U.S. patent application number 17/029390 was filed with the patent office on 2021-03-25 for cloud based corneal surface difference mapping system and method.
The applicant listed for this patent is Davco, LLC. Invention is credited to Stephen D Klyce, David A. Wallace.
Application Number | 20210085175 17/029390 |
Document ID | / |
Family ID | 1000005119342 |
Filed Date | 2021-03-25 |
United States Patent
Application |
20210085175 |
Kind Code |
A1 |
Wallace; David A. ; et
al. |
March 25, 2021 |
Cloud Based Corneal Surface Difference Mapping System and
Method
Abstract
A method to perform automatic corneal topography or tomography
difference mapping includes receiving one or more corneal
topography or tomography data files and/or a corneal image for an
examined patient from a corneal topography or tomography system;
receiving personal identification parameters from captured user
personal data communicated from the corneal topography or
tomography system; and comparing received patient identification
parameters to existing patient identification parameters in a
database to identify if there are existing topography or tomography
data files for a same patient in the database. The method may
further include retrieving a prior topography or tomography data
file for the patient from the database; and performing difference
mapping by comparing the received topography or tomography data
files to the prior topography or tomography data file retrieved
from the database to generate a topography or tomography difference
map.
Inventors: |
Wallace; David A.; (Los
Angeles, CA) ; Klyce; Stephen D; (Port Washington,
NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Davco, LLC |
Los Angeles |
CA |
US |
|
|
Family ID: |
1000005119342 |
Appl. No.: |
17/029390 |
Filed: |
September 23, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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62977652 |
Feb 17, 2020 |
|
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62904926 |
Sep 24, 2019 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G16H 40/63 20180101;
G16H 40/67 20180101; G16H 50/70 20180101; G06F 21/6245 20130101;
G06F 21/32 20130101; G16H 10/60 20180101; A61B 3/107 20130101; G16H
30/00 20180101 |
International
Class: |
A61B 3/107 20060101
A61B003/107; G16H 10/60 20060101 G16H010/60; G16H 50/70 20060101
G16H050/70; G16H 30/00 20060101 G16H030/00; G16H 40/63 20060101
G16H040/63; G16H 40/67 20060101 G16H040/67; G06F 21/62 20060101
G06F021/62; G06F 21/32 20060101 G06F021/32 |
Claims
1. A method to perform automatic corneal topography or tomography
difference mapping, comprising: computer-readable instructions
stored in one or more memory devices of one or more cloud-based
server devices; one or more processors in the one or more
cloud-based server devices configured with the computer-readable
instructions to: receive one or more corneal topography or
tomography data files and/or a corneal image for an examined
patient from a corneal topography or tomography system; receive
personal identification parameters from captured user personal data
communicated from the corneal topography or tomography system;
compare received patient identification parameters to existing
patient identification parameters in a database to identify if
there are existing topography or tomography data files for a same
patient in the database; retrieve a prior topography or tomography
data file for the patient from the database; and perform difference
mapping by comparing the received topography or tomography data
files to the prior topography or tomography data file retrieved
from the database to generate a topography or tomography difference
map.
2. The method of claim 1, the one or more processors in the one or
more cloud-based server devices configured with the
computer-readable instructions to: store the topography or
tomography difference map in the database and associate the
topography or tomography difference map with the user.
3. The method of claim 1, the one or more processors in the one or
more cloud-based server devices configured with the
computer-readable instructions to: analyze the topography or
tomography difference map to identify if a significant
topographical change has occurred, and if the significant
topographical change has occurred, communicate the topography
difference map and/or an advisory message associated with the
topography or tomography difference map to a provider computing
device for display to the provider.
4. The method of claim 1, the one or more processors in the one or
more cloud-based server devices configured with the
computer-readable instructions to: analyze the generated topography
or tomography difference map to identify if a significant
topographical change has occurred, and if the significant
topographical change has occurred, communicating an email or
electronic message to a provider computing device, the email or
electronic message comprising a link to the generated topography or
tomography difference map stored in the database.
5. The method of claim 3, where the significant topographical
change is a change of 0.25 Diopters from the prior topography or
tomography data file, optionally within a change in the range of
0.20 to 0.30 Diopters from the prior topography or tomography data
file, and optionally within a change in the range of 0.10 to 0.40
Diopters from the prior topography or tomography data file.
6. The method of claim 3, where the significant topographical
change is a change of 0.50 Diopters from the prior topography or
tomography data file, optionally within a change in the range of
0.40 to 0.60 Diopters from the prior topography or tomography data
file, and optionally within a range of 0.25 to 0.75 Diopters from
the prior topography or tomography data file.
7. The method of claim 3, wherein the significant topographical
change is associated with early keratoconus, form frust
keratoconus, changes in shape of cornea relating to Lasik,
stability loss after refractive surgery, or eye rubbing in
combination with a thin cornea.
8. The method of claim 1, wherein the database is a HIPAA compliant
database.
9. The method of claim 1, the one or more processors in the
cloud-based server devices further configured with instructions to:
determine that the performing of the difference mapping is being
completed on a correct eye of the patient.
10. The method of claim 1, the one or more processors in the
cloud-based server devices further configured with instructions to:
compare current date of examination to prior date of examination
for patient's existing topography or tomography data files to
confirm a correct timeframe has elapsed to perform difference
mapping.
11. The method of claim 1, wherein the personal identification
parameters include phone number, first name and last name of
patient, date of birth and email address of patient, and matching
of any one of the personal identification parameters confirms a
patient's record exists in the database.
12. The method of claim 1, the one or more processors in the
cloud-based server devices further configured with instructions to:
receive a patient thumbnail image communicated from the corneal
topography or tomography system; compare the received patient
thumbnail image to existing patient thumbnail images in a database
to identify if there are existing topography or tomography data
files for a same patient in the database.
13. The method of claim 1, the one or more processors in the
cloud-based server devices further configured with instructions to:
receive a patient conjunctival capillary vessel architecture image
communicated from the corneal topography or tomography system;
compare the received patient conjunctival capillary vessel
architecture image to existing patient conjunctival capillary
vessel architecture image in a database to identify if there are
existing topography or tomography data files for a same patient in
the database.
14. A method to perform automatic corneal topography difference
mapping, comprising: computer-readable instructions stored in one
or more memory devices of one or more cloud-based server devices;
one or more processors in the one or more cloud-based server
devices configured with the computer-readable instructions to:
receive one or more corneal topography or tomography data files
and/or a corneal image for an examined patient from a corneal
topography or tomography system; receive personal identification
parameters from captured user personal data communicated from the
corneal topography or tomography system; compare received patient
identification parameters to existing patient identification
parameters in a database to identify if there are existing
topography or tomography data files for a same patient in the
database; if there are no existing topography or tomography data
files for the same patient in the database, querying a provider
database, a regional database, a national database, a multi-nation
database, and/or other foreign nation databases to determine if any
of the databases include personal identification parameters
matching the received personal identification parameters; and
communicate a message to a provider computing device requesting the
provider to verify that the located personal identification
parameters correspond to the patient being examined if the received
personal identification parameters match personal identification
parameters in the provider database, the regional database, the
national database, the multi-nation database and/or the other
foreign nation databases; retrieve a prior data file for the
patient from the database where the match was found for the
received personal identification parameters; and perform difference
mapping by comparing the received topography or tomography data
files to the prior topography or tomography data file retrieved
from the database where the match was found to generate a
topography or tomography difference map.
15. The method of claim 14, wherein an end-user license agreement
(EULA) authorizes the medical provider or the database provider to
transfer patient personal identification parameters and/or
retrieved patient topography or tomography datafiles to the
database provider if the patient has moved from one jurisdiction to
another.
16. The method of claim 14, wherein the EULA authorizes the
database provider to directly contact the patient.
17. A method of receiving patient data for a patient database,
comprising: reviewing and accepting an end-user license agreement
(EULA) for a medical provider software application, the EULA
identifying that the medical provider stores personal data of the
user in the patient database and also stores user medical
examination diagnostic data and images in the patient database;
downloading the medical provider software application to a user's
mobile communication device, the medical provider software
application including a personal data transfer software
application; receiving a user's personal data and storing the
user's personal data in the personal data transfer software
application, wherein the user's personal data includes one or more
of a user's first name, a user's surname name, a user's cell phone
number, a user's physical address, a user's email address, a
contact method preference, and/or user's date of birth;
18. The method of claim 17, further comprising: initiating the
personal data transfer software application on the user's mobile
communication device; placing the user's mobile communication
device in proximity to a near field communication (NFC) transceiver
on the medical diagnostic device; in response to user input to the
user's mobile communication device, initiating the personal data
transfer software application to authorize transfer of the user's
personal data; transferring the user's personal data to the medical
diagnostic device; receiving, from the medical diagnostic device,
the user's personal data transferred via the transfer software
application and displaying the user personal data on a screen of
the mobile communication device.
