Ostial Stent Positioner for Accurate Artery Placement

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Solution Overview

Problem

Existing stent positioning devices face challenges in accurately placing the proximal end of a stent within ±2 mm of the ostial plane of an artery, especially at the aorto-ostial lesion, due to high friction and obstruction issues within the guiding catheter, limiting the use of contrast material and guide wires.

Innovation Solution

A wire-based ostial stent positioner with a short expandable cylinder and legs that can be deployed to gently engage the aortic wall, allowing for precise alignment and placement of the stent's proximal end using a guiding catheter, which includes a variable diameter slit cylinder for reduced friction and a radiopaque marker for clear visualization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a cylindrical sheath extends for the entire length of the guiding catheter, then stent positioning accuracy is improved, but friction between the sheath and catheter wall increases making operation difficult

Engineering Contradiction:
Improvestent positioning accuracyVSAvoidoperation difficulty
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The sheath is segmented into a distal positioning portion and a proximal delivery portion. The distal portion (10-20 mm) provides positioning accuracy while the proximal portion remains flexible and low-friction for easy advancement through the guiding catheter.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The distal portion of the sheath is constructed with different properties than the proximal portion - the distal end has increased rigidity and radiopaque markers for positioning, while the proximal portion maintains flexibility and low profile for navigation.

Inventive Principle:
Principle #3Local quality

2Measurement precision

If a cylindrical sheath extends for the entire length of the guiding catheter, then stent positioning accuracy is improved, but the internal cross-section of the guiding catheter is substantially obstructed

Engineering Contradiction:
Improvestent positioning accuracyVSAvoidcatheter obstruction
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The sheath is confined to the distal 10-20 mm of the guiding catheter rather than extending the full length. This segmentation allows the proximal 80-90% of the catheter interior to remain open for contrast injection and guide wire passage.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The sheath transitions from a potential full-length obstruction to a localized distal structure, changing the spatial distribution from one-dimensional full-length coverage to a concentrated three-dimensional structure at the catheter tip.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Device complexity

If the expandable distal portion is not optimized for easy usage, then device simplicity is maintained, but ease of operation deteriorates

Engineering Contradiction:
Improvedevice simplicityVSAvoidease of usage
Core Design Contradiction:
Device complexityVSEase of operation

Solution Approach 1:

The expandable distal portion is pre-positioned within the guiding catheter before the procedure begins. The interventionalist simply needs to deploy it by inflating a balloon or releasing a constraint, eliminating complex manual manipulation.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Manual mechanical manipulation of the distal portion is replaced by a simple balloon inflation mechanism or constraint release system, reducing the skill level and effort required for deployment.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS7651520B2Means and method for the accurate placement of a stent at the ostium of an artery
Publication Date: 2010.01.26 MERIT MEDICAL SYSTEMS INC
  • US7651520B2 patent drawing
  • US7651520B2 patent drawing
  • US7651520B2 patent drawing

AI summary

Disclosed is an ostial stent positioner that has the form of a wire for most of its length and having a short cylinder with a longitudinal slit and expandable legs situated at the positioner's distal end. The slit cylinder with its attached wire acts as an introducer sheath to introduce a stent delivery system with a stent into the artery that is to be stented. A second aspect of the present invention is a method for accurately placing a stent at the ostium of an artery that would have an ostial stenosis. Examples of such arteries that have ostial stenoses are the right and left main coronary arteries, a saphenous vein graft as used in coronary bypass surgery and the renal arteries. Also disclosed are designs for the slit cylinder that provides a variable diameter so as to fit snugly within guiding catheters having different inside diameters.