Interspinous Spacer Instrument with Deployment Indicator
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Solution Overview
Problem
Current surgical methods for implanting interspinous spacers require larger incisions and invasive techniques, leading to longer recovery times, and there is a need for minimally invasive instruments that can facilitate both percutaneous and open or mini-open procedures while ensuring accurate deployment of the spacer.
Innovation Solution
A spacer instrumentation system comprising an inserter, a driver, and a deployment indicator that allows for the secure attachment and deployment of an interspinous process spacer, with the inserter configured to transition the spacer from an undeployed to a deployed configuration and the deployment indicator providing visual feedback on the degree of deployment to the user.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional surgical methods are used for implanting interspinous spacers, then the spacer can be implanted, but larger incisions and more invasive techniques are required leading to longer recovery times
Solution Approach 1:
The spacer is inserted through a minimally invasive percutaneous approach where the spacer device is nested within an inserter instrument. The inserter itself is inserted through a small incision, allowing the spacer to be delivered to the interspinous space without requiring large surgical exposures, thereby reducing surgical invasiveness and associated recovery time
Solution Approach 2:
The inserter instrument serves as an intermediary device that facilitates the delivery of the spacer through a minimally invasive pathway. The inserter mediates between the small percutaneous incision and the spacer implant, enabling placement without direct surgical exposure of the interspinous space
2Loss of time
If minimally invasive instruments are used for spacer implantation, then recovery time is reduced, but accurate deployment of the spacer becomes more difficult to ensure
Solution Approach 1:
The driver instrument incorporates visual indicators that provide real-time feedback to the surgeon during spacer deployment. As the driver advances or retracts, the indicator shows the degree of spacer deployment, allowing the surgeon to precisely control and confirm full deployment of the spacer wings even through minimally invasive access
Solution Approach 2:
The deployment indicator uses visual cues such as color changes or positional indicators that become visible through the driver instrument. These visual changes provide clear, real-time information about the spacer's deployment status, ensuring accurate placement without requiring large incisions for direct visualization
3Length of moving object
If percutaneous approach is used for spacer insertion, then incision size is reduced, but visual feedback on spacer deployment is limited
Solution Approach 1:
The driver instrument acts as an intermediary that translates the internal deployment state of the spacer into external visual information. The visual indicator on the driver provides a window into the spacer's deployment status, allowing the surgeon to detect and measure deployment progress without direct visual access through the small percutaneous incision
Data Source
AI summary
A percutaneous and minimally invasive instrument system for implanting an interspinous process spacer into a patient is disclosed. The insertion instrument system includes an inserter and a driver. The inserter is configured to releasably clamp to an interspinous process spacer for its delivery, implantation and deployment. The driver is configured for removable insertion into a proximal end of a passageway of the inserter. The driver has a distal spacer engaging portion configured to engage that part of the spacer requiring activation for the deployment of the spacer from at least one undeployed configuration to at least one deployed configuration and vice versa. As the spacer goes from the undeployed to the deployed configuration and vice versa, the system advantageously provides a degree of deployment information to the user via at least one deployment indicator.