19. The method of claim 18, further comprising: validating that the
owner of the mobile communication is the user transferring the
user's personal data by communicating with an identification
verification system in the mobile communication device; verifying
the copy of the user personal data received by the medical
diagnostic device is correct; and performing a medical diagnostic
procedure on the user;
20. The method of claim 19, further comprising: generating, by the
medical diagnostic device, one or more medical diagnostic image
files and/or one or more medical diagnostic data files; encrypting,
at the medical diagnostic device, the user personal data to create
encrypted user personal data; transferring, by the medical
diagnostic device, the encrypted user personal data to a
cloud-based server device; and transferring, by the medical
diagnostic device, the one or more medical diagnostic images files
and/or the one or more medical diagnostic datafiles to the
cloud-based server device; and storing the encrypted user personal
data, the one or more medical diagnostic image files and/or the one
or more medical diagnostic datafiles in the patient database of the
cloud-based server device.
Description
RELATED APPLICATIONS
[0001] This application claims priority to U.S. provisional patent
application Ser. No. 62/904,926, filed Sep. 24, 2019 and U.S.
provisional patent application Ser. No. 62/977,652, filed Feb. 17,
2020, the disclosures of which are both hereby incorporated by
reference.
BACKGROUND
[0002] Corneal topographers measure corneal shape and optical
power; they are a key diagnostic tool in many sectors of eye care.
Corneal topography instruments measure the anterior surface of the
cornea and generate datafiles based on the anterior surface
curvature measurements. Corneal tomography systems measure the
posterior surface of the cornea and the anterior surface of the
cornea and generate datafiles based on the anterior and posterior
elevation measurements. While the specification below focuses on
discussions of corneal topography, the devices, apparatus and
methods described herein in the claimed subject matter apply also
to corneal tomography systems. The instruments are commonly used
for diverse applications including routine eye examination,
evaluating corneal disease states, aiding contact lens fitting,
assessing candidacy for cataract and intraocular lens implant
surgery, and/or evaluating patients for laser vision correction
surgery (LASIK, SMILE, PRK). Current corneal topography equipment
consists of sizeable, table-mounted instruments that may interface
with dedicated computers to produce color-coded topographic power
maps and statistical analyses of the corneal surface that are
displayed on a computer monitor, to be evaluated by the eye care
practitioner. Some of these systems have an integral display
screen, and do not interface with an external computer. Test
results can be printed out on a separate printer and image files
stored locally, such as on the local computer running the corneal
topography device, and/or in local area network ("LAN") locations,
and/or in local Electronic Health Record ("EHR") systems. Although
reasonably precise with their readings, these corneal topographers
are large, not portable, not typically useable in the standard exam
room or "lane," and cost in the range of $12,000 to $50,000+,
depending upon features. The combination of the size, the
non-portability and/or the cost limits the prior corneal topography
systems use and market reach.
[0003] In the case of Placido reflectance topography systems, each
corneal device projects a specific illuminated source pattern to
the eye being tested (typically a series of concentric illuminated
rings) and captures an image of the ring reflections from the
cornea. Each corneal topography system creates a unique data file
from the captured rings image, for each eye studied. The data files
are numeric representations allowing 3-D reconstruction of the
corneal surface curvature based on of the locations of the ring
edges, compared to a calibration reference surface. For the purpose
of this discussion and within this specification, "power" may be
used as a synonym for "curvature" consistent with common use and
these terms may be used interchangeably throughout the
specification. Different corneal topography systems may structure
their data files differently. These data files may not be
interchangeable; and are typically only stored on the corneal
topography system performing the measurements, however derivative
maps (axial power maps) may be stored on network drives or output
to EHR systems. The underlying data files are generally not shared,
are not stored on network drives, or output to EHR systems.
[0004] Placido-based corneal topography is described in detail in
Klyce S D, Oshika T: Placido-based topography. In: Corneal Surgery:
Theory, Technique, & Tissue. Part II. Testing and Measuring
Corneal Function. 4th edition. Ed., F S Brightbill F S, McDonnell P
J, Farjo A A, McGhee C N J, Serdarevic O N, Mosby Elsevier, New
York, N.Y., 2009, pp 75-82, the disclosure of which is incorporated
herein by reference.
[0005] In specific situations, it is advantageous to compare two
different corneal topography examinations (or exams) on the same
eye from different test dates. This kind of testing may be referred
to as "difference mapping," and may identify very early topographic
change consistent with early keratoconus and/or unexpected corneal
topographic change after laser vision correction surgery. The
latter condition has been referred to as "post-LASIK ectasia" or
keratectasia. In order to generate a difference map, a provider
typically directs a technician to sit at the console of the corneal
topography device, select a patient to be studied, select the
"difference mapping" subroutine, highlight dates of studies from
which difference maps will be constructed, and generate the output
in a specific "difference map" format. An example of a difference
map is shown in FIG. 1, which illustrates output of a difference
map subsystem according to the prior art.
[0006] In the topographic difference map shown in FIG. 1, green
colors (the light areas in FIG. 1) map represent stable areas on a
corneal surface (e.g., little or no topographical change). In FIG.
1, warmer colors (yellow and red which are represented by the
"steeper" reference or legend in FIG. 1) on a difference map
represent areas of the cornea that became steeper (higher in
power), while cooler colors (blue and purple colors which are
represented by the "flatter" reference or legend in FIG. 1)
represent areas that became flatter (lower in power). Historically
with these prior corneal topography systems, it has typically not
been possible to create difference maps where topography studies on
two different exam dates were performed by different corneal
topography instruments. Therefore, even if other printouts such as
power maps are available, they can't be used to construct
difference maps as the underlying data files are not associated
with these types of output. In other words, the underlying data
files from the different corneal topography systems are not
compatible with each other and cannot be compared with one another
with commercially available software. A difference mapping process
compares corresponding datapoints and associated measurements of
the examined cornea from two selected studies on the different
dates and does not compare the power maps (e.g., images). The
datapoints are generated by analyzing the images captured by the
corneal topography instruments. FIG. 1 shows topographic maps
several months apart of a keratoconus patient. The images look
similar, but with the difference map (right most panel), areas that
become steeper and flatter are indicted by arrows or identifier.
These herald progression of the keratoconus disease, which alerts
the health care professional that treatment is needed.
[0007] FIG. 2 shows the corneal topography changes that occur after
a treatment for presbyopia. The left panel is a pre-treatment
examination, whittle the central panel is the corneal topography
after 1 month and the right most panel is the corneal topography
after 3 months. While the changes are subtle, difference maps
(lower panels) show the changes produced by the presbyopia
treatment are stable with time. The lighter regions in the fierce
maps indicate areas of higher induced power on the corneal
surface.
[0008] Difference mapping is also the best way to identify small,
early topographic change. It is significantly better than visually
comparing different corneal topography examinations separately, as
shown in FIG. 2. FIG. 2 illustrates output of a prior art
difference mapping system. In FIG. 2, there is a small increase in
corneal power between Exam A and Exam B taken one month apart
(B-A). In the third study, C, one month further on, the change
remains the same (C-A). This patient would be followed in
subsequent months to ensure a stable topography that does not lead
to ectasia and a reduction in vision. These examples show the
importance of difference mapping in early diagnosing of diseases
associated with small early topographic change.
[0009] The influence of therapeutic options including UV corneal
cross-linking ("CXL")--For decades, pathology states of the cornea
such as keratoconus could not be stabilized or reversed with any
therapy. During the period of roughly 1970 through about 2010,
keratoconus was one of the leading causes of need for corneal
transplant surgery worldwide. Patients with keratoconus required
specialized care, fitting with custom rigid gas permeable contact
lenses, and other measures before some ultimately required
transplant care. This created significant direct costs in medical
care, as well as indirect costs including lost educational
opportunity, lost work, reduced earning potential, affliction with
a sometimes visually disabling chronic condition, and often
psychological consequences.
[0010] In 1998, a treatment method called UV Corneal Cross-Linking
("CXL") was introduced (Spoerl E, Huhle M, Seiler T. Induction of
cross-links in corneal tissue. Exp. Eye Res. 1998 January;
66(1):97-103). This treatment involved application of a Riboflavin
solution to the cornea and then treatment with ultra-violet ("UV")
light. The photochemistry is nuanced, but the result is that
corneal collagen and the inter-collagen matrix could be
strengthened by this treatment. CXL has become commonplace in the
European union and many parts of the world; in 2017 a form of this
treatment received FDA approval for commercial use in the US.
