Annulus Rings with Integrated Suture Clips

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Solution Overview

Problem

The conventional method of securing prosthetic devices using sutures by tying knots is time-consuming, difficult to control, and prone to loosening, especially in hard-to-reach locations, necessitating a more efficient and reliable method for attachment.

Innovation Solution

The integration of suture clips into an annular frame, which can be formed from a single piece of flat material using laser cutting, allows for secure engagement and tensioning of sutures without knots, enabling quick and precise placement of prosthetic devices like annuloplasty rings at native heart valve annuli.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If knots are tied in sutures to secure prosthetic devices, then the sutures can be secured together and to tissue, but the process is time-consuming and difficult to control

Engineering Contradiction:
Improvesuture securityVSAvoidimplantation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent removes the knot-tying operation from the suture securing process by introducing suture clips that mechanically engage and lock sutures in place. The clips extract the time-consuming knot manipulation and replace it with a simple insertion and clipping action, directly resolving the time-loss contradiction while maintaining suture security.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The suture clip acts as an intermediary device between the sutures and the tissue/prosthetic device. Instead of directly tying knots in the sutures, the clip mediates the securing function by engaging the suture ends and providing a mechanical lock, thereby eliminating the time-consuming knot-tying process while ensuring reliable suture fixation.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If knots are tied in sutures to secure prosthetic devices, then the sutures can be anchored, but the knots can accidentally come loose

Engineering Contradiction:
Improvesuture anchoringVSAvoidknot control
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent extracts the problematic knot-tying operation and replaces it with suture clips that provide a more reliable mechanical engagement. The clips eliminate the human error associated with knot tying and provide consistent, controlled anchoring that cannot accidentally come loose, thereby improving reliability while enhancing ease of operation.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The suture clips are designed to self-lock onto the sutures once inserted, providing automatic anchoring without requiring complex knot manipulation. The clips engage the sutures in a manner that is inherently secure and resistant to loosening, making the anchoring process both easier to operate and more reliable.

Inventive Principle:
Principle #25Self-service

3Reliability

If conventional suture methods are used, then prosthetic devices can be secured, but the amount of slack in sutures is difficult to control

Engineering Contradiction:
Improvesuture attachmentVSAvoidsuture tension control
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The suture clip serves as a precision intermediary that allows controlled tensioning of sutures. By engaging the sutures at specific points and providing a mechanical lock, the clips enable precise control over the amount of slack or tension in the sutures, thereby improving manufacturing precision while maintaining reliable attachment.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If knots are tied in hard-to-reach locations, then sutures can be secured, but the process becomes even more difficult and time-consuming

Engineering Contradiction:
Improvesuture fixationVSAvoidsuture tying difficulty
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent extracts the difficult knot-tying operation from hard-to-reach locations and replaces it with suture clips that can be easily inserted and engaged. The clips eliminate the need for dexterous knot manipulation in constrained spaces, thereby maintaining reliable suture fixation while dramatically improving ease of operation in hard-to-reach locations.

Inventive Principle:
Principle #2Taking out (Extraction)

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

This solution reduces the time and difficulty in securing sutures, minimizes the risk of clips coming loose, allows precise control of suture tension, and facilitates quicker implantation of prosthetic devices, reducing personnel and facility costs while maintaining robust functionality.

Implementation Method 1

The suture clips are configured to engage sutures inserted through the gripping region to restrict the inserted sutures from moving through the suture clips in a direction opposite of insertion

Methodology Applied
Scientific EffectFriction: Friction

Implementation Method 2

Each suture clip comprises a pair of opposing, resiliently flexible tabs that are configured to allow at least one suture to advance in one longitudinal direction through the suture clip while gripping the suture to prevent the suture from moving in an opposite longitudinal direction

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS12138166B2Annulus rings with suture clips
Publication Date: 2024.11.12 EDWARDS LIFESCIENCES CORP
  • US12138166B2 patent drawing
  • US12138166B2 patent drawing
  • US12138166B2 patent drawing

AI summary

Disclosed herein are annular prosthetic devices, such as annuloplasty rings, that include suture clips integrated into or mounted within an annular frame. The clips can quickly secure to sutures to obviate the need to tied knots in the sutures during implantation. Embodiments comprise an annular frame having an open central region and a plurality of suture clips spaced angularly apart around the frame. Each of the suture clips can comprise two opposing tabs that extend toward each other such that the suture clip forms a gripping region between ends of the tabs and the gripping region is configured to grip a suture inserted through the suture clip between the two tabs. The annular frame and the plurality of suture clips can be formed from a single piece of flat material with the suture clip tabs being formed by laser cutting the piece of flat material, or the suture clips can be movable along a track formed in the annular frame.