Expandable intervertebral implant and method

Abstract

The invention is an expandable intervertebral implant and method. A device includes a core defining a first internal thread and a second internal thread. A first member includes a first body and a first drive screw coupled to the first body, the first drive screw configured to engage the first internal thread. A second member includes a second body and a second drive screw coupled to the second body, the second drive screw configured to engage the second internal thread. A first plate is coupled to the core and the first body. The first plate includes a first vertebral engaging surface. A second plate is coupled to the core and the second body. The second plate includes a second vertebral engaging surface. The drive screws are configured to rotate independently relative to the core to pivot the first plate relative to the core and change a distance between the first vertebral engaging surface and the second vertebral engaging 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 implant systems and methods for treating the spine. Background Technology

[0002] Spinal disorders (such as degenerative disc disease, herniated disc, osteoporosis, vertebral lordosis, 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 collapses, severe pain and discomfort can occur due to the pressure exerted on nerves and the 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 can utilize intervertebral implants. This disclosure describes improvements to these prior art. 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 and a second internal thread. A first member includes a first body and a first drive screw coupled to the first body. The first drive screw has a first external thread configured to engage the first internal thread. A second member includes a second body and a second drive screw coupled to the second body. The second drive screw has a second external thread configured to engage the second internal thread. 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 the second body. The second plate includes a second vertebral engagement surface. The drive screw is configured to rotate independently relative to the core, causing the first plate to pivot relative to the core and change the distance between the first vertebral engagement surface and the second vertebral engagement surface.

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

[0006] In one embodiment, according to the principles of this disclosure, a device for spaced out vertebral components includes a core extending along a longitudinal axis between opposing proximal and distal ends. The core defines a first internal thread and a second internal thread spaced apart from the first internal thread. The greater diameter of the first internal thread is smaller than the greater diameter of the second internal thread. A first component includes a first body and a first drive screw coupled to the first body. The first drive screw has a first external thread configured to engage the first internal thread. A second component includes a second body and a second drive screw coupled to the second body. The second drive screw has a second external thread configured to engage the second internal thread. The first drive screw and the second drive screw are coaxial. The second drive screw includes a drilled hole coaxial with a central longitudinal axis defined by the first drive screw, such that an instrument can be positioned through the drilled hole and into a socket of the first 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 the second body. The second plate includes a second vertebral engagement surface. The drive screw is configured to rotate independently relative to the core, causing the first plate to pivot relative to the core and changing the distance between the first vertebral engagement surface and the second vertebral engagement surface. Rotation of the first drive screw relative to the core causes the first body to translate along the longitudinal axis, causing the first plate to pivot relative to the core, moving the device from a first orientation to a second orientation in which the first vertebral engagement surface extends parallel to the longitudinal axis and the second vertebral engagement surface, and in the second orientation in which the first vertebral engagement surface extends at an acute angle relative to the longitudinal axis and the second vertebral engagement surface. Rotation of the first drive screw relative to the core in an opposite second rotational direction causes the first body to translate along the longitudinal axis in an opposite second direction, causing the first plate to pivot relative to the body, moving the device from the second orientation to the first orientation. Rotation of the second drive screw relative to the core in the first rotational direction causes the second body to translate relative to the core along the longitudinal axis in a first longitudinal direction, moving the device from a first configuration to a second configuration in which the vertebral engagement surfaces are spaced apart by a first distance, and in the second configuration in which the vertebral engagement surfaces are spaced apart by a second distance. The second distance is greater than the first distance. The rotation of the second drive screw relative to the core in the opposite second rotational direction causes the second body to translate along the longitudinal axis in the opposite second longitudinal direction, thereby moving the device from the second configuration to the first configuration.The second body includes an inclined surface that slides along the inclined surface of the second plate as the second body translates relative to the core along the longitudinal axis to move the device from the first configuration to the second configuration. The second plate includes a plurality of tracks, each extending perpendicular to the longitudinal axis, and the core includes a plurality of slots, each extending perpendicular to the longitudinal axis. As the device moves between the first configuration and the second configuration, each track translates within one of the slots. 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 perspective view of an embodiment of an implant based on the principles of this disclosure;

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

[0010] Figure 3 yes Figure 1 The image shows a side view of the implant components, with some parts separated.

[0011] Figure 4 yes Figure 1 The side cross-sectional view of the implant shown is shown.

[0012] Figure 5 yes Figure 1 The side cross-sectional view of the implant shown is shown.

[0013] Figure 6 yes Figure 1 A perspective view (partially outlined) of the components of the implant shown;

[0014] Figure 7 yes Figure 1 A perspective view of the components of the implant shown;

[0015] Figure 8 yes Figure 1 A perspective view of the components of the implant shown;

[0016] Figure 9 yes Figure 1 A perspective view of the components of the implant shown;

[0017] Figure 10 yes Figure 1 A perspective view of the components of the implant shown;

[0018] Figure 11 yes Figure 1 A side view of the components of the implant shown;

[0019] Figure 12 yes Figure 1 A perspective view of the components of the implant shown;

[0020] Figure 13 yes Figure 1 A perspective view of the components of the implant shown;

[0021] Figure 14 yes Figure 1 A perspective view of the components of the implant shown;

[0022] Figure 15 yes Figure 1 A perspective view of the components of the implant shown;

[0023] Figure 16 yes Figure 1 A perspective view of the components of the implant shown;

[0024] Figure 17 yes Figure 1 A perspective view of the implant shown (partially outlined);

[0025] Figure 18 yes Figure 1 A perspective view of the implant shown (partially outlined);

[0026] Figure 19 yes Figure 1 A side view of the components of the implant shown;

[0027] Figure 20 The instruments are connected to the system based on the principles of this disclosure. Figure 1 The side view of the implant shown;

[0028] Figure 21 It is connected to Figure 20 The instrument shown Figure 1 A perspective view of the implant shown (partially outlined);

[0029] Figure 22 It is connected to Figure 20 The instrument shown Figure 1 The side view of the implant shown; and

[0030] Figure 23 It is connected to Figure 20 The instrument shown Figure 1 The side view of the implant shown. Detailed Implementation

[0031] Exemplary embodiments of the expandable intervertebral implants and related uses 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 conceivable that the implant system can provide, for example, fusion, decompression, sagittal balance restoration, and resistance to subduction into tissues (e.g., the surface of the vertebral endplate).

[0032] In some embodiments, the expandable interbody implants of the systems disclosed herein are used to achieve implant geometry that is otherwise impossible or difficult to insert with minimal morbidity. The expandable interbody implants allow expansion in two independent, controlled manner. One component increases the overall height of the implant (parallel expansion), while another component manipulates the angle of the implant's endplates.

[0033] In some embodiments, both independent parallel expansion 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, two separate actuators can control individual expansion of each drive screw. In some embodiments, a single actuator can be manufactured to advance both drive screws simultaneously. In some embodiments, the implant is posteriorly filled with a bone graft.

[0034] It is conceivable that, since any combination of height and angle of the implant is achievable, 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 required 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 testing or interference, which will also reduce traditional surgical steps.

[0035] In some embodiments, the expandable interbody implant of the system disclosed herein includes a proximal driving screw and a distal driving screw. The proximal driving screw controls parallel expansion and is larger and hollow through the center to allow the actuator of the distal driving screw to pass through and insert graft material after implantation and expansion. The distal driving screw controls angular expansion and is aligned with the proximal screw. Both driving screws are aligned with the insert.

[0036] In some embodiments, the expandable interbody implant of the system disclosed herein includes a first component coupled to a distal drive screw and a second component coupled to a proximal drive screw. The first component relates to adjusting the angle of a top member of the implant relative to the core of the implant. The second component relates to moving the top member toward and away from a bottom member of the implant. In some embodiments, the first component has a raised section that engages with a slot on the top member to provide stability. In some embodiments, the first component has a groove for housing the top member to provide stability. In some embodiments, the top member is attached to the core via a pin connection. In some embodiments, the top member is attached to the core via a relief cut into the core, such that a cylinder is directly machined into the top member. The second component may be keyed to engage the proximal drive screw, or may be attached to the proximal drive screw via a pin, collet, or clasp.

