Encapsulated Hourglass Stent Manufacturing via Mandrel Sintering

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Solution Overview

Problem

Existing systems lack effective methods for manufacturing encapsulated hourglass shaped stents for treating congestive heart failure and other disorders, as previous technologies are inadequate in providing long-term patency and preventing tissue ingrowth within the stent lumen.

Innovation Solution

The method involves using a mandrel assembly to configure and encapsulate an hourglass shaped stent with biocompatible materials, ensuring secure lodging in the atrial septum and preventing tissue ingrowth, by compressing the stent-graft assembly and bonding the materials through heating to form a monolithic layer.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing stent manufacturing methods are used, then the stent can be produced, but the stent lacks long-term patency and allows tissue ingrowth within the lumen

Engineering Contradiction:
Improvelong-term patencyVSAvoidmanufacturing method effectiveness
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent applies nesting by placing a second biocompatible material layer within the lumen of the stent, creating a nested structure where one material is contained within another. This nested configuration prevents tissue ingrowth while maintaining patency, directly resolving the contradiction between reliability and ease of manufacture.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent uses composite materials by combining multiple biocompatible materials with different properties - an outer material layer and an inner material layer within the lumen. This composite structure provides both long-term patency and tissue ingrowth prevention, overcoming the limitations of single-material stents.

Inventive Principle:
Principle #40Composite materials

2Ease of operation

If the stent is compressed to reduce size for delivery, then the stent can be delivered through catheters, but the stent requires complex compression and expansion mechanisms

Engineering Contradiction:
Improvedelivery capabilityVSAvoidcompression mechanism
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent applies dynamics by designing the stent with dynamic compressibility - the stent can be compressed to a reduced diameter for delivery through catheters and then expanded to its full operational size at the target location. This dynamic capability enables easy delivery while avoiding complex permanent compression mechanisms.

Inventive Principle:
Principle #15Dynamics

3Strength

If the stent is made from rigid materials to maintain structural integrity, then the stent provides strong support, but the stent cannot be compressed for delivery through catheters

Engineering Contradiction:
Improvestructural integrityVSAvoidcompressibility for delivery
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The patent resolves this contradiction through dynamic material behavior - the stent is designed to be compressible when needed for delivery and then expandable to provide strong structural support at its operational size. This dynamic transformation allows the stent to be both strong and deliverable without requiring complex mechanisms.

Inventive Principle:
Principle #15Dynamics

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 results in long-term patency and prevents tissue ingrowth within the stent lumen, effectively treating congestive heart failure and other conditions like pulmonary hypertension.

Implementation Method 1

Heating the stent-graft assembly may cause the biocompatible material and the second biocompatible material to sinter together to form a monolithic layer of biocompatible material.

Methodology Applied
Scientific EffectSintering: Sintering

Data Source

PatentUS11497631B2Systems and methods for making encapsulated hourglass shaped stents
Publication Date: 2022.11.15 WAVE LTD V
  • US11497631B2 patent drawing
  • US11497631B2 patent drawing
  • US11497631B2 patent drawing

AI summary

Systems and methods for the manufacture of an hourglass shaped stent-graft assembly comprising an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilatation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension.