Expandable Balloon for Anatomical Landmark Identification

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Solution Overview

Problem

Current methods for implanting left bundle branch pacing leads are inaccurate and impractical due to difficulties in visualizing anatomical landmarks during procedures, leading to complications such as lead-induced tricuspid regurgitation and high pacing thresholds.

Innovation Solution

A method using an expandable balloon attached to a delivery sheath, which is advanced across the tricuspid valve to identify anatomical landmarks like the moderator band and inlet septum through X-ray or fluoroscopy, allowing precise placement of pacing leads within the right ventricle.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If fluoroscopy is used to guide lead placement, then the procedure can be performed, but anatomical landmarks are difficult to visualize leading to inaccurate placement

Engineering Contradiction:

Improveanatomical landmark identification accuracyVSAvoidvisualizability of anatomical landmarks

Core Design Contradiction:

Measurement precisionVSDifficulty of detecting and measuring

Solution Approach 1:

A radiopaque marker is introduced as an intermediary object that can be clearly visualized via fluoroscopy. This marker is positioned at a known anatomical location (tricuspid annulus) to serve as a reference point, enabling indirect identification of other anatomical landmarks through spatial relationships rather than direct visualization of the landmarks themselves.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The radiopaque marker creates a visual copy or surrogate representation of the tricuspid annulus location. Instead of directly visualizing the soft tissue annulus, the marker provides a radiographic copy that can be detected with standard fluoroscopy, allowing operators to use this surrogate to guide lead placement accurately.

Inventive Principle:

Principle #26Copying

2Reliability

If the lead is placed deep into the interventricular septum to achieve left bundle pacing, then pacing synchronization is improved, but the risk of lead-induced tricuspid regurgitation increases

Engineering Contradiction:

Improvepacing synchronizationVSAvoidtricuspid regurgitation risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The radiopaque marker is positioned at the tricuspid annulus before lead insertion to establish a reference point. This preliminary positioning allows the operator to plan the lead trajectory in advance, calculating the optimal depth and angle to reach the left bundle branch while maintaining a safe distance from the tricuspid valve plane, thereby preventing regurgitation before it occurs.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The radiopaque marker provides continuous visual feedback during the procedure. As the lead is advanced, the operator can monitor its position relative to the marker, ensuring the lead does not penetrate too deeply or at too steep an angle, which would risk damaging the tricuspid valve and causing regurgitation.

Inventive Principle:

Principle #23Feedback

3Measurement precision

If real-time ultrasound imaging is used to identify anatomical landmarks, then landmark visualization is improved, but the procedure becomes more expensive and less practical

Engineering Contradiction:

Improveanatomical landmark identification accuracyVSAvoidimaging system complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

Instead of using expensive, complex real-time ultrasound imaging systems, the invention employs a simple, inexpensive radiopaque marker that works with standard fluoroscopy equipment. This disposable-like approach (the marker is a simple component) provides sufficient anatomical reference information without requiring advanced imaging technology, reducing overall procedure cost and complexity.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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 approach enables safer and more accurate placement of pacing leads, reducing the risk of tricuspid regurgitation and improving long-term pacing efficiency by clearly visualizing anatomical structures and avoiding damage to the tricuspid valve.

Implementation Method 1

A moderator band (especially its septal attachment) or an anterior papillary muscle or the trabeculum septomarginalis is identified by the deformation of one or more balloons, using X-ray or fluoroscopy.

Methodology Applied

Scientific EffectDeformation: Deformation

Implementation Method 2

Methodology Applied

Scientific EffectX-ray: X-Ray

Data Source

PatentUS20240407855A1Systems and methods for identifying anatomical landmarks inside a human body for placement of a medical device

Publication Date: 2024.12.12 KRISHNAN SUBRAMANIAM C

AI summary

A method for identifying an anatomical landmark inside a human body for lead fixation of a medical device. One or more balloons are inflated using air or fluid. A delivery sheath having a distal end attached to the one or more balloons is advanced across a tricuspid valve to a right ventricle. A moderator band or an anterior papillary muscle is identified by the one or more balloons, using X-ray or fluoroscopy. The one or more balloons is then moved to be adjacent to a smooth portion of an inlet septum using the delivery sheath or inflation of the one or more balloons. Using X-ray or fluoroscopy, compression or deformation of the one or more balloons is visualized when an outer curvature and/or a distal pole of the one or more balloons contacts the inlet septum. Using a lumen of the delivery sheath, a lead of a medical device is advanced into the inlet septum.