Biocompatible Membrane Composite for Immune Isolation and Vascularization

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Solution Overview

Problem

Existing implantable devices face challenges in maintaining the viability of encapsulated bioactive entities by preventing an immune response that impedes the formation of blood vessels close to the cells, restricting access to oxygen and nutrients.

Innovation Solution

A biocompatible membrane composite with a cell impermeable layer and a mitigation layer that includes solid features to reduce foreign body giant cell formation, allowing vascular ingrowth and nutrient transfer while maintaining immune isolation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a cell impermeable membrane is used to isolate implanted cells from the host immune system, then immune isolation is achieved, but foreign body giant cells form at the interface preventing blood vessel formation close to the cells

Engineering Contradiction:
Improveimmune isolationVSAvoidforeign body giant cell formation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The membrane is divided into two distinct layers: a cell impermeable layer for immune isolation and a mitigation layer with solid features to prevent foreign body giant cell formation. This segmentation allows each layer to perform its specific function independently, resolving the contradiction between immune isolation and preventing harmful cell formation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The mitigation layer acts as an intermediary between the cell impermeable membrane and the host tissue. It modifies the immune response by preventing foreign body giant cell formation while allowing the cell impermeable layer to maintain its isolation function, thus mediating the interaction between the implant and host.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If the diffusion distance for oxygen and nutrients is minimized to maintain cell viability, then cell productivity is improved, but the formation of foreign body giant cells prevents blood vessels from forming close to the cells

Engineering Contradiction:
Improvecell viabilityVSAvoidbarrier to vascularization
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

By segmenting the membrane into two functional layers, the invention enables the mitigation layer to specifically address vascularization barriers while the cell impermeable layer maintains isolation, allowing blood vessels to form close to the cells for optimal nutrient diffusion and cell productivity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The mitigation layer introduces local quality changes at the membrane interface by incorporating solid features that specifically prevent foreign body giant cell formation in the region where vascularization is needed, without affecting the overall immune isolation function.

Inventive Principle:
Principle #3Local quality

3Object-affected harmful factors

If a smooth non-adhesive surface is used to prevent cellular attachment, then immune cell adhesion is reduced, but blood vessel formation close to the cells is also inhibited

Engineering Contradiction:
Improvecellular adhesionVSAvoidblood vessel formation
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The invention applies local quality by creating distinct surface properties in different layers: the cell impermeable layer has a smooth non-adhesive surface to prevent immune cell adhesion, while the mitigation layer has solid features that create a controlled interface promoting blood vessel formation without foreign body giant cell interference.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

Segmenting the membrane surface into two layers with different adhesive properties allows the invention to simultaneously prevent harmful cellular adhesion at the cell impermeable interface while facilitating beneficial blood vessel formation through the mitigation layer.

Inventive Principle:
Principle #1Segmentation

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 composite layer supports the survival of encapsulated cells by facilitating vascularization and nutrient delivery, minimizing the formation of foreign body giant cells at the interface, thereby ensuring the viability and functionality of implanted cells.

Implementation Method 1

the bioactive entities must maintain access to nutrients, such as oxygen, which are delivered through the blood vessels of the host

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 2

The device is formed of one or more biocompatible membranes or other biocompatible materials that permit the passage of nutrients through but prevent the passage of the cells encapsulated therethrough

Methodology Applied
Scientific EffectPermeation: Permeation

Data Source

PatentEP3975925B1Biocompatible membrane composite
Publication Date: 2026.01.28 WL GORE & ASSOC INC
  • EP3975925B1 patent drawingFigure 1A~1B
  • EP3975925B1 patent drawingFigure 2
  • EP3975925B1 patent drawingFigure 3A~3B

AI summary

A biocompatible membrane composite including a cell impermeable layer and a mitigation layer is provided. The cell impermeable layer is impervious to vascular ingrowth and prevents cellular contact from the host. Additionally, the mitigation layer includes solid features. In at least one embodiment, mitigation layer has therein bonded solid features. In some embodiments, the cell impermeable layer and the mitigation layer are intimately bonded or otherwise connected to each other to form a composite layer having a tight/open structure. A reinforcing component may optionally be positioned external to or within the biocompatible membrane composite to provide support to and prevent distortion. The biocompatible membrane composite may be used in or to form a device for encapsulating biological entities, including, but not limited to, pancreatic lineage type cells such as pancreatic progenitors.