U.S. patent application number 15/573432 was filed with the patent office on 2018-12-13 for devices, methods, and systems for acquiring medical diagnostic information and provision of telehealth services.
The applicant listed for this patent is Ryan Boucher, Lionel Nelson. Invention is credited to Ryan Boucher, Lionel Nelson.
Application Number | 20180353073 15/573432 |
Document ID | / |
Family ID | 57248658 |
Filed Date | 2018-12-13 |
United States Patent
Application |
20180353073 |
Kind Code |
A1 |
Boucher; Ryan ; et
al. |
December 13, 2018 |
Devices, Methods, and Systems for Acquiring Medical Diagnostic
Information and Provision of Telehealth Services
Abstract
The invention relates generally to various systems, tools and
methods for acquiring diagnostic information, including medical
information, for a user, transmitting the information to a remote
location, assessing the information, and transmitting resulting
diagnosis and treatment information to the user and/or a third
party for subsequent action. The present invention provides
consumer and user-friendly telemedicine systems and procedures
which enable health services and/or diagnosis to be provided at a
distance remotely.
Inventors: |
Boucher; Ryan; (San
Francisco, CA) ; Nelson; Lionel; (Los Altos Hills,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boucher; Ryan
Nelson; Lionel |
San Francisco
Los Altos Hills |
CA
CA |
US
US |
|
|
Family ID: |
57248658 |
Appl. No.: |
15/573432 |
Filed: |
May 12, 2016 |
PCT Filed: |
May 12, 2016 |
PCT NO: |
PCT/US16/32223 |
371 Date: |
November 10, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62160468 |
May 12, 2015 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 1/227 20130101;
A61B 2090/036 20160201; A61B 5/05 20130101; A61B 1/07 20130101;
G16H 40/67 20180101; A61B 1/273 20130101; A61B 1/233 20130101; A61B
90/361 20160201; G16H 30/20 20180101; G16H 50/20 20180101; A61B
1/0669 20130101; A61B 7/04 20130101; A61B 1/04 20130101; A61B
5/0022 20130101; A61B 5/684 20130101; A61B 5/682 20130101; A61B
5/6817 20130101; A61B 1/00 20130101; A61B 1/00016 20130101; A61B
7/003 20130101; A61B 1/24 20130101; G16H 10/60 20180101; G16H 80/00
20180101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/05 20060101 A61B005/05; A61B 7/04 20060101
A61B007/04; A61B 1/227 20060101 A61B001/227; A61B 1/233 20060101
A61B001/233; A61B 1/24 20060101 A61B001/24; A61B 1/273 20060101
A61B001/273; A61B 7/00 20060101 A61B007/00; A61B 1/07 20060101
A61B001/07; A61B 1/00 20060101 A61B001/00; A61B 1/04 20060101
A61B001/04; A61B 1/06 20060101 A61B001/06; A61B 90/00 20060101
A61B090/00; G16H 30/20 20060101 G16H030/20; G16H 50/20 20060101
G16H050/20 |
Claims
1-55. (canceled)
56. A medical diagnostic device for diagnosis of a subject's
condition, the device comprising: (A) a main body comprising a
power source and processing components; (B) an extension or
attachment having an anatomical interface which is applied to a
subject's body and obtains visual, audio, or electrical measurement
of the subject's condition; and (C) diagnostic elements, wherein
the diagnostic elements are contained in the main device or in the
extension or attachment, characterized in that the anatomical
interface is structurally configured to position, align, or
stabilize the device or a subject's tissue when the device is
applied to the subject's body.
57. The device according to claim 56, wherein: (a) the main body
further comprises electrical contacts, a light source, and a video
capturing element; and (b) the extension or attachment further
comprises a lens system, a light output, and optical fibers which
channel light from the light source in the main body to the light
output.
58. The device according to claim 57, wherein the main body further
comprises a wireless chip, a microphone, and/or a video chip.
59. The device according to claim 58, wherein the device further
comprises one or more capturing elements which are located in the
main body, in the extension or attachment, or both.
60. The device according to claim 56, wherein the extension or
attachment captures images or sounds of the ear, oral cavity,
throat, nose, nasal passages, chest, heart, or lungs.
61. The device according to claim 56, wherein the extension or
attachment has a stop to prevent overinsertion.
62. The device according to claim 56, wherein the device and the
extension or attachment are connected and communicate wirelessly or
via a direct connection.
63. The device according to claim 56, wherein the extension or
attachment is flexible, hinged, rotatable, curved, or angled, or
the attachment is inflatable or expandable.
64. The device according to claim 56, wherein the extension or
attachment has diagnostic elements at its tip.
65. The device according to claim 56, wherein the anatomical
interface has an extendable structure having a variable length for
adjustment of position of diagnostic elements when applied to a
subject's body.
66. The device according to claim 56, wherein the device is in the
form of a stethoscope and comprises a camera structurally
configured to assist a user to position the device and/or to
confirm correct positioning of the device on the subject's
body.
67. The device according to claim 56, wherein the device is
structurally configured for placement into a subject's ear canal
for imaging of the ear canal or ear drum, and the device is
configured to obtain an image of the ear canal or ear drum without
substantial manipulation of the subject's outer ear during use.
68. The device according to claim 56, wherein the device is
structurally configured for application to a subject's oral cavity
or throat, and the device comprises a light input and/or output
which is positioned within the oral cavity during use.
69. An attachment for a medical diagnostic device for diagnosis of
a subject's condition, the attachment structurally configured to be
affixed to a main body having a power source, processing
components, and diagnostic elements and having an anatomical
interface which is applied to a subject's body to capture obtains
visual, audio, or electrical measurement of the subject's body and
thereby obtain measurement of the subject's condition,
characterized in that the anatomical interface is structurally
configured to position, align, or stabilize the device or a
subject's tissue when the device is applied to the subject's
body.
70. The attachment according to claim 69, wherein the attachment
has a stop to prevent overinsertion, and the attachment optionally
has an extendable structure having a variable length for adjustment
of position of diagnostic elements when applied to a subject's
body.
Description
[0001] This application claims the priority benefit of U.S.
provisional patent application Ser. No. 62/160,468, filed on 12 May
2015 and incorporated herein in its entirety. This application also
incorporates herein by reference in their entirety U.S. patent
application Ser. No. 13/929,591, filed on Jun. 27, 2013, and U.S.
provisional patent application Ser. No. 61/664,920, filed on 27
Jun. 2012.
FIELD OF THE INVENTION
[0002] The invention relates generally to various systems, tools
and methods for acquiring diagnostic information, including medical
information, for a user, transmitting the information to a remote
location, assessing the information, and transmitting resulting
diagnosis and treatment information to the user and/or a third
party for subsequent action. More specifically, the present
invention relates to consumer and user-friendly telemedicine
systems and procedures which enable health services and/or
diagnoses to be provided remotely.
BACKGROUND OF THE INVENTION
[0003] Currently, subjects with an injury or undiagnosed pain are
typically forced to visit one or more physicians or medical
treatment centers to have their condition diagnosed. If the subject
is a small child, or if the condition is thought to be serious or
in need of immediate treatment, the long waiting periods for a
physician appointment may seem unreasonable or unacceptable, and
the subject often ends up going to an emergency room and/or urgent
care center on a "walk-in" basis. At the medical facility, the
subject (or his/her guardian or caregiver) fills out medical
history forms, answers questions about the condition, and has a
clinician perform a physical examination to learn about the
condition. In many cases, the waiting period at the facility can
consume many hours, depending upon facility capacity and other
subject needs (e.g., emergency cases treated as priority, etc.).
Ultimately, the subject's visit may have been unnecessary, as the
condition was not truly "urgent" or "critical," and thus treatment
could have been delayed and/or accommodated at a regularly
scheduled appointment, or the condition would have resolved itself
with little or no intervention by the physician.
[0004] In many cases, the stress and uncertainty associated with
the subject's condition can be more debilitating than the condition
itself, especially where the subject is a small child, and the
caregiver is an inexperienced parent who is anxious about his or
her child's condition. Moreover, because emergency treatment
centers such as emergency rooms and urgent care centers are
operating at or over capacity, the long wait times at such
facilities can further exacerbate stress, leading to a wide variety
of potential medical situations including hypertension, heart
attacks and/or strokes, as well as possible physical and/or mental
altercations between subjects and/or caregivers. Moreover, the
unnecessary use of emergency and urgent care facilities levies a
heavy cost on the nation's health care and health care insurance
systems, as such services are generally much more expensive than
similar services provided on a scheduled or appointed basis.
SUMMARY OF THE INVENTION
[0005] The various inventions disclosed herein include the
identification of a need for consumer-/and/or user-friendly devices
that can be employed by untrained or semi-trained individuals to
safely and effectively capture, store, transmit, display, download
and/or update medical or other information, including assessments,
examinations, and evaluations, of a subject's condition via
electronic media for use by subjects, clinicians, health care
providers, and system administrators. In accordance with one
exemplary embodiment of the present disclosure, the method
includes, without limitation, a non-medical professional (e.g., a
consumer or other subject, etc.) utilizing a device to perform an
examination protocol for a subject's condition, the device having
the capability to store and/or transmit relevant information for
use in an asynchronous or other telemedicine environment.
[0006] The performing of the examination can include storing
information about the subject's condition in a storage medium,
include storage media accessed remotely (e.g., USB-accessible,
LAN-accessible and/or internet accessible storage devices), as well
as localized storage associated with the device (e.g., RAM or flash
memory, SD cards, attached smartphone memory, etc.). The device can
simultaneously and/or subsequently upload stored data to a general
or specialized storage network, or remote access to the electronic
storage medium can be provided over a computer or other
communication network. The stored data can then be accessed by a
competent medical professional or other caregiver, properly
assessed, and recommendations regarding the condition and/or
treatment can be transmitted or otherwise given to the subject or
guardian.
[0007] Various embodiments disclosed herein include the
manufacture, distribution and use of specialized and/or generalized
devices that can be utilized by non-medical personnel (e.g.,
consumers) to collect subject information in a home-care or
non-medical facility location. The information can then be
transmitted and/or otherwise accessed by qualified medical and
care-giving personnel, and appropriate assessment, condition and/or
treatment information can be transmitted or otherwise provided to
the subject. In various embodiments, the device can be a part of
and/or used in conjunction with electronic communications and/or
display systems such as telephones, cell phones, smart phones,
computers, wireless radios and/or other communications media known
in the art. Desirably, the disclosed systems will allow a subject
to transmit sufficient information to the medical professional to
enable assessment of the subject's condition, which may include
information relevant to immediate and/or critical treatment of the
condition that may not be readily apparent to the subject. In
various embodiments, the inventive systems allow trained personnel
to direct the subject's actions and/or use of the diagnostic tools,
such as requesting information regarding specific anatomical
features which may be imaged by the diagnostic device in the hands
of the subject as requested "real time" by the physician.
[0008] In various embodiments, the disclosed systems and methods
include the ability to collect subject information at a plurality
of times or conditions, whereby the information can be transmitted
and/or otherwise accessed by the medical professional and used in
the assessment of the subject's condition. Such information may be
stored for various periods of time, at differing locations, and
previously-stored data can be transmitted and/or made available in
conjunction with current subject information and used in the
assessment of the subject's condition. Similarly, subject
information collected via other methods, including routine
physicals and/or during doctor office visits, can be collected and
provided with current subject information in a similar manner. If
desired, the specialized and/or generalized consumer device (or
other device such as a smartphone or computer) can include memory
features that collect and store such information, such as the
identity and dosages of medicines currently being taken by the
subject or the fact that the subject has diabetes or other medical
conditions.
[0009] Various alternative embodiments include the provision of an
internet-accessible healthcare system to consumers, whereby the
consumer can provide subject information (as previously described)
to the system, and can receive assessment, condition and/or
treatment information from a healthcare professional associated
with the system. In various embodiments, the system can provide the
consumer and/or subject with status updates and/or other relevant
information during the process to: (1) confirm receipt and/or
integrity of the relevant subject information, including subject
medical data and payment information, if necessary, (2) identify
various steps of the process, and the subject information's current
status (e.g., data assigned to a physician or specialist, data
currently being reviewed, medical recommendations being prepared,
system scheduling a local physician visit on subject's behalf,
system directing subject to a local emergency room, system
dispatches an ambulance or paramedics to the subject's location,
etc.), (3) request additional information from the subject (either
using the current device and/or additional devices, some of which
may be immediately available to the subject) which may include
initiating a live-call or other communication between the medical
professional and the subject, (4) providing assessment, treatment
and/or other information to the subject, and (5) forwarding
prescription or other treatment information to the subject,
hospital, pharmacy or other care-giver as requested by the subject
and/or assigned by the system.
[0010] In various embodiments, the provision of the type of updates
can significantly reduce subject anxiety while waiting for
treatment information, as well as confirm to the subject whether
the subject information has been received and/or is being reviewed
by the system. In addition, in situations where the subject is
unable or unwilling to access emergency services directly (e.g.,
the subject is stuck in an accident on the road, lost in the
wildness, climbing a mountain, located in a collapsed building,
etc.), the present system and methods described herein can provide
critical care data directly to the subject, as well as provide
emergency response personnel with detailed information about a
subject's condition, that may take mere seconds for the device to
collect, allowing responders to prioritize their response and/or
equip themselves for specialized medical responses.
[0011] In various embodiments, the present system can be associated
with various healthcare-providing organizations and/or payors,
including clinics, hospitals, insurance companies, employers and/or
governmental entities, as necessary and/or allowed by current or
future laws (e.g., privacy and health care information
accessibility statutes, etc). The use of such systems by such
entities can significantly reduce congestion of existing emergency
as well as non-emergency health services (by reducing the number
and/or frequency of unnecessary subject visits) as well as
significantly improve the provision of health care to the general
consuming population in a highly effective and cost-efficient
manner. Moreover, various embodiments of the system can
significantly reduce the need for medical professionals to be
located proximate to their subjects, and can even promote and/or
encourage "time shifting" of medical care by subjects and/or
medical professionals.
[0012] Various technical features of the invention generally relate
to devices, systems and methods that facilitate remote connection
and communication between two or more parties for medical, health
and/or wellness purposes, herein collectively referred to as
telehealth. In various embodiments, technical features are
disclosed that generally relate to devices, systems and methods for
capturing, displaying, recording and/or transmitting diagnostic
information, including remote control manipulation of devices
and/or diagnostic information. Other technical features of the
invention generally relate to devices, systems and methods that
provide the infrastructure, logistics and user interfaces to make
possible remote or at home diagnosis, advice and/or coaching for
medical, health and/or wellness purposes (herein collectively
referred to as health purposes). Other technical features of the
invention generally relate to devices, systems and methods
providing advanced features for a more pleasurable user experience
and/or more elaborate telehealth system.
[0013] In various embodiments, the systems and methods disclosed
herein can facilitate one or more of the following (including
various combinations thereof):
[0014] A. Reduction of health care costs for both payer and
subject/consumer;
[0015] B. Providing adequate subject access to primary care
physicians. The invention desirably accommodates reducing the
number of primary care physicians and increasing the number of
subjects able to be served;
[0016] C. Early diagnosis focusing to help minimize disease
progression;
[0017] D. Accommodation of modern fast-paced life/culture. Modern
communications methods and widespread internet/wireless connections
have created consumers' expectations for more convenient and more
rapid answers and access to information, including 24-hour and/or
"real time" access to services;
[0018] E. Consumer-friendly and/or ruggedized information capture
devices: The invention provides access to telemedicine and creates
a need for the ability to capture diagnostic information remotely;
and
[0019] F. Reduction of the number of high-cost visits to an
emergency room or facility/urgent care.
[0020] The present disclosure relates to devices, systems and
methods to capture diagnostic information for health and wellness.
As one example of a system, a parent uses a device to capture an
image of a child's eardrum while at home. The device transfers the
images to a local computing device, such as a laptop, tablet or
smart phone. If the parent is using the computing device for a live
video or chat consultation with a provider, the images may be sent
to the provider in real time. An alternative method does not
require the images to be sent in real time. The store and forward
method allows a user to send the images to a provider at any time
for review without a communication connection between the user and
provider. Current home diagnostic devices and attachments are
typically modeled after doctor instruments. These devices often
require training and practice and are typically awkward, unfamiliar
and uncomfortable. This disclosure describes devices, systems and
methods to improve tolerance, safety, ease of use and portability
(for example, a compact kit). Some features which serve to
accomplish this are the use of familiar interfaces (for example,
comparable to a Bluetooth headset or a pacifier), providing support
and/or alignment and the use of flexible and/or soft portions which
interface with the body.
[0021] Other features to increase the ability to capture this
information may also be incorporated. For example, a speaker may be
incorporated to emit pleasant sounds to calm the subject, which may
be especially useful when capturing images of a child's ear drum.
Oral attachments or sleeves placed over attachments or devices may
be chilled or flavored for a more pleasant experience for the
subject. Additional diagnostic elements may be included with any of
these devices. For example, a thermometer or sensors (i.e. for
oxygen saturation, pulse etc.) may be incorporated into the main
body of the device and/or incorporated into an ear or oral device
or attachment. Similarly, a single device may incorporate one or
more features of the present disclosure. For example, a device may
have a built in component which serves as a stethoscope to listen
to the heart and lungs (i.e. it does not require an additional
stethoscope attachment) and also have a camera to look into the ear
and throat. This camera may be at the tip of an extension or at the
base of an extension. In this case it may be possible to capture
images of the ear and throat without additional attachments but
attachments may be supplied as optional accessories, for example to
allow easier, more reliable or more comfortable use. Alternatively,
a kit (device and/or attachments) can be provided for capturing
other diagnostic information, such as images of the eye and skin or
a device or attachment can be supplied to capture information at
only one location.
[0022] In various alternative embodiments, similar systems and
methods as described herein may have varying levels of utility in
non-health care applications, including the collection of relevant
data using similar devices and/or the provision of "expert" advice
for various other purposes, including non-medical diagnostics such
as carpentry, plumbing, auto repair, etc.
[0023] It is to be understood that a reference to an individual
encompasses singular and plural instances of the individual. For
example, a medical care professional or provider may be a single
person providing medical care, or multiple individuals working in
concert to provide complementary service(s) to the subject or
caregiver. Similarly, a caregiver can be a single individual such
as a parent, or multiple individuals such as attendants at a
nursing home.
[0024] In certain instances herein, components of the invention may
alternatively be referred to as elements. These terms, as well as
other comparable terms, are to be considered as
interchangeable.
[0025] An embodiment of one aspect of the present invention is
directed to an imaging apparatus for obtaining images inside a
subject's ear canal. The imaging apparatus according to this
embodiment comprises a main body and an extension having a central
axis structurally configured for insertion into the subject's ear
canal. The imaging apparatus comprises an imaging element for
obtaining images which are angled and/or offset relative to the
central axis of the extension into the ear canal. Alternatively,
the imaging apparatus may be configured to obtain images in line
with the central axis of the extension but where the extension is
offset and/or angled relative to the ear canal central axis.
Further, the imaging apparatus may obtain images which are angled
and/or offset relative to the central axis of the extension and
angled and/or offset relative to the central axis of the ear canal.
The main body and/or extension may engage with the outer ear or ear
canal to encourage these positions
[0026] The imaging apparatus may comprise an engagement member
which is structurally configured to be supported in-use by a
subject's ear or head so that the user, provider, or caregiver does
not need to support or hold the apparatus in position.
[0027] The imaging apparatus may comprise a wireless transmission
element for wirelessly transmitting the obtained images to a
processing or computing device. Alternatively, the imaging
apparatus may communicate with a processing or computing device via
a wired connection. A non-limiting list of examples of computing
devices include mobile telephones, smartphones, laptop computers,
tablet computers, desktop computers, servers, mainframes, and
dedicated hardware computing devices. These devices can operate
using mobile operating systems such as iOS (from Apple Inc.) and
Android (from Google Inc.), desktop operating systems such as OSX
(from Apple Inc.) and Windows (from Microsoft Corp.), or any other
kind of operating system or platform. The computing device can also
be custom-designed and manufactured for use specifically with the
imaging apparatus.
[0028] The extension portion of the imaging apparatus may have a
soft outer surface for improved subject comfort during insertion of
the extension into the subject's ear canal.
[0029] An embodiment of another aspect of the present invention is
directed to an oral imaging apparatus in the shape of a pacifier.
The imaging apparatus may comprise an imaging element configured
for taking an image of the oral cavity of a subject; and a
transmission element for transmitting the image to a processing or
computing device.
[0030] An embodiment of another aspect of the present invention is
directed to a kit for collecting diagnostic information of a
subject. Although different embodiments of the kit may contain
different components, a useful combination comprises a main body
and one or more attachments. The main body comprises diagnostic
equipment, such as processing and/or computing elements, for
obtaining medical diagnostic information of the subject, and a
transmission element for transmitting the diagnostic information
via wired or wireless connection to a computing device.
[0031] A useful first attachment for the main body comprises an
imaging element structurally configured for imaging the ear canal
and/or the ear drum of the subject. A useful second attachment for
the main body comprises an imaging element structurally configured
for imaging the oral cavity and/or throat of the subject. The kit
may also comprise a third attachment having a sound accessing
element structurally configured to obtain internal sounds of the
subject's body. The kit may comprise any combination of first
and/or second and/or third attachments.
[0032] The transmission element in the kit may be configured to
transmit the diagnostic information in real time as the device is
in use, or the diagnostic information may be transmitted upon
receipt of an instruction from a user or provider. The transmission
element may have the capability of transmitting the diagnostic
information in a plurality of image resolutions, image sizes, or
transmission speeds, or combinations thereof. For example, the
transmission element can be configured to send images at VGA, SVGA,
HVGA, or another resolution, or video at 12 frames per second, 24
frames per second, or another frame rate.
[0033] Any of the components of the kit such as the main body may
be structurally configured as a hands-free unit while in-use, or as
a handheld unit while in-use.
[0034] Another aspect of the present invention provides for a
method of remotely providing medical information to a subject by a
health care professional. The method may comprise the steps of:
[0035] a. providing, via a remote connection, the subject's current
medical data to the health care professional;
[0036] b. optionally providing the health care professional with
the subject's medical history;
[0037] c. causing the health care profession to develop an
assessment of the subject's current physical condition on the basis
of the current medical data and the medical history if available;
and
[0038] d. communicating the assessment to the subject or subject's
caregiver over an electronic communications channel.
[0039] The method may also include providing, by the health care
professional, the subject or subject's caregiver with treatment
information (but not limited to). The treatment instructions can
include any kind of medical advice or instructions, such as
providing the subject with a prescription for a drug or a
laboratory procedure; or directions to visit a medical care
provider, pharmacy, hospital, or laboratory. Multiple instructions
can also be given to multiple parties. For example, the health care
professional can provide (a) the subject's caregiver with verbal
medical care instructions; (b) a pharmacy with a prescription for
filling; and (c) a laboratory with advance notice that the subject
will need a certain kind of test to be performed.
[0040] Another aspect of the present invention is directed to a
method of remotely providing medical information by a health care
provider to a subject. The method may comprise the steps of:
[0041] a. providing, via a remote connection, instructions to an
untrained or semi-trained consumer to perform an examination
protocol for a subject's condition using an examination device
which stores and/or transmits current subject medical data for use
in an asynchronous or telemedicine environment;
[0042] b. transmitting, by the consumer, the examination protocol
data to the health care provider;
[0043] c. causing the healthcare provider to develop an assessment
of the subject's current physical condition on the basis of the
data obtained by the examination device; and
[0044] d. communicating the assessment to the subject or the
subject's caregiver over the remote connection.
[0045] The method may further comprise providing, by the health
care professional, the subject or subject's caregiver with
treatment information for the subject.
[0046] The examination protocol data can be transmitted to the
health care provider in real time, as the data is acquired, or not
in real time, for example, upon receipt of an instruction or
request from the provider or health care professional for this
data. In such embodiments, the examination protocol data can be
stored in a storage medium such as a flash drive in a device
participating in the performance of the invention. The examination
protocol data can also be saved in a computing device, or be
uploaded to a cloud-based data storage facility for retrieval by
the health-care provided in real-time or upon issuance of an
instruction.
[0047] An embodiment of another aspect of the present invention is
directed to an examination device for performing an examination
protocol for a subject's condition. The examination device can
comprise:
[0048] a. an anatomical interface structurally configured for
application to a predetermined area of the subject's body;
[0049] b. an accessing and capturing component which obtains
current medical data of the subject after application of the
anatomical interface to the subject's body;
[0050] c. a diagnostic processing component which processes the
medical data obtained by the accessing and capturing component;
and
[0051] d. a communications link over which the processed medical
data is transmitted to a communications component for viewing and
interpretation by a medical care provider.
[0052] The anatomical interface is structurally configured for
application to the subject's ear, nose, throat, eye, wrist, skin,
head, skin, extremities, torso, or into a body orifice such as the
inside of the mouth or nose. In this manner, the anatomical
interface of the device will facilitate providing accurate subject
medical status information.
[0053] Any of the disclosed devices, systems, or components may
comprises a remote control component which is structurally
configured to respond to control signals sent remotely by the
medical care provider or a caregiver over a communications link.
The communications link can transmit the obtained medical data in
the form of still images, a video feed, an audio feed, a data
stream, or a combination thereof, to the medical care provider.
[0054] Any of the disclosed devices, systems, or components may
comprises a port or jack configured for attachment to a computing
device such as a mobile telephone, laptop computer, tablet
computer, or desktop computer. The port or jack may be conventional
such as a minijack, USB port, Apple iDevice port (such as an iPhone
or iPad), or custom-designed by the manufacturer.
[0055] Examples of the accessing and capturing component of the
present invention include a mobile telephone, laptop computer,
tablet computer, desktop computer, or a custom-designed hardware
element.
[0056] Examples of the diagnostic processing component of the
present invention include a mobile telephone, laptop computer,
tablet computer, desktop computer, or a custom-designed hardware
element. In certain embodiments of the invention, the accessing and
capturing component and the diagnostic processing component can be
the same hardware element. That is, the hardware element can have
multiple functions as discussed and provided in this
specification.
[0057] An embodiment of another aspect of the present invention is
directed to a telehealth system for remote diagnosis of a subject's
medical condition. The telehealth system can comprise elements such
as: [0058] A. a user subsystem configured for receiving a subject's
current medical data, the user subsystem comprising: [0059] 1. a
communication device; [0060] 2. a diagnostic processing device; and
[0061] 3. a diagnostic capture device; [0062] B. a provider
subsystem configured for communicating with a health care provider,
the provider subsystem comprising: [0063] 1. a communication
device; and [0064] C. an infrastructure subsystem configured to
process and store medical data and diagnostic information received
from the user subsystem and the provider subsystem, the
instrastructure subsystem comprising: [0065] 1. an application
server comprising computer instruction code configured to
communication with: [0066] a. a database configured to store a
subject's personal information and electronic health record; [0067]
b. diagnostic computer instruction code configured to receive
current subject medical information and to provide diagnostic
information concerning the subject's medical condition; and [0068]
c. a database configured to store archived diagnostic information;
[0069] 2. a server comprising computer instruction code configured
to communicate with one or more third-party subject personal
information or electronic health record databases; and [0070] 3. a
server comprising computer instruction code configured to
communicate with a third party telehealth system,
[0071] wherein the user, provider, and infrastructure subsystems
are structurally configured to communicate information over an
electronic data network.
[0072] Another aspect of the present invention is directed to an
imaging apparatus for obtaining images within a body cavity of a
subject, the imaging apparatus comprising a main body, an extension
having a central axis structurally configured for insertion into
the body cavity, and an imaging element structurally configured to
facilitate the capture of images from a perspective offset from the
extension. In an embodiment of the invention, the body cavity is
the ear canal of the subject.
[0073] Another aspect of the present invention is directed to a
medical diagnostic device comprising at least one anatomical
interface and which is structurally configured to position, align,
or stabilize the device or a subject's tissue when the device is
applied to the subject's body.
[0074] Another aspect of the present invention is directed to an
attachment for a medical diagnostic device, the attachment
comprising at least one anatomical interface and which is
structurally configured to position, align, or stabilize the device
or a subject's tissue when the device is applied to the subject's
body.
[0075] Another aspect of the present invention is directed to a
medical diagnostic device comprising at least one anatomical
interface and which is structurally configured to position, align,
or stabilize the device or a subject's tissue when the device is
applied to the subject's body, wherein the anatomical interface has
an extendable structure having a variable length for adjustment of
position of diagnostic elements when applied to a subject's
body.
[0076] Another aspect of the present invention is directed to an
attachment for a medical diagnostic device, the attachment
comprising at least one anatomical interface and which is
structurally configured to position, align, or stabilize the device
or a subject's tissue when the device or attachment is applied to
the subject's body, wherein the anatomical interface has an
extendable structure having a variable length for adjustment of
position of diagnostic elements when applied to a subject's
body.
[0077] Another aspect of the present invention is directed to an
imaging apparatus structurally configured for application to a
subject's oral cavity or throat, wherein the apparatus comprises a
light input and/or output which is positioned within the oral
cavity during use.
[0078] Another aspect of the present invention is directed to an
attachment for an imaging apparatus, the attachment structurally
configured for application to a subject's oral cavity or throat,
wherein the attachment comprises a light input and/or output which
is positioned within the oral cavity.
