Barb Element Anchoring Stent Graft Manufacturing

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Solution Overview

Problem

Existing methods for manufacturing medical devices with barbs, such as stent grafts, face challenges including high costs and handling risks with integral barbs, material incompatibility for heat-treated stents, and additional manufacturing steps for sutured barbs, which can lead to premature wear and device failure.

Innovation Solution

A method involving a barb element mechanically coupled to a stent and sutured to a graft member, where the barb is wrapped around the stent and secured with a single suture, allowing for easy assembly and using shape memory materials like Nitinol for enhanced anchoring and deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If barbs are integrally formed with the stent, then the barbs have enhanced rigidity and function, but the manufacturing cost increases and handling risk increases

Engineering Contradiction:

Improvebarb rigidityVSAvoidmanufacturing cost

Core Design Contradiction:

StrengthVSEase of manufacture

Solution Approach 1:

The barb is separated from the stent as an independent component that is subsequently attached to the stent structure. This segmentation allows the stent to be manufactured separately using standard processes, then the barb is added in a later assembly step, reducing overall manufacturing complexity and cost while maintaining barb strength through dedicated design.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The barb is pre-formed as a separate component with its final shape and structural properties established before attachment to the stent. This preliminary formation allows optimization of barb geometry for strength without constraining the stent manufacturing process, and enables quality control of the barb independent of stent production.

Inventive Principle:

Principle #10Preliminary action

2Strength

If barbs are integrally formed with the stent, then the barbs have enhanced rigidity and function, but the handling risk increases due to snagging

Engineering Contradiction:

Improvebarb rigidityVSAvoidhandling ease

Core Design Contradiction:

StrengthVSEase of operation

Solution Approach 1:

By separating the barb from the stent into distinct components, the handling risks associated with integral barbs are eliminated. The stent can be handled and deployed without the snagging hazards of protruding barbs, while the barb component is only introduced at the final assembly stage when it is securely attached to the graft material.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The barb is pre-attached to the graft material before stent integration, allowing the stent to be handled and deployed without exposure to barb-related snagging risks. The barb-graft assembly is prepared in advance and then integrated with the stent in a controlled manner.

Inventive Principle:

Principle #10Preliminary action

3Adaptability or versatility

If barbs are sutured to graft material, then the assembly flexibility increases, but the manufacturing time increases

Engineering Contradiction:

Improveassembly flexibilityVSAvoidmanufacturing time

Core Design Contradiction:

Adaptability or versatilityVSLoss of time

Solution Approach 1:

The barb is pre-attached to the graft material in a preliminary assembly step using a standardized suturing procedure. This pre-assembly allows the barb-graft unit to be prepared in advance with consistent positioning and secure attachment, reducing the time required during final device assembly while maintaining the flexibility to accommodate different stent and graft configurations.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The barb attachment to the graft material is combined with the stent integration process in a coordinated assembly sequence. The barb-graft assembly is integrated with the stent in a single operational phase, merging multiple steps into one efficient process that reduces overall manufacturing time while preserving assembly flexibility.

Inventive Principle:

Principle #5Merging (Combining)

4Adaptability or versatility

If barbs are sutured to graft material, then the assembly flexibility increases, but the wear risk increases

Engineering Contradiction:

Improveassembly flexibilityVSAvoiddevice durability

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The stent structure serves as an intermediary between the barb and the graft material, providing a rigid support framework that prevents direct rubbing and wear between the barb and other hard structures. The barb is secured to the stent, which in turn is attached to the graft, creating a protected mechanical arrangement that eliminates wear pathways while maintaining assembly flexibility.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The barb is pre-positioned and secured to the stent structure before final graft integration, ensuring that the barb is held in a fixed, protected position that prevents contact with other hard structures. This preliminary positioning eliminates wear risks while preserving the flexibility to configure the complete device assembly.

Inventive Principle:

Principle #10Preliminary action

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

This approach simplifies the manufacturing process, reduces handling risks, and provides a strong, durable anchoring system that minimizes wear and migration risks, suitable for various stent materials and deployment conditions.

Implementation Method 1

the barb element is mechanically coupled to the stent and sutured in position by means of a suture between the barb element, the stent and the graft member

Methodology Applied

Scientific EffectMechanical coupling through wrapping:

Implementation Method 2

sutured in position by means of a suture between the barb element, the stent and the graft member

Methodology Applied

Scientific EffectSuturing:

Implementation Method 3

the barbs benefit from support of the stent and thus have enhanced rigidity and function

Methodology Applied

Scientific EffectStructural support:

Implementation Method 4

using shape memory materials like Nitinol for enhanced anchoring and deployment

Methodology Applied

Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentUS8747457B2Medical device and method of manufacturing same

Publication Date: 2014.06.10 COOK MEDICAL TECHNOLOGIES LLC

AI summary

A stent (10) has wrapped therearound a barb element (12) formed of a length of wire provided with first and second ends (14, 16) forming barb prongs. In intermediate zone (22), the barb element (12) is wrapped or coiled. The two pronged ends (14, 16) extend out of the graft element (26) to provide an anchoring function to the medical device. As well as being wrapped onto a strut of the stent (10), the barb element (12) is sutured to the stent (10) and to the graft material (26) by suture stitching (28). The turns of the coiling or wrapping in section (22) assist in fixing the barb element (12) relative to the suture (28) and thus to the stent graft (24). The barb elements (12) could be made of any suitable material, including Nitinol. This structure of barb elements provides an effective arrangement which is easy to manufacture, which provides strong barbs able to withstand the high processing temperatures required for setting shape memory elements of the device.