[0011] The advent of CXL is now recognized as a vital step in
treating early keratoconus to prevent progression of disease, and
the potentially vision-threatening consequences thereof. The need
for corneal transplant care has dropped precipitously in the
population of keratoconus patients who have received CXL treatment.
The collateral consequences of lost educational opportunity, lost
work, reduced earning potential and other societal costs have also
dropped noticeably.
[0012] It is increasingly recognized that CXL represents a very
practical treatment strategy for KC, and possibly other corneal
conditions. Pioneers in this field recognize that to be maximally
effective, a strategy of early screening and early detection needs
to be put in place. The role of a small, cost-effective topography
system such as Delphi, that creates a global topography database,
may be important in expanding screening opportunities and, in
combination with cloud-based difference mapping, enabling early
disease detection. In essence, the advent of a new treatment
modality (CXL) stimulates the desire to have a broad-based
topography screening methodology in place that is cost effective,
simple, and easy to use.
INCORPORATION BY REFERENCE
[0013] All patents, applications, and publications referred to and
identified herein are hereby incorporated by reference in their
entirety, and shall be considered fully incorporated by reference
even though referred to elsewhere in the application.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The patent or application file will contain two drawings in
color (as well as black and white copies of the drawings. Copies of
this patent or patent application publication with color drawing(s)
will be provided by the Office upon request and payment of the
necessary fee.
[0015] A better understanding of the features, advantages and
principles of the present disclosure will be obtained by reference
to the following detailed description that sets forth illustrative
embodiments, and the accompanying drawings of which:
[0016] FIG. 1 illustrates output of a difference map subsystem
according to the prior art;
[0017] FIG. 2 illustrates output of a prior art difference mapping
system according to the prior art;
[0018] FIG. 3 illustrates a method of performing automatic
difference mapping of corneal topography examinations according to
some embodiments;
[0019] FIG. 4 illustrates a system including multiple corneal
topography devices communicating with a cloud-based server
computing device according to some embodiments;
[0020] FIG. 5A illustrates a flow chart for creating a patient
database according to some embodiments;
[0021] FIG. 5B illustrates a flow chart for creating a patient
database according to some embodiments; and
[0022] FIG. 5C illustrates a flow chart for creating a patient
database according to some embodiments.
DETAILED DESCRIPTION
[0023] The following detailed description and provides a better
understanding of the features and advantages of the inventions
described in the present disclosure in accordance with the
embodiments disclosed herein. Although the detailed description
includes many specific embodiments, these are provided by way of
example only and should not be construed as limiting the scope of
the inventions disclosed herein.
[0024] In some embodiments, the claimed subject matter may include
difference-mapping computer-readable instructions stored in one or
more memory devices. In some embodiments, the difference-mapping
computer-readable instructions may be loaded into one or more
volatile memory devices and may be executable by one or more
processors of server computing devices that are located on the
World Wide Web, the Internet or a global communications network.
These server devices may be referred to as cloud-based server
devices. In some embodiments, the difference mapping
computer-readable instructions executable by the one or more
processors on the cloud-based server devices may be referred to as
cloud-based difference mapping ("CBDM") software. In some
embodiments, a cloud-based difference mapping ("CBDM") system may
include the cloud-based server devices that are running or
executing the CBDM software.
[0025] As detailed above, the computing devices and systems
described and/or illustrated herein broadly represent any type or
form of computing device or system capable of executing
computer-readable instructions, such as those contained within the
modules described herein. In their most basic configuration, these
computing device(s) may each comprise at least one memory device
and at least one physical processor.
[0026] The CBDM system may further store patient corneal diagnostic
information, patient identification information and/or patient
corneal datafiles in a database installed or resident on the
cloud-based server devices. In other words, the CDBM system may
also include one or more databases stored on the cloud-based server
devices. These cloud-based server devices may be located in the
same location or in many different locations. In some embodiments,
medical providers may have accounts in the CBDM system where their
patient records are stored in local cloud-based server devices.
This database may be referred to as a provider corneal database or
a provider database. In addition, the CBDM system may also link
and/or associate with local databases in other cloud-based server
devices located within a specific geographic area (e.g., within
California, for example) to determine if other corneal topography
studies have been performed on the patient. These databases may be
referred to as local corneal databases or local databases. In some
embodiments, the CBDM system may also link and/or associate with
other databases in other cloud-based server devices within specific
countries in order to allow the CBDM software to search and see if
other corneal studies have been performed on the patient. In many
cases, national or regional governmental and/or privacy regulations
and/or considerations require patient information to be stored in
cloud-based server devices that are physically located within the
specific country and/or region. The linking and association of the
local database to other databases within the specific county or
region may be referred to as a national database. In addition, the
CBDM may also link and/or be associated with other databases in
cloud-based server devices throughout the world. The linking and
association of the local database to the other databases throughout
the world may be referred to as a global database. In other words,
the global database is stored in one or more cloud-based server
devices stored throughout the world.
[0027] The claimed subject matter and subject matter described
herein focuses on the automation of and significant improvement to
current corneal difference mapping. The CBDM system makes it
possible to automate and significantly improve the corneal
difference mapping process. In addition, the claimed subject matter
described herein reduces the potential number of examiner errors.
Further, it improves the process of notifying the examining
provider and the patient (or parent/legal guardian) of potential
corneal issues. In some embodiments, the CBDM software on the CBDM
system may automatically perform difference mapping on two corneal
topography studies if, for example, the examined patient has two
studies separated by some established or threshold time interval
(typically 6 to 12 months). Thus, in some embodiments, if there is
any even slight topographic change consistent with a condition of
concern, or a pathology state (e.g., a clinically relevant
topography change), the CBDM software may electronically notify the
medical provider (e.g., via email, text message, or other alerts).
In some embodiments, after alerting the medical provider, the CBDM
software may further notify the patient (or parent or legal
guardian) via email or text message to a mobile communication
device associated with this patient record.
[0028] An improved difference mapping process facilitates easier,
automatic and earlier detection of pathology states such as
keratoconus. This is significant to medical providers because
treatment methods exist to stabilize corneal collagen, including
corneal cross-linking ("CXL"), and an improved difference mapping
process makes it possible to identify candidate patients for
treatment sooner. Earlier detection and treatment can prevent many
of the adverse consequences of later diagnosis, including
significant topographic change with consequent optical degradation
of the cornea resulting in visual loss. Prior to the advent of CXL
therapy, keratoconus carried risk of significant lifestyle
disruption, with loss of educational opportunity (missed days in
school), lost work time, diminished earning potential, and need for
specialized tertiary care from corneal specialists. This typically
might include special testing, fitting with special contact lenses
(now scleral rigid gas-permeable or "scleral RGP" lenses, formerly
with hard plastic "PMMA" lenses) and occasionally might require
surgical intervention including corneal transplant care.
[0029] In some embodiments, the Delphi corneal topography system is
a small, portable corneal topographer that integrates a proprietary
Placido disc illumination system and Keplerian telescope imaging
optics with a dedicated smartphone or mobile communication device.
In some embodiments, computer-readable instructions executable by
one or more processors (e.g., a proprietary software application)
1) stores provider information, receives subject or patient
information; 2) facilitates image capture; 3) finds the ring edges
within the image; 4) constructs a data file of the ring edge
locations according to a specific protocol; 5) Derives various
types of corneal power maps for display on the mobile communication
device display screen; and/or 6) transmits or communicates
essential data including each unique "data file" and calibration
reference data to a cloud server via secure, encrypted,
HIPAA-compliant means; and 7) displays computer-generated
interpretations or analyses of the study. In some embodiments, the
Delphi corneal topography system may be offered to eye care
professionals for a nominal cost plus an affordable monthly
subscription fee, which is a unique pricing paradigm for essential
diagnostic equipment in the healthcare industry. This revenue model
may be attractive to eye care professionals globally, as it enables
them to incorporate industry-leading technology into their care
delivery processes without incurring significant upfront costs;
matching equipment/service expenses to their revenue streams.
