WO2021195107A1 - Motion preserving spinal implant for total disc replacement - Google Patents
Motion preserving spinal implant for total disc replacement Download PDFInfo
- Publication number
- WO2021195107A1 WO2021195107A1 PCT/US2021/023721 US2021023721W WO2021195107A1 WO 2021195107 A1 WO2021195107 A1 WO 2021195107A1 US 2021023721 W US2021023721 W US 2021023721W WO 2021195107 A1 WO2021195107 A1 WO 2021195107A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- end plate
- core
- outer core
- plate
- inner core
- Prior art date
Links
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- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30576—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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- A61F2002/30649—Ball-and-socket joints
- A61F2002/30654—Details of the concave socket
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- A61F2002/30657—Non-spherical concave inner surface made of different partially-spherical concave portions
- A61F2002/30658—Non-spherical concave inner surface made of different partially-spherical concave portions having a central conforming area surrounded by a peripheral annular non-conforming area
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30621—Features concerning the anatomical functioning or articulation of the prosthetic joint
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
- A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
- A61F2002/443—Intervertebral or spinal discs, e.g. resilient made of articulated components having two transversal endplates and at least one intermediate component
Definitions
- the present invention relates generally to human body implants. More particularly, the present invention relates to a motion preserving spinal implant for replacement of a spinal disc.
- Spinal implants are intended to treat degenerative disc disease (DDD) or other disc injuries.
- Spinal fusion treatment is a widely used treatment to alleviate pain, but limits range of motion and mobility for a patient.
- Total disc replacement is another treatment for disc degenerative disease that aims to preserve motion and limit complications related to spinal fusion such as adjacent level wear and disc degeneration.
- Total disc replacement is an effective solution for degenerative disc disease and gaining interest due to increasing prevalence of neck pain, lower back pain, and pain in general.
- spinal implants that reduce wear due to metal to metal sliding and corrosive surfaces, increase cushioning, improve shock absorption, reduce wear debris of metal, and maintain spinal motion range.
- the present invention solves these problems by providing a treatment solution that reduces degeneration due to metal wear because of no sliding between metal plates, increases cushioning with effective inner core design features, and uses special polymeric and elastomeric materials having varying hardness and physical properties such as silicone or liquid silicon rubber that also provides shock absorption, and maintains range of motion due to effective outer core design, its features, and choice of materials. All components in the assembly are designed such that it can effectively resist compression forces, shear-compression forces, and torsion forces. Additional advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Additional advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the detailed description of the invention section. Further benefits and advantages of the embodiments of the invention will become apparent from consideration of the following detailed description given with reference to the accompanying drawings, which specify and show preferred embodiments of the present invention.
- FIG. l is a side view of the present invention.
- FIG. 2 is an exploded perspective view of the present invention.
- FIG. 3 is a front view of the present invention.
- FIG. 4 is a rear view of the present invention.
- FIG. 5 is a top view and a side sectional view of the present invention.
- FIG. 6 is a top view and a front sectional view of one of the end plates of the present invention.
- FIG. 7 is a top view, a side sectional view, and a side view of the inner core of the present invention.
- FIG. 8 is a top view, a side sectional view, and a side view of the outer core of the present invention.
- FIG. 9 is a top view and a side sectional view of an alternative embodiment of the present invention incorporating anchoring protrusions.
- FIG. 10 is a top view and a side sectional view of one of the end plates in the alternate embodiment.
- FIG. 11 is a top view and a side sectional view of the outer core in the alternate embodiment.
- FIG. 12 is an exploded perspective view of a second alternate embodiment of the present invention.
- FIG. 13 is a top view and a side sectional view of the second alternate embodiment.
- FIG. 14 is a top view, a side sectional view, and a side view of the inner core of the second alternate embodiment.
- FIG. 15 is a top view, a side sectional view, and a side view of the outer core of the second alternate embodiment.
- FIG. 16 is an exploded perspective view of a third alternate embodiment of the present invention.
- FIG. 17 is a top view and a side sectional view of one of the end plates of the third alternate embodiment.
- FIG. 18 is a top view, a side sectional view, and a side view of the inner core of the third alternate embodiment.
