WO2012137067A2 - Intraocular pressure monitoring device and methods - Google Patents

Intraocular pressure monitoring device and methods Download PDF

Info

Publication number
WO2012137067A2
WO2012137067A2 PCT/IB2012/000831 IB2012000831W WO2012137067A2 WO 2012137067 A2 WO2012137067 A2 WO 2012137067A2 IB 2012000831 W IB2012000831 W IB 2012000831W WO 2012137067 A2 WO2012137067 A2 WO 2012137067A2
Authority
WO
WIPO (PCT)
Prior art keywords
transceiver
intraocular
millimeters
substrate
pressure sensor
Prior art date
Application number
PCT/IB2012/000831
Other languages
French (fr)
Other versions
WO2012137067A3 (en
Inventor
Paolo Orsatti
Peter Stegmaier
Lorenzo Leoni
Jörg DRAEGER
Olaf Morcher
Original Assignee
Oculox Technology
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 Oculox Technology filed Critical Oculox Technology
Publication of WO2012137067A2 publication Critical patent/WO2012137067A2/en
Publication of WO2012137067A3 publication Critical patent/WO2012137067A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/16Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for measuring intraocular pressure, e.g. tonometers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0204Operational features of power management
    • A61B2560/0214Operational features of power management of power generation or supply
    • A61B2560/0219Operational features of power management of power generation or supply of externally powered implanted units

Definitions

  • the technology relates in part to an improved medical device and methods for sensing eye pressure.
  • the technology also relates in part to small intraocular pressure monitoring devices with telemetry systems that can be curled and rolled.
  • the technology relates in part to methods and carriers for rolling intraocular pressure monitoring devices for surgical implantation into the eye of a subject.
  • Glaucoma is a disease affecting millions of people in the world every year and is a major cause for blindness. Glaucoma frequently is caused by increased pressure of the fluid in the eye (aqueous humour), also referred to as increased intraocular pressure (IOP). Pressure in the eye is determined by a balance between the production of aqueous humour (e.g., a transparent liquid that fills the region between the cornea at the front of the eye and the lens) and its exit through the trabecular meshwork and Schlemm' s canal (major route) or via uveal scleral outflow (minor route).
  • aqueous humour e.g., a transparent liquid that fills the region between the cornea at the front of the eye and the lens
  • Intraocular devices are capable of being curled into a substantially rolled state.
  • the effective cross-sectional diameter of the device in its substantially rolled state is sufficiently small for permitting insertion of the intraocular device through an incision routinely made in suture-less lens surgery.
  • an intraocular pressure monitoring device comprising: a substantially annular substrate, which substrate is substantially flexible; a pressure sensor and a transceiver mounted to the substrate, which pressure sensor is in a location on the device separate from the location of the transceiver, and which pressure sensor and transceiver are aligned on a single axis; an antenna mounted to the substrate, which antenna, pressure sensor and transceiver are in effective connection; which device is capable of transitioning from a substantially flat state to a substantially rolled state and from the substantially rolled state to the substantially flat state; and which device, when in the substantially rolled state, is configured to fit within a substantially cylindrical void having a cross-sectional diameter of less than 2.6 millimeters.
  • a first portion of the substrate sometimes comprises a first thickness and a second portion of the substrate comprises a second thickness, which first thickness is narrower than the second thickness.
  • Pressure sensor, transceiver and/or capacitor components often are located at the second portion of the substrate.
  • a first portion of the substrate sometimes comprises a first width and a second portion of the substrate comprises a second width, which second width is greater than the first width.
  • a pressure sensor under which is disposed an aperture traversing the substrate thickness often is located at the second portion.
  • An intraocular device sometimes is in association with a replacement lens, and in some embodiments, an intraocular device is in association with a capsular ring.
  • An intraocular device sometimes is in a substantially rolled state, and sometimes is in a substantially flat state.
  • An aspect also pertains to a system comprising an intraocular device comprising a telemetry transceiver described herein and a remote transceiver configured to receive a signal from the telemetry transceiver in the intraocular device.
  • An aspect pertains also to a system comprising an intraocular device described herein and a remote transceiver configured to supply power to the transceiver in the intraocular device.
  • An aspect also pertains to a method for supplying energy from the external device to the intraocular device for the intraocular device to function.
  • An aspect also pertains to a carrier comprising a substantially cylindrical void, which void comprises an intraocular device described herein in its substantially rolled state.
  • An aspect pertains also to a carrier comprising a substantially flat void, which void comprises an intraocular device described herein in its substantially flat state.
  • An aspect also pertains to a method for implanting an intraocular device into the lens cavity of the eye, which comprises inserting an intraocular device described herein in its substantially rolled state into the lens cavity of the eye through an incision having a length of 3.0 millimeters or less, using suture-less cataract surgical methods, under conditions in which the device assumes the substantially flat state after the device is inserted into the lens cavity.
  • An aspect pertains also to an intraocular pressure monitoring system, comprising: an intraocular device described herein, which device is configured to obtain intraocular pressure readings in the ocular cavity of an eye of a subject; and an external device configured to reside outside the eye of the subject, which external device comprises at least one external transceiver configured to receive by telemetry the intraocular pressure readings from the intraocular device.
  • An aspect also pertains to a method for transmitting intraocular pressure information, comprising: obtaining intraocular pressure readings by the pressure sensor of an intraocular device described herein that has been implanted in the ocular cavity of an eye of a subject; and transmitting by telemetry the intraocular pressure readings from the transceiver of the intraocular device to an external transceiver in an external device residing outside the eye of the subject.
  • FIG. 1 A shows a top view of an intraocular pressure sensor monitoring device embodiment.
  • FIG. 1 B shows a cross section view at lines 1 B to 1 B of FIG. 1A.
  • FIG. 1 C shows a cross section view at lines 1 C to 1 C of FIG. 1A.
  • FIG. 1 D shows a cross section view at lines 1 D to 1 D of FIG. 1A.
  • FIG. 1 E shows a bottom view of the intraocular pressure sensor monitoring device shown in FIG. 1A.
  • FIG. 1 F shows a cross section view of an intraocular device at a pressure sensor and shows a biocompatible coating.
  • FIG. 2 and FIG. 3 show top views of intraocular pressure monitoring device embodiments.
  • FIG. 4A shows a top view of an intraocular pressure monitoring device embodiment that includes anchors.
  • FIG. 4B shows a cross section of an eye cavity and a top view of an implanted intraocular pressure sensor monitoring device embodiment held in place in the eye cavity by anchors. Sensor and transceiver components are on separate chips as shown in FIG. 4B.
  • FIG. 5A shows a cross section view of a cylindrical void and therein a side view of a rolled intraocular sensing device having a pressure sensor, capacitor and telemetry transceiver and associated electronics rolled and inserted into the cylindrical void.
  • FIG. 5B shows a cross section view of a cylindrical void and therein a side view of a rolled intraocular pressure sensing device comprising two pressure sensors.
  • FIG. 6A is a side view cross section of an ocular cavity illustrating the positioning of an intraocular pressure monitoring device having intraocular anchors, behind a lens (e.g., a replacement lens).
  • FIG. 6B is a side view cross section of an ocular cavity with an intraocular pressure monitoring device attached to the lens (e.g., a replacement lens).
  • FIG. 6C shows a top view of an intraocular device embodiment comprising anchors and a substantially trapezoidal region of increased width, which device is in association with an artificial replacement lens comprising hooks.
  • FIG. 7 shows a side view cross section of the ocular cavity having an internal intraocular device positioned within the ocular cavity behind the lens (e.g., a replacement lens).
  • FIG. 7 also shows a side view of an extracorporeal transceiver for use with an internal intraocular device.
  • FIG. 8 shows a schematic representation of data flow between an intraocular pressure monitoring device, a transceiver mounted in an eyeglass frame, and an external device with display, storage and internet functionality.
  • FIG. 9 shows a schematic representation of data and/or energy flow between an intraocular device, an associated external reader and various internet enabled devices (e.g., computer, smartphone, PDA, Bluetooth transmitter, the like and combinations thereof), to a remote health monitor that provides service to a subject implementing the system.
  • various internet enabled devices e.g., computer, smartphone, PDA, Bluetooth transmitter, the like and combinations thereof
  • conductive element e.g., conductive metal
  • conductive element e.g., conductive metal
  • substrate width (e.g., about 0.75 mm to about 1.5 mm)
  • inner diameter e.g., unobstructed diameter of about 5 mm to about 8 mm
  • 188 sensor length (e.g., about 0.5 mm to about 0.9 mm)
  • 191 capacitor length (e.g., about 0.3 mm to about 1 .5 mm)
  • sensor width (e.g., about 0.5 mm to about 1 .5 mm)
  • cylindrical void diameter (e.g., about 1 .5 mm to about 3.5 mm)
  • transceiver width (e.g., about 0.5 mm to about 1.5 mm)
  • transceiver length (e.g., about 1 mm to about 5 mm)
  • aperture diameter or width (e.g., about 500 ⁇ to about 700 ⁇ )
  • sensors 12, 12a, 12b, 12c, 12e and 12f are in device embodiments shown in FIG. 1A, FIG. 2, FIG. 3, FIG. 4A, FIG. 5B and FIG. 6C, respectively.
  • the sensors may be the same, similar or different in various embodiments.
  • transeivers 14, 14a, 14b, 14c and 14f are in device
  • FIG. 1A, FIG. 2, FIG. 3, FIG. 4A and FIG. 6C respectively.
  • the transceivers may be the same, similar or different in various embodiments.
  • Glaucoma is an eye disorder in which the optic nerve suffers damage, permanently impacting vision in the affected eye(s) and progressing to complete blindness if untreated. Glaucoma often is associated with increased pressure of the fluid in the eye. Nerve damage involves loss of retinal ganglion cells in a characteristic pattern. There are many different sub-types of glaucoma, but all can be considered a form of optic neuropathy. Raised intraocular pressure is a significant risk factor for developing glaucoma (e.g., threshold value 21 mmHg or 2.8 kPa). One person may develop nerve damage at a relatively low pressure, while another person may have high eye pressure for years and yet never develop damage. Untreated glaucoma leads to permanent damage of the optic nerve and resultant visual field reduction, which can progress to blindness. The damaged visual field cannot be recovered.
  • threshold value 21 mmHg or 2.8 kPa One person may develop nerve damage at a relatively low pressure, while another person may have high eye pressure for years and yet never develop damage.
  • Glaucoma is the second leading cause of blindness. Glaucoma can be divided roughly into two main categories, "open angle” and “closed angle” glaucoma. Closed angle glaucoma can appear suddenly and is often painful. Visual loss can progress quickly but the discomfort often leads patients to seek medical attention before permanent damage occurs. Open angle, chronic glaucoma tends to progress at a slower rate and a patient may not notice that they have lost vision until the disease has progressed significantly. If the condition is detected early enough it is possible to arrest the development or slow the progression utilizing medical and surgical means.
  • IOP intraocular pressure
  • Internal pressure measurements often are a more realistic measure of the pressure inside the eye when compared to measurements taken by indirect external pressure measurements.
  • Current clinical practice methods of measuring IOP are suboptimal often due to only performing periodic IOP measurements during regular office hours. Diurnal and 24-hour IOP measurements obtained on an in-patient basis can increase the frequency of measurements, but are inconvenient and expensive. Diurnal and 24-hour IOP measurements typically do not allow ambulatory monitoring of IOP.
  • intraocular pressure monitoring devices that include a small intraocular portion that can be rolled and then inserted into the lens cavity or lens bag of the eye as part of standard suture-less ophthalmology surgical techniques (e.g., cataract replacement surgery). Also provided in certain embodiments are intraocular pressure monitoring devices suitable for measuring intraocular pressure several times a day or throughout the day without the need for frequent visits to an ophthalmologist. Provided also in some embodiments are intraocular pressure monitoring devices that wirelessly transmit the pressure measurement data to an external receiver for further processing, analysis and/or storage, thus allowing ambulatory, 24-hour monitoring of IOP. Intraocular pressure monitoring devices
  • Intraocular pressure (IOP) monitoring systems described herein are telemetry systems that can measure the IOP of an eye and send the information back to an associated telemetry reader.
  • the telemetry transmissions often are carried on one of the industrial, scientific or medical (ISM) electromagnetic frequency bands.
  • IOP monitoring systems provided herein often include a device that is implanted into the eye of a subject, which is referred to as an "intraocular device” or “internal device” herein.
  • a system often also includes another device that is external to the subject and receives from, transmits information to and/or transmits an electric field, or magnetic field or electromagnetic field, to an intraocular device, which is referred to as an "external device” or “reader” herein.
  • An intraocular device often is configured for curling, rolling and/or folding and insertion into the eye of a subject (e.g., lens cavity or lens bag) by a suitable surgical procedure.
  • a suitable surgical procedure often is one that requires no sutures in the eye, and such procedures often include cutting a small incision in the eye.
  • the incision often is 3.0 millimeters or less in length or 2.5 millimeters or less in length (e.g., about 2.5 millimeters, 2.4 millimeters, 2.3 millimeters, 2.2 millimeters, 2.1 millimeters, 2.0 millimeters, 1 .9 millimeters, 1 .8 millimeters, 1 .7 millimeters, 1 .6 millimeters or 1.5 millimeters or less in length).
  • a carrier can be utilized for the purpose of transmitting an intraocular device into the eye through the incision.
  • a portion of the carrier sometimes inserts into the interior of the eye through the incision, and the carrier often includes a void into which the intraocular device is loaded for delivery into the interior of the eye.
  • the void in the carrier can be of any suitable geometry, such as a cylinder, frustrum, hexahedron, rhombohedron and the like).
  • the carrier sometimes comprises a substantially cylindrical void, and sometimes the carrier comprises a needle in which there is a void.
  • a void sometimes has a cross section (e.g., a circle in a substantially cylindrical void) having a width or diameter of 3.5 millimeters or less (e.g., about 3.5 millimeters, 3.4 millimeters, 3.3 millimeters, 3.2 millimeters, 3.1 millimeters, 3.0 millimeters, 2.9 millimeters, 2.8 millimeters, 2.7 millimeters, 2.6 millimeters, 2.5 millimeters, 2.4 millimeters, 2.3 millimeters, 2.2 millimeters, 2.1 millimeters, 2.0 millimeters, 1 .9 millimeters, 1 .8 millimeters, 1.7 millimeters, 1 .6 millimeters or 1 .5 millimeters or less).
  • 3.5 millimeters or less e.g., about 3.5 millimeters, 3.4 millimeters, 3.3 millimeters, 3.2 millimeters, 3.1 millimeters
  • Intraocular devices provided herein often are capable of rolling and being contained for a period of time in a substantially rolled state after being inserted into a carrier having a void described herein.
  • a device in a substantially rolled state need not form a perfect cylinder.
  • substantially rolled state is substantially cylindrical or can fit within a substantially cylindrical void.
  • Intraocular devices often are capable of deforming to a substantially flat or substantially planar state, and sometimes have little or substantially no memory of the substantially rolled state.
  • a device in the substantially flat state often does not include a curled edge when unrolled from the substantially rolled state after a certain period of time (e.g., within about 5 minutes, 10 minutes, 20 minutes, 30 minutes, 60 minutes).
  • Certain design aspects permit an intraocular device to assume a rolled state that can be contained in a substantially cylindrical void having a cross sectional diameter of 3.5 millimeters or less.
  • a device often includes separate transceiver and sensor components, and sometimes includes one or more separate capacitors or other separate components. Two or more components often are located on separate structures. The structures sometimes are substantially inflexible or substantially rigid.
  • a structure is an integrated circuit, silicon chip and/or die.
  • Two or more separate components of a device often are aligned along a single axis, which axis is longitudinal and tangential to the top surface of the device in its substantially flat state.
  • the axis generally intersects two points on the perimeter of the device in the substantially flat state. This axis is referred to herein as a "flat axis.”
  • the flat axis intersects two points on the outer perimeter and no points on the inner perimeter of the intraocular device in the substantially flat state.
  • the flat axis intersects two points on the outer perimeter and two points on the inner perimeter of the intraocular device in the substantially flat state.
  • alignment of separate components and/or structures on a single axis can promote rolling of the device into a cylindrical void having a substantially small cross- sectional diameter.
  • Certain embodiments include: (i) the midlines of the aligned components and/or structures are aligned on the flat axis; (ii) the same edges of the aligned components and/or structures are aligned on the flat axis (e.g., the right edges, the left edges, the top edges or the bottom edges of the components and/or structures are aligned on the flat axis); (iii) a line parallel to an edge or midline and spaced from the edge or midline, of one or more of the aligned components and/or structures, is aligned on the flat axis; and (iv) combinations of the foregoing.
  • a separate component or structure sometimes includes two sides of unequal length, and the side having the longer length, or a line parallel to and spaced from that side, often is aligned on the flat axis.
  • the effective width of the separate components and/or structures aligned on the flat axis which effective width is the dimension perpendicular to the flat axis that contains the outermost edges of all of the aligned components and/or structures, is about 1 .3 millimeters or less (e.g., 1 .2 millimeters or less, 1.1 millimeters or less, 1.0 millimeters or less, 0.9 millimeters or less or 0.8 millimeters or less).
  • edges of a group of components and/or structures are aligned, and opposite edges are aligned (e.g., a right edge of one structure is aligned on the flat axis with the left edge of another structure), the components and/or structures are not aligned on the flat axis.
  • the components and/or structures need not be aligned along the entire length of the axis, which length of the axis is defined by the two outer edges of the device intersected by the axis.
  • the components and/or structures often are aligned along a portion of the axis length, and sometimes are aligned on 50% to 95% of the axis length (e.g., aligned on about 55%, 60%, 70%, 75%, 80%, 85%, 90% of the axis length).
  • the majority of separate components and/or structures e.g., sensor or sensors, transceiver and/or optional capacitor
  • all but one of the separate components and/or structures or all of the separate components and/or structures of the device are aligned on the flat axis.
  • a non-limiting example of a flat axis 159 is shown in FIG. 1A, which flat axis is a longitudinal axis tangential to the top surface of the device body, which top surface is in effective connection with components 12, 14 and 19.
  • the midlines of components 12, 14 and 19 are aligned along flat axis 159 in the embodiment shown in FIG. 1A.
  • a device sometimes includes separate components and/or structures aligned on a flat axis and one or more separate components and/or structures not aligned on the flat axis.
  • the separate components and/or structures not aligned on the flat axis sometimes are aligned on another axis, referred to as a "rolled axis," with one of the components or structures aligned on the flat axis.
  • the rolled axis generally is transverse to, and spans and intersects two points on the perimeter of, a cross-section of an intraocular device in the substantially rolled state.
  • a component or structure on the flat axis and a component or structure not on the flat axis often align on the rolled axis.
  • An edge, midline, or line parallel to an edge or midline and spaced from the edge or midline, of such components or structures sometimes is aligned on the rolled axis when the device is in the substantially rolled state.
  • a non-limiting example of a rolled axis is shown as axis 160 in FIG. 5A and FIG. 5B.
  • the effective diameter of a rolled intraocular device also can be minimized by other structural features described herein.
  • devices that include a region with a first thickness, at which certain components are located, and a region with a second thickness thinner than the first thickness can minimize the effective diameter of the rolled intraocular device.
  • devices that include a region with a first width and a region with a second width wider than the first width at which certain components are located also can minimize the effective diameter of the substantially rolled intraocular device.
  • Such features are described in greater detail herein.
  • An intraocular device for internal use can include any type of sensor suitable for a target measurement.
  • a sensor can be selected for sensing osmotic pressure, sugar level (e.g., glucose level), electrical activity (e.g., of the heart), electromagnetic spectrum (light), temperature, pH, or pressure (e.g., blood pressure, IOP), for example.
  • Pressure can be expressed as the force required to stop a fluid from expanding, and generally is defined in terms of force per unit area.
  • a pressure sensor often is considered a transducer that generates a signal as a function of the pressure applied against the sensor.
  • a signal generated by a pressure sensor often is an electrical signal.
  • a pressure sensor measures the variation of resistance during a measurement (e.g., impedance).
  • Pressure sensors sometimes also are referred to as pressure transducers, pressure transmitters, pressure senders, pressure indicators, pressure piezometers, and manometers.
  • any suitable form of pressure sensor can be used in an intraocular device described herein.
  • force collector type pressure sensors suitable for use in embodiments described herein include piezo resistive strain gauge sensors, capacitive sensors, electromagnetic sensors, resonant pressure sensor and piezoelectric sensors.
  • Examples of pressure sensors that can be utilized in embodiments described herein are known (e.g., United States Patent Nos. 6,443,893 (Schnakenberg et al.) and 6,796,942 (Kreiner et al.), and International Application Publication WO 2005/048835 (Bodecker et al.)).
  • An intraocular capacitive pressure sensor is discussed in United States Patent Nos. 6,447,449 and 6,579,235, for example.
  • a micro-machined pressure sensor is discussed in United States Patent No: 6,443,893, for example.
  • Pressure sensors suitable for use with an intraocular device often are in effective connection with (i) a substrate, (ii) a telemetry transceiver, (iii) an antenna, and/or (iv) various combinations thereof.
  • an IOP sensor is in effective connection with an antenna, a telemetry transceiver, an optional energy storing capacitor or resonant circuit and/or a substrate via biocompatible flexible metal interconnections.
  • an IOP sensor is in effective connection with an antenna, a telemetry transceiver, an optional energy storing capacitor or resonant circuit and/or a substrate via flexible semi-conductive or conductive ink printed on the substrate.
  • two or more of a sensor, transceiver, antenna and optional capacitor are in direct connection.
  • the two or more components are in direct connection by one or more track connections (e.g., wire track or conductive ink track from sensor integrated circuit to transceiver integrated circuit) and/or by one or more via connections (e.g., a via connection between an antenna element and one or more other components (e.g., sensor, transceiver, capacitor)).
  • a substrate is in direct connection with a component when the component is adhered (e.g., welded) to a member in connection with the substrate (e.g., integrated circuit affixed by an underfill to the substrate).
  • a component mounted to a portion of a substrate sometimes is directly connected to the substrate and sometimes is indirectly connected to the substrate by an intermediate structure (e.g., weld, stud, landing pad, globetop, underfill and/or conductive adhesive).
  • an intermediate structure e.g., weld, stud, landing pad, globetop, underfill and/or conductive adhesive.
  • Two or more components can be in indirect or functional connection between two or more components.
  • Non-limiting examples of intraocular device components that can be in indirect or functional connection (e.g., functional connection, operational connection, mechanical connection, electrical connection, magnetic connection, the like and combinations thereof) include: pressure sensor with antenna; telemetry transceiver with antenna, pressure sensor with telemetry transceiver; capacitor with antenna, capacitor with pressure sensor; capacitor with telemetry transceiver; inductor and capacitor; resonant circuit and tuned resonant circuit tank, the like and combinations thereof.
  • an intraocular device includes one or more pressure sensors that measure pressure by deformation of a sensible membrane.
  • a pressure sensor has a pressure range of between about 0 to about 50 mmHg (e.g., about 0 mmHg, about 5 mmHg, about 10 mmHg, about 15 mmHg, about 20 mmHg, about 21 mmHg, about 22 mmHg, about 23 mmHg, about 24 mmHg, about 25 mmHg, about 26 mmHg, about 27 mmHg, about 28 mmHg, about 29 mmHg, about 30 mmHg, about 31 mmHg, about 32 mmHg, about 33 mmHg, about 34 mmHg, about 35 mmHg, about 40 mmHg, about 45 mmHg, and about 50 mmHg) above atmospheric pressure (e.g., about 760 mmHg).
  • mmHg e.g., about 0 mmHg, about 5 mmHg, about 10 mmHg, about 15 mmHg, about 20 mmHg
  • the final pressure reading often is determined by measuring the difference between the absolute lOP and the external atmospheric pressure.
  • the absolute range of a pressure sensor also can be stated as being between about 760 mmHg and 810 mmHg at sea level in certain embodiments. In some embodiments, a pressure sensor has an accuracy of 0.1 mmHg or better.
  • pressure sensor 12, 12a, 12b, 12c, 12e or 12f refers generically to a pressure sensor, which sensor may be the same, similar or of a different type in various embodiments.
  • FIG. 1 B shown is a cross section view of a device embodiment at the line connecting 1 B to 1 B in FIG. 1A.
  • Pressure sensor 12 includes sensor top 161 and sensor base 164, and chamber 312, which chamber often is under vacuum (e.g., substantially perfect vacuum).
  • Sensor 12 can be electrically connected to a substrate landing pad 170 on substrate 15 by bumps 136 (e.g., stud bumps) and adhesive 139 (e.g., isotropically conductive adhesive).
  • a globe top 133 or fillet can support sensor 12 on the substrate. Also shown in FIG.
  • the sensor can measure pressure (e.g., IOP) by referring to the displacements of the sensible membrane 121 (membrane-based pressure sensor).
  • the aperture 124 often traverses the thickness of the device body (e.g., substrate), and may be of any suitable minimum width or diameter for monitoring IOP (e.g., about 500 micrometers to about 700 micrometers).
  • the aperture may be of any suitable profile for the sensor to measure IOP, and sometimes is substantially cylindrical, frustrum, hexahedron, rhombohedron, and the like.
  • the aperture at the bottom of surface of mask 167 may be of any suitable shape, including substantially circular, oval, rhomboid, rectangle and the like, for example.
  • FIG. 1 E shows a bottom view of an intraocular device, and illustrates a circular aperture 176 that can define the bottom opening of channel 124.
  • the width or diameter of the aperture sometimes is about 500
  • micrometers to about 700 micrometers e.g., about 500 micrometers, 550 micrometers, 600 micrometers, 650 micrometers, 700 micrometers.
  • the channel can be manufactured by any suitable process, and sometimes is drilled or ablated in the device body (e.g., flexible printed circuit board (FCP)).
  • FCP flexible printed circuit board
  • FIG. 1 F A cross section view of a membrane-based pressure sensor also is shown in FIG. 1 F.
  • the intraocular device can be covered in a biocompatible coating 300 (e.g., parylene coating).
  • the sensor can include a top layer 303 (e.g., borosilicate glass), a base 306 (e.g., silicon-etched structure) in connection with top layer 303 and a chamber 312 that often is under vacuum (e.g., substantially perfect vacuum).
  • the sensor can be connected, in some embodiments, to the substrate 15 or device body (e.g., flexible printed circuit board (FCP)) by, for example, a conductive adhesive and bumps 136 (e.g., gold bumps).
  • FCP flexible printed circuit board
  • An aperture in the device body, having diameter or width 309 can allow the sensor to measure the environmental pressure through a channel 124d.
  • Diameter or width 309 sometimes is about 500 micrometers to about 700 micrometers (e.g., about 500 micrometers, 550 micrometers, 600 micrometers, 650 micrometers, 700 micrometers).
  • sensor body 306 and top 303 differ from sensor body 164 and top 161 in FIG. 1 B as the former in part form the perimeter of a chamber 312d that has different dimensions than chamber 312.
  • a transceiver can perform transmitter and/or receiver functions, which can be combined and share common circuitry and/or a single housing.
  • Transceivers sometimes also are referred to as transponders, transverters, and repeaters, which can be used interchangeably.
  • a transceiver in an intraocular device and/or external device often is a telemetry transceiver.
  • Telemetry is a technology that enables remote measurement and reporting of information.
  • Telemetry systems often are configured to perform a measurement task and then broadcast the information when queried, without needing an incoming command to perform the function.
  • Telemetry systems often wirelessly transfer sensor data (e.g., wireless or infrared transmission systems; time-variant sensor data), and sometimes a telemetry systems can utilize wired or fiber optic networks.
  • sensor data e.g., wireless or infrared transmission systems; time-variant sensor data
  • a telemetry systems can utilize wired or fiber optic networks.
  • Telemetry systems often include an electromagnetic frequency source (e.g., radio frequency source or infrared light source), an antenna, and a power source for powering the telemetry system and/or transmitting the telemetry data.
  • electromagnetic frequency source e.g., radio frequency source or infrared light source
  • Any suitable electromagnetic frequency source suitable for implantation in the lens cavity of an eye can be used.
  • Non-limiting examples of electromagnetic frequency sources suitable for use in an intraocular device described herein include: radio data telemetry transceivers working in various frequency bands (e.g., low frequency (LF), high frequency (HF), very high frequency (VHF), ultra wideband (UWB), and the like), infrared sources, the like and combinations thereof.
  • a frequency often is chosen according to tissue absorption criteria.
  • a transceiver utilized in an intraocular device often communicate via one of the industrial, scientific, and medical (ISM) electromagnetic frequencies (e.g., bands) suitable for use in biomedical implants for power induction (e.g., inductive coupling) and data transmission, in some
  • ISM industrial, scientific, and medical
  • ISM bands currently are defined by the International Telecommunication Union (e.g., ITU), ITU Radiocommunication Sector (ITU-R), as the following ranges, given as the frequency range, followed by the center frequency: 100 kHz to 150 kHz ; 6.765 MHz to 6.795 MHz, 6.780 MHz; 13.553 MHz to 13.567 MHz, 13.560 MHz; 26.957 MHz to 27.283 MHz, 27.120 MHz; 40.66 MHz to 40.70 MHz, 40.68 MHz; 433.05 MHz to 434.79 MHz, 433.92 MHz; 902 MHz to 928 MHz, 915 MHz; 2.400 GHz to 2.500 GHz, 2.450 GHz; 5.725 GHz to 5.875 GHz, 5.800 GHz; 24 GHz to 24.25 GHz, 24.125 GHz; 61 GHz to 61 .5 GHz, 61 .25 GHz;
  • Radio-frequency identification is a technology that communicates via radio waves to exchange data between a reader and an electronic tag attached to an object.
  • RFID generally is not configured to transmit time-variant data, but rather identification information on the object to which the tag is attached.
  • Telemetry systems described herein can transmit sensor information (e.g., time-variant data) using modulation principles and power concepts similar to those used in RFID technology.
  • an intraocular device uses an electromagnetic frequency range centered around 13.560 MHz. In certain embodiments, an intraocular device uses an electromagnetic frequency range centered around 27.120 MHz.
  • a transceiver can include an integrated circuit and can include components that can store and/or process information (e.g., flash memory for storing pressure calibration, random access memory (RAM) for processor function), modulating and demodulating a radio-frequency (RF) signal, and other specialized functions (e.g., microcontroller functions, analog to digital converter (ADC), signal conditioning)).
  • a transceiver often functions in association with an antenna for receiving and transmitting a signal.
  • Telemetry systems can be passive (e.g., no battery or power source, powered by inductive coupling), active, (e.g., contain a power source that controls transmission upon activation by an external reader), and battery assisted passive (e.g., requiring an external interrogation to become active, but have a longer transmission range than passive systems, due to the power for signal bursts provided by the battery).
  • passive e.g., no battery or power source, powered by inductive coupling
  • active e.g., contain a power source that controls transmission upon activation by an external reader
  • battery assisted passive e.g., requiring an external interrogation to become active, but have a longer transmission range than passive systems, due to the power for signal bursts provided by the battery.
  • an intraocular device functions
  • radio frequency identification e.g., RFID
  • RFID radio frequency identification
  • a transceiver often is in effective connection with a pressure sensor on or in an intraocular device, and sometimes is in effective connection with an optional second pressure sensor, one or more optional energy storing capacitors, an antenna, and/or a substrate.
  • intraocular devices that include a telemetry transceiver are shown in FIGS. 1 A, 2 and 3.
  • the telemetry systems are shown in effective connection with a pressure sensor, an optional second pressure sensor, one or more optional energy storing capacitors, an antenna, and a substrate.
  • Various combinations of a telemetry system in connection with the aforementioned components also are possible, in various
  • a transceiver is in connection with an antenna, an lOP sensor, an optional energy storing capacitor or resonant circuit and/or a substrate via flexible metal interconnections, which often are biocompatible.
  • a transceiver is in connection with an antenna, an lOP sensor, an optional energy storing capacitor or resonant circuit and/or a substrate via flexible semi-conductive or conductive ink printed on the substrate.
  • components used in an lOP sensor described herein include a flexible silicon semiconductor chip printed with a semiconductor material, adding to the flexible nature of the device.
  • lOPs are measured by a pressure sensor and transmitted by a transceiver in conjunction with the associated coil or loop antenna.
  • a transceiver of an intraocular device can communicate with another external device, as described herein.
  • a system can include an external reader that is capable of transmitting radio frequency to interrogate the telemetry chip, provide resonant inductive coupling, provide magnetic inductive coupling, receive and/or store transmitted telemetry data, provide for data output and/or display, and further transmission to a server based system or remote computer, in various embodiments.
  • an external reader is battery powered, and in certain embodiments, the external reader is power line powered. Non-limiting examples of external reader embodiments are shown in FIGS. 7 and 9.
  • Intraocular devices described herein also can utilize near field communication (NFC) systems in the place of RFID-like telemetry systems.
  • NFC near field communication
  • Near field communication refers to a group of short- range based technologies that can transmit data wirelessly over the 13.56 MHz frequency, at bit rates of between about 106 kbit/s to about 848 kbit/s.
  • the effective transmission range of NFC systems is between about 4 centimeters to about 20 centimeters.
  • near-field communication also takes advantage of magnetic induction between two loop antennas located within each other's near field. The proximity of the antenna in the intraocular and external devices has the effect of producing an air-core transformer.
  • Near field communication devices can operate in one of two modes.
  • passive communication mode an initiator device provides a carrier field (e.g., magnetic field generated by the antenna of the initiator device) and the target device responds by modulating the field generated by the initiator device.
  • the target device sometimes draws its operating power from the initiator-provided electromagnetic field (e.g., the target device is a transponder).
  • active communication mode an initiator device and target device communicate by alternately generating their own fields.
  • the operating frequency and the associated modulation schemes correspond to the upcoming standards for NFC such that the extracorporeal transceiver can be complemented by use of any NFC enabled device (e.g., current and future cell phones, and the like).
  • NFC enabled device e.g., current and future cell phones, and the like.
  • An IOP can be rapidly measured using NFC enabled devices.
  • a telemetry transceiver can include NFC transceivers and transponders and RFID-like transceivers and transponders.
  • An antenna can function as a transducer that transmits or receives electromagnetic, or electric or magnetic waves, and converts the respective radiation into an electrical signal, or vice versa.
  • An antenna can also function as one or more conductors that cause an electromagnetic field when a voltage is applied across the antennas' terminal (e.g., conductor terminals) to create an alternating current. For reception, the reverse occurs, and an electromagnetic field from another source can induce an alternating current in the antenna conductors, which in turn causes a voltage at the antenna terminal.
  • Antenna can be used to generate power in the implanted portion of the intraocular device that does not include a battery. Antenna used in this manner can generate power that can be used to power one or more pressure sensors, a telemetry transceiver and/or other electronics by coupling, in some embodiments.
  • Inductive coupling refers to the induction of a current in a first device (e.g., external reader) which causes a magnetic field that can interact with the antenna of a second device (e.g., implanted intraocular device). The interaction of the magnetic field with the antenna of the second device induces a current in the second device. The current induced in the second device can be used to power a component in the second device and/or to charge a capacitor in the second device.
  • the reader's antenna coil generates an electro-magnetic field (e.g., an inductor in the reader (i.e., external device) generates a current which in turn generates an electro-magnetic field in the reader's antenna), which penetrates the cross-section of the intraocular device antenna coil area and the area around the coil.
  • an electro-magnetic field e.g., an inductor in the reader (i.e., external device
  • the electro-magnetic field may be treated as a simple magnetic alternating field with regard to the distance between transponder and reader antenna.
  • the electric component of the electromagnetic field may be screened so that only the magnetic component is used for transmission of energy and for reception of data.
  • the antenna coil in the implanted portion of the intraocular device in turn magnetically resonates with the magnetic field of the reader, which in turn induces a current at the antenna terminal.
  • the induced current can be used to directly power an intraocular device component, or can be used to charge an optional capacitor, in various embodiments.
  • the amount of current induced is dependent on the power of the source, and on the distance between the antenna and the wavelength of the radio frequency and the relative sizes of the first and second antenna.
  • Antenna used in association with intraocular devices are known. Examples of remote intraocular devices with antenna can be found in United States Patent Nos: 6,443,893, 6,447,449 and 6,579,235.
  • an antenna of an intraocular device is a coil antenna.
  • an antenna comprises a flexible conductive material and the material sometimes is biocompatible (e.g., conductive polymer, conductive metal (e.g., gold, platinum, silver, copper).
  • an antenna is printed on or in a substrate using a semi-conductive or conductive ink.
  • Intraocular device embodiments described herein can include a substantially annular substrate or device body. Top view edges of a device body often are co-extensive with the top view width of a substrate of a device, less any biocompatible coating.
  • a substrate sometimes is substantially annular and sometimes is annular.
  • a substantially annular substrate may include one or more regions that deviate from perfect annularity, and in some embodiments include one or more regions that are substantially linear.
  • FIG. 1A shows a transition region 7 in which the radius of curvature for an annular portion of a substrate transitions to a larger radius of curvature or no radius of curvature (e.g., linear portion), for example.
  • An intraocular device may include one, two or more regions that deviate from perfect annularity.
  • a substrate which often forms the backbone of a flexible electronic device or flex circuit, often comprises a material that is electrically conductive, insulating and/or biocompatible.
  • Any substrate e.g., flexible electronics
  • Non-limiting examples of substrates suitable for use in an intraocular device include: polyimide films (e.g., Kapton, Apical, UPILEX, VTEC PI, Norton TH), transparent conductive polyesters, polyether ether ketone (PEEK), shape memory PEEK, biocompatible shape memory polymers, transparent conductive polyester, the like or combinations thereof.
  • an intraocular device includes one or two layers of substrate material.
  • an intraocular device includes a substrate in effective connection with a pressure sensor, a transceiver (e.g., telemetry wireless transceiver), an antenna printed on or embedded in the annular substrate, an optional capacitor (e.g., energy storing capacitor and/or decoupling capacitor), the like or combination thereof.
  • An antenna sometimes is in connection with a surface of the annular substrate (e.g., the same surface as the telemetry transceiver and/or pressure sensor), and sometimes is embedded within the substrate.
  • one or more of a pressure sensor, a second pressure sensor and a transceiver are associated with the substrate by conductive interconnections, which sometimes comprise a conductive material (e.g., conductive metal; copper, platinum, silver, gold) and/or flexible biocompatible material (e.g., gold; conductive polymer).
  • a conductive material e.g., conductive metal; copper, platinum, silver, gold
  • flexible biocompatible material e.g., gold; conductive polymer
  • one or more of a pressure sensor, a second pressure sensor and a transceiver are sealed with an underfill, and in certain embodiments, the underfill is an epoxy resin. In some embodiments, the epoxy resin is biocompatible.
  • a telemetry transceiver and pressure sensor often are in connection with the same surface of a substrate.
  • one or more integrated circuits e.g., electronic circuits, capacitors, the like and or combinations thereof
  • electrical connections are printed on the substrate using a semi-conductive or conductive ink.
  • a biocompatible coating material is a Parylene material (e.g., Parylene C, Parylene AF-4, Parylene SF, Parylene HT, Parylene VT-4, Parylene CF, Parylene N).
  • Parylene material e.g., Parylene C, Parylene AF-4, Parylene SF, Parylene HT, Parylene VT-4, Parylene CF, Parylene N).
  • FIGS. 1A, 2, 3, 4A, 4B, 6A, 6B, 6C, 7 and 10 Shown in FIGS. 1A, 2, 3, 4A, 4B, 6A, 6B, 6C, 7 and 10 are various embodiments of an intraocular device with components in effective connection with a substrate.
  • the overall dimensions of the substrate often are substantially similar to the dimensions of the telemetry transceiver antenna (e.g., between about 9 millimeters to about 1 1 millimeters outer diameter for sensor embodiments using a larger antenna).
  • a substrate and/or device body has an unobstructed inner diameter or inner width (e.g., diameter/width 185 in FIG. 1 A) of about 5.0 millimeters to about 8.0 millimeters (e.g., about 5.0 millimeters, about 5.1 millimeters, about 5.2 millimeters, about 5.3 millimeters, about 5.4 millimeters, about 5.5 millimeters, about 5.6 millimeters, about 5.7 millimeters, about 5.8 millimeters, about 5.9 millimeters, about 6.0 millimeters, about 6.1 millimeters, about 6.2 millimeters, about 6.3 millimeters, about 6.4 millimeters, about 6.5 millimeters, about 6.6 millimeters, about 6.7 millimeters, about 6.8 millimeters, about 6.9 millimeters, about 7.0 millimeters, about 7.0 millimeters, about 7.1 millimeters, about 7.2 millimeters
  • diameter/width 185 is about 5.5 millimeters to about 6.5 millimeters (e.g., about 6.0 millimeters). Diameters/widths 185a and 185b can have substantially identical dimensions as diameter/width 185.
  • a substrate and/or device body has an outer diameter or width (e.g., diameter/width 182 or diameter/width 215 of FIG.
  • 1A of about 7.0 millimeters to about 1 1.0 millimeters (e.g., about 7.0 millimeters, about 7.1 millimeters, about 7.2 millimeters, about 7.3 millimeters, about 7.4 millimeters, about 7.5 millimeters, about 7.6 millimeters, about 7.7 millimeters, about 7.8 millimeters, about 7.9 millimeters, about 8.0 millimeters, about 8.1 millimeters, about 8.2 millimeters, about 8.3 millimeters, about 8.4 millimeters, about 8.5 millimeters, about 8.6 millimeters, about 8.7 millimeters, about 8.8 millimeters, about 8.9 millimeters, about 9.0 millimeters, about 9.1 millimeters, about 9.2 millimeters, about 9.3 millimeters, about 9.4 millimeters, about 9.5 millimeters, about 9.6 millimeters, about 9.7 millimeters, about 9.8 milli
  • diameter/width 215 is about 8.0 millimeters to about 9.0 millimeters (e.g., about 8.4 millimeters or about 8.5 millimeters).
  • diameter/width 182 is about 9.0 millimeters to about 10.0 millimeters (e.g., about 9.4 millimeters or about 9.5 millimeters).
  • Diameters/widths 182a and 182b can have substantially identical dimensions as diameter/width 182.
  • an intraocular device includes a region of a first thickness and a region of a second thickness greater than the first thickness.
  • a device comprising a larger surface area region of a narrower thickness and smaller surface area region of increased thickness can decrease the effective cross-sectional diameter of a void required to contain the intraocular device in its substantially rolled state.
  • the majority of the surface area of the substrate and/or device body can have a narrower thickness, which can reduce the effective cross-sectional diameter of the rolled device, and only certain components benefited by a wider thickness are located on or in one or more regions of increased width that represent a smaller surface area of the device.
  • a device includes only one region of increased thickness, and sometimes a device includes only two regions of increased thickness.
  • a region of second thickness constitutes about 1 % to about 30% (e.g., about 5%, 10%, 15%, 20% or 25%) of the surface area of an intraocular device.
  • a region of wider thickness in the substrate and/or device body is in proximity to one or more components of the device.
  • components of the device are located in or on separate substantially inflexible structures and/or integrated circuits.
  • a region of the first thickness includes conductive elements in association with one side of a substrate (e.g., antenna elements).
  • a region of the second thickness includes conductive elements in association with both sides of the substrate (e.g., antenna members on one side of the substrate and component mounting members on the other side of the substrate).
  • FIGS. 1A, 1 B, 1 C and 1 D show regions of different thickness in certain device embodiments.
  • FIG. 1A shows transition or boundary 158 at which a region of first thickness is to the right of the transition and a region of a second thickness, thicker than the first thickness, is to the left of the transition.
  • Components 12, 14, 16 and 19 are located in or on the region of the second thickness, and only component 16 is located in the region of the first thickness.
  • FIG. 1 B shown in cross section is a region of second thickness under a sensor component, which region comprises conductive elements in association with both surfaces of substrate 15.
  • Antenna elements 173 are in association with the bottom surface of the substrate, and landing pad 170 is in association with the top surface of the substrate.
  • FIG. 1A shows transition or boundary 158 at which a region of first thickness is to the right of the transition and a region of a second thickness, thicker than the first thickness, is to the left of the transition.
  • Components 12, 14, 16 and 19 are located in or on the
  • Conductive elements 172 sometimes are tracks (e.g., wire tracks) that connect two or more components of a device (e.g., sensor, transceiver and/or capacitor). The tracks sometimes track between components and connect the components only, and sometimes the tracks track around the entire substantially annular substrate. Shown also are masks 166 and 167 (e.g., solder masks) on each surface of the substrate.
  • transition or boundary 158 at which the region of the second thickness on the left tapers to the region of first thickness on the right.
  • Mask 166 in the second thickness can taper to substrate 15 at or about transition or boundary 158.
  • an intraocular device comprising a device body including a region of first thickness and a region of second thickness thicker than the first thickness, which second thickness tapers to the first thickness.
  • a tapered transition from a region of second thickness to a region of first thickness can promote rolling of the device rather than folding.
  • antenna elements 173 are of the same or similar cross sectional surface area, and/or of the same or similar dimensions, as elements 172. In FIG.
  • the region of first thickness (e.g., thickness 221 in FIG. 1 D) is about 35 micrometers to about 65 micrometers (e.g., about 35 micrometers, 40 micrometers, 45
  • the region of second thickness is about 65 micrometers to about 95 micrometers (e.g., about 65 micrometers, 70 micrometers, 75 micrometers, 76 micrometers, 77 micrometers, 78 micrometers, 79 micrometers, 80 micrometers, 81 micrometers, 82 micrometers, 83 micrometers, 84 micrometers, 85 micrometers, 90 micrometers, 95 micrometers).
  • the substrate 15 thickness is about 5 micrometers to about 35 micrometers (e.g., about 5, 10, 15, 20, 25, 30, 35 micrometers)
  • the antenna element 173 thickness is about 5 micrometers to about 15 micrometers (e.g., about 5, 6, 7, 8, 9, 10, 1 1 , 12, 13, 14, 15 micrometers)
  • the mask 166, 167 thickness is about 10 micrometers to about 20 micrometers (e.g., 10, 12, 15, 17, 20 micrometers)
  • the conductive element (e.g., track) 172 thickness is about 5 micrometers to about 15 micrometers (e.g., about 5, 6, 7, 8, 9, 10, 1 1 , 12, 13, 14, 15 micrometers).
  • an intraocular device comprises a region having a first width (e.g., width 179 in FIG. 1A).
  • the first width sometimes is about 0.7 millimeters to about 1.5 millimeters (e.g., about 0.7 millimeters, 0.8 millimeters, 0.9 millimeters, 1 .0 millimeters, 1 .1 millimeters, 1.2 millimeters, 1 .3 millimeters, 1 .4 millimeters, 1.5 millimeters).
  • an intraocular device includes a region having a second width, which second width is of increased width relative to the first width (e.g., region of increased width 13 in FIG. 1A or 13f in FIG. 6C).
  • the region of increased width sometimes has a maximum width or diameter that is about 0.1 millimeters to about 0.5 millimeters greater than the first width (e.g., about 0.1 millimeters, 0.2 millimeters, 0.3 millimeters, 0.4 millimeters, 0.5 millimeters greater than the first width).
  • a device comprising a larger surface area region of a narrower width and smaller surface area region of increased width can decrease the effective cross-sectional diameter of an intraocular device in its substantially rolled state, and decrease the cross-sectional diameter of a void required to contain the intraocular device in its substantially rolled state.
  • the majority of the surface area of the substrate and/or device body can have a narrower top view width, which can reduce the effective cross-sectional diameter of the rolled device, and only certain components benefited by a wider footprint are located on or in one or more regions of increased width that represent a smaller surface area of the device.
  • a device includes no regions of increased width, one region of increased width, or two regions of increased width.
  • a region or regions of increased width constitute about 0% to about 15% (e.g., about 5% or 10%) of the surface area of an internal device. Width 179a or 179b sometimes is the same or substantially the same as width 179.
  • a region of increased width can be of any suitable shape to accommodate a component benefiting from a wider footprint on the device than other components.
  • the region of increased width is substantially circular (e.g., region 13 of FIG. 1A), ovoid, rhomboid, rectangular, trapezoidal (e.g., isosceles trapezoidal, right trapezoidal (e.g., region 13f in FIG. 6C)), the like and combinations of the foregoing.
  • regions of increased width having one or more sides transitions to one or more of the sides may be curved or non-curved.
  • a region of increased width supports a sensor component.
  • antenna components can be configured around (e.g., routed around) the aperture and/or channel in the device body.
  • Antenna components may transition from a first radius to a second radius in a region of increased width in some
  • Antenna components may transition from a curved configuration to a linear configuration in a region of increased width, in certain embodiments (e.g., transition 17f in FIG. 6C).
  • Antenna components in a region of increased width often are configured around an aperture in the substrate or device body in the same general shape as the channel aperture (e.g., substantially circular for the channel under sensor 12 in FIG. 1 A, and substantially rectangular or trapezoidal for the channel under sensor 12f in FIG. 6C).
  • Intraocular devices configured for implantation include intraocular anchors, in some embodiments.
  • An intraocular anchor can ensure correct positioning and alignment of an intraocular device within the lens cavity of the eye.
  • Intraocular anchors often are associated or in connection with a substrate.
  • anchors are uniformly distributed around the perimeter of the substrate and/or device body. Anchors are configured to permit rolling of the substantially annular substrate during preparation for insertion, and are exposed in an intraocular device when it is in its substantially flat state to position the device correctly within the lens cavity.
  • An anchor can be of any size or shape suitable for use in positioning an intraocular device.
  • Anchors can be made of any suitable biocompatible material that has or can be made to have a spring force tension, to allow the anchors to open for positioning and securing.
  • Non-limiting examples of anchor shapes include, circular, semi circular, J-shaped, L-shaped, the like or combinations thereof.
  • Non-limiting examples of materials suitable for use as anchors include plastics, polymers, metals, metal alloys, memory plastics and polymers, the like and combinations thereof.
  • the size of an anchor generally is inversely related to the size of the device. The larger the device, the smaller the anchors necessary to correctly position and/or anchor the device against the inner surfaces of the eye cavity, as shown in FIG. 4B. Conversely, the smaller the device, the larger the anchors necessary to correctly position and/or anchor the device against the inner surfaces of the eye cavity.
  • Intraocular device embodiments configured for association with a replacement lens sometimes do not include anchors when they are affixed to the replacement lens.
  • the anchors or hooks in association with the replacement lens can serve to properly locate the intraocular device due to the placement of the device on the replacement lens.
  • Any suitable method of associating the lens and intraocular device can be utilized, non-limiting examples of which include adhesive, friction, the like or combination thereof.
  • Intraocular devices that utilize anchors are known.
  • An example of an intraocular device utilizing anchors is shown in United States Patent No: 6,443,893.
  • Non-limiting examples of intraocular device anchors are shown in FIG. 4B and FIG. 6C as anchors 18c and 18f, respectively.
  • Non-limiting embodiments of intraocular devices are shown in FIGS. 1 A, 2, 3, 4A, 4B and 6C each shown in a substantially flat state.
  • Non-limiting examples of intraocular devices in a substantially rolled state are shown in FIG. 5A and FIG. 5B.
  • FIG. 1A Shown in FIG. 1A is an intraocular device embodiment comprising substrate 15, which substrate has an inner perimeter 9 and outer perimeter 8. Also shown are antenna 16, pressure sensor 12, transceiver 14 and optional capacitor 19. The midlines of components 12, 14 and 19 are aligned on flat axis 159.
  • the substrate is substantially annular and includes two substantially linear portions, one of which substantially linear portions presents at a curved to linear transition 7.
  • the device embodiment shown in FIG. 1A also includes a first thickness to second thickness transition 158 at which a first thickness to the right of transition 158 transitions to a thicker second thickness to the left of the transition.
  • the device embodiment also includes a region of increased width 13, in which antenna elements curve around a channel below sensor 12 at about transition 17 (see FIG. 1 E showing aperture 176 at the channel opening).
  • a device may have a region of increased width, a region of increased thickness, components aligned on a flat axis, or a combination of the foregoing.
  • Shown in FIG. 2 is an annular device embodiment in which the midlines of components 12a, 14a, and 19a are aligned on a flat axis that intersects two points on the outside perimeter 8a and no points on the inner perimeter 9a of the device.
  • FIG. 3 shows an annular device embodiment in which the midlines of components 12b, 14b and 19b are aligned on a flat axis that intersects two points on the outside perimeter 8b and two points on the inner perimeter 9b of the device.
  • FIG. 4A shows an annular device embodiment comprising anchors 18c.
  • FIG. 4B shows ocular cavity 148 in which a device is affixed via anchors 18c.
  • FIG. 4A and FIG. 4B shows a device embodiment having transceiver 14c and sensor 12c in separate structures (e.g., separate integrated circuits; separate chips).
  • FIG. 6C Shown in FIG. 6C is a device embodiment similar to the embodiment shown in FIG. 1 A.
  • FIG. 6C shows a region of increased width 13f having a substantially trapezoidal shape, as compared to the substantially circular shape of the region in FIG. 1 A.
  • the intraocular device which comprises anchors 18f, is in effective association with lens 1 1f, which lens comprises hooks 10Of. The hooks and anchors secure the lens and device in the ocular cavity of the eye.
  • the intraocular device shown in FIG. 6C is outside the field of vision.
  • FIG. 5A shows an intraocular device embodiment in its substantially rolled state having one pressure sensor and all integrated circuit structures aligned on a flat axis.
  • Illustrated in FIG. 5B is an intraocular device embodiment having two pressure sensors, curled and inserted into a cylindrical void of 3.5 millimeters or less (e.g., 3.0 millimeters or less, 2.5 millimeters or less, 2.0 millimeter or less cylindrical void diameter), in preparation for implantation. Implantation can be accomplished using standard cataract surgical techniques that do not require surgical sutures.
  • any of the intraocular devices, and/or external devices described hereafter, can include one or more integrated circuits (e.g., silicon chips).
  • One or more components e.g., sensor, transceiver, capacitor
  • An integrated circuit also can include additional electronic components.
  • Such electronic components can facilitate the function of various components, including, for example, power up, pressure measurement and transmission of telemetry data.
  • Non-limiting examples of electronic functions that can be included in the circuitry of an integrated circuit include micro controller function, analog to digital conversion (ADC) function, signal conditioning (e.g., amplifier) function, flash memory, random access memory (RAM), power storage, the like and various combinations thereof.
  • ADC analog to digital conversion
  • signal conditioning e.g., amplifier
  • flash memory e.g., flash memory
  • RAM random access memory
  • no component or structure (e.g., integrated circuit) in or on an intraocular device extends past the inner perimeter and/or outer perimeter (e.g., inner perimeter 9, outer perimeter 10 in FIG. 1A).
  • the entirety of an intraocular device is outside the field of vision when implanted in an ocular cavity, and in certain embodiments, the entirety of an intraocular device is outside the perimeter of a lens when the device is in association with a lens.
  • an intraocular device generally is approximately 37 degrees Celsius.
  • An intraocular device generally does not substantially increase the intraocular temperature through its operation.
  • An intraocular device often is configured to avoid transient peaks of temperature while operating.
  • an intraocular device as described herein has a target lifetime of about 10 to about 20 years or more (e.g., about 10 years, about 12 years, about 14 years, about 15 years, about 16 years, about 18 years, or about 20 years or more).
  • Intraocular device embodiments described herein are configured for implantation into the lens cavity of an eye.
  • An intraocular device can be implanted using a cataract lens replacement method involving surgical incisions of less than 2.5 millimeters. Utilizing incisions smaller than 2.5 millimeters allows suture-less wound healing, thereby easing the recovery period for the patient and physician.
  • An intraocular device often includes a substantially flexible substrate, and often is configured with aligned hard components, such that the device can be compactly curled and placed into a cylindrical void of 3 millimeters or less (e.g., cylindrical void is about 2.5 millimeters, about 2.0 millimeters).
  • the cylindrical void of 3 millimeters or less corresponds to the bore of a needle configured for curling (e.g., rolling, folding, wrapping) and insertion of the device into the lens cavity of an eye, through an incision smaller than 2.5 millimeters, in some embodiments.
  • a cylindrical void is within a hollow needle in some embodiments.
  • a carrier device can be utilized to roll, contain and/or deliver into an ocular cavity an intraocular device.
  • an intraocular device is suspended in a liquid and drawn through the carrier, the carrier being configured with one or more internal passages that correctly orient and curl the intraocular device in preparation for insertion into an eye.
  • a carrier device sometimes includes a needle configured to curl the intraocular device in preparation for insertion into the lens cavity of an eye.
  • a carrier in some embodiments, includes a first void that can contain an intraocular device in a substantially flat state and a second void that can contain the intraocular device in a substantially rolled state.
  • the second void sometimes is substantially cylindrical, and the carrier, first void and second void can be configured to roll the intraocular device from a substantially flat state in the first void to a substantially rolled state in the second void as the intraocular device is transferred from the first void to the second void.
  • the intraocular device may be transferred from the first void to the second void by application of a positive or negative pressure, in some embodiments.
  • a driving member sometimes is in association with a carrier or integrated in a carrier, which driving member sometimes is configured to apply a positive pressure or negative pressure in a void of the carrier sufficient to transfer an intraocular device from the void.
  • a driving member is a syringe in some embodiments.
  • Embodiments of an intraocular device rolled and contained in a substantially cylindrical void are shown in FIG. 5A and FIG. 5B.
  • Carrier 203 contains cylindrical void 204, shown in cross section, which has diameter 200.
  • an intraocular device in a substantially rolled state which intraocular device comprises substrate 15e and sensors 12e and 21 e, which sensors are aligned on rolled axis 160.
  • FIG. 5A shows an embodiment of an intraocular device having one pressure sensor contained within a void in a substantially rolled state (e.g., the intraocular device shown in FIG. 1A).
  • an intraocular devices often is configured for curling and containment in a cylindrical void having a cross-sectional diameter of less than 3 millimeters. Curling the device into the void allows for containment of the intraocular device into an implantation device (e.g., carrier) that can be utilized during standard cataract replacement surgery.
  • an implantation device e.g., carrier
  • Current state of the art cataract surgery typically utilizes a surgical incision of less than 2.5 millimeters, thereby allowing wound closure without the use of sutures. This method allows for faster healing while minimizing complications associated with sutures.
  • an intraocular device is inserted through the same incision using a dedicated implantation device (e.g., carrier). The intraocular device delivery sometimes is performed before or after the insertion of the replacement lens.
  • a method for inserting an intraocular device, in association with or not in association with a replacement lens including: (i) providing a curled intraocular device described herein, and (ii) inserting the curled intraocular device into the lens cavity of the eye through an incision of 2.5 millimeters of less, using suture-less cataract surgical methods, whereby the intraocular device assumes its original uncurled shape upon uncurling.
  • the intraocular device is implanted during cataract replacement surgery.
  • the intraocular device is inserted prior to inserting a replacement cataract lens.
  • the intraocular device is inserted after inserting a replacement cataract lens.
  • the intraocular device is in association with a replacement cataract lens.
  • a lens comprising an intraocular device described herein.
  • the intraocular device sometimes is associated with the lens ex vivo or in vivo using a suitable method (e.g., a lens resides within the inner diameter/width of the intraocular device and is not attached to the device; the lens is attached to the device).
  • a method of inserting an intraocular device including: inserting a curled intraocular device into the lens cavity of an eye, using cataract replacement surgical techniques that do not require the use of sutures to close the surgical incision.
  • the method includes curling the intraocular device to fit into the bore of a carrier having a diameter of 3 millimeters or less prior to delivery of the device into the lens cavity.
  • the intraocular device is inserted independently of a replacement lens, and placed in the lens cavity of the eye prior to insertion of a replacement lens.
  • the intraocular device is inserted independently of a replacement lens, and placed in the lens cavity of the eye after insertion of a replacement lens.
  • the intraocular device inserted in the lens cavity includes an antenna.
  • Also provided is a method of inserting an intraocular device which includes associating an intraocular device described herein with a replacement lens, curling the replacement lens and associated intraocular device to fit into the bore of a needle having a diameter of 3 millimeters or less, and inserting the curled replacement lens and associated intraocular device into the lens cavity of an eye, using cataract replacement surgical techniques that do not require the use of sutures to close the surgical incision.
  • a method of inserting an intraocular device that includes associating an intraocular device with a replacement lens, curling the replacement lens and associated intraocular device to fit into the bore of a needle having a diameter of 3 millimeters or less, and inserting the curled replacement lens and associated intraocular device into the lens cavity of an eye, using cataract replacement surgical techniques that do not require the use of sutures to close the surgical incision.
  • a method of inserting a replacement lens and an intraocular device embodiment described herein including: curling the replacement lens including an intraocular device to fit into the bore of a needle having a diameter of 3 millimeters or less, and inserting the curled replacement lens into the lens cavity of an eye, using cataract replacement surgical techniques that do not require the use of sutures to close the surgical incision, where the pressure monitoring
  • the components are aligned on a flat axis and further where the pressure monitoring components are embedded within the haptic area of the lens.
  • the intraocular device is embedded within the haptic area of the lens.
  • the substrate assumes its original unrolled shape upon insertion into the eye.
  • Anchors on the device generally are configured to correctly position the intraocular device within the lens cavity of the eye.
  • the anchors can be omitted.
  • the lens assumes its original unrolled shape upon insertion into the eye, and the anchors and/or hooks associated with the replacement lens correctly position the lens within the lens cavity of the eye.
  • FIG. 6A and FIG. 6B Shown in FIG. 6A and FIG. 6B are non-limiting examples of an intraocular device implanted into a lens cavity.
  • FIG. 6A shows the position of an intraocular device 10f behind lens 1 1f (e.g., a replacement lens).
  • FIG. 6B shows an intraocular device 10f attached to lens 1 1 f (e.g., a replacement lens).
  • Shown are zonular fibers 106, capsular bag 103, aqueous humour 109 and optical axis 224.
  • the capsular bag holds the natural ocular lens or lens replacement.
  • the zonular fibers are attached to the ciliary muscle and to the capsular bag, and can in part maintain lens position. During cataract surgery the bag is emptied and cleaned of the natural lens.
  • IOL intraocular lens
  • Systems and methods of use lOP monitoring systems provided herein often are configured to include an intraocular device that is implanted into the eye, and one or more external devices that typically are worn by a user.
  • An external device sometimes includes one or more components chosen from: a processor; a power source; an antenna; a radio frequency generator, a data logger, the like and combinations thereof.
  • An lOP monitoring system can continuously measure lOP and transmit all or a subset of the pressure readings to an external device or other device in an lOP system, in some embodiments.
  • An lOP monitoring system may measure lOP several times a day or throughout the day without the need for frequent visits to a health care provider (e.g., ophthalmologist) in certain embodiments.
  • An lOP monitoring system can wirelessly transmit pressure measurement data to an external receiver for further processing, analysis and/or storage, thus allowing ambulatory, 24-hour monitoring of lOP in certain embodiments.
  • FIG. 7 Shown in FIG. 7 is a schematic representation of an lOP monitoring system 1 , which system includes an intraocular device 10f that is implanted into the natural lens bag of the eye 103 (capsular bag), and external device 20.
  • External device 20 can include external antenna 22 and external transceiver 24.
  • Such components can be mounted on any device external to the eye, and an external device often is worn by a user.
  • An external device can be mounted to an eyeglass frame in certain embodiments.
  • FIGS. 7 and 9 Non-limiting examples of functional components suitable for use on or in one or more external devices or portions of an lOP monitoring system are shown in FIGS. 7 and 9, and include:
  • telemetry transceiver 24 one or more antenna 22, for receiving telemetry data (e.g., pressure sensor measurements) from, and/or transmitting instructions (e.g., power up command, measurement command, transmit command, the like and combinations thereof) to an internal component; eyeglasses 26 or other wearable headgear having one or more transceiver antenna 22; portable reader 30, including but not limited to; power source (e.g., battery or power line);
  • power source e.g., battery or power line
  • processor e.g., memory
  • software for device operation, data display, data conversion, data analysis, data transmission to a server based system e.g., software and/or hardware
  • anti-collision e.g., multiread
  • air interface component e.g., software and/or hardware
  • output or display device e.g., RS-232 connection, LCD screen, printer, audible alarm, the like or combinations thereof
  • radio frequency signal (RF) generator e.g., RS-232 connection, LCD screen, printer, audible alarm, the like or combinations thereof
  • electromagnetic power induction energy storing capacitor
  • LC resonance circuit e.g., electromagnetic power induction
  • wireless transmission protocol and/or wired connection for communicating with a computer 40 or data server; the like and combinations thereof.
  • an lOP monitoring system also includes a carrier (or implantation device, e.g., a syringe) that ensures correct folding and/or rolling of the internal portion of the device for insertion into the eye. Additional software, firmware and hardware functions and circuits also can be included in an extracorporeal reader portion (i.e., external device) of an lOP monitoring system.
  • a suitable security algorithm can be applied to the communication protocol operating between an intraocular device and an extracorporeal device to assure privacy of user information.
  • an lOP monitoring system measures lOPs as follows: (i) an external device (e.g., reader device) produces a current which induces a magnetic field in the antenna embedded in the external device (e.g., wearable headgear); (ii) the magnetic field produced by the antenna in the external device interacts with an antenna of the implanted intraocular device, thereby producing a current at the antenna terminal in the intraocular device, which is sometimes associated with an optional capacitor; (iii) the current induced in the implanted intraocular device powers the pressure sensor, which takes a pressure reading, and can also power the telemetry transponder/transceiver, (iv) the transponder/transceiver in the intraocular device transmits the telemetry data (e.g., pressure reading(s)) to the transceiver in the external device.
  • an external device e.g., reader device
  • the magnetic field produced by the antenna in the external device interacts with an antenna of the implanted intraocular device,
  • the external device sometimes transmits the pressure reading(s) to an output component on the external device or outside the external device.
  • the external device transmits the data to another portable or fixed device.
  • additional functions or processes are performed on the telemetry data (e.g., analysis, conversion, display, transmission to a remote computer, the like and combinations thereof).
  • An external device often is configured to communicate with an output component or device, remote computer and/or a server or internet based user interface.
  • FIGS. 8 and 9 Non-limiting examples of information flow between various portions of a system are shown in FIGS. 8 and 9.
  • portable reader 30, which can include a transmitter, receiver; memory, and a communication module for communication with a remote computer 40.
  • Computer 40 sometimes includes an output device that permits a health monitor to analyze IOP reads from the intraocular device.
  • pressure measurements are transmitted from the implanted intraocular device to an intermediary transceiver within wearable headgear, which in turn transmits the data to a reader (portable or stationary), for display, analysis, and/or transmission to a server to be remotely accessible to healthcare professionals.
  • a reader portable or stationary
  • FIG. 9 illustrates an external device and devices with which the external device can communicate.
  • the devices illustrated in FIG. 9 can be near field communication enabled and/or RFID-like telemetry system based. Illustrated in FIG.
  • a remote health monitor including in some embodiments a physician or other health care provider, who can respond to the telemetry data communicated to the extracorporeal reader and subsequent information flow via the internet and administer appropriate care to the patient.
  • a health monitor can be a person or a software program in some embodiments.
  • a health monitor can administer instructions for reducing or maintaining IOP in some embodiments, and sometimes may prescribe administration of a drug for such purposes.
  • an external device e.g., device 20 in FIG. 7
  • other device e.g., device 30 in FIG. 9 of an IOP monitoring system can include an internet enabled component and/or display component.
  • an external device or other device in the system can provide an audible and/or visible alarm if a threshold pressure value is exceeded, thus alerting the user to take certain steps or seek medical help.
  • An alarm can be transmitted over the internet to a server-based user interface to alert an appropriate medical professional.
  • An intraocular pressure monitoring device comprising:
  • a pressure sensor and a transceiver mounted to the substrate, which pressure sensor is in a location on the device separate from the location of the transceiver, and which pressure sensor and transceiver are aligned on a single axis;
  • A1.2 The device of embodiment A1 , wherein the single axis is tangentially oriented along the device in the substantially flat state and intersects two points on the outer perimeter and two points on the inner perimeter of the device.
  • A2 The device of any one of embodiments A1 to A1 .2, wherein the cross-sectional diameter of the substantially cylindrical void is 2.5 millimeters or less.
  • A3. The device of embodiment A2, wherein the cross-sectional diameter of the substantially cylindrical void is 2.0 millimeters or less.
  • A5. The device of any one of embodiments A1 to A4, wherein the pressure sensor and the transceiver each are independently located on separate structures.
  • A6. The device of embodiment A5, wherein one or more of the separate structures are integrated circuits.
  • A8 The device of any one of embodiments A1 to A7, wherein the transceiver is a radio frequency telemetry transceiver.
  • A9 The device of any one of embodiments A1 to A8, which further comprises an energy storing capacitor.
  • A10 The device of embodiment A9, wherein the transceiver, the pressure sensor and the energy storing capacitor are aligned on the single axis when the device is in the substantially flat state.
  • A1 1 The device of any one of embodiments A1 to A10, which further comprises a second pressure sensor.
  • A12 The device of any one of embodiments A1 to A1 1 , wherein the second pressure sensor and one or more of the pressure sensor, the energy storing capacitor, and the transceiver are aligned along a single axis, which single axis is oriented along the device in the substantially rolled state and intersects two edges of the device in the substantially rolled state.
  • A14.1 The device of any one of embodiments A1 to A14, wherein the pressure sensor, transceiver, and antenna are mounted to the substrate by an effective connection with the substrate.
  • the device of any one of embodiments A1 to A14.1 wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises a substantially flexible and conductive material.
  • A16 The device of embodiment A15, wherein the conductive material is biocompatible.
  • A17 The device of embodiment A15 or A16, wherein the conductive material comprises a metal, polymer or combination thereof.
  • A18 The device of any one of embodiments A15 to A17, wherein the conductive material comprises gold, silver, copper, platinum, a conductive polymer or combination thereof.
  • A19 The device of any one of embodiments A1 to A18, wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises an isotropically conductive adhesive.
  • A20 The device of any one of embodiments A1 to A19, wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises a landing pad.
  • A22 The device of embodiment A21 , wherein the conductive material comprises a metal, conductive polymer or combination thereof.
  • A23. The device of any one of embodiments A1 to A22, wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises a globe top connection.
  • A24. The device of any one of embodiments A1 to A22, wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises an underfill.
  • A27 The device of any one of embodiments A1 to A26, wherein the antenna is a coil antenna.
  • A28. The device of any one of embodiments A1 to A27, wherein the antenna is connected to the surface of the substrate.
  • A29 The device of embodiment A28, wherein the antenna is printed on the substrate.
  • A30 The device of any one of embodiments A1 to A27, wherein the antenna is embedded in the substrate.
  • A31 The device of any one of embodiments A1 to A30, wherein the antenna comprises a conductive material.
  • A34 The device of any one of embodiments A31 to A33, wherein the conductive material comprises a metal, a conductive polymer or combination thereof.
  • A35 The device of any one of embodiments A31 to A34, wherein the conductive material comprises gold, silver, platinum, copper, a conductive polymer or combination thereof.
  • A36 The device of any one of embodiments A1 to A35, comprising a region comprising one conductive layer and a region comprising two conductive layers.
  • A37 The device of embodiment A36, wherein one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor and the transceiver are located in the region comprising two conductive layers.
  • A40 The device of any one of embodiments A36 to A39, wherein the region comprising two conductive layers comprises a landing pad and/or metal track as a first conductive layer and an antenna coil as a second conductive layer, which metal track electrically connects two or more of the pressure sensor, the second pressure sensor, the energy storing capacitor and the transceiver.
  • A41 The device of any one of embodiments A36 to A40, wherein the region comprising two conductive layers comprises a first conductive layer in connection with one side of the substrate and a second conductive layer in connection with the opposite side of the substrate.
  • A42 The device of any one of embodiments A36 to A41 , wherein the region comprising the one conductive layer comprises an antenna coil.
  • A43 The device of any one of embodiments A36 to A42, wherein the region comprising the one conductive layer comprises the one conductive layer in connection with one side of the substrate.
  • each conductive layer independently comprises elements comprising a metal, conductive polymer or combination thereof.
  • A43.2 The device of any one of embodiments A36 to A43.1 , wherein each conductive layer comprises elements comprising a biocompatible material.
  • A43.3 The device of embodiment A43.1 or A43.2, wherein the elements comprise gold, silver, platinum, copper, a conductive polymer or combinations thereof.
  • A44 The device of any one of embodiments A1 to A43.3, which comprises a solder mask.
  • A45 The device of embodiment A44, wherein a first solder mask is in connection with a first side of the substrate.
  • A46 The device of embodiment A44 or A45, wherein a second solder mask is in connection with a second side of the substrate opposite of the first side of the substrate.
  • A47 The device of any one of embodiments A1 to A46, wherein the substrate comprises an aperture under the first sensor or second sensor, or the first sensor and the second sensor.
  • A48 The device of embodiment A47, wherein the antenna is disposed around the aperture.
  • A49 The device of embodiment A48, wherein a portion or all of the antenna bends around the aperture.
  • A50 The device of any one of embodiments A47 to A49, wherein the aperture is substantially circular or substantially rectangular.
  • A51 The device of any one of embodiments A1 to A50, wherein a first portion of the substrate comprises a first width and a second portion of the substrate comprises a second width, wherein the second width is greater than the first width.
  • A52 The device of embodiment A51 , wherein the second portion is substantially circular.
  • A53 The device of embodiment A51 , wherein the second portion is substantially rectangular.
  • A54 The device of any one of embodiments A51 to A53, wherein the first sensor is located in or on the second portion.
  • A55 The device of any one of embodiments A1 to A54, wherein the substrate is annular.
  • A56 The device of any one of embodiments A1 to A54, wherein the substrate comprises one or more substantially linear portions.
  • A57 The device of embodiment A56, wherein one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor and the transceiver are located in or on one of the one or more substantially linear portions.
  • A59 The device of any one of embodiments A1 to A58, wherein the substrate comprises a polymer.
  • A60 The device of any one of embodiments A1 to A59, wherein the substrate comprises a biocompatible polymer.
  • A61 The device of embodiment A59 or A60, wherein the substrate comprises Kapton, Apical, UPILEX, VTEC PI, Norton TH, polyether ether ketone (PEEK), a transparent conductive polyester, or combination thereof.
  • the substrate comprises Kapton, Apical, UPILEX, VTEC PI, Norton TH, polyether ether ketone (PEEK), a transparent conductive polyester, or combination thereof.
  • A62 The device of any one of embodiments A1 to A61 , which further comprises one or more intraocular anchors.
  • transceiver is a telemetry transceiver that comprises a near-field communication (NFC) compatible air interface.
  • NFC near-field communication
  • A64 The device of any one of embodiments A1 to A63, wherein the pressure sensor, the second pressure sensor, the energy storing capacitor and the transceiver are located on separate structures.
  • A65 The device of any one of embodiments A5 to A64, wherein one or more of the structures are substantially inflexible.
  • A66 The device of any one of embodiments A5 to A65, wherein one or more of the structures are silicon chips.
  • A67 The device of embodiment A66, wherein the silicon chips are backlapped for improved flexibility.
  • A68 The device of any one of embodiments A1 to A65, wherein one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, the antenna and the transceiver are printed, or comprise printing, using conductive ink or semi-conductive ink.
  • A69 The device of any one of embodiments A1 to A68, wherein the device is coated with a biocompatible material.
  • biocompatible coating comprises Parylene, Parylene C, Parylene AF-4, Parylene SF, Parylene HT, Parylene VT-4, Parylene CF, Parylene N, or combination thereof.
  • A71 The device of any one of embodiments A1 to A70, which is not in association with an artificial lens.
  • A74 The device of any one of embodiments A1 to A70, which is in association with an artificial lens.
  • A76 The device of embodiment A74 or A75, which is in association with an artificial lens in vivo.
  • A77 The device of any one of embodiments A1 to A76, which is in association with a capsular ring.
  • A78 The device of any one of embodiments A1 to A77, wherein the device is in the substantially rolled state.
  • A79 The device of embodiment A78, wherein the device is in the substantially rolled state during insertion into an ocular cavity.
  • A80 The device of any one of embodiments A1 to A77, wherein the device is in the substantially flat state.
  • A81 The device of embodiment A80, wherein the device is in the substantially flat state after insertion into an ocular cavity.
  • a system comprising a device of any one of embodiments A1 to A79 and a remote transceiver configured to receive a signal from the transceiver in the device.
  • a system comprising a device of any one of embodiments A1 to A79 and B1 and a remote transceiver configured to supply power to the transceiver in the device.
  • the remote transceiver is configured to transmit a signal to the transceiver.
  • the remote transceiver further comprises one or more components chosen from a processor; a power source; an antenna; a radio frequency generator; a data logger; and combinations thereof.
  • remote transceiver is a telemetry transceiver that comprises a near-field communication (NFC) compatible air interface.
  • NFC near-field communication
  • a carrier comprising a substantially cylindrical void, which void comprises a device of any one of embodiments A1 to A81 in its substantially rolled state.
  • C2 The carrier of embodiment C1 , wherein the cross-sectional diameter of the substantially cylindrical void is 3.0 millimeters or less.
  • a carrier comprising a substantially flat void, which void comprises a device of any one of embodiments A1 to A81 in its substantially flat state.
  • the carrier of embodiment C9 which comprises a substantially cylindrical void in effective connection with the substantially flat void, which substantially cylindrical void is configured to contain a device of any one of embodiments A1 to A81 in its substantially rolled state.
  • C15 The carrier of embodiment C10, wherein the cross-sectional diameter of the substantially cylindrical void is 1 .5 millimeters or less.
  • C16 The carrier of any one of embodiments C9 to C15, which is a needle.
  • a method for implanting an intraocular pressure monitoring device into the lens cavity of the eye which comprises inserting a device of any one of embodiments A1 to A81 in its substantially rolled state into the lens cavity of the eye through an incision having a length of 3.0 millimeters or less, using suture-less cataract surgical methods, under conditions in which the device assumes the substantially flat state after the device is inserted into the lens cavity.
  • D7 The method of any one of embodiments D1 to D6, wherein the device is inserted as part of a cataract replacement surgery.
  • D8 The method of any one of embodiments D1 to D7, wherein a carrier of any one of embodiments C1 to C5 is utilized to insert the device into the lens cavity of the eye.
  • An intraocular pressure monitoring system comprising:
  • a device of any one of embodiments A1 to A81 which device is configured to obtain intraocular pressure readings in the intraocular cavity of an eye of a subject as an intraocular device;
  • an external device configured to reside outside the eye of the subject, which external device comprising at least one external transceiver configured to receive by telemetry the intraocular pressure readings from the intraocular device.
  • E2 The system of embodiment E1 , wherein the intraocular device is implanted in the intraocular cavity of an eye of a subject.
  • E3. The system of embodiment E1 or E2, wherein the external device comprises an antenna.
  • E4 The system of any one of embodiments E1 to E3, wherein the external device comprises a power source.
  • E5. The system of any one of embodiments E1 to E4, wherein the external device comprises an eyeglass frame or portion thereof.
  • E6 The system of any one of embodiments E1 to E5, which comprises an output component configured to display the intraocular pressure readings from the intraocular device.
  • E9 The system of embodiment E8, which comprises an internet enabled component configured to transmit the intraocular pressure readings from the external device to the output component.
  • E10. The system of embodiment E9, wherein the internet enabled component is not part of the external device.
  • E1 1.
  • a method for transmitting intraocular pressure information comprising:
  • F5. The method of any one of embodiments F1 to F4, wherein the external device comprises an output component configured to display the intraocular pressure readings from the intraocular device.
  • F6. The method of any one of embodiments F1 to F5, which comprises transmitting the intraocular pressure readings by the external transceiver to an output component configured to display the intraocular pressure readings from the intraocular device.
  • F7. The method of embodiment F6, wherein the output component is part of the external device.
  • F8 The method of embodiment F6, wherein the output component is not part of the external device.
  • F9 The method of embodiment F8, which comprises transmitting the intraocular pressure readings from the external device to the output component by an internet enabled component.
  • F1 1 The method of embodiment F9 or F10, which comprises transmitting information to the subject from a health monitor by a messaging component.
  • F13 The method of embodiment F1 1 or F12, wherein the messaging component transmits the information to an output component configured to display the information.
  • F14 The method of any one of embodiments F6 to F13, wherein the output component configured to display the information and the internet enabled component are integrated in a remote device.
  • a or “an” can refer to one of or a plurality of the elements it modifies (e.g., "a reagent” can mean one or more reagents) unless it is contextually clear either one of the elements or more than one of the elements is described.
  • the term “about” as used herein refers to a value within 10% of the underlying parameter (i.e., plus or minus 10%), and use of the term “about” at the beginning of a string of values modifies each of the values (i.e., "about 1 , 2 and 3" refers to about 1 , about 2 and about 3).
  • a weight of "about 100 grams” can include weights between 90 grams and 1 10 grams.

Abstract

Disclosed herein are intraocular pressure monitoring systems and devices useful for continuously measuring intraocular pressure of an eye in a subject, such as a subject afflicted with glaucoma. Devices described herein can communicate measured pressures wirelessly to a receiver positioned externally to the subject. Also disclosed herein are portable readers, in connection with an intraocular pressure monitoring device, which can be used for data storage, data analysis, data display, and/or data transmission.

Description

INTRAOCULAR PRESSURE MONITORING DEVICE AND METHODS
Related Patent Application This patent application claims the benefit of U.S. provisional patent application no. 61/472,998, filed on April 7, 201 1 , entitled INTRAOCULAR PRESSURE MONITORING DEVICE AND
METHODS, naming Paolo Orsatti, Peter Stegmaier, Lorenzo Leoni, Olaf Kurt Morcher, and Jorg Draeger as inventors, and having attorney docket no. OLX-1001 -PV. The entirety of the foregoing provisional application, including all text and drawings, is incorporated herein by reference.
Field
The technology relates in part to an improved medical device and methods for sensing eye pressure. The technology also relates in part to small intraocular pressure monitoring devices with telemetry systems that can be curled and rolled. The technology relates in part to methods and carriers for rolling intraocular pressure monitoring devices for surgical implantation into the eye of a subject.
Background
Glaucoma is a disease affecting millions of people in the world every year and is a major cause for blindness. Glaucoma frequently is caused by increased pressure of the fluid in the eye (aqueous humour), also referred to as increased intraocular pressure (IOP). Pressure in the eye is determined by a balance between the production of aqueous humour (e.g., a transparent liquid that fills the region between the cornea at the front of the eye and the lens) and its exit through the trabecular meshwork and Schlemm' s canal (major route) or via uveal scleral outflow (minor route). Increased intraocular pressure, the most common cause of glaucoma, irreversibly damages the optic nerve, killing the ganglion cell axons and leading to progressive loss of visual field. If untreated, glaucoma can lead to blindness. Regular monitoring of IOP, can facilitate prevention, early detection and treatment of glaucoma. Summary
Provided herein are intraocular devices, systems and methods for monitoring intraocular pressure (IOP) in a subject. Intraocular devices provided herein are capable of being curled into a substantially rolled state. The effective cross-sectional diameter of the device in its substantially rolled state is sufficiently small for permitting insertion of the intraocular device through an incision routinely made in suture-less lens surgery.
In one aspect, provided is an intraocular pressure monitoring device, comprising: a substantially annular substrate, which substrate is substantially flexible; a pressure sensor and a transceiver mounted to the substrate, which pressure sensor is in a location on the device separate from the location of the transceiver, and which pressure sensor and transceiver are aligned on a single axis; an antenna mounted to the substrate, which antenna, pressure sensor and transceiver are in effective connection; which device is capable of transitioning from a substantially flat state to a substantially rolled state and from the substantially rolled state to the substantially flat state; and which device, when in the substantially rolled state, is configured to fit within a substantially cylindrical void having a cross-sectional diameter of less than 2.6 millimeters. A first portion of the substrate sometimes comprises a first thickness and a second portion of the substrate comprises a second thickness, which first thickness is narrower than the second thickness. Pressure sensor, transceiver and/or capacitor components often are located at the second portion of the substrate. A first portion of the substrate sometimes comprises a first width and a second portion of the substrate comprises a second width, which second width is greater than the first width. A pressure sensor under which is disposed an aperture traversing the substrate thickness often is located at the second portion. An intraocular device sometimes is in association with a replacement lens, and in some embodiments, an intraocular device is in association with a capsular ring. An intraocular device sometimes is in a substantially rolled state, and sometimes is in a substantially flat state.
An aspect also pertains to a system comprising an intraocular device comprising a telemetry transceiver described herein and a remote transceiver configured to receive a signal from the telemetry transceiver in the intraocular device. An aspect pertains also to a system comprising an intraocular device described herein and a remote transceiver configured to supply power to the transceiver in the intraocular device. An aspect also pertains to a method for supplying energy from the external device to the intraocular device for the intraocular device to function. An aspect also pertains to a carrier comprising a substantially cylindrical void, which void comprises an intraocular device described herein in its substantially rolled state. An aspect pertains also to a carrier comprising a substantially flat void, which void comprises an intraocular device described herein in its substantially flat state.
An aspect also pertains to a method for implanting an intraocular device into the lens cavity of the eye, which comprises inserting an intraocular device described herein in its substantially rolled state into the lens cavity of the eye through an incision having a length of 3.0 millimeters or less, using suture-less cataract surgical methods, under conditions in which the device assumes the substantially flat state after the device is inserted into the lens cavity.
An aspect pertains also to an intraocular pressure monitoring system, comprising: an intraocular device described herein, which device is configured to obtain intraocular pressure readings in the ocular cavity of an eye of a subject; and an external device configured to reside outside the eye of the subject, which external device comprises at least one external transceiver configured to receive by telemetry the intraocular pressure readings from the intraocular device.
An aspect also pertains to a method for transmitting intraocular pressure information, comprising: obtaining intraocular pressure readings by the pressure sensor of an intraocular device described herein that has been implanted in the ocular cavity of an eye of a subject; and transmitting by telemetry the intraocular pressure readings from the transceiver of the intraocular device to an external transceiver in an external device residing outside the eye of the subject.
Certain embodiments are described further in the following description, examples, claims and drawings.
Brief Description of the Drawings
The drawings illustrate embodiments of the technology and are not limiting. For clarity and ease of illustration, the drawings are not made to scale and, in some instances, various aspects may be shown exaggerated or enlarged to facilitate an understanding of particular embodiments.
FIG. 1 A shows a top view of an intraocular pressure sensor monitoring device embodiment. FIG. 1 B shows a cross section view at lines 1 B to 1 B of FIG. 1A. FIG. 1 C shows a cross section view at lines 1 C to 1 C of FIG. 1A. FIG. 1 D shows a cross section view at lines 1 D to 1 D of FIG. 1A. FIG. 1 E shows a bottom view of the intraocular pressure sensor monitoring device shown in FIG. 1A. FIG. 1 F shows a cross section view of an intraocular device at a pressure sensor and shows a biocompatible coating.
FIG. 2 and FIG. 3 show top views of intraocular pressure monitoring device embodiments. FIG. 4A shows a top view of an intraocular pressure monitoring device embodiment that includes anchors. FIG. 4B shows a cross section of an eye cavity and a top view of an implanted intraocular pressure sensor monitoring device embodiment held in place in the eye cavity by anchors. Sensor and transceiver components are on separate chips as shown in FIG. 4B.
FIG. 5A shows a cross section view of a cylindrical void and therein a side view of a rolled intraocular sensing device having a pressure sensor, capacitor and telemetry transceiver and associated electronics rolled and inserted into the cylindrical void. FIG. 5B shows a cross section view of a cylindrical void and therein a side view of a rolled intraocular pressure sensing device comprising two pressure sensors.
FIG. 6A is a side view cross section of an ocular cavity illustrating the positioning of an intraocular pressure monitoring device having intraocular anchors, behind a lens (e.g., a replacement lens). FIG. 6B is a side view cross section of an ocular cavity with an intraocular pressure monitoring device attached to the lens (e.g., a replacement lens). FIG. 6C shows a top view of an intraocular device embodiment comprising anchors and a substantially trapezoidal region of increased width, which device is in association with an artificial replacement lens comprising hooks. FIG. 7 shows a side view cross section of the ocular cavity having an internal intraocular device positioned within the ocular cavity behind the lens (e.g., a replacement lens). FIG. 7 also shows a side view of an extracorporeal transceiver for use with an internal intraocular device.
FIG. 8 shows a schematic representation of data flow between an intraocular pressure monitoring device, a transceiver mounted in an eyeglass frame, and an external device with display, storage and internet functionality.
FIG. 9 shows a schematic representation of data and/or energy flow between an intraocular device, an associated external reader and various internet enabled devices (e.g., computer, smartphone, PDA, Bluetooth transmitter, the like and combinations thereof), to a remote health monitor that provides service to a subject implementing the system.
Certain elements shown in the drawings are summarized in the following table.
Figure imgf000006_0001
Callout Element*
136 stud bumps
139 adhesive
145 loop antenna
148 eye cavity
154 cutting location
158 transition from first thickness to second thickness
159 flat axis
160 rolled axis
161 sensor top
164 sensor base
166 top solder mask
167 bottom solder mask
170 substrate landing pad
172 conductive element (e.g., conductive metal)
173 conductive element (e.g., conductive metal)
176 sensor aperture
179 substrate width (e.g., about 0.75 mm to about 1.5 mm)
182 outer diameter (e.g., about 7 mm to about 1 1 mm)
185 inner diameter (e.g., unobstructed diameter of about 5 mm to about 8 mm)
188 sensor length (e.g., about 0.5 mm to about 0.9 mm)
191 capacitor length (e.g., about 0.3 mm to about 1 .5 mm)
194 capacitor width (e.g., about 0.1 mm to about 0.5 mm)
197 sensor width (e.g., about 0.5 mm to about 1 .5 mm)
200 cylindrical void diameter (e.g., about 1 .5 mm to about 3.5 mm)
203 perimeter of carrier
204 cylindrical void
206 transceiver width (e.g., about 0.5 mm to about 1.5 mm)
209 transceiver length (e.g., about 1 mm to about 5 mm)
212 inner surface of eye cavity
215 horizontal diameter
218 second thickness (e.g., about 65 μηη to about 95 μηη)
221 first thickness (e.g., about 35 μηη to about 65 μηη)
224 optical axis
227 device body
300 biocompatible coating
303 sensor top Callout Element*
306 sensor base
309 aperture diameter or width (e.g., about 500 μηη to about 700 μηη)
312 chamber
*certain dimensions referenced in the table are in millimeters (mm) or micrometers (μηη)
An element shown in different embodiments sometimes is referenced in drawings with the same callout number in the foregoing table or the callout number with an "a," "b," "c," "d," "e" or "f" suffix. Such an element may have the same structure, same function, similar structure, similar function, different structure and/or different function in different embodiments. For example, sensors 12, 12a, 12b, 12c, 12e and 12f are in device embodiments shown in FIG. 1A, FIG. 2, FIG. 3, FIG. 4A, FIG. 5B and FIG. 6C, respectively. The sensors may be the same, similar or different in various embodiments. In another example, transeivers 14, 14a, 14b, 14c and 14f are in device
embodiments shown in FIG. 1A, FIG. 2, FIG. 3, FIG. 4A and FIG. 6C, respectively. The transceivers may be the same, similar or different in various embodiments.
Detailed Description
Glaucoma is an eye disorder in which the optic nerve suffers damage, permanently impacting vision in the affected eye(s) and progressing to complete blindness if untreated. Glaucoma often is associated with increased pressure of the fluid in the eye. Nerve damage involves loss of retinal ganglion cells in a characteristic pattern. There are many different sub-types of glaucoma, but all can be considered a form of optic neuropathy. Raised intraocular pressure is a significant risk factor for developing glaucoma (e.g., threshold value 21 mmHg or 2.8 kPa). One person may develop nerve damage at a relatively low pressure, while another person may have high eye pressure for years and yet never develop damage. Untreated glaucoma leads to permanent damage of the optic nerve and resultant visual field reduction, which can progress to blindness. The damaged visual field cannot be recovered.
Worldwide, glaucoma is the second leading cause of blindness. Glaucoma can be divided roughly into two main categories, "open angle" and "closed angle" glaucoma. Closed angle glaucoma can appear suddenly and is often painful. Visual loss can progress quickly but the discomfort often leads patients to seek medical attention before permanent damage occurs. Open angle, chronic glaucoma tends to progress at a slower rate and a patient may not notice that they have lost vision until the disease has progressed significantly. If the condition is detected early enough it is possible to arrest the development or slow the progression utilizing medical and surgical means.
Early detection and treatment of glaucoma often involves regular pressure monitoring by an ophthalmologist, and frequently involves the use of pressure measuring devices that involve direct or indirect contact with an external portion of the eye to measure intraocular pressure. In aggressive cases of glaucoma, or in patients who have recently undergone surgery to relieve intraocular pressure, pressure measurements often involve frequent visits to the eye doctor, sometimes as often as once or twice a week, for pressure measurement and monitoring.
While these methods help treat the progression of the disease, intraocular pressure (IOP) can vary through out the day, with pressure peaks sometimes occurring in the evening or while a patient sleeps. Internal pressure measurements often are a more realistic measure of the pressure inside the eye when compared to measurements taken by indirect external pressure measurements. Current clinical practice methods of measuring IOP are suboptimal often due to only performing periodic IOP measurements during regular office hours. Diurnal and 24-hour IOP measurements obtained on an in-patient basis can increase the frequency of measurements, but are inconvenient and expensive. Diurnal and 24-hour IOP measurements typically do not allow ambulatory monitoring of IOP.
Provided in some embodiments are intraocular pressure monitoring devices that include a small intraocular portion that can be rolled and then inserted into the lens cavity or lens bag of the eye as part of standard suture-less ophthalmology surgical techniques (e.g., cataract replacement surgery). Also provided in certain embodiments are intraocular pressure monitoring devices suitable for measuring intraocular pressure several times a day or throughout the day without the need for frequent visits to an ophthalmologist. Provided also in some embodiments are intraocular pressure monitoring devices that wirelessly transmit the pressure measurement data to an external receiver for further processing, analysis and/or storage, thus allowing ambulatory, 24-hour monitoring of IOP. Intraocular pressure monitoring devices
Intraocular pressure (IOP) monitoring systems described herein are telemetry systems that can measure the IOP of an eye and send the information back to an associated telemetry reader. The telemetry transmissions often are carried on one of the industrial, scientific or medical (ISM) electromagnetic frequency bands.
IOP monitoring systems provided herein often include a device that is implanted into the eye of a subject, which is referred to as an "intraocular device" or "internal device" herein. A system often also includes another device that is external to the subject and receives from, transmits information to and/or transmits an electric field, or magnetic field or electromagnetic field, to an intraocular device, which is referred to as an "external device" or "reader" herein. An intraocular device often is configured for curling, rolling and/or folding and insertion into the eye of a subject (e.g., lens cavity or lens bag) by a suitable surgical procedure. A suitable surgical procedure often is one that requires no sutures in the eye, and such procedures often include cutting a small incision in the eye. The incision often is 3.0 millimeters or less in length or 2.5 millimeters or less in length (e.g., about 2.5 millimeters, 2.4 millimeters, 2.3 millimeters, 2.2 millimeters, 2.1 millimeters, 2.0 millimeters, 1 .9 millimeters, 1 .8 millimeters, 1 .7 millimeters, 1 .6 millimeters or 1.5 millimeters or less in length).
In certain surgical processes a carrier can be utilized for the purpose of transmitting an intraocular device into the eye through the incision. A portion of the carrier sometimes inserts into the interior of the eye through the incision, and the carrier often includes a void into which the intraocular device is loaded for delivery into the interior of the eye. The void in the carrier can be of any suitable geometry, such as a cylinder, frustrum, hexahedron, rhombohedron and the like). The carrier sometimes comprises a substantially cylindrical void, and sometimes the carrier comprises a needle in which there is a void. A void sometimes has a cross section (e.g., a circle in a substantially cylindrical void) having a width or diameter of 3.5 millimeters or less (e.g., about 3.5 millimeters, 3.4 millimeters, 3.3 millimeters, 3.2 millimeters, 3.1 millimeters, 3.0 millimeters, 2.9 millimeters, 2.8 millimeters, 2.7 millimeters, 2.6 millimeters, 2.5 millimeters, 2.4 millimeters, 2.3 millimeters, 2.2 millimeters, 2.1 millimeters, 2.0 millimeters, 1 .9 millimeters, 1 .8 millimeters, 1.7 millimeters, 1 .6 millimeters or 1 .5 millimeters or less). Intraocular devices provided herein often are capable of rolling and being contained for a period of time in a substantially rolled state after being inserted into a carrier having a void described herein. A device in a substantially rolled state need not form a perfect cylinder. Sometimes the
substantially rolled state is substantially cylindrical or can fit within a substantially cylindrical void. Intraocular devices often are capable of deforming to a substantially flat or substantially planar state, and sometimes have little or substantially no memory of the substantially rolled state. A device in the substantially flat state often does not include a curled edge when unrolled from the substantially rolled state after a certain period of time (e.g., within about 5 minutes, 10 minutes, 20 minutes, 30 minutes, 60 minutes).
Certain design aspects permit an intraocular device to assume a rolled state that can be contained in a substantially cylindrical void having a cross sectional diameter of 3.5 millimeters or less. A device often includes separate transceiver and sensor components, and sometimes includes one or more separate capacitors or other separate components. Two or more components often are located on separate structures. The structures sometimes are substantially inflexible or substantially rigid. In some embodiments, a structure is an integrated circuit, silicon chip and/or die.
Two or more separate components of a device often are aligned along a single axis, which axis is longitudinal and tangential to the top surface of the device in its substantially flat state. The axis generally intersects two points on the perimeter of the device in the substantially flat state. This axis is referred to herein as a "flat axis." In some embodiments, the flat axis intersects two points on the outer perimeter and no points on the inner perimeter of the intraocular device in the substantially flat state. In certain embodiments, the flat axis intersects two points on the outer perimeter and two points on the inner perimeter of the intraocular device in the substantially flat state.
Without being limited by theory, alignment of separate components and/or structures on a single axis can promote rolling of the device into a cylindrical void having a substantially small cross- sectional diameter. Certain embodiments include: (i) the midlines of the aligned components and/or structures are aligned on the flat axis; (ii) the same edges of the aligned components and/or structures are aligned on the flat axis (e.g., the right edges, the left edges, the top edges or the bottom edges of the components and/or structures are aligned on the flat axis); (iii) a line parallel to an edge or midline and spaced from the edge or midline, of one or more of the aligned components and/or structures, is aligned on the flat axis; and (iv) combinations of the foregoing. A separate component or structure sometimes includes two sides of unequal length, and the side having the longer length, or a line parallel to and spaced from that side, often is aligned on the flat axis. In some embodiments, the effective width of the separate components and/or structures aligned on the flat axis, which effective width is the dimension perpendicular to the flat axis that contains the outermost edges of all of the aligned components and/or structures, is about 1 .3 millimeters or less (e.g., 1 .2 millimeters or less, 1.1 millimeters or less, 1.0 millimeters or less, 0.9 millimeters or less or 0.8 millimeters or less). Where only edges of a group of components and/or structures are aligned, and opposite edges are aligned (e.g., a right edge of one structure is aligned on the flat axis with the left edge of another structure), the components and/or structures are not aligned on the flat axis.
There generally is separation on a flat axis between the components and/or structures aligned on the axis. The components and/or structures need not be aligned along the entire length of the axis, which length of the axis is defined by the two outer edges of the device intersected by the axis. The components and/or structures often are aligned along a portion of the axis length, and sometimes are aligned on 50% to 95% of the axis length (e.g., aligned on about 55%, 60%, 70%, 75%, 80%, 85%, 90% of the axis length). In some embodiments, the majority of separate components and/or structures (e.g., sensor or sensors, transceiver and/or optional capacitor), all but one of the separate components and/or structures or all of the separate components and/or structures of the device are aligned on the flat axis. A non-limiting example of a flat axis 159 is shown in FIG. 1A, which flat axis is a longitudinal axis tangential to the top surface of the device body, which top surface is in effective connection with components 12, 14 and 19. The midlines of components 12, 14 and 19 are aligned along flat axis 159 in the embodiment shown in FIG. 1A.
A device sometimes includes separate components and/or structures aligned on a flat axis and one or more separate components and/or structures not aligned on the flat axis. When such a device is in the substantially rolled state, the separate components and/or structures not aligned on the flat axis sometimes are aligned on another axis, referred to as a "rolled axis," with one of the components or structures aligned on the flat axis. The rolled axis generally is transverse to, and spans and intersects two points on the perimeter of, a cross-section of an intraocular device in the substantially rolled state. A component or structure on the flat axis and a component or structure not on the flat axis often align on the rolled axis. An edge, midline, or line parallel to an edge or midline and spaced from the edge or midline, of such components or structures sometimes is aligned on the rolled axis when the device is in the substantially rolled state. A non-limiting example of a rolled axis is shown as axis 160 in FIG. 5A and FIG. 5B.
The effective diameter of a rolled intraocular device (or the cross sectional diameter of a cylindrical void into which the rolled device can be placed) also can be minimized by other structural features described herein. For example, devices that include a region with a first thickness, at which certain components are located, and a region with a second thickness thinner than the first thickness, can minimize the effective diameter of the rolled intraocular device. In another example, devices that include a region with a first width and a region with a second width wider than the first width at which certain components are located also can minimize the effective diameter of the substantially rolled intraocular device. Such features are described in greater detail herein.
Sensors An intraocular device for internal use (e.g., in the eye) can include any type of sensor suitable for a target measurement. A sensor can be selected for sensing osmotic pressure, sugar level (e.g., glucose level), electrical activity (e.g., of the heart), electromagnetic spectrum (light), temperature, pH, or pressure (e.g., blood pressure, IOP), for example. Pressure can be expressed as the force required to stop a fluid from expanding, and generally is defined in terms of force per unit area. A pressure sensor often is considered a transducer that generates a signal as a function of the pressure applied against the sensor. A signal generated by a pressure sensor often is an electrical signal. In some embodiments, a pressure sensor measures the variation of resistance during a measurement (e.g., impedance). Pressure sensors sometimes also are referred to as pressure transducers, pressure transmitters, pressure senders, pressure indicators, pressure piezometers, and manometers.
Any suitable form of pressure sensor (e.g., force collector type, membrane or other type) can be used in an intraocular device described herein. Non-limiting examples of force collector type pressure sensors suitable for use in embodiments described herein include piezo resistive strain gauge sensors, capacitive sensors, electromagnetic sensors, resonant pressure sensor and piezoelectric sensors. Examples of pressure sensors that can be utilized in embodiments described herein are known (e.g., United States Patent Nos. 6,443,893 (Schnakenberg et al.) and 6,796,942 (Kreiner et al.), and International Application Publication WO 2005/048835 (Bodecker et al.)). An intraocular capacitive pressure sensor is discussed in United States Patent Nos. 6,447,449 and 6,579,235, for example. A micro-machined pressure sensor is discussed in United States Patent No: 6,443,893, for example.
Pressure sensors suitable for use with an intraocular device often are in effective connection with (i) a substrate, (ii) a telemetry transceiver, (iii) an antenna, and/or (iv) various combinations thereof. In some embodiments, an IOP sensor is in effective connection with an antenna, a telemetry transceiver, an optional energy storing capacitor or resonant circuit and/or a substrate via biocompatible flexible metal interconnections. In certain embodiments, an IOP sensor is in effective connection with an antenna, a telemetry transceiver, an optional energy storing capacitor or resonant circuit and/or a substrate via flexible semi-conductive or conductive ink printed on the substrate.
In some embodiments, two or more of a sensor, transceiver, antenna and optional capacitor are in direct connection. In certain embodiments, the two or more components are in direct connection by one or more track connections (e.g., wire track or conductive ink track from sensor integrated circuit to transceiver integrated circuit) and/or by one or more via connections (e.g., a via connection between an antenna element and one or more other components (e.g., sensor, transceiver, capacitor)). In some embodiments, a substrate is in direct connection with a component when the component is adhered (e.g., welded) to a member in connection with the substrate (e.g., integrated circuit affixed by an underfill to the substrate). A component mounted to a portion of a substrate sometimes is directly connected to the substrate and sometimes is indirectly connected to the substrate by an intermediate structure (e.g., weld, stud, landing pad, globetop, underfill and/or conductive adhesive). Two or more components can be in indirect or functional connection between two or more components. Non-limiting examples of intraocular device components that can be in indirect or functional connection (e.g., functional connection, operational connection, mechanical connection, electrical connection, magnetic connection, the like and combinations thereof) include: pressure sensor with antenna; telemetry transceiver with antenna, pressure sensor with telemetry transceiver; capacitor with antenna, capacitor with pressure sensor; capacitor with telemetry transceiver; inductor and capacitor; resonant circuit and tuned resonant circuit tank, the like and combinations thereof. In some embodiments, an intraocular device includes one or more pressure sensors that measure pressure by deformation of a sensible membrane. In certain embodiments, a pressure sensor has a pressure range of between about 0 to about 50 mmHg (e.g., about 0 mmHg, about 5 mmHg, about 10 mmHg, about 15 mmHg, about 20 mmHg, about 21 mmHg, about 22 mmHg, about 23 mmHg, about 24 mmHg, about 25 mmHg, about 26 mmHg, about 27 mmHg, about 28 mmHg, about 29 mmHg, about 30 mmHg, about 31 mmHg, about 32 mmHg, about 33 mmHg, about 34 mmHg, about 35 mmHg, about 40 mmHg, about 45 mmHg, and about 50 mmHg) above atmospheric pressure (e.g., about 760 mmHg). The final pressure reading often is determined by measuring the difference between the absolute lOP and the external atmospheric pressure. The absolute range of a pressure sensor also can be stated as being between about 760 mmHg and 810 mmHg at sea level in certain embodiments. In some embodiments, a pressure sensor has an accuracy of 0.1 mmHg or better.
In various drawings, pressure sensor 12, 12a, 12b, 12c, 12e or 12f refers generically to a pressure sensor, which sensor may be the same, similar or of a different type in various embodiments. In FIG. 1 B shown is a cross section view of a device embodiment at the line connecting 1 B to 1 B in FIG. 1A. Pressure sensor 12 includes sensor top 161 and sensor base 164, and chamber 312, which chamber often is under vacuum (e.g., substantially perfect vacuum). Sensor 12 can be electrically connected to a substrate landing pad 170 on substrate 15 by bumps 136 (e.g., stud bumps) and adhesive 139 (e.g., isotropically conductive adhesive). A globe top 133 or fillet can support sensor 12 on the substrate. Also shown in FIG. 1 B are mask 166 and mask 167 (e.g., solder mask) and conductive elements 173 (e.g., conductive wires). In FIG. 1 B, conductive elements 173 generally function as antenna elements. The sensor can measure pressure (e.g., IOP) by referring to the displacements of the sensible membrane 121 (membrane-based pressure sensor). The aperture 124 often traverses the thickness of the device body (e.g., substrate), and may be of any suitable minimum width or diameter for monitoring IOP (e.g., about 500 micrometers to about 700 micrometers). The aperture may be of any suitable profile for the sensor to measure IOP, and sometimes is substantially cylindrical, frustrum, hexahedron, rhombohedron, and the like. Thus, the aperture at the bottom of surface of mask 167 may be of any suitable shape, including substantially circular, oval, rhomboid, rectangle and the like, for example. FIG. 1 E shows a bottom view of an intraocular device, and illustrates a circular aperture 176 that can define the bottom opening of channel 124. The width or diameter of the aperture sometimes is about 500
micrometers to about 700 micrometers (e.g., about 500 micrometers, 550 micrometers, 600 micrometers, 650 micrometers, 700 micrometers). The channel can be manufactured by any suitable process, and sometimes is drilled or ablated in the device body (e.g., flexible printed circuit board (FCP)).
A cross section view of a membrane-based pressure sensor also is shown in FIG. 1 F. The intraocular device can be covered in a biocompatible coating 300 (e.g., parylene coating). The sensor can include a top layer 303 (e.g., borosilicate glass), a base 306 (e.g., silicon-etched structure) in connection with top layer 303 and a chamber 312 that often is under vacuum (e.g., substantially perfect vacuum). The sensor can be connected, in some embodiments, to the substrate 15 or device body (e.g., flexible printed circuit board (FCP)) by, for example, a conductive adhesive and bumps 136 (e.g., gold bumps). An aperture in the device body, having diameter or width 309 can allow the sensor to measure the environmental pressure through a channel 124d. Diameter or width 309 sometimes is about 500 micrometers to about 700 micrometers (e.g., about 500 micrometers, 550 micrometers, 600 micrometers, 650 micrometers, 700 micrometers). In FIG. 1 F, sensor body 306 and top 303 differ from sensor body 164 and top 161 in FIG. 1 B as the former in part form the perimeter of a chamber 312d that has different dimensions than chamber 312.
Transceivers
A transceiver can perform transmitter and/or receiver functions, which can be combined and share common circuitry and/or a single housing. Transceivers sometimes also are referred to as transponders, transverters, and repeaters, which can be used interchangeably. A transceiver in an intraocular device and/or external device often is a telemetry transceiver.
Telemetry is a technology that enables remote measurement and reporting of information.
Telemetry systems often are configured to perform a measurement task and then broadcast the information when queried, without needing an incoming command to perform the function.
Telemetry systems often wirelessly transfer sensor data (e.g., wireless or infrared transmission systems; time-variant sensor data), and sometimes a telemetry systems can utilize wired or fiber optic networks.
Telemetry systems often include an electromagnetic frequency source (e.g., radio frequency source or infrared light source), an antenna, and a power source for powering the telemetry system and/or transmitting the telemetry data. Any suitable electromagnetic frequency source suitable for implantation in the lens cavity of an eye can be used. Non-limiting examples of electromagnetic frequency sources suitable for use in an intraocular device described herein include: radio data telemetry transceivers working in various frequency bands (e.g., low frequency (LF), high frequency (HF), very high frequency (VHF), ultra wideband (UWB), and the like), infrared sources, the like and combinations thereof. A frequency often is chosen according to tissue absorption criteria.
A transceiver utilized in an intraocular device often communicate via one of the industrial, scientific, and medical (ISM) electromagnetic frequencies (e.g., bands) suitable for use in biomedical implants for power induction (e.g., inductive coupling) and data transmission, in some
embodiments. Any suitable ISM electromagnetic frequency range can be used in embodiments described herein. ISM bands currently are defined by the International Telecommunication Union (e.g., ITU), ITU Radiocommunication Sector (ITU-R), as the following ranges, given as the frequency range, followed by the center frequency: 100 kHz to 150 kHz ; 6.765 MHz to 6.795 MHz, 6.780 MHz; 13.553 MHz to 13.567 MHz, 13.560 MHz; 26.957 MHz to 27.283 MHz, 27.120 MHz; 40.66 MHz to 40.70 MHz, 40.68 MHz; 433.05 MHz to 434.79 MHz, 433.92 MHz; 902 MHz to 928 MHz, 915 MHz; 2.400 GHz to 2.500 GHz, 2.450 GHz; 5.725 GHz to 5.875 GHz, 5.800 GHz; 24 GHz to 24.25 GHz, 24.125 GHz; 61 GHz to 61 .5 GHz, 61 .25 GHz; 122 GHz to 123 GHz, 122.5 GHz; and 244 GHz to 246 GHz, 245 GHz. In some embodiments, telemetry transceivers used in embodiments described herein utilize frequencies between 100 kHz to 500 MHz for power induction and data transmission.
Radio-frequency identification (RFID) is a technology that communicates via radio waves to exchange data between a reader and an electronic tag attached to an object. RFID generally is not configured to transmit time-variant data, but rather identification information on the object to which the tag is attached. Telemetry systems described herein can transmit sensor information (e.g., time-variant data) using modulation principles and power concepts similar to those used in RFID technology.
ISM bands noted above also are widely used for RFID applications and telemetry applications. In some embodiments, an intraocular device uses an electromagnetic frequency range centered around 13.560 MHz. In certain embodiments, an intraocular device uses an electromagnetic frequency range centered around 27.120 MHz. A transceiver can include an integrated circuit and can include components that can store and/or process information (e.g., flash memory for storing pressure calibration, random access memory (RAM) for processor function), modulating and demodulating a radio-frequency (RF) signal, and other specialized functions (e.g., microcontroller functions, analog to digital converter (ADC), signal conditioning)). A transceiver often functions in association with an antenna for receiving and transmitting a signal.
Telemetry systems can be passive (e.g., no battery or power source, powered by inductive coupling), active, (e.g., contain a power source that controls transmission upon activation by an external reader), and battery assisted passive (e.g., requiring an external interrogation to become active, but have a longer transmission range than passive systems, due to the power for signal bursts provided by the battery). In some embodiments, an intraocular device functions
substantially similar to a radio frequency identification (e.g., RFID) transponder with the additional capability to transmit time variable sensor data to an extracorporeal transceiver.
A transceiver often is in effective connection with a pressure sensor on or in an intraocular device, and sometimes is in effective connection with an optional second pressure sensor, one or more optional energy storing capacitors, an antenna, and/or a substrate. Non-limiting examples of intraocular devices that include a telemetry transceiver are shown in FIGS. 1 A, 2 and 3. In embodiments illustrated in FIGS. 1A, 2 and 3 the telemetry systems are shown in effective connection with a pressure sensor, an optional second pressure sensor, one or more optional energy storing capacitors, an antenna, and a substrate. Various combinations of a telemetry system in connection with the aforementioned components also are possible, in various
embodiments.
In some embodiments, a transceiver is in connection with an antenna, an lOP sensor, an optional energy storing capacitor or resonant circuit and/or a substrate via flexible metal interconnections, which often are biocompatible. In certain embodiments, a transceiver is in connection with an antenna, an lOP sensor, an optional energy storing capacitor or resonant circuit and/or a substrate via flexible semi-conductive or conductive ink printed on the substrate. In some embodiments, components used in an lOP sensor described herein include a flexible silicon semiconductor chip printed with a semiconductor material, adding to the flexible nature of the device. In some embodiments, lOPs are measured by a pressure sensor and transmitted by a transceiver in conjunction with the associated coil or loop antenna. A transceiver of an intraocular device can communicate with another external device, as described herein. For example, a system can include an external reader that is capable of transmitting radio frequency to interrogate the telemetry chip, provide resonant inductive coupling, provide magnetic inductive coupling, receive and/or store transmitted telemetry data, provide for data output and/or display, and further transmission to a server based system or remote computer, in various embodiments. In some embodiments, an external reader is battery powered, and in certain embodiments, the external reader is power line powered. Non-limiting examples of external reader embodiments are shown in FIGS. 7 and 9. Intraocular devices described herein also can utilize near field communication (NFC) systems in the place of RFID-like telemetry systems. Near field communication refers to a group of short- range based technologies that can transmit data wirelessly over the 13.56 MHz frequency, at bit rates of between about 106 kbit/s to about 848 kbit/s. The effective transmission range of NFC systems is between about 4 centimeters to about 20 centimeters. Like inductive coupling described herein, near-field communication also takes advantage of magnetic induction between two loop antennas located within each other's near field. The proximity of the antenna in the intraocular and external devices has the effect of producing an air-core transformer.
Near field communication devices can operate in one of two modes. In passive communication mode an initiator device provides a carrier field (e.g., magnetic field generated by the antenna of the initiator device) and the target device responds by modulating the field generated by the initiator device. The target device sometimes draws its operating power from the initiator-provided electromagnetic field (e.g., the target device is a transponder). In active communication mode an initiator device and target device communicate by alternately generating their own fields.
In various embodiments, the operating frequency and the associated modulation schemes correspond to the upcoming standards for NFC such that the extracorporeal transceiver can be complemented by use of any NFC enabled device (e.g., current and future cell phones, and the like). An IOP can be rapidly measured using NFC enabled devices. Thus, a telemetry transceiver can include NFC transceivers and transponders and RFID-like transceivers and transponders. Antenna
An antenna can function as a transducer that transmits or receives electromagnetic, or electric or magnetic waves, and converts the respective radiation into an electrical signal, or vice versa. An antenna can also function as one or more conductors that cause an electromagnetic field when a voltage is applied across the antennas' terminal (e.g., conductor terminals) to create an alternating current. For reception, the reverse occurs, and an electromagnetic field from another source can induce an alternating current in the antenna conductors, which in turn causes a voltage at the antenna terminal.
Antenna can be used to generate power in the implanted portion of the intraocular device that does not include a battery. Antenna used in this manner can generate power that can be used to power one or more pressure sensors, a telemetry transceiver and/or other electronics by coupling, in some embodiments. Inductive coupling refers to the induction of a current in a first device (e.g., external reader) which causes a magnetic field that can interact with the antenna of a second device (e.g., implanted intraocular device). The interaction of the magnetic field with the antenna of the second device induces a current in the second device. The current induced in the second device can be used to power a component in the second device and/or to charge a capacitor in the second device.
An example of inductive coupling is described in the context of components described herein. The reader's antenna coil generates an electro-magnetic field (e.g., an inductor in the reader (i.e., external device) generates a current which in turn generates an electro-magnetic field in the reader's antenna), which penetrates the cross-section of the intraocular device antenna coil area and the area around the coil. Because the wavelength of the frequency range used (e.g., ISM bands) is several times greater than the distance between the reader's antenna and the implanted telemetry transponder, the electro-magnetic field may be treated as a simple magnetic alternating field with regard to the distance between transponder and reader antenna. In some embodiments, the electric component of the electromagnetic field may be screened so that only the magnetic component is used for transmission of energy and for reception of data. The antenna coil in the implanted portion of the intraocular device in turn magnetically resonates with the magnetic field of the reader, which in turn induces a current at the antenna terminal. The induced current can be used to directly power an intraocular device component, or can be used to charge an optional capacitor, in various embodiments. The amount of current induced is dependent on the power of the source, and on the distance between the antenna and the wavelength of the radio frequency and the relative sizes of the first and second antenna.
Antenna used in association with intraocular devices are known. Examples of remote intraocular devices with antenna can be found in United States Patent Nos: 6,443,893, 6,447,449 and 6,579,235.
In certain embodiments, an antenna of an intraocular device is a coil antenna. In certain embodiments, an antenna comprises a flexible conductive material and the material sometimes is biocompatible (e.g., conductive polymer, conductive metal (e.g., gold, platinum, silver, copper). In some embodiments, an antenna is printed on or in a substrate using a semi-conductive or conductive ink.
Substrates and device bodies
Intraocular device embodiments described herein can include a substantially annular substrate or device body. Top view edges of a device body often are co-extensive with the top view width of a substrate of a device, less any biocompatible coating. A substrate sometimes is substantially annular and sometimes is annular. A substantially annular substrate may include one or more regions that deviate from perfect annularity, and in some embodiments include one or more regions that are substantially linear. FIG. 1A shows a transition region 7 in which the radius of curvature for an annular portion of a substrate transitions to a larger radius of curvature or no radius of curvature (e.g., linear portion), for example. An intraocular device may include one, two or more regions that deviate from perfect annularity.
A substrate, which often forms the backbone of a flexible electronic device or flex circuit, often comprises a material that is electrically conductive, insulating and/or biocompatible. Any substrate (e.g., flexible electronics) can be used so long as it is safe for use when implanted in the lens cavity of an eye. Non-limiting examples of substrates suitable for use in an intraocular device include: polyimide films (e.g., Kapton, Apical, UPILEX, VTEC PI, Norton TH), transparent conductive polyesters, polyether ether ketone (PEEK), shape memory PEEK, biocompatible shape memory polymers, transparent conductive polyester, the like or combinations thereof. In certain embodiments, an intraocular device includes one or two layers of substrate material. In some embodiments, an intraocular device includes a substrate in effective connection with a pressure sensor, a transceiver (e.g., telemetry wireless transceiver), an antenna printed on or embedded in the annular substrate, an optional capacitor (e.g., energy storing capacitor and/or decoupling capacitor), the like or combination thereof. An antenna sometimes is in connection with a surface of the annular substrate (e.g., the same surface as the telemetry transceiver and/or pressure sensor), and sometimes is embedded within the substrate. In some embodiments, one or more of a pressure sensor, a second pressure sensor and a transceiver are associated with the substrate by conductive interconnections, which sometimes comprise a conductive material (e.g., conductive metal; copper, platinum, silver, gold) and/or flexible biocompatible material (e.g., gold; conductive polymer). In some embodiments, one or more of a pressure sensor, a second pressure sensor and a transceiver are sealed with an underfill, and in certain embodiments, the underfill is an epoxy resin. In some embodiments, the epoxy resin is biocompatible. A telemetry transceiver and pressure sensor often are in connection with the same surface of a substrate. In certain embodiments, one or more integrated circuits (e.g., electronic circuits, capacitors, the like and or combinations thereof) and/or electrical connections are printed on the substrate using a semi-conductive or conductive ink.
In certain embodiments, the entire device is coated with a biocompatible material. In certain embodiments, a biocompatible coating material is a Parylene material (e.g., Parylene C, Parylene AF-4, Parylene SF, Parylene HT, Parylene VT-4, Parylene CF, Parylene N).
Shown in FIGS. 1A, 2, 3, 4A, 4B, 6A, 6B, 6C, 7 and 10 are various embodiments of an intraocular device with components in effective connection with a substrate. The overall dimensions of the substrate often are substantially similar to the dimensions of the telemetry transceiver antenna (e.g., between about 9 millimeters to about 1 1 millimeters outer diameter for sensor embodiments using a larger antenna).
In certain embodiments, a substrate and/or device body has an unobstructed inner diameter or inner width (e.g., diameter/width 185 in FIG. 1 A) of about 5.0 millimeters to about 8.0 millimeters (e.g., about 5.0 millimeters, about 5.1 millimeters, about 5.2 millimeters, about 5.3 millimeters, about 5.4 millimeters, about 5.5 millimeters, about 5.6 millimeters, about 5.7 millimeters, about 5.8 millimeters, about 5.9 millimeters, about 6.0 millimeters, about 6.1 millimeters, about 6.2 millimeters, about 6.3 millimeters, about 6.4 millimeters, about 6.5 millimeters, about 6.6 millimeters, about 6.7 millimeters, about 6.8 millimeters, about 6.9 millimeters, about 7.0 millimeters, about 7.0 millimeters, about 7.1 millimeters, about 7.2 millimeters, about 7.3 millimeters, about 7.4 millimeters, about 7.5 millimeters, about 7.6 millimeters, about 7.7 millimeters, about 7.8 millimeters, about 7.9 millimeters, or about 8.0 millimeters). In some embodiments, diameter/width 185 is about 6.5 millimeters to about 7.5 millimeters (e.g., about 7.0 millimeters). In some embodiments, an inner diameter or inner width perpendicular to
diameter/width 185 is about 5.5 millimeters to about 6.5 millimeters (e.g., about 6.0 millimeters). Diameters/widths 185a and 185b can have substantially identical dimensions as diameter/width 185. In some embodiments, a substrate and/or device body has an outer diameter or width (e.g., diameter/width 182 or diameter/width 215 of FIG. 1A) of about 7.0 millimeters to about 1 1.0 millimeters (e.g., about 7.0 millimeters, about 7.1 millimeters, about 7.2 millimeters, about 7.3 millimeters, about 7.4 millimeters, about 7.5 millimeters, about 7.6 millimeters, about 7.7 millimeters, about 7.8 millimeters, about 7.9 millimeters, about 8.0 millimeters, about 8.1 millimeters, about 8.2 millimeters, about 8.3 millimeters, about 8.4 millimeters, about 8.5 millimeters, about 8.6 millimeters, about 8.7 millimeters, about 8.8 millimeters, about 8.9 millimeters, about 9.0 millimeters, about 9.1 millimeters, about 9.2 millimeters, about 9.3 millimeters, about 9.4 millimeters, about 9.5 millimeters, about 9.6 millimeters, about 9.7 millimeters, about 9.8 millimeters, about 9.9 millimeters, about 10.0 millimeters, about 10.1 millimeters, about 10.2 millimeters, about 10.3 millimeters, about 10.4 millimeters, about 10.5 millimeters, about 10.6 millimeters, about 10.7 millimeters, about 10.8 millimeters, about 10.9 millimeters, or about 1 1.0 millimeters). In some embodiments diameter/width 215 is about 8.0 millimeters to about 9.0 millimeters (e.g., about 8.4 millimeters or about 8.5 millimeters). In certain embodiments, diameter/width 182 is about 9.0 millimeters to about 10.0 millimeters (e.g., about 9.4 millimeters or about 9.5 millimeters). Diameters/widths 182a and 182b can have substantially identical dimensions as diameter/width 182.
In some embodiments, an intraocular device includes a region of a first thickness and a region of a second thickness greater than the first thickness. Without being limited by theory, a device comprising a larger surface area region of a narrower thickness and smaller surface area region of increased thickness can decrease the effective cross-sectional diameter of a void required to contain the intraocular device in its substantially rolled state. In some embodiments, the majority of the surface area of the substrate and/or device body can have a narrower thickness, which can reduce the effective cross-sectional diameter of the rolled device, and only certain components benefited by a wider thickness are located on or in one or more regions of increased width that represent a smaller surface area of the device. In some embodiments, a device includes only one region of increased thickness, and sometimes a device includes only two regions of increased thickness. In some embodiments, a region of second thickness constitutes about 1 % to about 30% (e.g., about 5%, 10%, 15%, 20% or 25%) of the surface area of an intraocular device.
In some embodiments, a region of wider thickness in the substrate and/or device body is in proximity to one or more components of the device. In certain embodiments, components of the device are located in or on separate substantially inflexible structures and/or integrated circuits. In some embodiments a region of the first thickness includes conductive elements in association with one side of a substrate (e.g., antenna elements). In certain embodiments a region of the second thickness includes conductive elements in association with both sides of the substrate (e.g., antenna members on one side of the substrate and component mounting members on the other side of the substrate).
FIGS. 1A, 1 B, 1 C and 1 D show regions of different thickness in certain device embodiments. FIG. 1A shows transition or boundary 158 at which a region of first thickness is to the right of the transition and a region of a second thickness, thicker than the first thickness, is to the left of the transition. Components 12, 14, 16 and 19 are located in or on the region of the second thickness, and only component 16 is located in the region of the first thickness. In FIG. 1 B, shown in cross section is a region of second thickness under a sensor component, which region comprises conductive elements in association with both surfaces of substrate 15. Antenna elements 173 are in association with the bottom surface of the substrate, and landing pad 170 is in association with the top surface of the substrate. In FIG. 1 C, in cross section, shows a region of second thickness not located under a sensor component, which region comprises antenna elements 173 in association with one surface of substrate 15 and conductive elements 172 in effective connection with components (e.g., sensor and transceiver integrated circuits 12 and 14). Conductive elements 172 sometimes are tracks (e.g., wire tracks) that connect two or more components of a device (e.g., sensor, transceiver and/or capacitor). The tracks sometimes track between components and connect the components only, and sometimes the tracks track around the entire substantially annular substrate. Shown also are masks 166 and 167 (e.g., solder masks) on each surface of the substrate. Also shown is transition or boundary 158 at which the region of the second thickness on the left tapers to the region of first thickness on the right. Mask 166 in the second thickness can taper to substrate 15 at or about transition or boundary 158. Thus, provided in some embodiments is an intraocular device comprising a device body including a region of first thickness and a region of second thickness thicker than the first thickness, which second thickness tapers to the first thickness. Without being limited by theory, a tapered transition from a region of second thickness to a region of first thickness can promote rolling of the device rather than folding. In some embodiments antenna elements 173 are of the same or similar cross sectional surface area, and/or of the same or similar dimensions, as elements 172. In FIG. 1 D, in cross section, shown is a region of first thickness that includes antenna elements 173 in association with one surface of substrate 15, and mask 167. In certain embodiments, the region of first thickness (e.g., thickness 221 in FIG. 1 D) is about 35 micrometers to about 65 micrometers (e.g., about 35 micrometers, 40 micrometers, 45
micrometers, 50 micrometers, 51 micrometers, 52 micrometers, 53 micrometers, 54 micrometers, 55 micrometers, 60 micrometers, 65 micrometers). In certain embodiments, the region of second thickness (e.g., thickness 218 in FIG. 1 C) is about 65 micrometers to about 95 micrometers (e.g., about 65 micrometers, 70 micrometers, 75 micrometers, 76 micrometers, 77 micrometers, 78 micrometers, 79 micrometers, 80 micrometers, 81 micrometers, 82 micrometers, 83 micrometers, 84 micrometers, 85 micrometers, 90 micrometers, 95 micrometers). In some embodiments, the substrate 15 thickness is about 5 micrometers to about 35 micrometers (e.g., about 5, 10, 15, 20, 25, 30, 35 micrometers), the antenna element 173 thickness is about 5 micrometers to about 15 micrometers (e.g., about 5, 6, 7, 8, 9, 10, 1 1 , 12, 13, 14, 15 micrometers), the mask 166, 167 thickness is about 10 micrometers to about 20 micrometers (e.g., 10, 12, 15, 17, 20 micrometers), and/or the conductive element (e.g., track) 172 thickness is about 5 micrometers to about 15 micrometers (e.g., about 5, 6, 7, 8, 9, 10, 1 1 , 12, 13, 14, 15 micrometers). In certain embodiments, an intraocular device comprises a region having a first width (e.g., width 179 in FIG. 1A). The first width sometimes is about 0.7 millimeters to about 1.5 millimeters (e.g., about 0.7 millimeters, 0.8 millimeters, 0.9 millimeters, 1 .0 millimeters, 1 .1 millimeters, 1.2 millimeters, 1 .3 millimeters, 1 .4 millimeters, 1.5 millimeters). In some embodiments, an intraocular device includes a region having a second width, which second width is of increased width relative to the first width (e.g., region of increased width 13 in FIG. 1A or 13f in FIG. 6C). The region of increased width sometimes has a maximum width or diameter that is about 0.1 millimeters to about 0.5 millimeters greater than the first width (e.g., about 0.1 millimeters, 0.2 millimeters, 0.3 millimeters, 0.4 millimeters, 0.5 millimeters greater than the first width). Without being limited by theory, a device comprising a larger surface area region of a narrower width and smaller surface area region of increased width can decrease the effective cross-sectional diameter of an intraocular device in its substantially rolled state, and decrease the cross-sectional diameter of a void required to contain the intraocular device in its substantially rolled state. In some
embodiments, the majority of the surface area of the substrate and/or device body can have a narrower top view width, which can reduce the effective cross-sectional diameter of the rolled device, and only certain components benefited by a wider footprint are located on or in one or more regions of increased width that represent a smaller surface area of the device. In some embodiments, a device includes no regions of increased width, one region of increased width, or two regions of increased width. In certain embodiments, a region or regions of increased width constitute about 0% to about 15% (e.g., about 5% or 10%) of the surface area of an internal device. Width 179a or 179b sometimes is the same or substantially the same as width 179.
A region of increased width can be of any suitable shape to accommodate a component benefiting from a wider footprint on the device than other components. In some embodiments, the region of increased width is substantially circular (e.g., region 13 of FIG. 1A), ovoid, rhomboid, rectangular, trapezoidal (e.g., isosceles trapezoidal, right trapezoidal (e.g., region 13f in FIG. 6C)), the like and combinations of the foregoing. In regions of increased width having one or more sides, transitions to one or more of the sides may be curved or non-curved. In certain embodiments, a region of increased width supports a sensor component. In some embodiments, there is an aperture through the device body under a sensor component (e.g., aperture 176 in FIG. 1 E). In such embodiments, antenna components can be configured around (e.g., routed around) the aperture and/or channel in the device body. Antenna components may transition from a first radius to a second radius in a region of increased width in some
embodiments (e.g., at about transition 17 in FIG. 1A, where the second radius in the region of increased width is smaller than the first radius outside the region of increased width). Antenna components may transition from a curved configuration to a linear configuration in a region of increased width, in certain embodiments (e.g., transition 17f in FIG. 6C). Antenna components in a region of increased width often are configured around an aperture in the substrate or device body in the same general shape as the channel aperture (e.g., substantially circular for the channel under sensor 12 in FIG. 1 A, and substantially rectangular or trapezoidal for the channel under sensor 12f in FIG. 6C). Intraocular anchors
Intraocular devices configured for implantation include intraocular anchors, in some embodiments. An intraocular anchor can ensure correct positioning and alignment of an intraocular device within the lens cavity of the eye. Intraocular anchors often are associated or in connection with a substrate. In some embodiments, anchors are uniformly distributed around the perimeter of the substrate and/or device body. Anchors are configured to permit rolling of the substantially annular substrate during preparation for insertion, and are exposed in an intraocular device when it is in its substantially flat state to position the device correctly within the lens cavity. An anchor can be of any size or shape suitable for use in positioning an intraocular device. Anchors can be made of any suitable biocompatible material that has or can be made to have a spring force tension, to allow the anchors to open for positioning and securing.
Non-limiting examples of anchor shapes include, circular, semi circular, J-shaped, L-shaped, the like or combinations thereof. Non-limiting examples of materials suitable for use as anchors include plastics, polymers, metals, metal alloys, memory plastics and polymers, the like and combinations thereof. The size of an anchor generally is inversely related to the size of the device. The larger the device, the smaller the anchors necessary to correctly position and/or anchor the device against the inner surfaces of the eye cavity, as shown in FIG. 4B. Conversely, the smaller the device, the larger the anchors necessary to correctly position and/or anchor the device against the inner surfaces of the eye cavity.
Intraocular device embodiments configured for association with a replacement lens sometimes do not include anchors when they are affixed to the replacement lens. The anchors or hooks in association with the replacement lens can serve to properly locate the intraocular device due to the placement of the device on the replacement lens. Any suitable method of associating the lens and intraocular device can be utilized, non-limiting examples of which include adhesive, friction, the like or combination thereof. Intraocular devices that utilize anchors are known. An example of an intraocular device utilizing anchors is shown in United States Patent No: 6,443,893. Non-limiting examples of intraocular device anchors are shown in FIG. 4B and FIG. 6C as anchors 18c and 18f, respectively. Intraocular device embodiments
Non-limiting embodiments of intraocular devices are shown in FIGS. 1 A, 2, 3, 4A, 4B and 6C each shown in a substantially flat state. Non-limiting examples of intraocular devices in a substantially rolled state are shown in FIG. 5A and FIG. 5B.
Shown in FIG. 1A is an intraocular device embodiment comprising substrate 15, which substrate has an inner perimeter 9 and outer perimeter 8. Also shown are antenna 16, pressure sensor 12, transceiver 14 and optional capacitor 19. The midlines of components 12, 14 and 19 are aligned on flat axis 159. The substrate is substantially annular and includes two substantially linear portions, one of which substantially linear portions presents at a curved to linear transition 7. The device embodiment shown in FIG. 1A also includes a first thickness to second thickness transition 158 at which a first thickness to the right of transition 158 transitions to a thicker second thickness to the left of the transition. The device embodiment also includes a region of increased width 13, in which antenna elements curve around a channel below sensor 12 at about transition 17 (see FIG. 1 E showing aperture 176 at the channel opening). A device may have a region of increased width, a region of increased thickness, components aligned on a flat axis, or a combination of the foregoing. Shown in FIG. 2 is an annular device embodiment in which the midlines of components 12a, 14a, and 19a are aligned on a flat axis that intersects two points on the outside perimeter 8a and no points on the inner perimeter 9a of the device. FIG. 3 shows an annular device embodiment in which the midlines of components 12b, 14b and 19b are aligned on a flat axis that intersects two points on the outside perimeter 8b and two points on the inner perimeter 9b of the device.
FIG. 4A shows an annular device embodiment comprising anchors 18c. FIG. 4B shows ocular cavity 148 in which a device is affixed via anchors 18c. FIG. 4A and FIG. 4B shows a device embodiment having transceiver 14c and sensor 12c in separate structures (e.g., separate integrated circuits; separate chips).
Shown in FIG. 6C is a device embodiment similar to the embodiment shown in FIG. 1 A. FIG. 6C shows a region of increased width 13f having a substantially trapezoidal shape, as compared to the substantially circular shape of the region in FIG. 1 A. The intraocular device, which comprises anchors 18f, is in effective association with lens 1 1f, which lens comprises hooks 10Of. The hooks and anchors secure the lens and device in the ocular cavity of the eye. The intraocular device shown in FIG. 6C is outside the field of vision.
FIG. 5A shows an intraocular device embodiment in its substantially rolled state having one pressure sensor and all integrated circuit structures aligned on a flat axis. Illustrated in FIG. 5B is an intraocular device embodiment having two pressure sensors, curled and inserted into a cylindrical void of 3.5 millimeters or less (e.g., 3.0 millimeters or less, 2.5 millimeters or less, 2.0 millimeter or less cylindrical void diameter), in preparation for implantation. Implantation can be accomplished using standard cataract surgical techniques that do not require surgical sutures.
Any of the intraocular devices, and/or external devices described hereafter, can include one or more integrated circuits (e.g., silicon chips). One or more components (e.g., sensor, transceiver, capacitor) can reside in or on one or more integrated circuits. An integrated circuit also can include additional electronic components. Such electronic components can facilitate the function of various components, including, for example, power up, pressure measurement and transmission of telemetry data. Non-limiting examples of electronic functions that can be included in the circuitry of an integrated circuit include micro controller function, analog to digital conversion (ADC) function, signal conditioning (e.g., amplifier) function, flash memory, random access memory (RAM), power storage, the like and various combinations thereof. In some embodiments, the entirety of an intraocular device is outside the field of vision. In certain embodiments, no component or structure (e.g., integrated circuit) in or on an intraocular device extends past the inner perimeter and/or outer perimeter (e.g., inner perimeter 9, outer perimeter 10 in FIG. 1A). In some embodiments, the entirety of an intraocular device is outside the field of vision when implanted in an ocular cavity, and in certain embodiments, the entirety of an intraocular device is outside the perimeter of a lens when the device is in association with a lens.
The operation temperature of an intraocular device generally is approximately 37 degrees Celsius. An intraocular device generally does not substantially increase the intraocular temperature through its operation. An intraocular device often is configured to avoid transient peaks of temperature while operating. In some embodiments, an intraocular device as described herein has a target lifetime of about 10 to about 20 years or more (e.g., about 10 years, about 12 years, about 14 years, about 15 years, about 16 years, about 18 years, or about 20 years or more). Carriers
Intraocular device embodiments described herein are configured for implantation into the lens cavity of an eye. An intraocular device can be implanted using a cataract lens replacement method involving surgical incisions of less than 2.5 millimeters. Utilizing incisions smaller than 2.5 millimeters allows suture-less wound healing, thereby easing the recovery period for the patient and physician.
An intraocular device often includes a substantially flexible substrate, and often is configured with aligned hard components, such that the device can be compactly curled and placed into a cylindrical void of 3 millimeters or less (e.g., cylindrical void is about 2.5 millimeters, about 2.0 millimeters). The cylindrical void of 3 millimeters or less corresponds to the bore of a needle configured for curling (e.g., rolling, folding, wrapping) and insertion of the device into the lens cavity of an eye, through an incision smaller than 2.5 millimeters, in some embodiments. A cylindrical void is within a hollow needle in some embodiments.
In some embodiments, a carrier device can be utilized to roll, contain and/or deliver into an ocular cavity an intraocular device. In some embodiments, an intraocular device is suspended in a liquid and drawn through the carrier, the carrier being configured with one or more internal passages that correctly orient and curl the intraocular device in preparation for insertion into an eye. A carrier device sometimes includes a needle configured to curl the intraocular device in preparation for insertion into the lens cavity of an eye.
In some embodiments, a carrier includes a first void that can contain an intraocular device in a substantially flat state and a second void that can contain the intraocular device in a substantially rolled state. The second void sometimes is substantially cylindrical, and the carrier, first void and second void can be configured to roll the intraocular device from a substantially flat state in the first void to a substantially rolled state in the second void as the intraocular device is transferred from the first void to the second void. The intraocular device may be transferred from the first void to the second void by application of a positive or negative pressure, in some embodiments. A driving member sometimes is in association with a carrier or integrated in a carrier, which driving member sometimes is configured to apply a positive pressure or negative pressure in a void of the carrier sufficient to transfer an intraocular device from the void. A driving member is a syringe in some embodiments. Embodiments of an intraocular device rolled and contained in a substantially cylindrical void are shown in FIG. 5A and FIG. 5B. Carrier 203 contains cylindrical void 204, shown in cross section, which has diameter 200. As shown in FIG. 5B, within the void is contained an intraocular device in a substantially rolled state, which intraocular device comprises substrate 15e and sensors 12e and 21 e, which sensors are aligned on rolled axis 160. FIG. 5A shows an embodiment of an intraocular device having one pressure sensor contained within a void in a substantially rolled state (e.g., the intraocular device shown in FIG. 1A).
Methods of insertion
As addressed above, an intraocular devices often is configured for curling and containment in a cylindrical void having a cross-sectional diameter of less than 3 millimeters. Curling the device into the void allows for containment of the intraocular device into an implantation device (e.g., carrier) that can be utilized during standard cataract replacement surgery. Current state of the art cataract surgery typically utilizes a surgical incision of less than 2.5 millimeters, thereby allowing wound closure without the use of sutures. This method allows for faster healing while minimizing complications associated with sutures. Generally, an intraocular device is inserted through the same incision using a dedicated implantation device (e.g., carrier). The intraocular device delivery sometimes is performed before or after the insertion of the replacement lens.
In some embodiments provided is a method for inserting an intraocular device, in association with or not in association with a replacement lens, including: (i) providing a curled intraocular device described herein, and (ii) inserting the curled intraocular device into the lens cavity of the eye through an incision of 2.5 millimeters of less, using suture-less cataract surgical methods, whereby the intraocular device assumes its original uncurled shape upon uncurling. In some embodiments, the intraocular device is implanted during cataract replacement surgery. In certain embodiments, the intraocular device is inserted prior to inserting a replacement cataract lens. In some embodiments, the intraocular device is inserted after inserting a replacement cataract lens. In certain embodiments, the intraocular device is in association with a replacement cataract lens. Thus, in some embodiments, provided is a lens comprising an intraocular device described herein. The intraocular device sometimes is associated with the lens ex vivo or in vivo using a suitable method (e.g., a lens resides within the inner diameter/width of the intraocular device and is not attached to the device; the lens is attached to the device). Provided also is a method of inserting an intraocular device including: inserting a curled intraocular device into the lens cavity of an eye, using cataract replacement surgical techniques that do not require the use of sutures to close the surgical incision. In certain embodiments, the method includes curling the intraocular device to fit into the bore of a carrier having a diameter of 3 millimeters or less prior to delivery of the device into the lens cavity. In some embodiments, the intraocular device is inserted independently of a replacement lens, and placed in the lens cavity of the eye prior to insertion of a replacement lens. In certain embodiments, the intraocular device is inserted independently of a replacement lens, and placed in the lens cavity of the eye after insertion of a replacement lens. In some embodiments, the intraocular device inserted in the lens cavity includes an antenna.
Also provided is a method of inserting an intraocular device which includes associating an intraocular device described herein with a replacement lens, curling the replacement lens and associated intraocular device to fit into the bore of a needle having a diameter of 3 millimeters or less, and inserting the curled replacement lens and associated intraocular device into the lens cavity of an eye, using cataract replacement surgical techniques that do not require the use of sutures to close the surgical incision. In certain embodiments, provided is a method of inserting an intraocular device that includes associating an intraocular device with a replacement lens, curling the replacement lens and associated intraocular device to fit into the bore of a needle having a diameter of 3 millimeters or less, and inserting the curled replacement lens and associated intraocular device into the lens cavity of an eye, using cataract replacement surgical techniques that do not require the use of sutures to close the surgical incision. Provided also herein is a method of inserting a replacement lens and an intraocular device embodiment described herein, the method including: curling the replacement lens including an intraocular device to fit into the bore of a needle having a diameter of 3 millimeters or less, and inserting the curled replacement lens into the lens cavity of an eye, using cataract replacement surgical techniques that do not require the use of sutures to close the surgical incision, where the pressure monitoring
components are aligned on a flat axis and further where the pressure monitoring components are embedded within the haptic area of the lens.
In some embodiments, the intraocular device is embedded within the haptic area of the lens. In some embodiments, the substrate assumes its original unrolled shape upon insertion into the eye. Anchors on the device generally are configured to correctly position the intraocular device within the lens cavity of the eye. In certain embodiments in which an intraocular device is associated with a replacement lens prior to insertion, the anchors can be omitted. In certain embodiments involving a replacement lens having an integrated intraocular device, the lens assumes its original unrolled shape upon insertion into the eye, and the anchors and/or hooks associated with the replacement lens correctly position the lens within the lens cavity of the eye.
Shown in FIG. 6A and FIG. 6B are non-limiting examples of an intraocular device implanted into a lens cavity. FIG. 6A shows the position of an intraocular device 10f behind lens 1 1f (e.g., a replacement lens). FIG. 6B shows an intraocular device 10f attached to lens 1 1 f (e.g., a replacement lens). Shown are zonular fibers 106, capsular bag 103, aqueous humour 109 and optical axis 224. The capsular bag holds the natural ocular lens or lens replacement. The zonular fibers are attached to the ciliary muscle and to the capsular bag, and can in part maintain lens position. During cataract surgery the bag is emptied and cleaned of the natural lens. Its mechanical structure is used to hold an artificial lens (intraocular lens (IOL)), and attached to the replacement lens are associated hooks 100f that retain the lens. Also shown are components of the implanted device 10f, which includes sensor 19f, transceiver 14f, capacitor 12f and anchors 18f.
Systems and methods of use lOP monitoring systems provided herein often are configured to include an intraocular device that is implanted into the eye, and one or more external devices that typically are worn by a user. An external device sometimes includes one or more components chosen from: a processor; a power source; an antenna; a radio frequency generator, a data logger, the like and combinations thereof. An lOP monitoring system can continuously measure lOP and transmit all or a subset of the pressure readings to an external device or other device in an lOP system, in some embodiments. An lOP monitoring system may measure lOP several times a day or throughout the day without the need for frequent visits to a health care provider (e.g., ophthalmologist) in certain embodiments. An lOP monitoring system can wirelessly transmit pressure measurement data to an external receiver for further processing, analysis and/or storage, thus allowing ambulatory, 24-hour monitoring of lOP in certain embodiments.
Certain non-limiting embodiments of a system are shown in FIG. 7. Shown in FIG. 7 is a schematic representation of an lOP monitoring system 1 , which system includes an intraocular device 10f that is implanted into the natural lens bag of the eye 103 (capsular bag), and external device 20. External device 20 can include external antenna 22 and external transceiver 24. Such components can be mounted on any device external to the eye, and an external device often is worn by a user. An external device can be mounted to an eyeglass frame in certain embodiments.
Non-limiting examples of functional components suitable for use on or in one or more external devices or portions of an lOP monitoring system are shown in FIGS. 7 and 9, and include:
telemetry transceiver 24, one or more antenna 22, for receiving telemetry data (e.g., pressure sensor measurements) from, and/or transmitting instructions (e.g., power up command, measurement command, transmit command, the like and combinations thereof) to an internal component; eyeglasses 26 or other wearable headgear having one or more transceiver antenna 22; portable reader 30, including but not limited to; power source (e.g., battery or power line);
processor; memory; software for device operation, data display, data conversion, data analysis, data transmission to a server based system; anti-collision (e.g., multiread) air interface component (e.g., software and/or hardware) to allow simultaneous measurement from one or more pressure sensor in one or both eyes; output or display device (e.g., RS-232 connection, LCD screen, printer, audible alarm, the like or combinations thereof); radio frequency signal (RF) generator; electromagnetic power induction; energy storing capacitor; LC resonance circuit; and/or wireless transmission protocol and/or wired connection for communicating with a computer 40 or data server; the like and combinations thereof. In certain embodiments, an lOP monitoring system also includes a carrier (or implantation device, e.g., a syringe) that ensures correct folding and/or rolling of the internal portion of the device for insertion into the eye. Additional software, firmware and hardware functions and circuits also can be included in an extracorporeal reader portion (i.e., external device) of an lOP monitoring system. In certain embodiments, a suitable security algorithm can be applied to the communication protocol operating between an intraocular device and an extracorporeal device to assure privacy of user information.
In some embodiments an lOP monitoring system measures lOPs as follows: (i) an external device (e.g., reader device) produces a current which induces a magnetic field in the antenna embedded in the external device (e.g., wearable headgear); (ii) the magnetic field produced by the antenna in the external device interacts with an antenna of the implanted intraocular device, thereby producing a current at the antenna terminal in the intraocular device, which is sometimes associated with an optional capacitor; (iii) the current induced in the implanted intraocular device powers the pressure sensor, which takes a pressure reading, and can also power the telemetry transponder/transceiver, (iv) the transponder/transceiver in the intraocular device transmits the telemetry data (e.g., pressure reading(s)) to the transceiver in the external device. The external device sometimes transmits the pressure reading(s) to an output component on the external device or outside the external device. In some embodiments, the external device transmits the data to another portable or fixed device. In certain embodiments, additional functions or processes are performed on the telemetry data (e.g., analysis, conversion, display, transmission to a remote computer, the like and combinations thereof).
An external device often is configured to communicate with an output component or device, remote computer and/or a server or internet based user interface. Non-limiting examples of information flow between various portions of a system are shown in FIGS. 8 and 9. Also shown in the embodiment illustrated in FIG. 9 are portable reader 30, which can include a transmitter, receiver; memory, and a communication module for communication with a remote computer 40. Computer 40 sometimes includes an output device that permits a health monitor to analyze IOP reads from the intraocular device. In certain embodiments, pressure measurements are transmitted from the implanted intraocular device to an intermediary transceiver within wearable headgear, which in turn transmits the data to a reader (portable or stationary), for display, analysis, and/or transmission to a server to be remotely accessible to healthcare professionals. In some embodiments,
communication between a portable reader 30 and remote computer 40 is by wireless transmission, and in certain embodiments, communication between a portable reader and remote computer is via wired connection (e.g., USB cable, USB2.0 cable, USB3.0 cable, Firewire, eSATA, and the like). In some embodiments, remote computer 40 is connected to an internet-based user interface for managing collected pressure data. FIG. 9 illustrates an external device and devices with which the external device can communicate. The devices illustrated in FIG. 9 can be near field communication enabled and/or RFID-like telemetry system based. Illustrated in FIG. 9, is a remote health monitor, including in some embodiments a physician or other health care provider, who can respond to the telemetry data communicated to the extracorporeal reader and subsequent information flow via the internet and administer appropriate care to the patient. A health monitor can be a person or a software program in some embodiments. A health monitor can administer instructions for reducing or maintaining IOP in some embodiments, and sometimes may prescribe administration of a drug for such purposes. In some embodiments, an external device (e.g., device 20 in FIG. 7) or other device (e.g., device 30 in FIG. 9) of an IOP monitoring system can include an internet enabled component and/or display component. In some embodiments an external device or other device in the system can provide an audible and/or visible alarm if a threshold pressure value is exceeded, thus alerting the user to take certain steps or seek medical help. An alarm can be transmitted over the internet to a server-based user interface to alert an appropriate medical professional.
Examples of embodiments Provided hereafter are certain examples of non-limiting embodiments of the technology.
A1. An intraocular pressure monitoring device, comprising:
a substantially annular substrate, which substrate is substantially flexible,
a pressure sensor and a transceiver mounted to the substrate, which pressure sensor is in a location on the device separate from the location of the transceiver, and which pressure sensor and transceiver are aligned on a single axis;
an antenna mounted to the substrate, which antenna, pressure sensor and transceiver are in effective connection;
which device is capable of transitioning from a substantially flat state to a substantially rolled state and from the substantially rolled state to the substantially flat state; and
which device, when in the substantially rolled state, is configured to fit within a substantially cylindrical void having a cross-sectional diameter of less than 2.6 millimeters.
A1.1. The device of embodiment A1 , wherein the single axis is tangentially oriented along the device in the substantially flat state and intersects two points on the outer perimeter and no points on the inner perimeter of the device.
A1.2. The device of embodiment A1 , wherein the single axis is tangentially oriented along the device in the substantially flat state and intersects two points on the outer perimeter and two points on the inner perimeter of the device.
A2. The device of any one of embodiments A1 to A1 .2, wherein the cross-sectional diameter of the substantially cylindrical void is 2.5 millimeters or less. A3. The device of embodiment A2, wherein the cross-sectional diameter of the substantially cylindrical void is 2.0 millimeters or less.
A4. The device of embodiment A3, wherein the cross-sectional diameter of the substantially cylindrical void is 1 .5 millimeters or less.
A5. The device of any one of embodiments A1 to A4, wherein the pressure sensor and the transceiver each are independently located on separate structures. A6. The device of embodiment A5, wherein one or more of the separate structures are integrated circuits.
A7. The device of embodiment A5 or A6, wherein edges of the structures closest to one another are separated by a distance of about 30 micrometers to about 500 micrometers on the substrate.
A8. The device of any one of embodiments A1 to A7, wherein the transceiver is a radio frequency telemetry transceiver.
A9. The device of any one of embodiments A1 to A8, which further comprises an energy storing capacitor.
A10. The device of embodiment A9, wherein the transceiver, the pressure sensor and the energy storing capacitor are aligned on the single axis when the device is in the substantially flat state. A1 1 . The device of any one of embodiments A1 to A10, which further comprises a second pressure sensor.
A12. The device of any one of embodiments A1 to A1 1 , wherein the second pressure sensor and one or more of the pressure sensor, the energy storing capacitor, and the transceiver are aligned along a single axis, which single axis is oriented along the device in the substantially rolled state and intersects two edges of the device in the substantially rolled state.
A13. The device of any one of embodiments A1 to A12, wherein the substrate has an
unobstructed inner diameter of about 5 millimeters to about 8 millimeters. A14. The device of embodiment A13, wherein the substrate has an outer diameter of about 7 millimeters to 1 1 millimeters.
A14.1 . The device of any one of embodiments A1 to A14, wherein the pressure sensor, transceiver, and antenna are mounted to the substrate by an effective connection with the substrate.
A15. The device of any one of embodiments A1 to A14.1 , wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises a substantially flexible and conductive material.
A16. The device of embodiment A15, wherein the conductive material is biocompatible. A17. The device of embodiment A15 or A16, wherein the conductive material comprises a metal, polymer or combination thereof.
A18. The device of any one of embodiments A15 to A17, wherein the conductive material comprises gold, silver, copper, platinum, a conductive polymer or combination thereof.
A19. The device of any one of embodiments A1 to A18, wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises an isotropically conductive adhesive. A20. The device of any one of embodiments A1 to A19, wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises a landing pad.
A21 . The device of embodiment A20, wherein the landing pad comprises a conductive material.
A22. The device of embodiment A21 , wherein the conductive material comprises a metal, conductive polymer or combination thereof. A23. The device of any one of embodiments A1 to A22, wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises a globe top connection. A24. The device of any one of embodiments A1 to A22, wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises an underfill.
A25. The device of embodiment A24, wherein the underfill comprises an epoxy resin.
A26. The device of embodiment A25, wherein the epoxy resin is a biocompatible epoxy resin.
A27. The device of any one of embodiments A1 to A26, wherein the antenna is a coil antenna. A28. The device of any one of embodiments A1 to A27, wherein the antenna is connected to the surface of the substrate.
A29. The device of embodiment A28, wherein the antenna is printed on the substrate. A30. The device of any one of embodiments A1 to A27, wherein the antenna is embedded in the substrate.
A31. The device of any one of embodiments A1 to A30, wherein the antenna comprises a conductive material.
A32. The device of embodiment A31 , wherein the conductive material is biocompatible.
A33. The device of embodiment A31 or A32, wherein the conductive material is substantially flexible.
A34. The device of any one of embodiments A31 to A33, wherein the conductive material comprises a metal, a conductive polymer or combination thereof. A35. The device of any one of embodiments A31 to A34, wherein the conductive material comprises gold, silver, platinum, copper, a conductive polymer or combination thereof.
A36. The device of any one of embodiments A1 to A35, comprising a region comprising one conductive layer and a region comprising two conductive layers.
A37. The device of embodiment A36, wherein one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor and the transceiver are located in the region comprising two conductive layers.
A38. The device of embodiment A37, wherein the pressure sensor is located in a first region comprising two conductive layers.
A39. The device of embodiment A38, wherein the second pressure sensor is located in a second region comprising two conductive layers.
A40. The device of any one of embodiments A36 to A39, wherein the region comprising two conductive layers comprises a landing pad and/or metal track as a first conductive layer and an antenna coil as a second conductive layer, which metal track electrically connects two or more of the pressure sensor, the second pressure sensor, the energy storing capacitor and the transceiver.
A41. The device of any one of embodiments A36 to A40, wherein the region comprising two conductive layers comprises a first conductive layer in connection with one side of the substrate and a second conductive layer in connection with the opposite side of the substrate.
A42. The device of any one of embodiments A36 to A41 , wherein the region comprising the one conductive layer comprises an antenna coil.
A43. The device of any one of embodiments A36 to A42, wherein the region comprising the one conductive layer comprises the one conductive layer in connection with one side of the substrate.
A43.1 . The device of any one of embodiments A36 to A43, wherein each conductive layer independently comprises elements comprising a metal, conductive polymer or combination thereof. A43.2. The device of any one of embodiments A36 to A43.1 , wherein each conductive layer comprises elements comprising a biocompatible material.
A43.3. The device of embodiment A43.1 or A43.2, wherein the elements comprise gold, silver, platinum, copper, a conductive polymer or combinations thereof.
A44. The device of any one of embodiments A1 to A43.3, which comprises a solder mask.
A45. The device of embodiment A44, wherein a first solder mask is in connection with a first side of the substrate.
A46. The device of embodiment A44 or A45, wherein a second solder mask is in connection with a second side of the substrate opposite of the first side of the substrate. A47. The device of any one of embodiments A1 to A46, wherein the substrate comprises an aperture under the first sensor or second sensor, or the first sensor and the second sensor.
A48. The device of embodiment A47, wherein the antenna is disposed around the aperture. A49. The device of embodiment A48, wherein a portion or all of the antenna bends around the aperture.
A50. The device of any one of embodiments A47 to A49, wherein the aperture is substantially circular or substantially rectangular.
A51. The device of any one of embodiments A1 to A50, wherein a first portion of the substrate comprises a first width and a second portion of the substrate comprises a second width, wherein the second width is greater than the first width. A52. The device of embodiment A51 , wherein the second portion is substantially circular.
A53. The device of embodiment A51 , wherein the second portion is substantially rectangular. A54. The device of any one of embodiments A51 to A53, wherein the first sensor is located in or on the second portion.
A55. The device of any one of embodiments A1 to A54, wherein the substrate is annular.
A56. The device of any one of embodiments A1 to A54, wherein the substrate comprises one or more substantially linear portions.
A57. The device of embodiment A56, wherein one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor and the transceiver are located in or on one of the one or more substantially linear portions.
A58. The device of embodiment A57, wherein the pressure sensor, the energy storing capacitor and the transceiver are located in or on one of the one or more substantially linear portions.
A59. The device of any one of embodiments A1 to A58, wherein the substrate comprises a polymer.
A60. The device of any one of embodiments A1 to A59, wherein the substrate comprises a biocompatible polymer.
A61. The device of embodiment A59 or A60, wherein the substrate comprises Kapton, Apical, UPILEX, VTEC PI, Norton TH, polyether ether ketone (PEEK), a transparent conductive polyester, or combination thereof.
A62. The device of any one of embodiments A1 to A61 , which further comprises one or more intraocular anchors.
A63. The device of any one of embodiments A1 to A62, wherein the transceiver is a telemetry transceiver that comprises a near-field communication (NFC) compatible air interface.
A64. The device of any one of embodiments A1 to A63, wherein the pressure sensor, the second pressure sensor, the energy storing capacitor and the transceiver are located on separate structures. A65. The device of any one of embodiments A5 to A64, wherein one or more of the structures are substantially inflexible.
A66. The device of any one of embodiments A5 to A65, wherein one or more of the structures are silicon chips.
A67. The device of embodiment A66, wherein the silicon chips are backlapped for improved flexibility. A68. The device of any one of embodiments A1 to A65, wherein one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, the antenna and the transceiver are printed, or comprise printing, using conductive ink or semi-conductive ink.
A69. The device of any one of embodiments A1 to A68, wherein the device is coated with a biocompatible material.
A70. The device of embodiment A69, wherein the biocompatible coating comprises Parylene, Parylene C, Parylene AF-4, Parylene SF, Parylene HT, Parylene VT-4, Parylene CF, Parylene N, or combination thereof.
A71. The device of any one of embodiments A1 to A70, which is not in association with an artificial lens.
A72. The device of embodiment A71 , wherein the device is not in association with the artificial lens ex vivo.
A73. The device of embodiment A72, wherein the device is in proximity to a natural lens in vivo.
A74. The device of any one of embodiments A1 to A70, which is in association with an artificial lens.
A75. The device of embodiment A74, which is in association with an artificial lens ex vivo.
A76. The device of embodiment A74 or A75, which is in association with an artificial lens in vivo. A77. The device of any one of embodiments A1 to A76, which is in association with a capsular ring.
A78. The device of any one of embodiments A1 to A77, wherein the device is in the substantially rolled state.
A79. The device of embodiment A78, wherein the device is in the substantially rolled state during insertion into an ocular cavity. A80. The device of any one of embodiments A1 to A77, wherein the device is in the substantially flat state.
A81. The device of embodiment A80, wherein the device is in the substantially flat state after insertion into an ocular cavity.
B1. A system comprising a device of any one of embodiments A1 to A79 and a remote transceiver configured to receive a signal from the transceiver in the device.
B1.1. A system comprising a device of any one of embodiments A1 to A79 and B1 and a remote transceiver configured to supply power to the transceiver in the device.
B2. The system of embodiment B1 or B1.1 , wherein the remote transceiver is configured to transmit a signal to the transceiver. B3. The system of any one of embodiments B1 to B2, wherein the remote transceiver further comprises one or more components chosen from a processor; a power source; an antenna; a radio frequency generator; a data logger; and combinations thereof.
B4. The system of any one of embodiments B1 to B3, wherein the remote transceiver is a telemetry transceiver that comprises a near-field communication (NFC) compatible air interface.
C1 . A carrier comprising a substantially cylindrical void, which void comprises a device of any one of embodiments A1 to A81 in its substantially rolled state. C2. The carrier of embodiment C1 , wherein the cross-sectional diameter of the substantially cylindrical void is 3.0 millimeters or less.
C3. The carrier of embodiment C1 , wherein the cross-sectional diameter of the substantially cylindrical void is less than 2.6 millimeters.
C4. The carrier of embodiment C1 , wherein the cross-sectional diameter of the substantially cylindrical void is 2.5 millimeters or less. C5. The carrier of embodiment C1 , wherein the cross-sectional diameter of the substantially cylindrical void is 2 millimeters or less.
C6. The carrier of embodiment C1 , wherein the cross-sectional diameter of the substantially cylindrical void is 1 .5 millimeters or less.
C7. The carrier of any one of embodiments C1 to C6, comprising a substantially flat void in effective connection with the substantially cylindrical void, which substantially flat void is configured to contain a device of any one of embodiments A1 to A81 in its substantially flat state. C8. The carrier of any one of embodiments C1 to C7, which is a needle.
C9. A carrier comprising a substantially flat void, which void comprises a device of any one of embodiments A1 to A81 in its substantially flat state. C10. The carrier of embodiment C9, which comprises a substantially cylindrical void in effective connection with the substantially flat void, which substantially cylindrical void is configured to contain a device of any one of embodiments A1 to A81 in its substantially rolled state.
C1 1. The carrier of embodiment C10, wherein the cross-sectional diameter of the substantially cylindrical void is 3.0 millimeters or less.
C12. The carrier of embodiment C10, wherein the cross-sectional diameter of the substantially cylindrical void is less than 2.6 millimeters. C13. The carrier of embodiment C10, wherein the cross-sectional diameter of the substantially cylindrical void is 2.5 millimeters or less.
C14. The carrier of embodiment C10, wherein the cross-sectional diameter of the substantially cylindrical void is 2 millimeters or less.
C15. The carrier of embodiment C10, wherein the cross-sectional diameter of the substantially cylindrical void is 1 .5 millimeters or less. C16. The carrier of any one of embodiments C9 to C15, which is a needle.
D1 . A method for implanting an intraocular pressure monitoring device into the lens cavity of the eye, which comprises inserting a device of any one of embodiments A1 to A81 in its substantially rolled state into the lens cavity of the eye through an incision having a length of 3.0 millimeters or less, using suture-less cataract surgical methods, under conditions in which the device assumes the substantially flat state after the device is inserted into the lens cavity.
D2. The method of embodiment D1 , wherein the device is inserted prior to inserting an artificial lens.
D3. The method of embodiment D1 , wherein the device is inserted after inserting an artificial lens.
D4. The method of any one of embodiments D1 to D3, wherein the device is inserted in a surgery separate from a surgery in which the artificial lens was inserted.
D5. The method of any one of embodiments D1 to D3, wherein the device and the artificial lens are inserted in the same surgery.
D6. The method of embodiment D1 , wherein the device is connected to an artificial lens ex vivo, thereby generating a lens and device combination, and the combination is inserted into the lens cavity of the eye.
D7. The method of any one of embodiments D1 to D6, wherein the device is inserted as part of a cataract replacement surgery. D8. The method of any one of embodiments D1 to D7, wherein a carrier of any one of embodiments C1 to C5 is utilized to insert the device into the lens cavity of the eye.
E1. An intraocular pressure monitoring system, comprising:
a device of any one of embodiments A1 to A81 , which device is configured to obtain intraocular pressure readings in the intraocular cavity of an eye of a subject as an intraocular device; and
an external device configured to reside outside the eye of the subject, which external device comprising at least one external transceiver configured to receive by telemetry the intraocular pressure readings from the intraocular device.
E2. The system of embodiment E1 , wherein the intraocular device is implanted in the intraocular cavity of an eye of a subject. E3. The system of embodiment E1 or E2, wherein the external device comprises an antenna.
E4. The system of any one of embodiments E1 to E3, wherein the external device comprises a power source. E5. The system of any one of embodiments E1 to E4, wherein the external device comprises an eyeglass frame or portion thereof.
E6. The system of any one of embodiments E1 to E5, which comprises an output component configured to display the intraocular pressure readings from the intraocular device.
E7. The system of embodiment E6, wherein the output component is part of the external device.
E8. The system of embodiment E6, wherein the output component is not part of the external device.
E9. The system of embodiment E8, which comprises an internet enabled component configured to transmit the intraocular pressure readings from the external device to the output component. E10. The system of embodiment E9, wherein the internet enabled component is not part of the external device.
E1 1. The system of embodiment E9 or E10, which comprises a messaging component configured to transmit information to the subject from a health monitor.
E12. The system of embodiment E1 1 , wherein the messaging component is part of the external device. E13. The system of embodiment E1 1 or E12, wherein the messaging component transmits the information to an output component configured to display the information.
E14. The system of any one of embodiments E6 to E13, wherein the output component configured to display the information and the internet enabled component are integrated in a remote device separate from the external device.
F1. A method for transmitting intraocular pressure information, comprising:
obtaining intraocular pressure readings by the pressure sensor of a device of any one of embodiments A1 to A81 implanted in the intraocular cavity of an eye of a subject, which device is an intraocular device; and
transmitting by telemetry the intraocular pressure readings from the transceiver of the intraocular device to an external transceiver in an external device residing outside the eye of the subject. F2. The method of embodiment F1 , wherein the external device comprises an antenna.
F3. The method of embodiment F1 or F2, wherein the external device comprises a power source.
F4. The method of any one of embodiments F1 to F3, wherein the external device comprises an eyeglass frame or portion thereof.
F5. The method of any one of embodiments F1 to F4, wherein the external device comprises an output component configured to display the intraocular pressure readings from the intraocular device. F6. The method of any one of embodiments F1 to F5, which comprises transmitting the intraocular pressure readings by the external transceiver to an output component configured to display the intraocular pressure readings from the intraocular device. F7. The method of embodiment F6, wherein the output component is part of the external device.
F8. The method of embodiment F6, wherein the output component is not part of the external device. F9. The method of embodiment F8, which comprises transmitting the intraocular pressure readings from the external device to the output component by an internet enabled component.
F10. The method of embodiment F9, wherein the internet enabled component is not part of the external device.
F1 1 . The method of embodiment F9 or F10, which comprises transmitting information to the subject from a health monitor by a messaging component.
F12. The method of embodiment F1 1 , wherein the messaging component is part of the external device.
F13. The method of embodiment F1 1 or F12, wherein the messaging component transmits the information to an output component configured to display the information. F14. The method of any one of embodiments F6 to F13, wherein the output component configured to display the information and the internet enabled component are integrated in a remote device.
The entirety of each patent, patent application, publication and document referenced herein hereby is incorporated by reference. Citation of the above patents, patent applications, publications and documents is not an admission that any of the foregoing is pertinent prior art, nor does it constitute any admission as to the contents or date of these publications or documents. Modifications may be made to the foregoing without departing from the basic aspects of the technology. Although the technology has been described in substantial detail with reference to one or more specific embodiments, those of ordinary skill in the art will recognize that changes may be made to the embodiments specifically disclosed in this application, yet these modifications and improvements are within the scope and spirit of the technology.
The technology illustratively described herein suitably may be practiced in the absence of any element(s) not specifically disclosed herein. Thus, for example, in each instance herein any of the terms "comprising," "consisting essentially of," and "consisting of" may be replaced with either of the other two terms. The terms and expressions which have been employed are used as terms of description and not of limitation, and use of such terms and expressions do not exclude any equivalents of the features shown and described or portions thereof, and various modifications are possible within the scope of the technology claimed. The term "a" or "an" can refer to one of or a plurality of the elements it modifies (e.g., "a reagent" can mean one or more reagents) unless it is contextually clear either one of the elements or more than one of the elements is described. The term "about" as used herein refers to a value within 10% of the underlying parameter (i.e., plus or minus 10%), and use of the term "about" at the beginning of a string of values modifies each of the values (i.e., "about 1 , 2 and 3" refers to about 1 , about 2 and about 3). For example, a weight of "about 100 grams" can include weights between 90 grams and 1 10 grams. Further, when a listing of values is described herein (e.g., about 50%, 60%, 70%, 80%, 85% or 86%) the listing includes all intermediate and fractional values thereof (e.g., 54%, 85.4%). Thus, it should be understood that although the present technology has been specifically disclosed by representative
embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and such modifications and variations are considered within the scope of this technology.
Certain embodiments of the technology are set forth in the claims that follow.

