U.S. patent application number 13/498546 was filed with the patent office on 2013-02-28 for intravaginal monitoring device and network.
This patent application is currently assigned to Illuminare Holdings Ltd.. The applicant listed for this patent is James D. Bennett, Witold Andrew Ziarno. Invention is credited to James D. Bennett, Witold Andrew Ziarno.
Application Number | 20130053657 13/498546 |
Document ID | / |
Family ID | 43796249 |
Filed Date | 2013-02-28 |
United States Patent
Application |
20130053657 |
Kind Code |
A1 |
Ziarno; Witold Andrew ; et
al. |
February 28, 2013 |
INTRAVAGINAL MONITORING DEVICE AND NETWORK
Abstract
Various types of intravaginal monitoring devices (IMD) along
with various supporting medical and computing devices within a
communication network service pluralities of femal reproductive
systems An IMD alone or with assistance from one or more supporting
systems assists in detection, monitoring, therapy delivery and
efficacy evaluations of various types of physiologic conditions of
the various femal reproductive systems Exemplary conditions include
those related to pregnancy, premature birth, fertility, ovulation,
diseases, infections, fluids, flora, pre-cancerous conditions,
cancer, non-human animal estrus, etc Various types of IMDs include
those with multiple sensors within a housing sized for at least
partial insertion into a vaginal channel of a reproductive system
In some IMDs, only a single sensor such as an optical imager might
be found, while in others multiple such imagers and as temperature,
pH, glucose, electrolyte, sonogram, magnetic resonance, pressure,
ultrasound, microphone, etc, sensors can also be included.
Inventors: |
Ziarno; Witold Andrew;
(Thalheim, DE) ; Bennett; James D.; (Hroznetin,
CZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ziarno; Witold Andrew
Bennett; James D. |
Thalheim
Hroznetin |
|
DE
CZ |
|
|
Assignee: |
Illuminare Holdings Ltd.
Dubai
AE
|
Family ID: |
43796249 |
Appl. No.: |
13/498546 |
Filed: |
September 27, 2010 |
PCT Filed: |
September 27, 2010 |
PCT NO: |
PCT/US10/50329 |
371 Date: |
November 9, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61246405 |
Sep 28, 2009 |
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61246375 |
Sep 28, 2009 |
|
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|
61246396 |
Sep 28, 2009 |
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61263416 |
Nov 23, 2009 |
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61290792 |
Dec 29, 2009 |
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Current U.S.
Class: |
600/304 ;
600/476; 600/511; 600/588; 600/591 |
Current CPC
Class: |
G16H 15/00 20180101;
A61B 5/14532 20130101; A61B 1/00034 20130101; A61B 1/00016
20130101; A61B 1/00177 20130101; A61B 17/42 20130101; A61B 7/023
20130101; A61B 1/00096 20130101; A61B 5/4839 20130101; A61B 8/12
20130101; A61B 8/4472 20130101; A61B 1/05 20130101; A61B 5/4343
20130101; G16H 40/67 20180101; A61B 1/00135 20130101; A61B 1/00142
20130101; A61B 5/6846 20130101; A61N 2005/0611 20130101; A61B 1/303
20130101; A61B 5/4318 20130101; A61B 5/68 20130101; A61B 8/4416
20130101; A61B 8/445 20130101; A61B 5/035 20130101; A61B 17/425
20130101; A61B 5/0444 20130101; A61B 5/14539 20130101; G16H 30/20
20180101; A61B 1/042 20130101; A61N 5/0603 20130101; G16H 40/63
20180101 |
Class at
Publication: |
600/304 ;
600/591; 600/476; 600/588; 600/511 |
International
Class: |
A61B 5/103 20060101
A61B005/103; A61B 5/11 20060101 A61B005/11; A61B 5/0444 20060101
A61B005/0444; A61B 6/00 20060101 A61B006/00 |
Claims
1-5. (canceled)
6. A method used by a self-powered device that can be
communicatively coupled with a computing device, the device sized
for at least partial insertion into a female reproductive system
via a vaginal channel, the method comprising: capturing by a first
sensor, when the device is at least partially inserted within the
vaginal channel, first sensor data relating to the female
reproductive system; capturing by a second sensor, when the device
is at least partially inserted within the vaginal channel, second
sensor data relating to a physiological parameter of a fetus within
said female's womb; and wirelessly communicating the first sensor
data and the second sensor data to the computing device.
7-11. (canceled)
12. A device that is sized for at least partial insertion into a
female reproductive system via a vaginal channel, the device
comprising: a housing; a first sensor disposed in the housing at a
location that supports gathering of first sensor data from the
female reproductive system; processing circuitry disposed in the
housing that receives input; memory, disposed in the housing, that
is coupled to the processing circuitry; the memory storing
operating instructions to he carried out by the processing
circuitry, the operating instructions defining at least two
operating procedures, said operating procedures related to periodic
pregnancy monitoring; and the processing circuitry selecting one of
the at least two operating procedures based on the input.
13-20. (canceled)
21. A method associated with a female reproductive system, the
method comprising: retrieving optical imager data related to a
target area within the female reproductive system, the target area
being accessible via a vaginal channel of the female reproductive
system; performing an automated analysis of the optical imager
data; and producing information based on the analysis, the
information at least assisting in identifying a status for at least
a portion of the female reproductive system.
22-26. (canceled)
27. A method used by a computing device that interacts with a
monitoring device, the monitoring device having an optical imager
that captures imager data from a female reproductive system via a
vaginal channel, the method comprising: receiving a first portion
of the imager data, the first portion of the imager data having
been captured by the optical imager during a first imaging session;
storing the first portion of the imager data; receiving a second
portion of the imager data, the second portion of the imager data
having been captured by the optical imager during a second imaging
session; retrieving the first portion of the imager data from
storage; comparing the first portion of the imager data with the
second portion of the imager data; and producing, based at least in
part on the comparison, status information relating to at least a
portion of the female reproductive system.
28-31. (canceled)
32. The method of claim 27, wherein the status information relates
to a non-human animal estrus event.
33. A method used by a server in a communication network, the
communication network also having a plurality of sensor devices and
a support computer, each of the plurality of sensor devices
capturing sensor data via a vaginal channel of a female
reproductive system, the method comprising: establishing
communication with the plurality of sensor devices; receiving the
sensor data captured by at least one of the plurality of sensor
devices via the vaginal channel of the female reproductive system;
generating display data based on the sensor data received; and
delivering the display data to the support computer.
34. (canceled)
35. The method of claim 33, wherein the server supports sales.
36-37. (canceled)
38. A method used by a server in a communication network to make a
related data selection from a plurality of data, the communication
network comprising a medical sensor device that captures sensor
data via a vaginal channel of a female reproductive system, the
method comprising: establishing communication with the medical
sensor device; receiving the sensor data captured by the medical
sensor device; and selecting the related data from the plurality of
data, the selection being based at least in part on the sensor data
received.
39. The method of claim 38, wherein the plurality of data comprises
a plurality of advertisement data.
40. The method of claim 38, wherein the plurality of data comprises
a plurality of data.
41-63. (canceled)
64. A method of decreasing insurer or governmental health system
costs comprising: providing an intravaginal monitoring device
capable of identifying an event during a pregnancy; determining
whether or not a pregnant female is having a pre-mature birthing
event; and treating said pregnant female to increase the gestation
time of a being within the womb of said pregnant female.
65. A telemedicine system comprising: a wireless, battery powered,
intravaginal monitoring device having at least two cervical
sensors, the two cervical sensors selected from the group
consisting of a cervical dilation sensor and a cervical effacement
sensor; and, an external wireless, battery powered, electronic
smart patch having at least two sensors, the two sensors selected
from the group consisting of a maternal contraction sensor and a
fetal heart rate sensor; and an external communication device
communicatively and wireless linked to the intravaginal monitoring
device and the electronic smart patch.
66-68. (canceled)
69. The telemedicine system of claim 65, further comprising a
remote server, in which the external communication device is
communicatively linked to the remote server, the remote server post
processing data harvested by the cervical dilation sensor, cervical
effacement sensor, maternal contraction sensor and fetal heart rate
sensor to obtain post processed data, and the post processed data
being communicated to a second communication device.
70. The telemedicine system of claim 69, in which the second
communication device is a microprocessor controlled device
comprising a graphical user interface, the graphical user interface
presenting a graph, the graph selected from the group consisting of
a cervical dilation graph, a cervical effacement graph, a fetal
heart rate graph, and a maternal contraction rate graph.
71-72. (canceled)
73. A telemedicine system comprising a communication device, a
server, and a plurality of wireless, self-powered intravaginal
monitoring devices communicating data harvested from a plurality of
females to said server, and said server communicating said data to
said communication device.
74-75. (canceled)
76. The telemedicine system of claim 73 in which said females
comprise females estrus.
77. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application incorporates by reference herein in their
entirety and makes reference to, claims priority to, and claims the
benefit of:
[0002] a) U.S. Provisional Application Ser. No. 61/246,375 filed
Sep. 28, 2009, entitled "Intravaginal Monitoring Device" by Ziarno
et al.;
[0003] b) U.S. Provisional Application Ser. No. 61/246,405 filed
Sep. 28, 2009, entitled "Network Supporting Intravaginal Monitoring
Device, Method and Post Harvesting Processing of Intravaginally
Processed Data" by Ziarno et al.;
[0004] c) U.S. Provisional Application Ser. No. 61/246,396 filed
Sep. 28, 2009, entitled "Network Supporting Intravaginal Monitoring
Device" by Ziarno et al.
[0005] d) U.S. Provisional Application Ser. No. 61/290,792 filed
Dec. 30, 2009, entitled "Network Supporting Intravaginal Monitoring
Device, Method and Post Harvesting Processing of Intravaginally
Processed Data" by Ziarno et al.; and
[0006] e) U.S. Provisional Application Ser. No. 61/263,416 filed
Nov. 23, 2009, entitled "Intravaginal Monitoring Architecture" by
Ziarno et al.
[0007] Also incorporated herein by reference in their entirety
are:
[0008] a) U.S. patent application Ser. No. ______ filed on even
date herewith by Ziarno et al., entitled "Intravaginal Monitoring
Device" client docket number PUS-L019-001;
[0009] b) U.S. patent application Ser. No. ______ filed on even
date herewith by Bennett et al., entitled "Network Supporting
Intravaginal Monitoring Device" client docket number
PUS-L019-002;
[0010] c) U.S. patent application Ser. No. ______ filed on even
date herewith by Bennett et al., entitled "Analysis Engine within a
Network Supporting Intravaginal Monitoring" client docket number
PUS-L019-003;
[0011] d) U.S. patent application Ser. No. ______ filed on even
date herewith by Bennett et al., entitled "Intravaginal Monitoring
Support Architecture" client docket number PUS-L019-004;
[0012] e) U.S. patent application Ser. No. ______ filed on even
date herewith by Bennett et al., entitled "Intravaginal Therapy
Device" client docket number PUS-L019-006;
[0013] f) U.S. patent application Ser. No. ______ filed on even
date herewith by Bennett et al., entitled "Intravaginal
Dimensioning System" client docket number PUS-L019-007; and
[0014] g) U.S. patent application Ser. No. ______ filed on even
date herewith by Bennett et al., entitled "Intravaginal Optics
Targeting System" client docket number PUS-L019-008; and
[0015] h) PCT Patent Application Ser. No. ______ filed on even date
herewith by Bennett et al., entitled "Intravaginal Monitoring
Device and Network" client docket number PWO-L019-001.
BACKGROUND
[0016] 1. Technical Field
[0017] The invention generally relates to intravaginal monitoring
devices, methods, and networks, as well as smart phone devices
communicating with the intravaginal monitoring devices, and smart
phone devices communicating with other nodes on a network.
[0018] 2. Related Art
[0019] Reproductive health covers a wide area of a female's health
and it is of critical importance to be able monitor this aspect of
a female's life. Monitoring of a female's reproductive health
should begin during the teen years and proceed all the way through
end of life. However, a shortage of health care professionals and
prohibitive costs make it difficult to continuously monitor
intravaginal conditions that include conditions that can be
monitored via vaginal fluid discharges, discharges from the uterus
that are exuded through the cervical canal into the vagina,
cervical colors and color changes, ovulation related conditions,
menopause related conditions, sexually transmitted diseases related
conditions, and child birth related conditions. In addition to all
these conditions, treatments and therapies also necessitate
constant monitoring to determine their efficacy for various female
health problems and events.
[0020] These conditions are typically monitored by a gynecologist
or obstetrician by inserting a speculum and examining or inspecting
the inside of the vagina, cervix, and uterus for the possibilities
of the aforementioned conditions and efficacy of treatments. That
is, patients need to visit the gynecologist or obstetrician
routinely and these routine checkups needs to be done during
visiting hours of the health care professionals (gynecologist or
obstetrician). Travel is necessitated, relocation, the effort
required to locate a new gynecologist, long lines in waiting rooms,
potential embarrassment, all serve to discourage female from
routinely having these checkups, and present potential dangers for
the female in the event of a quickly deteriorating event or
condition, e.g., Chlamydia infection, progression of a cancer to
dangerous stages and the like.
[0021] For instance, the fluid discharge (e.g., non colored,
colored, opaque, pussy) indicates conditions such as normal (small
amount of clear or slightly milky vaginal discharge), yeast
infections, abnormal vaginal flora, menstrual cycle, menopause,
infections or STD--sexually transmitted diseases--(much more
discharge than normal, discolored discharge, or abnormal
discharge). By way of example, STDs include Chlamydia (increased
vaginal discharge), Human Papiloma Virus (HPV--white lesions on the
cervix during infection), Gardnerella (grayish, foamy discharge,
with a strong fishy smell), Candida (thick creamy whitish
discharge, with a yeasty smell), Gonorrhea (yellow or greenish
discharge with a strong smell), Trichomonas (TV) (a frothy
discharge, sometimes a yellow-green color) and so forth. In
addition, externally and or internally, cysts, lumps and bumps,
conditions related to in growing hairs, acne spots, and blocked
glands are also observed via inspections. These routine checkups
become even more difficult when the female is in a remote location
and this is even truer in the developing regions of the world where
there are be no specialists, medical clinics or medical help
located close to the female. These females are forced to proceed to
the nearest town or larger city where a female's health care
provider are located. This may involved hours or even days of
travel by train or bus further discouraging the female from seeking
needed medical care or treatment.
[0022] These and other exemplary limitations and deficiencies
associated with the related art are more fully appreciated by those
skilled in the art after comparing such related art with various
aspects of the present invention as set forth herein with reference
to the figures.
BRIEF SUMMARY OF THE INVENTION
[0023] The present invention is directed to a device, apparatus and
methods of operation that are further described in the following
Brief Description of the Drawings, the Detailed Description of the
Invention, and the claims. Other features and advantages of the
present invention will become apparent from the following detailed
description of the invention made with reference to the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 is a schematic block diagram illustrating a
gynaecological analysis engine incorporated into the intravaginal
monitoring devices and its supporting network infrastructure;
wherein the gynaecological analysis engine, having a database that
has association with various gynaecological conditions, makes a
first preliminary analysis of possible gynaecological
conditions;
[0025] FIG. 1b is a schematic block diagram illustrating an
intravaginal monitoring device and its supporting network
infrastructure; wherein the intravaginal monitoring device
communicates via a communication interface to external devices
and/or external servers via wired and/or wireless network
pathways;
[0026] FIG. 2 is a schematic block diagram illustrating various
powering schemes for intravaginal monitoring devices, of FIG.
1b;
[0027] FIG. 3 is a schematic block diagram illustrating various
sensor placement schemes for intravaginal monitoring devices of
FIG. 1b;
[0028] FIG. 4 is a schematic block diagram illustrating fluid flush
cleaner on the surface of the cap, that cleans both the surface of
the cap and the target area of intravaginal monitoring devices of
FIG. 1b;
[0029] FIG. 5 is a schematic diagram illustrating placement of the
intravaginal monitoring device of FIG. 1b, placed so as to face the
outer surface of the cervix in which the device's cap or head takes
images of the outer surface of the cervix as well as sensor
readings via many other built-in electronic sensors, to monitor the
well being of a female (and developing fetus in case of the female
being pregnant);
[0030] FIG. 6 is a schematic diagram illustrating the components of
the intravaginal monitoring device of FIG. 1b (that may be found in
exemplary intravaginal monitoring devices such as those found in
FIGS. 1-5);
[0031] FIG. 7 is a schematic diagram illustrating data flow between
intravaginal monitoring device and various systems or devices
within the supporting network infrastructure;
[0032] FIG. 8 is a schematic diagram illustrating a snapshot of one
of the health care management web pages or system interfaces of
FIG. 1b wherein the snapshot depicts user's data view page;
[0033] FIG. 9 is a schematic diagram illustrating a snapshot of one
of the health care management web pages or system interfaces of
FIG. 1b wherein the snapshot depicts user's record page;
[0034] FIG. 10a is a schematic diagram illustrating a snapshot of
one of the health care management web pages or system interfaces of
FIG. 1b wherein the snapshot depicts user's queries page;
[0035] FIG. 10b is a schematic diagram illustrating a snapshot of
one of the health care management web pages or system interfaces of
FIG. 1b wherein the snapshot depicts user's queries page;
[0036] FIG. 11 is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b wherein the snapshot depicts user's mail
page;
[0037] FIG. 12a is a schematic diagram illustrating a snapshot of
one of the health care management web pages or system interfaces of
FIG. 1b wherein the snapshot depicts user's forum page;
[0038] FIG. 12b is a schematic diagram illustrating a snapshot of
one of the health care management web pages or system interfaces of
FIG. 1b wherein the snapshot depicts user's forum page;
[0039] FIG. 13 is a schematic diagram illustrating a snapshot of
one of the health care management web pages or system interfaces of
FIG. 1b wherein the snapshot depicts user's research page;
[0040] FIG. 14a is a schematic diagram illustrating a snapshot of
one of the health care management web pages or system interfaces of
FIG. 1b wherein the snapshot depicts user's account page;
[0041] FIG. 14b is a schematic diagram illustrating a snapshot of
one of the health care management web pages or system interfaces of
FIG. 1b wherein the snapshot depicts user's account page;
[0042] FIG. 15a is a schematic diagram illustrating a snapshot of
one of the health care management web pages or system interfaces of
FIG. 1b wherein the snapshot depicts user's IMD setup page;
[0043] FIG. 15b is a schematic diagram illustrating a snapshot of
one of the health care management web pages or system interfaces of
FIG. 1b wherein the snapshot depicts a user's IMD setup page;
[0044] FIG. 16 is a schematic diagram illustrating a snapshot of
one of the health care management web pages or system interfaces of
FIG. 1b wherein the snapshot depicts a user's support page;
[0045] FIG. 17 is a schematic diagram illustrating a snapshot of
one of the health care management web pages or system interfaces of
FIG. 1b wherein the snapshot depicts a user's shopping page;
[0046] FIG. 18a is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b wherein the snapshot depicts a health care
professional's patients page;
[0047] FIG. 18b is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b wherein the snapshot depicts a health care
professional's patient's accounts view page;
[0048] FIG. 18c is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b wherein the snapshot depicts a health care
professional's patient's records view and invoicing page;
[0049] FIG. 19 is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b wherein the snapshot depicts a health care
professional's patient's billing page;
[0050] FIG. 20 is a perspective diagram illustrating an exemplary
support architecture configuration wherein the service involves use
of real-time analysis engine functionality;
[0051] FIG. 21 is a schematic and perspective block diagram
illustrating a support architecture employing gynaecological
analysis engine operations that may reside in one or more of a
plurality of supporting devices and systems such as diagnostic
equipment located at a health care facility;
[0052] FIG. 22 is a schematic block diagram illustrating analysis
engine operations within an intravaginal monitoring device (IMD),
built in accordance with various aspects of the present
invention;
[0053] FIG. 23 is a schematic block diagram illustrating components
of an analysis engine that is found in whole or in part within one
or more of the various devices and systems of a network supporting
intravaginal monitoring wherein the analysis engine illustrates
various aspects of the present invention;
[0054] FIG. 24 is a schematic block diagram illustrating an
analysis engine such as that of FIG. 23, placed at least in part
within a server to illustrate server based analysis engine
functionality along with other server operations related thereto,
the server and underlying functionality;
[0055] FIG. 25 is a schematic block diagram illustrating another
embodiment of analysis engine integration within a network
supporting intravaginal monitoring;
[0056] FIG. 26 is a cross-sectional diagrams illustrating one of
many possible variations in dimensions, contour, and orientations,
i.e., form factors, of a cap and optics assembly of an IMD sized to
correspond to various "form factors" of intravaginal and cervical
regions. Therein, the IMD is inserted via a mostly axial direction
of a vaginal channel;
[0057] FIG. 27 is a diagram illustrating three different wearable
forms of the intravaginal monitoring device that are part of a kit,
each possessing varyingly angled cap and adjustable angles of the
cap;
[0058] FIG. 28 is a schematic diagram illustrating four different
wearable forms of the intravaginal monitoring device that are part
of a kit, possessing multi-sized caps;
[0059] FIG. 29 is a diagram illustrating two different wearable
forms of the monitoring device;
[0060] FIG. 30 is a schematic diagram illustrating hermetically
sealed intravaginal monitoring device in which the illustration
depicts a flexible cap that opens up upon proper placement of
intravaginal monitoring device and then pushing the bottom half of
the stem;
[0061] FIG. 31 is a schematic diagram illustrating hermetically
sealed intravaginal monitoring device; wherein the illustration
depicts a flexible cap that opens up upon proper placement of
intravaginal monitoring device and then pushing the bottom half of
the stem, which is another variation of the intravaginal monitoring
device of FIG. 30;
[0062] FIG. 32 is a schematic diagram illustrating intravaginal and
cervical regions of a woman's body along with an intravaginal
monitoring device (herein an "IMD") to be inserted into place;
wherein the intravaginal monitoring device is capable of guiding
inside the optics cap to capture images of large portions of
intravaginal and cervical regions that come in a wide ranging
variation in dimensions;
[0063] FIGS. 33a through 4h are schematic diagrams illustrating
construction of one of the embodiments of the intravaginal
monitoring device, along with typical dimensions, having manually
adjustable optics encased with a (flexible) transparent optics
cap;
[0064] FIGS. 34a-e are schematic diagrams illustrating construction
of two embodiments of an intravaginal monitoring device along with
typical dimensions, thereof, and having an actuator-controlled
optical system and built in accordance with and to illustrate
several aspects of the present invention;
[0065] FIGS. 35a-d are perspective diagrams illustrating further
details regarding the adjustable optics assembly that supports two
imager assemblies;
[0066] FIG. 36 is a perspective and cross-section diagram
illustrating a wearable snake-like intravaginal treatment device
(ITD) inserted into the cervical channel for capturing imager data,
delivering light treatment, and wirelessly communicating to deliver
such imager data and, in some embodiments, to receive control
signals, e.g., regarding treatment delivery;
[0067] FIGS. 37a-b are perspective diagrams that illustrate a
structure of a snake like intravaginal treatment device (ITD) with
a segmented stem that is flexible to support guidance deep into
uterus, fallopian tube, and ovarian region and carries an imager
and light source assembly for capturing images and video,
selectively delivering light therapy, and, in FIG. 37b, a fluid
delivery nozzle, all in accordance with various aspects of the
present invention;
[0068] FIG. 38 is a perspective diagram illustrating a fluid
delivery embodiment for an intravaginal treatment device (ITD) with
a fluid nozzle and an imager and light source assembly, both
disposed within a cervical cap, that selectively delivery fluids
and light therapies, respectively, and wherein squeeze ball and
tube for manual fluid injection via the nozzle;
[0069] FIG. 39 is a perspective diagram illustrating another
embodiment of an intravaginal treatment device (ITD) having a
built-in fluid reservoir, a fluid nozzle and dual imager and light
source assemblies, and built in accordance with various aspects of
the present invention, to capture imager data and deliver fluid and
light source therapy;
[0070] FIG. 40 is a perspective diagram of an embodiment of an
optics assembly having a stem, mounting structures and two mounted
imager and light source assemblies that may be used in some
embodiments of an intravaginal treatment device (ITD) in accordance
with the present invention to delivery light therapy and capture
imager data;
[0071] FIG. 41 is a schematic block diagram illustrating exemplary
components and circuitry that may be found in whole or in part
within the many embodiments of an intravaginal treatment device
(ITD) of the ITDs set forth herein and built in accordance with
various aspects of the present invention; and
[0072] FIG. 42 is a perspective and cross-sectional diagram
illustrating an inserted ITD having a radial illumination mechanism
to support delivery of light therapy along the length of the
vaginal canal.
DETAILED DESCRIPTION OF THE DRAWINGS
[0073] FIG. 1 is a schematic block diagram illustrating
gynaecological analysis engine 135, 165, 175, 185 incorporated into
the intravaginal monitoring devices 105 and its supporting network
infrastructure 167, 177, 187 (communicatively coupled via wired and
wireless communication pathways 151 that includes 153, 155, 157 and
159); wherein the gynaecological analysis engine 135, 165, 175,
185, having a database that has association with various
gynaecological conditions, makes a first preliminary analysis of
possible gynaecological conditions. In specific, based upon
correlations with prior known results of various conditions that
include normal, sexually transmitted diseases and pregnancy related
conditions, the gynaecological analysis engine 135, 165, 175, 185
conducts preliminary analysis and arrives at preliminary
conclusions. Once the preliminary conclusions are arrived at, the
gynaecological analysis engine 135, 165, 175, 185, via systems it
is incorporated into (such as the supporting server 177), intimates
to the respective healthcare professionals and user. This allows
the healthcare professionals (who cannot afford to inspect minute
by minute data from the intravaginal monitoring devices 105,
because of having not enough time) to arrive at a final diagnosis
very quickly and proceed with treatment procedures thereafter.
[0074] The supporting server 177, in conjunction with the
gynaecological analysis engine 135, 165, 175, 185, also provides a
forum with which a user can join a community of users,
pharmaceutical professionals and even doctors. To facilitate this
functionality as well as increase the probability of arriving at
accurate conclusions, the intravaginal monitoring devices 105 and
its supporting network infrastructure 167, 177, 187 also utilize
general medical information 131, 161, 171, 181 and incorporate
(possibly, health care professional prescribed treatments)
information from supporting medical systems 133, 163, 173, 183. The
supporting medical systems 133, 163, 173, 183 may include blood
testing, blood pressure, temperature, electrocardiogram results and
so forth, of the user.
[0075] To further increase the probability of arriving at accurate
conclusions, during analysis, the gynaecological analysis engine
135, 165, 175, 185 also utilizes data collected via a questionnaire
that is specifically designed to determine the patient's history
(that, in part, may also be obtained via general medical
information 131, 161, 171, 181 and supporting medical systems 133,
163, 173, 183). The questionnaire may be in a tree structure that
helps narrow down possible conditions, in addition to having access
to sensor data. Then, the gynaecological analysis engine 135, 165,
175, 185 provides referral to different gynaecologists (to choose
from), and options of call back, email and so forth, for
appointment scheduling.
[0076] In automatically arriving at conclusions, statistical
analysis and conclusions on statistical bases are also provided.
For instance, 95% chances that it is not serious, 2% chances that
it is one type of condition and 3% another condition. To arrive at
conclusion, the gynaecological analysis engine 135, 165, 175, 185
may also utilize all of the available abovementioned information,
at once. For instance, one particular color of the image and high
temperatures for more than three days (in conjunction with
patient's personal history, questionnaire information, other sensor
data and so forth) is likely to indicate one particular condition.
These analyses are completely done by gynaecological analysis
engine 135, 165, 175, 185; while in other cases, it might be done
by some gynaecologists (doctors); such as in menstrual cycles and
menopause (which have their own symptoms).
[0077] Once such conclusions are arrived at, the gynaecological
analysis engine 135, 165, 175, 185 intimates both the user and
corresponding gynaecologist (doctor) via email/SMS/MMS and/or by
logging into the supporting server 177 website. This intimation may
include a color or numbered importance scheme, for instance, the
higher the number, the more is the importance of severity of a
gynaecological condition. The color codes may include yellow or 8
to 10 (an immediate scheduling with healthcare professional is
essential), red 6 to 8 (severe, but the user may schedule with
doctor within a week's times), and so forth. Moreover,
gynaecological analysis engine 135, 165, 175, 185 also allows the
user to ask questions, such as "What is the state of art kind of
treatment available for this condition?" and so forth.
[0078] Similarly, a gynaecologist's display shows: (a) Ability to
see the images 5 years back and correlate it with that of today;
(b) Generate an image with every month one image in a play forward,
backward, slow motion movement; (c) Video showing graphs with the
sensor data; (d) Different color along with image; (d) Markers that
gives ability to go anywhere in the timeline and expand over a
region over a week, month, year; (e) Provisions for digital zoom in
or zoom out) and so forth.
