Deformable Scleral Implant for Glaucoma Pressure Relief

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Solution Overview

Problem

Existing methods for draining aqueous humor from the eye to relieve glaucoma often result in abnormal intraocular pressure buildup due to device placement that stimulates vascular tissue and contacts the corneal endothelium, leading to complications such as vision loss and the need for corneal transplantation.

Innovation Solution

A method and device for inserting a deformable pressure-relieving implant into the sclera without incising the conjunctiva or tenon's tissue, using a pocketmaker device to create a chamber and insert a device with channels or passageways that allows fluid drainage while avoiding contact with the corneal endothelium, allowing the device to expand and return to its original shape for secure placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stress or pressure

If a device is implanted in the sclera to drain aqueous humor, then intraocular pressure is reduced, but vascular tissue stimulation occurs leading to abnormal pressure buildup

Engineering Contradiction:
Improveintraocular pressureVSAvoidpressure control stability
Core Design Contradiction:
Stress or pressureVSReliability

Solution Approach 1:

The invention extracts the device placement site from the vascular-rich conjunctival area and relocates it to the scleral area remote from vascular tissue. This extraction eliminates the harmful interaction between the implant and vascular tissue, preventing the healing response that causes pressure buildup, while still achieving the desired aqueous humor drainage function.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention introduces the sclera as an intermediary tissue layer that is remote from both the corneal endothelium and the conjunctival vascular tissue. By placing the device in this intermediate scleral region, the patent creates a safe zone that avoids direct contact with harmful structures while enabling effective fluid drainage.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If a device contacts the corneal endothelium to provide drainage, then aqueous humor flow is improved, but corneal decompensation occurs leading to vision loss

Engineering Contradiction:
Improveaqueous humor drainage efficiencyVSAvoidcorneal endothelial damage
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The invention extracts the device from proximity to the corneal endothelium by placing it in the sclera, which is remote from the cornea. This extraction eliminates direct contact between the implant and the corneal endothelium, preventing the harmful effects of endothelial cell death while maintaining effective drainage through the scleral tissue.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention moves the device placement from a two-dimensional corneal or conjunctival surface to a three-dimensional scleral space. This dimensional transition allows the device to be positioned deep within the sclera, far from the corneal endothelium, while still maintaining functional access to the aqueous humor drainage pathway.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Ease of operation

If the conjunctiva is incised to insert the device, then device placement is achieved, but healing response blocks fluid egress

Engineering Contradiction:
Improvedevice insertionVSAvoidfluid drainage patency
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The invention extracts the incision from the conjunctival tissue by approaching the sclera from the anterior chamber through a small corneal incision. This extraction eliminates the need to cut the conjunctiva, thereby preventing the healing response that would otherwise form scar tissue and block the drainage pathway.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

Instead of making an incision in the conjunctiva and working outward, the invention inverts the approach by making a small incision in the cornea and working inward to the sclera. This inverted approach allows device placement without violating the conjunctiva, thus avoiding the harmful healing response.

Inventive Principle:
Principle #13The other way round (Inversion)

4Stability of the object's composition

If a rigid device is used for secure placement, then device stability is improved, but insertion through small incision becomes difficult

Engineering Contradiction:
Improvedevice placement stabilityVSAvoiddevice insertion
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The invention employs a deformable device that can dynamically change its shape during insertion and deployment. The device is inserted in a compressed or deformed state through the small corneal incision, then expands to its full size within the scleral pocket, achieving both easy insertion and secure stable placement.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention changes the physical parameters of the device by using materials that can alter their shape and volume. The device transitions from a compressed low-volume state during insertion to an expanded high-volume state for stable placement, allowing it to overcome the size constraint of the small incision while achieving secure fixation.

Inventive Principle:
Principle #35Parameter changes

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 effectively reduces intraocular pressure without stimulating healing responses in the conjunctiva or tenon's tissue, preventing fluid egress blockage and maintaining normal vision, while avoiding corneal decompensation and the need for transplantation.

Implementation Method 1

a deformable pressure-relieving implant into the sclera... allowing the device to expand and return to its original shape for secure placement

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS10219942B1Eye implant devices and method and device for implanting such devices for treatment of glaucoma
Publication Date: 2019.03.05 OMEGAD LLC
  • US10219942B1 patent drawing
  • US10219942B1 patent drawing
  • US10219942B1 patent drawing

AI summary

The present invention provides for a deformable, insertable device for relieving intraocular pressure comprising a body portion composed of a biocompatible porous material with pores throughout to permit drainage of fluid from the anterior chamber to the scleral tissue without collapse of the anterior chamber. The invention also includes a method for inserting the device into the eye and for using ultrasound intraoperatively to determine the position of surgical tools and devices within the sclera. The invention also includes a device excising sclera in an eye to create a chamber for insertion of the insertable device into the eye.