Steerable Imaging Element for Cardiac Device Placement

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current medical devices for treating heart valve incompetency face challenges in visualization and imaging during minimally-invasive procedures, particularly in maintaining a non-skewed, unblocked view of the implant site and accurately positioning and anchoring devices like annuloplasty devices at the mitral valve annulus.

Innovation Solution

A visualization/imaging system integrated with the implantable device, featuring a flexible elongate member with a movable imaging element that can alter its angle and position relative to the implant site, allowing for enhanced visualization and imaging during delivery and deployment, and includes a steering mechanism for optimal positioning without external force.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a fixed imaging system is used during device delivery, then the system structure is simple, but the visualization quality deteriorates due to skewed or blocked views of the implant site

Engineering Contradiction:

Improvesystem structureVSAvoidvisualization quality

Core Design Contradiction:

Device complexityVSMeasurement precision

Solution Approach 1:

The imaging system incorporates a flexible elongate member with an imaging element that can dynamically change its angular position and orientation relative to the implantable device and implant site. This dynamic positioning capability allows the imaging element to maintain optimal viewing angles throughout the delivery and deployment process, preventing skewed or blocked views while enabling high-quality visualization of the implant site and device configuration.

Inventive Principle:

Principle #15Dynamics

2Device complexity

If the imaging element position is fixed relative to the device, then the device structure is simpler, but the ability to maintain centered/coaxial view deteriorates

Engineering Contradiction:

Improvedevice structureVSAvoidviewing alignment

Core Design Contradiction:

Device complexityVSEase of operation

Solution Approach 1:

The imaging element is mounted on a flexible elongate member that allows dynamic adjustment of the imaging element's angular position. This enables the operator to actively maintain centered, coaxial, and unblocked views of the implant site during device delivery and deployment, significantly improving viewing alignment compared to a fixed imaging element configuration.

Inventive Principle:

Principle #15Dynamics

3Measurement precision

If a movable imaging element on flexible elongate member is used, then the visualization capability is improved, but the device complexity increases

Engineering Contradiction:

Improveimaging accuracyVSAvoidsystem structure

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The imaging element is mounted on a flexible elongate member that can be steered and positioned without requiring complex mechanical actuation systems. The flexibility of the elongate member allows it to navigate through the delivery system and position the imaging element accurately at the implant site, achieving high imaging accuracy while keeping the overall system structure relatively simple compared to rigid, mechanically actuated imaging systems.

Inventive Principle:

Principle #30Flexible shells and thin films

4Measurement precision

If external force is applied to position the imaging element, then the positioning precision is improved, but the ease of operation deteriorates due to additional control complexity

Engineering Contradiction:

Improvepositioning precisionVSAvoidcontrol simplicity

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The flexible elongate member is designed to be self-steering or easily steerable through the delivery system without requiring complex external actuation mechanisms. The member can navigate and position the imaging element through its inherent flexibility and compliance, allowing it to conform to the delivery path and automatically achieve optimal positioning at the implant site, thereby maintaining positioning precision while preserving operational simplicity.

Inventive Principle:

Principle #25Self-service

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

This system facilitates clearer and more accurate imaging, improving the precision and efficiency of device placement and anchoring, reducing procedural time and associated risks, and enabling better visualization of the implant site and device configuration.

Implementation Method 1

The flexible elongate member may include at least one shape memory section such that bending of the flexible portion of the flexible elongate member is achieved without application of external force to the flexible elongate member

Methodology Applied

Scientific EffectElasticity: Elasticity

Implementation Method 2

Methodology Applied

Scientific EffectShape memory: Shape Memory Alloy

Data Source

PatentUS20220378578A1Devices, systems, and methods for imaging and implanting cardiac devices

Publication Date: 2022.12.01 BOSTON SCIENTIFIC SCIMED INC

AI summary

Devices, systems, and methods for delivering various implantable devices, such as heart valve implants, with the use of a steerable imaging element are described. An imaging element is positioned adjacent the implantable device and implant site, a relationship between the implantable device and the implant site is visualized and/or imaged, and the implantable device is anchored and/or adjusted with reference to the visualization and/or imaging thereof.