U.S. patent application number 12/890811 was filed with the patent office on 2011-08-04 for intravaginal therapy device.
Invention is credited to James D. Bennett, Andrew W. Ziarno.
Application Number | 20110190689 12/890811 |
Document ID | / |
Family ID | 43796249 |
Filed Date | 2011-08-04 |
United States Patent
Application |
20110190689 |
Kind Code |
A1 |
Bennett; James D. ; et
al. |
August 4, 2011 |
INTRAVAGINAL THERAPY DEVICE
Abstract
An intravaginal treatment device (ITD) provides therapeutic
light and fluid treatments. Vision systems throughout supporting
networks and devices allow for directed control of the treatment
processes. The ITD uses illumination to gather various types of
imager data that is used to identify and conditions, monitor the
treatment process, and evaluate treatment efficacy. Specific
frequency light emissions and associated fluids are used to reduce
overabundant flora, at least assist in elimination of fungal, viral
and bacterial invaders, and enhance the detection process. Several
configurations and sizes of ITDs with light and fluid therapy, also
have a built in optics assembly (camera, light sources, etc.) for
capturing intravaginal still images and video of vaginal channels,
cervix, cervical channels, uterus and fallopian tubes. Some ITD
configurations are also wearable and include full fluid delivery
infrastructure unlike some other ITDs with external components.
Supporting devices include local and remotely located computing
devices such as laptops, smart phones, and independent monitors.
ITDs can be fully or partially inserted via the vaginal channel,
and operate in a stand-alone mode or pursuant to remote control.
Therapy procedures may be preset or programmed to deliver
continuous, periodic and scheduled performance with various
underlying parameters defined in the preset or programming
processes.
Inventors: |
Bennett; James D.;
(Hroznetin, CZ) ; Ziarno; Andrew W.; (Thalheim,
DE) |
Family ID: |
43796249 |
Appl. No.: |
12/890811 |
Filed: |
September 27, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61246375 |
Sep 28, 2009 |
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61246405 |
Sep 28, 2009 |
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61246396 |
Sep 28, 2009 |
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61290792 |
Dec 29, 2009 |
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61263416 |
Nov 23, 2009 |
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Current U.S.
Class: |
604/21 ;
607/88 |
Current CPC
Class: |
A61B 1/00016 20130101;
A61B 1/00177 20130101; A61B 8/4472 20130101; A61B 5/4839 20130101;
G16H 40/67 20180101; A61B 1/303 20130101; A61B 1/00096 20130101;
A61B 5/035 20130101; A61B 1/05 20130101; A61B 7/023 20130101; A61B
8/4416 20130101; A61B 1/00142 20130101; G16H 15/00 20180101; A61B
5/4343 20130101; A61B 5/68 20130101; G16H 40/63 20180101; A61B
1/042 20130101; A61B 1/00034 20130101; A61B 5/14532 20130101; A61B
5/6846 20130101; A61B 17/425 20130101; A61B 1/00135 20130101; A61B
17/42 20130101; A61B 5/14539 20130101; A61B 8/445 20130101; G16H
30/20 20180101; A61B 5/4318 20130101; A61B 8/12 20130101; A61B
5/344 20210101; A61N 2005/0611 20130101; A61N 5/0603 20130101 |
Class at
Publication: |
604/21 ;
607/88 |
International
Class: |
A61M 37/00 20060101
A61M037/00; A61N 5/06 20060101 A61N005/06 |
Claims
1. A therapeutic device that delivers therapy to areas within a
female reproductive system via a vaginal channel, the therapeutic
device comprising: a housing that is sized to reach at least a
partially inserted position within the vaginal channel; a first
light source disposed on the housing that delivers light within the
female reproductive system when the housing is in the at least the
partially inserted position within the vaginal channel; and the
light delivered by the light sources being selected to provide a
therapeutic result.
2. The therapeutic device of claim 1, further comprising a therapy
nozzle disposed on the housing and through which the therapy can be
delivered within the female reproductive system.
3. The therapeutic device of claim 1, further comprising a light
sensor.
4. The therapeutic device of claim 3, wherein the light sensor
comprises an imager, and the therapeutic device further comprising
a second light source disposed on the housing which delivers
illumination to support the imager.
5. The therapeutic device of claim 1, further comprising a second
light source disposed on the housing that produces a light of a
different frequency from that of the first light source.
6. The therapeutic device of claim 2, wherein the therapy and the
light delivered by the first light source are both used in the
attempt to provide a therapeutic result, and the therapeutic result
relating to a single gynecological condition.
7. A device that delivers a fluid to areas within a female
reproductive system via a vaginal channel, the device comprising: a
housing that is sized to reach at least a partially inserted
position within the vaginal channel; a nozzle, disposed on the
housing, and through which a fluid is delivered into the female
reproductive system when the housing is in the at least the
partially inserted position within the vaginal channel; and an
light source disposed on the housing that produced light within the
female reproductive system when the housing is in the at least the
partially inserted position within the vaginal channel.
8. The device of claim 7, further comprising a reservoir disposed
within the housing, and, wherein, the reservoir and the nozzle are
connected via a fluid flow pathway.
9. The device of claim 7, wherein the light source provides light
therapy.
10. The device of claim 7, further comprising an imager, and
wherein the light source provides illumination for the imager.
11. The device of claim 8, further comprising a pump, and wherein
the fluid flow pathway becomes active in response to control
signaling delivered to the pump.
12. The device of claim 7, further comprising a fluid container
disposed outside of the housing, and, wherein the fluid container
and the nozzle are connected via a fluid flow pathway.
13. The device of claim 12, wherein the fluid flow pathway becomes
active in response to a manual force exerted on the fluid
container.
14. A method used by a device to deliver therapy, the device being
sized for at least partial insertion into a female reproductive
system via a vaginal channel, the method comprising: delivering
illumination lighting to a target area within the female
reproductive system; capturing imager data based on at least some
reflections of the illumination lighting delivered; and delivering
therapy into at least a portion of the target area.
15. The method of claim 14, wherein the therapy comprising fluid
therapy.
16. The method of claim 14, wherein the therapy comprising light
therapy.
17. The method of claim 14, wherein the therapy comprising both
fluid and light therapy.
18. The method of claim 14, wherein the capture of the imager data
supports guidance of the device into the at least the partially
inserted position.
19. The method of claim 14, wherein the capture of the imager data
supports efficacy evaluations related to the therapy delivered.
20. The method of claim 14, wherein the at least the partially
inserted position comprising a fully inserted position.
Description
CROSS REFERENCES 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 PW0-L019-001.
BACKGROUND
[0016] 1. Technical Field
[0017] The present invention relates generally to monitoring and
providing a diagnosis and/or therapy for intravaginal and/or sex
organ infections and diseases using therapeutic light sources,
pharmaceutical fluid deliveries, diagnostic agent, and video image
capturing devices.
[0018] 2. Related Art
[0019] Very often, the reproductive organ diseases have been one of
the major health hazard faced by many a women. Some of these
diseases are of sexual origin caused by microorganisms that invade
into womens reproductive organs, some are habit related, and some
others are hereditary related diseases. The diseases which are of
sexual origin are often caused by invasion of microorganisms such
as bacteria, viruses, fungus, etc., into reproductive organs of
women through unhygienic sexual practices. When once disease
causing microorganisms invade the sensitive reproductive organs of
women, it becomes virtually impossible to check their growth and
get rid of them from the body by normal surgical and medication
techniques. This becomes even more challenging to treat, when a
woman is pregnant.
[0020] Conventionally, antibiotics which kill or inhibit the growth
of microorganisms are used to cure the womens reproductive organ
related diseases. But antibiotics are known to cause side effects,
causing harmful effects to the body of the patient. Therefore the
antibiotic treatments result in complications in vital organs such
as kidneys, heart, lung, livers, brain, and so forth.
[0021] The complications of antibiotic treatment are severe when a
woman is pregnant; the reason for this being that the risk of side
effects is very real for both the mother and fetus when treated
with antibiotics. In some extreme cases abortion becomes
inevitable. This is really shocking for parents who are expecting
to have a baby through unconventional and expensive means, such as
vitro fertilization and artificial insemination. There are no
proven safety medical techniques to save the pregnancy if there are
severe side effects due to antibiotics.
[0022] Some of the techniques currently practiced for birth control
or any other surgery on the reproductive organs, which becomes
inevitable due to complications, leads to permanent damage to
uterus and the associated organs. This easily leads to permanent
pregnancy failures (infertility), which is a known risk during
inadvertent surgery or drug treatments. There are no obvious means
of finding the cause of pregnancy failures in such patients. The
pregnancy failure may be due to simple cause of abrasion of the
cervical channel, chronicle lesions, or infections. Lack of precise
detection of the causes is another limitation of the current
treatment practices during treatment of reproductive organ of
women.
[0023] Some of the diseases are normally asymptomatic, that is, do
not manifest at very early stages, making it very hard to diagnose
at the early stages (e.g., STD infections, precancerous conditions,
etc.). Such diseases are often only diagnosed through doctor's
visits which unfortunately occur on an infrequent basis, or, for
example, when the disease or related condition becomes outwardly
noticeable or intolerable to a patient.
[0024] Currently used techniques, such as colposcopy for detecting
cancerous growth, are invasive techniques meant to cure diseased
parts of female reproductive organs. In these techniques, the
health care professional carries on biopsies in areas considered to
be cancerous or infected. This is discomforting surgical procedure
and causes severe pain to the patient under treatment. In addition,
the colposcopy detects cancer on probabilistic basis, since the
health care professional is not certain of cancer or infections
until the region is tested through biopsy, in detail. When the
invasive or surgical techniques are used on a woman who is
undergoing the treatment, it causes severe pain, most of the time,
particularly when the anesthesia is not advised or not administered
properly. The anesthesia used can have severe side effects, and can
even be fatal if not controlled properly during its administration
into the body.
