Nested Occlusion Balloon Radial Collapse Seal
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Solution Overview
Problem
Existing vaso-occlusive devices for occluding blood vessels lack effective sealing mechanisms and retention methods, leading to potential leaks and dislodgment during inflation and use.
Innovation Solution
The design of an occlusion balloon with an inner and outer balloon member, where the inner balloon member collapses radially inward to form a seal when forces on the outer wall exceed those on the inner wall, and is attached to the outer balloon member, utilizing different compliances and self-sealing members to maintain occlusion and allow passage of small shafts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single balloon member is used for occlusion, then the device structure is simple, but effective sealing and retention are insufficient leading to leaks and dislodgment
Solution Approach 1:
The occlusion balloon is divided into an inner balloon member and an outer balloon member, each performing distinct functions. The inner balloon provides the primary occlusion seal while the outer balloon provides structural support and additional sealing, thereby improving reliability without creating an overly complex structure.
Solution Approach 2:
The inner balloon member is nested within the outer balloon member, with the inner balloon positioned inside the outer balloon's lumen. This nested configuration allows both balloon members to work together synergistically, where the inner balloon creates the seal and the outer balloon provides reinforcement and retention.
2Reliability
If the inner balloon member maintains a lumen for shaft passage, then delivery of therapeutic agents is enabled, but sealing effectiveness is reduced
Solution Approach 1:
The inner balloon member is designed to dynamically change its state based on inflation pressure. During delivery, it maintains a patent lumen to allow catheter and shaft passage. Upon inflation at the target site, the increased pressure causes the inner balloon to collapse radially inward, forming a tight seal that prevents leaks while still allowing the system to function.
Solution Approach 2:
The compliance of the inner balloon member is specifically engineered to allow it to collapse under inflation pressure. By changing the physical state of the inner balloon from expanded (during delivery) to collapsed (during occlusion), the system achieves both shaft passage capability and effective sealing.
3Reliability
If the inner balloon member is made highly compliant for collapse, then seal formation is improved, but structural stability during delivery is reduced
Solution Approach 1:
The system separates the functions of structural stability and seal formation into two distinct components: the outer balloon member provides structural stability during delivery, while the inner balloon member is optimized for seal formation through its collapse capability. This functional segmentation allows each component to be optimized for its specific purpose.
Solution Approach 2:
The occlusion balloon system uses composite construction with an inner balloon member made of highly compliant material for collapse and sealing, nested within an outer balloon member made of more structurally stable material for delivery support. This composite approach combines the advantages of both material types.
4Reliability
If inflation pressure is increased to ensure occlusion, then sealing is improved, but risk of dislodgment and vessel damage increases
Solution Approach 1:
The dual-balloon design distributes the mechanical loads and forces across two separate structures. The inner balloon creates the seal at lower pressures, while the outer balloon provides structural support and anchors the assembly, reducing the risk of dislodgment even when inflation pressure is increased to ensure complete occlusion.
Solution Approach 2:
The outer balloon member acts as a protective cushion that prevents the inner balloon from exerting excessive localized pressure on the vessel wall. This pre-positioned protective structure distributes forces more evenly and reduces the risk of vessel damage and dislodgment before they can occur.
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
The occlusion balloon effectively seals blood vessels, preventing leaks and dislodgment, and allows for the delivery of therapeutic agents while maintaining occlusion, enhancing the reliability and safety of vascular occlusion procedures.
Implementation Method 1
when forces acting on the inner wall of the inner balloon member equal forces acting on the outer wall of the inner balloon member, the inner balloon member defines a lumen
Implementation Method 2
when forces acting inward on the outer wall of the inner balloon member are greater than forces acting outward on the inner wall of the inner balloon member, the inner wall of the inner balloon member collapses radially inward
Implementation Method 3
the inner balloon member is attached to the outer balloon member
Data Source
Figure 1A
Figure 1B
Figure 2
AI summary
Medical devices and methods for forming the medical devices are disclosed in the present application. In one illustrative example an occlusion balloon comprises an outer balloon member, and an inner balloon member having an inner wall and an outer wall and extending through at least a portion of the outer balloon member, in at least some examples, when forces acting on the inner wall of the inner balloon member equal forces acting on the outer wall of the inner balloon member, the inner balloon member defines a lumen.