Bi-Directional Fixating/Locking Transvertebral Body Screw/Intervertebral Cage Stand-Alone Constructs

Patent No. US10925753 (titled "Bi-Directional Fixating/Locking Transvertebral Body Screw/Intervertebral Cage Stand-Alone Constructs") was filed by Moskowitz Family Llc on Mar 22, 2019.

What is this patent about?

’753 is related to the field of spinal fusion, specifically addressing the need for improved intervertebral devices. Traditional spinal fusion techniques often involve supplemental fixation methods like pedicle screws or anterior plating, which can lead to complications such as nerve or vascular injury, blood loss, and adjacent segment disease. The background highlights the limitations of existing solutions and the ongoing need for less invasive and more reliable methods for achieving spinal stability and fusion.

The underlying idea behind ’753 is to create a stand-alone intervertebral device that combines the functions of a spacer and a bi-directional fixation system. This is achieved by integrating angled screw guides within an intervertebral cage, allowing screws to be inserted through the cage and into the adjacent vertebral bodies in opposing directions. This bi-directional screw fixation aims to provide immediate stability and promote fusion without the need for additional hardware like plates or pedicle screws.

The claims of ’753 focus on an intervertebral apparatus with internal screw guides and fixation. The apparatus includes an intervertebral spacer with a top wall, a bottom wall, and sidewalls, defining an open space for bone filling. The key feature is the integration of internal screw guides within the spacer, directing screws into adjacent vertebral bodies. A screw lock mechanism is included to prevent screw back-out. The claims also cover specific features like indentations on the cage surface and the geometry of the screw locks.

In practice, the device is inserted into the prepared disc space, and screws are then inserted through the internal guides into the vertebral bodies above and below. The angled trajectory of the screw guides ensures that the screws engage the vertebral bodies in a way that provides immediate stability. The screw locking mechanism, which may involve a separate component or indentations in the cage itself, prevents the screws from loosening over time, ensuring long-term fixation and promoting fusion.

This design differentiates itself from prior approaches by eliminating the need for supplemental fixation hardware. The integrated screw guides simplify the surgical procedure and reduce the risk of misplaced screws. The bi-directional screw placement provides enhanced stability compared to traditional interbody spacers, while the screw locking mechanism addresses the common problem of screw back-out, a frequent cause of revision surgeries. The indentations on the cage surface further enhance screw engagement and prevent loosening, contributing to a more robust and reliable fusion.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2000s when ’753 was filed, spinal fusion hardware was typically implemented using metal alloys such as titanium or stainless steel, at a time when intervertebral cages commonly relied on a press-fit design or supplemental fixation with screws and plates rather than integrated screw-cage constructs, and when achieving rigid fixation while minimizing adjacent segment degeneration was non-trivial.

Novelty and Inventive Step

Claims 88-107 were rejected on the ground of nonstatutory double patenting. The examiner stated that the claims were not patentably distinct from claims in U.S. Patent Nos. 7,972,363, 9,744,052, 9,603,713 and 10,238,505. The examiner also stated that certain claim limitations were being interpreted under 35 U.S.C. 112(f). The prosecution record does NOT describe the technical reasoning or specific claim changes that led to allowance.

Claims

This patent contains 38 claims, of which claims 1, 13, and 31 are independent. The independent claims are directed to an intervertebral combination internal screw guide and fixation apparatus. The dependent claims generally add specific features, materials, or configurations to the apparatus defined in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
First Screw
(Claim 1, Claim 13, Claim 31)
“A first screw member 30 having a tapered end and a threaded body and a second screw member 40 having a tapered end and a threaded body are disposed within the first internal screw guide 80 and the second internal screw guide 82 of the intervertebral cage 10.”A screw with a head and a threaded body, designed to be inserted through the first internal screw guide.
Internal Screw Guide
(Claim 1, Claim 13, Claim 31)
“For example, FIGS. 1A-1C and 2A-2G illustrate three-dimensional views of an exemplary embodiment of an anterior cervical intervertebral cage/BDFT construct including an intervertebral cage 10 for maintaining disc height. The intervertebral cage 10 can include a first internal screw guide 80 and a second internal screw guide 82.”A feature within the intervertebral spacer that directs the screws. It has an entry opening on the top surface and an exit opening on the bottom and side surfaces of the top wall.
Intervertebral Spacer
(Claim 1, Claim 13, Claim 31)
“Herein described are a plurality of device embodiments which combine in a single stand-alone construct the dual functions of: a) an intervertebral cage spacer which can be filled with bone fusion material maintaining disc height, and, b) a bi-directional fixating/fusion transvertebral body screw apparatus.”A component with a top wall, bottom wall, and sidewalls, defining an open space for bone filling and vertebral body facing surfaces. It includes internal screw guides for screw insertion.
Screw Lock
(Claim 1, Claim 13, Claim 31)
“The cage 10 can be supplemented by, and is compatible with, any screw locking mechanism, for example screw locking member 20, that prevents the first screw member 30 and/or the second screw member 40 from pulling-out of the first internal screw guide 80 and the second internal screw guide 82.”A component positioned within the intervertebral spacer that deforms or engages with the screws to prevent their removal.
Second Screw
(Claim 1, Claim 13, Claim 31)
“A first screw member 30 having a tapered end and a threaded body and a second screw member 40 having a tapered end and a threaded body are disposed within the first internal screw guide 80 and the second internal screw guide 82 of the intervertebral cage 10.”A screw with a head and a threaded body, designed to be inserted through the second internal screw guide.

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US10925753

MOSKOWITZ FAMILY LLC
Application Number
US16362294
Filing Date
Mar 22, 2019
Status
Granted
Expiry Date
Aug 23, 2025
External Links
Slate, USPTO, Google Patents