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WO2017027494A1 - Mesure de pression intraoculaire à travers une paupière fermée - Google Patents

Mesure de pression intraoculaire à travers une paupière fermée Download PDF

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Publication number
WO2017027494A1
WO2017027494A1 PCT/US2016/046119 US2016046119W WO2017027494A1 WO 2017027494 A1 WO2017027494 A1 WO 2017027494A1 US 2016046119 W US2016046119 W US 2016046119W WO 2017027494 A1 WO2017027494 A1 WO 2017027494A1
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WO
WIPO (PCT)
Prior art keywords
pressure
eyelid
probe
measurement
locations
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2016/046119
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English (en)
Inventor
G. B. Kirby Meacham
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Barron Precision Instruments LLC
Original Assignee
Barron Precision Instruments LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Barron Precision Instruments LLC filed Critical Barron Precision Instruments LLC
Publication of WO2017027494A1 publication Critical patent/WO2017027494A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/16—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for measuring intraocular pressure, e.g. tonometers

Definitions

  • the present invention is directed to a method, device and system for measuring intraocular pressure in the human eye to detect glaucoma and monitor the efficacy of treatment.
  • the device and method measure the intraocular pressure through the closed eyelid to avoid direct contact with the cornea, allowing the measurement to be made outside a clinical setting, even by the patients themselves.
  • Glaucoma is a progressive and irreversible deterioration of the optic nerve, and may result in serious loss of vision.
  • Medications and surgical treatments to reduce intraocular pressure are well known and effective in slowing or stopping the progression of glaucoma, and clinical measurement of intraocular pressure is used to screen for elevated pressure and monitor the treatment.
  • Prior art intraocular pressure measurements are typically made by a mechanical member contacting the corneal membrane of the open eye and measuring its force-deflection characteristics of to infer the pressure of the aqueous humor, the fluid contained by the cornea.
  • These open-eye methods are effective, but are generally limited to a clinical setting by several factors.
  • the person making the measurement must be trained in the use of the device to avoid the possibility of injury.
  • infection control steps are needed to avoid transmitting microorganisms to the eye from the environment or between patients. Self- measurement or large scale screening using relatively untrained personnel are not practical with devices using direct corneal contact.
  • the physical properties and geometry of the human eye and eyelid are important elements in this invention.
  • the cornea When the eyes are closed and the gaze is straight ahead, the cornea is entirely or almost entirely covered by the upper eyelid, with the lashes and contact area between the upper and lower eyelids beneath the cornea.
  • the eyelid tissue over the cornea in this condition is therefore relatively thin and uniform, and behaves as a very soft elastomer or gel in the sense that it is a "contained fluid".
  • a "contained fluid” it will conform to contacting surfaces, transmit static pressures, and yet not flow out of a confined pressurized gap beyond a limited amount related to its elastic properties.
  • the present invention is directed to devices and methods for making intraocular pressure measurements through the closed eyelid to eliminate the need for anesthetic eye drops and to minimize the skill required to avoid injury and control infection while getting valid pressure measurements. It is further directed to making self-measurements practical.
  • the device of the invention comprises a probe with a concave face that is gently pressed against the closed eyelid over the cornea.
  • the concave face has a diameter, e.g., 10 millimeters, approximately equal to the corneal diameter and a spherical radius, e.g., 11 millimeters, approximately equal to the spherical radius of the closed eyelid over the cornea.
  • a number, e.g., 7, of contact pressure sensors are arrayed on the concave face such that they measure the contact pressure distribution of the probe against the eyelid.
  • the array comprises a central sensor ringed by a regularly spaced ring of sensors, but other arrangements are possible.
  • the device optionally incorporates a concentric sleeve surrounding the probe that contacts the eyelid at a larger diameter, e.g., 20 millimeters, to assist the user in centering the probe on the eyeball and the cornea.
  • MEMS microelectromechanical systems
  • the sensors may be covered with a thin layer of soft elastomer gel that transmits the eyelid pressure to the sensor while protecting the sensor and presenting a smooth surface to the eyelid.
  • Either differential or absolute pressure sensors may be used, since the sensors may be zeroed in software for each measurement.
  • the probe and sensor array are believed to respond to intraocular pressure through the eyelid through hydrostatic pressure transfer in an elastic media in a manner analogous to measuring blood pressure in an artery surrounded by soft tissue using a blood pressure cuff.
  • the cornea Prior to probe contact, the cornea is a thin spherical membrane tensioned by the internal aqueous humor pressure and supported at the circular edge by the relatively stiff sclera.
  • the hydrostatic pressure applied to the eyelid by the probe equals the internal pressure
  • the corneal membrane tension equals zero and the eyelid pressure is equal to the internal pressure and may be measured by the probe sensors.