[0079] Another aspect of the present invention is directed to a
stethoscope device comprising a camera structurally configured to
assist a user to position the device and/or to confirm correct
positioning of the device.
[0080] Another aspect of the present invention is directed to a
stethoscope attachment for a device, the attachment comprising a
camera structurally configured to assist a user to position the
stethoscope attachment and/or to confirm correct positioning of the
stethoscope attachment.
[0081] Another aspect of the present invention is directed to a
medical device structurally configured for placement into a
subject's ear canal for imaging of the ear canal or ear drum,
wherein the device is configured to obtain an image of the ear
canal or ear drum without substantial manipulation of the subject's
outer ear during use.
[0082] Another aspect of the present invention is directed to an
attachment for a medical device, the attachment structurally
configured for placement into a subject's ear canal for imaging of
the ear canal or ear drum, wherein the attachment is configured to
obtain an image of the ear canal or ear drum without substantial
manipulation of the subject's outer ear during use.
Definitions
[0083] For convenience, further information regarding the following
terms is provided below. Other and equivalent terms in this
description may be used to describe similar concepts.
[0084] Subject: One or more individuals desiring or needing health
advice. A subject may be a group, e.g. exercise class or sport
team.
[0085] Caregiver: One or more individual(s) that assist the subject
with his or her health concern. This individual is usually known to
the subject, e.g. a son or daughter or parent or coach.
[0086] User: One or more subject(s) and/or caregiver(s).
[0087] Health Professional: Any individual certified or experienced
within a health related field. Examples include a physician,
surgeon, nurse, physician assistant (PA), nurse practitioner (NP),
physical therapist, nutritional expert, medic, paramedic, EMT,
etc.
[0088] Nurse Hotline: A service provided by an insurance company or
health-related entity that provides health advice or helps connect
an individual with the appropriate health professional.
[0089] Call Center: A service, that may be provided by a non-health
related entity, that provides health advice or helps connect an
individual with the appropriate health professional.
[0090] Provider: One or more health professional(s), nurse hotline
and/or call center.
DESCRIPTION OF VARIOUS EXEMPLARY EMBODIMENTS
[0091] Although the disclosure hereof is detailed and exact to
enable those skilled in the art to practice the invention, the
physical embodiments herein disclosed merely exemplify the
invention, which may be embodied in a manner not expressly
described. While the preferred embodiment has been described, the
details may be changed without departing from the invention, which
is defined by the various disclosures and claims provided
herein.
BRIEF DESCRIPTION OF THE FIGURES
[0092] FIGS. 1 and 2 illustrate exemplary embodiments of a
telehealth system in use.
[0093] FIG. 3 illustrates linked components of an exemplary
embodiment of a telehealth system.
[0094] FIG. 4 illustrates three components of a telehealth system
in accordance with an exemplary embodiment of the invention.
[0095] FIGS. 5-7 illustrate exemplary embodiments of user devices
which are structurally configured for insertion into the human ear
and which communicate a subject's current medical status in
accordance with the present invention.
[0096] FIGS. 8 and 9 show a cross-section of the ear region of a
subject's head for purposes of reference.
[0097] FIGS. 10-20 illustrate exemplary embodiments of an ear
imaging device comprising an anatomical interface to facilitate
positioning and image quality and may also serve as safety
mechanisms that prevent over-insertion.
[0098] FIG. 21 illustrates features of the outer human ear for
purposes of reference.
[0099] FIGS. 22-24 illustrate exemplary embodiments of an over-ear
device for obtaining a subject's current medical status.
[0100] FIGS. 25-26 illustrate exemplary embodiments of an over-ear
device having different configurations of the outer ear
elements.
[0101] FIGS. 27 and 28 illustrate side and bottom views of an
exemplary ear imaging device.
[0102] FIGS. 29 and 30 illustrate exemplary embodiments of
anatomical interfaces for an medical device for insertion into a
subject's mouth or ear.
[0103] FIG. 31 illustrates an exemplary embodiment of a medical
diagnostic instrument equipped with a microphone.
[0104] FIGS. 32-35 illustrate exemplary embodiments of medical
diagnostic instruments for collection of subject medical
information.
[0105] FIGS. 36-37 illustrate exemplary embodiments of kits
comprising devices for accessing, capturing, and at least partial
processing of medical diagnostic information in accordance with the
present invention.
[0106] FIGS. 38A-38E illustrate exemplary embodiments of medical
diagnostic devices in accordance with the present invention which
are structurally configured to be placed on, in, or adjacent to a
subject's body for obtaining medical diagnostic information.
[0107] FIGS. 39A-40B illustrate the basic anatomy of the ear canal
and oral cavity, respectively.
[0108] FIG. 41A-41B shows embodiments of interfaces for the oral
cavity.
[0109] FIG. 42A-42B illustrate difficulties associated with use of
an otoscope which are addressed by the present invention.
[0110] FIGS. 43A-45B illustrate ear position and speculum
positioning during an examination with an otoscope.
[0111] FIGS. 46-48 illustrate visualization of the throat using
conventional diagnostic instruments and techniques.
[0112] FIG. 49 illustrates an exemplary new device for accessing
and capturing diagnostic information in the ear.
[0113] FIGS. 50A and 51B show exemplary reference positions and
angles for obtaining diagnostic information in the ear.
[0114] FIGS. 52A-56B show examples of preferred positions and
angles for obtaining diagnostic information in the ear.
[0115] FIGS. 57A-61B show examples of anatomical interfaces which
help to support, stabilize, position, and/or align devices,
components or attachments in, on or near the visible portion of the
ear, head, neck or cheek.
[0116] FIGS. 62A-65E show examples of anatomical interfaces which
help to support, stabilize, position, and/or align devices,
components or attachments in or near the ear canal.
[0117] FIGS. 66A-67B show examples of light output locations and
image/light input locations for diagnostic elements intended for
the ear.
[0118] FIGS. 68A-71B show examples of inflatable, expandable, or
hinged components for use with diagnostic elements.
[0119] FIGS. 72A-74J show various positions of devices and
configurations of imaging elements, including angle and field of
view, for viewing the oral cavity and throat.
[0120] FIG. 75A-79G show various profiles of devices and examples
of positions of diagnostic elements; examples of anatomical
interfaces with different configurations and profiles; and
exemplary shapes of anatomical interfaces and positions of imaging
elements.
[0121] FIG. 80A-80D show a side view and bottom view of an
attachment for imaging skin and having legs to provide an offset
from the skin surface.
[0122] FIG. 81A-81B show examples of attachments for capturing
temperature in the ear.
[0123] FIGS. 82A-83C show examples of anatomical interfaces for
imaging the nose or nasal cavity and eye.
[0124] FIGS. 84A-89C show elements of diagnostic kit devices for
imaging the ear canal and ear drum, and including a main device and
various attachments.
[0125] FIG. 90A-90C illustrate a main diagnostic device with an
extension that contains diagnostic elements at the tip to emit
light, and a video chip to capture light.
[0126] FIGS. 91A-104 show attachments for a main device and
examples of configurations of the main device. FIG. 91A-91B show a
display attachment that can connect to the back of the main device.
FIG. 92A-92B illustrate a slim ear bud sleeve that can connect to
the main device and allow imaging of either the right or left ear.
FIGS. 93A-101B illustrate ear bud attachments to the main device,
including attachments which have light source and light measurement
capabilities, and attachments which rotate.
[0127] FIG. 102A-102C illustrate a stethoscope attachment for
connection to the main device illustrated in FIG. 90.
[0128] FIG. 103A-103B illustrate an oral attachment which attaches
over a diagnostic extension of a main device.
[0129] FIG. 104 illustrates an ear temperature attachment for
connection to a diagnostic extension of a main device.
[0130] FIGS. 105 through 109C show various configurations of
extendable, rotatable or moveable diagnostic sections or extensions
of a device.
[0131] FIG. 110A-110B show diagnostic extensions or sections which
are steerable and rotatable.
[0132] FIGS. 111A through 113 show devices with diagnostic
extensions that can fit attachments with different lengths.
[0133] FIG. 114A-H show a configuration of a main diagnostic device
where the diagnostic elements are contained in the body of the main
device and not in an extension.
[0134] FIG. 115 shows an example of a configuration with diagnostic
elements in the main body of a device that allows extension and
retraction.
[0135] FIG. 116A-116B shows a device with various diagnostic
elements at different locations in a device.
[0136] FIGS. 117-119 show various other configurations of devices
and kits, including long extensions which can attach to other
attachments or elements.
DETAILED DESCRIPTION
[0137] This disclosure discusses and describes devices, methods,
systems and features which reduce or eliminate the safety,
tolerance, comfort or usability issues that exist with current
diagnostic devices and allow for an easier and more comfortable
experience, even if the user has minimal or no training. The
preferred device designs perform the same function as instruments
found in a doctor's office, but are packaged in forms and shapes
which are more familiar and/or more comfortable to both a child and
parent. These features reduce nervousness for subjects (especially
children) whose senses are usually naturally threatened by medical
instruments, and also reduces nervousness for the user, who has
more confidence using the more familiar and comfortable device.
I. PERTINENT ANATOMY OF THE EAR, ORAL CAVITY AND THROAT
[0138] It will be useful to provide a brief summary of the
pertinent anatomy of the ear, oral cavity, and throat, as
embodiments of the invention will be described with reference to
such anatomical features.
[0139] A. Outer Ear and Ear Canal
[0140] 1. Outer Ear Anatomy
[0141] The outer ear consists of the visible portion of the ear,
called the pinna or auricle, as well as the external acoustic
meatus, or ear canal, which leads to the external surface of the
tympanic membrane, or ear drum (see FIGS. 8,9,21). The tympanic
membrane is translucent and part of the middle ear may be
visualized through the membrane. The most prominent feature is the
malleus. The condition of the tympanic membrane and ability to view
the malleus are often used to diagnose ear problems. In an
unhealthy ear, the tympanic membrane may be bulged or cloudy in
appearance and it may be difficult to distinguish the malleus. The
visible portion of the ear may also be referred to as the external
ear. The pinna contains the concha, the tragus, the antitragus and
the antihelix as well as other features. The concha is the bowl
shaped part of the ear and leads into the ear canal. The tragus is
located at the front of the concha and the antitragus is located
below the concha. The antitragus is located behind as well as above
the concha. The cavum concha is the inner portion of the concha
that leads into the ear canal.
[0142] It will generally be clear in the following disclosure and
on text as to whether the visible portion of the ear is intended,
or whether the discussion is also applicable to or the entire outer
ear which also contains the ear canal. However, the context of the
description should be taken into account.
[0143] 2. Ear Canal
[0144] The external acoustic meatus, or ear canal, is generally
oval shaped and largest at the entrance. The ear canal is curved in
an S shape, directed superiorly and posteriorly (up and back) in
the first section and then moving inferiorly and anteriorly (down
and forward). The canal is straighter in newborns, gradually taking
on the general shape of an adult's ear canal through growth, and
the ear canal is generally shaped similarly to an adult after 12
months of age. The canal entry is generally in the range of 9 mm
vertically (inferior/superior direction) by 6.5 mm horizontally
(anterior/posterior direction) for adults. The canal length varies
from about 1.5 cm in infants to approximately 2.5 cm long for
adults. The ear canal diameter then decreases to an average
diameter of approximately 6-7 mm in adults and 3 mm in infants. The
ear canal consists of a cartilaginous section and a bony section.
The cartilaginous section extends for almost the entire length in
newborns and for approximately the first 1/3 of the length in
adults. This outer portion the ear canal is where longer hairs are
located, as well where wax is secreted. FIG. 39A is a horizontal,
or transverse, section (upper, or superior, half shown) of the ear
and ear canal showing the different parts of the ear as well as the
curvature of the ear canal. The ear canal first runs posteriorly
(to the back) and then anteriorly (to the front), as shown in FIG.
39A. The horizontal (anterior/posterior) dimension of the ear canal
is shown to be similar throughout the length, which is
approximately 6-7 mm on average in adults.
[0145] FIG. 39B is a frontal, or coronal, section (back, or
posterior half shown) and shows the superior and then inferior
shape of the ear canal (up and then down). The beginning section of
the ear canal has a larger dimension in this section. The starting
vertical (inferior/superior) dimension is approximately 9 mm on
average in the adult and decreases to approximately 6-7 mm for the
remaining length of the canal. Note that the sections may not be
exact frontal and transverse sections showing the center of the ear
canal due to the curvature of the ear canal in both directions.
[0146] B. The Mouth, Throat and Oral Examinations
[0147] 1. The Mouth, or Oral Cavity
[0148] The main structures of the mouth, or oral cavity, are the
teeth, the tongue and the palate (see FIGS. 40A,40B). The oral
cavity is connected to the outside by the lips at the front, or
anterior end, and connects to the oropharynx (part of the throat)
at the back, or posterior end. The oral cavity consists of two
parts, the vestibule and the oral cavity proper. The vestibule is
the area between the teeth, lips and cheeks. The inside of the
cheeks are lined with the buccal mucosa. The top and part of the
back of the oral cavity is formed by the palate, which separates
the oral and nasal cavities. The front, or anterior, two thirds of
the palate is the hard palate and the back, or posterior, third is
the soft palate. The uvula extends down from the middle of the soft
palate. The top, or superior, surface of the tongue is called the
dorsum. The front two-thirds of the dorsum are part of the oral
cavity. The oral cavity contains many small glands that, along with
the three major salivary glands, produce saliva to keep the mouth
moist and help keep the body healthy. These glands lubricate the
mouth, help with swallowing, protect the teeth against bacteria and
aid in the digestion of food.
[0149] 2. The Oropharynx (Part of the Throat)
[0150] The oral cavity is connected at the back to part of the
throat called the oropharynx (See FIGS. 40A,B). The oropharynx is
connected to the nasopharynx at the top, which then connects to the
nasal cavity. The bottom, or inferior border, of the oropharynx is
defined by the epiglottis, at which point the hypopharynx (also
called the laryngopharynx) begins. The side, or lateral, walls of
the oropharynx contain a triangular recess which is defined by the
tonsillar pillars. The front (anterior) pillar is called the
palatoglossal arch and the back (posterior) pillar is called the
palatopharyngeal arch. The palatine tonsils, or just tonsils, are
contained within this triangular recess in the lateral walls of the
oropharynx. The back wall of the oropharynx, or throat, is called
the posterior pharyngeal wall. The back, or posterior, one third of
the tongue surface (dorsum), or base of the tongue, forms part of
the front, or anterior side, of the oropharynx.
[0151] 3. Oral Examinations
[0152] Many structures may be visualized through the mouth to help
a health care professional determine overall health and diagnose
conditions. The general condition of the teeth and mucosa of the
cheeks, gums and tongue are often inspected during a checkup at the
doctor's office. The condition and size of the soft palate,
tonsils, uvula, back wall of the throat, and opening of the throat
are often helpful to indicate, diagnose or differentiate many
conditions such as a cold, flu, sore throat, strep throat or
tonsillitis. These structures, as well as the size of the tongue,
are also important in determining the size of the airway and may be
inspected to help determine if a sleep condition such as sleep
apnea may exist.
II. CURRENT DEVICES AND DIAGNOSTIC METHODS
[0153] A. Usability, Safety and Tolerance of Devices and
Methods
[0154] 1. Safety and Tolerance
[0155] Current diagnostic devices and methods often incorporate
intimidating interfaces that are unpleasant and can create
tolerability and safety problems, especially when in the hands of
an inexperienced consumer rather than a trained professional.
Examples of these interfaces are speculums and tongue depressors
(see FIG. 41). Tongue depressors are usually used when viewing the
oral cavity and throat in order to depress the tongue, which
usually blocks the view of structures such as the throat and
tonsils. They can be uncomfortable and can cause safety problems,
especially if used at home, for example, if the depressor is
inserted too far or the child moves his or her head quickly and the
depressor hits the back of the throat. Speculums are cone-shaped
extensions on otoscopes which are inserted into the ear canal in
order to visualize the ear drum. A speculum is typically inserted
far enough into an ear canal to see beyond the hairs and wax inside
the ear canal. The walls of the ear canal may be delicate and
sensitive, especially when an ear infection is present. The bony
portion of the ear canal, which runs the last 2/3 of the length of
the ear canal, is especially delicate and sensitive and can be
injured by objects such as the tip of a speculum. Tolerability
problems can make it very difficult to view the ear drum and
sometimes it is not possible at all. This situation is most common
in younger children who are scared and uncooperative.
[0156] Forced use of these uncomfortable devices may cause at least
a mild traumatic experience and even more difficulty diagnosing the
child in the future due to the memory of the experience and refusal
to cooperate when a similar situation presents itself. While these
problems may be partially overcome through training and practice,
as is done by providers such as physicians and nurses, they do not
go away. While this training and practice is practical for a
provider such as a nurse or physician, it is not practical to
expect such training from the majority of consumers, for whom the
risks and problems may still outweigh the potential benefits. In
addition, the design of current diagnostic devices are unfamiliar
(resembling medical office instruments) with intimidating
interfaces that are inherently uncomfortable and which may seem to
be threatening to the senses. Children are usually cautious of such
devices and scared of them and a parent or other user does not feel
confident using them. Training and practice do not eliminate these
underlying factors which at best create an unpleasant
experience.
[0157] 2. Usability
[0158] Current devices are typically difficult to use and usually
require training and practice. In order to image the ear drum with
an otoscope, several variables need to be controlled. There are
three parts (head, ear and otoscope) which move relative to each
other. One hand is used to pull the ear back relative to the head
in order to straighten the ear canal. The other hand is used to
hold and position the otoscope. In order to maintain the position
of the ear and otoscope relative to the head, one hand is often
braced against the head and usually also against the otoscope which
is being held in the other hand. All of these variables, as well as
the orientation and depth of the tip of the speculum (portion of
the otoscope which is inserted into the ear canal), are adjusted
and controlled by the user in order to safely use the device and
image the ear drum. A user should be able to see or feel the
position of these moving parts while looking through a lens or at
screen to know if the ear drum is in view. This is a difficult
enough operation to describe, let alone to perform, and usually
requires training, practice and "feel".
[0159] FIGS. 42A-42B show an otoscope in use. The user's left hand
is pulling the ear to straighten the ear canal with some of the
fingers braced against the upper neck. The otoscope is being held
with the right hand, and it is also braced against the left hand
while the user controls the orientation and depth of the speculum
while looking through the viewing piece. This procedure is
difficult enough to perform on an adult (as shown in FIG. 42), let
alone on a young scared, child. Even a trained professional can
sometimes have difficulties managing these variables in particular
cases.
[0160] Similar difficulties exist when imaging the oral cavity and
throat. The mouth is kept opened, the tongue is held down (usually
achieved using a tongue depressor as shown in FIG. 41B) and an
imaging device is oriented to capture the desired anatomy while the
user looks through a viewfinder or at a screen (see FIG. 46). In
this case, variables include head position, jaw position, tongue
position and device position, as well as palate position in some
cases. The user or medical provider may also look inspect the
device or subject's oral cavity with his or her unaided eye,
usually while shining a light into the mouth and throat.
[0161] B. Visualizing the Ear Drum and Diagnosing Ear Infections
with Existing Diagnostic Instruments
[0162] 1. Overview
[0163] As previously discussed, current otoscopes consist of a hand
held device with a cone shaped extension called a speculum. In
order to visualize the ear drum, the ear is pulled back and up in
order to straighten the ear canal. In babies under 12 months, the
ear may be pulled back and down as the canal is straighter in
newborns. The tip of the speculum is then inserted into the ear
canal to visualize the ear drum. Caution must be used to not insert
the speculum too far as well as to avoid pressure of the tip
against the walls of the ear canal. The speculum is moved and
angled in order to direct the axis of the speculum toward the ear
drum in order to get a straight view to the ear drum. Otoscopes
usually have magnification to be able to view a close up of the ear
drum, making alignment even more difficult as the field of view is
limited. The otoscope is usually held with one hand with part of
the hand resting against the head or cheek in order to stabilize
the device, while the other hand is used to pull the ear to
straighten the ear canal. Users need to practice and become skilled
in order to view the ear drum. Skill is even more important to
perform the task rapidly and as comfortably as possible, especially
since the ear is more sensitive when an ear infection is present.
Children are especially difficult to examine due to discomfort and
fussiness, fear of devices and/or the doctor office, and often
being uncooperative. Devices and speculums are unfamiliar and
intimidating devices which are perceived as being threatening.
[0164] 2. Ear Position and Speculum Position During an
Examination.
[0165] Solid lines and dotted lines with arrows will be used in the
figures to represent imaging instrument positions and general
viewing directions.
[0166] FIG. 43 shows an otoscope in use with the speculum inserted
into the ear canal. The position of the imaging instrument, in this
case an otoscope and speculum, is indicated by the solid black line
and the general viewing direction is indicated by the dotted line
and arrow. FIGS. 44,45 show cross sections of the ear and ear canal
and positions/angles of a speculum inserted into the ear canal, and
the position of a cone shaped speculum is represented by the solid
black lines. FIG. 44A is a frontal section, showing the upward and
then slightly downward curvature of the canal. FIG. 44B shows a
horizontal cross section of the ear, showing the back and then
forward curvature of the ear canal. These figures show an ear in a
normal anatomic position. Speculums inserted into the ear canal are
generally correctly oriented to view the ear drum with the ear in
this position, especially with magnified devices. This is why the
ear is pulled back and up to straighten the ear canal for
examination. Both two-dimensional views should be considered to
determine the proper position of an imaging instrument relative to
the 3D structure of the ear canal and ear drum, and whether there
is an unobstructed or obstructed path towards the ear drum.
[0167] FIG. 45 A,B show the ear position, ear canal shape and
position of a speculum when the ear is pulled back and up for an
otoscopic examination. (For an infant, the ear may be pulled back
or back and down due to the different shape of the ear canal as
previously discussed.) With the ear pulled back and up, the tip of
the speculum is usually angled forward and downward (anteriorly and
inferiorly) in order to align with the axis of the ear canal and
provide a view of the ear drum.
[0168] As discussed earlier, the angle of the speculum attached to
the otoscope that the user holds must be controlled in order to
view the ear drum. The large dashed lines show examples of
variability of the speculum direction and position. Small
variations from the desired position/angle may still allow an image
of the ear drum to be captured but the user should achieve and
maintain a position close to the desired angle (i.e. less variation
than is shown by the dotted lines). The depth also needs to be
controlled, so that the instrument is deep enough to acquire an
adequate image and not so deep as to injure the ear drum or walls
of the ear canal that are more sensitive closer to the ear canal.
The side to side and up and down motion must also be controlled to
limit the discomfort and potential injury by hitting the ear canal
walls, especially with the tip of the device.
[0169] 3. Visualizing the Throat with Existing Diagnostic
Instruments and Techniques.
[0170] When a person opens his or her mouth wide, the features that
are usually seen are the teeth, the tongue, the hard palate and
part of the soft palate. The tongue usually blocks the view back
into the throat (see FIGS. 47 A,B). In order to visualize the back
of the throat and the tonsils, a health care professional or other
observer, such as a parent, usually shines a light into the back of
the mouth, usually while looking through a viewing instrument, and
the subject opens his or her mouth and says "aah" (see FIG. 46.).
Sometimes this action lowers the tongue and elevates the soft
palate and uvula enough to see the posterior pharyngeal wall (back
of the throat) and the tonsils. However, it is often necessary to
use a tongue depressor to push down on the tongue in order to see
past it into the throat. In this case, proper positioning of the
tongue depressor is important. It should be placed far enough back
to depress that portion of the tongue that is blocking the view
into the throat but not so far back that it causes a gag reflex.
FIG. 48 shows a tongue depressor in use and a view of the throat
and tonsils.
[0171] Having the tongue depressed is typically an uncomfortable
experience. While it can often be performed routinely in older
children and adults (although it is still unpleasant), younger
children are often not cooperative, especially if they are sick or
have a sore throat. In addition, an inexperienced person may have
difficulty depressing the tongue enough to see into the throat
without causing a gag reflex, or worse, may induce injury to
tissues while using the tongue depressor, especially if it is
inserted all the way into the throat. An inexperienced person may
also require more time and number of attempts to see into the
throat, causing discomfort or distress to the subject.
III. TELEHEALTH SYSTEM: AN OVERVIEW
[0172] The current invention overcomes, or at least greatly
reduces, the problems associated with prior art diagnostic
visualization methods. In various embodiments, the disclosed
systems and methods include the ability to collect subject
information at a plurality of times or conditions, whereby the
information can be transmitted and/or otherwise accessed by the
medical professional and used in the assessment of the subject's
condition.
[0173] The various figures described herein depict a variety of
telehealth and/or other systems for remote diagnosis of health
concerns. It should be understood that, while these exemplary
systems include many different elements, which will be described in
the sections that follow, various other embodiments of such
system(s) may also include additional or fewer elements, as desired
by the user and contemplated by the present disclosure. Some of
these simpler or more complex systems will be discussed later.
[0174] A. Introduction and Exemplary System
[0175] FIG. 1 shows an exemplary telehealth system in accordance
with the invention. A consumer contacts a healthcare provider to
request advice or diagnosis for a health ailment, for example using
a video call. The consumer explains the problem and provides
background health information. The consumer then uses a device to
collect diagnostic information and send it to the provider. The
provider may view this information live on a portion of the monitor
or display screen while also seeing and communicating with the
consumer on the remaining portion of the monitor or display screen.
Information may be transmitted in a lower resolution than it is
collected in depending on the data speeds available. Higher
resolution data can still be collected and maintained on the user
side and selected segments or the entire length of the video can be
transmitted to the provider during or after the live transmission
(see FIG. 2). The provider reviews the information and data and
provides advice or a diagnosis which may include a request that the
consumer comes into the doctor's office, a referral for the subject
to see a different provider, or a prescription for medicine.
[0176] A system (see FIG. 3) typically consists of one or more of
the following subsystems: 1) A user system, 2) a provider system
and 3) a logistics and infrastructure system. For example, a user
opens a software application on a communication device such as
smartphone. This software establishes a link over the internet with
an application server which enables the user to further establish a
link through the internet with a provider whose information is
stored in a database connected to the application server. The
user's information and health records may also be obtained through
the server. The user may then communicate with the provider who is
using a device such as a tablet, smartphone, laptop or desktop
computer. The provider may request additional diagnostic
information, such as images of the user's ear drum. The user then
captures these images with a diagnostic device which sends the
information over the internet to the application server which
stores the information and relays it to the provider. The user and
provider may communicate via a video call and the provider may view
the diagnostic information in real time and/or remotely control
aspects of the diagnostic device (such as zooming, angling the
camera, adjusting lighting, etc).
[0177] B. Other Examples of Systems
[0178] A user may collect images or a video which is analyzed by
software that provides advice or a diagnosis. This software may
reside locally on the user's device, such as a smartphone, or
remotely on a server. A virtual provider produced by the software
may communicate with the user.
[0179] Multiple providers may be involved. For example, a provider
may forward information to a specialist who then communicates with
the user and provider. Alternatively, a specialist or other
additional provider may join the communication between the primary
provider and user, and all parties may view diagnostic information
in real time.
[0180] A system may be used to monitor conditions and alert a user
or provider if certain conditions exist. A user may collect this
information periodically, or a device may continuously or
periodically collect information without the user's input. The
provider may then initiate contact with a user when notified of
certain conditions.
[0181] A user may send information to friends, family or other
users for input or advice. The information may be sent to a group
of users or all users on a system who can then provide feedback.
Such transmissions will be conducted in accordance with applicable
regulations regarding sharing of medical information.
[0182] C. Communication Component and Remotely Linking One or More
User(s) and/or Provider(s)
[0183] A telehealth system will preferably include a method to
remotely link one or more parties through communication devices and
enable voice, video and/or text communication. Alternatively, a
system may employ communication devices to allow a user to record
and/or upload video, voice, text, background health information
and/or diagnostic information, and enable a provider to evaluate
and provide a diagnosis or advice without live communication with
the user.
[0184] The communication component(s) may take a variety of forms.
For example, the user may communicate with a computer, a tablet, a
landline phone, a standard mobile phone, a smart phone such as the
Apple iPhone, a unique communication device specialized for use
with a telehealth system, or any other device that allows
recording, transmission and/or uploading of voice, video, text,
files and/or diagnostic information. In various embodiments, the
device will desirably allow receiving of similar information and
enable the user to receive a diagnosis or advice from the provider.
In one embodiment, the provider communication component is of
similar design and capability. Although in other embodiments, the
user and provider can have dissimilar communications devices and
components which still communicate and allow for sharing of
text/voice/data as may be applicable.
[0185] Desirably, the provider communication device will be able to
receive information from the user and transmit a diagnosis or
advice to the user. The user and/or provider may use more than one
communication device concurrently or sequentially. For example, a
user may use a landline phone to communicate by voice with a
provider and use a computer to receive and transmit diagnostic
information. While the device that transmits diagnostic information
may also have (or may be) a communication device, it will also be
described as a diagnostic processor, which may be separate from the
communication device(s).
