Variable-Diameter Medical Balloon With Embedded Fibers
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Solution Overview
Problem
Existing medical balloons face challenges in achieving a variable diameter for dilation purposes while maintaining high compliance, puncture resistance, and high burst pressures with thin walls, particularly in applications requiring navigation through tortuous paths.
Innovation Solution
A medical balloon with embedded fibers in a compliant tubing, formed from ultra-compliant materials like silicone or polyurethane, allows for variable diameter expansion through controlled radial growth via braided fibers that resist expansion, attached seamlessly to a catheter shaft for smooth passage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If high pressure non-compliant balloons are formed from PET films to achieve high burst pressures and thin walls, then burst pressure and wall thickness are improved, but puncture resistance deteriorates and stiffness increases
Solution Approach 1:
The patent uses a composite structure combining PET film layers with elastomeric materials. The PET provides tensile strength and burst pressure, while the elastomeric layers provide puncture resistance and flexibility. This composite approach resolves the contradiction by combining materials with complementary properties.
Solution Approach 2:
The patent applies different material properties to different regions of the balloon wall. The outer wall uses PET for strength and burst pressure, while inner layers use elastomeric materials for puncture resistance and compliance. This local differentiation allows each region to optimize for its specific function.
2Strength
If high pressure non-compliant balloons are formed from PET films to achieve high burst pressures, then burst pressure is improved, but trackability deteriorates due to increased stiffness
Solution Approach 1:
The composite structure combines rigid PET outer wall with flexible elastomeric inner layers, allowing the balloon to maintain burst pressure while achieving better trackability through the compliant inner material that can deform to navigate tortuous paths.
Solution Approach 2:
The patent creates different functional zones within the balloon wall - the outer PET layer handles burst pressure requirements while the inner elastomeric layer handles trackability and navigation requirements, allowing each property to be optimized independently.
3Ease of operation
If compliant balloons are used to improve trackability and puncture resistance, then trackability and puncture resistance are improved, but burst pressure and wall thickness are worsened
Solution Approach 1:
The patent combines elastomeric materials with PET film in a layered composite structure where the elastomer provides compliance and trackability while the PET layer provides burst pressure resistance, achieving both properties simultaneously.
Solution Approach 2:
The patent assigns different functional requirements to different wall layers - the inner elastomeric layer provides compliance for trackability while the outer PET layer provides strength for burst pressure, allowing both properties to be optimized without compromise.
4Ease of operation
If balloon walls are made thinner to reduce profile and improve trackability, then trackability and profile are improved, but burst pressure and puncture resistance are worsened
Solution Approach 1:
The patent uses a composite wall structure where thin elastomeric layers are combined with PET film layers, allowing the overall wall to remain thin for improved trackability while the PET layers provide the necessary burst pressure and puncture resistance.
Solution Approach 2:
The patent creates a differentiated wall structure where thin elastomeric regions provide compliance and trackability while integrated PET regions provide strength and burst pressure resistance, allowing the balloon to achieve both thin profile and high strength.
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 balloon achieves controlled variable diameter expansion with high compliance, puncture resistance, and high burst pressures, facilitating navigation through complex anatomies with reduced profile and discomfort.
Implementation Method 1
The fiber may be in a braided pattern with either a consistent low winding angle or a variable winding angle along the length of the tubing... the embedded fibers only allow for radial growth of the compliant material forming the medical balloon with increasing pressure and in a controlled manner as the fibers resist expansion
Implementation Method 2
Low pressure compliant medical balloons are typically formed from elastomers such as latex, polyurethane and other thermoplastic elastomers. Low pressure compliant medical balloons may expand by 100% or greater upon inflation
Implementation Method 3
The proximal and distal end of the compliant tubing forming the medical balloon may be welded directly to opposed ends of a catheter shaft
Data Source
AI summary
A medical apparatus (10) includes an inflatable medical balloon (12) formed of a compliant material having one or more fibers (14) embedded therein, which may be braided or form intersections having a first lower angle at a first lower state of inflation of the medical balloon and a second higher at a second higher state of inflation of the medical balloon. A catheter shaft may connect to a tubing for forming the inflatable medical balloon. The outer diameter of the tubing may be substantially flush with outer diameters of the opposed ends of the catheter shaft. A guidewire tube may pass through the catheter shaft and the tubing and connect to a distal tip of the catheter shaft. A proximal hub includes a first port for supplying an inflation fluid to the catheter shaft and a second port adapted for receiving a guidewire for passing through the catheter shaft.