Expandable Spinal Implant And Tool System
Patent No. US11376136 (titled "Expandable Spinal Implant And Tool System") was filed by Moskowitz Family Llc on Jan 16, 2020.
What is this patent about?
’136 is related to the field of spinal fusion, specifically devices and methods for achieving intervertebral fusion with reduced complications compared to traditional pedicle screw fixation. The background acknowledges the drawbacks of pedicle screws, including lengthy procedures, tissue damage, misplaced screws, blood loss, and adjacent segment disease. Existing interbody fusion devices also suffer from limited vertebral endplate coverage and a risk of bone graft intrusion into the thecal sac.
The underlying idea behind ’136 is to provide a self-drilling bone fusion screw apparatus that combines the functions of an intervertebral spacer and transvertebral body fusion screws. This is achieved through a box-like structure placed between vertebral bodies, housing screws that penetrate into the adjacent vertebrae. An adjuster mechanism allows for controlled expansion of the box, customizing it to the disc space height. The device aims to simplify spinal fusion, reduce the need for pedicle screws, and minimize complications.
The claims of ’136 focus on a system comprising a tool assembly and an expandable spinal implant. The tool assembly includes a first tool with engagement prongs and an adjusting tool passage, and a second adjusting tool with a screw engagement portion. The expandable spinal implant has first and second expandable structures, an adjusting screw, and tool engagement portions for receiving the first tool's prongs. The second adjusting tool extends through the first tool to engage the adjusting screw, allowing for expansion of the implant.
In practice, the surgeon prepares the intervertebral space and inserts the screw box. The first tool, with its prongs engaged in the implant's tool engagement portions, holds the implant steady. The second tool, passing through the first tool's passage, then turns the adjusting screw, expanding the implant to fit the space. The screws within the box then penetrate the vertebral bodies, providing immediate fixation. Bone graft material can be packed within the box to promote fusion.
This approach differs from prior solutions by integrating the spacer and screw functions into a single device, potentially eliminating the need for supplemental pedicle screw fixation. The expandable design allows for a custom fit, maximizing contact with the vertebral endplates. The horizontal mini-plate, when used, acts as a barrier to prevent bone graft migration, a unique feature not found in conventional interbody fusion devices. The facet staples offer a less invasive alternative to pedicle screws for posterior cervical and lumbar stabilization.
How does this patent fit in bigger picture?
Technical landscape at the time
In the mid-2000s when ’136 was filed, spinal fusion procedures were commonly supplemented with pedicle screw placement at a time when significant tissue dissection and muscle retraction were typical. Systems commonly relied on screw-based fixation, and hardware constraints made minimally invasive techniques non-trivial.
Novelty and Inventive Step
The claims were rejected during prosecution. Specifically, claims 21-40 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims of two US patents. The examiner also objected to claims 21 and 29 due to informalities. The prosecution record does NOT describe the technical reasoning or specific claim changes that led to allowance.
Claims
This patent contains 20 claims, with independent claims numbered 1, 9, and 18. The independent claims are directed to a system comprising a tool assembly and an expandable spinal implant. The tool assembly includes a first tool with an adjusting tool passage and a second adjusting tool. The dependent claims generally elaborate on specific features and configurations of the system described in the independent claims, such as the structure of the spinal implant, the engagement between the tools and the implant, and methods of using the system.
Key Claim Terms New
Definitions of key terms used in the patent claims.
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Date
Description
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US11376136
- Application Number
- US16744755
- Filing Date
- Jan 16, 2020
- Status
- Expired
- Expiry Date
- Mar 17, 2026
- External Links
- Slate, USPTO, Google Patents