U.S. patent application number 12/890847 was filed with the patent office on 2011-08-04 for intravaginal optics targeting system.
Invention is credited to James D. BENNETT, Witold Andrew Ziarno.
Application Number | 20110190582 12/890847 |
Document ID | / |
Family ID | 43796249 |
Filed Date | 2011-08-04 |
United States Patent
Application |
20110190582 |
Kind Code |
A1 |
BENNETT; James D. ; et
al. |
August 4, 2011 |
INTRAVAGINAL OPTICS TARGETING SYSTEM
Abstract
Intravaginal monitoring devices (IMDs) with adjustable optics
assemblies support local and remote control of mechanical and
electro-mechanical mechanisms associated with multiple imagers and
other sensors for tailoring an IMD to meet the specific dimensions
and characteristics of various female reproduce systems. Such
mechanisms also assist in guiding and analyzing pathways through a
vaginal channel to and including a cervix. Exemplary pivoting,
rotational, and telescopic infrastructures with integrated, local
and remote control and monitoring are supported with external
visual displays of images and video streams in devices such as
phones, tablet and laptop computers, and servers for use by a
patient or any medical support staff. Such multiple images or video
streams may be combined to provide an enhanced viewing
experience.
Inventors: |
BENNETT; James D.;
(Hroznetin, CZ) ; Ziarno; Witold Andrew;
(Thalheim, DE) |
Family ID: |
43796249 |
Appl. No.: |
12/890847 |
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: |
600/109 |
Current CPC
Class: |
A61B 5/68 20130101; A61B
5/035 20130101; A61B 17/42 20130101; A61B 7/023 20130101; A61N
5/0603 20130101; A61B 8/12 20130101; G16H 40/63 20180101; A61B
1/00034 20130101; A61B 1/303 20130101; A61B 5/14539 20130101; A61B
1/042 20130101; A61B 5/344 20210101; A61B 5/4839 20130101; A61B
1/05 20130101; A61B 5/6846 20130101; A61B 5/4343 20130101; A61B
1/00096 20130101; A61B 5/4318 20130101; A61B 1/00177 20130101; G16H
15/00 20180101; A61B 8/4472 20130101; A61B 8/4416 20130101; A61B
1/00135 20130101; A61B 5/14532 20130101; A61B 17/425 20130101; A61N
2005/0611 20130101; G16H 40/67 20180101; A61B 1/00016 20130101;
A61B 1/00142 20130101; A61B 8/445 20130101; G16H 30/20
20180101 |
Class at
Publication: |
600/109 |
International
Class: |
A61B 1/04 20060101
A61B001/04 |
Claims
1. A monitoring device sized for at least partial insertion into a
plurality of vaginal channels, each of the plurality of vaginal
channels having a corresponding one of a plurality of cervixes
disposed therein at different locations and orientations, the
monitoring device comprising: a first imager that captures data in
a first field of view; a second imager, disposed in an adjustable
configuration, that captures data within a second field of view;
the first imager being disposed in a more axial orientation than
that of the second imager; and adjustments made to the adjustable
configuration of the second imager assist in placing the second
field of view to at least partially contain a first cervix of the
plurality of cervixes within a first vaginal channel of the
plurality of vaginal channels.
2. The monitoring device of claim 1, further comprising an
electro-mechanical component that manipulates the adjustable
configuration of the second imager.
3. The monitoring device of claim 1, further comprising a
mechanical structure supporting manual interaction to manipulate
the adjustable configuration of the second imager.
4. The monitoring device of claim 2, further comprising
communication circuitry through which control signals are received,
the control signals directing the electro-mechanical component in
performing the manipulation of the adjustable configuration.
5. The monitoring device of claim 1, further comprising
communication circuitry through which the data captured by the
second imager from the second field of view is delivered.
6. The monitoring device of claim 5, further comprising an
electro-mechanical component that responds to control signals to
change the adjustable configuration of the second imager, and the
delivery through the communication circuitry of the data captured
by the second imager from the second field of view supports
generation of the control signals.
7. The monitoring device of claim 1, wherein the data captured in
the first field of view by the first imager comprising video
data.
8. The monitoring device of claim 1, wherein the data captured in
the first field of view by the first imager comprising still image
data.
9. A monitoring device sized for at least partial insertion into a
plurality of vaginal channels, a first vaginal channel of the
plurality of vaginal channels having there within a first
intravaginal target, the monitoring device comprising: an imager,
disposed at an adjustable angle, that captures data within a field
of view; an electro-mechanical component disposed to change the
adjustable angle of the imager; and circuitry that directs the
electro-mechanical component to assist in at least partially
encompassing within the field of view the first intravaginal target
of the first vaginal channel.
10. The monitoring device of claim 9, further comprising: control
circuitry coupled to the electro-mechanical component;
communication circuitry, coupled to the control circuitry, through
which control signals are received and forwarded to the control
circuitry; and the control circuitry responding to the control
signals by directing the electro-mechanical component in making the
change to the adjustable angle of the imager.
11. The monitoring device of claim 9, further comprising
communication circuitry, and the captured data is communicated
outside of the monitoring device via the communication
circuitry.
12. The monitoring device of claim 10, wherein the captured data is
communicated outside of the monitoring device via the communication
circuitry to support generation of the control signals.
13. The monitoring device of claim 11, wherein a computing device
outside of the monitoring device receives and displays the captured
data.
14. A method used to capture data within a vaginal channel, the
method comprising: inserting an imager at an orientation angle into
the vaginal channel; adjusting the orientation angle of the imager
via electronic signaling that originates outside of the vaginal
channel; and forwarding data captured by the imager within the
vaginal channel to a location outside of the vaginal channel.
15. The method of claim 14, wherein the adjustments of the
orientation angle and forwarding of data occur within a first
device housing, and further comprising: receiving the forward data
within a second device housing; displaying the received data; and
generating the electronic signaling from within the second device
housing.
16. The method of claim 14, wherein the forwarded data is routed
through a communication network.
17. The method of claim 14 performed within a first device housing,
and wherein the forwarded data is received within a second device
housing.
18. The method of claim 17, wherein the second device housing
comprising a hand-held device housing.
19. The method of claim 17, wherein the second device housing
comprising a computing device housing, and the forwarding comprises
routing through a communication network.
20. The method of claim 17, wherein the vaginal channel and the
first device housing are located at a first premises, and the
second device housing is located at a second premises.
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.;
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.;
[0003] c) U.S. Provisional Application Ser. No. 61/246,396 filed
Sep. 28, 2009, entitled "Network Supporting Intravaginal Monitoring
Device" by Ziarno et al.
[0004] 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
[0005] e) U.S. Provisional Application Ser. No. 61/263,416 filed
Nov. 23, 2009, entitled "Intravaginal Monitoring Architecture" by
Ziarno et al.
[0006] Also incorporated herein by reference in their entirety
are:
[0007] 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;
[0008] 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;
[0009] 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;
[0010] 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;
[0011] 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;
[0012] 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
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
[0013] h) PCT patent application Ser. No. ______ filed on even date
herewith by Bennett et al., entitled "Intravaginal Monitoring
Device and Network" client docket number PWO-L019-001.
BACKGROUND
[0014] 1. Technical Field
[0015] The invention generally relates to medical devices, and more
particular to medical devices used in obstetrics and
gynecology.
[0016] 2. Related Art
[0017] The anatomical characteristics of a human reproductive
system vary greatly from one woman to the next. For example, race,
age, bladder condition, reproductive and surgical history, and
current reproductive status, among many other factors, may affect
sizes and orientations of underlying vaginal channels and cervical
dimensions and orientations.
[0018] More particularly, across the spectrum of all women,
anatomical characteristics of reproductive systems exhibit major
variations in: (a) lengths between vaginal orifices to posterior
fornices (.about.60% variance); (b) lengths between vaginal
orifices to anterior fornices (.about.40% variance); (c) sizes of
the introitus (.about.70% variance); (d) straight line lengths
between anterior to posterior fornices (.about.70% variance); (e)
straight line widths between lateral fornices (.about.80%
variance); and (f) vaginal orifice, mid vaginal and anterior fornix
vaginal widths.
