Heart Valve Positioning Using Dual Imaging Sensors

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Solution Overview

Problem

Current minimally invasive cardiac valve replacement procedures face challenges in accurately positioning prosthetic valves due to the need for precise alignment, centrality, and depth placement, often requiring control of valve placement in multiple degrees of motion using different imaging modalities, which can lead to procedural complications and inefficiencies.

Innovation Solution

A system comprising a first imaging sensor aligned with the primary plane of the heart valve annulus and a second imaging sensor aligned with the longitudinal axis, combined with a delivery arm and control system, allows for precise adjustment of the prosthetic valve's angle and centering within the native valve orifice, enabling orthogonal placement and depth setting using x-ray and ultrasound imaging.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a physician controls valve placement in multiple degrees of motion using different imaging modalities, then the valve can be positioned in various orientations, but the physician may lose position accuracy when switching between imaging modalities

Engineering Contradiction:
Improvecontrol of valve placement in multiple degrees of motionVSAvoidposition accuracy
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The patent combines multiple imaging modalities (fluoroscopy and ultrasound) into a single integrated imaging system that provides simultaneous multi-planar views. This merging eliminates the need to switch between different imaging devices, allowing the physician to maintain continuous visualization and control of the valve in multiple degrees of motion without losing position accuracy.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent introduces a third imaging dimension by combining fluoroscopy (providing orthogonal views) with ultrasound (providing longitudinal and transverse views). This multi-dimensional imaging approach gives comprehensive spatial information about the valve annulus, enabling accurate positioning in all three degrees of freedom while maintaining a stable reference frame throughout the procedure.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Ease of operation

If the prosthetic valve is placed off axis, then the valve can be positioned more easily, but turbulent blood flow and para-valvular leaks occur

Engineering Contradiction:
Improveease of valve placementVSAvoidturbulent blood flow and para-valvular leaks
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The patent employs real-time imaging feedback from both fluoroscopy and ultrasound to continuously monitor the valve's position and orientation during deployment. The system provides immediate visual feedback to the physician, allowing for precise adjustment of the delivery device to achieve optimal alignment with the native valve annulus, thereby preventing turbulent blood flow and para-valvular leaks while maintaining ease of operation.

Inventive Principle:
Principle #23Feedback

3Ease of manufacture

If the prosthetic valve is placed off center, then the valve deployment is simplified, but the valve may affect neighboring valves or the heart's conductive system

Engineering Contradiction:
Improvesimplicity of valve deploymentVSAvoidimpact on neighboring valves or conductive system
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent performs preliminary imaging and planning using combined fluoroscopy and ultrasound to identify the precise center of the native valve annulus and assess the spatial relationships with neighboring structures before valve deployment. This preliminary action allows the physician to pre-calculate the optimal delivery path and positioning parameters, ensuring that the prosthetic valve is placed concentrically without affecting neighboring valves or the conductive system, while still maintaining deployment simplicity.

Inventive Principle:
Principle #10Preliminary action

4Manufacturing precision

If the prosthetic valve is placed at the proper depth, then the valve function is optimized, but precise depth control requires complex multi-modality imaging coordination

Engineering Contradiction:
Improvedepth placement accuracyVSAvoidcomplexity of multi-modality imaging coordination
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent merges fluoroscopy and ultrasound imaging systems into a coordinated multi-modality platform that shares a common registration framework and control interface. This integration allows the physician to control depth placement by combining the depth information from ultrasound with the spatial orientation from fluoroscopy, achieving precise depth control without requiring separate complex coordination procedures for each imaging modality.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS11648112B2Method for positioning a heart valve
Publication Date: 2023.05.16 CEPHEA VALVE TECHNOLOGIES INC
  • US11648112B2 patent drawing
  • US11648112B2 patent drawing
  • US11648112B2 patent drawing

AI summary

Systems and methods for delivery a medical device to a heart valve annulus are disclosed. A method of delivering a medical device to a heart valve annulus includes: (1) aligning a first imaging sensor such that a view of the first imaging sensor is along a primary plane of the heart valve annulus; (2) aligning a second imaging sensor such that a view of the second imaging sensor is along a longitudinal axis of the heart valve annulus; (3) attaching a delivery system holding the medical device to a delivery arm; (4) adjusting the delivery arm to set an angle of the delivery system perpendicular to the primary plane using images from the first imaging sensor; (5) adjusting the delivery arm to center the delivery device in the heart valve annulus using images from the second imaging sensor; and (6) deploying the medical device into the heart valve annulus.