U.S. patent application number 16/286416 was filed with the patent office on 2019-06-20 for ophthalmic lens with a microfluidic system.
The applicant listed for this patent is Johnson & Johnson Vision Care, Inc.. Invention is credited to Frederick A. Flitsch, Randall B. Pugh, Karson S. Putts.
Application Number | 20190183397 16/286416 |
Document ID | / |
Family ID | 51062905 |
Filed Date | 2019-06-20 |
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United States Patent
Application |
20190183397 |
Kind Code |
A1 |
Pugh; Randall B. ; et
al. |
June 20, 2019 |
OPHTHALMIC LENS WITH A MICROFLUIDIC SYSTEM
Abstract
The present invention described a system for an energized
ophthalmic device with a media insert that includes microfluidic
elements upon or within the media insert. In some embodiments, the
microfluidic elements may be useful for the purpose of analyzing an
analyte such as glucose in a fluid sample. In addition, some
embodiments can function with a medicament administering device to
treat an abnormal condition identified during the analyte analysis
in the fluid sample.
Inventors: |
Pugh; Randall B.;
(Jacksonville, FL) ; Flitsch; Frederick A.; (New
Windsor, NY) ; Putts; Karson S.; (Lafayette,
IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Johnson & Johnson Vision Care, Inc. |
Jacksonville |
FL |
US |
|
|
Family ID: |
51062905 |
Appl. No.: |
16/286416 |
Filed: |
February 26, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13896708 |
May 17, 2013 |
10213140 |
|
|
16286416 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/6821 20130101;
A61F 2/16 20130101; A61F 2002/1699 20150401; A61B 5/14507 20130101;
A61B 5/7282 20130101; A61B 5/14532 20130101; A61B 10/0045 20130101;
A61B 2010/0067 20130101; A61F 9/0017 20130101; A61B 5/4839
20130101; G02C 7/04 20130101; A61B 2010/008 20130101 |
International
Class: |
A61B 5/145 20060101
A61B005/145; A61B 10/00 20060101 A61B010/00; A61B 5/00 20060101
A61B005/00; G02C 7/04 20060101 G02C007/04 |
Claims
1. A method of treating abnormal glucose levels, comprising:
programming glucose biomarkers normal concentrations level
thresholds; placing an ophthalmic device in contact with an
anterior ocular surface of an eye; obtaining an ocular fluid sample
using a microfluidic element of the ophthalmic device; measuring
one or more properties of the ocular fluid using one or more sensor
components of the ophthalmic device; processing the measurements of
the one or more properties of the ocular fluid to determine whether
the concentration of glucose biomarkers are within the
preprogrammed thresholds; and outputting a signal to a medicament
dispensing device based on the measurement.
2. The method of claim 1, additionally comprising: determining
patterns in the changes of glucose concentrations corresponding to
a time of the day.
3. The method of claim 1, additionally comprising: alerting the
user of an abnormal glucose level when the levels are outside the
pre-programmed thresholds.
4. The method of claim 1, additionally comprising: applying an
algorithm to compensate for a time delay in the change of the
measured properties to the condition causing the change.
5. A method of treating abnormal glucose levels, comprising:
programming glucose biomarkers normal concentrations level
thresholds; placing an ophthalmic device in contact with an
anterior ocular surface of an eye; obtaining an ocular fluid sample
using a microfluidic element of the ophthalmic device; measuring
one or more properties of the ocular fluid using one or more sensor
components of the ophthalmic device; applying an algorithm to
compensate for a time delay in the change of the measured
properties to a condition causing the abnormal level; processing
the measurements of the one or more properties of the ocular fluid
to determine whether the concentration of glucose biomarkers are
within the preprogrammed thresholds; and identifying the condition
causing the change in glucose levels.
6. The method of claim 5, additionally comprising: storing measured
properties to be included as part of a user's medical history.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a division of, and claims priority to,
U.S. patent application Ser. No. 13/896,708, filed May 17, 2013,
the entire contents of which are hereby incorporated by
reference.
FIELD OF USE
[0002] This invention describes a method and system for an
Ophthalmic Devices with microfluidic components, and more
specifically, the microfluidic components which are capable of
performing ocular fluid analysis.
BACKGROUND
[0003] Traditionally, an ophthalmic device, such as a contact lens,
an intraocular lens, or a punctal plug, included a biocompatible
device with a corrective, cosmetic, or therapeutic quality. A
contact lens, for example, may provide one or more of vision
correcting functionality, cosmetic enhancement, and therapeutic
effects. Each function is provided by a physical characteristic of
the lens. A design incorporating a refractive quality into a lens
may provide a vision corrective function. A pigment incorporated
into the lens may provide a cosmetic enhancement. An active agent
incorporated into a lens may provide a therapeutic functionality.
Such physical characteristics are accomplished without the lens
entering into an energized state. An ophthalmic device has
traditionally been a passive device.
[0004] Novel ophthalmic devices based on energized ophthalmic
inserts have recently been described. These devices may use the
energization function to power active optical components. For
example, a wearable lens may incorporate a lens assembly having an
electronically adjustable focus to augment or enhance performance
of the eye.
[0005] Moreover, as electronic devices continue to be miniaturized,
it is becoming increasingly more likely to create wearable or
embeddable microelectronic devices for a variety of uses. For
example, in one unrelated field, components which include
microfluidic regions have become useful tools for diverse purposes.
Amongst those purposes, the function of performing the analysis of
an analyte in a fluid sample may be possible.
[0006] Testing of ocular fluid samples have demonstrated that it
contains various chemical constituents that can be useful to
identify biomarkers therein. However, the sampling and testing of
ocular fluid requires abrasive procedures to the patient and
complex equipment. As a result, an ophthalmic device that can
incorporate microfluidic elements to perform ocular fluid
analytical procedures in convenient and useful ways that are
innocuous to a user are desired.
SUMMARY
[0007] Accordingly, the foregoing needs are met, to a great extent,
by the methods and systems of the present disclosure. In accordance
with some embodiments, an ophthalmic device can include a Media
Insert with microfluidic analytical systems that can enable small
volume fluid sample control.
[0008] According to some aspects of the present disclosure, an
ocular fluid analysis system for an ophthalmic device can include
an energy source capable of energizing the ophthalmic device. The
energized ophthalmic device can be suitable to be worn while placed
in contact with ocular fluid of a user's eye and includes a
microfluidic analytical system in electrical communication with the
energy source. Further, the microfluidic analytical system can be
configured operatively to measure one or more properties of an
ocular fluid sample using a processor capable of executing a
program. The program which can include preprogrammed threshold
values for one or more of the ocular fluid properties and output a
signal when the received measurements are outside the corresponding
preprogrammed threshold values.