[0025] The present techniques, such as endoscopy and exploratory
biopsy, cause permanent damages to the sensitive tissues in the
vaginal and cervical regions. This will lead to permanent
infertility in woman. Often, this discourages the patient from
undergoing such treatments, due to fears of the likely negative
consequences.
[0026] When endoscopy or colposcopy is performed on a woman, any
random and unpredictable errors may result in inaccurate diagnosis
of the illness. This leads to wrong medication to be given, which
may further complicate the condition of the patient. In addition,
conventional endoscopy and colposcopy are performed in a doctor's
facility (office or hospital, for example) with shared equipment.
Failing to follow strict hygienic procedures can lead to disastrous
spreading of the very bacteria and viruses at issue. Moreover,
because of the typically low frequency of use of colposcopy
equipment and such equipment's limited functionality, even patients
diagnosed and subject to ongoing treatment have few means to
evaluate treatment efficacy.
[0027] Conventional techniques of localized drug deliveries often
cause allergic reactions in the areas of the infections, in the
vaginal or cervical channels, such as itching, burning, or
inflammations effects, especially when the drugs are not
administered properly. This may subject a patient to tolerable
discomfort or cause more significant complications, the cause and
impact not fully appreciated for long periods of time.
[0028] These and other limitations and deficiencies associated with
the related art may be 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
figures.
BRIEF SUMMARY OF THE INVENTION
[0029] The present invention is directed to 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
[0030] FIG. 1 is a cross-sectional diagram illustrating insertion
of an intravaginal treatment device (ITD), built in accordance with
various aspects of the present invention, placed inside a vaginal
channel, wherein the ITD assists in the identification, diagnosis
and treatment of conditions within female reproductive systems.
[0031] FIG. 2 is a cross-sectional diagram illustrating a
snake-like intravaginal treatment device (ITD) with slender stem
guided through vaginal and cervical channels and into a uterus,
wherein the ITD also assists in the identification, diagnosis and
treatment of conditions within female reproductive systems, in
accordance with the present invention.
[0032] FIG. 3 is a perspective diagram of a wearable type of
intravaginal treatment device (ITD) that can be controlled through
wireless communication links or via pre-programmed settings,
wherein the ITD has an optics assembly with two imager and light
source assemblies disposed thereon, and each imager and light
source assembly being used for image capture and for delivery of
light therapy.
[0033] FIGS. 4a-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. 4b, a fluid
delivery nozzle, all in accordance with various aspects of the
present invention.
[0034] FIG. 5 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.
[0035] FIG. 6 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.
[0036] FIG. 7 is a perspective diagram illustrating a tethered
interconnect between one embodiment of an intravaginal treatment
device (ITD) and a laptop computer running support software,
wherein via the tether, collected data may be process, reviewed and
forward, and control signals generated and delivered to the
ITD.
[0037] FIG. 8 is a conceptual block diagram illustrating many
possible configurations and embodiments of intravaginal treatment
devices (ITDs) and supporting systems that can be built in
accordance with the present invention.
[0038] FIG. 9 is perspective diagram of an exemplary intravaginal
treatment device (ITD) interfaced with a hand held device (with a
display and diagnosis software) through, for example, a universal
serial bus (USB) port in accordance with one embodiment of the
present invention.
[0039] FIG. 10 is a perspective diagram of another embodiment of an
intravaginal treatment device (ITD) tethered to a supporting hand
held device illustrating that more or less of functionality carried
out by the ITD can be moved to or from the domain of such
supporting hand held device.
[0040] FIG. 11 is a perspective diagram of a further embodiment of
an intravaginal treatment device (ITD) that has a wireless
transceiver circuitry for communicating to a supporting hand held
device, wherein the circuitry and an antenna is integrated within
the tail end of the ITD to attempt to minimize any negative effects
that may be caused by transmissions within or near body
tissues.
[0041] FIG. 12 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.
[0042] FIG. 13 is a perspective diagram of another embodiment of an
optics assembly that may be used in constructing an intravaginal
treatment device (ITD) in accordance with the present invention,
wherein the optics assembly has a stem, mounting structure, and an
array of radial imager and light source assemblies for capturing a
variety of types of images and producing light source therapy.
[0043] FIG. 14 is a perspective diagram illustrating another
approach for integrating light sources into an imager and light
source assembly of an overall optics assembly, wherein one light
source is used for illumination and the other for delivering light
therapy.
[0044] FIG. 15 is a perspective diagram of an optics assembly
having an imager and light source assembly that employs optical
fiber through which a variety of frequencies of light can be
delivered from light sources either within or outside of the
intravaginal treatment device (ITD).
[0045] FIG. 16 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.
[0046] FIG. 17 is a schematic block diagram of a monitoring and
treatment architecture built in accordance with aspects of the
present invention, and which an intravaginal treatment device (ITD)
couples with various control and monitoring devices distributed
physically across many locations.
[0047] FIG. 18 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.
[0048] FIG. 19 is a cross-sectional diagram illustrating use of a
plurality of light emitting diodes (LEDs) disposed along a
snake-like stem of an intravaginal treatment device (ITD) for
delivering light treatment deep within a female's reproductive
organs in accordance with various aspects the present
invention.
[0049] FIG. 20 is a perspective diagram of a scanning optics
assembly inside the head end of intravaginal treatment device (ITD)
of one embodiment of the present invention wherein light therapy
can be scanned across an overall scanning region of the scanning
optics, or directed only to an area of interest within the overall
scanning region using laser light duty cycle control.
[0050] FIG. 21 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.
DETAILED DESCRIPTION OF THE DRAWINGS
[0051] FIG. 1 is a cross-sectional diagram illustrating insertion
of an intravaginal treatment device (ITD), built in accordance with
various aspects of the present invention, placed inside a vaginal
channel, wherein the ITD assists in the identification, diagnosis
and treatment of conditions within female reproductive systems. The
ITD is guided into the vaginal channel 131. The ITD of present
invention is also used in the cervical region 145 to detect
infection and to treat them. The ITD 161 is a tubular structure
with 3 distinguished parts; the end which is inserted into the
reproductive organ of women is called as head end 115. The tubular
extension of the head end 115 is called the stem 139 of the ITD
161. The extension of the stem 139 to the other end of ITD 161 to
which an external cable assembly 137 is connected is called tail
end 111 in the present invention.
[0052] Inside the head end 115 is an optics assembly 113; the
optics assembly 113 is electrically tethered to a "control and
monitoring system" 153 having computing capability with built in
display screen. The computing capability of the control and
monitoring system 153 is required to process the video images
captured and sent by the optics assembly 113. The display (screen)
is required to project the video image sent by the optics assembly
113. The optics assembly 113 transmits the video images captured
through the cable assembly 137 or through any wireless link
(discussed later) into the control and monitoring system 153.
[0053] The tethering cable assembly 137 comprises a set of wires. A
set of wire in the tethering cable assembly 137 are used to convey
electric power (supply) to optics assembly 113 and to energize
associated circuitry; and to convey video frames from optics
assembly 113 to the control and monitoring system 153. In another
embodiment of present invention, the ITD 161 will have rechargeable
battery built in for supplying the optics assembly 113. The term
control and monitoring system herein refers to any devices like
PCs, laptops, cell phones, and PDAs or any other devices that are
coupled through wire or wireless channel which are assisting in
analyzing and displaying video image data. Using the control and
monitoring system 153 doctors performs remote controlling operation
of optics assembly 113 inside the ITD 161.
[0054] Doctors can control various components of the optics
assembly 113 instantaneously by observing the movie pictures of
internal view of reproductive organ. The video image helps the
doctors in guiding the ITD 161 head end into deeper regions 145 of
the reproductive organ for diagnosis and treatment purpose. During
this process the doctors have various control options in a
Graphical User Interface (GUI) on the display. They can control the
orientation of the optics assembly 113 and they can also control
orientation of the individual components on the optics assembly
113, e.g., light sources. Controllable components on optics
assembly 113 include a plurality of video image capturing devices,
light sources of different colors, fluid pump, etc., discussed
below. This feature provides a quick means diagnosis and an easier
means of and treating the diseases
[0055] A plurality of light sources of different colors (or
frequencies): IR (infrared) light, UV (ultraviolet) light, red
light, blue light, monochromatic light, and laser are generated
internally using low power LEDs (light emitting diodes) built in to
optics assembly 113 (inside ITD head end 115) in one embodiment of
the present invention. Light sources of required color and
intensity is also conveyed from an external source using optical
fiber cable into the optics assembly 113 in the case where
footprint of the optics assembly 113 needs to be minimized by
removing internal light sources in another embodiment of the
present invention.
[0056] In the present invention, the light sources are used for two
main purposes; for illuminating the wall of reproductive organ
during the video image capturing, and for light therapy in treating
the infections of reproductive organ region of a woman under
diagnosis. For example, the use of blue light in treating the acne
vulgaris is known; similarly the use of lasers and X-rays for
treating cancer. That knowledge is used to treat diseases in the
deeper invisible parts of women.