[0019] Similarly, as measured from the vaginal channel axis,
cervical orientation exhibits substantial variation not only from
woman to woman, but also within the same woman over time or
depending upon circumstances. For example, significant variations
across spectrum of women and within the same women occur due to
the: (i) natural orientation of uterus; (b) vaginal channel
alignment during later stages of pregnancy; (iii) reorientation
with full/empty bladder; (vi) retraction during arousal; and (v)
relocation post birthing with or without involvement of cesarean
procedures.
[0020] In addition, vaginal channel does not usually run along a
straight axis, but typically comprises one or more bends and
associated curvatures between vaginal openings to the anterior
fornix.
[0021] Cervical orientation also depends upon orientation of the
uterus under the aforementioned situations. About eighty percent of
women have a normal cervical orientation that varies throughout a
90 degree range, while tilted cervical orientations found in about
twenty percent of women span about 45 degrees outside of the normal
range.
[0022] Such large variations in female reproductive systems are
also found in many other species beyond that of homo sapiens.
BRIEF SUMMARY OF THE INVENTION
[0023] 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
[0024] FIG. 1 is a schematic diagram illustrating intravaginal and
cervical regions of a woman's body along with an intravaginal
monitoring device (herein an "IMD") to be inserted into place;
wherein the intravaginal monitoring device is capable of guiding
inside the optics cap to capture images of large portions of
intravaginal and cervical regions that come in a wide ranging
variation in dimensions;
[0025] FIG. 2 is a cross-sectional diagram illustrating various
details and dimensional ranges underlying the reproductive system
of the FIG. 1;
[0026] FIG. 3 is a further cross-sectional diagram illustrating
other variants and angular frames of reference for the intravaginal
and cervical regions of the female reproductive system of the FIG.
1 to be monitored by an IMD built in accordance with the present
invention;
[0027] FIGS. 4a through 4h are schematic diagrams illustrating
construction of one of the embodiments of the intravaginal
monitoring device, along with typical dimensions, having manually
adjustable optics encased with a (flexible) transparent optics
cap;
[0028] FIGS. 5a-c are cross-sectional diagrams illustrating a wide
ranging variation in dimensions and orientations of intravaginal
and cervical regions with the IMD of FIG. 4 inserted therein, and
wherein such IMD having multiple imager assemblies disposed within
one type of transparent optics cap;
[0029] FIGS. 6a-c are cross-sectional diagrams illustrating
variations in dimensions, contours, and orientations of
intravaginal and cervical regions, and, inserted therein, an IMD
built in accordance with various aspects of the present invention
such as having an adjustable optics assembly may be manipulated to
better conform to such variations;
[0030] FIGS. 7a-d are cross-sectional diagrams illustrating a wide
ranging variation in dimensions and orientations of intravaginal
and cervical regions with the IMD of FIG. 4 inserted therein, and
wherein such IMD having multiple imager assemblies disposed within
yet other alternate shaped, transparent optics caps;
[0031] FIGS. 8a-e are schematic diagrams illustrating construction
of two embodiments of an intravaginal monitoring device along with
typical dimensions, thereof, and having an actuator-controlled
optical system and built in accordance with and to illustrate
several aspects of the present invention;
[0032] FIGS. 9a-f are diagrams illustrating construction of two
embodiments of the intravaginal monitoring device along with
typical dimensions, wherein such IMDs having mechanical and/or
electro-mechanical structures supporting adjustable optics
assemblies;
[0033] FIGS. 10a-d are perspective diagrams illustrating further
details regarding the adjustable optics assembly of FIGS. 9a-b that
supports two imager assemblies;
[0034] FIG. 11 is a perspective diagram illustrating an exemplary
physical construction of an intravaginal monitoring device built in
accordance with various aspects of the present invention to support
manual optical system adjustment;
[0035] FIG. 12 is a schematic diagram illustrating internal
circuitry involved in the construction of telescopic, actuator
controlled, multi-directional front-end imager assembly guiding
systems of various embodiments, of the FIGS. 4 through 9, of the
intravaginal monitoring device;
[0036] FIG. 13 is a diagram illustrating a separate
hand-held-device in communication with a dual imaging IMD with
electro-mechanical image adjustment mechanisms built therein, and
wherein two video sequences are simultaneously displayed to assist
in both tailoring such IMD for use by a particular female, and
assisting in insertion, framing, zooming, panning, and otherwise
targeting of a cervical region within a vaginal channel;
[0037] FIG. 14 is a diagram illustrating a laptop computer, in
communication with a dual imaging IMD with electro-mechanical image
adjustment mechanisms built therein, wherein much like the
hand-held device of FIG. 13, two video sequences are simultaneously
displayed to assist in both tailoring such IMD for use by a
particular female, and assisting in insertion, framing, zooming,
panning, and otherwise targeting of a cervical region within a
vaginal channel; and
[0038] FIG. 15 is a conceptual diagram illustrating visually a
programmatic process of stitching the resulting images or video
frames to obtain a wider angle view of the intravaginal and
cervical regions, wherein such process may take place on an IMD or
within any external, supporting device.
DETAILED DESCRIPTION OF THE DRAWINGS
[0039] FIG. 1 is a schematic diagram illustrating a vaginal channel
113 and cervical regions 117, 121 of a woman's body along with an
intravaginal monitoring device 191 to be inserted into place;
wherein the intravaginal monitoring device 191 is capable of
guiding inside the optics cap 171 to capture images of large
portions of vaginal channel 113 and cervical regions 117, 121 that
comprise a wide ranging variation in dimensions. The current
illustration depicts an introitus 123 of a vaginal channel 113,
cervix 121, outer surface 117 of the cervix 121, interior 119 of a
uterus 107 in a normal orientation, fallopian tube 111, and ovary
109. Also, depicted is an exemplary overlay of a tilted uterus 115.
As can be appreciated, the cervical orientation depends on, among
other factors, the orientation of the uterus 107 (or uterus 115)
under the various situations. Typical angular orientations in
relation to the axial direction 195 of the vaginal channel 113
include normal orientations 151 and tilted orientations 153.
[0040] Wide ranging variations in the vaginal channel 113 and the
cervical regions 117, 121 are important factors in design
considerations of the Intravaginal Monitoring Device (IMD) 191.
Considerations include, for example, focal lengths, fields of
views, comfort and targeting with or without guidance
assistance.
[0041] Multiple studies show that variations in the vaginal channel
113 and the cervical regions 117, 121 of a woman's reproductive
system involve: (a) length between the introitus 113 and posterior
fornix within the cervical regions 117, 121 (variations may range
up to sixty one percent); (b) length between the introitus 113 and
anterior fornix (may vary up to thirty seven percent); (c) size of
the introitus (variations may be up to sixty seven percent); (d)
straight line length between anterior to posterior fornices (may
vary up to seventy two percent); (e) straight line widths between
lateral fornices (variations may be up to sixty eight percent); and
(f) widths and heights of the vaginal channel 113 (significant
variations typically exist through the entire length). In addition,
studies show significant variations across spectrum of women and
within the same woman that occur due, for example, to: (a) natural
orientation of uterus; (b) alignment of the vaginal channel 113
during stages of pregnancy; (c) reorientation with full or empty
bladder; (d) retraction during arousal; and (e) relocation post
birthing (especially evident after cesarean procedures).
[0042] In addition to the abovementioned factors, an intravaginal
monitoring device 191 should also account for cervical orientation
and insertion depth. Insertion depth of the intravaginal monitoring
device 191 to the posterior fornix may not be easy across the
spectrum of all women due to: (a) abnormal anatomical
configurations; (b) cervical impact being misinterpreted as the
posterior fornix; (c) anterior fornix being misinterpreted as the
anterior fornix; or (d) insufficient nerve feedback of successful
positioning. Moreover, for some women based on their current
anatomical configurations, full insertion into the posterior fornix
may not be optimal for capturing images and further information
about the cervix or other areas within the vaginal channel 113. For
a variety of reasons, including abnormal anatomical configurations
and other reasons mentioned above, insertion by a particular woman
over time (including monthly cycles or state of pregnancy) may
involve insertion to differing depths.
