Interspinous Spacer with Rotatable Arms for Scoliosis
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Solution Overview
Problem
Patients with scoliosis, characterized by misaligned spinous processes, face challenges in receiving interspinous spacers due to the need for surgical devices that accommodate lateral or sideways curvature, which existing minimally invasive techniques struggle to address effectively.
Innovation Solution
An implant designed for placement between adjacent spinous processes, featuring rotatable arms with adjustable extensions and bridges to accommodate scoliotic curves, allowing for lateral stabilization and minimally invasive implantation through small incisions, utilizing a clamshell construction and actuator assembly for deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If existing minimally invasive techniques are used for interspinous spacer implantation, then tissue disruption and recovery time are minimized, but the ability to accommodate scoliotic curves with misaligned spinous processes is insufficient
Solution Approach 1:
The spacer incorporates rotatable arms that can dynamically adjust their orientation to accommodate misaligned spinous processes in scoliotic spines. The arms are capable of rotation relative to the body of the spacer, allowing the device to adapt to various anatomical configurations while maintaining minimally invasive implantation benefits
Solution Approach 2:
The spacer is divided into distinct functional segments: a body portion and multiple rotatable arms. This segmentation allows each component to perform its specific function - the body provides structural support while the arms provide adaptability to misaligned spinous processes, resolving the contradiction between versatility and ease of operation
2Adaptability or versatility
If rotatable arms with adjustable extensions are added to accommodate scoliotic curves, then adaptability to misaligned spinous processes improves, but device complexity increases
Solution Approach 1:
The actuator assembly is nested within the body of the spacer, with the actuator positioned inside and connected to the rotatable arms. This nesting arrangement allows the complex actuation mechanism to be contained within the compact spacer structure, reducing overall device complexity while maintaining the adaptability function
Solution Approach 2:
The actuator assembly is designed to be self-contained within the spacer body, requiring no external power sources or control systems. The mechanical actuation mechanism uses springs and cam surfaces to automatically adjust the arm positions, eliminating the need for complex external control systems
3Reliability
If the spacer is designed to laterally stabilize relative to misaligned spinous processes, then spinal canal openness is maintained, but the implantation difficulty increases
Solution Approach 1:
The rotatable arms are pre-configured with receiving portions that are designed to engage with spinous processes in various orientations. The arms can be initially inserted in a neutral position and then rotated into their final stabilized position, allowing for simplified initial implantation followed by sequential adjustment to achieve lateral stabilization
Data Source
AI summary
An implantable spacer for placement between adjacent spinous processes in a spinal motion segment is provided. The spacer includes a body defining a longitudinal passageway. A first arm and a second arm are connected to the body. Each arm has a pair of extensions and a saddle defining a receiving portion configured for seating a spinous process of a scoliotic spine or a spine with misaligned spinous processes. Each arm has a proximal caming surface and is capable of rotation with respect to the body. An actuator assembly is disposed inside the longitudinal passageway and connected to the body. When advanced, a threaded shaft of the actuator assembly contacts the caming surfaces of arms to rotate them from an undeployed configuration to a deployed configuration. In the deployed configuration, the distracted adjacent spinous processes are seated in the superior and inferior arms of the spacer.