[0057] The ITD 161 has built in fluid pump for delivering the
various fluids supplementing the light treatment. The fluid pump
has many chambers, with each chamber containing specific fluid
which is injected into the reproductive organ region using pumping
(like a squeeze ball) or injecting mechanism (like a syringe),
electrically or manually actuated. The integration of the optical
light sources, imagers, and fluid pump into the ITD 161 facilitates
a multi functional capability of imaging, light treatment, and drug
therapy. Fluid injection mechanism for injecting the fluids into
the reproductive organ is discussed in detail in subsequent
figures, FIG. 4-6. Different configurations of optics assembly 115
in accordance with various embodiments of present invention are
discussed with relevant figures in subsequent paragraphs. Different
ITD structures and light sources for light therapy are also
discussed in detail. Various ITD functionality mapping options over
different blocks of implementations, and various communication
interface or communication standard options with remote control and
monitoring system are discussed in detail, later.
[0058] For example, a woman, in conjunction with a doctor,
purchases an ITD, upon detection of a viral infection (such as
STDs--Sexually Transmitted Diseases). Then, the woman inserts the
device as per the doctors advice, and based upon remote execution
of firmware codes by a doctors remote device or manual control by
the woman herself, applies medication or light sources to the
regions affected . . . .
[0059] FIG. 2 is a cross-sectional diagram illustrating a
snake-like intravaginal treatment device (ITD) with slender stem
guided through vaginal and cervical channels and into a uterus,
wherein the ITD also assists in the identification, diagnosis and
treatment of conditions within female reproductive systems, in
accordance with the present invention. In particular, within a
monitoring and therapy environment 201, an ITD 265 with slender
stem has been routed and is located within a uterus 275. Therein,
identification and diagnosis of conditions can be observed via
video and image feeds communicated to a control, monitoring, and
fluid source system 253. Light or fluid therapies can also be
delivered via the ITD 265.
[0060] At a head end of the ITD 265, an imager and light source
assembly 269 and a fluid nozzle 273 can be found. Snap shot images
and video can be displayed (on a screen associated with the
control, monitoring, and fluid source system 253) in real time, or
reviewed later via storage associated with the control, monitoring,
and fluid source system 253. Some of the light sources associated
with the imager and light source assembly 269 are dedicated to
illumination for purposes of imager data capture. Others, under the
control of the control, monitoring, and fluid source system 253,
are used for delivery of light therapy. Similarly, the control,
monitoring, and fluid source system 253 manages the flow of fluids
from a container via a pump (not shown but both located within the
system 253), and through a tube located within a flexible stem 279
that leads to the fluid nozzle 273. Fluids for therapy, e.g.,
douches or pharmaceutical constructs, can be disposed with the
container in advance or during the monitoring process.
[0061] Control, power and data exchange signaling between the
system 253 and the electrical components of the ITD 265 utilize a
communication pathway (e.g., wiring) also located within the
flexible stem 279. The control, monitoring, and fluid source system
253 can be a single or multi-piece, dedicated unit, or may comprise
(i) a general purpose computing device (e.g., a PC, laptop, cell
phone, PDA, tablet computer, etc.); (ii) a tailored software
application running thereon; and (iii) a fluid pumping reservoir
with electrical and fluid interfaces for attaching the stem 279 and
communicatively coupling with the computing device.
[0062] Each portion of the functionality underlying the control,
monitoring, and fluid source system 253 can also be migrated in
whole or in part into the ITD 265 and into local and remote
computers, servers, systems and equipment. Using the functionality
of the control, monitoring, and fluid source system 253, a doctor
or patient may manage the overall process.
[0063] The fluid nozzle 273 is connected to fluid pump which
controls the timing, dosage, and intensity of the spraying events.
Such events can be monitored visually via a display screen
associated with the control, monitoring, and fluid source system
253.
[0064] Imagers include an array of photodiodes, such as a charge
coupled device array (a "CCD array") or a complementary metal oxide
semiconductor array (a "CMOS array"). Imager assemblies typically
include lensing mounted within an optical mounting element (often a
hollow tube) that attaches to orient the lensing with the imager.
Integrating or attaching light sources for purposes of illumination
in support of imager data capture are known.
[0065] In addition, light sources that provide therapy can also be
integrated upon or within the optical mounting element of an imager
assembly and/or anywhere else within or on the ITD. Exemplary light
from the imager and light source assembly 269, includes typical
white light of the illuminators for image capture, and therapeutic
light such as infrared (IR), ultraviolet (UV), and particular
frequencies of red, blue, etc. Laser diodes can be tuned and used
for a variety of such light although other sources are
contemplated. In some embodiments, such as were no internal light
sources are used, optical fiber can be used to route the light from
external sources and through an ITD to the target regions.
[0066] FIG. 3 is a perspective diagram of a wearable type of
intravaginal treatment device (ITD) that can be controlled through
wireless communication links or via pre-programmed settings,
wherein the ITD has an optics assembly with two imager and light
source assemblies disposed thereon, and each imager and light
source assembly being used for image capture and for delivery of
light therapy. In particular, a wearable type of ITD 335 with a
stem 303, an optics assembly 305, and a transparent cap 307. The
optics assembly 305 consists of a mounting structure 337 on which
axial and radial imager assemblies 309 and 313, respectively,
affixed thereon. The axial imager assembly 309 captures imager data
(e.g., snap shot images and video) along an axial direction along a
channel of a reproductive organ. The radial imager assembly 313
captures the imager data along the radial direction.
[0067] Imager data from the imager assembly 309 can be used to
assist in real time guidance of the ITD 335 along the intravaginal
channel to and in an appropriate orientation near a cervix, for
example. A finger ring 323 can be used not only during insertion,
but, importantly, during extraction of the ITD 335. The optics
assembly 305 is protected by the transparent cap 307 surrounding
the optics assembly 305. Within the stem 303, all the required
processing circuitry, batteries, and wireless and wired
communication interfaces supporting the functionalities of the ITD
335 can be found.
[0068] As the ITD 335 is a wearable type, communication to deliver
imager data or to receive control instructions involves deployment
of internal wireless communication circuitry such as that
supporting low power and short range proprietary or industry
standard approaches, e.g., cellular, Bluetooth, Zig-bee, or Wi-Fi
standards. Internet and cellular infrastructures can be also used
to extend delivery of imager data and receive control signals from
well beyond the local premises wherein the patient is using the ITD
335.
[0069] The radial imager assembly 313 is mounted on the mounting
structure 337. The mounting structure 337 helps maintain
orientation of the radial imager 313 in the mostly radial direction
relative to the axis of the ITD 303. A plurality of the light
sources 325 placed at the periphery of the axial imager assembly
309 emit light in the mostly axial direction. Similarly, a
plurality of light sources 311 are placed at the periphery of the
radial imager assembly 313 to emit light in a mostly radial
direction. Some of the lights in the plurality of light sources 325
and 311 provide illumination in a white light range to assist in
imager data capture by the underlying imagers housed within the
imager assemblies 309 and 313. In addition, others of the lights in
the plurality of light sources 325 and 311 support light therapy by
delivering light of various other often monochromatic frequencies
that are selected for their therapeutic affects. Outer lenses 315
and 333 of lensing systems within the imager assemblies 333 and 309
assist in focusing reflected illumination from the imager target
onto the imagers within the imager assemblies.
[0070] The embodiment of FIG. 3 supports remote monitoring
functionality for disease or infection reactions (or responses) for
a particular drug or light therapy administered remotely. The
patient under diagnosis will be treated as an outpatient but will
be under the supervision of the doctors through remote wired and
wireless links. The patient can be admitted to hospital as an
outpatient or in some cases the she can even stay at home, but
still be under regular supervision of doctors.
[0071] FIGS. 4a-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. 4b, a fluid
delivery nozzle, all in accordance with various aspects of the
present invention.
[0072] FIG. 4a illustrates a snake like ITD 401 with a segmented
stem 407 carrying an imager assembly at the head end. The segments
405 of the stem 407 makes the ITD of 401 very flexible. The
components of the ITD 401 are mounted such that they conform to the
bending of the stem 407.
[0073] A plurality of light source emitters 417 of the imager
assembly 409 provide illumination and therapy lighting. The imager
assembly also contains lensing 415 and an underlying imager (not
shown). The emitters 417 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 417 may merely comprise optical fiber and
dispersion lensing, and wherein such fiber is routed along side of
or within the stem 407 to a lower portion of the ITD 401 (not
shown). Particular light sources of the emitters 417 can be
selected depending upon the requirement. For example, to disrupt 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.
[0074] The imager assembly 409 communicates with associated
circuitry in a supporting portion of the ITD 401 (not shown) via
wired cabling running within the stem 407. 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
409.
[0075] In FIG. 4b, a fluid delivery system has been piggybacked
onto an ITD 301 which, other than the fluid delivery components, is
identical to the ITD 401 (FIG. 4b). In particular, a fluid delivery
head 423 has a plurality of nozzles 419 for various fluids to areas
within and beyond a vaginal channel via a tube 42. Such fluids
include cleaning solutions and various solutions containing drugs,
dyes, bio-markers, or other pharmacological, biological or
biochemical fluids. Other fluids include fluids used to assist in
diagnosis. Exemplary fluids include acetic acid test solutions,
cervical cancer screening solutions, cervical abnormality screening
solutions, and the like.
[0076] In some embodiments, the tube 421 routes inside a segmented
stem 427, but in the present embodiment, it runs alongside (and may
be affixed to) the segmented stem 407. The tube 421 is connected to
the nozzle fluid delivery head 423 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 421 and out the plurality of
nozzles 419. The pumping pressure can also be adjusted via such
control signaling.
[0077] 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).
[0078] 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."
[0079] 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 401'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
401 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).
[0080] 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.
[0081] 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.
[0082] Light therapy signaling to the one or more light therapy
sources of the plurality of light source emitters 417 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.
[0083] 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.
[0084] FIG. 5 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 501 has a cervical cap 511 covering an imager assembly 509 and
fluid nozzles 517 at a head end (or anterior end of the ITD 501),
and has a squeeze ball 503 at the tail end (or posterior end of the
ITD 501).