- FIG. 19 is a top view, a side sectional view, and a side view of the outer core of the third alternate embodiment.
- FIG. 20 is an exploded perspective view of a fourth alternate embodiment of the present invention.
- FIG. 21 is a top view and a side sectional view of the fourth alternate embodiment.
- FIG. 22 is a top view and a side sectional view of one of the end plates of the fourth alternate embodiment.
- FIG. 23 is a top view, a side sectional view, and a side view of the inner core of the fourth alternate embodiment.
- FIG. 24 is a top view, a side sectional view, and a side view of the outer core of the fourth alternate embodiment.
- the present invention is a spinal implant intended for use in total replacement of a degenerated spinal disc.
- the present invention comprises a first end plate 1, a second end plate 2, an inner core 3, and an outer core 4.
- the first end plate 1, the second end plate 2, the inner core 3, and the outer core 4 each have generally radial geometry, though it may be noted that other geometries may be utilized as desired or useful.
- the inner core 3 and the outer core 4 are substantially wider than tall, having a certain thickness, or axial height.
- the inner core 3 and the outer core 4 each have radial geometry and are generally disc shaped, having a radial axial cross section.
- first end plate 1, the second end plate 2, the inner core 3, and the outer core 4 may have other general geometries.
- the first end plate 1, the second end plate 2, the inner core 3, and the outer core 4 each have generally rectilinear peripheral geometry with rounded corners.
- the inner core 3 is positioned within the outer core 4.
- the inner core 3 is positioned concentrically within the outer core 4, wherein the inner core 3 comprises an inner core centerline 16 and the outer core 4 comprises an outer core centerline 17, as shown in FIGS. 2, 5, 7, 8, 12, 13, and 21.
- the inner core centerline 16 and the outer core centerline 17 are positioned coincident with each other in order for the inner core 3 and the outer core 4 to be positioned concentrically with each other, as illustrated in FIG. 5.
- the inner core 3 and the outer core 4 may be positioned such that they are not exactly concentric, or nonconcentric, with each other, and thus the inner core centerline 16 and the outer core centerline 17 are positioned offset from each other, either through translation or rotation, or both.
- the outer core 4 comprises an inner cavity 40, and the inner cavity 40 centrally traverses through the outer core 4. Said central traversement is not intended to mean that the inner cavity 40 is necessarily concentric with the outer perimeter of the outer core 4, but rather that the inner cavity 40 traverses through the outer core 4 in a generally centralized position relative to the outer perimeter of the outer core 4.
- the inner cavity 40 is positioned concentrically within the outer core 4, such that the inner cavity 40 centrally and axially traverses through the outer core 4. In some other embodiments, the inner cavity 40 may be positioned nonconcentrically within the outer core 4.
- the inner core 3 is positioned within the inner cavity 40 of the outer core 4, wherein the inner core 3 is sealed by the outer core 4, the first end plate 1 and the second end plate 2. In some embodiments, the inner core 3 is positioned concentrically within the inner cavity 40.
- the internal lateral geometry of the inner cavity 40 may be determined by the external lateral geometry of the outer core 4. In some other embodiments, the inner core 3 may be positioned nonconcentrically within the inner cavity 40.
- first end plate 1, second end plate 2, inner core 3, and outer core 4 may be positioned concentrically with each other, wherein each of the first end plate 1, second end plate 2, inner core 3, and outer core 4 comprise a centerline, wherein the centerlines of the first end plate 1, second end plate 2, inner core 3, and outer core 4 are aligned with each other when the first end plate 1, second end plate 2, inner core 3, and outer core 4 are positioned concentrically with each other.
- one or more of the first end plate 1, second end plate 2, inner core 3, and outer core 4 may not be positioned concentrically, or nonconcentrically, with each other, wherein the centerlines of one or more of the said components may be positioned offset from each other, either through linear translation or rotation - an offset centerline may be positioned parallel to one or more other centerlines of the aforementioned components, but offset through a linear distance, or an offset centerline may be oriented at an angle offset to one or more other centerlines of the aforementioned components.
- such a said centerline may also correspond to a radial axis, or axis of revolution, of the generally radial features of said components.
- the outer core 4 is connected between the first end plate 1 and the second end plate 2. In some embodiments, as shown in FIGS. 1-11, the outer core 4 is connected between the first end plate 1 and the second end plate 2 through a plurality of interlocking members 5. In some embodiments, the outer core 4 is connected between the first end plate 1 and the second end plate 2 through an adhesive. FIGS. 12-15 and FIGS. 20-24 illustrate examples of such embodiments.
- the adhesive may be any suitable adhesive appropriate for the intended use of the present invention. The adhesive should be sterile, biodegradable and biocompatible.
- the adhesive may be based on, derived from, or comprise, but is not limited to, bone cement, polyurethane, acrylates, rubbers, polymers, epoxy resins, phenolic resins, natural adhesives, synthetic adhesives, or any other suitable adhesive substances.
- the adhesive may be the result of any suitable manufacturing process, as opposed to a distinct adhesive substance.
- the inner core 3 and the outer core 4 are sandwiched by the first end plate 1 and the second end plate 2.
- the outer core 4 comprises the inner cavity 40 that centrally and traverses through the outer core 4, with the inner core 3 being positioned within the inner cavity 40 of the outer core 4, such that the inner core 3 is sealed by the outer core 4, the first end plate 1 and the second end plate 2
- the inner core 3 is constructed of a polymeric material. More particularly, in various embodiments, the inner core 3 is preferably constructed of a medical or implant grade polymeric or elastomeric material which may have varying hardness and other physical properties in various embodiments. In some embodiments, the inner core 3 is constructed of a liquid silicon rubber material, wherein the liquid silicon rubber material may have varying hardness properties in different embodiments. In some embodiments, the inner core 3 is constructed of a medical or implant grade silicone elastomer with a hardness ranging from 60 shore A to 90 shore A. In some embodiments, the inner core 3 may be constructed of a liquid silicone rubber (LSR) material. Such material is inert and widely used in medical breast implants.
- LSR liquid silicone rubber
- Silicone rubber has the ability to retain its initial shape and mechanical stress under high compression, shear-compression, flexural, torsional, and tensile stresses and has excellent creep properties.
- other appropriate materials may be used to manufacture the inner core 3.
- the inner core 3 serves as a solid “diaphragm” or cushion that resists and withstands localized compression, shear-compression, torsion, and other forces.
- the diameter of the inner core 3 may range from approximately 0.125 inches to 2.25 inches, but it should be understood herein that various dimensions of the present invention may vary without departing from the intended spirit and scope of the present invention.
- the inner core 3 comprises a first core convexity 30 and a second core convexity 31, as shown in FIGS. 5 and 7.
- the first core convexity 30 and the second core convexity 31 are positioned opposite each other along a thickness of the inner core 3, along the inner core centerline 16.
- the first core convexity 30 and the second core convexity 31 are positioned axially opposite each other along the thickness of the inner core 3, wherein the first core convexity 30 and the second core convexity 31 are concentrically positioned with the inner core centerline 16.
- the first core convexity 30 and the second core convexity 31 may be positioned offset, nonconcentrically, from the inner core centerline 16.
- the first core convexity 30 and the second core convexity 31 are essentially bulges centrally positioned on the inner core 3 that contribute to the inner core’s 3 capabilities to resist and withstand any forces the inner core 3 is subject to while installed in a human spine.
- the first core convexity 30 and the second core convexity 31 further correspond to and mate with inner concavities on the first end plate 1 and the second end plate 2, as will be discussed hereinafter.
- a convexity angle of the first core convexity 30 and the second core convexity 31 may range from 5 degrees to 60 degrees, and an outer radius of the first core convexity 30 and the second core convexity 31 may range from 0.075 inches to 2 inches in various embodiments.
- the inner core 3 further comprises a lateral wall with a convex curvature, whose radius may range in various embodiments from 0.063 inches to 2.250 inches, but it should be understood herein that various dimensions of the present invention may vary without departing from the intended spirit and scope of the present invention.
- the inner core 3 comprises an inner core centerline 16 and the outer core 4 comprises an outer core centerline 17.
- the inner core centerline 16 and the outer core centerline 17 may be considered in some embodiments to be an axis equidistant from the outer perimeter of the inner core 3 and outer core 4, respectively, and/or an axis of revolution for other radial features in some embodiments.
