Patent Application
20230346570
Not Applicable.
Not Applicable.
This invention relates to orthopedic implant systems, in particular an orthopedic implant systems configured to alter the alignment of bones such as vertebral bodies in a mammalian spine.
In the field of spinal correction, available literature supports that trauma and degenerative spinal conditions resulting in back pain and leg pain lead to debilitation, loss of work and life happiness.
Compression fractures account for more than 60% of thoracolumbar fractures. Types of injuries associated with this type of injury may include: endplate impaction, wedge impaction fractures, vertebral body collapse, split fractures and coronal split fractures.
Patients with spine issues all start with collapsing of the disc, which happens due to loss of nutrition as aging occurs, which leads to loss of normal cushioning. Next, the endplates can no longer handle normal stress on the endplates, which leads to microfractures in the adjacent vertebral bodies. The chronic factures in a collapsed or fractured vertebral body may then create a cascade of other conditions in the spine, including (but not limited to) degenerative scoliosis, facet joint subluxation and facet joint degeneration, nerve root compression, and further vertebral body collapse.
Studies have also shown that degenerative disc disease and degenerative scoliosis may be associated with significant pain, mental anguish, anxiety, and functional disability as well as diminished self-perception/mental health and decreased function.
Patients with degenerative disc disease associated with degenerative scoliosis many times have a collapsing foramen on the concave slide of the spine. As this happens the superior facet of the vertebra below slides cephalad and pinches the nerve root in the now narrowed foramen. There is no good minimal surgical treatment with lasting symptom relief available in 2021. Common treatments are decompression without fusion, decompression with limited fusion, and extended (extensive) fusion and reconstruction.
Decompression without Fusion Treatments: A collapsing disc and vertebral body collapse, which allows the facet from below to come up into the foramen and cause compression of the nerve root. Some surgeons take a minimalist approach and try to open the foramen by surgically removing parts of the facet joint and some disc to give the nerve root space. While the conservative decompressive procedure without a fusion may be appropriate for selected patients, studies have demonstrated “greater risk of deformity progression, poor outcomes, and higher rates of reoperations” in these cases. It is believed that this is due to failure to address the cause of the narrowed foramen that being subluxation of the facet joints secondary to further disc collapse and further microfractures in the vertebral body leading to further wedging, and the foramen gets narrower again.
Decompression with Limited Fusion Treatments: Decompression with limited fusion is applicable for patients whose symptoms are limited to specific and short segments (1-3 levels), but care must be taken in assessing and correcting the sagittal and coronal alignment.2 Patients with uncorrected misalignment many times have poor outcomes after decompression with limited fusion. Fusions of any kind in the lumbar spine can many times start a cascade of events by putting increase stress through transferring lumbar spine motion to the unfused segments of the spine resulting in more deterioration of the adjacent levels requiring further treatment which is usually additional fusion. This is referred to in the literature as adjacent level disease.
Extended Reconstruction Treatments: Extended reconstruction (>3 levels) of the lumbar spine has been a foundation of correction for adult degenerative scoliosis. Fusions of this scope starts a cascade of events by putting increase stress through transferring lumbar spine motion to the unfused segments of the spine resulting in more deterioration of the adjacent levels requiring further treatment which is usually additional fusion. Clinical presentation of adjacent segment deterioration, with coronal, sagittal or both deformities above or below causing severe back pain often occur necessitating further additional levels requiring fusion.
One means of addressing leg pain is to decompress the neural elements. Specifically, the nerves that exit the spinal foramen are particularly venerable to compression as disc height, vertebral body and/or just the vertebral wall collapse conspire to narrow the amount of space available to the exiting nerve root. Accordingly, there is a dire need for a vertebral implant system and method of use to treat the chronic trauma and fractures resulting in collapsed vertebra and intervertebral disc and causing nerve root compression resulting in back pain and or leg pain that addresses the above shortcomings.
Another means of addressing leg pain is a more traditional decompression and fusion by implanting a device between two vertebral bodies. In this intervertebral procedure, after the neural elements are decompressed, two or more vertebra may be fused, or joined, together with the implant device to stabilize the spine and permanently stop the movement between bones that are causing pain or ensure appropriate space for exiting nerve roots. The stabilization may also be used to correct alignment of the spine in multiple planes.
For other joints, embodiments of an orthopedic implant system similar in design to those disclosed herein, may be used in an arthrodesis procedure. In this arthrodesis procedure, adjacent bones of a joint are immobilized by fusing, or joining them with an implant device that securer the adjacent bones. Stabilization may also be used to correct alignment of the bones of the joint.
Accordingly, there is need for an orthopedic implant system and methods of use to treat orthopedic trauma and fractures that addresses the above shortcomings.
The following summary is included only to introduce some concepts discussed in the Detailed Description below. This summary is not comprehensive and is not intended to delineate the scope of protectable subject matter, which is set forth by the claims presented at the end.
The disclosed orthopedic implant system is intended to treat address orthopedic issues such as the collapse of the vertebral body wedging, which is the result of microfractures of the vertebral body endplates. These microfractures occur because of the collapsed disc creates abnormal stress areas in the vertebral body. The vertebral body wedging, secondary to the microfractures, creates a coronal deformity and causes back pain through misaligned facet joints. The source of the back pain can be confirmed by diagnostic local anesthetic agents around the painful facet joint. Correction of the coronal deformity in the vertebral body will reduce the back pain by realigning the facet joints in this select group of patients. This is analogous to the use of high tibial osteotomies for treatment of knee arthritis. The implant design allows for careful and patient-specific sagittal and coronal alignment to prevent the clinical outcomes of misalignment. The implant system and implant device for vertebral applications may be used as an intervertebral implant device between two vertebra or it may be used as an intravertebral implant device between two portions of a vertebra.