[0085] A silicone rubber tube 505 may be detached from a housing
stem 503 of the ITD 501 for convenience when the fluid system is
not being used or during the process of cleaning and filling the
squeeze ball 503 with fluids. Although a squeeze ball 503 is
illustrated, other shapes and manual injections configurations such
as a syringe may replace the squeeze ball 503 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 503 and the
tube 505, if needed.
[0086] A fluid nozzle assembly 519 has the fluid nozzles 517
disposed thereon. The fluid nozzle assembly 519 provides a fluid
pathway to the fluid nozzles 517 and there through to a target area
with a vaginal channel such as a cervical area. In other words,
when the squeeze ball 503 is squeezed, fluid will be forced from
the interior of the squeeze ball 503 and, in sequence, through the
tube 505, an internal pathway 521 within the housing stem 507, the
assembly 519, and, finally, through the nozzles 517.
[0087] The cervical cap 511 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 511, a more controlled treatment
environment within the cervical region can be maintained. More
specifically, along with the fluid nozzle assembly 519, the imager
assembly 509 can is disposed within the cervical cap 511. 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 501. As can be seen, the fluid nozzles 517
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 501 once it has been inserted
and in operation.
[0088] The squeeze ball 503 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.
[0089] The size and angle of the cervical cap 511 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 515 to assist in the illumination and
light therapy process.
[0090] FIG. 6 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 601 has a
fluid reservoir and pumping system 605 disposed with a housing stem
619. Because a cap 603 fully encloses an optics assembly 617, fluid
nozzles 609 are disposed on the outside surface of the cap 603 and
aimed in a typical direction where a cervix may be found, which
differs greatly from female to female.
[0091] As can be appreciated, the target of the nozzles 609 and a
mostly radial imager assembly 613 have at least substantial
overlap. Thus, the nozzles 609 are provided to mostly service the
area of the interest to the mostly radial imager assembly 613 and
not that of a mostly (if not fully) axial imager assembly 611. An
additional nozzle set servicing the imager assembly 611 could be
added at a different location on the cap 603 with service from the
fluid reservoir and pumping system 605 or an independent
counterpart thereof, if so desired.
[0092] As in other embodiments, the size and shape of the cap 603
can be changed by merely replacing the cap 603 with another and
reattaching the new fluid nozzles to a fluid carrying pipe 607.
Although the fluid reservoir and pumping system 605 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.
[0093] The ITD 601 may comprise a wearable ITD (with a relatively
short version of the housing stem 619) or have a hand maneuverable
length (i.e., with a relatively long version of the housing stem
619) that can be grasped even when the ITD 601 is fully inserted.
Triggering of light and fluid therapy approaches are identical to
that discussed in relation to the ITD of FIG. 5. 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 613 (for example) along with twisting,
torquing and adjusting insertion depth of the ITD 601, 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
611, 613 as well.
[0094] 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.
[0095] In addition, although only light sensing imager arrays
(sensors) that are contained within the imager assemblies 611, 613
are illustrated, the ITD 601 can be fitted with a wide variety of
additional sensors such as those described for example with
reference to FIGS. 16 and 17 herein. 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.
[0096] FIG. 7 is a perspective diagram illustrating a tethered
interconnect between one embodiment of an intravaginal treatment
device (ITD) and a laptop computer running support software,
wherein via the tether, collected data may be process, reviewed and
forward, and control signals generated and delivered to the ITD. In
an overall architecture 701 supporting intravaginal therapies, an
ITD 711 is connected to a local laptop computer 731 running
software to process data, control and support targeting of the ITD
711. Such software supports analysis, diagnosis and treatment of
infections and conditions as mentioned with reference to previous
figures.
[0097] The laptop 731 in the present embodiment acts much like the
control and monitoring system 153 (FIG. 1). It receives imager data
from an optics assembly 713, analyzes the imager data, draws
conclusions, and, for such imager data, provides an analysis,
confirmation, and review environment for a user of the laptop 731.
To provide such functionality, the laptop computer 731 runs
application software tailored to support the ITD 711. The software
provides a graphical user interface (GUI) acting as a workbench
from which, for example, a patient or doctors can control setup and
operation of the ITD 711.
[0098] In addition, the ITD 711 can be placed into modes of
operation that have been predefined to provide specific treatment
and functionality. These modes may include predefined treatment
sequences and regimens that instruct a user regarding even fluid
type acquisition, optimal physical orientations, and operating
schedules and durations.
[0099] The ITD 711 operates much the same of the ITD 161 (FIG. 1),
and thus at least most of the description related thereto applies
equally here. The ITD 711 is guided along and through reproductive
organ channels assisted by real time viewing of video and snap shot
images extracted from imager data. Such viewing takes place on a
display 741 of the laptop computer 731, and supports the guiding of
the ITD 711 into an adequate position for both capturing imager
data from and delivering light therapy to a target area within such
channels. As a side benefit, providing such viewing to a patient
while a medical practitioner performs the guidance and diagnosis or
therapy process will help to calm the patient during the entire
process and provide a more rational frame of reference in which to
evaluate a diagnosis.
[0100] For example, after self guiding the ITD 711 into position
using real time video displayed on the laptop computer 731, a
patient captures a fixed, snap shot image (with or without fluid
enhancing support) of her cervix by interacting through the
keyboard of the computer 731. Through colorization analysis tools
and/or comparison with prior images, for example, she may recognize
that a fluid and/or light therapy seem to be reducing a diagnosed
condition. In a note and associated electronic delivery to remote
medical personnel, such at home analysis can be confirmed. This is
possible due to such medical personnel having a copy of such
software running within their remote premises and which receive not
only the note but also have access to all of the sensor and
treatment data collected from and delivered by the ITD 701.
[0101] Likewise, growths, rashes or expelled fluids can be at least
initially "home diagnosed" in a similar way. For example, with
dyes, marker fluids, etc., and/or other sensor or colorization
analysis techniques, chlamydia versus a yeast product or seminal
fluids might be at least tentatively confirmed.
[0102] Potentially cancerous cells could be visualized at early
stages via current high resolution images as compared to similar
images captured some time ago to reveal growth. Such visualization
can be performed "manually" by the patient or doctor or
automatically as a normal process performed by the laptop computer
731 via software direction.
[0103] Other diseases for example venereal warts, sores, vitiligo,
etc. can also be detected at their early stages, simplifying the
treatment process, which can be treated at least in part via fluid
and light therapy delivery via an ITD such as the ITD 701.
[0104] Other noninvasive diagnosis techniques via other sensors
disposed on the ITD 701 (not shown) can supplement the
visualization process, or can be used independent thereof when
visualization offers no discernible value. For example, other types
of sensors can be used to detect or assist in detecting a variety
of characteristics that reveal indications of reproductive system
health, including for example, pH levels, salt levels, viscosity of
intravaginal fluids, colors of uterine fluid discharge, body
temperature, cervical temperature contours, EKG (of mother and
fetus), fetal movement or inactivity, fetal position and size, etc.
Thus, other embodiments of the ITD 711 can include corresponding
sensors beyond merely a visual light sensor array (visual light
imager) illustrated.
[0105] In addition, the ITD 711 as illustrated is tethered to a
universal serial bus (USB) port 773 using a cable assembly 719. The
USB dongle 771 provides an interface between ITD 711 and the laptop
731. For example, the USB dongle 771 provides temporary storage
facility for sensor data (including imager data) collected by the
ITD 711. It also may provide a variety of functionality via
circuitry and firmware therein that assists the optical assembly
713 and the software of the laptop computer 731 in carrying out all
of the aforementioned operations by not only forwarding data and
control signaling, but also via internal processing.
[0106] In some embodiments of the ITD 701, instead of having
illumination and/or therapy lighting within the optical assembly
713, corresponding one or more light sources may be located within
the dongle 771 with optical fiber routing and delivery via the
cable assembly 719.
[0107] Thus, as may be appreciated, overall ITD functionality
described throughout the present application may, as a matter of
design choice, be incorporated in whole or in part within one or
more of the ITD 711, a supplemental intermediary unit such as the
dongle 771, and local and remote, dedicated and general purpose
computing devices such as the laptop computer 731.
[0108] FIG. 8 is a conceptual block diagram illustrating many
possible configurations and embodiments of intravaginal treatment
devices (ITDs) and supporting systems that can be built in
accordance with the present invention. Configurations of ITDs and
supporting architecture distributed over the various blocks
illustrated can be grouped, divided and placed into a distinct
physical forms involving ITDs, local supporting devices, remote
supporting devices, servers, etc., and via wired, wireless point to
point and networked links in accordance with various embodiments of
the present invention.
[0109] The illustrated configuration consists of 4 conceptual
blocks, although more could be added and others subdivided. In
particular, a block 803 comprises various imager assemblies
supported by various monochromatic, polychromatic or panchromatic
light frequencies, illuminating light emitters of such frequencies,
therapy light emitters, fluid nozzles in or out of alignment of
various ones of the imagers' field of views, fluid nozzles aiming
at optics system components for cleaning purposes, and systems for
containing and selectively delivering ones of pluralities of fluids
to such nozzles. Although not shown, other types of sensors can be
provided by the block 803. From these options, at least an
insertable portion of a single or a multi-element ITD can be
constructed.
[0110] A block 807 conceptually contains processing and interface
circuitry 807 that at least assists in managing all of the
functionality described in the various specific embodiments found
in this application. Typically, the content of the block 807 is
distributed in various ways between an ITD, supporting local units
or dongles, supporting local or remote computing (client or server)
devices via communication links supported by various interface
circuitry.
