Geometrically Deformable Implant Containment for Cell Viability

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Solution Overview

Problem

Existing implantable biological devices trigger an immune response, restricting access to oxygen and nutrients for housed biological moieties, leading to cell viability and health issues when placed in or around blood vessels.

Innovation Solution

An implantable encapsulation device with a composite structure, including an inner and outer layer separated by a containment layer with structural elements that maintain a separation distance, allowing for geometric deformation and placement of biological moieties in reservoir spaces, thereby minimizing immune response and ensuring access to nutrients.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If an implantable device is placed in or around a blood vessel to house biological moieties, then the device can be positioned for direct access to oxygen and nutrients, but an immune response occurs causing cells to be crushed and/or killed during implantation

Engineering Contradiction:
Improvecell viabilityVSAvoidimmune response
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device is segmented into multiple functional layers: an inner layer with reservoir spaces for housing biological moieties, a containment layer with structural elements to maintain separation distance, and an outer layer. This segmentation allows the device to provide direct access to oxygen and nutrients while protecting cells from immune response during implantation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The containment layer acts as an intermediary between the inner layer housing biological moieties and the outer layer interfacing with the body environment. This intermediate layer with structural elements maintains the separation distance that protects cells from harmful immune responses while allowing the device to be positioned for direct access to nutrients.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If an implantable device triggers an immune response, then the device can be implanted, but blood vessels cannot form in close proximity restricting access to oxygen and nutrients

Engineering Contradiction:
Improveimplantation capabilityVSAvoidaccess to oxygen and nutrients
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

Different layers of the device have different local qualities: the inner layer provides a controlled environment for biological moieties, the containment layer provides structural support and separation, and the outer layer interfaces with the body. This local differentiation allows implantation capability while ensuring access to oxygen and nutrients through the designed separation distance.

Inventive Principle:
Principle #3Local quality

3Stability of the object's composition

If the separation distance between inner and outer layers is maintained under external compressive and internal expansive forces, then the structural integrity is preserved, but the device complexity increases

Engineering Contradiction:
Improveseparation distance maintenanceVSAvoidstructural elements
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The structural elements within the containment layer are pre-configured to maintain the separation distance between the inner and outer layers. These elements are designed in advance to withstand both external compressive forces and internal expansive forces, preserving structural integrity without requiring complex real-time adjustments.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20240123205A1Geometrically deformable implantable containment devices for retention of biological moieties
Publication Date: 2024.04.18 WL GORE & ASSOC INC
  • US20240123205A1 patent drawing
  • US20240123205A1 patent drawing
  • US20240123205A1 patent drawing

AI summary

Described herein are encapsulation devices that include an inner layer, an outer layer, a cell containment layer positioned between the inner and outer layer, and structural elements disposed within the cell containment layer to separate the inner and outer layers by a separation distance. The structural elements define reservoir spaces for the retention of a biological moiety (such as cells) therein. The structural elements maintain a separation distance both under external compressive forces and under internal expansive forces, such as undergoing a geometric change in the encapsulation device or during crushing and subsequent expansion of the cell encapsulation device. In some embodiments, a reinforcing layer is positioned between the inner layer and the cell containment layer. In addition, the encapsulation device may include at least one configuration element. Methods of placing encapsulation devices in a body conduit intra-luminally, extra-luminally, and via an open surgical procedure are also disclosed.