This osteotomy procedure and intravertebral implant device can relieve pain symptoms while maintaining lumbar spine mobility and prevent or delay adjacent level disease. The implant device does not have any motion itself. The implant device stabilizes a corrected vertebral body for 12 weeks while it heals.
With the disclosed intravertebral implant system, a vertebral body osteotomy with the intravertebral implant device can correct the wedged segment of the spine through the vertebral body. This opens the foramen and relieves the pinched nerve and therefore relieves the patient's radiculopathy symptoms. The implant design allows for careful and patient-specific sagittal and coronal alignment to prevent the clinical outcomes of misalignment.
This technology will lead to an improved quality of life when compared to current standard surgical techniques and technology when used as part of a decompression strategy. The patient will have relief from back and/or leg pain without a loss of spine mobility, which can significantly reduce or eliminate the risk of adjacent level accelerated degeneration in the other levels of the spine. The custom alignment that can be created with the implant device can prevent the clinical outcomes of misalignment.
In one example embodiment, an orthopedic implant device is provided comprising: a plate; a coupling device; a staple; the coupling device the staple and the plate operably coupled whereby the plate and the staple are configured to be secured to a sidewall of a bone; and whereby the orthopedic implant device is secured across the bone. In some embodiments, the staple and the plate are configured to secure the orthopedic implant device to the bone with a compressive force. In some embodiments, the sidewall of the bone comprises one or more lateral sidewall of a vertebral body. In some embodiments, the sidewall of the bone comprises a first lateral sidewall and a second lateral sidewall of a vertebral body, and the staple is configured to secure the orthopedic implant device to the first lateral sidewall and the plate is configured to secure the orthopedic implant device to the second lateral sidewall whereby the orthopedic implant device is secured to the vertebral body with a compressive force. In some embodiments, the sidewall of the bone comprises an anterior sidewall and a posterior sidewall of a vertebral body, and the staple is configured to secure the orthopedic implant device to the posterior sidewall and the plate is configured to secure the orthopedic implant device to the anterior sidewall whereby the orthopedic implant device is secured to the vertebral body with a compressive force.
In one example embodiment, a staple configured to secure an orthopedic implant device to a bone is provided, the staple having one or more staple tines configured to engage a sidewall of the bone, the staple coupled with a coupling device, the staple configured to position the one or more staple tines relative to the bone, and the staple and the coupling device are configured to position the staple in a deployed position by a positioning force from the coupling device. In some embodiments, the staple is configured to position the staple in a deployed position relative to the bone by a rotation of the staple about a longitudinal axis of the orthopedic implant device. In some embodiments, the deployed position of the staple positions the one or more staple tines proximal to the sidewall of the bone. In some embodiments, the staple and the coupling device are configured to position the staple in a deployed position by a rotation of the coupling device. In some embodiments, the staple and the coupling device are further configured to retract the staple towards the orthopedic implant device by a retracting force from the coupling device. In some embodiments, the staple and the coupling device are configured to retract the staple towards the orthopedic implant device by a rotation of the coupling device. In some embodiments, the staple further comprises a proximal end having a radiused corner profile whereby when the coupling device is rotated in a positioning rotation direction, the proximal end of the staple engages the bone to stop a further rotation of the staple. In some embodiments, the coupling device further comprises a distal threaded portion, and the positioning force from the coupling device is a positioning rotational force to rotate the coupling device in a positioning rotation direction whereby the coupling device positions the staple in a deployed position. In some embodiments, the positioning force from the coupling device is a positioning rotational force to rotate the coupling device in a positioning rotation direction whereby the coupling device positions the one or more staple tines proximal to the sidewall of the bone, the coupling device is further configured to retract the staple towards the orthopedic implant device by a retracting force from the coupling device, and the retracting force from the coupling device is a retracting rotational force to rotate the coupling device in a retracting rotation direction whereby the coupling device adjusts a device length of the orthopedic implant device to retract the staple towards the orthopedic implant device. In some embodiments, the coupling device further comprises a distal threaded portion, and the orthopedic implant device comprises a distal threaded portion configured to mate with the distal threaded portion of the coupling device whereby the retracing rotational force rotates the distal threaded portion of the coupling device in the distal threaded portion of the orthopedic implant device and retracts the staple towards the orthopedic implant device. In some embodiments, the orthopedic implant device comprises one orthopedic implant device selected from the group comprising: a second staple, a wedge, a plate, and a cage. In some embodiments, the bone is a vertebral body, and the staple is configured to secure the orthopedic implant device to two pieces of the vertebral body in an intravertebral application. In some embodiments, the bone is a first vertebral body and a second vertebral body, and the staple is configured to secure the orthopedic implant device to the first vertebral body and the second vertebral body in an intervertebral application. In some embodiments, the staple is configured to secure the orthopedic implant device to the bone and a second bone in a fusion or fracture repair application. In some embodiments, the staple is configured to secure the orthopedic implant device to two pieces of the bone in an arthrodesis application. In some embodiments, the staple further comprises a staple swivel coupler configured to couple the staple to the coupling device and allow the staple to articulate relative to the coupling device whereby the staple better accommodates a sidewall of the bone.