[0111] For example, processing circuitry can be built into an ITD
which performs a vast amount of functionality to operate
independently, or which may performs few functions and thus be
heavily reliant on external processing circuitry support. Beyond
blocks 807 and 803, it is typical to find at least a local display
device to be used at a minimum to calm or educate an examined
patient or provide ITD insertion guidance assistance. Lastly, a
block 815 is also typically present to, for example, at least allow
a remote doctor gain access to ITD data and operations.
[0112] More particularly, in the block 815, a remote networked
server or a remote client device may be configured to connect
through a link 813 to a local display device at the block 811. The
link 813 may represent either or both of wired or wireless links
connecting the local system display device (e.g., a control and
monitoring system) with a remote networked server/client device.
From a remote site, doctors may control the modes and
functionalities of the ITD inside vaginal channel and cervical
region in real-time, or merely monitor the condition of the patient
post facto or in real-time depending on the embodiment.
[0113] Brackets within FIG. 8, indicate several possible grouping
of various functionalities distributed over different blocks 803,
807, 811, and 815. In one embodiment, for example, an ITD consists
of a single block 803 and the associated component functionality as
indicated by the bracket 817. In another embodiment, the
functionality of the block 803 and a part of the functionality of
the block 807 are merged into an ITD as indicated by the bracket
819. At least a portion of the communication link 805 in this case
will be a local connectivity internal to such ITD.
[0114] In yet another embodiment, complete functionality of the
blocks 803, 807 are built within an ITD as indicated by the bracket
821. In such configuration, the link 805 represents internal
connectivity. Similarly, an overall intravaginal therapy
architecture can be built wherein the functionality of the block
807 and the functionality of the block 811 are merged together as
indicated by the bracket 823, perhaps within the laptop computer
731 of FIG. 7, while the block 817 comprises the ITD. In another
overall architecture option, the functionalities of all the 3
blocks 807, 811, and 815 can be merged together as indicated by the
bracket 825. This is equivalent to embodying the functionality of
all the 3 blocks, 807, 811, and 815 into a remote control and
monitoring system at the remote doctors site that connects via an
Internet network pathway to a very simplistic ITD embodiment
supporting not much more that the functionality of the block
817.
[0115] Merging of the functionalities in this manner as indicated
in FIG. 8 provides high degree flexibility during the complete
control and monitoring system design and implementation. It also
provides easy testability of the ITD functionalities along with the
associated software tools.
[0116] FIG. 9 is perspective diagram of an exemplary intravaginal
treatment device (ITD) interfaced with a hand held device (with a
display and diagnosis software) through, for example, a universal
serial bus (USB) port in accordance with one embodiment of the
present invention. For ease of use and carrying, an ITD 911 is
configured with a dongle 931 and tethered interconnect 919 there
between is supported by an application program downloaded into a
hand held device 933 such as a smart phone. Both the hand held
device 933 and the ITD 911 form at least a part of an overall
intravaginal therapy architecture 901 which can be extended, for
example, through a wireless cellular network via antenna 939 to
some remote servers or client devices, e.g., devices used by a
remotely located doctor.
[0117] The hand held device 933 has a display 935 on which imager
data can be displayed in real time or reviewed at any time
thereafter. Analysis procedures coded in software support imager
data review. Similarly, if other sensors are present, other
analysis procedures that are independent or supplemental thereto
can be found. The hand held device has a connector 941 that accepts
in a "plug-in" like mating, the dongle 931. The connector 941 may
comprise a proprietary or industry standard serial or parallel,
electrical or optical link that may be available. It may also be
replaced with a wireless link. The dongle 931 itself may merely
comprise a communication pathway if additional circuitry and
functionality associated with the communication standard therefore
is built within the ITD 911. Otherwise, such circuitry and
functionality may be built within the dongle 931 itself.
[0118] The hand held device 933 facilitates video image processing
and display functions, and, for example, diagnosis and treatment of
a condition or disease by directing operation of light and fluid
therapy delivery. Because of the hand held sizing, a woman can
easily insert and guide the ITD 911 into position with one hand,
while viewing to support or initiate such guidance, analysis, and
therapy delivery.
[0119] The software that runs on the hand held device 933 provides
a simple GUI environment via the screen 935 and a keypad 937. The
GUI acts can also act as a workbench from which doctors or the
patient can setup, program, or pre-program the functionality of the
ITD 911. It can also be used to launch analysis procedures, route
collected sensor data for remote storage or review, and facilitate
doctor-patient communications relating thereto.
[0120] The ITD 911 itself consists of the optics assembly 913
within an enclosure 943, a stem 917, a tethered cable assembly 919,
and the dongle 931. The cable assembly 919 carries wires, optical
fibers and/or fluid pathways (not shown) for conveying or
exchanging power, data and control signaling, and light (if any of
the light sources are disposed within the dongle 931 for
example).
[0121] The dongle 931 may also provide temporary storage of battery
power or data and control signals such that the ITD 911 can be
operated even when the hand held device 933 is powered down or
performing another unrelated function. The dongle 931 may also be
integrated in whole or in part into the ITD 911. As such,
attachment of an interconnecting cable (between the integrated
dongle and the hand held) or substituting such wired link with a
wireless approach can allow for an overall operation between the
ITD 911 and the device 933. Other such variations are also
contemplated including, for example, having some or most of the
functionality of the hand held device 933 migrated to (or
duplicated at) a remotely located device (client or server, for
example).
[0122] FIG. 10 is a perspective diagram of another embodiment of an
intravaginal treatment device (ITD) tethered to a supporting hand
held device illustrating that more or less of functionality carried
out by the ITD can be moved to or from the domain of such
supporting hand held device. Carrying on with the migration
concepts set forth in FIG. 9 above, an ITD 1011 communicates
through a direct link, i.e., a cable 1019, to a hand held device
1033, wherein all functionality that might otherwise be located in
a dongle (and possibly more functionality that would otherwise be
performed by the hand held device 1033) can be found to be
performed by a circuit 1031.
[0123] As before, the hand held device 1033 has a display 1035,
keyboard 1037, socket 1041, and an antenna 1039. The ITD 1011
consists of an optics assembly 1013, an optics cover 1043, a stem
1017, the circuit 1031 and the cable 1019.
[0124] The hand held device 1033 runs application software tailored
for interacting with the ITD 1011. Such software provides a simple
(graphical user interface) GUI environment on the display 1035. A
user (patient or medical staff) through the GUI may set both the
software and the ITD 1011 in one of a plurality of different modes
of operation. Such setup can also be conducted by remote support
devices via the antenna 1039. Modes and specific settings related
thereto can be accessed, for example, via tabs, drop-down menus,
etc., presented on the display 1035. Components within the ITD 1011
may be represented in the form of an icon or a tab in the GUI
window. Any operation defined via the icon or tab will in-turn
assist in a physical configuration of the respective component
inside the ITD 1011.
[0125] Defined modes may include testing modes, monitoring modes,
diagnosis modes, and treatment modes. During one treatment modes,
for example, selection of a fluid along with a volume, rate or
duration and schedule, will trigger a confirmation and subsequent,
appropriate fluid delivery. Light therapies independent thereof or
integrated therewith may also be so set up via a treatment
mode.
[0126] The circuit 1031 may contain digital signal processing (DSP)
functionality that may process sensor (including imager) data in
advance of delivery to the hand held device 1033. The circuit 1031
may also manage all control signals received from the hand held
device 1033 (pursuant to its application software) to carry out
control of the components of the ITD 1011. The circuitry 1031 may
also comprise communication and power regulation circuitry. As
shown, the circuitry 1031 may be placed within the stem 1017 at one
particular location. Alternatively, it may be distributed in one or
more other locations within the ITD 1011.
[0127] The optics assembly 1013 may contain multiple imager
assemblies, multiple light treatment emitters, and multiple
illuminators assisting such multiple imager assemblies. Fluid
therapy infrastructure (although not shown) can also be integrated
within the ITD 1011 and perhaps under the control of the circuitry
1031.
[0128] FIG. 11 is a perspective diagram of a further embodiment of
an intravaginal treatment device (ITD) that has a wireless
transceiver circuitry for communicating to a supporting hand held
device, wherein the circuitry and an antenna is integrated within
the tail end of the ITD to attempt to minimize any negative effects
that may be caused by transmissions within or near body tissues.
Therein, an ITD 1111 and its underlying components and structures
perform with identical operations and have nearly identical
possible variations as the ITD 1011 (FIG. 10). One clear difference
in the illustration can be found in the location of radio circuitry
at the base of and within a stem 1117 which replaces the cable 1019
(FIG. 10)
[0129] More specifically, within the ITD 1111, with a wireless
transceiver chip 1133 integrated in its tail end. The wireless
transceiver chip communicatively couples with a hand held device
1141 via a wireless link 1135 to a radio antenna 1137 of the hand
held device 1141. The radio antenna 1137 connects to a transceiver
circuit (not shown) within the hand held device 1141 to provide
communication flow between an application program running thereon
that is tailored for interacting with the ITD 1111. The same
transceiver circuitry and the radio antenna 1137 or additional
counterparts therefor and within the hand held device 1141 support
additional wireless communication via wireless link 1143 which
leads to other local or remote supporting systems.
[0130] The power for the various components inside the ITD 1111 is
provided by batteries encapsulated in the tail end of the ITD 1111
(not shown). All the raw or preprocessed imager data and control
signals can be exchanged wirelessly (in real time or post facto
from storage) between the hand held device 1141 and the ITD 1111.
As illustrated, the ITD 1111 contains a processing circuitry 1131,
the transceiver circuitry 1133, and the optics system 1113. The
optics system 1113 includes light therapy emitters and illuminators
supporting various imagers. Although not shown, fluid therapy
infrastructure can also be integrated therein.