[0009] According to additional aspects of the present disclosure, a
method of treating abnormal glucose levels is disclosed. The method
which can include: programming glucose biomarkers normal
concentrations level thresholds, placing an ophthalmic device in
contact with an anterior ocular surface of an eye, obtaining an
ocular fluid sample using a microfluidic element of the ophthalmic
device, measuring one or more properties of the ocular fluid using
one or more sensor components of the ophthalmic device, processing
the measurements of the one or more properties of the ocular fluid
to determine whether the concentration of glucose biomarkers are
within the preprogrammed thresholds, and outputting a signal to a
medicament dispensing device based on the measurement. In some
embodiments, the method can include the use of an algorithm that is
capable of compensating for a time delay in the change of the
measured properties to a condition causing the abnormal level.
DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1A illustrates a top view of an exemplary Media Insert
100 for an energized ophthalmic device.
[0011] FIG. 1B illustrates an isometric view of an exemplary
energized Ophthalmic Device 150 with two partial cross
sections.
[0012] FIG. 2 illustrates a top view of an exemplary multi-piece
annular shaped form insert 200.
[0013] FIG. 3 illustrates a top view of an exemplary Microfluidic
Analytical System 300 of an ophthalmic device.
[0014] FIG. 4 illustrates a magnified top view partial section of
the Microfluidic Analytical System 300 of FIG. 3 with an exemplary
pumping mechanism 400 as well as sampling regions and controlling
components.
[0015] FIG. 5 illustrates a top view partial section of an
exemplary Microfluidic Analytical System 500 with a fluid sample
being flowed through the microfluidic analysis component.
[0016] FIG. 6 illustrates a top view section of an exemplary
Microfluidic Analytical System component 600 with a waste storage
element 630.
[0017] FIG. 7 illustrates a top view section of an exemplary
pumping mechanism 700 for a Microfluidic Analytical System using
lab on a chip components.
[0018] FIG. 8 illustrates a schematic design of an exemplary
pumping system 800 that may be useful for implementing aspects of
the disclosure.
[0019] FIG. 9 illustrates a schematic design of an exemplary
artificial pore 900 for an energized ophthalmic device capable of
receiving a fluid sample into a Microfluidic Analytical System.
[0020] FIG. 10 illustrates a schematic diagram of an exemplary
cross section of a stacked die integrated components implementing
microfluidic elements incorporated within ophthalmic devices.
[0021] FIG. 11 illustrates a schematic diagram of a processor that
may be used to implement some aspects of the present
disclosure.
[0022] FIG. 12 illustrates exemplary method steps that may be used
to monitor glucose levels of a user wearing the ophthalmic lens
according to aspects of the present disclosure.
[0023] FIG. 13 illustrates exemplary method steps that may be used
to treat the glucose levels of a user wearing the ophthalmic lens
according to aspects of the present disclosure.
DETAILED DESCRIPTION OF THE INVENTION
[0024] The present invention relates to an ophthalmic device having
microfluidic elements and a system that can be used to perform
analysis of ocular fluid while in contact with an ocular surface.
In the following sections detailed descriptions of embodiments of
the invention will be given. The description of both preferred and
alternative embodiments are exemplary embodiments only, and it is
understood that to those skilled in the art that variations,
modifications and alterations may be apparent. It is therefore to
be understood that said exemplary embodiments do not limit the
scope of the underlying invention.
GLOSSARY
[0025] In this description and claims directed to the presented
invention, various terms may be used for which the following
definitions will apply:
[0026] Electro-wetting on Dielectric or EWOD: as used herein refers
to a class of devices or a class of portions of devices where a
combination of immiscible fluids or liquids, a surface region with
defined surface free energy and an electro-potential field are
present. Typically, the electro-potential field will alter the
surface free energy of the surface region, which may alter the
interaction of the immiscible fluids with the surface region.
[0027] Energized: as used herein refers to the state of being able
to supply electrical current to or to have electrical energy stored
within.
[0028] Energy: as used herein refers to the capacity of a physical
system to do work. Many uses within this invention may relate to
the said capacity being able to perform electrical actions in doing
work.
[0029] Energy Source: as used herein refers to a device or layer
that is capable of supplying Energy or placing a logical or
electrical device in an Energized state.
[0030] Energy Harvester: as used herein refers to a device capable
of extracting energy from the environment and converting it to
electrical energy.
[0031] Functionalized: as used herein refers to making a layer or
device able to perform a function including for example,
energization, activation, or control.
[0032] Leakage: as used herein refers to unwanted loss of
energy.
[0033] Lens or Ophthalmic Device: as used herein refers to any
device that resides in or on the eye. These devices may provide
optical correction, may be cosmetic, or may provide functionality
unrelated to the eye. For example, the term lens may refer to a
contact lens, intraocular lens, overlay lens, ocular insert,
optical insert, or other similar device through which vision is
corrected or modified, or through which eye physiology is
cosmetically enhanced (e.g. iris color) without impeding vision.
Alternatively, the Lens may provide non-optic functions such as,
for example, monitoring glucose or administrating medicine. In some
embodiments, the preferred lenses of the invention are soft contact
lenses are made from silicone elastomers or hydrogels, which
include, for example, silicone hydrogels, and fluorohydrogels.
[0034] Lithium Ion Cell: as used herein refers to an
electrochemical cell where Lithium ions move through the cell to
generate electrical energy. This electrochemical cell, typically
called a battery, may be reenergized or recharged in its typical
forms.
[0035] Media Insert: as used herein refers to an encapsulated
insert that will be included in an energized ophthalmic device. The
energization elements and circuitry may be incorporated in the
Media Insert. The Media Insert defines the primary purpose of the
energized ophthalmic device. For example, in embodiments where the
energized ophthalmic device allows the user to adjust the optic
power, the Media Insert may include energization elements that
control a liquid meniscus portion in the Optical Zone.
Alternatively, a Media Insert may be annular so that the Optical
Zone is void of material. In such embodiments, the energized
function of the Lens may not be optic quality but may be, for
example, monitoring glucose or administering medicine.
