Percutaneous Spinous Process Stapler with Locking Wedge
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Solution Overview
Problem
Current spinal stabilization techniques lack a minimally invasive method for both spinous process immobilization and interspinous process distraction that can be effectively and securely applied percutaneously.
Innovation Solution
A system comprising staples with holes at their heads for connecting rods, a locking screw mechanism, and a stabilizing plate, allowing for percutaneous delivery and secure immobilization of spinous processes, along with a clamp and delivery system for precise placement and adjustment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If percutaneous delivery method is used, then tissue disruption is minimized, but secure immobilization and distraction capability is compromised
Solution Approach 1:
The stabilization system is divided into separate components (staples, connecting rod, stabilizing plate, locking mechanism) that can be delivered percutaneously in a minimally invasive manner while still achieving secure immobilization when assembled together. The segmentation allows each component to be optimized for its specific function while maintaining overall system reliability.
Solution Approach 2:
The staples are delivered through a delivery system where the connecting rod is inserted first, followed by the staples being nested onto the rod through the delivery tube. The stabilizing plate and locking mechanism are then sequentially assembled, creating a nested delivery sequence that enables percutaneous placement while ensuring secure immobilization capability.
2Reliability
If traditional open surgical technique is used, then secure immobilization is achieved, but tissue disruption and invasiveness increases
Solution Approach 1:
A delivery tube acts as an intermediary tool that guides the staples and connecting rod through the tissue to the target spinous processes. This intermediary device enables percutaneous delivery of the stabilization components without requiring open surgical exposure, thereby reducing tissue disruption while maintaining secure immobilization capability.
3Reliability
If multiple components (staples, rod, plate, locking mechanism) are used, then immobilization reliability is improved, but device complexity increases
Solution Approach 1:
The delivery system combines multiple components (connecting rod, staples, stabilizing plate, locking mechanism) into a single integrated assembly that can be delivered through one percutaneous access point. This merging approach maintains the functional benefits of multiple components for reliable immobilization while simplifying the delivery process and reducing overall procedural complexity.
4Object-affected harmful factors
If percutaneous delivery system is used, then invasiveness is reduced, but precision of placement and adjustment capability is compromised
Solution Approach 1:
The system incorporates adjustment capabilities where the connecting rod can be positioned at different locations along the staples after delivery, and the locking mechanism allows for precise securing of the components. This feedback mechanism enables the surgeon to make precise adjustments to the placement and configuration of the stabilization system after percutaneous delivery, ensuring optimal positioning while maintaining minimally invasive benefits.
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
Enables secure and minimally invasive spine stabilization and distraction by allowing for the percutaneous placement and adjustment of staples and connecting rods, providing effective immobilization of spinous processes while minimizing tissue disruption.
Implementation Method 1
The small locking screws, when tightened into their respective holes in the heads of the staples, cam against the surface of the locking wedge and thereby lock the locking wedge (inside the head of the staples) securely against the common connecting rod.
Implementation Method 2
a clamp, in the preferred form resembling a centrally linked or hinged pair of pliers, is provided to introduce the staples, connecting rod, stabilizing plate and locking caps or nuts into position about the spinal processes and to then allow the physician to manually compress the finger grips of the clamp to draw the staples (held together as a unit by the connecting rod) through the processes, and to clamp them through the stabilizing plate and into the locking caps or nuts.
Data Source
AI summary
Spinous stabilizing system comprises spaced apart, pointed staples held to a connecting rod, a stabilizing plate and a set of locking caps for the staple's tips. The tips are forced through the spinous process and captured/secured by the locking caps, pulling the stabilizing plate against the spinous process and toward the heads of the staples and connecting rod. A pair of pliers loaded with the components on the lever arms can be squeezed together to cause the tips of the staple to penetrate the spinous processes and then become frictionally captured within the locking caps. The spacing between the staples are adjusted, pre-installation, by a locking screw acting on the connecting rod or, alternatively, after the device is percutanteously inserted, by laterally directed locking screws which mate with and cam a locking wedge. Matingly engageable speculated plates, installed by pliers, can also be used for spinous fixation.