In one example embodiment, an orthopedic implant system is provided comprising an orthopedic implant device, a staple, a coupling device, the staple having one or more staple tines, the one or more staple tines are configured to engage a bone and the coupling device is configured to couple the staple to the orthopedic implant device. In some embodiments, the staple and the coupling device are configured to position the staple by a positioning force from the coupling device and retract the staple towards the orthopedic implant device by a retracting force from the coupling device. In some embodiments, orthopedic implant system is a vertebral implant system and the bone is a vertebral body. In some embodiments, the staple is configured to secure the orthopedic implant device to the bone in one application selected from the group comprising: securing two pieces of a vertebral body in an intravertebral application, securing a vertebral body to another vertebral body in an intervertebral application, securing two bones to each other in an arthrodesis application, and securing two pieces of a bone in an osteotomy application.
In one example embodiment, an intravertebral implant configured to alter an alignment of a spine is provided comprising a wedge, a plate having an external surface configuration and one or more plate tine, a coupling device, a staple having one or more staple tine, the one or more plate tine and the one or more staple tine are configured to engage a vertebral body, and the coupling device is configured to couple the wedge, the plate and the staple whereby when the vertebral implant is secured in the vertebral body, the external surface configuration of the plate alters a relative orientation of a superior endplate surface plane and an inferior endplate surface plane of the vertebral body and alters the alignment of the spine. In some embodiments, the coupling device is configured to adjust a device length of the vertebral implant device whereby an adjustment of the device length secures the one or more staple tine to a side wall of the vertebral body and secures the one or more plate tine to an opposing side wall of the vertebral body. In some embodiments, the coupling device comprises a screw and a nut, the screw further comprises a screw swivel coupler, and the staple comprises a staple swivel coupler to mate with the screw swivel coupler whereby the staple is configured to swivel about a longitudinal axis of the screw. In some embodiments, the external surface configuration of the plate is defined by a plate longitudinal angle between a longitudinal surface plane of a superior surface of the plate and a longitudinal surface plane of an inferior surface of the plate, and a plate height proximal to the one or more plate tine. In some embodiments, the external surface configuration of the plate is further defined by a plate transverse angle between a transverse surface plane of a superior surface of the plate and a transverse surface plane of an inferior surface of the plate. In some embodiments, an external surface configuration of the wedge is defined by a wedge longitudinal angle between a longitudinal surface plane of a superior surface of the wedge and a longitudinal surface plane of an inferior surface of the wedge, and a wedge height proximal to the one or more wedge tine. In some embodiments, the external surface configuration of the wedge is further defined by a wedge transverse angle between a transverse surface plane of a superior surface of the wedge and a transverse surface plane of an inferior surface of the wedge. In some embodiments the screw further comprises a drive portion configured to be engaged by a drive tool, the screw further comprises a distal threaded portion, the plate further comprises a threaded through hole to engage the distal threaded portion of the screw whereby when the drive portion is rotated in a first rotation direction by the drive, the screw adjusts the device length to a shorter length, and the staple further comprises a proximal end having a radiused corner profile whereby when the drive portion is rotated in the first rotation direction by the drive, the proximal end of the staple engages the vertebral body to position the one or more staple tine to engage the side wall of the vertebral body. In some embodiments, the coupling device is configured to adjust a device height of the vertebral implant device whereby an adjustment of the device height alters the external surface configuration of the plate and alters the relative orientation of a superior endplate surface plane and an inferior endplate surface plane of the vertebral body. In some embodiments, the coupling device comprises a screw and a nut, the plate further comprises a two-pronged u-shaped body defining a cavity configured to receive the wedge and the screw, the screw is configured to be received in a bore of the wedge, and the nut is configured to be received in the bore of the wedge and couple to the screw whereby the screw and the nut secure the wedge in the cavity of the plate. In some embodiments, the two-pronged u-shaped body comprises an angularly flexible body, and the device height is affected by an external surface configuration of the wedge.
In some embodiments, the screw further comprises a screw swivel coupler and a drive portion, the staple comprises a staple swivel coupler to mate with the screw swivel coupler whereby the staple is configured to swivel about a longitudinal axis of the screw, and the staple further comprises a proximal end having a radiused corner profile whereby when the drive portion is rotated in a first rotation, the proximal end of the staple engages the vertebral body to stop a further rotation of the staple.
In some embodiments, the wedge comprises a plurality of wedges configured to be exchangeable with the plate, and each of the plurality of wedges having a different external surface configuration.
In some embodiments, a vertebral implant system configured to alter an alignment of a spine is provided comprising a nut, a screw, a staple having one or more tine, a plate having a cavity configured to receive a wedge and the screw, the wedge selected from a set of wedges, the set of wedges comprising at least a first wedge and a second wedge wherein the first wedge has a first external dimension and the second wedge has a second external dimension, and the plate configured to receive either the first wedge or the second wedge whereby: when the first wedge is received in the plate, a first implant device external dimension is created to alter a relative orientation of a superior endplate surface plane and an inferior endplate surface plane of a vertebral body and alter the alignment of the spine to a first degree, and when the second wedge is received in the plate, a second implant device external dimension is created to alter the relative orientation of a superior endplate surface plane and an inferior endplate surface plane of the vertebral body and alter the alignment of the spine to a second degree. In some embodiments, the plate comprises at least a first plate and a second plate wherein, the first plate has a first external dimension, the second plate has second external dimension, and the first plate and the second plate are exchangeable whereby: when the first wedge is received in the first plate, a third implant device external dimension is created to alter the relative orientation of a superior endplate surface plane and an inferior endplate surface plane of the vertebral body and alter the alignment of the spine to a third degree, and when the first wedge is received in the second plate, a forth implant device external dimension is created to alter the relative orientation of a superior endplate surface plane and an inferior endplate surface plane of the vertebral body and alter the alignment of the spine to a forth degree. In some embodiments, the plate comprises at least a first plate and a second plate, the first implant device external dimension is defined by: a first plate longitudinal angle between a longitudinal surface plane of a superior surface of the plate and a longitudinal surface plane of an inferior surface of the plate, and a first plate height; and the second implant device external dimension is defined by: a second plate longitudinal angle between a longitudinal surface plane of a superior surface of the plate and a longitudinal surface plane of an inferior surface of the plate, and a second plate height. In some embodiments, the first implant device external dimension is defined by: a first wedge longitudinal angle between a longitudinal surface plane of a superior surface of the first wedge and a longitudinal surface plane of an inferior surface of the first wedge, a plate thickness, and a plate height; and the second implant device external dimension is defined by: a second wedge longitudinal angle between a longitudinal surface plane of a superior surface of the second wedge and a longitudinal surface plane of an inferior surface of the second wedge, the plate thickness, and the plate height.
