Surgical Spacer Shape Control via In Situ Filling
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Solution Overview
Problem
Current surgical spacers for spacing adjacent interspinous processes are not customizable to different anatomical sizes and require preformed devices that may not fit perfectly, necessitating open techniques and destruction of anatomical stabilizers.
Innovation Solution
A flexible, impermeable container that can be filled in situ with a compressible material, coupled with a structure for shape control, allowing for adjustable sizing and placement between spinous processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If preformed surgical spacers are used, then the device structure is simple and manufacturing is easy, but the device cannot be customized to different anatomical sizes and may not fit perfectly
Solution Approach 1:
The spacer transitions from a static preformed device to a dynamic adjustable device. The expansion mechanism allows the spacer to change size after implantation, enabling customization to different anatomical sizes while maintaining a relatively simple initial device structure that can be deployed minimally invasively.
Solution Approach 2:
The spacer employs a nested structure where the expandable elements are contained within a delivery catheter during implantation. This allows the complex adjustable mechanism to be delivered through a simple catheter, resolving the contradiction between adaptability and device complexity by nesting the complex functional elements within a simple delivery system.
2Reliability
If open techniques are used to implant preformed spacers, then precise placement can be achieved, but anatomical stabilizers must be destroyed
Solution Approach 1:
A delivery catheter serves as an intermediary device that enables minimally invasive implantation. The catheter guides the spacer to the precise location between spinous processes without requiring open surgical exposure, thereby achieving placement precision while avoiding destruction of anatomical stabilizers through traditional open techniques.
Solution Approach 2:
The patent replaces the mechanical open surgical approach with a minimally invasive percutaneous delivery system. Instead of using open techniques to position the spacer, the invention uses a catheter-based delivery system that can be inserted through small incisions, substituting the harmful mechanical disruption of open surgery with a less invasive delivery mechanism.
3Strength
If rigid spacers are used, then structural support is strong, but the device cannot be adjusted after implantation
Solution Approach 1:
The spacer incorporates expandable elements that allow it to transition from a compact implantable state to an expanded load-bearing state. This dynamic capability enables the device to provide strong structural support after expansion while maintaining the ability to be adjusted to different sizes, resolving the contradiction between strength and adaptability.
Solution Approach 2:
The spacer utilizes changeable physical parameters, specifically volume and rigidity. The expandable elements can be filled with fluid or solid material to increase volume and adjust rigidity characteristics. This allows the device to be strong when needed while maintaining adjustability through controlled parameter changes after implantation.
Data Source
AI summary
A surgical spacer comprising first and second hollow support members, a flexible container, and a compressible material disposed in the container is disclosed. The first and second support members each have an exterior and an interior cavity. The exteriors of the first and second support members are affixed together and the interior cavities of the first and second support members are connected via a connecting opening. The container is disposed in the interior cavities and extends through the connecting opening. In addition, the container is substantially impermeable to the compressible material. The first and second support members are more rigid than the flexible container. A combination of the first and second support members controls the shape of the flexible container, with the compressible material disposed therein, in response to a compressive load applied to an exterior of the spacer.