  • the slack corneal membrane deflects inward at nearly constant pressure.
  • the measured center pressure will rise first, followed by the surrounding measured pressures. When all the sensors measure similar values, the measured values are essentially equal to the intraocular pressure. If the probe is pressed too far, the surrounding sensors will measure higher pressures because the edge of the cornea has relatively stiff mechanical support from the sclera compared to the mechanically unsupported center. Also, if the probe is tipped or off-center, there will be significant variation in the surrounding sensor values. It is therefore possible to determine when the sensor array contacting the eyelid is measuring the true intraocular pressure by considering the pressure distribution among the sensors in the array and only selecting "good" sets of sensor pressure values.
  • the device further comprises means for energizing the contact pressure sensors, acquiring the instantaneous pressure reading of each sensor, computation resources to process the pressure readings in real time, e.g., 50 times per second, and display means to present the results.
  • the method of the invention comprises pressing the concave probe gently against the closed eyelid approximately concentric with the cornea, acquiring contact pressure reading data sets from the sensor array at a rate of e.g., 50 datasets per second, analyzing each data set in real time to determine if it is "good”, calculating an intraocular pressure from each "good” data set, and averaging these calculated values to determine and report an intraocular pressure result when specified conditions such as acquiring a certain number of "good” readings are met, and indicating that the measurement is successful or must be repeated.
  • a "good" data set meets a set of criteria such as the following:
  • At least two valid approaches may be used for calculating the pressure value reported for a "good" data set.
  • the center value may be used, since it is removed from edge effects and may better reflect the aqueous humor pressure transmitted through the cornea and the eyelid.
  • a simple average or weighted average may reduce noise and also give a valid result.
  • the best algorithm may vary from user to user, and may optionally be a selectable device feature.
  • FIGURE 1 A is a sectional side elevation of an intraocular pressure measuring device approaching the closed eyelid
  • FIGURE IB is a similar view showing the device pressed against the closed eyelid in the measuring position
  • FIGURE 2A through FIGURE 2D contain four sectional side elevation details of the intraocular pressure measuring device in contact with the eyelid illustrating different contact pressure distributions;
  • FIGURE 3 contains multiple views of a probe according to the invention wherein the
  • MEMS pressure sensors measure differential pressure
  • FIGURE 4 contains multiple views of a probe according to the invention wherein the
  • MEMS pressure sensors measure absolute pressure
  • FIGURE 5 is a block diagram illustrating an exemplary system embodying the invention.
  • Figure 1A shows a generic intraocular pressure measuring device 100 according to the invention and a patient eye 101 prior to the probe 102 contacting the closed upper eyelid 103
  • Figure IB shows it in the measuring position contacting and pressing against the eyelid.
  • the probe 102 has a concave face 104 that is gently pressed against the closed eyelid 103 over the cornea
  • the concave face 104 has a diameter, e.g., 10 millimeters, approximately equal to the corneal diameter and a spherical radius, e.g., 11 millimeters, approximately equal to the spherical radius of the closed compressed eyelid 103 over the cornea 105.
  • a number, e.g., 7, of contact pressure sensors 106 are arrayed in the concave face 104 such that they measure the contact pressure distribution of the probe 102 against the eyelid 103.
  • the array comprises a central sensor
  • the device optionally incorporates a concentric sleeve 107 surrounding the probe that contacts the eyelid 103 at a larger diameter, e.g., 20 millimeters, to assist the user in centering the probe on the eyeball 108 and the cornea 105.
  • the device also may include a support body 109 that connects the concentric sleeve 107 to the probe 102 through an adjustable connection such as the screw thread connection 110.
  • An elastomer seal ring 111 may be included to allow adjustment of the sleeve 107 while excluding contaminants from the device and permitting application of liquid cleaning and disinfecting solutions.
  • the device and the system further comprises (not shown) means for energizing the contact pressure sensors, acquiring the instantaneous pressure reading of each sensor, computation resources to process the pressure readings in real time, e.g., 50 times per second, and display means to present the results.
  • display means to present the results.
  • it includes visual indicators such as blinking lights or audible indicators such as beeps to let the user whether the device is making "good” measurements, indicate the end of the test, and warn against excessive pressure of the probe against the eye that result in "too hard” readings.
  • the probe and sensor array are believed to respond to intraocular pressure through the eyelid through hydrostatic pressure transfer in an elastic media in a manner analogous to measuring blood pressure in an artery surrounded by soft tissue using a blood pressure cuff.
  • the cornea 105 Prior to probe 102, contact with the upper eyelid 103, the cornea 105 is a thin spherical section membrane tensioned by the internal aqueous humor intraocular pressure 200 as shown in Figure 2 A.
  • Figure 2B illustrates a "good" reading with the probe 102 lightly compressing the eyelid 103 against the cornea 105.
