Suturing Device with Segmented Arms for Minimally Invasive Cardiac Closure

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Solution Overview

Problem

Conventional suturing methods for closing openings in the heart, such as punctures, often require invasive procedures that can lead to complications like infection, delayed recovery, and increased pain, and may not effectively maintain haemostasis, especially when accessing the heart through the pericardial sac.

Innovation Solution

A suturing device with suture arms and needles that can be extended and retracted to place sutures through the heart wall without penetrating the pericardium, maintaining haemostasis by creating a space for blood collection outside the heart and using negative pressure to drain blood, allowing for minimally invasive procedures and reducing the risk of cardiac tamponade.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional suturing methods are used to close openings in the heart, then the opening can be closed, but invasive procedures are required that lead to infection risk, delayed recovery, and increased pain

Engineering Contradiction:
Improveeffectiveness of closing openingVSAvoidinfection risk, pain, recovery delay
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device segments the suturing function into multiple suture arms (first, second, third, and fourth suture arms) that can independently deploy needles and place sutures at different locations around the opening, allowing comprehensive closure while maintaining a single minimally invasive access point

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device employs nested structures where needles are retractable within the suture arms, and the entire suture arm assembly can be deployed from and retracted into the catheter body, enabling complex functionality through a single minimally invasive access point

Inventive Principle:
Principle #7Nested doll (Nesting)

2Reliability

If conventional suturing methods are used, then openings can be closed, but haemostasis is not effectively maintained, especially when accessing through the pericardial sac

Engineering Contradiction:
Improvehaemostasis maintenanceVSAvoidblood collection between pericardium and heart wall
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The device places sutures around the opening before removing the catheter, and can deploy occlusion elements or expandable structures to seal the opening preliminarily, ensuring haemostasis is established before the access route is removed

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The device introduces intermediary elements such as occlusion balloons, expandable cages, or surgical patches that can be deployed at the opening site to maintain haemostasis and prevent blood collection between the pericardium and heart wall

Inventive Principle:
Principle #24Intermediary (Mediator)

3Device complexity

If a single suture arm is used, then device complexity is reduced, but the ability to suture multiple locations around the opening is limited

Engineering Contradiction:
Improvenumber of suture armsVSAvoidability to suture multiple locations
Core Design Contradiction:
Device complexityVSAdaptability or versatility

Solution Approach 1:

Each suture arm is designed as a universal module capable of independent deployment and retraction, with identical needle and suture placement functionality, allowing the system to adapt to different suture patterns and opening sizes by activating different combinations of arms

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

Data Source

PatentEP3597115B1Suturing devices for suturing an anatomic structure
Publication Date: 2025.01.15 HEARTSTITCH
  • EP3597115B1 patent drawingFigure 1A
  • EP3597115B1 patent drawingFigure 1B
  • EP3597115B1 patent drawingFigure 2

AI summary

Suturing devices and systems used to close openings into a biological structure. The suturing device can comprise an elongate member having a proximal end, a distal end, one or more arms, and one or more needles. One or more sheaths may be used with the device to maintain or substantially maintain haemostasis while the device is used and while a procedure is performed in the biological structure.