Balloon-Stabilized Transseptal Puncture Device

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Solution Overview

Problem

Current cardiac catheterization techniques face challenges in precisely and safely puncturing the interatrial septum to access the left atrium, often resulting in accidental damage and requiring complex instruments that lack precision.

Innovation Solution

A transseptal insertion device with a sheath, balloon, and dilator system that inflates to prevent accidental punctures, stabilizes the septum, and uses RF energy for precise puncturing without needles, allowing for controlled access to the left atrium.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional puncturing instruments are used to access the left atrium, then the procedure can be performed, but the precision and safety of puncturing the interatrial septum deteriorates, leading to accidental damage

Engineering Contradiction:

Improvesafety of transseptal punctureVSAvoidprecision of puncture location

Core Design Contradiction:

ReliabilityVSMeasurement precision

Solution Approach 1:

The balloon is inflated before puncture to stabilize the interatrial septum and create a safe landing zone, preventing accidental puncture of surrounding structures. This preliminary stabilization action ensures both safety and precision during the subsequent puncture procedure

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The balloon acts as an intermediary device between the puncturing instrument and the interatrial septum, providing stabilization and protection while enabling precise positioning and safe puncture of the target tissue

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If complicated instruments are used for transseptal puncture, then various challenges can be addressed, but the device complexity increases and precision is not guaranteed

Engineering Contradiction:

Improvesafety of transseptal punctureVSAvoidcomplexity of puncturing instruments

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The device combines the balloon stabilization function and the puncture guidance function into a single integrated transseptal insertion device, reducing overall complexity while maintaining safety and precision capabilities

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The transseptal insertion device performs multiple functions including septum stabilization, puncture guidance, and post-puncture catheter delivery through a single integrated system, eliminating the need for multiple separate complicated instruments

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Object-affected harmful factors

If extreme precision is required for transseptal puncture, then accidental damage can be avoided, but the procedure time and complexity increase

Engineering Contradiction:

Improveaccidental puncture damageVSAvoidprocedure time

Core Design Contradiction:

Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The balloon is inflated in advance to create a stable, protected target zone on the interatrial septum, which accelerates the puncture process by eliminating the need for repeated positioning adjustments and reduces overall procedure time while maintaining safety

Inventive Principle:

Principle #10Preliminary action

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

Facilitates quick and safe transseptal puncturing, reducing the risk of accidental damage and improving precision, enabling effective access to the left atrium for interventions.

Implementation Method 1

a balloon that is connected to the distal end of the sheath, in which the balloon, when inflated and the transseptal insertion device is in use, overhangs and extends past the distal end of the sheath, preventing accidental puncturing of the cardiac interatrial septum and stabilizing the transseptal insertion device against fossa ovalis of the cardiac interatrial septum

Methodology Applied

Scientific EffectMechanical stabilization:

Implementation Method 2

a dilator that is positioned within the at least one lumen when the transseptal insertion device is in use. The dilator has a distal end and is designed to and is capable of precisely puncturing the cardiac interatrial septum without the use of a needle or other sharp instrument

Methodology Applied

Scientific EffectMechanical puncture:

Data Source

PatentEP3658045B1Directional balloon transseptal insertion device for medical procedures

Publication Date: 2024.04.24 EAST END MEDICAL LLC

Figure 1A~1B
Figure 1C
Figure 2

AI summary

A transseptal insertion device suitable for facilitating precise and safe transseptal puncture of a cardiac interatrial septum includes a sheath (12) that defines a lumen and has a distal end that is closest to the cardiac interatrial septum of a patient and a proximal end that is external to the patent, a balloon (14) that is connected to the distal end of the sheath (12), in which the balloon (14), when inflated, overhangs and extends past the distal end of the sheath (12), preventing accidental puncturing of the cardiac interatrial septum and stabilizing the transseptal insertion device against fossa ovalis of the cardiac interatrial septum, and a dilator (16) that is positioned within the at least one lumen. The dilator (16) has a distal end and is designed to and is capable of precisely puncturing the cardiac interatrial septum without the use of a needle or other sharp instrument.