[0079] Moreover, when logging into the web pages of the supporting
server 177, the gynaecologist (doctor) may look at the color or
number code and determine which users should be given priority
based on their case details. For instance, the gynaecologist may
see a list of patients with yellow or 8 to 10 (at the top of the
list) and may first wish to go through their cases immediately.
Then, the gynaecologist may turn the attention toward other users
(with yellow or green color coded) whose cases may not be of
urgency.
[0080] To make the analysis and arriving at conclusions fast, the
gynaecological analysis engine 135, 165, 175, 185 also utilizes the
opinion of the user (and also that of the gynaecologists/healthcare
professionals). The opinions of the user may come from personal
knowledge, knowledge databases and encyclopaedias available in book
forms or in the websites (including that in the support servers
177), or via forums and discussions with other users (that are
supported by the support servers 177). To generate such a database,
the gynaecological analysis engine 135, 165, 175, 185 uploads,
stores and utilizes the images, sensor readings and prior
healthcare professional's (gynaecologist's) diagnosis based upon
these uploaded and stored data. In addition, where the images do
not seem to correlate well (based upon an indication of changes
that occurred), the gynaecological analysis engine 135, 165, 175,
185, makes a best judgement call (against prior known good
condition of the user or even good condition of other people); and
informs so to the user and gynaecologist.
[0081] The components of gynaecological analysis engine 135, 165,
175, 185, supporting medical systems 133, 163, 173, 183 and/or
general medical information 131, 161, 171, 181 may in part or whole
may be distributed anywhere between intravaginal monitoring device
105 to supporting network infrastructure 167, 177, 187 (such as
intravaginal monitoring systems 105, iPods, cell phones, personal
computers 167, central support server 177, gynaecologist's servers
187).
[0082] In all these, a nominal charge may be billed during
registration by the user, rest of the revenues are collected via
billing user and gynaecologist (doctor) upon a successful
appointment is done. Revenues are also collected by ways of
targeted advertising to the user and doctors, for instance, from
the pharmaceutical companies. The following additional
functionalities, billing and advertising scheme are also
applicable.
[0083] The device and the nodes on the network described include
functionality or modules to process and correlated intravaginal and
extravaginal physiologic or persona use information with
advertising related information such as cost per click (CPC) or
cost per thousand impressions. Two primary models for determining
cost per click: flat-rate and bid-based are used by way of example
in the invention contained herein. In both cases the advertiser
(e.g. a woman's consumer product marketer, a baby food vendor, a
diaper's vendor), considers the potential value of a click from a
given source. This value is based on the type of individual the
advertiser is expecting to receive as a visitor to his or her
website, (who's advertising is made directly on a remote device
itself or intravaginal device) and what the advertiser can gain
from that visit, e.g. revenue, product visibility. By way of
example, an advertisement for baby diapers appears on a smart phone
or computer of an expectant mother or expectant father, this
information is presented simultaneously with physiological (or
other information from the device) on the smart phone or computer
in a separate window. In another variant, the advertising
information is presented for a time out period and charged to the
advertiser based upon the amount of time that the advertisement
window appears on the target's remote device. The device itself
communicates with one or more nodes on the network to communicate
the time the advertisement appeared on the expectant mother or
father's smart phone or computer. Based upon the viewing time, or
cost per click or cost per thousand impressions, the advertiser
then gets billed for the advertising using a billing module based
on one or more nodes of the network.
[0084] In another variant of the invention, the flat-rate model
module is used. A fixed charge is entered on one or more computers
connected to nodes of the module that establish what will be paid
for each click. This information, in one variant of the invention
take from rate card database that lists the CPC within different
areas of a website presenting data from the intervaginal device.
These various amounts are often related to the content on pages
displayed.
[0085] In another variant of the invention, the bid-based model
module is used on one or more nodes of the network to which data
from the intravaginal device is communication. By way of example,
the a software module is used to permit a first advertiser to
compete against other advertisers in a private auction hosted by a
website associated with said intravaginal device data or data
collected from a plurality of intravaginal devices or, more
commonly, an Internet based advertising network. Data on the
network for each advertiser informs the host of the maximum amount
that the advertiser is willing to pay for a given ad spot. The
auction plays out in an automated fashion every time a visitor
triggers the ad spot on the network to which the intravaginal
device is communicatively linked.
[0086] In another variant of the invention, the major advertising
networks are connected to the network of a plurality of
intravaginal devices are communicatively linked. Contextual ad data
is placed on the web properties of a 3rd-party to which the
intravaginal devices are communicatively linked. Publishers
electronically sign up to host ads on behalf of the network. In
return, they receive a portion of the ad revenue that the network
generates, which can be anywhere from 50% to over 80% of the gross
revenue paid by advertisers. These properties are often referred to
as a content network and the ads on them as contextual ads.
Advertisers are automatically and electronically billed and pay for
each click they receive, with the actual amount paid based on the
amount bid. It is common practice amongst auction hosts to charge a
winning bidder just slightly more (e.g. one euro cent) than the
next highest bidder or the actual amount bid, whichever is
lower.
[0087] To maximize success and achieve scale, automated bid
management systems are deployed on the intravaginal device network
of the present invention and include method steps to implement
automated bid management and advertising systems on one or more
nodes on the intravaginal device network. These systems can be used
directly by the advertiser, though they are more commonly used by
advertising agency computer systems that offer PPC bid management
modules as a service. These tools generally allow for computerized
and automated bid management at scale, with thousands or even
millions of PPC bids controlled by a highly automated system. The
system generally sets each bid based on the goal that has been set
for it, such as maximize profit, maximize traffic at breakeven, and
so forth. The system is usually tied into the advertiser's website
and fed the results of each click, which then allows it to set
bids.
[0088] By way of further example, a targeted advertising module is
used in the present invention. Intravaginal device detects a female
condition, e.g. a pregnancy, a sexually transmitted disease (STD),
a precancerous condition, a cancer, a medical abnormality. This
information is communicated to one or more nodes on the network.
Advertising data for the treatment of the STD, e.g. for a drug used
to treat the STD or other condition, from a particular
pharmaceutical company or one or more companies, is then sent to
the intravaginal device or other remote device on the network, for
a user or doctor to review. Treatment option data are also
communicated in another variant of the invention to the
intravaginal device and or remote device. With respect to pregnancy
data, baby gift data or products used with babies are displayed on
the intravaginal device or remote device. In yet another aspect of
the information, a module is provided to provided to mask, conceal
or render anonymous the indentity of a user of the intravaginal
device while still permitting the information concerning the
treatment for the users condition, state or intravaginal event to
be used to direct advertising to the user needing a particular drug
or treatment regimen.
[0089] In yet a further aspect of the invention (optionally using
GPS functionality for locating or placing the intravaginal device
at a geographic location, e.g. or a remote device, (e.g. mobile
phone communicating the intravaginal device), patient candidate and
drug recipient candidates data is collected. User specific
condition or event data is collected on one or more nodes on the
network and correlated to treatment advertising data, and or
medical specialist, or hospital data. It is appreciated that drug
companies will be able to provide targeted advertising data or
their therapies and/or drugs to exactly the users who are suffering
from conditions or events which their products provide beneficial
treatments, e.g. drugs that treat STD's, drugs that treat cancers,
etc.
[0090] In yet other aspects of the invention a user profile module
is provided, and a method of monitoring and controlling the spread
of sexually transmitted diseases. The user enters personal
information, medical information, condition information, social
information, e.g. the names of sex partner data, date and times of
intercourse with specific partners, etc. This information is
correlated with data collected from the intravaginal device. By way
of further example, a sexually active female takes baseline data
with the intravaginal device of the present invention. The data is
time and date stamped, a record of the health or condition of her
cervix is recorded on the device or one or more nodes of the
network. She then has intercourse with a sex partner. In one
scenario, if the partner is free of STDs a follow up record of the
cervical or vaginal condition can be compared with the baseline
data and archivally recorded. In another scenario, if the sex
partner had an STD, then the user uses the device and notices that
there are abnormal cervical and or vaginal changes, and these are
archivally recorded and or an alert is sent to a remote device,
e.g. the user's or doctor's, and one or more of the advertising
modules above is activated. Similarly, the sex partner is notified
early of the STD condition. It is appreciated that the early
notification of the condition for the user and the sex partner can
stop the spread of the disease to other sex partners that may
occur, e.g. in the case of HPV transmission.
[0091] There are various types of support architectures that can be
found operating within the supporting network infrastructure of
FIG. 1. For example, the IMD 105 may operate entirely independent
from all other supporting computers or devices, e.g., when out of
range or when otherwise detached. As such, the IMD 105 would be the
only source of analysis engine operations. When in attached, the
IMD 105 (or any other of the various IMDs that may be operating in
the network infrastructure) might interact with any selected
computing device located anywhere within the infrastructure (e.g.,
a computing device selected from one of the supporting personal
computing devices 167, the supporting servers 177, and the medical
supporting computing devices 187). Together, the selected computing
device and the IMD form a support architecture to service a female
reproductive system via a communication link. The communication
link can be a direct point to point link or comprise a network
routed pathway, both as illustrated by the communication pathways
151.
[0092] A two device support architecture through which analysis
engine functionality is provided might involve, for example, the
IMD and a single one of the supporting personal computing devices
167. It might also involve only the IMD and one of the supporting
servers 177. Similarly, a two device support architecture might
involve the IMD and one of the systems/devices 187. With any of
these support architectures, the functionality of the analysis
engine may be fully disposed solely within one of the two devices
or distributed across both of the devices. For example, an IMD
captures raw image data. It may also pre-process the data to
generate measurement data. Lastly, after some initial analysis
engine operations, the final processing by the analysis engine of
the supporting device might take over with further analysis engine
functionality.
[0093] In other words, at a stage 1, raw sensor data from an IMD
along with, perhaps, other medical data produced by other medical
systems, and manual input data is collected regarding a patient and
their underlying physiology. At a stage 2, the raw sensor data from
the IMD and, possibly, from other raw data from other medical
devices, is pre-processed if necessary to generate measurement data
therefrom. At stage 3, the analysis engine (or portions thereof)
receives and processes the raw sensor data, retrieved data from
other sources, manual input data, and measurement data, to either
reach at least an intermediate assessment regarding the status of
the reproductive system under service, or to reach a determination
that further or supplemental input is needed. If needed, the
analysis engine can either direct further operations of any
supporting computing devices, IMD, etc., to automatically gather
such needed information, automatically request delivery of further
information or data from supporting systems or devices, or make
requests (via supporting computing devices) to the patient, medical
staff, or third parties therefor. After receiving any supplemental
input, the analysis engine generates the at least the intermediate
assessment (or again makes supplemental request cycling until it is
able to make such assessment).
[0094] After the at least intermediate assessment of a status
relating to the reproductive system under service, various actions
can take place. For example, medical staff might further interact
with the analysis engine to verify or redirect the analysis engine
operations to generate yet other assessment results. Alternatively,
only a human's (medical staffs or patient's) verification might be
applied. Either way, once the stage 3 cycling ends, at a stage 4,
automated actions based on such assessment can be carried out. Such
automated actions might involve, for example, sending immediate
notifications (along with underlying and relevant identification of
the underlying female) to medical staff, ambulances, patient,
patient's relatives (e.g., baby is on the way!), pharma
salespersons and other third parties. Such automated actions may
involve human confirmation, and may be related to scheduling,
transport, pharma or other treatment regime selection, etc.
Automated actions may also involve sending control signals to the
IMD or other medical equipment. Automated communications may take
any of a variety of forms such as email, sms/mms, voice generation
from text that is delivery via telephony networks to phones,
letters, etc., and via the various visual working environments on
the corresponding various supporting computing devices.
[0095] The IMD may be configured to both provide the preprocessing
of the raw sensor data it captures to generate measurement
information (before analysis engine operations), and a beginning
portion but not all of the analysis engine functionality. With the
raw sensor data, measurement information and output from the
beginning portion of the analysis engine functionality, a
supporting device may then take over analysis engine operations and
perform yet other portions or all of the analysis engine
operations, i.e., produce a conclusory status assessment or provide
information on through which a human can complete or verify the
task. Likewise, the IMD may only send the raw sensor (including
imager) data to the single supporting device which performs the
entire sequence of the analysis system operations, without
assistance from the IMD.
[0096] Of course, three or more devices within a support
architecture are also possible, and analysis engine operations can
be spread across all of such devices or handled by one or a
sub-group thereof. For example, in a three device configuration, an
IMD and two computing devices, such as one of the supporting
servers and a supporting personal computing device, might interact
to carry out the servicing of a female reproductive system. Over a
series of sessions (insertion events on differing dates or times),
the IMD might collect and forward to a supporting server for full
analysis engine operations. A patient using the supporting personal
computing device interacts with the supporting server to not only
view the sensor data (e.g., images and video and temperature
charts), but also to view resultant analysis engine output such as
measurement information, rates of change, colorization analysis
results, comparisons with such patients prior sensor data, prior
analysis engine results, physiological condition profiles, alerts,
etc.
[0097] Final conclusions regarding the physiological status of the
reproductive system under service may be entirely provided by one
or more of the IMD and other computing devices in the network
illustrated via analysis engine operations. In addition, medical
staff or the patient themselves may provide manual input (via
typing, etc.) into the process and either confirm or make the final
determination regarding the physiologic status. To support this
process, a visual working environment, via software application
definition, is provided on all of the devices in the illustrated
network. Through such visual working environment presented by one
of the medical computing devices 187, a doctor can interact to view
the sensor data collected over the sessions along with output from
the various stages of analysis engine operations to verify and
supplement such operations, if needed. As a result, the analysis
engine with or without doctor verification and input yields status
information regarding the reproductive system under examination
which is displayed in the visual working environment. Similarly,
such a working environment may be provided to the patient and even
other third parties for viewing the sensor data and analysis engine
operation output, and may allow such persons an opportunity to
assist and possibly enhance the analysis engine's performance.
[0098] More particularly, the servicing of the female reproductive
system in part involves capturing, exchanging, and displaying
images generated from to the various types of raw sensor data and
pre-processed measurement data, along with related "support
information", e.g., information from the supporting medical systems
133, 183, 163, 173, supporting information from the medical
information 181, 161, 171, 131 and manual input by the patient,
medical staff and third parties. In addition, the servicing of the
female reproductive system involves analysis engine operations
which are based on such raw sensor data, pre-processed measurement
data, and such "support information." The analysis involves
functionality such as: a) extracting usable information from the
raw sensor data and pre-processed measurement data, changes over
time, colorization information, etc.; b) identifying, gathering and
applying selections from the "support information"; c) comparing
prior session data received (that is, image and other sensor data
received on perhaps a different day and from that produced by the
same patient in the current day's session, and including multiple
sensor data groupings for comparisons with such and other
information where beneficial); d) comparisons of such sensor data
(including imager data) and "support information" along with
intermediate stage results of the analysis engine operations with
corresponding known status profiles and thresholds; and e)
production of visual information (related to any of the previous
elements) for use in various working environments displayed on the
various computing devices throughout the network.
[0099] In other words, the analysis engine output in some limited
situations, e.g., such as when used with an IMD with limited
functionality in a point to point link with a hand-held computer
(perhaps both off-line from other device and 3rd party assistance),
might involve a few preliminary steps or operations of the analysis
engine only. Even so, such analysis system output, does provide
better information than that of merely viewing a representation of
the raw sensor data and, perhaps, pre-processed measurement data,
and, as such, provides greater assistance in the drawing of
conclusion regarding the physiological condition or status of a
reproductive system under examination.
[0100] The raw sensor data is often in a form that is not easily
understood even when presented in a visual form. By pre-processing
to generate measurement information, e.g., scaling or dimensioning
information, such raw sensor data and measurement information can
be used to produce more readily understood visual presentations. In
addition, together they support a more detailed analysis by a human
or the analysis engine in any attempt to draw conclusions
(intermediate or final) regarding the status of the reproductive
system under service.
[0101] FIG. 1b is a schematic block diagram illustrating an
intravaginal monitoring device 1 and its supporting network
infrastructure; wherein the intravaginal monitoring device 1
communicates via a communication interface 21 to local external
devices 71 and/or external servers 51, 61 via wired and/or wireless
network pathways 31. In specific, the depiction shows flow of data
between the intravaginal monitoring device 1 and the supporting
network infrastructure 71, 51, 61 via communication pathways 33,
35, 37, 39 and/or 41. Essentially, this flow of data is meant to
look into the image (or sensor) data collected within the memory
(are be a built-in memory, flash memory, memory cards, and or one
or more memory stick) of the intravaginal monitoring device 1 and
then deliver themes, for inspection, suggestions, annotations,
readings, recommendations, discussions and/or as a basis for a
treatment or therapy, to the user, health care professionals, user
Internet or Intranet discussion forums, social networking sites
where female share their experiences related to their reproductive
health, or for secure storage at a data archive farm located
externally from a plurality of intravaginal monitoring devices in
the field, back up storage servers, and databases, private storage
devices, Amazon.sup.SM storage device, EC2.sup.SM storage servers,
alone or in combination. The data is sent in an encrypted form so
as to be able to maintain the privacy of the female, that is,
without the female's (user's) permission the data cannot be seen by
anyone within the support network infrastructure. The data is
decrypted at one or more nodes of the network. The system, network
and nodes on the network serve to protect the privacy of the
medical data in one mode of operation. Privacy is protected vis a
vis third party interception of the data, which can include the
female's private medical history, images of the female's cervix and
other parts of her anatomy, et al.
[0102] The data is reviewed by the user, health care professionals,
and/or user forums only with the user permission, in one variant,
and the support infrastructure provides facilities to choose one or
more user forums (to be able to discuss a reproductive health
related problem, for instance), health care professionals
(gynecologist or obstetrician) to receive treatments or for general
checkups. The users are also wish to see the images (or, sensor
readings) for one's own routine inspections and checkups of
reproductive health, possibly in conjunction with health care
professionals. Exemplary forums used in the invention include
Facebook.sup.SM, a private forum associated with a manufacturer of
the intravaginal device, alone or in combination.
[0103] For instance, the image and other sensor readings, of the
intravaginal device, of an external electronic, wireless,
monitoring patch applied to the skin of a female, alone or in
combination (taken remotely from a medical facility, in one
variant, and or taken within a medical facility or clinic, in
another variant) allow the female, users of the forums, health care
professionals, to inspect, suggest, annotate, create reports from
the data, create electronic medical records, update electronic
medical records, annotate the data, recommend, discuss and/or treat
one or more of conditions and events related to: (a) Routine
reproductive health; (b) Menstrual cycles, both normal and
abnormal; (c) Menopause, and therapies related thereto, including
but not limited to hormonal therapies; (d) Sexually transmitted
diseases, and the efficacy of therapies therefore, e.g. drug
therapies, cryo therapy; (e) Pregnancy checkups, and or (f) pre
and/or post coitus periods. All of these checkups otherwise would
necessitate the presence of the female in question at the health
care professional's office, consuming valuable time and adding to
needless health care costs. Using the intravaginal monitoring
device 101 and knowledge of reproductive health and well being
(which is provided on a smart phone node or computer node of the
network described herein) transferred over the Internet to the
user, the female are herself observe the cervix, her vagina (and
the vaginal and or cervical discharges therefrom) and be able to
use sensor readings taken by the intravaginal device or associated
external device (and hence be able to judge health conditions and
events, possibly, in conjunction with health care professionals).
It is appreciated that early notification of an abnormal condition
by the female herself or a health care professional leads to early
treatment of the event, e.g. cervical incompetence via suture
therapy or cervical ring therapy, and a positive health outcome for
the female. In variants of the invention, the intravaginal device
and network provided herein provide early notification in patient
pools at risk for a premature birth event or a threshold event,
prior to which therapy or effective treatment can be provided, and
an adverse event, e.g. premature birth, can be prevented.
[0104] It is appreciated that the method of extending the term of a
gestation cycle is provided herein. The method consists of
providing early notification of an event associated with a probably
premature birth using the intravaginal monitoring device and
network described herein, and providing a therapy to extend the
term of gestation of a being in a womb. The therapy is selected
from the group consisting of a drug therapy, a medical device
therapy, e.g. cervical ring, a surgical therapy, e.g. suturing the
cervix shut, alone or in combination. In yet a further variant,
post therapy monitoring is also provided by the device to determine
the efficacy of the treatment or therapy. In one variant, a kit is
provided comprising an intravaginal monitoring device and a therapy
to extend the gestation period of a being in the womb. It is
appreciated that extending the gestation period of a being in a
womb, e.g. by weeks or months, has significant short term and long
term benefits for the being in the womb, e.g. organ development
proceeds further, increasing the likelihood of survival of the
being in the womb, and the long term prognosis should the being in
the womb be born.
[0105] By way of further example, the method, system and network
includes: a female utilizing intravaginal monitoring device and
network described herein. The device monitors and tracks
intravaginal physiologic conditions (e.g. whether there has been a
release or waters (e.g. detecting a fast rush of anterior waters
and or detecting a slow release of posterior waters), position of
the cervix and or cervical channel (e.g. if it is anterior,
posterior, or center (positioned for birth)), whether the cervix is
ready for birth or not yet ready for birth, cervical dilation (e.g.
absolute opening size of the cervical channel), the three
dimensional shape of the cervix, e.g. cervical effacement, and
optionally using an ancillary electronic measuring device
externally measures other parameters, e.g. fetal heart rate,
female's heart rate, tonus, e.g. uterine muscle contraction and or
relaxation, provides data for a trace or digital indication of
fetal EKG over time on a first graph, and provides data measuring
contraction intensity (e.g. either using the intravaginal device,
the external wirelessly communicating monitoring device, alone or
in combination), (the graphs of EKG and contraction intensity are
positioned one above another in one variant), and other sensor data
described herein. An alert is sent to a remote device, e.g. the
female's or the doctor's iPhone.TM. or computer over the Internet
or cell phone network, once one or more of the parameters measured,
alone or in combination, indicate a premature or normal birth
condition or that a series or cascade of events detrimental to the
gestation of the being in the womb have happened or are about to
happen. In one variant, a doctor reviews the data collected calls
the female to advise her to rush to a clinic for therapy or
treatment. The female does so. The doctor or medical professional
provides the female therapy, e.g. cervical suturing, drug therapy,
bed rest, or application of a cervical ring. The therapy results in
a longer gestation time of the being or fetus in the womb. The
fetus continues fetal development, improving its chances at
survival and normal in womb development. The intravaginal device is
continued to be used post therapy to monitor the efficacy of the
therapy in one variant. Should other abnormal events occur post
therapy, the intravaginal device, network and method is again used
to monitor events and conditions in one variant.
[0106] Fluid discharge monitoring observed via a small moving image
video clip (taken at distinct points in time and over a period of
time) allows the female, users of the forum or health care
professionals to identify reproductive health based upon one or
more of: (a) Small amount of clear or slightly milky vaginal
discharge (considered to be normal); (b) Menstrual cycle
discharges; (c) Menopause discharges; (d) infections or
STD--sexually transmitted diseases--(much more discharge than
normal, or discolored discharges). And in case of any observable
discrepancies observed by the sensors or image comparison, during
pregnancy or during normal occurrences of pre and post coitus (due
to concerns about STD) or at all other periods, or upon periodic
request by a health care specialist (gynecologist or obstetrician)
(the device is remotely activated or placed into a mode of
operation), the sensor readings and images obtained via the
intravaginal monitoring device 1 are be utilized in taking
precautionary actions or advise the female to seek medical
professional intervention.
[0107] The intravaginal monitoring device 1 can communicate with
the supporting infrastructures such as user's IMD (Intravaginal
Monitoring Device) client systems 71, supporting server(s) 51
and/or supporting IMD (Intravaginal Monitoring Device) client
systems and devices 61 in many different ways: (a) A memory stick
intravaginal monitoring device 1 and USB and or mini USB port
within the client module (inside the personal computer 77 or mobile
phone or smart phone) assist in viewing the data contents on the
personal computer 77 and deliver directly to the supporting
server(s) 51 and viewed through web pages. To enable this, the
intravaginal monitoring device 1 contains a unique network ID; (b)
The intravaginal monitoring device 1 are be plugged directly to a
television 73 (or communicate with a wireless connection through an
intranet wireless network connection or Internet connection) or
personal computer 77 display using display management 10 and
display driver (all of the software is driven by the display
management 10); (c) The intravaginal monitoring device 1 are be
plugged it into a personal computer 77 (and the personal computer
77 considers it as a memory device and copies all of the files and
data from the intravaginal monitoring device 1 to the personal
computer (and optionally this can happen from the personal computer
to the device 1 in another variant), the personal computer 77 uses
memory device interface 85 to do this); (d) The browser goes on to
query mode and the website or server 51 connects to the
intravaginal monitoring device 1 and pulls out information data
(female subject data with time and date stamped data, unit data,
software version data, etc.); and (e) A served up web page, real
server module 65 or locally populated server module (without
connecting to the supporting server 51) extracts information from
the intravaginal monitoring device 1 (the client module 83 are not
detect intravaginal monitoring device 1, it are be turned off). The
data is pushed from device 1 in one variant onto the servers. In
another variant, the data is pulled from the device 1 upon
interrogation of the device.
[0108] These supporting local personal computing devices 71 are
include cell phones 75, personal computers 77 and video recorder
79, or simply an access point, for instance. Exemplary phones
include the Apple brand, iPhone, the Google brand, Android, and
Blackberry branded phones. The intravaginal monitoring device 1,
while inserted in place (inside the vaginal channel) or after usage
and removal, allows an authenticated supporting personal computing
device 71 to send control signals (as well as firmware and other
logistical program codes) and receive images/video clips/sensor
data and so forth from the intravaginal monitoring device 1. In one
variant, the device 1 harvests and stores data in a memory on the
device 1 and has the wireless chip in standby mode or disabled
mode. Once the device 1 is removed from the vaginal channel, the
device 1 senses the removal of the device therefrom and once the
device is outside the vaginal channel communication of the data via
a wireless communication communicates the data from the device to
remote devices. The data transfer mode of operation is also
manually activated by a user once the device is outside the
female's body. In another variant, device 1 includes a sonogram
mode of operation for imaging the position of the fetus head or
other body parts. It is appreciated that periodic images are taken
by device 1. These images provide useful data selected from the
group consisting of the size and dimensions of the head or rest of
the body of the fetus, the position of the fetal head or other body
part in relation to the female's anatomy, etc.
[0109] In other words, the communication is be initiated by the
intravaginal monitoring device 1, upon removal from the vaginal
channel, upon switching off the intravaginal monitoring device 1,
upon memory full, upon emergency situations, and upon communication
button press (if there exists one) by the user. These logistical
codes are built into the intravaginal monitoring device 1; however,
they might also be received from supporting servers 51, by request.
The receiving of images/video clips/sensor data are also be
initiated remotely by supporting servers 51 (as per certain
logistics) or supporting intravaginal monitoring device client
systems and devices 61 (as per a health care professional's
instructions or commands from a device used by a health care
professional, for instance).
[0110] To make all of the aforementioned functionality and flow of
data possible, the intravaginal monitoring device 1 contains a head
or cap 5, stem 3, 7 (that contains many of the electronic
components including a display 13, some or all of the sensors and
batteries), bottom cap 9 (that allows insertion and removal or
recharging of batteries and exposes mini USB port for wired
communications) and an on/off switch 15. The on/off switch 15 also
allows independent selections of modes, wireless on/off, wired
on/off (by keeping on clicking 15 until the mode is selected). It
also contains a server module (SM) 11 and display management 10
unit.
[0111] The user's IMD (Intravaginal Monitoring Device) client
systems 71, in addition, contain server module 81, client module
83, memory device interface 85 and application programming
interface 87. Similarly, the supporting IMD (Intravaginal
Monitoring Device) client systems and devices 61 also contain
server module 91, client module 93, memory device interface 95 and
application programming interface 97. The supporting IMD
(Intravaginal Monitoring Device) client devices 61, for instance,
are be a blood pressure monitor or thermometer, which could be in
the patient's or health care professional's hands. Moreover, the
sensor data can be supported by supplemental data, and the sensor
data itself can be stored remotely from the support server(s) 51, a
supporting management company such as 53, 55, 57 or supporting IMD
(Intravaginal Monitoring Device) client systems and devices 61.
[0112] For instance, a female are purchase intravaginal monitoring
device 1 kit, consisting of intravaginal monitoring device 1 as
well as a dock where the intravaginal monitoring device 1 can be
placed for charging and for communications (alternatively,
communication are also occur while in vaginal channel). The female
are also sign up with supporting server(s) 51, 53, 55 or 57 and in
addition are also sign up for service from local/regional/remote
health care professionals (which is possible via the supporting IMD
(Intravaginal Monitoring Device) client systems and devices
61).
[0113] Then, to use the intravaginal monitoring device 1, the
female are begin to follow the instructions provided within the
intravaginal monitoring device 1 kit, from the supporting servers
51 and/or supporting IMD (Intravaginal Monitoring Device) client
systems and devices 61 (via the health care professionals from whom
the female has requested service). The instructions are be
streamlined for various specific circumstances that include routine
checkups, menstrual cycles, menopause, sexually transmitted
diseases and pregnancy checkups (are also include pre and/or post
coitus periods).
