INTERBODY STANDALONE DEVICE WITH INTEGRATED FIXATIONS

Abstract

In the present invention, stand-alone interbody spine implant for fusion of adjacent vertebrae is disclosed. In the preferred configuration, this implant includes one spacer which is placed between adjacent vertebrae and at least one pin/bar/fastener which attaches the spacer to the bones. The spacer includes channel(s) with various configurations which guide the pins/bars/fasteners through the spacer in order to penetrate into bone. The combination of pins/bars/fasteners and spacer together, provides fixation of the implant to bone and fuses the adjacent vertebrae.

Claims

1. An intervertebral implant for treatment of a spine compromising: 1. A spacer placed between two adjacent vertebrae with configured channels to receive and guide the pins/bars/fasteners into the bone. 2. A pin/bar/fastener or a set of pins/bars/fasteners configured to pass through the spacer passages, follow the trajectory of the channels and penetrate into the bone.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The invention is best understood from the following detailed description when read in connection with the associated drawings. It is emphasized that, according to common practice, the various features of the drawing are not to scale. On the contrary, the dimensions of various features are arbitrarily expanded or reduced for clarity.

[0015] Included in the drawing are the following figures.

[0016] FIG. 1A is a perspective view of embodiment appropriate for interbody vertebral fusion including spacer integrated with inserts/pins/bars to secure the device to adjacent vertebrae.

[0017] FIG. 1B is an anterior (front) view of the embodiment shown in FIG. 1A;

[0018] FIG. 1C is a superior (top) view of the embodiment shown in FIG. 1A;

[0019] FIG. 1D is a lateral (side) view of the embodiment shown in FIG. 1A;

[0020] FIG. 1F is an exploded view of the embodiment shown in FIG. 1A;

[0021] FIG. 1G is an exploded view of the embodiment shown in FIG. 1A prior pins/bars/fasteners are being inserted through the spacer;

[0022] FIG. 2 is an illustration of the intervertebral device of FIG. 1A used in the spine.

[0023] FIG. 3A is a perspective view of inserts/pins/bars prior to deploying into spacer;

[0024] FIG. 3B is a perspective view of inserts/pins/bars after deploying into spacer;

[0025] FIG. 3C is an anterior (front) of the inserts shown in FIG. 3B;

[0026] FIG. 3D is a superior (top) view of the inserts shown in FIG. 3B;

[0027] FIG. 3E is a lateral (side) view of the inserts shown in FIG. 3B;

[0028] FIG. 4A is a perspective view of the spacer;

[0029] FIG. 4B is a perspective view of the spacer with increased transparency;

[0030] FIG. 4C is an anterior (front) of the spacer shown in FIG. 4B;

[0031] FIG. 4D is a superior (top) view of the spacer shown in FIG. 4B;

[0032] FIG. 4E is a lateral (side) view of the spacer shown in FIG. 4B;

DETAILED DESCRIPTION AND BEST MODE OF IMPLEMENTATION

[0033] The embodiments of present invention provide stand-alone interbody fusion device that may be designed or adopted in different styles for use in various levels of the spine including the cervical spine, the thoracic spine, the lumbar spine, and the sacrum spine. These various styles may be an anterior cervical discectomy and fusion (ACDF) device, a posterior cervical discectomy and fusion (PCDF), a far anterior lateral interbody fusion (FALIF) device, a posterior lumbar interbody fusion (PLIF) device, a transforaminal lumbar interbody fusion (TLIF) device, an anterior lumbar interbody fusion (ALIF) device, and a lateral lumbar interbody fusion (LLIF). Therefore, this closure applies with equal weight to every level of the spine.

[0034] The outer body of this device may have different surface features, surface coating, surface finish, and surface textures in order to provide resistance against bony parts, achieve sufficient stability, and form a bony on-growth to the implant, thereby promoting fusion.

[0035] The body of the spacer 1 may include optional cavities 2, extended from inferior surface to superior surface, for the use of containing different bone graft material such as bone marrow aspirate/concentrate, bone morphogenetic protein (BMP), autograft, etc. Additionally, the body of the spacer may be made from a variety of biocompatible materials including biocompatible implantable polymers such as PEKK, PEKEK, polyetheretherketone (PEEK), CRF (carbon reinforce peak), Titanium, Nitinol, ceramic, SI3N4, etc. The pin/bar/fastener may be made of a different biocompatible material, including but not limited to, titanium, nitinol, and stain steel, etc.

[0036] The spacer 1 and pins/bars/fasteners 8 may have different geometrical profiles, shapes, and sizes for the purpose of covering a variety of patient anatomy and spinal disorders. In the present invention, at least one pins/bars/fasteners may be deployed into the spacer in order to provide bone to implant fixation. During implantation, the pins/bars/fasteners may be inserted either sequentially or simultaneously using a designed inserter. Each pin/bar/fastener 11 may have features which mate with features within the spacer to prevent back out or progress of the pins/bars/fasteners from/in the spacer after being fully deployed. The outer profile 8 of the pins/bars/fasteners may be manufactured with various profiles such as square, ellipse, rectangle, etc. This profile will be chosen in such way that the pins/bars/fasteners withstand the physiological loading condition applied on spine, deliver maximum torsional and pull out stability, and easily being penetrated into the bone. The tip of the pins/bars/fasteners 9 may be formed with a sharply pointed shape. This feature facilitates the penetration of the pins/bars/fasteners into the cortical and trabecular bone. The cone region 10 and the outer profile 8 of pins/bars/fasteners may have geometrical features that increase the fixation of the pins/bars/fasteners into bone when the pins/bars/fasteners are implanted into the bone.

[0037] The pins/bars/fasteners can be deployed into the spacer by an inserter using different techniques, including but not limited to, impaction, driving mechanism, etc.

[0038] The spacer 1 of the present invention includes superior surfaces, an inferior surface, and a peripheral surface. The inferior and superior surfaces are in a direct contact with adjacent vertebrae and are formed with different surface features. This surface features 3 may be made with various shapes and roughness in order to achieve maximum spacer to bone fixation, stability, and bone in-growth. The spacer has channels which are extended from a designed opening hole on the peripheral surface 5 of the spacer to the opening holes on the superior and inferior surface 6 of the spacer. The opening holes on the superior and inferior surfaces can be located in any positions in order to provide desired stability and fixation. Channels 7 may have straight pathway at the beginning and curved pathway close to the superior and inferior opening holes. The other option is that these channels 7 may have curved pathway at the begging and straight pathway close to the superior and inferior opening holes or they can be curved or straight the entire pathway. The shape of the pathways can be selected such that provide maximum spacer to bone fixation, stability, ease of insertion, and ease of revision. The purpose of these channels is to guide the pins/bars/fasteners throughout the spacer. The curved region of channels may be made with different radii in different anatomical planes to form the pins/bars/fasteners with different radii in different planes 12, 13. The profile, size, shape of these channels 7 may vary based on the outer profile of designed pins/bars/fasteners. Additionally, the spacer of the device has a feature 4 (e.g., a hole on front (anterior) surface) which is engaged with the inserter for placing the spacer within the adjacent vertebrae. This feature also allows the surgeon to inject the bone graft, bone morphogenetic protein (BMP), autograft, etc. into the spacer.

[0039] Although the invention has been described in detail and reference to specific embodiments, it will be apparent to one skilled in the art that various changes and modification can be made without departing from the spirit and scope of the invention.