Helical Tissue Attaching Device for Suture-Free Conduit Insertion

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Solution Overview

Problem

Current conduit systems for heart surgery, particularly for procedures like apicoaortic conduit (AAC) insertion, are invasive and difficult due to the need for sutures in active cardiac and vascular tissue, leading to complications such as bleeding and increased mortality.

Innovation Solution

A system with a helical attaching device that advances along a helical path through the tissue wall, creating inward pressure to secure a conduit connector or port, and a method to assess tissue elasticity for safe insertion, reducing the need for sutures and minimizing invasive procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional conduit systems are used for heart surgery, then access to the cardiac cavity can be obtained, but the procedure becomes highly invasive requiring sutures in active cardiac tissue, leading to bleeding complications and increased mortality

Engineering Contradiction:
Improvesafety of conduit insertionVSAvoidinvasiveness of procedure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The conduit system is divided into separate components: an outer tube for initial access, an inner tube for fluid communication, and a sealing element. This segmentation allows each component to perform its specific function with minimal tissue disruption, eliminating the need for complex suture placement in active cardiac tissue.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces an intermediary sealing element that mediates between the conduit system and the tissue wall. This sealing element creates a fluid-tight barrier without requiring direct suturing of the tissue, thereby reducing invasiveness while maintaining reliability of the conduit insertion.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Strength

If sutures are used to secure conduits in active cardiac tissue, then the conduit can be anchored, but bleeding complications occur and mortality increases

Engineering Contradiction:
Improveanchoring strength of conduitVSAvoidbleeding complications
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the traditional mechanical suture system with a sealing element-based anchoring system. The sealing element provides both sealing and anchoring functions through its structural design, eliminating the need for sutures that cause tissue trauma and bleeding while maintaining sufficient anchoring strength.

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

Solution Approach 2:

The sealing element is designed with specific geometric parameters (frustoconical shape, angled surface) that optimize its interaction with the tissue wall. By changing the structural parameters of the sealing element, the system achieves strong anchoring without the harmful effects of sutures, reducing bleeding complications.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If highly invasive procedures are performed to maintain organ function during surgery, then control of fluid within the organ is achieved, but the procedure complexity and patient risk increase

Engineering Contradiction:
Improvecontrol of fluid within organVSAvoidease of surgical procedure
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The sealing element serves multiple functions simultaneously: it provides fluid sealing, anchors the conduit system, and maintains tissue integrity. This multi-functionality allows for effective fluid control within the organ while simplifying the surgical procedure by eliminating the need for separate anchoring and sealing steps.

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

The system simplifies beating heart treatments by reducing cardiopulmonary bypass and global cardiac ischemia effects, improving the ease and safety of conduit insertion, and reducing bleeding complications.

Implementation Method 1

an attaching device extending from a distal end of the outer tube. The attaching device is configured for advancing along a helical path at least partially through the tissue wall

Methodology Applied
Scientific EffectHelical motion: Helix

Implementation Method 2

the attaching device may define a radially-expanding helix as the attaching device extends away from the distal end of the outer tube. In such configuration the insertion of the radially expanding helix within the tissue will create inward pressure or contraction of said tissue within the circumference of the coil.

Methodology Applied
Scientific EffectRadial expansion: Compression

Data Source

PatentUS11116542B2Systems and methods for percutaneous access, stabilization and closure of organs
Publication Date: 2021.09.14 APICA CARDIOVASCULAR
  • US11116542B2 patent drawing
  • US11116542B2 patent drawing
  • US11116542B2 patent drawing

AI summary

Systems and methods for accessing, stabilizing and sealing a device attached to a tissue surface comprising a tissue attaching device having an outer base ring defining an opening therethrough and a distally projecting tissue attachment element. The systems variously utilize annular sealing flanges distally attached to the outer base ring outside or inside the tissue attachment element to create a fluid tight seal. The systems variously utilize coils with regions of differing pitch to create sealing tissue pressure. Methods for installing an apical attaching device with a transapical port into a patient, comprising assessing the patient's viability for installation of the apical attaching device by determining an Index of Tissue Elasticity (ITE).