, elastomer composites, including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, and epoxy resins. Rigid polymers, bone materials including autologous grafts, allogeneic grafts, xenografts, or transgenic cortical and / or cortical cancellous bone, as well as tissue growth or differentiation factors, partially reabsorbable materials (e.g., composites of metals and calcium-based ceramics, composites of PEEK and calcium-based ceramics, composites of PEEK and reabsorbable polymers), fully reabsorbable materials (e.g., calcium-based ceramics, such as calcium phosphate, tricalcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate), or other reabsorbable polymers (e.g., polylactide, polyglycolic acid, polytyrosine carbonate, polycaprolactone), and combinations thereof. Various components of system 300 can be manufactured from material composites including the aforementioned materials to achieve various desired properties, such as strength, stiffness, elasticity, flexibility, compliance, biomechanical properties, durability, and radiation permeability or imaging preference. Components of system 300 can also be made individually or collectively from heterogeneous materials, such as combinations of two or more of the aforementioned materials.

[0024] System 300 can be used in fusion and fixation procedures, for example, for patients with spinal disorders, to provide intervertebral height restoration, decompression, sagittal balance restoration, and / or resistance to subduction into the vertebral endplates. Components of System 300 may be integrally formed, integrally connected, or include fastening elements and / or devices, as described herein.

[0025] System 300 includes an implant, such as an intervertebral implant 314. Implant 314 is configured to expand both parallel and at an angle, as described herein. Implant 314 is configured to be positioned within an intervertebral space, wherein the height and angle of implant 314 can selectively increase and / or decrease as implant 314 is positioned within the intervertebral space. The height and angle of implant 314 increase and / or decrease simultaneously. That is, the height of implant 314 cannot be increased or decreased without increasing or decreasing the angle of implant 314, and vice versa.

[0026] Implant 314 includes a core 316, a member 318, a member 320, a plate 322, and a plate 324. Implant 314 also includes a drive screw 326 having an external thread 328 configured to engage with an internal thread 330 of member 318 and an external thread 332 configured to engage with an internal thread 334 of core 316, such that rotation of screw 326 relative to core 316 and member 318 causes members 318 and 320 to translate along longitudinal axis X1 in a first direction, simultaneously increasing and / or decreasing the angle and height of implant 314. Screw 326 includes an unthreaded portion 336 extending through an opening in member 320, such that when the angle and height of implant 314 simultaneously increase and / or decrease, screw 326 is rotatable relative to member 320 to cause member 320 to translate along axis X1. Figure 3 Translate in the directions indicated by the middle arrows A and B.

[0027] In some embodiments, at least one of threads 328, 330, 332, and 334 is a right-hand thread, and at least one of threads 328, 330, 332, and 334 is a left-hand thread. In some embodiments, threads 328 and 330 are right-hand threads, while threads 332 and 334 are left-hand threads, to allow member 318 to advance faster than member 320 when the screw 326 rotates relative to the core 316 and member 318 to cause members 318 and 320 to translate together in opposite directions along axis X1, as described herein. In some embodiments, threads 328 and 330 are threads with the opposite helix to threads 332 and 334, to allow member 318 to advance faster than member 320 when the screw 326 rotates relative to the core 316 and member 318 to translate members 318 and 320 together in opposite directions along axis X1, as described herein.