In some embodiments, the orthopedic implant system may be used as an arthrodesis device, intravertebral device or intervertebral implant device.
A method to alter an alignment of a spine is provided comprising performing an osteotomy procedure through a vertebral body inferior to a pedicle of the vertebral body, inserting a plate and a staple into a vertebral opening created by the osteotomy procedure, deploying the staple whereby the staple extends outside of the vertebral opening, rotating the staple whereby one or more staple tines are positioned general perpendicular to the osteotomy to engage a side wall of the vertebral body, tightening a screw coupled to the staple whereby the staple tines are drawn towards the plate and engage the side wall of the vertebral body, positioning a wedge over a proximal end of the screw and into a cavity of the plate, coupling a nut on the proximal end of the screw and into a bore of the wedge, tightening the nut on the screw whereby the plate is distracted by the wedge as it is drawn into the vertebral body, and further tightening the nut onto the screw whereby the wedge is secured within the cavity of the plate defining an external surface configuration of the plate to alter a relative orientation of a superior endplate surface plane and an inferior endplate surface plane of the vertebral body and alter the alignment of the spine. In some embodiments, the implant device is inserted from a lateral approach. In some embodiments, the implant device is inserted from an anterior approach. In some embodiments, the implant device is inserted from an oblique approach.
In some embodiments, the methods may use the orthopedic implant system as an arthrodesis, intravertebral or intervertebral implant device in an arthrodesis, intervertebral or intervertebral implant procedure.
Other objects, features, and advantages of the techniques disclosed in this specification will become more apparent from the following detailed description of embodiments in conjunction with the accompanying drawings.
In order that the manner in which the above-recited and other advantages and features of the invention are obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
COPYRIGHT NOTICE: A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. The following notice applies to any text as described below and in the drawings hereto: Copyright © 2020-2023, NOFUSCO Corporation, All Rights Reserved.
Orthopedic implant systems and methods of use will now be described in detail with reference to the accompanying drawings. Notwithstanding the specific example embodiments set forth below, all such variations and modifications that would be envisioned by one of ordinary skill in the art are intended to fall within the scope of this disclosure.
Some embodiments of the orthopedic implant system, when used as a vertebral implant system, may be used in the thoracolumbar spine (T11-L5) to replace a portion of and/or restore height of a collapsed, damaged, or unstable vertebral body due to trauma (i.e., fracture) or osteotomy. The system is to be placed unilaterally and used with autograft or allograft and may be used with supplemental spinal fixation as part of the device.
Some embodiments of the orthopedic implant system are intended to treat collapse of the vertebral body wedging, which is the result of microfractures of the vertebral body endplates.
This coronal deformity of the vertebrae may or may not be associated with leg radiculopathy from a narrowed foramen in addition to back pain as above or as a separate clinical problem. When the vertebra is wedged and the disc space collapses the facet joints sublux with the superior facet of the lower vertebra riding high in the foramen (narrowed foramen) pinching the exiting nerve root. This radiculopathy pain would be relieved by indirect decompression through the osteotomy, placement of the orthopedic implant device indirectly opens the foramen through reducing the subluxed facet joints and then stabilizes the correction until healing of the vertebral body occurs in 12 weeks.
The disclosed orthopedic implant systems and methods will lead to an improved quality of life when compared to current standard surgical techniques and technology when used as part of a decompression strategy. The patient will have relief from back and/or leg pain without a loss of spine mobility, which will significantly reduce or eliminate the risk of adjacent level accelerated degeneration in the other levels of the spine. The custom alignment that can be created with the implant device can prevent the problematic clinical outcomes of misalignment.
When used as an intravertebral body fusion device the orthopedic implant system is intended for use in skeletally mature patients who have had six months of non-operative treatment. The implant device is intended for use at one level or two levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. This procedure and the orthopedic implant device treat some cases of back pain caused by malalignment of the facet joints secondary to collapse or degeneration of the disc confirmed by history, radiographic studies, and diagnostic facet joint injections with local anesthetic to confirm source of pain being from the malaligned facet joints. This is analogous to the use of high tibial osteotomies for treatment of knee arthritis. Additionally, the orthopedic implant system can be used as an adjunct to correct the spine coronal deformity in patients diagnosed with degenerative scoliosis. The orthopedic implant system is intended for use with or without supplemental fixation.