[0043] The cervical orientation may be referred to as an angular
measurement between the cervical plane & vaginal channel axis.
For example, if a cervical plane is parallel to a vaginal axis,
cervical orientation would be 0 degrees; a vaginal axis that is
normal to a cervical plane would have a cervical orientation of 90
degrees. The cervical orientation exhibits substantial variation
not only from woman to woman, but also within the same woman over
time (for example, changes occur during pregnancy, based on bladder
volume, in response to arousal, etc.). Vaginal axis is not usually
a straight line, but typically comprises a bend or two and
curvature between vaginal openings to the anterior fornix,
complicating image capture.
[0044] In accordance with the present invention, the design
considerations of the intravaginal monitoring device's 191 guiding
procedures, and optics attempt to address all these variations.
Such considerations are important whether the IMD comprises a "one
size fits all" design or several independent designs (with each of
the several designs being directed toward groups of women with
relatively similar anatomical configurations).
[0045] Design considerations also take into consideration the
woman's comfort involving characteristics such as stem flexibility,
wear-ability, stem length, overall stem and cap widths and
curvatures, and cap lengths and compressibility.
[0046] Although herein described with reference to human women, the
various IMD embodiments within the present application are equally
applicable to the reproductive systems of non-human female species.
In particular, the IMD 191 employs a variety of techniques to
address the wide variance in reproductive systems usable for all
species.
[0047] In particular, with reference to the human female, the
optics and guiding techniques of the IMD 191 address at least some
of the anatomical variations of a female reproductive system. An
optics assembly 177 may be adjusted to various positions within an
inner cavity of a cap or optics cap 171. The optics assembly 177
includes two imager assemblies 173 and 175 to cover a wider field
of view than would ordinarily be possible by using only a single
imager assembly. The angle of the imager assembly 173 may also be
manually or electro-mechanically adjusted. For comfort and to
maintain rather optimal focal lengths, the optics cap 171 is
relatively transparent, and can be made from a medical grade
compressible polymer material, e.g., a soft silicone rubber. Most
of these and other features and feature options not only
accommodate reproductive system variations but also support
comfortable, ease of use.
[0048] As previously mentioned, the optics assembly 177 may involve
manual or electro-mechanical adjustment of both or either of the
telescopic optics assembly and the angle of the imager assembly
173. The electro-mechanical approach involves, for example, the use
of miniature piezo-electric actuators. Manual or electro-mechanical
rotation of the optics assembly around the axis of the stem of the
IMD 191 may also be employed to address a laterally oriented target
such as a laterally situated cervix.
[0049] Control of the various actuators (controlling tilt, rotation
and depth within the optics cap 171 can be controlled directly via
an interface placed on the IMD 191, remotely by the user via a
local computing device, and other computing devices remote from the
user. Specifically, for example, such control might involve: (a) an
dedicated hand-held device in local communication with the IMD 191;
(b) a multipurpose device (such as a mobile phone, tablet computer
or laptop computer) in local communication with the IMD 191; (c) a
remotely located, dedicated or multipurpose device in communication
with the IMD 191 via the Internet; (d) manual interaction via a
user interface placed on the IMD 191 (e.g., a button); or (e) via
twisting, turning, adjusting insertion depth, and otherwise
manually manipulating the IMD 191 directly and without
automation.
[0050] The imager assembly 175 is adjustable in a mostly radial
direction 197, while imager assembly 173 is adjustable in a mostly
axial direction 195. The images or video acquired from the imager
assemblies 173, 175 may be displayed one at a time in a small or
full screen window, or, if preferred, at the same time on a remote
or local display. For example, upon insertion of the IMD 191 into
the vaginal channel 113, a first image/video produced via the
imager assembly 173 may be displayed (or primarily displayed) to
support "gross" guidance of the IMD 191 into position. When in such
gross position, a second image/video produced via the imager
assembly 175 can be displayed (or become the primary display) to
fine tune targeting of a radially located cervix. Primary display
may involve replacing the first image/video with the second, but
may also involve placing both image/video on the same display
screen at the same time (perhaps even with an overlay scheme).
Alternatively, in one particular configuration, the first and
second image/video may also be stitched together to gain a wide
angle image that covers more than 150 degree view of the outer
surface of the cervix 117. Three dimensional imaging/video can also
be constructed therefrom.
[0051] For instance, a woman who purchases and adjusts the optics
assembly of an intravaginal monitoring device 191 to fit her
present anatomy (possibly with the assistance of a health care
professional) may continue to use the imager (with perhaps minor
adjustment over the course of pregnancy) using guidance techniques
provided by the IMD 191 and perhaps an external hand-held device.
Adjustment is possible in the aforementioned ways, such as via the
manually controlled or actuator controlled telescoping, rotation or
angular adjustments of and within the optics assembly 177. Even the
optics cap 171 can be replaced to adjust focal lengths or comfort
as the area near the cervix 117 changes.
[0052] FIG. 2 is a cross-sectional diagram illustrating various
details and dimensional ranges underlying the reproductive system
of the FIG. 1. Specifically, the following description of the human
reproductive system sets forth substantial variations in the
dimensions found in female reproductive anatomy which the various
aspects of the present invention attempt to accommodate.
[0053] For example, multiple studies show that variations of: (a) a
posterior vaginal depth 211 between a vaginal orifices to a
posterior fornix from 4.1 to 10.6 cm and average between 6.7 to 8.8
(depending on the study); (b) an anterior vaginal depth 213 between
the vaginal oriface to an anterior fornix from 5.8 to 9.3 cm with
an average of about 7.6 cm; (c) an introitus depth 217 from 1.5 to
4.6 cm with an average of 2.6 cm; (d) a cervix base length 215 that
follows a straight line between the anterior and posterior fornices
from 1.3 to 4.8 cm with an average of 2.9 cm; (e) a cervix base
width (not shown) that follows a straight line between lateral
fornices from 2.6 to 8.3 cm with an average of 4.2 cm; (f) a
vaginal orifice width (not shown) from 1.9 to 3.7 cm with an
average of 2.8 cm; (g) mid-vaginal channel width (not shown) from
1.6 to 3.7 cm with an average of 2.8 cm; and (h) anterior vaginal
channel width (not shown) from 2.2 to 6.5 cm with an average of 3.3
cm.
[0054] To address at least some of these significant variations,
one or more of the various adjustable characteristics, guidance
techniques and comfort factors set forth in this application, can
be combined with or incorporated into an intravaginal monitoring
device in accordance with the present invention.
[0055] FIG. 3 is a further cross-sectional diagram illustrating
other variants and angular frames of reference for the intravaginal
and cervical regions of the female reproductive system of the FIG.
1 to be monitored by an IMD built in accordance with the present
invention. The current depiction focuses on the wide ranging
variation in the anterior fornix vaginal widths 395 that is to be
taken into design considerations, since the wide angle image
capturing depends upon these variations.
[0056] These variations of the anterior fornix vaginal widths can
vary between 2.2 and 6.5 cm, with an average of 3.3 cm, as many
studies show. Hence, there is a wide ranging variation between
smallest 371 and largest 373 anterior fornix vaginal widths and the
design considerations of the intravaginal monitoring device and its
guiding process, in accordance with the present invention,
encompass these important variations as well. In addition, the
design considerations take into consideration the woman's comfort
as well. A woman having a smaller anterior fornix vaginal width, as
in the case of 371, may find it very uncomfortable to wear an
intravaginal monitoring device of larger dimensions, designed with
an average sized woman, as in the case of 379.
[0057] The depiction also shows: (a) Lengths between vaginal
orifices to posterior fornix 311; (b) Lengths between vaginal
orifices to anterior fornix 313; (c) Sizes of introitus 317; (d)
Straight line lengths between anterior to posterior fornix 315; (e)
Straight line widths between lateral fornix 315; (f) Vaginal
orifice; (g) mid vaginal width; and (h) anterior fornix vaginal
width.
