Integrated Dilator Coupling for Single-Step Transseptal Access

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Solution Overview

Problem

Current devices for creating punctures or perforations in heart tissues, such as the Brockenbrough™ Needle and radiofrequency perforation apparatuses, often require multiple exchanges and additional steps due to differences in sheath sizes, leading to inefficiencies and increased risk of embolisms during transseptal procedures.

Innovation Solution

An enhanced dilator with a resilient coupling system and reinforcing member, designed to support flexible puncturing devices like RF guidewires, allowing for a single device to perform both puncturing and sheath insertion, reducing the need for multiple exchanges and simplifying the procedural workflow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple devices are used for puncturing and sheath insertion, then puncture creation capability is improved, but device complexity and procedural steps increase

Engineering Contradiction:

Improvepuncture creation capabilityVSAvoidnumber of devices required

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the puncturing device and dilator into a single integrated assembly. The puncturing device is positioned within the dilator, allowing both functions to be performed by one device rather than requiring separate devices for puncture creation and sheath insertion.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The dilator is designed with multi-functionality, serving both as a protective sheath and as a dilating instrument. The dilator can be advanced through the puncture site to enlarge the opening while simultaneously providing a pathway for the therapy sheath, eliminating the need for separate specialized devices.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Reliability

If multiple device exchanges are performed, then access to left atrium is achieved, but procedural time and embolism risk increase

Engineering Contradiction:

Improveaccess to left atriumVSAvoidprocedural time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The dilator is pre-positioned within the puncturing device before the procedure begins. As the puncturing device creates the initial puncture, the dilator is already in place to immediately follow through and enlarge the opening, eliminating the need for subsequent device exchanges to achieve left atrium access.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The integrated design allows continuous action from puncture creation through dilation to sheath insertion. The puncturing device and dilator work in sequence without interruption, maintaining continuous progress toward left atrium access and reducing procedural pauses or exchanges.

Inventive Principle:

Principle #20Continuity of useful action

3Force

If stiff needle is used for puncture, then puncture creation force is improved, but flexibility and trackability worsen

Engineering Contradiction:

Improvepuncture creation forceVSAvoidflexibility

Core Design Contradiction:

ForceVSAdaptability or versatility

Solution Approach 1:

The puncturing device is segmented into a stiff proximal portion for force transmission and a more flexible distal portion for navigation. This segmentation allows the device to maintain the necessary stiffness for creating the puncture while having sufficient flexibility to navigate the vascular pathway to reach the target site.

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS12564706B2Enhanced dilator and methods of using the same

Publication Date: 2026.03.03 BOSTON SCI MEDICAL DEVICE LTD

AI summary

An enhanced dilator includes a dilator shaft defining a lumen for receiving a functional device (e.g., a puncturing device) therethrough. The dilator shaft includes a proximal portion for manipulation by a user and a distal portion to placement in or near the heart. A dilator hub is coupled to the proximal portion of the dilator shaft and includes a rotational coupling structure for coupling to a corresponding hub of a therapy sheath.