[0114] During the usage (while on continuously wearing) or after
usage, depending upon the aforementioned specific circumstances,
based upon the permission given by the female, the intravaginal
monitoring device 1 are transmit the captured images/video
clips/sensor data to the supporting server(s) 51 (via user's IMD
client systems 71 such as an access point, cell phone 75 or
computers 77, for instance). Alternatively, the female are also opt
to watch these images/video clips/sensor data all by herself and
decide whether to send them to the support server(s) 51 (and then
to the health care professionals via the supporting intravaginal
monitoring device client systems and devices 61), make her own
personal decisions, or discard the images/video clips/sensor data.
These options are always available to the individual female.
[0115] Later, the female logs into her account in the supporting
servers 51, selectively upload images/video clips/sensor data of
interest to her or the health care professionals and then give
permission to the supporting IMD (Intravaginal Monitoring Device)
client systems and devices 61 of the health care professionals for
further investigation (of a routine occurrence or a specific
condition, for instance). Alternatively, the female are opt to
access suggestions from other users, from another server (user
forum servers, such as 53, 55 or 57, for instance) by sending
certain information stored in her account in the supporting
server(s) 51 (for no fees at all, for instance).
[0116] Once the health care professionals gain access to the
images/video clips/sensor data, they are able to provide
recommendations/treatments options via the same supporting
server(s) 51 back to the female. These recommendations/treatment
options are be informed via emails or directly via the supporting
server(s) 51 (which is more secured). These cycles of monitoring
and recommendations/treatments can be done routinely during routine
checkups, menstrual cycles, menopause, sexually transmitted
diseases and pregnancy checkups (are also include pre and/or post
coitus periods), thereby saving the time of the female and the
health care professionals.
[0117] Note that in all cases of the female, the very same
processes are applicable to female animals; in that case instead of
female, the case would be that of a female animal in conjunction
with its caretaker and the health care professional are be a
veterinarian or artificial insemination technician.
[0118] FIG. 2 is a schematic block diagram illustrating various
powering schemes for intravaginal monitoring devices, of the FIG.
1b. A typical intravaginal device 205 consists of a head or cup
207, a stem 209 and a bottom cap. Near the bottom cap, there would
be an on/off switch that assists the user to switch on and off the
intravaginal monitoring device 205 and also selects various modes.
The modes are include WiFi on/off, WiMac on-off, various sensors
on/off selections, so forth.
[0119] As depicted in the intravaginal monitoring device 225, the
bottom most part of the stem contains batteries 227. Batteries 227
can be inserted or removed by unscrewing the stem bottom cap 229
(that also contains on/off and mode switch 231), or be rechargeable
batteries. Still further down the bottom most part is an
unscrewable cap 233, which when unscrewed exposes a mini USB
communication port or other suitable communication port. This port
assists in communicating with local external devices or external
servers via an access point. Alternatively, the bottom part are
also consist of a WiFi port, in which case the bottom cap 233 acts
as a battery 227 insertions or removal opening.
[0120] The depiction 245 shows a rechargeable battery 247 variant
of intravaginal monitoring device 245 that comes with a cord 253 to
charge the battery 247. The depiction shows a WiFi communication
variant (other exemplary variants include WiMax communication
functionality and circuitry, cellular phone communication
functionality, Bluetooth communication functionality, etc.), but
the unit are also have a mini USB port (which exposes itself when
the bottom cap 249 is unscrewed). The depiction also shows an
on/off or mode selection switch 251.
[0121] Finally, the depiction 265 shows another variety of
intravaginal monitoring device 265 that comes with a recharging
dock 283. When the intravaginal monitoring device 265 is not in
use, it can be docked in the recharging dock 283 and after few
hours of charging of the batteries 271, the intravaginal monitoring
device 265 is ready for use again. The depiction 265 also shows
placements of few of sensors 267, 269, 279 and recharging plugs
281.
[0122] FIG. 3 is a schematic block diagram illustrating various
sensor placement schemes for intravaginal monitoring devices, of
the FIG. 1b. In specific, the depictions of 305, 325, 345 and 365
show placements of (video) camera 309, 347, sonogram 315, 335,
electrocardiogram 331, pressure 329 and temperature 327, 349, 367
sensors and user interfaces that includes an on/off/mode selection
switch 313, 333, 353, 373.
[0123] In other words, the illustrations 305, 325, 345 and 365 show
placement of electronic components, as they appear externally. The
electronic components that appear from one side of the wearable
(used for longer term monitoring) or non-wearable (in another
variant) intravaginal monitoring devices 305, 325, 345 and 365
include conductive rings 331 (the top one being on the surfaces of
the cup or head 307 or 337; through which electrical potential can
be measured, for instance, in case of pregnancy, baby's EKG),
electrolyte, PH, glucose sensors 311 (these sensors, in reality,
are not co-located), infrared temperature sensor window, plate for
thermal temperature sensing 327, 349, 367, microphone 315 (for
instance, piezo) affixed to either the inside or the outside of the
cap (such that cap amplifies mother-fetus heartbeats or infant
movement sounds), hermetically sealed on/off switch with fingertip
texture 313, 333, 353, 373, light emitting display (for instance,
indicating green on ready; red on servicing required--battery,
storage full, etc.; no light indicating power off and so forth),
and mini-liquid crystal display. Also note that all sensor
positions illustrated are merely illustrative; any sensor could be
located anywhere on intravaginal monitoring device housing or there
within (if operational), or externally thereof. The depiction 345
also show bottom cap 359 that can be sealed while screwing back 355
(with a washer 357 that makes the intravaginal monitoring device
345 water resistant/proof).
[0124] FIG. 4 is a schematic block diagram illustrating fluid flush
cleaner on the surface of the cap that cleans both the surface of
the cap and the target area of intravaginal monitoring devices, of
the FIG. 1b. Specifically, the illustration depicts typical
placement of few of the electronic components 419, 423, 425, 417,
457 within the hermetically sealed transparent cap 413, 453 and
stem 421 that includes camera, an infrared thermometer and other
sensors, processing circuitry and memory, communication and user
interfaces and batteries 425, and a fluid flush cleaner 415, 455 on
the surface of the cap 413, 453. The electronic components are
placed over one or more circuit boards, such as the 419. The
circuit boards 419 hold most of the electronic components that
capture images and take sensory readings (from the front side of
the outer surface of the cervix).
[0125] The illustration also shows a fluid tube 427, 459 for lens
cleaning or sperm injection; whereas the depicted fluid tube 427 is
built internal to the intravaginal monitoring device 443, the fluid
tube 459 is built removably outside of the intravaginal monitoring
device 473. Note that the squeeze rubber bulb/ball 429 are either
be filled with vinegar and water type solutions; alternatively, a
syringe containing cleaning solution (or, sperm injection) as well
is used. Moreover, the syringe attachment could also be used to
deliver drugs. Likewise, instead of the exterior tube 427 cleaning
solution/sperm/drug could be stored in interior intravaginal
monitoring device 473 cavity (for instance, within the stem 421),
with an injection grommet for initial delivery and pumping (or a
pressurized cavity and valve). In addition, drain holes (when the
cleaning system 429, 427, 459 and 415, 455 is not used as a sperm
delivery device) can be added to the cap 411 for cleaning fluid
delivery and vaginal-uterus discharges. Also note that the tube 427
can assist in device insertion-removal.
[0126] FIG. 5 is a schematic diagram illustrating placement of the
intravaginal monitoring device 511 of FIG. 1b, placed so as to face
the outer surface of the cervix 543; wherein the device's cap or
head 513 takes images of the outer surface of the cervix 543 as
well as sensor readings via many other built-in electronic sensors,
to monitor the well being of a female (and developing fetus in case
of the female being pregnant).
[0127] Including during pregnancy, a female person's reproductive
health is observed using the intravaginal monitoring device 511,
directly or indirectly (by a gynecologist or obstetrician, to
determine the health conditions), include Vulva 521, Vaginal
Channel 531, Exterior Portion of Vaginal Channel 533, Interior
Portion of Vaginal Channel 535, Cervix 541, Outer Surface of Cervix
543, Exterior Orifice (opening) of Cervix 545, Interior Orifice
547, Cervical Channel 549, Uterus 551, Fallopian Tube 561, and
Ovary 571.
[0128] The intravaginal monitoring device 511 itself contains a cap
or head 513 (that contains most of the built in electronics), stem
515 (that aids user in insertion/removal and
stabilization/orientation during wear) and bottom cap (or, finger
ring) 517 that assists insertion/removal. The stem 515 are, in some
configurations, also contain built in electronics. The cap 513 and
stem 515 are include one or more of camera and illumination system,
sensors, user interfaces, power management system, communication
interfaces. The sensors include temperature sensors, pressure
sensor, glucose sensor, PH sensor, EKG sensor, and sonogram sensor.
Other sensor systems that assist in determining other gynecological
conditions (and in cases of other needs for physiological
reproductive data) are also contemplated. The intravaginal
monitoring devices 511 are inserted in one variant by applying some
lubricant on the surface of the cap 513.
[0129] Features that are incorporated in various embodiments of the
intravaginal monitoring device 511 of the present invention
include: (a) a Camera unit containing wide angle lensing as well as
"fish eye" lensing and image recovery; (b) Transparent latex or
other biocompatible material is used to cover the device for use
and to protect the lensing cap of some of the designs (this also
extends the life of the medical grade rubber device); (c) Time
stamping sensor data capture (to be able to follow up and
investigate the vaginal conditions by a health care professional)
is also provided in another variant; (d) Live video is used for
guidance of the device into place and proper orientation for
imaging desired anatomy; and (e) Linear, symmetric device with a
very flexible neck and stem to assist in fitting the space; and (f)
Making the intravaginal monitoring device able to bend and face
toward cervix (straight ahead, in a line of sight; note that a
female moves the intravaginal monitoring device 511 to orient it
properly, an optional audible or visible alert is given to the user
once the device detects it in a mode of operation that provides
device assisted positioning--this can also be accomplished by
viewing the images in an external device or with an algorithm on
the device indicating to the user the device is properly
imaging).
[0130] In addition, there are two exemplary variants of the
intravaginal monitoring devices 511, the first one that is wearable
(for continuously wearing during night or other periods, and for
long term monitoring) and the second one is non-wearable (for
shorter term monitoring and quick assessments at the gynecologist's
presence, for instance). These two types come in different shapes
and sizes, depending upon their applications and the anatomy or
events to be monitored in the female. One or more portions of the
device are composed medical grade silicon for flexibility and
adjustability of the cap or head or other suitable metal
biocompatible material or plastic material, to snugly but
comfortably fit into the cervix area 543. Other types of plastics
or rubber are also used herein, including hypoallergenic materials.
Moreover, the cap 513 (or head 513, shaped like a bulb) appear to
be made of a flexible, medical grade silicon rubber cap, with most
of the electronics located in the bottom of the cap or inside of
the stem and in one variant, the user interfaces are visible
externally (for the images and sensor readings to be transmitted to
a video system such as phone, camera, television, computer and so
forth, or transmitted to a health care center via Internet and a
server). All of the electronics and user interfaces are placed
within the hermetically sealed areas of the intravaginal monitoring
device 511, so as to be able to handle vaginal discharges, and then
be able to wash and clean after use.
[0131] FIG. 6 is a schematic diagram illustrating the components of
the intravaginal monitoring device of FIG. 1b (that may be found in
exemplary intravaginal monitoring devices such as those found in
FIGS. 1-5). The intravaginal monitoring device 611 contains wired
and/or wireless communication interfaces 661 as well as firmware
and program & operational logic codes 693 that makes it
possible for the intravaginal monitoring device 611 to communicate
with the local external electronic devices as well as receive
control signals via (immediate) external electronic devices.
Moreover, the intravaginal monitoring device 611 also contains
memory 681, processing circuitry 641, displays 663 and user input
devices 665. The memory 681 additionally contains network
management module 683, display management module 685, application
programming module 687, external memory management module 689, IMD
server module (SM) 691, sensor data 695 and workspace 697.
[0132] Firmware and program & operational logic codes 683 allow
the intravaginal monitoring device 611 to perform in accordance
with specific logic that includes: (a) Receiving and/or executing
instructions, in case of wearable intravaginal monitoring device
611, as to when to switch on and off functionality on the device,
when and at what points in time to take images/video clips/sensor
data, and at what interval they should be taken; (b) Receiving
and/or executing instructions to vibrate/beep, and then, switch off
and transfer data to an external device or external servers (such
as after enough data to make diagnosis has been taken and it is
time to switch off until some other time or in emergency situations
such as sometime before delivery of a baby); (c) Receiving and/or
executing instructions that involves exceeding limits in cases of
sensor data; and/or (d) Monitoring the battery operations and
informing the user to recharge batteries, if need be; and so
forth.
[0133] The sensors and devices that are incorporated into the
intravaginal monitoring device 611 include components of one or
more of: (a) UV and IR emitter and detectors 621, to monitor
temperature; (b) Piezo microphones and speakers 623, to monitor
heartbeat sounds of fetus, for instance; (c) Electrolyte and EKG
interfaces 625, to take electrocardiogram graphs of heartbeat of a
fetus, for instance; (d) Pressure transducers 629, to make pressure
measurements within the intravaginal channel, to monitor dilations,
for instance; (e) Thermal contact assembly 631, to take temperature
measurements in cases of wearable intravaginal monitoring device
611, for instance; (f) Glucose sensor 633, to take glucose
measurements; (g) PH sensor 635; and/or (h) Sonogram head unit
639.
[0134] In all of the above-mentioned sensor cases, a processing
circuitry 641 executes, as mentioned above, the operational logics,
and takes measurements at appropriate intervals and also verifies
if the limits are exceeded and precautionary actions should be
taken. Other components of the intravaginal monitoring device 611
depicted include normal (infrared and ultraviolet) illuminators
667, fixed-manual-auto focus lensing 669, a bunch of photodetector
arrays 673, 675 (or one or more arrays positioned at predetermined
locations on the device) and fixed-manual-auto focus microscopic
lensing 679. The wired and wireless communication interface
circuitry 661 also contains: (a) Display interface 649, to support
on screen displays on external monitors, for instance (on a smart
phone or other mobile communications device, e.g. two way); (b)
External memory interfaces 643, to interface with external
computers and deliver the memory contents; (c) Communication
interface 645; and/or (d) Application program interface 647, alone
or in combination.
[0135] Although the intravaginal monitoring devices 611 shows a
variety of basic types of functionalities, a variety of other
intravaginal monitoring devices 611 (shown FIGS. 1 through 5, for
example) may also be built with all of those functionality or some
portions of them, still others may also be built with further
functionalities, such as having more sensors, more photo sensor
arrays, or illuminators and so forth.
[0136] The intravaginal monitoring device 611 is used to gather
sensor information from the variety of sensors illustrated when the
intravaginal monitoring device is at partially inserted into the
vaginal channel. For example relating to an imager (i.e., the
photodetector array 673, the processing circuitry 641 receives user
input from the user input devices 665 and responds by (i)
delivering power from the batteries 653 to at least one of the
illuminators 667, and (ii) producing a control signal delivered to
the photodetector array 673 directing that imager data (still
images and/or video data) is to be captured. The photodetector
array 673 responds by capturing reflections of the illumination
from the target area (e.g., a cervix), and delivers such imager
data captures to the processing circuitry 641. Also, in addition to
of performing the above behavior in response to the user input, the
processing circuit 641 can also do so in response to control
signals received via the communication interface 645 from external
devices. Although described in reference to the photodetector array
673, such operations performed by the processing circuitry 641
apply equally to all other sensors of the IMD 611.
[0137] The processing circuitry may a) send the imager data (or a
processed version thereof) to the display 663; b) store the sensor
data along with previously captured imager data within the sensor
data 695 of the memory 681; c) forward the captured imager data via
the communication interface 645 (in real time during the capture
process or otherwise) to external supporting devices; d)
pre-process the imager data to produce measurement information for
use in the above a-c; and e) perform at least a portion of the
analysis engine functionality. Whether or not the processing
circuitry 641 performs each element a-e above depends on the
particular configuration of the IMD 611, and may vary pursuant to
configurable modes of setup that is maintained by the operational
logic 693. Such modes can be set via the user input devices 665 or
via control signals originating, for example, from an external
supporting computing device via the communication interface 645.
Although described in reference to the imager data captured by the
photodetector array 673, such operations performed by the
processing circuitry 641 apply equally to all other sensor data
captured by the various other sensors of the IMD 611.
[0138] Thus, the IMD 611 can operate in an independent mode and
under control of the processing circuitry 641 pursuant to the
program and operational logic 693 within the memory 681. All
control signaling in such mode originate within the IMD and, at
times, in response to the user input devices 665. However, the IMD
611 as shown can operate in a dependent mode wherein various
control signals originating from other supporting devices outside
of the IMD 611.
[0139] Switching between independent and dependent modes can occur
automatically or require further control signals that direct the
switch. For example, in one mode of operation (via configuration or
setup), the IMD 611 begins operating in the independent mode.
During such independent operations, an external control signal is
received via the communication interface 647. In response to the
receipt, the IMD 611 enters a controlled mode to carry out the
underlying task. After such task is completed, the IMD 611 returns
to the independent mode to continue locally directed operations.
Alternatively, the IMD 611 can be placed in a slave mode wherein no
functionality is performed without direction from externally
originating control signals. That is, the IMD 611 can wait (e.g.,
in a low power, idle state) for external control signals. Upon
receipt, underlying procedures are carried out and, once completed,
the IMD 611 returns to the idles state awaiting further
instructions (i.e., awaiting further control signals from an
external supporting device).
[0140] The program and operational logic 693 (of the memory 681)
consist of operating instructions that direct the processing
circuitry 641 in carrying out the various independent and dependent
modes of operation. Moreover, the program and operation logic 693
defines processes for the selection from the plurality of modes and
switching there between. As mentioned, such definition involves,
for example, responding to the user input devices 665 and to
incoming control signals from external supporting computing
devices. In addition, the IMD 611 can be placed in various initial
modes of operation (either via the user input devices 665 or via
externally originating control signals) in advance of insertion or
at any time thereafter by, for example, setting parameters within
the memory 681 that are used to configure the operating
instructions of the program and operational logic 693 for use by
the processing circuitry 641.
[0141] Thus, the program and operational logic 693 may have a
plurality of operational procedures from which a user of the IMD
611 or a user of a supporting external device can select and
configure. Some of the operational procedures may be tuned to
service particular physiological aspects of the specific
reproductive system under service. One procedure, for example,
might involve using a first type of illuminator and corresponding
imager, while another might involve a different group of sensors
entirely and so on.
[0142] FIG. 7 is a schematic diagram illustrating data 755 flow
between each of the plurality of intravaginal monitoring devices
719 and various systems or devices 711, 713, 715, 717, 721 within
the supporting network infrastructure. Within the supporting
infrastructure, there are various entities such as the 711, 713,
715, 717, 721, all of which in a centralized or distributed form
hold sensor data (sensor information/query information) from a
plurality of intravaginal monitoring devices 719. Also note that
each IMD of the plurality of IMDs 719 is used to monitor a
corresponding one of a plurality of female reproductive systems
under service. The
[0143] In addition, the data/information 755 also contains data
generated via queries, as remedies to various reproductive health
related issues or as data collected from auxiliary devices (such as
blood pressure, heart rate, blood chemistry, physiological
parameter inputs), R&D systems/devices inputs 713, user IMD
support systems/devices 717, practitioner's supporting
systems/devices 715, pharmaceutical computing systems/devices 721
and central supporting systems 711 (or in another variant
distributed computing systems including but not limited to cloud
networks).
[0144] Each of these entities is responsible for dissemination of
information/data 755 and they flow with permission from the
respective entities 711, 713, 715, 717, 721, 719 in an encrypted
form. These data or information flow in turn assist R&D
systems/devices inputs 713 develop new medicines, user IMD support
systems/devices 717 to take care of the data and avail user forum
suggestions and recommendations, practitioner's supporting
systems/devices 715 to provide treatments to the users of IMD 719,
pharmaceutical computing systems/devices 721 to develop or
recommend medicines and central supporting systems 711 to possibly
govern and control all of the movements of data and information in
a secured manner.
[0145] The supporting devices, e.g., the devices 711, 713, 715,
717, 721 establish communication with each of the plurality of IMDs
719, for example, to retrieve sensor data therefrom. Such retrieved
data can be stored, analyzed (analysis engine functionality) and
displayed along with any reproductive system status generated. The
communication between such supporting devices can be direct point
to point links or involve network routing, both via wired and/or
wireless infrastructures. The sensor data retrieval and storage can
be repeated to cover the many sessions (e.g., insertion sessions)
carried out by the each of the plurality of IMDs 719. The display
presented can illustrate differences by merely simultaneously
presenting data from, for example, a first session and a second
session that is perhaps gathered weeks later. Moreover to assist in
detecting the differences, analysis engine functionality can be
applied and resulting output can be also presented so that a viewer
can easily and fully appreciate the underlying changes. Such
presentations may involve historical tracking of features,
overlays, highlighting, etc.
[0146] FIG. 8 is a schematic diagram illustrating a snapshot of one
of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts a user's data
view page. The snapshot of the user's data view page of the
reproductive health management system 811 depicts data view page of
the current registered user. Additionally, all of the available
user's pages include records, queries, electronic mail, forum,
research, accounts, IMD setup, support, educational, tutorial and
shopping, among others (depicted in the FIGS. 9 through 17). All
these user's pages assist in making the intravaginal monitoring
device functional in very specific ways that are designed to assist
follow up of routine reproductive health care or a specific
reproductive health care related condition.
[0147] The snapshot depicts, in all four major windows. The right
side window, named as "Time Position Status", shows various sensor
boxes as applicable to the current device. Hence, the Time Position
Status window are consist of temperature, viscosity, acidity-PH,
electrolytes, heart rate, fetal rate, dilation, cervical face,
vaginal channel, user symptoms and so forth (along with a notes
text box). Any of these selected sensor data/information is
pictured in the left side graphical window (which are show live
sensor data or select group of sensor data in a time lapse
sequence) and/or image window (which are show live video or select
group of images in a time lapse sequence). These windows appear on
a smart phone display in one variant, in full or condensed format,
and or on various tabs or pages that are open on the smart
phone.
[0148] A chronological time line chart bar/marker (shown as a
dashed straight line in the graphical window) shows the
data/information about the selected sensors at the Time Position
Status window. The corresponding image or video clip is shown on
the top-left window. Shown on the top of this image window is the
time limit, that is, begin and end times as well as the current
position. This current position is selected by using marker at the
bottom graphical window (chart bar/marker shows exact time line and
allows user to drag left or right).
[0149] Moreover, the snapshot also shows a tool box, containing
various tool icons, that includes magnify, mark, select, notes for
the current image and general notes, mail, database storage and so
forth. A small tool bar at the top of these icons is associated
with the video and image displays and allows the user to playback,
start, stop, pause, fast forward, fast reverse the displayed video
images.
[0150] Additionally, all of the available user's pages, such as the
records, queries, mail, forum, research, accounts, IMD setup,
support and shopping, among other pages (depicted in the FIGS. 9
through 17) also contain tool boxes that are enabled by clicking on
the "Tools" icon. The client's browser 825 (which can be the user,
third party or the health care professional, for instance) also
shows a status bar indicating current IMD status 813 and on line
status 815. For instance, the current data points of the graphical
window, shown in dashed lines are for normal female data, e.g.
normal within medical ranges, along with the current user data.
Similarly, the tool bar allows zoom in or out a select area, cut
and mark a select area to show gynecological or obstetrics notes
add notes to them, and then, store those images in the database and
mail them if necessary (the user are write a small note such as "Is
this normal?" and send the current image via email). A small button
or icon or tab on the right side of the graph allows the graphical
window to be collapsed.
[0151] FIG. 9 is a schematic diagram illustrating a snapshot of one
of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts user's record
page. This simple records page 911 contains listing of all of the
various types of available intravaginal monitoring devices (such as
LUM-F106, LUM-G13A) as well as other work records of the current
user (such as query: user or query: doctor). All these records are
listed in the current record page. Again, these web pages appear on
a standard PC or laptop in one variant, or in another variant
appear on a smart phone screen, alone or in combination with the
same views or views created or adjusted for presentation on the
appropriate remote device, e.g. PC or smart phone
[0152] The record page also is provided with many buttons
(displayed at the bottom) that allows the user to view, search,
delete, select all or clear selections. Each of these displayed
records contains date, duration (if applicable, as in the case of
video clippings), description and a select check box fields. These
fields assist the user in remembering the contents as appropriate
and to select a relevant record for detailed viewing (shown in
FIGS. 10a and 10b).
[0153] To view any of the records, the user are click on the select
box on the left side of the record and then click on the view
button, which takes the user to the next pages depicted in FIGS.
10a and 10b. Additionally, all of the available user's pages, such
as the records, queries, mail, forum, research, accounts, IMD
setup, support and shopping, among other pages (depicted in the
FIGS. 9 through 17) also contain tool boxes that can be enabled by
clicking on the "Tools" icon such as 927. The client's browser 925
also shows a status bar indicating current IMD status 913.
[0154] FIG. 10a is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts a user's
queries page. The queries page provides all the data records listed
in rows, each containing the fields of select, category,
subcategory, last (sensor readings), due (date of sensor readings),
and estimate (sensor reading take time). The query pages permit a
user of health care professional to augment data from the
intravaginal monitoring device, with other data relevant to a
diagnosis or tracking of a female medical event or condition, and
provide for more facts upon which a diagnosis or tracking of a
condition of an event can be made by the user or medical
professional. The device and method herein are used to create or
augment an electronic medical record for a user which can be stored
on the device, on a smart phone communicatively linked to the
device, or at a remote database to which this electronic medical
record data is sent.
[0155] These fields allow the user to select a particular record
(such as an ovulation electronic medical record data) and then
communicate the data to whichever server/systems that the user
intends to send queries to. The major categories are predefined
such as ovulation, coitus, impregnation, 1.sup.st, 2.sup.nd,
3.sup.rd trimester, postpartum, STD-detect, cervix-artifact,
measurement, background and so forth, in one variant of the
invention. Similarly, a subcategory is also predefined, to assist
the user to quickly determine the query to be sent, for instance,
to a health care professional. The last date of the sensor reading
taken and due date of sensor readings to be taken are also
preprogrammed, with the help of a health care professional for
instance, to further assist the user.
[0156] At the bottom of the queries page, buttons are provided to
initiate a query, view last query, delete, select all and clear
selection. These buttons allow the user to further the proceedings
from the listing toward reading and communicating with the relevant
health care professional, a user forum, R&D of a medical device
manufacturer computer system, or pharmaceutical manufacturer
computer system, or pharmaceutical personnel. All of the available
user's pages, such as the records, queries, mail, forum, research,
accounts, IMD setup, support and shopping, among other pages
(depicted in the FIGS. 9 through 17) also contain tool boxes that
can be enabled by clicking on the "Tools" icon. The client's
browser 1025 also shows a status bar indicating current IMD status
1013.
[0157] FIG. 10b is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts user's queries
page. This query page 1051 allows the client (which can be anyone
who has the access to these queries, including the user, users of a
forum, health care professional, R&D and pharmaceutical
personnel) to read query messages and reply to them (in the next
mail window of the FIG. 11), if necessary. Query pages include
entry pages regarding a history of sexual activity, the name of the
patient, insurance information, week of pregnancy information,
consulting physician information, primary health care provider
information, HMO information, social security number information,
national health care information, method of payment information,
credit card information, family member information, insured
information, type of insurance policy information, number of
pregnancy information, date of last menstruation information,
allergy information, allergy to drug information, previous abortion
information, number of children information, the ability for the
patient to take a photo icon and include it in the electronic
medical record profile, electronic medical record information, the
ability to download electronic medical record information from a
remote source connected to the Internet, information about a
woman's moods or feelings, information about the tenderness of a
woman's breasts, information about the sensitivity of a woman's
nipples, bloating information, history of sec partner information,
name of sex partner information, marital status, history of
sexually transmitted disease information, history of therapy
information, current drug intake information, history of anal sex
information, number of sex partner information, history of previous
gynecological or obstetrics events or conditions, history of
endometriosis information, and an relevant information that would
assist a physician to make a diagnosis, and or provide a treatment
for a condition or event. The query page answers are stored on a
smart phone described herein, on a memory of said intravaginal
device, on a remote data base communicatively linked to these
devices, alone or in combination. The query information as well as
information harvested by the intravaginal device, e.g. all or
select portions thereof, are selectively, on any one of these
devices and databases, alone or in combination.