[0030] It is anticipated that this mobile communication
device-based corneal topography system may facilitate the
following: 1) Expansion of topography access to eye care
professionals worldwide. Currently, commercially available
computer-based corneal topography instruments are often
prohibitively expensive for practitioners, particularly in smaller
offices in urban or rural locations, or less economically
privileged geographies worldwide. Providing high-quality systems at
very low cost enables significant improvement in availability of
diagnostic eye care for patients served by eye care professionals
globally. 2) Exam room convenience and improved patient
experience--The Delphi system (mobile communication device-based
corneal topography system) is designed to attach to a slit lamp
microscope, which is present in virtually every eye care
practitioner's office worldwide. This concept enhances patient
experience by minimizing their movement while allowing them to be
examined in a familiar environment with a non-intimidating
equipment that provides the examining physician rapid access to
precise diagnostic data. By comparison, legacy topography devices
are much larger, affixed to dedicated personal computers, and are
mounted on motorized power tables that occupy a significant enough
footprint. In offices that do have room to accommodate these larger
systems, patients typically are first taken through separate
testing rooms where these devices and others are located and are
then taken into traditional exam rooms or "lanes" where the basic
eye examination is performed. By making the device very small,
smartphone (or mobile communication device)-based, and portable,
the workflow is enhanced for the provider. 3. Cloud storage,
telemedicine, and aggregate data analysis opportunity--In some
embodiments, a cloud portal will allow provider access to studies
of their patients which are retained in (HIPAA- and GDPR-compliant)
cloud-based servers or remote computing devices. In some
embodiments, medical providers may access their cloud data through
login with unique account userID and password. In these
embodiments, Delphi's cloud-based architecture may permit easy data
access and sharing with eye care professionals (from any tablet,
laptop or desktop computing device) who have account access. This
access feature permits numerous telemedicine applications, allowing
experts anywhere in the world the opportunity to review test data,
enabling them to assist in the diagnostic process, or conduct
research.
[0031] In U.S. patent application Ser. No. 16/447,642, filed Jun.
20, 2019, entitled "Use of Near Field Communications Technology to
Transfer Patient-Related Data to Diagnostic Medical Equipment in a
Medical Office or Other Healthcare Facility", a system and method
for transmitting certain patient identifier information using
near-field communications protocol and associated chipsets ("NFC")
is detailed and/or described. In some embodiments, a patient may be
invited to download a software application ("app") to their own
smartphone (or mobile communication device), accept an end-user
license agreement ("EULA") and then use the app for a variety of
functions related to their eye care professional's office. In some
embodiments, these functions included in the software app includes
providing an office address, providing contact info, providing
driving directions, providing appointment reminders and/or
scheduling, detailing aftercare instructions and providing other
medical-related information for the patient. In some embodiments, a
module or portion of the software app may allow the patient to
enter personal info to be conveyed to a diagnostic device such as
the NFC-enabled Delphi mobile communication device-based corneal
topography system. In some embodiments, by having the software
application include contact information such as email address and
mobile phone number, the software app may meet and/or address GDPR
requirements that require any provider of cloud storage that stores
personal info to have a system in place allowing any client (or
patient) to request removal of information, or redaction of
personal info from data collected.
[0032] Corneal topography systems evaluating the anterior surface
of the cornea (e.g., like a Placido-reflectance system) generate
data files including parameters or measurements of ring edge
locations which represent these locations in polar coordinates
through 360 degrees of arc, typically in 1 degree increments for
all of the reflected Placido ring edges that can be identified in
the captured rings image. Values for corneal power (axial,
refractive, and tangential) and elevation are calculated by
processor or processors within the Delphi unit and/or the mobile
communication device for each found ring edge location and stored
in the relevant data file for that examination. The data files also
include calibration reference information and measurements along
with patient diagnostic information. This patient diagnostic
information includes right or left eye identifier data, exam time
and date data, a topographer device identifier, a clinic and/or
provider identifier, and exam alignment and quality data. This is
not the patient identifier data which will be utilized by the CBDM
software to locate prior patient corneal studies (which will be
discussed below).
[0033] Corneal tomography systems evaluating the posterior surface
and/or the anterior surface of the cornea acquire or generate
elevation coordinates at multiple points on the corneal surface
which are compared to points on a computer-generated best fit
spherical or toroidal surface. In some embodiments, some devices
utilize corneal tomography for the acquisition of spatial
coordinates of multiple points from both the anterior and posterior
corneal surfaces. In some embodiments, a device may utilize corneal
topography to generate curvature coordinates on the anterior
corneal surface and may utilize corneal tomography to generate
elevation coordinates at multiple points on the posterior corneal
surface.
[0034] In some embodiments, the cloud storage (e.g., the
cloud-based server devices) of the CBDM system may create an
opportunity to amass a large global topography database including
patients from all over the world, with attendant research and
data-mining opportunities, as discussed above and below. In these
embodiments, these features may be compelling, both from a
statistical analysis standpoint (being able to identify local,
regional and possibly ethnic differences in pathology prevalence,
hence risk) and from a "big data" perspective.
[0035] In some embodiments, a corneal topography system may have
certain patient identifier information associated with each study.
In some embodiments, this may, at a minimum, include a patient
first name, a patient last name, and a date of birth, as well as a
GPS location (or other geographic indicator) of the study. In
addition, other patient identifier information may include a
provider's EHR account number, contract information for the medical
provider, and/or contact info for the patient including email
address and/or mobile phone number. In some embodiments, other
patient identifier information may include biometric information of
the patient, e.g., fingerprints, voice files, facial feature data,
and/or retinal scans. Any of the identifier information described
above may be utilized alone and/or in combination with other
identifier information in order to come up with a unique patient
identifier (or unique ID). This unique ID may be utilized to
determine if prior existing corneal studies exist for the patient
in the databases of the CBDM system. Misspelling of patient names
remains an issue in any storage of patient data which hinders
searching for patients in any global database. Developing a unique
ID for the patient helps address and alleviate this issue. Please
note that the unique patient ID should not include any patient
diagnostic or examination data.
[0036] In other words, the unique patient ID may allow the
envisioned system to identify the same patient even if the patient
has been studied at offices of two or more different (unrelated)
provider offices, and/or has moved to a different geographic
location (even if that different location is in another country).
For example, if a patient has been studied at two different
provider offices with the corneal topography system and data files
have been stored in a database of the CBDM system, the CBDM
software may search for the patient's identifier in one of the
databases (e.g., the local database, the national database and/or
the global database) and if a match is found with one or more of
the patient's identifier, the CBDM software may be initiated and a
difference map between the previous study and the most recent study
may be performed and/or completed. In some embodiments, the CBDM
software may communicate and/or alert the patient's computing
device and/or the provider's (e.g., the most recent eye exam
provider) computing device if necessary (e.g., if a clinically
significant topographic change has been identified by the
difference mapping process). In some embodiments, the CBDM software
may allow and/or provide a global early-detection system that is
larger than any provider office, network, or health-care
system.
[0037] FIG. 3 illustrates a method of performing automatic
difference mapping of corneal topography examinations according to
some embodiments. A person of ordinary skill in the art will
recognize that any process or method disclosed herein can be
modified in many ways. The process parameters and sequence of the
steps described and/or illustrated herein are given by way of
example only and can be varied as desired. For example, while the
steps illustrated and/or described herein may be shown or discussed
in a particular order, these steps do not necessarily need to be
performed in the order illustrated or discussed. The various
exemplary methods described and/or illustrated herein may also omit
one or more of the steps described or illustrated herein or
comprise additional steps in addition to those disclosed. Further,
a step of any method as disclosed herein can be combined with any
one or more steps of any other method as disclosed herein. The
steps of the process listed below may be performed by the CBDM
software.
[0038] In some embodiments, in step 310, a patient may authorize or
facilitate collection of limited personal information to be used in
association with storage of topography data files and/or corneal
images in a database in the CBDM system. In some embodiments, a
patient may have provided this authorization when downloading
and/or operating a dedicated software application (e.g., by
accepting an end user license agreement or EULA as described
above).
[0039] In some embodiments, in step 315, a patient may have a
corneal examination performed by a corneal topography system (e.g.,
a Delphi mobile communication device-based corneal topography
system). In some embodiments, the corneal topography system may
communicate one or more corneal topography data files and/or one or
more corneal images. In some embodiments, the one or more
topography data files may include reference data or measurements.
In some embodiments, the one or more topography data files may also
include time measurements (e.g., timestamps) to identify when the
study was completed by the corneal topography system. In some
embodiments, the data files and/or corneal images may be
communicated for each eye of the patient. In some embodiments, the
data files and/or corneal images for each eye may be communicated
at the same time or at different times. In some embodiments, the
topography data files and the corneal images may be transmitted at
different times.
[0040] In some embodiments, in step 320, the CBDM software may
automatically compare patient identification parameters in the
received one or more topography data files to existing patient
identification parameters stored in a database in the cloud-based
server computing device to confirm and/or find that the patient has
existing topography datafiles and/or associated studies in the
database. In some embodiments, the CBDM software may first look in
a provider database of the CDBM system. In some embodiments, the
CBDM software may also look in a local database of the CDBM system.