- a radial axis may be considered as said axis of revolution, and may be considered as distinct from the inner core centerline 16 and the outer core centerline 17 for the inner core 3 and outer core 4, respectively.
- the radial axis may be positioned offset from the inner core centerline 16 and the outer core centerline 17.
- the first core convexity 30 and the second core convexity 31 of the inner core 3 are concentrically positioned about the radial axis of the inner core 3. Furthermore, the inner cavity 40 of the outer core 4 is positioned concentrically about the radial axis of the outer core 4 in such embodiments. In other embodiments, however, the first core convexity 30 and the second core convexity 31 of the inner core 3 may be nonconcentrically positioned about the radial axis of the inner core 3, and the inner cavity 40 of the outer core 4 may be positioned nonconcentrically about the radial axis of the outer core 4 in such embodiments.
- the outer core 4 acts as a sealing ring for the inner core 3 and provides the necessary motion to the spine once the present invention is implanted in a human body.
- the outer core 4 is constructed of a polymeric or elastomeric material with varying hardness and other physical properties in various embodiments.
- the outer core 4 may be constructed of various materials.
- the outer core is constructed of a polymeric material.
- the outer core is constructed of a liquid silicon rubber material, wherein the liquid silicon rubber material may have varying hardness properties in different embodiments.
- the outer core 4 may be constructed of an ultra-high molecular weight polyethylene (UHMWPE) material.
- UHMWPE ultra-high molecular weight polyethylene
- the outer core 4 may be constructed of a medical grade polypropylene (PP) material, though the material of the outer core 4 may vary in different embodiments as desired. In general, it is desired to use a material with superior abrasive and corrosive resistance, high strength, light weight, and low coefficient of friction in the outer core 4.
- the diameter of the outer core 4 may range from 0.175 inches to 2.375 inches, though as previously mentioned, any dimensions listed for the various components of the present invention should not be considered to be limiting and may vary in different embodiments.
- the first end plate 1 and the second end plate 2 are each constructed of a polyether ether ketone (PEEK) material, though the material of the first end plate 1 and the second end plate 2 may vary in different embodiments.
- PEEK polyether ether ketone
- the material of the first end plate 1 and the second end plate 2 may vary in different embodiments.
- PEEK is increasingly employed as a biomaterial for trauma treatments, orthopedic, and spinal implants. It is inherently strong, inert, and biocompatible. Properties that make PEEK a material of choice for the end plates include: modulus similar to bone, reduced stress shielding, artifact-free imaging, and an osteoconductive surface for bone on-growth.
- PEEK material can be used in combination with a titanium material or with a titanium plasma spray on the external surfaces of the outer core 4.
- the first end plate 1 and the second end plate 2 may be externally treated with a titanium material.
- the first end plate 1 and the second end plate 2 each comprise a plate body 20, an inner side 21, an outer side 22, a plate convexity 23, and a concavity 24, wherein a thickness of the plate body 20 extends between the inner side 21 and the outer side 22.
- the diameter of the plate body 20 may range from 0.375 inches to 2.5 inches, while the thickness may range from 0.031 inches to 0.375 inches, but it should be understood herein that various dimensions of the present invention may vary without departing from the intended spirit and scope of the present invention.
- the plate body 20 of the first end plate 1 and the plate body 20 of the second end plate 2 are oriented at a specified tilt angle 6 to each other, as illustrated in FIG. 1.
- the specified tilt angle 6 defines a deviation of the plate bodies of the first end plate 1 and second end plate 2 from being oriented parallel to each other.
- the specified tilt angle 6 may vary in different embodiments, mainly to correspond with different spinal disc types to replace. In various embodiments, the specified tilt angle 6 may range from 0.5 degrees to 15 degrees. In some embodiments, the specified tilt angle 6 may be less than 0.5 degrees. In some embodiments, the specified tilt angle 6 may be 0 degrees, such that the first end plate 1 and the second end plate 2 are oriented parallel to each other. In some embodiments, the specified tilt angle 6 may exceed 15 degrees.
