Bleb Formation Wire Loop for Single-Puncture Glaucoma Surgery

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Solution Overview

Problem

Existing glaucoma treatments require multiple incisions or punctures for bleb formation, which are invasive and time-consuming, and separate tools are needed for tissue disruption and cauterization.

Innovation Solution

A minimally invasive bleb formation device comprising an introducer sheath and a wire that can both disrupt and cauterize tissue, simplifying the procedure by integrating these functions into a single tool.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple separate tools are used for tissue disruption and cauterization, then each function can be performed with specialized equipment, but the procedural complexity and time increase

Engineering Contradiction:
Improvetissue disruption and cauterization effectivenessVSAvoidnumber of separate tools required
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines tissue disruption and cauterization functions into a single integrated device. The introducer sheath with deployable wire performs both functions sequentially: the wire is advanced to disrupt tissue and form a bleb, then the same wire is used to cauterize the disrupted tissue to minimize bleeding. This eliminates the need for separate surgical instruments for each function.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The wire component serves multiple functions within a single device system. It acts as both a tissue disruption element (forming the bleb) and a cauterization element (controlling bleeding). The introducer sheath itself serves as both the delivery mechanism and the cauterization tool when electrical current is applied through its wall, providing universal functionality for the procedure.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Ease of operation

If multiple incisions or punctures are made for bleb formation, then adequate access to target tissue is achieved, but patient trauma and procedural invasiveness increase

Engineering Contradiction:
Improveaccess to target tissueVSAvoidpatient trauma and invasiveness
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The procedure is segmented into distinct phases using a single access point: first the introducer sheath is inserted through one puncture to establish access, then the wire is deployed through the sheath lumen to perform tissue disruption, and finally cauterization is performed through the same access. This segmentation of functions through a single entry point minimizes trauma while maintaining operational ease.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The introducer sheath acts as an intermediary device that provides a protected pathway through the tissue. It allows the wire to be advanced to the target site through a single controlled puncture, protecting surrounding tissues and providing a stable platform for both tissue disruption and cauterization without requiring multiple direct incisions.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If separate procedures are used for bleb formation and cauterization, then each step can be optimized independently, but overall procedural time increases

Engineering Contradiction:
Improvebleb formation qualityVSAvoidtotal procedural time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The procedure maintains continuous useful action by performing tissue disruption and cauterization in immediate succession using the same device components. The wire that creates the bleb remains in position and is immediately used for cauterization without requiring device exchange or repositioning. This continuous action eliminates idle time between critical procedural steps while maintaining quality of each function.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The introducer sheath is inserted and positioned in advance to establish the access pathway before tissue disruption begins. This preliminary action prepares the delivery system so that when the wire is deployed, both disruption and subsequent cauterization can proceed immediately without delays for device setup or repositioning, reducing overall procedural time while ensuring proper bleb formation.

Inventive Principle:
Principle #10Preliminary action

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

Reduces procedural invasiveness and time by using a single tool for bleb formation and cauterization, minimizing bleeding and simplifying surgical techniques for glaucoma treatment.

Implementation Method 1

disrupting target tissue to form a bleb via the wire loop

Methodology Applied
Scientific EffectMechanical force: Mechanical Force

Implementation Method 2

cauterizing the disrupted target tissue by applying an electrical current to the disrupted target tissue via the wire loop

Methodology Applied
Scientific EffectElectrical current: Electrical Resistance

Data Source

PatentUS12551268B2Minimally invasive bleb formation devices and methods for using such devices
Publication Date: 2026.02.17 SHIFAMED HLDG LLC
  • US12551268B2 patent drawing
  • US12551268B2 patent drawing
  • US12551268B2 patent drawing

AI summary

The present technology provides systems, devices, and methods for forming blebs to treat ocular hypertension or glaucoma. In some embodiments, a minimally invasive bleb formation device comprises an introducer sheath having a lumen extending longitudinally therethrough. The lumen has a distal end aperture insertable adjacent to a target tissue. The device further includes a wire positionable within the lumen of the introducer sheath. The wire has a first end portion, a second end portion, and an intermediate region between the first end portion and the second end portion. At least a segment of the intermediate portion is configured to extend through the distal end aperture to form a wire loop. The wire loop is moveable between a plurality of positions and is configured to disrupt and cauterize the target tissue.