[0058] The design considerations of the optics and guiding systems,
in general, take into consideration these variations by ways of
manually controlled or actuator controlled telescopic and
stationary or actuator controlled rotating imager assembly of the
imagers to focus upon specific regions of cervix and capture
images. Hence, the variations that occur naturally in anatomy or
due to circumstantial considerations, depth of insertion and
variations of cervical orientation (based upon the range of 351,
353), from woman to woman and within a single woman over time are
considerations for which many of the various aspects of the present
invention are directed.
[0059] The depiction also shows angular measurements between the
cervical plane & vaginal channel axis. For instance, if a
cervical plane is parallel to a vaginal axis, cervical orientation
would be 0 degrees; a vaginal axis that is normal to a cervical
plane would have a cervical orientation of 90 degrees. Typically,
studies show that eighty percentage of women have a normal cervical
orientation (based upon the range of 353) that vary approximately
between 0 degrees (as mentioned above) to 90 degrees (toward the
backside, looking from the front); while twenty percentages of
women have tilted cervical orientation (based upon the range of
351) that vary approximately between 0 degrees (as mentioned above)
to 45 degrees (toward the front side, looking from the front).
[0060] The depiction also shows axial direction 377 and cervical
angle 375 that are factors in designing the IMD and associated
guidance process as well. The orientations of the axial and radial
imager assemblies 173, 175 depend upon the cervical orientations or
other intravaginal targets, which vary largely from woman to woman
and within a single woman, during various circumstances.
[0061] FIGS. 4a through 4h are schematic diagrams illustrating
construction of one of the embodiments of the intravaginal
monitoring device, along with typical dimensions, having manually
adjustable optics encased with a (flexible) transparent optics cap.
The illustration of FIG. 4g depicts an intravaginal monitoring
device that consists of a dual segmented housing stem 431 (one
which can be taken apart for storage within a small carrying case
for example), and optics assemblies 429, optics cap 427 and bottom
cap 433. The overall length of the IMD, the sum of dimensions 457
and 459, may vary depending on the inner electronics and batteries
incorporated. In the illustrated embodiment, for example, the
overall length may be 24 cm.
[0062] The FIGS. 4a, 4b, 4c, 4d, 4e, 4f and 4h depict individual
parts and steps of constructing an intravaginal monitoring device
such as that of the FIG. 4g. In particular, an optics assembly 429
(FIG. 4g) consists of a telescopic stem 411 (FIG. 4a) that has been
cut to support a mounting arrangement as shown in FIG. 4b (e.g., a
telescopic stem portion 415 of a width 465 sized to fit within the
housing stem 431). A platform portion 413 can be folded and
manually adjust and readjusted, see folded platform 419 of FIG. 4c,
to support a desired radial mounting angle for an imager assembly
421 of FIG. 4d. The axial mounting involves fixing an imager
assembly 423 within a telescopic stem 425 as shown in FIG. 4d. The
optics system 429 can be adjusted by manually positioning the depth
of the telescopic stem within the housing stem 431 and through
clockwise or counterclockwise rotation.
[0063] In an alternate embodiment, the telescopic stem 428 can be
extended and configured for rotation mechanically by a user via the
end cap 433. Similarly, mechanical constructs (not shown) are
contemplated to support pivoting of the axially mounted imager
assembly. Such configurations would eliminate the need to remove
the optics cap to gain access to and adjust the optics assembly
orientation.
[0064] Among other details, the illustration also shows, an optics
cap 435 depicted in the FIG. 4e that is, in this embodiment, shaped
irregularly with a bulge on one side so as to maximize focal length
to the cervical area while taking advantage of natural elasticity
associated with the region of the vaginal channel opposite the
cervical surface. Typical dimensions 451 and 453 of the outer cap
435 can typically be 36 mm and 28 mm to serve a variety of types of
women's reproductive systems and the specific underlying optics
assembly requirements.
[0065] A battery compartment 499 contains batteries that are
rechargeable or disposable. One or more buttons or other user input
devices may be placed on the IMD. For example, a power button is
illustrated as being located on the bottom of an end cap 495. The
location of field of views 473, 475 of the axially and radially
located imager assemblies are adjusted to minimize one imager
assembly's image capture of the other to prevent having to crop or
present a perhaps distracting element within each image/video
stream captured.
[0066] Lastly, although only two imager assemblies are shown, many
more are contemplated so as to provide full or partial 3D coverage
of the vaginal space. Such multiple images and video streams can be
presented independently or via a 3D merged image (video) viewing
environment.
[0067] FIGS. 5a and 5b are schematic diagrams illustrating a wide
ranging variation in dimensions of intravaginal and cervical
regions and FIG. 5c illustrating construction of the intravaginal
monitoring device of FIG. 4, having a telescopic, actuator
controlled, multi-directional front-end imager assembly guiding
systems, having a (flexible) transparent optics cap that faces and
fits snugly and flexibly onto the outer surface of the cervix. In
specific, FIGS. 5a, 5b and 5c depict the variations in the
intravaginal and cervical regions, whereas some are larger in
sizes, others are smaller, and some deviate from axial direction
either way by smaller cervical angles or larger cervical
angles.
[0068] FIGS. 5a-c are cross-sectional diagrams illustrating a wide
ranging variation in dimensions and orientations of intravaginal
and cervical regions with the IMD of FIG. 4 inserted therein, and
wherein such IMD having a multiple imager assembly disposed within
a further type of transparent optics cap. An axial imager assembly
509 covers an axial field of view 551. A radial imager assembly 513
covers a radial field of view 553. Both the radial and axial fields
of view 551, 553 may be designed to cover, for example, a range of
90-100 or more degrees. Also, the label "radial" and "axial" as
used above are not necessarily fully axial aligned, fully radially
aligned, or have a 90 degrees angle of separation. In fact, as
shown, the radial imager assembly 513 is about 30 degrees of the
radial axis, while the axial imager assembly 509 is nearly in axial
alignment but offset from the center of the axis of the telescopic
stem. So as used herein, radial imagers are those comprising a
location with a substantial radial component, while axially
directed imagers comprise a substantial axial component.
[0069] Both of the axial field of view 551 and radial field of view
553 together cover about one hundred and fifty degrees, and with
about forty degrees of overlap. Other configurations and
embodiments with greater or lesser coverage and greater or lesser
overlap is contemplated.
[0070] By using appropriate software in the IMD, a hand-held
device, mobile device, personal digital assistant or computer, the
a single "panoramic-like" image can be stitched and stretched
together. Similarly, in the region of overlap, 3D images and video
can be constructed from the two sources of image data (i.e., from
the assemblies 513, 509). Alternatively, the axial field of view
551 and radial field of view 553 can also be viewed separately
either by switching between each image/video stream or by
simultaneously displaying both image/video streams.
[0071] FIGS. 5b-c illustrate the vast differences in cervical sizes
and orientations that will impact the performance of the IMD of
FIG. 5a. Although the positioning and repositioning process (e.g.,
via guidance supported procedures) may vary in difficulty, the
illustrated IMD is able to capture adequate images for such
variations.
[0072] FIGS. 6a-c are cross-sectional diagrams illustrating
variations in dimensions, contours, and orientations of
intravaginal and cervical regions, and, inserted therein, an IMD
built in accordance with various aspects of the present invention
such as having an adjustable optics assembly may be manipulated to
better conform to such variations. FIG. 6a shows an exemplary
insertion of an IMD through the vaginal channel and in an
orientation that adequately captures images and video a cervix that
falls within a field of view of a radial imager assembly 607. An
axial imager assembly 611 captures only a portion of the cervical
area but can be used: a) to assist in the guidance process by
allowing the user to find and target the cervical area for image
and video capture by the radial imager assembly 611; b) along with
the image and video capture from the radial imager assembly 607 to
construct a panorama, 3D imagery, etc.; and c) to support
measurements of the cervical area such as the height of the
cervix--an important indication during pregnancy.
