Curvilinear Cavity Formation for Vertebral Stabilization
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Solution Overview
Problem
Current methods for treating vertebral compression fractures, such as vertebroplasty, face challenges in containing bone cement within the fracture site due to leakage risks and uneven distribution, which can lead to complications like cement embolism and require multiple access points, increasing procedure time and risk.
Innovation Solution
A method and device for creating a curvilinear cavity within the vertebral body using a multifilament co-braided stent and flexible drill and reamer assemblies, allowing for symmetrical cement distribution from a single access point, which includes a collapsible stent impregnated with polymer and a drill/reamer system capable of curvilinear translation and rotation to form and enlarge the cavity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional vertebroplasty is used to treat vertebral compression fractures, then bone cement can be injected into the fracture site, but cement leakage beyond the bone confines occurs leading to serious complications
Solution Approach 1:
A balloon catheter is inserted and inflated within the vertebral body before cement injection to pre-form a containment cavity. This preliminary action creates a defined space that restricts cement flow pathways, preventing leakage into the spinal canal or venous system while allowing subsequent cement injection to fill the pre-prepared cavity safely
Solution Approach 2:
The balloon catheter serves as an intermediary device between the cement injection system and the vertebral bone. It temporarily occupies the fracture cavity, directs cement flow along controlled pathways, and acts as a barrier that prevents direct uncontrolled injection, thereby mediating the interaction between cement and bone to eliminate harmful leakage effects
2Manufacturing precision
If multiple access points are used to achieve symmetrical cement distribution in the vertebral body, then cement can be evenly distributed, but procedure time and surgical risk increase
Solution Approach 1:
The balloon catheter is designed with a curved or spherical expansion profile that allows it to expand symmetrically within the vertebral body cavity. This curved geometry enables uniform cement distribution from a single access point, as the balloon's three-dimensional expansion creates equal pressure zones in all directions, achieving symmetrical cement placement without requiring multiple needle insertions
Solution Approach 2:
The balloon catheter system performs multiple functions: it creates the cavity, directs cement flow, ensures symmetrical distribution, and prevents leakage—all from a single access point. This multi-functionality consolidates what would traditionally require multiple separate procedures or access points into one unified intervention, reducing both time and surgical risk
3Manufacturing precision
If high injection pressure is used to fill the fracture void with bone cement, then the cement penetrates the interstices of broken trabecular bone effectively, but cement may be forced into the venous system causing embolism
Solution Approach 1:
The balloon catheter creates a localized containment structure within the vertebral body that confines high-pressure cement injection to a specific region. The balloon's presence locally modifies the injection dynamics, allowing high pressure to be applied safely within the contained cavity while the balloon itself acts as a barrier that prevents cement from being forced into adjacent venous structures, thus enabling effective penetration without harmful embolism
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 complete stabilization of the vertebral body with a single surgical access point, reducing procedure time, minimizing risks associated with cement leakage, and improving the efficiency and safety of the treatment.
Implementation Method 1
The balloon catheter is inflated to a predetermined volume with contrast medium or other suitable material to form a seal against the inner surface of the vertebral body and to pre-form a cavity within the vertebral body
Implementation Method 2
bone cement is injected through the catheter into the pre-formed cavity... The cement is pressurized by a syringe or similar plunger mechanism, thus causing the cement to fill the void and penetrate the interstices of a broken trabecular bone
Data Source
AI summary
The invention provides a method for creating a curvilinear void created in a bony structure. The method includes inserting a distal end of a reamer device through a cannula and into a curvilinear void created in a bony structure, the reamer device having a flexible reamer shaft assembly which includes (i) a pivotable reaming element at a distal end thereof, and (ii) a mechanism for pivoting adjustably the reaming element. The method also includes deploying the reaming element within the curvilinear void and manipulating the reaming element to enlarge the curvilinear void.