[0037] In some embodiments, the proximal drive screw achieves parallel expansion by acting on the distal inclined surface of the second component against the distal inclined surface of the bottom component. In some embodiments, the proximal drive screw achieves parallel collapse by acting on the proximal inclined surface of the second component against the proximal inclined surface of the bottom component. In some embodiments, the proximal drive screw is attached to the second component as a collet, which is prevented from collapsing by the driver when the driver is inserted to advance or retract the screw. In some embodiments, the proximal drive screw is attached to the second component by a retaining ring or pinned to the second component. In some embodiments, the bottom component has a tab that engages the second component to prevent the second component from opening. In some embodiments, the core has a slot that guides a track of the bottom component. In some embodiments, the second component includes an opening adjacent to the opening of the core and includes a cap to engage the second component to the core. In some embodiments, the core has a central opening and does not require a cap because the structures are held together by the track of the bottom component.

[0038] It is conceivable 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 can be used in conjunction with other bone and skeletal applications, including those related to diagnosis and treatment. Further consideration has been given to the possibility that the disclosed expandable intervertebral implant can be used alternatively in surgical treatments in which the patient is 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 with surgeries for treating the lumbar, cervical, thoracic, and pelvic regions of the spine. The expandable intervertebral implant and methods of this disclosure can also be used on animals, bone models, and other non-biological substrates, for example, in training, testing, and demonstration.

[0039] 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 incorporating 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 at least include said particular value. A range herein may be expressed as from “about” or “approximately” one particular value and / or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from one particular value and / or to another particular value. Similarly, when a value is expressed as an approximation using the antecedent “about,” it should be understood that said 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”.

[0040] Furthermore, as used in the specification and including the appended claims, "treating" or "treatment" of a disease or condition refers to performing a surgical procedure to attempt to alleviate the signs or symptoms of a disease or condition, which may involve administering one or more medications to a patient. Relief may occur before or after the onset of signs or symptoms of a disease or condition. Therefore, treating / treatment includes preventing / preventing a disease or condition (e.g., preventing a disease from occurring in a patient who may be susceptible to the disease but has not yet been diagnosed with it). Additionally, treatment does not require complete relief of signs or symptoms, does not require a cure, and particularly includes procedures with only marginal effects on the patient. Treatment may include: suppressing a disease, such as inhibiting its progression; or alleviating a disease, such as causing it to subside. For example, treatment may include: reducing acute or chronic inflammation; relieving pain and moderating and inducing the regeneration of new ligaments, bone, and other tissues; as an adjunct to surgical procedures; and / or any reparative surgery. Furthermore, as used in the specification and in the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage, and / or bone, unless otherwise specifically mentioned.

[0041] The following discussion includes a description of expandable interbody implants based on the principles of this disclosure and related methods of using 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... Figure 1-23 The components of an interbody implant system 30 based on the principles of this disclosure are shown.

[0042] The components of System 30 may be manufactured from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, bone materials, and / or composites thereof, depending on the specific application and / or preference of the medical practitioner. For example, the components of System 30 may be manufactured individually or collectively from materials such as stainless steel alloys, industrially pure titanium, titanium alloys, Grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, stainless steel alloys, superelastic metal alloys (e.g., nickel-titanium), and superelastic plastic metals such as GUM manufactured by Toyota Materials Corporation of Japan. ), ceramics and their composites, such as calcium phosphate (e.g., SKELITE manufactured by Biologix Inc.). TMThermoplastics, such as polyaryletherketone (PAEK), including polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 polymer rubber, polyethylene terephthalate (PET), fabrics, silicone resins, polyurethane, silicone-polyurethane copolymers, polymer rubber, polyolefin rubber, hydrogels, semi-rigid and rigid materials, elastomers, rubber, thermoplastic elastomers, thermosetting elastomers, elastomer composites, rigid polymers, including polyphenylene, polyamide, polyimide, polyetherimide, and polyethylene. The system 30 comprises epoxy resins, bone materials including autologous, allogeneic, xenograft, or transgenic cortical and / or cortical cancellous bone, as well as tissue growth or differentiation factors, partially resorbable materials such as, for example, metal and calcium-based ceramic composites, PEEK and calcium-based ceramic composites, PEEK and resorbable polymer composites, and fully resorbable materials such as, for example, calcium-based ceramics such as calcium phosphate, tricalcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polylactide, polyglycolic acid, polytyrosine carbonate, polycarboxylic acid, and combinations thereof. Various components of system 30 may be manufactured from composite materials (including the aforementioned materials) to achieve various desired properties such as strength, rigidity, elasticity, flexibility, compliance, biomechanical properties, durability, and radiolucency or imaging preference. Components of system 30 may also be manufactured individually or collectively from heterogeneous materials, such as combinations of two or more of the aforementioned materials.

[0043] System 30 can be used, for example, in fusion and fixation surgeries for patients with spinal disorders to provide intervertebral height restoration, decompression, sagittal balance restoration, and / or resistance to subduction into the vertebral endplates. As described herein, for example, components of system 30 may be integrally formed, integrally connected, or contain fastening elements and / or instruments.

[0044] System 30 includes an implant, such as an intervertebral implant 32. As discussed herein, implant 32 is configured for individually controlled parallel and angled expansion. Implant 32 includes a distal end 34 and an opposing proximal end 36. Implant 32 includes a core member or assembly, such as a core 38. Core 38 extends along a central longitudinal axis X1 between distal end 40 and opposing proximal end 42. End portion 40 includes an end wall 44, and end portion 42 includes an end wall 46 opposite to wall 44. Core 38 includes a top wall 48 continuously extending from wall 44 to wall 46 and a bottom wall 50 opposite to wall 48. Core 38 further includes opposing side walls 52, 54 between wall 44 and wall 46 and between wall 48 and wall 50. The inner surfaces of walls 48, 50, 52, 54 define internal threads 56 and 58. Thread 56 defines a channel 60, and thread 58 defines a channel 62. Wall 44 defines an opening 64 communicating with channel 60, and wall 46 defines an opening 66 communicating with channel 62. The large diameter of thread 56 is smaller than the large diameter of thread 58. The maximum diameter of channel 60 is smaller than the maximum diameter of channel 62. In some embodiments, channels 60, 62 are coaxial with axis X1. In some embodiments, channels 60 and / or channel 62 may be positioned in alternating orientations relative to axis X1, such as lateral and / or other angular orientations (e.g., acute or obtuse angles), and / or may be offset or staggered. In some embodiments, core 38 includes a non-threaded drill hole 65 positioned between channel 60 and opening 64, such as... Figure 12 As best illustrated. In some embodiments, the maximum diameter of the drill hole 65 is smaller than the maximum diameter of the channel 60 to prevent the drive screw with thread 56 from moving through the opening 64, as discussed herein.

[0045] Threads 56 and 58 are spaced apart by a gap, for example, a cavity 68 configured for placement of material (e.g., bone graft material). Wall 48 defines an aperture 70, and wall 50 defines an aperture 72. Apertures 70 and 72 each communicate with cavity 68 and are configured to introduce a bone graft or other material into cavity 68 after the height and / or angle of implant 32 has been selectively adjusted, as discussed herein. In some embodiments, aperture 70 and aperture 72 are coaxial. In some embodiments, cavity 68 is unthreaded and / or without threads. In some embodiments, aperture 70 and / or aperture 72 may have various shape configurations, such as circular, elliptical, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable, and / or conical. In some embodiments, aperture 70 and / or aperture 72 may be positioned in alternating orientations relative to axis X1, such as lateral, vertical, and / or other angular orientations (e.g., acute or obtuse angles), coaxial, and / or offset or staggered.

[0046] Wall 48 includes end segments 74, 76 and an intermediate segment 78 positioned between segments 74 and 76, such that segment 76 is spaced apart from segment 74 by segment 78, as... Figure 5 As best shown. Wall 48 includes a recess 75 between segment 74 and segment 78 and a recess 77 between segment 76 and segment 78. Segment 78 is configured to be positioned in the recess of the component of implant 32 prior to angular expansion of implant 32, as discussed herein. In some embodiments, segment 78 surrounds orifice 70. That is, segment 78 extends 360 degrees around orifice 70. In some embodiments, segment 78 extends only a portion of orifice 70, such as extending around three of the four sides of orifice 70, as... Figure 12 As shown in the figure. In some embodiments, section 78 may have various shape configurations, such as circular, elliptical, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable and / or conical.

