Process of fabricating implants having three distinct surfaces

Abstract

Processes of fabricating different surface topographies, which may include separate macro processing, micro processing, and nano processing steps, in order to produce an interbody spinal implant having at least three distinct surfaces including (1) at least one integration surface having a roughened surface topography including macro features, micro features, and nano features, without sharp teeth that risk damage to bone structures; (2) at least one graft contact surface having a coarse surface topography including micro features and nano features; and (3) at least one soft tissue surface having a substantially smooth surface including nano features.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a divisional of U.S. patent application Ser. No. 13 / 557,727, filed on Jul. 25, 2012, which is a continuation-in-part of U.S. patent application Ser. No. 12 / 151,198, filed on May 5, 2008, and issued as U.S. Pat. No. 8,262,737, which is a continuation-in-part of U.S. patent application Ser. No. 11 / 123,359, filed on May 6, 2005, and issued as U.S. Pat. No. 7,662,186. The contents of all prior applications are incorporated by reference into this document, in their entirety and for all purposes.TECHNICAL FIELD[0002]The present invention relates generally to interbody spinal implants and methods of making such implants and, more particularly, to spinal implants having at least three distinct surfaces.BACKGROUND OF THE INVENTION[0003]In the simplest terms, the spine is a column made of vertebrae and discs. The vertebrae provide the support and structure of the spine while the spinal discs, located between the vertebrae, act a...

AI Technical Summary

Benefits of technology

[0007]The present invention provides for interbody spinal implants having at least three distinct surfaces: (1) at least one integration surface; (2) at least one graft contact surface; and (3) at least one soft tissue surface. The integration surface includes macro, micro, and nano features having a fusion and biologically active surface geometry and frictionally engages preserved bone structures. The graft contact surface includes micro and nano features, which positively influence naturally occurring biological bone remodeling and fusion responses. The soft tissue surface includes a low friction surface with nano features (and optionally micro features) to avoid unintentional laceration or abrasion of delicate soft tissues (e.g., blood vessels, nerves, and muscles) the implant contacts during insertion, after insertion, or both. The soft tissue surface can also provide an anchoring point and signaling function to bone forming cells in order to positively influence the fusion and healing processes. Various implant body shapes are provided to allow for implantation through various access paths to the spine through a patient's body. The structures and surfaces are designed to work in concert to preserve endplate bone structures, provide for sufficient bioactivity in each respective location, and provide stability within the disc space and the graft containment axial column. In particular, the shapes and textures of the bioactive surfaces vary based on the implant insertion path, location within the disc space, and frictional characteristics of the surfaces.

Problems solved by technology

Over time, the discs may become diseased or infected, may develop deformities such as tears or cracks, or may simply lose structural integrity (e.g., the discs may bulge or flatten).

Impaired discs can affect the anatomical functions of the vertebrae, due to the resultant lack of proper biomechanical support, and are often associated with chronic back pain.

There are a number of problems, however, with traditional spinal implants including, but not limited to, improper seating of the implant, implant subsidence (defined as sinking or settling) into the softer cancellous bone of the vertebral body, poor biomechanical integrity of the endplates, damaging critical bone structures during or after implantation, and the like.

Such challenges include: (1) end-plate preparation; (2) implant difficulty; (3) materials of construction; (4) implant expulsion; (5) implant subsidence; (6) insufficient room for bone graft; (7) stress shielding; (8) lack of implant incorporation with vertebral bone; (9) limitations on radiographic visualization; and (10) cost of manufacture and inventory.

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