Suture Clip Deployment via Radial Crimping

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Solution Overview

Problem

Current suture locking devices for surgical procedures, especially in endoscopic surgery, are complex and require multiple steps, making them time-consuming and difficult to perform accurately, particularly in limited spaces like the heart, where easy access and precise tensioning of sutures are challenging without knots.

Innovation Solution

The development of improved suture-clip delivery devices and systems that include a suture clip with a flat shape and a handheld device for deploying the clip, utilizing a crimping assembly to securely engage sutures with a distributed radially compressive force, eliminating the need for knots and allowing for easy access and tensioning during surgeries like heart valve repair.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional knot-tying methods are used for suture locking, then secure suture retention is achieved, but surgical time increases and procedure complexity increases

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

Solution Approach 1:

The patent extracts the knot-tying step from the suture locking process by introducing a separate suture locking device that secures sutures without requiring traditional knots. The device is delivered independently and applied to the suture to provide retention, eliminating the time-consuming multi-step knot-tying procedure while maintaining secure suture locking.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The suture locking device acts as an intermediary between the suture and the tissue, providing a mechanical means of retention without requiring the suture to form knots. The device mediates the locking function by engaging the suture and preventing slippage, thereby achieving reliable suture retention through a intermediate component rather than direct knot formation.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If traditional knot-tying methods are used for suture locking, then secure suture retention is achieved, but device complexity and procedural difficulty increase

Engineering Contradiction:
Improvesuture retentionVSAvoidprocedural complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts the locking function from the suture itself (which would normally require knots) and places it in a separate, dedicated device. This separation simplifies the overall procedure by allowing the suture to remain simple while the locking device handles the complexity of secure retention, reducing procedural difficulty.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The suture locking device is designed to be self-contained and self-operating, requiring minimal manipulation by the surgeon. The device can be delivered and deployed with simple actions, and it automatically secures the suture without requiring complex manual knot-tying maneuvers, thereby reducing procedural complexity while maintaining reliability.

Inventive Principle:
Principle #25Self-service

3Productivity

If suture locking devices are used to eliminate knots, then surgical time is reduced, but ease of operation in confined spaces deteriorates

Engineering Contradiction:
Improvesurgical efficiencyVSAvoidaccess in confined spaces
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The suture locking device is designed with a nested structure where components are contained within one another during delivery. The device can be collapsed or compressed to fit through small endoscopic channels, and then expanded or deployed at the target site, allowing easy access to confined spaces while maintaining the functionality to secure sutures efficiently.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The suture locking device incorporates dynamic elements that allow it to change shape or configuration between delivery and deployment states. The device can be flexible or collapsible during delivery to navigate confined spaces, and then becomes rigid or stable when deployed to perform the locking function, thereby improving ease of operation in confined spaces without sacrificing surgical efficiency.

Inventive Principle:
Principle #15Dynamics

4Productivity

If suture locking devices are used to eliminate knots, then surgical time is reduced, but device complexity increases

Engineering Contradiction:
Improvesurgical efficiencyVSAvoiddevice structure
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The suture locking device is segmented into distinct functional components, each performing a specific task. This segmentation allows the device to be delivered through small channels in a compressed state and then deployed in a controlled manner. The modular structure reduces the complexity of any single component while maintaining overall device functionality, thereby improving surgical efficiency without excessive device complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The suture locking device is designed to perform multiple functions within a single integrated structure. It can deliver the locking mechanism, secure the suture, and potentially provide additional functions such as tissue approximation or marking. This multi-functionality reduces the need for multiple separate devices or steps, thereby improving surgical efficiency while keeping the overall device complexity manageable through consolidation of functions.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

These devices reduce surgical time by eliminating the need for knots, improve ease of implantation in confined spaces, and provide accurate tensioning of sutures, enhancing the efficiency and precision of minimally invasive surgeries.

Implementation Method 1

The crimping assembly can be configured to plastically deform the suture clip such that the suture aperture is closed, at least substantially closed, or otherwise secures the suture line(s), while reducing or eliminating bending or buckling of the axial suture clip surfaces.

Methodology Applied
Scientific EffectPlastic deformation: Plasticity

Data Source

PatentUS12193661B2Suture clips, deployment devices therefor, and methods of use
Publication Date: 2025.01.14 EDWARDS LIFESCIENCES CORP
  • US12193661B2 patent drawing
  • US12193661B2 patent drawing
  • US12193661B2 patent drawing

AI summary

A device for deploying a suture clip onto a suture can include a proximal handle portion that includes an actuation mechanism. The device can also include an outer shaft defining an inner lumen. A crimping assembly can be at least partially disposed within a distal end of the outer shaft. The crimping assembly can include a plurality of crimping members configured to receive and radially compress a suture clip. The actuating mechanism can be configured to move the plurality of crimping members radially inwardly from a first position, where the crimping members are configured to receive a suture clip, to a second position where the plurality of crimping members are configured to radially compress the suture clip, causing the suture clip to plastically deform and become secured around one or more sutures.