Some embodiments of the orthopedic implant system are configured to treat collapse of the disc and vertebral body creating a coronal deformity and causing back pain through malaligned facet joints. The source of the back pain can be confirmed by diagnostic local anesthetic agents around the painful facet joint. This coronal deformity may or may not be associated with leg radiculopathy from a narrowed foramen. This radiculopathy pain could be relieved by indirect decompression through the osteotomy and placement of orthopedic implant system which opens the foramen and then stabilizes the correction until healing of the vertebral body occurs in 12 weeks.
Some embodiments of the orthopedic implant system comprise an orthopedic implant device comprising a plate and a wedge. In some embodiments, the orthopedic implant device further comprises a staple and a coupling device.
In some embodiments, the orthopedic implant system comprises an intravertebral implant system and device. For illustration purposes and not for limitation, one example embodiment of the intravertebral implant device is shown in
As shown in
In one example embodiment, all of the components of the intravertebral implant device are made of a surgical grade metal such as Titanium (e.g., ASTM F136 Wrought 6A14V Ti for Implant). The intravertebral implant device may be manufactured utilizing conventional machining technology e.g., milling and turning, mass media and/or electropolish finishing, color anodizing and passivation.
When assembled and implanted in the vertebral body, the external surface dimensions and configuration of the intravertebral implant device is able to correct the relative orientation of a superior endplate surface plane and an inferior endplate surface plane of a vertebral body to alter the alignment of the spine. The external surface configuration of the intravertebral implant device may be altered by using different configuration of intravertebral implant device components. For example, the wedge may be configured to have different surface angles to create different external surface configuration when mated with the plate; the wedge may be flat, coronal angled, sagittal angled, or both coronal and sagittal angled. And sets of multiple exchangeable wedge configurations can provide implant device options to accommodate different vertebra, different sized patients and different orientations of insertion.
Referring to
Referring to
In some embodiments, the screw 160 may be rotated in a direction that allows the staple 140 to move longitudinally from an undeployed longitudinal position and extend away from the plate 120 to an extended longitudinal position away from the plate 120. During this longitudinal extension, the staple may be between bone portions and may be kept in the undeployed rotational position by the staple tines 142 that are constrained by the bone surface until the staple tines 142 extend beyond the sidewalls of the bone. As the staple tines 142 extend beyond the sidewalls, the stop, such as the radiused profile of the staple 140, may keep the staple 140 in the undeployed rotational position and an extended longitudinal position. At this point, the screw 160 may be rotated in the opposite direction to rotate the staple 140 to a deployed rotational position and retract and draw the staple 140 and the plate 120 together. In embodiments with the radiused corner profile, the staple 140 is able to rotate until the larger radius section engages the internal surface of the vertebral body which stops further rotation of the staple at the deployed rotational position and the deployed longitudinal position. As the staple is rotated further, the staple 140 is retracted and the staple tines 142 become mechanically embedded and stabilized into the bone sidewall in a stabilized rotational and longitudinal position. As the staple is rotated further, the staple 140 and the staple tines 142 becomes further embedded into the bone until the staple 140 is in the stabilized rotational and longitudinal position.
In some embodiments, the positioning of the tines may be provided by other configurations of the staple and staple tines. For example only, and not for limitation, the staple tines may be positioned against the bone by tines that physically reposition against the bone by springing open or being otherwise urged open once a force is removed or the tines may be positioned from a force pushing them into position. Additionally, the tines may pivot around an axis.
The coupling device is configured to adjust the positional relationship of the staple 140 relative to the plate 120 and allow the staple to be moved between an undeployed position, an extended position, a deployed position and a stabilized position. In some embodiments, the different positions comprise both a rotational position and a longitudinal position of the staple relative to the plate and the bone. These different positions of the staple describe both the rotational alignment of the staple and the longitudinal position of the staple relative to other elements of the implant device.
Referring to
The threaded portions of the screw may have a locking thread profile to mate and lock with the mating threads. For example, a locking thread profile may be created when tapping the female thread and is created by a sloped surface which taper-locks the apex of the external/male thread. For example, when the screw or nut is tightened, the crests of the male threads on the bolt are pulled up against the sloped surface of the female threads and wedged into place creating a locking thread.
During insertion of the intravertebral implant device, the staple 140 is configured in an undeployed rotational position and undeployed longitudinal position, generally parallel with transverse surface planes of the plate 120, for ease of insertion. The staple 140 is then configured to be rotated into a vertical/perpendicular/deployed position (see
The plate generally provides the structure to secure the implant device to both sides of the vertebra. The plate is configured to adjustably couple with the screw and staple to secure the implant device to one side wall of the vertebra and the plate has tines on a proximal end to secure the implant device to the other side wall of the vertebra.
Referring to
Referring to
The wedge tines 152 on the wedge 150 engage the plate tines to prevent them from separating. This resists tensile forces, bending forces and resists the osteotomy from opening further. The wedge tines 152 may also engage the bone to further secure the implant device to the vertebra.
The wedge 150 also has a through bore 154 extending along its length and shaped to receive the screw and the nut. The wedge 150 may also have a concave recess 156 at its proximal end to receive and countersink the head of the nut when the implant device is secured to the vertebra.
Referring to
In some embodiments, an additional plate longitudinal angle (not shown) is formed by a change of thickness of the plate prongs along their longitudinal axis creating an angle between the exterior surface planes of the plate prongs and interior surface planes of the plate prongs.
Consistent with the screw 260 embodiments shown in
The ability to mix plate components and wedge components allows for multiple implant device dimensions to be created so that different alterations can be made to the alignment of the spine. These different implant device dimensions can be made to be suitable to support insertion from different angles and use in different regions of the spine. In addition, devices sizes may vary for use with different patients.
