Catheter-Based Heart Valve Suturing Device

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Solution Overview

Problem

Conventional suturing methods for heart valves are invasive, risky, and often require extensive procedures, leading to complications such as infection, pain, and delayed recovery, and are ineffective for valves with structural defects like regurgitation or incompetence.

Innovation Solution

Development of suturing devices with elongate bodies, deployable arms, and needles that can securely hold and deploy sutures within heart valves, allowing for minimally invasive procedures to repair or replace valve structures, such as the Alfieri technique, annuloplasty, and chordae tendineae management.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional suturing methods are used to close heart valve openings, then the valve can be repaired, but the procedure becomes invasive and carries high risk of infection, pain, and delayed recovery

Engineering Contradiction:
Improvevalve repair effectivenessVSAvoidinfection risk, pain, recovery time
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A catheter-based delivery system serves as an intermediary to transport the suturing device through the vasculature to the heart valve location, enabling minimally invasive access without requiring open chest surgery. The catheter acts as a mediator between the operator and the valve, allowing precise delivery of the suturing apparatus through existing vascular pathways.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces traditional mechanical open-chest surgical access with a minimally invasive catheter-based approach. Instead of making large incisions and stopping the heart, the system uses guided catheter delivery through blood vessels to reach the valve, substituting a less invasive mechanical pathway for the traditional surgical approach.

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

2Reliability

If conventional open-chest procedures are used to access heart valves, then the valve can be reached for repair, but the procedure requires stopping the heart and using heart-lung machines

Engineering Contradiction:
Improvevalve accessibilityVSAvoidprocedure complexity, equipment requirements
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The catheter serves as an intermediary pathway that allows access to the heart valve through the vascular system rather than requiring direct surgical access. This mediator enables the suturing device to reach the valve without needing to stop the heart or use complex heart-lung bypass machinery.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system segments the complex surgical procedure into separate components: catheter delivery through the vasculature, positioning of the suturing device at the valve, and execution of the suturing task. This segmentation allows each component to be optimized independently and eliminates the need for simultaneous heart stopping and complex support machinery.

Inventive Principle:
Principle #1Segmentation

3Ease of operation

If traditional suturing devices are used, then sutures can be placed in the valve, but the devices lack the precision and control needed for minimally invasive procedures

Engineering Contradiction:
Improvesuturing precisionVSAvoiddevice structure, control mechanisms
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The suturing device incorporates dynamic elements including rotatable arms that can be independently controlled, allowing precise angular positioning. The device transitions between different operational states (e.g., arm rotation, needle deployment, suture tightening) providing dynamic adaptability to the specific anatomical requirements of the valve while maintaining minimally invasive capabilities.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The device integrates multiple functions within a single system: the same catheter-based platform performs valve access, positioning, suturing, and device withdrawal. The rotatable arms and adjustable mechanisms provide universal applicability across different valve types and repair techniques, eliminating the need for multiple specialized devices.

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

Data Source

PatentUS20240108327A1Suturing devices and methods for suturing an anatomic valve
Publication Date: 2024.04.04 HEARTSTITCH
  • US20240108327A1 patent drawing
  • US20240108327A1 patent drawing
  • US20240108327A1 patent drawing

AI summary

Suturing apparatuses configured to suture biological tissue, such as an anatomical valve, are disclosed. The suturing apparatuses can include an elongate member having a proximal end, a distal end, one or more arms, and one or more needles. A protective member may be used to inhibit contact between a distal end of a needle and surrounding tissue. Methods for suturing bodily tissue such as an anatomical valve may be performed with the suturing apparatuses. The suturing apparatuses may be used to suture adjacent valve leaflets or the base of a valve in order to treat or repair the valve.