IP Verse

Expandable Intervertebral Device

Patent No. US12011367 (titled "Expandable Intervertebral Device") was filed by Moskowitz Family Llc on Aug 20, 2021.

What is this patent about?

’367 is related to the field of spinal fusion devices, specifically expandable intervertebral spacers designed to restore disc height and promote fusion between vertebral bodies. Traditional spinal fusion often involves supplemental fixation with pedicle screws or anterior plating, which can lead to complications such as nerve injury, blood loss, and adjacent segment disease. Existing non-expandable spacers require forceful distraction of the vertebral bodies and may not provide a precise fit.

The underlying idea behind ’367 is to provide a zero-profile expandable intervertebral spacer that can be inserted in a collapsed state and then expanded in situ to achieve a tailored fit and controlled distraction of the disc space. This calibrated expansion aims to reduce the trauma associated with forceful distraction and improve the stability and fusion potential of the implant. The device can be used stand-alone or supplemented with other forms of screw stabilization.

The claims of ’367 focus on an expandable intervertebral device comprising a first body and a second body, a sliding wedge positioned between the two bodies, and a cavity for bone fusion materials. The first body has an angled housing surface that engages with the angled surface of the wedge. As the wedge slides, it presses against the first body, causing it to move relative to the second body, thereby expanding the device. The wedge remains axially confined within the device in both compressed and expanded configurations.

In practice, the surgeon inserts the collapsed spacer into the prepared disc space. Using a specialized tool, the surgeon then advances the wedge, causing the first body to separate from the second body and expand the device. The angled housing surface on the first body ensures a controlled and predictable expansion. The bone fusion cavity is packed with bone graft material to promote osseointegration and fusion between the vertebral bodies. The device's zero-profile design minimizes the risk of soft tissue impingement and vascular injury.

The key differentiation from prior approaches lies in the combination of calibrated expansion and zero-profile design. Unlike traditional spacers that require forceful distraction, this device allows for gradual and controlled restoration of disc height. The internal wedge mechanism provides a stable and reliable means of expansion, while the bone fusion cavity promotes solid fusion. The device can be inserted via various surgical approaches, offering versatility and adaptability to different patient anatomies and surgical preferences.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2000s when ’367 was filed, spinal fusion techniques were typically supplemented with posterior pedicle screw placement and/or anterior (or lateral) plating. At a time when intervertebral spacers were commonly manufactured in different heights to be selected for insertion, vertebral bodies were forcefully distracted to allow placement of an imperfectly fitting spacer. These were most often supplemented with pedicle screw and/or plate fixation.

Novelty and Inventive Step

Claims 21-35 were allowed in a Notice of Allowance, but upon further search, new prior art was found. Claim 23 was objected to for informalities. Claim 21 was rejected for nonstatutory double patenting over claim 1 of U.S. Patent No. 10,016,284 B2 and under pre-AIA 35 U.S.C. 102(a) as being anticipated by Glerum et al. Claims 36-40 are allowed. Claims 22-35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form.

Claims

This patent contains 21 claims, with independent claims numbered 1, 8, and 17. The independent claims are directed to expandable intervertebral devices comprising first and second bodies and a wedge. The dependent claims generally elaborate on specific features, configurations, and methods of use for the intervertebral devices described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Angled housing surface
(Claim 1, Claim 8, Claim 17)		“The exemplary embodiments of ZP-EIS devices without incorporated BDFT screws described herein have the ability to incrementally and uniformly separate and distract the vertebral bodies. Each embodiment has a very unique mechanically designed mechanism of incremental expansion.”A surface on the interior of the first body that is angled and shaped to engage with the angled wedge surface of the wedge, facilitating the expansion of the device.
Angled wedge surface
(Claim 1, Claim 8, Claim 17)		“The exemplary embodiments of ZP-EIS devices without incorporated BDFT screws described herein have the ability to incrementally and uniformly separate and distract the vertebral bodies. Each embodiment has a very unique mechanically designed mechanism of incremental expansion.”A surface of the wedge that is angled and interacts with the angled housing surface of the first body to cause expansion of the device.
Compressed configuration
(Claim 1, Claim 8)		“The exemplary embodiments described herein can allow a more precisely tailored complimentary fit between spacer and disc space, allowing the spacer to expand gradually in a calibrated manner, and to incrementally achieve the precise fit and degree of distraction desirable.”A state of the expandable intervertebral device where the first and second bodies are in a substantially closed position, prior to expansion by the wedge.
Expanded configuration
(Claim 1, Claim 8)		“The exemplary embodiments described herein can allow a more precisely tailored complimentary fit between spacer and disc space, allowing the spacer to expand gradually in a calibrated manner, and to incrementally achieve the precise fit and degree of distraction desirable.”A state of the expandable intervertebral device where the first body has moved relative to the second body due to the action of the wedge, increasing the height of the device.
Vertebral body engagement surface
(Claim 1, Claim 8, Claim 17)		“Herein described are exemplary embodiments of multiple ZP-EIS devices which combine in a single construct the dual functions of calibrated expandable intervertebral spacer distraction maintaining disc space height, and simultaneous segmental vertebral body spinal fusion.”A surface on the first or second body of the device that is designed to contact a vertebral body. This surface may include ridges to improve the interface with the vertebral body.

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US12011367

MOSKOWITZ FAMILY LLC
Application Number
US17408068
Filing Date
Aug 20, 2021
Status
Expired
Expiry Date
Mar 15, 2026
External Links
Slate, USPTO, Google Patents