[0186] The link between the user and provider may be created using
a variety of methods. A user(s) can initiate a telehealth session
by submitting a request for care. This request may be directed to a
specific provider (for example, the subject's primary care
physician), a limited network of providers, or it may be
"crowd-sourced" to any available provider, which may facilitate a
more rapid response. In addition, the request may be routed to a
nurse hotline or call center that may provide a preliminary
evaluation and as necessary forward the connection to an
appropriate provider, such as a doctor or medical practitioner.
[0187] A provider then accepts the request for care and, in various
embodiments, a secure link between the user(s) and the provider(s)
can be established. This link may be as simple as a phone call but
more desirably includes a video link between the user(s) and
provider(s). Also, as previously stated, the secure link may only
involve the transmission of information (e.g. video, voice and/or
diagnostic information) and not require "real time" live
communication. The diagnostic information and/or other information
such as a recorded voice and video transmission may be reviewed by
a provider and/or software analysis tool offline from the user and
a diagnosis or advice forwarded to the user.
[0188] D. Collecting and Transmitting Diagnostic Information and
Relevant Medical History
[0189] The provider(s) then collect and/or review the relevant
health history from the user(s) and a description of the health
issue that the user(s) requires help for. If some or all of this
information is contained in the user's account or available for
retrieval from a remote location, the user may elect to directly
share this information with and/or authorize release of this stored
data to the provider(s). In addition, it may be desirable for the
user to share up-to-date (current) diagnostic information with the
provider. This information may have been collected recently, over
time, or during the call through the use of various home diagnostic
devices. Examples of subject information can include blood pressure
readings or blood glucose levels. These devices may provide the
data only to the user, and the user can then share this data with
the provider, or the devices can allow the data to be sent or
shared directly with the provider through a communication channel.
This diagnostic information may also be collected through the use
of diagnostic devices described herein.
[0190] Ideally, the diagnostic device is connected to a
communication channel which gives the provider one or more feeds of
the diagnostic data and (when applicable) the ability to control or
refine diagnostic feeds or download snapshots or segments to allow
high resolution or more precise information to be viewed. Relevant
health history information may also include information or data
stored or otherwise obtained from the diagnostic device or a linked
device, such as geographic location data from a smartphone GPS
and/or credit card, payment information from an electronic wallet,
etc.
[0191] The next step is for the provider to determine a diagnosis
or give advice to the user. This may include an e-prescription
(which may include directions to a local pharmacy identified using
GPS geographic information from the user), scheduling a follow-up
consultation and/or recommending the user proceed to a doctor's
office, urgent care or emergency room (which may include directions
to a local service provider based on the subject's location). The
user and provider then agree that a sufficient resolution has been
reached. A third party may be contacted to help reach a
satisfactory outcome if there is disagreement on the
resolution.
[0192] The final step of subject care under this exemplary system
can involve termination of the consultation (e.g. provision of
subject care instructions) and completion of logistics. This may
include submission of an e-prescription for subject collection,
processing of payment, electronic links to or emails containing the
details or summary of the call, and/or creation and submission of
insurance forms or other formal documentation.
[0193] E. Accounts, Logistics and Infrastructure
[0194] In various embodiments, it may be preferred that one or more
user accounts of some type are created prior to the initiation of
the communication. Desirably, a user account should contain
sufficient information to verify that the subject or other
responsible person is able to pay for access to a provider. This
account may be anonymous in nature, containing as little as payment
information only, or may contain detailed information on subject
history and/or a link to a subject's Electronic Health Record
(EHR). Desirably, the provider account should contain sufficient
information to ensure his/her identity and expertise in order to
provide the requested care. This account may be part of a larger
account established and maintained by a physician group, an
insurance company, or other similar responsible group.
[0195] F. Telehealth Systems and Additional Features
[0196] There are several types of systems and features which may be
incorporated into a telehealth system. The telehealth system may be
as simple as a phone call between a user and a provider, or include
videoconferencing and live transmission of diagnostic data such as
images being captured in real time by the user with a device. The
system may also allow text and file sharing as well as links and
updates to a subject's electronic health record (EHR). The provider
may simply give advice or provide a formal diagnosis and submit an
e-prescription. The system may also incorporate computer analysis
of diagnostic data, for example, to give the user probabilities of
certain conditions, or to provide a provider with a more thorough
analysis.
[0197] Multiple types of connections will be described, including
the ability to connect a caregiver at one location, a subject at a
second location, and one or more providers on the same "call". The
user may select specific physicians based on a ranking and pay
appropriately, or offer a specific amount of money and wait for a
provider to accept the fee. There may also be
social/gaming/educational elements built into the system. For
instance, users may wish to "crowd-source" their health issues for
comments and advice from other users. Users may be offered
discounts for achieving a certain level of accuracy in their
feedback to other users. The system may include video-game type
three-dimensional tours through or around the body with examples of
health ailments and ways to prevent or treat these issues. Users
may be given points and increase their status based on correct
identification for exemplary health ailments.
IV. COMPONENTS OF TELEHEALTH SYSTEMS
[0198] Several embodiments of devices, methods and systems which
help facilitate the described telehealth system as well as simpler
and more complex systems are described herein. It should be noted
that that diagnostic embodiments may be used without a telehealth
system, and that telehealth embodiments may be utilized without the
use of diagnostic devices.
[0199] A. User Subsystem for Remote Monitoring and Diagnosis: An
Overview
[0200] Devices, systems and methods of the invention will typically
be described from the perspective of use by consumers but such
aspects of the invention may also be used by providers. It is
preferable that higher end devices and components, such as better
lenses, higher intensity lighting, higher resolution video chips,
more sensitive microphones, additional options for manipulating
data (for example, modifying images and filtering sounds) are
incorporated for use by providers. It is also preferable that
devices allow for more fine control by a skilled provider with
fewer limitations for placement and location. For example, a device
may allow a provider to angle an extension in the ear canal to a
greater extent and to place it deeper than a similar device
intended for use by a consumer.
[0201] A user system (see FIG. 4) typically consists of one or more
of the following components: 1) a communication component, 2) a
component for accessing and/or capturing diagnostic data and 3) a
component for processing diagnostic information. Many
configurations of systems and these components, as well as other
components and features, are possible. For example, a system can
include one diagnostic device which contains all three components.
Alternatively, a system can include 1) a diagnostic device which
contains an accessing and capturing component and a component for
partial processing of diagnostic data (for example, transmitting
data to a smartphone or directly to a provider and/or recording
data) along with 2) a computing device such as a smartphone which
includes a communication component for voice, video or text
communication with a provider as well as a component for processing
diagnostic information (receiving from the diagnostic device and
transmitting to a provider and/or analyzing data).
[0202] B. Communication Component
[0203] A communication component allows the user to connect with
another party, such as other users or a provider, to share
information, and to request and receive advice or diagnosis.
Examples include a laptop, tablet, cellphone or smartphone and
landline phone. Communication may occur by one or more methods, for
example via text, voice or video.
[0204] C. Accessing and Capturing Component
[0205] The accessing and capturing component typically consists of
one or more of the following: 1) an accessing element, 2) a
capturing element, and 3) an anatomical interface.
[0206] Accessing and capturing elements are collectively referred
to as diagnostic elements and are used to access and capture
diagnostic information.
[0207] 1. Accessing Element
[0208] Accessing elements transfer diagnostic information to and
from capturing elements and areas of the body. Access elements
include inputs and outputs such as lenses that transmit light from
a light source towards an object as well as lenses that collect
light and channel it towards a video chip to capture the light.
Access elements include any means to access, collect and transfer
diagnostic information between an area of the body and a capturing
element. These include open channels, reflective surfaces and
mirrors, fiber optics, lenses, diaphragms and other means to
collect and transfer energy including heat, sound, electricity,
light, motion, and magnetic fields. Access elements may also be
used for tissue or fluids of the body. Access elements may conform
to an area of the body where the shape, texture or other
characteristic is of interest.
[0209] 2. Capturing Element
[0210] Capturing elements include elements which are used to create
and/or capture diagnostic-related information. These include source
elements, such as light sources and pressure sources, as well as
destination elements such as video chips. For example, an LED uses
electricity to produce light which can be transmitted towards an
ear drum. This light is then absorbed or reflected back towards a
lenses which focuses the light onto a video chip which translates
the information into electricity to be processed (stored, recorded,
output on screen etc.). A capturing element can also be a user's or
provider's eye or ear, for example, for gathering light or sound
which is then processed by the brain. Pressure transducers may be
used to capture force in order to reproduce a tactile feel which is
similar to nerve receptors on fingers.
[0211] 3. Anatomical Interface
[0212] An anatomical interface may serve many purposes. In general,
an anatomical interface contacts an area of the body to help
facilitate accessing and capturing diagnostic information. For
example, a feature may fit into or on the ear or ear canal to help
align lenses in the ear canal so that the lenses transmit light
towards the ear drum and collect it from the ear drum. A feature
may also be used to help position anatomical structures so that
diagnostic information is better captured, for example, by
depressing the tongue for a view of the throat.
[0213] Anatomical interfaces may also serve as accessing elements.
For example, part of a diaphragm or a balloon in contact with the
body can collect and transfer sound. The interface may also be used
to conduct electricity to or from the body. Interfaces may also
help with safety, tolerance and comfort.
[0214] D. Processing Component
[0215] The processing component includes elements which convert or
process signals or transmit, receive, record, or output diagnostic
information. For example, an image processor and wireless chip may
be included in an ear bud for imaging the ear. After the signal is
captured by a video chip, it is processed and wirelessly sent to a
computing device such as a smartphone. This smartphone receives the
information and records it, displays it on the screen, and sends it
to a provider. Both the ear bud and the smartphone will typically
have processing components.
V. OVERVIEW OF VARIOUS USER DEVICES AND SYSTEMS
[0216] An anatomical interface is provided which serves as a guide
for devices. For example, an ear bud may have a support surface or
through hole to guide an existing otoscope and speculum.
[0217] Attachments or supplies are provided for existing
instruments/devices. Examples of attachments are: a speculum with
an anatomical interface, such as an ear bud molded onto it, that is
attached to existing instruments; an ear bud may be separately
formed and slipped onto or otherwise connected to a speculum; a
curved or flexible speculum structured to fit onto a standard
camera or smartphone; a flavored sleeve that is slipped over an
oral scope for imaging the throat, or a soft sleeve that is placed
over a tongue depressor or a semi rigid tongue depressor with a
soft outside.
[0218] Diagnostic devices are wired to a small "box" which then
processes diagnostic information. Multiple devices may be supplied
which can attach to and be detached from the box. The box may send
information to a computing device such as a smartphone or directly
over the internet to a server. This box may be rigidly attached to
some diagnostic devices (for example, with wireless contacts into
an oral device) and connected by wire to other devices, such as a
small ear bud for imaging the ear. Devices may also send
information wireless to the box for further processing.
[0219] A single device may capture and process information. For
example, an ear device may capture images from the ear and send the
information directly over the internet to a server. Alternatively,
the device may send the information to a computing device, such as
a smartphone, to output or record information, and to a local "box"
to other wise process information, such as sending it directly over
the internet to a server. The device may also have communication
elements, such as a microphone and speaker. This device may link to
a smartphone via Bluetooth for communication. Alternatively, the
"box" may contain communication elements and serve as a standalone
communication device or be linked to a smartphone which establishes
the communication.
[0220] A device may have multiple diagnostic elements and
anatomical interfaces built into it, so that it can be used to
access and capture one or more types of diagnostic information at
one or more locations of the body. The device may alternatively
have processing elements and be supplied with attachments that have
diagnostic elements, there may be a combination of the two. For
example, a device can be supplied with multiple capturing elements
such as a video chip and other sensors (such as MEMs, or
microelectromechanical sensors). Some interfaces built into the
device allow the use of some of the sensors to collect information
from the body. Other attachments with anatomical interfaces help
access additional diagnostic information at other locations. Still
other attachments can be supplied with sensors to capture
information and can also include anatomic interfaces.
VI. COMMUNICATION DEVICES, SYSTEMS AND METHODS
[0221] A. Communication Component
[0222] Subject/caregiver communication devices can have any kind of
structure, and can include devices which allow connection to a
distant location, ideally allowing video, text, file sharing and/or
other data connection. A plurality of communication devices can
also be used in tandem. For example, one communication device may
be used for video/voice communication, and a second communication
device may be used as a channel to display and/or transmit
diagnostic information to the medical services provider. Also,
users may be more comfortable speaking over a landline telephone
but can see the provider on their computer (a communication device)
which also serves as the data diagnostic processing unit to
transfer data to the medical services provider. Examples of
communications devices are provided below, and they may be used
alone or in combination with other communication devices, for
example: [0223] landline telephone, which can be used for a simple
phone call or with a diagnostic device with wireless/wifi
capability or other internet connection which connects to a
conference call with, and feeds information to, the provider. A
user can also use a landline phone with a computing device to
provide video capability; [0224] mobile telephone; [0225] computer
and telephone; [0226] tablet and telephone; [0227] tablet only;
[0228] computer only (with a standalone diagnostic device as
applicable); [0229] supplied device specifically for communicating
with this system. Such devices are ideally suited for the elderly
and they may also serve as the diagnostic computer. The device may
be connected cellularly or have an RF or other wireless
transmission mode for connection to the Internet or to a base
station connected to internet or wireless; and
[0230] monitoring device or system set up in a bedroom having wide
view or zoom capabilities, which may be initiated by a caregiver
(e.g. for elderly subjects). The system may comprise one or more
cameras located in one or more rooms of the house. Users may be
connected to these communication devices in a variety of ways. One
method, especially useful in case of an urgent issue, is a push
button device worn on the body (such as a watch, bracelet, or
necklace).
[0231] Examples of a provider's communication device include:
[0232] telephone only (landline);
[0233] telephone and computing device for video or other data
connection;
[0234] mobile phone only;
[0235] tablet only;
[0236] computer only;
[0237] video conference room; and
[0238] simultaneous feeds to other providers for training or
additional physician (e.g. a specialist).
[0239] A communication device preferably has software providing a
user interface to facilitate communication, provide a user
experience, transfer of diagnostic information, recording,
output/display, and/or other features to aid in the telehealth
service.
[0240] A communication device may also serve as a diagnostic
processor (further described below). This device may output
diagnostic information (e.g. display images) and transfer the
diagnostic information to the provider. When used in this fashion,
the device may switch from video/voice communication to a voice
call only while collecting and transmitting diagnostic
information.
[0241] B. Systems and Methods for Remote Linking of One or More
Parties
[0242] A connection between the subject/caregiver and the
provider(s) may include any of the following steps, which may be
performed in any order:
[0243] 1. Request connection time, for example, as soon as possible
while waiting, request first available appointment, request
appointment at specific time, or within a particular date or time
window;
[0244] 2. Select preferred provider (e.g. primary care
physician);
[0245] 3. Select preferred group (e.g. primary care and
associates). Groups of medical practitioners may be available for
selection, or a consumer may be able to select several individual
physicians;
[0246] 4. Select crowd source option, e.g., for instantaneous
access, or for first to respond;
[0247] 5. Select tier base of providers, wherein users pay more for
higher credentials or higher ranked providers;
[0248] 6. Select tiered approach for provider selection. For
example, if the primary care physician is not available, the
request for medical care will then pass to the next larger group
after a predetermined time period, then to associates, then
crowd-sourced;
[0249] 7. Triage by an instant connection with a nurse hotline, and
then routed to an appropriate provider (e.g., physician assistant,
nurse practitioner, primary care, pediatrician, dermatologist,
etc.);
[0250] 8. Call center to answer and route call;
[0251] 9. Emergency/distress request. This urgent request for
assistance may be initiated with a panic button or a device worn on
the body with a distress button. This button initiates a call
and/or enables video devices in the area of the user. The button
may also directly contact 911 services or other emergency response
services. Upon initiation, the system may automatically collect
data, download relevant information (e.g., GPS location
information, current medical conditions such as diabetes, or
current medication and prescription information) and/or maintain
connection/control by remote user (e.g., medical personnel or
police) throughout the entirety of the call to monitor the
emergency situation and/or provide assistance.
[0252] Any of these options may be first initiated by a caregiver,
and then the subject can be linked to the communication.
[0253] A connection between a caregiver and a subject may be
received in any number of ways. For example, there may be a request
from a subject to one or more caregivers. A request could be sent
out to a single person, a few select people, or to many caregivers.
Alternatively, there may be a request from a caregiver to a
subject. The caregiver could open a video or communication
connection without the need for the subject to "answer". For
example, the caregiver can activate multi-room cameras or a camera
in the bedroom or a bedside device.
[0254] C. User Interface and Software
[0255] A provider or other party can be provided with the ability
to remotely select snapshots or a short segment of a video feed (or
other type of diagnostic data such as sound) for high resolution
download.
[0256] The user interface of the present invention allows for a
simple and fast method of establishing a connection with a provider
in the user's preferred method (e.g. crowd-sourced or only to
primary care physician, etc., as discussed earlier). This software
may be part of a standalone system, or the software may be provided
as an interface for the user which links with third-party
telehealth services. This option may be especially useful when the
user's insurance company already has a contract with a telehealth
service but the user (and optionally the insurance company as well)
desires the use of diagnostic devices described herein. The user
interface would establish the easiest and clearest way for the user
to manage the call and diagnostic devices while still using the
third-party telehealth system as the "backbone" of the
communication.
VII. FEATURES AND ADVANTAGES OF NEW DIAGNOSTIC DEVICES, SYSTEMS AND
METHODS
[0257] The subsequent discussion focuses on the different
techniques used to gather diagnostic information, such as imaging
and sound, as well as devices that incorporate these methods and
which interface with the human anatomy to allow reliable data
capture; and connecting these devices to diagnostic processing
components to transmit, output, record, and/or upload the data and
techniques used to manipulate or remotely control the data and/or
device for higher quality or more efficient viewing of data for a
more accurate diagnosis. Diagnostic devices may be fully or
partially composed of one or more features discussed in this
section, including: 1) accessing and capturing components, 2)
anatomical interfaces, and 3) diagnostic processing components. For
example, a diagnostic device may incorporate a lens and fiber
optics (accessing), which channel images to a video chip
(capturing) which is encapsulated within a thermoplastic shape,
which fits into the ear canal (anatomical interface) and attaches
to a small external ear component which records images and sends
the information via BlueTooth.RTM. (diagnostic processing) to a
smart phone for display, recording, and transfer to the internet
(diagnostic processing). In this example, the smart phone may also
be used as the communication component.
[0258] A. Overview
[0259] Devices, systems and methods are described which enable a
user, especially an untrained consumer, to more easily capture
health and diagnostic information; allow for safer use and provide
a more tolerable and comfortable experience for the subject; enable
or facilitate remote assessments or diagnoses; or perform data
analysis to give a probability that a certain condition exists or
help a provider determine the correct diagnosis. Features and
methods are described which reduce or eliminate relative motion
between the device and the body part being examined, reducing user
error and making it easier to collect diagnostic information.
Certain positions and angles and methods of achieving these
positions are described which are advantageous for capturing
desired data. Additionally, structures are described which position
or align devices or elements into (or close to) these desired
positions. Familiar structures that are used in a similar fashion
as existing consumer devices (such as an earphone) are described
which enable a user, especially a consumer with limited experience,
to use the devices with limited or no training or practice. These
and other features may also provide for safer use, better
tolerability, and an overall more comfortable experience for the
subject. A subject is more comfortable seeing a familiar device and
knowing, at least generally, how it will be used and what to
expect. Softer, conformable and better fitting structures also
provide a more comfortable experience, as do features which
stimulate other senses, for example, a speaker in a device for
imaging the ear, or a pleasant tasting oral device warm/cool/cold
oral or ear device. Other features prevent or reduce the likelihood
of injury to the subject. Existing devices, such as a smartphone or
tablet, may be positioned so that the subject sees what is
happening, if he or she if so desires. This feature may be
especially beneficial for a single user trying to capture images
under the thigh or on the back with a device that transmits signals
to a computing device, (such as a smartphone), for viewing.
[0260] These and other features help to empower consumers, making
them more likely to address health ailments, and also to do so
sooner than they might otherwise have. These devices, systems and
methods may also be used by providers such as nurse and doctors.
Although many features are described as serving a particular
purpose, the features may have additional or alternative
functions.
[0261] B. Anatomical Interfaces
[0262] Devices, including attachments, may be constructed with one
or more components or features which are structured for contacting
parts of the body, creating an interface between the device and the
body. These interfaces can make it easier to use a device or
provide for improved safety, tolerance or comfort. For instance,
interfaces may provide support or stability and reduce relative
motion between components and the subject; help to encourage or
achieve preferred positions and angles for accessing and capturing
diagnostic information; reduce potential for injuring tissues; or
provide soft and/or conforming interfaces for comfort. Interfaces
may position a device with diagnostic elements in a preferred
position or close to or within a window around preferred positions,
thereby reducing the amount of user input or manipulation required
to achieve a preferred position (a position capable of capturing
desired diagnostic information). Interfaces may serve as locating
features which help position a device at or close to a desired
location or position prior to final positioning of other components
or parts of the device, diagnostic elements, additional anatomic
interfaces, or other accessing and capturing components. For
example, an ear bud component with a through hole can be positioned
in the ear prior to deploying an extension, attachment, or other
part of the device through the ear bud into the ear canal.
[0263] Similarly, an ear bud with a partially deployed extension
may be positioned in the ear and ear canal respectively, which may
then be in a position to capture diagnostic information or may
require additional manipulation, extension or other positioning.
Similar devices may be structured for capturing diagnostic
information at other areas of the body, for example in the mouth,
or oral cavity.
[0264] C. Usability
[0265] 1. Positions and Angles
[0266] Preferred positions are positions and angles of the device,
components and/or elements which enable the desired diagnostic
information to be captured. Several preferred positions and angles
will be described for components and elements which are involved in
accessing and capturing diagnostic information. These positions may
allow more relevant, accurate, reliable, easier, comfortable and/or
safer collection of diagnostic data such as images, sounds and
electrical signals. Methods of using devices and components as well
as features of devices, components or elements help to access
and/or encourage these positions. Preferred positions may be
achieved in a variety of ways. For example, with anatomical
interfaces can help to position sections of a device, attachment,
diagnostic element, in conjunction with the shapes of extensions or
other sections of devices, (for example, as shown in FIGS. 17, 19,
99 and 101), attachments.
[0267] 2. Support and Stability
[0268] Features may provide for anatomical interfaces which help
achieve preferred positions and/or provide support or stability to
the device or parts of the device. These interfaces may directly
help to encourage a preferred position. For example, an oval
feature can be shaped to fit into the entry of the ear canal with a
smaller profile extension extending further into the ear canal.
This extension may be offset and/or angled from the center axis of
the oval part or may also be located in the center of the part and
extend straight out (for example, see FIGS. 27 and 28). The oval
feature may be part of the device, an attachment for the device, or
a guide placed into the ear/ear canal prior to using a device. This
guide may have a through hole, or part of the oval may be cut away
so that an extension of a device with diagnostic elements, or
another component for diagnosing conditions (such as a speculum),
may slide through or past the guide and be encouraged into a
preferred position. This oval (which can be part of the device, an
attachment, or a separate guide), as well as other features
described throughout, may serve other or multiple purposes, such as
protecting the tissue in the ear canal walls from being injured or
preventing over-insertion and injury to the ear drum.
[0269] An interface may also indirectly help a user to maneuver the
device into a location that is capable of capturing the desired
diagnostic information (a preferred position) by providing support
to help stabilize the device, and reduce or eliminate the relative
motion (up/down, side to side, in/out, rotation etc.) between the
device and the ear or other body part. For example, a cheek pad or
an over-the-ear retaining component similar to an ear phone may
help to both support and stabilize a device. A stabilizing
component can support all or part of the device weight.
[0270] Interfaces may both directly and indirectly encourage a
preferred position. For example, an ear bud may be structured to
fit within the concha in a certain position to provide support and
stability to the device and to have an extension extending at a
certain position (from the center or offset from the center) or
angle relative to the ear bud. Part of the ear bud may also be
structured to fit into the ear canal. This interface may be thought
of as a combination of structures, one fitting into the concha and
one fitting into the ear canal.
[0271] The ear bud, with or without a part that fits into the ear
canal (or other support structure such as a cheek pad) may be
compressible or have a compressible member (such as a spring)
joining it to other part(s) of the device to provide stability and
support prior to the device being moved into a position to collect
diagnostic information, thereby helping with both usability and
tolerability of the apparatus. For example, an ear bud with a
certain width may have a hole through which a small diameter
extension or speculum may pass through. The ear bud is attached to
the device, extension or speculum at the side furthest from the ear
canal. When the ear bud is placed into the concha, the extension or
similar component is positioned at or near the entrance to the ear
canal. When the device/extension is moved towards the ear, the ear
bud compresses to less than the original width, allowing the
extension or similar component to move further into the ear canal,
and preferably into a more anatomically-suitable position.
[0272] Another example of an interface is a structure which fits
fit into the oral cavity and has diagnostic elements for imaging
the throat which are positioned at the end and near the top
(posteriorly and superiorly). Preferably, the elements are angled
slightly downward. This structure positions elements away from and
above the tongue in order to see towards the back of the throat and
down and behind the tongue.
[0273] 3. Variations of Anatomical Interfaces for Improved
Usability
[0274] Other features or variations of anatomical interfaces may
also be incorporated to facilitate positioning of the device,
components or elements into a position capable of capturing desired
diagnostic information (a preferred position), or otherwise make
the device more usable. Examples included flexible or conformable
anatomical interfaces, such as a small diameter flexible tube
placed in the ear canal, which conform to the body or passageways
into the body (such as the ear canal or oral cavity and tongue),
angled elements, such as at the end or tip of extensions or
attachments and/or combinations of multiple elements in different
positions or placed at different angles. Sections or extensions may
also be shaped or curved to help achieve preferred positions.
Flexible or elastic structures, such as extensions, can be formed
with a certain shape to help achieve preferred positions, and which
can move to conform or partially conform to anatomy to also help
achieve preferred positions. For example, such structures can
contain a shape memory structure that helps the component return to
the original shape when forces are removed. Examples of shape
memory structures include wires or coils, for example, those made
with a shape memory plastic, stainless steel, or nickel titanium
(nitinol). Examples of shaped components which can also be
structured to flex or bend and which can return to their original
shape are shown in FIGS. 17, 19, 99 and 101. A device, component,
or attachment may also have a portion which may be extended by the
user, or it may have a hole through which a component is extended
through, optionally requiring a compression force to be applied by
the user in order to extend the element. For example, a spring
mounted extension (for example, a speculum or a device which fits
into the oral cavity) may be deployed by the user after positioning
a device with an anatomical interface (for example, an ear bud with
a through hole for the speculum or a mouth or oral piece with a
through hole for a smaller extension to extend through) by pressing
a button in. This extension may extend straight out or extend at an
angle, possibly being placed at a position or in a configuration
that would have been difficult to insert if the components were
fixed relative to each other. This feature may also provide for
increased tolerability and comfort by allowing rapid insertion,
data capture, and retraction. Another feature which may allow
positioning a device in a desired position or location is a camera
mounted in, on or near a diagnostic accessing or capturing
component/element. For example, a camera at the edge of or near an
opening in a diaphragm for a stethoscope can allow a remote
provider to guide the user in positioning the stethoscope or allow
the provider to confirm the correct positioning of the
stethoscope.
[0275] Another example of a feature to help improve usability is
the addition of small screens or speakers on devices in order to
see or hear the information that is being collected. A device may
also have features which allow attaching it to an existing device,
such as a smartphone or tablet, to which the information is being
transferred and by which the information can be seen or heard. A
device may also be tethered to the component which is close to the
body and which collects the diagnostic information. For example, a
small ear bud containing one or more video chips and LEDs is
connected by a flexible wire, (which may be retractable), to a
separate component which houses the battery, electronics and
wireless chip. This separate component may also incorporate a
screen and/or be able to be secured to a smartphone or tablet to
help view or listen to the diagnostic information being
collected.
[0276] D. Safety, Tolerance and Comfort
[0277] 1. Position and Depth Control to Reduce or Prevent
Possibility of Injury
[0278] Features or components which control the position or depth
can be used in order to help avoid sensitive areas or to reduce the
likelihood of causing an injury. For example, a feature can provide
for an anatomical interface to prevent the tip of a device from
being forced into the side wall of an ear canal or into the ear
drum. Alternatively, features can prevent over-insertion into the
oral cavity and contact with the posterior (back) wall of the
throat by being stopping against the outside of the mouth or
against the teeth or gums.
[0279] 2. Familiar or Benign Devices
[0280] Devices and components which are more familiar and/or benign
looking to the user and subject can be used for an improved subject
experience. Such components may reduce the anxiety and stress
commonly induced by foreign-looking objects and instruments such as
those typically found in a doctor's office. Examples of more
familiar devices or components are structures which resemble an
earphone or pacifier. An extension into the ear that is closer in
form and shape to a cotton swab than a speculum is preferred. An
extension into the mouth which resembles a pacifier, a popsicle, or
other object commonly inserted into the mouth is preferred over an
instrument which looks like a tongue depressor or endoscope.
[0281] 3. Soft Outer Surfaces
[0282] Soft outer surfaces (such as urethane, silicone or
thermoplastic elastomer) are preferred on components which contact
the body, i.e. anatomical interfaces. These surfaces are preferably
slightly compressible if room allows and any edges are contoured or
rounded.
