Umbilical Cord Biologic Stent Dynamic Rigidity Transition

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Solution Overview

Problem

Current stents used in blood vessels and other tissues face challenges with precise implantation and risk of leakage, requiring careful placement to avoid complications such as additional surgeries or infections.

Innovation Solution

A biologic stent made from umbilical cord with a semi-rigid or rigid structure that maintains an open fluid passageway during implantation, transitioning to a soft, conformable form after placement, utilizing a polyampholyte cryoprotectant coating to ensure stability during surgery and enhance healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a stent is made rigid or semi-rigid to maintain open conduit during implantation, then the ease of operation during implantation is improved, but the stent cannot conform to the vessel wall after implantation

Engineering Contradiction:
Improveease of implantationVSAvoidconformability to vessel wall
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The stent is designed to dynamically change its mechanical properties from rigid/semi-rigid during implantation to soft and conformable after implantation. This dynamic transition allows the stent to first provide structural support for easy implantation, then adapt to the vessel wall geometry to prevent leakage, resolving the contradiction between ease of operation and adaptability.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The stent utilizes changes in physical or chemical parameters (such as temperature, moisture, or pH) to transition from a rigid state during implantation to a soft state after implantation. This parameter-driven transformation enables the stent to maintain openness during placement while conforming to the vessel wall afterward, addressing both requirements simultaneously.

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If a stent is made soft and pliable to conform to vessel wall, then the adaptability is improved, but the stent cannot maintain open conduit during implantation

Engineering Contradiction:
Improveconformability to vessel wallVSAvoidease of implantation
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The stent dynamically transitions from soft/pliable after implantation to rigid/semi-rigid during implantation. This reverse temporal sequence ensures the stent is conformable when needed for vascular adaptation but rigid when needed for surgical manipulation and placement, resolving the contradiction between adaptability and ease of operation.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The stent utilizes parameter changes (temperature, moisture, pH) to switch between soft and rigid states. This allows the stent to be conformable during vascular adaptation but rigid during implantation procedures, simultaneously satisfying both adaptability and ease of operation requirements.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If a stent transitions from rigid to soft after implantation, then the reliability is improved, but the manufacturing complexity increases

Engineering Contradiction:
Improvereliability of conduit functionVSAvoidmanufacturing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The stent utilizes natural parameter changes in the body (temperature, moisture, pH) to achieve the rigid-to-soft transition, eliminating the need for complex mechanical actuators or control systems. This biological parameter-driven transition improves reliability while keeping manufacturing relatively simple, as only the material composition needs to be designed to respond to these natural conditions.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The stent performs the transition from rigid to soft automatically upon implantation through its inherent material properties responding to body conditions. This self-service mechanism eliminates the need for external control systems or complex manufacturing processes, improving reliability while minimizing manufacturing complexity.

Inventive Principle:
Principle #25Self-service

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 stent allows for easier and safer implantation with reduced risk of leakage, maintaining conduit functionality while promoting tissue integration and healing, as it softens and becomes pliable within the body.

Implementation Method 1

The biologic stent is coated or perfused with a non-toxic liquid and dried forming the semi-rigid or rigid condition during manufacturing through a cryo-lyophilization step. The non-toxic fluid for coating the biologic stent is a polyampholyte cryoprotectant.

Methodology Applied
Scientific EffectCryoprotectant coating:

Implementation Method 2

The biologic stent is coated or perfused with a non-toxic liquid and dried forming the semi-rigid or rigid condition during manufacturing through a cryo-lyophilization step.

Methodology Applied
Scientific EffectCryo-lyophilization: Freeze Drying

Implementation Method 3

the tissue body structure softens to a conformable stent inside the vessel duct, or bowel being repaired or reinforced

Methodology Applied
Scientific EffectBiologic resorption: Decomposition (biological)

Data Source

PatentUS20240066188A1Umbilical cord biologic stent or conduit
Publication Date: 2024.02.29 VIVEX BIOLOGICS GRP INC
  • US20240066188A1 patent drawing
  • US20240066188A1 patent drawing
  • US20240066188A1 patent drawing

AI summary

A biologic stent or conduit made from an umbilical cord has a tissue body structure having a fluid passageway configured to be open to pass bodily fluids from a first end through a second end. The tissue body structure has an internal surface defining a boundary interior wall of the open fluid passageway and an external surface defining an exterior wall of the tissue body structure. The tissue body structure is made semi-rigid or rigid to maintain the stent or conduit open during the implantation and securing of the tissue body structure into the vessel, duct, or bowel. After a predetermined time sufficient to suture or otherwise fix the ends of the stent or conduit, the tissue body structure softens to a conformable stent inside the vessel duct, or bowel being repaired or reinforced.