[0158] The listing in this page have the columns of select,
category, by (sent by), usage, Q# (query number), description and
Q-Triggers (that is, in response to which query). The client can
read these short messages on the window at the bottom along with
any attached notes. At the top of the page, many links are also
available that assist the user in searching, sorting and also
quickly find the messages. These links include predefined queries,
query builder, reports, database, chart and display. The query page
also provides buttons at the bottom that includes view, add,
search, delete, edit, initiate and hide detail. Among other actions
(similar to those in the query page of the FIG. 10a), the buttons
also allow the user to initiate a new query via the next mail page
of FIG. 11. All of the available user's pages, such as the records,
queries, mail, forum, research, accounts, IMD setup, support and
shopping, among other pages (depicted in the FIGS. 9 through 17)
also contain tool boxes that can be enabled by clicking on the
"Tools" icon. The client's browser 1055 also shows a status bar
indicating current IMD status 1053.
[0159] FIG. 11 is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts user's mail
page. The client's mail page is a typical mail page that contains
an inbox, and categories of sent, draft, trash, compose, select
all, clear all and search. These assist in performing any of the
mentioned tasks that includes searching through the inbox or other
groupings.
[0160] The mail page contains the columns of select, from:category
(such as gynecologist, obstetrician, pharmaceutical, R&D and so
forth), from (the name of the sender), regarding (subject of the
communication sent), date, views, query, other.
[0161] The user are view any of the massages by selecting them and
the bottom window displays the corresponding message. These
massages are be general, sent for instance by a gynecologist or
obstetrician to all of the patients or are be specific, sent only
to the client. The message window also shows attachments, if there
are any (such as an image of a healthy reproductive parts to a
patient who would like to know whether a particular condition is
normal or not). These attachments also include word processed
documents, electronic digital photos (e.g. historically taken
images by the intravaginal device), etc. The intravaginal device,
and or smart phone then processes real time or near real time data
with historical data, e.g. images, and displays the images, e.g. or
other sensor data, side by side on a display of the smart phone or
PC. The algorithms described herein can perform a comparison and
highlight discrepancies or changes in the images and sensor data
automatically in one variant of the invention. All of the available
user's pages, such as the records, queries, mail, forum, research,
accounts, IMD setup, support and shopping, among other pages
(depicted in the FIGS. 9 through 17) also contain tool boxes that
can be enabled by clicking on the "Tools" icon. The client's
browser 1125 also shows a status bar indicating current IMD status
1107.
[0162] FIG. 12a is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts user's forum
page. The forum page 1205 of the user or client is meant for the
clients (which includes users of the IMD) to read the contents of
the postings by other users as well post one's own messages (and
read responses for those postings).
[0163] The forum page is designed on the basis of categories such
as news, obstetrics, gynecology, support, IMDs, shopping, account,
search (and logout, once the reading and/or posting is
accomplished). Each of these categories come with their own
subcategories such as general discussions, family planning,
abortions, the physcological effects of abortions, adoption
options, miscarriage, first, second, third trimester, sonogram and
complications. These postings are arranged in rows, each row
containing the above mentioned subcategories, while the columns are
arranged by contents such as obstetrics (a main category) and posts
(that is, number of posts) and recent posts (most recent relevant
posts that might be of interest to the user; displayed with subject
head, date/time of posting). Clicking on one of the subcategory
entry such as general discussions takes the user to a next page
depicted in the FIG. 12b. All of the available user's pages, such
as the records, queries, mail, forum, research, accounts, IMD
setup, support and shopping, among other pages (depicted in the
FIGS. 9 through 17) also contain tool boxes that can be enabled by
clicking on the "Tools" icon. The client's browser 1225 also shows
a status bar indicating current IMD status 1207.
[0164] FIG. 12b is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts user's forum
page. The depiction shows a page that the user arrived into, by
clicking the general discussions subcategory in FIG. 12a and the
current page provides facilities to search, go back to forum home
page or logout. The general discussion entries are arranged in
rows, each row having columns such as title (or, subject head),
latest reply (are in response be to the user's own postings
previously), by (those who responded), replies (number of replies),
views (number of people who viewed the corresponding posting). All
of the available user's pages, such as the records, queries, mail,
forum, research, accounts, IMD setup, support and shopping, among
other pages (depicted in the FIGS. 9 through 17) also contain tool
boxes that can be enabled by clicking on the "Tools" icon. The
client's browser 1255 also shows a status bar indicating current
IMD status 1253.
[0165] FIG. 13 is a diagram illustrating a snapshot of one of the
reproductive health care management web pages or system interfaces
of FIG. 1b, wherein the snapshot depicts user's research page. The
research page 1305 of the client is reserved for the clients to
read the contents of latest research postings by research
establishments. This is of particular interest to those users who
are undergoing treatments for a certain condition, for which new
research and developments by various institutions and organizations
(that includes medical schools, for instance) have been going on.
Hence, the user is able to get all these research and developmental
information in one convenient place. This information is optionally
displayed on the smart phone screen in one or more pages permitting
the user or medical professional to truly be informed about the
best and most innovative options of therapy for a given event or
condition, long prior to coming to the doctor for consultation. It
is appreciated the device and system described herein creates a
truly knowledgeable female about her own body and the events and
conditions that are affecting it, including infectious diseases in
obstetrics and gynecology.
[0166] The research page contains categories such as professional
publications, peer reviewed journals news, obstetrics publications,
gynecology publications, pharma publications, IMD data, accounts
functionality, account functionality, search functionality (and
logout, once the reading and/or posting are accomplished). Each of
these categories come with their own subcategories such as a
published medical database data and information, rapid research
notes, obstetrics today, pregnancy magazines, mothering magazines,
STD related magazines, and newsletters (e.g. published magazine),
British medical journal (are be published magazine), webmd.com (are
be an on line publication organization) and so forth. These
postings are arranged in columns, each column is arranged by
contents such as obstetrics (a main category) and overview (that
is, brief explanation of the subcategory). Clicking on one of the
subcategory entry such as general discussions takes the user to a
next page containing detailed entries from the same institutions or
organizations. This information is displayed on a PC related device
or on a smart phone in an appropriate format. It is appreciated
that the intravaginal device sends data to a remote node on the
network regarding the female's particular condition or event. This
data is then used to select the appropriate return information feed
so that only relevant information and or website links for the
female is transmitted back to the smart phone or laptop to educate
the female or the medical professional as to the condition.
Similarly, in another variant, where the user of the methods and
system described herein is a medical professional, information or
web site links regarding current treatment protocols, drug
therapies, complication information for the condition or event are
sent to from a node on the network and provided to the medical
professionals smart phone or PC for display thereon. It is
appreciated that the medical professional and the female has access
to state of the art drug therapies, new treatment technologies,
treatment protocols approved by professional organizations, IVF
procedures, costs and the like.
[0167] All of the available user's pages, such as the medical
records, queries, mail, forum, research, accounts, IMD setup,
support and shopping, among other pages (depicted in the FIGS. 9
through 17) also contain tool boxes that can be enabled and or
disabled by clicking on the "Tools" icon. The client's browser 1325
also shows a status bar indicating current IMD status 1309.
[0168] FIG. 14a is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts user's account
page. The user accounts page 1405 maintains user's personal
information, some of which are be made available to health care
professionals (in case of treatments for a condition is sought) and
other login information to various user forums, R&D pages,
shopping, mail and VOIP phone facilities. These web pages are
presented on a smart phone, PC, workstation to appropriate users,
e.g. a female, a sex partner, a medical professional, an
obstetrician, a gynecologist, a hospital administrator, an
insurance company employee or consultant, a researcher, an
engineer, a medical device company individual, etc. The web pages
permit a female or other party described to manage the woman's
gynecological and or obstetrics health throughout her lifetime,
e.g. from early years of life through end of life.
[0169] The user information itself, e.g. as input on a query page
(e.g. on a smart phone or PC) contain name (first, middle, last),
address, city, state/country, zip codes or postal codes, phone
numbers and email addresses, e.g. including the female patient, the
doctor, the midwife, the hospital admissions staff, a nurse, an
insurance company. This information, with user permission, are be
made available to other entities (such as health care professional
nodes, R&D establishment nodes, pharmaceutical company nodes,
insurance provider nodes, National Health Care System nodes on the
network described herein and so forth; described with reference to
the FIG. 7). In addition, user information and data also include
login information that assists the user to quickly login without
entering user name (handle) and password each time. The login
information or data contain a login handle (user name or userID), a
password, website (to which the user has subscribed) or which is
entered automatically by the smart phone or intravaginal device,
and include a select box that lets the reproductive health care
management software and node know and interpret whether an auto
login mode of functionality is enabled.
[0170] A "Related Medical Information" button allows the user to
enter personal medical information (described with reference to the
FIG. 14b) that is made available to health care professional nodes,
R&D establishment nodes, pharmaceutical company or supplier
nodes and so forth, as well. All of the available user's pages,
such as the records, queries, mail, forum, research, accounts, IMD
setup, support and shopping, among other pages (depicted in the
FIGS. 9 through 17) also contain tool boxes that can be enabled by
clicking on the "Tools" icon. The client's browser 1425 also shows
a status bar indicating current IMD status 1407 and on line status
1409.
[0171] FIG. 14b is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of another variant of FIG. 1b, wherein the snapshot
depicts user's account page. The current user accounts page
contains same personal information as in the case of FIG. 14a, such
as the name (first, middle, last), address, city, state/country,
zip codes, phone numbers and email addresses; and in addition also
contains related medical information about the IMD user, identifier
data of the specific intravaginal device, e.g. serial number, user
profile, etc.
[0172] The related medical information are includes but is not
limited to, age, height, weight, prior known related conditions,
cholesterol, other information, blood group, blood pressure, lower
waist line circumference, belly button waist circumference, under
breast circumference, breast-chest circumference, week of
pregnancy, and so forth, including the other information described
herein; any or all of which are gathered from queries (by the
health care professionals, for instance) or extracted from a remote
medical records archive node on the network described herein.
[0173] All of the available user's pages, such as the records,
queries, mail, forum, research, accounts, IMD setup, support and
shopping, among other pages (depicted in the FIGS. 9 through 17)
also contain tool boxes that can be enabled by clicking on the
"Tools" icon. The client's browser 1457 also shows a status bar
indicating current IMD status 1453 and on line status 1455.
[0174] FIG. 15a is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b in another variant of the system and network,
wherein the snapshot depicts user's IMD setup page. IMD setup page
1505 can be exhaustive, nonetheless, many of the information are be
filled in automatically by auto detect and remotely by health care
professionals opting for a follow up of a particular medical
condition (by downloading a condition follow up firmware, for
instance). The user then onwards are simply have to follow up the
instructions provided in the data view, records or queries pages.
In yet another mode of operation of the invention, the system and
network include a mode of operation in which historical female
health condition information, e.g. electronic medical records of
different medical professionals are harvested from many different
nodes on the network where they reside in databases so as to
provide a complete profile of the female from the medical records
point of view.
[0175] A typical IMD set up page contains columns such as select
(to select a particular model and version or firmware), model,
version, support site (where additional help and firmware are be
available) and description (of the follow up firmware, connection
type--wireless or wired, type--wearable or non-wearable and so
forth). This information also comes up with auto detect, add and
delete buttons and modes of operation to take appropriate
actions.
[0176] Once selected or auto detected, the bottom half of the page
provides various configurations. As mentioned above, these are also
be automatically opted by the user or remotely by a support server,
based upon the type of usage (such as pregnancy-follow-up, for
instance). The depiction shows the configuration information for a
particular model such as LUM-F106 and IMD status (inserted),
battery levels, memory available, wireless reception (in this case
of tethered wiring, it is N/A--not available). It is appreciated
that the system, methods and network of the present invention
provide for an automatic set up mode for the user, e.g. on the
smart phone or PC, that is a function of the condition or event the
female is currently being treated for or experiencing. Other
configuration modes include operational modes, video camera mode,
temperature mode, wearable duration and indications (along with
buttons that assist in settings, update, visit support, order kits,
manual and test the device). The settings button or icon takes the
user to a next IMD setup page. All of the available user's pages,
such as the records, queries, mail, forum, research, accounts, IMD
setup, support and shopping, among other pages (depicted in the
FIGS. 9 through 17) also contain tool boxes that can be enabled by
clicking on the "Tools" icon. The client's browser 1525 also shows
a status bar indicating current IMD status 1507 and on line status
1509.
[0177] FIG. 15b is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts user's IMD
setup page. The current (depicted) page allows various specific
configuration modes to be set up (based upon the selection made in
the IMD set up page of FIG. 15a, LUM-F106, for instance). The
preset modes (on the right window of the page) allow the user (or
remotely, by professionals) various settings as follows: (a)
General Health--a routine checkup mode set by the user, without
expecting any assistance by external servers or professionals, for
instance; (b) Cancer Detect/Monitor mode--that allows the auto
enabling many particular sensors on the left side of the window, in
conjunction with health care professional's assistances--that are
include routine images taken by the Main camera, IR camera, UV
camera, Microscope and temperature sensors, drug dispenser (a
compartment within the IMD that delivers drugs to the correct
area--e.g., cervix--or delivery over time when worn), for instance,
and moreover, enabling Dye Douche Kits--assisting detection of
cancer; (c) STD Detect/Monitor--an under "Light Treatment",
including certain blue frequencies that are used to minimize
bacterial/fungal growth--it should be noted here that such blue
frequency is a common acne treatment today; all UV causes DNA/RNA
damage to both the virus/bacteria/fungus and the patient so low
doses and correct UV is used herein; it also noted that this can be
used to reduce the amount of normal female yeast; some female have
excessive amounts and yeast infections commonly (also, enabling Dye
Douche Kits--assisting detection of fluids, bacteria, fungus,
etc.); (d) Fertility Cycling; (e) Conception Avoidance--are
necessitate monitoring and certain treatments or fluid delivery and
PH Douche--Environment Promoting Gender+Ovulation Sync via Douche
Kit; (f) Pregnancy Promotion--are necessitate monitoring and
certain seminal fluid delivery--to promote impregnation using "cap"
containment with automatic or manual alerts (audible, vibrating,
LEDs, phone call, phone/pc display indications to user to use a
syringe attachment, rubber ball squeeze injection, etc.); (g)
Pregnancy Follow-up--an enabled microphone, that allows measurement
of mother's heart rate, fetal heart rate, fetal activity detection
on trimester basis, so forth. It is appreciated that the system and
mode of operation provides for an intravaginal device that can be
used to treat undesirable vaginal flora and infections, e.g. yeast
infections and the like, as well as track the progress of the
disease, inflammatory state of the female organs, and the like. All
of the available user's pages, such as the records, queries, mail,
forum, research, accounts, IMD setup, support and shopping, among
other pages (depicted in the FIGS. 9 through 17) also contain tool
boxes that can be enabled by clicking on the "Tools" icon. The
client's browser 1557 also shows a status bar indicating current
IMD status 1553 and on line status 1555.
[0178] FIG. 16 is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts user's support
page. The user's support page 1605 is intended to provide the user
assistance in searching for a gynecologist, obstetrician, other
doctors (such as fertility specialists) and find retailers (who
sell products other than the ones provided by reproductive health
management). In this variant of the invention, it is appreciated
that the system, e.g. the smart phone or PC, node in the network
automatically provides the female with data, e.g. name, appointment
calendar, location, of a medical professional that can address the
medical needs of the female. A register of medical professionals is
provided on a database. The system selects appropriate specialists
in the vicinity of the user, e.g. through GPS functionality,
displays their information and data to the user on the smart phone,
and their availability for an appointment. This reduces the stress
on the user and the need to wait to obtain a therapy or treatment
for the condition they have of the event they are experiencing.
This reduces the amount of physcological physical suffering the
female experiences by reducing the time from an indication of an
abnormal condition to the time that actual treatment or therapy is
administered.
[0179] The support page 1605 contains several main links (all of
which are meant to provide assistances to the user) such as
referral (e.g., doctoral refferal), IMD (provide IMD related
support, for instance), site (provide reproductive health
management site related support, for instance), PC-software (such
as latest firmware), phone-PDA software (that is, firmware for
supporting phones or PDAs), clinical(s) (provide assistances with
latest clinical stages research and developments), organizations
and logout. The smart phone and or intravaginal device also has a
mode of operation that communicatively links (with appropriate
access authorization and security functionality) to a medical
records node on the network to transmit appropriate data from the
intravaginal device directly. The medical records node on the
network, in another variant, is a medical records archive node that
stores electronic medical records data from a multiplicity of
female users located in remote locations globally. The archive
receives and processes several terabytes of data from remote nodes
on the network, e.g. including by way of example, millions of
intravaginal devices communicating with smart phones and PCs, alone
or in combination.
[0180] Each of these main links provides their own categories to
help in getting assistance in a quickly and in a very efficient
manner, automatically without or with very little human
intervention. For instance, the referrals main link, as depicted,
contains several categories such as find an obstetrician,
gynecologist, local retailer, on line retailer and so forth (along
with overview or descriptions for each of the category). Each main
link has a sub link, provided automatically or selected manually by
a user of sub-specialists or other medical professionals. All of
the available user's pages, such as the records, queries, mail,
forum, research, accounts, IMD setup, support and shopping, among
other pages (depicted in the FIGS. 9 through 17) also contain tool
boxes that can be enabled by clicking on the "Tools" icon. The
client's browser 1625 also shows a status bar indicating current
IMD status 1607.
[0181] FIG. 17 is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts user's shopping
page. The user's shopping page 1705 is designed to provide the user
assistance in shopping for IMDs, software applications,
pharmaceuticals and so forth. The shopping pages or tabs are
provided on a smart phone node on the network, a PC node on the
network, a laptop node on the network, and other nodes on the
network described herein. For example, a link to the Pampers.TM.
web site is provided, a link to a vendor is provided, an
advertisement, is provided.
[0182] The shopping page 1705 contains main links (all of which are
meant to provide quick and easy shopping interfaces to the user)
such as referral, IMD (provide IMD related shopping), site (provide
reproductive health management site related shopping, for
instance), PC-software, phone-PDA software (for example, shopping
firmware and software for the IMD supporting phones or PDAs),
clinical(s), support organizations and logout. It is appreciated
that other nodes on the network provide for billing, shipping and
payment functionality, e.g. credit or debit card functionality, as
well as a node on the network providing functionality to obtain a
percentage of each sale of product or service as well as referral
fees for professional services, returning to a commercial
enterprise node on the network, e.g. including but not limited to a
medical device manufacturer node on the network.
[0183] Each of these main links come with their own categories,
tabs, sub-tabs, that makes shopping an easy experience, such as,
IMD, software applications, pharmaceuticals, homeopathy and baby
products (along with overview or descriptions for each of the
category) under referral. Included on the smart phone is a mode of
functionality that permits the selection of applications both for
the smart phone and also for the intravaginal device. These
applications are paid for by the user and or insurance carrier and
or by a national health care system automatically or via payment
screens and functionality on the smart phone node of the network.
By way of further example, applications include a pregnancy
monitoring application, a premature birth monitoring application,
an ovulation monitoring application, a fertility monitoring
application, an STD detection application, a birthing application,
a post birth monitoring application, a precancerous cell detection
application, a cervical cancer monitoring application, an infection
detection application, a rhythm method application, a birth control
application, a therapy monitoring application, a cervical health
monitoring application, a vaginal health monitoring application, a
genital warts monitoring application, and an HPV monitoring
application. All of the available user's pages, such as the
records, queries, mail, forum, research, accounts, IMD setup,
support and shopping, among other pages (depicted in the FIGS. 9
through 17) also contain tool boxes that can be enabled by clicking
on the "Tools" icon. The client's browser 1725 also shows a status
bar indicating current IMD status 1707.
[0184] FIG. 18a is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts health care
professional's patients page 1805. The health care professional's
patients page 1805 contains a list of patients (all of whom are
associated with one of several models/versions of the IMDs that are
available for shopping and with a concerned gynecologist,
obstetrician or any other specialist), each of the patients having
associated with certain codes and relative importance in terms of
seeking medical care/advice. It is appreciated that the smart phone
node also serves to manage a medical professionals time by
automatically alerting a medical professional as to the medical
condition of a patient under his or her care. In another variant,
the patient data sent to the medical professionals smart phone node
is queued as a function of the immediacy of the need of the medical
professionals intervention, e.g. several pregnant patients are
ranked by the system on a node of the network, and the women who
are at the point of giving birth or needing an epidural or other
therapy or treatment are presented first to the medical
professional smart phone node of the network on a tab, e.g. which
can flash different colors, e.g. red, yellow, and green, according
to their immediacy of the need of the intervention. This
functionality permits the medical professional or clinic or
birthing center with an accurate way to provide efficient and
timely medical services. The list of patients in this health care
professional's patients page 1805 is arranged in rows, with each
column containing a list of patient's names, ID# (identity number
of the patient), due, time (due date and time for any of the IMD
related procedures, such as taking sensor readings at one instant
or for a prolonged period), regarding and code. The regarding
column includes reminder notes to the doctor such as a first
visit-general or routine examination, annual checkup, repeat:
fertility treatment, monthly checkup.
[0185] The health care professional's patients page 1805 also comes
with a select column and many buttons such as view, search, delete,
select all, clear selection (all of which have similar functions as
that of the user's records page 911 of the FIG. 9). For instance,
when the health care professional selects a patient and click on
the view button, the page of FIG. 18b appears (which provides an
overview and billing aspects with regards to the selected patient).
In another variant, these pages permit searching of archived
medical records and images, and comparison of archived data with
current day data harvested from the intravaginal device. This
permits ready tracking of disease conditions, therapies and the
like, as well as an electronic medical record of the state of the
female's sex organs over the course of her life.
[0186] The specialist sees a photograph or video of the patient by
clicking on a face icon 1827 (which pops up an image or small
video--of a first visit, for instance). The entire available health
care professional's patients pages, such as the records, queries,
mail, forum, research, accounts, IMD setup, support and shopping,
among other pages (depicted in the FIGS. 18a through 19) also
contain tool boxes that can be enabled by clicking on a "Tools"
icon. The health care professional's browser 1825 also shows a
status bar indicating current IMD status 1807. Similarly, there
appears on the page a photo of the woman taken at different points
in her life, allowing the medical professional to associate the
data for the female with her current electronic medical record
information, some or all of which was harvested by the intravaginal
monitoring device. The same digital photo of the woman appears on
the medical professional's smart phone node on the network.
[0187] FIG. 18b is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts a health care
professional's patient's accounts overview page 1851. The depiction
shows another of the health care professional's patients page 1851,
which is also a patient's records page. Similar to the conventional
files of a patient that contains several personal and medical
details as pertaining to the selected patient, the current depicted
page and that of the FIG. 18c also contain many of the personal
overview, medical and billing details as pertaining to the patient.
Similarly, the medical professional smart phone network nodes
provides the physician billing and commercial information about
specific users so that he or she can manage his or her business
aspects of the practice of medicine.
[0188] The patient personal information/overview contains patient
ID, name (first, middle, last), address, city, state/country, zip
codes or postal code, phone numbers, age, email addresses, mobile
phone numbers, electronic medical record information, and a photo
or small video. In addition, a button or icon for emailing, smsing
or contacting the patient and another button for VOIP or direct
phone call is also available. It is appreciated that another node
on the network (including appropriate links, icons and tabs)
includes a Skype.TM. node on the network, an instant messaging node
on the network, a Facebook.TM. node on the network, a Google.TM.
node on the network, a National Health Care system node, an
insurance company node on the network, an HMO node on the network,
a PPO node on the network, a hospital node on the network, a
physicians practice group node on the network, a Twitter.TM. node
on the network, an emergency first responder node on the network, a
social networking node on the network, a drug company node on the
network, a medical device company node on the network, and a birth
control vendor node on the network to facilitate communication
between users of various nodes on the network, and other data
transmission modes of operation. The health care professional's
patients page 1855 also comes with many buttons such as view,
search, delete, select all, clear selection. For instance, when the
health care professional clicks on the view button, the page of
FIG. 18c appears (which provides a billing aspects with regards to
the patient, among other information).
[0189] Also, at this time of attending to the patient, a timer (or,
a time counter) also goes on in one variant, indicating how much
time the doctor/health care specialist has spent on the patient.
This information is used to bill for the doctors time, and produce
an invoice to the patient, National Health Care system, private
insurance carrier, etc. (described further with reference to the
FIG. 18c). Reimbursement code data is also correlated with other
data and electronic medical records and other data harvested from
the intravaginal monitoring device and transmitted therefrom to
other nodes on the network. The current health care professional's
patient's accounts overview page 1851 also provides a brief medical
summary of the patient's medical history along with a provision to
annotate the medical records or information harvested from the
intravaginal device, and write further notes base upon the current
status of the patient, derived from the new IMD data. The health
care professional's patients pages, such as the records, queries,
mail, forum, research, accounts, IMD setup, support and shopping,
among other pages (depicted in the FIGS. 18a through 19) also
contain tool boxes that can be enabled by clicking on the "Tools"
icon. The health care professional's browser 1851 also shows a
status bar indicating current IMD status 1853.
[0190] FIG. 18c is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts health care
professional's patient's records view and invoicing page 1871. The
health care professional arrives at the current health care
professional's patient's records view and invoicing page 1871 by
clicking on the view button in the page of FIG. 18b. Here, the
health care professional is allowed to select on the type of the
interaction, professional advise, medical diagnosis, therapy
performed with reference to the current patient (whose name, user
ID and phone numbers appear on the top of the page; and if unable
to remember the patient, the health care professional is allowed to
see a digital photograph or video clip of the patient by clicking
on a face icon on the bottom-right of the page). In another
variant, a digital record of an examination of the female is also
archived and correlated with the patients other electronic medical
records, including data harvested by the intravaginal device. The
selections for the health care professional (in the current health
care professional's patient's records view and invoicing page 1871)
include type of the interaction, date and time, duration (based
upon the timer) and description (based upon the notes left by the
specialist, for instance). The depiction shows the IMD LUM-F106
being selected and the description includes video image and
temperature data collection (upon which the health care specialist
deliberated, analyzed, reported on, and wishes to produce an
invoice).
[0191] The bottom of the page contains the type of billing (such as
based upon hourly rate, flat fee, reimbursement code or fixed
rate), timer duration, invoice description and notes and
annotations. The entire available health care professional's
patients pages, such as the records, queries, mail, forum,
research, accounts, IMD setup, support and shopping, among other
pages (depicted in the FIGS. 18a through 19) also contain tool
boxes that can be enabled by clicking on the "Tools" icon. The
health care professional's browser 1875 also shows a status bar
indicating current IMD status 1873. It is appreciated that with the
smart phone network node the medical professional has global access
to patient data and can work from anywhere in the world in real
time given the patient data access. For example, a physician can be
at a medical conference in Hawaii while simultaneously reviewing in
real time patient medical records, and providing analysis, feedback
and even making phone consultations with patients and other medical
professionals. By way of further example, medical consultation with
world thought leaders can be obtained using the network nodes of
system described herein. For example, a world thought leading
specialist in premature birthing located in Switzerland can be
consulted by a doctor in Ukraine regarding a patient with an
untypical condition or rare condition. The Swiss expert can review
on his smart phone network node and or his or her PC, in real time
the patient data and provide a consultation.
[0192] FIG. 19 is a schematic diagram illustrating a snapshot of
one of the reproductive health care management web pages or system
interfaces of FIG. 1b, wherein the snapshot depicts health care
professional's patient's billing page 1905. The health care
professional's patient's billing page 1905 is exclusively reserved
for billing aspects of the current patient and specialist, based
upon the interactions that have taken place so far. Hence, the
health care professional's patient's billing page 1905 contains a
listing of bills produced (with reference to the current patient
and specialist) and service records. The list of columns includes
service, (service) date, invoiced (date), invoice # and notes. The
bottom half of the page contains the type of current billing (such
as based upon hourly rate or fixed rate), timer duration, invoice
description and notes. Again, the entire available health care
professional's patients pages, such as the electronic medical
records, queries, mail, forum, research, accounts, IMD setup,
support and shopping, among other pages (depicted in the FIGS. 18a
through 19) also contain tool boxes that can be enabled by clicking
on the "Tools" icon. The health care professional's browser 1925
also shows a status bar indicating current IMD status 1907. During
billing or any other times, if the health care specialist is unable
to remember the patient, the health care professional is allowed to
see a photograph or video of the patient by clicking on a face icon
on the bottom-right of the page.
[0193] FIG. 20 is a perspective diagram illustrating an exemplary
support architecture configuration for servicing a female
reproductive system, wherein the service involves use of real-time
analysis engine functionality in accordance with various aspects of
the present invention. Therein, an IMD 2017, a wearable IMD, has
been inserted via a vaginal channel 2015 into a female reproductive
system 2005. The IMD 2017 has a plurality of sensors disposed
therein, including, for example, an axial optical imager, a radial
optical imager, a pair of imagers, a temperature sensor, a
microphone, a glucose sensor, an EKG sensor, etc. While inserted
and operating to capture sensor data during an insertion session,
the IMD 2017 maintains wireless communication one or more various
supporting devices, such as a laptop computer 2045, support systems
2093, and a smart phone 2041. The IMD 2017 may maintain such
communication either directly in a point to point fashion or via an
access point 2043 and a communication network 2091. Some of such
communication can also be maintained with some of the supporting
devices via others of the supporting devices.