[0047] Wall 50 includes end segments 80, 82 and an intermediate segment 84 positioned between segments 80 and 82, such that segment 84 is spaced apart from segment 80 by segment 82, as shown. Figure 5 As best shown herein. Wall 50 includes a recess 85 between segment 80 and segment 84 and a recess 87 between segment 82 and segment 84. Segment 84 is configured to be positioned in the recess of the component of implant 32 prior to angular expansion of implant 32, as discussed herein. In some embodiments, segment 84 surrounds aperture 72. That is, segment 84 extends 360 degrees around aperture 72. In some embodiments, segment 84 extends only a portion of aperture 72, for example, around three of the four sides of aperture 72. In some embodiments, segment 84 may have various shape configurations, such as circular, elliptical, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable, and / or conical.

[0048] The core 38 includes a slot 86 extending through the wall 48 and communicating with the channel 60. The slot 86 extends parallel to axis X1 along its entire length. The slot 86 is configured to slidably position components of the implant 32 as the angle of the implant 32 selectively increases and decreases, as discussed herein. The slot 86 extends through the wall 44 and has a width w1, as shown in Figure 12. In some embodiments, the width w1 is uniform along the entire length of the slot 86. In some embodiments, the width w1 gradually narrows toward the wall 44. In some embodiments, the width w1 gradually narrows toward segment 78.

[0049] The core 38 includes a slot 88 extending through the wall 50 and communicating with the channel 60. The slot 88 extends parallel to axis X1 along its entire length. The slot 88 is configured to slidably position components of the implant 32 as the angle of the implant 32 selectively increases and decreases, as discussed herein. The slot 88 extends through the wall 44 and has a width w2, as shown in Figure 12. In some embodiments, the width w2 is uniform along the entire length of the slot 88. In some embodiments, the width w2 gradually narrows toward the wall 44. In some embodiments, the width w2 gradually narrows toward segment 78. In some embodiments, the width w2 is equal to the width w1. In some embodiments, the width w2 is greater than the width w1. In some embodiments, the width w2 is less than the width w1.

[0050] Wall 52 includes spaced-apart slots, such as recesses 90, 92, and 94, and wall 54 includes spaced-apart recesses 96, 98, and 100, wherein recess 96 is opposite to recess 90, recess 98 is opposite to recess 92, and recess 100 is opposite to recess 94. Recess 96 is the same as or similar to recess 90. Recess 98 is the same as or similar to recess 92. Recess 100 is the same as or similar to recess 94. Recesses 90, 92, 94, 96, 98, and 100 are configured as tracks for slidingly positioning components of implant 32 as the height of implant 32 selectively increases and / or decreases, as discussed herein. Recesses 90, 92, 94, 96, 98, and 100 extend parallel to each other. Recesses 90, 92, 94, 96, 98, and 100 extend perpendicular to axis X1. In some embodiments, at least one of the grooves 90, 92, 94, 96, 98, 100 may be arranged in alternating orientations relative to axis X1, such as lateral and / or other angular orientations (e.g., acute or obtuse angles), and / or may be offset or staggered.

[0051] It is conceivable that the core 38 may have different designs without altering its function and / or the operation of the implant 32. Specifically, it is conceivable that the core 38 may include different designs containing openings in different regions of the core 38. For example, in some embodiments, the implant 32 includes a bottom-open version of the core 38, such as... Figure 12 As shown, it includes an opening 72 to allow assembly of the implant 32 without a cap. That is, it includes... Figure 12 The implant 32 of the embodiment of the core 38 shown is assembled without a cap, such that the opening 72 remains open when the implant is assembled. In some embodiments, the implant 32 comprises, as Figure 15The open version of the core 38 shown includes an opening similar to the opening 64 between slots 86, 88, which communicates with channel 60 and is configured to allow the implant 32 to be assembled with cap 41, the cap closing the opening when the implant 32 is assembled, as shown. Figure 17 As shown in some embodiments, the implant 32 comprises as shown in the diagram. Figure 16 The shown open version of the core 38 includes an opening 66 configured to allow assembly of the implant 32 with a cap 39, the cap closing the opening 66 when the implant 32 is assembled. Figure 18 As shown in the diagram. Therefore, the various designs of the core 38 allow medical practitioners a variety of options for assembling the implant 32. It is conceivable that the cap 39 and / or cap 41 can be attached to the core via welding, adhesives, press fitting, or other fixation techniques.

[0052] Implant 32 includes a distal member, such as member 102. Member 102 includes a distal body 104 and a distal drive screw 106 coupled to the body 104. Member 102 is configured to translate relative to core 38 along axis X1 in opposite directions to selectively increase and decrease the angle of implant 32, as discussed herein. Screw 106 is configured for placement in channel 60 and includes external threads 108 configured to engage with thread 56 such that rotation of screw 106 relative to core 38 about axis X1 in a first rotational direction (e.g., clockwise) will cause screw 106 to rotate in a first axial direction (e.g., by...). Figure 5 The screw 106 is translated along axis X1 in the direction indicated by arrow A in the diagram, and a rotation of the screw 106 relative to the core 38 about axis X1 in the opposite rotational direction (e.g., counterclockwise) will cause the screw 106 to rotate in the opposite cross-sectional axial direction (e.g., by the direction indicated by arrow A in the diagram). Figure 5 Translate along axis X1 in the direction indicated by arrow B in the diagram.

[0053] In some embodiments, the body 104 is keyed to engage the screw 106, such that the screw 106 is positioned relative to the core 38 by... Figure 5 The translation along axis X1 in the direction indicated by arrow A also causes the body 104 relative to the core 38 to be in the direction indicated by arrow A. Figure 5 The screw 106 is translated along axis X1 in the direction indicated by arrow A, and the screw 106 is positioned relative to the core 38 by... Figure 5 The translation along axis X1 in the direction indicated by arrow B also causes the main body 104 relative to the core 38 to be in the direction indicated by arrow B. Figure 5The screw 106 is translated along axis X1 in the direction indicated by arrow B. In some embodiments, the screw 106 is connected to the body 104 by a pin. In some embodiments, the screw 106 is connected to the body 104 by a collet. In some embodiments, the screw 106 is connected to the body 104 by a retaining ring. In some embodiments, the screw 106 may be connected to the body 104 in various ways, such as monolithic, integral, friction engagement, threaded engagement, intergrooving, screw, adhesive, nail, barb, protruding element, long nail, clip, snap, friction fit, compression fit, expansion rivet, sewn nail, fixing plate, key / keyway, groove tongue, wedge tenon, magnetic connection and / or post.

[0054] The body 104 includes a engagement portion 110 configured to engage a screw 106 to attach the screw 106 to the body 104, as discussed herein. When the screw 106 is positioned in the channel 60 and the thread 108 engages the thread 56, the portion 110 is coaxial with axis X1, and is movable within the channel 60 as the screw 106 translates relative to the core 38 along axis X1. The body 104 includes a wall 112 connected to the portion 110. When the screw 106 is positioned in the channel 60 and the thread 108 engages the thread 56, the wall 112 extends at an angle α relative to axis X1, and is movable within a slot 86 as the screw 106 translates relative to the core 38 along axis X1, as discussed herein. Figure 5As shown in the diagram. Wall 112 is configured to engage a top member or assembly (e.g., plate 114 of implant 32) to selectively increase and decrease the angle of plate 114 relative to axis X1, as discussed herein. In some embodiments, body 104 includes a flange 116 extending outward from wall 112 and configured to be positioned in a slot 118 of plate 114 when member 102 translates in opposite directions along axis X1 to selectively increase and decrease the angle of plate 114 relative to axis X1. In some embodiments, flange 116 extends at an angle α relative to axis X1 when screw 106 is positioned in channel 60 and thread 108 engages thread 56, and wall 86 is movable within slot 86 when screw 106 translates relative to core 38 along axis X1. In some embodiments, the body 104 includes a slot extending into the wall 112 and configured to be positioned in the flange of the plate 114 when the member 102 translates in opposite directions along the axis X1 to selectively increase and decrease the angle of the plate 114 relative to the axis X1. In some embodiments, angle α is an angle between about 120 degrees and about 179 degrees. In some embodiments, angle α is an angle between about 130 degrees and about 179 degrees. In some embodiments, angle α is an angle between about 140 degrees and about 179 degrees. In some embodiments, angle α is an angle between about 150 degrees and about 179 degrees. In some embodiments, angle α is an angle between about 160 degrees and about 179 degrees.

[0055] The screw 106 includes a socket 120 configured to accommodate a driver drill bit configured to rotate the screw 106 about an axis X1 in opposite directions relative to the core 38, as discussed herein. In some embodiments, the socket 120 includes a hexagonal cross-sectional configuration configured to engage with a driver drill bit having a hexagonal cross-sectional configuration to rotate the screw 106. However, it is contemplated that the socket 120 may include square, triangular, polygonal, or star-shaped cross-sectional configurations configured to engage a correspondingly shaped driver drill bit.

[0056] Implant 32 includes a proximal component, such as component 122. Component 122 includes a distal body 124 and a distal drive screw 126 coupled to the body 124. Component 122 is configured to translate relative to the core 38 along axis X1 in opposite directions to selectively increase and decrease the height of implant 32, as discussed herein. Screw 126 is configured for placement in channel 62 and includes external threads 128 configured to engage with thread 58 such that rotation of screw 126 relative to the core 38 about axis X1 in a first rotational direction (e.g., clockwise) will cause screw 126 to rotate in a first axial direction (e.g., by...). Figure 5The screw 126 is translated along axis X1 in the direction indicated by arrow A in the diagram, and a rotation of the screw 126 relative to the core 38 about axis X1 in the opposite rotational direction (e.g., counterclockwise) will cause the screw 126 to be rotated in the opposite cross-sectional axial direction (e.g., by the direction indicated by arrow A in the diagram). Figure 5 Translate along axis X1 in the direction indicated by arrow B in the diagram.

[0057] In some embodiments, the body 124 is keyed to engage the screw 126, such that the screw 126 is positioned relative to the core 38 by... Figure 5 The translation along axis X1 in the direction indicated by arrow A also causes the main body 124 relative to the core 38 to be in the direction indicated by arrow A. Figure 5 The screw 126 is translated along axis X1 in the direction indicated by arrow A, and the screw 126 is positioned relative to the core 38 by... Figure 5 The translation along axis X1 in the direction indicated by arrow B also causes the main body 124 relative to the core 38 to be in the direction indicated by arrow B. Figure 5 The screw 126 is translated along axis X1 in the direction indicated by arrow B. In some embodiments, the screw 126 is connected to the body 124 by a pin. In some embodiments, the screw 126 is connected to the body 124 by a collet. In some embodiments, the screw 126 is connected to the body 124 by a retaining ring. In some embodiments, the screw 126 may be connected to the body 124 in various ways, such as monolithic, integral, friction engagement, threaded engagement, intergrooving, screw, adhesive, nail, barb, protruding element, long nail, clip, snap, friction fit, compression fit, expansion rivet, sewn nail, fixing plate, key / keyway, groove tongue, wedge tenon, magnetic connection and / or post.

[0058] The body 124 includes a engagement portion 130 configured to engage a screw 126 to attach the screw 126 to the body 124, as discussed herein. The body 124 includes an arm 132 connected to the portion 130 via a transverse wall 134 and an arm 136 connected to the portion 130 via a transverse wall 138. Arm 132 extends from wall 134 in a cantilever configuration, and arm 136 extends from wall 138 in a cantilever configuration. The portion 130 includes an opening 140 configured for receiving the screw 126. The opening 140 defines a central longitudinal axis X2 and has a diameter d1. Arms 132 and 136 each extend parallel to axis X2. In some embodiments, the screw 126 includes a plurality of spaced splines 142 movable relative to each other to move a portion of the screw 126 defined by the splines 142 from a first configuration to a second configuration. In the first configuration, the portion of the screw 126 defined by the splines 142 has a first diameter such that the splines 142 are spaced apart from the portion 130 when the portion of the screw 126 defined by the splines 142 is positioned within an opening 140. In the second configuration, the portion of the screw 126 defined by the splines 142 has an increased second diameter such that the splines 142 directly engage the inner surface of the portion 130 defining the opening 140 when the portion of the screw 126 defined by the splines 142 is positioned within the opening 140, preventing translation of the screw 126 relative to the body 124 while allowing rotation of the screw 126 relative to the body 124. The portion of the screw 126 defined by the splines 142 is biased to the second configuration. In other words, a force must be applied to the spline 142 to move the splines toward each other in order to move the portion of the screw 126 defined by the spline 142 from the second configuration to the first configuration.

[0059] Wall 134 includes an inclined surface 144 and an inclined surface 146 opposite to surface 144. Arm 132 includes spaced-apart extensions 148 and 150 extending from the inner surface of arm 132. Extension 148 includes an inclined surface 152 and an inclined surface 154 opposite to surface 152. Extension 150 includes an inclined surface 156 and an inclined surface 158 opposite to surface 156. Wall 138 includes an inclined surface 160 and an inclined surface 162 opposite to surface 160. Arm 136 includes spaced-apart extensions 164 and 166 extending from the inner surface of arm 136. Extension 164 includes an inclined surface 168 and an inclined surface 170 opposite to surface 168. Extension 166 includes an inclined surface 172 and an inclined surface 174 opposite to surface 172. Surfaces 144, 146, 152, 154, 158, 160, 162, 168, 170, 172, and 174 are each angled relative to axis X2 and configured to engage the inclined surfaces of the bottom member or assembly (e.g., plate 176 of implant 32) to selectively increase and decrease the height of implant 32 as member 122 translates relative to core 38 along axis X1, as discussed herein.

[0060] Screw 126 includes a socket 178 configured to accommodate a drill bit of an actuator, the drill bit being configured to rotate screw 126 about axis X1 in opposite directions relative to core 38, as discussed herein. In some embodiments, socket 178 includes a hexagonal cross-sectional configuration configured to engage with a drill bit of an actuator having a hexagonal cross-sectional configuration to rotate screw 126. However, it is contemplated that socket 120 may include square, triangular, polygonal, or star-shaped cross-sectional configurations configured to engage a correspondingly shaped drill bit of an actuator. Screw 126 includes a bore 180 coaxial with and communicating with socket 178, such that an instrument can be positioned through socket 178 and bore 180 and into socket 120. Thus, socket 178 and bore 180 are coaxial with socket 120, and the diameter of bore 180 is equal to or greater than the diameter of socket 120. That is, when screw 106 is positioned within channel 60 such that thread 108 engages thread 56 and screw 126 is positioned within channel 62 such that thread 128 engages thread 58, socket 178 and bore 180 are coaxial with socket 120. In some embodiments, bore 180 is defined by the inner surface of spline 142.

[0061] Plate 114 extends along a longitudinal axis X3 between end 182 and opposite end 184. End 182 slidably engages body 104 and end 184 engages core 38 such that end 184 is pivotable or rotatable relative to core to selectively increase or decrease the angle of axis X3 relative to axis X1, as discussed herein. In some embodiments, core 38 includes a hole 182 extending through walls 52, 54, and plate 114 includes a passage 184 extending through spaced legs 186, 188 and aligned with hole 182. Pin 190 extends through hole 182 and passage 184 such that plate 114 is rotatable about pin 190 relative to core 38. In some embodiments, plate 114 includes a cylindrical extension 192 extending from the inner surface of leg 186 and a cylindrical extension 194 extending from the inner surface of leg 188, such that extension 194 faces extension 192, as... Figure 8 As shown in the diagram, extensions 192 and 194 are configured to be disposed in holes 182 such that plate 114 can rotate relative to core 38 about extensions 192 and 194.

[0062] Leg sections 186 and 188 are spaced apart by a gap 196. The gap 196 is configured to receive all or part of the end portion 42 such that, when the implant 32 is in a collapsed or non-expanded configuration, the vertebral engagement surface 198 of the plate 114 is flush with or substantially flush with the surface of the end portion 42, as... Figure 1 As shown in the diagram. Legs 186 and 188 each extend outward from the body 200 in a cantilever configuration. The body 200 includes an opening 202 configured to receive a segment 78 such that when the implant 32 is in a collapsed or non-expanded configuration, surface 198 is flush with or substantially flush with the surface of segment 78, as shown in the diagram. Figure 1 As shown in the diagram. The body 200 further includes spaced-apart cavities 204, 206, each configured to receive a segment of the portion 74 such that when the implant 32 is in a collapsed or non-expanded configuration, surface 198 is flush with or substantially flush with the surface of portion 74, as shown in the diagram. Figure 1 As shown in the figure. In some embodiments, the gap 196, the orifice 202, the cavity 204 and / or the cavity 206 may have various cross-sectional configurations, such as circular, elliptical, rectangular, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable and / or conical.