As shown in the examples of Table A of
Examples of general sizes of the implant device are also shown in Table A of
Examples of sizes and configurations for the vertebral implant device are illustrated in the following description of embodiments in operation.
In some embodiments, the orthopedic implant system is configured to be used as part of an intervertebral implant system and device. For illustration purposes and not for limitation, one example embodiment of the intervertebral implant device is shown in
As shown in
As with the other embodiments of the orthopedic implant system, the staple and the coupling device are configured to position the staple in a deployed position by a positioning force, such as a rotation of the coupling device and the staple and the coupling device are further configured to retract the staple towards the orthopedic implant device by a retracting force from the coupling device.
Embodiments and adaptations of an orthopedic implant system similar in design to the above orthopedic implant systems may be used in an arthrodesis device and procedure for other joints. As done for the joining of two vertebra or two portions of one vertebra, an implant device may be provided that is configured to be secured to opposing sides of articulating bones in a joint to fuse those bones. The stabilization may also be used to correct alignment of the bones of the joint. For example, the orthopedic implant system may be sized and configured so that the staple and proximal plate tines secure the implant device between two bones of a finger joint.
The orthopedic implant system generally uses the exterior surface planes of the implant device to alter the alignment of skeletal components of a mammalian body. As an example, and not for limitation, operation of an orthopedic implant system as an intravertebral implant device for correcting a mammalian spine will be illustrated. It is understood that in some embodiments, orthopedic implant devices may be configured and used for intervertebral arthrodesis procedures such as fusions.
Referring to
Referring to
Described below in detail is a lateral approach for creating a vertebral body osteotomy and then for placing the implant totally within the vertebral body for correction in the coronal plane. With the disclosed systems and methods, spine correction is established, while the spine flexibility through the disc and facet joints is retained, and the vertebral body then fuses in a period of time, such as 12 weeks, for a solid corrected vertebral structure.
Referring to
As shown in
As shown in
As shown in
Referring to
Referring to
Referring to
For safety purposes, locking thread profiles may be provided on internal machine screw threads of the hole in the plate and the internal threads of the nut to prevent loosening or disengagement of the vertebral implant device once it is implanted.
In some embodiments, the vertebral implant device may provide additional correction in the sagittal plane. In these embodiments, the wedge surfaces will have a single angle and the inside of the plate will have a single angle and there will be transverse angles on the outside of the plate. This transverse angle of the plate additionally provides some correction in the sagittal plane and when implanted from a lateral approach.
In some embodiments, the vertebral implant device may be inserted from other approaches or may be used to alter alignment in other planes. With other approaches, the general method of inserting and securing the implant device is similar to the methods above. The different approach direction will require different configurations of the implant device so that the exterior surface planes provide the desired alteration in superior endplate surface plane and the inferior endplate surface plane of the vertebra in the appropriate plane.
Example Embodiments of Orthopedic Implant Devices to be Used with Lateral Insertion:
Example embodiments of orthopedic implant devices configured as intravertebral implant devices suitable for insertion from a lateral approach will be described below. Because the implant device is configurable, many of the implant device components are the same; the difference is in selecting different sized components to suit the direction of insertion, the spinal plane to be corrected and the area of the spine to be corrected. The descriptions below utilize an implant device consistent with the embodiments described above and shown in
It is understood that embodiments of the disclosed orthopedic implant device may be used with posterior lateral insertion procedures such as those used with Transforaminal Lumbar Interbody Fusion (TLIF). These devices and procedures may be used for interbody as well as intrabody applications. These embodiments may be applied in any lumbar, thoracic, or cervical segments. In some embodiments used with the TLIF procedure, the orthopedic implant may preferably be used with the T12-L1 down to L5-S1 segments.
Lateral Insertion to Adjust Coronal Alignment.
One example embodiment of an intravertebral implant device suitable for insertion from a lateral approach to correct vertebral alignment in the coronal plane is described above and shown in
For insertion from the lateral direction to correct spinal alignment in the coronal plane, an intravertebral implant device will be selected that has a suitable implant device longitudinal angle. In most embodiments, this implant device longitudinal angle is dictated by the wedge longitudinal angle. For example, referring to Table A in
For use in the thoracic area, the intravertebral implant device will be similarly configured but will generally have smaller dimensions. For example, referring to Table A in
It is understood, that if additional alignment correction is desired in the sagittal plane, the intravertebral implant device may be selected with implant device transverse angles to provide this correction. This implant device transverse angle may be provided by either a plate transverse angle or a wedge transverse angle. For example, referring to Table A in
Lateral Insertion to Adjust Sagittal Plane Alignment.
One example embodiment of an intravertebral implant device suitable for insertion from a lateral approach to correct vertebral alignment in the sagittal plane is described above and shown in
For insertion from the lateral direction to correct spinal alignment in the sagittal plane, an intravertebral implant device will be used that has a suitable implant device transverse angle. In most embodiments, this implant device transverse angle is dictated by the plate transverse angle. For example, referring to Table A in
For use in the thoracic area, the intravertebral implant device will be similarly configured but will generally have smaller dimensions. For example, referring to Table A in
It is understood that although the above example shows the implant device transverse angle being provided by the plate transverse angle, a wedge transverse angle, or a combination of the wedge transverse angle and the plate transverse angle may provide the device transverse angle.