[0131] As mentioned, the antenna 1137 facilitates wireless coupling
between the ITD 1111, the hand held device 1141, and possibly
remote supporting devices (not shown). Using the antenna 1137 and
any counterparts, the hand held device 1141 can consume, process
and/or forward sensor data, control signals, textual notes in
upstream (to other supporting devices) or downstream (to the ITD
1111). Such wireless communication may involve wireless cellular,
WAN, WLAN, WPAN, or direct wireless point to point links.
[0132] FIG. 12 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 1201 contains a
radial imager assembly 1207 (containing a mostly-radial oriented
imager 1206) and the axial imager assembly 1215 (containing a
mostly-axial oriented imager--not shown). The imager assemblies
1207 and 1215 are attached to a mounting structure 1203 of optics
assembly 1241. The optics assembly 1241 can be moved in an axial
direction 1239 and a rotational direction 1237.
[0133] To increase focal distance in a mostly radial direction, the
radial imager assembly 1207 is mounted slightly off center and upon
a flexible portion 105 of the mounting structure 1203. The imager
assembly 1207, in addition to the imager 1206, has a lensing system
1227, a plurality of light therapy sources capable of emitting
light at any specified one or more frequencies, i.e., via an IR
light source 1223, UV light source 1225, monochromatic blue light
source 1219, and monochromatic red light source 1221. The light
therapy sources 1219, 1221, 1223 and 1225 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.
[0134] The axial imager assembly 1215 is mounted slightly off
center of the cylindrical base 1203 to allow mounting space for the
radial imager assembly 1207. The axial imager assembly 1215 is
attached to a flexible vertical portion 1217 of the mounting
structure 1203. The axial imager assembly 1215 also has lensing
1213 (supporting the underlying imager) and a plurality of light
therapy sources mounted thereon, including: an IR light source
1211; UV light source 1213; blue light source 1233; and red light
source 1229. Power, power level and duty cycle control as with the
light therapy sources of the imager assembly 1207, can be fully
controlled by internal processing circuitry, devices outside of the
ITD, or by a combination of both.
[0135] Light source illuminators supporting image data capture by
the imagers within the imager assemblies 1207 and 1215 are not
shown but may also be incorporated into the imager assemblies 1207
and 1215 or into either another location within the optical
assembly 1201 or at some other location within an ITD that includes
such optical assembly 1201. 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.
[0136] The radial imager assembly 1207 can be moved in the
direction indicated by the arrow 1235 by perhaps .+-.20.degree. to
fit a particular female's anatomy. Similar adjustments may be made
to the axial imager assembly 1215. The complete optics assembly
1241 can be axially moved along the direction of a stem of an ITD,
or rotated for better alignment as illustrated by arrow 1237.
[0137] FIG. 13 is a perspective diagram of another embodiment of an
optics assembly that may be used in constructing an intravaginal
treatment device (ITD) in accordance with the present invention,
wherein the optics assembly has a stem, mounting structure, and an
array of radial imager and light source assemblies for capturing a
variety of types of images and producing light source therapy.
Therein, an optics assembly 1301 has a mechanical structure 1303
with a flexible mounting portion 1307 that supports an attached
plurality of imager assemblies. The radial, axial and rotational
adjustability of the optics assembly 1201 (FIG. 12), applies
equally herein, e.g., via radial 1305, axial 1339 and rotational
1337 adjustments.
[0138] The plurality of imager assemblies 1309, 1311, 1313 and 1315
each contain an imager for capturing images of an intravaginal
target such as a region of a cervix. But instead of having all such
imagers operate solely in the white light region, each imager is
directed to capturing images in differing electromagnetic wave
frequencies or ranges. Specifically, the imager within the imager
assembly 1309 is designed for use in the white (visible) light
range and with RGB filter elements that assist in the imager's
ability to capture high resolution color imager data (i.e., color
images and video). To assist in this process, all four periphery
light sources disposed in the imager assembly 1309 emit white
light.
[0139] Similarly, an imager located within the imager assembly 1315
is selected for infrared (IR) image capture at a frequency range
typically associated with cervical temperature ranges. When
capturing images of the cervix within such temperature range, no
other emitter but the cervix itself is needed. Even so, the four
periphery mounted light sources of the imager assembly 1315 may
selected to cover various other therapeutic frequencies or
frequency ranges. Likewise, the imager within the imager assembly
1311 is directed to UV frequencies for image capture and includes a
corresponding four periphery mounted UV light sources which can not
only be used to assist in image capture, but can also be used for
therapeutic light delivery.
[0140] The imager within imager assembly 1311 may operate at any
other frequency range or for binocular pairing with any other of
the imager assemblies with the peripheral light sources mounted
thereon assisting in such purpose as illuminators and, if desired,
in providing light therapy as well.
[0141] FIG. 14 is a perspective diagram illustrating another
approach for integrating light sources for light therapy or for
illumination for imager data capture into an optics assembly 1401.
In particular, a light source 1409 constitutes an illuminator as it
operates to produce reflections from an intravaginal target to
assist an imager 1407 in capturing imager data. The light source
1415 produces light for therapy, i.e., produces light at a
therapeutical frequency or frequency range.
[0142] The light sources 1409 and 1415 are mounted on the outside
of an imager assembly 1406, but could be mounted anywhere else in
the optics assembly 1401 or outside thereof in association with
some other construct of an ITD. By being co-mounted, however,
targeting using real time displays generated from image capture
data allow for co-targeted exposure areas for light therapy
treatment.
[0143] All other aspects regarding the optics assembly 1401 can be
found with reference to corresponding parts and functionalities
described with reference to FIGS. 12 and 13.
[0144] FIG. 15 is a perspective diagram of an optics assembly 1501
having an imager assembly that employs optical fiber through which
a variety of frequencies of light can be delivered from light
sources either within or outside of an intravaginal treatment
device (ITD). The optics assembly 1501 is fitted with two optical
fibers 1511 and 1513. The fibers 1511 and 1513 are attached and in
mostly optical alignment with an optical pathway of an imager
assembly 1507.
[0145] Connected at the opposite end of the fibers 1511 and 1513, a
plurality of light sources (not shown) can be found. Such light
sources, depending on the configuration, could be located within
the housing of an ITD or be found outside of an ITD in a supporting
device. Either way, such plurality of light sources include light
sources that provide (i) illumination light of a frequency or
frequencies to be used to support image capture by an imager 1506
of the imager assembly 1507 such as white light, and (ii)
therapeutic light of a frequency or frequencies to be used in
providing light therapy. In this way, a variety of light can be
delivered to serve various purposes and as needed without
significantly impinging on the limited space within the optics
assembly 1501.
[0146] The ends of the fibers 1513 and 1511 can also be formed,
polished, abraded or otherwise processed to provide better
dispersion of light or adjust a coverage area (e.g., such as
mapping the illumination area to the field of view of the imager
1506). Alternatively, the fibers 1513 and 1511 can be fitted with
end caps providing the same or other optics functions with elements
therein such as polarizers, apertures, filters, diffusers, etc.
Moreover, both fibers 1511 and 1513 may operate to deliver
identical types of light or work separately and simultaneously for
two types of therapy delivery or to deliver therapy while capturing
imager data.
[0147] FIG. 16 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 1601 includes an interface and control
circuitry 1607 which arbitrates and prioritizes data acquisition
and transmission to and from various ITD components and supporting
devices and systems outside of the ITD.
[0148] For example, the interface and control circuitry 1607
directs the capture of imager data via control signals delivered to
imager devices 1603 and retrieves resultant captured imager data
therefrom. The circuitry 1607 may store such image data locally
within a memory 1609 and/or route to devices outside of the IDT via
wired and/or wireless communication interfaces 1619 and 1621. The
circuitry 1607 is responsive to incoming commands and controls via
the communication interfaces 1619 and 1621 as well. Such commands
and control are translated by circuitry 1607 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 1603 and providing illumination
therefore, activating fluid pump 1623, delivering stored
information via the wireless communication interface 1621, etc.
[0149] Other activities of the circuitry 1607 include activation,
retrieval, storage and forwarding of other sensor data from a
microphone 1615 and supplemental sensors such as orientation and
motion indicators, fluid level indicators (fluid reservoir), pH
sensors, thermometers, sonograms, EKGs, and a variety of other
bio-sensors, for example.
[0150] Sensor data retrieved may also be processed or preprocessed
by the circuitry 1607 in preparation for display or analysis. If
so, even further, automatic analysis could lead to conclusions all
possibly performed by the circuitry 1607 or by an external support
device. The circuitry 1607 also manages directly (or indirectly via
remote control) the application of light and fluid therapies.
[0151] Each of the imager devices 1603 responds to control signals
to capture and forward imager data. The imager assembly 1603 may
contain one or more of a monochromatic light sensitive imager 1631,
a UV light source sensitive imager 1633, an IR light sensitive
imager 1635, MRI (magnetic resonance imaging) imager 1637 and other
source sensitive imagers 1651, 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.
[0152] The light therapy block 1605 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 1639
may be used for example to kill bacteria which respond to a
specific frequency or frequencies in the UV spectrum. A red light
source 1641 may be used to illuminate lesions, abrasions and cuts,
by inducing tissue healing. A blues light source 1643 may be used
against bacteria or virus infected tissues. The other light sources
1645 pertain to any therapy that involves light energy such as
X-rays, laser, IR light, etc.
[0153] The internal light sources 1649 are the sources of light of
specific frequencies and frequency ranges housed within an ITD of
the present invention. An external light source 1647 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.
