Methods, devices, and systems for monitoring intraocular pressure
Inventors
KAMTHAN, Gautam • Ianchulev, Tsontcho
Assignees
Icahn School of Medicine at Mount Sinai
Publication Number
US-12285217-B2
Publication Date
2025-04-29
Expiration Date
2041-05-14
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Abstract
Disclosed herein are methods, devices, and systems for monitoring fluid outflow behavior of an eye of a subject, for example, during ocular surgery. Changes to intraocular pressure can reflect fluid outflow behavior. Fluid outflow behavior can be a critical factor in the successful outcome of a surgery and determining likelihood of post-operative side effects. Large fluctuations in intraocular pressure, ocular hypertension, and hypotony can be associated with vision loss or poor ocular health.
Core Innovation
The invention provides methods, devices, and systems for monitoring fluid outflow behavior of an eye of a subject, particularly during ocular surgery. The monitoring is based on continuous measurement of intraocular pressure (IOP) over time, reflecting fluid outflow through natural or artificial pathways. The real-time characterization of fluid outflow behavior helps guide medical interventions and improve surgical outcomes by reducing postoperative complications related to IOP fluctuations, ocular hypertension, or hypotony.
The problem addressed by the invention is the lack of dynamic, continuous, and real-time intraoperative monitoring of IOP and fluid outflow behavior. Existing techniques, such as tonometry, provide only static pressure readings that are inaccurate during surgery due to corneal edema and do not provide information on dynamic outflow behavior. Current assessments rely on subjective visual and tactile surgeon inspection, which does not provide comprehensive or predictive insight into intraocular fluid homeostasis or the success of surgical interventions.
Claims Coverage
The claims include one independent system claim and several method claims focusing on monitoring fluid outflow and intraocular pressure behavior of an eye and presenting the results for surgical guidance.
System for monitoring fluid outflow facility of an eye
A system comprising an infusion line inserted into the eye delivering fluid; a sensor communicatively coupled to the infusion line configured to continuously detect fluid outflow of the eye over time in response to the fluid delivery; and a processor configured to generate a representation of the fluid outflow behavior indicative of a behavior pattern, and to provide an indication of whether that behavior is normal or abnormal.
Probe insertion with sealed entry port
The infusion line is inserted through a probe comprising a sealed entry port preventing fluid leakage at the insertion site. The sensor can be located at or remote from the probe.
Real-time, continuous detection and representation
The sensor continuously detects fluid outflow or intraocular pressure in real-time and in vivo. The processor concurrently generates the representation of fluid outflow behavior during detection.
Pump-based infusion control
The system may include a pump to infuse a replacement fluid into the eye through the infusion line, with the representation further based on pressure changes from this infusion.
Representation modalities and intervention recommendations
The representation of fluid outflow can be visual, audio, or tactile. The processor provides surgical intervention recommendations based on detected abnormal flow patterns, selecting interventions to increase or decrease fluid outflow as indicated.
Methods for fluid infusion and monitoring
Methods comprising infusing fluid into the eye via an infusion line; continuously detecting the infused fluid volume or intraocular pressure; generating a representation of fluid outflow facility; and performing or modifying surgical interventions based on this representation.
The claims collectively cover a comprehensive system and methods for real-time, continuous monitoring of intraocular fluid outflow behavior using an insertion-based infusion line with pressure sensing and processing to generate actionable representations supporting surgical decisions and interventions.
Stated Advantages
Provides continuous, dynamic, real-time monitoring of intraocular pressure and fluid outflow behavior during surgery.
Enables a more comprehensive and predictive assessment of ocular fluid balance compared to static pressure measurements.
Facilitates early detection and intervention to reduce postoperative risks such as pressure spikes or hypotony.
Supports personalized, patient-specific surgical adjustments to improve outcomes.
Reduces subjectivity of current visual and tactile surgical assessments with objective biometric data.
Allows evaluation of device functionality, such as glaucoma drainage implants.
Supports fluid challenge testing to dynamically characterize eye responses to fluid infusion.
Potentially reduces unnecessary postoperative office visits by early risk identification.
Documented Applications
Monitoring fluid outflow behavior during ocular surgeries such as glaucoma surgery, cataract surgery, and retinal surgery.
Guiding intraoperative surgical decisions, such as adjusting incision size or stented pathways to modulate fluid outflow and maintain desired IOP.
Assessing pre-operative, intra-operative, and post-operative fluid outflow and IOP behavior to inform interventions.
Evaluating functionality of ocular devices, e.g., glaucoma valve implants, by monitoring dynamic IOP changes post-implantation.
Performing fluid challenge testing by infusing controlled fluid volumes to characterize ocular dynamic outflow responses.
Providing representations of fluid outflow behavior in visual, audio, or tactile modalities to assist surgeons and clinicians.
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