[0028] When the screw 326 rotates about axis X1 in the first rotational direction, the screw 326 moves along axis X1. Figure 3 The component 318 is translated in the direction indicated by arrow A, such that it is moved along axis X1. Figure 3 The component 320 moves in the direction indicated by arrow A, and along axis X1... Figure 3 Translation in the direction indicated by arrow A, the surface or inclined surface 340 of member 318 slides along the surface or inclined surface 342 of plate 322, while the inclined surface 344 of member 320 slides along the inclined surface 346 of plate 324, to simultaneously increase the angle and height of implant 314. In some embodiments, the cavity 345 of implant 314 is configured for placing material, such as bone graft material, and the cavity 345 has a first volume v1 before the angle and height of implant 314 are increased, such as... Figure 5 As shown, and with an increased second volume v2 following the increase in the angle and height of the implant 314, as... Figure 6As shown. In some embodiments, plate 322 is coupled to core 316 by a pin 412 extending through an opening 414 in core 316 and an opening 416 in plate 322, such that plate 322 is pivotable relative to core 316 about pin 412. In some embodiments, opening 414 includes first and second openings 414 spaced apart, opening 416 includes a first opening 416 aligned with the first opening 414 and a second opening 416 aligned with and spaced apart from the first opening 416, and 412 includes a first pin 412 extending through the first openings 414 and 416 and a second pin 412 extending through the second openings 414 and 416, such that the second pin 412 is spaced apart from the first pin 412.

[0029] When the screw 326 rotates about axis X1 in the opposite second rotational direction, the screw 326 along axis X1... Figure 3 The component 318 is translated in the direction indicated by arrow B, such that it is moved along axis X1. Figure 3 The component 320 moves in the direction indicated by arrow B, and moves along axis X1. Figure 3 The inclined surface 338 slides along the inclined surface 340, while the inclined surface 342 of the member 320 slides along the inclined surface 344 of the plate 324, so as to simultaneously reduce the angle and height of the implant 314.

[0030] A core 316 extends along a central longitudinal axis X1 between a distal end 350 and an opposing proximal end 360. The core 316 includes a wall 352 defining a thread 334. The inner surfaces of the thread 334 and the wall 352 define a channel 354. In some embodiments, the channel 354 is coaxial with the axis X1. In some embodiments, the channel 354 may be arranged in an alternating orientation relative to the axis X1, such as laterally and / or at other angles, such as acute or obtuse angles, and / or may be offset or staggered.

[0031] The wall 352 includes end segments 356 and 358 and an intermediate segment 362 located between segments 356 and 358. Segment 356 is configured to be positioned in a recess 364 of the plate 322 prior to expansion of the implant 314, such that a portion of the top surface 366 of the wall 352 is flush with or substantially flush with the vertebral engagement surface 368 of the plate 322. That is, prior to expansion of the implant 314, a portion of the defining segment 356 of surface 366 is flush with or substantially flush with surface 368 of the plate 322. Segment 358 is configured to be positioned in a gap 370 of the plate 322 prior to angular expansion of the implant 314, such that surface 366 is flush with or substantially flush with surface 368. That is, prior to expansion of the implant 314, a portion of the defining segment 358 of surface 366 is flush with or substantially flush with surface 368. In some embodiments, segment 356 includes spaced-apart extensions 356a, 356b, and recess 364 includes spaced-apart recesses 364, each recess configured to accommodate one of the extensions 356a, 356b. Segment 362 is configured to be disposed in recess 372 of plate 322 prior to angular expansion of implant 314, such that surface 366 is flush with or substantially flush with surface 368. That is, prior to expansion of implant 314, a portion of the portion defining segment 362 of surface 366 is flush with or substantially flush with surface 368. In some embodiments, segments 356, 358, 362, recess 364, gap 370, and / or recess 372 may have a variety of shape configurations, such as circular, elliptical, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, and / or conical.

