Steerable Catheter with RF Cutting Edge for Spinal Stenosis
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Solution Overview
Problem
Current surgical techniques for lumbar spinal stenosis, such as laminectomy, are invasive and pose risks due to difficulty in maneuvering catheters within the interspinous space for accurate tissue dissection and evacuation, leading to potential injury to adjacent areas.
Innovation Solution
A steerable catheter system with a curved RF cutting edge and non-cutting areas, equipped with a vacuum for tissue removal, allowing precise dissection and evacuation of hypertrophied ligamentum flavum while minimizing collateral damage, and optionally incorporating a flexible camera for direct visualization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional catheters are used for spinal surgery, then the procedure can be performed, but it is difficult to maneuver and make accurate cuts within the interspinous space
Solution Approach 1:
The catheter incorporates a shape memory alloy inner member that can dynamically change its configuration between a constrained linear state (when inside the cannula) and a steered arcuate state (when deployed), allowing the catheter to adapt its shape for both easy insertion and precise positioning
Solution Approach 2:
The catheter is divided into functional segments: a flexible shaft with cavities for steering, an inner member for shape control, a cutting tip with RF electrode, and a non-cutting protective area, allowing each segment to perform its specific function independently
2Productivity
If traditional cutting methods are used, then tissue can be removed, but there is increased risk of unintentional injury to adjacent areas
Solution Approach 1:
The catheter tip features a differentiated design where only specific portions (cutting edges) are equipped with RF cutting capability, while other areas are made of non-cutting material to protect adjacent structures, allowing precise localization of the cutting action
Solution Approach 2:
The non-cutting area acts as an intermediary protective barrier between the RF cutting edge and adjacent tissues, preventing unintended thermal or mechanical damage while allowing the cutting function to proceed
3Object-affected harmful factors
If minimally invasive techniques are used, then patient trauma is reduced, but it is difficult to fit and maneuver catheters within the geometry of the interspinous space
Solution Approach 1:
The catheter employs a flexible shaft construction that can bend and conform to the narrow, irregular geometry of the interspinous space, allowing minimally invasive access while maintaining maneuverability for precise positioning
Solution Approach 2:
The catheter system uses a nested configuration where the flexible catheter is delivered through a stiff cannula, allowing the soft flexible catheter to be constrained during insertion and then deployed into its functional shape at the target site
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, precise dissection and evacuation of tissue with reduced risk of injury to adjacent structures, facilitating effective treatment of lumbar spinal stenosis through accurate cutting and suction capabilities.
Implementation Method 1
at least one electrode disposed on the cutting edge configured to emit a cutting radio frequency signal
Implementation Method 2
a vacuum attached to the proximal end of the shaft so as to provide suction to clear cut tissue from the passageway
Data Source
AI summary
A steerable catheter system is provided including an elongated shaft having a proximal end, a distal end and an outer surface. The outer surface includes at least one cavity configured to facilitate movement of the distal end relative to the proximal end so as to steer the elongated shaft. A catheter tip is attached to the distal end of the shaft. The catheter tip comprises a curved body having at least one RF cutting edge and at least one non-cutting area recessed from the at least one cutting edge.