Transseptal Access Device Using Negative Pressure Suction

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Solution Overview

Problem

Current transseptal access methods often face difficulties due to fibrosed tissue, leading to complications such as puncture of the opposite atrial wall and increased risk of perforation, especially in cases where significant pressure is required to advance the needle through heavily fibrotic septums.

Innovation Solution

A device with a flared distal end and a funnel-shaped polymer element that applies negative pressure to pull the septal tissue towards a stationary needle, reducing the need for positive pressure and minimizing the risk of perforation, and allowing for safer access to the left atrium.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If significant pressure is applied to advance the needle through heavily fibrotic septums, then access to the left atrium is achieved, but the risk of puncturing the opposite atrial wall increases

Engineering Contradiction:

Improveaccess achievementVSAvoidopposite wall puncture risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

Instead of advancing the needle forward through the septum, the invention inverts the approach by maintaining a stationary needle and pulling the septal tissue backward over the needle using negative pressure applied through a funnel-shaped element. This reversal eliminates the need for forceful forward advancement and reduces the risk of perforating the opposite atrial wall.

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The invention replaces the traditional mechanical pushing system with a negative pressure suction system. A vacuum source is connected to the funnel to create negative pressure that draws the fibrotic septal tissue toward the stationary needle, enabling penetration without the need for significant forward force that could cause opposite wall puncture.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If the sheath and dilator are pushed forward to penetrate the septum, then transseptal access is obtained, but the tissue tension increases causing further tenting and stress on the target tissue

Engineering Contradiction:

Improvetransseptal accessVSAvoidtissue stress

Core Design Contradiction:

ReliabilityVSStress or pressure

Solution Approach 1:

The invention inverts the traditional approach by keeping the needle stationary and moving the tissue backward over the needle using negative pressure, rather than pushing the needle forward through the tissue. This eliminates the additional tissue tenting and stress that occurs when the sheath and dilator are pushed forward.

Inventive Principle:

Principle #13The other way round (Inversion)

3Reliability

If a long needle is advanced through the dilator to puncture the fossa ovalis, then access to the left atrium is achieved, but the procedure complexity increases

Engineering Contradiction:

Improveleft atrium accessVSAvoidprocedure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The invention extracts the needle from the complex multi-component system of sheath-dilator-needle and makes it a simple stationary element. The needle is held in place within the funnel, and only the funnel needs to be advanced and positioned, significantly simplifying the procedure while maintaining reliable left atrium access.

Inventive Principle:

Principle #2Taking out (Extraction)

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

The solution significantly reduces the chance of cardiac wall puncture and simplifies the access procedure by using negative pressure to pull the septal tissue towards the needle, thereby reducing the stress on the tissue and minimizing complications.

Implementation Method 1

a vacuum, suction, or other negative pressure may be applied

Methodology Applied

Scientific EffectNegative pressure: Suction

Data Source

PatentUS10220134B2Transseptal access device and method of use

Publication Date: 2019.03.05 WIECZOREK MARK D

AI summary

Systems, devices, and methods are provided for transseptal access of septa within a patient. The device can be advanced to a septum, e.g., towards a fossa ovalis. Instead of applying positive pressure to "tent" the septum, a negative pressure is applied to a lumen within a sheath, e.g., within an elongated member slidable within the sheath, via a negative pressure source such as a syringe on the proximal end of the sheath. This results in the septum pulling inward. The sheath employs a stationary needle-like central core component contained within the lumen of the sheath that punctures the septum when the same is pulled passed it by the negative pressure. The stationary needle-like central core component may be hollow and may form a portion of the elongated member or may be coupled to a distal end thereof.