Flexible Puncture Needle with Support Sheath for Transseptal Access

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Solution Overview

Problem

Conventional transseptal procedures using needles face limitations such as lack of atraumaticity, excessive force on tissue, difficulty in correcting device placement, repeatability issues, inadequate anchoring, and increased procedural time and complexity.

Innovation Solution

A system comprising a puncture device with two components: a separate, flexible, and atraumatic puncturing component, and a stiff supporting member that can be used independently or together to facilitate transseptal puncture, enhancing procedural efficiency and safety.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a needle is used for transseptal puncture, then the puncture can be performed, but tissue damage and trauma increase

Engineering Contradiction:

Improvepuncture effectivenessVSAvoidtissue damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The puncture device is divided into separate components: a flexible puncture needle that can be advanced independently from the supporting sheath. This segmentation allows the needle to perform the puncture function while the sheath provides support and control, reducing tissue trauma compared to rigid needles.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The puncture needle is designed to be flexible rather than rigid, allowing it to conform to tissue contours and reduce mechanical trauma during insertion. The flexible needle can bend and adapt to the tissue path, minimizing damage compared to conventional rigid needles.

Inventive Principle:

Principle #30Flexible shells and thin films

2Reliability

If excessive force is applied during puncture, then the puncture can be achieved, but tissue damage increases

Engineering Contradiction:

Improvepuncture successVSAvoidtissue trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The puncture device incorporates dynamic elements including a flexible needle that can bend and adapt during insertion. The system allows for controlled force application through the flexible needle, which can deflect and follow tissue paths rather than requiring excessive force, thereby reducing tissue trauma.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The needle flexibility parameter is optimized to balance puncture effectiveness with tissue protection. The flexible needle can transmit sufficient force to penetrate tissue while its flexibility allows it to yield to tissue resistance, preventing excessive force application and associated damage.

Inventive Principle:

Principle #35Parameter changes

3Measurement precision

If device placement needs correction, then proper positioning can be achieved, but procedural time increases

Engineering Contradiction:

Improvedevice positioning accuracyVSAvoidprocedural time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The flexible needle can be advanced and repositioned dynamically within the sheath without requiring complete device withdrawal. This allows for corrective maneuvers and positioning adjustments to be made efficiently, reducing the time penalty associated with placement corrections compared to rigid needle systems.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The sheath acts as an intermediary that facilitates needle repositioning and correction. The needle can be withdrawn and re-advanced within the sheath for positioning adjustments, allowing corrections to be made without removing the entire assembly, thereby minimizing procedural time loss.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Adaptability or versatility

If multiple device exchanges are performed, then procedural needs can be met, but complexity and time increase

Engineering Contradiction:

Improveprocedural flexibilityVSAvoidnumber of device exchanges

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The puncture needle and supporting sheath are combined into a single integrated assembly that can be inserted as one unit. This merging eliminates the need for separate insertion of multiple components, reducing the number of device exchanges and simplifying the procedure while maintaining the functional versatility of having both a flexible needle and supportive sheath.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The integrated assembly serves multiple functions: the sheath provides support, routing, and protection while the needle performs puncture. This multi-functional design reduces the need for separate devices and exchanges, simplifying the procedural workflow while maintaining adaptability for different procedural needs.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS20250127537A1Methods and devices for puncturing tissue

Publication Date: 2025.04.24 BOSTON SCI MEDICAL DEVICE LTD

AI summary

A method and system are disclosed for puncturing tissue, comprising a puncture device for puncturing tissue and a supporting member for supporting the puncture device. The puncture device is capable of being insertable within the supporting member and being selectively usable in co-operation therewith during a portion of a procedure for puncturing tissue and wherein the puncture device is usable independently therefrom during another portion of the procedure.