[0154] As mentioned, the supplemental sensors 1613 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 1615 is an audio range sensor that can be used to
capture fetal or female heart rate(s), movement, etc.
[0155] The user interface 1617 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) 1617. Such user could be the patient, doctor, medical
assistants, etc.
[0156] The wired communication interface 1619, 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 1621 may also offer proprietary and industry standard
communication, such as Bluetooth, Zig-bee, or Wi-Fi.
[0157] A fluid pump 1623 associated with a fluid reservoir 1625 may
contain any number of fluids as described in detail relating to the
preceding figures.
[0158] The power regulator unit 1611 manages power delivery to ITD
components and circuitry. Depending on the construct, power can be
delivered wirelessly, via wire, replaceable or rechargeable
batteries 1629, etc. Power charging and regulation circuitry 1627
manages the delivery to insure stable and sufficient power is
distributed and, if employed, the rechargeable batteries 1629
receive adequate recharging.
[0159] FIG. 17 is a schematic block diagram of a monitoring and
treatment architecture 1701 built in accordance with various
aspects of the present invention, and which an intravaginal
treatment device (ITD) 1703 couples with various control and
monitoring devices distributed physically across many locations. At
locations within the same premises of the ITD 1703, local support
devices 1705 can be found that assist the ITD 1703 in detecting,
monitoring and treating reproductive system issues.
[0160] The local support devices 1705 include, for example, a cell
phone 1733, PDA 1735, laptop 1737, and other local supporting
systems 1739, such as: (i) local medical diagnostics equipment,
external sensors (e.g., microphones, cameras, blood pressure, heart
monitors, glucose measurement devices, etc.); (ii) other local
computing devices (e.g., tablet computers, desk top units, servers,
etc.); and (iii) imager data display devices (e.g., dedicated
monitors and television screens).
[0161] Similarly, at locations remote from the ITD 1703, such as at
a health care center, on a home of medical staff member (e.g., via
a tablet computer or smart phone), and/or any other remote facility
or location, remote support devices 1707 such as a supporting
computer system 1741 and supporting medical diagnostic equipment
1743 can be found.
[0162] Another supporting system, a server or access point 1709 may
be located locally or remotely (or both via comprising two
independent units). As a local server (perhaps running on one of
the patient's local computing devices) or remote server (e.g., an
Internet server), the server or access point 1709 provides both
direct and indirect support to the ITD 1703. For example, the
direct support might involve captured data processing and/or
analysis. The indirect support includes the provision of real time
and delayed routing pathways (via postings and delayed, subsequent
retrievals) between the various components of the monitoring and
treatment architecture 1701.
[0163] At the same premises as the ITD 1703, either during direct
interaction with the ITD 1703 during a monitoring and treatment
procedure or after the fact to extract information related thereto,
the ITD 1703 interacts with one or more of the local support
devices 1705 via a wired or wireless link 1763 or 1765,
respectively, for communication exchange. For example, the ITD 1703
delivers collected imager data (e.g., still images and/or video
image data, each at one or more resolutions) for real time display
on the laptop 1737 for use by a patient in such patient's insertion
guidance, condition detection, therapy targeting and management,
and determining treatment efficacy. Other sensor data may be
similarly delivered and utilized. Such deliveries may involve point
to point communication (via the links 1763 or 1765) or via routing
through ones of links 1745, 1755, 1747 and 1749 and the server or
access point 1709.
[0164] The ITD 1703 also receives a variety of types of control
signals that may originate in local support devices 1705, the
server or access point 1709 (when comprising a server), or the
remote support devices 1707. Such control signals may also or
alternatively originate with the external server 1709 or the remote
support devices 1707. They may be conveyed directly to the ITD 1703
via a point to point link, or indirectly via routing
infrastructures that may or may not involve ones of the underlying
local support devices 1705, the external server 1709 and the remote
support devices 1707.
[0165] The controls signals are used, for example, to direct
operations of light sources (on, off and intensity), imager other
sensor's data collection, collected data (pre)processing and
delivery, fluid injection, local memory management, etc. That is,
the control signals at least assist if not fully control the
management of one or more functional procedures performed by the
ITD 1703.
[0166] The communication protocol for wireless local and remote
communication could be selected from one or more proprietary or
industry standard approaches, such as Bluetooth, Zig-Bee, Wi-Fi,
etc. Similarly, wired communications defined by one or more
proprietary or industry standards, such as USB, Ethernet, firewire,
etc., might also be included.
[0167] The local support devices 1705 are communicatively coupled
with the ITD 1703. The local support devices 1705 are also coupled
indirectly through the server or access point 1709 with the ITD
1703. The use of direct or indirect coupling may depend on
functionality goals or communication link availability.
[0168] The computer systems 1741 of the remote support devices 1707
might similarly comprise the same types of the local support
devices 1705. Moreover, remote and local labeling is relative to
the current location of the ITD 1703. For example, when the ITD
1703 is used in the locality of the support devices 1705, such
devices earn the illustrated label "local." Similarly, when using
the ITD 1703 locally at the premises of the support devices 1707,
the label "remote" should be changed to "local" and so on. Thus,
the labels "remote" or "local" are based on the location of the ITD
1701 at the time of use thereof. For example, when at the doctor's
facilities, the local support devices 1705 might all be doctor's
devices, and the remote support devices 1707 might comprise
patient's devices within the patient's home.
[0169] The local and remote support devices 1705 and 1707 may
comprise proprietary and dedicated support devices or general
purpose devices that each execute application software that directs
ITD support. Such devices 1705 and 1707 may intercommunicate
directly or via the server or access point 1709, and may be highly
portable. For example, doctors using one such device (e.g., a
tablet computer) may freely move within a "local" facility and to
"remote" locations, while continuing to interact with the ITD 1703
or captured data therefrom.
[0170] The computer systems 1741 and the medical diagnostic
equipment 1743 may intercommunicate via a local area network (LAN)
within the remote location (e.g., a health care center). The
computer systems 1741, in general, provide for primary interaction
with the ITD 1703. The medical diagnostic equipment 1743, in
general, provide supplemental information and analysis for the
computer systems 1741. For example, the equipment 1743 might
include an analysis system that responds to an input (such as data
or tissue), and might output measurements and conclusions based
thereon, and wherein such measurements and conclusions being
delivered to the computer systems 1741 and being for integration
into the condition identification, therapy selection and delivery,
and efficacy determination processes. Such analysis might be in
real time, based on real time data from the various sensors within
the ITD 1703, or post facto.
[0171] The input to the equipment 1743 might comprise data from the
ITD 1703 or, based thereon, post processed information from the
local or remote support devices 1705 and 1707. Such data might be
derived from any of the sensors within the ITD 1703, e.g., pH,
glucose, temperature, imager, ultrasound, magnetic resonance,
microphone, or any other bio-mechanical, bio-electrical or
bio-chemical sensors disposed inside the ITD 1703. In addition,
such data might be generated from the other local supporting
systems 1739. For example, other sensors (including, but not
limited to, those types disposed in the ITD 1703) may be integrated
into independent devices, i.e., into one or more of the other
supporting systems 1739 outside of the ITD 1703. The input to the
equipment 1743 may also comprise manually collected input of
tissues, bio-fluids or other bio-material collected without
assistance from the ITD 1703.
[0172] The medical device equipment 1743 may involve merely direct
computer analysis of input data, and may involve a complex manual
and automated process using cultures, marking or other biochemical
operations to produce the measurements, further data and
conclusions to be delivered to the computer systems 1741.
[0173] The ITD 1703 of the present embodiment has
sensor/instruments 1711, fluid container and pump 1713,
imagers/photodetector 1715, light sources 1717, communication
interfaces 1719, user interfaces 1727, memory 1729, processing
circuitry 1731, and power regulator and management circuitry
1721.
[0174] The other sensor/instruments 1711 is a plurality of
supplemental sensors like pH sensors, temperature sensor,
biochemical sensors, and so on. They may directly measure or
provide indications of the current state of a female's reproductive
system, such a pH value, body temperature, yeast levels, fetal
heart rate, etc. The fluid container and pump 1713 is a fluid
reservoir component (discussed in FIG. 4-6) having multiple fluid
chambers; in each fluid chamber, fluids of specific type is stored.
The fluid container and pump 1713 provides a smooth injection of
these fluids into the reproductive organs of the woman under
diagnosis.
[0175] The imagers 1715 are optical imagers discussed earlier, for
example, with reference to FIG. 12-15, that captures imager data
(still image data and/or video data) of various intravaginal
targets within the female's reproductive system. The light sources
1717 include both illuminators supporting the imagers 1715, and
therapy delivery light sources. For therapy lighting, the light
sources 1717 include a plurality of adjustable intensity, (mono-,
pan-, and poly-chromatic) light sources of different frequencies or
frequency ranges. The processing circuitry 1731 may direct such
intensity to deliver modulation, duty cycling, etc., to optimize
and otherwise manage therapy. Such direction may be initiated by
the processing circuitry 1731 itself, or in response to external
control signals from the local or remote support devices 1705 and
1707.
[0176] The ITD 1703 has user interfaces 1727 which provides a mean
of user interaction with ITD 1703. For example, for delivering user
input, buttons, touch pads, keyboards, microphones, motion
detection sensors, switches, etc., might be included in or on a
housing of the ITD 1703. For communications from the ITD 1703 to a
user, speakers (for delivering voice, beeps, vibrations, music,
etc.), displays (presenting a GUI and/or imager data, for example),
LED indicators, etc., might similarly be disposed within the ITD
1703. Overall, the user interface 1727 provides a mechanism through
with a user can configure, control and receive feedback from the
ITD 1703.
