Vascular Branch Characterization for Cardiac Lead Placement

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Solution Overview

Problem

The challenge in cardiac resynchronization therapy is the difficulty in navigating and placing a left ventricular pacing lead in the left ventricle due to variable venous anatomy, which can lead to complications such as dissection or perforation, and the inability to determine a priori whether a lead will fit well within a particular branch.

Innovation Solution

A method and device for characterizing a region of interest within the body using a sensor to measure position and orientation data, generating geometric data sets that include length, bifurcation location, angle, and curvature characteristics, and estimating dimensions such as diameter and tortuosity to aid in selecting the appropriate lead and implantation site.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Difficulty of detecting and measuring

If fluoroscopic imaging is used to guide lead implantation, then real-time visualization of the lead position is achieved, but the patient and clinician are exposed to extensive fluoroscopic radiation

Engineering Contradiction:
Improvelead position visualizationVSAvoidfluoroscopic radiation exposure
Core Design Contradiction:
Difficulty of detecting and measuringVSObject-affected harmful factors

Solution Approach 1:

The system performs preliminary 3D mapping of the coronary venous anatomy before lead implantation. By acquiring position data from catheters or guidewires and generating a three-dimensional map of the venous branches in advance, the system enables selection of appropriate lead size and target site without requiring extensive fluoroscopic imaging during the actual implantation procedure.

Inventive Principle:
Principle #10Preliminary action

2Productivity

If lead implantation is performed without prior venous characterization, then the procedure can be completed quickly, but the ability to determine a priori whether a lead will fit well within a particular branch is lost

Engineering Contradiction:
Improveimplantation procedure speedVSAvoidvenous anatomy information
Core Design Contradiction:
ProductivityVSLoss of information

Solution Approach 1:

The system performs preliminary 3D mapping of the coronary venous anatomy before lead implantation. By acquiring position data from catheters or guidewires and generating a three-dimensional map of the venous branches in advance, the system enables selection of appropriate lead size and target site without requiring extensive fluoroscopic imaging during the actual implantation procedure.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system creates a three-dimensional digital copy or map of the patient's coronary venous anatomy based on position data acquired during a preliminary mapping procedure. This digital replica allows the physician to visualize branch dimensions, angles, and tortuosity, and to simulate lead placement before the actual implantation, thereby preserving venous anatomy information for future reference.

Inventive Principle:
Principle #26Copying

3Adaptability or versatility

If the venous anatomy is highly variable with sharp or acute takeoff angles, then anatomical diversity is accommodated, but the possibility of complications such as dissection or perforation increases

Engineering Contradiction:
Improveanatomical variation accommodationVSAvoidprocedure safety
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The system performs preliminary 3D mapping of the coronary venous anatomy before lead implantation. By acquiring position data from catheters or guidewires and generating a three-dimensional map of the venous branches in advance, the system enables selection of appropriate lead size and target site without requiring extensive fluoroscopic imaging during the actual implantation procedure.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system provides detailed three-dimensional information about specific local characteristics of the venous anatomy, including branch diameter, takeoff angles, and curvature at each segment. This localized information allows the physician to identify segments with sharp angles or small diameters that may be prone to complications and to select alternative target sites with more favorable anatomy.

Inventive Principle:
Principle #3Local quality

4Adaptability or versatility

If multiple lead models with different lengths and diameters are available, then lead selection flexibility is improved, but the ability to determine before implantation whether a particular lead will fit in a particular branch is reduced

Engineering Contradiction:
Improvelead model selectionVSAvoidlead fitting determination
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system creates a three-dimensional digital copy or map of the patient's coronary venous anatomy based on position data acquired during a preliminary mapping procedure. This digital replica allows the physician to visualize branch dimensions, angles, and tortuosity, and to simulate lead placement before the actual implantation, thereby preserving venous anatomy information for future reference.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The system provides feedback by comparing the dimensions and characteristics of available lead models with the measured venous branch characteristics from the 3D map. This allows the physician to determine in advance which lead models are appropriate for each branch, reducing the need for trial-and-error implantation and minimizing the complexity of lead selection.

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS11426081B2Vascular branch characterization
Publication Date: 2022.08.30 PACESETTER INC
  • US11426081B2 patent drawing
  • US11426081B2 patent drawing
  • US11426081B2 patent drawing

AI summary

An apparatus and method for characterizing a region of interest (ROI) including measuring position and orientation data within the ROI; and generating a geometric data set to include one or more of: length, bifurcation location, angle and curvature characteristics of the ROI. Also, sequentially taking an image of a tool within the ROI; comparing tool dimensions with ROI dimensions; and estimating diameter, length, take-off angle, and/or tortuosity characteristics based on the comparisons.