In some embodiments, the CBDM software may further look in a
national database of the CDBM system. In some embodiments, in
addition, the CBDM software may further look in the global database
of the CDBM system. In some embodiments, the patient identification
parameters may be a patient name, a numerical identifier, whether
the data file is for a right eye or a left eye, a patient email
address, and/or other identification parameters. In some
embodiments, this just verifies that there is an existing datafile
for the correct eye of the patient that is being examined. The
examiner is not involved in making any of these determinations
because the difference mapping software application may be
programmed to automatically perform this confirmation and/or
finding step. Thus, the use of the CBDM software application may
eliminate any human or operator errors that may occur if different
patient's studies were improperly selected and/or compared during
the difference mapping process. This is a significant benefit of
the CBDM application. In some embodiments, the CBDM software may be
programmed to communicate with the cornea topography system if
there are not existing topography data files for either eye or both
eyes of the patient. Please note that the CBDM software being
programmed or programmed to perform certain actions means that no
operator or technician intervention is needed in order to perform
these specific actions. In other words, the software executes this
step (or steps) on its own after being initiated or initialized.
The software also allows additional steps to be performed.
[0041] In some embodiments, in step 325, the CBDM software may be
programmed to retrieve the patient's one or more most recent
topography data files. In some embodiments, this may occur after
CBDM software determines that the patient has existing studies in
the database of the CBDM system. In some embodiments, this
retrieved topography data file may be the data file to which the
received current topography datafile will be compared.
[0042] In some embodiments, the CBDM software may be programmed to
confirm that the topography data file being retrieved is for the
correct eye. Again, the confirmation and/or the retrieval are
initiated by the CBDM software and do not require any examiner or
patient intervention. This also provides the advantage of
eliminating operator error in retrieving the wrong topography data
file by an operator selecting the wrong date (e.g., not the most
recent topography data file for the patient), the wrong patient
and/or in selecting the data file for the wrong eye.
[0043] In some embodiments, in step 330, the CBDM software may be
programmed to perform difference mapping. In some embodiments, the
received one or more topography data files (from the corneal
topography device) may be automatically compared to the retrieved
next most recent topography data file from one of the databases of
the CBDM system. In some embodiments, the CBDM software may
generate a difference map data file and/or a topography difference
map image. In some embodiments, the CBDM software program may be
programmed to be executed or performed for both eyes and their
corresponding received topography data files (which are compared to
the most recent study's topography data files for both eyes
retrieved from the database of the CBDM system).
[0044] In some embodiments, an additional step may involve the CBDM
software may be programmed to determine when the last topography
examination of the patient was completed and then performing
difference mapping against the last (or next most recent)
topography data file if a date threshold has been met. In some
embodiments, if the current date is Aug. 23 2019, the most recent
topography data file had a timestamp of Sep. 23 2018, and the date
threshold is 10 months from last examination in order to perform
difference mapping, then the CBDM software may proceed with
performing the automatic difference mapping. In some embodiments,
the CBDM software may be programmed to include an option to display
a list of all exams for a significant patient, so that a provider
may select the exams to compare. For example, this may be helpful
when repeat exams are performed in the same session owing to a
technician or operator being challenged in obtaining a really good
exam.
[0045] In some embodiments, the CBDM software may be programmed to
generate a topography difference map data file and/or a topography
difference map image. In some embodiments, the CBDM software may
store the generated difference map data file and/or difference map
image in the database (e.g., the provider database or a local
database) in the CBDM system. In some embodiments, in step 335, the
CBDM software may be programmed to communicate the generated
difference map file and/or difference map image to a provider's
mobile communication device (or a provider computing device). In
some embodiments, there may be more than one difference map data
files and/or difference map images communicated to the provider's
mobile communication device. In some embodiments, difference map
data file(s) and/or difference map image(s) may be communicated for
each of the patient's eyes (e.g., the left eye and the right
eye).
[0046] In some embodiments, in step 340, the CBDM software may be
programmed to analyze the results of the difference mapping and
determine that some clinically relevant topography change has
occurred in the timeframe between the current examination and the
most recent examination. In some embodiments, if a clinically
relevant topography change has occurred, the CDBM software may
automatically generate a message to notify the medical provider
(e.g., via email, SMS text or other alerts to the medical provider
computing device) of the clinically relevant topography change. In
some embodiments, the CBDM software may automatically generate a
message to notify the patient (e.g., via email, SMS text or other
alerts to the patient computing device) of the clinically relevant
topography change and may suggest a need for follow-up eye care. In
some embodiments, the CBDM software may not communicate a message
to the patient computing device unless the provider and/or patient
has authorized that the message may be sent.
[0047] The above-identified process and/or method may be utilized
for performing difference mapping for corneal topography systems
that utilize an anterior corneal imaging device (e.g., a Delphi
mobile communication device-based corneal topography system which
utilizes reflectance Placido imaging), or a dual-surface corneal
examination device (which evaluates and images both the anterior
and posterior surface of the cornea). The data in the one or more
data files of any of these corneal topography and/or tomography
examination systems is a mathematical description of the examined
patient's anterior corneal surface if a Placido-type reflectance
system, and of both the anterior and posterior corneal surface if
both are imaged by the corneal examination system. In some
embodiments, each of the corneal imaging systems generate the
associated corneal data for a left eye, a right eye and/or both
eyes. Accordingly, corneal tomography datafiles may be compared by
the CBDM system.
[0048] In some embodiments, the utilization of the regional,
national and/or global databases in the CBDM system may provide
additional advantages. For example, the CBDM system may identify
patients that have changed eye care providers or moved to a new
location and may perform difference mapping automatically in order
to recognize potentially progressive eye conditions that appear to
be worsening. In some embodiments, for example, if the CBDM
software identifies that the current eye care professional does not
have a previous eye study for the patient being examined (e.g. by
checking the provider database), the CBDM software may
automatically query a provider database, a local database, a
national database, and/or a global database of topography data
files generated by other corneal topography systems (having a
compatible corneal topography software application as the corneal
topography software application that generated the original patient
study) in order to identify one or more existing topography data
files for the patient. In some embodiments, the CBDM software then
retrieve and utilize a most recent topography data file for the
patient and automatically perform the difference mapping described
above by comparing the received topography data file from the
current examination and comparing it to the most recent topography
data file retrieved from the provider database, local database,
national database or global database.
[0049] In some embodiments, the CBDM software on the CBDM system
may also evaluate whether a clinically relevant topographic change
has occurred. In some embodiments, the CBDM software may also
communicate a message via email or text message to the Provider's
mobile communication device, or by posing a message in the
Provider's cloud account portal to alert the medical provider that
a prior topography data file exists, and that a clinically relevant
topography change has occurred. In some embodiments, after first
contacting or attempting to contact the provider, the CBDM software
may also communicate a message to a patient's mobile communication
device to alert the patient that a prior study was completed and
that the difference mapping has identified possible clinically
relevant topography change for which professional evaluation is
advised. In some embodiments, the communication of the message to
the patient may also occur via email, via text and/or any
communication method the patient had originally provided when
downloading the application to their mobile communication device
allowing near-field communication conveyance of their personal
identification information, accepting the End User License
Agreement before first use, and thus giving the consent to the
cloud server to store their personal information, contact
information and/or corneal topography data files and/or images.
[0050] FIG. 4 illustrates a system including multiple corneal
topography devices communicating with the CBDM system according to
some embodiments. In some embodiments, the CBDM system may comprise
a first mobile communication device-based corneal topography system
405, a second mobile communication device-based corneal topography
system 410 and/or one or more cloud-based server devices 415. In
some embodiments, the one or more cloud-based server computing
devices 415 may comprise one or more processors 420, one or more
non-volatile memory devices 422, one or more volatile memory
devices 423, the CBDM software 424 and/or one or more databases
460, 461 462, and/or 463. In some embodiments, the CBDM system may
also comprise a provider computing device 450 and/or a patient
computing device 455. In some embodiments, the first mobile
communication device-based corneal topography system 405 and/or the
second mobile communication device-based corneal topography system
410 may have operators perform corneal topography studies on
patients. In some embodiments, either of the mobile communication
device-based corneal topography systems may then communicate and/or
transmit the generated one or more topography data files and/or
associated images to the cloud-based server device 415. In some
embodiments, the CBDM software 424 may be stored in one or more
non-volatile memory devices 422. In some embodiments, the CBDM
software may be loaded into the one or more volatile memory devices
423 and executed by the one or more processors 420. In some
embodiments, the CBDM software 424 may communicate with the
provider database 460, the local database 461, the national
database 462 and/or the global database 463 to determine if the
patient has had prior corneal examination studies performed. In
some embodiments, if the CBDM software determines that a prior
study exists, the CBDM software may communicate with the identified
database (either 460, 461, 462 and/or 463) in order to retrieve the
prior topography data files in order to perform difference mapping.