Claims

What is claimed is:
1. An intraocular pressure monitoring device, comprising:
a substantially annular substrate, which substrate is substantially flexible,
a pressure sensor and a transceiver mounted to the substrate, which pressure sensor is in a location on the device separate from the location of the transceiver, and which pressure sensor and transceiver are aligned on a single axis;
an antenna mounted to the substrate, which antenna, pressure sensor and transceiver are in effective connection;
which device is capable of transitioning from a substantially flat state to a substantially rolled state and from the substantially rolled state to the substantially flat state; and
which device, when in the substantially rolled state, is configured to fit within a substantially cylindrical void having a cross-sectional diameter of less than 2.6 millimeters.
2. The device of claim 1 , wherein the single axis is tangentially oriented along the device in the substantially flat state and intersects two points on the outer perimeter and no points on the inner perimeter of the device.
3. The device of claim 1 , wherein the single axis is tangentially oriented along the device in the substantially flat state and intersects two points on the outer perimeter and two points on the inner perimeter of the device.
4. The device of any one of claims 1 to 3, wherein the cross-sectional diameter of the substantially cylindrical void is 2.5 millimeters or less.
5. The device of claim 4, wherein the cross-sectional diameter of the substantially cylindrical void is 2.0 millimeters or less.
6. The device of claim 5, wherein the cross-sectional diameter of the substantially cylindrical void is 1.5 millimeters or less.
7. The device of any one of claims 1 to 6, wherein the pressure sensor and the transceiver each are independently located on separate structures.
8. The device of claim 7, wherein one or more of the separate structures are integrated circuits.
9. The device of claim 7 or 8, wherein edges of the structures closest to one another are separated by a distance of about 30 micrometers to about 500 micrometers on the substrate.
10. The device of any one of claims 1 to 9, wherein the transceiver is a radio frequency telemetry transceiver.
1 1 . The device of any one of claims 1 to 10, which further comprises a energy storing capacitor.
12. The device of claim 1 1 , wherein the transceiver, the pressure sensor and the energy storing capacitor are aligned on the single axis when the device is in the substantially flat state.
13. The device of any one of claims 1 to 12, which further comprises a second pressure sensor.
14. The device of any one of claims 1 to 13, wherein the second pressure sensor and one or more of the pressure sensor, the energy storing capacitor, and the transceiver are aligned along a single axis, which single axis is oriented along the device in the substantially rolled state and intersects two edges of the device in the substantially rolled state.
15. The device of any one of claims 1 to 14, wherein the substrate has an unobstructed inner diameter of about 5 millimeters to about 8 millimeters.
16. The device of claim 15, wherein the substrate has an outer diameter of about 7 millimeters to 1 1 millimeters.
17. The device of any one of claims 1 to 16, wherein the pressure sensor, transceiver, and antenna are mounted to the substrate by an effective connection with the substrate.
18. The device of any one of claims 1 to 17, wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises a substantially flexible and conductive material.
19. The device of claim 18, wherein the conductive material is biocompatible.
20. The device of claim 18 or 19, wherein the conductive material comprises a metal, polymer or combination thereof.
21 . The device of any one of claims 18 to 20, wherein the conductive material comprises gold, silver, copper, platinum, a conductive polymer or combination thereof.
22. The device of any one of claims 1 to 21 , wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises an isotropically conductive adhesive.
23. The device of any one of claims 1 to 22, wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises a landing pad.
24. The device of claim 23, wherein the landing pad comprises a conductive material.
25. The device of claim 24, wherein the conductive material comprises a metal, conductive polymer or combination thereof.
26. The device of any one of claims 1 to 25, wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises a globe top connection.
27. The device of any one of claims 1 to 25, wherein the effective connection between the substrate and one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, antenna and the transceiver, comprises an underfill.
28. The device of claim 27, wherein the underfill comprises an epoxy resin.
29. The device of claim 28, wherein the epoxy resin is a biocompatible epoxy resin.
30. The device of any one of claims 1 to 29, wherein the antenna is a coil antenna.
31 . The device of any one of claims 1 to 30, wherein the antenna is connected to the surface of the substrate.
32. The device of claim 31 , wherein the antenna is printed on the substrate.
33. The device of any one of claims 1 to 30, wherein the antenna is embedded in the substrate.
34. The device of any one of claims 1 to 33, wherein the antenna comprises a conductive material.
35. The device of claim 34, wherein the conductive material is biocompatible.
36. The device of claim 34 or 35, wherein the conductive material is substantially flexible.
37. The device of any one of claims 34 to 36, wherein the conductive material comprises a metal, a conductive polymer or combination thereof.
38. The device of any one of claims 34 to 37, wherein the conductive material comprises gold, silver, platinum, copper, a conductive polymer or combination thereof.
39. The device of any one of claims 1 to 38, comprising a region comprising one conductive layer and a region comprising two conductive layers.
40. The device of claim 39, wherein one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor and the transceiver are located in the region comprising two conductive layers.
41 . The device of claim 40, wherein the pressure sensor is located in a first region comprising two conductive layers.
42. The device of claim 41 , wherein the second pressure sensor is located in a second region comprising two conductive layers.
43. The device of any one of claims 39 to 42, wherein the region comprising two conductive layers comprises a landing pad and/or metal track as a first conductive layer and an antenna coil as a second conductive layer, which metal track electrically connects two or more of the pressure sensor, the second pressure sensor, the energy storing capacitor and the transceiver.
44. The device of any one of claims 39 to 43, wherein the region comprising two conductive layers comprises a first conductive layer in connection with one side of the substrate and a second conductive layer in connection with the opposite side of the substrate.
45. The device of any one of claims 39 to 44, wherein the region comprising the one conductive layer comprises an antenna coil.
46. The device of any one of claims 39 to 45, wherein the region comprising the one conductive layer comprises the one conductive layer in connection with one side of the substrate.
47. The device of any one of claims 39 to 46, wherein each conductive layer independently comprises elements comprising a metal, conductive polymer or combination thereof.
48. The device of any one of claims 39 to 47, wherein each conductive layer comprises elements comprising a biocompatible material.
49. The device of claim 47 or 48, wherein the elements comprise gold, silver, platinum, copper, a conductive polymer or combinations thereof.
50. The device of any one of claims 1 to 49, which comprises a solder mask.
51 . The device of claim 50, wherein a first solder mask is in connection with a first side of the substrate.
52. The device of claim 50 or 51 , wherein a second solder mask is in connection with a second side of the substrate opposite of the first side of the substrate.
53. The device of any one of claims 1 to 52, wherein the substrate comprises an aperture under the first sensor or second sensor, or the first sensor and the second sensor.
54. The device of claim 53, wherein the antenna is disposed around the aperture.
55. The device of claim 54, wherein a portion or all of the antenna bends around the aperture.
56. The device of any one of claims 53 to 55, wherein the aperture is substantially circular or substantially rectangular.
57. The device of any one of claims 1 to 56, wherein a first portion of the substrate comprises a first width and a second portion of the substrate comprises a second width, wherein the second width is greater than the first width.
58. The device of claim 57, wherein the second portion is substantially circular.
59. The device of claim 57, wherein the second portion is substantially rectangular.
60. The device of any one of claims 57 to 59, wherein the first sensor is located in or on the second portion.
61 . The device of any one of claims 1 to 60, wherein the substrate is annular.
62. The device of any one of claims 1 to 60, wherein the substrate comprises one or more substantially linear portions.
63. The device of claim 62, wherein one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor and the transceiver are located in or on one of the one or more substantially linear portions.
64. The device of claim 63, wherein the pressure sensor, the energy storing capacitor and the transceiver are located in or on one of the one or more substantially linear portions.
65. The device of any one of claims 1 to 64, wherein the substrate comprises a polymer.
66. The device of any one of claims 1 to 65, wherein the substrate comprises a biocompatible polymer.
67. The device of claim 65 or 66, wherein the substrate comprises Kapton, Apical, UPILEX, VTEC PI, Norton TH, polyether ether ketone (PEEK), a transparent conductive polyester, or combination thereof.
68. The device of any one of claims 1 to 67, which further comprises one or more intraocular anchors.
69. The device of any one of claims 1 to 68, wherein the transceiver is a telemetry transceiver that comprises a near-field communication (NFC) compatible air interface.
70. The device of any one of claims 1 to 69, wherein the pressure sensor, the second pressure sensor, the energy storing capacitor and the transceiver are located on separate structures.
71 . The device of any one of claims 7 to 70, wherein one or more of the structures are
substantially inflexible.
72. The device of any one of claims 7 to 71 , wherein one or more of the structures are silicon chips.
73. The device of claim 72, wherein the silicon chips are backlapped for improved flexibility.
74. The device of any one of claims 1 to 71 , wherein one or more of the pressure sensor, the second pressure sensor, the energy storing capacitor, the antenna and the transceiver are printed, or comprise printing, using conductive ink or semi-conductive ink.
75. The device of any one of claims 1 to 74, wherein the device is coated with a biocompatible material.
76. The device of claim 75, wherein the biocompatible coating comprises Parylene, Parylene C, Parylene AF-4, Parylene SF, Parylene HT, Parylene VT-4, Parylene CF, Parylene N, or combination thereof.
77. The device of any one of claims 1 to 76, which is not in association with an artificial lens.
78. The device of claim 77, wherein the device is not in association with the artificial lens ex vivo.
79. The device of claim 78, wherein the device is in proximity to a natural lens in vivo.
80. The device of any one of claims 1 to 76, which is in association with an artificial lens.
81 . The device of claim 80, which is in association with an artificial lens ex vivo.
82. The device of claim 80 or 81 , which is in association with an artificial lens in vivo.
83. The device of any one of claims 1 to 76, which is in association with a capsular ring.
84. The device of any one of claims 1 to 83, wherein the device is in the substantially rolled state.
85. The device of claim 84, wherein the device is in the substantially rolled state during insertion into an ocular cavity.
86. The device of any one of claims 1 to 83, wherein the device is in the substantially flat state.
87. The device of claim 86, wherein the device is in the substantially flat state after insertion into an ocular cavity.
88. A system comprising a device of any one of claims 1 to 85 and a remote transceiver configured to receive a signal from the transceiver in the device.
89. A system comprising a device of any one of claims 1 to 85 and 88 and a remote transceiver configured to supply power to the transceiver in the device.
90. The system of claim 88 or 89, wherein the remote transceiver is configured to transmit a signal to the transceiver.
91 . The system of any one of claims 88 to 90, wherein the remote transceiver further comprises one or more components chosen from a processor; a power source; an antenna; a radio frequency generator, a data logger, and combinations thereof.
92. The system of any one of claims 88 to 91 , wherein the remote transceiver is a telemetry transceiver that comprises a near-field communication (NFC) compatible air interface.
93. A carrier comprising a substantially cylindrical void, which void comprises a device of any one of claims 1 to 87 in its substantially rolled state.
94. The carrier of claim 93, wherein the cross-sectional diameter of the substantially cylindrical void is 3.0 millimeters or less.
95. The carrier of claim 93, wherein the cross-sectional diameter of the substantially cylindrical void is less than 2.6 millimeters.
96. The carrier of claim 93, wherein the cross-sectional diameter of the substantially cylindrical void is 2.5 millimeters or less.
97. The carrier of claim 93, wherein the cross-sectional diameter of the substantially cylindrical void is 2 millimeters or less.
98. The carrier of claim 93, wherein the cross-sectional diameter of the substantially cylindrical void is 1.5 millimeters or less.
99. The carrier of any one of claims 93 to 98, comprising a substantially flat void in effective connection with the substantially cylindrical void, which substantially flat void is configured to contain a device of any one of claims 1 to 87 in its substantially flat state.
100. The carrier of any one of claims 93 to 99, which is a needle.
101. A carrier comprising a substantially flat void, which void comprises a device of any one of claims 1 to 87 in its substantially flat state.
102. The carrier of claim 101 , which comprises a substantially cylindrical void in effective connection with the substantially flat void, which substantially cylindrical void is configured to contain a device of any one of claims 1 to 87 in its substantially rolled state.
103. The carrier of claim 102, wherein the cross-sectional diameter of the substantially cylindrical void is 3.0 millimeters or less.
104. The carrier of claim 102, wherein the cross-sectional diameter of the substantially cylindrical void is less than 2.6 millimeters.
105. The carrier of claim 102, wherein the cross-sectional diameter of the substantially cylindrical void is 2.5 millimeters or less.
106. The carrier of claim 102, wherein the cross-sectional diameter of the substantially cylindrical void is 2 millimeters or less.
107. The carrier of claim 102, wherein the cross-sectional diameter of the substantially cylindrical void is 1.5 millimeters or less.
108. The carrier of any one of claims 101 to 107, which is a needle.
109. A method for implanting an intraocular pressure monitoring device into the lens cavity of the eye, which comprises inserting a device of any one of claims 1 to 87 in its substantially rolled state into the lens cavity of the eye through an incision having a length of 3.0 millimeters or less, using suture-less cataract surgical methods, under conditions in which the device assumes the substantially flat state after the device is inserted into the lens cavity.
1 10. The method of claim 109, wherein the device is inserted prior to inserting an artificial lens.
1 1 1. The method of claim 109, wherein the device is inserted after inserting an artificial lens.
1 12. The method of any one of claims 109 to 1 1 1 , wherein the device is inserted in a surgery separate from a surgery in which the artificial lens was inserted.
1 13. The method of any one of claims 109 to 1 1 1 , wherein the device and the artificial lens are inserted in the same surgery.
1 14. The method of claim 109, wherein the device is connected to an artificial lens ex vivo, thereby generating a lens and device combination, and the combination is inserted into the lens cavity of the eye.
1 15. The method of any one of claims 109 to 1 14, wherein the device is inserted as part of a cataract replacement surgery.
1 16. The method of any one of claims 109 to 1 15, wherein a carrier of any one of claims 93 to 97 is utilized to insert the device into the lens cavity of the eye.
1 17. An intraocular pressure monitoring system, comprising:
a device of any one of claims 1 to 87, which device is configured to obtain intraocular pressure readings in the intraocular cavity of an eye of a subject as an intraocular device; and an external device configured to reside outside the eye of the subject, which external device comprising at least one external transceiver configured to receive by telemetry the intraocular pressure readings from the intraocular device.
1 18. The system of claim 1 17, wherein the intraocular device is implanted in the intraocular cavity of an eye of a subject.
1 19. The system of claim 1 17 or 1 18, wherein the external device comprises an antenna.
120. The system of any one of claims 1 17 to 1 19, wherein the external device comprises a power source.
121. The system of any one of claims 1 17 to 120, wherein the external device comprises an eyeglass frame or portion thereof.
122. The system of any one of claims 1 17 to 121 , which comprises an output component configured to display the intraocular pressure readings from the intraocular device.
123. The system of claim 122, wherein the output component is part of the external device.
124. The system of claim 122, wherein the output component is not part of the external device.
125. The system of claim 124, which comprises an internet enabled component configured to transmit the intraocular pressure readings from the external device to the output component.
126. The system of claim 125, wherein the internet enabled component is not part of the external device.
127. The system of claim 125 or 126, which comprises a messaging component configured to transmit information to the subject from a health monitor.
128. The system of claim 127, wherein the messaging component is part of the external device.
129. The system of claim 127 or 128, wherein the messaging component transmits the information to an output component configured to display the information.
130. The system of any one of claims 122 to 129, wherein the output component configured to display the information and the internet enabled component are integrated in a remote device separate from the external device.
131. A method for transmitting intraocular pressure information, comprising:
obtaining intraocular pressure readings by the pressure sensor of a device of any one of claims 1 to 87 implanted in the intraocular cavity of an eye of a subject, which device is an intraocular device; and
transmitting by telemetry the intraocular pressure readings from the transceiver of the intraocular device to an external transceiver in an external device residing outside the eye of the subject.
132. The method of claim 131 , wherein the external device comprises an antenna.
133. The method of claim 131 or 132, wherein the external device comprises a power source.
134. The method of any one of claims 131 to 133, wherein the external device comprises an eyeglass frame or portion thereof.
135. The method of any one of claims 131 to 134, wherein the external device comprises an output component configured to display the intraocular pressure readings from the intraocular device.
136. The method of any one of claims 131 to 135, which comprises transmitting the intraocular pressure readings by the external transceiver to an output component configured to display the intraocular pressure readings from the intraocular device.
137. The method of claim 136, wherein the output component is part of the external device.
138. The method of claim 136, wherein the output component is not part of the external device.
139. The method of claim 138, which comprises transmitting the intraocular pressure readings from the external device to the output component by an internet enabled component.
140. The method of claim 139, wherein the internet enabled component is not part of the external device.
141. The method of claim 139 or 140, which comprises transmitting information to the subject from a health monitor by a messaging component.
142. The method of claim 141 , wherein the messaging component is part of the external device.
143. The method of claim 141 or 142, wherein the messaging component transmits the information to an output component configured to display the information.
144. The method of any one of claims 136 to 143, wherein the output component configured to display the information and the internet enabled component are integrated in a remote device.
PCT/IB2012/000831 2011-04-07 2012-04-06 Intraocular pressure monitoring device and methods WO2012137067A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161472998P 2011-04-07 2011-04-07
US61/472,998 2011-04-07

Publications (2)

Publication Number Publication Date
WO2012137067A2 true WO2012137067A2 (en) 2012-10-11
WO2012137067A3 WO2012137067A3 (en) 2013-04-04

Family

ID=46582018

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2012/000831 WO2012137067A2 (en) 2011-04-07 2012-04-06 Intraocular pressure monitoring device and methods

Country Status (1)

Country Link
WO (1) WO2012137067A2 (en)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014099494A1 (en) * 2012-12-17 2014-06-26 Alcon Research, Ltd. Wearable user interface for use with ocular surgical console
JP2015503981A (en) * 2012-01-17 2015-02-05 インプランダータ オフタルミック プロドゥクツ ゲーエムベーハー Implant device, sensor module, disposable infusion apparatus and method for manufacturing implant device
WO2015026414A1 (en) * 2013-08-22 2015-02-26 Novartis Ag Systems and methods for intra-operative eye biometry or refractive measurement
US9119699B2 (en) 2012-10-22 2015-09-01 Alcon Research, Ltd. Pressure control in phacoemulsification system
US9119701B2 (en) 2012-10-22 2015-09-01 Alcon Research, Ltd. Pressure control in phacoemulsification system
WO2015191208A1 (en) * 2014-06-13 2015-12-17 Google Inc. System for aligning a handheld rfid reader
US9307905B2 (en) 2012-09-14 2016-04-12 University Of Washington Intraocular pressure sensing devices and associated systems and methods
EP3135186A1 (en) * 2015-08-28 2017-03-01 Heraeus Deutschland GmbH & Co. KG Implantable sensor
US9814387B2 (en) 2013-06-28 2017-11-14 Verily Life Sciences, LLC Device identification
CN107432733A (en) * 2016-05-27 2017-12-05 深圳硅基传感科技有限公司 Implanted intraocular pressure monitor
WO2018078026A1 (en) * 2016-10-28 2018-05-03 Implandata Ophthalmic Products Gmbh Ring implant
US10449037B1 (en) 2016-08-08 2019-10-22 Verily Life Sciences Llc Flexible transparent conductors for electrowetting lenses
WO2019214823A1 (en) * 2018-05-09 2019-11-14 Implandata Ophthalmic Products Gmbh Flat module for determining interocular pressure for implanting in the human body
US10874506B2 (en) 2018-01-30 2020-12-29 Verily Life Sciences Llc Intraocular lens with reinforcing layer
CN114569063A (en) * 2022-04-24 2022-06-03 明澈生物科技(苏州)有限公司 Intraocular pressure sensor

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6443893B1 (en) 1997-07-01 2002-09-03 Acritec Gmbh Device for measuring the intra-ocular pressure
US6447449B1 (en) 2000-08-21 2002-09-10 Cleveland Clinic Foundation System for measuring intraocular pressure of an eye and a MEM sensor for use therewith
US6579235B1 (en) 1999-11-01 2003-06-17 The Johns Hopkins University Method for monitoring intraocular pressure using a passive intraocular pressure sensor and patient worn monitoring recorder
US6796942B1 (en) 1999-09-24 2004-09-28 Acritec Gesellschaft Fur Ophthalmologische Produkte Mbh Device for measuring physical quantities, especially for measuring pressure in the eye
WO2005048835A1 (en) 2003-11-14 2005-06-02 Mesotec Gmbh Implant for carrying out intracorporal measurements

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19858172A1 (en) * 1998-12-16 2000-06-21 Campus Micro Technologies Gmbh Artificial lens implant for measuring eye internal pressure has telemetric endosystem for continuous pressure monitoring incorporated in peripheral rim of artificial lens
US20070123767A1 (en) * 2002-05-31 2007-05-31 Valentino Montegrande Intraocular pressure sensor and method of use
FR2881043B1 (en) * 2005-01-21 2007-04-27 Corneal Ind Sa FLEXIBLE INTRAOCULAR IMPLANT INJECTOR
WO2007136993A1 (en) * 2006-05-17 2007-11-29 Mayo Foundation For Medical Education And Research Monitoring intraocular pressure
EP2786701B1 (en) * 2006-08-29 2015-12-23 California Institute of Technology Microfabricated implantable wireless pressure sensor for use in biomedical applications and pressure measurement and sensor implantation methods
DE102008042312A1 (en) * 2008-09-24 2010-04-01 Robert Bosch Gmbh Sensor module for the acquisition of physiological data

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6443893B1 (en) 1997-07-01 2002-09-03 Acritec Gmbh Device for measuring the intra-ocular pressure
US6796942B1 (en) 1999-09-24 2004-09-28 Acritec Gesellschaft Fur Ophthalmologische Produkte Mbh Device for measuring physical quantities, especially for measuring pressure in the eye
US6579235B1 (en) 1999-11-01 2003-06-17 The Johns Hopkins University Method for monitoring intraocular pressure using a passive intraocular pressure sensor and patient worn monitoring recorder
US6447449B1 (en) 2000-08-21 2002-09-10 Cleveland Clinic Foundation System for measuring intraocular pressure of an eye and a MEM sensor for use therewith
WO2005048835A1 (en) 2003-11-14 2005-06-02 Mesotec Gmbh Implant for carrying out intracorporal measurements

Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015503981A (en) * 2012-01-17 2015-02-05 インプランダータ オフタルミック プロドゥクツ ゲーエムベーハー Implant device, sensor module, disposable infusion apparatus and method for manufacturing implant device
US9307905B2 (en) 2012-09-14 2016-04-12 University Of Washington Intraocular pressure sensing devices and associated systems and methods
US9849030B2 (en) 2012-10-22 2017-12-26 Alcon Research, Ltd. Pressure control in phacoemulsification system
US10052228B2 (en) 2012-10-22 2018-08-21 Alcon Research, Ltd. Pressure control in phacoemulsification system
US9119699B2 (en) 2012-10-22 2015-09-01 Alcon Research, Ltd. Pressure control in phacoemulsification system
US9119701B2 (en) 2012-10-22 2015-09-01 Alcon Research, Ltd. Pressure control in phacoemulsification system
US11510811B2 (en) 2012-10-22 2022-11-29 Alcon Inc. Pressure control in phacoemulsification system
WO2014099494A1 (en) * 2012-12-17 2014-06-26 Alcon Research, Ltd. Wearable user interface for use with ocular surgical console
CN104869922B (en) * 2012-12-17 2018-05-15 爱尔康研究有限公司 For the wearable user interface being used together with eye surgery operation console
US9681982B2 (en) 2012-12-17 2017-06-20 Alcon Research, Ltd. Wearable user interface for use with ocular surgical console
CN104869922A (en) * 2012-12-17 2015-08-26 爱尔康研究有限公司 Wearable user interface for use with ocular surgical console
US9814387B2 (en) 2013-06-28 2017-11-14 Verily Life Sciences, LLC Device identification
WO2015026414A1 (en) * 2013-08-22 2015-02-26 Novartis Ag Systems and methods for intra-operative eye biometry or refractive measurement
WO2015191208A1 (en) * 2014-06-13 2015-12-17 Google Inc. System for aligning a handheld rfid reader
US11213254B2 (en) 2015-08-28 2022-01-04 Heraeus Deutschland GmbH & Co. KG Implantable sensor
EP3135186A1 (en) * 2015-08-28 2017-03-01 Heraeus Deutschland GmbH & Co. KG Implantable sensor
CN107432733A (en) * 2016-05-27 2017-12-05 深圳硅基传感科技有限公司 Implanted intraocular pressure monitor
US10449037B1 (en) 2016-08-08 2019-10-22 Verily Life Sciences Llc Flexible transparent conductors for electrowetting lenses
WO2018078026A1 (en) * 2016-10-28 2018-05-03 Implandata Ophthalmic Products Gmbh Ring implant
US20190321219A1 (en) * 2016-10-28 2019-10-24 Implandata Ophthalmic Products Gmbh Ring implant
JP2019533525A (en) * 2016-10-28 2019-11-21 インプランダータ オフタルミック プロドゥクツ ゲーエムベーハー Ring implant
US10874506B2 (en) 2018-01-30 2020-12-29 Verily Life Sciences Llc Intraocular lens with reinforcing layer
WO2019214823A1 (en) * 2018-05-09 2019-11-14 Implandata Ophthalmic Products Gmbh Flat module for determining interocular pressure for implanting in the human body
CN114569063A (en) * 2022-04-24 2022-06-03 明澈生物科技(苏州)有限公司 Intraocular pressure sensor

Also Published As

Publication number Publication date
WO2012137067A3 (en) 2013-04-04

Similar Documents

Publication Publication Date Title
WO2012137067A2 (en) Intraocular pressure monitoring device and methods
EP3082570B1 (en) Contact lens for measuring intraocular pressure
EP2517619B1 (en) Improvements in or relating to glaucoma management and treatment
US20100161004A1 (en) Wireless dynamic power control of an implantable sensing device and methods therefor
EP2412305A1 (en) Integrated flexible passive sensor in a soft contact lens for IOP monitoring
US20120238857A1 (en) Expandable implantable pressure sensor for intraocular surgery
JP2019518546A (en) Implantable intraocular pressure sensor and method of use
US20100016704A1 (en) Method and system for monitoring a condition of an eye
JP2017520337A (en) Ultra-low power rechargeable implantable sensor with wireless interface for patient monitoring
US10383575B2 (en) Minimally-invasive procedures for monitoring physiological parameters within internal organs and anchors therefor
US10980630B1 (en) Contact lens-based methods to deliver power to intraocular devices
EP3973933A1 (en) Glaucoma drain implant system with pressure sensor and valve, and external reading unit
US11291391B2 (en) Implantable ocular glucose sensor devices and methods
US20090216149A1 (en) Self-contained, implantable, intracranial pressure sensing device and methods for its use in monitoring intracranial pressure
TW201242572A (en) Wireless intraocular pressure monitoring apparatus, sensing unit and reading unit
Kakaday et al. Advances in telemetric continuous intraocular pressure assessment
WO2014096973A2 (en) Systems and methods for internal analyte sensing
Kouhani et al. Wireless intraocular pressure sensor using stretchable variable inductor
CN107106012B (en) Physiological parameter monitoring arrangement
US20240028535A1 (en) Remotely-powered sensing system with multiple sensing devices
Mansouri et al. Ambulatory 24-h intraocular pressure monitoring in the management of glaucoma
CN205885406U (en) Non - implanted intraocular pressure sensor based on interdigital capacitor
EP3861924A1 (en) Contact lens device and related pressure monitoring kit and system comprising the same
Xu et al. Recent progress of continuous intraocular pressure monitoring
EP3516529B1 (en) Remotely-powered sensing system with multiple sensing devices

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 12740199

Country of ref document: EP

Kind code of ref document: A2

NENP Non-entry into the national phase in:

Ref country code: DE

32PN Ep: public notification in the ep bulletin as address of the adressee cannot be established

Free format text: NOTING OF LOSS OF RIGHTS PURSUANT TO RULE 112(1) EPC (EPO FORM 1205N DATED 13/12/2013)

122 Ep: pct application non-entry in european phase

Ref document number: 12740199

Country of ref document: EP

Kind code of ref document: A2