Angioplasty Balloon Concealed Wire Design for Calcified Lesions
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Solution Overview
Problem
Conventional balloon catheters face difficulties in properly dilating stenosed regions that are hardened or calcified, as these regions resist expansion pressures, making it challenging to achieve complete dilation.
Innovation Solution
A balloon catheter design featuring a wire situated within a pocket or sheath along its outer surface, where the wire is encapsulated and secured by a retaining element, allowing for focused force distribution and reduced adhesion, enabling effective dilation of calcified lesions at lower inflation pressures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional balloon catheters are used to dilate stenosed regions, then the procedure is simple and widely applicable, but hardened or calcified regions resist expansion pressures and cannot be completely dilated
Solution Approach 1:
The balloon catheter incorporates wires with different properties (stiffness, shape, material) at specific locations along the balloon surface to concentrate expansion force at targeted sites within the stenosed region, enabling effective dilation of hardened or calcified areas while maintaining overall procedural simplicity
Solution Approach 2:
The catheter combines multiple materials with different mechanical properties including the balloon material, wire materials (such as shape memory alloys or superelastic materials), and potentially coating materials to create a composite structure that can effectively dilate resistant calcified lesions through controlled force distribution
2Reliability
If wires are exposed on the balloon surface to concentrate force, then dilation effectiveness improves, but the wires may contact tissue and cause trauma
Solution Approach 1:
A pocket structure is introduced as an intermediary element between the wire and the surrounding tissue. This pocket allows the wire to remain concealed within the balloon wall while still transmitting expansion forces effectively to the stenosed region, preventing direct wire-tissue contact and reducing vascular trauma
Solution Approach 2:
The wire is nested within a pocket formed in the balloon wall structure, creating a hierarchical arrangement where the wire is contained within the balloon material. This nesting configuration allows the wire to function internally while being protected from direct tissue interaction
3Reliability
If multiple inflations are performed to achieve complete dilation, then more thorough treatment is achieved, but procedure time and risk increase
Solution Approach 1:
The balloon catheter is pre-configured with wires positioned and oriented to optimally address the specific stenosed region characteristics before insertion. This preliminary configuration allows the wires to immediately engage the calcified lesion upon inflation, achieving complete dilation in a single procedure rather than requiring multiple sequential inflations
Data Source
AI summary
A balloon catheter having wires situated between an outer layer and a surface of a balloon is described. Each wire may be confined within an interior space of a pocket or encapsulated within a sheath. The pocket includes the outer layer and the balloon surface. The outer layer and balloon surface are unattached to allow the wire to slidably fit between therewithin. The pocket is selectively bonded to the balloon. The sheath includes a preformed shape that completely circumscribes the wire along the longitudinal and radial directions of the wire. The confined and encapsulated feature of the wires enable the wires to be atraumatic and remain spaced apart during treatment of calcification of a lesion.