[0073] The optics assembly of the IMD includes a stem 613, inserted
within a main housing stem 614, that supports the imager assemblies
611, 607. An optics cap 609 may be made with a firm but
compressible material (such as silicone rubber) that permits
installation, removal and replacement. This may be accomplished by
feeding the optics assembly into the inner chamber of the optics
cap 609. Radial tension of the opening portion of the optics cap
609 due to elasticity of the optics cap 609 supports at least a
partial hermetic seal and mechanical constraint.
[0074] The opening of the optics cap 609, although not shown, can
be extended to mate with the housing stem 614 as an alternative to
mating with the stem 613 (as shown). By mating with the housing
stem 614, mechanical or electro-mechanical methods for extending
the optics assembly further in or out of the inner area of the
optics cap 609 might provide a more adequate seal, e.g., where the
stem 613 is telescopic.
[0075] As illustrated, the field of view and underling mounting
angle of the radial imager assembly 607 is adequately matched to
the illustrated reproductive system's orientation and size.
Exemplary fine tuning adjustment, however, might involve one or
more of: a) installation of a different sized and shaped optics
cap; b) relocating the radial imager 607 to provide better field of
view coverage of the present cervix; c) changing the angle of the
radial imager 607 to provide view more normal to the surface of
plane of the cervix; d) extending or retracting the axial imager
assembly 611 directly (or relatively via use of a longer cap) to
(i) minimize having the radial imager assembly 607 within the field
of view of the axial imager assembly 611, (ii) minimize having the
axial imager assembly 611 within the field of view of the radial
imager assembly 607, and (iii) attempting a better lateral image of
the cervix by relocating the axial imager assembly 611. If
selection of a different optics cap is not possible and the present
optics cap is not sufficient, some of the adjustments identified
above may be incapable of providing the best image and video
capture, but may be the best compromise under the given
reproductive system and IMD characteristics. Also note that larger
optics caps may give rise to more difficult and uncomfortable
insertion of an IMD. Thus, opting for a larger optics cap may not
be a viable option.
[0076] FIG. 6b demonstrates that with a slightly wider optics cap
610 replacing the optics cap 609 of FIG. 6a along with
repositioning of the angle of the radial imager assembly 607,
better image and video capture of the exemplary cervix can be
obtained. But note, however, that because the radial imager
assembly 607 falls within the field of view of the axial imager
assembly 611, the viewer of images and video captured by the axial
imager assembly 611 will either have to be tolerated or the axial
imager assembly 611 will also have to be moved. Although not shown,
by moving the axial imager assembly 611 further into the cavity of
the optics cap 610, the field of view impingement of the radial
imager assembly 607 can be reduced, but at a cost to the capture by
the axial imager assembly 611 of lateral cervical images and video.
Such movement may also cause the axial imager assembly 611 to
impinge on the field of view of the radial imager assembly 607.
Although a yet larger optics cap might be used, it may very well be
intolerable due to comfort and insertion constraints.
[0077] Also note that all movement and readjustments can be
accomplished through direct manual interaction with the optics
assemblies themselves, manual interaction with external mechanisms
that cause mechanical readjustment of the optics assemblies,
electro-mechanical interaction, or a combination of more than one
of the above. This applies no matter how many imager assemblies are
involved. Similarly, some portions of the optics assemblies may be
fixed into stationary, non-adjustable arrangements, while other
portions are fully adjustable. All such configurations are
reasonable design choices for particular IMDs for certain targeted
users and at various sales price points.
[0078] FIG. 6c illustrates the insertion of an IMD much like that
of FIG. 6a within an entirely different vaginal channel and
cervical orientation. Therein, it can be appreciated that a single
imager assembly might be sufficient, as both of imager assemblies
627 and 631 are capable of capturing adequate images and video. Of
course, by using dual imagers, 3D reconstruction or panoramic
stretching and stitching might be used to provide a more rich
viewing presentation. Adjustments to the position of the axial
imager assembly 627 can be seen appreciated with reference to the
"unadjusted" version within FIG. 6a (i.e., the imager 607). Without
such adjustment, the image and video captured by the imager
assembly 627 would not span the cervical area.
[0079] FIGS. 7c-d are schematic diagrams illustrating a wide
ranging variation in dimensions of intravaginal and cervical
regions and FIGS. 7a and 7b illustrating construction of the
intravaginal monitoring device of FIG. 4, having a telescopic,
actuator controlled, multi-directional front-end imager assembly
guiding systems, having a (flexible) transparent optics cap that
faces and fits snugly and flexibly onto the outer surface of the
cervix.
[0080] FIGS. 7a-d are cross-sectional diagrams illustrating a
ranging variation in dimensions and orientations of intravaginal
and cervical regions with the IMD of FIG. 4 inserted therein, and
wherein such IMD having a multiple imager assembly disposed within
yet other alternate shaped, transparent optics caps. FIG. 7a
depicts the front-end portions of the intravaginal monitoring
device inserted into place to capture images of a relatively small
sized cervix. As depicted, it can be appreciated that a single
imager assembly solution could be used (for example, by removing or
disabling an axial imager assembly 713. With such removal,
adjustments in a telescopic stem 715, via rotation or
extension/retraction, and/or adjusting the location and angle of a
radial imager assembly 711 could be made to "tune" the illustrated
IMD to fit the current image and video capture environment.
[0081] In FIG. 7b, an IMD much like that of FIG. 7 has received a
different type of optics cap, an optics cap 729, than that found in
FIG. 7a (an optics cap 709). Such IMD is inserted within a
differing shaped reproductive system. Instead of inserting the IMD
until the optics cap 729 touches the cervical region, the insertion
is stopped short thereof for possible capture of a larger region
that includes the cervix. By doing so, the axial imager assembly
733 seems well capable of performing capture operations without the
aid of the radial imager assembly 731. Thus, the radial imager
assembly may be removed or turned off for such user.
[0082] FIG. 7c illustrates a large tilted cervix wherein an IMD may
itself be rotated (before or after insertion) or the underlying
optics assembly may be rotated in accommodation of the tilt.
Likewise, the relatively smaller cervix illustrated in FIG. 7d may
be services with a single imager assembly configuration and a much
narrower and perhaps longer optics cap, and with or without the
aforementioned accommodations for tilt. As mentioned previously,
the process for selecting an initial IMD configuration--model
and/or optics cap depends greatly on the features desired and the
personal characteristics of the underlying female's reproductive
system. The fitting process may be minimal if such reproductive
system falls well within the ranges suggested by a particular IMD.
When outside of such ranges, perhaps a different IMD and/or optics
cap would be more appropriate. Such considerations may be addressed
with professional selection and fittings (e.g., by an OBGYN), self
exam, or trial and error.
[0083] FIGS. 8a-e are schematic diagrams illustrating construction
of two embodiments of an intravaginal monitoring device along with
typical dimensions, thereof, and having controllable optical
systems built therein accordance with and to illustrate several
aspects of the present invention. In each embodiment, the
intravaginal monitoring devices use electrically powered actuators
(such as miniature piezo actuators) to support the tailoring of an
IMD to attempt to comfortably conform to dimensions and
orientations of a specific user's reproductive system. In the IMD
of FIG. 8a, in addition to electro-mechanical control, fully
mechanical tailoring of some parts of the optical system is also
shown.
[0084] In both of the IMDs of FIGS. 8a and 8b, the optics systems
can not only be controlled prior to insertion, but also during the
insertion process and when fully inserted. As mentioned before,
such control and tailoring of the optics system to fit a current
user is one purpose of the electro-mechanical and mechanical
enhancements. Another is to provide a mechanism for panning,
zooming, framing, and otherwise exploring a target area. All of
these goals are easily accommodated with electro-mechanical and
some mechanical adjustment mechanisms.
[0085] Specifically, in FIG. 8a, a piezo actuator 813 controls the
angle of a pivoting imager assembly 811. Beyond "tailoring," such
pivot control can also be used, for example, to assist in the
guidance of an IMD 817 into position to target a cervix, and to
pan, zoom, frame during insertion and at the insertion destination.
