Interspinous Balloon Catheter Diagnostic Sizing
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Solution Overview
Problem
Current methods for selecting patients suitable for interspinous process spacer implantation in treating lumbar spinal stenosis are limited in identifying appropriate candidates and determining the necessary spacer size, often relying on invasive procedures and lacking precision in outpatient settings.
Innovation Solution
The development of an interspinous process spacer diagnostic balloon catheter, which allows percutaneous insertion and controlled expansion to temporarily decompress the spinal motion segment, enabling physicians to assess candidate suitability and determine the required spacer size through ambulatory testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional diagnostic methods (history, physical examination, imaging) are used to select patients for interspinous process spacer implantation, then the diagnostic process is non-invasive and can be performed in outpatient settings, but the ability to accurately identify appropriate candidates and determine spacer size is limited
Solution Approach 1:
The diagnostic balloon catheter performs preliminary action by temporarily decompressing the spinal motion segment before actual spacer implantation. This allows the physician to assess patient response and determine appropriate spacer size in advance, improving diagnostic accuracy without requiring full surgical intervention.
Solution Approach 2:
The expandable balloon catheter serves as an intermediary device between non-invasive imaging and permanent spacer implantation. It provides reversible, adjustable decompression that mimics the effect of the final implant, enabling accurate candidate selection and sizing without committing to surgery.
2Reliability
If decompressive laminectomy is performed to treat lumbar spinal stenosis, then the spinal canal is decompressed and nerve pressure is relieved, but the procedure is invasive requiring general anesthesia and hospital surgery
Solution Approach 1:
The treatment approach is segmented into two distinct phases: (1) diagnostic phase using the expandable balloon catheter to assess responsiveness to decompression, and (2) treatment phase with permanent spacer implantation only for confirmed candidates. This segmentation reduces unnecessary surgical interventions and associated risks.
Solution Approach 2:
The diagnostic balloon catheter performs preliminary decompression to predict surgical outcomes before committing to invasive laminectomy. Patients who do not respond to the temporary balloon decompression can be identified as non-candidates, avoiding unnecessary surgery and its associated harms.
3Stability of the object's composition
If an interspinous process spacer is implanted to maintain vertebral separation, then the desired distraction is maintained, but patient selection accuracy is insufficient leading to potential unsuccessful outcomes
Solution Approach 1:
The diagnostic balloon catheter provides dynamic, adjustable decompression that can be incrementally increased to determine the optimal spacer size. The balloon can be expanded to different diameters to find the threshold at which symptom relief occurs, enabling precise spacer sizing rather than using fixed-size implants.
Solution Approach 2:
The diagnostic procedure incorporates real-time feedback from patient response during balloon inflation. Physicians can assess symptom relief at each expansion stage and use this feedback to determine both candidate suitability and the specific spacer size needed to maintain effective vertebral separation.
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 non-invasive, outpatient means to determine if a patient will benefit from an interspinous process spacer, allowing for precise sizing and identifying candidates for follow-up surgical implantation, thereby improving treatment efficacy and reducing unnecessary surgical interventions.
Implementation Method 1
the expandable member is inflatable with fluid to a known expanded volume sufficient to expand the expandable member to a known expanded diameter
Implementation Method 2
The expandable member may be percutaneously inserted into the interspinous space
Data Source
AI summary
An interspinous process spacer diagnostic balloon catheter and method. The balloon catheter has a main expandable member, a distal expandable member and a proximal expandable member that all can be expanded from a collapsed configuration to an expanded configuration and then collapsed again to a collapsed configuration. The device can be used to determine whether a particular patient is a candidate for implantation of an interspinous process spacer to treat the symptoms of lumbar spinal stenosis and the size of such a spacer if indicated.