[0036] Microfluidic Analytical Systems: as used herein can refer to
a low energy consumption system including one or more pore(s) from
which a fluid sample may be collected from, and in some
embodiments, moved through a channel or diffused, for the
characterization of one or more properties of the fluid sample. In
some embodiments, the Microfluidic Analytical Systems can include
active microfluidic components, such as micro-pumps and
micro-valves. Alternatively or additionally, in some embodiments,
droplets may be controlled, for example, using electrowetting
and/or electrophoresis techniques.
[0037] Operating Mode: as used herein refers to a high current draw
state where the current over a circuit allows the device to perform
its primary energized function.
[0038] Optical Zone: as used herein refers to an area of an
ophthalmic lens through which a wearer of the ophthalmic lens
sees.
[0039] Power: as used herein refers to work done or energy
transferred per unit of time.
[0040] Rechargeable or Re-energizable: as used herein refers to a
capability of being restored to a state with higher capacity to do
work. Many uses within this invention may relate to the capability
of being restored with the ability to flow electrical current at a
certain rate and for a certain, reestablished period.
[0041] Reenergize or Recharge: as used herein refers to restoring
to a state with higher capacity to do work. Many uses within this
invention may relate to restoring a device to the capability to
flow electrical current at a certain rate and for a certain,
reestablished period.
[0042] Reference: as use herein refers to a circuit which produces
an, ideally, fixed and stable voltage or current output suitable
for use in other circuits. A reference may be derived from a
bandgap, may be compensated for temperature, supply, and process
variation, and may be tailored specifically to a particular
application-specific integrated circuit (ASIC).
[0043] Reset Function: as used herein refers to a self-triggering
algorithmic mechanism to set a circuit to a specific predetermined
state, including, for example, logic state or an energization
state. A Reset Function may include, for example, a power-on reset
circuit, which may work in conjunction with the Switching Mechanism
to ensure proper bring-up of the chip, both on initial connection
to the power source and on wakeup from Storage Mode.
[0044] Sleep Mode or Standby Mode: as used herein refers to a low
current draw state of an energized device after the Switching
Mechanism has been closed that allows for energy conservation when
Operating Mode is not required.
[0045] Stacked: as used herein means to place at least two
component layers in proximity to each other such that at least a
portion of one surface of one of the layers contacts a first
surface of a second layer. In some embodiments, a film, whether for
adhesion or other functions may reside between the two layers that
are in contact with each other through said film.
[0046] Stacked Integrated Component Devices or SIC Devices: as used
herein refers to the products of packaging technologies that
assemble thin layers of substrates that may contain electrical and
electromechanical devices into operative-integrated devices by
means of stacking at least a portion of each layer upon each other.
The layers may comprise component devices of various types,
materials, shapes, and sizes. Furthermore, the layers may be made
of various device production technologies to fit and assume various
contours.
[0047] Storage Mode: as used herein refers to a state of a system
comprising electronic components where a power source is supplying
or is required to supply a minimal designed load current. This term
is not interchangeable with Standby Mode.
[0048] Substrate Insert: as used herein refers to a formable or
rigid substrate capable of supporting an Energy Source within an
ophthalmic lens. In some embodiments, the Substrate insert also
supports one or more components.
[0049] Switching Mechanism: as used herein refers to a component
integrated with the circuit providing various levels of resistance
that may be responsive to an outside stimulus, which is independent
of the ophthalmic device.
Energized Ophthalmic Device
[0050] Proceeding to FIG. 1A, a top view of an exemplary Media
Insert 100 for an energized ophthalmic device is depicted. The
Media Insert 100 may comprise an Optical Zone 120 that may or may
not be functional to provide vision correction. Where the energized
function of the ophthalmic device is unrelated to vision, the
Optical Zone 120 of the Media Insert 100 may be void of material.
In some embodiments, the Media Insert 100 may include a portion not
in the Optical Zone 120 comprising a substrate 115 incorporated
with energization elements 110 and electronic components 105.
[0051] In some embodiments, a power source 110, which may be, for
example, a battery, and a load 105, which may be, for example, a
semiconductor die, may be attached to the substrate 115. Conductive
traces 125 and 130 may electrically interconnect the electronic
components 105 and the energization elements 110. In some
embodiments, the Media Insert 100 can be fully encapsulated to
protect and contain the energization elements 110, traces 125 and
130, and electronic components 105. In some embodiments, the
encapsulating material may be semi-permeable, for example, to
prevent specific substances, such as water, from entering the Media
Insert 100 and to allow specific substances, such as ambient
gasses, fluid samples, and/or the byproducts of reactions within
energization elements 110, to penetrate and/or escape from the
Media Insert 100.
[0052] Referring now to FIG. 1B, an isometric view of an exemplary
energized Ophthalmic Device 150 with two partial cross sections is
depicted. In some embodiments, the Media Insert 100 may be included
in/or an Ophthalmic Device 150, which may comprise a polymeric
biocompatible material. The Ophthalmic Device 150 may include a
rigid center, soft skirt design wherein a central rigid optical
element comprises the Media Insert 100. In some specific
embodiments, the Media Insert 100 may be in direct contact with the
atmosphere and the corneal surface on respective anterior and
posterior surfaces, or alternatively, the Media Insert 100 may be
encapsulated in the Ophthalmic Device 150. The periphery 155 of the
Ophthalmic Device 150 may be a soft skirt material, including, for
example, a hydrogel material. The infrastructure of the Media
Insert 100 and the Ophthalmic Device 150 can provide an environment
to perform analysis of ocular fluid while in contact with an ocular
surface according to aspects of the present invention. Ocular fluid
samples can include any one, or a combination of: tear fluid,
aqueous humour, vitreous humour, and other interstitial fluids
located in the eye.
[0053] Referring now to FIG. 2A, a top view of an exemplary
multi-piece annular shaped insert 200 is depicted. As depicted, the
exemplary multi-piece annular shaped insert 200 may be a ring of
material around a central optical zone that is devoid of material.
Moreover, the annular shaped insert 200 may be defined by an
exterior extent 220 and an internal annulus edge 230. Included in
between the exterior extend 220 and the internal annulus edge 230
may be found energization elements 240, interconnect features 245
of various types and/or an electronic circuit element 250.
[0054] In some embodiments, the front insert piece 291 and the rear
insert piece 292 may be joined and sealed together. In different
embodiments, other structural features and means can be implemented
to join both pieces together. Also in an encapsulated location may
be an integrated circuit element 293 connected to interconnection
elements.