All imager assemblies described throughout this application at a
minimum contain an imager, such as, for example, CCD (Charge
Coupled Device) or CMOS (Complementary Metal Oxide Semiconductor)
varieties. Any other type of imager may be used which captures
images and in some cases video are contemplated. In addition, such
imagers need not operate in the visible optics range. For example,
ultraviolet, infrared or other frequency electromagnetic wave
imagers could be employed. Imager assemblies as described herein
may also include one or more light (or other frequency) sources, a
housing (supporting an optical pathway), lensing, aperatures,
filters, polarizers, and auto-focus and auto-zoom mechanism. Other
imager assemblies mentioned throughout the present application may
be similarly constructed. Moreover, throughout this disclosure one
or dual imager assemblies are used in each embodiment presented.
Adding further imager assemblies, although not shown, is
contemplated. All imagers underlying the imager assemblies herein
are capable of capture still images (i.e., "snap shots"), video
streams, or both.
[0086] A telescopic stem 815 may be manually adjusted to
accommodate both an optimal radial angle in relation to a power
button 819 (via depth adjustments via threading or tension), and
the depth at which the optics assembly fits within an optics cap
(shown in FIG. 8c). It can also be adjusted through rotation of the
telescopic stem 815 to accommodate off center or tilted image/video
capture targets. The IMD also uses a flexible stem 817 (made of a
for example silicone rubber) that contains the circuitry and power
storage elements (e.g., batteries). A bottom cap 821 may also screw
on or off to at least partially hermetically seal or expose or gain
access to electrical or optical connectors, batteries, circuitry,
etc. Although only a power button 819 is illustrated, a much more
substantial user interface including a display is contemplated for
some embodiments.
[0087] A typical example of a procedure for tailoring, guiding and
targeting with the IMD of FIG. 8a might first involve a doctor's
measurement of a particular patient's reproductive system.
Thereafter, with or without such information, the doctor or such
patient might tailor (adjust) the optics assembly to fit the
patient. That is, the doctor or patient may: a) manually adjust the
depth of the telescopic stem 815 within the flexible stem 817; b)
manually adjust (via optical assembly rotation) the pivoting plane
with reference to the radial location of the power button 819; c)
select and install a particular one of several sizes and shapes of
optics caps (such as the optics cap 835 of FIG. 8c); d) insert the
device with guidance support via an externally viewable display; e)
further adjust the angle of the imager assembly during insertion
and upon after reaching the target insertion location; and f)
remove and readjust the telescopic stem via rotation or insertion
extent into the flexible stem 817 if necessary. The adjustment of
the angle of the imager assembly 811 via the piezo actuator 813 may
not only involve tailoring, but also supports dynamic viewing along
with zoom, pan, and framing desires and capabilities of inherent in
the imager assembly 811.
[0088] Guidance support might involve for example using the
illustrated axial orientation of the imager assembly 811 during the
insertion process to deliver a streaming video feed to an external
viewing screen (not shown) through which guidance and initial
positioning can be monitored. Through such screen, a user can
determine when the target insertion location has been reached. They
can also then control, via an external user input device, the piezo
actuator 813 create a radial angle orientation to support image and
video capture of a radially located cervix or artifact. Radial
viewing might also be used during the insertion process to better
examine vaginal channel walls prior to reaching the target
insertion location.
[0089] In FIG. 8b, similar operation can be found with the addition
of further electro-mechanical elements that may support control
before and after insertion and from external and remote devices. In
addition to the electro-mechanical pivoting control of the IMD in
FIG. 8a, the IMD of FIG. 8b is configured with automated
telescoping and rotation. In particular, an imager assembly 823 is
mounted such that a piezo actuator 825 can direct the imager
assembly 823 through a wide range of radial angles such as that
shown, and including a fully axial position (0 degrees as shown in
FIG. 8a). An actuator 826 is used to not only control the extension
of a telescopic stem 827 into an optics cap, but also controls the
rotational position of the pivot plane of the imager assembly 823
in relation to the power button 831.
[0090] Specifically, the base of the actuator 826 is inserted and
affixed to the inner wall of a housing stem 829. The top end of a
threaded (or ratcheted) post element of the actuator 826 connects
to the telescopic stem 827 for raising, lowering, and seeking
rotational alignment locations for the entire optical assembly.
[0091] With this configuration and whether or not fully or
partially inserted, using an external display and user interface,
the IMD of FIG. 8B can be fully adjusted to assist in insertion
guidance, zooming, panning, framing, and tracking interesting
intravaginal targets. Depending on the embodiments, a user
interface interacting with the IMD's of FIGS. 8a-b might only
support direct and simplistic control commands such as
clock-wise/counter clock-wise rotation, in-out telescoping, and
up-down pivoting. Other embodiments also support actual angles of
rotation and pivoting, and millimeter based telescoping positions
with full "go to" functionality. Control may also involve any other
three dimensional coordinate relocation as well, and, in any
configuration, smooth or fixed movement increments at course and
fine tuning speeds are employed. Moreover, the approaches to
integrate electro-mechanical and mechanical adjustment techniques
underlying the optics assemblies are merely exemplary as many other
approaches and configurations are possible and contemplated.
[0092] Any IMD in accordance with aspects of the present invention
can be built using various fully or partially automatic and/or
manual techniques for best positioning elements thereof in any or
all of three dimensions. As illustrated, such positioning elements
comprise imager assembly and entire optics systems, but other IMD
elements such as other sensors, emitters, drug or fluid delivery or
fluid sampling systems that are integrated within an IMD may also
benefit from the up to three dimensional mechanical or
electro-mechanically driven repositioning systems shown throughout
the figures. Thus, all positioning techniques described herein can
be used along with guidance techniques and feedback from imagers or
any IMD element to assist in its underlying function.
[0093] Manual control can be asserted directly by whomever inserts
the IMD (depth, angles, torque, rotation, etc.) and by the woman's
repositioning of her own body which also effects reproductive
system dimensioning. Automatic positioning control over sensors
such as an imager assembly, can be made via buttons placed on the
IMD itself and monitoring of positioning feedback may be collected
via a display disposed on the IMD housing. Positioning control may
also be managed via a tethered or wireless link by a local
computing device such as a cell phone, tablet computer or laptop.
Remote positioning control may also be carried out via a longer
distance link such as a wireless cellular network or Internet link
to a remote computing device. The remote computing device may also
be a phone, tablet computing device, server, or workstation
computer through a doctor's or staffs interaction to analyze and
diagnose a remotely inserted IMD.
[0094] Positioning of an optical assembly may also be used to
assist in focusing, zooming or otherwise maintaining an adequate
focal length to a target such as the cervix or opening of the
cervical channel, or some other a gynecological event, artifact or
condition. Positioning of other elements of an IMD to assist in
their underlying functions is also contemplated as mentioned above
for much of the same reasons. Such latter positioning may be
carried out via integration with the former position mechanisms or
via separate positioning constructs. For example, further sensors
could be attached to a pivoting image assembly and benefit by
sharing such pivot even though such sensors have alternate targets
than the imager assembly and so the pivoting function could be
time-shared. As an alternative, a separate pivoting platform under
control via a further actuator would allow simultaneous operation
although at the expense of extra materials and volume--which
overall should be kept to a minimum for comfort, fitting and other
reasons enumerated above.
[0095] In FIG. 8c, among other details, the illustration shows a
specific one of a plurality of types and sizes of optics caps,
e.g., the optics cap 835. By being made of a somewhat flexible
material such as medical grade, silicone rubber, the optics cap 835
may conform to sliding over optics assemblies while maintaining a
hermetic seal with either or both of the telescopic stems 815, 827
or the housing stems 817, 829. Such hermetic seal may involve
merely elastic tension associated with the diameters of the housing
817, 829 versus that of the optics cap 835. Such hermetic seal may
be improved with a bonding agent or glue and/or a mechanical
constraint such as ribbing or threading. End caps 821, 841 may
similarly be attached using tension or with threading and/or other
mechanical constraints (e.g., a grommet 839 of FIG. 8e or glue) to
at least provide partial hermetic sealing.
