Nested Puncture Needle Structure for Calcified Tissue Penetration

Solution Overview

Problem

Existing puncture needles face difficulties in smoothly penetrating hardened biological tissues such as calcified lesions due to insufficient rigidity, especially when treating small-diameter blood vessels with stenosed parts.

Innovation Solution

A puncture needle design featuring an outer needle with protruding portions and an inner needle with an inclined surface, allowing for rotation to form a perforation by crushing the target site while maintaining a gap for smooth movement, with the outer needle having greater hardness than the inner needle.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the puncture needle diameter is reduced to match small-diameter blood vessels, then the needle can access smaller vessels, but the rigidity becomes insufficient for penetrating hardened tissues

Engineering Contradiction:

Improveapplicability to small-diameter blood vesselsVSAvoidrigidity

Core Design Contradiction:

Adaptability or versatilityVSStrength

Solution Approach 1:

The puncture needle is divided into an outer needle and an inner needle that can be separated. The outer needle has a larger diameter for rigidity and crushing function, while the inner needle has a smaller diameter for accessing small vessels. This segmentation allows each needle to have optimized dimensions for its specific function.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The inner needle is nested inside the outer needle during the puncture procedure. The inner needle with smaller diameter fits within the outer needle, allowing the system to maintain the rigidity of the outer needle while enabling access to small-diameter blood vessels through the inner needle's smaller profile.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Strength

If the puncture needle diameter is increased to ensure sufficient rigidity, then the rigidity is adequate for penetrating hardened tissues, but the needle cannot access small-diameter blood vessels

Engineering Contradiction:

ImproverigidityVSAvoidapplicability to small-diameter blood vessels

Core Design Contradiction:

StrengthVSAdaptability or versatility

Solution Approach 1:

The puncture needle is divided into an outer needle and an inner needle that can be separated. The outer needle has a larger diameter for rigidity and crushing function, while the inner needle has a smaller diameter for accessing small vessels. This segmentation allows each needle to have optimized dimensions for its specific function.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The inner needle is nested inside the outer needle during the puncture procedure. The inner needle with smaller diameter fits within the outer needle, allowing the system to maintain the rigidity of the outer needle while enabling access to small-diameter blood vessels through the inner needle's smaller profile.

Inventive Principle:

Principle #7Nested doll (Nesting)

3Strength

If a penetrating wire with high rigidity is used to treat stenosed parts, then the wire can penetrate hardened tissues, but the procedure becomes more complex requiring additional equipment

Engineering Contradiction:

ImproverigidityVSAvoidprocedure complexity

Core Design Contradiction:

StrengthVSDevice complexity

Solution Approach 1:

The outer needle is designed to serve multiple functions: it acts as both a puncture needle for initial access and as a crushing tool for penetrating hardened tissues through rotation. This multi-functionality eliminates the need for separate penetrating wires, simplifying the procedure while maintaining the ability to treat stenosed parts.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

Instead of using a thin penetrating wire that requires complex delivery mechanisms, the invention inverts the approach by using a larger-diameter outer needle that can be directly manipulated. The outer needle's distal end is rotated to crush and penetrate hardened tissues, reversing the conventional approach of pushing a thin wire through the tissue.

Inventive Principle:

Principle #13The other way round (Inversion)

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

Enables effective penetration through hardened tissues by rotating the needle to crush and create a perforation, ensuring smooth progression even in calcified lesions.

Implementation Method 1

the inner needle distal end is disposed such that the inclined surface forms a gap with an inner surface of the first protruding portion and/or an inner surface of the second protruding portion

Methodology Applied

Scientific EffectFriction reduction through gap formation: Friction

Implementation Method 2

a distal end of the outer needle main body includes a first protruding portion and a second protruding portion each having a blade surface on a side surface

Methodology Applied

Scientific EffectMechanical crushing force: Impact Force

Data Source

PatentUS20250332355A1Puncture needle

Publication Date: 2025.10.30 TERUMO KK

AI summary

A puncture needle that includes an outer needle, and an inner needle configured to be insertable into the outer needle, in which in a connected state in which an inner needle main body of the inner needle is inserted into an outer needle main body of the outer needle and an inner needle hub and an outer needle hub are connected together, a most distal end of an inner needle distal end is located on the distal end side from a most distal end of a first protruding portion of the outer needle and a most distal end of a second protruding portion of the outer needle, and the inner needle distal end of the inner needle is disposed such that an inclined surface forms a gap between an inner surface of the first protruding portion and/or an inner surface of the second protruding portion.