  • the hydrostatic pressure 20 IB applied to the eyelid 103 by the probe equals the internal pressure 200
  • the differential pressure across the cornea 105 vanishes
  • the corneal membrane tension equals zero
  • the eyelid pressure is substantially equal to the internal pressure 200 and may be measured by one or more of the probe sensors 106A and 106B.
  • the probe 102 is pressed further, the slack corneal membrane 105 deflects inward at a nearly constant contact pressure 201. If the probe 102 geometry is such that the center sensor 106A is closer to the cornea 105 than the surrounding sensors 106B, the measured center pressure will rise first, followed by the surrounding measured pressures. When all the sensors measure similar values, the measured values are essentially equal to the intraocular pressure.
  • the surrounding sensor 106 B will measure higher pressures than the center sensor 106 A values in the contact pressure distribution 20 ID because the edge of the cornea 105 has relatively stiff mechanical support from the sclera 202 compared to the mechanically unsupported center.
  • At least two valid approaches may be used for calculating the pressure value reported for a "good" data set.
  • the center value measured by sensor 106A may be used, since it is removed from edge effects and may better reflect the pressure of the aqueous humor 200 transmitted through the cornea 105 and the upper eyelid 103.
  • a simple average or weighted average may reduce noise and give a valid result.
  • the best algorithm may vary from user to user, and may optionally be a selectable device feature.
  • Figure 3A and Figure 3B show an exemplary implementation of the invention that has been built and tested as a proof of principle functional model.
  • the pressure sensors 300 are Allsensors MEMS piezoresistive DIE-L30G with a range of +/-30 inches of water ⁇ +1-56 millimeters of mercury).
  • the sensors are differential, with the diaphragm front faces 301 contacting a thin layer of silicone rubber gel 302 forming the concave face 104 of the probe 102 and rear faces of the diaphragms 301 vented to atmosphere through holes 303 in the rear of the sensor dies 300.
  • the sensor dies sit in cylindrical pockets in a die carrier 304, and are held in place by a retainer shell 305.
  • the retainer has portholes 306 positioned to expose the sensor diaphragms 301 to the silicone rubber 302.
  • the silicone rubber has been shown to transfer contact pressure from the probe contact face 104 to the sensor diaphragms 301 with negligible losses.
  • electrical connections to the pressure sensor dies 300 are made through flex circuits 307 that are joined to the front faces of the dies using known flip chip techniques. These techniques provide electrical contact between the die contact pads and the conductive traces 308 of the flex circuits as well as an adhesive mechanical bond.
  • the flex circuits 307 include soldering pads 309 at the opposite ends for connection to a cable leading to the power supply and signal conditioning and analysis modules that interface with the sensors (not shown). They also include an opening 310 at the sensor end to expose the diaphragm 301 to the pressure transmitted by the silicone rubber 302.
  • FIG. 4A and Figure 4B show a second exemplary implementation of the invention using absolute rather than differential MEMS pressure sensor dies in the probe 102.
  • the absolute pressure sensors 400 in the illustration are Amphenol NovaSensor MEMS piezoresistive P-330 dies with a range of 450 to 1050 millimeters of mercury or -310 to +290 millimeters of mercury relative to 760 millimeters of mercury standard atmospheric pressure.
  • the sensors 400 are bonded to a flex circuit 401.
  • the contact pads 402A-402D on the sensor are connected to flex circuit traces 403 A- 403 C on the flex circuit 401 by gold wire bonds 404A-404D using known wire bonding techniques.
  • the sensor die 400 comprises a silicon body 404 with a evacuated cavity 405 closed by a piezoresistive sensing membrane 406.
  • the piezoresistive elements of the membrane change resistance with changes in pressure between the media outside of the membrane and the vacuum in the cavity 405.
  • the power supply and signal conditioning and analysis modules (not shown) that interface with the sensors 400 through the flex circuit traces 403 measure the resistance change to determine the absolute pressure of the media outside the sensor 400.
  • Each of the sensors 400 is positioned in a separate pocket 407 in the probe head body 408 by the flex circuits 401 such that they are just below the surface of a silicone rubber gel layer 409 (shown cutaway) that forms the concave contact face 104.
  • the flex circuits 401 each pass from the rear of the probe head body 408 into the pockets through conduit openings 410, and may be connected to the conduit walls by a bond 411 to fix their positions and resist stresses on the flex circuits during and after addition of the silicone rubber layer 409.
  • Rubber layer 409 is preferably added as a catalyzed liquid and cured in place so that it makes intimate contact with the probe head body 408, the sensor dies 400, and the portions of the flex circuits 401 within the head pockets 407, and at least a portion of the conduit openings 410.
  • the sensor dies 400 measure the absolute hydrostatic pressure of the silicone rubber layer 409 in the vicinity of the sensor die, thereby measuring the absolute hydrostatic pressure of the adjoining tissue of the eyelid 103, thus enabling the measurement of intraocular pressure as described in reference to Figure 2. Since changes in weather and altitude change the absolute ambient pressure, it is necessary to subtract the absolute pressure sensor readings prior to pressing the probe 102 against the eyelid 103 from the subsequent readings to obtain correct hydrostatic pressure readings relative to atmospheric pressure as required for intraocular pressure readings. This may be done automatically in software during instrument startup.
  • FIG. 5 is a block diagram illustrating a complete intraocular pressure measurement system employing the probe 100 and the measurement method described in reference to Figure 2.
  • the sensor power supply 500 provides a controlled excitation voltage to the sensors in probe 100.
  • the resulting analog pressure signals are converted to digital pressure data by the analog/digital converter 501 a rate of e.g., 50 conversions per second per sensor and passed on to the computation and control module 502.
  • the user interface module 503 accepts user commands, provides real time visual and/or audible guidance to the user during the measurement, and displays the measurement results and other data.
  • the measurement guidance to the user includes but is not limited to "good" measurement, pressing too hard, and measurement complete.
  • the user commands include but are not limited to instrument on/off, start test, abort test, user identification, and left or right eye identification.
  • the other data includes but is not limited to a need to retest, a history of prior test results, and the quality of the measurement based on the variability of the "good" results averaged for the final value.
  • the user turns the system on through the user interface 503, starting the computation and control module 502 and energizing the sensor power supply.
  • the initial pre-contact measurements from probe 100 are digitized by analog/digital converter 501 and stored in the computation and control module 502 to provide zero-correction values for subsequent pressure data values.
  • the subsequent corrected pressure measurements at each time point are evaluated using the method described in reference to Figure 2 to determine if it is a "good” reading. "Good” readings are indicated to the user by an audible and/or visual means, and warnings that the user is pressing the probe too hard are indicated by a distinctly different audible and/or visual means. The "good” results counted and the results are averaged, while the other readings are discarded.
  • a measurement is successfully completed when a criterion such as accumulating a given number of "good” readings, e.g., 50 is met. More complex criteria that consider factors such as the variability between the "good” values as well as the number are possible and considered to be within the scope of the invention. Success is indicated to the user by a distinct audible and/or visual means, and the result is displayed and optionally stored.
  • a criterion such as accumulating a given number of "good” readings, e.g., 50 is met. More complex criteria that consider factors such as the variability between the "good” values as well as the number are possible and considered to be within the scope of the invention. Success is indicated to the user by a distinct audible and/or visual means, and the result is displayed and optionally stored.
  • the measurement is aborted when it goes on too long, e.g., 10 seconds, without obtaining enough "good" readings to form a successful measurement. Consistent failure to obtain good measurements may require refinement of the user's technique or adjustment of the concentric sleeve 107 surrounding the probe 100 to better match the patient's eye.
  • a new measurement is started by the user through the user interface module 503, causing the computation and control module 502 to perform actions including storing the prior reading, resetting the routine that counts, averages and displays "good" values, and updating the zero-correction values.
  • the user may also have the opportunity to identity the patient and indicate left or right eye.
  • the system is turned off when measurements are complete through the user interface module 503. Stored data are maintained using known means.
  • the entire system may vary without departing from this invention.
  • One variation is to include the entire system within a hand-held device. This option is expected to be most suitable for a user measuring intraocular pressure of another individual, since they can use both audible and visual features of the user interface module 503. Visual features are less useable for a user who is self-testing, and a user interface module separate from the probe 102 may be more easily viewed by the open eye. Connection may be made by known cable or wireless techniques, and at least a portion of the control and computation module 502 may be physically incorporated within the separate user interface module 503.
  • a device such as a smartphone or personal computer with a suitable software application may be used to perform the functions of the user interface module 503 and at least most of the functions of the control and computation module 502. It will be obvious to those skilled in the art that a number of such permutations and combinations are within the scope of the invention.
  • Each wirelessly connected physical portion of the system will require its own power source.
  • FIG. 1 through Figure 5 and the accompanying description are primarily intended to illustrate the conceptual features of the invention, and it will be obvious to those skilled in the art that a number of equivalent functional elements and construction details may be used to implement the concept.
  • the general proportions and scale of the device 100 are depicted in the drawings to be compatible with the human eye and to depict practical implementations of the invention.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Ophthalmology & Optometry (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Eye Examination Apparatus (AREA)

