Implant Retention String for Cardiac Delivery

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Solution Overview

Problem

Current percutaneous delivery systems for cardiac implants face challenges in accurately assessing the deployment status of implants in the atrial septum without distortion, leading to potential improper deployment and the need for retrieval mechanisms to prevent embolization.

Innovation Solution

A delivery system with an implant retention mechanism, including flexible and rigid retention strings or wires, that allows for assessment of implant deployment without distortion and facilitates secure retention and retrieval of the implant, using mechanisms like exploding knots or shape memory properties to ensure accurate positioning and release.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the implant is deployed from the delivery system at an acute angle to the atrial septum, then the implant can be delivered percutaneously through the right heart catheterization procedure, but the implant deployment position becomes distorted by the strain imposed by the delivery system

Engineering Contradiction:

Improvepercutaneous deliveryVSAvoidimplant deployment position

Core Design Contradiction:

Ease of operationVSManufacturing precision

Solution Approach 1:

A retention string is introduced as an intermediary element that connects the implant to the delivery system. This string allows the implant to be delivered percutaneously while maintaining a direct line of pull to the implant, enabling the clinician to assess and control the true deployment position independent of the delivery system's acute angle strain.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the traditional mechanical constraint system (where the delivery system directly holds the implant) with a string-based retention system. This substitution allows for more accurate positioning assessment because the string can be pulled taut to eliminate distortion, providing a direct mechanical link to the implant that is independent of the delivery system's geometry.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Stability of the object's composition

If the implant is released from the delivery system, then the distorted septum can resume its natural state, but the implant deployment position may change and require retrieval

Engineering Contradiction:

Improveseptum natural stateVSAvoidimplant deployment accuracy

Core Design Contradiction:

Stability of the object's compositionVSReliability

Solution Approach 1:

The retention string provides continuous feedback to the clinician about the implant's true deployment position. By maintaining a direct mechanical connection to the implant, the string allows real-time assessment of deployment accuracy even after release, enabling the clinician to detect and correct positioning issues before the septum fully resumes its natural state.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The retention string is established in place before the implant is released from the delivery system. This preliminary action ensures that the clinician has immediate control over the implant's position upon release, allowing for assessment and adjustment before the septum's natural state changes cause permanent positioning errors.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If a separate implant retrieval mechanism is used, then the implant can be retrieved to prevent embolization, but the device complexity increases

Engineering Contradiction:

Improveembolization preventionVSAvoidretrieval mechanism

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The retention string is designed to serve multiple functions: it retains the implant during delivery, allows assessment of deployment accuracy, and enables retrieval if needed. This multi-functionality eliminates the need for separate retrieval mechanisms, reducing overall device complexity while maintaining reliable embolization prevention through the same simple string structure.

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

Enables confident assessment and secure deployment of cardiac implants, reducing the risk of improper positioning and embolization, while allowing for retrieval if necessary, thereby improving the efficacy of cardiac implant placement procedures.

Implementation Method 1

The implant comprises a generally cylindrical body portion, a pair of generally annular distal flags, a pair of generally annular proximal flags, and a shape memory alloy wire

Methodology Applied

Scientific EffectShape memory effect: Shape Memory Alloy

Implementation Method 2

self-expanding implant

Methodology Applied

Scientific EffectElastic recovery: Elastic Recovery

Data Source

PatentUS10588611B2Implant retention attachment and method of use

Publication Date: 2020.03.17 CORVIA MEDICAL INC

AI summary

The present teachings generally relate a delivery system having an implant retention mechanism. Specifically, the delivery system includes a delivery sheath, a delivery catheter, and a flexible or a rigid implant retention mechanism. The flexible implant retention mechanism includes an implant retention string having a fixed end and a free end where the free end extends from the fixed end, crosses a retention outlet of an implant, and extends proximally through a lumen of the delivery sheath. The rigid implant retention mechanism includes an implant retention wire having a fixed end and a free end where the free end extends from the fixed end, crosses a retention outlet of an implant, and extends proximally through a lumen of the delivery sheath.