[0096] In one embodiment, the dimensions 851, 855, 857, 859, 861,
863 and 865 are such that the intravaginal monitoring device is
able to accommodate the inner electronics appropriately, while
attempting to support comfortable insertion, positioning, and
maneuverability for a relatively large percentage of women. For
example, the dimensions 851, 855, 857, 859, 861, 863 and 865 are
approximately 235 mm, 16 mm, 25 mm, 16 mm, 35 mm, 15 mm and 10 mm
respectively, though the dimensions may vary to accommodate other
goals such as fitting within a small carrying case or purse, fully
wearable versions, permanently tethered versions, versions
supporting groups of females with different reproductive system
profiles, to accommodate additional sensors or feature
functionality, etc.
[0097] FIGS. 9a-f are diagrams illustrating construction of two
embodiments of the intravaginal monitoring device along with
typical dimensions, wherein such IMDs having mechanical and/or
electro-mechanical structures supporting adjustable optics
assemblies. The embodiment of FIG. 9a closely parallels that of
FIG. 8a and thus most of the description thereof applies equally to
here. This applies to end cap 919, power button 917, housing stem
915 and most of the same adjustable optics mechanisms. For example,
through manually rotating and adjusting the elevation of the stem
913 and electronic pivot control via a piezo-actuator 911, the
illustrated IMD can be fitted to adequately match a variety of
females. Post the beginning of the insertion process, the
piezo-actuator can be controlled either internally, remotely or
locally to assist in, for example, further insertion guidance,
targeting and examination of a gynecological artifact, event or
condition.
[0098] Similarly, FIG. 9b is similar to the embodiment of FIG. 8b,
and as before can share most of the aforementioned detailed
description regarding FIG. 8b. For example, such details are
applicable to power button 917, housing stem 929 and much of the
same adjustable optics mechanisms. Through electro-mechanical
adjustment via actuator 926, rotating and adjusting the elevation
of the stem 927 along with electronic pivot control via a
piezo-actuator 925, the illustrated IMD as before can also be
fitted to adequately match a variety of females and further assist
in the guidance, targeting, and examination within the vaginal
channel.
[0099] A substantive difference between FIGS. 8a-b and FIGS. 9a-b,
is that the latter includes a dual imager assembly
arrangement--that is in addition to the imager assemblies 911, 923
imager assemblies 909, 921 can be found.
[0100] FIG. 9c is an exemplary symmetric optics cap which is merely
one of many types and sizes available to help tailor the IMD to the
particular patient. FIG. 9d illustrates an inner cap 933 that is
relatively harder plastic that can be used with the IMD of FIG. 9b
for example to cover and hermetically sealed the optics assembly.
When the inner cap 933 is used, an outer cap such as the outer cap
935 of FIG. 9c provides a secondary covering by sliding it over the
inner cap 933. In this way, the flexibility of the outer cap 935
will provide comfort and adequately expand the intravaginal areas
to be imaged.
[0101] In general, the dimensions 951, 953, 955, 957, 959, 961,
963, 991, 993, 995 and 965 are such that the intravaginal
monitoring device is able to accommodate the inner electronics
appropriately, and at the same time a woman is able to insert and
maneuver it in place (as well as with considerations of comfortable
wear for the woman). In a specific embodiment, dimensions are
nearly the same as that set forth in relation to FIGS. 8a-e
above.
[0102] FIGS. 10a-d are perspective diagrams illustrating further
details regarding the adjustable optics assembly of FIGS. 9a-b that
supports two imager assemblies. Space is at a premium within optics
caps. Initially, such cap sizes take into account the need function
of spreading the tissues in the target insertion zone so that
adequate illumination and image capture can take place. Small form
factor on the other hand is a desire for insertion comfort reasons.
An optics cap length can also be shortened or lengthened to
accommodate targets such as the cervix which may be axially located
very close to the vaginal oriface or, alternatively, at the back of
the vaginal channel. Overall cap size must also take into account
focal lengths, imager and mounting assembly sizes, etc.
[0103] In FIG. 10a, a standard, side-by-side arrangement of two
imager assemblies 1013 and 1015 is shown. Through manual or
electro-mechanical control, a stem 1017 can be rotated and
elevated, and a mounting platform 1011 can be pivoted.
[0104] FIG. 10b illustrates that a rivet 1020 or other tension
based interconnect between imager assemblies 1019, 1021 may further
permit an angular adjustment between the two imager assemblies
1019, 1021. To save space yet sacrifice such angular adjustment,
FIG. 10c illustrates overlapping cavities of imager assemblies
1023, 1025 to a level that does not cause interference with each
optical path. Fully overlapping cavities are also possible yet not
shown. In FIG. 10d, although imager assemblies 1027, 1029 appear to
be connected, they are merely co-located with separate mounting
platforms and corresponding separate actuators to provide separate
pivot control for each.
[0105] FIG. 11 is a perspective diagram illustrating an exemplary
physical construction of an intravaginal monitoring device built in
accordance with various aspects of the present invention to support
manual optical system adjustment. The illustration depicts an axial
imager assemblies 1111 and a radial imager assembly 1115 disposed
on a mounting bracket 1117. The mounting bracket 1117 may be
metallic or otherwise made to conform under normal finger pressures
to various positions. Specifically, platform 1113, of the mounting
bracket 1117, supports the radial imager assembly 1115. The
platform 1113 may be bent to conform to optics demands required by
a particular user. Likewise, a platform 1116 portion of the
mounting bracket 1117 can be bent to readjust the angle of the
axial imager 1111, if need arises. The mounting bracket is inserted
via a screw cap 1119 and into a telescopic stem 1121 that is also
capable of rotation. Glue can be added to hermetically adhere the
portion of the mounting bracket 1117 spanning inside the stem 1121.
By inserting the telescopic stem 1121 through the bottom of a
housing stem 1127 (only an upper portion of which is shown), a
flange within the housing stem 1127 (not shown) and corresponding
lip 1123 prevent the telescopic stem 1121 from falling out of the
housing stem 1127 in the upward direction. By first adjusting the
depth and rotation angle of the telescopic stem 1121 and then
tightening the screw cap 1119, the optics assembly can be adjusted
and secured for further use.
[0106] FIG. 12 is a schematic diagram illustrating exemplary
internal circuitry utilizing electro-mechanically controlled optics
elements, which may be employed in whole or in part within the
various IMDs illustrated in the various figures of the present
application. Electronic circuitry and components shown are
typically located within a hermetically sealed portion of an
intravaginal monitoring device. Such electronics are mostly located
within a housing stem of an IMD, but specific components or
particular portions of the circuitry may be located elsewhere,
e.g., within an optics cap, an end cap, or in a device remote from
the IMD itself.
[0107] The electronics include sensors such as image capture
assemblies 1207 that deliver still images (i.e., "snap shots") and
streamed video, and that may comprise for example an axial imager
(or imager assembly) 1209, a radial imager (or imager assembly)
1211, distance sensor 1221 (which may comprise for example an axial
laser diode pair 1223 and a radial laser diode pair 1225. Other
sensors and components may be added, such as a thermometer 1231 or
a microphone 1233. Other components include a power button 1235,
USB circuitry 1241, Bluetooth.RTM. communication circuitry 1243,
and flash memory 1255. Positional control circuitry &
electro-mechanical components 1245 enable an interface and control
circuitry 1257 used to fully or partially adjust the up to three
dimensional positioning of any sensor or optical element within the
IMD. A power regulation circuitry 1263 manages power delivery from
a battery pack 1265, and, if so configured, supports recharging
thereof via external power. The battery pack 1265 may be
rechargeable or disposable.
[0108] The interface and control circuitry 1257 also manages and
controls all of the components and circuitry by using either
internal preprogrammed firmware, a loaded software application, or
a combination of both. Such program code can be replaced by using
well known schemes such as local downloading, flash memory
installation, over the Internet or over the air updates, etc.