- the plate convexity 23 is centrally positioned on the outer side 22 of the plate body 20 for each of the first end plate 1 and the second end plate 2, similarly, the concavity 24 is centrally positioned on the inner side 21 of the plate body 20 for each of the first end plate 1 and the second end plate 2
- the thickness of the plate body 20 is constant, and the plate convexity 23 and the concavity 24 are formed through a deviation from the generally flat geometry of the plate body 20, such that the thickness of the end plates at the plate convexity 23 and concavity 24 is equal to the thickness of the end plates at their perimeter.
- the plate convexity 23 and the concavity 24 of the first end plate 1 and the second end plate 2 may be formed independently of each other.
- a fillet may be formed between the plate body 20 and the plate convexity 23 with a radius of, for example, but not limited to, a range from 0.015 inches to 0.5 inches. The fillet serves to reduce any polymeric stress due to vertical localized compression forces on the first and second end plates 2
- the first core convexity 30 is positioned within the concavity 24 of the first end plate 1 and the second core convexity 31 is positioned within the concavity 24 of the second end plate 2
- the outer core 4 is connected between the first end plate 1 and the second end plate 2 through the plurality of interlocking members 5
- the inner core 3 is further connected between the first end plate 1 and the second end plate 2 in the same manner through the plurality of interlocking members 5 though this is not considered a requirement. More particularly, the inner side 21 of the first end plate 1 is connected to the outer core 4 through the plurality of interlocking members 5 and the inner side 21 of the second end plate 2 is connected to the outer core 4 opposite the first end plate 1 axially along the inner core 3 through the plurality of interlocking members 5
- the first end plate 1 and the second end plate 2 each further comprise an attachment flange 25 and at least one fastener aperture 26 as shown in FIGS. 1 6
- the attachment flange 25 may be used to anchor the present invention to adjoining vertebrae through one or more implant screws.
- the inclusion of the attachment flange 25 in various embodiments will depend on end product requirements.
- the attachment flange 25 is perpendicularly and perimetrically connected to the plate body 20, and extends away from the inner side 21, past the outer side 22 for each of the first end plate 1 and the second end plate 2, wherein the attachment flange 25 is connected along a flange arc segment of the perimeter of the plate body 20.
- the attachment flange 25 does not extend past the inner side 21, though this may vary in different embodiments.
- the at least one fastener aperture 26 traverses through the attachment flange 25 for each of the first end plate 1 and the second end plate 2.
- Each of the at least one fastener aperture 26 may be a counterbore hole, a countersink hole, a through hole, or other types of holes suitable for receiving various fasteners in different embodiments.
- the attachment flange 25 comprises an inner groove 27.
- the inner groove 27 traverses into and radially through the attachment flange 25 along the flange arc segment adjacent to the outer side 22 of the plate body 20 and adjacent to a perimeter of the plate body 20 for each of the first end plate 1 and the second end plate 2.
- the inner groove 27 serves to provide clearance to the edge of adjoining vertebra where the total disc replacement is being performed to reduce any wear from vertebral edges.
- the outer core 4 comprises a first plurality of core interlocking members 50 and a second plurality of core interlocking members 51 from the plurality of interlocking members 5, wherein the first plurality of core interlocking members 50 and the second plurality of core interlocking members 51 are positioned opposite each other along a thickness of the outer core 4.
- the first plurality of core interlocking members 50 and the second plurality of core interlocking members 51 are positioned axially opposite each other along the thickness of the outer core.
- the first end plate 1 and the second end plate 2 each further comprise a plurality of plate interlocking members 52 from the plurality of interlocking members 5.
- the plurality of plate interlocking members 52 is positioned concentrically around the concavity 24 on the inner side 21 of the plate body 20 for each of the first end plate 1 and the second end plate 2.
- the first plurality of core interlocking members 50 of the outer core 4 is engaged with the plurality of plate interlocking members 52 of the first end plate 1
- the second plurality of core interlocking members 51 of the outer core 4 is engaged with the plurality of plate interlocking members 52 of the second end plate 2.
- the present invention further comprises a plurality of interlocking member receiving channels 7, as shown in FIGS. 2, 5, 6, and 8- 11.
- Each of the plurality of interlocking member receiving channels 7 is positioned concentrically with and adjacent to one of the plurality of interlocking members 5, and each of the plurality of interlocking members 5 is positioned within one of the plurality of interlocking member receiving channels 7.
