Vertebral Height Restoration via Balloon Distraction and Controlled Cement Injection
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Solution Overview
Problem
Current surgical methods for treating vertebral compression fractures, such as vertebroplasty and kyphoplasty, face challenges in controlling bone filler distribution and ensuring adequate vertebral height restoration due to issues with needle size, bone filler viscosity, and pressure, which can lead to extravasation and instability.
Innovation Solution
A method involving the introduction of a solid distraction component within the bone, followed by an injection cannula to directly inject a fluent material into the cancellous bone adjacent to the distraction component, allowing the material to surround and interdigitate with the surrounding bone, reducing the risk of extravasation and enhancing structural support.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a needle is used to inject bone filler into the vertebral body, then the filler can be delivered to the target site, but the filler may extravasate from the vertebral body causing spinal cord trauma
Solution Approach 1:
The patent introduces a balloon catheter as an intermediary device between the injection site and the vertebral body. The balloon is inflated within the vertebral body to create a controlled expansion space, acting as a mediator that directs the bone filler into the cancellous bone while preventing extravasation into the spinal canal. This intermediary mechanism allows safe delivery of the filler without direct needle-to-target contact.
Solution Approach 2:
The balloon catheter is inflated before bone filler injection to pre-establish the containment space and delivery pathway. This preliminary action creates a controlled environment within the vertebral body, ensuring that subsequent filler injection remains contained and directed into the cancellous bone, preventing harmful extravasation.
2Productivity
If high pressure is used to inject bone filler, then the filler can be forced into the vertebral body, but the filler may extravasate from the vertebral body
Solution Approach 1:
The balloon catheter serves as a pressure-distributing intermediary that converts high injection pressure into controlled expansion force within the vertebral body. The balloon membrane distributes the pressure uniformly across the cancellous bone, enabling efficient filler delivery without creating localized pressure peaks that would cause extravasation into the spinal canal.
Solution Approach 2:
The patent changes the pressure distribution parameter by using the balloon's elastic membrane to transform concentrated injection pressure into distributed expansion pressure. This parameter transformation allows maintaining high delivery efficiency while reducing the risk of extravasation, as the pressure is evenly distributed across the bone structure rather than focused at a single point.
3Ease of operation
If low viscosity bone filler is used, then the filler can be injected easily, but the filler cannot be contained within the vertebral body
Solution Approach 1:
The balloon catheter acts as a temporary containment structure that allows injection of low-viscosity filler without immediate extravasation. The balloon's physical barrier enables easy injection of flowable filler while preventing it from leaking into the spinal canal, and the balloon's gradual deflation allows controlled filler distribution within the vertebral body.
Solution Approach 2:
The inflated balloon provides a cushioning barrier that prevents low-viscosity filler from escaping the vertebral body. This beforehand cushioning creates a safe containment zone during injection, allowing the use of easily injectable low-viscosity filler while preventing the harmful effect of extravasation until the filler is properly positioned.
4Strength
If the vertebral body is compressed by fracture, then the bone structure is damaged, but the vertebral height is reduced causing spinal deformity
Solution Approach 1:
The inflated balloon exerts an upward counterforce against the compressed vertebral body, opposing the compressive forces that caused the fracture. This anti-weight mechanism gradually restores vertebral height by pushing the fractured bone surfaces apart, counteracting the deforming forces and preventing further spinal deformity while maintaining structural integrity.
Solution Approach 2:
The balloon inflation performs preliminary height restoration before final bone healing occurs. By gradually expanding the vertebral body and separating fractured surfaces, the balloon preliminarily restores vertebral height and alignment, preventing permanent spinal deformity and creating optimal conditions for subsequent bone healing and structural strengthening.
Data Source
AI summary
A system and method is provided for distracting opposite surfaces from the interior of a bone, such as a vertebral body. A working channel cannula provides a working channel through which an inserter and an injection cannula can simultaneously pass. The inserter transports a plurality of wafers into the interior of the bone to form a load-bearing stack bearing against the opposite surfaces. The injection cannula is used to inject a fluent material into and/or around the stack. In certain embodiments, the fluent material is a load-bearing or hardenable material, such as bone cement. In other embodiments, the fluent material can be a BMP, HAP, or other osteo-inductive, osteo-conductive, or pharmaceutical compositions. A syringe containing the fluent material is engaged to the injection cannula and is operable to inject the fluent material into the vertebral body under controlled pressure.