Frangible Catheter Balloon for Secure Vessel Occlusion

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Solution Overview

Problem

Current vaso-occlusive devices for occluding blood vessels lack efficient detachment mechanisms and materials that can effectively occlude blood flow in complex vascular structures, such as aneurysms and tumors, while minimizing tissue damage and ensuring long-term occlusion.

Innovation Solution

A medical device featuring a catheter shaft with a frangible portion and a detachable balloon member, where the frangible portion can be designed with varying wall thickness, perforations, or recesses to facilitate detachment, and the balloon member can be made compliant to fit vessel shapes and coated with biologically safe adhesives for secure occlusion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a catheter shaft with multiple lumens is used to deliver vaso-occlusive devices, then the device can effectively occlude blood flow in complex vascular structures, but the device complexity increases

Engineering Contradiction:
Improveocclusion effectivenessVSAvoidcatheter structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The catheter shaft is divided into multiple lumens that can be independently controlled, allowing different vaso-occlusive devices to be delivered through separate pathways. This segmentation enables precise placement in complex vascular structures while maintaining manageable device architecture through modular design

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The multi-lumen catheter shaft serves multiple functions: delivering different sized vaso-occlusive devices, providing separate access pathways for complex vascular anatomy, and enabling simultaneous or sequential deployment of multiple occlusion elements. This multi-functionality addresses complex vascular occlusion needs without proportionally increasing operational complexity

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Ease of operation

If a frangible portion is added to enable balloon detachment from catheter, then the ease of operation improves, but the device complexity increases

Engineering Contradiction:
Improvedetachment mechanismVSAvoidcatheter structure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The frangible portion is pre-formed during catheter manufacturing as a predetermined weak point in the adhesive bond between balloon and catheter shaft. This preliminary preparation allows for simple, reliable detachment through minimal manual manipulation during the procedure, improving ease of operation without requiring complex detachment mechanisms

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The frangible portion creates a localized region of reduced bond strength between the balloon and catheter shaft, while the rest of the adhesive bond remains strong. This local quality differentiation enables selective detachment at the frangible site while maintaining secure attachment elsewhere, achieving simple detachment without overall increase in device complexity

Inventive Principle:
Principle #3Local quality

3Adaptability or versatility

If balloon member is made compliant to fit vessel shapes, then the adaptability improves, but the strength of occlusion may be reduced

Engineering Contradiction:
Improvevessel fittingVSAvoidocclusion force
Core Design Contradiction:
Adaptability or versatilityVSStrength

Solution Approach 1:

The balloon material properties are optimized to provide compliance for vessel conformability while maintaining sufficient radial strength for effective occlusion. By carefully selecting elastomeric materials with appropriate durometer ratings and wall thicknesses, the balloon achieves the desired balance between adaptability to vessel shapes and mechanical strength for secure occlusion

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The balloon is constructed from composite materials or multi-layer structures that combine the compliance needed for vessel fitting with the strength required for occlusion. This may include layered elastomeric materials or reinforcement structures that provide both flexibility and mechanical integrity, resolving the contradiction between adaptability and strength

Inventive Principle:
Principle #40Composite materials

4Reliability

If biologically safe adhesive is applied to balloon exterior for secure occlusion, then the reliability of occlusion improves, but the potential for tissue damage from adhesive increases

Engineering Contradiction:
Improveocclusion securityVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The adhesive properties are optimized by adjusting parameters such as adhesive strength, viscosity, and curing characteristics to achieve secure occlusion while minimizing tissue damage. By carefully controlling these parameters, the adhesive provides reliable attachment to the vessel wall without excessive force that could cause tissue injury

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The adhesive is applied in controlled patterns or quantities to specific regions of the balloon exterior, concentrating the occlusive effect where needed while minimizing adhesive contact with surrounding healthy tissue. This localized application maintains occlusion reliability while reducing the overall potential for harmful effects on adjacent tissues

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP3253301B1Occlusion devices
Publication Date: 2019.06.05 BOSTON SCIENTIFIC SCIMED INC
  • EP3253301B1 patent drawingFigure 1
  • EP3253301B1 patent drawingFigure 2A~2C
  • EP3253301B1 patent drawingFigure 3A

AI summary

Medical devices and methods for forming the medical devices are disclosed in the present application. In one illustrative example, a medical device may comprise a catheter shaft extending from a proximal end to a distal end and may include a plurality of lumens extending through at least a portion of the catheter shaft. In some examples, the medical device may further include a balloon member disposed proximate the distal end of the catheter shaft, and the catheter shaft may comprise a frangible portion disposed proximate the distal end of the catheter shaft.