Vertebral Augmentation Delivery Cannula with Low-Pressure Cement Flow
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Solution Overview
Problem
Current systems for delivering bone cement to treat compression fractures face challenges such as high pressure requirements, balloon device failures, uncontrollable flow of materials, and leakage issues, which can lead to complications like extravasation and poor visualization during fluoroscopic guidance.
Innovation Solution
A system comprising a delivery cannula with a push rod that moves elements and a fluent material into the vertebral body under low pressure, allowing controlled delivery and stabilization, while the elements carry the material to form an implant that sets to lock them in place, preventing leakage and enhancing visualization with radiopaque materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stress or pressure
If high pressure is used to deliver bone cement, then the material can be forced into the vertebral body, but the material flows uncontrollably and leaks into vascular structures and fracture lines
Solution Approach 1:
The delivery system is divided into multiple segments: a master syringe for controlling the overall delivery, a delivery catheter with multiple lumens, and individual element carriers. This segmentation allows independent control of the bone cement flow through the master syringe while the elements are delivered through separate pathways, preventing uncontrolled material flow and leakage into vascular structures.
Solution Approach 2:
The patent introduces an intermediary substance - a biocompatible carrier or adhesive - that facilitates the delivery of bone cement and elements. This intermediary material controls the flow dynamics, allowing the bone cement to be delivered in a controlled manner rather than under high pressure, thereby preventing leakage into fracture lines and vascular structures while maintaining ease of operation.
2Strength
If balloon-like devices are used to create cavities, then bone compaction is achieved, but the devices fail during inflation due to high pressures and thin membranes
Solution Approach 1:
The patent extracts and eliminates the problematic balloon-like device from the delivery system. Instead of using a balloon to create cavities and compact bone, the system directly delivers structural elements and bone cement through a catheter-based approach. This removes the source of device failure while maintaining the ability to achieve bone compaction and stabilization through the delivered materials.
Solution Approach 2:
The patent replaces the mechanical balloon inflation system with a controlled delivery mechanism using a master syringe and multi-lumen catheter. Instead of relying on high-pressure balloon expansion to compact bone, the system uses controlled injection of bone cement and structural elements through the catheter lumens, achieving the same stabilization effect without the reliability issues of balloon devices.
3Productivity
If pressure type devices are used to deliver bone cement, then the material flows into the cavity, but the flow is uncontrollable and cannot be influenced by the practitioner
Solution Approach 1:
The patent incorporates feedback mechanisms through fluoroscopic guidance and pressure monitoring. The practitioner can observe the real-time flow of bone cement and elements through fluoroscopy, allowing immediate adjustment of the master syringe plunger position to control delivery rate. Pressure sensors provide feedback on the force applied, enabling precise control over material flow while maintaining high productivity, thus resolving the contradiction between delivery rate and practitioner control.
4Volume of stationary object
If high inflation pressures are used to expand balloons, then cavity size is achieved, but the thin balloon membranes are pierced by sharp tools or bony structures
Solution Approach 1:
The patent removes the thin balloon membrane from the system entirely, eliminating the vulnerability to piercing by sharp tools or bony structures. The cavity is created and maintained through the delivery of structural elements and bone cement through a catheter system, avoiding the use of thin membranes that are prone to failure and piercing while still achieving the necessary cavity size for treatment.
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 system enables controlled delivery of bone cement and structural elements to stabilize vertebral bodies effectively, reducing leakage and improving visualization, thereby enhancing the safety and efficacy of vertebral augmentation procedures.
Implementation Method 1
A push rod is movably disposed within the delivery passage of the delivery cannula to apply a force to the first element and transfer the force through the first element to the second element to move the elements through the delivery passage and into the interior of the vertebral body
Implementation Method 2
A fluent material, capable of setting to a hardened condition, is disposed within at least a portion of the void space in the delivery passage
Data Source
AI summary
A system for forming an implant to stabilize an interior of a vertebral body is provided. The system includes a delivery cannula. A plurality of elements are disposed adjacent to one another in the delivery cannula with void spaces defined between the elements. A fluent material, capable of setting to a hardened condition, is disposed within at least a portion of the void space in the delivery cannula. A push rod is movably disposed within the delivery cannula to apply a force to move the elements through the delivery cannula and into the interior of the vertebral body. Upon application of the force, the elements simultaneously carry the fluent material through the delivery cannula and into vertebral body to delivery the fluent material at a low pressure. The fluent material sets to the hardened condition to secure the elements and form the implant.