Shape Memory Suture Device for Knot-Free Tissue Closure

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Solution Overview

Problem

Existing suture devices face issues such as increased infection and inflammatory reactions due to porous surfaces, variability in suture stitch strength, material waste, and complexity in handling, particularly due to the need for multiple instruments and needle usage.

Innovation Solution

A suture device made from shape memory material, such as Nitinol, with a pointed extremity for piercing and a thermally deformable design that transitions between initial and final configurations without knots, using a single instrument and eliminating the need for needles, thereby reducing infection risk and ensuring uniform stitch strength.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a porous suture element surface is used, then the suture device can be manufactured with conventional materials, but the risk of infection and inflammatory reactions increases considerably

Engineering Contradiction:

ImprovemanufacturabilityVSAvoidinfection risk

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The suture element is made of shape memory material (such as Nitinol) which provides both manufacturability and a non-porous surface that reduces infection risk. The composite nature combines the beneficial properties of shape memory alloys with surface treatments or coatings that eliminate porosity while maintaining the ability to be formed into the required geometry.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The surface properties of the suture element are modified by changing physical or chemical parameters during manufacturing, such as applying surface treatments, coatings, or heat treatments that close pores and create a smooth, non-porous surface that resists bacterial adhesion while maintaining the shape memory functionality.

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If manual knot formation is used, then the suture device is simple to operate, but the strength of suture stitches varies and knots cause pain, ischemia, and increased scar reaction

Engineering Contradiction:

Improveoperational simplicityVSAvoidsuture stitch strength uniformity

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The mechanical knot-tying system is replaced with a thermal activation system. The suture element is made of shape memory material that responds to temperature changes. By applying localized heat to the suture element after it has been positioned through the tissue, the material undergoes a phase transformation that causes it to constrict and secure itself automatically, eliminating the need for manual knots while providing uniform, controlled strength.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Ease of operation

If a needle element is used to pass the suture element through wound flaps, then the suture device can create the passage, but the passage hole enlarges increasing infection risk and reducing suture strength

Engineering Contradiction:

Improvepassage creation capabilityVSAvoidinfection risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The needle element is completely removed from the suture device. Instead of using a needle to create a passage, the suture element itself is designed with a pointed extremity that allows it to be manually inserted through the tissue flaps without requiring a separate needle instrument. This eliminates the passage enlargement effect and associated infection risks.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The suture element is designed to perform multiple functions: it serves as both the suture material and the insertion instrument. The pointed extremity of the suture element allows it to pierce the tissue flaps under manual pressure, eliminating the need for a separate needle element while maintaining the ability to create the necessary passage.

Inventive Principle:

Principle #6Universality (Multi-functionality)

4Ease of operation

If a needle element is used, then the suture device can pierce tissue, but the handling becomes difficult and complicated and requires multiple auxiliary instruments

Engineering Contradiction:

Improvetissue piercing capabilityVSAvoidnumber of instruments

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

Inventive Principle:

Principle #2Taking out (Extraction)

5Extent of automation

If the suture element is heated to determine thermal deformation, then the suture closes on itself, but the operator must take eyes away from the suture increasing risk of error and healing time

Engineering Contradiction:

Improvethermal deformation capabilityVSAvoidsuture procedure interruption

Core Design Contradiction:

Extent of automationVSLoss of time

Solution Approach 1:

The suture procedure is designed to be continuous without interruptions. The suture element remains in place throughout the entire process, and the thermal activation is performed in-situ without requiring removal or repositioning. The operator maintains visual contact with the suture throughout the heating process, eliminating the need to look away and reducing the risk of errors.

Inventive Principle:

Principle #20Continuity of useful action

Solution Approach 2:

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 device allows for a seamless, knot-free suture process with reduced material waste and operator risk, ensuring uniform stitch strength and minimizing complications like infection and ischemia, while maintaining ease of use and efficiency.

Implementation Method 1

the suture element (2) is made of a shape memory material and is movable, by heating, between: an initial configuration, wherein the suture element itself is fitted through the flaps (3)... and a final configuration, wherein the suture element (2) is fitted astride of the flaps (3), and has the extremities (4, 11) and the flaps (3) reciprocally moved closer to define a suture (5)

Methodology Applied

Scientific EffectShape memory effect: Shape Memory Alloy

Implementation Method 2

a first pointed extremity (4) adapted to pierce the flaps (3) of the surgical wound to allow the passage of the suture element (2) through the latter

Methodology Applied

Scientific EffectMechanical piercing: Mechanical Force

Data Source

PatentEP3474754B1Suture device

Publication Date: 2020.10.28 PROMEV

Figure 1~4
Figure 5~10
Figure 11

AI summary

The suture device (1) comprises a suture element (2) of elongated shape and intended to be inserted through the flaps (3) of a surgical wound, in which the suture element (2) is made of a shape memory material and has a first pointed extremity (4) adapted to pierce the flaps (3) to allow the passage of the suture element (2) through the latter and their mutual approach to define a suture (5), and a second extremity (11) opposite the first extremity (4), and by the fact that the suture element (2) comprises an initial configuration wherein the extremities (4, 11) and the flaps (3) are spaced apart from one another and a final configuration wherein the extremities (4, 11) and the flaps (3) are mutually approached to define the suture (5).