[0194] The supporting devices illustrated may be located at the
same premises as that of the female reproductive system 2005 or
located at an entirely different location. Either way, the real
time sensor data from the IMD 2017 is delivered so as to support a
real-time display (based on such sensor data) in a visual working
environment on each of the supporting devices. In addition,
analysis engine operations (within one or more of the various
illustrated elements of the support architecture) also receive such
sensor data such that output from the analysis engine can also be
displayed in virtually real time along with the representations of
the sensor data within such visual working environments. Additional
input into the analysis engine operations is received from the
various supporting devices, the IMD or third party sources (not
shown). Such input involves (i) sensor data or test data from other
types of supporting medical systems 2097, and (ii) general medical
information 2095, 2051, 2071. All input is either automatically or
manually (via patient, medical staff, or third party input)
delivered into the analysis engine.
[0195] Based on the input, various intermediate and final
conclusions regarding a particular status of the reproductive
system 2005 can generated by analysis engine operations and output
for visual display and storage, or to other systems such as the
supporting medical systems 2097, 2053, 2073 (or another medical
device local to the reproductive system 2005) for their own further
processing. Control signals and alerts based on such conclusions
may also be generated. For example, control signals might be
delivered to a supporting medical system 2097 or to the IMD 2015 to
adjust one or more characteristics or operations thereof. They may
also comprise requests for further capture. As mentioned, the
overall analysis engine functionality can be placed on one or more
of the devices as illustrated by the gynecological analysis engine
blocks 2099, 2075, 2055. Note also that the blocks 2051, 2053,
2055, 2057 are merely representative of counterparts that may be
found within the laptop computer 2045, the IMD 2017, the smart
phone 2041 and perhaps an additional type of IMD or other type of
medical device 2021.
[0196] FIG. 21 is a schematic and perspective block diagram
illustrating another possible support architecture employing
gynecological analysis engine operations that may reside in one or
more of a plurality of supporting devices and systems such as
diagnostic equipment located at a health care facility. Therein, an
intravaginal monitoring device (not shown) may be inserted within a
vaginal channel within the health care facility or be located
remote therefrom. Either way, the intravaginal monitoring device is
in communication via the communication network 2191 with the
various supporting architecture shown. As with the particular
support architecture of FIG. 20, general medical information 2195,
2113, 2131, supporting medical systems 2197, 2115, 2133, and
analysis engine operations 2199, 2117, 2135 can be found within any
one or more of the elements of the present support architecture
2105. Such elements include a communication network 2191, an access
point 2111, cell phones 2123, 2151, laptops 2121, 2153 and even
within supporting diagnostic equipment illustrated within a block
2157.
[0197] Within such a support infrastructure vast pluralities of
IMDs and associated other patient medical devices can be supported,
even when the patient has no supporting computing devices of their
own. Within the visual working environments of a medical staffs
system 2125 or a doctor's systems 2155, a patient can be selected
from a plurality of patients under care can be made. Such selection
changes the visual working environment to one directed at the
selected patient's reproductive system by accessing (i) previously
retrieved sensor information, related data and notes, and (ii)
generated analysis output based thereon. If currently active, the
sources of sensor data and real time analysis engine output can be
fielded to provide a virtually real time visual working environment
for review, evaluation and analysis.
[0198] FIG. 22 is a schematic block diagram illustrating analysis
engine operations within an intravaginal monitoring device (IMD),
built in accordance with various aspects of the present invention.
More specifically, IMDs can be built without any analysis engine
functionality. They may merely deliver raw sensor data (which
includes optical imager sensor data) with or without measurement
pre-processing performed thereon or related thereto. They may also
only perform a selection of the overall analysis engine operations
found in a support architecture, or may perform all such
operations. The IMD illustrated does perform at least part of the
overall analysis engine functionality.
[0199] Within the illustrated IMD, the firmware and program &
operational logic codes 2265 allow the intravaginal monitoring
device to perform in accordance with specific logic, in one
variant, that includes: (a) receiving and/or executing
instructions, in case of wearable intravaginal monitoring device,
as to when to switch on and off, when to take images/video
clips/sensor data, and at what interval they should be taken; (b)
receiving and/or executing instructions to vibrate/beep, and then,
switch off and transfer data to an external device or external
servers (such as after enough data to make diagnosis has been taken
and it is time to switch off until some other time or in emergency
situations such as sometime before delivery of a baby); (c)
receiving and/or executing instructions that involves exceeding
limits in cases of sensor data; (d) monitoring the battery
operations and informing the user to recharge batteries, if need
be; and so forth.
[0200] In fact, the illustrated IMD may operate in one of a
plurality of modes based on: (i) input via a user input device of
the user input devices and displays 2255 and (ii) control signals
originating outside of the IMD from a supporting device. For
example, in a wearable mode of operation, the device can be worn by
the user continuously, but its functionality is turned on or off at
different times during the wearing session per mode settings to
save battery power and conform to session measurement goals.
Similarly, a mode can specify when specific functionality within
the IMD becomes active or in an idle state, when communications
should be sent and to which supporting systems, the type of
analysis operations to perform (if any) and when, etc.
[0201] In addition to one or a plurality of optical imager sensors,
other sensors and components that may be incorporated into the IMD
may include components of one or more of: (a) IR emitter and
detectors 2221 used perhaps to monitor temperature or blood flow;
(b) piezo microphones 2223, to monitor heartbeat sounds of a female
and/or her fetus, for instance; (c) EKG contacts 2225, to take
electrocardiogram graphs of heartbeat of a fetus, for instance; (d)
piezo speaker 2227, to produce a soothing sound for the fetus, for
instance; (e) pressure transducers 2229, to make pressure
measurements within the intravaginal channel, to monitor dilations,
for instance; (f) thermal contact assembly 2231, to take
temperature measurements in cases of wearable intravaginal
monitoring device, for instance; (g) glucose sensor 2233, to take
glucose measurements; (h) pH sensor 2235; (i) electrolyte sensor
2237; (j) fetal brain activity monitors; and/or a (k) Sonogram head
unit 2239.
[0202] In all of the above-mentioned sensor cases, a processing
circuitry 2261 executes, as mentioned above, the operational
logics, and gathers sensor data and performs pre-processing to
extract consumable, measurement information based thereon. From the
raw sensor data, the related measurement information produced,
historical counterparts thereof stored within a memory 2273, and
any of a plurality of types of other sensor data or information
(medical information, historical data, human input, etc.) received
via the communication interfaces from supporting devices outside
thereof, operations, the processing circuitry 2261 performs various
analysis engine operations pursuant to analysis engine instructions
2269 retrieved from the memory 2273. All of the analysis engine
operations mentioned through out this application with reference to
various figures herein, or a subset thereof, can be performed.
[0203] Other components of the IMD depicted include displays 2255,
user interface devices and displays 2255, normal (infrared and
ultraviolet) illuminators 2251, fixed-manual-auto focus lensing
2247, a plurality of photodetector arrays (i.e., imager arrays)
2245, 2243, fixed-manual-auto focus microscopic lensing 2241, and
lens zoom capability (mechanical and or digital).
[0204] The analysis engine 2255 functions as an automatic servicing
entity, that is to provide service to the clients as well as the
healthcare professionals in assisting to come to a conclusion on
the bases of the measured and quantized parameters that emerge from
the intravaginal monitoring device, not only at the present time,
not only based upon the historical data emerged from that
intravaginal monitoring device but also based upon the data emerged
from a plurality of intravaginal monitoring devices.
[0205] Lastly, as constructed, the illustrated IMD may operate in
an entirely self contained mode, or under control of one or more
external supporting devices. In the later case, all or part of the
functionality defined within the analysis engine instructions 2269
can be turned on or off or replaced or supplemented by such
supporting device or devices. In other words, like other
controllable modes of operation, the illustrated IMD can be placed
in an independent and various controlled modes of operation. Such
placement can be via the user input devices and displays 2255 or
via external control signals originating from such support
device(s).
[0206] FIG. 23 is a schematic block diagram illustrating components
of one embodiment of an analysis engine that may be found in whole
or in part within one or more of the various devices and systems of
a network supporting intravaginal monitoring, wherein the analysis
engine illustrates various aspects of the present invention. That
is, the various blocks of the analysis engine can correspond to
software instructions and/or dedicated hardware depending on the
design of the particular device in which such blocks are found.
They and other components of the analysis engine 2311 may be found
in whole or in part, for example, on a supporting server, further
medical systems and computers, a patient's supporting computing
device, a medical staff member's computing device, etc.
[0207] In particular, processing circuitry 2321 pursuant to the
operational logic 2323 (firmware or software) carries out various
analysis engine operations based on a variety of input data such
as: a) a user's or patients input data 2341; b) doctor's or medical
staff data 23343; c) data 2345, 2347 from external supporting
medical device of a user or a doctor; d) diagnosis and treatment
information, conclusions and data 2349; e) IMD sensor data 2351,
2353 from a current and prior sensor data gathering session; f)
medical information data 2355; g) analysis logic data 2357 (which
can be modified via external control signals as can the operational
logic 2323). With such data which may be interactively gathered via
automated requests or through automatic direction via control
signals and preprocessing,
[0208] The operational logic 2323 and the analysis logic data 2357
together define the various operations of the analysis engine 2311,
including how and when to abate one to all operations, for example,
in response to control or direction originating outside of the
analysis engine 2311. The term "outside" as used above may still be
within the particular device in which the analysis engine 2311
resides, or may be outside of such device entirely and within a
different supporting device or IMD.
[0209] FIG. 24 is a schematic block diagram illustrating an
analysis engine such as that of FIG. 23, placed at least in part
within a server to illustrate server based analysis engine
functionality along with other server operations related thereto,
the server and underlying functionality built in accordance with
various aspects of the present invention. Therein, a supporting
server 2411 contains analysis engine operations 2455 and other
supporting operations 2421. Such operations 2411, 2455 are carried
out pursuant to application software tailored for support
operations and hardware typically found in a conventional
servers.
[0210] Within the analysis engine operations 2455 all or a portion
of the analysis engine operations mentioned within this
specification, for example, may be included. For example, analysis
of sensor data 2437 and related various types of supporting data
and information 2429 (some retrieved from a data storage 2453 and
other received via the communication processing functionality 2441)
can be utilized to produce either intermediate or final status
conclusions about a plurality of reproductive systems serviced by
the supporting server 2411 via, at least in part, a corresponding
plurality of IMDs.
[0211] The supporting operations 2421 include: a) registration
management 2423, account management 2423; b) directed advertising
2427 (based on revealed characteristics of a particular female
being serviced); c) alert and other conclusion processing 2431; d)
third party (non patient and non medical staff) interaction support
2433 (e.g., pharmaceutical or research organizations); e) doctor
and patient interaction support 2435, 2433; f) the communication
processing 2441; and g) presentation management associated with the
various visual working embodiments found in the corresponding
various supporting computing devices within the overall support
network. Regarding the latter, the supporting server 2411, using
typical web servering or "app" serving approach, may deliver
conclusion information, gather further information from patients,
doctors and third parties or their computing systems, and otherwise
at least assist in creating tailored visual working environments
for a patient's supporting computer, a doctor's computer or phone,
etc.
[0212] As before, although the entirety of possible analysis engine
operations are illustrated within the supporting server 2411, they
can be distributed in whole or in part throughout the various other
possible network components. To support the many configurations of
support architectures, IMD capabilities and supporting system
capabilities, the analysis engine operations 2455 use of particular
analysis operations can be selected to best conform to such
configurations. In other words, for a first patient with a
relatively simplistic IMD design and no supporting devices beyond
the server 2411, only those analysis operations that apply to such
IMD are performed by the server 2411. Yet in another embodiment
with a relatively advanced IMD and a plurality of other supporting
systems, a more full set of analysis options becomes available for
use by the supporting server. Even so, less that the "more full
set" might be employed if such other supporting devices or such
more advanced IMD is designated to carry out all or a portion of
such analysis operation "set."
[0213] FIG. 25 is a schematic block diagram illustrating another
embodiment of analysis engine integration within a network
supporting intravaginal monitoring, and build in accordance with
and illustrative of various aspects of the present invention.
Therein, within the network infrastructure 2505, central support
servers 2591 service various supporting operations to support a
plurality of IMDs of differing levels of functionality (some of
which relates to analysis engine operations). Each of the plurality
of IMDs are used by a corresponding plurality of females via
intravaginal insertion into their reproductive system. Regional and
remote health care servers 2551, 2539 and remote health care
servers also provide support to each other, the central support
servers 2591 and, of course, to the plurality of IMDs. Such support
is provided via wired/wireless, point-to-point, Internet/Intranet
network pathways 2513, 2511. The support server 1289, in
conjunction with the regional and remote health care professional
servers 1259, 1239, enables many of the functionalities including
the analysis engine operations and support for presenting visual
working environments for various supporting computer systems.
[0214] In particular, at the remote server(s) 2539, perhaps located
within a doctor's office, local supporting medical information 2521
can be retrieved in an automatic, automated or manual fashions
(depending on the underlying infrastructure) from supporting
medical systems 2529, and can be used along with other general
medical information 2527 as input to an analysis engine function
2531. Other input for the analysis engine function, 2531 includes
for example IMD sensor information 2525 and medical personnel data
(extracted via the interface 2523). Therefrom, all, none or
portions of the overall analysis engine functionality can be
performed.
[0215] Similarly, corresponding infrastructure supporting analysis
engine operations within the regional and central servers 2551 and
2591 can be found. Overall, it can be appreciated that the servers
2591, 2551, 2539 together contain a vast amount of analysis engine
operations and data. Such data can be exchanged there between as
needed such that the servers can each carry out their designated
and available analysis engine operations. Designation may involve
not only the selection of which server will handle a particular
operation, but also includes whether a non-server supporting device
(not shown) or IMD (not shown) will have such responsibility.
[0216] By way of further example, a targeted advertising module is
used in the present invention. Intravaginal device detects a female
condition, e.g. a pregnancy, a sexually transmitted disease (STD),
a precancerous condition, a cancer, a medical abnormality. This
information is communicated to one or more nodes on the network.
Advertising data for the treatment of the STD, e.g. for a drug used
to treat the STD or other condition, from a particular
pharmaceutical company or one or more companies, is then sent to
the intravaginal device or other remote device on the network, for
a user or doctor to review. Treatment option data are also
communicated in another variant of the invention to the
intravaginal device and or remote device. With respect to pregnancy
data, baby gift data or products used with babies are displayed on
the intravaginal device or remote device. In yet another aspect of
the information, a module is provided to provided to mask, conceal
or render anonymous the indentity of a user of the intravaginal
device while still permitting the information concerning the
treatment for the users condition, state or intravaginal event to
be used to direct advertising to the user needing a particular drug
or treatment regimen.
[0217] In yet a further aspect of the invention (optionally using
GPS functionality for locating or placing the intravaginal device
at a geographic location, e.g. or a remote device, (e.g. mobile
phone communicating the intravaginal device), patient candidate and
drug recipient candidates data is collected. User specific
condition or event data is collected on one or more nodes on the
network and correlated to treatment advertising data, and or
medical specialist, or hospital data. It is appreciated that drug
companies will be able to provide targeted advertising data or
their therapies and/or drugs to exactly the users who are suffering
from conditions or events which their products provide beneficial
treatments, e.g. drugs that treat STD's, drugs that treat cancers,
etc.
[0218] In yet other aspects of the invention a user profile module
is provided, and a method of monitoring and controlling the spread
of sexually transmitted diseases. The user enters personal
information, medical information, condition information, social
information, e.g. the names of sex partner data, date and times of
intercourse with specific partners, etc. This information is
correlated with data collected from the intravaginal device. By way
of further example, a sexually active female takes baseline data
with the intravaginal device of the present invention. The data is
time and date stamped, a record of the health or condition of her
cervix is recorded on the device or one or more nodes of the
network. She then has intercourse with a sex partner. In one
scenario, if the partner is free of STDs a follow up record of the
cervical or vaginal condition can be compared with the baseline
data and archivally recorded. In another scenario, if the sex
partner had an STD, then the user uses the device and notices that
there are abnormal cervical and or vaginal changes, and these are
archivally recorded and or an alert is sent to a remote device,
e.g. the user's or doctor's, and one or more of the advertising
modules above is activated. Similarly, the sex partner is notified
early of the STD condition. It is appreciated that the early
notification of the condition for the user and the sex partner can
stop the spread of the disease to other sex partners that may
occur, e.g. in the case of HPV transmission.
[0219] FIG. 26 is a cross-sectional diagrams illustrating one of
many possible variations in dimensions, contour, and orientations,
i.e., form factors, of a cap 2609 and optics assembly 2613 of an
IMD 2605 sized to correspond to various "form factors" of
intravaginal and cervical regions. Therein, the IMD 2605 is
inserted via a mostly axial direction of a vaginal channel 2601.
Within the vaginal channel 2601 at a mostly radial angle therein, a
cervical region 2603 is illustrated. The insertion of the IMD 2605
proceeds until the cap 2609 falls within an area near the cervical
region 2603.
[0220] The insertion process may benefit from visual guidance of
the process via the display of live imager data on an associated
display (not shown), and wherein the live imager data is captured
by the mostly axially oriented imager 2611. When reaching the
illustrated position, the cervical region 2603 falls within a field
of view of a mostly radial imager assembly 2607. The mostly radial
imager assembly 2607 can thus be used to provide further imager
data for a more detailed evaluation of various aspects of the
cervical region 2603.
[0221] That is, the imager assembly 2611 captures only a portion of
the cervical area, but such capture can be used: a) to assist in
the guidance process by allowing the user to find and target the
cervical region 2603 for image and video capture by the imager
assembly 2611; b) along with the image and video capture from the
imager assembly 2607 to construct a panorama, 3D information, etc.;
c) to support analysis and viewing of other artifacts, events or
conditions outside of the cervical region 2603 but within the
vaginal channel 2601; and d) to support pre-processing measurements
of the cervical region 2603 such as the height, length, width,
etc., of the cervix or associated cervical opening portions of the
cervical area--an important indication during pregnancy. The optics
assembly 2613 of the IMD 2605 is inserted within a main housing
stem 2614. The optics assembly 2613 supports the imager assemblies
2611, 2607. The cap 2609 may be made with a firm but compressible
material (such as silicone rubber) that permits installation,
removal and replacement. This may be accomplished by feeding the
optics assembly into the inner chamber of the cap 2609. Radial
tension of the opening portion of the cap 2609 due to elasticity of
the cap 2609 supports at least a partial hermetic seal and
mechanical constraint.
[0222] As illustrated, the field of view and underling mounting
angle of the radial imager assembly 2607 is adequately matched to
the illustrated reproductive system's orientation and size.
Exemplary fine tuning adjustment, however, might involve one or
more of: a) installation of a different sized and shaped optics
cap; b) relocating the radial imager assembly 2607 to provide
better field of view coverage of the present cervix; c) changing
the angle of the radial imager assembly 2607 to provide view more
normal to the surface of plane of the cervical region 2603; d)
extending or retracting the axial imager assembly 2611 directly (or
relatively via use of a longer cap) to (i) minimize having the
radial imager assembly 2607 within the field of view of the axial
imager assembly 2611, (ii) minimize having the axial imager
assembly 2611 within the field of view of the radial imager
assembly 2607, and (iii) attempting a better lateral image of the
cervical region 2603 by relocating the axial imager assembly 2611.
Moreover, further imager assemblies (not shown) could be added to
the optical imager assembly, or one of the imager assemblies 2607
or 2611 can be removed. An imager assembly may have integrated
illumination lighting and lensing, or other optical elements
supporting an imager array installed therein.
[0223] The illustrated cap is termed an asymmetric cap as it does
not maintain symmetry in the radial direction. Of course fully
symmetric caps can be used, such as that illustrated in FIG. 1. the
Similarly, to maximize the target coverage area for a field of view
2615 of the imager assembly 2607, the imager assembly 2607 is
oriented off center and in the opposite radial direction from that
of the cervical region 2603 (the intended target). Similarly, the
imager assembly 2607 having a field of view 2607 is positioned with
a significant distance to the end of the cap 2615. With such
positioning, it is more likely that a reasonably large target
coverage area for capturing imager data (by the imager assembly
261) can be maintained. In addition, the extended axial length of
the cap 2615 can help in positioning the imager assembly 2607 in
its mostly axial position that orients fairly well with the
opposing orientation and axial location of the cervical region
2603. If for example, a female's cervical region is much smaller
than that illustrated and located closer to the entrance to the
vaginal channel, the cap 2609 might be replaced with a longer
counterpart. If the cervical region of another female is located in
a normal orientation as viewed from the axial direction, a
centrally located axial imager assembly only might be used with a
symmetric cap of perhaps narrower dimensions.
[0224] If installation of a replacement for the cap 2609 is
insufficient to address a mismatch between the optical assembly and
the desired target, e.g., the cervical region 2603 (which varies
greatly from female to female), the optics assembly 2613 might be
swapped with another via an electrical and mechanical mating
engagement, e.g., a connector within the stem 2614 which matingly
engages with a counterpart connector on the base of the optics
assembly 2613.
[0225] However, note that although larger optics assemblies and
caps may be optimal, they may give rise to more difficult and
uncomfortable insertion of an IMD. Thus, where these "fitting"
processes are limited by comfort and insertion concerns, other cap
and optics assembly selections may still prove useful as a
compromise under the given reproductive system.
[0226] FIG. 27 is a schematic diagram illustrating three different
wearable forms of the intravaginal monitoring device 2751, 2753,
2755 that are part of a kit, each possessing varyingly angled caps
2711, 2721, 2731 and some others having adjustable angles of the
cap. The illustration shows three different types (of course, more
or less than three different types are also provided) of wearable
intravaginal monitoring devices 2751, 2753, 2755 (that can be used
over a short period of time or prolonged period of time) that
consists of a stem 2715, 2725, 2735 and a finger ring 2717, 2727,
2737 (to be able to insert and remove the intravaginal monitoring
device 2751, 2753, 2755). The electronics that is part of the
intravaginal monitoring device 2751, 2753, 2755 is not shown in
this figure; nonetheless they are incorporated within the cap 2711,
2721, 2731, the stem 2715, 2725, 2735, or combination thereof with
appropriate connectors (e.g. mechanical, optical or
electrical).
[0227] Each of the designs of the intravaginal monitoring devices
2751, 2753, 2755 vary slightly and are applicable for different
conditions, events, situations and circumstances, which include
vaginal anatomy (for ease of use and comfortable wearing) and
intended period of usage. For instance, the intravaginal monitoring
device 2751 has an angled cap 2711 and has a shorter stem 2715 that
can only accommodate a small battery 2713 (e.g. standard or
rechargeable) and is intended for short term usage. The
intravaginal monitoring device 2753, on the contrary, has a
slightly lesser angled cap 2721 and has a larger stem 2725 that can
only accommodate a large battery 2723 and is intended for long term
usage and better comfort.
[0228] The intravaginal monitoring device 2755 has an angle
adjustable cap 2731 and has a larger stem 2735 that can only
accommodate a large battery 2733 and is intended for long term
usage and better ease of use. Some of these hermetically sealed
intravaginal monitoring devices 2751, 2753, 2755 have the same cap
2711, 2721, 2731 size (with rear mounted stem, for optics assembly)
and are designed in sizes and dimensioned to fit comfortably to
varieties of vaginal anatomies.
[0229] FIG. 28 is a schematic diagram illustrating four different
wearable forms of the intravaginal monitoring device 2851, 2853,
2855, 2857 that are optionally part of a kit, possessing
multi-sized caps 2811, 2831, 2841, 2821. The illustration shows
four different types of wearable intravaginal monitoring devices
2851, 2853, 2855, 2857 (that comes in four different cap 2811,
2831, 2841, 2821 sizes) that consists of a stem 2815, 2835, 2845,
2825 and a finger ring 2847 (to be able to insert and remove the
intravaginal monitoring device 2851, 2853, 2855, 2857--shown only
in case of the intravaginal monitoring device 2855). The
electronics that is part of the intravaginal monitoring device
2851, 2853, 2855, 2857 is not shown; nonetheless they are
incorporated within the cap 2811, 2831, 2841, 2821 and the stem
2815, 2835, 2845, 2825.
[0230] Each of the three designs of the intravaginal monitoring
devices 2851, 2853, 2855, 2857 vary slightly (in specific, the cap
2811, 2831, 2841, 2821 sizes) and are applicable for different
vaginal anatomies, for ease of use and comfortable wearing, and
intended period of usage. Each of the hermetically sealed
intravaginal monitoring devices 2851, 2853, 2855, 2857 is made up
of medical grade silicon rubber (or other medical grade plastics)
that are adjustable at the neck and the cap 2811, 2831, 2841, 2821
itself is flexible so as to fit snugly at the face of outer surface
of the cervix. The neck is flexible so that the angle between the
cap and the stem flexes and conforms the natural angles between the
lower vaginal canal and the upper part of the vaginal canal. It is
appreciated that this flexible or pivoting neck contributes to the
level of comfort for the female user and also provides for
adjustment of the imaging angle between the image capture
components of the device and the target cervix or other part of the
vagina which is a desired target capture image. The neck can flex
through a variety of angles in a planar dimension or can rotate
freely across 360 degrees in another variant.
[0231] FIG. 29 is a schematic diagram illustrating two different
wearable forms of the intravaginal monitoring device 2951, 2953,
2955, possessing multi-sized caps 2911, 2921, 2931 and stems 2915,
2925, 2935; the cap 2911, 2921, 2931 being perforated to allow flow
of any vaginal discharges. Various natural or abnormal vaginal
discharges are created by various cells or floral within the
vagina, in the cervical canal, or up further in the female anatomy.
It is appreciated that detection of discharges assists in the
analysis of the health of the female reproductive anatomy.
Detection, imaging and sensing of the type of discharge (e.g.
color, texture, opacity, consistency, is a feature of the device,
and provides a method for determining abnormal pathologies of the
female reproductive system.
[0232] The illustration shows three different types of wearable
intravaginal monitoring devices 2951, 2953, 2955 (which comes in
three different perforated cap 2911, 2921, 2931 sizes) that
consists of a stem 2915, 2925, 2935 and a finger ring 2917, 2927
(to be able to insert and remove the intravaginal monitoring device
2951, 2953, 2955--shown only in case of the intravaginal monitoring
devices 2951, 2953). The electronics that is part of the
intravaginal monitoring device 2951, 2953, 2955 is not shown in
this figure; nonetheless they are incorporated within the cap 2911,
2921, 2931 and the stem 2915, 2925, 2935. As is illustrated,
various form factors that permit detection of various intravaginal
conditions are used herein.
[0233] Each of the three designs of the intravaginal monitoring
devices 2951, 2953, 2955 vary slightly (in specific, the cap 2911,
2921, 2931 sizes) and are applicable for various vaginal anatomies,
for ease of use and comfortable wearing, and intended period of
usage. Each of the optionally hermetically sealed intravaginal
monitoring devices 2951, 2953, 2955 is made up of medical grade
silicon rubber (or other medical grade plastics, glass, acrylics,
biocompatible material, biocompatible carbon coated materials,
biocompatible metals, or combinations thereof) that are flexible at
the neck 2919, 2929, 2939 and the cap 2911, 2921, 2931 itself is
flexible so as to fit snugly at the face of outer surface of the
cervix. The cap 2911, 2921, 2931 spreads the vaginal tissue to
provide line of sight and perforations (openings) allow fluid
flow.
[0234] It is further appreciated, that one or more components of
the device described herein are reusable and or disposable in one
or more combinations. By way of example, caps are disposable. In
this variant, replacement disposable caps are provided in cap kits.
By way of further example, sheaths are provided for the device that
are transparent and or translucent. For example, materials from
which condoms are constructed are used for the disposable
components of device and system. Use of the kits provides for
hygienic conditions to be provided to a user, and to keep various
parts of the device free of bodily fluids. A user may simply insert
a sheath over one or more components of the device in the same
manner as a condom is placed over a penis. The sheath conforms
snugly over one or more components of device and or cap, and is
constructed of a very thin elastic, hypoallergenic material. By
virtue of the elasticity of the material, a watertight or water
proof seal with made between the elastic covering and the device.
