Radial Balloon Structure With Support Coil for Open Perfusion
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Solution Overview
Problem
Current cardiovascular procedures using expandable balloons to deploy heart valves or stents temporarily block or restrict blood flow, complicating the procedure and increasing the risk of injury due to unstable implant positioning, necessitating rapid pacing which is only feasible for a limited time.
Innovation Solution
A balloon catheter with a plurality of radially arranged balloons forming a lumen, each with a keystone shape and a support coil, maintaining stability and allowing continuous blood perfusion during inflation, and optionally featuring a surrogate valve to prevent backflow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single balloon is used to deploy the heart valve, then the device complexity is reduced, but blood flow is blocked or restricted during the procedure
Solution Approach 1:
The single balloon is divided into multiple segments or lobes that are arranged radially around a central axis. Each segment can be independently inflated or deflated, allowing blood to flow through the central lumen while the outer segments provide structural support for valve deployment. This segmentation resolves the contradiction by maintaining device simplicity while eliminating blood flow blockage.
Solution Approach 2:
The balloon structure is designed with nested lumens - an inner lumen for blood flow and outer lumens for balloon inflation. The balloon wall itself forms a barrier between the inflated outer chamber and the patent inner blood flow channel. This nesting allows the balloon to provide deployment function while simultaneously maintaining an open passage for blood flow.
2Loss of time
If the balloon is inflated for a brief period to complete the procedure quickly, then blood flow blockage time is reduced, but implant positioning stability decreases
Solution Approach 1:
The balloon is segmented into multiple independent lobes that can be inflated sequentially or to different pressure levels. This allows the operator to inflate the balloon gradually while monitoring implant positioning, providing time for precise placement without requiring rapid completion. The segmented structure also allows selective deflation of individual segments if adjustment is needed.
Solution Approach 2:
The balloon incorporates dynamic control capabilities where different segments can be inflated or deflated independently during the procedure. This dynamic adjustment allows the operator to optimize implant positioning by selectively inflating segments to provide anchoring force in specific directions, then deflating them for repositioning if necessary, thereby maintaining stability throughout the procedure regardless of duration.
3Stability of the object's composition
If rapid ventricular pacing is employed to increase stability during balloon inflation, then implant positioning stability improves, but the procedure can only be carried out for a limited time span
Solution Approach 1:
The segmented balloon structure provides inherent stability through its radial lobe configuration, which distributes anchoring forces evenly around the implant. This structural stability reduces the need for rapid ventricular pacing to maintain positioning during inflation. The operator can inflate the balloon at normal heart rates while the segmented structure maintains implant stability throughout the procedure.
Solution Approach 2:
The balloon structure acts as an intermediary between the delivery catheter and the native valve tissue. The radial lobes of the balloon provide a stable interface that distributes deployment forces, reducing the need for rapid pacing to prevent implant migration. The balloon mediates the interaction between the delivery system and the heart, providing mechanical stability that reduces dependence on physiological interventions like rapid pacing.
4Object-generated harmful factors
If the balloons are arranged radially to form a lumen for blood flow, then blood flow perfusion is maintained, but the balloons may move relative to each other
Solution Approach 1:
The balloon lobes are designed with asymmetric cross-sectional shapes, such as keystone or wedge shapes, rather than symmetric circular sections. These asymmetric shapes create interlocking geometries between adjacent lobes that prevent relative movement. The wider base of each keystone-shaped lobe abuts against the adjacent lobe, creating a mechanically interlocked arrangement that maintains radial positioning while allowing the central lumen to remain open for blood flow.
Solution Approach 2:
The balloon structure incorporates curved or rounded transitions between lobes rather than sharp angles. These curved geometries allow the lobes to conform to each other and maintain stable radial arrangement through gentle mechanical interlocking. The curvature provides continuous contact surfaces between adjacent lobes, preventing slippage while maintaining the open central lumen configuration for blood flow.
Data Source
AI summary
Disclosed herein are designs for improved inflatable structures for use during minimally invasive cardiovascular procedures. These inflatable structures facilitate the perfusion of blood through an anatomical structure, such as a heart valve, during the cardiovascular procedure. The inflatable structures are formed of a plurality of balloons arranged radially around a central location. The plurality of balloons form a lumen through which blood flows. Each balloon of the plurality is shaped or configured to stabilize the adjacent balloons, limiting their movement relative to each other. For example, some embodiments can feature balloons with a keystone shape that limits movement of the balloons inward toward the lumen. Some implementations can also include a support coil running through the lumen. The support coil holds enables the lumen to be open to perfusion even in the early stages of balloon inflation.