It is understood, that if additional alignment correction is desired in the coronal plane, the intravertebral implant device may be selected with implant device longitudinal angles to provide this additional correction. As described above for correction in the coronal plane, the implant device longitudinal angle may be provided by either a plate longitudinal angle or a wedge longitudinal angle or a combination of them. For example, referring to Table A in
Example Embodiments of Implant Devices to be Used with Anterior Insertion:
Example embodiments of orthopedic implant devices configured as intravertebral implant devices suitable for insertion from an anterior approach will be described below. Similar to the device embodiments described above for lateral insertion, the difference in the devices used is in selecting different sized components to suit the direction of insertion, the spinal plane to be corrected and the area of the spine to be corrected. The descriptions below utilize an implant device consistent with the embodiments described above and shown in
It is understood that embodiments of the disclosed orthopedic implant device may be used with anterior insertion procedures such as those used with Anterior Lumbar Interbody Fusion (ALIF). These devices and procedures may be used for interbody as well as intrabody applications. These embodiments may be applied in any lumbar, thoracic, or cervical segments of the spine. In some embodiments used with the ALIF procedure, the orthopedic implant may preferably be used with the L5-S1, L4-L5 or L3-L4 segments.
Anterior Insertion to Adjust Coronal Plane Alignment.
One example embodiment of an intravertebral implant device suitable for insertion from an anterior approach to correct vertebral alignment in the coronal plane is described above and shown in
For insertion from the anterior direction to correct spinal alignment in the coronal plane, an intravertebral implant device will be used that has a suitable implant device transverse angle. This device transverse angle may be provided by either a plate transverse angle or a wedge transverse angle. For example, referring to Table A in
For use in the thoracic area, the intravertebral implant device will be similarly configured but will generally have smaller dimensions. For example, referring to Table A in
Similarly, for use in the cervical area, the intravertebral implant device will be similarly configured but will generally have smaller dimensions. For example, referring to Table A in
It is understood, that if additional alignment correction is desired in the sagittal plane from this angle of insertion, the intravertebral implant device may be selected with implant device longitudinal angles to provide this correction. This implant device longitudinal angle may be provided by either a plate longitudinal angle or a wedge longitudinal angle. In most embodiments, this implant device longitudinal angle is provided by the wedge longitudinal angle. For example, referring to Table A in
Anterior Insertion to Adjust Sagittal Plane Alignment.
One example embodiment of an intravertebral implant device suitable for insertion from an anterior approach to correct vertebral alignment in the sagittal plane is described above and shown in
For insertion from the anterior direction to correct spinal alignment in the sagittal plane, an intravertebral implant device will be used that has a suitable implant device longitudinal angle. In most embodiments, this implant device longitudinal angle is provided by the wedge longitudinal angle. For example, referring to Table A in
For use in the thoracic area, the intravertebral implant device will be similarly configured but will generally have smaller dimensions. For example, referring to Table A in
Similarly, for use in the cervical area, the intravertebral implant device will be similarly configured but will generally have smaller dimensions. For example, referring to Table A in
It is understood, that if additional alignment correction is desired in the coronal plane, the intravertebral implant device may be selected with implant device transverse angles to provide this correction. This implant device transverse angle may be provided by either a plate transverse angle or a wedge transverse angle. For example, referring to Table A in
Example Embodiments of Implant Device to be Used with Oblique Insertion:
Example embodiments of orthopedic implant devices configured as intravertebral implant devices suitable for insertion from an oblique approach will be described below. Similar to the device embodiments described above for lateral and anterior insertion, the difference in the devices used is generally in selecting different sized components to suit the direction of insertion, the spinal plane to be corrected and the area of the spine to be corrected. The uniqueness of insertion from an oblique direction is that the implant device must accommodate more complicated implant device surface plane angles.
The descriptions below utilize an implant device consistent with the embodiments described above and shown in
Oblique Insertion to Adjust Coronal Plane Alignment.
One example embodiment of an intravertebral implant device suitable for insertion from an anterior approach to correct vertebral alignment in the coronal plane is described above and shown in
For insertion from the oblique direction to correct spinal alignment in the coronal plane, an intravertebral implant device will be used that has a suitable implant device transverse and longitudinal angles to alter the vertebra surface planes as desired. These implant device surface plane angles may be provided by either transverse or longitudinal angles of the wedge or plate exterior surfaces or some combinations of these angles. For example, for a primarily coronal plane adjustment, the implant device surface plane angles are configured to primarily alter the vertebra surface planes in the coronal plane. With the oblique orientation of the implant device, to only alter the vertebra surface planes in the coronal plane, the plate transverse angle may vary along its length and the longitudinal angle may vary along its width. Similarly, the wedge may have a longitudinal angle that varies along its width and may have a wedge transverse angle that varies along its length. The resulting dimensions of the implant device, for a primarily coronal correction, should be configured to primarily alter the vertebra surface planes in the coronal plane.
For a simple illustration, without accounting for the variations of the plate and wedge angles along their width and length, an example of suitable dimensions is shown in Table A in
For use in the thoracic area, the intravertebral implant device will be similarly configured but will generally have smaller dimensions. For example, referring to Table A in
Similarly, for use in the cervical area, the intravertebral implant device will be similarly configured but will generally have smaller dimensions. For example, referring to Table A in
For additional correction in the sagittal plane, the configuration of the implant device surface planes, as effected by the plate and wedge surface planes, can be selected to also alter the implant device and vertebra surface planes in the sagittal plane.
Oblique Insertion to Adjust Sagittal Plane Alignment.