The device is used, the sheath removed and discarded. By way of
further example, the top portions of the caps described herein, in
another variant, include a thin clear plastic film (tensioned or
non tensioned) covering the top portion thereof, or open area. This
plastic film can come in direct contact with the cervix. When
spotting occurs the spotting will be visible on the thin plastic
film and imaged by the camera. It is appreciated that these
variants of the invention provide both hygienic benefits as well as
the benefits of keeping the lens assembly (and indeed where the
sleeve covers the entire device) free from bodily fluids and
microbes. Typical types of materials used include biocompatible
shrink wrap material, and other medical grade plastics. Of course,
the sheath in different variants covers all of the device,
substantially all of the device, part of the device, and the top
portion of the sheath or plastic film can have markings thereon
(e.g. crosshairs, and other measurement markings such as
circumferential measurement markings, quadrant markings, grid
pattern markings) so that the imager images both the markings and
the markings in relation to the cervix itself. This feature also
assists in visually positioning the device in relation to the
cervix, e.g. the cross hairs can be positioned over the opening of
the cervical canal. Where the film is elastic it can also provide a
three dimensional topography of the cervix including contours. It
is appreciated that the device of the present invention includes a
reusable member and also a kit including one or more disposable
members.
[0235] FIG. 30 is a schematic diagram illustrating hermetically
sealed intravaginal monitoring device 3051, 3053, 3055, 3057;
wherein the illustration depicts a flexible cap 3011, 3021, 3031,
3041 that opens up upon proper placement of intravaginal monitoring
device 3051, 3053, 3055, 3057 and then pushing the bottom half of
the stem 3015, 3025, 3035, 3045. Specifically, the illustration
shows wearable intravaginal monitoring device 3051, 3053, 3055,
3057 that provides the female an expanding cap (that expands only
after insertion; somewhat like tampon insertion--something wearers
would be familiar and comfortable with). In one variant, the cap is
self expanding and biased outward to expand and move the tissue of
the vagina out to expose the cervix for imaging. The different
wearable intravaginal monitoring device 3051, 3053, 3055, 3057
contains a stem 3013, 3023, 3033, 3043 and finger ring 3049 (to be
able to insert and remove the intravaginal monitoring device 3051,
3053, 3055, 3057--shown only in case of the illustration 3057, upon
proper placement). In addition to or in place of the finger ring a
string or looped string is provided to assist in removal of the
device from the vagina. The string is constructed of a
biocompatible material that is microbe resistant. The electronics
that is part of the intravaginal monitoring device 3051, 3053,
3055, 3057 is not shown; nonetheless they are incorporated within
the cap 3011, 3021, 3031, 3041 and the stem 3015, 3025, 3035,
3045.
[0236] In yet another variant of the invention the body of the
devices described herein is constructed of a material that kills
microbes upon surface contact. Alternatively, a lubricant that
contains microbe killing properties is used with the device
described herein. The lubricant assists woman who do not have
adequate moisture in their vaginas to properly and comfortably
insert the device.
[0237] This particular design of the intravaginal monitoring device
3051, 3053, 3055, 3057 employs a telescopic bottom half of the stem
3015, 3025, 3035, 3045 (that is hermetically sealed by screwing up
the bottom cap 3017, 3027, 3037, 3047), so that the entire
intravaginal monitoring device, as depicted in 3051, appears to be
sized and dimensioned like a tampon. Upon insertion, as shown in
illustrations 3053, 3055, 3057, the intravaginal monitoring device
3051, 3053, 3055, 3057 opens up to provide line of sight view of
the outer surface of the cervix, to the camera which is built in
the device. Then, as depicted in the illustration 3057, 3059 the
bottom half of the stem 3015, 3025, 3035, 3045 is removed and kept
in a safe place. The intravaginal monitoring device 3051, 3053,
3055, 3057 then can be used for short term or long period of time,
depending upon the needs. Moreover, other expansion schemes may
also be employed, for instance, a spring release cap, screw out cap
and so forth. The intravaginal monitoring device 3051, 3053, 3055,
3057 can also be non-wearable and usually is made up of medical
grade silicon rubber.
[0238] FIG. 31 is a schematic diagram illustrating hermetically
sealed intravaginal monitoring device 3151, 3153, 3155; wherein the
illustration depicts a flexible cap 3113, 3123, 3131 that
self-opens upon proper placement of intravaginal monitoring device
3151, 3153, 3155 and then pushing the bottom half of the stem 3115,
3125, which is another variation of the intravaginal monitoring
device of FIG. 30. The illustration shows wearable intravaginal
monitoring device 3151, 3153, 3155 that provides the female a
folding 3111, 3121 within the cap 3113, 3123, 3131 (that expands
only after insertion). The wearable (that can also be a
non-wearable) intravaginal monitoring device 3151, 3153, 3155
illustrations also show a telescopic stem 3115, 3125 and a finger
ring 3135 (to be able to insert and remove the intravaginal
monitoring device 3151, 3153, 3155--shown only in case of the
illustration 3155, that detaches upon proper placement). The
electronics that is part of the intravaginal monitoring device
3151, 3153, 3155 is not shown; nonetheless they are incorporated
within the cap 3113, 3123 and the stem 3115, 3125.
[0239] In one variant of the invention, the stem is totally within
the female body. It is appreciated that in this configuration,
there is little risk of accidental displacement of the device so
that is presses unintentionally up and into a woman's body in an
abnormal fashion. Moreover, when totally within the vaginal cavity,
it is not noticeable that the user is using the device and that the
device is harvesting data. In yet another variant, the device is
sized and dimensioned to be wholly contained, enclosed, or hidden
within the vaginal cavity so that the outside world does not know
the device is within the user. In a variant, a string may hang
outside the vagina to remind the user that the device is still
inserted.
[0240] This design of the current illustration of the intravaginal
monitoring device 3151, 3153, 3155 uses a telescopic bottom half of
the stem 3115, 3125 (that is hermetically sealed by screwing up the
bottom cap 3117, 3127), so that the entire intravaginal monitoring
device, as depicted in 3151, appears like a tampon. Upon insertion,
the intravaginal monitoring device 3151, 3153, 3155 opens up to
provide line of sight view of the outer surface of the cervix, to
the camera built in. The intravaginal monitoring device 3151, 3153,
3155 then can be used for short term or long period of time,
depending upon the needs. Moreover, other expansion schemes may
also be employed, for instance, a spring release cap, screw out cap
and so forth. Moreover, although not shown in the figures, note
that the bulb, cage or any other type folding for placement within
the insertion housing may also be employed. The intravaginal
monitoring device 3151, 3153, 3155 can also be non-wearable and
made of medical grade silicon rubber.
[0241] FIG. 32 is a schematic diagram illustrating a vaginal
channel 3213 and cervical regions 3217, 3221 of a woman's body
along with an intravaginal monitoring device 3291 to be inserted
into place; wherein the intravaginal monitoring device 3291 is
capable of guiding inside the optics cap 3271 to capture images of
large portions of vaginal channel 3213 and cervical regions 3217,
3221 that comprise a wide ranging variation in dimensions. The
current illustration depicts an introitus 3223 of a vaginal channel
3213, cervix 3221, outer surface 3217 of the cervix 3221, interior
3219 of a uterus 3207 in a normal orientation, fallopian tube 3211,
and ovary 3209. Also, depicted is an exemplary overlay of a tilted
uterus 3215. As can be appreciated, the cervical orientation
depends on, among other factors, the orientation of the uterus 3207
(or uterus 3215) under the various situations. Typical angular
orientations in relation to the axial direction 3295 of the vaginal
channel 3213 include normal orientations 3251 and tilted
orientations 3253. Wide ranging variations in the vaginal channel
3213 and the cervical regions 3217, 3221 are important factors in
design considerations of the Intravaginal Monitoring Device (IMD)
3291. Considerations include, for example, focal lengths, fields of
views, comfort and targeting with or without guidance
assistance.
[0242] Multiple studies show that variations in the vaginal channel
3213 and the cervical regions 3217, 3221 of a woman's reproductive
system involve: (a) length between the introitus 3213 and posterior
formix within the cervical regions 3217, 3221 (variations may range
up to sixty one percent); (b) length between the introitus 3213 and
anterior formix (may vary up to thirty seven percent); (c) size of
the introitus (variations may be up to sixty seven percent); (d)
straight line length between anterior to posterior formices (may
vary up to seventy two percent); (e) straight line widths between
lateral formices (variations may be up to sixty eight percent); and
(f) widths and heights of the vaginal channel 3213 (significant
variations typically exist through the entire length). In addition,
studies show significant variations across spectrum of women and
within the same woman that occur due, for example, to: (a) natural
orientation of uterus; (b) alignment of the vaginal channel 3213
during stages of pregnancy; (c) reorientation with full or empty
bladder; (d) retraction during arousal; and (e) relocation post
birthing (especially evident after cesarean procedures).
[0243] In addition to the abovementioned factors, an intravaginal
monitoring device 3291 should also account for cervical orientation
and insertion depth. Insertion depth of the intravaginal monitoring
device 3291 to the posterior formix may not be easy across the
spectrum of all women due to: (a) abnormal anatomical
configurations; (b) cervical impact being misinterpreted as the
posterior formix; (c) anterior formix being misinterpreted as the
anterior formix; or (d) insufficient nerve feedback of successful
positioning. Moreover, for some women based on their current
anatomical configurations, full insertion into the posterior formix
may not be optimal for capturing images and further information
about the cervix or other areas within the vaginal channel 3213.
For a variety of reasons, including abnormal anatomical
configurations and other reasons mentioned above, insertion by a
particular woman over time may involve insertion to differing
depths.
[0244] The cervical orientation may be referred to as an angular
measurement between the cervical plane & vaginal channel axis.
For example, if a cervical plane is parallel to a vaginal axis,
cervical orientation would be 0 degrees; a vaginal axis that is
normal to a cervical plane would have a cervical orientation of 90
degrees. The cervical orientation exhibits substantial variation
not only from woman to woman, but also within the same woman over
time (for example, changes occur during pregnancy, based on bladder
volume, in response to arousal, etc.). Vaginal axis is not usually
a straight line, but typically comprises a bend or two and
curvature between vaginal openings to the anterior formix,
complicating image capture.
[0245] In accordance with the present invention, the design
considerations of the intravaginal monitoring device's 3291 guiding
procedures, and optics attempt to address all these variations.
Such considerations are important whether the IMD comprises a "one
size fits all" design or several independent designs (with each of
the several designs being directed toward groups of women with
relatively similar anatomical configurations). Design
considerations also take into consideration the woman's comfort
involving characteristics such as stem flexibility, wear-ability,
stem length, overall stem and cap widths and curvatures, and cap
lengths and compressibility.
[0246] Although herein described with reference to human women, the
various IMD embodiments within the present application are equally
applicable to the reproductive systems of non-human female species.
In particular, the IMD 3291 employs a variety of techniques to
address the wide variance in reproductive systems usable for all
species. In particular, with reference to the human female, the
optics and guiding techniques of the IMD 3291 address at least some
of the anatomical variations of a female reproductive system. An
optics assembly 3277 may be adjusted to various positions within an
inner cavity of a cap or optics cap 3271. The optics assembly 3277
includes two imager assemblies 3273 and 3275 to cover a wider field
of view than would ordinarily be possible by using only a single
imager assembly. The angle of the imager assembly 3273 may also be
manually or electro-mechanically adjusted. For comfort and to
maintain rather optimal focal lengths, the optics cap 3271 is
relatively transparent, and can be made from a medical grade
compressible polymer material, e.g., a soft silicone rubber. Most
of these and other features and feature options not only
accommodate reproductive system variations but also support
comfortable, ease of use.
[0247] As previously mentioned, the optics assembly 3277 may
involve manual or electro-mechanical adjustment of both or either
of the telescopic optics assembly and the angle of the imager
assembly 3273. The electro-mechanical approach involves, for
example, the use of miniature piezo-electric actuators. Manual or
electro-mechanical rotation of the optics assembly around the axis
of the stem of the IMD 3291 may also be employed to address a
laterally oriented target such as a laterally situated cervix.
Control of the various actuators (controlling tilt, rotation and
depth within the optics cap 3271 can be controlled directly via an
interface placed on the IMD 3291, remotely by the user via a local
computing device, and other computing devices remote from the user.
Specifically, for example, such control might involve: (a) an
dedicated hand-held device in local communication with the IMD
3291; (b) a multipurpose device (such as a mobile phone, tablet
computer or laptop computer) in local communication with the IMD
3291; (c) a remotely located, dedicated or multipurpose device in
communication with the IMD 3291 via the Internet; (d) manual
interaction via a user interface placed on the IMD 3291 (e.g., a
button); or (e) via twisting, turning, adjusting insertion depth,
and otherwise manually manipulating the IMD 3291 directly and
without automation.
[0248] The imager assembly 3275 is adjustable in a mostly radial
direction 3297, while imager assembly 3273 is adjustable in a
mostly axial direction 3295. The images or video acquired from the
imager assemblies 3273, 3275 may be displayed one at a time in a
small or full screen window, or, if preferred, at the same time on
a remote or local display. For example, upon insertion of the IMD
3291 into the vaginal channel 3213, a first image/video produced
via the imager assembly 3273 may be displayed (or primarily
displayed) to support "gross" guidance of the IMD 3291 into
position. When in such gross position, a second image/video
produced via the imager assembly 3275 can be displayed (or become
the primary display) to fine tune targeting of a radially located
cervix. Primary display may involve replacing the first image/video
with the second, but may also involve placing both image/video on
the same display screen at the same time (perhaps even with an
overlay scheme). Alternatively, in one particular configuration,
the first and second image/video may also be stitched together to
gain a wide angle image that covers more than 150 degree view of
the outer surface of the cervix 3217. Three dimensional
imaging/video can also be constructed therefrom.
[0249] For instance, a woman who purchases and adjusts the optics
assembly of an intravaginal monitoring device 3291 to fit her
present anatomy (possibly with the assistance of a health care
professional) may continue to use the imager (with perhaps minor
adjustment over the course of pregnancy) using guidance techniques
provided by the IMD 3291 and perhaps an external hand-held device.
Adjustment is possible in the aforementioned ways, such as via the
manually controlled or actuator controlled telescoping, rotation or
angular adjustments of and within the optics assembly 3277. Even
the optics cap 3271 can be replaced to adjust focal lengths or
comfort as the area near the cervix 3217 changes.
[0250] The FIGS. 33a, 33b, 33c, 33d, 33e, 33f and 33h depict
individual parts and steps of constructing an intravaginal
monitoring device such as that of the FIG. 33g. In particular, an
optics assembly 3329 (FIG. 33g) consists of a telescopic stem 3311
(FIG. 33a) that has been cut to support a mounting arrangement as
shown in FIG. 33b (e.g., a telescopic stem portion 3315 of a width
3365 sized to fit within the housing stem 3331). A platform portion
3313 can be folded and manually adjust and readjusted, see folded
platform 3319 of FIG. 33c, to support a desired radial mounting
angle for an imager assembly 3321 of FIG. 33d. The axial mounting
involves fixing an imager assembly 3323 within a telescopic stem
3325 as shown in FIG. 33d. The optics system 3329 can be adjusted
by manually positioning the depth of the telescopic stem within the
housing stem 3331 and through clockwise or counterclockwise
rotation.
[0251] In an alternate embodiment, the telescopic stem 3328 can be
extended and configured for rotation mechanically by a user via the
end cap 3333. Similarly, mechanical constructs (not shown) are
contemplated to support pivoting of the axially mounted imager
assembly. Such configurations would eliminate the need to remove
the optics cap to gain access to and adjust the optics assembly
orientation.
[0252] Among other details, the illustration also shows, an optics
cap 3335 depicted in the FIG. 33e that is, in this embodiment,
shaped irregularly with a bulge on one side so as to maximize focal
length to the cervical area while taking advantage of natural
elasticity associated with the region of the vaginal channel
opposite the cervical surface. Typical dimensions 3351 and 3353 of
the outer cap 3335 can typically be 36 mm and 28 mm to serve a
variety of types of women's reproductive systems and the specific
underlying optics assembly requirements.
[0253] A battery compartment 3399 contains batteries that are
rechargeable or disposable. One or more buttons or other user input
devices may be placed on the IMD. For example, a power button is
illustrated as being located on the bottom of an end cap 3395. The
location of field of views 3373, 3375 of the axially and radially
located imager assemblies are adjusted to minimize one imager
assembly's image capture of the other to prevent having to crop or
present a perhaps distracting element within each image/video
stream captured. Lastly, although only two imager assemblies are
shown, many more are contemplated so as to provide full or partial
3D coverage of the vaginal space. Such multiple images and video
streams can be presented independently or via a 3D merged image
(video) viewing environment.
[0254] FIGS. 34a-e are schematic diagrams illustrating construction
of two embodiments of an intravaginal monitoring device along with
typical dimensions, thereof, and having controllable optical
systems built therein accordance with and to illustrate several
aspects of the present invention. In each embodiment, the
intravaginal monitoring devices use electrically powered actuators
(such as miniature piezo actuators) to support the tailoring of an
IMD to attempt to comfortably conform to dimensions and
orientations of a specific user's reproductive system. In the IMD
of FIG. 34a, in addition to electro-mechanical control, fully
mechanical tailoring of some parts of the optical system is also
shown.
[0255] In both of the IMDs of FIGS. 34a and 34b, the optics systems
can not only be controlled prior to insertion, but also during the
insertion process and when fully inserted. As mentioned before,
such control and tailoring of the optics system to fit a current
user is one purpose of the electro-mechanical and mechanical
enhancements. Another is to provide a mechanism for panning,
zooming, framing, and otherwise exploring a target area. All of
these goals are easily accommodated with electro-mechanical and
some mechanical adjustment mechanisms. Specifically, in FIG. 34a, a
piezo actuator 3413 controls the angle of a pivoting imager
assembly 3411. Beyond "tailoring," such pivot control can also be
used, for example, to assist in the guidance of an IMD 3417 into
position to target a cervix, and to pan, zoom, frame during
insertion and at the insertion destination. All imager assemblies
described throughout this application at a minimum contain an
imager, such as, for example, CCD (Charge Coupled Device) or CMOS
(Complementary Metal Oxide Semiconductor) varieties. Any other type
of imager may be used which captures images and in some cases video
are contemplated. In addition, such imagers need not operate in the
visible optics range. For example, ultraviolet, infrared or other
frequency electromagnetic wave imagers could be employed. Imager
assemblies as described herein may also include one or more light
(or other frequency) sources, a housing (supporting an optical
pathway), lensing, apertures, filters, polarizers, and auto-focus
and auto-zoom mechanism. Other imager assemblies mentioned
throughout the present application may be similarly constructed.
Moreover, throughout this disclosure one or dual imager assemblies
are used in each embodiment presented. Adding further imager
assemblies, although not shown, is contemplated. All imagers
underlying the imager assemblies herein are capable of capture
still images (i.e., "snap shots"), video streams, or both.
[0256] A telescopic stem 3415 may be manually adjusted to
accommodate both an optimal radial angle in relation to a power
button 3419 (via depth adjustments via threading or tension), and
the depth at which the optics assembly fits within an optics cap
(shown in FIG. 34c). It can also be adjusted through rotation of
the telescopic stem 3415 to accommodate off center or tilted
image/video capture targets. The IMD also uses a flexible stem 3417
(made of a for example silicone rubber) that contains the circuitry
and power storage elements (e.g., batteries). A bottom cap 3421 may
also screw on or off to at least partially hermetically seal or
expose or gain access to electrical or optical connectors,
batteries, circuitry, etc. Although only a power button 3419 is
illustrated, a much more substantial user interface including a
display is contemplated for some embodiments.
[0257] A typical example of a procedure for tailoring, guiding and
targeting with the IMD of FIG. 34a might first involve a doctor's
measurement of a particular patient's reproductive system.
Thereafter, with or without such information, the doctor or such
patient might tailor (adjust) the optics assembly to fit the
patient. That is, the doctor or patient may: a) manually adjust the
depth of the telescopic stem 3415 within the flexible stem 3417; b)
manually adjust (via optical assembly rotation) the pivoting plane
with reference to the radial location of the power button 3419; c)
select and install a particular one of several sizes and shapes of
optics caps (such as the optics cap 3435 of FIG. 34c); d) insert
the device with guidance support via an externally viewable
display; e) further adjust the angle of the imager assembly during
insertion and upon after reaching the target insertion location;
and f) remove and readjust the telescopic stem via rotation or
insertion extent into the flexible stem 3417 if necessary. The
adjustment of the angle of the imager assembly 3411 via the piezo
actuator 3413 may not only involve tailoring, but also supports
dynamic viewing along with zoom, pan, and framing desires and
capabilities of inherent in the imager assembly 3411.
[0258] Guidance support might involve for example using the
illustrated axial orientation of the imager assembly 3411 during
the insertion process to deliver a streaming video feed to an
external viewing screen (not shown) through which guidance and
initial positioning can be monitored. Through such screen, a user
can determine when the target insertion location has been reached.
They can also then control, via an external user input device, the
piezo actuator 3413 create a radial angle orientation to support
image and video capture of a radially located cervix or artifact.
Radial viewing might also be used during the insertion process to
better examine vaginal channel walls prior to reaching the target
insertion location.
[0259] In FIG. 34b, similar operation can be found with the
addition of further electro-mechanical elements that may support
control before and after insertion and from external and remote
devices. In addition to the electro-mechanical pivoting control of
the IMD in FIG. 34a, the IMD of FIG. 34b is configured with
automated telescoping and rotation. In particular, an imager
assembly 3423 is mounted such that a piezo actuator 3425 can direct
the imager assembly 3423 through a wide range of radial angles such
as that shown, and including a fully axial position (0 degrees as
shown in FIG. 34a). An actuator 3426 is used to not only control
the extension of a telescopic stem 3427 into an optics cap, but
also controls the rotational position of the pivot plane of the
imager assembly 3423 in relation to the power button 3431.
[0260] Specifically, the base of the actuator 3426 is inserted and
affixed to the inner wall of a housing stem 3429. The top end of a
threaded (or ratcheted) post element of the actuator 3426 connects
to the telescopic stem 3427 for raising, lowering, and seeking
rotational alignment locations for the entire optical assembly.
With this configuration and whether or not fully or partially
inserted, using an external display and user interface, the IMD of
FIG. 34b can be fully adjusted to assist in insertion guidance,
zooming, panning, framing, and tracking interesting intravaginal
targets. Depending on the embodiments, a user interface interacting
with the IMD's of FIGS. 34a-b might only support direct and
simplistic control commands such as clock-wise/counter clock-wise
rotation, in-out telescoping, and up-down pivoting. Other
embodiments also support actual angles of rotation and pivoting,
and millimeter based telescoping positions with full "go to"
functionality. Control may also involve any other three dimensional
coordinate relocation as well, and, in any configuration, smooth or
fixed movement increments at course and fine tuning speeds are
employed. Moreover, the approaches to integrate electro-mechanical
and mechanical adjustment techniques underlying the optics
assemblies are merely exemplary as many other approaches and
configurations are possible and contemplated.
[0261] Any IMD in accordance with aspects of the present invention
can be built using various fully or partially automatic and/or
manual techniques for best positioning elements thereof in any or
all of three dimensions. As illustrated, such positioning elements
comprise imager assembly and entire optics systems, but other IMD
elements such as other sensors, emitters, drug or fluid delivery or
fluid sampling systems that are integrated within an IMD may also
benefit from the up to three dimensional mechanical or
electro-mechanically driven repositioning systems shown throughout
the figures. Thus, all positioning techniques described herein can
be used along with guidance techniques and feedback from imagers or
any IMD element to assist in its underlying function.
[0262] Manual control can be asserted directly by whomever inserts
the IMD (depth, angles, torque, rotation, etc.) and by the woman's
repositioning of her own body which also effects reproductive
system dimensioning. Automatic positioning control over sensors
such as an imager assembly, can be made via buttons placed on the
IMD itself and monitoring of positioning feedback may be collected
via a display disposed on the IMD housing. Positioning control may
also be managed via a tethered or wireless link by a local
computing device such as a cell phone, tablet computer or laptop.
Remote positioning control may also be carried out via a longer
distance link such as a wireless cellular network or Internet link
to a remote computing device. The remote computing device may also
be a phone, tablet computing device, server, or workstation
computer through a doctor's or staffs interaction to analyze and
diagnose a remotely inserted IMD.
[0263] Positioning of an optical assembly may also be used to
assist in focusing, zooming or otherwise maintaining an adequate
focal length to a target such as the cervix or opening of the
cervical channel, or some other a gynecological event, artifact or
condition. Positioning of other elements of an IMD to assist in
their underlying functions is also contemplated as mentioned above
for much of the same reasons. Such latter positioning may be
carried out via integration with the former position mechanisms or
via separate positioning constructs. For example, further sensors
could be attached to a pivoting image assembly and benefit by
sharing such pivot even though such sensors have alternate targets
than the imager assembly and so the pivoting function could be
time-shared. As an alternative, a separate pivoting platform under
control via a further actuator would allow simultaneous operation
although at the expense of extra materials and volume--which
overall should be kept to a minimum for comfort, fitting and other
reasons enumerated above.
[0264] In FIG. 34c, among other details, the illustration shows a
specific one of a plurality of types and sizes of optics caps,
e.g., the optics cap 3435. By being made of a somewhat flexible
material such as medical grade, silicone rubber, the optics cap
3435 may conform to sliding over optics assemblies while
maintaining a hermetic seal with either or both of the telescopic
stems 3415, 3427 or the housing stems 3417, 3429. Such hermetic
seal may involve merely elastic tension associated with the
diameters of the housing 3417, 3429 versus that of the optics cap
3435. Such hermetic seal may be improved with a bonding agent or
glue and/or a mechanical constraint such as ribbing or threading.
End caps 3421, 3441 may similarly be attached using tension or with
threading and/or other mechanical constraints (e.g., a grommet 3439
of FIG. 34e or glue) to at least provide partial hermetic
sealing.
[0265] In one embodiment, the dimensions 3451, 3455, 3457, 3459,
3461, 3463 and 3465 are such that the intravaginal monitoring
device is able to accommodate the inner electronics appropriately,
while attempting to support comfortable insertion, positioning, and
maneuverability for a relatively large percentage of women. For
example, the dimensions 3451, 3455, 3457, 3459, 3461, 3463 and 3465
are approximately 235 mm, 16 mm, 25 mm, 16 mm, 35 mm, 15 mm and 10
mm respectively, though the dimensions may vary to accommodate
other goals such as fitting within a small carrying case or purse,
fully wearable versions, permanently tethered versions, versions
supporting groups of females with different reproductive system
profiles, to accommodate additional sensors or feature
functionality, etc.
[0266] FIGS. 35a-d are perspective diagrams illustrating further
details regarding the adjustable optics assembly of FIGS. 9a-b that
supports two imager assemblies. Space is at a premium within optics
caps. Initially, such cap sizes take into account the need function
of spreading the tissues in the target insertion zone so that
adequate illumination and image capture can take place. Small form
factor on the other hand is a desire for insertion comfort reasons.
An optics cap length can also be shortened or lengthened to
accommodate targets such as the cervix which may be axially located
very close to the vaginal orifice or, alternatively, at the back of
the vaginal channel. Overall cap size must also take into account
focal lengths, imager and mounting assembly sizes, etc.
[0267] In FIG. 35a, a standard, side-by-side arrangement of two
imager assemblies 3513 and 3515 is shown. Through manual or
electro-mechanical control, a stem 3517 can be rotated and
elevated, and a mounting platform 3511 can be pivoted. FIG. 35b
illustrates that a rivet 3520 or other tension based interconnect
between imager assemblies 3519, 3521 may further permit an angular
adjustment between the two imager assemblies 3519, 3521. To save
space yet sacrifice such angular adjustment, FIG. 35c illustrates
overlapping cavities of imager assemblies 3523, 3525 to a level
that does not cause interference with each optical path. Fully
overlapping cavities are also possible yet not shown. In FIG. 35d,
although imager assemblies 3527, 3529 appear to be connected, they
are merely co-located with separate mounting platforms and separate
actuators to provide separate pivot control for each.
[0268] FIG. 36 is a perspective and cross-section diagram
illustrating a wearable snake-like intravaginal treatment device
(ITD) inserted into the cervical channel for capturing imager data,
delivering light treatment, and wirelessly communicating to deliver
such imager data and, in some embodiments, to receive control
signals, e.g., regarding treatment delivery. The ITD 3609 is
intravaginally inserted through the vaginal channel while operating
to capture and display imager data in real time on supporting
devices. Guidance into the cervical channel and beyond is greatly
assisted by such real time imaging.
[0269] In particular, the snake-like portion of the ITD 3609, a
segmented section 3607 along with the head end portion 3613, as
illustrated is routed into a uterus 3611. A much larger portion
relative to the snake-like portion, i.e., a base 3621, includes at
least a majority of underlying circuitry and batteries. The base is
remains inserted into the cervical channel for light (and, if so
configured, with fluid) therapy deliveries, as well as imager data
capture support, preprocessing and storage. Via wireless
infrastructure, while within the intravaginal regions, the ITD 3609
communicatively couples with external devices. Such coupling
involves both the exchange of such imager data as well as any other
sensor data captures, and the exchange of control signals relating
thereto.
