Glaucoma Shunt Device with Stent Basket for Aqueous Humor Drainage

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Solution Overview

Problem

Current treatments for glaucoma, such as bleb formation and valve implants, often fail due to scarring and encapsulation, leading to increased intraocular pressure and the need for repeated surgeries, as they are prone to leaks and difficult to maintain effectively.

Innovation Solution

A shunt device with a tube body and stent basket is implanted to divert aqueous humor from the anterior chamber to the retrobulbar space, maintaining a space between the tube and retro-orbital tissue to facilitate fluid drainage, reducing intraocular pressure and minimizing the risk of scarring.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a bleb is formed with conjunctiva tissue to create a drainage system, then aqueous humor outflow is increased, but the bleb is prone to scarring and encapsulation which blocks outflow and increases intraocular pressure again

Engineering Contradiction:
Improvedurability of drainage systemVSAvoidscarring and encapsulation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

A biocompatible plate is introduced as an intermediary barrier between the aqueous humor and the conjunctival tissue. This plate prevents direct contact between the drainage system and host tissue, thereby eliminating the scarring and encapsulation response while maintaining effective aqueous humor drainage through the created space.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention extracts the problematic conjunctival tissue from the drainage pathway by placing a plate between the aqueous humor and the conjunctiva. This removal of the offending tissue element prevents the harmful scarring and encapsulation process while preserving the drainage function.

Inventive Principle:
Principle #2Taking out (Extraction)

2Reliability

If plates are placed on top of the sclera and sewn against the sclera to create additional space for the bleb, then the likelihood of bleb scarring is reduced, but the system requires watertight seals which are difficult to form and time consuming to create

Engineering Contradiction:
Improvebleb stabilityVSAvoidsurgical complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention removes the need for complex watertight sealing by extracting the conjunctival tissue from the drainage pathway using a plate. This eliminates the requirement for intricate suturing and sealing procedures while maintaining bleb stability and preventing scarring.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

This principle is not applicable to the invention. The solution relies on physical separation rather than material property changes.

Inventive Principle:
Principle #32Color changes

3Reliability

If valve implants are used to maintain fluid connections and facilitate aqueous humor outflow, then drainage is improved, but the valves can become surrounded by fibrous inflammatory tissues called encapsulation rendering the procedure ineffective

Engineering Contradiction:
Improvedrainage functionVSAvoidfibrous inflammatory tissue encapsulation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

A biocompatible plate serves as an intermediary barrier between the aqueous humor and the host tissue. This plate prevents the formation of fibrous inflammatory encapsulation around the drainage system while maintaining effective aqueous humor outflow through the created space.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention extracts the conjunctival tissue from contact with the drainage system by placing a plate between them. This removal prevents the harmful encapsulation response while preserving the valve's drainage function.

Inventive Principle:
Principle #2Taking out (Extraction)

4Reliability

If repeated follow-up surgeries are performed to repair failed blebs, then intraocular pressure can be managed, but the patient undergoes multiple time consuming and complex procedures with inherent risks

Engineering Contradiction:
Improveintraocular pressure controlVSAvoidrepeated surgical procedures
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The biocompatible plate is placed during the initial surgery to prevent future scarring and encapsulation problems. This preliminary preventive action eliminates the need for repeated follow-up surgeries by addressing the root cause of bleb failure before it occurs.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The plate acts as a protective barrier that cushions against the formation of fibrous tissue and scarring. By providing this protective layer beforehand, the invention prevents future complications and eliminates the need for multiple revision surgeries.

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

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 shunt device effectively reduces intraocular pressure by creating a stable fluid passage, reducing the need for frequent follow-up surgeries and minimizing the risk of bleb failure, as it leverages the eye's natural healing processes to maintain the drainage pathway.

Implementation Method 1

the tube body provides fluid passage for aqueous humor from the anterior chamber of the eye to the retrobulbar space, whereby the aqueous humor flows from the first end portion into the retrobulbar space

Methodology Applied
Scientific EffectFluid flow through pressure gradient: Pressure Gradient

Data Source

PatentUS10314744B2Method and apparatus for reducing intraocular pressure of an eye
Publication Date: 2019.06.11 RYNERSON JAMES M
  • US10314744B2 patent drawing
  • US10314744B2 patent drawing
  • US10314744B2 patent drawing

AI summary

A method and shunt device for treating glaucoma includes positioning a first end portion of a tube body into the retrobulbar space of an eye. The method also includes positioning a second end portion of the tube body into the anterior chamber of the eye. The tube body provides fluid passage for aqueous humor such that the aqueous humor flows from the first end portion into the retrobulbar space. A surgical kit for reducing the intraocular pressure in the eye includes the shunt device, an introducer, and a stylet. The introducer has a distal end for positioning in the retrobulbar space and a proximal end for positioning exterior of the eye. The introducer has a radius of curvature adapted to circumvent the eye for insertion into the retrobulbar space.