In some embodiments, after the CBDM software 424 automatically
performs difference mapping, the CBDM software 424 may communicate
with the provider database 460 to store difference mapping
topography data files and/or difference mapping images. In some
embodiments, the CBDM software may communicate or transmit the
generated difference mapping topography data files and/or
difference mapping images to the provider computing device 450 for
viewing and/or analysis by the medical provider. In some
embodiments, the CBDM software 424 may also automatically determine
if a clinically significant topographic change has occurred. If the
CBDM software 424 makes this determination, the CBDM system may
communicate a message to the provider computing device 450
identifying that a clinically significant topographic change has
occurred and follow-up with the patient may be recommended. In some
embodiments, the CBDM system may communicate a message to the
patient computing device 455 to identify that a clinically
significant topographic change has occurred, and that follow-up
medical care may be recommended. (This is the end of the first
provisional patent application).
[0051] FIGS. 5A, 5B and 5C illustrate a flow chart for creating a
patient database according to some embodiments. A person of
ordinary skill in the art will recognize that any process or method
disclosed herein can be modified in many ways. The process
parameters and sequence of the steps described and/or illustrated
herein are given by way of example only and can be varied as
desired. For example, while the steps illustrated and/or described
herein may be shown or discussed in a particular order, these steps
do not necessarily need to be performed in the order illustrated or
discussed. The various exemplary methods described and/or
illustrated herein may also omit one or more of the steps described
or illustrated herein or comprise additional steps in addition to
those disclosed. Further, a step of any method as disclosed herein
can be combined with any one or more steps of any other method as
disclosed herein.
[0052] In some embodiments, in step 502, a user may review and
accept an end-user license agreement (EULA) for a medical provider
software application. In some embodiments, the EULA may identify
that the medical provider stores personal data of the user in the
patient database and also stores user medical examination
diagnostic data and images in the patient database. In some
embodiments, in step 504, the user may download the medical
provider software application to a user's mobile communication
device, where the medical provider software application includes a
personal data transfer software application. In some embodiments,
the software application may receive a user's personal data and may
store the user's personal data in a personal data transfer software
application. In some embodiments, the user's personal data may
include one or more of a user's first name, a user's surname, a
user's cell phone number, a user's physical address, a user's email
address, a contact method preference, and/or a user's date of
birth. In some embodiments, the user's personal data may include
user geolocation data and/or one or more of ethnic status, national
origin, or gender data.
[0053] In some embodiments, in step 506, the user may initiate the
personal data transfer software application on the user's mobile
communication device. This may be initiated by selecting a button
or icon and/or voice activation. In some embodiments, in step 508,
a user may place the user's mobile communication device in
proximity to a near field communication (NFC) transceiver on the
medical diagnostic device. In some embodiments, the user may place
the NFC transceiver in the user's mobile communication device over
and/or next to the NFC transceiver in the medical diagnostic
device. Specifically, in a mobile communication device-based
corneal topography system, the NFC transceivers in the two mobile
communications devices (the user's and the corneal topography
system's) may need to be in close proximity in order for the data
transfer to occur.
[0054] In some embodiments, in step 510, the software application,
in response to user input to the user's mobile communication
device, may initiate the personal data transfer software
application to authorize transfer of the user's personal data to
the medical diagnostic device. In some embodiments, in step 512,
the software application may transfer the user's personal data to
the medical diagnostic device. In some embodiments, in step 514,
the software on the medical diagnostic device may receive the
user's personal data transferred via the transfer software
application and may display the user personal data on a screen of
the mobile communication device so that the user may see the
received data. In some embodiments, other computing devices may be
utilized or the medical diagnostic device may have a computing
device included and/or integrated therein and those displays may be
utilized to display the user's personal data on a screen.
[0055] In some embodiments, in step 516, the software application
may validate that the owner of the mobile communication device is
the user transferring the user's personal data to the medical
diagnostic device by communicating with an identification
verification system in the mobile communication device. In some
embodiments, the identification verification system may be FaceID,
Touch ID or another biometric identification/validation system. In
some embodiments, in step 518, the software application may verify
that the copy of the user personal data is correct. In some
embodiments, in step 520, a medical diagnostic procedure may be
performed on the user.
[0056] In some embodiments, in step 522, the medical diagnostic
device may generate (or the software application installed thereon)
one or more medical diagnostic image files and/or one or more
medical diagnostic data files. In some embodiments, in step 524,
the user personal data files may be encrypted at the medical
diagnostic device (or computing device utilized therewith). In some
embodiments, in step 526, the medical diagnostic device (or
computing device utilized therewith) may transfer the encrypted
user personal data to a cloud-based server device. In some
embodiments, the user personal data may not need to be encrypted
but that may create a security risk. In some embodiments, in step
528, the medical diagnostic device (or computing device utilized
therewith) may transfer the one or more medical diagnostic images
files and/or the one or more medical diagnostic datafiles to the
cloud-based server device. In some embodiments, this transmission
of personal data, one or more medical diagnostic data files, and/or
one or more medical diagnostic images files may be secure,
encrypted and protected from outside third parties. In some cases,
the transmission may be performed according to HIPAA guidelines. In
some embodiments, in step 530, the software (or the cloud-based
server device) may store the encrypted user personal data, the one
or more medical diagnostic image files and/or the one or more
medical diagnostic datafiles in a patient database of the
cloud-based server device.
[0057] In some embodiments, in step 532, the user or patient may go
to a new medical diagnostic device in the same facility as the
medical diagnostic device and some of steps 502 to 530 may be
performed at the new medical diagnostic device. This allows
multiple medical diagnostic machines to be utilized with one
patient during many visits. In some embodiments, the new medical
diagnostic device may be within 200 feet of the first or original
medical diagnostic device.
[0058] In some embodiments, in step 534, a new patient may come
into the medical office and steps 502 to 532 may be performed in
order to accumulate records in the cloud-based patient database. In
some embodiments, the cloud-based patient database may be HIPAA
compliant for some or all of the data and/or images stored
therein.
[0059] In some embodiments, in step 536, computer-readable
instructions that are executable by one or more processors of the
cloud-based server device may perform analytics utilizing the
patient personal data, the received patient medical diagnostic data
files and/or the received patient medical diagnostic image files
data and in some embodiments, may analyze the received patient
medical diagnostic data files and/or patient medical diagnostic
image files based on patient ethnic status, gender, or national
origin. In some embodiments, the data may be analyzed according to
other factors.
[0060] The patient and image data collected may be for a variety of
medical diagnostic procedures and stored in one or more memory
devices of the cloud-based server device. In some embodiments, the
medical diagnostic device may be a corneal topography device, the
one or more medical diagnostic image files may be corneal
topography image files, and the one or more medical diagnostic
datafiles may be corneal topography datafiles. In some embodiments,
computer-readable instructions are executable by one or more
processors of the cloud-based server device (the CBDM software) may
perform difference mapping on the received corneal topography
datafiles and a previous corneal topography datafile stored in the
database. In some embodiments, the medical diagnostic device may be
a corneal tomography device, the one or more medical diagnostic
image files may be corneal tomography image files, and the one or
more medical diagnostic datafiles may be corneal tomography
datafiles. In some embodiments, computer-readable instructions are
executable by one or more processors of the cloud-based server
device (the CBDM software) may perform difference mapping on the
received corneal tomography datafiles and a previous corneal
tomography datafile stored in the database.
[0061] In some embodiments, the medical diagnostic device may be an
autorefractor, the one or more medical diagnostic images files may
include autorefractor image files and the one or more medical
diagnostic datafiles may include corneal autorefractor data files.
In some embodiments, computer-readable instructions may be
executable by one or more processors of the cloud-based server
device (the CBDM software) may perform difference mapping on the
received autorefractor data files and a previous autorefractor data
file stored in the database and retrieved therefrom.
[0062] In some embodiments, the medical diagnostic device may
include wavefront sensors, the one or more medical diagnostic image
files may include wavefront image files and the one or more medical
diagnostic datafiles may include wavefront data files. In some
embodiments, computer-readable instructions may be executable by
one or more processors of the cloud-based server device (the CBDM
software) may perform difference mapping on the received wave front
sensor data files and a previous wavefront sensor data file stored
in the database.