- the plurality of interlocking members 5 and the plurality of interlocking member receiving channels 7 are configured to resist extrusion of the inner core 3 and outer core 4 when the inner core 3 and outer core 4 are subject to external forces.
- the specific configuration and shape of the plurality of interlocking members 5 and the plurality of interlocking member receiving channels 7 may vary in different embodiments.
- the plurality of interlocking members 5 and the plurality of interlocking member receiving channels 7 have a dovetail mating configuration as shown in FIGS. 2 and 5-8, wherein a cross section width of each of the plurality of interlocking members 5 increases with distance away from the axial center of the outer core 4, and wherein each of the plurality of interlocking member receiving channels 7 is shaped inversely to the plurality of interlocking members 5 to accommodate them.
- a cross section of each of the plurality of interlocking members 5 resembles a “tooth”, having an angled protrusion with a circular element at the end, wherein the cross section of the interlocking member receiving channels 7 would have correspondingly negative geometry to receive the tooth.
- the distal geometry of the interlocking members 5 has a greater radial width than the remainder of the interlocking members 5, facilitating securement of the interlocking members 5 within the interlocking member receiving channels 7.
- the interlocking members 5 and receiving channels 7 may not vary in thickness, as shown in FIG. 9.
- FIGS. 9-11 illustrate an alternative embodiment wherein each of the plurality of interlocking members 5 is oriented at a specified anti -extrusion angle 53 in order to adequately resist extrusion of the inner core 3 and/or outer core 4 as previously described.
- each of the first plurality of core interlocking members 50, the second plurality of core interlocking members 51, and the plurality of plate interlocking members 52 is oriented at the specified anti -extrusion angle 53.
- the specified anti-extrusion angle 53 may be defined in various ways, but herein the specified anti-extrusion angle 53 is defined in relation to a central axis 15 of the present invention.
- the central axis 15 may be considered to be an axis about which the radial features of the present invention, such as, but not limited to the inner core 3 and the outer core 4, and the plate body 20 are positioned concentrically about. Separate central axes may be defined as appropriate for the inner core 3, outer core 4, and plate body 20 in order to account for any angular discrepancies due to the specified tilt angle 6.
- the previously discussed inner core centerline 16 and outer core centerline 17 may, in various embodiments, be the same as or distinct from the central axis 15.
- the specified anti-extrusion angle 53 should be oriented radially outward from the central axis, such that an imaginary line extending outward from any given member of the first plurality of core interlocking members 50 or the second plurality of core interlocking members 51 does not intersect with the central axis. This is important because an inwardly-oriented anti-extrusion angle 53 would not be effective or as effective and may not provide effective interlock as an outwardly -oriented anti-extrusion angle.
- the plurality of interlocking members 5 and the plurality of interlocking member receiving channels 7 function primarily to secure the inner core 3 to the first end plate 1 and the second end plate 2, but also secondarily to resist extrusion of the outer core 4 (and inner core 3, in applicable embodiments) when the present invention is subjected to external forces, compressive forces in particular.
- the inner core 3 and outer core 4 will tend to deform a certain amount in compression axially and in expansion laterally.
- portions of the inner core 3 and outer core 4 will “extrude” out of their designated positions and potentially become misaligned or damaged.
- the quantity of both the plurality of interlocking members 5 and the plurality of interlocking member receiving channels 7 may vary in different embodiments, from 1 to 9, for example, though any quantity of interlocking members 5 and interlocking member receiving channels 7 may be included as desired in various embodiments.
- the first end plate 1 and the second end plate 2 may be oriented at a specified tilt angle 6 to each other in order to imitate the geometry of a spinal disc to be replaced by the present invention.
- the plate body 20 of the first end plate 1, the plate body 20 of the second end plate 2, the inner core 3 and the outer core 4 may be understood to extend in a longitudinal direction between a proximal end 8 and a distal end 9.
- the proximal end 8 and the distal end 9 are positioned diametrically opposite each other for each of the plate body 20, the inner core 3, and the outer core 4.
- proximal ends 8 are defined herein to be radially aligned with each other and the distal ends 9 are radially aligned with each other for each of the plate bodies of the first end plate 1 and the second end plate 2, the inner core 3, and the outer core 4.
