Expandable Balloon Catheter for Foraminal Decompression
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Solution Overview
Problem
Current methods for treating lateral spinal stenosis lack a less invasive approach for decompression, with existing techniques either requiring significant bone resection or being technically demanding and difficult to control, especially when targeting the neuroforamen.
Innovation Solution
The use of catheter devices combined with expandable structures, such as balloons, for foraminal decompression, allowing for precise localization and treatment of lateral spinal stenosis through non-surgical or minimally invasive procedures by advancing and inflating the balloons within the spinal area to address impingements causing stenosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical approaches (medial or transforaminal) are used to decompress lateral spinal stenosis, then decompression can be achieved, but significant bone resection is required and the procedure is technically demanding with difficulty in visualizing foramen content
Solution Approach 1:
A balloon catheter is introduced as an intermediary device to perform decompression of lateral spinal stenosis. The balloon is navigated through the intervertebral foramen using a guide wire and delivers controlled expansion to decompress neural structures without requiring extensive bone resection or complex surgical exposure, thereby simplifying the surgical approach while maintaining decompression effectiveness
Solution Approach 2:
The invention utilizes pneumatic expansion of a balloon catheter to achieve decompression of lateral spinal stenosis. By inflating the balloon within the foramen under fluoroscopic guidance, controlled hydraulic pressure is applied to displace compressing structures and create space for neural elements, providing an alternative to mechanical bone resection
2Ease of operation
If medial approach is used for foraminal decompression, then surgeon familiarity through laminotomy is achieved, but excess bone resection leads to iatrogenic instability and risk of nerve root injury
Solution Approach 1:
The balloon catheter serves as an intermediary tool that allows decompression through the foramen without requiring the surgeon to manually navigate and manipulate structures in the deep lateral foramen. The balloon can be precisely positioned and expanded under imaging guidance, reducing the need for extensive bone removal and minimizing direct manipulation that could injure nerve roots
Solution Approach 2:
The balloon is positioned and expanded before any significant bone resection is performed. This preliminary decompression action creates space and reduces compression on neural structures beforehand, allowing for more conservative bone removal and reducing the risk of iatrogenic instability and nerve injury
3Object-generated harmful factors
If transforaminal approach is used for foraminal decompression, then less bone resection and faster recovery are achieved, but the approach is technically demanding with difficulty in visualizing foramen content
Solution Approach 1:
The balloon catheter utilizes fluoroscopic imaging guidance to navigate and position the balloon within the foramen. The radiopaque balloon and catheter components allow real-time visualization of foramen content and balloon position during the procedure, eliminating the visualization difficulties associated with the transforaminal approach while maintaining its benefits of minimal bone resection
Solution Approach 2:
The balloon catheter system acts as an intermediary that bridges the gap between the lateral approach and direct visualization. By using fluoroscopy to guide the radiopaque balloon, the system provides indirect visualization of foramen content, allowing the surgeon to proceed with confidence without direct visual exposure
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
This method provides a controlled and minimally invasive approach to decompress the spinal canal, reducing the risk of nerve injury and bone resection, while allowing for precise targeting and treatment of stenosis in various zones of the spinal canal, offering a viable alternative to traditional surgical methods.
Implementation Method 1
The expandable structure is inflated in a step-wise fashion to treat the stenosis
Data Source
AI summary
Catheter system, devices and methods for diagnosing and treating lateral stenosis causing back pain and or leg pain. The devices comprise a tubular part for insertion into a working cannula to self-position itself safely within the foramen, and minimize the risk of displacement medially or laterally, to prevent nerve or dura injury. An expandable membrane is configured to maintain the catheter device within the foramen. Expansion of this membrane would decompress the nerve within the foramen by opening the foraminal canal as the membrane expands.