[0055] A gap or pore may be formed to allow some portion of the
interior of the annular shaped insert 200 to be open to an external
environment. There may be numerous components 298 that may connect
to this opening, and can themselves be encapsulated within the
annular shaped insert 200. Accordingly, the ability to allow
component(s) 298 to be situated within the annular shaped insert
200 to controllably interface with fluids and/or gasses in their
exterior environment can, in some embodiments, enable for the
incorporation of microfluidic elements within ophthalmic
device.
Microfluidic Elements for Analyte Analysis
[0056] Referring now to FIG. 3, a top view of an exemplary
Microfluidic Analytical System 300 of an ophthalmic device is
depicted upon an ophthalmic Media Insert. In addition to
energization elements 320, control circuitry 310, and interconnect
features 340, in some embodiments, the Media Insert can include a
Microfluidic Analytical System 300 including a waste fluid
retention component 335. The Microfluidic Analytical System 300 may
be capable of determining an analyte/biomarker, in terms of its
presence or its concentration, in a fluid sample.
[0057] Referring now to FIG. 4, a magnified top view partial
section of the Microfluidic Analytical System 300 of FIG. 3 with an
exemplary pumping mechanism 400 as well as sampling regions and
controlling components is depicted. As shown, in some embodiments
control circuitry 440 may be electrically connected to components
of the microfluidic analytical system through interconnect(s) 420.
A control element 450 for a pore (not shown) may be included and be
useful for connecting the Microfluidic Analytical System 300 to
fluid (not shown) outside of the insert. Exemplary aspects of
different designs of pores may be found in following sections;
however, the pore may allow fluid samples to be passed from outside
the insert environment to a pumping element 460.
[0058] In some embodiments, the pumping element 460 may have an
activating or driving component 430 that can be capable of engaging
the pump 460. In one example, the pump element 460 may comprise a
flexible and collapsible membrane that may be activated by the
application of pressure upon the membrane. There may be numerous
manners for driving the application of pressure upon the membrane.
For example, a fluid may fill a cavity 431 and flow through a tube
435 connecting the cavity 431 to the pumping element 460.
Accordingly, the cavity 431 may include features allowing the
application of pressure upon the fluid contained within. For
example, piezoelectric components may be used to expand volume on
the application of voltage thus pressurizing the contained fluid.
In other embodiments, thermo-compressive materials may respond to a
temperature change that may be controlled by the application of
electric energy to a heating element. In a yet another embodiment,
an Electrowetting on Dielectric (EWOD) component may exert a
pressure on the fluid by a change in the wetting characteristics of
a surface in cavity 431 upon the application of a potential. There
may also be other means of driving a pump mechanism that may also
be directly engaged at the pump element 460 itself. Still further
diversity may derive from the use of EWOD components to influence
the flow of fluids themselves rather than the use of mechanical
pumping means.
[0059] The pump element 460 may force fluid to flow through a
channel 470 and subsequently into an analyzing chamber 405 of the
Microfluidic Analytical System 400. Further detail of the
components in such chambers 405 will be described in following
sections, but briefly stated the fluid may flow through the
analyzing chamber 405 and cause influences to occur on electrode(s)
410 which may be part of the components.
[0060] Referring now to FIG. 5, a top view partial section of an
exemplary Microfluidic Analytical System 500 with a fluid sample
being flowed through the microfluidic analysis component is
illustrated. Because of the nature of an annular system, the
components may be observed to be deployed in a curvilinear fashion
as there may be numerous details that change in a curvilinear
system including, for example, the exact shapes of electrodes and
chamber cross sections. In other embodiments, however, linear
analytical systems may be formed that have dimensions that allow
them to fit in the ocular environment. Further, in additional
embodiments, regardless of the nature of the system along the
analysis chamber, the entire substrate that the chamber rests upon
can be curved allowing it to rest upon the roughly spherical
surface of an eye. The details of the three dimensional nature of
the analysis chamber may factor into models related to the
performance of the systems. For illustration purposes, however,
this description declares these nuances, but will illustrate an
exemplary embodiment by curving the features of a linear
Microfluidic Analytical System 500.
[0061] Depicted in the portion of the Microfluidic Analytical
System 500, a micro-channel 550 for receiving and transporting
fluid samples is shown. These fluid samples may be pumped, for
example, by the previously discussed pumping system (e.g. 460 in
FIG. 4) from an external location. For example, fluid samples may
be sampled from ocular fluid that may surround a contact lens
containing the Microfluidic Analytic System 500. An analyte sensor
570 may be found for example along the micro-channel. This analyte
sensor 570 may be capable of performing one or more of: an
electrochemical analysis step, a photometric analysis step or other
analytical steps upon fluid samples. In an exemplary embodiment,
the analysis step may relate to a photometric sensing of glucose
concentration based on a fluorescence sensor typology using one or
more components. In another example, the sensor may detect the
presence of reaction products from a glucose oxidase interaction
with portions of the analyte sensor 570 and the fluid sample. There
may be numerous electrical interconnections 520 which connect the
sensing element 570 to control electronics.
[0062] Fluid may flow into the micro-channel 550 from a pump
channel 540. As the fluid flows into the micro-channel it may
displace other fluid in a particular region, or on an initial use
may displace ambient gas in the channel. As a fluid flows, it may
be sensed by a pre-sensor micro-channel portion comprising
electrodes 560 and 561 as well as a post-sensor portion comprising
electrodes 562 and 563. In some embodiments the measurement of
impedence between electrodes such as 560 and 561 may be used to
sense the flow of material. In other embodiments, the resistance of
a chain of electrodes 562 and 563 may be altered by the presence of
a fluid within the micro-channel 550, or the presence of a front
between two fluids of different characteristics residing in the
micro-channel 550. A fluid 580 may flow through the micro-channel
from an empty region of the micro-channel 590 to be sampled.
Alternatively, micro-channel portion at 590 may represent a
different solution of fluid that may for example have different
concentration of electrolytes, and therefore, conductivity than
that of typical tear fluid.