[0109] The interface and control circuitry 1257 can also be
directed, in part, remotely, via the Bluetooth.RTM. or USB
communication circuitry 1243 and 1241 via wireless or wired links,
respectively. Such links could support communication through which
data (images, video, sensor information, etc.) and commands could
be sent or received. The recipient or sender of such communications
could be, for example, (a) a dedicated device designed for use with
IMDs (e.g., a hand-held device with a display and user interface);
(b) a general purpose device running an application designed for
use with the IMD (e.g., a smart phone, tablet computer, laptop
computer, etc.); or (c) a server or stand-alone computing system
running an application designed for use with IMDs. In any of the
above examples, such devices can be local to the IMD and used by
the person managing the local insertion and data collection using
an IMD (e.g., the patient, doctor or assistant). Likewise the
examples could involve remotely located devices reachable via
wireless cellular and/or Internet connectivity.
[0110] As mentioned previously, electro-mechanical control can be
carried out using one or more servo actuators, such as the ones
available from various companies such as Alps Electric Co,
Ltd..RTM.. Such actuators may control, for example, telescopic,
rotational, pivoting or other motion of an optics element or
assembly (e.g., imager assemblies 1209 and 1211) and any other
sensor or element within the IMD. The positional control circuitry
1245, in response to directions received from the interface &
control circuitry 1257, controls an electro-mechanical actuator,
for example, to rotate an optics assembly, at a fixed rate, in
clockwise or counterclockwise directions. The circuitry 1245 may
also controls other actuators to cause elevation of a telescopic
stem portion of an optics assembly. Other types of actuator
configurations and resultant movements of any element within the
IMD is also contemplated.
[0111] FIG. 13 is a diagram illustrating a separate
hand-held-device, in communication with a dual imaging IMD with
electro-mechanical image adjustment mechanisms built therein,
wherein two video sequences are simultaneously displayed to assist
in both tailoring such IMD for use by a particular female, and
assisting in insertion, framing, zooming, panning, and otherwise
targeting of a cervical region within a vaginal channel. The
hand-held device is communicatively coupled to an IMD (not shown)
to receive images and video streams and to exchange control
signals. As illustrated, the hand-held device is receiving and
displaying a first video stream from an axial imager assembly of
the IMD within a window 1353. Simultaneously, the hand-held device
receives and displays in a sub-window 1351 a second video stream
that originates from a radial imager assembly within the IMD. The
video being displayed within the window 1353 can be swapped with
that being displayed in the sub-window 1351 by the user as desired.
Both steams can be delivered in a wired or wireless manner and via
any or no communication node intermediaries (that is, via either
point to point or routed pathways). Such communicative may involve
any of a large number wired or wireless interfaces such as USB,
Bluetooth.RTM., infrared, and WiFi.
[0112] Repositioning of various optical systems or elements thereof
can be controlled via a user interface associated with the
hand-held device. For example, zooming, panning, focusing pivoting,
etc., can be directed through button input or through other
interface techniques such as finger pinching, double finger
twisting, and finger sliding motions while in contact with a touch
sensitive screen infrastructure. Guidance during insertion and
positioning of the IMD can be more easily achieved and confirmed by
observing one or both of the screens 1353 and 1351, during such
processes. All other types of control and adjustments mentioned
throughout this specification are also possible via the illustrated
device.
[0113] In addition, the hand-held device also contains a plurality
of buttons, such as record button 1311, IMD power button 1313,
volume button 1315, snapshot button 1317 and IMD status button
1321. The record button 1311 allows continuous local and remote
storage of the video streams being received and displayed in the
windows 1353, 1351. Recorded video need not be of the same
resolution of that being displayed. This can be accomplished
through interaction with the IMD or via transcoding within the
hand-held device. Similarly, the snapshot button 1317 triggers an
image capture command's delivery to the imager assemblies within
the IMD. In response, captured images (with perhaps differing
resolution of that of the video stream) are delivered via the
communication link and can be displayed via the windows 1353, 1351
and remotely and locally stored. Alternatively, images could be
reconstructed from the ongoing video stream, if resolution an
adequate quality is present.
[0114] The hand-held device may also contain a plurality of light
status indicators 1355 (which could be other types of indicators or
display elements) that indicate power status, communication link
status, snapshot and recording indications, and so forth.
[0115] Configuring other aspects of the IMD and the present
hand-held device may be made via software instructions underlying
the setup button 1321. To check on the overall status of the IMD,
software underlying the IMD status button 1321 will trigger a
communication exchange of status information such as operational
condition, storage usage, ownership information, etc. The IMD power
button 1313 may also assist by triggering or otherwise displaying
the remaining power and usage characteristics of the associated
IMD.
[0116] FIG. 14 is a diagram illustrating a laptop computer, in
communication with a dual imaging IMD with electro-mechanical image
adjustment mechanisms built therein, wherein much like the
hand-held device of FIG. 13, two video sequences are simultaneously
displayed to assist in both tailoring such IMD for use by a
particular female, and assisting in insertion, framing, zooming,
panning, and otherwise targeting of a cervical region within a
vaginal channel. All of the description provided with respect to
FIG. 13 applies equally to the laptop computer 1417 illustrated in
FIG. 14. The only exception perhaps is that a patient conducting
the IMD insertion and monitoring process may find that interacting
with the hand-held device somewhat easier to manage. This
distinction may apply equally to anyone that desires to perform the
insertion while reviewing video or image feeds.
[0117] For example, the communicative coupling between an
intravaginal monitoring device and the laptop computer 1417 may be
accomplished via any point to point or routed communication
infrastructure, e.g., wired or wireless interfaces such as USB,
Bluetooth.RTM., infrared or WiFi and through the Internet or
cellular network infrastructures. The laptop computer 1417 may be
located in the same room as the patient and IMD, yet may
alternatively be located remotely.
[0118] Instead of one main window and one sub-window (or frame),
the much larger screen 1415 of the laptop computer 1417 versus that
of the hand-held device (FIG. 13) permits the presentation of two
reasonably large sized "split-screen" windows 1411, 1413 of image
and video feeds received from the IMD as they are captured.
[0119] Once communicatively coupled to the IMD, the laptop computer
1417 provides two images or video streams (e.g., a first from an
axial imager and a second from a radial imager). The video streams
or images are then presented in the two windows 1411 and 1413 which
can be resized, stretched or overlapped in typical fashion.
[0120] The laptop computer 1417 operates pursuant to a program
application designed for use with the IMD. In addition to directing
the management of the screens 1411, 1413 and user input devices
(keypad or pad), the program application provides control signals
to manipulate the electro-mechanical components within the IMD as
discussed throughout this application.
[0121] FIG. 15 is a conceptual diagram illustrating visually a
programmatic process of stitching the resulting images or video
frames to obtain a wider angle view of the intravaginal and
cervical regions, wherein such process may take place on an IMD or
within any external, supporting device. Particularly, stitching
software receives two simultaneously captured images (or video
frames) 1511, 1513 (perhaps one axially and one radially collected)
from the IMD. The stitching software uses correlation techniques
and known positional information regard the underlying imager
locations and cervical distances to create (via stretching,
stitching, and combining) a single two dimensional image by
combining the received image data. This process is roughly
illustrated via a single screen 1515 through which the images are
modified and merged.
[0122] Although the various aspects of the present invention have
been described in relation to the human species, similar constructs
of IMDs of perhaps differing sizes and shapes are contemplated
employing such various aspects of the present invention to support
monitoring of female reproductive systems of other species.
[0123] The terms "circuit" and "circuitry" as used herein may refer
to an independent circuit or to a portion of a multi-functional
circuit that performs multiple underlying functions. For example,
depending on the embodiment, processing circuitry may be
implemented as a single chip processor or as a plurality of
processing chips. Likewise, a first circuit and a second circuit
may be combined in one embodiment into a single circuit or, in
another embodiment, operate independently perhaps in separate
chips. The term "chip", as used herein, refers to an integrated
circuit. Circuits and circuitry may comprise general or specific
purpose hardware, or may comprise such hardware and associated
software such as firmware or object code.
[0124] 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."
[0125] 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.
[0126] 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.
[0127] 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.
[0128] 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.
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