[0063] In some embodiments, the medical diagnostic device may
include a fundus camera, the one or more medical diagnostic image
files may include fundus image files and the one or more medical
diagnostic datafiles may include fundus data files. In some
embodiments, computer-readable instructions may be executable by
one or more processors of the cloud-based server device (the CBDM
software) may perform difference mapping on the received fundus
data files and a previous fundus data file stored in the
database.
[0064] In some embodiments, the medical diagnostic device may
capture video of the user's cornea, the one or more medical
diagnostic images files may be corneal video files and the one or
more medical diagnostic data files may be corneal datafiles. In
some embodiments, computer-readable instructions may be executable
by one or more processors of the cloud-based server device (the
CBDM software) may perform tear film break up time analysis by
analyzing the received video of the user's cornea.
[0065] In some embodiments, the medical diagnostic device may
capture images of a user's cornea and may generate corneal data
files, may communicate the corneal images and the corneal data
files to a database server. In some embodiments, the
computer-readable instructions may be executable by one or more
processors of the database server to perform ocular surface
analysis based at least in part of the received corneal images
and/or the corneal data files.
[0066] In some embodiments, a method to perform automatic corneal
topography or tomography difference mapping may include
computer-readable instructions stored in one or more memory devices
of one or more cloud-based server devices. In some embodiments, the
one or more processors in the one or more cloud-based server
devices may be configured with the computer-readable instructions
to receive one or more corneal topography or tomography data files
and/or a corneal image for an examined patient from a corneal
topography or tomography system; receive personal identification
parameters from captured user personal data communicated from the
corneal topography or tomography system; compare received patient
identification parameters to existing patient identification
parameters in a database to identify if there are existing
topography or tomography data files for a same patient in the
database; retrieve a prior topography or tomography data file for
the patient from the database; and perform difference mapping by
comparing the received topography or tomography data files to the
prior topography or tomography data file retrieved from the
database to generate a topography or tomography difference map. In
some embodiments, the one or more processors in the one or more
cloud-based server devices may be configured with the
computer-readable instructions to: store the topography or
tomography difference map in the database and associate the
topography or tomography difference map with the user. In some
embodiments, the one or more processors in the one or more
cloud-based server devices may be configured with the
computer-readable instructions to analyze the topography or
tomography difference map to identify if a significant
topographical change has occurred. In some embodiments, if the
significant topographical change has occurred, the software may
communicate the topography difference map and/or an advisory
message associated with the topography or tomography difference map
to a provider computing device for display to the provider. In some
embodiments, the one or more processors in the one or more
cloud-based server devices may be configured with the
computer-readable instructions to analyze the generated topography
or tomography difference map to identify if a significant
topographical change has occurred. In some embodiments, if the
significant topographical change has occurred, the one or more
processors in the one or more cloud-based server devices may be
configured with the computer-readable instructions to communicate
an email or electronic message to a provider computing device. In
some embodiments, the email or electronic message may include a
link to the generated topography or tomography difference map
stored in the database.
[0067] In some embodiments, the significant topographical change
may be a change of 0.25 Diopters from the prior topography or
tomography data file, and optionally may be within a change in the
range of 0.20 to 0.30 Diopters from the prior topography or
tomography data file. In some embodiments, the significant
topographical change optionally may be within a change in the range
of 0.10 to 0.40 Diopters from the prior topography or tomography
data file. In some embodiments, the significant topographical
change may be a change of 0.50 Diopters from the prior topography
or tomography data file, or optionally may be within a change in
the range of 0.40 to 0.60 Diopters from the prior topography or
tomography data file. In some embodiments, the significant
topographical change may optionally be within a change in the range
of 0.25 to 0.75 Diopters from the prior topography or tomography
data file. In some embodiments, the significant topographical
change may be associated with early keratoconus, form frust
keratoconus, changes in shape of cornea relating to Lasik,
stability loss after refractive surgery, or eye rubbing in
combination with a thin cornea.
[0068] In some embodiments, the one or more processors in the
cloud-based server devices may be further configured with
instructions to determine that the performing of the difference
mapping is being completed on a correct eye of the patient by
checking the personal information parameters that are associated
with the datafiles. In some embodiments, the one or more processors
in the cloud-based server devices further may be configured with
instructions to compare current date of examination to prior date
of examination for patient's existing topography or tomography data
files to confirm a correct timeframe has elapsed to perform
difference mapping. In some embodiments, the personal
identification parameters may include a phone number, a first name
and last name of patient, a date of birth and an email address of
patient, and matching of any one of the personal identification
parameters confirms a patient's record exists in the database.
[0069] In some embodiments, the one or more processors in the
cloud-based server devices may further be configured with
instructions to receive a patient thumbnail image communicated from
the corneal topography or tomography system and compare the
received patient thumbnail image to existing patient thumbnail
images in a database to identify if there are existing topography
or tomography data files for a same patient in the database. In
some embodiments, the one or more processors in the cloud-based
server devices may further be configured with instructions to
receive a patient conjunctival capillary vessel architecture image
communicated from the corneal topography or tomography system and
may compare the received patient conjunctival capillary vessel
architecture image to existing patient conjunctival capillary
vessel architecture image in a database to identify if there are
existing topography or tomography data files for a same patient in
the database.
[0070] In some embodiments, a method to perform automatic corneal
topography difference mapping may include computer-readable
instructions stored in one or more memory devices of one or more
cloud-based server devices. In some embodiments, the one or more
processors in the one or more cloud-based server devices may be
configured with the computer-readable instructions to: a) receive
one or more corneal topography or tomography data files and/or a
corneal image for an examined patient from a corneal topography or
tomography system; b) may receive personal identification
parameters from captured user personal data communicated from the
corneal topography or tomography system and c) may compare received
patient identification parameters to existing patient
identification parameters in a database to identify if there are
existing topography or tomography data files for a same patient in
the database. In some embodiments, if there are no existing
topography or tomography data files for the same patient in the
database, the one or more processors in the one or more cloud-based
server devices may be configured with computer-readable
instructions to query a provider database, a regional database, a
national database, a multi-nation database, and/or other foreign
nation databases to determine if any of the databases include
personal identification parameters matching the received personal
identification parameters. In some embodiments, the one or more
processors in the one or more cloud-based server devices may be
configured with computer-readable instructions to communicate a
message to a provider computing device requesting the provider to
verify that the located personal identification parameters
correspond to the patient being examined if the received personal
identification parameters match personal identification parameters
in the provider database, the regional database, the national
database, the multi-nation database and/or the other foreign nation
databases. In some embodiments, the one or more processors in the
one or more cloud-based server devices may be further configured
with computer-readable instructions to retrieve a prior data file
for the patient from the database where the match was found for the
received personal identification parameters; and perform difference
mapping by comparing the received topography or tomography data
files to the prior topography data file retrieved from the database
where the match was found to generate a topography or tomography
difference map. In some embodiments, the end-user license agreement
(EULA) may authorize the medical provider or the database provider
to transfer patient personal identification parameters and/or
retrieved patient topography datafiles to the database provider if
the patient has moved from one jurisdiction to another. In some
embodiments, the EULA may authorize the database provider to
directly contact the patient.
[0071] In some embodiments, an external validation process may
verify that the person providing the personal data via near-field
communication (NFC) is the mobile communication device that
actually stores the personal data. Accordingly, before the personal
data is transferred to the medical diagnostic device, the NFC
transfer software application make an external communication or
call to an identification (ID) verification system or subsystem
already resident on the mobile communication device to verify
and/or validate it is owner who is attempting to transfer the
personal data stored in the phone. In some embodiments, after the
ID verification system performs the verification, the PHI transfer
application communicates the personal information via the NFC
transceivers to the medical diagnostic device. In some
implementations, such as with Apple mobile communication devices,
the ID verification system may be either the Touch ID verification
system or the Face ID verification system. In other mobile
communication devices, other biometric ID verification systems may
be utilized. In other mobile communication devices, other owner ID
verification systems may be utilized that utilizes challenge words
and/or user specific test questions.
[0072] First, in association with transfer of personal information
by NFC, it may make sense to externally validate that the person
sending is in fact the owner of the phone that is storing the
information. Apple does this with Touch ID and Face ID and other
phone manufacturers have similar systems. In some embodiments, the
NFC app make an external call to an ID verification system already
available on the phone that uses touch ID, Face ID, or similar
owner identification before sending identifying information via NFC
channels.