- the specified tilt angle 6 is defined in a plane coincident with the proximal ends 8 and the distal ends 9.
- the flange attachment is positioned at the proximal end
- the orientation and alignment of the specified tilt angle 6 may vary however, and should not be considered to be limited to the foregoing description.
- the specified tilt angle 6 may be realized through a diametrical difference in thickness of the inner core 3 and the outer core 4, so that the axial outer ends of the inner core 3 and outer core 4 are oriented at the specified tilt angle 6 to each other, and thus the first end plate 1 and the second end plate 2, being generally flat, are oriented at the specified tilt angle 6 to each other as a result.
- a proximal thickness 10 and a distal thickness 11 of both the inner core 3 and the outer core 4 may be defined, wherein the proximal thickness 10 of the outer core 4 is the thickness of the outer core 4 at the proximal end 8 of the outer core 4, the distal thickness 11 of the outer core 4 is the thickness of the outer core 4 at the distal end 9 of the outer core 4, the proximal thickness 10 of the inner core 3 is the thickness of the inner core 3 at the proximal end 8 of the inner core 3, and the distal thickness 11 of the inner core 3 is the thickness of the inner core 3 at the distal end 9 of the inner core 3.
- the proximal thickness 10 of the inner core 3 is greater than the distal thickness 11 of the inner core 3, and the proximal thickness 10 of the outer core 4 is greater than the distal thickness 11 of the outer core 4.
- the specified tilt angle 6 may be determined in some embodiments by the difference between the proximal thicknesses 10 and the distal thicknesses 11.
- the specified tilt angle 6 may be determined through other means; for example, the thickness of the inner core 3 and outer core 4 may be constant, while the thickness of the first end plate 1 and second end plate 2 may vary instead.
- the first end plate 1 and the second end plate 2 further comprise a plurality of anchoring protrusions 12.
- the plurality of anchoring protrusions 12 serve as an alternative means of mounting the first end plate 1 and the second end plate 2 to adjacent vertebrae.
- the anchoring protrusions 12 are connected to the outer side 22 and are preferably oriented perpendicular to the plate body 20.
- the anchoring protrusions 12 are distributed around the outer side 22 in any desirable configuration, such as, but not limited to, four anchoring protrusions positioned in a concentric 90 degree pattern around the plate convexity 25.
- each of the anchoring protrusions 12 may comprise a plurality of teeth 13 positioned at a distal end 14 of the anchoring protrusions 12.
- the components of the present invention may be manufactured through any desirable manufacturing process, such as, but not limited to, 3D printing, CNC machining, injection molding, compression bolding, or other manufacturing processes.
- the inner core 3 is preferably injection molded through an insert molding process where the first end plate 1 and the second end plate 2 serve as inserts.
- the inner core 3 can be produced independently through an injection molding, compression molding, or 3D printing process and is subsequently assembled with the first end plate 1 and the second end plate 2.
- the outer core 4 is preferably either injection molded or compression molded using an insert molding process where an assembly of the first end plate 1, second end plate 2, and inner core 3 serve as inserts.
- the outer core 4 can be produced independently through injection molding, compression molding, or 3D printing and subsequently assembled with the first end plate 1, second end plate 2, and inner core 3. Furthermore, in the preferred embodiment, at every stage of assembly of the present invention, the external surfaces of the various components of the present invention are treated to increase surface bonding to achieve sufficient covalent, cohesive and/or adhesive bonds.
- FIGS. 12-15 show a second alternate embodiment of the present invention wherein the inner cavity 40 of the outer core 4 is positioned offset from concentric with the outer core centerline 17, and the first core convexity 30 and second core convexity 31 of the inner core 3 are positioned offset from concentric with the inner core centerline 16. Furthermore, the inner core centerline 16 and the outer core centerline 17 are also offset from each other. This geometric arrangement may have various advantages in different use cases, such as facilitating conformity to a patient’s vertebrae.
- the second alternate embodiment additionally utilizes the previously discussed adhesive to bond the outer core 4 to the first end plate 1 and the second end plate 2.
