Interspinous Spacer with Rotatable Arms for Minimally Invasive Spinal Stenosis Treatment
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Solution Overview
Problem
Current interspinous spacers for spinal stenosis treatment require larger incisions and invasive surgical techniques, leading to longer recovery times, as they lack minimally invasive deployment mechanisms that can effectively contain and distract adjacent spinous processes.
Innovation Solution
An implantable spacer with rotatable arms and an actuator assembly that deploys from a compact, undeployed configuration to a deployed state, allowing for minimal incision placement and effective containment of spinous processes, accompanied by a specialized insertion instrument for precise deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional interspinous spacers are used, then the spacer can effectively open the spinal canal and relieve pain, but the incision size must be large and surgical technique is invasive
Solution Approach 1:
The spacer is divided into multiple deployable arms that can be independently positioned to contain spinous processes. These segmented arms allow the device to be inserted in a compact form through small incisions and then deployed to achieve the full functional effect of traditional larger spacers.
Solution Approach 2:
The spacer employs deployable arms with bearing surfaces that can dynamically adjust from a compact insertion configuration to a deployed functional configuration. This dynamic transformation enables minimally invasive insertion while maintaining the reliability of effective spinal canal opening and pain relief.
2Stability of the object's composition
If traditional interspinous spacers are used, then the spacer can maintain distance between vertebral bodies, but recovery time is prolonged
Solution Approach 1:
The spacer arms are pre-configured with camming surfaces and bearing surfaces that automatically engage and lock into the deployed position once inserted. This preliminary configuration of the deployment mechanism allows for rapid stabilization of vertebral spacing without requiring prolonged surgical manipulation or extended recovery periods.
3Ease of operation
If the spacer includes deployable arms with camming surfaces, then minimally invasive insertion is enabled, but device complexity increases
Solution Approach 1:
The camming surfaces and bearing surfaces are designed to automatically engage and deploy the arms into the correct position through the natural insertion motion itself. This self-deploying mechanism eliminates the need for complex external deployment tools or multi-step activation procedures, reducing operational complexity despite the sophisticated internal geometry.
4Reliability
If the arms are made rotatable with extensions, then effective containment of spinous processes is achieved, but manufacturing complexity increases
Solution Approach 1:
The arms are constructed with thin-walled structures that provide the necessary rotational flexibility and extension capability while maintaining structural integrity for spinous process containment. This thin-film construction approach simplifies manufacturing compared to robust rigid structures, allowing the arms to be formed through standard fabrication processes while achieving the required functional complexity.
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 minimally invasive surgical procedures with reduced tissue disruption, facilitating quicker recovery by allowing the spacer to be deployed through small incisions and effectively relieving spinal stenosis-related pain by maintaining neural foramen space.
Implementation Method 1
The actuator has at least one bearing surface at the distal end that is configured to engage each camming surface. The actuator is connected to the body and configured to move inside the longitudinal passageway relative to the body to contact each camming surface with the at least one bearing surface and thereby move the arms from an undeployed configuration to a deployed configuration
Data Source
Figure 1a~1b
Figure 1c~1e
Figure 2a~2b
AI summary
A novel implantable spacer for placement between adjacent spinous processes in a spinal motion segment is provided. The spacer includes a body defining a longitudinal passageway. A first arm and a second arm are connected to the body. Each arm has a pair of extensions and a saddle defining a U-shaped configuration for seating a spinous process therein. Each arm has a proximal camming surface and is capable of rotation with respect to the body. An actuator assembly is disposed inside the longitudinal passageway and connected to the body. When advanced, the actuator assembly contacts the camming surfaces of the arms to rotate them from an undeployed configuration to a deployed configuration. In the deployed configuration, the distracted adjacent spinous processes are seated in the U-shaped portion of the arms providing sufficient distraction to open the neural foramen to relieve pain. An insertion instrument is provided for implanting the interpsinous process spacer. The system is configured for quick implantation through a small percutaneous incision employing minimally invasive techniques.