[0283] E. Portability and Modularity
[0284] The present invention allows for compact and modular
devices. One or more features may be combined into a single device
to perform one or more diagnostic procedures (i.e. capturing an
image). This device may allow for attachments to perform additional
diagnostic procedures or to improve the capturing of diagnostic
information, for example, to create a safer, more accurate, or more
comfortable device. Attachments may also be created for existing
devices or attachments using described features. For example, a
flexible optical extension coupled to a smartphone camera or an
attachment for a speculum can be used to that help achieve a
preferred position.
[0285] F. System, Functions and Processing
[0286] The device, alone or in combination with a separate
processing unit (such as a smart phone, computer or tablet), may
provide functions which allow easier or better capturing,
processing and/or output, as well as storage, of diagnostic
information. For example, lights may automatically be adjusted for
intensity or angle, or can be turned on and off to capture a better
image of the desired object or location. Lights with different
wavelengths may be turned on or off to collect different types of
diagnostic information. An image may automatically, or upon a
user's (consumer, provider, etc.) request be enlarged and cropped
to display the object or location of interest. This feature would
make it easier to use a wide angle to capture an image and allow
for a larger margin of error when using a device, while still
showing a detailed image of the desired object or location. A user
may be guided with images, video and/or sounds during placement or
while adjusting the position of a device to help achieve a position
to collect the desired diagnostic information. Sounds or images and
video may be analyzed with software to autodiagnose conditions,
give a probability that a certain condition exists, or help a
provider determine the correct diagnosis.
[0287] G Diagnostic Information
[0288] Various types of diagnostic information may be useful to
help provide a provider give a diagnosis or medical advice to a
user. For example, a user may be concerned that his or her child
has an ear infection. The provider may desire images of the ear
drum, body temperature, and medical history. In this case, a light
sensor (e.g. CCD or CMOS video chip) may be used to image the ear
drum. A standard thermometer or a device with a temperature sensor
may be used to record the body temperature and transmit the data to
the provider.
[0289] Another example of an illness where telehealth systems may
be helpful is an upper respiratory infection. In this case, the
provider may wish to know how the upper airway and/or oral cavity
appears, as well as obtain lung sounds and heart rate. A device
with a light sensor may be used to collect images from the upper
airway and a device with a microphone may be used to listen to lung
sounds as well as the heart rate. This information may then be
transmitted live to a provider or uploaded for review at a separate
time by a provider. The medical test data or diagnosis information
may be stored locally by the user, by the medical practitioner, or
by the medical care facility. The data may also be transmitted to a
medical data storage location, or saved in the cloud as is known in
the art.
[0290] Various other potential ailments may be evaluated. For
example, images of the skin may be useful for diagnosing rashes,
skin cancer or poison ivy. Images of the eye may be collected for
eye problems such as red eye or foreign bodies. Images inside the
nose may be useful for evaluating potential allergies or nasal
infections. Sounds of the knee joint or other musculoskeletal areas
may be recorded to help diagnosis arthritis or other ailments.
[0291] As will be discussed, a multitude of other data types
(light, sound, electrical, temperature, strain, etc.) may be useful
to examine an individual for an untold number of potential
ailments.
[0292] H. Accessing and Capturing Diagnostic Data or
Information
[0293] Capturing devices can include a data capturing element such
as a microphone or light sensor (i.e. CMOS or CCD chip). Examples
of capturing devices include commercially-available and standard
off-the-shelf devices as well as specialty devices. Examples of
standard devices are those which may readily purchased from vendors
and include smart phones, tablets and computers. Specialty devices
are devices built or supplied specifically for purposes of the
invention as described herein or supplied by other vendors for
purposes similar to that described herein. Examples of specialty
devices include devices which are similar in form to a smart phone
as well devices which are incorporated into an anatomical interface
and/or processing unit, which will be described in further detail
below. Examples include speakers incorporated into a belt, such as
those which are similar in form to a heart rate monitor; and a
video chip incorporated into an earphone device that is similar to
an earbud or a device that includes an over ear retaining
piece.
[0294] 1. Imaging
[0295] Accessing and capturing light for displaying images can be a
very useful diagnostic tool. Light is emitted by a light source
(for example, a light bulb, flash, ambient, or LED) and then
reflected or absorbed by the environment (for example, the
atmosphere, skin, or mucous) prior to being captured, for example,
using a film camera, CCD or CMOS chip. Lenses and similar
components are considered herein as accessing elements. Light
continues to be modified or transmitted until it hits the
capturing/sensor element, for example, a CMOS or CCD chip. The
light may be accessed, focused, and transmitted prior to reaching
the capturing element by means of devices such as lenses, fibers,
mirrors, and filters. The captured image may differ depending on
the light source. For example, in the morning and evening, the
ambient light from the sun is different and the scene viewed by an
observer is different. Likewise, different LEDs or filters may be
used to provide light of different wavelengths. Wavelengths outside
of the visible spectrum may also be emitted, filtered or captured.
For example, certain wavelengths may be useful in distinguishing
whether there is biofilm present, which is indicative of an
infection, or be absorbed or reflected differently when there is
fluid behind the ear drum. Variations of these features and/or
methods may be incorporated into a diagnostic device.
[0296] Light may be captured by any light capturing device at any
location on the device, for example, near the end of the device,
using a video chip (e.g. CMOS or CCD), or accessed at any location
on the device, for example, by means such as lenses, fibers and/or
mirrors and channeled to a light capturing element. Devices
containing light capturing elements may take many forms. For
example, light may be channeled to a light capturing element in an
existing device such as a smart phone, tablet or computer. Light
capturing elements may also be incorporated into specialty devices
such as an earphone-type device or a specialty diagnostic
instrument which may have a form factor similar to that of a smart
phone. Light may be captured/accessed directly in from the end of
the device, or capturing/accessing elements may be configured at an
angle or to the side of the end of the device.
[0297] Multiple accessing and capturing elements may be
incorporated into a device. For example, two or more fiber bundles
may be configured so that their ends are at different angles or
locations. These fibers then channel the light to one or more light
capturing elements (e.g. CCD or CMOS chip). This configuration will
allow different images to be seen. If the light is channeled to a
single capturing element, two different images may be seen in the
same display. Software may be used to alternate the display the
desired portion of the image on the full screen. Alternatively, a
mirror may rotate to alternate the displayed images from the two or
more different fibers. If the fibers are positioned at left and
right positions, the two images may be combined in order to create
a 3-D image. If a single capturing element is used, software may be
used to differentiate the images and then create the 3-D image.
Alternatively, straight channels and/or channels and mirrors may be
used to transmit the light to the light capturing element without
the use of fibers. In other embodiments, light capturing elements
may be located the end of the device and capture the light at that
location, at multiple locations and/or multiple angles.
[0298] Light may be supplied in a variety of ways as well. Light
may be emitted from a light source (e.g. LED) at the end of the
device or light may be transmitted to the end of the device. For
example, fibers, mirrors, or straight channels may be used to
transmit the light to the desired output location. Various filters
may be used to change the emitted wavelength, and more than one
color or wavelength light source may be incorporated into a device.
Filters may also be placed just in front of the capturing element
and/or software used to modify the exposure so that certain
wavelengths, brightnesses, or other types of image variables are
modified or restricted from the image. Light may be output in a
variety of geometric shapes or configurations as well. For
instance, light may be output in a ring surrounding the video
accessing and/or capturing elements; emitted from a single location
adjacent to the accessing/capturing element(s); or emitted from a
plurality of locations relative to the accessing/capturing
elements.
[0299] Multiple accessing and capturing elements may be positioned
to image different areas. For example, the user or practitioner may
desire to see an image of the skin, throat, or ear while also
seeing a more contextual image, such as how the device is being
used and positioned. An example of one configuration is using one
of the cameras of a smartphone to capture an image of a child, and
channeling light using fibers from the child's ear to the second
camera on the smart phone. Imaging accessing and capturing elements
may also be positioned to capture images in different locations of
a desired target area, for example, in the oral cavity and then
further away in the back of the throat. Imaging elements may also
be located close to one another while still capturing images at
different locations by having different focal lengths. This may be
accomplished using lenses or other components, for example,
software that can focus an image after capture in conjunction with
a capturing element that identifies angles of captured light, e.g.,
using Lytro camera technology.
[0300] Various methods may be used to maintain a clear image. For
example, air or water may be channeled to or away from the end of
the device to maintain a clean and clear end of the accessing
element (such as a lens), or air and water can be circulated around
or behind the lens or other accessing or capturing element to
prevent condensation or fogging. Anti-fogging fluid may also be
applied to the device prior to use.
[0301] An accessing element may also be expandable. For example, a
tube may be compressed for accessing a location and then expanded
(for example, by inflation) to expand its diameter or size and
thereby access a greater imaging area. Another example of an
expandable device is one constructed of a central expandable member
with accessing and/or capturing elements surrounding this member.
When the central member is expanded, the surrounding elements are
pushed out, accessing a larger area. Expandable members may also be
used to change the position or angle of the accessing/capturing
elements. For example, an expandable member may push the
accessing/capturing elements up into the top of the oral cavity or
to one side of an ear canal. Similar techniques may also be used
for light sources.
[0302] Accessing and/or capturing elements may be configured for
flexibility to allow conformance to a desired location (for
example, an ear canal) and/or incorporate elements that allow the
flexible elements to be manipulated. For example, a fiber bundle
may be steered by a user in a fashion similar to endoscopes, or be
remotely steered by a provider or other person. Alternatively, just
the tip elements (such as a lens, mirror and/or light sensing chip)
may be steered or manipulated. Manipulation of the elements may
include modification of the focal length.
[0303] Other imaging techniques may also be incorporated into
diagnostic devices. One example includes ultrasonic imaging.
Combinations of multiple imaging techniques are also with the scope
of the present invention.
[0304] 2. Detection of Sound
[0305] Sound can be detected using a diagnostic by any number of
techniques. Sound may also be accessed and captured by a variety of
methods. In contrast to light, sound may be captured through the
air, or captured after being transmitted through fluids or tissue
or devices. Microphones may be mounted on probes to record sounds
when the probe is in contact with the body or when placed into
cavities such as the mouth. These microphones may be placed at the
tips of the probes or away from the tips, and they may record
vibrations transmitted through the probes. Microphones may also be
mounted on or in surface-mounted devices. Examples of these devices
include pads placed on, attached to, wrapped around, or worn on a
body part, such as a knee brace, belt, or vest. These devices may
be designed to capture sounds such as those emitted by joints, the
heart and/or the lungs or airway. Microphones located at or close
to the surface of the device near tissue may capture more localized
sound while microphones located deeper in devices and further from
tissue may capture sounds from a larger area. Sound may also be
accessed at a distance and channeled through one or more tube(s) to
a microphone in a capturing unit.
[0306] Sound accessing elements may be "open", or natural, or
constructed similar to a diaphragm. This diaphragm may be designed
to conform to the desired area for a more thorough and reliable
contact area, or to amplify the sounds or to collect sound from a
broader area. The diaphragm may be similar in configuration to that
of a stethoscope. It may attach to a capturing device with a
microphone, such as a smart phone or a small unit with a microphone
that transmits the sound, preferably wirelessly, to a diagnostic
processing device such as a smart phone. Alternatively, the
diaphragm and microphone may be incorporated into the same unit
which attaches to a diagnostic processor which transmits the data,
preferably wirelessly, to another diagnostic processing unit such
as a smart phone which may output and/or store and/or send the data
through the internet. This diaphragm, with or without microphone,
may attach to the same diagnostic processor as the light accessing
element.
[0307] Sound may also be filtered and/or amplified. For example,
when using a diaphragm and stethoscope-type device, sounds related
to heart and/or lung ailments may be filtered and amplified while
other sounds may be filtered and discarded. This filtering may be
done by the diagnostic processing unit or at the provider end and
may be controlled by the provider. Also, microphones with different
sensitivities may be used in order to collect a larger range of
frequency of sounds and/or larger range of amplitudes. Once again,
filters may then be used if desired or appropriate.
[0308] The invention also provides for a heart rate (HR) type belt
or similar device (FIG. 32) which can be used to detect breathing
sounds and to listen to the lungs as well as to check the
heartbeat. For example, the capturing elements can include
microphones for sound and sensors for electrical activity, as well
as other sensors such as accelerometers which may be useful to
capture motion (i.e. body movement or chest movement for breathing)
while awake or asleep. Other examples of devices to detect sounds
are a vest with microphones (FIG. 33); and a small interface
similar in size to the end of a stethoscope which is attachable to
a smart phone or other device with a microphone (FIG. 31A,B) or
containing a microphone and interfacing with an adapter to send the
sounds to a computer. These devices may also contain various types
of capturing elements (i.e. electrical sensors,
accelerometers).
[0309] One or more of various types of microphones (capturing
elements) can be contained in a stethoscope-type device or
attachment to convert sound into an electric signal, for example, a
dynamic, condenser or piezoelectric microphone. A typical diaphragm
consists of a thin walled polymer with space behind it (i.e.
similar to a balloon) or other structure that allows motion or
transmits pressure changes, can be used to access sounds of the
chest cavity or other areas of the body. These materials or
diaphragms can also access and transmit electric signals, for
example, when formed from or containing conducting materials or
elements such attachments may also contain or connect to sensors,
for example, in order to detect electrical signals of the heart.
Diaphragms, a conforming polymer material, or other materials which
access or capture electrical signals can be structured for
application to various areas of the body, including the forehead,
wrist and hand. Microphones may be set at a distance from the
diaphragm, as may be preferred with a dynamic microphone, or in
direct contact with a material or matrix of materials which
includes the diaphragm or sound/pressure/movement accessing
material. For example, a piezoelectric microphone may be mounted on
a piece of rubber which is connected to a diaphragm.
[0310] Microphones may have different sensitivities when there is
more than one microphone in a device or attachment. A camera may be
positioned in a location to view the placement of the device (i.e.
by the provider), for example in the center of the device or near
the outside of the device. The diaphragm may be offset under a
camera, structured to surround the camera, or multiple diaphragms
or sections of a diaphragm can surround the camera. A light pointer
can also be used to help with placing a device. For example, a
focused beam of light can be emitted from the device to show where
the device or diaphragm or other accessing component is facing. A
provider may then direct the user to move or position the device as
desired. Software may also be used to detect the position of this
light beam (by analyzing the image viewing with a camera in the
device or attachment) and to direct the user to the correct or
desired location.
[0311] A doppler stethoscope attachment which both transmits and
receives sound, such as case ultrasonic waves may also be supplied.
A plurality of types of sound sensing techniques may be
incorporated into a signal attachment and used at the same time or
at different times. Alternatively, sound may be collected by an
attachment and transferred, for example through open sound tubes or
through vibrating material(s), to the main device which houses the
capturing element(s). FIGS. 31, 38E, 86D, 87C, 88D and 102 show
exemplary embodiments of various stethoscope attachments.
[0312] Certain embodiments of the invention provide for a method to
detect internal sound by external diagnostic equipment. One goal of
such embodiments is to give the practitioner or user a sense of
what the subject feels, and such embodiments are particularly
useful for orthopedics.
[0313] An example of a device having sound capture features is a
brace for the back, knee or other area to pick up sounds
(preferably internal) that may provide a diagnosis when used alone,
or which provide reassurance when combined with other diagnostic
data such as images. Similar methods and structures as discussed
for stethoscopes can be used to pick up these other internal sounds
of the body, such as the sounds of joints that are moving.
Microphones located away from the surface of the body may also be
used to pick up the external sound of joints.
[0314] 3. Movement or Motion
[0315] Movement can be detected or captured using any kind of
motion-detecting device. Examples of such devices are strain gages
and accelerometers. Pressure in tubes can also be used to detect
expansion/contraction, and pressure or sound changes in
bags/compartments can be used to detect motion, for example,
devices placed under a mattress. Such devices can also be placed
around a subject's legs, knees, or other body part for detection of
muscle or limb motion.
[0316] In certain embodiments, GPS units can be used to detect
motion. External stereotactic devices, which devices track three or
more points, can be mounted on various worn items; or wrapped on or
affixed to a subject's legs, vest, belt, or other part of the body
or clothing.
[0317] 4. Other Measurements
[0318] Muscle spasms or tension can be monitored to detect or
diagnose conditions such as headaches which are often
musculoskeletal.
[0319] Headband or bandage-type devices which contain strain gauges
or other mechanisms can be used to detect motion and/or strain.
Video cameras or motion sensors such as the Kinect device can also
be used. Microelectricalmechanical (MEMS) sensors and devices worn
on the body containing MEMS sensors (e.g., vest, belt, wraps,
leggings, etc.) are also useful.
[0320] Reflexes can be detected or captured, for example, by
determining a subject's quickness in pushing buttons or other
responses. The responses can be tested in a gaming environment
which can be hardware or software-based. Devices can also have a
mechanism for hitting nerves or other tissue to elicit a reflex
response. The diagnostic instrument may be integrated into a knee
or elbow wrap or mount.
[0321] Subject health can be assessed using electrical-based
diagnostic equipment to detect or diagnose conditions such as eye
movement; hydration (resistance), and fat content (resistance), via
electrooculography, electroretinograms, EEG, EKG, and/or EMG.
[0322] Temperature can be detected using various methodology, such
as infrared, e.g. ear temperature or skin surface; or conductance;
for example, using a standard thermometer. Relative temperature can
also be used between different body surfaces or regions.
[0323] Touch and pressure can be sensed using gloves with pressure
sensors to indicate how hard a subject is pressing on something.
Such sensors may give a numerical or other scale feedback or
provide a tactile output through device on the provider end. For
example, a glove with pressure compartments may be modified to
duplicate the pressures felt/recorded on the user end. Socks with
pressure sensors can be used for gait, or for podiatrist
assistance.
[0324] Other senses that can be measured include kinesthetics
(relative position of body parts--e.g., a subject is asked to touch
his or her nose with a finger with the eyes closed); or balance,
magnetic/electrical fields, and pain.
[0325] The invention can also be used to measure or monitor
standard diagnostics or vitals. That is, the invention can be used
to obtain standard diagnostic information and vital signs such as
pulse, oximetry, pulse oximetry, CO2 blood levels, cardiac output
(arterial pulse), heart rate, glucose monitoring, blood pressure,
and weight.
[0326] Other tests or diagnostics that can be used with the
invention include, for example, swabs or blood pin-pricks. Third
party diagnostic devices and tests can also be incorporated through
release of standard interfaces or programming information.
[0327] I. Moldable, Compressible and Conformable Components
[0328] Components may be compressible and conformable. For example
a foam exterior on a section that engages with the entrance of the
ear canal may compress as it is being inserted. Or this section may
be compressed and formed prior to placing into the ear in a similar
fashion as foam ear plugs. The foam or other material may be
constructed to slightly expand after insertion or it may generally
retain the formed shaped. Components may be manufactured
specifically for a subject. For example, pictures or scans (ideally
3D scans using technology such as MRI or light or products from
companies such as Lantos Technologies) may be used in order to
construct components (SLA, mold, 3D print). Parts may also be
bendable and/or conformable. Ideally, heat is applied to soften
materials and allow a user to form a desired shape which is then
generally maintained after the material(s) cool. Alternatively, a
component may be structured with materials that allow plastic
deformation, such as a piece of wire inside of a flexible material
such as silicone, that bends under force and holds a general
position while still allowing some flexibility. Components may
extend and compress (for example the stem extending from an ear bud
up and over an ear), for example a rod in a cylinder design, to
conform to different users and anatomy. These components may also
allow rotation and be formable or bendable.
[0329] J. Exemplary Methods of Diagnosis
[0330] Methods and types of diagnosis can be based on any
combination of diagnostic information. There are numerous health
ailments which may be diagnosed using any one of or a combination
of the techniques discussed above. Below is a short list of
examples.
[0331] 1. Imaging of the ear drum for ear infections. Such
diagnostic tests may also take an infrared temperature reading;
[0332] 2. Listening to sounds of four quadrants or lung on the back
of a subject. Such tests may help to diagnose asthma or a
respiratory infection;
[0333] 3. Imaging of the skin to detect skin cancer, rashes, poison
ivy, or other such ailments;
[0334] 4. Images of the mouth and throat for upper respiratory
ailments/infections;
[0335] 5. Epiglottitis by listening to sounds near trachea; and
[0336] 6. Diagnosing flu and common cold, using data such as body
temperature, images of the throat and listening to lungs.
[0337] K. Accessing and Capturing at Different Locations of the
Body and Anatomical Interfaces for Diagnostic Devices
[0338] Anatomical interfaces for diagnostic devices can have any
shape or structure. Examples of devices with anatomical interfaces
include otoscopes, rhinoscopes, and throat visualizers. While
interfaces may be discussed in reference to a specific diagnostic
technique and/or device, such as an otoscope for imaging the ear,
similar anatomic interfaces and/or devices may be used to collect
any type of diagnostic information. An example is an anatomical
interface for the ear similar used to collect temperature
information rather than imaging information. Anatomical interfaces
may include elements to collect more than one type of diagnostic
information. Non-limiting examples of such devices will now be
discussed in further detail.
[0339] 1. Ear
[0340] An otoscope may have features such as a flexible extension
for easier insertion into the ear and for alignment to the ear drum
and to conform to the ear canal. This extension may have a feature
to prevent over-insertion or to limit the amount of force that is
encountered. For example, the extension may be spring loaded and
able to fully or partially retract depending on the forces
encountered. This retraction, or force limiting mechanism, may be
incorporated into a more rigid extension as well.
[0341] There may be a soft outer material on the extension for
comfort during insertion and while imaging. These may also be more
rigid internal material to maintain a desired shape. The extension
may have a stop that interfaces with the subject to prevent over
insertion into the ear canal. In one embodiment, the stop presses
into outer ear and does not compress tissue into ear canal. There
may also be hole to allow air to escape during insertion and
imaging, or to prevent echoing or other bothersome noises.
[0342] The stop can be incorporated into a disposable sleeve, or it
can have a shape similar to an earphone bud, or a cup around the
ear. The diameter of the extension can also increase, thereby
functioning as a stop in the ear canal. There may also be
adjustable stops or different-sized sleeves to fit different
ages.
[0343] Ear buds that snugly fit in the ear such as the Doc's Ear
Plug, may have an extension into the ear canal. Over ear devices
similar to ear phones can also serve as a stop or to provide
alignment and/or to hold an imaging device in place.
[0344] A small bud or a bud with an over ear holder can have one or
more small flexible wires connecting the bud to another device, or
the bud may be self-contained and having RF, wifi, or other
wireless communication link with a diagnostic computer and/or
processor. Such devices allow significant motion and hands-free
capturing of data, and such embodiments help with freeing up a user
to manipulate the ear. There may also be an LED at the tip or
channeled from the outer ear into the tip.
[0345] Other types of known diagnostic elements or components may
be incorporated into an ear device instead of, or in addition to,
lighting and imaging elements. For example, a device may contain an
element(s) for capturing a subject's temperature, such as an
infrared or resister sensor. A pressurizing component may be
connected to or embedded within an ear device in order to apply
pressure to the ear drum to see how well it moves. Speakers may be
used to transmit sound in order to evaluate how well someone hears.
Alternatively, sound may be used to comfort the subject while
diagnostic information is collected. These diagnostic and other
elements and components may be located in, on or near the device or
attachments or in existing devices such as smart phones.
Information may be channeled to sensors using a variety of means
such as fiber optics or sound tubes.
[0346] Screw type or other adjustments can be used to change the
length of insertion, and a balloon or other dilation method can be
used to stop and hold the device in place.
[0347] Such devices fit into the ear and align the capturing and/or
accessing elements. Ideally, the device will be able to image the
ear drum with minimal or no manipulation of the ear. The
capturing/accessing elements may be offset from the central axis of
the ear canal and/or angled relative to the axis.
[0348] The extension into the inner ear may be formed of a polymer
or other material. A lens can be in a central position, or it can
be offset, and optionally offset posteriorly. This extension may
dilate the canal if desired.
[0349] There may also be different attachments for the left and
right ears, and such attachments may connect to a capturing device
and channel images from the tip. A tip which rotates to fit into
and align elements with left and right ear canal and ear drum is
also possible and within the scope of the present invention.
[0350] Dilation of the ear canal is also possible by means of a
balloon or other inflation device. This dilation may push imaging,
light, or other channels outward for a larger viewing field and/or
additional viewing angles.
[0351] Multiple attachments to fit different ear sizes or subject
ages are possible and encompassed by the present invention. Such
pieces may be very inexpensive and therefore disposable. There may
also be moldable attachments for subject-specific fittings.
[0352] There may also be an extendable piece or longer extension
fittings to see deeper in the ear canal for better clarity and/or
to get past ear hairs. A head band, hat or similar retaining device
can be used to help secure and hold the ear imaging device in
place.
[0353] 2. Nose
[0354] Many of the above features will also be useful in other
anatomical interface embodiments.
[0355] For example, a rhinoscope may consist of a nose plug with
various insert lengths and shapes, and a soft tip. There may be a
soft outer material surrounding a more rigid inner material that
maintains its shape. There may also be dual tips for both nostrils,
which can be useful for imaging nasal cavities.
[0356] 3. Oral Cavity and Throat
[0357] The invention also provides for an attachment to look into
the throat. The attachment may consist of a narrower fiberscope
when viewed from the side that more naturally conforms with the
shape of the oral cavity, optionally with a mouth piece to depress
the tongue and to open the oral cavity for better imaging. The
mouth piece may be similar in shape to a pacifier. The attachment
may also have a slight downward curve to depress the tongue and to
provide a downward angle further back in the oral cavity to image
the throat. Similar to a pacifier, the outer material of this oral
device would preferably be soft and/or semi-compressible. The oral
device may have any shape, and in one embodiment is oval in shape,
as pacifiers generally are, to more naturally conform with the oral
cavity. This oral device may be generally flexible in nature and
bend with motions in an oral cavity should a subject, such as a
child, resist to the device being used.
[0358] Devices and attachments may be structured with various
diagnostic and/or processing elements. A device may be a standalone
device for imaging the oral cavity or attachments supplied for
existing instruments or devices or for devices contemplated in this
disclosure. In addition, components are described which do not
necessarily contain diagnostic or processing elements and can serve
as sleeves or attachments for other devices or attachments, for
example in order to provide a soft surface, position a device or
anatomy or provide a taste or cooling effect to the oral
cavity.
[0359] Oral devices with a softer outside material are preferred
(for example urethane or silicone). These devices or attachments
may also be compressible for even more comfort and contouring
within the oral cavity, as well as safety, especially with rapid
motion by a subject.
[0360] Devices are intimidating for children. Devices which are
more familiar in feel and look would be more likely to be accepted.
These may be sleeves to go around existing devices such as
cylindrical endoscopes. One example of a preferred shape is a
pacifier. For example, this can be a device that is wider than tall
or a shape closer to a round ball that is soft and flexible.
Ideally these devices would reach further back into the oral cavity
than a typical pacifier and/or be shaped to better depress the
tongue or otherwise expose more of the oral cavity and back of the
throat.
[0361] One or more diagnostic element is typically contained in the
oral interface, for example a light source and an image sensor.
Multiple light sources, image sensors and/or other diagnostic
elements may be contained and/or positioned by the oral interface
and be located at various positions and angles. One preferred
position for a light source and image sensor is displaced above and
away from the tongue, and preferably pointing down and back into
the throat. In this case, it is preferred that an anatomical
interface for the oral cavity have some height, with the elements
positioned near the top or superior part of the interface. The
device could extend past this point, for example to depress the
tongue beyond the position of the elements. In this case, it is
preferred that the height is reduced in this section.
[0362] Additions to devices to make them more appealing and
tolerable. Examples would be a flavored coating or a coating, fluid
filled chamber or other material that may be chilled. The device or
attachment may be structured to be able to be dipped into a
flavored or chilled liquid. A sleeve that is flavored and/or
chilled may be added to the device or attachment prior to use.
Preferably the sleeve does not cover the imaging and light emitting
elements.
[0363] 4. Skin
[0364] The invention also provides for a dermatoscope, which can
maintain a specific distance from the object to be imaged to enable
measurements over time. A dermatoscope may incorporate an object of
known size for reference in images obtained. For example, a feature
located in or connected to an attachment for imaging the skin.
[0365] Devices or attachments can allow the camera to be at a set
distance, or within a distance range, from the skin for a known or
approximate magnification and size of the image. Attachments may be
constructed with various configurations and combinations of access
and/or capture elements. For example, attachments can contain a
through hole to image through, one or more lenses to channel the
light and image to a sensor in a device or a video chip to capture
light. The attachments can have light sources or access elements
that transfer light from the main device and can be open to outside
light or partially or fully sealed off from the environment so that
the light supplied for imaging is more consistent. Multiple lens
systems and/or video chips can be used. For example, two different
lens systems can be used which channel light to the same video
chip, preferably to two different areas of the video chip, or to
two different video chips. These lens systems can produce images
with different magnifications, for example one image that is
magnified and another image that is closer to actual size. One or
more filters can be supplied which can be connected near or over
the light outputs to allow different wavelengths of light to be
emitted towards the skin. Filters can also be built into the
attachment or the device. Different types of light sources can also
be contained in the device or attachment to emit different
wavelengths of light. Light sources can be selectively turned on or
off, by the user, the provider or by software, to emit a chosen
wavelength or range of wavelengths. Similar features can be
incorporated into other types of devices or attachments for imaging
other locations of the body. FIG. 80 shows examples of
configurations of anatomical interfaces and attachments to create
devices for imaging the surface of the skin (dermatoscopes).