[0063] Plate 114 includes an inner surface 208 opposite to surface 198 and a protrusion 210 extending outward from surface 208. Protrusion 210 includes a slot 118 and is configured to engage with body 104 when member 102 translates relative to core 38 along axis X1, causing plate 114 to rotate relative to core 38 to selectively increase or decrease the angle of axis X3 relative to axis X1. Specifically, protrusion 210 includes a surface defining a ramp 212 extending at an angle β relative to axis X3. Slot 118 extends into ramp 212. In some embodiments, slot 118 extends at an angle β relative to axis X3. In some embodiments, angle β is an acute angle. In some embodiments, angle β is an angle between about 1 degree and about 90 degrees. In some embodiments, angle β is an angle between about 1 degree and about 80 degrees. In some embodiments, angle β is an angle between about 1 degree and about 70 degrees. In some embodiments, angle β is an angle between about 1 degree and about 60 degrees. In some embodiments, angle β is an angle between about 1 degree and about 50 degrees. In some embodiments, angle β is an angle between about 1 degree and about 40 degrees. In some embodiments, angle β is an angle between about 1 degree and about 30 degrees. In some embodiments, angle β is an angle between about 1 degree and about 20 degrees. In some embodiments, angle β is an angle between about 1 degree and about 10 degrees. In some embodiments, slot 118 has a uniform width along its entire length. In some embodiments, slot 118 gradually narrows toward orifice 202. In some embodiments, slot 118 gradually narrows away from orifice 202.

[0064] When screw 106 is relative to core 38, by Figure 5 When the main body 104 translates along axis X1 in the direction indicated by arrow A, it also moves relative to the core 38 by... Figure 5 The wall 112 is translated along axis X1 in the direction indicated by arrow A, causing the wall 112 to slide along ramp 212, thereby pivoting the plate 114 relative to the core 38, and moving the implant from a parallel configuration to a non-parallel configuration, in which axis X3 extends parallel to axis X1, as shown in the image. Figure 1 and 4 As shown, in the non-parallel configuration, axis X3 extends relative to axis X1 at an angle γ, as... Figure 2 and 5As shown in the diagram. In some embodiments, angle γ is an acute angle. In some embodiments, angle γ is an angle between about 1 degree and about 90 degrees. In some embodiments, angle γ is an angle between about 1 degree and about 80 degrees. In some embodiments, angle γ is an angle between about 1 degree and about 70 degrees. In some embodiments, angle γ is an angle between about 1 degree and about 60 degrees. In some embodiments, angle γ is an angle between about 1 degree and about 50 degrees. In some embodiments, angle γ is an angle between about 1 degree and about 40 degrees. In some embodiments, angle γ is an angle between about 1 degree and about 30 degrees. In some embodiments, angle γ is an angle between about 1 degree and about 20 degrees. In some embodiments, angle γ is an angle between about 1 degree and about 10 degrees. In some embodiments, surface 198 may be smooth, flat, and / or polished to prevent damage to tissue, or may be rough, textured, porous, semi-porous, recessed, convex, toothed, and / or grooved to facilitate adhesion to tissue.

[0065] Plate 176 includes an end wall 214 and tracks 216, 218 extending from the wall 214 in a cantilever configuration. Track 216 is connected to track 218 via bridge 220 and bridge 222 spaced apart from bridge 220. Track 216 extends parallel to track 218, and bridges 220, 222 extend perpendicular to track 216, 218. Plate 176 includes a recess 224 between the wall 214 and bridge 220. Recess 224 is configured to receive all or part of segment 80 such that when implant 32 is in a collapsed or non-expanded configuration, the vertebral conduit surface 226 of plate 176 is flush with or substantially flush with the surface of segment 80, such as... Figure 1 As shown in the diagram, plate 176 includes an aperture 228 between bridges 220 and 222. The aperture 228 is configured to receive segment 84 such that surface 226 is flush with or substantially flush with the surface of segment 84 when implant 32 is in a collapsed or non-expanded configuration, as shown in the diagram. Figure 1 As shown in the diagram. Plate 176 further includes spaced gaps 230 defined by the surfaces of bridge 222 and tracks 216, 218. Gap 230 is configured to receive segment 82 such that surface 226 is flush with or substantially flush with the surface of segment 82 when implant 32 is in a collapsed or non-expanded configuration, as shown in the diagram. Figure 1As shown in the figure. In some embodiments, the gap 230, the orifice 228, and / or the recess 224 may have various cross-sectional configurations, such as circular, elliptical, rectangular, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, deformable, and / or conical. In some embodiments, the surface 226 may be smooth, flat, and / or polished to prevent damage to the tissue, or it may be rough, textured, porous, semi-porous, recessed, convex, toothed, and / or grooved to facilitate adhesion to the tissue.

[0066] Plate 176 extends along a longitudinal axis X4 between end 232 and opposite end 234. Tracks 216 and 218 extend parallel to axis X4, and bridges 220 and 222 extend perpendicular to axis X4. Plate 176 includes an inner surface 236 opposite to surface 226. Track 216 includes spaced-apart extensions 238, 240, and 242 extending outward from surface 236. Extension 238 includes an inclined surface 244. Extension 240 includes an inclined surface 246 and an inclined surface 248 opposite to surface 246. Extension 240 includes an inclined surface 250 and an inclined surface 252 opposite to surface 250. Wall 214 includes an inclined surface 254. Track 218 includes spaced-apart extensions 256, 258, and 260 extending outward from surface 236. Extension 256 includes an inclined surface 262. Extension 258 includes an inclined surface 264 and an inclined surface 266 opposite to surface 264. Extension 260 includes an inclined surface 268 and an inclined surface 270 opposite to surface 268. Wall 214 includes an inclined surface 272.

[0067] Surfaces 144, 146, 152, 154, 158, 160, 162, 168, 170, 172, and 174 are each angled relative to axis X4 and configured to engage surfaces 144, 146, 152, 154, 158, 160, 162, 168, 170, 172, and 174 to selectively increase and decrease the height of implant 32 when member 122 translates relative to core along axis X1. Specifically, component 122 is connected to plate 176 such that surface 244 engages surface 144, surface 246 engages surface 146, surface 248 engages surface 152, surface 250 engages surface 154, surface 252 engages surface 156, surface 254 engages surface 158, surface 262 engages surface 160, surface 264 engages surface 162, surface 266 engages surface 168, surface 268 engages surface 170, surface 270 engages surface 172, and surface 272 engages surface 174. Thread 128 engages thread 54 such that rotation of screw 126 relative to body 124 and core 38 in a first rotational direction (e.g., clockwise) causes screw 126 and body 124 to be... Figure 5The movement in the direction indicated by arrow A causes surface 244 to slide along surface 144, surface 246 to slide along surface 146, surface 248 to slide along surface 152, surface 250 to slide along surface 154, surface 252 to slide along surface 156, surface 254 to slide along surface 158, surface 262 to slide along surface 160, surface 264 to slide along surface 162, surface 266 to slide along surface 168, surface 268 to slide along surface 170, surface 270 to slide along surface 172, and surface 272 to slide along surface 174, thereby increasing the height of implant 32 before or after selectively increasing or decreasing the angle between axes X1 and X3. That is, when axis X3 is parallel to axis X1 or when axis X3 is not parallel to axis X1, the height of implant 32 can be increased by rotating screw 126 relative to body 124 and core 38 in the first rotational direction.

[0068] Rotation of screw 126 relative to body 124 and core 38 in opposite second rotational directions (e.g., counterclockwise) causes screw 126 and body 124 to be in contact with each other by... Figure 5 The movement in the direction indicated by arrow B causes surface 244 to slide along surface 144, surface 246 to slide along surface 146, surface 248 to slide along surface 152, surface 250 to slide along surface 154, surface 252 to slide along surface 156, surface 254 to slide along surface 158, surface 262 to slide along surface 160, surface 264 to slide along surface 162, surface 266 to slide along surface 168, surface 268 to slide along surface 170, surface 270 to slide along surface 172, and surface 272 to slide along surface 174, thereby reducing the height of implant 32 before or after selectively increasing or decreasing the angle between axes X1 and X3. That is, when axis X3 is parallel to axis X1 or when axis X3 is not parallel to axis X1, the height of implant 32 can be reduced by rotating screw 126 relative to body 124 and core 38 in the second rotational direction.

