Temporary Hydrogel Scaffold for DMEK Tissue Insertion

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Solution Overview

Problem

The adoption of Descemet Membrane Endothelial Keratoplasty (DMEK) surgery has been slow due to the fragility and propensity of DMEK tissue to scroll-up, requiring a highly specialized technique and intensive training, while Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) is more adaptable due to its additional stromal layer providing thickness and strength.

Innovation Solution

A synthetic stromal scaffold (SSS) comprised of a hydrogel biomaterial is coupled with DMEK tissue to impart properties similar to DSAEK, allowing for easier handling and insertion by making DMEK behave like DSAEK, including thickness, strength, flexibility, and shape memory, and is dissolvable or removable post-surgery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If DMEK tissue is used for endothelial keratoplasty, then clinical outcomes are superior to DSAEK, but the tissue is fragile and prone to scrolling requiring specialized training

Engineering Contradiction:

Improveclinical outcomeVSAvoidhandling difficulty

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

A temporary synthetic stromal scaffold serves as an intermediary carrier that provides mechanical support to the fragile DMEK tissue during surgical manipulation and implantation. The scaffold acts as a mediator between the thin endothelial layer and the surgical environment, enabling standard surgical techniques to be used without requiring specialized training for handling delicate DMEK tissue.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention combines the DMEK tissue layer with a synthetic stromal scaffold to create a composite structure. This composite material provides both the biological functionality of the endothelial layer and the mechanical properties of the scaffold, resolving the contradiction between tissue fragility and ease of handling.

Inventive Principle:

Principle #40Composite materials

2Stability of the object's composition

If DMEK tissue is used, then anatomical correctness is improved, but the tissue requires intensive training and specialized technique

Engineering Contradiction:

Improveanatomical correctnessVSAvoidsurgical technique complexity

Core Design Contradiction:

Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The synthetic stromal scaffold serves as a temporary intermediary structure that simplifies the surgical procedure. It allows surgeons to use familiar DSAEK-like techniques for tissue insertion and positioning, reducing the complexity of the surgical technique while maintaining the anatomical correctness of the DMEK graft.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The DMEK tissue is pre-mounted on the synthetic scaffold before surgery, preparing it in advance for implantation. This preliminary action ensures the tissue maintains its anatomical structure and reduces the technical complexity during the actual surgical procedure.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If DMEK tissue is used, then visual restoration is improved, but handling and insertion become more difficult

Engineering Contradiction:

Improvevision restorationVSAvoidinsertion difficulty

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

By creating a composite structure of DMEK tissue combined with synthetic stromal scaffold, the invention maintains the vision-restoring properties of the endothelial layer while adding the mechanical strength and handling characteristics needed for easier surgical insertion.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The synthetic scaffold acts as a temporary mediator that facilitates the insertion process. It provides a stable platform for manipulating and positioning the DMEK tissue within the eye, after which the scaffold can be removed, leaving only the functional endothelial layer for vision restoration.

Inventive Principle:

Principle #24Intermediary (Mediator)

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

This approach enables DSAEK surgeons to perform DMEK without additional training, reducing the learning curve and expanding the applicability of DMEK surgery to various eye conditions and donor tissues.

Implementation Method 1

a synthetic scaffold adhered to the Descemet membrane endothelial tissue layer

Methodology Applied

Scientific EffectAdhesion: Adhesive

Implementation Method 2

Methodology Applied

Scientific EffectShape memory: Shape Memory Polymer

Implementation Method 3

and is dissolvable or removable post-surgery

Methodology Applied

Scientific EffectDissolution: Hydrolysis

Data Source

PatentUS12453628B2Temporary synthetic carrier for corneal tissue insertion and tissue delivery

Publication Date: 2025.10.28 CORNELL UNIVERSITY

AI summary

The present solution can temporarily impart the handling characteristics of corneal stroma to the otherwise very thin, flimsy, coiling, and fragile Descemet membrane endothelial keratoplasty (DMEK) tissue during its insertion into the anterior chamber and positioning in apposition against the cornea of the recipient eye. The device of the present solution can be configured in a number of ways. In a first configuration, a scaffold can be coupled with the endothelial side of the DMEK graft. In a second configuration, the scaffold can be coupled with the stromal side of the DMEK graft. In a third configuration, one or more scaffolds can be coupled with both the endothelial and stromal side of the DMEK graft.