Cell Encapsulation Pouch Eversion for Atraumatic Removal

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Solution Overview

Problem

Conventional implantable devices for biological therapies are difficult to remove without causing trauma to the surrounding tissue, leading to patient discomfort and limiting the reusability of the tissue for future procedures.

Innovation Solution

The development of a therapeutic device with composite layers that include a cell permeable layer allowing vascularization and a cell retentive layer preventing ingrowth, featuring a pouch design with a removal element for eversion, enabling atraumatic removal by applying a tensile force to peel the device from the tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional removal methods (cutting surrounding tissue) are used, then the device can be removed from the tissue, but tissue trauma occurs and patient discomfort results

Engineering Contradiction:

Improvedevice removalVSAvoidtissue trauma

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The device is segmented into a removable component and an implantable component. The removable component can be detached and pulled through the implantable component to extract the entire device from the tissue pocket without cutting surrounding tissue, thereby enabling easy removal while minimizing tissue trauma.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Instead of cutting the tissue to remove the device, the removal element is pulled through the device in the opposite direction, causing the device to be extracted through the original implantation site. This inverted approach avoids tissue cutting and reduces trauma while maintaining removal capability.

Inventive Principle:

Principle #13The other way round (Inversion)

2Duration of action of moving object

If the device is implanted temporarily, then it can be removed after use, but tissue ingrowth makes removal difficult and limits future procedures

Engineering Contradiction:

Improvetemporary implantationVSAvoidremoval difficulty

Core Design Contradiction:

Duration of action of moving objectVSDevice complexity

Solution Approach 1:

By dividing the device into removable and implantable components, the system allows complete extraction of the temporary device through the implantation site. This segmentation enables temporary implantation functionality while simplifying removal procedures and preserving tissue for future use.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The device is designed with a built-in removal mechanism (removal element) that is prepared in advance for easy extraction. This preliminary design feature ensures that when removal is needed after temporary implantation, the device can be easily extracted without complex procedures, maintaining tissue可用性 for future procedures.

Inventive Principle:

Principle #10Preliminary action

3Device complexity

If a single layer design is used, then the device structure is simple, but it cannot simultaneously allow vascularization and prevent cell ingrowth

Engineering Contradiction:

Improvedevice structureVSAvoidfunctional performance

Core Design Contradiction:

Device complexityVSAdaptability or versatility

Solution Approach 1:

The composite layer incorporates regions with different pore sizes within the same structure. Areas with larger pores allow vascular tissue ingrowth for nutrient supply, while areas with smaller pores prevent cell migration into the device. This local quality variation enables the simple single-layer structure to achieve multiple functional performance requirements simultaneously.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The device uses a composite layer combining materials or structures with different pore characteristics. This composite approach allows the single layer to perform dual functions: facilitating vascularization in some regions while blocking cell ingrowth in others, thereby achieving versatile functional performance without increasing overall structural complexity.

Inventive Principle:

Principle #40Composite materials

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 device allows for the atraumatic removal of implantable biological devices, minimizing tissue trauma and enabling reuse of the implantation site for future procedures.

Implementation Method 1

a first cell permeable layer extending between the opposed first and second ends

Methodology Applied

Scientific EffectDiffusion: Diffusion

Implementation Method 2

a first cell retentive layer extending between the opposed first and second ends

Methodology Applied

Scientific EffectPhysical barrier (porosity): Porosity

Data Source

PatentUS12472337B2Atraumatic removable cell encapsulation devices

Publication Date: 2025.11.18 WL GORE & ASSOC INC

AI summary

A therapeutic device includes a pouch having opposed first and second ends and first and second composite layers extending between the opposed first and second ends. The first composite layer includes a first cell permeable layer extending between the opposed first and second ends and a first cell retentive layer extending between the opposed first and second ends. The pouch includes a reservoir formed between the first and second composite layers, contacting the first cell retentive layer, and at least one port in fluid communication with the reservoir. The therapeutic device further includes a removal element configured to operably engage the first end of the pouch, to cause the first end to be moveable towards the second end by eversion. In some embodiments, each of the first and second composite layers includes a plurality of wrinkles that are incrementally disengaged from a tissue to remove the therapeutic device atraumatically.