Intravascular Cell Delivery Graft for Islet Survival

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Solution Overview

Problem

Current methods for treating Type 1 Diabetes, such as pancreas and islet transplants, face challenges due to organ donor shortages and low islet survival rates due to inflammatory responses, oxidative stress, and abnormal blood flow, necessitating a stable environment for islet cells to function effectively.

Innovation Solution

Intravascular retrievable cell delivery systems comprising an outer and inner graft with a central expanded portion, allowing for the transplantation of cells like pancreatic islet cells embedded in a biocompatible polymer-based carrier material, such as PPCN, which provides a supportive microenvironment and facilitates nutrient and insulin exchange within the vasculature.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If islets are transplanted into the liver or hepatic portal vein, then transplantation can be performed, but islet survival rates are low due to acute inflammatory responses, oxidative stress, and abnormal blood flow

Engineering Contradiction:

Improveislet survival rateVSAvoidinflammatory responses, oxidative stress, abnormal blood flow

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device employs a nested structure with an inner graft containing islet cells embedded in carrier material, surrounded by an outer graft. This nested configuration protects the transplanted islets from harmful blood flow dynamics and inflammatory factors while allowing nutrient and insulin exchange through the graft walls.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The biocompatible polymer-based carrier material (PPCN) acts as an intermediary between the transplanted islet cells and the blood flow environment. It provides a protective microenvironment that reduces oxidative stress and inflammatory responses while facilitating necessary exchanges.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If a stable environment is provided for islets to survive and function, then islet survival and insulin production improve, but device complexity increases due to the need for specialized graft structures

Engineering Contradiction:

Improveislet survival rateVSAvoidgraft structure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The device is divided into distinct functional segments: an inner graft for containing islet cells and carrier material, an outer graft for structural support and vascular integration, and a central expanded portion for housing the transplant. This segmentation allows each component to be optimized for its specific function while simplifying the overall design.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The graft structure serves multiple functions simultaneously: it provides mechanical support, creates a protective microenvironment, facilitates nutrient and insulin exchange, and enables easy implantation and retrieval. This multi-functionality reduces the need for additional specialized components.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Productivity

If organ donor shortage is addressed by increasing transplantation procedures, then more patients can be treated, but the limited number of viable donor pancreases restricts treatment availability

Engineering Contradiction:

Improvenumber of treatmentsVSAvoidavailable donor pancreases

Core Design Contradiction:

ProductivityVSQuantity of substance

Solution Approach 1:

The invention extracts islet cells from donor pancreases and transplants them separately using the protected graft device, rather than transplanting entire pancreases. This approach maximizes the utilization of limited donor tissue and enables treatment of more patients with smaller amounts of donor material.

Inventive Principle:

Principle #2Taking out (Extraction)

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 system enhances islet cell survival and function by providing a stable environment, improving oxygenation, and protecting cells from deleterious blood flow dynamics, while allowing for easy implantation and retrieval, thus potentially offering a more effective treatment for Type 1 Diabetes.

Implementation Method 1

The inner lumen of the inner element is configured to allow blood to flow through the inner lumen, when inserted into the vasculature of a subject

Methodology Applied

Scientific EffectBlood flow: Convection

Implementation Method 2

The inner element is configured to allow fluids, nutrients, peptides, and/or proteins to pass between the inner lumen of the inner element and the void between the inner element and the outer graft

Methodology Applied

Scientific EffectDiffusion: Diffusion