[0063] In general, measuring impedances, or ohmic resistances,
between position electrodes 560-563 in embodiments of the present
invention can be accomplished by applying a voltage therebetween
and measuring the resulting current. Either a constant voltage or
an alternating voltage can be applied between the position
electrodes 560-563 and the resulting direct current (DC) or
alternating current (AC), respectively, measured. The resulting DC
or AC current can then be used to calculate the impedance or ohmic
resistance. Furthermore, one skilled in the art will recognize that
measuring impedance can involve measuring both an ohmic drop (i.e.,
resistance [R] in Ohms or voltage/current) and measuring
capacitance (i.e., capacitance in Farads or coulombs/volt). In
practice, impedance can be measured, for example, by applying an
alternating current to the position electrode(s) 560-563 and
measuring the resulting current. At different frequencies of
alternating current, either resistive or capacitive effects prevail
in determining the measured impedance. The pure resistive component
can prevail at lower frequencies while the pure capacitive
component can prevail at higher frequencies. To distinguish between
the resistive and capacitive components, the phase difference
between the applied alternating current and the measured resulting
current can be determined. If there is zero phase shift, the pure
resistive component is prevailing. If the phase shift indicates
that the current lags the voltage, then the capacitive component is
significant. Therefore, depending on the frequency of an applied
alternating current and position electrode configuration, it can be
beneficial to measure either resistance or a combination of
resistance and capacitance.
[0064] Referring back to the specific example of FIG. 5, impedance
measurements can be performed by, for example, applying an
alternating voltage between first position electrode 530 and a
final position electrode connection 510 and measuring the resulting
alternating current. Since the chain of electrodes including 560,
561, 562 and 563 can be a portion of a capacitor, (along with any
substance [e.g., air or a liquid sample] within micro-channel 550
between subsequent position electrodes and any layers that may be
separating the position electrodes from direct contact with the
fluid in the micro-channel 550), the measured current can be used
to calculate the impedance. The presence or absence of a liquid
sample in micro-channel 550, 590 between electrodes will affect the
measured current and impedance. The frequency and amplitude of the
alternating voltage applied between a first and second position
electrodes 560-563 can be predetermined such that the presence of a
liquid sample between a first and second position electrodes
560-563 can be detected by a significant increase in measured
current.
[0065] With respect to the measurement of impedance or resistance,
the magnitude of the applied voltage can be, for example, in range
from about 10 mV to about 2 volts for the circumstance of an
ophthalmic tear fluid sample and carbon-based or silver-based ink
position electrodes. The lower and upper limits of the applied
voltage range are dependent on the onset of electrolysis or
electrochemical decomposition of the liquid sample. In instances
where an alternating voltage is employed, the alternating voltage
can be applied, for example, at a frequency that results in a
negligible net change in the liquid sample's properties due to one
or more electrochemical reaction. Such a frequency range can be,
for example, from about 10 Hz to about 100 kHz with a voltage
waveform symmetrical around 0 Volts (i.e., the RMS value of the
alternating voltage is approximately zero).
[0066] As depicted, analyte sensor 570 and position electrodes
560-563 can each be in operative communication with the
micro-channel 550. It should be noted that position electrodes
560-563 employed in embodiments of the present invention can be
formed of any suitable conductive material known to those skilled
in the art, including conductive materials conventionally used as
analytical electrode materials and, in particular, conductive
materials known as suitable for use in flexible circuits,
photolithographic manufacturing techniques, screen printing
techniques and flexo-printing techniques. Suitable conductive
materials include, for example, carbon, noble metals (e.g., gold,
platinum and palladium), noble metal alloys, conductive
potential-forming metal oxides and metal salts. Position electrodes
can be formed, for example, from conductive silver ink, such as the
commercially available conductive silver ink Electrodag 418 SS.
[0067] Referring now to FIG. 6, a top view section of an exemplary
Microfluidic Analytical System component 600 with a waste storage
element 630 is depicted. In the exemplary embodiments, electrode
610 for measuring the flow rate of fluid in the system may be an
end electrode of many others (not depicted in FIG. 6). Fluid may
flow through the micro-channel 620 and continue to a fluid
retention vessel 630. The fluid rentention vessel may be used, for
example, for higher volume of fluid analysis therein. In some
embodiments, a pore 640 can include a pore control element 645 for
connecting the fluid retention vessel 630, which may be also be
used as a waste storage element, 630 to regions located external to
the insert. In addition, in some embodiments the pore control
element 645 connection may be useful for equalizing gas pressure as
the microfluidic components fill with fluid. In other embodiments,
the pore 640 and pore control element 645 may be useful for
emitting fluid from the ophthalmic device. The pore 640 may also be
useful for connecting an end of the Microfluidic Analytical System
to its external region in an eye environment, which can allow for
continuous monitoring without the removal of the ophthalmic device.
In other embodiments, the pore 640 and pore control element 645 may
be useful for flow control through the Microfluidic Analytical
System in a storage location, such as the fluid retention vessel
630. For example, while in storage, the Microfluidic Analytical
System may be cleansed or refreshed by the flowing of solutions
through the system and, in some embodiments, subjected to
calibration protocols. Control of these functions may be performed
by the integrated circuit components within the lens which may also
be in communication with external controlling systems.
Energized Ophthalmic Devices with Lab on a Chip Components
[0068] Referring now to FIG. 7, a top view section of an exemplary
pumping mechanism 700 for a Microfluidic Analystical System using
lab on a chip component 710 is depicted. A lab on a chip component
710 may share many aspects with the embodiment of the Microfluidic
Analytical System that has been previously discussed. Similarly,
however, in some embodiments small droplets may be moved around
within the lab on a chip 710 not through the action of a pump 760
but by control of the droplets with EWOD components. Droplets may
be combined in elements of the lab on a chip component 710 to
perform chemical processing. Numerous analysis techniques that may
be performed. For example, in some embodiments the analysis of
glucose as an analyte may be performed. The technique for this
analysis may include, for example, an electrochemical or
photometric technique as described or other techniques that may
relate to the mixing of chemical substances that may be initially
stored in the lab on a chip component 710.
[0069] Various components such as energization elements (not
shown), interconnects 740, and sealing aspects previously described
may take place in the annular Media Insert piece of the present
example. Further, an electronic circuit 720 capable of controlling
various components including a lab on a chip component 710 can be
implemented. A pore 750 and a pore control system 755 may control
the sampling of fluid samples from the ophthalmic device
environment. A pump actuator 730 may actuate a pump 760 which may
be mechanical in nature such as a membrane based pump. Droplets of
a fluid sample may be pumped into micro-channel 715 for metering of
the volume and sample flow rate through the use of electrodes such
as electrode 716 as described in the present disclosure. The
droplets may be provided to the lab on a chip component 710 through
a channel 711 where it may be further processed. The lab on a chip
component 710 may use the pumped action on the sample to control
flow within itself, or in other embodiments, it may control the
flow rate of the sample provided to it on its own.
