Inflatable Balloon With Constricting Elements for Medical Device Delivery
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Solution Overview
Problem
Existing balloon-based delivery systems for implantable medical devices face issues such as device slippage, incomplete expansion, and bulk addition, which affect precision and flexibility during deployment in vascular procedures.
Innovation Solution
A delivery system featuring a catheter unit with an inflatable balloon and circumferential constraining elements that maintain a non-smooth shape, providing secure device retention without adding bulk, and allowing for precise deployment and higher inflation pressures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If solid protruding elements (ridges) are added to the balloon to engage the medical device, then device retention is improved, but balloon bulk increases and compressibility is impaired
Solution Approach 1:
The patent uses a thin-film constraining element (such as a laser-cut metal sheet or mesh) wrapped around the balloon to create engagement features. This thin-film approach provides the necessary mechanical engagement for device retention while maintaining the balloon's compressibility and flexibility, avoiding the bulk added by solid protruding elements.
Solution Approach 2:
The patent changes the physical state and properties of the constraining element by using a flexible, compressible material that can change its density and firmness in response to inflation pressure. This allows the engagement features to be firm enough to hold the device during deployment but compressible enough to allow the balloon to be delivered through narrow vasculature.
2Reliability
If solid protruding elements are added to the balloon to engage the medical device, then device retention is improved, but balloon flexibility when deflated is reduced
Solution Approach 1:
The thin-film constraining element maintains the balloon's flexibility when deflated because it is designed to be compliant and conformable to the collapsed balloon shape. This allows the balloon to navigate tortuous vasculature while still providing adequate device engagement when inflated.
Solution Approach 2:
The constraining element is designed to dynamically change its mechanical properties based on the balloon's inflation state. When deflated, it remains flexible and conformable; when inflated, it becomes firm enough to provide reliable device engagement. This dynamic adaptation resolves the contradiction between flexibility and retention.
3Manufacturing precision
If the balloon is made less compressible to improve device retention, then device placement accuracy is improved, but trackability through vasculature is adversely affected
Solution Approach 1:
The patent employs a constraining element made of material or structure that changes its compressibility parameter in response to inflation pressure. During delivery, the balloon remains highly compressible for excellent trackability; during deployment, the inflated balloon activates the constraining element to become sufficiently firm for accurate device placement.
Solution Approach 2:
The system dynamically transitions from a soft, trackable state during delivery to a firm, placement-accurate state during deployment. The constraining element is designed to activate or become effective only when the balloon is inflated to deployment pressure, providing the necessary firmness for precise device placement while maintaining deliverability through narrow and tortuous vessels.
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 system ensures accurate placement and expansion of medical devices with reduced risk of slippage and incomplete deployment, maintaining flexibility and compressibility of the balloon, even at higher pressures.
Implementation Method 1
the delivery balloon being inflatable so as to cause the body portion to expand to an inflated diameter
Data Source
AI summary
A delivery system includes an inflatable delivery balloon formed with a plurality of constraining elements which create constrained regions in a body portion of the balloon, interposed between unconstrained regions. The constrained regions create recesses for receiving a medical device or part of a medical device. The constraining elements are preferably formed by woven or braided material, advantageously embedded within the wall of the inflatable balloon. The constraining elements provide a structure that will not flatten upon inflation of the balloon and also a structure which can readily be folded or wrapped for endoluminal delivery purposes, and which retains flexibility of the delivery device.