Epidural Clearing Tool with Segmented Inner Body
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Solution Overview
Problem
Conventional tools for clearing the epidural space for medical lead implantation, such as rigid and soft plastic tools, face issues like pressure on the spinal cord, inadequate clearing ability, and difficulty in navigating the space due to angle and size constraints, particularly with newer paddle leads.
Innovation Solution
A clearing tool with an outer body that can deflect and an inner body that extends from a lumen to clear the space, allowing for precise navigation and clearance, then retracts to facilitate the insertion of a medical lead, with features like malleability, flexibility, and a distal tip of greater diameter for effective clearing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a rigid plastic tool is used to clear the epidural space, then the tool maintains structural stability, but it creates pressure points on the spinal cord causing discomfort and potential paralysis
Solution Approach 1:
The clearing tool is divided into two functional segments: an outer body for navigation and an inner body for clearing. The inner body can be extended or retracted relative to the outer body, allowing the stiff clearing surface to be deployed only when needed while the outer body remains flexible during navigation.
Solution Approach 2:
The inner body is made dynamically extendable and retractable within the outer body. When retracted, the tool is flexible for navigation; when extended, the inner body provides a stiff clearing surface. This dynamic transformation allows the tool to adapt its mechanical properties based on operational requirements.
2Force
If a rigid plastic tool is used to clear the epidural space, then the tool provides clearing force, but it has minimal deflection when entering at an angle creating pressure points
Solution Approach 1:
The tool separates the navigation function (outer body) from the clearing function (inner body). The outer body is flexible for easy insertion, while the inner body provides rigid clearing force when extended.
Solution Approach 2:
Different parts of the tool have different mechanical properties: the outer body is flexible for navigation, while the inner body is stiff for clearing. This local differentiation allows each part to perform its specific function optimally without compromising the other.
3Ease of operation
If a soft plastic tool is used to clear the epidural space, then the tool deflects to enter at shallow angles, but it deflects in undesired directions and lacks stiffness to track in the ideal direction
Solution Approach 1:
The tool is segmented into an outer body for flexible navigation and an inner body for stable clearing. The inner body's stiffness provides tracking stability when extended, while the outer body maintains flexibility for insertion.
Solution Approach 2:
The inner body is made of stiffer material than the outer body, creating a local quality difference. This allows the inner body to maintain its trajectory and provide stable clearing while the outer body adapts to the insertion path.
4Adaptability or versatility
If the paddle width increases for newer lead designs, then more stimulation sites are available, but the likelihood of snagging blockages in the epidural space increases
Solution Approach 1:
The clearing tool is used before lead insertion to remove blockages and prepare the epidural space. This preliminary clearing action creates a clear path that accommodates wider paddle leads without snagging, enabling the use of larger leads with more stimulation sites.
5Stability of the object's composition
If a rigid plastic tool with minimal deflection is used, then the tool maintains its shape, but it cannot enter at a shallow enough angle to allow adequate insertion distance
Solution Approach 1:
The tool separates navigation (outer body) from clearing (inner body). The outer body's flexibility enables shallow angle insertion, while the inner body's rigidity maintains shape for effective clearing when extended.
Solution Approach 2:
The inner body can be extended or retracted dynamically. During insertion, it remains retracted to allow flexible navigation at shallow angles. Once positioned, it extends to provide rigid clearing force for adequate insertion distance.
Data Source
AI summary
An epidural space is cleared of fat and scar tissue in preparation for implantation of a medical lead by utilizing a clearing tool. The clearing tool has an outer body and an inner body present within a lumen of the outer body. The outer body may be malleable and have a pre-set deflection or may be flexible and achieve deflection when being inserted into the epidural space. Once in the epidural space, the inner body is extended distally from the lumen of the outer body such that a distal tip on the inner body extends further into the epidural space to provide clearing to the target site without requiring further ingress of the outer body. The inner body is retracted and the clearing tool is removed. The medical lead is then inserted through the window and cleared epidural space until reaching the target site.