Transseptal Access Device Using Negative Pressure Puncture

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Solution Overview

Problem

Current transseptal access methods often result in complications such as difficulty obtaining access, increased tension on the septal wall, and a high risk of puncture of the opposite wall, leading to severe adverse events due to the need for significant pressure to advance the needle through a potentially fibrotic septum.

Innovation Solution

A device with a flared distal end featuring a funnel-shaped polymer element and a center core with a pointed feature, where negative pressure is applied to pull the septal tissue towards a stationary needle, reducing the need for positive pressure and minimizing the risk of perforation, and allowing for guidewire insertion post-puncture.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If significant pressure is applied to advance the needle through a fibrotic septum, then puncture of the septum is achieved, but the risk of puncturing the opposite wall increases

Engineering Contradiction:

Improvesuccessful puncture of septumVSAvoidrisk of opposite wall puncture

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

Instead of advancing the needle forward through the septum with positive pressure, the invention inverts the approach by using negative pressure to retract the septal tissue toward a stationary needle. This reverses the traditional force application direction, allowing the needle to remain stationary while the tissue moves into position, thereby reducing the risk of uncontrolled penetration and opposite wall puncture

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The invention applies negative pressure beforehand to gently retract and position the septal tissue against the stationary needle tip. This cushioning effect allows controlled tissue engagement before puncture occurs, preventing sudden uncontrolled needle advancement that could lead to opposite wall penetration

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

2Ease of operation

If the sheath is advanced forward with the needle, then access to the left atrium is obtained, but the sheath and needle slide up or down instead of moving forward, increasing tension on the fossa ovalis

Engineering Contradiction:

Improveaccess to left atriumVSAvoidcontrol of puncture process

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The invention inverts the traditional transseptal puncture method by keeping the needle stationary within the sheath and using negative pressure to retract the septal tissue toward the needle tip. This prevents the sheath and needle from sliding up or down on the septum, maintaining stable positioning and control throughout the puncture process while still achieving successful left atrium access

Inventive Principle:

Principle #13The other way round (Inversion)

3Productivity

If a long needle is advanced through the dilator to puncture the fossa ovalis, then transseptal access is achieved, but the needle may suddenly exert force through the septum causing perforation

Engineering Contradiction:

Improvespeed of punctureVSAvoidsudden needle exertion causing perforation

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The invention replaces the traditional method of advancing a long needle through the septum with a stationary needle approach. Negative pressure is applied to retract the septal tissue toward the stationary needle tip, enabling controlled puncture without the sudden uncontrolled force exertion that occurs when advancing a long needle, thereby preventing perforation while maintaining procedural efficiency

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The invention substitutes the mechanical advancement of a long needle with a pneumatic/negative pressure system. Instead of using manual force to push the needle through the septum, negative pressure is applied to retract the tissue toward the stationary needle, providing more controlled and gradual tissue engagement that prevents sudden perforation

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 method significantly reduces the chance of cardiac wall puncture and simplifies the access procedure by creating a stable base for puncture, thereby enhancing safety and reducing procedural time.

Implementation Method 1

negative pressure is applied and the funnel tip prolapses, pulling the FO towards the stationary needle feature, puncturing the FO and obtaining access to the LA

Methodology Applied

Scientific EffectNegative pressure: Pressure Gradient

Data Source

PatentUS11419632B2Transseptal access device and method of use

Publication Date: 2022.08.23 MARK D WIECZOREK P C

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.