Atraumatic Cell Encapsulation Pouch with Eversion 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 atraumatic cell encapsulation devices with composite layers that allow for eversion or wrinkled structures, enabling minimally invasive removal by applying a tensile force to engage a removal element, allowing the device to be peeled away from the tissue without causing trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional implantable devices are removed by cutting surrounding tissue, then the device can be removed, but tissue trauma and patient discomfort occur
Solution Approach 1:
The device is divided into multiple layers with different functions: an inner layer that promotes tissue ingrowth for secure implantation, and an outer layer that prevents tissue ingrowth to enable clean removal. This segmentation allows the device to be firmly anchored during use but easily removed afterward without tissue cutting.
Solution Approach 2:
The invention inverts the conventional approach by designing the outer surface to be non-ingrowth while the inner surface promotes ingrowth. This reversal allows the device to be removed by peeling the outer layer away from the tissue rather than cutting through tissue to extract the device.
2Stability of the object's composition
If temporary devices are implanted to allow tissue ingrowth for stability, then device stability improves, but device removal becomes difficult and traumatic
Solution Approach 1:
The device separates the stabilization function (inner layer with tissue ingrowth) from the removal function (outer layer preventing ingrowth). This allows the device to achieve stability through controlled tissue integration while maintaining a clean interface for atraumatic removal.
Solution Approach 2:
Different surfaces of the device have different properties: the inner surface promotes tissue ingrowth for stability, while the outer surface prevents ingrowth to facilitate removal. This local differentiation of properties resolves the contradiction between needing stability and ease of removal.
3Device complexity
If devices are designed with single-layer structures, then device complexity is reduced, but the ability to achieve both stable implantation and atraumatic removal is compromised
Solution Approach 1:
The device uses multiple layers with distinct functions: one layer for secure implantation via tissue ingrowth and another layer for clean removal by preventing ingrowth. This segmentation enables the device to perform both stable implantation and atraumatic removal, which a single-layer structure cannot achieve.
Solution Approach 2:
The device employs composite construction with layers having different biological interaction properties. This composite structure allows simultaneous achievement of stable implantation and easy removal, providing versatility that simple single-material structures cannot deliver.
Data Source
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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.