Perfusion Dilation Catheter with Self-Expanding Frame

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current dilatation catheters obstruct blood flow during procedures and struggle to effectively dilate heavily calcified heart valves, limiting the duration of balloon inflation and the extent of radial expansion.

Innovation Solution

A perfusion dilation catheter system featuring a resilient tubular frame with self-expanding capabilities and a helically wrapped balloon, allowing for blood flow through open slots in the frame, which combines mechanical dilation with radial expansion forces from both the frame and the balloon to treat calcified valves.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Force

If a traditional catheter balloon is inflated to dilate the valve, then radial expansion force is achieved, but blood flow is completely obstructed

Engineering Contradiction:
Improveradial expansion forceVSAvoidblood flow obstruction
Core Design Contradiction:
ForceVSObject-affected harmful factors

Solution Approach 1:

The frame is divided into multiple struts (first strut, second strut, third strut, fourth strut) that are spaced apart to create slots between them. This segmentation allows blood to flow through the slots while the struts collectively provide radial expansion force against the calcified valve.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The frame structure functions as a porous design with slots between struts and openings at proximal and distal ends, allowing fluid passage while maintaining structural integrity for dilation. The helical balloon also creates a porous-like effect with its wrapped configuration that permits fluid flow through the lumen.

Inventive Principle:
Principle #31Porous materials

2Duration of action of moving object

If balloon inflation time is extended to effectively dilate calcified valves, then dilation efficacy improves, but hypotension complications increase

Engineering Contradiction:
Improveballoon inflation timeVSAvoidhypotension
Core Design Contradiction:
Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The frame's segmented strut design with slots allows continuous blood flow through the device during inflation, preventing the profound hypotension that limits traditional balloon inflation time to just a few seconds.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The open slot configuration enables continuous blood perfusion throughout the procedure, allowing the balloon to remain inflated for extended periods without causing hypotension, thus enabling prolonged effective dilation of resistant calcified valves.

Inventive Principle:
Principle #20Continuity of useful action

3Stress or pressure

If a non-distensible plastic balloon is used to achieve high pressure, then dilation pressure is sufficient, but the balloon cannot expand beyond a fixed diameter

Engineering Contradiction:
Improvedilation pressureVSAvoiddiameter adjustability
Core Design Contradiction:
Stress or pressureVSAdaptability or versatility

Solution Approach 1:

The system merges a non-distensible plastic balloon (for high pressure generation) with a self-expanding resilient frame structure (for diameter control and adaptability). The frame provides the structural support that enables the balloon to achieve both high pressure and controlled expansion to predetermined diameters.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The self-expanding frame is configured to expand to a predetermined diameter upon deployment, while the balloon can be inflated to various pressures within that fixed diameter constraint. This allows independent control of pressure and diameter parameters to optimize dilation efficacy.

Inventive Principle:
Principle #35Parameter changes

4Device complexity

If a helical balloon alone is used for dilation, then the structure is simple, but radial expansion force is insufficient for heavily calcified valves

Engineering Contradiction:
Improvecatheter structureVSAvoidradial expansion force
Core Design Contradiction:
Device complexityVSForce

Solution Approach 1:

The invention combines a self-expanding resilient frame structure with a helical balloon, merging the mechanical expansion force of the frame with the inflatable pressure of the balloon to generate sufficient radial expansion force for heavily calcified valves while maintaining relative structural simplicity.

Inventive Principle:
Principle #5Merging (Combining)

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

Enables prolonged balloon inflation and greater radial expansion of calcified heart valves while maintaining perfusion, effectively addressing the limitations of existing catheter designs by providing a combined dilating force and allowing continuous blood flow during the procedure.

Implementation Method 1

a resilient tubular frame having a self-expanded configuration

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

The balloon is then inflated to dilate the diseased valve opening

Methodology Applied
Scientific EffectPressure: Pressure Increase

Data Source

PatentUS9480823B2Perfusion dilation catheter system and methods of use
Publication Date: 2016.11.01 MEDTRONIC VASCULAR INC
  • US9480823B2 patent drawing
  • US9480823B2 patent drawing
  • US9480823B2 patent drawing

AI summary

A system includes an elongate catheter having a self-expanding frame disposed at the distal end of the catheter. The frame includes a plurality of longitudinal struts defined by parallel slots. The frame may be constrained into a radially compressed configuration for delivery to a treatment site. A helical balloon is mounted about the frame. Upon release from the constraining mechanism, the frame returns to a heat-set radially expanded configuration to initiate dilation of a treatment site in a patient. Inflating the balloon around the expanded frame further expands the initial radial dilation of the site. Proximal and distal ends of the slots are unobstructed by the balloon to permit flow of a fluid through the slots and through a lumen defined by an interior surface of the balloon when the frame is in the radially expanded configuration.