Annulus Constricting Cord Fastening and Proximal Cord Cutting

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Solution Overview

Problem

Existing methods for fastening and cutting constricting cords around cardiac or anatomic annuli are time-consuming, labor-intensive, and require large fasteners to prevent slippage, with suboptimal cutting processes.

Innovation Solution

A fastening apparatus with a sliding member and shear pins that securely fasten the cord by sliding to immobilize it within a housing, and a cutting apparatus with a cutting element that uses a slit-shaped distal portion to efficiently cut the cord after constriction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If prior art knot-tying methods are used to fasten the cord, then the cord can be secured, but the process becomes time-consuming and labor-intensive

Engineering Contradiction:
Improvecord fastening reliabilityVSAvoidfastening process time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent replaces the manual knot-tying mechanical system with a crimping mechanism that uses a crimping tool to compress a crimp sleeve onto the cord. This substitution eliminates the need for manual knot manipulation, significantly reducing procedure time while maintaining secure fastening through mechanical compression of the cord within the crimp sleeve.

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

2Productivity

If prior art crimp-based fasteners are used, then the cord can be fastened quickly, but the fastener must be relatively large to exert enough force to prevent slippage

Engineering Contradiction:
Improvefastening speedVSAvoidfastener size
Core Design Contradiction:
ProductivityVSArea of stationary object

Solution Approach 1:

The patent employs a composite fastening system combining a crimp sleeve made of radiopaque material (such as stainless steel or nitinol) with a radiopaque marker. This composite structure provides both the mechanical crimping function and radiopacity for imaging verification, allowing the fastener to be small while maintaining sufficient crimping force and enabling precise positioning verification through radiographic imaging.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent changes the material parameters of the crimp sleeve by using radiopaque materials with high strength-to-size ratios. This allows the fastener to maintain adequate crimping force in a smaller size, as the radiopaque materials can be engineered to provide both structural integrity and radiopacity, eliminating the need for larger fastener dimensions.

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If prior art cutting methods are used, then the cord can be cut, but the process becomes labor-intensive

Engineering Contradiction:
Improvecord cutting easeVSAvoidcutting process efficiency
Core Design Contradiction:
Ease of manufactureVSProductivity

Solution Approach 1:

The patent merges the cord cutting function with the existing catheter delivery system by incorporating a cutting element that can be advanced through the catheter to cut the cord at the desired location. This integration eliminates separate cutting procedures and manual manipulation, allowing the cord to be cut efficiently during the same procedure while maintaining precision through the guided delivery system.

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

The apparatus efficiently fastens and secures the cord, reducing labor and time, while the cutting apparatus effectively cuts the cord with minimal damage, ensuring reliable annulus constriction and reduced diameter maintenance.

Implementation Method 1

a first shear pin arranged to hold the sliding member at the initial position until the first shear pin is sheared by a force that exceeds a first threshold

Methodology Applied
Scientific EffectShear stress: Shear Stress

Implementation Method 2

the distal end of the opening will enter the channel and push a first part of the cord to a position at which the first part of the cord will be squeezed between the upper surface of the sliding member and the upper wall of the housing, and also push a second part of the cord to a position at which the second part of the cord will be squeezed between the lower surface of the sliding member and the lower wall of the housing

Methodology Applied
Scientific EffectCompression: Compression

Data Source

PatentUS11058409B2Fastening a constricting cord in a reduced-diameter state around a cardiac valve annulus, and cutting proximal portions of the cord
Publication Date: 2021.07.13 EDWARDS LIFESCIENCES CORP
  • US11058409B2 patent drawing
  • US11058409B2 patent drawing
  • US11058409B2 patent drawing

AI summary

A cord that has been previously affixed around an annulus can be fastened with a fastener that is movable from a first state in which the cord is free to slide to a second state in which the cord is locked in place. After the fastener is moved to the second state, a cutting element with a slit shaped distal portion oriented in the distal-to-proximal direction with sharp edges slides with respect to a shelf and cuts off portions of the cord that are proximal with respect to the two locked parts.