[0032] The wall 352 includes end segments 374 and 376 and an intermediate segment 378 located between segments 374 and 376. Segment 374 is configured to be positioned in a recess 380 of the plate 324 prior to expansion of the implant 314, such that a portion of the bottom surface 382 of the wall 352 is flush with or substantially flush with the vertebral engagement surface 384 of the plate 324. That is, prior to expansion of the implant 314, a portion of the defining segment 374 of the surface 382 is flush with or substantially flush with the surface 384 of the plate 324. Segment 376 is configured to be positioned in a gap 386 of the plate 324 prior to angular expansion of the implant 314, such that the surface 382 is flush with or substantially flush with the surface 384. That is, prior to expansion of the implant 314, a portion of the defining segment 376 of the surface 382 is flush with or substantially flush with the surface 384. Segment 378 is configured to be positioned in a recess 388 of plate 322 prior to angular expansion of implant 314, such that surface 382 is flush with or substantially flush with surface 384. That is, prior to expansion of implant 314, a portion of the defining segment 378 of surface 382 is flush with or substantially flush with surface 384. In some embodiments, segments 374, 376, 378, recess 380, gap 386, and / or recess 388 may have various shape configurations, such as circular, elliptical, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, and / or conical.

[0033] Component 318 is configured to translate relative to core 316 in opposite directions along axis X1 to selectively increase and decrease the angle of implant 314, as discussed herein. Screw 326 is configured to be disposed in a channel 390 of component 318 defined by thread 330, such that thread 328 engages thread 330. Rotation of screw 326 relative to core 316 about axis X1 in a first rotational direction (e.g., clockwise) will cause component 318 relative to core 316 in a first axial direction (e.g., clockwise) along axis X1. Figure 3 The screw 326 translates in the direction indicated by the middle arrow A, and the screw 326 rotates relative to the core 316 about the axis X1 in the opposite rotational direction (e.g., counterclockwise), which will cause the member 318 to move relative to the core 316 along the axis X1 in the opposite cross-sectional axial direction (e.g.,...). Figure 3 Translate in the direction indicated by the middle arrow B.

[0034] When component 318 is relative to core 316 along axis X1 Figure 3 When translated in the direction indicated by the middle arrow A, the inclined plane 340 slides along the inclined plane 342 to increase the angle of the implant 314. For example, the member 318 may be positioned relative to the core 316 along axis X1. Figure 3Translation in the direction indicated by the middle arrow A to move the implant 314 from the first orientation to the second orientation, in which the longitudinal axis X2 defined by the plate 322 extends parallel to the axis X1, as shown in the image. Figure 1 and 2 As shown, in the second orientation, axis X2 extends at an acute angle relative to axis X1, as... Figure 3 As shown. When the implant 314 moves between the first and second orientations, the longitudinal axis X3 defined by the plate 324 extends parallel to the axis X1. In some embodiments, the bevel 340 includes a protrusion, such as a flange 392, which slides within a groove 394 of the bevel 342 as the implant 314 moves between the first and second orientations. In some embodiments, the bevel 342 includes a protrusion, such as a flange, which slides within a groove of the bevel 340 as the implant 314 moves between the first and second orientations.

[0035] When component 318 is relative to core 316 along axis X1 Figure 3 When translated in the direction indicated by the middle arrow B, the inclined plane 340 slides along the inclined plane 342 to reduce the angle of the implant 314. For example, the member 318 can be positioned relative to the core 316 along axis X1. Figure 3 Translation in the direction indicated by the middle arrow B, to move the implant 314 from its second orientation (as shown by the arrow) where its central axis X2 extends at an acute angle relative to axis X1. Figure 3 As shown, it moves to the first orientation in which the longitudinal axis X2 defined by plate 322 extends parallel to axis X1 (as shown). Figure 1 and 2 (As shown).

[0036] The screw 326 includes a socket 396 configured to accommodate a drill bit of a drive member configured to rotate the screw 326 relative to the core 316 in opposite directions about axis X1, as discussed herein. In some embodiments, the socket 396 includes a hexagonal cross-sectional configuration configured to engage a drill bit of a drive member having a hexagonal cross-sectional configuration to rotate the screw 326. However, it is contemplated that the socket 396 may include square, triangular, polygonal, or star-shaped cross-sectional configurations configured to engage drill bits of a corresponding shape of the drive member.

