Catheter with Segmented Needle for Septal Puncture

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Solution Overview

Problem

Current methods for delivering therapeutic devices to the left atrium or ventricle of the heart, such as valve repair or replacement, face challenges in penetrating the interatrial septum effectively, particularly at the fossa ovalis, which requires precise apparatus and techniques to navigate and puncture the septum safely and efficiently.

Innovation Solution

The development of a catheter system with a braided portion and flexible longitudinal members that can be deployed to locate and stabilize the fossa ovalis, accompanied by a hollow needle with a flexible distal portion, allows for transvascular insertion and precise puncture of the interatrial septum, enabling the introduction of therapeutic devices into the left atrium.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a rigid needle is used to puncture the interatrial septum, then puncture precision is improved, but the ability to navigate and locate the fossa ovalis deteriorates

Engineering Contradiction:

Improvepuncture precisionVSAvoidnavigation capability

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The needle is divided into two distinct segments: a proximal rigid portion for puncturing the septum and a distal flexible portion for navigation and locating the fossa ovalis. This segmentation allows each portion to perform its specific function optimally without compromising the other.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different portions of the needle are given different mechanical properties: the proximal portion is rigid for precise puncture, while the distal portion is flexible for navigation. This local differentiation of properties enables the needle to simultaneously achieve both puncture precision and navigation capability.

Inventive Principle:

Principle #3Local quality

2Ease of operation

If a flexible needle is used to locate the fossa ovalis, then navigation capability is improved, but puncture precision deteriorates

Engineering Contradiction:

Improvenavigation capabilityVSAvoidpuncture precision

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Inventive Principle:

Principle #3Local quality

3Ease of operation

If the catheter wall is made entirely of braided material, then flexibility and ease of navigation are improved, but structural strength and stability deteriorate

Engineering Contradiction:

ImproveflexibilityVSAvoidstructural strength

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The catheter wall is segmented into braided and unbraided portions, with the braided portion providing flexibility for navigation and the unbraided portion providing structural strength and stability. This segmentation allows the catheter to simultaneously achieve both flexibility and strength.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The catheter wall combines braided and unbraided materials to create a composite structure that leverages the advantages of both materials: flexibility from the braided portion and strength from the unbraided portion.

Inventive Principle:

Principle #40Composite materials

4Strength

If the catheter wall is made entirely of unbraided material, then structural strength is improved, but flexibility and ease of navigation deteriorate

Engineering Contradiction:

Improvestructural strengthVSAvoidflexibility

Core Design Contradiction:

StrengthVSEase of operation

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Inventive Principle:

Principle #40Composite materials

Data Source

PatentUS12121292B2Interatrial septum penetration

Publication Date: 2024.10.22 TRANSSEPTAL SOLUTIONS

AI summary

A method is provided including inserting a catheter into a right atrium and advancing a distal portion of the catheter toward a roof of the right atrium. A flexible longitudinal member is deployed from the catheter, such that a deployed portion of the flexible longitudinal member is loop-shaped. The deployed portion of the flexible longitudinal member is brought into contact with a single stabilization site located on the roof of the right atrium, between the roof and an interatrial septum, or on the interatrial septum superior to a fossa ovalis. A needle is deployed from the catheter and brought in contact with a hole site on a surface of the interatrial septum outside the fossa ovalis. A hole is formed through the interatrial septum at the hole site with the needle. The deployed portion of the flexible longitudinal member is withdrawn toward the catheter. Other embodiments are also described.