[0270] As such, the segmented section 3607 is designed to be
flexible enough to be guided along curvilinear intravaginal
channels within the reproductive system 3601. In addition, on the
tail-end of the ITD 3609, a finger ring 3615 provides finger grip
that assists in insertion, removal and stabilization during wear.
The base 3621 of the ITD 3609 may be configured for relatively
simplistic or advanced modes of operation, with corresponding
functional components and circuits built inside. For example,
within the base 3621, signal processing, communication interface,
sensor, battery power and user interface circuitry and associated
components can be found. The cylindrical base 3621, if so
configured, also contains a fluid reservoir and pump that injects
fluids via the segmented section 3607 and nozzles mounted in the
head end portion 3613.
[0271] Herein, often referenced throughout the present application,
the female reproductive system of humans can be found. Even so, the
present invention and various aspects thereof can be found in ITDs
and associated supporting devices and networks designed to service
any other species.
[0272] FIG. 37a illustrates a snake like ITD 3701 with a segmented
stem 3707 carrying an imager assembly at the head end. The segments
3705 of the stem 3707 makes the ITD of 3701 very flexible. The
components of the ITD 3701 are mounted such that they conform to
the bending of the stem 3707. A plurality of light source emitters
3717 of the imager assembly 3709 provide illumination and therapy
lighting. The imager assembly also contains lensing 3715 and an
underlying imager (not shown). The emitters 3717 are LEDs
specifically chosen for their illumination or therapeutic
performance, e.g., IR, UV, blue, red, and other monochromatic or
polychromatic light. Alternatively, some or all of the emitters
3717 may merely comprise optical fiber and dispersion lensing, and
wherein such fiber is routed along side of or within the stem 3707
to a lower portion of the ITD 3701 (not shown). Particular light
sources of the emitters 3717 can be selected depending upon the
requirement. For example, to treat a certain infection, perhaps
blue LED's might be turned on continuously, while illumination for
image capture occurs once per hour for a snap shot session, and all
the while with an infrared LED turned off. The imager assembly 3709
communicates with associated circuitry in a supporting portion of
the ITD 3701 (not shown) via wired cabling running within the stem
3707. Such other portion may also be inserted at least in part into
the vaginal channel or remain entirely outside thereof. Some
circuitry in addition to the present imager may also be embedded in
or near the imager assembly 3709.
[0273] In FIG. 37b, a fluid delivery system has been piggybacked
onto an ITD 301 which, other than the fluid delivery components, is
identical to the ITD 3701 (FIG. 37b). In particular, a fluid
delivery head 3723 has a plurality of nozzles 3719 for various
fluids to areas within and beyond a vaginal channel via a tube
3721. Such fluids include cleaning solutions and various solutions
containing drugs, dyes, bio-markers, or other pharmacological,
biological or biochemical fluids. In some embodiments, the tube
3721 routes inside a segmented stem 3727, but in the present
embodiment, it runs alongside (and may be affixed to) the segmented
stem 3707. The tube 3721 is connected to the nozzle fluid delivery
head 3723 on one end, and to fluid reservoirs and a pumping
mechanism on the other. The pumping mechanism can be a manual
mechanism such as a squeeze ball or syringe. Alternatively, such
pumping mechanism can be electro-mechanical, comprising a fluid
pump. A fluid pump responds to control signaling by deliver all or
a fixed amount of the fluid within a reservoir through the tube
3721 and out the plurality of nozzles 3719. The pumping pressure
can also be adjusted via such control signaling.
[0274] Such pump control signaling can be generated directly via
direct interaction with a supporting user interface by the patient,
doctor, or other assistants located locally or remotely.
Alternatively, pump control signaling can be automatically produced
according to preprogrammed settings. Such settings might define
parameters for and invoke one or more of: (i) scheduled one time
delivery; (ii) periodic repeating deliveries per schedule; (iii)
series of unrelated deliveries per schedule; (iv) slow, continuous
"drip" delivery; (v) fluid volume per delivery; and (vi) type of
fluid (where multiple fluid reservoirs and supporting pumping
arrangements are available). For example, via a setup screen
associated with a wearable ITD, 10 ml of a first type of fluid
might be automatically delivered at a rate of 1 ml per second, once
per hour for three days. Alternatively through such setup screen,
beginning at midnight, a 30 ml of a first cleaning fluid is
delivered at a 3 ml per second rate, followed 30 minutes thereafter
by delivery of a second fluid in a continuous, 3 hour "drip."
[0275] Fluid delivery may also automatically initiate in response
to detected conditions. For example, via a setup screen, pump
initiation of fluid delivery may be tied to sensor data. If for
example, a pH sensor determines that the acidity level is beyond a
desired threshold, a pump control signal can be delivered which
causes the pump to deliver one or more quantities of a pH balancing
fluid at once or over multiple delivery events. Similarly, upon
determining natural yeast particulates above a threshold as
identified from periodic images captures, such and other types of
fluids might be similarly automatically delivered. Likewise via
other settings, upon the ITD 3701's detecting an onset of
ovulation, fluid containing concentrations of spermatozoa could be
dispensed every fifteen minutes while a patient sleeps at night.
Such detection could involve an analysis of imager data while the
ITD 3701 is being worn, and the fluid delivery triggering could
occur only when such event is detected and associated timing is
met. Confirmation of timing such as during nighttime sleep is
accomplished via one or more of clock circuitry and orientation
and/or motion sensors disposed within the ITD).
[0276] Basically, output of any one or more sensors (including
imagers) can be analyzed within an ITD or outside thereof (on
supporting computing systems) to determine whether thresholds have
been exceeded or a condition or event has occurred. Such analyses
may yield pump control signals automatically or via confirmation by
the patient or supporting medical staff. Moreover, such sensor data
analysis may be completely performed by: (i) the ITD's and/or
supporting system's software and hardware; (ii) the patient or
supporting medical staff; or (iii) a both of the above working
together.
[0277] Similarly, decisions regarding light therapy can be made via
the same setup procedures and using the same infrastructures. In
fact, light therapy and fluid delivery procedures can be
intertwined into an overall therapy approach. Light therapy
signaling to the one or more light therapy sources of the plurality
of light source emitters 3717 can also be generated directly via
direct interaction with a supporting user interface by the patient,
doctor, or other assistants located locally or remotely, and in a
manner similar to that of the pump control signaling.
Alternatively, as with the pump control signaling, the light
therapy signaling can be automatically produced according to
preprogrammed settings. Such settings might define parameters for
and invoke one or more of: (i) scheduled one time delivery; (ii)
periodic repeating deliveries per schedule; (iii) series of
unrelated deliveries per schedule; (iv) continuous delivery; (v)
power intensity per delivery; and (vi) type or types of light being
delivered.
[0278] Also as with fluid delivery, events or conditions detected
(via various types of on board sensors) can (alone or with patient
or medical staff assistance, initiation or confirmation) trigger
one or more of the aforementioned preprogrammed settings. For
example, based on colorization changes (via image data analysis)
and pH level variations, automatically and without requirement of
confirmation, a first preprogrammed cleansing wash process
triggers, followed immediately thereafter by both a continuous red
light therapy and a short duration UV therapy process, wherein both
light therapy processes are defined via preprogrammed settings.
Many other types of triggering events with automatic and/or manual
causation and intermixed sequential and/or parallel fluid and light
therapy regimes are contemplated. For example, some fluids may be
delivered for causing responses that are emphasized or fully
activate when exposed to light, and thus the resulting performance
requires a controlled overall procedure manageable by the ITD,
patient or medical staff, and/or supporting systems.
[0279] FIG. 38 is a perspective diagram illustrating a fluid
delivery embodiment for an intravaginal treatment device (ITD) with
a fluid nozzle and an imager and light source assembly, both
disposed within a cervical cap, that selectively delivery fluids
and light therapies, respectively, and with a squeeze ball and tube
for controlling manual fluid injection via the nozzle. Therein, an
ITD 3801 has a cervical cap 3811 covering an imager assembly 3809
and fluid nozzles 3817 at a head end (or anterior end of the ITD
3801), and has a squeeze ball 3803 at the tail end (or posterior
end of the ITD 3801).
[0280] A silicone rubber tube 3805 may be detached from a housing
stem 3803 of the ITD 3801 for convenience when the fluid system is
not being used or during the process of cleaning and filling the
squeeze ball 3803 with fluids. Although a squeeze ball 3803 is
illustrated, other shapes and manual injections configurations such
as a syringe may replace the squeeze ball 3803 temporarily or
permanently. That is, a variety of types of injection mechanisms,
some purely mechanical and some electro-mechanical can replace (for
all or some types of fluid deliveries) the squeeze ball 3803 and
the tube 3805, if needed. A fluid nozzle assembly 3819 has the
fluid nozzles 3817 disposed thereon. The fluid nozzle assembly 3819
provides a fluid pathway to the fluid nozzles 3817 and there
through to a target area with a vaginal channel such as a cervical
area. In other words, when the squeeze ball 3803 is squeezed, fluid
will be forced from the interior of the squeeze ball 3803 and, in
sequence, through the tube 3805, an internal pathway 3821 within
the housing stem 3807, the assembly 3819, and, finally, through the
nozzles 3817.
[0281] The cervical cap 3811 is sized to cover (and perhaps even
contain portions of) a cervix. With illuminators for the imager,
light sources for therapy, and nozzles for fluid delivery being
disposed within the cervical cap 3811, a more controlled treatment
environment within the cervical region can be maintained. More
specifically, along with the fluid nozzle assembly 3819, the imager
assembly 3809 can is disposed within the cervical cap 3811. As
illustrated in detail with reference to various other figures
herein, the imager assembly contains a imager, lensing and a
housing with illuminating white light supporting imager data
capture (images and/or video data) as well as various therapeutic
light sources. Although integrated into the housing as illustrated,
all or some of such light sources may be disposed at other
locations within the ITD 3801. As can be seen, the fluid nozzles
3817 are designed for delivery of fluids to at least partially
encompass the imager's field of view. In other words, fluids
injected should contact at least part the target area being (or to
be) imaged. Additionally, an extra nozzle can be added that targets
the head end of the imager assembly so that cleaning thereof can be
carried out without having to remove the ITD 3801 once it has been
inserted and in operation.
[0282] The squeeze ball 3803 can also be used to deliver fluid
during the insertion or the removal process so as to coat the
entire vaginal channel. Likewise, when only partially inserted,
fluid deliver can be invoked to, for example, target a specific
artifact at a particular location perhaps midway into the vaginal
channel that is not cervix related. The size and angle of the
cervical cap 3811 can be changed by merely selecting and installing
an alternate one of a plurality of differing sized and oriented
counterpart cervical caps (not shown). The cervical cap can be made
of any bio-compatible material such as soft, medical-grade silicone
rubber. It may also comprise a reflective inner surface 3815 to
assist in the illumination and light therapy process.
[0283] FIG. 39 is a perspective diagram illustrating another
embodiment of an intravaginal treatment device (ITD) having a
built-in fluid reservoir, pump, a fluid nozzle and dual imager and
light source assemblies, and built in accordance with various
aspects of the present invention, to capture imager data and
deliver fluid and light source therapy. Therein, an ITD 3901 has a
fluid reservoir and pumping system 3905 disposed with a housing
stem 3919. Because a cap 3903 fully encloses an optics assembly
3917, fluid nozzles 3909 are disposed on the outside surface of the
cap 3903 and aimed in a typical direction where a cervix may be
found, which differs greatly from female to female.
[0284] As can be appreciated, the target of the nozzles 3909 and a
mostly radial imager assembly 3913 have at least substantial
overlap. Thus, the nozzles 3909 are provided to mostly service the
area of the interest to the mostly radial imager assembly 3913 and
not that of a mostly (if not fully) axial imager assembly 3911. An
additional nozzle set servicing the imager assembly 3911 could be
added at a different location on the cap 3903 with service from the
fluid reservoir and pumping system 3905 or an independent
counterpart thereof, if so desired.
[0285] As in other embodiments, the size and shape of the cap 3903
can be changed by merely replacing the cap 3903 with another and
reattaching the new fluid nozzles to a fluid carrying pipe 3907.
Although the fluid reservoir and pumping system 3905 as illustrated
only contains a single fluid reservoir, multiple reservoir chambers
can be added and serviced by one or more pumps for delivering a
corresponding multiple types of fluids. The ITD 3901 may comprise a
wearable ITD (with a relatively short version of the housing stem
3919) or have a hand maneuverable length (i.e., with a relatively
long version of the housing stem 3919) that can be grasped even
when the ITD 3901 is fully inserted. Triggering of light and fluid
therapy approaches are identical to that discussed in relation to
the ITD of FIG. 38. For example, the fluid injection process may be
triggered after automatically detecting a condition that is
confirmed remotely by a doctor at a certain hour of the day during
the generation of video and with before and after images. A
preprogrammed process associated with the above triggering might be
terminated mid sequence upon determining that enough fluid has
reached the target. That is, process initiation might not only be
started (triggered) by conditions or events detected (by sensor
data analysis by the ITD, associated support systems and/or staff)
but may be stopped due to identification of the lack of such
condition or event or yet another condition or event entirely.
Moreover, with a real time video feed from the imager 3913 (for
example) along with twisting, torquing and adjusting insertion
depth of the ITD 3901, a patient or medical staff can direct the
delivery of fluid to more accurately and effectively hit a target.
The aforementioned applies equally to directing the light therapy
emitters within the imager assemblies 3911, 3913 as well.
[0286] As mentioned before, fluids that may be delivered include
almost any hopefully non-toxic and beneficial solutions such as:
(i) drug suspensions; (ii) pH balancing and other cleaners; (iii)
anti-coagulants; (iii) birth control (including "morning after")
suspensions; (iv) anti-bacterial, anti-viral or anti-fungal
solutions; (v) preparatory solutions to assist any ITD sensor
(optical or otherwise) such as those including acids, dyes,
markers, conductive materials, etc.; and (vi) preparatory or
enhancing solutions to assist the light therapy process such as
with solutions containing selective binding agents having light
activated responses.
[0287] In addition, although only light sensing imager arrays
(sensors) that are contained within the imager assemblies 3911,
3913 are illustrated, the ITD 3901 can be fitted with a wide
variety of additional sensors. Such other sensors can benefit from
various types of fluids as mentioned above. In addition, they can
be fully responsive to reflections from the light therapy sources
directly. For example, if an ultraviolet (UV) light emitter might
be used to provide a particular therapy via (i) direct tissue
interaction (ii) activation resulting from a delivered fluid, or
(iii) direct interaction with viral, bacterial or fungal
constructs. In addition, reflections of such UV lighting may also
be detected by a sensor (such as an imager array) that is tuned to
sense UV frequencies, and which produces imager data (images and
video) that can be translated into the visible range for viewing by
patients and medical staff in real time or reviewed post facto.
[0288] FIG. 40 is a perspective diagram of an embodiment of an
optics assembly having a stem, mounting structures and two mounted
imager and light source assemblies that may be used in some
embodiments of an intravaginal treatment device (ITD) in accordance
with the present invention to delivery light therapy and capture
imager data. In particular, an optics assembly 4001 contains a
radial imager assembly 4007 (containing a mostly-radial oriented
imager 4006) and the axial imager assembly 4015 (containing a
mostly-axial oriented imager--not shown). The imager assemblies
4007 and 4015 are attached to a mounting structure 4003 of optics
assembly 4041. The optics assembly 4041 can be moved in an axial
direction 4039 and a rotational direction 4037.
[0289] To increase focal distance in a mostly radial direction, the
radial imager assembly 4007 is mounted slightly off center and upon
a flexible portion 4005 of the mounting structure 4003. The imager
assembly 4007, in addition to the imager 4006, has a lensing system
4027, a plurality of light therapy sources capable of emitting
light at any specified one or more frequencies, i.e., via an IR
light source 4023, UV light source 4025, monochromatic blue light
source 4019, and monochromatic red light source 4021. The light
therapy sources 4019, 4021, 4023 and 4025 are switched off or on at
various power levels or duty cycles pursuant to local or remote
control. In addition to continuous emission and fixed power levels,
active and continuously power level variations (or other modulation
techniques) over time may be employed to provide better therapeutic
results.
[0290] The axial imager assembly 4015 is mounted slightly off
center of the cylindrical base 4003 to allow mounting space for the
radial imager assembly 4007. The axial imager assembly 4015 is
attached to a flexible vertical portion 4017 of the mounting
structure 4003. The axial imager assembly 4015 also has lensing
4013 (supporting the underlying imager) and a plurality of light
therapy sources mounted thereon, including: an IR light source
4011; UV light source 4013; blue light source 4033; and red light
source 4029. Power, power level and duty cycle control as with the
light therapy sources of the imager assembly 4007, can be fully
controlled by internal processing circuitry, devices outside of the
ITD, or by a combination of both.
[0291] Light source illuminators supporting image data capture by
the imagers within the imager assemblies 4007 and 4015 are not
shown but may also be incorporated into the imager assemblies 4007
and 4015 or into either another location within the optical
assembly 4001 or at some other location within an ITD that includes
such optical assembly 4001. Light source illuminators and their
corresponding imagers may be selected or tuned to operate in any
electromagnetic wave frequency including in the white light range.
The radial imager assembly 4007 can be moved in the direction
indicated by the arrow 4035 by perhaps .+-.20.degree. to fit a
particular female's anatomy. Similar adjustments may be made to the
axial imager assembly 4015. The complete optics assembly 4041 can
be axially moved along the direction of a stem of an ITD, or
rotated for better alignment as illustrated by arrow 4037.
[0292] FIG. 41 is a schematic block diagram illustrating exemplary
components and circuitry that may be found in whole or in part
within the many embodiments of an intravaginal treatment device
(ITD) of the ITDs set forth herein and built in accordance with and
to illustrate various aspects of the present invention. In
particular, circuitry 4101 includes an interface and control
circuitry 4107 which arbitrates and prioritizes data acquisition
and transmission to and from various ITD components and supporting
devices and systems outside of the ITD.
[0293] For example, the interface and control circuitry 4107
directs the capture of imager data via control signals delivered to
imager devices 4103 and retrieves resultant captured imager data
therefrom. The circuitry 4107 may store such image data locally
within a memory 4109 and/or route to devices outside of the IDT via
wired and/or wireless communcation interfaces 4119 and 4121. The
circuitry 4107 is responsive to incoming commands and controls via
the communication interfaces 4119 and 4121 as well. Such commands
and control are translated by circuitry 4107 into sequences of
digital control signals delivered to various underlying components
to carry out the specified functionality, e.g., activation selected
ones of the imager devices 4103 and providing illumination
therefor, activating fluid pump 4123, delivering stored information
via the wireless communication interface 4121, etc.
[0294] Other activities of the circuitry 4107 include activation,
retrieval, storage and forwarding of other sensor data from a
microphone 4115 and supplemental sensors such as orientation and
motion indicators, fluid level indicators (fluid reservoir), pH
sensors, thermometers, sonigrams, EKGs, and a variety of other
bio-sensors, for example. Sensor data retrieved may also be
processed or preprocessed by the circuitry 4107 in preparation for
display or analysis. If so, even further, automatic analysis could
lead to conclusions all possibly performed by the circuitry 4107 or
by an external support device. The circuitry 4107 also manages
directly (or indirectly via remote control) the application of
light and fluid therapies.
[0295] Each of the imager devices 4103 responds to control signals
to capture and forward imager data. The imager assembly 4103 may
contain one or more of a monochromatic light sensitive imager 4131,
a UV light source sensitive imager 4133, an IR light sensitive
imager 4135, MRI (magnetic resonance imaging) imager 4137 and other
source sensitive imagers 4151, such as sonogram imaging elements
(not shown) or a select frequency of light that reveals venous
growth to provides an early indication of potential cancerous cell
activity.
[0296] The light therapy block 4105 indicates a various selection
of light sources that may be employed to treat a wide spectrum of
conditions within a female reproductive organ. The UV source 4139
may be used for example to kill bacteria which respond to a
specific frequency or frequencies in the UV spectrum. A red light
source 4141 may be used to illuminate lesions, abrasions and cuts,
by inducing tissue healing. A blues light source 4143 may be used
against bacteria or virus infected tissues. The other light sources
4145 pertain to any therapy that involves light energy such as
X-rays, laser, IR light, etc.
[0297] The internal light sources 4149 are the sources of light of
specific frequencies and frequency ranges housed within an ITD of
the present invention. An external light source 4147 are those
light sources located outside of the ITD that produce light
conveyed via fiber optics into the optics assembly of the ITD for
imaging (illumination) and light treatment. As mentioned, the
supplemental sensors 4113 are any of a variety of sensors that may
be included in a particular ITD, e.g., bio-sensors, thermal
sensors, pressure sensors, glucose sensors, IR sensors, position
sensor, velocity sensors, gene chips, etc. The microphone 4115 is
an audio range sensor that can be used to capture fetal or female
heart rate(s), movement, etc.
[0298] The user interface 4117 may be fairly simplistic and
comprise only a power button and relying on external support
devices for more complex input and display interaction.
Alternatively, an ITD can be configured with a more complex input
device and display supporting vastly superior interaction, and
perhaps without the need for a supporting external device to
operate and even display internally generated data or conclusions.
For example, a user can inject fluids using injection syringe or
squeeze ball (discussed in FIG. 5) or automatically direct such
functionality via internal pumps and reservoirs via the user
interface(s) 4117. Such user could be the patient, doctor, medical
assistants, etc.
[0299] The wired communication interface 4119, if present, may
utilize proprietary and industry standard communication protocols
compatible with external support devices, e.g., USB, firewire,
ethernet, etc. Similarly, if present, the wireless communication
interface 4121 may also offer proprietary and industry standard
communication, such as Bluetooth, Zig-bee, or Wi-Fi. A fluid pump
4123 associated with a fluid reservoir 4125 may contain any number
of fluids as described in detail relating to the preceding figures.
The power regulator unit 4111 manages power delivery to ITD
components and circuitry. Depending on the construct, power can be
delivered wirelessly, via wire, replaceable or rechargeable
batteries 4129, etc. Power charging and regulation circuitry 4127
manages the delivery to insure stable and sufficient power is
distributed and, if employed, the rechargeable batteries 4129
receive adequate recharging.
[0300] FIG. 42 is a perspective and cross-sectional diagram
illustrating an inserted ITD having a radial illumination mechanism
to support delivery of light therapy along the length of the
vaginal channel. As illustrated, within a reproducive system 4201,
a therapy light 4213 built within a stem portion of an ITD 4209 to
deliver light therapy to areas along the length of the vaginal
channel. Similarly therapy lighting is also placed as described
heretofor in an optics assembly 4215 of the ITD 4209. Both sources
of therapy lighting are controlled by underlying circuitry within
the ITD 4209, and may also be controlled via control signals
originating outside thereof from external support devices.
[0301] Outside of the reproductive system domain, it is known that
light of specific frequencies, frequency ranges, and under certain
modulations and duty cycles, can at least assist in curing
infections, e.g., the use of blue light for treating acne vulgaris,
and UV lighting to destroy bacteria or deliver therapy for
psoriasis and eczema. Also known outside of the reproductive system
domain is the use of therapy lighting to promote healing, e.g., red
light for healing skin roughness, cuts, etc. It is also known that
the X-rays destroy both cancer and surrounding. High intensity
laser light can be similarly useful.
[0302] If configured with appropriate therapy delivery and
monitoring infrastructure, the ITD 4209 can not only follow a
predefined therapy delivery procedure, but can also adjust the
procedure based on sensor data (e.g., imager data) feedback so as
to maximize the therapeutically effects while focusing in on the
desired areas to be treated and to optimize the during and
intensity of overexposure. Such feedback may be gathered during the
therapy session and at some time after a session in a series of
therapy sessions, to support such optimization. For example,
overexposure might not be revealed until some time after exposure
to the light therapy during a therapy session. In other cases, it
might be revealed by sensor data during a session. Mid-session
indications can then be used to adjust the intensity or duration of
therapy given at a current session, while post session indications
can be used to similarly adjust a subsequent therapy session.
Either way, such indications may yield a decision to terminate all
further therapy. And of course, this applies to any type of therapy
delivered by the ITD 4209, including but not limited to the various
light therapies illustrated, fluid therapies (used separately or in
conjunction with the light therapies), and other types of therapies
delivered by other bio-chemical, electrical or electro-mechanical
sources installed within the ITD 4209.
[0303] For example, an x-ray source emitter can be controlled to
target a particular optically discernible area on a cervix. During
exposure, either x-ray reflections can be targeted or heat
signatures from an infrared imager can be captured to produce real
time images and feedback as to where and how effective treatments
are proceeding. Intensity can be adjusted then to account for
cancerous growth depths across the various locations of the surface
region under treatment. With precise guidance of the x-ray or laser
emitter (perhaps via on-off and intensity control via raster
scanning arrangement similar to that of FIG. 20) such as an x-ray
beam or laser beam, an optical image can be used to confine
exposure of the emission to a specific target within the optical
field of view. For targeting confirmation and efficacy, reflections
to corresponding imagers or heat signature images from infrared
imagers can be used. The surface area of three dimensional targets
(artifacts) target can also require more or less overall intensity
(via emission intensity or duration of exposure) at each point
therein to correspond to the varying thickness of the underlying
artifact. For example, often central areas with greater depth and
treatment, and with lesser treatment at edges.
[0304] The therapy light 4213 may be a single or a plurality of
incandescent or fluorescent lamp with or without appropriate
filters (e.g., a "black light") or any other lighting mechanism
that provides a more radial light emission along the axis of the
stem portion of the ITD 4209 as shown. As with the therapy lighting
associated with the optics assembly 4215, the therapy light 4213
may produce light of one or more frequencies and/or one or more
frequency ranges, and in a continuous or modulated approach for a
specific therapeutic goal. Emissions from the therapy light 4213
impact organisms, viruses, fungus, fluids and tissues of or upon
the vaginal walls 4205. For example, if the light therapy is
directed to reduce an overabundant natural flora growth, such light
tuned to such flora will be adversely effected and either
illuminate or reduce the need for anti-fungal and anti-bacterial
cremes.
[0305] Similarly, the ITD 4209 of present invention is also used
for healing and enhancing the elasticity of the vaginal channel
walls 4205, for example, using red light emissions. Moreover, if
the optics assembly 4215 and end portion of the ITD 4209 are
appropriately sized, the ITD 4209 can be inserted into further
intravaginal areas such as through a cervical channel 4223 and
beyond into the uterus, and to provide similar therapies for
healing and to address therein viral, fungal and bacterial
intruders, for example. The guiding of the ITD 4209 inside the
vaginal channel and cervical region and monitoring thereof is
assisted by local or remote "control and monitoring system", which
have video display or screen showing the head end of ITD 4209. The
optics assembly 4215 with axial imager assembly 4217 and radial
imager assembly 4219 is used to capture video image (frames) of
intravaginal channel/intracervical region walls.
[0306] Other aspects of the present invention can be found in
additional functionality relating to all of the above embodiments
such as that set forth as follows.
[0307] In a first embodiment, an application runs on a mobile phone
that displays the data collected from an intravaginal monitoring
device. The mobile phone may be an Apple.TM. brand phone, a
Samsung.TM. brand phone, a Google.TM. brand phone, a Motorola.TM.
brand phone, a Blackberry.TM. brand phone, and a Nokia.TM. brand
phone, and so forth. The mobile phone may also be a smart
phone.
[0308] The mobile phone may also consist of a graphic reflecting an
event or condition associated with a female's reproductive health.
The graphic may be associated or related to: (1) an event or
condition associated with a family's fertility, female's
reproductive health; (2) female's strength of her vaginal muscles;
(3) female's pregnancy, detection of an infection; (4) detection of
a sexually transmitted disease condition or event; (5) detection of
a precancerous cervical condition; (6) detection of a human
papilloma virus detection; (7) detection related of a cervical
injuries; and/or (8) detection of an abortion.
[0309] The aforementioned mobile phone may also include a mode of
operation that consists of an automated rhythm method providing
electronic information to a female regarding her fertility cycle,
and in which data from the intravaginal device is used as an input
into the mode of operation. The mode of operation may include
displaying data related to a determination of a pregnancy. The
mobile phone's display may also have modes of operations that
depict: (1) a photo of a doctor; (2) a photo of a female; (3)
parameters related to prenatal monitoring; (4) parameters related
to a female; (5) parameters related to a fetus and a female; (6) a
labor prediction display; (7) a premature birth parameter display;
(8) a false labor display; (9) a true labor indicator; and (10)
illustrating contraction timing.
