Torus Balloon Lithotripsy Catheter for Calcium Softening
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Solution Overview
Problem
Existing medical devices fail to provide adequate control of blood flow during procedures involving blood clot removal or treatment, leading to prolonged interruption of blood supply and potential ischemic injury, especially in cases of sudden vessel blockages or highly calcified valves.
Innovation Solution
A catheter with a torus balloon and energy emitters is designed to temporarily bypass blood flow around clots or blockages, allowing immediate reperfusion and treatment, featuring proximal and distal openings, a filter to capture particles, and energy emitters for calcium softening.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a balloon catheter is inflated to block blood flow to a targeted site, then control of blood flow to the targeted site is achieved, but blood flow is completely interrupted to other sites near the targeted site
Solution Approach 1:
The balloon is divided into multiple independent segments that can be inflated or deflated independently. This allows selective control of blood flow to different vascular territories, enabling the operator to block flow to the targeted site while maintaining flow to adjacent sites, thereby preventing ischemic injury to non-targeted regions.
Solution Approach 2:
The balloon incorporates dynamic control capabilities with multiple inflation zones that can be adjusted in real-time during the procedure. The ability to selectively inflate and deflate different segments allows the system to adapt blood flow control to the specific procedural needs, providing precise control while minimizing harmful ischemic effects on surrounding tissues.
2Reliability
If thrombolytics are used to dissolve blood clots over time, then clot removal is achieved, but prolonged interruption of blood flow causes progressive ischemic injury
Solution Approach 1:
The segmented balloon design allows the operator to inflate only the portion of the balloon corresponding to the clot location while leaving other segments deflated. This localized approach maintains blood flow through non-affected vascular territories, preventing progressive ischemic injury during the extended thrombolytic infusion period required for complete clot dissolution.
Solution Approach 2:
The system applies thrombolytic therapy locally at the clot site while maintaining systemic blood flow through adjacent vessels. The segmented balloon creates a localized occlusion that confines the thrombolytic action to the targeted area, allowing prolonged treatment duration without causing global ischemic damage to other vascular territories.
3Reliability
If current bypass catheters are surgically implanted, then blood flow restoration is achieved, but immediate relief of progressive ischemia is not practical
Solution Approach 1:
The catheter is designed with multiple functions integrated into a single device: it can perform angioplasty, deliver thrombolytics, and provide temporary bypass all through the same segmented balloon structure. This multi-functionality eliminates the need for multiple separate devices and surgical implantation procedures, allowing immediate deployment for blood flow restoration while preventing progressive ischemic injury.
Solution Approach 2:
The catheter is pre-configured with the segmented balloon structure and necessary delivery mechanisms, allowing it to be rapidly deployed through minimally invasive access. The preliminary preparation of the device enables immediate blood flow restoration upon arrival at the clot site, preventing further progression of ischemic injury without requiring time-consuming surgical implantation procedures.
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 rapid restoration of blood flow, minimizing ischemic injury and facilitating clot dissolution or calcium softening, while reducing the need for multiple operations and immediate relief of ischemia.
Implementation Method 1
A catheter for intraluminal lithotripsy is provided having an outer wall, at least one balloon extending from the outer wall
Data Source
Figure 1~1C
Figure 2~3
Figure 4~4C
AI summary
A catheter for intraluminal lithotripsy including an outer wall, at least one balloon extending from the outer wall, the balloon having a first portion, a second portion proximal of the first portion and an intermediate portion between the first and second portions such that a transverse dimension of the intermediate portion is less than a transverse dimension of the first and second portions. The catheter includes a first lumen, at least one energy emitter mounted on the balloon for emitting energy to break down or soften calcium and a connector connecting the at least one energy emitter to an external energy source, the connector extending through the catheter.