Vacuum Limiter for Ophthalmic Aspiration Devices
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Solution Overview
Problem
In ophthalmic surgical procedures, especially vitreoretinal surgeries, there is a risk of tissue incarceration in the aspiration path due to the vacuum used to remove fluid and debris, which can lead to tissue damage and complications such as enlargement of retinal tears or holes, as the visibility is limited and fluid turbulences can cause the retina to become incarcerated.
Innovation Solution
A microsurgical aspiration device equipped with a vacuum limiter that automatically opens to reduce the vacuum when a threshold is exceeded, allowing air to enter the aspiration passage and preventing further tissue damage, while allowing the user to override the relief position to maintain high vacuum if needed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a vacuum is used to remove fluid and debris from the surgical site, then fluid and debris are effectively removed, but tissue can become inadvertently incarcerated into the aspiration path causing tissue damage
Solution Approach 1:
The vacuum limiter is pre-configured with a relief opening that automatically activates when vacuum pressure exceeds a predetermined threshold. This preliminary safety mechanism is built into the aspiration device before surgery, allowing automatic vacuum relief without requiring real-time user intervention when tissue incarceration begins
Solution Approach 2:
The vacuum limiter incorporates a feedback mechanism where the vacuum pressure within the aspiration device is continuously monitored. When the pressure reaches a critical threshold indicating potential tissue incarceration, the system automatically responds by opening the relief passage to reduce vacuum pressure, creating a closed-loop safety feedback system
2Object-affected harmful factors
If the user places finger over the hole in the aspiration line to disrupt aspiration, then tissue damage can be prevented, but the user must react quickly enough which may not always be possible
Solution Approach 1:
The vacuum limiter enables the aspiration device to protect itself automatically without requiring external user intervention. The self-regulating vacuum relief mechanism activates autonomously when vacuum pressure exceeds the threshold, eliminating the need for the user to manually detect and respond to tissue incarceration in real-time
Solution Approach 2:
The relief opening and vacuum limiter are pre-configured into the aspiration device before surgery begins. This preliminary safety arrangement ensures that automatic vacuum relief is immediately available without requiring the user to prepare or react, reducing the time delay between tissue incarceration and vacuum relief
3Productivity
If an aspiration tip is placed underneath a detached retina to remove subretinal fluid, then fluid can be aspirated, but visibility is limited and tissue incarceration risk increases
Solution Approach 1:
The vacuum limiter provides continuous feedback on vacuum pressure levels within the aspiration device. When the user aspirates subretinal fluid, any unexpected pressure changes indicating retinal contact or incarceration automatically trigger vacuum relief, compensating for the user's limited visibility and lack of direct visual feedback about tip position
4Productivity
If aspiration is performed close to a retinal break, then subretinal fluid can be removed, but fluid turbulences cause the detached retina to move and become incarcerated
Solution Approach 1:
The vacuum limiter monitors vacuum pressure continuously during aspiration near retinal breaks. When fluid turbulence or retinal movement causes sudden pressure changes, the system automatically responds by opening the relief passage to reduce vacuum, preventing retinal incarceration without requiring the user to visually detect the movement
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 vacuum limiter reduces the risk of tissue damage by automatically reducing the vacuum when it exceeds a certain limit, allowing safer detachment from incarcerated tissue and minimizing the risk of creating new or enlarging retinal holes, while allowing the user to maintain high vacuum when desired.
Implementation Method 1
a biasing element arranged to bias the actuator to a closed position that prevents passage of fluid through the opening
Implementation Method 2
a vacuum source in fluid communication with the aspiration line and configured to generate a vacuum in the aspiration line, the aspiration passageway, and the lumen of the aspiration needle
Implementation Method 3
configured to generate a vacuum in the aspiration line, the aspiration passageway, and the lumen of the aspiration needle
Implementation Method 4
the biasing element also may be structurally arranged to permit the actuator to displace from a closed position to a relief position so that fluid passes through the opening when a vacuum threshold is reached within the aspiration passageway
Data Source
AI summary
Systems, devices, and methods include a hand-held instrument with an aspiration conduit extending therethrough and with an aspiration needle arranged to aspirate fluid from a surgical site. A vacuum limiter is associated with the aspiration conduit. The vacuum limiter includes an opening formed in a wall of the aspiration conduit, an actuator disposed in the opening, and a biasing element biasing the actuator to a closed position that prevents passage of fluid through the opening. The biasing element is arranged to permit the actuator to displace from the closed position to a relief position so that fluid passes through the opening when a threshold vacuum is reached within the lumen. The actuator can further displace to an override position that prevents passage of fluid through the opening.


