Implantable coaptation assist devices with sensors and associated systems and methods

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Solution Overview

Problem

Current treatments for mitral valve regurgitation, such as surgical procedures and valve replacements, are invasive, painful, and require long recovery periods, and are highly dependent on the skill of the cardiac surgeon, with risks of improper device placement and limited radial support from surrounding tissue.

Innovation Solution

Implantable coaptation assist devices with sensors that include a coaptation structure to re-establish leaflet coaptation and fixation members for anchoring, combined with sensors for real-time monitoring of cardiac function and device functionality, allowing for minimally invasive deployment and wireless communication of data.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical procedures or valve replacements are used to treat mitral valve regurgitation, then effective treatment is achieved, but the treatment becomes invasive, painful, and requires long recovery periods

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidinvasiveness and patient morbidity

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device is divided into separate functional components: a coaptation structure with fixation members for mechanical repair, and integrated sensors for monitoring. This segmentation allows the mechanical function to be performed minimally invasively while the sensing function provides post-implantation monitoring capability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The coaptation assist device acts as an intermediary between the damaged native valve and the patient's cardiovascular system, providing mechanical support to restore valve function without requiring complete valve replacement, thereby reducing surgical invasiveness.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If traditional repair procedures are used, then valve repair is achieved, but the procedures are highly dependent on surgeon skill with risks of improper device placement

Engineering Contradiction:

Improvevalve repair effectivenessVSAvoidprocedure complexity and surgeon dependency

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The integrated sensors provide real-time feedback on valve function, leaflet coaptation, and hemodynamic parameters after implantation. This feedback mechanism allows for verification of proper device placement and function, reducing dependency on surgeon skill for assessing procedural success.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The device replaces complex manual surgical techniques with a standardized implantable structure that provides consistent mechanical support for leaflet coaptation, reducing variability associated with different surgical skills.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Strength

If annular or peri-annular rings are implanted for cinching, then annulus reinforcement is achieved, but the device lacks real-time monitoring capability

Engineering Contradiction:

Improveannular supportVSAvoidlack of functional monitoring data

Core Design Contradiction:

StrengthVSLoss of information

Solution Approach 1:

The patent merges the mechanical reinforcement function (coaptation structure with fixation members) and the monitoring function (integrated sensors) into a single hybrid device, allowing both annular support and real-time functional monitoring to be achieved simultaneously.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The device performs multiple functions: providing mechanical support for leaflet coaptation, anchoring to the annulus or surrounding tissue, and monitoring valve function and hemodynamics through integrated sensors, making it a multi-functional universal solution.

Inventive Principle:

Principle #6Universality (Multi-functionality)

4Reliability

If complete valve replacement is performed, then valve dysfunction is resolved, but the procedure becomes highly invasive with significant morbidity and long recovery

Engineering Contradiction:

Improvevalve function restorationVSAvoidsurgical trauma and recovery time

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts only the essential repair function (leaflet coaptation assistance) from complete valve replacement, creating a less invasive device that addresses the specific pathology without requiring removal of the native valve, thereby reducing surgical trauma.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

Instead of replacing the entire valve (traditional approach), the invention uses the native valve structure and adds a minimally invasive coaptation assist device that works with the existing anatomy, inverting the traditional replacement paradigm.

Inventive Principle:

Principle #13The other way round (Inversion)

Data Source

PatentUS12390331B2Implantable coaptation assist devices with sensors and associated systems and methods

Publication Date: 2025.08.19 MEDTRONIC INC

AI summary

Coaptation assist device for repairing cardiac valves and associated systems and methods are disclosed herein. A coaptation assist device configured in accordance with embodiments of the present technology can include, for example, a fixation member configured to press against cardiac tissue proximate to a native valve annulus, and a stationary coaptation structure extending away from the fixation member. The coaptation structure can include an anterior surface configured to coapt with a first native leaflet during systole and a posterior surface configured to displace at least a portion of a second native leaflet. The device also includes at least one sensor configured to detect parameters associated with at least one of cardiac function and device functionality. The sensors can be pressure sensors configured to detect left atrial pressure and/or left ventricular pressure.