[0366] The invention also provides for a small probe inserted
through the topmost layer(s) of the skin.
[0367] 5. Other Locations of the Body and Corresponding
Configurations
[0368] Devices and attachments with anatomical interfaces can be
created for other areas of the body and various types of diagnostic
information can be collected. For example, a device to collect
sounds of the chest cavity, a device to capture images of the skin,
devices to image the eye or position a device near the eye for a
user to see screen, a device to image the nose or nasal cavity,
more than one camera with the option to create a 3 dimensional
image, infrared detectors for body temperature, light sources with
various wavelengths and capturing chips designed to capture various
wavelengths. The various features and anatomical interfaces may be
used in a variety of structures, such as attachments for existing
devices, attachments supplied as part of a kit that also contains a
main device or in standalone devices.
[0369] The invention also provides for a probe which may be
inserted into a body cavity (e.g., oral, stomach, intestines,
etc.). Examination of the oral cavity may help with GERD diagnosis.
The obtained data can be used to correlate sounds with specific
ailments or to narrow down possibilities or identify potential
issues.
[0370] The invention also provides for a device for measuring
temperature, which may consist of an IR (infrared) detector built
into an ear bud or similar device. The ear device may be held in
place with a hat or head band. Alternatively, the temperature
detector can be built into a head band or hat device with skin
contact probes, and be optionally positioned on a subject's
forehead area.
[0371] The invention also provides for a device for measuring
oxygen saturation, for example, in the form of a finger or toe
attachment.
[0372] The invention also provides for a device for measuring blood
pressure, for example, for placement on a subject's wrist or
arm.
[0373] The invention also provides for a device in the form of an
eye piece (e.g. a cup-type shape) to provide safe imaging of eye
and surrounding tissue.
[0374] Particular embodiments of capturing devices have a thin
sleeve and/or covering that is disposable and which maintains a
barrier as well as providing padding for comfort during a medical
examination. There may also be stops to prevent over insertion
(e.g., for an otoscope). Adhesive patches for skin mounted or
contact devices can be used. The capturing device may also have a
moldable interface.
[0375] The capturing device may also be integrated with a device to
view, hear or otherwise observe or sense the diagnostic
information. This may be a diagnostic processing unit as discussed
later, or a simpler type interface such as an optical viewport to
see the images through the diagnostic device. This device may or
may not include components allowing storage or transfer of the
diagnostic information. Such components may include software,
mechanical elements, and/or other human interface to manipulate
output.
[0376] L. Diagnostic Processing and Link to Diagnostic Device
[0377] The diagnostic processing components (sometimes referred to
as diagnostic processors, or processors or processing components)
allow for receiving, transmitting, outputting and/or recording
diagnostic information and/or uploading the information to the
internet. The information may be stored at a remote location if the
information is being uploaded.
[0378] 1. Diagnostic Processing Components
[0379] The diagnostic processing components may communicate with
the diagnostic accessing and capturing components through a wired
or wireless connection. Examples of wireless communication include
RF (e.g. Bluetooth), wifi and/or wireless phone technology. An
example of such a configuration includes a small wireless
transmitter which attaches to and is wired to an image capturing
device and transmits (preferably wirelessly) the data to a smart
phone, tablet or other computer. This computer may then display the
images, record the information and/or upload the information to the
internet.
[0380] All processing components may be integrated into a single
device, for example, a tablet, smart phone or other computer. An
image accessing device with an anatomical interface is then
positioned in front of the computer camera. The computer is then
able to capture, record, display and/or upload the information.
This computer may also serve as the communication device.
[0381] 2. Communications Link to Diagnostic Device
[0382] The accessing and/or capturing components may also be
mechanically attached to the processing components. An example of
this is a cradle with handle and a device with an anatomical
interface housing a lens, video chip and RF transmitter, as well as
other electronics. The cradle holds a tablet, smart phone or other
computing device. The images are then sent (preferably wirelessly)
from the device to the computing device in the cradle for
displaying, recording and/or uploading. In another embodiment, a
folder, portfolio, or carry case may hold a computer tablet on one
side for communication and a smart phone or tablet on the other
side to receive, record, display and/or upload the diagnostic
information.
[0383] Part or all of the diagnostic processor may be the same as
the communication device (e.g. laptop, tablet, smart phone) or
other existing computer device (e.g. desktop, second communication
device).
[0384] The diagnostic processor engages in wired or wireless
communication to a diagnostic capturing device. The diagnostic
processor may also serve as the diagnostic capturing device, for
example, having an anatomical interface which attaches in front of
a smartphone camera.
[0385] The diagnostic processing components may be built into the
diagnostic capturing device. For example, a wireless transmitter
may be attached and wired to a capturing device. The diagnostic
information is uploaded directly to the internet and then may be
downloaded to a communication device.
[0386] Alternatively, the diagnostic processing components may be
located in another device, such as a base station. The base station
can be located anywhere in the home or other facility, and is
typically plugged in a power outlet and connected to the internet
or a wireless service. This station communicates with and receives
the information from the diagnostic capturing device. Information
may then be transferred to a communication device and/or directly
uploaded to the internet. If directly uploaded to the internet, the
information may then be downloaded for display or other output in
the communication device.
[0387] The diagnostic processing unit can also be a local "box"
that communicates/connects to the diagnostic capturing device. The
diagnostic capturing device may transmit the information wirelessly
(e.g. RF) to the local box or be connected with a wire.
[0388] The local box may optionally be configured to display
diagnostic information. This box may attach directly to the
diagnostic capturing device, be hand held and allow moving and
placing the diagnostic capturing device as desired
[0389] Other form forms include a watch or a flexible display that
may be unfolded if applicable and placed in a convenient location.
The local box or similar device is usually situated to be
mechanically and/or electronically attached or linked to a
communication device as previously discussed.
[0390] The device can also serve as a communication device,
particularly if it has a display screen.
[0391] The local box may transmit information to a smart phone,
tablet or other computer for outputting, recording and/or uploading
the information.
[0392] Multiple devices and communication methods may be combined.
For example, the diagnostic capturing device may have diagnostic
processing components built in to record the information and/or
display the information and also transfer the information to a
local computer or communication device as well as directly transmit
the information via the internet or wireless phone technology.
[0393] The local box or electronics may allow attachment to a
multitude of diagnostic devices and be able to transmit the data to
the internet, the communication device or other device as
previously described.
[0394] The diagnostic processing components may also have a
mechanical link for information transfer. The diagnostic accessing
device may have a hollow tube for transmission of sound or fiber
optics for transmission of images to a diagnostic processing
device. The diagnostic processing device may have the hardware
required to capture and process the information. Examples of
hardware include a camera and/or microphone, and may include a
cradle or other attachment to help align parts for adequate
capturing of the diagnostic information.
[0395] The diagnostic processing component(s) may be able to
communicate/connect to third party diagnostic devices as well. For
example, a local box as previously described may communicate with
heart rate monitors, pulse oximeter, scales, blood glucose
monitors, etc.
[0396] Other features of a diagnostic processor and/or capturing
device may include a conventional camera, a microphone, and/or a
recorder. These elements may include a mechanical and/or electronic
link between the anatomical interface and the camera or microphone
to provide for transfer of the diagnostic information.
IX. EXAMPLES OF DIAGNOSTIC DEVICES AND ADDITIONAL FEATURES
[0397] Different devices which are created by combinations of
disclosed features and components discussed in above sections can
allow for accessing and capturing of data, an anatomical interface,
and diagnostic processing.
[0398] A diagnostic device may have channels for secondary uses.
For example, an otoscope for visualizing the ear drum may have a
channel to allow air to be inserted into and pressurize the ear
canal to visualize motion of the ear drum. Alternatively,
additional diagnostic techniques which are not discussed herein may
be incorporated into any diagnostic device.
[0399] A diagnostic device may have multiple diagnostic capturing
elements. The diagnostic device may be held in place on the
subject's body using any generally available or suitable means. For
example, an otoscope may have an image capturing device and a
temperature probe (such as an infrared thermometer). This ear
device may be held in place with a head band, hat or similar
retaining device. The temperature reading apparatus may also be
positioned in the hat or head band rather than in the ear piece,
and have skin contact probes which are ideally positioned near or
on the forehead. Temperature readings may be recorded both within
the ear and on the forehead to increase the likelihood of recording
an accurate temperature.
[0400] Kits containing more than one type of diagnostic device
and/or anatomical interface are provided by and encompassed by the
present invention.
[0401] Diagnostic devices may have features to make them more
comfortable and/or acceptable to the subject. Such features may
include, but are not limited to a speaker in an ear piece (e.g.
otoscope) playing soothing sounds or music that the subject finds
enjoyable or vibration in a skin interface device (e.g.
dermatoscope). An oral device or device to look into the throat
(e.g. laryngoscope) may include a video screen situated in front of
the subject to play videos for the subject and/or include a
pleasant tasting mouth insert or the ability to apply a pleasant
taste to the oral device or laryngoscope.
[0402] As illustrated and described herein, many devices are formed
to be familiar to the user and therefore make them more comfortable
and pleasant to use. For example, an ear imaging device with an
earbud or over ear engagement member are similar in feel and use to
headphones. The user may feel comfortable using such device and
requires little or no instructions on using it. Similarly, an oral
device for capturing diagnostic information, such as images, may be
shaped in an oval form. This oval shape will more naturally conform
to the mouth. The oval shape may resemble a pacifier or have
another known shape. Users may feel more comfortable and safe using
a device on themselves or their child since the device resembles a
product they have used before. Further, devices are preferably
constructed to resemble consumer products rather than medical
devices to provide a more pleasant experience and also decrease the
time and effort to learn how to use the device.
[0403] Other types of known diagnostic tools can be incorporated
into a device or attachment. For example, an elastic hollow ball
can be connected with a tube to a device or attachment to allow
pneumatic otoscopy. The ball is squeezed to pressurize the ear
canal or blow air at the ear drum in order to watch for movement.
Ideally the air outlet is near the tip of a diagnostic extension or
in an ear bud or in a section that engages with the entry of an ear
canal or is otherwise located near or in the ear canal. The elastic
ball or bulb can also be connected directly to a device or
attachment so that an external tube is not required or just to
secure and hold the bulb in place. It is preferred that the bulb is
relatively small in this example. Another configuration of a
pressurizing system is a main device with a small hollow chamber
that has an external elastic cap or button which can be pressed to
blow air towards the ear drum pressurize the ear canal.
X. REMOTE CONTROL AND/OR MANIPULATION OF DIAGNOSTIC DEVICE AND/OR
DIAGNOSTIC INFORMATION
[0404] The invention can provide live feeds with the ability to
request a snapshot or segment in higher resolution. The invention
also permits low resolution viewing of large files such as MRIs,
and the ability to request high quality images of select images or
parts of images.
[0405] In certain embodiments, the invention can pull information
from electronic health records and/or a central location of stored
information. Such data files can be reviewed in low resolution and
then selected files or portions of files can be retrieved for high
resolution download.
[0406] The invention also provides the ability to modify device
settings, such as filtering of sounds, zooming cameras, selecting
which angle view is best, changing filters of images,
increasing/decreasing electrical power, changing light source,
selecting a camera, or modification of any other option previously
discussed. There is also the ability of remote monitoring and/or
control of a user device.
[0407] There may also be controlled articulation of a device, to
change an angle or other shape to help navigate or align an
instrument, or to change a tip angle or angle of elements such as a
mirror or video chip.
XI. ACCOUNTS, LOGISTICS AND INFRASTRUCTURE
[0408] A. Examples of User and Provider Account(s)
[0409] Several kinds of user accounts and provider accounts are
possible in accordance with the principles of the present
invention. There may be an anonymous account, in which billing and
personal information is processed by a company or service, or a
third-party service or telehealth service, or by the company
described within), but the provider does not know the subject's
identity and health records are not updated. This option allows
advice only, and no prescriptions.
[0410] There may also be a basic account with consumer
identification. Basic health information/background is collected
during call, similar to a visit to a pharmacy clinic.
[0411] There may also be a basic account with past medical history
completed for use with this system. Certain information, for
example, a simple health questionnaire, remains separate from other
subject records.
[0412] There may also be an account which provides for integration
with the subject's existing Electronic Health Records (EHRs). Such
accounts may pull out a subset of basic health information only for
purposes of use in conjunction with the current sick call to keep
the majority of the information private. The subject or caregiver
decides what kind of information or which categories of health
information is shared. This sharing could be done for each sick
call.
[0413] Shared information may optionally be linked to a third party
EHR. An EHR can be managed within this system. Health information
can also be sent as required to update the subject's record(s) and
pulled from other records as necessary.
[0414] Accounts can be created by the user, the user's health
insurance, employer, family member, or another interested
party.
[0415] An account can be created with health insurance information,
or the account can be completely private and provide for separate
billing via a self-pay model.
[0416] Subject accounts will be determined in accordance with
particular implementations of the invention. Such accounts are
envisioned to be fully HIPPA compliant, and the consumer controls
and chooses what information is shared and with whom. Permission
from the subject may be transmitted with any medical data and/or
via a separate/independent transmission method or file.
[0417] Provider account(s) may include call records maintained
(e.g. user satisfaction), and provider credentials.
[0418] Completion of Communication
[0419] Both parties may first need to agree that an acceptable
resolution has been reached prior to completing the call as well as
agree to which information may be stored prior to the uploading and
sharing of information to an EHR or updating of any other
record.
[0420] Billing and Insurance
[0421] The invention is amenable to different kinds of billing and
insurance modes. For example, there may be a self-pay mode, or the
user or provider can bill an insurance company and generate the
relevant forms.
[0422] Communication Security and Methods of Transferring
Information
[0423] The invention can use existing technology/company/software
such as Vidyo, or such technology can be created from the ground up
in-house.
[0424] B. Recording of Information
[0425] The invention can provide for multiple record storage
options. For example, the invention can record entire
communications and all imaging/collection of diagnostic
information, or the invention can record only short segments or
snapshots of diagnostic information selected by the provider and
the final diagnosis and/or advice given. Alternatively, the
invention can store only a form containing health history and a
written diagnosis by the provider, with or without images. Prior to
providing or receiving any service, the subject/consumer and health
care provider can agree on completed review and storage of
information.
[0426] C. Database Management
[0427] Database management for a particular implementation of the
invention will generally be conducted in accordance with industry
practices and regulations.
[0428] D. Interfacing with 3.sup.rd Party Software and Hardware
Including Electronic Medical Records (EMRs) and Diagnostic
Devices
[0429] The invention can also interface with third party software
and hardware providers, including those providing or storing
Electronic Medical Records (EMRs) and diagnostic devices.
XII. TELEHEALTH SYSTEMS AND FEATURES
[0430] Telehealth systems in accordance with the present invention
permit the linking of two or more parties at remote locations to
aid with or monitor medical conditions. The connections may be in
the form of a voice call, video call and/or text communication or
any of these with the addition of sharing information such as
photos, files and/or diagnostic information, collected previously
and/or collected during communication.
[0431] Communication methods may include cellular/mobile telephone,
through the internet, via satellite, landline or any other
technology enabling communication protocol.
[0432] Telehealth systems utilize diagnostic or health information
collected with a variety of methods or available from previous
health consultations. A third party device or a diagnostic device
described herein, or other information such as xrays, MRIs, blood
tests or information contained in an electronic health record can
be utilized.
[0433] Telehealth system in accordance with the invention may
involve an official diagnosis, e-prescriptions, billing (individual
and/or insurance), creation of insurance forms and/or updating
EHRs.
[0434] Such systems also use software and/or user interfaces to
facilitate capture, output (e.g. display or sound), transfer and/or
recording of information.
[0435] Infrastructure, including servers and databases, can be
purchased commercially or custom-designed, depending on the
implementation of the invention.
[0436] Health care providers such as physicians or other
professionals may be ranked by education, experience, user
satisfaction or other means by which a user may wish to select a
provider. Users or insurance companies may pay different amounts
depending on the rank of the provider, or based upon prior
negotiation.
[0437] Certain embodiments of the invention may be desirable for
use in a gaming, social, or educational setting. For example, the
invention can provide a 3D tour through the body and participants
would guess medical solutions or diagnoses based on real data or
examples for each location/area of the body. Users may get points
and compete against others.
[0438] There may also be crowd-sourcing to other users for opinions
without provider input. Users may compete against each other and be
ranked for knowledge which may help in the probability of obtaining
correct advice from the crowd.
[0439] The invention can also use real data for educational
purposes with an interactive interface, e.g., a 3D tour through the
body. The invention can also include demonstrations and
illustrations of how a health ailment may have been caused and how
to prevent or treat that condition.
[0440] Certain embodiments of the invention can be used for auto
detection of ailments, for example, ear infections and progression
of moles, and the invention can give the probability that the
subject has the illness with or without an additional provider
consultation. Software and analysis can be done on the user device
and/or as a "cloud" service.
[0441] There may also be crowd sourcing for two or more opinions
from providers. Such embodiments may be particularly applicable to
lower income countries or those having lower provider cost (such as
India) and for easily-diagnosed ailments requiring only an image or
similarly simple sharing of diagnostic information. This would give
a potential for extremely short provider review times, potentially
in just 10 seconds.
[0442] The invention can also be used to solicit bids from
providers for consultations, surgery or other care. A user may also
offer a set amount for diagnosis and treatment, and providers may
choose to accept the user's offer or not.
[0443] The invention can also be integrated with outside
diagnostics facilities, for example, for lab tests or culture
testing; to enable users to send samples such as blood, mucous, and
skin shavings for analysis; and to schedule appointments for blood
draws/testing or imaging tests such as xray or MRI.
[0444] Contacts between subjects/caregivers and medical care
providers can be in any form, such as the following:
[0445] 1. Direct peer to peer or through central server/gate or
simultaneously peer to peer and to central location;
[0446] 2. Caregiver and subject;
[0447] 3. Subject and provider (or nurse/call center for routing if
necessary);
[0448] 4. Subject, caregiver to provider(s)
[0449] 5. Caregiver to provider and separately to subject;
[0450] 6. Subject separately to caregiver and provider; and
[0451] 7. Any of the above with a facilitator such as a nurse or
other trained individual at a call center
[0452] A non-limiting list of examples of sick calls or requests
for medical services can include requests for second opinions;
treatment of acute ailments; treatment of chronic ailments;
requests for follow-up appointments; scheduling physical therapy;
monitoring, which can be initiated by caregiver and not require an
active answer by the subject; fitness or wellness visits; and
emergency and other urgent medical calls.
[0453] The invention can be provided to consumers in numerous ways,
such as by health insurance companies, employers, through
partnerships with health IT companies, or directly to
consumers.
[0454] Different kinds of systems are possible within the scope of
the present invention. For example, there may be a basic system,
which provides telemedicine with at least voice capability and
optionally video capability to enable remote diagnosis and
prescriptions as necessary. There may also be diagnostic device
services, in which the invention provides the ability to capture
and send medical data and information from a subject to a health
care provider. The systems may also have the ability to transfer a
live feed of diagnostic information from the subject to the
provider, or the ability for the provider to select snapshots or
short segment video to download in high resolution from the
diagnostic device.
[0455] There may also be a hardware or software interface to allow
connection of any diagnostic device, e.g. for example, from a third
party. These connections can be live feeds or collected over time
such as blood glucose or heart rate and input by user, for example,
by typing blood pressure readings into a diagnostic device. For
live feeds, in one embodiment, the invention allows for recordal of
information and data, and for remote transfer of high quality
images.
XIII. SYSTEMS WITH THERAPEUTIC ELEMENTS
[0456] The invention may also be in communications with medical
devices which provide remote therapeutic elements or services to a
subject. Examples of such devices are massage devices or muscle or
nerve stimulation devices. The medical provider can send remote
instructions to these devices so that the subject can obtain
therapeutic treatment.
[0457] As described herein, various embodiments of the disclosed
systems and methods significantly improve efficiency for subjects,
clinicians, health system managers, and third party payers. The
stored subject information allows reviewing clinicians to see the
subject examination and glean valuable information that a previous
clinician might have missed during a routine examination. Moreover,
multiple clinicians and/or specialists can access the subject
information simultaneously and/or sequentially, allowing additional
reviews to review the data and reduce the chance of something being
missed or overlooked.
[0458] The system can include features that allow consultants to
review the comments and recommendations of other clinicians. In
doing so, consultants may be exposed to the thoughts of other
clinicians, which in turn can broaden or focus the clinical
impressions more accurately, and again reduce the chances of error
or misdiagnosis. Such review will normally be done within the data
sharing permissions set by the subject, as well as within the scope
of medical record sharing laws and regulations.
[0459] Various features of the disclosed system may encourage
subject participation and involvement. The subject has opportunity
to see his or her case, actively monitor the progression and
assessment of the information by medical professionals, and review
the various comments and recommendations and actively participate
in his/her case. This may result in a more informed and involved
subject, and can significantly increase subject satisfaction with
the medical care and response.
[0460] In various embodiments, the user's initial subject
information and treatment request creates a query that becomes
available to the medical professionals (e.g., consulting
clinicians) via a secure web portal or other format. The system
provides the medical professional with the relevant subject data to
be used in providing recommendations regarding the subject
condition, assessment and/or treatment. The medical professional
can review the query on-line at any time after it has been posted
and can record his/her observations and recommendations into the
query file as necessary and/or desired. Depending upon the subject
condition and/or complexity, an initial assessment can be rapidly
completed, for example, in 15 minutes or less, by properly trained
personnel such as nurses, initial assessment technicians, or first
responders. Such initial assessment may take significantly less
time than needed for a clinician to evaluate the subject in person.
For subjects requiring further in-depth assessment and/or analysis,
their queries may be forwarded to a relevant specialist, while less
complex queries can be addressed and responded to by a wide variety
of less-expensive clinical specialists. This can significantly
reduce the costs incurred to evaluate the subject, which may result
in significantly lower costs for the subject and/or payor. In
addition, the subject does not need to directly meet with
clinicians individually, which may significantly increase the
convenience and accessibility of healthcare.
[0461] Various features of the disclosed systems and methods may
further facilitate the collection and recordation of subject
demographics, medical histories, complaints, illness histories,
height, weight, identification (e.g., fingerprints, facial
photographs, DNA or blood type information), subject statements,
video exam sequences, and physical characteristics such as physical
inspection results, thermal imaging, palpation, strength, sensation
and reflexes. In addition, various information relevant to the
complaint can include links to electronic medical records, links to
imaging databases, various clinical comments, and billing
information. Subjects can give permission for the attending
clinician to access their stored health records. The clinician can
provide the most rapid physical examination if a subject's records
are all available electronically. Nevertheless, the invention can
also be highly effective to start developing a subject's electronic
health record.
[0462] Use of the various systems and methods disclosed herein may
be of interest to health systems administrators as it may
facilitate a hospital or clinician group's expansion of their
service area, attract subjects to their treatment facilities,
promote utilization of participating providers, create multiple
revenue streams, and may be a powerful marketing tool. In various
embodiments, the systems add efficiency and increase clinical
productivity.
[0463] In various embodiments, researchers may utilize various
database information which may include data mining features,
standardization of examination methods, and an objective
documentation format. Similarly, health care professionals and/or
educators may utilize various features that provide a rich
educational format that can be accessed by students seeking to gain
knowledge regarding the evaluation and management of health issues.
The subject information files may be archived and used to provide
exposure to a wide variety of cases and demonstrate various
pathologies to students who might otherwise go years before seeing
an example of certain variant conditions. In various embodiments, a
multidisciplinary consultation feature can be provided that allows
exposure of subject information to a variety of medical
perspectives. Such data sharing will normally be used in accordance
with local privacy laws.
[0464] Various features of disclosed embodiments offer significant
direct cost savings, which may be realized when an emergency room
or full office visit consultation is avoided because the
information is available via the system. The system saves time
because the subject does not have to wait to attend a variety of
appointments and each clinician (if multiple medical professionals
are required or desired) can view the subject information remotely
on his or her own time. In addition, multiple consultations and
opinions can be collected via the system simultaneously.
[0465] Advantageously, the system can increase quality by making
multiple opinions available to the subject, which can increase
subject responsibility and autonomy and facilitate greater levels
of involvement in subjects' own health care. In various
embodiments, subjects may be given the option of selecting a
desired clinician or clinical specialty that they would like to
consult on their subject information. The subject can directly
review the various opinions and recommendations collected in the
system and make their own choices about how they would like to
proceed. Subjects can increase their understanding and knowledge of
their condition by allowing them (or anyone else they so choose) to
view their personal examination compilation in detail. In addition,
the system allows third party payers to have a more complete and
accurate assessment of the claimant's examination compilation.
XIV. DISCUSSION OF FIGURES
[0466] The present invention will now be described with reference
to the Figures, wherein like reference numerals refer to like
elements.
[0467] FIGS. 1 and 2 illustrate exemplary embodiments of a
telehealth system in use in accordance with an aspect of the
present invention. FIG. 1 illustrates a caregiver and a health care
provider engaged in a video call, thereby interacting in two-way
video and voice communications. A diagnostic device in accordance
with the present invention has been inserted in to the subject's
ear, and the diagnostic device acquires medical status data,
including diagnostic images, and provides this information to the
provider. During the video call, the provider can request that the
caregiver or subject provide additional medical information or
adjust the settings or placement of the diagnostic device. Although
the figure shows the caregiver using a laptop computer and the
provider using a desktop computer, the caregiver and provider can
use other kinds of computer systems, such as the illustrated
smartphone or tablet computer. In certain embodiments of the
invention, caregivers and/or providers will install an application
or an app on their devices to communicate. In view of current U.S.
federal privacy laws, it is expected that all communications
between a provider and subject/caregiver will be done over a secure
electronic connection.
[0468] FIG. 2 illustrates an exemplary embodiment of the invention
which provides for a plurality of data feed options to the provider
from the diagnostic device. In the illustrated embodiment, the
provider can choose to receive one or more high-resolution images
via download, or the provider can receive a low-resolution live
feed. The provider has the ability to manipulate the diagnostic
information and/or the device by a remote control feature. In this
specific Figure, the diagnostic data can be fed live to the
provider at low resolution for seamless transfer and communication.
The provider may select segments or snapshots of the diagnostic
feed which will be downloaded to him or her at a higher resolution.
The full stream of higher resolution data can be stored on the
user's device and/or at a central location, and accessed by the
provider for high resolution snapshots/segments or for later
review. The provider may use the remote control feature for other
actions, such as but not limited to focusing the image, controlling
tip deflection or the direction of an imaging device, and filtering
sounds.
[0469] FIG. 3 illustrates linked components of an exemplary
embodiment of a telehealth system according to the present
invention. The system is comprised of three components: (a) a user
subsystem configured for receiving a subject's current medical
data; (b) a provider subsystem configured for communicating with a
health care provider; and (c) an infrastructure subsystem
configured to process and store medical data and diagnostic
information received from the user subsystem and the provider
subsystem.
[0470] In the illustrated embodiment, the user subsystem comprises
a communication device; a diagnostic processing device; and a
diagnostic capture device. The provider subsystem comprises a
communication device. The infrastructure subsystem comprises: (a)
an application server comprising computer instruction code
configured for communication with (i) a database configured to
store a subject's personal information and electronic health record
as well as information on providers; (ii) diagnostic computer
instruction code configured to receive current subject medical
information and to provide diagnostic information concerning the
subject's medical condition; and (iii) a database configured to
store archived diagnostic information; (b) a server comprising
computer instruction code configured to communicate with one or
more third-party subject personal information or electronic health
record databases; and (c) a server comprising computer instruction
code configured to communicate with a third party telehealth
system.
[0471] FIG. 4 illustrates three components of a user subsystem of a
telehealth system in accordance with an exemplary embodiment of the
invention. The user subsystem comprises a communication device,
which can be capable of participating in a video conference. For
example, the communication device can be a laptop, tablet, or
smartphone equipped with a video camera.
[0472] The user subsystem also comprises a module which processed
diagnostic information. This system transmits information, receives
diagnostic information, outputs or displays information, records
any diagnostic data, and transfers this information to the
Internet, for example, to a storage unit which may be cloud-based
or stored or warehoused on a proprietary site and/or to the
communication device.
[0473] The user subsystem also comprises a module which accesses
and captures diagnostic information. This module can comprise an
anatomical interface, such as an earbud, and can focus and access
diagnostic information via a diaphragm, lens, fiberoptics, or other
element. This module can also capture diagnostic information via
speakers or a camera.
[0474] FIGS. 5-7 illustrate exemplary embodiments of user devices
structurally configured for insertion into the human ear which
communicate a subject's current medical status in accordance with
the present invention. The user devices can include various kinds
of communications devices, which may not have any diagnostic
capabilities (as shown in FIG. 5), or which can have a diagnostic
processor (as shown in FIG. 6), or which can have a partial
diagnostic processor (as shown in FIG. 7). In these Figures, an ear
bud having a camera is used to access and capture diagnostic
information, and the ear bud communicates directly with a
smartphone (FIGS. 5 and 6), or indirectly through a small
intermediate box which has a partial diagnostic processor for
receipt and transfer of information (FIG. 7). The earbud transmits
photos of the inside of the ear canal wirelessly via BlueTooth (BT)
or radio frequency (RF), although in certain embodiments this
information can be transmitted via a wire connected to the jack or
port of the tablet, smartphone, or other device.
