Eccentric Tip Vertebra Introducer Stylet for Kyphoplasty Access
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Solution Overview
Problem
Current kyphoplasty procedures for treating spinal compression fractures face challenges due to the limited diameter of existing instruments, which can cause tissue or bone fracture and lead to uncontrollable leakage of bone cement, posing risks to nerve or blood vessels, and there is a need for more effective vertebra introducer stylets to minimize these risks.
Innovation Solution
A percutaneous access path providing device comprising a vertebra access cannula and a vertebra introducer stylet with an eccentrically arranged tip, allowing for a transpedicular or extrapedicular approach with reduced risk of tissue or bone injury, and a kit that includes essential instruments for a safe and smooth kyphoplasty surgery, merging individual method steps to speed up the procedure and reduce instrument usage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a small diameter access cannula is used to minimize soft tissue and bone trauma, then tissue damage is reduced, but higher injection pressures are required which can cause uncontrollable leakage of bone cement to nerves or blood vessels
Solution Approach 1:
The access cannula is divided into multiple segments that can be extended or reconfigured. The cannula system includes a first cannula and a second cannula that can be combined to provide different effective lengths and diameters, allowing the surgeon to select the appropriate configuration for each patient's anatomy while maintaining controlled injection pressures
Solution Approach 2:
The access cannula system is designed to be dynamically adjustable in length and configuration. The cannulas can be inserted separately or combined, and the system allows for flexible adaptation to different vertebral access requirements, enabling optimized injection pressure control for each specific case
2Ease of operation
If a vertebra introducer stylet is used to penetrate and provide access into the vertebral body, then access path creation is enabled, but tissue or bone fracture can occur leading to tissue injury or bone fragments that may injure blood and nerve vessels
Solution Approach 1:
A tapered introducer stylet is used as an intermediary tool that gradually prepares the access path through the skin and soft tissue before the main cannula is inserted. The tapered design allows for progressive tissue displacement rather than sudden penetration, reducing the risk of bone fracture and vessel injury
Solution Approach 2:
The introducer stylet features a tapered geometry that changes the physical parameters of tissue interaction along its length. The gradual taper allows for controlled tissue displacement and path creation, transforming the interaction from a sudden high-stress event to a progressive low-stress process
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
The solution enables predictable and controlled access to the vertebral body, minimizing damage and optimizing preparation options, reducing the risk of complications and simplifying the kyphoplasty procedure by allowing for a lower risk of tissue injury and bone fracture, while also reducing the number of instruments needed and costs.
Implementation Method 1
an expandable structure of the balloon catheter expands in the cancellous bone structure and create a void
Implementation Method 2
As the balloon inflates, it compacts the soft cancellous bone to create a void inside the vertebral body and return the vertebral body to a natural height
Implementation Method 3
bone cement is injected into the void of a weakened and/or fractured bone in an attempt to reinforce the bone
Data Source
AI summary
The present invention concerns to a method, a percutaneous access path providing device and a kit of instruments for the treatment of fractured vertebrae, in particular for treating spinal compression fractures in humans. In particular the invention concerns to a percutaneous access path providing device comprising a vertebra access cannula and a vertebra introducer stylet, wherein the vertebra introducer stylet has a tip.