Interspinous Spacer Actuator Mechanism for Safe Deployment
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Solution Overview
Problem
Existing interspinous spacers face challenges in deployment and tissue interaction, which can lead to complications such as nerve impingement and pain, and there is a need for a device that can be safely and effectively implanted between adjacent spinous processes.
Innovation Solution
The proposed interspinous spacer features a body with a distal and proximal portion, an actuator, and first and second arms that are rotatably coupled to the body and actuator. Upon rotation of the actuator, the arms move from an undeployed position extending back towards the proximal portion to a deployed position extending away from the body, allowing for secure seating between spinous processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the spacer is implanted between adjacent spinous processes to open the spinal canal and relieve pain, then pain relief and spinal canal openness are improved, but there is a risk of damaging bone or tissue and causing nerve impingement
Solution Approach 1:
The spacer employs a dynamic deployment mechanism where arms transition from a collapsed configuration during insertion to an extended configuration after implantation. This dynamic transformation allows the device to be inserted through a minimally invasive percutaneous approach and then deployed to its functional position, reducing the risk of tissue damage during implantation while maintaining effective spinal canal opening.
Solution Approach 2:
The spacer is divided into multiple segments including a body portion and multiple deployable arms. This segmentation allows the device to be inserted in a compact form and then deployed by extending individual arms between the spinous processes, enabling precise positioning and reducing the risk of unintended tissue damage compared to a monolithic structure.
2Ease of operation
If a percutaneous interspinous spacer with rotatable arms is used, then ease of implantation and minimally invasive approach are improved, but device complexity increases
Solution Approach 1:
The rotatable arms are configured to be nested within or adjacent to the body portion during the insertion phase, allowing the entire spacer to be delivered through a percutaneous approach using a minimally invasive instrument. After implantation, the arms are deployed from their nested state to their functional extended position, achieving ease of implantation without excessive device complexity.
3Reliability
If the arms are configured to rotate at least 90 degrees from undeployed to deployed position, then the spacer effectiveness in maintaining distance between vertebral segments is improved, but the complexity of the actuation mechanism increases
Solution Approach 1:
The actuation mechanism utilizes a simple rotational movement of the arms by at least 90 degrees from an undeployed position to a deployed position. This dynamic transformation is achieved through a straightforward mechanical connection between the body and arms, allowing effective spacer deployment without requiring complex actuation systems.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This design enhances the safety and efficacy of interspinous spacer deployment by reducing the risk of tissue damage and nerve impingement, while providing effective pain relief by maintaining spinal canal openness and reducing stress on facet joints.
Implementation Method 1
the actuator, first arm, and second arm are configured, upon rotation of the actuator in a first direction, to move the first and second arms from an undeployed position
Implementation Method 2
The implanted spacer opens the spinal canal, maintains the desired distance between vertebral body segments
Data Source
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AI summary
An interspinous spacer that includes a body having a distal portion and a proximal portion; an actuator at least partially disposed in the body; and a first arm and a second arm, where the first and second arms are rotatably coupled to a distal portion of the body and coupled to the actuator, where the actuator, first arm, and second arm are configured, upon rotation of the actuator in a first direction, to move the first and second arms from an implantation position, in which the first and second arms extend from the distal portion of the body back toward the proximal portion of the body, to a deployed position, in which the first and second arms extend away from the body.