[0037] Component 320 is configured to translate relative to core 316 in opposite directions along axis X1 to selectively increase and decrease the height of implant 314, as described herein. Thread 332 engages thread 334 such that rotation of screw 326 relative to core 316 about axis X1 in a first rotational direction (e.g., clockwise) will cause screw 326 to rotate along axis X1 and component 320 in a first axial direction (e.g., clockwise). Figure 3Translation in the direction indicated by the middle arrow A, and rotation of the screw 326 relative to the core 316 about axis X1 in the opposite rotational direction (e.g., counterclockwise), will cause the screw 326 and the component 320 to move along axis X1 in opposite cross-sectional axial directions (e.g.,...). Figure 3 Translate in the direction indicated by the middle arrow B.

[0038] When component 320 is relative to core 316 along axis X1 Figure 3 When translated in the direction indicated by the middle arrow A, surface 344 slides along surface 346 to increase the height of implant 314, wherein the height of implant 314 is defined by the distance from surface 368 to surface 384. For example, member 320 may be positioned relative to core 316 along axis X1. Figure 3 Translate in the direction indicated by the middle arrow A to move the implant 314 from the... Figure 1 and 2 As shown, the implant 314 has a first configuration with a first maximum height H1, which is moved as follows: Figure 3 The implant 314 shown has a second configuration with an increased second height H2. As the implant 314 moves between the first and second configurations, axis X3 extends parallel to axis X1.

[0039] When component 320 is relative to core 316 along axis X1 Figure 3 When translated in the direction indicated by the middle arrow B, surface 344 slides along surface 346 to reduce the height of implant 314. For example, member 320 may be positioned relative to core 316 along axis X1. Figure 3 Translate in the direction indicated by the middle arrow B to move the implant 314 from the second configuration of the implant 314 having a height H2 (as shown by the middle arrow B). Figure 3 (As shown) Moved to the first configuration of implant 314 with height H1.

[0040] Component 320 includes an engagement portion 398 configured to engage a screw 326 to connect the screw 326 to component 320, as described herein. The portion 398 defines an opening 338. The opening 338 is configured to accommodate the screw 326 such that the screw 326 is rotatable relative to component 320, and translation of the screw 326 relative to the core 316 in a first direction along axis X1 also causes translation of component 320 relative to the core 316 in the first direction along axis X1, and translation of the screw 326 relative to the core 316 in the opposite second direction along axis X1 also causes translation of component 320 relative to the core 316 in the second direction along axis X1. In some embodiments, the opening 338 may have various shape configurations, such as elliptical, rectangular, polygonal, irregular, uniform, non-uniform, deformable, and / or conical.

[0041] Component 320 includes an arm 400 extending from a first side of portion 398 and an arm 402 extending from a second side of portion 398. Arm 402 is spaced apart from arm 400 by portion 398. Arm 400 includes spaced-apart extensions, such as flanges 404, 406 extending outward from arm 400, while arm 402 includes spaced-apart extensions, such as flanges 408, 410 extending outward from arm 402. Flanges 404, 406, 408, 410 define a surface 344. In some embodiments, flanges 404, 406, 408, 410 each include a surface 344 and a surface 344 opposite to surface 344. That is, flanges 404, 406, 408, 410 each include a surface 344 and a surface 344 facing away from surface 344.

[0042] In operation and use, System 300 is used in conjunction with surgical procedures, such as fusion treatment of the patient's spine involving the vertebrae and adjacent body regions, as described herein. System 300 can also be used for other surgical procedures, such as discectomy, laminectomy, nerve root retraction, foraminal incision, facet resection, decompression, and spinal, nucleus pulposus, or disc replacement.

[0043] For example, system 300 can be used in conjunction with surgical joint fixation procedures, such as interbody fusion for treating conditions or injuries to the affected portion of the spine and adjacent areas within the body (e.g., the intervertebral disc space between the first and second vertebrae). Consideration is given to the possibility that the intervertebral implant 314 of system 300 can be inserted within the intervertebral disc space to space the articular surfaces, providing support and maximizing vertebral stability. Further consideration is given to the possibility that the intervertebral implant 314 provides height restoration between vertebrae, decompression, sagittal balance restoration, and / or resistance to subduction into the vertebral endplates.