Abstract

La présente invention concerne un procédé, un dispositif et un système pour mesurer une pression intraoculaire dans l'œil humain à travers la paupière fermée pour éviter un contact direct avec la cornée. Une mesure d'œil fermé permet à la mesure d'être réalisée hors d'un environnement clinique, même par les patients eux-mêmes, étant donné qu'elle réduit les exigences de compétence d'utilisateur, élimine le besoin de gouttes oculaires anesthésiques et simplifie le contrôle d'infection. Une sonde avec une face concave est pressée contre la paupière fermée, produisant une pression hydrostatique dans le tissu de paupière qui équilibre la pression intraoculaire à travers la membrane de cornée. La face concave comprend un réseau spatial de multiples capteurs de pression de contact qui génèrent une séquence temporelle d'ensembles de données de pression de contact de tissu de paupière aux emplacements de capteur. Un algorithme de sélection et un algorithme de mesure fournissent des résultats représentés par des signaux audibles ou visuels.
PCT/US2016/046119 2015-08-10 2016-08-09 Mesure de pression intraoculaire à travers une paupière fermée Ceased WO2017027494A1 (fr)

Applications Claiming Priority (2)

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US201562202972P 2015-08-10 2015-08-10
US62/202,972 2015-08-10

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WO2017027494A1 true WO2017027494A1 (fr) 2017-02-16

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020036537A1 (fr) * 2018-08-16 2020-02-20 National University Hospital (Singapore) Pte Ltd Procédé et dispositif d'auto-mesure de pression intra-oculaire
CN115644797A (zh) * 2022-10-31 2023-01-31 清华大学 可穿戴式角膜接触镜、主动式连续眼压监测方法和装置
WO2023022668A3 (fr) * 2021-08-20 2023-05-11 National University Of Singapore Dispositif et procédé de capteur de pression intraoculaire

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020193675A1 (en) * 2001-06-13 2002-12-19 Sis Ag Surgical Instrument Systems Devices and methods for determining the inner pressure of an eye
US20090234215A1 (en) * 2006-05-12 2009-09-17 Gennadiy Konstantinovich Piletskiy Device for Measuring Intraocular Pressure Through an Eyelid
US20100152565A1 (en) * 2008-07-15 2010-06-17 Thomas Gordon A Non-invasive tonometer
US20110081333A1 (en) * 2010-12-10 2011-04-07 Shantha Totada R Apparatus and system for treatment and prevention of bags under eyes
US20140243645A1 (en) * 2011-10-05 2014-08-28 Sensimed Sa Intraocular Pressure Measuring and/or Monitoring Device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020193675A1 (en) * 2001-06-13 2002-12-19 Sis Ag Surgical Instrument Systems Devices and methods for determining the inner pressure of an eye
US20090234215A1 (en) * 2006-05-12 2009-09-17 Gennadiy Konstantinovich Piletskiy Device for Measuring Intraocular Pressure Through an Eyelid
US20100152565A1 (en) * 2008-07-15 2010-06-17 Thomas Gordon A Non-invasive tonometer
US20110081333A1 (en) * 2010-12-10 2011-04-07 Shantha Totada R Apparatus and system for treatment and prevention of bags under eyes
US20140243645A1 (en) * 2011-10-05 2014-08-28 Sensimed Sa Intraocular Pressure Measuring and/or Monitoring Device

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020036537A1 (fr) * 2018-08-16 2020-02-20 National University Hospital (Singapore) Pte Ltd Procédé et dispositif d'auto-mesure de pression intra-oculaire
US20210345877A1 (en) * 2018-08-16 2021-11-11 National University Hospital (Singapore) Pte Ltd Method and device for self-measurement of intra-ocular pressure
WO2023022668A3 (fr) * 2021-08-20 2023-05-11 National University Of Singapore Dispositif et procédé de capteur de pression intraoculaire
CN115644797A (zh) * 2022-10-31 2023-01-31 清华大学 可穿戴式角膜接触镜、主动式连续眼压监测方法和装置

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