Cutting Balloon Catheter Dual-Layer Adhesive Mounting
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Solution Overview
Problem
Current angioplasty balloons often struggle to effectively treat hardened or calcified lesions due to re-stenosis and trauma concerns, necessitating improved methods for mounting cutting elements to enhance treatment efficacy.
Innovation Solution
The use of a medical balloon catheter with cutting blades secured by a dual-layer polymeric adhesive system, where a high-strength, low-ductility adhesive forms a mounting pad around the blade's base and a high-ductility adhesive bonds the pad to the balloon, ensuring secure attachment and flexibility with balloon expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If cutting elements are mounted on angioplasty balloon to treat hardened lesions, then cutting capability is improved, but reliability of element attachment deteriorates
Solution Approach 1:
The adhesive system is segmented into two distinct layers: a first polymeric adhesive material forming a mounting pad that encases the cutting blade base, and a second polymeric adhesive material bonding the pad to the balloon. This segmentation allows each layer to perform its specific function optimally.
Solution Approach 2:
Different regions of the adhesive system have different properties tailored to local requirements. The first adhesive material (mounting pad) has lower ductility for strong mechanical interlocking with the blade, while the second adhesive material has higher ductility to accommodate balloon expansion and contraction.
Solution Approach 3:
The adhesive system uses a composite of two polymeric adhesive materials with different ductility characteristics. This composite structure combines the strengths of both materials: the first provides rigid mechanical attachment to the cutting blade, while the second provides flexible bonding to the expandable balloon.
2Reliability
If cutting elements are mounted on angioplasty balloon to reduce re-stenosis, then treatment efficacy is improved, but device complexity increases
Solution Approach 1:
The mounting pad and adhesive bonding layer are merged into a single integrated adhesive system applied in sequence. The first adhesive material forms the mounting pad structure, and the second adhesive material integrates this pad to the balloon surface, creating a unified attachment system.
Solution Approach 2:
The first polymeric adhesive material forming the mounting pad acts as an intermediary between the cutting blade and the second polymeric adhesive material. This intermediate mounting pad structure simplifies the overall mounting process by providing a pre-formed attachment base.
3Ease of manufacture
If single-layer adhesive is used to mount cutting blade, then manufacturing simplicity is improved, but adaptability to balloon expansion deteriorates
Solution Approach 1:
The dual-layer adhesive system assigns different local qualities to different layers: the first adhesive material provides structural integrity and mechanical interlocking, while the second adhesive material provides flexibility and adaptability to balloon expansion through its higher ductility.
Solution Approach 2:
The system changes the ductility parameter between the two adhesive layers. The first adhesive material has lower ductility for stable blade mounting, while the second adhesive material has higher ductility to accommodate the dynamic expansion and contraction of the balloon during use.
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
This configuration enhances the ability to cut or score lesions, reduces trauma, and effectively addresses re-stenosis by securely mounting cutting blades while accommodating balloon expansion, thereby improving angioplasty outcomes.
Implementation Method 1
at least one cutting blade is secured to the inflatable balloon by a first polymeric adhesive material forming a mounting pad encasing a base portion of the cutting blade therein
Implementation Method 2
a second polymeric adhesive material adhesively bonding the mounting pad to a surface of the balloon
Data Source
AI summary
A medical balloon catheter including a catheter shaft and an inflatable balloon secured to a distal portion of the catheter shaft. One or more cutting blades are secured to the inflatable balloon by a first polymeric adhesive material forming a mounting pad encasing a base portion of the cutting blade therein, and a second polymeric adhesive material adhesively bonding the mounting pad to a surface of the balloon. The first polymeric adhesive material has a first ductility and the second polymeric adhesive material has a second ductility greater than the first ductility.