- FIGS. 16-19 show a third alternate embodiment, wherein the peripheral geometry of the inner core 3 and outer core 4 are generally rectilinear. This geometric arrangement may also have similar various advantages in different use cases or implantation scenarios, such as facilitating ease of insertion of the present invention between vertebrae.
- FIGS. 20-24 show a fourth alternate embodiment, wherein the peripheral geometry of the inner core 3 and outer core 4 are generally rectilinear, as with the third alternate embodiment, while the outer core 4 is connected between the first end plate 1 and the second end plate 2 through the adhesive, as with the second alternate embodiment.
- Different embodiments comprising various combinations of the aforementioned features may be considered to be more or less advantageous in various situations, and the present invention should not be considered to be strictly limited to any of the specifically described embodiments herein.
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Neurology (AREA)
- Prostheses (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
Description
Claims
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
MX2022011720A MX2022011720A (en) | 2020-03-23 | 2021-03-23 | Motion preserving spinal implant for total disc replacement. |
BR112022019015A BR112022019015A2 (en) | 2020-03-23 | 2021-03-23 | SPINAL IMPLANT WITH MOTION PRESERVATION FOR TOTAL DISC REPLACEMENT |
AU2021244448A AU2021244448A1 (en) | 2020-03-23 | 2021-03-23 | Motion preserving spinal implant for total disc replacement |
CA3172643A CA3172643A1 (en) | 2020-03-23 | 2021-03-23 | Motion preserving spinal implant for total disc replacement |
EP21776497.6A EP4106680B1 (en) | 2020-03-23 | 2021-03-23 | Motion preserving spinal implant for total disc replacement |
JP2022557166A JP2023518959A (en) | 2020-03-23 | 2021-03-23 | Motion-preserving implant for artificial disc replacement |
CN202180034114.6A CN115515539A (en) | 2020-03-23 | 2021-03-23 | Remaining mobility spinal implant for total artificial disc replacement |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US16/826,742 US10758362B1 (en) | 2019-04-03 | 2020-03-23 | Motion preserving spinal implant for total disc replacement |
US16/826,742 | 2020-03-23 | ||
US16/940,234 | 2020-07-27 | ||
US16/940,234 US11478360B2 (en) | 2019-04-03 | 2020-07-27 | Motion preserving spinal implant for total disc replacement |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2021195107A1 true WO2021195107A1 (en) | 2021-09-30 |
Family
ID=77892659
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2021/023721 WO2021195107A1 (en) | 2020-03-23 | 2021-03-23 | Motion preserving spinal implant for total disc replacement |
Country Status (8)
Country | Link |
---|---|
EP (1) | EP4106680B1 (en) |
JP (1) | JP2023518959A (en) |
CN (1) | CN115515539A (en) |
AU (1) | AU2021244448A1 (en) |
BR (1) | BR112022019015A2 (en) |
CA (1) | CA3172643A1 (en) |
MX (1) | MX2022011720A (en) |
WO (1) | WO2021195107A1 (en) |
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-
2021
- 2021-03-23 JP JP2022557166A patent/JP2023518959A/en active Pending
- 2021-03-23 WO PCT/US2021/023721 patent/WO2021195107A1/en active Application Filing
- 2021-03-23 MX MX2022011720A patent/MX2022011720A/en unknown
- 2021-03-23 BR BR112022019015A patent/BR112022019015A2/en unknown
- 2021-03-23 EP EP21776497.6A patent/EP4106680B1/en active Active
- 2021-03-23 AU AU2021244448A patent/AU2021244448A1/en active Pending
- 2021-03-23 CA CA3172643A patent/CA3172643A1/en active Pending
- 2021-03-23 CN CN202180034114.6A patent/CN115515539A/en active Pending
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Also Published As
Publication number | Publication date |
---|---|
CA3172643A1 (en) | 2021-09-30 |
MX2022011720A (en) | 2023-01-04 |
EP4106680B1 (en) | 2024-07-03 |
EP4106680A1 (en) | 2022-12-28 |
CN115515539A (en) | 2022-12-23 |
JP2023518959A (en) | 2023-05-09 |
EP4106680A4 (en) | 2023-08-16 |
BR112022019015A2 (en) | 2023-03-07 |
AU2021244448A1 (en) | 2022-10-13 |
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