[0475] FIGS. 8 and 9 show a cross-section of the ear region of a
subject's head for purposes of reference.
[0476] FIGS. 10-20 illustrate exemplary embodiments of an ear
imaging device comprising an anatomical interface to facilitate
positioning and image quality and may also serve as safety
mechanisms that prevent over insertion. As discussed earlier,
diagnostic devices may contain any combination of elements
described. For example, in FIGS. 10-20, outer ear elements may
contain LEDs in the outer ear elements which emit light which is
transmitted by standard components such as fibers, channels or
light pipes.
[0477] FIG. 10 shows an ear bud which is used to position and
align, in the posterior of the ear canal, an imaging apparatus with
the ear drum to optimize the quality of the resultant images. The
ear bud and imaging apparatus are attached to a port on the
smartphone which aligns with the camera for image capturing.
[0478] FIG. 11 illustrates an ear bud attached to an outer ear
element. The ear bud contains the imaging apparatus with a video
chip at its tip. The outer ear element contains the necessary
electronics and transfers the image, via radio frequency,
BlueTooth, wire, or other protocol, to another device such as a
smartphone for output and display of the medical data to the
Internet.
[0479] FIG. 12 illustrates an ear bud and outer ear element. In
this Figure, the outer ear element contains the video chip as well
as any ancillary electronics. The ear bud has fiber optics or a
channel to allow transmission of the image to the video chip. The
entire embodiment consists of a single hardware element.
[0480] FIG. 13 illustrates another combination of an ear bud and a
detachable outer ear element. In contrast to FIG. 12 which shows a
single hardware element, FIG. 13 illustrates that the components
are detachable. This embodiment allow for different sizes of ear
buds to be supplied, as well as permitting different buds for left
and right ears when necessary.
[0481] FIG. 14 shows an embodiment of the inventive device in the
form of a standard speculum. This embodiment is configured with
extra material on the anterior (front) side in order to position
the speculum to a more posterior (backward) position for better
alignment with the ear drum.
[0482] FIG. 15 illustrates an embodiment of the inventive device in
the form of a speculum, with an anterior buildup and extension
attached to a smartphone for image capture. The speculum element
may alternatively be attached to a different diagnostic processing
device (such as the outer ear element shown in the earlier Figures)
to capture the image.
[0483] FIGS. 16-18 show alternative examples of ear buds and
imaging apparatus. FIG. 18 shows a compressible ear bud with an
imaging apparatus for conformity and secure fitting with an
individual's ear. FIGS. 19 and 20 show examples of an ear bud and
imaging apparatus that repositions itself as the ear is
manipulated.
[0484] FIG. 21 illustrates features of the outer human ear for
purposes of reference.
[0485] FIGS. 22-24 illustrate exemplary embodiments of an over-ear
device for obtaining a subject's current medical status. FIG. 22
shows a representative device for imaging the ear. It includes two
components: an outer ear element on the helix, and an ear bud
inside the ear canal. The main component fits over the ear and the
other component fits into the concha of the ear and/or ear canal.
FIG. 23 shows the embodiment of FIG. 22 separately from the ear for
clarity of view.
[0486] FIG. 24 shows an embodiment of an over ear device to which a
video chip, a light source, and a speaker have been affixed. FIG.
24 shows several elements which are contained in the main
component: a speaker, a light source (i.e. LEDs) and a video chip
(i.e. CMOS) for capturing images or video. The speaker can transmit
sounds for pleasure or for communication and the device can serve
as both a diagnostic and communication device. The second
component, or ear bud, transfers information (i.e. light and sound)
between the elements in the main device component and the ear
canal. These components can be permanently attached or the ear bud
can be detachable. Other attachments may fit over the permanently
attached ear bud, for example different sleeves to better fit
different size ears or a device which fits into the mouth for
imaging the oral cavity and throat. Alternatively, the ear bud can
be detached and other size ear buds or an oral device attached. The
device may be connected with a wire or by wireless means to a
computing device. A wireless device typically contains a battery, a
wireless chip and additional electronics.
[0487] FIGS. 25-26 illustrate exemplary embodiments of an over-ear
device and different configurations of the outer ear elements. FIG.
25 shows a bottom view of an over ear device. A video chip is
illustrated within the outer ear element (the over ear piece). FIG.
26 shows a plurality of different configurations of outer ear
elements, ear buds, and video chips. An outer ear element may be
configured with one or more video chips to allow for left and right
ear buds to be attached. More than one image may also be captured,
for example, at different locations of the ear, or at different
angles.
[0488] FIGS. 27 and 28 illustrate side and bottom views of an
exemplary ear imaging device. FIG. 27 shows a side view of an ear
imaging device. The device may be configured for interface with the
subject's anatomy so that the images are captured centrally or
off-center, as shown in the lower two illustrations. FIG. 26 shows
a bottom view of an ear imaging device. The device may be
configured and interfaced with the subject's anatomy so that images
are captured centrally, off-center, and/or at an angle, as
illustrated in the five drawings at the bottom of the Figure.
[0489] FIGS. 29 and 30 illustrate exemplary embodiments of
anatomical interfaces for a medical device for insertion into a
subject's mouth (FIG. 29) or ear (FIG. 30). The anatomical
interfaces are attached to a smartphone in the illustrated
embodiment. The attachment of the anatomical interface to the
device may be rigid (FIG. 29), or flexible as shown in FIG. 30 with
a spring/coil combination.
[0490] FIG. 31 illustrates an exemplary embodiment of a medical
diagnostic instrument equipped with a microphone. In the first
image, a diaphragm, anatomical interface, and accessing device are
shown attached to a smartphone with a microphone for capturing
sound. In the second image, a diaphragm, anatomical interface, and
accessing device are attached to a specialty diagnostic capturing
unit with a microphone which transmits sounds via a wired or
wireless connection. Such an embodiment can be used to listen to
heart or lung sounds, and the device can be used to perform the
functions of a standard stethoscope.
[0491] FIGS. 32-35 illustrate exemplary embodiments of medical
diagnostic instruments for collection of subject medical
information. FIG. 32 shows a strap with microphones. This
embodiment can be used, for example, to listen to a subject's chest
or lungs when applied to a subject's chest. Similarly, FIG. 33
shows a shirt or vest which contains microphones. When the subject
dons such articles as the strap or shirt/vest, the health care
provider can listen remotely to sounds from the subject's body and
thereby provide a diagnosis of a medical condition.
[0492] FIG. 34 illustrates an oral device, in the general form of a
pacifier, which contains a lens and video chip for use in examining
a subject's mouth or oral cavity. The oral device is equipped with
digital imaging elements which communicate with a diagnostic
processor to enable remote diagnoses. Such embodiments are useful
to any subject, although they will provide particular application
to small children.
[0493] FIG. 35 shows an embodiment of a medical device comprising
an oral device and an ear bud. The oral device and the ear buds
both have fiber optics or channel to interface with a device having
a video chip and the associated ancillary electronics, and these
elements communicate with a diagnostic processor to provide medical
data of at least two separate parts of subject's body.
[0494] FIGS. 36-37 illustrate exemplary embodiments of kits
comprising devices for accessing, capturing, and at least partial
processing of medical diagnostic information in accordance with the
present invention. FIG. 36 shows a kit comprising a strap equipped
with microphones, an oral device, nose attachments, and different
sized ear buds. These elements all communicate with a processing
box which interfaces with a communication device for transmission
of data to the medical provider. Any combination of these elements
can be used in accordance with the present invention to transmit
subject medical data to a provider. FIG. 37 shows a kit comprising
a computing device, such as a smartphone, tablet, or laptop, to
provide communication and partial processing of diagnostic
information. The kit also comprises devices for accessing and
capturing diagnostic information and at least partial processing of
the medical data, including transferring the information to a
communication device such as the smartphone, tablet, or laptop just
described.
[0495] User Subsystem--Overview of Exemplary Devices, Systems and
Methods
[0496] Exemplary Kit for Images of the Ear and Throat and Sounds of
the Heart and Lungs
[0497] FIGS. 38A-E show a representative kit which includes devices
to allow capturing images of the ear drum, oral cavity and throat
as well as capturing sounds in the chest, such as heart and lung
sounds. FIG. 38A shows the kit configured for imaging an ear. The
device has a component which fits around the ear, an earbud
component which fits in the concha of the ear and an extension
which enters the ear canal. These components help to support the
device as well as align diagnostic elements, in this case light
output and input, in the ear canal. These are shown in FIG. 38B.
Light sources can be contained in various locations, for example at
the tip of the extension, in the ear bud or in the over the ear
piece and transferred (i.e by fiber optics, light pipes, open
channels, lenses, mirrors etc.) to the tip of the device. Lenses at
the tip of the device may be used to focus light in one or more
preferred directions, with a narrow or wide beam. Software analysis
or user/provider indication of desired capture area may be used to
turn lights on or off in order to illuminate the desired object,
such as the ear drum. Similar features and options may be used to
capture light and images, with a video chip(s) located at the tip
of the device, in the ear bud or in the over ear component.
[0498] FIG. 38A shows an attachment sleeve which fits over the
extension into the ear canal and a portion of the ear bud component
and can be provided in different sizes to fit different size ears
to better support and/or align the device and elements. The
attachment may also be constructed to fit over the ear bud portion
of the device and extend only slightly into the ear canal or not
enter the ear canal at all. Many different forms of the device and
attachments as well as fastening methods may be used. For example,
rather than the extension into the ear canal being part of the main
device as is shown, the device may only contain an ear bud, with
the attachment containing the extension which fits into the ear
canal. Or, the main device main terminate at the lower portion of
the stem of the over the ear piece and the attachment would then
contain the ear bud and extension into the ear canal.
[0499] Additional attachments may be included in a kit to capture
images of the oral cavity and/or throat as well as sounds of the
chest, such as heart and lung sounds. FIGS. 38A-E show a main
device, which serves as the over ear piece when imaging the ear and
as a handle when imaging the throat or listening to the chest.
FIGS. 38C,D show an attachment for imaging the oral cavity and
throat. The device is configured to fit comfortably in the oral
cavity, with a preferred shape that is wider than it is tall for at
least a part of the length to accommodate the natural shape of the
oral cavity and stabilize the device. The attachment can resemble a
pacifier and preferably has a soft outside for comfort and safety.
FIG. 38E shows an attachment for listening to sounds of the lungs
and heart. The attachment creates a device which serves as a
stethoscope. The main device may contain elements such as
electronics, a wireless chip which may include Wifi or Bluetooth or
both, one or more microphones, one or more video chips, a battery,
LEDs and other elements to help facilitate capturing, storing or
transmitting diagnostic data. Some of these elements may
alternatively be contained in attachments to the main device. The
attachments shown serve as anatomical interfaces which mate with
the body and access the images and/or sounds.
[0500] FIGS. 38A-38E illustrate exemplary embodiments of medical
diagnostic devices in accordance with the present invention which
are structurally configured to be placed on, in, or adjacent to a
subject's body for obtaining medical diagnostic information. These
devices can contain a battery in an inner compartment for powering
the device or for transmission of obtained medical data.
[0501] FIGS. 38A-38B illustrate exemplary embodiments of medical
diagnostic devices having an anatomical interface, and which are
structurally configured to be placed into a subject's ear canal.
The illustrated devices are rotatable about certain positions to
permit optimal fitting into the ear canal.
[0502] FIGS. 38C-38D illustrate exemplary embodiments of medical
diagnostic devices which are structurally configured to be placed
in a subject's oral cavity. The devices have a main body which can
be inserted into the subject's oral cavity to permit optimal data
collection. These medical diagnostic devices have an anatomical
interface component which interfaces with the user's hand.
[0503] FIG. 38E illustrates an exemplary embodiment of a medical
diagnostic device which has stethoscope capabilities, and which is
structurally configured for listening to sounds from a subject's
body. The device has an anatomical interface component which can be
applied to a subject's chest, back, joint, or other location for
listening to sounds.
[0504] FIG. 39A is a horizontal, or transverse, section (upper, or
superior, half shown) of the ear and ear canal showing the
different parts of the ear as well as the curvature of the ear
canal. The ear canal first runs posteriorly (to the back) and then
anteriorly (to the front), as shown in FIG. 39A. The horizontal
(anterior/posterior) dimension of the ear canal is shown to be
similar throughout the length, which is approximately 6-7 mm on
average in adults.
[0505] FIG. 39B is a frontal, or coronal, section (back, or
posterior half shown) and shows the superior and then inferior
shape of the ear canal (up and then down). The beginning section of
the ear canal has a larger dimension in this section. The starting
vertical (inferior/superior) dimension is approximately 9 mm on
average in the adult and decreases to approximately 6-7 mm for the
remaining length of the canal. Note that the sections may not be
exact frontal and transverse sections showing the center of the ear
canal due to the curvature of the ear canal in both directions.
[0506] FIGS. 40-48 show various aspects of conducting examinations
of the ear and oral cavity. Although these Figures have already
been discussed above, it will nevertheless be useful to provide a
brief summary thereof.
[0507] FIG. 40 illustrates the basic anatomy of the oral cavity.
FIG. 41 shows existing devices and interfaces for the ear and oral
cavity. FIG. 42 illustrates difficulties associated with use of an
otoscope. FIG. 42A shows the different parts that move relative to
each other and that should be controlled during an examination of
the ear. FIG. 42B shows how it can be advantageous to have a child
held and/or constrained during an ear examination with existing
devices and techniques. FIGS. 43-45 illustrates ear position and
speculum positioning during an examination with an otoscope. FIGS.
46-48 illustrate visualization of the throat using conventional
diagnostic instruments and techniques.
[0508] Collecting Diagnostic Information in or Near the
Ear--Overview of an Exemplary Device and Features
[0509] FIG. 49 shows a diagnostic device for capturing diagnostic
information in the ear. Capturing and processing elements are
contained in the main body of the device, as well as accessing
elements and inputs and outputs for light. Information is captured
and sent wirelessly to a computing device which, in this system,
contains processing and communication components.
[0510] FIG. 49 shows a device which is supported by the ear with an
imaging extension that enters the ear canal. An attachment provides
additional alignment and support. It engages with the concha of the
ear and part of the length of the ear canal, in this case
approximately 5 mm. This attachment positions the extension
superiorly in the ear canal entrance so that the tip is positioned
near the bend of the ear canal (where it may be positioned more
centrally or even inferiorly in the ear canal) in order to provide
a view of the ear drum (a preferred position). Since the device is
supported by the ear, it moves with the ear and head and there is
generally one moving part composed of the device, head and ear. The
ear may need to be manipulated to straighten the ear canal in some
cases in order to achieve the best image of the ear drum. If this
is required, the device can move with the ear and the imaging
extension can remain in a position to capture an image of the ear
drum. This could be described as two moving parts, those being the
head and separately the ear and device. In generally, the support
and positioning of the device by the anatomy reduces relative
motion between parts and makes it easier to use the device and
capture and image of the ear drum. There are less moving parts
and/or relative motion than generally occurs with existing devices
that are not supported by the anatomy as shown in FIG. 42.
[0511] It is preferred that this imaging extension and the
attachment which supports it are flexible and can move with the
canal, especially if the ear is manipulated to straighten the ear
canal. This device can significantly reduce the variables that the
user encounters and needs to control in order to image the ear
drum. For example, when the user first places the device, one hand
can be used to stabilize either the head or ear while the other
hand is used to the place the device. In many cases, the device may
be able to be placed without requiring stabilization of the head.
Once the device is in place, an image or video can be captured.
[0512] The device and alignment are generally not affected by head
motion and the user can have his or her hands free for other
purposes, such as communicating with a provider or operating
software on a computing device. If the ear requires manipulation to
achieve the best image, only one hand may be required to move the
ear or both hands may be used if the user also wishes or needs to
stabilize the head. In other cases, the user may wish or need to
stabilize a child's head if the child is uncooperative, but not
require moving or stabilizing the device or the ear. The device
generally controls the orientation and depth of the extension into
the ear canal. In this case, there are two moving parts at most and
two hands to control them. In many cases, there is only one moving
part to control and in many cases the user's hands are completely
free.
[0513] Safety, Tolerance and Comfort
[0514] The soft and flexible features of the attachment also allow
for increased comfort and tolerance and reduce safety concerns by
limiting insertion of the extension into the ear canal as well as
potential for the extension to push into the side walls of the ear
canal. In addition, the ease of use and features which provide
support and alignment reduce the time and manipulation required to
capture an image, further increasing subject tolerance.
[0515] Relative Angles of the Head, Ear, Ear Canal and Concha.
[0516] Up and Down Positions and Angles
[0517] FIG. 50A shows reference positions and angles in a frontal,
or coronal, plane. Lines parallel to the head and ear are shown by
the dotted lines. The side of the head is approximately vertical
and the axis of the ear is offset at an angle of approximately 15
degrees. The concha may be approximately aligned at the same angle
of the ear. Two solid lines going through the center of the
entrance to the ear canal represent reference lines for further
discussion. HeadFront is a line perpendicular to the head in the
frontal plane and EarFront is a line perpendicular to the ear in
the frontal plane. Note that ear angles are discussed relative to
an ear in a normal anatomical position and remain relative to that
position, even when the ear is moved or pulled.
[0518] FIG. 50B shows the two reference lines, EarFront and
HeadFront, and dotted lines at a positive or negative angle
relative to the reference lines. These angles will be used to
describe positions of imaging elements and other devices. For
example, a device/element with a positive EarFront angle has an
axis which is angled upward, or superiorly, relative to the ear
reference in a direction into the ear. Likewise, a device/element
with a positive HeadFront angle is angled upward relative to the
head. If this is a shallow angle, for example 5 degrees, this
device/element would have a negative EarFront angle since the ear
reference (EarFront) is approximately 15 degrees offset from the
head reference (HeadFront).
[0519] Forward and Back Position and Angles
[0520] FIG. 51A shows a horizontal, or transverse, view of the head
and ear. Lines similar to those shown above in the frontal plane
are illustrated. HeadHorz is a reference line perpendicular to the
head and EarHorz is a reference line perpendicular to the ear, both
going through the center of the ear canal entrance. The ear is
angled approximately 25-35 degrees (30 average) from the head in
this view.
[0521] Reference lines are once again shown in FIG. 51B, along with
dotted lines at a positive or negative angle to the reference
lines. These angles will be used to describe the orientation of
elements/devices. An element with a positive EarHorz angle is
positioned so that its axis is directed forward, or towards the
nose, relative to the ear reference (EarHorz).
[0522] Preferred Positions and Angles of Devices and/or Diagnostic
Elements
[0523] FIG. 52 shows two horizontal cross sections of the ear
canal, positions of imaging devices, angle of imaging elements
relative to the device and field of view achieved by imaging
elements. FIG. 52A shows examples of two different viewing angles,
or field of view, with imaging elements pointing straight out from
the tip of the device, i.e. not angled. A smaller field of view,
for example 30 degrees (shown by the area with vertical lines),
with an imaging instrument in this position (indicated by the solid
line entering the ear canal) does not include an image of the ear
drum. However, imaging elements providing a larger field of view,
for example 90 degrees (shown by the area with horizontal lines),
are able to capture the ear drum. FIG. 52B shows an example of an
imaging instrument with angled imaging elements (access and/or
capture elements). Elements providing a small field of view,
approximately 30 degrees in this case, can in this case capture an
image of the ear drum. FIGS. 53 and 54A are two cross sections of
the ear canal, a horizontal and a frontal section. Included in each
cross section are reference lines indicating positions of imaging
elements or devices and an arrow indicating the general viewing
direction towards the ear canal. A view of the ear drum is obtained
by device positioning, field of view of the imaging elements and/or
angle of the imaging elements relative to the device. Several
positions have been found to be capable of capturing an image of
the ear drum without manipulation of the ear or applying pressure
to tissue, as is necessary in ear exams using current otoscopes.
Ideal imaging positions differ between individuals and some
positions are more reliable at capturing an image for any given
individual. For adults, the most reliable position using a wide
angle scope was found to be as follows: insert the imaging device
just below the tragus (through the intratragal notch), entering the
ear canal at the lower, or inferior, edge and pointing up with an
angle of approximately 45 degrees and pointing back with an angle
of approximately 25 degrees. This position is illustrated by the
EarHorz line (FIG. 53) and the +EarFront line with a negative
offset (FIG. 54A). Alternative positions that are also capable of
imaging the ear drum are shown by the other reference lines. For
example, if one keeps the imaging instrument perpendicular to the
head, the instrument should be positioned at the back (posterior)
of the ear canal (HeadHorz with negative offset in FIG. 53) and at
the top (superior) of the ear canal (HeadFront with a positive
offset in FIG. 54A). There are many configurations that may work,
depending on the size, magnification and field of view of the
imaging device, as well as how far the imaging device is inserted
into the ear canal, but this description and the figures give
guidelines on how to successfully align a device and design a
device to capture an image of the ear drum. The description and
figures describe straight imaging devices. Alternative
configurations, such as curved or flexible devices, may be
constructed to position the tip of the devices in similar
locations. It may also be desired to angle the accessing or
capturing element, such as a lens, at the tip of the device so that
it is directed straight at the ear drum. For example, if a device
is constructed to angle up as it enters the ear canal, the lens at
the tip may be angled downward relative to the device to better
align with the ear drum. This lens, or addition lenses, then align
the incoming light with the video chip. Alternatively, the device
may be curved at the tip to achieve a similar result as angled
elements. For example, if the device is angled up as it enters the
ear canal, the tip may be curved down to better align with the ear
drum.
[0524] Similar configurations may be used for LEDs, lenses or other
light sources that output light. Configurations and principles may
also be applied to other diagnostic elements that are intended to
align with the ear drum, or alternatively these configurations may
be avoided in order to align elements with the ear canal walls and
not align with the ear drum.
[0525] FIG. 54B shows an ear canal shape that is more
representative of an infant's along with representative preferred
positions and angles of imaging instruments. The ear canal is
generally flatter, and may even be directed downward in young
infants. Therefore, an imaging instrument with a horizontal angle
can be located more centrally in the ear canal than in an adult
(HeadFront), although the posterior (or back) angle or position is
still desired to image the ear canal without pulling the ear back.
A positive EarFront angle is usually not necessary as it is in an
adult. Rather, a negative EarFront angle may be more effective to
image the ear drum in an infant. Preferred positions of positive
and negative EarFront angles are shown with offsets in FIG.
54B.
[0526] The lines representing imaging devices, components or
elements (see FIGS. 53 and 54) are shown with various depths.
Shallower placement may allow better tolerance and deeper placement
may allow better imaging of the ear drum. The general principles
may be followed for various depths. It is preferred that the tip of
imaging devices or components enter at least 2 mm and do not go
further than 18 mm into the ear canal, although shallower and
deeper depths may be used. The tip should not enter further than 12
mm into an infant's ear canal. The ideal depth is just past any
obstructions, such as hair and outer ear wax, and approximately to
the bend in the ear canal. This results in a more preferred
position of 6 to 14 mm insertion and a most preferred position of 8
to 12 mm into the ear canal for an older child or adult. For a
toddler, a preferred depth is 4 to 10 mm and more preferred is 5 to
8 mm. These guidelines can be used to create devices with various
positions, angles and depths for viewing an ear drum with the ear
in a natural anatomical position. Similar depth guides can be used
to create devices to image the ear when the ear is pulled back, or
up and back, along with the angles and positions of devices shown
and discussed in other sections with the ear pulled back or up and
back. Angles and positions in between those shown and discussed for
an ear in the normal anatomic position and with the ear manipulated
for imaging (i.e. pulled back or up and back) may be used to create
a device or components which are capable of capturing images with
ear in a variety of positions. In this case, a sufficiently wide
viewing angle is preferred, for example, a 30, 45, 60, 90, 120 or
greater viewing angle.
[0527] Ear Bud Otoscope and Examples of Positions and Angles of
Extensions into the Ear Canal
[0528] FIGS. 55 and 56 show the position of an earbud otoscope and
examples of positions and angles of extensions into the ear canal
and imaging elements. Various configurations for an earbud otoscope
could be created. For example, it could be structured as a
standalone device with built in wireless and video chip, an
attachment to a separate device to help position the extension into
the ear canal or part of a larger device. For now, the earbud will
be discussed as an anatomical interface which helps support and
align the extension and imaging elements. Positions are shown for
an ear in the normal anatomical position and when the ear is pulled
back and up. An ear bud placed into the concha of the ear in the
normal anatomical position, and optionally part way into the
entrance of the ear canal, is generally aligned with the angle of
the ear. Therefore, an extension (with imaging elements including
light sources or output at the tip) at a perpendicular angle to the
ear bud, is generally aligned with reference lines EarHorz and
EarFront as shown in FIG. 55. An extension extending in these
directions into the ear canal is in a generally desirable position
to image the ear drum, preferably extending 6-14 mm into the ear
canal. Depending on depth, anatomy, size of extension and imaging
elements and other factors, it may be desirable to offset the
extension posteriorly and/or superiorly relative to the center of
the ear canal opening and/or angled superiorly and/or posteriorly.
Still other desirable positions are an extension beginning
inferiorly in the entrance of the ear canal and angled superiorly
(a +EarFront angle) or positioned anteriorly in the entrance of the
ear canal and angle posteriorly.
[0529] When the ear is pulled back (FIG. 56B), the ear bud, concha
and ear, may remain at an angle similar to a normal anatomical
position. An extension previously described may then be pointing
towards the posterior wall of the ear canal as the ear canal shape
is changed and straightened out with this maneuver. While this
position may still be able to capture an image of the ear drum, it
is desirable that the extension change angle relative to the ear
bud to better align with the modified shape of the ear canal, to a
more anterior angle, as shown by the dotted line in the top right
image. This may be achieved by several methods, including a
flexible extension that conforms with the ear canal or a hinge or
flexible joint in the extension or at the junction with the ear bud
that allows rotation. Alternatively, the soft tipped extension may
contact the ear canal and cause the ear bud to move in the ear
canal, allowing a more anterior angle without changing the angle
between the extension and the ear bud.
[0530] When the ear is pulled up (usually done with a subject older
than infant age), the ear bud, concha and ear, may move to a
different angle than they are when the ear is a normal anatomical
position (see FIG. 56A). They move into a position so that an
extension perpendicular to the ear bud is now at a +EarFront angle
and generally well aligned with the modified shape of the canal in
this view. In this case, it would generally be desirable that the
extension angle relative to the ear bud remain consistent. In some
cases, it is desirable that the extension changes angle. For
example, it is preferable that the extension is allowed to angle
slightly inferior relative to the ear bud when the ear is pulled
up, as indicated by the dotted line in FIG. 56A. This may not apply
to infants, who generally have a flatter shaped ear canal which
sometimes points inferiorly rather than superiorly, so that the ear
is not pulled up and sometimes is pulled slightly downward.
[0531] Other anatomical interfaces, used in conjunction with an ear
bud or instead of an ear bud, to facilitate alignment of diagnostic
elements with the ear drum (this includes lighting elements and
other types of elements such as temperature probes) will be
described later.
[0532] Anatomical Interfaces in, on or Near the Visible Portion of
the Ear, Head, Neck or Cheek
[0533] FIGS. 57-61 show examples of anatomical interfaces which
help to support, stabilize, position (including serving as stops to
prevent over-insertion) and/or align devices, components or
attachments. Several configurations are shown, many of which
identify sections of devices which fit behind tissue (shown by the
dotted lines). Alternatively, similar configurations of any of the
structures may also be used which move or push tissue out of the
way (as shown in FIG. 57 G) or rest against or on top of the tissue
as shown in FIG. 57 H. In one example, a section that fits in the
concha may encourage a superior position of an imaging extension
into the ear canal, or an imaging extension may extend at an angle,
for example up and back (or superior and posterior), into the canal
from the section that fits into the concha or otherwise interfaces
with the ear or head. FIG. 57M shows an example of an interface,
preferably flexible, that has a larger bottom, or inferior, portion
to encourage a superior position of an imaging extension into the
canal. Interfaces can be structured to flex and partially enter the
canal. These or similar structures may be incorporated into a new
device or attachment for imaging the ear, be standalone attachments
or be combined with devices or attachments that exist today. For
example, adding these support features to a standard speculum (as
shown in figures by the cone shaped feature) can help to increase
usability of a device using a speculum. Structures may
alternatively by attached to the main device rather than an
attachment, extension, or speculum. Other types of support and
alignment include overhead or behind head straps or supports
similar to current earphones.
[0534] Structures can be incorporated into a device or attachment
(or supplied as attachments themselves) which fit into either the
right or left ear, for example FIGS. 57A,B, or which can fit into
both ears, for example FIGS. 57H,J,K,M. Structures in FIGS. 57J,K
are preferably flexible or elastic and partially or fully conform
into the anatomy but do not allow over-insertion of an extension
into the ear canal.