[0044] In use, to treat the affected vertebral portion, the practitioner obtains access to the surgical site, including the vertebra, in any appropriate manner, such as through incision and contraction of tissue. It is foreseeable that the system 300 can be used in any existing surgical method or technique, including open surgery, micro-open surgery, minimally invasive surgery, and percutaneous surgical implantation, thereby accessing the vertebra through a micro-incision or cannula providing a protected passage to the region. Once access to the surgical site is obtained, a specific surgical procedure is performed to treat the spinal condition. The aforementioned interbody implant 314 is then used to enhance the surgical treatment. The interbody implant 314 can be delivered or implanted as a pre-assembled device, or it can be assembled in situ. The interbody implant 314 can be completely or partially modified, removed, or replaced in situ. It is considered that one or all components of the interbody implant system can be delivered to the surgical site by manual manipulation and / or freehand techniques. Further consideration is given to the possibility that the interbody implant 314 can be inserted posteriorly and then manipulated anteriorly and / or laterally and / or medially.

[0045] An incision is made within the patient, and cutting instruments create a surgical path for implanting the intervertebral implant 314. A guiding instrument is used to initially separate the first and second vertebrae. A sleeve or cannula is used to access the intervertebral disc space and facilitate the delivery and access of components of the intervertebral implant system. A preparation instrument can be inserted into the sleeve or cannula and positioned within the intervertebral disc space. The preparation instrument can be used to remove some or all of the intervertebral disc tissue, including the disc nucleus and fluid, adjacent tissue and / or bone, corticalize, scrape and / or remove tissue from the endplate surfaces of the first and second vertebrae, and aspirate and flush the area as required by the specific surgical application.

[0046] like Figure 1 and 2 As shown, an implant 314 is inserted into the patient using an instrument such as an inserter, wherein the implant 314 is configured to be undeployed or unexpanded. The implant 314 is delivered along the surgical path using a substantially posterior approach to position the implant 314 within the intervertebral disc space.

[0047] When it is desired to position the intervertebral implant 314 within the intervertebral disc space, the implant 314 unfolds within the intervertebral disc space to allow the implant 314 to be positioned as follows: Figure 1 and 2 The undeployed or unexpanded configuration shown (where implant 314 has a height H1 and axis X2 extends parallel to axis X1) is moved as follows: Figure 3The illustrated unfolded or expanded configuration (where the height and angle of implant 314 are increased, resulting in a height H2, and axis X2 extending at an acute angle relative to axis X1). Implant 314 is moved from a non-unfurled or non-expanded configuration to an unfolded or expanded configuration by inserting the drill bit of the drive member into recess 396, such that the drill bit engages with recess 396, and rotation of the drive member also rotates the screw 326. The drive member rotates in a first rotational direction, causing the screw 326 relative to the core 316 along axis X1. Figure 3 The screw 326 is translated in the direction indicated by the middle arrow A, causing the screw 326 to move relative to the core 326 along the axis X1. Figure 3 Translate components 318 and 320 in the direction indicated by the middle arrow A. When component 318 is relative to core 316 along axis X1... Figure 3 When translated in the direction indicated by the middle arrow A, the inclined plane 340 slides along the inclined plane 342 to increase the angle of the implant 314. When the member 320 is positioned relative to the core 316 along axis X1... Figure 3 When translated in the direction indicated by the middle arrow A, surface 344 slides along surface 346 to increase the height of implant 314.