[0070] In additional embodiments, the lab on a chip component 710
may be able to sense fluid in its environment without the need of
an external pumping systems. However, a pore such as item 750 can
still be useful to provide control over flow of external fluid into
the environment of the lab on a chip component. Thereafter the lab
on a chip component 710 may sample the introduced sample on its
own, for example, by the control through electrowetting on
dielectric or electrophoresis features that can attract and move
fluid samples.
[0071] The lab on a chip component 710 may comprise a design that
can be consistent with the present description including, for
example, very thin lab on chip flexible components to allow for the
deformation into a shape consistent with the three dimensional
shape of an ocular surface. In some embodiments, the shape and
thickness of the lab on a chip component 710 may allow it to be
included in a planar form within the ophthalmic insert device.
Energized Pumping Systems for Microfluidic Components
[0072] Referring now to FIG. 8, a schematic design of an exemplary
pumping system 800 that may be useful for implementing aspects of
the disclosure is depicted. As previously mentioned, in some
embodiments it is useful to provide a means of pumping fluid
samples both in and out of an ophthalmic device and also within
components located inside an ophthalmic device. In the present
example, pumping system 800 may have an inlet for fluid samples
with a flow controlling system 880. When fluid is allowed to flow
by flow controlling system 880 it can proceed through a channel
870. A membrane component 820 may be included so that when
deflected by a force upon it, it can cause gas and/or liquid fluids
to be compressed and act to pump them. In some embodiments, the
membrane component 820 may be located on a fluid path 840 between a
system of check valves 850 and 860, which may be included in the
pumping system 800 to ensure the flow in a preferred direction. In
other embodiments, the design and geometry of the flow regions may
effect a preferred flow condition. For example, as fluid is
compressed in flow path region 840, which is a continuation of a
flow path region 870, liquid sample can flow towards other regions
of the Microfluidic Analytic System.
[0073] A force upon a surface of the membrane component 820 can
cause actuation of the pumping system 800. The force may be
applied, for example, by an active component 810 that can provide
the deflection. In some embodiments a fluid may be capable of
providing the force for deflection. Through the use of hydraulic
principles, for example a larger volume of fluid may be
concentrated down to match up with the surface of the membrane
component 820. In these types of embodiments, elements that
pressurize the larger volume fluid may perform the required task.
Mechanical piston activation where electrostatic or magnetostatic
forces are used may also be included in some embodiments. Also,
thermal expansion and electrically (Piezoelectric) activated
expansion of materials that surround the fluid may also be used to
provide a means of pressurizing the fluid. For example, in some
embodiments, Electrowetting on dielectrics may be employed to
pressurize the fluid. A chamber 810 may be formed to have a surface
treatment that under the lack of an electric potential favors the
attraction of the fluid included in the chamber 810. With an
electrode (not shown) in contact with the fluid and another beneath
the treated surface, a potential field may be established across
the surface region. As the wetting of the region is changed by the
application of the potential field, the fluid may become
pressurized and with a hydraulic concentration, the resulting
pressure on the membrane component 820 may deflect it and effect a
pumping stroke. By reducing the potential field, the effect may be
reversed on the hydraulic fluid with the result being a relaxation
of the membrane component 820 and the completion of a pumping
cycle.
[0074] Other numerous means for pumping small amounts of fluids
within an ophthalmic device are also in the scope with the present
disclosure. The mechanical membrane based system is an example but
direct utilization of Electrowetting on dielectrics may provide
other alternatives. For example, in still further embodiments,
micro electro mechanical systems (MEMS) may also provide pumping
functions by compressing fluid samples or imparting impulse upon
fluid samples.
Energized Artificial Pores for Control of the Introduction of
Fluids into Ophthalmic Devices
[0075] Referring now to FIG. 9, a schematic design of an exemplary
artificial pore 900 for an energized ophthalmic device capable of
receiving a fluid sample into a microfluidic component is depicted.
A sample fluid may reside in a region schematically demonstrated
above pore access 910. In the operation of the artificial pore 900,
at desired times the fluid may be allowed to flow from that region
and into and ultimately through a fluid path channel 970. There may
be numerous manners to control the flow of fluids through the
channel including mechanical based mechanisms that may constrict or
eliminate the cross sectional profile of the fluid path channel 970
in regions that may block flow.
[0076] In the present example, Electrowetting on dielectric effects
may be used to create a repellant region in the pore access 910
region. A treated or formed surface 940 to be hydrophobic in nature
may decrease the ability of hydrophilic or polar solvents to
transverse the pore into fluid path channel 970. An electrode 960
may interact with fluids as they enter the pore region. A
corresponding electrode 930 may also be located around the
hydrophobic surface. This electrode 930 may be connected
electrically To allow for the application of an electrical field,
across electrodes 960 and 980, the surface wetting characteristic
of the hydrophobic surface 940 may be altered to better allow flow
through the region.
[0077] In some embodiments, an additional feature may be added to
the artificial pore 900 to allow for the non-energized blocking of
fluids preventing them from flowing through the pore access 910.
This may be particularly useful when a device including the
artificial pore 900 is in an initial storage after being produced.
For example, the pore access 910 may be a thin film metal blocking
feature. The film metal blocking feature may be connected through
interconnect features 920 and 990. It may be possible that upon
removal of the device containing the artificial pore 900 from a
storage, that an activation signal may be communicated and received
by the ophthalmic device. In some embodiments, when the ophthalmic
device is ready to receive fluid samples for the first time, it may
provide an electric potential across the metal interconnects 920
and 990 in such a manner that the current flow may be directed
across the thin metal film 910. In some embodiments, this current
flow may cause the thin metal film 910 to melt or evaporate, in
either case exposing the underlying channel region 970 of the
artificial pore 900.
Microfluidic Components in Stacked Integrated Die Embodiments
[0078] Reference has been made to electronic circuits making up
part of the componentry of ophthalmic devices incorporating
microfluidic elements. In some embodiments according to aspects of
the disclosure, a single and/or multiple discrete electronic
devices may be included as discrete chips, for example, in the
ophthalmic Media Inserts. In other embodiments, the energized
electronic elements can be included in the Media Insert in the form
of Stacked Integrated Components. Accordingly and referring now to
FIG. 10, a schematic diagram of an exemplary cross section of a
Stacked Integrated Components implementing microfluidic elements
incorporated within ophthalmic devices is depicted. In particular,
the Media Insert may include numerous layers of different types
which are encapsulated into contours consistent with the ophthalmic
environment that they will occupy. In some embodiments, these Media
Inserts with Stacked Integrated Component layers may assume the
entire annular shape of the Media Insert. Alternatively in some
cases, the Media Insert may be an annulus whereas the Stacked
Integrated Components may occupy just a portion of the volume
within the entire shape.
[0079] As shown in FIG. 10, there may be thin film batteries used
to provide energization. In some embodiments, these thin film
batteries may comprise one or more of the layers that can be
stacked upon each other, in this case layers 1030 may represent the
battery layers, with multiple components in the layers and
interconnections therebetween.
[0080] In some embodiments, there may be additional
interconnections between two layers that are stacked upon each
other. In the state of the art there may be numerous manners to
make these interconnections; however, as demonstrated the
interconnection may be made through solder ball interconnections
between the layers. In some embodiments only these connections may
be required; however, in other cases the solder balls may contact
other interconnection elements, as for example with a component
having through layer vias.
[0081] In other layers of the Stacked Integrated Component Media
Insert, a layer 1025 may be dedicated for the interconnections two
or more of the various components in the interconnect layers. The
interconnect layer 1025 may contain, vias and routing lines that
can pass signals from various components to others. For example,
interconnect layer 1025 may provide the various battery elements
connections to a power management unit 1020 that may be present in
a technology layer 1015. Other components in the technology layer
1015 can include, for example, a transceiver 1045, control
components 1050 and the like. In addition, the interconnect layer
1025 may function to make connections between components in the
technology layer 1015 as well as components outside the technology
layer 1015; as may exist for example in the Integrated Passive
Device 1055. There may be numerous manners for routing of
electrical signals that may be supported by the presence of
dedicated interconnect layers such as interconnect layer 1025.
[0082] In some embodiments, the technology layer 1015, like other
layer components, may be included as multiple layers as these
features represent a diversity of technology options that may be
included in Media Inserts. In some embodiments, one of the layers
may include CMOS, BiCMOS, Bipolar, or memory based technologies
whereas the other layer may include a different technology.
Alternatively, the two layers may represent different technology
families within a same overall family; as for example one layer may
include electronic elements produced using a 0.5 micron CMOS
technology and another layer may include elements produced using a
20 nanometer CMOS technology. It may be apparent that many other
combinations of various electronic technology types would be
consistent within the art described herein.
[0083] In some embodiments, the Media Insert may include locations
for electrical interconnections to components outside the insert.
In other examples, however, the Media Insert may also include an
interconnection to external components in a wireless manner. In
such cases, the use of antennas in an antenna layer 1035 may
provide exemplary manners of wireless communication. In many cases,
such an antenna layer 1035 may be located, for example, on the top
or bottom of the stacked integrated component device within the
Media Insert.
[0084] In some of the embodiments discussed herein, the battery
elements 1030 may be included as elements in at least one of the
stacked layers themselves. It may be noted as well that other
embodiments may be possible where the battery elements 1030 are
located externally to the stacked integrated component layers.
Still further diversity in embodiments may derive from the fact
that a separate battery or other energization component may also
exist within the Media Insert, or alternatively these separate
energization components may also be located externally to the Media
Insert.
[0085] A microfluidic element 1010 may be included in a Stacked
Integrated Component architecture. In some embodiments, the
microfluidic element 1010 component may be attached as a portion of
a layer. In other embodiments, the entire microfluidic element 1010
may also comprise a similarly shaped component as the other Stacked
Integrated Components. The various diversity of types of
microfluidic elements 1010 that have been discussed herein may be
consistent with a Stacked Integrated Component Device, where other
features such as pumps, pores and the like are either a portion of
a layer or alternatively attached either to the microfluidic cell
or the layer that it attaches to.
Control Systems for Ophthalmic Devices with Integrated Microfluidic
Components
[0086] Referring now to FIG. 11 a controller 1100 is illustrated
that may be used in some embodiments of the present disclosure. The
controller 1100 can include one or more processors 1110, which may
include one or more processor components coupled to a communication
device 1120. In some embodiments, a controller 1100 can be used to
transmit energy to the Energy Source placed in the ophthalmic
lens.
[0087] The processors 1110 are coupled to a communication device
configured to communicate energy via a communication channel. The
communication device may be used to electronically communicate with
components within the ophthalmic insert within the ophthalmic
device. The communication device 1120 may also be used to
communicate, for example, with one or more controller apparatus or
programming/interface device components.
[0088] The processor 1110 is also in communication with a storage
device 1130. The storage device 1130 may comprise any appropriate
information storage device, including combinations of magnetic
storage devices (e.g., magnetic tape and hard disk drives), optical
storage devices, and/or semiconductor memory devices such as Random
Access Memory (RAM) devices and Read Only Memory (ROM) devices.
[0089] The storage device 1130 can store a program 1140 for
controlling the processor 1110. The processor 1110 performs
instructions of a software program 1140, and thereby operates in
accordance with the present invention. For example, the processor
1110 may receive information descriptive of Media Insert placement,
component placement, and the like. The storage device 1130 can also
store ophthalmic related data in one or more databases 1150 and
1160. The database may include, for example, customized Media
Insert designs, predetermined ocular fluid sample measurement
thresholds, metrology data, and specific control sequences for
controlling energy to and from a Media Insert. The database may
also include parameters and controlling algorithms for the control
of microfluidic analysis components that may reside in the
ophthalmic device as well as data that result from their action. In
some embodiments, that data may be ultimately communicated to an
external reception device.
[0090] Referring now to FIG. 12, exemplary method steps that may be
used to monitor glucose levels of a user wearing the ophthalmic
lens according to aspects of the present disclosure are
illustrated. At step 1201, thresholds values can be programmed into
a software program. According to aspects of the present disclosure,
threshold values can include, for example, acceptable levels for
the concentration of glucose biomarkers in ocular fluid. The use of
other biomarkers used to monitor different conditions such as
depression, high blood pressure, and the such, are also within the
inventive scope of aspects of the present disclosure. In addition,
depending on whether the ocular fluid sample targeted is, for
example, tear fluid or an interstitial fluid, the preprogrammed
levels can be different. The program may be stored and executed
using one or both a processor forming part of the Media Insert of
the ophthalmic device and an exterior device in communication with
the processor of the Media Insert. An exterior device may include a
smart phone device, a PC, an ophthalmic device user interface, and
the such, and can be configured to include executable code useful
to monitor properties of ocular fluid samples. Ocular fluid
properties can be measured by one or more sensors contained in the
ophthalmic device. Sensors may include electrochemical sensors
and/or photometric sensors. In an exemplary embodiment, the sensor
analysis step may relate to a photometric sensing of glucose
concentration based on a fluorescence sensor typology. In another
example, the sensor may detect the presence of reaction products
from a glucose oxidase interaction with portions of the analyte
sensor and the fluid sample.
[0091] At step 1205, the ophthalmic device including a microfluidic
system may be placed in contact with a portion of the anterior
ocular surface of the eye and worn by a user. In some embodiments,
the ophthalmic device can be in a form of an energized contact lens
and the step may be achieved when the contact lens is placed on the
eye surface. In other embodiments, the ophthalmic device may be,
for example, in the form of an intraocular lens or a punctal plug,
and still include aspects of the microfluidic analytical system
described in the present disclosure. Although the ophthalmic device
is described throughout the specification in singular form, it will
be understood by one skilled in the art that two ophthalmic devices
(e.g. contact lenses), one placed on each eye, may function
together to provide functionality aspects of the present
disclosure.
[0092] At step 1210, concentration changes of biomarkers can be
monitored using the one or more sensors. The monitoring of the
biomarkers may occur at a predetermined frequency or upon demand
through a user interface and/or an activation sensor in the
ophthalmic device. Biomarkers can include those correlated to
glucose levels, depression, blood pressure and the such. At step
1220, the processor of the ophthalmic device can record the
measured property/condition from a sample of ocular fluid. In some
embodiments, the processor of the ophthalmic device may store it
and/or send it to one or more device(s) in communication with the
ophthalmic device. At step 1215, the value recorded can be stored
and analyzed in the user interface in communication with the
ophthalmic lens, and/or, at step 1225, the analysis and recording
can take place in the ophthalmic device.
[0093] At step 1230, one or both the ophthalmic device and the user
interface can alert the user, and/or a practitioner, of the
measured concentration. The alert can be programmed to occur when
the levels measured are outside the predetermined threshold values
programmed, received and/or calculated by the ophthalmic device. In
addition in some embodiments, the data and alerts may be analyzed
to perform one or more steps of: a) change measurement frequency
according to the time of the day, b) identify personal patters in
the changes of concentration levels measures, and c) change the
measurement frequency according to the changes in concentrations
measured. At step 1235, the time of the day may change the
frequency of measurements. For example, if the ophthalmic device is
one that would remain in the eye during sleep, the number of
measurements during 10 pm and 6 am can decrease or stop. Similarly,
during lunch and dinner times the frequency may increase to detect
changes due to the food consumption of the user. At step 1240,
patterns in changes of the concentration levels may be identified
by the system. Using the identified patterns, the system may alert
the user of causes and/or, at step 1245, change the frequency
according to the identified changes so that the system is more
alert during critical identified conditions. Critical conditions
can include events that would trigger a significant increase or
decrease in glucose levels. Events can include, for example,
holiday dates, exercise, location, time of the day, consumption of
medicaments and the like.
[0094] In some embodiments, at step 1250, the originally programmed
values may be customized, periodically or in real time, according
to identified patterns/conditions. This ability may allow the
system to increase its effectiveness by eliminating false alarms
and increasing sensitivity at a critical condition. Effectiveness
can promote user participation with the system thereby maximizing
the benefits of the ophthalmic device and thereby providing a safe
monitoring system. At step 1255, data relating to the user
including, for example, the identified patterns, measurements,
and/or preferences may become part of the medical history of the
user. Medical history may be stored securely by encrypting the data
and/or restricting its access.
[0095] Referring now to FIG. 13, exemplary method steps that may be
used to treat the glucose levels of a user wearing the ophthalmic
lens according to aspects of the present disclosure are
illustrated. At step 1301, an ophthalmic device including a
microfluidic analytical system is placed in contact with ocular
fluid. In some embodiments, the ophthalmic device can be in a form
of an energized contact lens and the step may be achieved when the
contact lens is placed on the eye surface. In other embodiments,
the ophthalmic device may be, for example, in the form of an
intraocular lens or a punctal plug, and still include aspects of
the microfluidic analytical system described in the present
disclosure.
[0096] At step 1305, changes in biomarkers in the ocular fluid can
be monitored. Methods of monitoring the biomarker changes can
include, for example, steps illustrated in FIG. 12. At step 1310,
measured changes can be communicated in real time to a
medicament-dispensing device in direct or indirect communication
with the ophthalmic device. Although the changes in concentration
of the monitored biomarkers in ocular fluid may include a time
delay in relation to the concentration changes in the bloodstream
of the user, upon detection, at step 1315 the medicament-dispensing
device may administer a medicament capable of lowering or raising
concentrations to a normal level. For example, glucose levels may
be monitored and treated when they are outside a normal level.
Continuous monitoring can prevent uncontrolled blood sugar levels
which can damage the vessels that supply blood to important organs,
like the heart, kidneys, eyes, and nerves. Because an individual
whose glucose levels may reach a level that exposes him/her to said
risks may feel ok, aspects of the present disclosure can help take
action upon early detection of the condition. Early detection may
not only bring back levels to a normal conditions and/or make the
user aware, but additionally prevent the more dramatic and
permanent consequences including, for example, a heart attack or
stroke, kidney failure, and blindness which have been known to
occur when abnormal glucose levels are left untreated.
[0097] In addition, in some embodiments the
medicament-administering device may send an alert to the user
through its interface or using component of the ophthalmic device.
For example, in some ophthalmic device embodiments the Media Insert
may include a light projection system, such as one or more LEDs,
capable of sending a signal to the user.
[0098] Subsequently at step 1320, any further drug administering
can be suspended to prevent overdosing of the system due to the
time delay of the effect of the drug and the effect to be reflected
in the tear fluid. For example, the medicament may require 10-30
minutes to counteract the abnormal level, and upon its effect, may
take another 20 minutes to equalize concentrations in tear fluid.
Consequently, programmed algorithms capable of correlating the
condition, time delay, and appropriate subsequent dosing of
medicaments can be programmed in the system to function safely. At
step 1325, data relating to one or both the measured conditions and
the medicament administration to the user may be stored and used as
part of a treatment and/or medical history of the user.
[0099] Specific examples and method steps have been described to
explain and enable different aspects of the present invention.
These method steps and examples are for illustration purposes and
are not intended to limit the scope of the claims in any manner.
Accordingly, the description is intended to embrace all embodiments
that may be apparent to those skilled in the art.
* * * * *