[0535] These structures may be manufactured in a variety of ways
with a variety of materials, but are preferably made of soft
materials that can flex such as silicone, urethane or other
thermoset or thermoplastic. Structures may be built with multiple
durometers of plastics, for example a harder inner durometer which
maintains the shape and a softer durometer outer shell to provide
comfort and which may also conform to the anatomy.
[0536] Structures may be joined to components, attachments or
devices by compressible means, such as springs, to allow some
motion. For example, a support structured for placement against the
ear or cheek may touch the ear, cheek or head prior to insertion of
a component into the ear canal. This allows the device to be
stabilized prior to insertion. Force is then applied to compress
the compressible member or members and allow a component to enter
the ear canal to image the ear drum. Similarly, the supports
themselves could be compressible or deformable, for example made of
foam or filled with air. If filled with air, the outer shell is
desirably elastic, similar to a balloon. See FIGS. 60 and 61 for
examples. FIG. 59 could also be compressible.
[0537] Structures may contain diagnostic elements and/or serve as
locations for attachments to collect additional diagnostic
information. For example, interfaces may contain sensors for
temperature, oxygen saturation, blood pressure, and/or heart rate.
Such sensors may be optical sensors which may use or monitor light
outputs of various wavelengths. Another example is a cheek support
that contains microphones. This cheek support may then be used as a
stethoscope. Ideally the microphones are covered by a diaphragm to
collect the sound or the support allows for a diaphragm attachment
or other means for channeling the sound to the microphones.
[0538] Anatomical Interfaces in or Near the Ear Canal
[0539] FIGS. 62-65 show examples of anatomical interfaces which
help to support, stabilize, position and/or align devices,
components or attachments. These or similar structures may be
incorporated into a new device or attachment for imaging the ear,
be standalone attachments or be combined with or incorporated into
devices or attachments that exist today. For example, adding
features that engage with the ear canal to a standard speculum may
help to increase alignment of the tip and the usability of a device
using a speculum. Speculums could be manufactured with these
features or sleeves or similar attachments made to mate with or
attach to a speculum. For example, a short sleeve made from
urethane or silicone or similar material may be slid over a
speculum to a distance away from the tip. This sleeve could have a
variety of outer shapes, such as a circle, oval or flower petal.
This sleeve can be structured to be close to the diameter of the
ear canal (and could even be slightly larger if it is made from a
compressible material such as foam) so that it helps to encourage a
position or alignment of the tip of the speculum. The sleeve may be
configured with a center hole or offset hole to encourage a more
central or more offset position of the speculum. Similarly the hole
through the sleeve could be at an angle, encouraging the speculum
to be angled in the ear canal. Instead of a sleeve, a speculum may
be molded with a similar structure.
[0540] FIG. 62 shows devices which include support and/or alignment
structures within the entry of the ear canal as well as structures
which engage with the visible part of the ear. FIGS. 63A,B show
other examples of structures both within the entry section of the
ear canal and further in. FIG. 63C shows an example of a structure
that has a longer lower (inferior) portion which encourages a
superior position of the extension. This structure is preferably
flexible. FIG. 63D shows a structure which has a more flexible top
(superior) section to encourage a superior position. FIG. 64 shows
various structures which may engage with both the outside visible
portion of the ear as well as in the entry of the ear canal. These
structures can encourage certain positions or angles of sections of
devices which extend into the ear canal, in these cases an
extension is shown in the upper, superior, region of the ear canal.
Structures can be flexible and allow partial entry into the ear
canal and help fit different sizes and shapes of ears and ear
canals. FIG. 64C shows a structure which is offset inferiorly
relative to the extension and ear canal. FIG. 64D shows a structure
which has two sections of with different flexibilities. The more
rigid section helps encourage a position of the extension, in this
case a superior position, and the more flexible section helps
conform to different ear sizes and shapes. FIG. 65 shows examples
of various profiles of structures that can be placed near the
entrance or in the ear canal.
[0541] Hand held devices or devices supported by the head and not
the visible portion of the ear may also be constructed with support
or alignment features within the ear canal. Devices which are
intended to be supported by the hand or facilitate the option to be
supported by the hands (see FIG. 62C) may also include one or both
features which engage with the ear canal or the outer visible ear.
Larger hand held devices may not inherently be supported by
components which are structured to engage with the ear canal
(although they may be supported by features which engage with the
visible ear). Ear canal interfaces may help with the alignment or
positioning of these devices as previously discussed (i.e. speculum
attachment). However, components or sections of larger devices may
be stabilized or positioned by ear canal interfaces. For example, a
large device with a flexible extension may have an anatomical
interface on the extension which supports and/or positions the
flexible extension while the larger device may be moved within a
limited range without moving the portion of the extension in the
ear canal or the portion just near the tip of the extension.
Smaller light weight devices may be supported or stabilized by
structures which are designed to interface with the ear canal and
provide support, stability or alignment.
[0542] These devices show support and alignment in the entry
portion of the ear canal which is larger in diameter as well as
alignment further in the ear canal. One or both of these locations
may be used to support and/or align the device and elements.
[0543] Examples of positioning the imaging or diagnostic extension
or elements. FIGS. 62A,B show a part of the device engaging with
the entry portion of the ear canal and an extension into the ear
canal containing image capture and/or access elements. In this
example, the extension is angled upward (superiorly) and backward
(posteriorly). FIG. 62C shows the extension at a generally
horizontal angle but offset upward (superiorly). Elements may be
contained directly in the part of the device engaging with the
entry portion of the ear canal and similarly be angled or offset
without an extension.
[0544] Support/Alignment features that engage with the entry of the
ear canal may take many shapes but are preferably oval in shape to
match the shape of the ear canal entrance.
[0545] Features may be short or long and may be conformable similar
to some ear plugs. The outside of these features should consist of
a soft polymer, such as polyurethane or silicone. Another example
is a half oval that is supported against the lower, or inferiorly,
wall of the ear canal. Other shapes and materials such as flanges,
cones, hair like or flower petal features, and solid, foam or air
filled materials may all be used to construct support and alignment
features in or near the ear canal. Two thin protrusions may extend
up and down from an extension into an ear canal (similar to two
thick hairs), and may serve as an oval (if the total length is
close to the major diameter of the oval) or circle engagement
because side to side motion would be resisted by the hairs which
would encourage a center alignment of the extension, unless one
hair is shorter than the other, in which case an offset position
would be encouraged.
[0546] While many positions and angles may be used to image the ear
canal, it is preferable that positioning features in the entry of
the ear canal position the extension in a superior position and/or
a superior angle when the ear is in a normal anatomical position.
If positioned at a superior angle, the extension may start
inferiorly, or lower, at the entrance of the ear canal and angle
superiorly, or upward. It is also preferable that the extension is
positioned or angled towards the back, or posteriorly, in the ear
canal. These positions and angles give a higher likelihood of
imaging the ear drum without moving the ear. If the ear is pulled
to straighten the ear canal, a more central positioning of imaging
elements is preferred. The imaging access is ideally positioned
past the hairs in the ear canal and approximately one third of the
way into the ear canal so to reach the bend in the ear canal. It is
also preferable that there is some flexibility in the extension
and/or position of the device if the ear is pulled back and up to
straighten the ear canal. Ideally, the extension will take less of
a posterior and superior position and/or angle if the ear is
moved.
[0547] It is preferable that the extension or imaging and lighting
elements are more centrally located further into the ear canal.
[0548] Another preferred embodiment includes an extension which is
angled superiorly and posteriorly (up and back) with imaging and
lighting elements angled relative to the axis of the extension.
Ideally the elements are angled inferiorly and anteriorly (down and
forward) relative to the extension. If the ear is pulled back, the
extension may flex to be more in line with the straightened ear
canal. This flex may cause the imaging and lighting elements to
move to be more in line with the extension, now that the extension
is more in line with the ear drum. In this case the elements move
relative to axis of the extension.
[0549] Diagnostic Elements
[0550] Lighting and Imaging Elements
[0551] FIGS. 66 and 67 show examples of locations of diagnostic
elements, in these cases illustrated as light output locations
(circular dots) and image/light input locations (lines). Elements
are shown contained 1) in an earbud (FIG. 66A), which is structured
to fit in the concha in the outer visible portion of the ear and
may also partially enter the ear canal 2) in an extension
structured to fit in the entrance of the ear canal (FIG. 66B), 3)
in an earbud and in an extension (FIG. 66C) and 4) in an extension
that extends from a section intended to engage with the entrance of
the canal (66D). Light output elements may take a variety of forms
such as LEDs, lenses, open channels or fibers. Likewise,
light/image inputs, or accessing elements, may be lenses, open
channels, fibers or other structure intended to allow light input.
Light output sources (such as LEDs) and light capture elements
(such as a CMOS video chip) may be located at or near these
locations, in another location in, on or near the device or
contained in an existing device such as a smartphone. Various
features, such as lenses, channels and fibers, may be used to
transmit light between locations. Other diagnostic elements may
also be located at these locations, such as temperature or
electrical contacts or sensors.
[0552] Inflatable or Expandable Elements
[0553] FIG. 68A,B show top views of an exemplary inflatable device
in a deflated state and in an inflated state. One or more parts of
the device may have chambers to allow inflation with air or another
fluid. The device may be inflated after being placed in the ear
during each use, allowing a tight fit or encouraging structures to
conform to anatomy and/or helping to achieve a preferred position
for capturing diagnostic information. The device may also be
inflated in order to adjust the size and then kept in that state
for future uses.
[0554] Flexible, Hinged, Rotating, Curved and Angled Components
[0555] FIG. 69 shows an example of a device with a rotating part.
In this embodiment, an extension into the ear canal is connected by
a hinge joint to an ear bud. When the device is placed into an ear
in its natural resting position, it may take a configuration
similar to the figure on the left. When the ear is pulled back, the
tragus or other surrounding tissue pushes on part of the extension
causing it to rotate and be directed more anteriorly, a more
favorable position for imaging the ear drum when the ear is pulled
back. This hinge allows the extension to better align with the ear
canal in different positions and in different people with different
shaped anatomy. Various types of joints may be incorporated,
including ball joints. Flexible material may be used to form a
hinge rather than using typical mechanical designs. This may allow
motion in any direction and also be deflected by anatomy of
different shapes or when the ear is pulled.
[0556] FIG. 70A shows a device with sections joined at angles
relative to each other. Angling parts relative to each other may be
used to better fit the shape of the ear and ear canal anatomy and
achieve a preferred position for collection diagnostic information.
Parts may also be curved or flexible to achieve this. FIG. 70B
shows sections joined by flexible members. The thicker section that
fits into the beginning of the ear canal is joined to the ear bud
with a narrower flexible joint while the narrower extension is
joined to the thicker section with a wider joint.
[0557] FIG. 71 shows parts that rotate to enable the device to be
used in both ears, as well as to enable the ear bud and extension
to conform to the ear anatomy of different people and when the ear
is in different positions (i.e. pulled to straighten the ear
canal). FIG. 71A shows an extension that rotates relative to the
earbud or other device and FIG. 71B shows a stem that allows the
earbud to rotate and also an extension that can rotate relative to
the earbud. A variation of joints and flexible parts may be
combined. For example, the arrows in FIG. 38AC show an ear device
that has a stem to rotate the bud to fit into left and right ears,
as well as a bud that rotates so that the extension fits left and
right ears.
[0558] Oral Cavity and Throat: Positions and Angles of Devices and
Accessing and Capturing Elements and Fields of View
[0559] FIGS. 72A-E show various positions of devices and
configurations of imaging elements, including angle and field of
view, for viewing the oral cavity and throat, some of which are in
preferred positions which in these cases allows a full view of the
tonsils. In general, it is preferred that a device and/or imaging
element is positioned at a distance above the tongue and further
into the oral cavity in order to view an image of the throat. If
anatomy is sufficiently open (i.e. jaw open, tongue depressed
and/or palate raised), a device positioned at the entrance to the
mouth may be in a position to view the desired areas of oral cavity
and throat. The figures show imaging elements configured at
different angles at the tip of devices (FIG. 72A), various field of
view angles (FIG. 72B), devices with multiple imaging elements
positioned at different locations (FIG. 72C,D) and an example of a
threshold (past the dotted line) and window where imaging elements
should be located in order to view the full tonsil (FIG. 72E). In
general, it is desirable for imaging elements to provide a large
field of view to make it easier to see the desired areas and
provide larger positioning windows for devices in order to capture
images of the desired areas and also for the elements to generally
point towards the desired area(s) to obtain the best image.
[0560] Positions of Anatomical Structures and Preferred Positions
and Angles of Accessing and Capturing Elements
[0561] FIG. 73 shows example of various preferred positions of
devices and/or imaging elements with anatomical structures in
different positions. FIG. 73A shows a device positioned to image
into the throat when the mouth is closed with minimal or no tongue
depression. The device can be configured with a curve or be
flexible to allow a curved shape to be obtained when placed into
the oral cavity or a combination of the two. FIG. 73B shows six
different positions and shapes of devices which are in preferred
positions with the mouth partially open and moderate tongue
depression. In order to view more of the throat and in this case
the bottom of the tonsil, imaging elements should be positioned at
the dotted line or further. It is preferred that some of these
devices have elements which are angled, for example numbers 1 and 2
should have imaging elements which are angled downward or also may
have imaging elements with large fields of view. Other devices are
shown which are curved at the tip to better angle towards the
throat and tonsil. FIG. 73C shows a situation with the mouth open
and more significant tongue depression. This situation allows
devices situated closer to the mouth entrance to have a fuller view
of the oral cavity and throat. In this situation, devices which are
positioned further above the tongue can be positioned closer to the
entrance of the mouth. Note that it is often not necessary to have
such a large or full view of the throat and/or tonsils, in which
case devices or imaging elements can be located closer to the
entrance of the mouth and/or closer to the surface of the
tongue.
[0562] Anatomical Interfaces
[0563] FIG. 74 shows various configurations of devices and
anatomical interfaces which help position diagnostic elements in
preferred positions. Devices can position diagnostic elements
and/or position anatomical structures. As discussed, devices or
attachments with anatomical interfaces can help reduce the number
of variables a user should control in order to safely image the
oral cavity or throat and/or help reduce the relative motion of
different moving parts (devices, attachments and/or anatomy) to
help the user safely image the oral cavity or throat. As shown and
discussed elsewhere, structures can be configured to contain
diagnostic elements, as sleeves or attachments to other devices or
attachments which contain diagnostic elements, or both contain
diagnostic elements and connect to other devices or attachments
which contain diagnostic elements. In general, it is preferred that
imaging elements are positioned at a distance above the tongue
and/or further in the oral cavity. The position of various
anatomical structures affect how much of the oral cavity and throat
is exposed for viewing. These structures include the tongue, the
jaw, and the soft palate and uvula. FIG. 74A shows a device which
minimally impacts anatomical structures, conforming to the tongue
and oral cavity shape, and positions imaging element(s) offset
higher in device, raised above the tongue for a fuller view of the
oral cavity and throat past the tip of the device. FIG. 74B shows a
device approximately midway into the oral cavity that helps to
depress the tongue as well as raise imaging element(s) above the
tongue. FIG. 74C shows a device which serves a similar purpose but
also has a portion which extends above the tongue which can help
achieve a better view of the throat by positioning the imaging
element further back without requiring contact or contact with high
force to an area of the tongue which is often more sensitive to
producing a gag reflex. FIG. 74D shows a device that is structured
for a more standard technique of depressing the tongue. FIG. 74E
shows a device which depresses the tongue and positions imaging
element(s) high in the oral cavity and closer to the entrance of
the mouth. FIG. 74F shows a device which can both depress the
tongue and elevate the soft palate (and therefore the uvula) which
can expose more of the tonsil and the throat. FIGS. 74G-J show
various other configurations, for example a larger diameter,
popsicle shaped, interface with diagnostic elements positioned
above the midline of the device (FIG. 74G), a device and diagnostic
elements positioned near the entrance to the mouth (FIG. 74H), a
device with a section that serves as a tongue depressor and a
section which is raised above this portion and that contains
diagnostic elements, in this case the raised portion is near the
entrance to mouth but can be positioned anywhere along the tongue
depressor section (FIG. 74I) and a similar device with a tongue
depressor section that has diagnostic elements near the tip, in a
position to view the throat, as well as a raised section that has
diagnostic elements, in this case in a position to view the oral
cavity (FIG. 74J).
[0564] In general, it is preferred that devices in contact with the
tongue have a certain height in order to provide viewing access to
a larger area or that devices are raised a certain height above the
tongue, or that devices are positioned far enough back, or further
into the mouth, to see down past the tongue when it is desired to
view the throat or that imaging elements are positioned at a
certain height in devices or anatomical interfaces or a combination
of one or more of these. For example, interfaces that are greater
than 3 mm, or 5 mm, or 10 mm, or 15 mm, or 20 mm or greater in
height, diagnostic elements that are positioned higher than 3 mm,
or 5 mm, or 10 mm, or 15 mm, or 20 mm or greater in a device or
interface. If a device is configured or used in a way to
significantly depress the tongue, it may not require this elevated
height or require elements to be at a height above the tongue. In
this case it may be possible to position elements near the surface
of the tongue as well as angle them up, rather than down as may be
desirable with a tall device.
[0565] If anatomical structures are sufficiently open, for example
the jaw open, the tongue depressed and/or the palate raised (which
can sometimes be achieved by a subject saying "aahh"), a device
with imaging elements may be positioned at or close to the entrance
of the mouth. A device can have a mouth piece to engage with the
lips and/or teeth to help maintain a mouth opening, position the
device or imaging elements or serve as a stop to prevent or reduce
the likelihood of the device being inserted too far into the oral
cavity. Various profiles of devices may be incorporated, for
example round, oval (either positioned horizontal to better match
the tongue surface or positioned vertically to help raise elements
and/or depress the tongue) or more complex shapes, such as one
which is generally flat to match the tongue with a middle "keel"
section that helps depress the tongue (FIG. 76). FIG. 75 shows
various profiles of devices and examples of positions of diagnostic
elements. In some of these examples, diagnostic elements are
positioned above the middle of the device in order to have a better
view. FIG. 75E shows a larger diameter device with diagnostic
elements in the middle while a smaller diameter device has
diagnostic elements positioned higher up to get a comparable view
(FIG. 75F). FIG. 75D shows an interface that positions diagnostic
elements near the sides of the tongue or oral cavity and in this
example also shows diagnostic elements that are positioned above
midline of the device. It may also be desirable to position
elements at or below midline in a similar structure, especially if
the device is long enough to reach near or beyond the back molars.
Devices may be wide or narrow or a combination, such as a wider
portion near the entrance to the mouth and a narrower section
further back in the midline or which can be offset to one side of
the mouth or the other.
[0566] FIGS. 76 and 77 show examples of anatomical interfaces with
different configurations and profiles. FIG. 76A is a top view of
one device showing a wider portion for the entry of the oral cavity
and a narrower section which extends further back. A wider section
stays outside the mouth to limit insertion of the device. Imaging
elements may be contained at various locations, for example at the
tip of the device and/or near the outside of the wider portion
prior to the narrower section. FIG. 76B,C show a front and side
view respectively and show a lower "keel" extension which helps
depress the tongue near the midline. FIG. 77A,B,C shows a simpler
construction with side, front and top views shown. FIG. 77A shows a
side view of a relatively thin device that has an oval profile
(FIG. 77B,C) to interface with the surface of the tongue. FIG. 77D
(top view), E (front view) shows a device which is configured to
position diagnostic elements near the sides of the tongue or oral
cavity.
[0567] FIGS. 78 and 79 show various shapes of anatomical interfaces
and some exemplary positions of imaging elements. Structures are
intended to fit with the oral anatomy, move anatomical structures,
help facilitate tolerance or comfort and/or position imaging or
other diagnostic elements. FIG. 78 shows top views and FIG. 79
shows side views. Shapes can be combined in a variety of ways to
facilitate accessing/capturing diagnostic information in the oral
cavity. While imaging elements have been shown, various other
diagnostic elements may also be included or included instead of
imaging elements. For example, microphones or pressure or
temperature sensors. Devices may also be able to capture fluids to
help diagnose conditions. Structures may retract or compress under
force, for example a compressible structure or sections joined by
springs. This may be especially beneficial if using a device to
collect fluids near the throat. For example a swab may be created
with a spring or other compressible member that deflects and/or
retracts if the swab encounters force, such as hitting the throat,
tongue or palate.
[0568] FIGS. 80A,B show a side view and bottom view of an
attachment that has legs to provide an offset from the skin
surface. Each leg has an anatomical interface at the ends that
contact the skin. These legs, the anatomical interface at the end
of the leg or other feature of an attachment, can be used as a
feature of known size in order to determine the size of an image of
the skin or near the skin, such as a mole, a rash or a tick. A
feature may also be attached to a leg or other area of an
attachment and can extend into the viewing area. It can be
configured to rotate or otherwise be moved into or out of the
viewing area. While an attachment can be configured with only one
or two legs that create a certain offset from the skin, it is
preferred that the attachment has at least three legs to provide a
more consistent offset distance as well as stability for the
attachment or device. The legs may be rigidly attached to the main
section or be flexibly or attached, for example with spring and/or
hinge connections, to allow the legs to move which may allow them
to conform better to the skin surface. The legs may also be rigid
or flexible, which can also provide for movement to conform to the
skin surface. The anatomical interfaces are shown as round
components but can be configured in a variety of ways, for example
as suction cups or flat pads. Surfaces may be hard (i.e. wood or
hard plastic) or soft (i.e. rubber, silicone or softer
polyurethane). Surfaces can be structured to glide over the skin or
to provide resistance to movement, for example with textured
surfaces or soft surfaces. The attachment has a connection for
joining it to a device which contains an image capturing element,
for example a CCD or CMOS video chip. One or more lenses channel
light from the skin to the device with the image capturing element.
Electrical contacts transfer electricity from the main device to
light sources in the attachment which emit light through an output,
for example an open channel or a lens. Alternatively the attachment
may contain batteries.
[0569] FIG. 80C,D show a side view and bottom view of attachments
with a light shield. This reduces or eliminates light from the
environment reaching the skin. An anatomical interface is located
at the bottom of this shield. Preferably, the interface is made of
a soft material. The attachment in FIG. 80C has a through hole to
allow light in and out from a main device that contains a light
source and video capture element. The attachment in FIG. 80D has a
lens which channels light to a video chip contained in the
attachment as well as two other lenses that emit light from light
sources contained in the attachment.
[0570] FIG. 81 shows two examples of an attachment for capturing
temperature in the ear. FIG. 81A shows a cone shaped device and
FIG. 81B shows a device that has a longer and thinner extension
that is joined to a section that fits into the entry section of the
ear canal and helps position the extension. The capturing element
is shown at the tip of both attachments, but can be located
elsewhere in the attachment, such as in a larger part of the device
that is positioned outside the ear canal or in a device that is
connected to the attachment. In the case, access elements would
collect and transmit the IR light to the capturing element.
Examples of capturing elements include a thermopile or pyroelectric
sensor.
[0571] FIG. 82 shows various configurations of anatomical
interfaces to image the nose or nasal cavity. FIG. 82A,B,C show
side views of three structures. FIG. 82A is configured as a nose
plug with a larger section that serves as a stop to prevent
inserting the piece too far. FIG. 82B is a similar shape but has a
thinner extension that reaches further into the nose. FIG. 82C is a
cone shape with the largest diameter greater than a nostril
opening. FIG. 82D,C shows a side view and front view of another
interface. This structure has a stop, or larger section, that is
offset and is ideally placed away from the lip (flatter side
towards the lip). These may be structured as attachments which
contain a connection for joining to a device which contains
capturing and/or processing elements or be part of a device.
Examples of light output locations are shown as well as light
inputs. Light sources and video capture elements can be located
near these locations at the tip, elsewhere in an attachment or in a
separate device.
[0572] FIG. 83 shows two configurations of attachments to image the
eye. Both of these incorporate a flexible interface in the form of
an eye piece that can contact locations near the eye, for example
above and below, or surround the eye. FIG. 83 A,B show a side cross
section and front views of an attachment which has an access
section which is positioned close to the eye which may allow better
quality close-ups. The attachment has electrical contacts to
deliver electricity to light sources. Light is transmitted through
access elements, such as plastic fibers, to the output or light
emitting element(s), for example a lens or open ends of fibers. A
lens array is shown which channels light from the input towards the
capturing element (video chip) contained in separate device which
is connected to the attachment. This access element can be
structured in a variety of other ways, for example as an open
channel or as two different lens systems, one which has greater
magnification than the other. Legs connect the eye pieces to the
attachment, and as discussed earlier, can be rigid or flexible and
can be rigidly or flexibly connected to the attachment.
[0573] FIG. 83C shows an attachment which has a circumferential eye
piece with a central opening. This attachment is configured with
leg supports and a light shield to reduce or eliminate
environmental light. This example shows an attachment that contains
light sources and a video chip. A device or attachment may also be
supplied which helps support or position a screen near the eye. For
example, FIG. 83C could be attached to a device with a screen, for
example FIG. 90, with the optional built-in or attachable screen,
and have a large through hole where the diagnostic elements are
shown in order to view the screen on the device. This may be used
for various purposes including diagnosing vision.
[0574] Diagnostic Kits
[0575] Imaging the Ear Canal and Ear Drum with Connections for
Optional Attachments
[0576] FIGS. 84A and 84B show a diagnostic device for imaging the
ear canal and ear drum, and including a main device and various
attachments. Most of the diagnostic elements are in the main
device. FIG. 84B is a view of the tip of the device with the over
ear piece excluded to show the locations of the light source and
light emitting elements. Several anatomical interfaces are shown.
The over ear piece and ear bud support the device and provide for
initial positioning and alignment of the device. An ear canal
engagement element protrudes from the ear bud and fits within the
ear canal entrance to further position and align the device. An ear
canal extension element then extends further into the ear
canal.
[0577] Power is supplied to LEDs contained in the engagement
section by the battery. Light is then carried from the LEDs by
optical fibers to the tip of the extension section. A ring shaped
lens is at the end of the fibers. The LEDs are contained within a
chamber that limits light from escaping and helps channel it into
the lenses and fibers. FIG. 84B shows the LEDs configured in a ring
in the engagement section and the light exiting out a smaller
diameter ring at the light output at the tip of extension
section.
[0578] Additionally, one or more lenses are contained in the tip of
the extension and serve as light input and access elements. These
lenses transmit light to the video chip capturing element. The
video chip captures images or video and transmits the signal to the
electronics. A signal then travels to the wireless communication
chip and is transmitted to an external device such as a computer or
smart phone.
[0579] Electrical contacts in the ear bud allow electricity to be
supplied to attachments. These attachments may take many forms,
such as a charging device, an attachment to enable connection to a
computing device or diagnostic attachments. Examples of diagnostic
attachments include attachments for viewing the oral cavity or
nasal cavity, a stethoscope for listening to sounds of the heart or
lungs, or sleeves or extensions to better fit ear anatomy or more
precisely align the device and elements for viewing the ear canal
and ear drum. This is especially beneficial to allow fitting users
of various ages and different anatomical shapes.
[0580] Main Device Containing Diagnostic Elements
[0581] FIGS. 85 and 86 show part of a diagnostic device similar to
the one in FIG. 85 and various attachments that connect to the
device.
[0582] FIG. 85A shows a simplified view of part a device similar to
the one in FIG. 84. This is a top view of the device positioned to
fit in a left ear. The ear bud with electrical contacts, ear canal
engagement section and extension with light outputs and light input
elements are shown. The ear bud may be part of a larger device that
includes an over piece (such as that shown in FIG. 84) or serve as
the main body of the device and contain a battery, processing
electronics and a wireless chip. The ear bud or over ear piece may
contain a variety of additional elements such as a data recorder,
small viewing screen, power indicator, recording indicator,
alignment indicator driven by software image recognition or
activated by a remote person viewing the image such as a
provider.
[0583] The light outputs may be LEDs positioned at the tip of the
extension or be the ends of optical fibers, channels or lenses that
light exits through which is channeled from LEDs or other light
sources positioned elsewhere in the device. Similarly, the light
access element may include a video chip at the tip of the
extension, ideally packaged with one or more lenses positioned in
front to focus light onto the video chip so that the desired image
or video is captured. Or, the light access element may be the ends
of optical fibers, channels and/or one or more lenses that light
enters and is channeled or transferred to a video chip (capture
element) positioned elsewhere in the device. A variety of
configurations and positions of lenses, light sources, video chips,
optical fibers, light pipes or tubes, mirrors, channels or other
known elements may be used to supply light and capture images.
[0584] FIG. 85B shows a cross section of a thin walled sleeve which
fits onto the device to better fit an individual's ear and ear
canal for added comfort, safety and/or better positioning of the
device and elements. The sleeve may be made from a polymer, such as
silicone or polyurethane, and ideally is soft on the outside. For
example, a durometer between 10 A and 90 A is preferred. Small
anatomical interface extensions protruding from the sleeve help to
position the device and elements as well as provide additional
comfort. The shell of the sleeve can be constructed from a harder
polymer or rubber and the extensions can be made of a softer
polymer or rubber. These extensions may be configured in a variety
of shapes and directions. For example, the extensions may be
hair-like, cone shaped circumferential flanges, ring shaped ribs
extending straight out or at angles, or small cylinders extending
out. Larger diameter features can be constructed with softer
material alongside smaller features of a slightly harder material,
maintaining comfort but not allowing too much movement in any
direction. This sleeve is shown with an opening at the end of the
device through which light exits and enters. Alternatively, the
sleeve may have one or more lenses or a transparent covering at the
end through which light exits and enters.