[0048] When implant 314 moves from a non-deployed or non-expanded configuration to a deployed or expanded configuration, surface 368 moves away from surface 384, causing surfaces 368 and 384 to press against the vertebrae, thereby moving the first vertebra away from the second vertebra and increasing the size of the intervertebral disc space. Considering both the deployed and expanded configurations, the intervertebral implant 314 provides height restoration, decompression, sagittal balance restoration, and resistance to subduction into the vertebral endplates between the first and second vertebrae. Implant 314 can be retained in the deployed or expanded configuration to maintain the increased size of the intervertebral disc space. In some embodiments, a material such as a bone graft is inserted into implant 314 to promote bone growth, thereby fusing the first and second vertebrae.

[0049] In some embodiments, the bone graft may be a particulate material that may include osteoconductive materials such as HA and / or bone-inducing agents such as bone morphogenetic proteins (BMPs) to enhance bone fixation of the intervertebral implant 314 to adjacent vertebrae. The bone graft may include therapeutic polynucleotides or peptides. Further consideration has been given to the pharmaceutical and / or bone graft composition that may include biocompatible materials, such as biocompatible metals and / or rigid polymers, such as elemental titanium, titanium powder, or titanium compositions; sterile bone materials, such as allogeneic or xenograft materials; synthetic bone materials, such as coral and calcium compositions, such as HA, calcium phosphate, and calcium sulfite; bioactive agents; and stepwise release compositions, such as by blending in a bioresorbable polymer, wherein the polymer releases one or more bioactive agents in a suitable time-dependent manner as the polymer degrades in the patient's body. Suitable bioactive agents include, for example, BMPs, growth and differentiation factor proteins (GDFs), and cytokines. The intervertebral implant 314 may be made of a radiation-permeable material such as a polymer. It may include radiolabels for identification under X-ray, fluoroscopy, CT, or other imaging techniques. It is foreseeable that bone grafts may include one or more therapeutic agents and / or agents for release, including sustained release, to treat, for example, pain, inflammation, and degeneration.

[0050] It is foreseeable that components of a system 300, which may include one or more intervertebral implants 314, can be delivered to the surgical site via alternative methods. In one embodiment, the intervertebral implant 314 is delivered into the intervertebral disc space via a surgical path along a transforaminal lumbar interbody fusion method and is configured in an unfolded or expanded configuration. In one embodiment, multiple intervertebral implants 314 are delivered into the intervertebral disc space via a surgical path along a posterior lumbar interbody fusion method and are configured in an unfolded or expanded configuration with a side-by-side orientation.

[0051] In some embodiments, the intervertebral implant 314 may expand from a non-deployed or non-expanded configuration to an alternating configuration between a non-deployed or non-expanded configuration and a deployed or expanded configuration. In some embodiments, the intervertebral implant 314 may retract from a deployed or expanded configuration to an alternating configuration between a deployed or expanded configuration and a non-deployed or non-expanded configuration.

[0052] By inserting the drill bit of the drive unit into the socket 396, causing the drill bit to engage with the socket 396, and by rotating the drive unit, also causing the screw 326 to rotate, the implant 314 can be moved from an expanded or discontinuous configuration to an unexpanded or non-discontinuous configuration. The drive unit rotates in the opposite direction of rotation, causing the screw 326 relative to the core 316 along the axis X1. Figure 3 The screw 326 is translated in the direction indicated by the middle arrow B, causing the screw 326 to move relative to the core 326 along the axis X1. Figure 3Translate components 318 and 320 in the direction indicated by the middle arrow B. When component 318 is relative to core 316 along axis X1... Figure 3 When translated in the direction indicated by the middle arrow B, the inclined plane 340 slides along the inclined plane 342 to reduce the angle of the implant 314. When the member 320 is positioned relative to the core 316 along axis X1... Figure 3 When translated in the direction indicated by the middle arrow B, surface 344 slides along surface 346 to reduce the height of implant 314. Once implant 314 is in an undeployed or unexpanded configuration, implant 314 can be moved within and / or removed from the intervertebral disc space as needed.

[0053] It should be understood that various modifications can be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as examples of various embodiments. Other modifications can be made by those skilled in the art within the scope and spirit of the appended claims.