[0073] In some embodiments, it may be beneficial to provide a
thumbnail image of the patient to the Examiner and/or the
cloud-based difference mapping system to verify that a same subject
is being examined by the testing apparatus. In some embodiments,
the thumbnail patient image may be associated with the topography
rings image. In some embodiments, a topography system or a mobile
communication device-based topography system may capture and image
of the patient's face as the patient is approaching the topography
system. In some embodiments, the topography system may create a
thumbnail patient image from the captured image. In some
embodiments, the patient thumbnail image may be linked with the
topography rings image and/or topography data files. In some
embodiments, the patient thumbnail image may be communicated to the
cloud-based server computing device. In some embodiments, an
imaging device may be positioned within, located on, or partially
enclosed on a side of the topography system that is facing the
patient (e.g., by the eye cup and/or proximity sensors).
[0074] In some embodiments, the patient thumbnail image may be
stored in a memory device of the cloud server computing device. In
some embodiments, the difference mapping software executing on the
cloud server computing device may compare the captured patient
thumbnail image with a previously stored patient thumbnail image in
order to verify that it is the same patient whose topographic data
files are being compared. In other words, the patient thumbnail
images from different dates may be compared against each other. In
some embodiments, the Examiner may also view the patient thumbnail
images in order to verify that the same patient is being examined
and topographic image compared.
[0075] In some embodiments, the cloud-based server computing device
may determine that the patient thumbnail images taken on different
dates are not the same or are not consistent (e.g., it is
potentially not the same individual), If the cloud-based server
computing device determines that there is a discrepancy in the
patient thumbnail image, the cloud-base server computing device may
send an error message to the medical provider and/or may not
perform difference mapping on the topography data files.
[0076] Second, there is probably some value to having a thumbnail
photo of a subject's face associated with the topography rings
image. In principle, this can be done by having one of the
forward-facing cameras grab a facial image as the subject is
approaching the front of the Delphi unit. Storage of thumbnail
images in association with Placido reflectance rings images would
enable an examiner (or possibly a cloud server system) to
externally validate and confirm that the same subject is in front
of the testing apparatus for topography study on a variety of
different dates. Conversely, the system for topography study on a
variety of different dates. Conversely, the system might identify
the condition where in the face of the subject is not consistent
between studies on different dates and this might send an error
flag. Performance of corneal topography difference mapping in the
cloud might potentially not be allowed if this condition is
identified.
[0077] In some embodiments, an additional method for verifying that
the same subject eye is being examined as the prior studies in the
database may be the comparing of a patient's eye conjunctival
capillary vessel architecture with the conjunctival capillary
vessel architecture for studies stored in the patient database.
This may be more accurate than utilizing a thumbnail image for
comparison because the appearance of the anterior conjunctival
vessels is consistent over decades (unless a patient has received
surgical care rendered for pterygium or other conditions). Thus, a
conjunctival capillary vessel architecture verification system
could be utilized to verify that the two studies are being
performed on the same eye of the same patient. A system that could
capture the capillary vessel "map", that would allow comparison
between studies taken on different dates, and would establish a
separate verification and validation scheme that the same eye is
being studied. This would be relevant since we anticipate
performing difference mapping between two studies of the same eye
of an individual subject on different dates.
[0078] In some embodiments, an imaging device in the corneal
topography system may capture a conjunctival capillary vessel
architecture image for the patient. In some embodiments, the
corneal topography system may communicate the conjunctival
capillary vessel architecture image with the topography datafiles
and/or topography images to the cloud-based server computing
device. In some embodiments, before difference mapping was
performed between the topography datafile(s) received from the
corneal topography system and the retrieved topography datafile(s)
captured on different dates, the cloud-based server computing
device would compare the conjunctival capillary vessel architecture
image received from the corneal topography system with the
conjunctival capillary vessel architecture images in the database
from different examination dates to verify the same eye of the same
patient is being examined. If the conjunctival capillary vessel
architecture images were different, the cloud-based server
computing device would generate an error message and/or would not
perform difference mapping on the topography data files.
[0079] The one or more processor(s) as disclosed herein can be
configured with instructions to perform any one or more steps of
any method as disclosed herein. These may be computer-readable
instructions that are executable by the one or more processor(s).
As detailed above, the computing devices and systems described
and/or illustrated herein broadly represent any type or form of
computing device or system capable of executing computer-readable
instructions, such as those contained within the modules described
herein. In their most basic configuration, these computing
device(s) may each comprise at least one memory device and at least
one physical processor. The cloud-based server devices and/or
remote computing devices may be one or more computing devices that
are physically located at a geographic location away from the
corneal topography systems (e.g., the Delphi mobile communication
device-based corneal topography systems).
[0080] The term "memory" or "memory device," as used herein,
generally represents any type or form of volatile or non-volatile
storage device or medium capable of storing data and/or
computer-readable instructions. In one example, a memory device may
store, load, and/or maintain one or more of the modules described
herein. Examples of memory devices comprise, without limitation,
Random Access Memory (RAM), Read Only Memory (ROM), flash memory,
Hard Disk Drives (HDDs), Solid-State Drives (SSDs), optical disk
drives, caches, variations or combinations of one or more of the
same, or any other suitable storage memory.
[0081] In addition, the term "processor" or "physical processor,"
as used herein, generally refers to any type or form of
hardware-implemented processing unit capable of interpreting and/or
executing computer-readable instructions. In one example, a
physical processor may access and/or modify one or more modules
stored in the above-described memory device. Examples of physical
processors comprise, without limitation, microprocessors,
microcontrollers, Central Processing Units (CPUs),
Field-Programmable Gate Arrays (FPGAs) that implement softcore
processors, Application-Specific Integrated Circuits (ASICs),
portions of one or more of the same, variations or combinations of
one or more of the same, or any other suitable physical
processor.
[0082] Although illustrated as separate elements, the method steps
described and/or illustrated herein may represent portions of a
single application. In addition, in some embodiments one or more of
these steps may represent or correspond to one or more software
applications or programs that, when executed by a computing device,
may cause the computing device to perform one or more tasks, such
as the method step.
[0083] In addition, one or more of the devices described herein may
transform data, physical devices, and/or representations of
physical devices from one form to another. For example, one or more
of the devices recited herein may receive image data of a sample to
be transformed, transform the image data, output a result of the
transformation to determine a 3D process, use the result of the
transformation to perform the 3D process, and store the result of
the transformation to produce an output image of the sample.
Additionally or alternatively, one or more of the modules recited
herein may transform a processor, volatile memory, non-volatile
memory, and/or any other portion of a physical computing device
from one form of computing device to another form of computing
device by executing on the computing device, storing data on the
computing device, and/or otherwise interacting with the computing
device.
[0084] The term "computer-readable medium," as used herein,
generally refers to any form of device, carrier, or medium capable
of storing or carrying computer-readable instructions. Examples of
computer-readable media comprise, without limitation,
transmission-type media, such as carrier waves, and
non-transitory-type media, such as magnetic-storage media (e.g.,
hard disk drives, tape drives, and floppy disks), optical-storage
media (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), and
BLU-RAY disks), electronic-storage media (e.g., solid-state drives
and flash media), and other distribution systems.
[0085] A person of ordinary skill in the art will recognize that
any process or method disclosed herein can be modified in many
ways. The process parameters and sequence of the steps described
and/or illustrated herein are given by way of example only and can
be varied as desired. For example, while the steps illustrated
and/or described herein may be shown or discussed in a particular
order, these steps do not necessarily need to be performed in the
order illustrated or discussed.
[0086] The various exemplary methods described and/or illustrated
herein may also omit one or more of the steps described or
illustrated herein or comprise additional steps in addition to
those disclosed. Further, a step of any method as disclosed herein
can be combined with any one or more steps of any other method as
disclosed herein.
[0087] Unless otherwise noted, the terms "connected to" and
"coupled to" (and their derivatives), as used in the specification
and claims, are to be construed as permitting both direct and
indirect (i.e., via other elements or components) connection. In
addition, the terms "a" or "an," as used in the specification and
claims, are to be construed as meaning "at least one of" Finally,
for ease of use, the terms "including" and "having" (and their
derivatives), as used in the specification and claims, are
interchangeable with and shall have the same meaning as the word
"comprising.
[0088] The processor as disclosed herein can be configured with
instructions to perform any one or more steps of any method as
disclosed herein.
[0089] As used herein, the term "or" is used inclusively to refer
items in the alternative and in combination.
[0090] As used herein, characters such as numerals refer to like
elements.
[0091] Embodiments of the present disclosure have been shown and
described as set forth herein and are provided by way of example
only. One of ordinary skill in the art will recognize numerous
adaptations, changes, variations and substitutions without
departing from the scope of the present disclosure. Several
alternatives and combinations of the embodiments disclosed herein
may be utilized without departing from the scope of the present
disclosure and the inventions disclosed herein. Therefore, the
scope of the presently disclosed inventions shall be defined solely
by the scope of the appended claims and the equivalents
thereof.
* * * * *