[0069] In some embodiments, track 216 includes spaced-apart tracks (e.g., ribs 282, 284), and track 218 includes spaced-apart tracks (e.g., ribs 286, 288). Ribs 282, 284, 286, and 288 extend parallel to each other. In some embodiments, ribs 282, 284, 286, and 288 each extend perpendicular to axis X4. Rib 282 is configured to be disposed in recess 90. Rib 284 is configured to be disposed in recess 94. Rib 286 is configured to be disposed in recess 96. Rib 288 is configured to be disposed in recess 100. Since the height of the implant 32 can be selectively increased or decreased by rotating the screw 126 relative to the body 124 and the core 38, the member 122 translates relative to the core 38 along axis X1, rib 282 translates within recess 90, rib 284 translates within recess 94, rib 286 translates within recess 96, and rib 288 translates within recess 100. In some embodiments, ribs 282, rib 284, rib 286 and / or rib 288 may be arranged relative to axis X4 in alternating orientations, such as lateral and / or other angular orientations (e.g., acute or obtuse angles), coaxial and / or offset or staggered.

[0070] The angle between axes X1 and X3 has not been selectively increased or decreased, such that axis X3 extends parallel to axis X1. The height of implant 32 can be selectively increased or decreased by rotating screw 126 relative to body 124 and core 38, such that the implant increases or decreases from a first height defined by the distance from surface 198 to surface 226 to a second height defined by the distance from surface 198 to surface 226, wherein when implant 32 has the first height and the second height, axis X4 is parallel to axis X3.

[0071] Alternatively, where the angle between axes X1 and X3 has been selectively increased or decreased such that axis X3 extends nonparallel to axis X1, the height of implant 32 can be selectively increased or decreased by rotating screw 126 relative to body 124 and core 38, such that the implant increases or decreases from a first height defined by the distance from surface 198 to surface 226 to a second height defined by the distance from surface 198 to surface 226, wherein when implant 32 has the first height and the second height, axis X4 is not parallel to axis X3.

[0072] Furthermore, it is conceivable that after the height of implant 32 has been selectively increased or decreased, the angle between axes X1 and X3 can be selectively increased or decreased such that axis X3 extends non-parallel to axis X1, wherein axis X4 is non-parallel to axis X3 when implant 32 has a first height and a second height. That is, before increasing or decreasing the height of implant from the first height to the second height, axis X1 can extend parallel to axis X3, and then after the implant has been moved to have the second height, the angle between axes X1 and X3 can be selectively increased or decreased, as discussed herein. This allows for the selective increase or decrease of the height of implant 32 before or after the angle between axes X1 and X3 is selectively increased or decreased.

[0073] System 30 includes an instrument (e.g., instrument 290) configured to individually control the parallel expansion and angular expansion of implant 32. Instrument 290 includes a sleeve 292 extending along a longitudinal axis X5 between end 294 and opposite end 296. Instrument 290 includes a shaft 298 including end 300 and opposite end 302 positioned within sleeve 292 such that end 302 is rotatable relative to sleeve 292 about axis X5 and is rotatable relative to sleeve 292 along axis X5. Figure 20 The direction indicated by arrow C and by Figure 20 Translation in the direction indicated by arrow D. Instrument 290 includes a shaft 304, which includes an end 306 and an opposing end 308 positioned within the shaft 298, such that the end 308 is rotatable relative to the sleeve 292 and the shaft 298 about axis X5 and is rotatable relative to the sleeve 292 and the shaft 298 along axis X5. Figure 20 The direction indicated by arrow C and by Figure 20 Translation in the direction indicated by arrow D. End 302 includes a drill bit 310 configured for placement in socket 178, and end 302 includes a drill bit 312 configured for placement in socket 120. In some embodiments, drill bit 310 and / or drill bit 312 may include a hexagonal, square, triangular, polygonal, star-shaped cross-sectional configuration or other configurations that match the corresponding shape of socket 120 or socket 178.

[0074] To connect the instrument 290 to the implant 32, the instrument 290 is positioned relative to the implant 32 such that end 296 engages end 36. The shaft 298 is positioned relative to the sleeve 292 by… Figure 20 The shaft 304 is translated along axis X5 in the direction indicated by arrow C, causing end 308 to move through channel 62 and drill bit 312 to move into socket 178. Figure 20The end 302 is translated along axis X5 in the direction indicated by arrow C, causing the end 302 to move through channel 62, borehole 180, and channel 60, and the drill bit 310 to move into the socket 120. It should be noted that the shaft 304 can be positioned relative to the shaft 298 along axis X5. Figure 20 Translation in the direction indicated by arrow C, such that the shaft 298 is translated relative to the sleeve 292 along axis X5. Figure 20 Before or after translation in the direction indicated by arrow C, end 302 moves through channel 62, borehole 180, and channel 60, and drill bit 310 moves into socket 120, such that end 308 moves through channel 62 and drill bit 312 moves into socket 178. In some embodiments, sleeve 212 and / or implant 32 include mating and / or locking features configured to engage sleeve 212 to implant 212, such that sleeve 212 is fixed relative to implant 32.

[0075] Once the instrument 290 is connected to the implant 32, with the drill bit 310 positioned in the socket 120 and the drill bit 312 positioned in the socket 178, the shaft 304 can rotate relative to the shaft 298 about the axis X5 in the first rotational direction, so that the component 102 relative to the core 38 is in a position where... Figure 5 The implant 32 moves in the direction indicated by arrow A, and the ramp 212 slides along the wall 112 to increase the angle of the implant 32 and / or to make the implant 32 extend from its axis X3 parallel to the axis X1 (as shown in the image). Figure 1 and 4 (As shown) Move to a configuration in which axis X3 is not parallel to axis X1 and / or extends at an angle relative to axis X1 (such as...) Figure 2 and 5 (As shown). The angle of implant 32 can be reduced and / or the implant can be moved from a configuration in which axis X3 is not parallel to axis X1 and / or extends at an angle relative to axis X1 to a configuration in which axis X3 extends parallel to axis X1 or at a reduced angle relative to axis X1. The shaft 304 can rotate about axis X5 in opposite cross-sectional rotation directions relative to shaft 298, such that member 102 relative to core 38 is in a position determined by... Figure 5 It moves in the direction indicated by arrow B and the ramp 212 slides along the wall 112.

[0076] Before or after the angle of implant 32 is selectively increased or decreased, as discussed herein, shaft 298 can rotate relative to sleeve 292 and shaft 304 about axis X5 in a first rotational direction, such that member 122 relative to core 38 is in a position determined by… Figure 5 The implant 32 moves in the direction indicated by arrow A and the inclined surface of member 122 slides along the inclined surface of plate 176 to increase the height of implant 32.

[0077] Alternatively, before or after the angle of implant 32 is selectively increased or decreased, as discussed herein, and / or before or after the height of implant has been selectively increased, as discussed herein, shaft 298 may rotate about axis X5 in opposite directions of rotation relative to sleeve 292 and shaft 304, such that member 122 relative to core 38 is in the direction of rotation. Figure 5 The implant 32 moves in the direction indicated by arrow B and the inclined surface of member 122 slides along the inclined surface of plate 176 to reduce the height of implant 32.

[0078] In operation and use, System 30 is used in conjunction with surgical procedures (fusion treatment of a patient's spine including the vertebrae and adjacent body regions), as discussed herein. System 30 can also be used with other surgical procedures (e.g., discectomy, laminectomy, nerve root traction, foraminal incision, vertebral facet resection, decompression, and vertebral, nucleus pulposus, or disc replacement).

[0079] For example, system 30 can be used with surgical joint fixation procedures, such as interbody fusion for treating applicable conditions or injuries in the affected segment of the spine and adjacent areas within the body (e.g., the intervertebral disc space between the first and second vertebrae). It is considered that the intervertebral implant 32 of system 30, as described above, can be inserted into the intervertebral disc space to space the articular surfaces, providing support to the vertebrae and maximizing stability. Further consideration is given to providing intervertebral height restoration, decompression, sagittal balance restoration, and / or resistance to subduction into the vertebral endplates.

[0080] In use, to treat the affected segment of the vertebra, the medical practitioner obtains access to the surgical site containing the vertebra by any appropriate means (e.g., through incision and tissue retraction). It is conceivable that system 30 can be used with 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 a sleeve providing a protected passage to the area. Once access to the surgical site is obtained, a specific surgical procedure can be performed to treat the spinal condition. The surgical treatment is then enhanced with an intervertebral implant 32 as described above. The intervertebral implant 32 can be delivered or implanted as a pre-assembled device, or it can be assembled in situ. The intervertebral implant 32 can be completely or partially modified, removed, or replaced in situ. It is considered that one or all components of the intervertebral implant system can be delivered to the surgical site by manual manipulation and / or freehand techniques. Further consideration is given to inserting the intervertebral implant 32 posteriorly and then manipulating anteriorly and / or laterally and / or medially.

