Stiffener-Tether Implantable Capsule for CNS Delivery

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Solution Overview

Problem

Current encapsulated cell therapy devices for treating brain and spinal cord disorders are cumbersome and time-consuming to insert due to the need for stiffening wires, which can be loose and risk penetrating the device, and require manual handling that risks contamination and damage.

Innovation Solution

A device with a stiffener attached to the tether makes the tether more rigid, allowing easier manipulation and insertion of the capsule by touching the stiffener, which is detachable and can be heated to release, reducing the risk of damage and contamination, and facilitating safer implantation and retrieval.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a stiffening wire is inserted into the tether to make it more rigid for manipulation, then the ease of operation is improved, but the device complexity increases and the reliability decreases due to loose insertion and risk of penetration

Engineering Contradiction:
Improvemanipulation of tetherVSAvoidinsertion of wire into tether
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The stiffener is integrated with the tether as a single unit rather than being a separate component. The stiffener forms an integral part of the tether structure, eliminating the need for separate insertion steps and reducing device complexity while maintaining manipulation ease.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The stiffener is pre-positioned within the tether during manufacturing, so that when the device is ready for use, the tether already has the required rigidity. This eliminates the need for surgical insertion of the stiffening wire and reduces procedural complexity.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If a stiffening wire is used to facilitate insertion, then the ease of operation is improved, but the reliability worsens due to risk of wire penetrating into the device core

Engineering Contradiction:
Improveinsertion of capsuleVSAvoidrisk of wire penetration
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The stiffener and tether are merged into an integral structure where the stiffener is permanently positioned within the tether's hollow cavity. This integration eliminates the risk of loose insertion and accidental penetration into the device core during manipulation.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The tether's hollow cavity is designed to accommodate the stiffener with appropriate clearance and structural features that prevent the stiffener from penetrating into the capsule core. This design cushioning is built in before use, preventing damage during insertion procedures.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Device complexity

If manual handling of the capsule is required for insertion, then the device complexity is reduced, but the ease of operation worsens due to risk of contamination and damage

Engineering Contradiction:
Improvestructure of deviceVSAvoidhandling of capsule
Core Design Contradiction:
Device complexityVSEase of operation

Solution Approach 1:

The stiffener serves as an intermediary handling element that extends from the capsule assembly. Surgeons can grip and manipulate the stiffener instead of directly handling the delicate capsule, reducing contamination and damage risks while maintaining procedural simplicity.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The capsule is designed with a protective outer membrane that can be handled through the stiffener interface. The membrane remains protected during manipulation, allowing simple device structure while improving handling safety through the stiffener interface.

Inventive Principle:
Principle #30Flexible shells and thin films

4Ease of operation

If the tether is made more rigid with a stiffener, then the ease of operation is improved, but the manufacturing precision requirements increase

Engineering Contradiction:
Improvemanipulation of deviceVSAvoidattachment of stiffener to tether
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The stiffener and tether are manufactured as an integral unified structure rather than separate components requiring attachment. This merging eliminates manufacturing precision requirements for joining operations while maintaining the rigidity benefits for ease of operation.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The tether is constructed using composite materials that inherently provide the required rigidity and structural integrity. This composite construction eliminates the need for separate stiffeners and their attachment, reducing manufacturing precision requirements while maintaining operational ease.

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 stiffener enhances the rigidity of the therapy system, simplifying handling and insertion, reducing the risk of contamination and damage, and allowing for safer implantation and retrieval, while also improving manufacturing efficiency and reducing the complexity of surgical procedures.

Implementation Method 1

a stiffener (7) attached to the tether (4) to make the tether (4) more rigid

Methodology Applied
Scientific EffectStructural reinforcement:

Implementation Method 2

the membrane being adapted to allow passage of the active factor

Methodology Applied
Scientific EffectPermeation: Permeation

Implementation Method 3

Cells are immunoisolated from the host by enclosing them within implantable polymeric capsules formed by a microporous membrane. This approach prevents the cell-to-cell contact between host cells and implanted cells

Methodology Applied
Scientific EffectPhysical barrier: Physical Containment

Data Source

PatentEP1883446B8An implantable therapy system for treating a living being with an active factor
Publication Date: 2017.11.15 GLORIANA THERAPEUTICS SARL

AI summary

The invention provides a device for Encapsulated Cell Therapy. The device includes an implantable capsule containing cells which secrete a biologically active compound for providing a biological function. The capsule has a semi permeable outer membrane for delivery of the compound e.g. at a site in the central nervous system or the spinal cord, e.g. in the brain of a patient. The capsule is connected to a tether which e.g. facilitates removal of the capsule from the patient. To facilitate insertion of the capsule into the patient, a stiffener may be attached to the tether to make the tether more rigid. The invention further provides a container for storing a cell therapy device and a method of locating the device in the body of a patient.