[0310] Additional measurements, display and illustrations done by
the aforementioned mobile phone may include: (1) a cervical
dilation measurement; (2) illustrating fluid flow; (3) illustrating
position of a cervix (position of the cervix is selected from the
group consisting of a central position, an anterior position, and a
posterior position, for example); (4) an advertising (selected from
the group consisting of a diaper advertisement, a baby food
advertisement, a baby furniture advertisement, a baby clothing
advertisement, an advertisement related to a product for a newborn,
an advertisement related to a product for a mother, an
advertisement related to a product for a father, an advertisement
related to a nutritional supplement for a newborn, an advertisement
related to medical services, an advertisement related to insurance
coverage, and an advertisement related to services related to a
premature baby); (5) indicating the condition of the tonus of a
female (the firmness or softness of muscles surrounding a female's
womb); (6) a time line related to the release of waters pre-birth;
(7) parameters related to a fetus in a womb (related to the
position of body parts of a being in a womb of a female); (8) a
condition of a female's cervix; (9) a post birth healing monitoring
mode of operation; (10) a menopause onset detection mode of
operation; and (11) graphics for an in-vitro fertilization mode of
operation.
[0311] A process for providing in vitro fertilization using the
intravaginal monitoring device and a mobile phone consists of: (1)
displaying on a mobile phone a calendar or chart indicating peak
fertility days to a female, and providing said female an in vitro
fertilization therapy, in combination and monitoring fertility drug
performance. The therapy itself consists of a drug therapy (such as
a fertility medication that is injected, a fertility medication
that is taken orally, a fertility medication that is taken by nasal
spray, and a fertility injection, for example). The mobile phone
mode of operations for coordinating administration of a fertility
therapy with a female's menstrual cycle, the mobile phone having a
mode of operation from receiving data from an intravaginal
monitoring device. The mobile phone itself may consist of a photo
of a sex partner, a photo of a doctor, a photo of family member's,
and a photo or graphic depicting a cervix or measurement associated
the said cervix. The aforementioned mobile phone mode of operation
also presents the information on the display of the screen so that
a user can determine infertile days.
[0312] In one embodiment, a system for getting pregnant, consisting
of a mobile phone having a fertility calendar, and an intravaginal
device for monitoring fertility events, is considered; such that
the device communicates with the mobile phone. In conjunction with
the system, a method for getting pregnant and a kit for getting
pregnant are considered here, consisting of a mobile phone and
intravaginal device system to determine peak fertility days, and
taking a fertility drug therapy. The aforementioned method and kit
may include: (1) having multi-orgasmic sex; (2) drug therapy is
selected from the group consisting of a progesterone therapy, a
gonadotropin therapy (for example, the gonadotropin therapy is a
recombinant gonadotropin therapy), alone or in combination with
other fertility drugs; (3) the drug therapy is selected from the
group consisting of a GnRH Agonist therapy, a Lupron Depot.RTM.
therapy, and a drug therapy administered on different calendar
schedules depending on the female; (4) the drug therapy is selected
from the group consisting of a gonadotropin-releasing Hormone
antagonist therapy, a drug therapy preventing the release of LH and
or FSH, a clomiphene citrate therapy, a Clomid.RTM. therapy, a drug
therapy to stimulate ovulation, a Clomid.RTM. therapy, a
Serophene.RTM. therapy, and a Milophene.RTM. therapy, and a human
Menopausal Gonadotropin (hMG) therapy.
[0313] The mobile phone may include a sonogram image of a being in
a womb of a female in data storage of the mobile phone, and a mode
of operation for presenting data associated with a pregnancy. The
mobile phone may consist of a communication link with an
intravaginal monitoring device.
[0314] A system for tracking events during a pregnancy and birthing
process are also considered in one of the embodiments, consisting
of a mobile phone (having an application to receive data from an
intravaginal monitoring device, an external electronic monitor
sized and dimensioned to be worn on a pregnant female's stomach,
the monitor consisting of a communication link to said mobile
phone). The mobile phone also has a graphic user interface
consisting: (1) a graphic depicting cervical opening size; (2) a
mode of operation for automatic birthing alerts to an expectant
father; (3) a mode of operation for displaying the expected weight
of the being in the womb, the weight being calculated based upon a
weight determination (such as a predetermined statistical weight
data file, and a weight determined by sonogram dimensions of the
being in the womb); (4) an expectant parent information about an
expected birth of a child (such as location information regarding
an expectant mother, location information regarding a birthing
center, location information regarding a medical professional
responsible for a birth, location information regarding an
expectant father, location information regarding an emergency
treatment center, location information regarding an institution
having facilities to manage a high risk birth, location information
for the fastest route to a location for giving birth, location
information regarding family or friends of an expectant mother, and
location information of a medical clinic).
[0315] The mode of operations of the mobile phones may include: (1)
a display for prediction of the time of active labor; (2) a display
that distinguishes between active labor and passive labor, and
provides an indicator (such as an audible indicator, a
preprogrammed voice indicator, a visual indicator, and audio visual
indicator, and a vibrational indicator) of same to a user; (3)
storing a plurality of data communicated from an intravaginal
monitoring device to the mobile phone; (4) storing a plurality of
data communicated from an intravaginal monitoring device to the
mobile phone; so forth.
[0316] The mobile phone's applications (for processing data
received from an intravaginal monitoring device) may include: (1) a
mode of operation for obtaining wired data from the intravaginal
monitoring device; (2) a mode of operation for obtained data
wireless from the intravaginal monitoring device; (3) a mode of
operation for transmitting said data from the mobile phone to a
remote device wireless communicating to the remote device (such as
a server communicatively linked to the Internet, a server
communicatively linked to an intranet, an electronic device forming
part of a wide area network, an electronic device forming part of a
metropolitan area network, an electronic device forming part of a
local area network). The mobile phone's applications may also
consist of a mode of operation for communicating data received from
an intravaginal monitoring device, and optionally an external
monitoring device having sensors thereon for monitoring
physiological parameters of an expectant mother and or being in a
womb.
[0317] Instead of the mobile phone, an independent electronic,
wireless device and network having the features, functionality and
modes of operation of the disclosures herein are also considered.
Similarly, an electronic, wired device and network having the
features, functionality and modes of operation of the disclosures
herein are also considered. Mobile phones consisting of: (1)
applications for receiving and post processing data received from a
wireless intravaginal device sensing physiological parameters
related to the health of a female; (2) applications for receiving
and post processing data received from a wireless intravaginal
device sensing physiological parameters related to a being in a
womb; (3) smart phone functionality and a post processing mode of
operation for receiving and processing data from an intravaginal
monitoring device; and so forth are also considered.
[0318] Similarly, an external data communication device (for
example, incorporated into an item of apparel) consisting of a mode
of operation for processing data harvested by an intravaginal
monitoring device, in which said processing comprising providing
displays regarding parameters related to a female's reproductive
health is also considered. A network consisting of a mobile phone
(for example, a smart phone with an operating system), and an
intravaginal monitoring device communicatively linked to the smart
phone is also considered. The smart phone supports email, the
emails related to: (1) the female reproductive health data; (2)
female and medical professional communications.
[0319] A mobile phone, further consisting of a mobile
communications device, communicatively linked to the aforementioned
smart phone; the mobile communications device may include another
smart phone, a smart phone with an application to provide a medical
professional with data about a patient, a smart phone with an
application to provide an expectant father with information about a
pregnant female, a smart phone with an application to provide an
expectant mother with information about a child within her womb,
and a smart phone with an application to provide to provide
insurance or national health care insurance information to a
provider of medical services, is considered in one another
embodiment.
[0320] The smart phone network consisting of an intravaginal
monitoring device and the smart phone is considered in one
embodiment. The smart phone consists of an application that
includes a personal organizer, advertising data, a female user
interface (including a miniature QWERTY keyboard, a touch screen, a
D-pad, a built-in camera, a contact management, an accelerometer,
built-in navigation hardware and software, the ability to read
document data, media software for playing music, browsing photos
and viewing video clips, Internet browsers). An intravaginal
monitoring device sized and dimensioned to provide data from with a
vagina, comprising an accelerometer is also considered. A network
consists of an intravaginal monitoring device and a mobile
communication device communicatively linked to the intravaginal
monitoring device, the monitoring device consisting of an
accelerometer, or optionally the mobile communication device
consisting of an accelerometer.
[0321] A network consisting of an intravaginal monitoring device
and mobile communications device, and a secure communication link
between the monitoring device and the mobile communications device
is also considered, in one of the embodiments. Further, the
aforementioned network may further consist of a secure
communication link between the mobile communications device and a
device communicatively linked to the Internet. A network consisting
of an intravaginal monitoring device and a mobile communications
device, and a data archive comprising image data from a plurality
of females of internal female organs is also considered in one of
the embodiments.
[0322] In another embodiment, a network comprising an intravaginal
monitoring device sized and dimensioned to fit inside a vagina and
a web site on the Internet accessible by a female to view data
harvested by said intravaginal monitoring device is considered. The
network may further consist of a smart phone (such as a
BlackBerry.TM. brand phone) that includes an application for
processing data harvested by said intravaginal monitoring device.
In the aforementioned network, the smart phone may also consist of
a contact list (that includes data of an obstetrics or gynecology
medical professional). The contact list data may also include data
of a sex partner of a female, data of a family member of a female,
data of a birthing center, data of a clinic, data of a clinic to
treat a female infertility problem, data of treatment center for a
sexually transmitted disease, data of a medical professional, data
of a medical professional treatment group, and data of a medical
diagnostic center.
[0323] A network, consisting of an intravaginal monitoring device
with a built in memory for storing physiological data, and a mobile
communication device with a built in memory (the monitoring device
having a mode of operation for sending data from the memory of the
monitoring device to the memory of the mobile communication device)
is considered in one of the embodiments. A network consisting of a
plurality of Nokia.TM. smart phones, each the smart phone
communicatively linked with an individual intravaginal monitoring
device is also considered.
[0324] A network consisting of a plurality of smart phones each of
the smart phones consisting of a smart phone camera for taking
pictures, the smart phone camera having a focal length suitable for
taking pictures at least 3 meters to infinity, and a plurality of
intravaginal monitoring devices communicatively linked to an
individual smart phone, each of the intravaginal monitoring devices
capable of harvesting a digital image with a camera having a focal
capable capturing an image from 0.1 cm to 10 cm from the camera is
also considered, in one of the embodiments. The aforementioned
camera may be a digital CMOS camera, for example; consisting of an
array. The smart phone itself may consist of hardware and software
permitting WiFi and or WiMax data communication. An intravaginal
monitoring device consisting of hardware and software permitting
wireless web browsing is also considered. A network consisting of
an intravaginal monitoring device and a smart phone communicating
therewith, said smart phone capable of wireless web browsing is
also considered.
[0325] A network consisting of an intravaginal monitoring device, a
mobile communications device, the mobile communications device, and
optionally the intravaginal monitoring device consisting of an
operating system is also considered. The aforementioned operating
system may include Windows CE Pocket PC OS, and a Palm OS.
[0326] A network consisting of an intravaginal monitoring device,
the device communicatively linked to a mobile communications
device, the mobile communications device consisting of an open
source platform is also considered. A network consisting of a
device sized and dimensioned to fit into a vagina, and be wearable,
and a mobile communications device consisting of an Android.TM.
operating system is also considered. A network consisting of a
device sized and dimensioned to fit into a vagina, and be wearable,
and a mobile communications device consisting of a HTC smart phone
is also considered. A network consisting of a device sized and
dimensioned to fit into a vagina, and be wearable, and a mobile
communications device consisting of a mode of operation for
navigating web pages is also considered.
[0327] A network consisting of a device sized and dimensioned to
fit into a vagina, and is wearable and self powered, and a mobile
communications device consisting of a software suite is also
considered. The software suite may consist of Google.TM.
applications such as a map application, calendar application, a
Gmail.TM. application, a Google Chrome Lite full HTML web browser,
and a third party application. The software suite may consist of a
paid for application downloadable from an Apple.TM. applications
node located on the Internet. The software suite may also be a
smart phone application delivered directly to the mobile
communications device, such as an iPhone.TM. and an iPod.TM., and
in which said software suite is delivered to said mobile
communications device directly over a cellular network, a wife
network, or a WiMax network, alone or in combination. The software
suite may include a Symbian operating system, an iPhone operating
system, a RIM operating system, a BlackBerry operating system, a
Windows Mobile operating system, a Linux operating system, a Palm
Web operating system, an Android operating system, an Android and
or Web operating system built on top of Linux, and an iPhone
operating system derived from an BSD operating system and or a
NeXTSTEP operating systems, alone or in combination.
[0328] A communications network consisting of a node consisting of
a self powered, intravaginal monitoring device, and a GPS receiver
located remotely from said intravaginal monitoring device, the
device and the GPS receiver consisting of a mode of operation for
communicating with one another, is also considered in one of the
embodiments. The GPS receiver may consist of a mode of operation
for providing the geographical location of the intravaginal
monitoring device. The communications network may further consist
of a node on the network for communication of data of the
geographical location to a location processing node on the network.
The geographical location data is may include a location of an
expectant mother, a location of an expectant father, a location of
a medical professional, a location of a clinic to treat a female
health condition and or event, a location of a hospital, a location
of a nearest health care provider, a location of a midwife, and a
location of a in vitro fertility center.
[0329] A self powered device, consisting of an intravaginal monitor
for monitoring conditions of a female and/or being within a womb of
the female, and a GPS receiver, is also considered in one of the
embodiments. The GPS receiver calculates its position by precisely
timing the signals sent by the GPS satellites above the Earth. The
GPS receiver consists of a trilateration algorithm and the position
of the device and the GPR receiver is displayed on a moving map
display. The moving map display further consists of direction and
speed data; and the GPS receiver and the device further consist of
an antenna. The antenna, or optionally multiple antennas, is tuned
to the frequencies transmitted by more than one satellite. The
communications network or intravaginal monitoring device of any of
the disclosures herein, in which the aforementioned receiver is
tuned to multiple channels, is also considered. The communications
network or intravaginal monitoring device of any of the disclosures
herein, in which said receiver relays position data to a receiving
node on a communications network is also considered.
[0330] The communications network or intravaginal monitoring device
of any of the claims herein, further consisting of a navigation
mode of operation. The navigation mode of operation may include a
navigation mode to direct a pregnant female to a birthing center, a
navigation mode of operation to guide a female to female health
condition or event crisis management center, a navigation mode of
operation to guide an expectant father to an expectant mother, a
navigation mode of operation to guide an expectant mother to a
medical professional, a navigation mode of operation to guide a
female to a clinic, a navigation mode of operation to guide a
plurality of people who have been involved in the procreation
process to a single location for a birth, a navigation mode of
operation to guide a medical professional to a female, a navigation
mode of operation to guide a first responder to a female in need of
medical attention related to a female condition or medical event,
and a navigation mode of operation.
[0331] A mobile communications device for two way communications
via a cellular or Internet network, consisting of a display having
an alert generated from data harvested from an intravaginal
monitoring device, whereby the intravaginal monitoring device is
communicatively linked to the mobile communications device is also
considered in one of the embodiments. A mobile communications
device for two way communications via a cellular or Internet
network, consisting of a display having graphic or text generated
from data harvested from an intravaginal monitoring device, the
data consisting of heart rate data is also considered in one of the
embodiments. The heart rate data may include an expectant mother's
heart rate, and a being the womb's heart rate. The aforementioned
mobile communications device further consists of an identification
data consisting of a name of a female, data of a week of pregnancy,
data on the number of pregnancies of a female, data of the last
menstruation of a female, data of a medical professional, data
representative of a sonogram of a being within a womb.
[0332] A mobile communications device for two way communications
via a cellular or Internet network, consisting of a display having
data representative of a cervix is also considered in one of the
embodiments. A mobile communications device for two way
communications via a cellular or Internet network, consisting of a
display showing cervical dilation is also considered in one of the
embodiments. A mobile communications device for two way
communications via a cellular or Internet network, consisting of a
display having a numerical indication of cervical dilation is also
considered in one of the embodiments. A mobile communications
device for two way communications via a cellular or Internet
network, consisting of a display showing a date and time, and
cervical dilation at said data and time is also considered in one
of the embodiments. A mobile communications device for two way
communications via a cellular or Internet network, consisting of a
display showing cervical dilation over time is also considered in
one of the embodiments. A mobile communications device for two way
communications via a cellular or Internet network, consisting of a
display having showing data harvested from an intravaginal
monitoring device is also considered in one of the embodiments. A
mobile communications device for two way communications via a
cellular or Internet network, consisting of a display having an
alert generated from data harvested from an intravaginal monitoring
device, whereby the intravaginal monitoring device is
communicatively linked to said mobile communications device is also
considered in one of the embodiments. A mobile communications
device for two way communications via a cellular or Internet
network, consisting of a graphic user interface for an expectant
father illustrating data on an expectant mother, and optionally
data on a child in said expectant mother's womb is also considered
in one of the embodiments.
[0333] A kit for a mobile communications device for two way
communication via a cellular or Internet network, consisting of the
mobile communications device, and an intravaginal monitoring device
(consisting of an electronic portion) is also considered in one of
the embodiments. The kit may include: (1) a plurality of
interchangeable heads (containing the electronic portions), sized
and dimensioned to provide a field of view with a vagina; (2) a
plurality of disposable transparent sleeves, sized and dimensioned
to fit over said intravaginal monitoring device; (3) a carrying
case; such that it: (i) is sized and dimensioned to fit into a
female's handbag; (ii) is shaped so as to provide removability of
the mobile communications device and the intravaginal monitoring
device; (iii) includes a plurality of pouches and a zipper; and
(iv) consists of two halves, and in which said two halves snap shut
and snap open; (4) the intravaginal monitoring device consisting of
a plurality of sensors for monitoring physiological conditions or
events.
[0334] A network consisting of: an intravaginal monitoring device
for visualizing conditions or events within a vagina, the device
consisting of a camera, and having a wireless data transmission
mode of functionality, and a remote device, the remote device
located outside of a female's body is also considered in one of the
embodiments. In one embodiment, a method is used by a server in a
communication network, e.g. communication network. The
communication network has a plurality of sensor devices and a
support computer. Within such a network, it is appreciated that the
management of a group of pregnant females in a birthing center, and
outside of a birthing center pregnant females is facilitated using
the method, and the communication pathways provided for by the
method. For example, Hospital A's birthing center admits pregnant
female patient's B-Z. Patient's B-Z are utilizing the device and
methods of the invention prior to admission so that clinically
relevant data on each patient is provided while each of the
pregnant females B-Z, are at home, work, at the birthing center, or
any location remote from the birthing center.
[0335] These patient's mobile phones are provided instructions so
as to properly time their admission depending on how advanced their
labor cycle is, and otherwise proceed under Doctor's orders. The
appropriate nurse midwife or physician is provided with a visual
working environment through their work stations with real time or
substantially real time information of which patient will next go
into active labor (vs. being in passive labor), and delivery. The
medical professional's time and hospital beds and other resources,
including monitors, are then brought to where they are needed, just
in time. If simultaneous pregnant females go into active labor,
then additional resources can be organized in advance and obtained
in a timely manner without stretching existing resources, e.g.
doctors and nurses, to thin or creating a life threatening
situation for the pregnant females or their unborn babies because
of lack of qualified staff or specialists.
[0336] Within the birthing center, the visual working environment
displays, for example, include information related to the sensed
data, in whole or in part, on pregnant females B-F. Clinically,
pregnant female B is in passive labor, has a window with her image
data, relevant medical information data, location data, image of
her cervix data (including all relevant clinical parameters),
contraction information data, breaking of the waters status data,
information sensed related to her fetus data, etc. in the same
window (or other screen), Clinically, pregnant female C is in
active labor. A window with Female C's image data, room number
data, cervical diameter (greater than 6 cm) data, effacement
information data, temperature data, next of kin contact information
data, and fetal information data appear in the visual work
environment. The nurse midwife's work station or smart phone issues
an alert regarding pregnant female patient C. The alert notifies
Nurse Mid Wife Z's, and she focuses resources on pregnant female C,
as she is about to deliver.
[0337] By way of further example, pregnant female D is 26 weeks
pregnant, is at risk for a premature birth event, and is being
monitored remotely by nurse midwife Z utilizing device 105. Nurse
midwife Z notices several disturbing trends concerning pregnant
female D on a window reflecting data relating to pregnant female C.
Graphs and other visual interfaces of cervical depth data taken
over the last three hours indicates that pregnant female D's cervix
has been thinning, that her cervical OS has gone from 0.5 cm to 2.5
cm, and that other clinically relevant parameters indicate that she
is at high risk of a premature birthing event imminently. Nurse
midwife Z is presented with an alert in her visual working
environment.
[0338] As a result of the alert, the method causes Nurse midwife
Z's phone to ring with a pre-recorded voice message alert. The
pre-recorded message alert results in an automated call to pregnant
female D on her mobile phone and sends an sms to her and to her
Doctor, Doctor D, and instructs pregnant female D that the system
has sent an alert to dispatched an ambulance to pregnant female D's
location for her so that she can be admitted to the birthing center
immediately.
[0339] Pregnant female D's location data was provided to the
ambulance operator via his mobile phone on his visual working
environment display using the GPS functionality of pregnant female
D's mobile phone and/or the intravaginal monitoring device and
system. An alert was provided to pregnant female D's husband
support device over the communication network when he was at work,
providing a pre-recorded message requesting that he call his wife
regarding the pregnancy. This happens, and the husband and wife
immediately discuss the status of the pregnancy.
[0340] D's husband tracks his wife's physical location in the
ambulance using GPS functionality on his phone (via a specific
application) in his visual working environment which is
communicatively linked to the server and the intravaginal
monitoring device and/or wife's cell phone's GPS functionality, and
follows the ambulance to the hospital to be there for his wife. The
ambulance brings pregnant female D to the birthing center within 15
minutes of Nurse Midwife Z's alert and call.
[0341] At the birthing center, Doctor D determines, that since
pregnant female D arrived to the birthing center in a quickly, and
before her condition deteriorated further, she is a candidate for a
therapy. He performs the therapy, which involves placement of a
cervical prosthesis, bed rest, and other therapies. The therapy is
successful and pregnant female D gives birth to a healthy newborn
son at 38 weeks of gestation. The combination of the method of
diagnosis utilizing the communication network of the present
invention, and therapy results in a successful outcome. In one
embodiment, a method of decreasing insurer or governmental health
system costs is provided. The method includes providing an
intravaginal monitoring device capable of identifying an event
during a pregnancy; determining whether or not a pregnant female is
having a pre-mature birthing event; and, treating the pregnant
female to increase the gestation time of a being within the womb of
the pregnant female.
[0342] By way of further example, pregnant female E is 37 weeks
pregnant during her first pregnancy, and being home monitored with
an intravaginal monitoring device 105. Clinically, pregnant female
E feels periodic contractions. She feverishly calls her husband and
has her husband leave his job as a school bus driver, and drives
home immediately believing she is going into labor. She calls the
birthing center from her mobile phone by pressing a preprogrammed
number in her mobile phone application, and requests to speak with
her Doctor, Doctor E, now. Doctor E is not at the birthing center
since he has taken a long overdue vacation with his wife in
Hawaii.
[0343] At home, pregnant female E and her husband are panicking
since they are scared and unsure what to do since this is their
first baby. Pregnant female E actuates the intravaginal monitoring
device 105 and inserts it into her vaginal canal. Device 105
harvests sensor data and communicates it via the communication
network to a support device. The support device analyzes the sensor
data to determine if one or more clinically relevant threshold
parameters are met. If yes, an appropriate alert is generated, and
communicated and routed over the communication network to nodes on
the network.
[0344] The method also generates a patient profile, e.g. using one
or more applications. Nurse Mid Wife Z reviews pregnant female E's
profile on her visual working environment in real time and while in
real time the network shares the profile with Doctor E who views it
on his iPad on the golf course in Hawaii. The visual working
environment display generated using applications running on one or
more nodes in the network indicates that pregnant female E is
having periodic contractions, that she does not evidence cervical
effacement, and that her cervical OS graph does not show any change
over time and is at 0.5 cm, and that fetal parameters are all
normal. No alerts are activated for network distribution since the
sensed data, and or combination thereof, has not reached relevant
thresholds. A conclusion is made by the application software that
no hospital admission alert is necessary, and that it is likely
that pregnant female E is only having Brixton-Hicks contractions
and that no hospital admission is required, and communicates, and
properly addresses this information for routing to Nurse Mid Wife Z
and Doctor E respective support devices. Nurse Mid Wife Z consults
with Doctor E, and Doctor E, and optionally humanly confirms that
pregnant female E is having Brixton-Hicks contractions, that she is
not in active labor, and that no hospital admission is required.
Doctor E, presses a button on his wirelessly connected iPad
accessing an application related to the intravaginal monitoring
device specific to patient E, and or data files related to patient
E created from data harvested by the monitoring device, performs a
confirmatory human review of the data, and then calls patient E,
and instructs pregnant patient E that she should stay at home, and
not proceed to the hospital for admission at this time, as she is
not in active labor. Pregnant female E follows Doctor E's orders,
and takes some bed rest and the Brixton-Hicks contractions
pass.
[0345] Two weeks later, pregnant patient E has another set of
periodic contractions which are being remotely monitored by the
intravaginal device 105 with its sensors. The sensor data is
communicated and properly routed via the communication pathways
described herein. The sensor data indicates that pregnant female E
is entering normal labor, and an alert is issued via the
communication pathway to the Mid Wife's and Doctor's supporting
devices. At this time Nurse Midwife Z, notices the alert and
reviews pregnant patient E's profile remotely and confirms that the
sensed profile parameters indicate that pregnant patient E is going
into normal labor as the alert indicated, and instructs her to come
to the birthing center for admission. Pregnant patient E's husband
is alerted that is the "real deal" via an alert communicated to his
supporting device via the communication network and communication
pathway, and that the baby will arrive in the range of 2 to 6 hours
based upon trend analysis of the sensed data. He rushes home from
work, drives his wife to the hospital, where she is admitted, goes
into normal labor and delivery, and delivers a healthy baby girl.
Doctor E was alerted via an alert presented on his smart phone of
the impending delivery in advance so he was able to hop out of the
shower, review patient E's pregnancy profile data communicated to
his support device via the communication pathway and communication
network, and delivered the healthy baby girl. It is appreciated
that the device and methods of the previous invention reduce
stressful, wasteful, unnecessary hospital admissions when they are
not need, and provide for timely hospital admissions when they are
most needed, saving lives and reducing the incidence of premature
birth (with the huge emotional and financial drain associated
therewith) when coupled with efficacious, and timely therapies.
[0346] Throughout the present application, various embodiments are
used to illustrate some of various aspects of the present
invention. It should be clear to one of ordinary skill in the art
that yet other embodiments constructed based on elements extracted
from several or more of the embodiments specifically described
herein are contemplated.
[0347] The terms "circuit" and "circuitry" as used herein are refer
to an independent circuit or to a portion of a multi-functional
circuit that performs multiple underlying functions. For example,
depending on the embodiment, processing circuitry are be
implemented as a single chip processor or as a plurality of
processing chips. Likewise, a first circuit and a second circuit
are be combined in one embodiment into a single circuit or, in
another embodiment, operate independently perhaps in separate
chips. The term "chip", as used herein, refers to an integrated
circuit. Circuits and circuitry are comprise general or specific
purpose hardware, or are comprise such hardware and associated
software such as firmware or object code.
[0348] As one of ordinary skill in the art will appreciate, the
terms "operably coupled" and "communicatively coupled," as are be
used herein, include direct coupling and indirect coupling via
another component, element, circuit, or module where, for indirect
coupling, the intervening component, element, circuit, or module
does not modify the information of a signal but are adjust its
current level, voltage level, and/or power level. As one of
ordinary skill in the art will also appreciate, inferred coupling
(i.e., where one element is coupled to another element by
inference) includes direct and indirect coupling between two
elements in the same manner as "operably coupled" and
"communicatively coupled."
[0349] The present invention has also been described above with the
aid of method steps illustrating the performance of specified
functions and relationships thereof. The boundaries and sequence of
these functional building blocks and method steps have been
arbitrarily defined herein for convenience of description.
Alternate boundaries and sequences can be defined so long as the
specified functions and relationships are appropriately performed.
Any such alternate boundaries or sequences are thus within the
scope and spirit of the claimed invention.
[0350] The present invention has been described above with the aid
of functional building blocks illustrating the performance of
certain significant functions. The boundaries of these functional
building blocks have been arbitrarily defined for convenience of
description. Alternate boundaries could be defined as long as the
certain significant functions are appropriately performed.
Similarly, flow diagram blocks are also have been arbitrarily
defined herein to illustrate certain significant functionality. To
the extent used, the flow diagram block boundaries and sequence
could have been defined otherwise and still perform the certain
significant functionality. Such alternate definitions of both
functional building blocks and flow diagram blocks and sequences
are thus within the scope and spirit of the claimed invention.
[0351] One of average skill in the art will also recognize that the
functional building blocks, and other illustrative blocks, modules
and components herein, can be implemented as illustrated or by
discrete components, application specific integrated circuits,
processors executing appropriate software and the like or any
combination thereof. Moreover, although described in detail for
purposes of clarity and understanding by way of the aforementioned
embodiments, the present invention is not limited to such
embodiments. It will be obvious to one of average skill in the art
that various changes and modifications are be practiced within the
spirit and scope of the invention, as limited only by the scope of
the appended claims.
* * * * *