Superelastic Capsularhexis Device with Resistive Heating Element
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Solution Overview
Problem
Conventional methods for performing capsularhexis during cataract surgery are challenging due to the difficulty in controlling the cutting tip, leading to radial tears, capsule instability, and increased risk of vitreous loss and complications such as retinal detachment and infection, especially when achieving a smooth and properly sized capsular opening.
Innovation Solution
A capsularhexis device featuring a resistive-heating element made from a superelastic wire formed into a loop, which is heated to create a localized burn on the anterior capsule, allowing for a smooth circular or oval opening with reduced risk of radial tearing, using a handle and tubular insertion cartridge for precise control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a cystotome cutting tip is used to make capsular incisions, then the surgeon can perform the initial incision, but controlling the path of the cutting tip becomes extremely difficult leading to radial tears and tags
Solution Approach 1:
The patent replaces the mechanical cutting action of a cystotome with a thermal cutting mechanism using a resistive heating element. The heating element is inserted through a small incision, heated to melt and seal the capsule tissue, creating a smooth circular opening without radial tears or tags that plague mechanical cutting methods
Solution Approach 2:
The patent changes the physical state and properties of the heating element by controlling temperature parameters. The resistive heating element is heated to specific temperatures to melt capsule tissue cleanly, while the superelastic wire allows the device to transition between compressed insertion state and expanded cutting state, solving the control difficulty
2Ease of manufacture
If small capsular tears with tags are created, then the initial incision can be made, but radial capsular tears may extend into the posterior capsule causing vitreous loss and retinal detachment
Solution Approach 1:
The patent replaces mechanical tearing and cutting with thermal melting using a resistive heating element. This thermal approach melts the capsule tissue smoothly along a controlled circular path, sealing edges as it cuts, thereby preventing radial tears from extending into the posterior capsule and eliminating the harmful effects of capsular tags
Solution Approach 2:
The heating element acts as an intermediary between the surgeon's control and the capsule tissue. By controlling the heating element's position and temperature, the surgeon can create a smooth circular opening without direct mechanical contact, eliminating the forceful tearing that causes radial tears and vitreous loss
3Ease of operation
If a small or misplaced capsular opening is created, then the initial cut can be made, but the lens nucleus removal and IOL insertion are impeded requiring additional stress on the capsule
Solution Approach 1:
The patent uses thermal melting instead of mechanical cutting to create the capsular opening. This allows precise control over the opening size and position, ensuring it is appropriately dimensioned for safe lens nucleus removal and IOL insertion without requiring additional stress on the capsule that could cause breakage
Solution Approach 2:
The surgeon can control the heating element's position and the heating duration to precisely determine the size and position of the capsular opening. This feedback control ensures the opening is optimally sized and positioned before proceeding with lens removal and IOL insertion, preventing the need for additional stressful maneuvers
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 device enables a safe and effective capsularhexis with reduced radial tears and improved capsule integrity, facilitating proper IOL placement and reducing the risk of secondary cataracts and complications like vitreous loss and infection.
Implementation Method 1
A bare surface of this loop may be applied to the anterior capsule and heated with an electrical current to cause localized heating, or 'burning' of the capsule
Implementation Method 2
a resistive-heating element formed from an electrically resistive, superelastic wire formed into a loop
Data Source
AI summary
A capsularhexis device comprises a resistive-heating element formed from an electrically resistive, superelastic wire formed into a loop. A bare surface of this loop is applied to the anterior capsule and electrically heated to define a rhexis boundary, such that a smooth circular or oval capsule portion may be removed. In some embodiments, the superelastic wire is formed to include a loop, so that first and second ends of the wire are adjacent to one another and extend away from the loop to form a lead section. An electrically insulating material may completely or partly surround the first and second ends of the wire so that the first and second ends of the superelastic wire are electrically separated. A handle engages at least a portion of the lead section so that the loop-shaped heating element may be moved in and out of the anterior chamber.