Expandable Exoskeleton Catheter for Deeper Tissue Scoring
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Solution Overview
Problem
Current scoring balloon catheters for angioplasty procedures are limited by the number of score marks they can make and the depth of each score, which restricts the effectiveness of drug delivery to treated tissue, and post-angioplasty treatments are limited to prolonged medication administration.
Innovation Solution
An exoskeleton device with an expandable section that includes struts capable of rotating upon expansion, allowing for deeper scoring of tissue and simultaneous delivery of medicaments, which can be formed from materials like stainless steel or nitinol, with slits arranged in a 'brickwork' pattern to enable resilient return to the original shape.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If current scoring balloon catheters with limited blades are used, then the device complexity remains low, but the productivity of tissue scoring is insufficient due to limited number of score marks per pass
Solution Approach 1:
The balloon catheter is divided into multiple scoring blades arranged circumferentially around the balloon surface. Each blade is a separate scoring element that can independently engage tissue, allowing multiple score marks to be created simultaneously during a single balloon inflation pass through the vessel.
Solution Approach 2:
The scoring blades are positioned on the outer surface of the balloon rather than inside it, representing a dimensional shift from internal to external scoring mechanism. This external positioning allows the blades to protrude outward and engage the vessel wall from the outside during balloon expansion.
2Manufacturing precision
If scoring blades with limited protrusion distance are used, then the device complexity remains simple, but the manufacturing precision of score depth is insufficient to achieve adequate tissue penetration
Solution Approach 1:
The scoring blades are designed with varying local properties: different lengths, angles, and protrusion distances from the balloon surface. This allows specific blades to create scores at different depths and orientations, enabling precise control over tissue penetration depth to match specific treatment requirements.
Solution Approach 2:
The scoring blades incorporate adjustable parameters including blade length, angle of inclination, and distance from the balloon surface. These parameters can be modified during device design or operation to control the depth and characteristics of tissue scoring, allowing optimization for different treatment scenarios.
3Productivity
If multiple inflations are performed to improve drug delivery effectiveness, then the productivity of treatment increases, but the duration of action and loss of time increase
Solution Approach 1:
The device combines multiple scoring blades and drug delivery mechanisms into a single integrated balloon catheter system. By performing all scoring and drug delivery functions during one balloon inflation, the need for multiple separate procedures is eliminated, reducing overall treatment time while maintaining therapeutic effectiveness.
Solution Approach 2:
The scoring blades are positioned and prepared on the balloon surface before the procedure begins. When the balloon is inflated, all scoring actions occur simultaneously and preliminarily create the necessary tissue channels, allowing drug delivery to immediately follow without requiring additional preparatory inflation steps.
4Ease of operation
If scoring blades protrude beyond the balloon surface are used, then the ease of operation for tissue engagement improves, but the object-affected harmful factors increase due to potential tissue damage
Solution Approach 1:
The scoring blades are designed to be dynamic rather than static, with the ability to engage tissue only when the balloon is inflated. When deflated, the blades remain retracted or flush with the balloon surface, minimizing potential harm during navigation. Upon inflation, the blades dynamically extend to engage tissue, providing ease of operation only when needed.
Solution Approach 2:
The protrusion distance of the scoring blades is carefully controlled and can be adjusted as a variable parameter. By optimizing the protrusion distance to be sufficient for effective tissue engagement but not excessive, the device achieves adequate tissue penetration while minimizing unnecessary tissue damage and procedural risks.
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 exoskeleton device enhances tissue scoring depth and facilitates effective drug delivery directly to treated areas, improving treatment efficacy without the need for multiple inflations and prolonged medication use.
Implementation Method 1
the expandable section may be capable of expanding, upon expansion of the expandable instrument over which that portion of the expandable section is positioned
Implementation Method 2
the expandable section may be capable of resiliently returning to substantially its original shape
Data Source
AI summary
An exoskeleton device is capable of being positioned over an expandable instrument, such as a balloon catheter. The exoskeleton device may include an expandable section that receives an expander of the expandable instrument. Expansion of the expander may cause the expandable section of the exoskeleton device to expand and force the expandable section of the exoskeleton device against a surface to be treated. The expandable section may be capable of scoring the surface against which it is forced.