Claims

1. A device for separating vertebral components, the device comprising: A core extending along a longitudinal axis between opposing proximal and distal ends, the core defining a first internal thread; A transmission screw includes a first end and a second end, the first end including a first external thread and the second end including a second external thread, the second external thread engaging the first internal thread; A first body containing a second internal thread is connected to the first end such that the first external thread engages with the second internal thread. The second body is connected to the transmission screw; A first plate, comprising a first vertebral engagement surface, is connected to the core and the first body; and A second plate is attached to the core, the second plate including a second vertebral engagement surface. The drive screw is configured to rotate relative to the core so as to simultaneously pivot the first plate relative to the core and change the distance between the first vertebral engagement surface and the second vertebral engagement surface; as well as The second plate includes a plurality of first inclined surfaces, and the second body includes a plurality of second inclined surfaces. The second inclined surfaces are configured to slide along the first inclined surfaces to change the distance between the first vertebral engagement surfaces and the second vertebral engagement surfaces.

2. The apparatus according to claim 1, wherein, The first body includes a first inclined surface, and the first plate includes a second inclined surface, the second inclined surface being configured to slide along the first inclined surface to pivot the first plate relative to the core.

3. The apparatus according to claim 1, wherein, The second internal thread is a left-hand thread, and the first internal thread is a right-hand thread.

4. The apparatus according to claim 1, wherein, The first external thread and the second internal thread are left-hand threads, and the second external thread and the first internal thread are right-hand threads.

5. The apparatus according to claim 1, wherein, The large diameter of the first internal thread is smaller than the large diameter of the second internal thread.

6. The apparatus according to claim 1, wherein, At least one of the core, the first body, the second body, the first plate, and the second plate is made of polyetheretherketone.

7. The apparatus according to claim 1, wherein, The drive screw includes a threadless portion between the first external thread and the second external thread, the threadless portion being positioned in an opening of the second body such that the drive screw can rotate relative to the second body, and translation of the drive screw along the longitudinal axis causes translation of the second body along the longitudinal axis.

8. The apparatus according to claim 7, wherein, The opening is circular.

9. The apparatus according to claim 1, wherein, The rotation of the drive screw relative to the core in a first direction moves the device from a first configuration to a second configuration, in which the vertebral surfaces extend parallel to the longitudinal axis and are spaced apart from each other by a first distance, and in the second configuration, the first vertebral surfaces extend at an acute angle relative to the longitudinal axis and are spaced apart from each other by an increased second distance.

10. The apparatus according to claim 9, wherein, When the device moves from the first configuration to the second configuration, the first body moves toward the second body.

11. The apparatus according to claim 9, wherein, The rotation of the drive screw in the opposite direction relative to the core moves the device from the second configuration to the first configuration.

12. The apparatus according to claim 9, wherein, The first internal thread defines a cavity, which has a first volume when the device is in the first configuration and an increased second volume when the device is in the second configuration.

13. The apparatus according to claim 9, wherein, When the device is in the second configuration, the surface of the second vertebra extends parallel to the longitudinal axis.

14. The apparatus according to claim 9, wherein, When the device moves between the first configuration and the second configuration, the protrusion of the first body slides within the groove of the first plate.

15. The apparatus according to claim 9, wherein, The longitudinal axis is a first longitudinal axis, and the second internal thread defines a channel that extends along the second longitudinal axis. When the device moves between the first configuration and the second configuration, the second longitudinal axis is coaxial with the first longitudinal axis.

16. The apparatus according to claim 9, wherein, The longitudinal axis is a first longitudinal axis, and the second body extends along a second longitudinal axis. When the device moves between the first configuration and the second configuration, the second longitudinal axis is parallel to the first longitudinal axis.

17. The apparatus according to claim 1, wherein, The first plate is connected to the core by a pin, allowing the first plate to pivot relative to the core about the pin.

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