[0585] As mentioned earlier, the ear bud in FIG. 85A can be part of
a larger device (indicated by the broken line). Instead of an over
ear piece, the additional component to the device may extend
directly out to the side from the ear bud and contain elements such
as a battery, electronics and a wireless chip. This component may
take several forms and shapes and may be fully supported by the ear
bud or other support component built into the device or may also be
fully or partially supported and manipulated by a user. The
connection to an additional device component may be flexible rather
than rigid and may take the form of wire. This wire may attach to a
box or small hand held device which serves as a computing device or
houses elements required to transfer data to a computing device or
directly to a wireless or wired router. The extension and/or
engagement section may also be structured to mechanically decouple
(not rigidly connected) from the ear bud and remain connected by
means such as a retractable flexible wire. In this case the
extension and/or engagement section, housing the light source and
light accessing and capturing elements, may be inserted further
into or in the end of a different longer attachment, such as an
oral device for imaging the oral cavity and throat. Likewise, the
ear bud may decouple from the additional device component (such as
the over ear piece or side positioned component). In this case the
ear bud is secured within the oral device attachment or other
diagnostic attachment where it is desired to have the light output,
light capture or other functional element at a further distance.
The main device component (i.e. over ear piece, side positioned
component, or ear bud) may also fit into a cradle on a smartphone
or other computing or display device.
[0586] FIG. 86A,B show an oral attachment, similar in shape to a
pacifier, which connects to the ear canal section of the device
shown in FIG. 85A. Various connection methods can be used, such as
a tight fitting sleeve section and/or snap a fitting. The oral
device is shown with an open channel running through the interior
of the device with an open end input to allow light to pass
through. This channel may also incorporate mirrors, lenses and/or
fibers to channel the light. This is preferred if the channel takes
other shapes, such as a curve, in order to better access desired
anatomy. Similarly, the end of the channel may have one or more
lenses or a clear covering rather than being open. The inside of
this device is constructed of a harder material to maintain a
desired shape and the outer material is a soft material for comfort
and safety during use. The larger diameter ring serves as a stop to
prevent over insertion and to engage with the lips. This similarity
to a pacifier is intended to create a familiar device that may
require little or no training or instructions.
[0587] FIG. 86C shows an alternative oral device attachment. This
attachment connects to the ear bud with a tight fitting sleeve,
with snaps or other known connection means. Optical fibers and/or
individual channels that are open or contain lenses connect
elements at the end of the extension in FIG. 85A to elements at the
tip of the oral attachment. These connections are represented by
single lines in FIG. 86C. One or more lenses are configured at each
location for light output and light input. Here and elsewhere in
descriptions of devices, lenses refer to any transparent elements,
including those which have at least one curved surface to bend
light as well as elements that have flat faces on both sides to
allow light to pass straight through with less or no change of
direction.
[0588] FIG. 86D shows a stethoscope attachment which uses one or
more capturing elements (such as a dynamic, condenser or
piezoelectric microphone) to convert sound into an electric signal,
and can be used to listen to sounds inside the body, such as sounds
of the heart and lungs. The attachment connects to the device by
fitting over the ear bud section of the device in FIG. 85A. A
diaphragm access sounds to the body and transmits the information
to the microphone(s). In a different configurations, the diaphragm
can access sounds and transmit them through various means, for
example through a sound tube or through vibrations in a solid
material, to one or more capturing microphones in a device. For
example, these microphones can be contained in the ear bud section
of the device in FIG. 85A.
[0589] Diagnostic Elements Contained in the Attachments
[0590] FIG. 87 shows an alternative design of a main body and
attachments. In this configuration, diagnostic elements such as a
video chip and a microphone are contained in the attachments.
Accessing and capturing elements in the attachments convert the
diagnostic information to electrical signals that are transmitted
to the main device through electrical contacts located at the
connection between the attachment and the device. FIG. 87A is the
main diagnostic device and FIG. 87B is an attachment for imaging
the ear canal, FIG. 87C is an attachment to listen to sounds of the
body, such as sounds of the lungs and heart (stethoscope), and FIG.
87D,E shows a side and top view of an oral attachment for imaging
inside the mouth and throat. Various locations and configurations
and angles of video chips and light sources are shown. These
locations may instead be configured as inputs and outputs and light
sources and video chips contained elsewhere in the attachments.
[0591] Capturing Elements Located in Both the Main Body and in the
Attachments
[0592] FIG. 88A shows a main diagnostic device that contains
processing elements (wireless chip, electronics), a battery,
electrical contacts, a light source and a video chip capturing
element. FIG. 88B is an attachment for imaging the ear. It contains
a lens system to channel light from the light input to the video
chip in the main device, optical fibers to channel light from the
light source in the main device to the light out output, and a
light source at the tip. FIG. 88C is an oral attachment for imaging
inside the mouth and throat. It contains a lens system that
channels light from two different inputs that collect light from
different locations back to the video chip in the main device.
These inputs may also capture light from similar locations but at
different magnifications. The lens system may be comprised of two
different channels with lenses, or two subsystems. It is preferred
that the light from two different inputs is channeled to two
different locations on the video chip, for example the left and
right sides. Software can be used to display both of the images or
only one of the images. This example shows three light outputs near
the end of the oral attachment. FIG. 88D shows a stethoscope
attachment. This attachment has two different diaphragms and sound
inputs and two microphones to capture sound. In between these two
diaphragms is an access element comprised of a lens system to
transfer light from the light input back to the video chip in the
main device of FIG. 88A.
[0593] Main Body Configured to Allow Easier Support by a Users'
Hands
[0594] FIG. 89A shows a main device which is configured to allow a
user to support and manipulate the device. It contains diagnostic
elements, a video chip and two light sources. A similar device is
shown in FIG. 89C with a display screen built in. FIG. 89B shows an
attachment for imaging the ear. It contains access elements,
optical fibers to channel light from the light input to the video
chip in the main device as well as from the light sources in the
main device to the light outputs at the tip of the ear attachment.
The sections of the ear attachment are shown angled relative to one
another. The sections may also be flexible or be joined to each
other by flexible means. The optical fibers transmit the light to
the desired locations regardless of the position of these
sections.
[0595] A similar device may be constructed to be lightweight and
fully supported by the ear anatomy. For example, a device similar
to a Bluetooth headset that hangs down near the cheek or just
outside the ear. The device is shown with only an ear attachment
but attachments similar to those shown previously and later may
also be provided. In addition, FIG. 89C shows a small display built
into the device. This display may be small and light enough to
still allow hands free use. This screen may be incorporated into
higher end devices or may also be inexpensive enough to be
incorporated into standard devices. The display may be high enough
resolution to allow a diagnosis or be a low resolution display that
is intended only to allow the user to see general alignment of the
device and confirm that the required information has been captured
which may be displayed in higher resolution on a separate display,
such as on a tablet, smart phone, or laptop.
[0596] Various Configurations of Devices, Attachments and
Features
[0597] FIG. 90 shows three views of a main diagnostic device with
an extension that contains diagnostic elements at the tip, to emit
light and a video chip to capture light. A lens or lens system
preferably if positioned in front of the video chip to access the
light and channel it to the video chip. Light sources can be
positioned at the tip or elsewhere in the device and channeled to
outputs at the tip. This device has a main body section that can
serve as a handle, an ear canal engagement section and an ear bud
and stop to prevent over insertion into an ear canal. This device
may be used in the configuration shown to image the ear canal or
other locations of the body, or used with attachments that provide
added comfort, safety or precision. The device is configured to
allow imaging either the left or right ear. The ear bud is narrow
enough fit into either ear and large enough to prevent over
insertion. The imaging extension is positioned towards the top, or
superiorly, on the ear canal engagement section. This device is
shown with electrical contacts on the neck portion as well as on
the back near the optional built in display. A device preferably
has one or more locations for connecting attachments. Several
connection locations are shown in FIG. 90. The device has one or
connections multiple locations to connect attachments. Components
and sections, including the extension, can be rigid or flexible, or
be connected with rigid or flexible joints.
[0598] FIGS. 91 through 104 show attachments for a main device,
such as the one shown in FIG. 90, and examples of configurations of
the main device.
[0599] FIG. 91 shows a display attachment that can connect to the
back of the main device and FIG. 92 shows an over the ear piece
attachment which can connect into the top of the main device.
[0600] FIG. 93 shows a slim ear bud sleeve that can connect to the
main device and allow imaging either the right or left ears. FIG.
93A is a side view, FIG. 93B a front view and FIGS. 93C,D are top
views. FIG. 93C shows the connection to the main device and a
tapered ear canal engagement section. This taper may allow a
tighter fit into the canal and/or help to reduce motion and
maintain a position. FIG. 93D shows a slightly different shape of
the ear canal engagement section. The ear bud section tapers down
to the engagement section which is then a consistent thickness.
This may allow easier insertion or more comfort as well as allow
the user to move the device and imaging extension more easily in
order to capture the desired image. The opening through the ear
canal engagement section is shown to be large in this example. This
allows the extension to more easily move up and down (if it is
flexible). Alternatively, the through hole can be configured
smaller and be offset or angled through this section to position
the extension to one side or at an angle, for example, angled up or
down in the canal.
[0601] FIG. 94 shows an ear bud attachment for a main device. This
ear bud is structured to fit the left or right ear. This bud may be
detached, rotated and reattached to fit the opposite ear or be
constructed of flexible material to allow it to be rotated around
the attachment section of the main device. The large through hole
in the ear canal engagement section allows the attachment to fit a
device with an extension positioned to one side, for example
positioned upward as shown in FIG. 90A, regardless of which
direction the attachment is rotated in to fit the left or right
ear. Alternatively, two different attachments configured
specifically for the left and right ears can be supplied with
smaller through holes in this section which can fit an offset
extension or help to position or angle an extension, especially a
flexible extension.
[0602] Many configurations of light inputs and outputs can be
created at the tip of an extension or at another location of a
device or attachment. Capturing and light source elements can be
located near or at these locations or further away and have light
transmitted to and from them to the light input and output
locations which can be configured in various ways. FIGS. 95 and 96
show various examples of the tip of an extension and diagnostic
elements. One or more lenses for light output may be placed around
a central lens for light input (FIG. 95A). These may emit light
that is transferred from one or more light sources or be directly
in front of the light source. Light sources may be located at these
locations without an additional lens. A light output can be
configured in a crescent or similar shape to one side of the light
input (FIG. 95B). Small or large optical fibers can transmit light
from light sources to the tip and emit light circumferentially
around a light input (FIG. 95C,D). These may instead be open
channels. Tips of extensions or configurations of other locations
with light inputs and outputs do not have to be circular. For
example, light may be emitted from one side of an elongated circle
shape or from both sides of an oval shape, in both cases to the
side of a light input (FIG. 95E,F).
[0603] FIG. 96 shows cross sections of exemplary tip
configurations. Tips have light sources, optical fibers, a video
chip and a lens system. FIG. 96A shows a slightly bulbous tip,
similar in shape to a cotton swab. Light sources may instead be
located in front of the video chip and not require optical fibers.
Or fibers may thin out (to limit the diameter increase of the tip)
and spread out from one or more light sources to surround or
partially surround the light input. For example, optical fibers or
channels or lenses can form a circumferential light output or two
crescent shaped outputs. Light can also be directed towards the
axis of the extension by pointing the light in this direction, as
shown in FIG. 96A, or lenses can be used to direct light in one or
more directions, for example towards the midline of an extension
into an ear canal or towards the midline of the ear canal. FIG. 96B
show an example of positioning one or more larger light sources
behind a video chip and optical fibers which transmit the light to
the light outputs at the tip.
[0604] FIG. 97 shows an ear bud with a concha piece to provide
further support to the device or attachment. In one ear, the concha
piece curves up and in the other ear it curves down. This component
can have a connection configured similarly to the ear bud in FIG.
94. It can be removed, rotated and reattached to fit an opposite
side ear or it can be made of flexible material which allows the
component to be rotated around a connection of a device.
[0605] A section of an attachment may also rotate. For example, as
shown in FIG. 98, a concha piece in a device or attachment may be
rotated to fit the left or right ear. Or a larger section of an
attachment, a rotating component, configured as a larger ear bud or
more similar to a concha retainer, can rotate around another
section. FIG. 99 shows a two part attachment that connects to the
ear bud section of the main device in FIG. 90.
[0606] Other examples of rotating components and connections, in
these cases one piece attachments, are shown attached to various
configurations of connections of a main device. FIG. 100 show an
attachment which connects from the side. FIG. 101 shows cross
sections of two variations of rotating attachments which connect
from the front and are placed over the extension of the main
device. These figures also show two other configurations of ear
canal extensions. One extends straight from the center of the ear
canal engagement section and the other angles upwards. It is
preferred that these extension are flexible.
[0607] FIG. 102 shows two different stethoscope attachments that
can connect to the main device in FIG. 90A. FIGS. 102A and 102B
show an attachment which allows imaging through the center. This
example has more than one sound access section, in this case four
separate diaphragms, which can be configured to access different
types, frequencies or amplitudes of sound. Alternatively, all
desired sound may be captured by a microphone and filtered with
software as desired. Various types of microphones, discussed
earlier, can be used in one or more sound access sections. The
diaphragms can be configured to immediately contact the skin
directly upon placement (as shown in previous FIGS. 31, 38, 86, 87
and 88), which is preferred in most cases, or be offset from the
skin surface (as shown in FIG. 102), for example by rubber rings
which surround the diaphragms. Applying pressure can change the
amount of contact between the diaphragms and the skin. For example,
the rings can be flexible and move inward or outward. Different
sections can be created with varying areas of skin contact or with
varying degrees of flexibility to allow different contact areas to
be created with pressure applied. Different types of diaphragms
with different thicknesses or flexibility can also be used. FIG.
102C shows an attachment with a single diaphragm or other sound
access element which attaches to the main device and does allow
imaging through it. However, a camera in a main device or other
capture device may be offset up or down relative to the attachment
to see past a side of the attachment. Microphones are shown
generally placed. They are shown in large sound access areas or
placed against the diaphragm. However, various other methods and
configurations to access and capture sound that are generally known
in the manufacturing of stethoscopes can be used. For example
larger sound access areas may funnel down to a small area or a tube
where microphones are located.
[0608] FIG. 103 shows various views of an oral attachment which
attaches over a diagnostic extension of a main device. Alignment of
the tip of the diagnostic extension with the diagnostic elements in
the oral attachment can be important in order to efficiently
transfer light to the outputs and receive light back from the input
and the access elements, in this case shown as a lens system. In
order to best align the tip with the beginning of the diagnostic
elements in the oral device, the oral device has an elastic joint
section that can stretch to connect to the main device and force
the tip of the diagnostic extension into the end of the receiving
channel in the oral device, creating the desired alignment of
diagnostic elements in both parts. Various other methods and
configurations can be used to align the two ends of the two
different parts and ensure that optical or other elements are at
the desired positions and separations. At least one of the parts or
components can apply force when the parts are connected. Among
other things, this can accommodate for variations in manufacturing
and lengths of parts. For example, the extension can retract or
compress under force when the attachment is connected. Elastic
sections in the parts or in the connections can be used to apply
force when the parts are connected. Spring pins or other locating
features can be used to locate the parts as desired. These may also
be used to maintain a desired distance between the ends of the two
parts, in this case the end of the diagnostic channel and the end
of the receiving channel.
[0609] A close up of the receiving channel in FIG. 103D also shows
a seal or gasket. This reduces or prevents light from the light
outputs in the diagnostic extension of the main device from
reflecting into or otherwise entering the other light channel in
the diagnostic extension, in this case the light input. Various
configurations of the end of the receiving channel can be used. In
this case, it is shown as open where the light input part of the
diagnostic extension ends. There is a distance prior to the first
lens in the lens system of the attachment. A lens can also be at
this location and mate with the end of the diagnostic
extension.
[0610] FIG. 104 shows an attachment for capturing temperature, in
this in the ear, which connects to a main device shown in FIG. 90.
A sensor, for example an infrared sensor such as a thermopile or
pyroelectric sensor, is shown at the tip of the device. This sensor
may also be located elsewhere in the attachment or in the main
device and temperature related diagnostic data, such as infrared
light, accessed and transferred to the sensor.
[0611] FIGS. 105 through 109 show various configurations of
extendable, rotatable or moveable diagnostic sections or extensions
of a device. These may be moved before or after a device is placed.
For example, a device may be placed in a generally desired position
prior to extending or moving a diagnostic extension. Alternatively,
a diagnostic extension or section may be moved prior to placing the
device and locked into position, for example with a tightening
screw, by twisting a lock handle or positioning rod or by various
other known means. Sections or extensions may also be locked or
secured into position after placing the device. Friction may also
be used to maintain a position while still allowing the user to
modify the position by applying force, for example by pushing a
positioning rod. Extensions or sections may also retract or move
when force is encountered. For example, if an extension is inserted
into the wall of an ear canal, the extension may retract if the
user attempts to push the device further. This can help with both
comfort and safety.
[0612] FIG. 105 shows elastic members, such as springs, which keep
a diagnostic extension generally retracted. A positioning rod can
be pushed to extend the diagnostic extension.
[0613] FIG. 106 shows an elastic or compressible attachment, in
this case for diagnosing in the ear. The anatomical interface helps
position the device and the elastic section compresses when force
is applied to the device and the diagnostic extension extends
further out through the anatomical interface.
[0614] FIG. 107 shows a device which allows both extension and
retraction. The extension is normally partially extended. When it
is positioned to capture diagnostic information, it can retract if
force is encountered. The user may also further extend the
extension if desired.
[0615] FIG. 108 shows extensions which exit the device at a
different angle form the positioning rod. This may desired for a
variety of reasons, for example if anatomical structures are in the
way of a straight path. The distal portion of the extension in FIG.
108A can be rigid so that it maintains shape under force. The
distal portion of the extension in FIG. 108B should be flexible to
allow it bend in the channel. The device in FIG. 108B is shown
configured as an ear bud which has a section that interfaces with
the entry of the ear canal. It can have elastic structures which
maintain a preferred shape when it exits, for example a metal (i.e.
steel or nitinol) coil or wire.
[0616] FIG. 109 shows example of other configurations of movable,
extendable and rotating diagnostic extensions or sections as well
as electrical connections between the parts. In FIG. 109A, the
extension will retract if it encounters force, even while the user
is attempting to push the extension in. In this case the
positioning rod and the extension can move relative to each other.
FIG. 109B shows an extension that moves to conform to anatomy or
force encountered without input from the user. This extension can
also be connected to a positioning rod that the user can control.
FIG. 109C shows an extension which rotates depending on force
encountered.
[0617] Diagnostic extensions or sections may also be steerable. For
example, wires or other connections can connect a positioning rod
or structure to a diagnostic extension or part of the extension or
section, for example the tip. Connections can also connect a
positioning rod or structure to diagnostic elements, i.e. a video
chip, in the extension or other section. The user can then move a
positioning rod or structure to position the extension, part of the
extension or elements contained in the extension, or other
diagnostic section. Sections or elements may also be steered with
electromechanical means, where a remote person such as a provider
can steer the device or elements or a user may use software to
steer or the user may move a positioning rod or similar device
which then translates that motion to electrical signals which are
sent to the sections or elements of the device where
microelectromechanical components move the parts.
[0618] FIG. 110A shows a device which allows rotating the full
length of extension. FIG. 110B shows examples of wires (for example
Bowden cables) that steer or rotate the tip of an extension (show
as the shaded area). This extension can also be extended by the
handle. Multiple wires can be incorporated to steer the extension
or a portion of the extension in several directions, for example by
using two pairs of Bowden cables or other steering means. The
handles in both figures can take a variety of forms and can also
contain a display to view images while steering the device.
Similarly, any positioning rod, for example in previously discussed
figures, can contain a display. These extensions may also move or
retract when encountering forces, such as when the extensions are
pushed into anatomical structures such as the ear canal wall.
[0619] FIGS. 111 through 113 show devices with diagnostic
extensions that can fit attachments with different lengths. FIG.
111 shows an extension which can be extended to fit longer
attachments. Various means can be used to lock or maintain the
extension in place, for example friction, twisting the handle to
secure a latch, a lock screw or spring positioning pins. FIG. 112
shows an extendable and retractable extension, in this case that
wraps and unwraps from a wheel or coil. FIG. 113 shows a device
which retracts to fit shorter attachments. The extension has a
larger diameter section to prevent over-insertion into the ear
canal even when the ear attachment is not connected. In general it
is desired that a main device has features such as this for safety
in case an attachment is not used.
[0620] FIG. 114 shows an alternative configuration of a main
diagnostic device where the diagnostic elements, i.e. a video chip
and LEDs, are contained in the body of the main device and not in
an extension. It may be possible to incorporate a larger, higher
resolution and/or less expensive video chip, as well as brighter
light sources, in this case. The device can be constructed with a
variety of connections, for example an internal thread and an
external rim to snap or slip attachments onto. The device can
connect directly to attachments for certain areas of the body, for
example various extensions to image the ear as shown in FIGS.
114B,C,D. FIG. 114B shows an attachment similar to a standard
speculum which can connect to the main device and which has an open
channel (access element) running through it to channel light. FIGS.
114C,D show variations of a speculum. Attachments can have a lens
or lens array in a channel and can also have optical fibers to
channel light to the tip. The main device can also be configured to
connect to a standard speculum. A variety of attachments can be
created, for example as described earlier. Adapters can also
connect to the main device which then connect to various
attachments. FIG. 114E shows an adapter which has a lens and is
configured to connect to standard speculums. FIG. 114F shows an
attachment similar to a standard speculum that has a stop to
prevent over insertion. This anatomical interface may also be
configured to help align the attachment. The stop or anatomical
interface may be permanently connected to the speculum (i.e.
overmolded) or can be constructed to slide over a speculum. FIG.
114G shows another adapter which has an anatomical interface and
stop and which can connect to a standard speculum or be configured
to connect to a variety of other attachments. The adapter is open
on one side to receive the speculum in from the side due to its
tapered shape, rather than in form the end. Additional attachments
may be connected to the adapter in addition to the speculum, for
example an earbud can connect to the stop. FIG. 114H shows an
attachment which is similar to part of the device in FIG. 90. This
attachment can channel light to and from the tip to the diagnostic
elements in the main device, or can contain diagnostic elements and
have electrical connections to the main device, or a combination of
the two. Additional attachments can connect to this attachment.
[0621] FIG. 115 shows an example of a configuration with diagnostic
elements in the main body of a device that allows extension and
retraction.
[0622] FIG. 116 shows a device with various diagnostic elements
(i.e. light source, video chips, pressure sensors, infrared
sensors) at different locations in a device. For example, the
device may have sensors to record temperature by contact to and/or
at a distance from the forehead, electrical and/or optical sensors
to record other physiologic parameters such as blood pressure,
heart rate and pulse oximetry. Alternatively these types of sensors
may be incorporated into attachments. One or more of these or
similar locations can be used and attachments configured
accordingly. Various connection structures can be incorporated into
the main device. Different attachments can use different diagnostic
elements. For example an ear attachment uses the elements in the
thin extension while a skin imaging attachment uses a larger higher
resolution chip located to the side of the extension. The elements
at the tip of the thin extension may be a video chip and light
source or alternatively, as discussed earlier, be configured as
lenses that output light from one or more light sources contained
away from the tip or within the larger body of the device and
gather light at the tip and transfer it to one or more video chips
further away from the tip or in the body of the larger section.
Multiple elements may be used at the same time. For example, a
large chip with wide angle lens is used to image the body and show
where a device is being placed while a video chip at a different
location is used with an attachment with a zoom lens to image a
specific location. The device can be structured in a variety of
ways. For example, as discussed elsewhere, a device similar to an
earbud, an over the ear piece or a small diameter device as shown
in FIGS. 118 and 119.
[0623] FIGS. 117-119 show various other configurations of devices
and kits.
[0624] FIG. 117 shows a small diagnostic device which fits into,
snaps into, or otherwise connects to an anatomical interface for
imaging the oral cavity and throat. The diagnostic device can be
used to image the ear and can connect to other attachments.
[0625] FIG. 118 shows another configuration of a main device and
attachments. FIG. 118A shows an attachment which has a wire and
connection to a main device. The attachment is a small diameter
device which can be configured with a tip shape similar to a cotton
swab and can be used to image the ear canal or oral cavity.
Ideally, this attachment has a stop to prevent over-insertion into
the ear canal, such as a flared section or larger diameter section
which can be configured in many ways, such as has been described
earlier for various anatomical interfaces that serve as a stop
and/or to otherwise help position or stabilize the device. A video
chip and light source may be located at the tip of the device, or
lenses or other inputs/outputs may be located at the tip of the
device and one or more video chips and light sources located
further away from the tip, for example in the larger diameter
section of the device. FIG. 118B shows another attachment to the
main device which contains additional diagnostic elements and
connections for other attachments.
[0626] FIG. 119 shows a diagnostic device that has a long narrow
extension with diagnostic elements at the tip. The tip can be
configured similar to a cotton swab, i.e. slightly larger rounded
diameter. The main body of this device contains other elements such
as a battery, video chip and electronics, for example for partial
signal processing. This device can be used to image the ear, oral
cavity or other body area. It can also be configured with other
diagnostic elements, for example to record temperature by inserting
into the ear canal or by pointing towards or contacting the
forehead. It can also be configured to connect to attachments for
the ear or oral cavity or other area of the body, for example to
help position the device or anatomy. Ideally, the device has a stop
to prevent over-insertion into the ear canal, for example a larger
diameter section. The device may also fit into other attachments,
similar to the device in FIG. 117, FIG. 111 or FIG. 102. The
extension, or part of the extension can be flexible and/or elastic.
For example, part of the extension can be constructed with a spring
wire or coil (i.e stainless steel or nitinol) or other elastic
means that helps maintain a certain shape that can be manipulated
or bent, and that then returns to the original shape. The extension
can also be structured to allow its shape to be bent and formed
into a desired shape which it then maintains.
[0627] The various embodiments described above can be combined to
provide further embodiments. Aspects of the embodiments can be
modified, if necessary to employ concepts of the various patents,
application and publications to provide yet further
embodiments.
[0628] Other objects, advantages and embodiments of the various
aspects of the present invention will be apparent to those who are
skilled in the field of the invention and are within the scope of
the description and the accompanying figure. For example, but
without limitation, structural or functional elements might be
rearranged, or method steps reordered, consistent with the present
invention. Similarly, a device may comprise a single instance of a
device or comprise a plurality of devices, such plurality
functioning as a single device working in tandem. For example, a
computing device may consist of a plurality of computing devices
which together provide the desired functionality. The device types
described in various embodiments are not meant to limit the
possible types of devices that may be used in embodiments of
aspects of the present invention, and other types of devices that
may accomplish similar tasks may be implemented as well. Similarly,
principles according to the present invention, and methods and
systems that embody them, could be applied to other examples,
which, even if not specifically described here in detail, would
nevertheless be within the scope of the present invention.
[0629] The following listing identifies elements illustrated in the
Figures and provides the respective reference numeral for each of
the identified elements.
TABLE-US-00001 Reference Numeral Element 10 Telehealth system 12
Provider 14 Caregiver 16 Subject 18 Diagnostic device 20
Communication component 22 Processing component 24 Accessing
element(s) 26 Capturing element(s) 28 Anatomical interface
component or feature 30 Light source 32 Speaker 34 Microphone 36
Diaphram 38 Kit 40 Oral device/attachment/component 42 Light
emitting 44 Battery 160 Over ear piece 162 Ear bud 164 Ear canal
engagement section to fit entrance of ear canal 166 Diagnostic
extension 168 Sleeve fitting/component 170 Stop for oral
device/attachment 172 Light input 174 Main diagnostic device 176
Stop for ear device/attachment 178 Over ear piece 180 Concha
part/section 200 Provider system 202 User system 204 Accounts,
logistics and infrastructure system 206 Diagnostic information/data
210 Diagnostic element(s) 212 Input and/or output 214 Source
element 216 Video chip 218 Wireless chip 220 Electronics 222 Ear
device/attachment/component 224 Skin device/attachment/component
226 Eye device/attachment/component 228 Stethoscope
device/attachment/component 230 Field of view 232 Primary
input/output direction (for example, center of field of view or
diagnostic view) 234 Electrical contacts 236 Electrical
connection/wire 238 Lens or lens system 240 Connection/fitting 242
Leg of device/attachment/component 244 Light shield 246 Temperature
sensor 248 Nose device/attachment/component 250 Eye piece 252
Access opening in eye piece 254 Optical fibers 256 Open channel 258
Display/screen 260 Handle or main body section 262 Display
attachment 264 Hinge/joint 266 Rotating component/section 268
Seal/gasket 270 Elastic joint or section 272 End of receiving
channel 274 Elastic member 276 Positioning structure, rod or handle
278 Adapter 280 Other attachment 282 Steering cable 284 Steerable
section 286 Otoscope/other viewing instrument 288 Speculum 290
Tongue depressor 292 Stiffer section 294 Inflatable/expandable
section 296 Flexible section
* * * * *