Removable Coronary Sinus Displacement Unit for Mitral Valve Repair

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Solution Overview

Problem

Existing annuloplasty devices implanted in the coronary sinus for treating defective mitral valves are less effective in retaining the desired geometry, require complex and difficult procedures, and can cause traumatic effects on the anatomy, leading to potential long-term complications and increased patient risk.

Innovation Solution

A removable and flexible elongate displacement unit with a proximal reversibly expandable portion and a distal anchoring portion that can be temporarily activated to modify the shape of the mitral valve annulus, featuring a lumen with distal and proximal openings to facilitate blood flow and minimize trauma, and a helix-shaped loop structure for permanent fixation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If permanent implants are introduced into the coronary sinus to replace annuloplasty rings, then the valve geometry can be maintained, but the implants cause traumatic effects on the coronary sinus and require lengthy implantation time

Engineering Contradiction:

Improvevalve geometry retentionVSAvoidtraumatic effects on coronary sinus

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The patent employs a dynamic, temporary implant that is inserted into the coronary sinus only during the valve repair procedure and then removed. This temporary implant provides the necessary geometric support during surgery without causing long-term traumatic effects on the coronary sinus anatomy, resolving the contradiction between maintaining valve geometry and avoiding permanent trauma.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The implant is positioned in the coronary sinus beforehand to establish the correct valve geometry during the repair procedure, and then removed after the repair is complete. This preliminary action ensures proper geometric support is available when needed while avoiding prolonged presence that would cause trauma.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If complex devices are deployed in the coronary sinus to ensure correct function over time, then valve function can be maintained, but the procedure becomes difficult to operate and requires frequent adjustment

Engineering Contradiction:

Improvevalve function maintenanceVSAvoidprocedure complexity

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The device is designed as a simple, temporary structure that provides reliable geometric support during the brief period it is implanted. Its simplicity makes the procedure easy to operate and eliminates the need for frequent adjustments or complex operational mechanisms, while still maintaining valve function during the critical repair period.

Inventive Principle:

Principle #15Dynamics

3Stability of the object's composition

If fixation structures are used to ensure correct position of the device in the coronary sinus over time, then device positioning can be maintained, but traumatic effects on the coronary sinus increase

Engineering Contradiction:

Improvedevice positioningVSAvoidtraumatic effects on coronary sinus

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The device uses temporary fixation structures that provide sufficient positioning stability during the implantation procedure and valve repair, but are designed to be removed afterward. This dynamic approach maintains device positioning when needed while eliminating long-term fixation-related trauma to the coronary sinus.

Inventive Principle:

Principle #15Dynamics

4Object-affected harmful factors

If the displacement unit is made flexible and removable for temporary insertion, then atraumatic engagement is achieved, but the device complexity increases

Engineering Contradiction:

Improveatraumatic engagementVSAvoiddevice structure

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The displacement unit employs a flexible structure that can be inserted through a catheter and expanded within the coronary sinus to provide gentle,atraumatic engagement with the surrounding tissue. This flexibility allows the device to conform to the anatomy without causing damage, while the overall design remains relatively simple and removable.

Inventive Principle:

Principle #30Flexible shells and thin films

Data Source

PatentUS11793641B2Medical system for annuloplasty

Publication Date: 2023.10.24 HVR CARDIO OY

AI summary

An annuloplasty device is disclosed for treating a defective mitral valve having an annulus, comprising a removable and flexible elongate displacement unit for temporary insertion into a coronary sinus (CS) adjacent the valve, wherein the displacement unit has a delivery state for delivery into the CS, and an activated state to which the displacement unit is temporarily and reversibly transferable from said delivery state, the displacement unit comprises a proximal reversibly expandable portion, a distal anchoring portion being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to said activated state in which the shape of the annulus is modified to a modified shape, wherein the proximal expandable portion is reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS.