Toroidal Implantable Apparatus with Shape Memory Retrieval

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Solution Overview

Problem

Existing implantable biological devices face challenges in being placed and replaced in patients without damaging or disturbing surrounding tissues, due to the formation of fibrotic capsules and vascular tissue growth, which complicates surgical retrieval and reduces the viability of therapeutic devices.

Innovation Solution

An implantable containment apparatus with a conduit having resealable ports and a shaping element made of shape memory material, allowing the apparatus to be deformable from a toroidal configuration to a linear configuration for easy insertion and subsequent return to the toroidal configuration for therapeutic device placement and retrieval.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional implantable devices are implanted in a patient, then therapeutic product can be delivered through vascular tissues, but surgical retrieval becomes difficult and painful due to tissue growth and fibrotic capsule formation

Engineering Contradiction:
Improvetherapeutic product deliveryVSAvoidsurgical retrieval
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The implantable device is divided into two functional segments: a permanent implantable body that remains in the patient for therapeutic product delivery, and a temporary access component that facilitates initial placement and subsequent retrieval. The access component can be removed after the permanent device is established, avoiding the need to surgically retrieve the entire device while maintaining therapeutic functionality.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A temporary access component serves as an intermediary element during the implantation and retrieval process. This component provides initial access to the implantable device, enables therapeutic product delivery during the critical early period, and can be subsequently removed without disturbing the permanent implant or surrounding tissues. The intermediary component mediates between the need for easy access and the need for stable long-term implantation.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If surgical dissection is used to retrieve implanted devices, then the device can be removed, but significant tissue damage and patient pain occur

Engineering Contradiction:
Improvedevice removalVSAvoidtissue damage
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The access component is extracted or removed separately from the permanent implantable device after it has served its initial purpose. This extraction of the temporary access element allows for minimally invasive removal without requiring dissection of the permanent device or surrounding vascular tissues, thereby eliminating significant tissue damage and patient pain associated with conventional surgical retrieval.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The access component is designed as a temporary, disposable element that is discarded after serving its initial access and stabilization function. This disposable component absorbs the trauma of initial implantation and subsequent removal, protecting the permanent device and surrounding tissues from damage during both implantation and retrieval procedures.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Productivity

If injection methods are used to deliver biological moieties, then therapeutic agents can be introduced, but trauma to host tissue and shearing forces reduce viability and efficacy

Engineering Contradiction:
Improvetherapeutic agent deliveryVSAvoidbiological moiety viability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The device replaces high-shear mechanical injection methods with a low-trauma delivery system. The access component provides a controlled access channel that allows biological moieties to be delivered without the high shear forces and pressure spikes associated with conventional needle injection into dense tissue. This mechanical substitution preserves biological moiety viability while maintaining effective therapeutic agent delivery.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The access component utilizes flexible, biocompatible materials that can be gently inserted into tissue with minimal trauma. These flexible structures allow for controlled delivery of biological moieties without the rigid, high-impact mechanics of traditional needle injection, thereby preserving the viability and efficacy of sensitive biological agents while maintaining effective therapeutic delivery.

Inventive Principle:
Principle #30Flexible shells and thin films

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 apparatus reduces trauma to host tissues during implantation, enables immediate vascularization for effective therapy delivery, and allows for easy access and replacement of therapeutic devices without causing significant tissue damage.

Implementation Method 1

a shaping element made of shape memory material, allowing the apparatus to be deformable from a toroidal configuration to a linear configuration for easy insertion and subsequent return to the toroidal configuration

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentEP3538021B1Implantable apparatus for retention of biological moieties
Publication Date: 2025.04.02 WL GORE & ASSOC INC
  • EP3538021B1 patent drawingFigure 1A~2B
  • EP3538021B1 patent drawingFigure 3~4B
  • EP3538021B1 patent drawingFigure 5~6

AI summary

An implantable containment apparatus for receiving and retaining a biological moiety or a therapeutic device within a tissue bed is disclosed. The device includes a shaping element to maintain the device in a generally toroidal configuration and to return the apparatus to that configuration after deformation. The apparatus can be placed in a host tissue with minimal trauma to the patient. Methods for implanting and using the apparatus are also disclosed.