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
Engineering 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
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
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
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
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
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
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
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
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
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
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
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
Data Source
Figure 1
Figure 2A~2C
Figure 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.