1. Technical Field
The invention generally relates to medical devices, and more particular to medical devices used in obstetrics and gynecology.
2. Related Art
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.
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 (˜60% variance); (b) lengths between vaginal orifices to anterior fornices (˜40% variance); (c) sizes of the introitus (˜70% variance); (d) straight line lengths between anterior to posterior fornices (˜70% variance); (e) straight line widths between lateral fornices (˜80% variance); and (f) vaginal orifice, mid vaginal and anterior fornix vaginal widths.
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.
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.
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.
Such large variations in female reproductive systems are also found in many other species beyond that of homo sapiens.
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.
a 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;
a-c are cross-sectional diagrams illustrating a wide ranging variation in dimensions and orientations of intravaginal and cervical regions with the IMD of
a-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;
a-d are cross-sectional diagrams illustrating a wide ranging variation in dimensions and orientations of intravaginal and cervical regions with the IMD of
a-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;
a-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;
a-d are perspective diagrams illustrating further details regarding the adjustable optics assembly of
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.
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).
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
a 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
The
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.
Among other details, the illustration also shows, an optics cap 435 depicted in the
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.
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.
a and 5b are schematic diagrams illustrating a wide ranging variation in dimensions of intravaginal and cervical regions and
a-c are cross-sectional diagrams illustrating a wide ranging variation in dimensions and orientations of intravaginal and cervical regions with the IMD of
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.
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.
b-c illustrate the vast differences in cervical sizes and orientations that will impact the performance of the IMD of
a-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.
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.
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.
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.
b demonstrates that with a slightly wider optics cap 610 replacing the optics cap 609 of
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.
c illustrates the insertion of an IMD much like that of
c-d are schematic diagrams illustrating a wide ranging variation in dimensions of intravaginal and cervical regions and
a-d are cross-sectional diagrams illustrating a ranging variation in dimensions and orientations of intravaginal and cervical regions with the IMD of
In
c 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
a-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
In both of the IMDs of
Specifically, in
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
A typical example of a procedure for tailoring, guiding and targeting with the IMD of
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.
In
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.
With this configuration and whether or not fully or partially inserted, using an external display and user interface, the IMD of
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.
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.
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.
In
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.
a-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
Similarly,
A substantive difference between
c 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.
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
a-d are perspective diagrams illustrating further details regarding the adjustable optics assembly of
In
b 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,
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® 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.
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.
The interface and control circuitry 1257 can also be directed, in part, remotely, via the Bluetooth® 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.
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.®. 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.
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.
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.
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.
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.
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®, 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.
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 (
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.
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.
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.
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.
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.”
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.
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.
One of average skill in the art will also recognize that the functional building blocks, and other illustrative blocks, modules and components herein, can be implemented as illustrated or by discrete components, application specific integrated circuits, processors executing appropriate software and the like or any combination thereof.
Moreover, although described in detail for purposes of clarity and understanding by way of the aforementioned embodiments, the present invention is not limited to such embodiments. It will be obvious to one of average skill in the art that various changes and modifications may be practiced within the spirit and scope of the invention, as limited only by the scope of the appended claims.
This application incorporates by reference herein in their entirety and makes reference to, claims priority to, and claims the benefit of: 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.; c) U.S. Provisional Application Ser. No. 61/246,396 filed Sep. 28, 2009, entitled “Network Supporting Intravaginal Monitoring Device” by Ziarno et al. 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 e) U.S. Provisional Application Ser. No. 61/263,416 filed Nov. 23, 2009, entitled “Intravaginal Monitoring Architecture” by Ziarno et al. Also incorporated herein by reference in their entirety are: 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; 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; 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; 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; 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; 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 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.
Number | Date | Country | |
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61246375 | Sep 2009 | US | |
61246405 | Sep 2009 | US | |
61246396 | Sep 2009 | US | |
61290792 | Dec 2009 | US | |
61263416 | Nov 2009 | US |