[0177] The processing circuitry 1731 of ITD 1703 may comprise a
signal processing circuitry for processing imager data captured by
the imager 1715 for display by the ITD 1703 or by a supporting
device 1705 or 1707. Such processing may also involve analysis used
to assist in identification of a gynecological event, artifact or
condition.
[0178] Power may be delivered via a tethered (wired) connection,
via disposable batteries, or wirelessly. The power regulator and
power management circuitry 1721 manages the stable delivery of
power within the ITD 1703. As illustrated, the ITD 1703 is fitted
with a rechargeable battery 1761 through which the circuitry 1721
derives power. The circuitry 1721 also manages charging of the
batteries 1761 when wireless or wired external power sources become
available.
[0179] FIG. 18 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 reproductive system 1801,
a therapy light 1813 built within a stem portion of an ITD 1809 to
deliver light therapy to areas along the length of the vaginal
channel. Similarly therapy lighting is also placed as described
heretofore in an optics assembly 1815 of the ITD 1809. Both sources
of therapy lighting are controlled by underlying circuitry within
the ITD 1809, and may also be controlled via control signals
originating outside thereof from external support devices.
[0180] 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.
[0181] If configured with appropriate therapy delivery and
monitoring infrastructure, the ITD 1809 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 1809, 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 1809.
[0182] 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.
[0183] The therapy light 1813 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 1809 as shown. As with the therapy lighting
associated with the optics assembly 1815, the therapy light 1813
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 1813
impact organisms, viruses, fungus, fluids and tissues of or upon
the vaginal walls 1805. 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.
[0184] Similarly, the ITD 1809 of present invention is also used
for healing and enhancing the elasticity of the vaginal channel
walls 1805, for example, using red light emissions. Moreover, if
the optics assembly 1815 and end portion of the ITD 1809 are
appropriately sized, the ITD 1809 can be inserted into further
intravaginal areas such as through a cervical channel 1823 and
beyond into the uterus, and to provide similar therapies for
healing and to address therein viral, fungal and bacterial
intruders, for example.
[0185] The guiding of the ITD 1809 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 1809. The optics assembly 1815
with axial imager assembly 1817 and radial imager assembly 1819 is
used to capture video image (frames) of intravaginal
channel/intracervical region walls.
[0186] FIG. 19 is a cross-sectional diagram illustrating use of a
plurality of light emitting diodes (LEDs) disposed along a
snake-like stem of an intravaginal treatment device (ITD) 1903 for
delivering light treatment deep within a female's reproductive
organs in accordance with various aspects the present invention.
Within an intravaginal region of a reproductive system 1901, a
snake-like ITD 1903 having an array of low power LEDs of specific
color(s) used for light treatment deep inside reproductive organ of
woman in accordance with the present invention. The LED array
emitting optical frequencies: IR, UV, blue light, red light,
monochromatic light, laser, etc. are used for light therapies for
the reproductive system 1901.
[0187] A series of light therapy elements 1925, each element such
as an LED (light emitting diode) 1927, may be either disposed on
the surface the ITD 1903, or disposed entirely within the stem
housing of the ITD 1903. In the latter case, the light therapy
elements are supported by transparent or translucent light pathways
of the housing of the ITD 1903. As illustrated, the light therapy
elements 1925 are arranged in series (of course, each could been
independently driven or connected in parallel). The ITD 1903,
although usable within the vaginal channel 1923, is sized to be
guided inside deeper intravaginal regions of the reproductive
system 1901, such as within and beyond the cervix, i.e., cervical
channel, uterus, fallopian tube, ovarian region, etc. For
illustration purposes, the width of the stem portion of the ITD
1903 is exaggerated to allow details of the inner lighting
structure to be identified. Similarly, the length of the stem of
the ITD 1903 may be much longer so as to be able to reach the inner
recesses of the reproductive system 1901 while perhaps
simultaneously delivering therapy throughout.
[0188] The light therapy elements 1925 may be of a single frequency
(or single frequency range) for delivery of one type of therapy, or
comprise groupings of light elements with each group being directed
to other frequencies or frequency ranges. Each such grouping may be
spread and intermixed with other of such groupings within the ITD
1903.
[0189] A controller and driver 1911 of the ITD 1903 manages
operations of the light therapy elements 1925 through a cable 1937
via electronic power and, depending on the embodiment, control
signaling. In some embodiments, at least some of the sources of
light for the light therapy elements 1925 originate from within the
controller and driver 1911, e.g., via light elements attached to
optical fibers associated with the cable 1937. In yet other
embodiments, at least some of the controller and driver 1911
functionality is moved within the snake-like stem of the ITD 1903,
possibly eliminating the need for the independent controller and
driver unit 1911. In addition, the snake-like stem of the ITD 1903
may remain outside of the intravaginal regions or be sized for full
or partial insertion therein. In the latter case, the cable 1937
might be replaced with a direct connection between the stem portion
and the controller and driver element 1911. Lastly, the controller
and driver unit 1911 might further comprise all or any part of the
functionality described herein with relation to other ITDs
embodiments set forth herein.
[0190] In addition, although not necessary to for therapy delivery,
an optics assembly may be placed at the head end 1941 of the ITD
1903, such as in higher cost versions. Therein, such optics
assembly may be configured and perform in the same ways described
in relationship to the various optics assemblies described
here.
[0191] FIG. 20 is a perspective diagram of a scanning optics
assembly inside the head end of intravaginal treatment device (ITD)
of one embodiment of the present invention wherein light therapy
can be scanned across an overall scanning region of the scanning
optics, or directed only to an area of interest within the overall
scanning region using laser light duty cycle control. Therein, a
scanning optics assembly 2033 within a head end 2003 of the ITD
2011 is illustrated. The scanning optics assembly 2033 has a
mirrors 2007 and 2019 which are correspondingly driven by rocker
motors 2009 and 2027. The mirrors are mounted on a motor shaft in
an adjustable orientation. A light source 2029 is disposed in the
scanning optics assembly 2033, and it emits light at a particular
therapeutic frequency.
[0192] Although as illustrated, the light source 2029 is only a
single laser diode, additional laser diodes and other directional
light sources (e.g., sources of the same or different therapeutic
frequencies or ranges, and/or sources for non-therapy purposes such
as illuminators) can be added. If so, such other light sources can
take advantage of the scanning functionality described herein.
[0193] Specifically, the light source 2029 emits a light beam 2005
toward the mirror 2007 which rocks back and forth in a scanning
motion along a first axis. The scanning rate and range of the
mirrors 2007, 2019 are controlled via both the design of the motors
2009, 2027 and to some extent by control signaling originating from
within or outside of the ITD 2001.
[0194] The light beam 2005 reflects off the mirror 2007 in a first
axis scanning fashion to impact the mirror 2019 which oscillates at
a different rate and range in a second axis scanning fashion. As a
result, the light beam 2005 is reflected (as illustrated by a light
beam 2025) in a row and column scanning fashion across two axes. As
with the motor 2009, the motor 2027 may be controlled via design
and internally or externally originating control signals.
[0195] By turning on and off the light source 2029, a lesser area
within a full scanning field can be exposed. By changing the rocker
motors 2009, 2027 rocking angle, the full scanning area can be
reduced or otherwise resized to correspond to a target area. By
changing rocking frequencies, scanning resolutions can be changed.
By changing the emission intensity of the light source 2029 or
adjusting duty cycles, control over therapy or illumination can be
exacted.
[0196] In other words, the optics assembly 2033 can be controlled
in a precise way such that the light beam 2025 scans a two
dimensional (2D) area in a manner similar to raster scanning in
cathode ray television tubes. This scanning in 2D area is achieved
for example when the mirror 2007 scans slowly along y-axis, while
the mirror 2019 scanning relatively fast along an x-axis.
[0197] To either monitor a therapy process or wherein the light
source 2029 also comprises an illuminator, a single photodetector
or imager 2013 can be included. As illustrated, the reflections to
the photodetector or imager 2013 return outside of the scanning
process, but can also follow the same return path with proper
re-orientation of the device 2013.
[0198] FIG. 21 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 2109 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.
[0199] In particular, the snake-like portion of the ITD 2109, a
segmented section 2107 along with the head end portion 2113, as
illustrated is routed into a uterus 2111. A much larger portion
relative to the snake-like portion, i.e., a base 2121, 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 2109
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.
[0200] The snake-like stem portion, the segmented section 2107, of
the ITD 2109 is similar to that discussed with reference to FIGS. 2
and 4, and with much the same characteristics and functionality. As
such, the segmented section 2107 is designed to be flexible enough
to be guided along curvilinear intravaginal channels within the
reproductive system 2101. In addition, on the tail-end of the ITD
2109, a finger ring 2115 provides finger grip that assists in
insertion, removal and stabilization during wear.
[0201] The base 2121 of the ITD 2109 may be configured for
relatively simplistic or advanced modes of operation, with
corresponding functional components and circuits built inside such
as those described with reference to FIG. 16 or 17. For example,
within the base 2121, signal processing, communication interface,
sensor, battery power and user interface circuitry and associated
components can be found.
[0202] The cylindrical base 2121, if so configured, also contains a
fluid reservoir and pump that injects fluids via the segmented
section 2107 and nozzles mounted in the head end portion 2113.
[0203] 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.
[0204] Throughout the present disclosure, 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 are
contemplated.
[0205] As one of ordinary skill in the art will appreciate, the
terms "operably coupled" and "communicatively coupled," as may 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 may 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."
[0206] 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.
[0207] 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 may 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.
[0208] 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.
[0209] 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 may be practiced within the spirit and scope of
the invention, as limited only by the scope of the appended
claims.
* * * * *