Transseptal Access Device Using Negative Pressure Pull

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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 the septum, then puncture of the septum is achieved, but the risk of puncturing the opposite wall increases

Engineering Contradiction:

Improvesafety of transseptal accessVSAvoidrisk of opposite wall puncture

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

Instead of advancing the needle forward through the septum using positive pressure, the invention inverts the approach by applying negative pressure through a funnel-shaped element to pull the septal tissue toward the stationary needle, thereby achieving puncture without forward needle advancement and reducing the risk of opposite wall puncture

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The funnel-shaped element acts as an intermediary between the needle and the septal tissue. It concentrates and transmits the negative pressure to the septum, enabling controlled tissue engagement and puncture while the needle remains stationary, thus preventing harmful opposite wall puncture

Inventive Principle:

Principle #24Intermediary (Mediator)

2Productivity

If the sheath is advanced forward with the needle, then transseptal access is obtained, but the sheath slides up or down instead of moving forward

Engineering Contradiction:

Improveefficiency of access procedureVSAvoidcontrol of sheath advancement

Core Design Contradiction:

ProductivityVSEase of operation

Solution Approach 1:

The invention inverts the traditional advancement mechanism by keeping the sheath and needle stationary while using negative pressure applied through the funnel to pull the septal tissue forward toward the needle, eliminating the sliding problem and improving procedural control

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The septal tissue itself is utilized to advance through the needle by being pulled via negative pressure, rather than requiring external mechanical advancement of the needle or sheath, thereby simplifying the operation and improving control

Inventive Principle:

Principle #25Self-service

3Strength

If the septum is heavily fibrotic, then structural integrity is maintained, but significant pressure is required to advance the needle

Engineering Contradiction:

Improvestructural integrity of septumVSAvoidpressure required for needle advancement

Core Design Contradiction:

StrengthVSForce

Solution Approach 1:

Instead of applying significant forward pressure to push the needle through fibrotic tissue, the invention applies negative pressure to pull the fibrotic septal tissue toward the stationary needle, achieving puncture with reduced force requirements while preserving structural integrity

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The invention replaces the traditional mechanical push-based needle advancement system with a pressure-based pull system using negative pressure applied through the funnel, which is more effective for penetrating fibrotic tissue without requiring excessive force

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 improves safety by creating a stable base for puncture, simplifying the access procedure and reducing the time required to achieve left atrial access.

Implementation Method 1

where negative pressure is applied to pull the septal tissue towards a stationary needle

Methodology Applied

Scientific EffectNegative pressure: Pressure Gradient

Data Source

PatentUS20230414252A1Transseptal access device and method of use

Publication Date: 2023.12.28 MARK D WIECZOREK PC

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.