Variable Length Balloon Catheter with Pressure Rupture Strictures
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Solution Overview
Problem
Current balloon angioplasty procedures face challenges in accurately estimating and adjusting the length of the balloon catheter due to limited access and calcification in blocked arterial vessels, making it difficult to select the appropriate balloon size for effective treatment in critical limb ischemia.
Innovation Solution
A variable length balloon catheter assembly with pressure-dependent stricture mechanisms that divide the balloon into longitudinal sections, allowing for inflation to a desired length by rupturing specific sections at predetermined pressures, enabling flexible length adjustment during the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed-size balloon is used for angioplasty, then the balloon can be manufactured with precise dimensions, but it cannot be adjusted to match the actual occlusion size, leading to either insufficient coverage or excessive length
Solution Approach 1:
The balloon is divided into multiple sealed longitudinal sections separated by stricture mechanisms. Each section can be independently inflated or deflated, allowing the balloon length to be adjusted by selectively rupturing stricture mechanisms to merge sections. This segmentation enables the balloon to adapt to different occlusion lengths while maintaining a manageable structure.
Solution Approach 2:
The balloon transitions from a static fixed-length structure to a dynamic variable-length structure through the use of pressure-dependent stricture mechanisms. These mechanisms allow the balloon to change its configuration during the procedure, adapting to the actual occlusion size discovered during access, thereby resolving the contradiction between adaptability and structural complexity.
2Measurement precision
If the balloon length is determined before the procedure, then the manufacturing process is simplified, but the ability to accurately match the balloon length to the occlusion size is compromised due to limited access for sizing
Solution Approach 1:
The balloon is pre-configured with stricture mechanisms at predetermined pressure thresholds during manufacturing, preparing the structure for future length adjustment. This preliminary segmentation allows the operator to later determine the exact occlusion size and adjust the balloon length accordingly, improving measurement precision without requiring extensive pre-procedure sizing that would lose time.
Solution Approach 2:
The balloon length parameter can be dynamically changed during the procedure by controlling the inflation pressure to rupture specific stricture mechanisms. This allows the operator to optimize the balloon length to match the actual occlusion size with high precision, eliminating the need for time-consuming pre-sizing procedures while maintaining simple manufacturing processes.
3Adaptability or versatility
If multiple balloon sizes are prepared for different occlusion lengths, then the adaptability to various occlusion sizes is improved, but the device complexity and inventory management become more complex
Solution Approach 1:
A single balloon catheter design with variable length capability replaces the need for multiple fixed-size balloons. The universal design incorporates stricture mechanisms that allow the same balloon to be configured into multiple effective lengths during the procedure, providing adaptability to various occlusion sizes while simplifying the overall system by eliminating the need to manage multiple different balloon sizes.
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 precise adjustment of balloon length during angioplasty, improving procedural efficiency and effectiveness by allowing the balloon to be inflated to a working length that matches the occlusion size without the need for pre-sizing, facilitating better access and treatment in calcified arteries.
Implementation Method 1
The first pressure dependent stricture mechanism constricts a first circumferential portion of the balloon wall proximate the outer surface of the catheter and has a first pre-determined rupture pressure. The second pressure dependent stricture mechanism constricts a second circumferential portion of the balloon wall proximate the outer surface of the catheter and has a second pre-determined rupture pressure.
Implementation Method 2
for each of the plurality of stricture mechanisms, rupturing the stricture mechanism by introducing fluid into the inner volume of the balloon sufficient to exceed the rupture pressure threshold of the stricture mechanisms
Data Source
AI summary
A variable length balloon catheter assembly and methods for inflating a variable length balloon to a predetermined length. The variable length balloon catheter has a balloon at a distal end and a plurality of stricture mechanisms securing the balloon to the catheter. The stricture mechanisms are provided at known intervals and have a known rupture pressure. The balloon is inflated and a known number of stricture mechanisms are ruptured providing for a variable balloon length based on the number of stricture mechanisms ruptured.