[0081] An incision is made inside the patient, and the cutting instrument creates a surgical path for implanting the intervertebral implant 32 into the patient's body. A guiding instrument is used to initially transfer the first vertebra from the second vertebra. A sleeve or cannula is used to enter the intervertebral disc space and facilitate the delivery and entry 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 nucleus pulposus and fluid, adjacent tissue, and / or cortical bone), remove and / or scrape tissue from the surface of the endplates of the first and second vertebrae, and aspirate and flush the area as required by the specific surgical application.

[0082] As discussed above, the intervertebral implant 32 is connected to the instrument 290, and the instrument 290 is used to insert the implant 32 into the patient's body, wherein the implant 32 is positioned in a non-deployed or non-expanded configuration, such as... Figure 20 As shown in the diagram. Implant 32 is delivered via a substantially posterior approach along the surgical path to position implant 32 within the intervertebral disc space.

[0083] When the intervertebral implant 32 is to be positioned within the intervertebral disc space, the implant 32 is deployed within the intervertebral disc space such that the implant 32 is configured without deployment or expansion. Figure 20 and 21 (As shown) Move to the first unfolded or expanded configuration ( Figure 22 As shown, in the first unfolding or expanding configuration, the angle of the implant 32 is increased by rotating the shaft 304 relative to the shaft 298 about the axis X5 in a first rotational direction, such that the member 102 relative to the core 38 is in a position determined by... Figure 5 The implant 32 moves in the direction indicated by arrow A and slides along the wall 112. That is, the implant 32 is configured such that its central axis X3 extends parallel to the central axis X1 (as shown in the image). Figure 1 and 4 (As shown) Move to a configuration in which axis X3 is not parallel to axis X1 and / or extends at an angle relative to axis X1 (such as...) Figure 2 and 5 (As shown in the diagram). The angle of implant 32 can be reduced and / or the implant can be moved from a configuration in which axis X3 is not parallel to axis X1 and / or extends at an angle relative to axis X1 to a configuration in which axis X3 extends parallel to axis X1 or at a reduced angle relative to axis X1. The shaft 304 can rotate about axis X5 in the opposite second rotational direction relative to shaft 298, such that member 102 relative to core 38 is in a position determined by… Figure 5 It moves in the direction indicated by arrow B and the ramp 212 slides along the wall 112.

[0084] In some embodiments, the implant 32 is deployed or expanded from a first deployment or expansion configuration ( Figure 22 (As shown) Move to the second unfolded or expanded configuration ( Figure 23 As shown, in the second unfolding or expanding configuration, the height of the implant 32 is increased by rotating the shaft 298 relative to the sleeve 292 and the shaft 304 about the axis X5 in the first rotational direction, such that the member 122 relative to the core 38 is... Figure 5 The component 122 moves in the direction indicated by arrow A and its inclined surface slides along the inclined surface of plate 176. Alternatively, the implant 32 can be configured from a first deployment or expansion position. Figure 22 (As shown) Move to a third unfolding or expanding configuration, in which the height of the implant 32 is increased by rotating the shaft 298 relative to the sleeve 292 and the shaft 304 in opposite rotational directions about axis X5, such that the member 122 relative to the core 38 is in the position of the core 38. Figure 5 The component 122 moves in the direction indicated by arrow B and slides along the inclined surface of plate 176. However, as discussed herein, the height of implant 32 may be selectively increased and / or decreased before or after the angle of implant 32 is selectively increased or decreased.

[0085] In some embodiments, the intervertebral implant 32 may expand from a non-deployed or non-expanded configuration to an alternating configuration between a non-deployed or non-expanded configuration and a first deployed or expanded configuration, to expand the intervertebral implant 32 as needed. In some embodiments, the intervertebral implant 32 may expand from a first deployed or expanded configuration to an alternating configuration between a first deployed or expanded configuration and a second deployed or non-expanded configuration, to expand the intervertebral implant 32 as needed.

[0086] As the implant 32 moves from its undeployed or unexpanded configuration to the first and / or second deployed or expanded configuration, surface 198 moves away from surface 226, causing surfaces 198, 226 to press against the vertebrae, thereby moving the first vertebra away from the second vertebra and increasing the size of the intervertebral disc space. It is considered that, in the first and / or second deployed or expanded configurations, the intervertebral implant 32 provides height restoration between the first and second vertebrae, decompression, sagittal balance restoration, and resistance to subduction into the vertebral endplates. The implant 32 can remain in the first and / or second deployed or expanded configurations to maintain the increased size of the intervertebral disc space. In some embodiments, material (e.g., a bone graft) is positioned within the cavity 68, orifice 70, and / or orifice 72 to promote bone growth for fusion of the first and second vertebrae. In some embodiments, the implant 32 can be moved directly from a non-deployed or non-expanded configuration to a second deployed or expanded configuration, such that the engagement surface 198 extends parallel to the engagement surface 226 when the implant 32 is in the second deployed or expanded configuration within the intervertebral disc space, to push the vertebrae apart without increasing or decreasing the angle of the implant 32. In some embodiments, after the implant 32 has pushed the vertebrae apart, the implant 32 can be moved from the second deployed or expanded configuration to a first deployed or expanded configuration.

[0087] In some embodiments, the bone graft may be a particulate material that may contain osteoconductive materials (such as HA) and / or bone-inducing agents (such as bone morphogenetic proteins (BMPs)) to enhance bone fixation of the intervertebral implant 32 to adjacent vertebrae. The bone graft may contain therapeutic polynucleotides or peptides. Further consideration has been given to the pharmaceutical and / or bone graft composition containing biocompatible materials, such as biocompatible metals and / or rigid polymers (e.g., elemental titanium, titanium, or titanium-based powders), 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); and bioactive agents, such as compositions that are gradually released by incorporation into a bioabsorbable polymer, said composition releasing one or more bioactive agents in an appropriate time-dependent manner as the polymer degrades in the patient's body. Suitable bioactive agents include, for example, BMPs, growth and differentiation factor (GDF) proteins, and cytokines. Intervertebral implant 32 may be made of a radiolucent material (such as a polymer). It may contain radiolabelers for identification under X-ray, fluoroscopy, CT, or other imaging techniques. It is conceivable that the bone graft may contain one or more therapeutic agents and / or medications for the release (including sustained release) of treatments such as pain, inflammation, and degeneration.

[0088] It is conceivable that components of system 30 (which may include one or more intervertebral implants 32) can be delivered to the surgical site via alternative methods. In one embodiment, the intervertebral implant 32 is delivered into the intervertebral disc space via a surgical path through a transforaminal lumbar interbody fusion approach and positioned in an expanded or extended configuration. In another embodiment, multiple intervertebral implants 32 are delivered into the intervertebral disc space via a surgical path through a posterior lumbar interbody fusion approach and positioned side-by-side facing upward in an expanded or extended configuration.

[0089] In some embodiments, the intervertebral implant 32 may collapse from a second deployed or expanded configuration to an alternating configuration between the second deployed or expanded configuration and a first deployed or expanded configuration, to allow the intervertebral implant 32 to collapse as needed to reposition relative to the intervertebral disc space or to remove the intervertebral implant 32 from the intervertebral disc space. In some embodiments, the intervertebral implant 32 may collapse from a first deployed or expanded configuration to an alternating configuration between the first deployed or expanded configuration and a non-deployed or non-expanded configuration, to allow the intervertebral implant 32 to collapse as needed to reposition relative to the intervertebral disc space or to remove the intervertebral implant 32 from the intervertebral disc space.

[0090] The implant 32 can be moved from the first and / or second deployed or expanded configuration to the undeployed or unexpanded configuration. Once the implant 32 is in the undeployed or unexpanded configuration, the implant 32 can be moved within and / or removed from the intervertebral disc space as needed.

[0091] 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 rather as illustrative of various embodiments. Other modifications within the scope and spirit of the appended claims will be contemplated by those skilled in the art.

