Hydraulically Inflatable Stabilizers for Catheter Alignment

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Solution Overview

Problem

Current percutaneous transluminal angioplasty (PTA) methods face complications due to over-inflation of balloon catheters, leading to undesirable distention of blood vessels, potential for new atherosclerotic lesions, and risks of dissection or rupture, as well as challenges in maintaining the stability of catheter apparatuses during manipulation within curved biological vessels.

Innovation Solution

A catheter system with a first catheter and a second catheter inserted into it, featuring hydraulically inflatable stabilizers that compress against the inner surface of the first catheter shaft, fixing the position of the second catheter and maintaining a coaxial disposition, thereby preventing deformation and relative motion during PTA procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If balloon catheters are inflated to widen narrowed blood vessels, then the blood vessel is expanded and the atherosclerotic lesion is disrupted, but over-inflation can result in undesirable persistent distention of the blood vessel which may disrupt laminar blood flow and lead to new atherosclerotic lesions or regrowth

Engineering Contradiction:
Improveprecision of vessel wideningVSAvoidvessel distention and new lesion formation
Core Design Contradiction:
Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The patent employs controlled inflation parameters by using a balloon catheter with specific dimensions and inflation pressure ranges to achieve precise vessel widening without over-inflation. The balloon is designed to expand to a controlled diameter that matches the target vessel size, and inflation pressure is regulated to stop expansion at the desired point, preventing persistent distention and new lesion formation.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If balloon catheters are inflated to disrupt atherosclerotic lesions, then the lesion is disrupted and blood flow is improved, but localized forces can induce fissures and tears in the inner blood-vessel-wall lining resulting in dissection

Engineering Contradiction:
Improvelesion disruption effectivenessVSAvoidvessel wall dissection
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent controls the inflation pressure and duration to optimize lesion disruption while minimizing vessel wall damage. The balloon is inflated to a pressure sufficient to compress and disrupt the atherosclerotic plaque but not so high as to cause fissures or tears in the healthy vessel wall. The inflation is maintained for a controlled period to ensure complete lesion disruption without excessive force that would lead to dissection.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If PTA catheters are used within support catheters for enhanced maneuvering and vessel shielding, then maneuverability and protection are improved, but the apparatus becomes more complex and manipulation within curved vessels is complicated

Engineering Contradiction:
Improvevessel shielding and maneuveringVSAvoidcatheter apparatus complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent utilizes a nested catheter configuration where the PTA catheter is inserted within the support catheter. This nested arrangement allows the smaller PTA catheter to be guided and protected by the larger support catheter, improving maneuverability through curved vessels and providing vessel shielding. The nested structure enables controlled deployment and retrieval while maintaining relative simplicity through the coordinated movement of the two catheters.

Inventive Principle:
Principle #7Nested doll (Nesting)

4Adaptability or versatility

If the second catheter is inserted into the first catheter for PTA procedures, then the apparatus can perform angioplasty functions, but the catheter may deform and experience relative motion during manipulation within curved biological vessels

Engineering Contradiction:
ImprovePTA procedure capabilityVSAvoidcatheter alignment stability
Core Design Contradiction:
Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The patent incorporates localized stabilization features at specific positions along the catheter length. These features include anchoring elements or friction-enhancing surfaces at the interface between the inner PTA catheter and outer support catheter, providing stability where needed during manipulation. The local quality enhancement ensures that the catheters maintain proper alignment and relative positioning without requiring complete rigidity throughout the entire apparatus, allowing flexibility where needed while maintaining stability where required.

Inventive Principle:
Principle #3Local quality

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 stabilizers effectively prevent deformation and maintain the coaxial alignment of catheter components, reducing the risk of complications such as vessel distention, new lesion formation, and apparatus failure, ensuring smoother and safer PTA procedures.

Implementation Method 1

one or more hydraulically inflatable stabilizers being in fluid communication with the second lumen. The one or more stabilizers is/are adapted when being hydraulically inflated via the second lumen to form an inflation-fluid chamber being inflatable radially outward

Methodology Applied
Scientific EffectHydraulic inflation: Hydraulic Press

Implementation Method 2

compressing the stabilizer against an inner surface of the first catheter shaft and fixing the position of the second catheter within the first catheter and constrain the second catheter to a coaxial disposition

Methodology Applied
Scientific EffectRadial compression: Compression

Data Source

PatentUS20240100308A1Catheter system with hydraulically inflatable stabilizers
Publication Date: 2024.03.28 BIOTRONIK AG
  • US20240100308A1 patent drawing
  • US20240100308A1 patent drawing
  • US20240100308A1 patent drawing

AI summary

PTA catheters and improved PTA methods address problems associated with PTA procedures. One or more stabilizers are activated to hold or fix the PTA catheter at a desired relative position within a support catheter. Timely activation of the stabilizers can prevent deformation of the PTA apparatus during manipulation of the PTA apparatus within biological vessels.