One example embodiment of an intravertebral implant device suitable for insertion from an anterior approach to correct vertebral alignment in the sagittal plane is described above and shown in
As described above for insertion from the oblique direction to correct spinal alignment in the sagittal plane, for altering spinal alignment in the sagittal plane, an intravertebral implant device will be used that has a suitable device transverse and longitudinal angle to alter the vertebra surface planes as desired. These implant device surface plane angles may be provided by either transverse or longitudinal angles of the wedge or plate or combinations of these angles. For example, for a primarily sagittal plane adjustment, the implant device surface plane angles are configured to primarily alter the vertebra surface planes in the sagittal plane. With the oblique orientation of the implant device, to only alter the vertebra surface planes in the sagittal plane, the plate transverse angle may vary along its length and its longitudinal angle may vary along its width. Similarly, the wedge may have a longitudinal angle that varies along its width and may have a wedge transverse angle that varies along its length. The resulting dimensions of the implant device, for a primarily sagittal correction, should be configured to primarily alter the vertebra surface planes in the sagittal plane.
For a simple illustration, without accounting for the variations of the plate and wedge angles along their width and length, an example of suitable dimensions is shown in Table A in
For use in the thoracic area, the intravertebral implant device will be similarly configured but will generally have smaller dimensions. For example, referring to Table A in
Similarly, for use in the cervical area, the intravertebral implant device will be similarly configured but will generally have smaller dimensions. For example, referring to Table A in
For additional correction in the coronal plane, the configuration of the device surface planes, as effected by the plate and wedge surface planes, can be selected to also alter the vertebra surface planes in the coronal plane.
In some embodiments, supplemental fixation may be provided by elements such as holes in the plate or wedge that receive and allow a screw to pass through the hole to the bone whereby the screw further secures the implant device to the vertebra. In some embodiments, the supplemental fixation is provided on the proximal sidewall (the direction of insertion) opposite the staple on the distal sidewall whereby the supplemental fixation and the staple secure the implant device to the bone with a compressive force. In some embodiments, supplemental fixation may be provided by coupling the fixation device to the implant device and further securing the implant device to the bone with screws through the fixation device. Screws in these embodiments may be secured to a sidewall of the bone or they may be secured to the endplate cortical bone or the cancellous bone of the vertebra. In some embodiments, this supplemental fixation may be the only proximal side fixation of the device to the bone.
In some embodiments, the wedge tines may be configured to provide supplemental fixation of the implant device to the vertebra. For example, the wedge tines may be extended and be longer along the height of the wedge and through holes may extend through the wedge tine to allow a device such as a screw to further secure and affix the wedge and the implant device to the vertebra. In some embodiments, the intravertebral implant system further includes one or more navigation and robotic connections.
In some embodiments, the intravertebral implant system further includes one or more osteotomy guides.
In some embodiments, the intravertebral implant system further includes electro-field mechanisms. In these embodiments, a mechanism within the intravertebral implant may be activated by electromagnetic field, RFID, or other external field to cause the implant to produce a force on the fused vertebral body to change correction. This employs the effect of Wolff's Law where the bone responds to force to attain a level of stress, similar to orthodontia.
In some embodiments, the intravertebral implant system further includes percutaneous mechanisms. In these embodiments, a mechanism within the intravertebral implant may be activated by a percutaneous puncture of a tool to engage with the implant and cause the implant to create a force on the fused vertebral body to change correction. This also employs the effect of Wolff's Law where the bone responds to force to attain a level of stress, similar to orthodontia.
In some embodiments of the intravertebral implant system may be configured to provide non-surgical adjustment after the original surgery for further additional correction of the spine. These adjustments may be applied:
In some embodiments, two implants can be placed side by side for increased strength and sagittal correction.
In some embodiments, a cortical bone graft can be placed alongside the implant(s) for a stronger fusion.
Although this invention has been described in the above forms with a certain degree of particularity, it is understood that the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention which is defined in the claims and their equivalents.
This application is a continuation in part application of pending U.S. patent application Ser. No. 18/051,732, filed on Nov. 1, 2022; this application is a continuation in part of pending U.S. patent application Ser. No. 17/676,609, filed on Feb. 21, 2022; U.S. patent application Ser. No. 18/051,732 claims benefit of U.S. Patent App. No. 63/369,330, filed on Jul. 25, 2022; U.S. patent application Ser. No. 18/051,732 is a continuation in part application of pending U.S. patent application Ser. No. 17/676,609; U.S. patent application Ser. No. 18/051,732 is a continuation in part application of PCT Patent App. No. US2021/037,285 filed on Jun. 14, 2021; U.S. patent application Ser. No. 17/676,609 is a continuation application of U.S. patent application Ser. No. 17/347,492, filed on Jun. 14, 2021, now U.S. Pat. No. 11,259,936, issued on Mar. 1, 2022; U.S. patent application Ser. No. 17/676,609 is a continuation application of PCT Patent App. No. US2021/037,285; U.S. patent application Ser. No. 17/347,492 claims benefit of U.S. Patent App. No. 63/039,242, filed on Jun. 15, 2020; PCT Patent App. No. US2021/037,285 claims benefit of U.S. Patent App. No. 63/039,242; and the entire content of these applications are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63369330 | Jul 2022 | US | |
| 63039242 | Jun 2020 | US | |
| 63039242 | Jun 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17347492 | Jun 2021 | US |
| Child | 17676609 | US | |
| Parent | PCT/US2021/037285 | Jun 2021 | US |
| Child | 17347492 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 18051732 | Nov 2022 | US |
| Child | 18347655 | US | |
| Parent | 17676609 | Feb 2022 | US |
| Child | 18051732 | US | |
| Parent | 17676609 | Feb 2022 | US |
| Child | 17676609 | US | |
| Parent | PCT/US2021/037285 | Jun 2021 | US |
| Child | 17676609 | US |