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 and a second internal thread; A first component, the first component including a first body and a first drive screw coupled to the first body, the first drive screw having a first external thread configured to engage the first internal thread; The second component includes a second body and a second drive screw coupled to the second body, the second drive screw having a second external thread configured to engage the second internal thread; A first plate, the first plate being connected to the core and the first body, the first plate including a first vertebral engagement surface; and A second plate, which is connected to the core and the second body, includes a second vertebral engagement surface. The drive screw is configured to rotate independently relative to the core, the rotation of the first drive screw changing the angle of the first plate relative to the central longitudinal axis of the core, and the rotation of the second drive screw changing the distance between the first vertebral engagement surface and the second vertebral engagement surface.

2. The device of claim 1, wherein rotation of the first drive screw relative to the core in a first rotational direction causes the first body to translate along the longitudinal axis in the first direction, causing the first plate to pivot relative to the core, thereby moving the device from a first orientation to a second orientation, in the first orientation, the first vertebral engagement surface extending parallel to the longitudinal axis and the second vertebral engagement surface, and in the second orientation, the first vertebral engagement surface extending at an acute angle relative to the longitudinal axis and the second vertebral engagement surface.

3. The device of claim 2, wherein rotation of the first drive screw relative to the core in an opposite second rotational direction causes the first body to translate along the longitudinal axis in an opposite second direction, such that the first plate pivots relative to the core, thereby moving the device from the second orientation to the first orientation.

4. The device of claim 1, wherein rotation of the second drive screw relative to the core in a first rotational direction causes the second body to translate relative to the core along the longitudinal axis in a first longitudinal direction, thereby moving the device from a first configuration to a second configuration, wherein in the first configuration the vertebral engagement surfaces are spaced apart from each other by a first distance, and in the second configuration the vertebral engagement surfaces are spaced apart from each other by a second distance, the second distance being greater than the first distance.

5. The device of claim 4, wherein the second body includes an inclined surface that slides along the inclined surface of the second plate as the second body translates relative to the core along the longitudinal axis to move the device from the first configuration to the second configuration.

6. The device of claim 4, wherein rotation of the second drive screw relative to the core in an opposite second rotational direction causes the second body to translate along the longitudinal axis in an opposite second longitudinal direction, thereby moving the device from the second configuration to the first configuration.

7. The device of claim 4, wherein the vertebral engagement surfaces are parallel to each other when the device moves between the first configuration and the second configuration.

8. The apparatus of claim 4, wherein the second plate includes a plurality of tracks each extending perpendicular to the longitudinal axis, and the core includes a plurality of slots each extending perpendicular to the longitudinal axis, wherein, as the apparatus moves between the first configuration and the second configuration, the tracks each translate within one of the slots.

9. The apparatus according to claim 1, wherein: Rotation of the first drive screw relative to the core causes the first body to translate along the longitudinal axis, causing the first plate to pivot relative to the core, so that the device moves from a first orientation to a second orientation, in the first orientation, the first vertebral engagement surface extends parallel to the longitudinal axis and the second vertebral engagement surface, and in the second orientation, the first vertebral engagement surface extends at an acute angle relative to the longitudinal axis and the second vertebral engagement surface; and Rotation of the second drive screw relative to the core in the first rotational direction causes the second body to translate relative to the core along the longitudinal axis in the first longitudinal direction, thereby moving the device from a first configuration to a second configuration, in the first configuration the vertebral engagement surfaces are spaced apart by a first distance, and in the second configuration the vertebral engagement surfaces are spaced apart by a second distance, the second distance being greater than the first distance.

10. The device according to claim 1, wherein the first drive screw is coaxial with the second drive screw.

11. The apparatus of claim 1, wherein the first internal thread is spaced apart from the second internal thread.

12. The apparatus of claim 1, wherein the first internal thread is spaced apart from the second internal thread by a certain gap, and a portion of the second drive screw is configured to be positioned within the gap.

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

14. The apparatus of claim 1, wherein the second drive screw includes a drilled hole coaxial with a central longitudinal axis defined by the first drive screw, such that the instrument can be positioned through the drilled hole and into the socket of the first drive screw.

15. The device of claim 1, wherein the first plate includes an inner surface opposite to the first vertebral engagement surface, the first plate includes a flange extending outwardly from the inner surface, the flange including a groove, and the first body includes a protrusion movably disposed in the groove when the first plate is pivoted relative to the core.

16. The device of claim 1, further comprising a pin extending through the first plate and the core, such that the first plate is pivotable about the pin relative to the core.

17. The device of claim 1, wherein the first plate includes a body comprising the first vertebral engagement surface, the body of the first plate including spaced-apart cylindrical extensions, the core including spaced-apart openings, each opening being configured to accommodate one of the extensions such that the first plate is pivotable relative to the core about the extension.

18. The apparatus of claim 1, wherein the second body includes a collar defining an opening, the second drive screw includes a first portion and a second portion, the first portion including the second external thread, the second portion including a plurality of spaced splines defining a collet, the collet being positioned within the opening to prevent the second body from translating relative to the second drive screw as the second drive screw rotates relative to the core.

19. 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 and a second internal thread; A first component, the first component including a first body and a first drive screw coupled to the first body, the first body including a first ramp, the first drive screw having a first external thread configured to engage the first internal thread; The second component includes a second body and a second drive screw coupled to the second body, the second body including a plurality of spaced-apart first inclined surfaces, and the second drive screw having a second external thread configured to engage the second internal thread; A first plate, the first plate being connected to the core and the first body, the first plate including a first vertebral engagement surface and a second ramp; and A second plate, connected to the core and the second body, includes a second vertebral engagement surface and a plurality of spaced-apart second inclined surfaces. The drive screw is configured to rotate independently relative to the core, wherein rotation of the first drive screw causes the second ramp to move along the first ramp to pivot the first plate relative to the core, and rotation of the second drive screw causes the second inclined surface to slide along the first inclined surface to change the distance between the first vertebral engagement surface and the second vertebral engagement surface.

20. 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 and a second internal thread spaced apart from the first internal thread, the major diameter of the first internal thread being smaller than the major diameter of the second internal thread; A first component, the first component including a first body and a first drive screw coupled to the first body, the first drive screw having a first external thread configured to engage the first internal thread; The second component includes a second body and a second drive screw connected to the second body. The second drive screw has a second external thread configured to engage the second internal thread. The first drive screw is coaxial with the second drive screw. The second drive screw includes a drill hole coaxial with a central longitudinal axis defined by the first drive screw, such that the instrument can be positioned through the drill hole and into the socket of the first drive screw. A first plate, the first plate being connected to the core and the first body, the first plate including a first vertebral engagement surface; as well as A second plate, which is connected to the core and the second body, includes a second vertebral engagement surface. The drive screw is configured to rotate independently relative to the core, causing the first plate to pivot relative to the core and changing the distance between the first vertebral engagement surface and the second vertebral engagement surface. The rotation of the first drive screw relative to the core causes the first body to translate along the longitudinal axis, causing the first plate to pivot relative to the core, thereby moving the device from a first orientation to a second orientation. In the first orientation, the first vertebral engagement surface extends parallel to the longitudinal axis and the second vertebral engagement surface; in the second orientation, the first vertebral engagement surface extends at an acute angle relative to the longitudinal axis and the second vertebral engagement surface. The rotation of the first drive screw relative to the core in the opposite second rotational direction causes the first body to translate along the longitudinal axis in the opposite second direction, thereby pivoting the first plate relative to the core to move the device from the second orientation to the first orientation. The second body includes an inclined surface that slides along the inclined surface of the second plate when the second body is translated relative to the core along the longitudinal axis to move the device from a first configuration to a second configuration. The second plate includes a plurality of tracks, each extending perpendicular to the longitudinal axis, and the core includes a plurality of slots, each extending perpendicular to the longitudinal axis. As the device moves between the first configuration and the second configuration, each track translates within one of the slots. The rotation of the second drive screw relative to the core in the first rotational direction causes the second body to translate relative to the core along the longitudinal axis in the first longitudinal direction, thereby moving the device from a first configuration to a second configuration. In the first configuration, the vertebral engagement surfaces are spaced apart by a first distance, and in the second configuration, the vertebral engagement surfaces are spaced apart by a second distance, the second distance being greater than the first distance. The rotation of the second drive screw relative to the core in the opposite second rotational direction causes the second body to translate along the longitudinal axis in the opposite second longitudinal direction, so that the device can be moved from the second configuration to the first configuration.

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