US20110190582A1 - Intravaginal optics targeting system - Google Patents
Intravaginal optics targeting system Download PDFInfo
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- US20110190582A1 US20110190582A1 US12/890,847 US89084710A US2011190582A1 US 20110190582 A1 US20110190582 A1 US 20110190582A1 US 89084710 A US89084710 A US 89084710A US 2011190582 A1 US2011190582 A1 US 2011190582A1
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Definitions
- the invention generally relates to medical devices, and more particular to medical devices used in obstetrics and gynecology.
- 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.
- 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.
- 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.
- 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.
- 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;
- IMD intravaginal monitoring device
- FIG. 2 is a cross-sectional diagram illustrating various details and dimensional ranges underlying the reproductive system of the FIG. 1 ;
- 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
- FIGS. 4 a through 4 h 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;
- FIGS. 5 a - 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;
- FIGS. 6 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;
- FIGS. 7 a - 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;
- FIGS. 8 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
- FIGS. 9 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;
- FIGS. 10 a - d are perspective diagrams illustrating further details regarding the adjustable optics assembly of FIGS. 9 a - b that supports two imager assemblies;
- 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;
- 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;
- 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;
- 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
- 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.
- 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 .
- depicted is an exemplary overlay of a tilted uterus 115 .
- 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 .
- IMD Intravaginal Monitoring Device
- 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).
- 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.
- 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.
- the various IMD embodiments within the present application are equally applicable to the reproductive systems of non-human female species.
- the IMD 191 employs a variety of techniques to address the wide variance in reproductive systems usable for all species.
- 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.
- 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.
- 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 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.
- 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
- 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.
- 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.
- 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).
- 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.
- a woman who purchases and adjusts the optics assembly of an intravaginal monitoring device 191 to fit her present anatomy 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.
- FIG. 2 is a cross-sectional diagram illustrating various details and dimensional ranges underlying the reproductive system of the FIG. 1 .
- 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.
- 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.
- 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.
- anterior fornix vaginal widths can vary between 2.2 and 6.5 cm, with an average of 3.3 cm, as many studies show.
- 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 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.
- 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.
- 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.
- FIGS. 4 a through 4 h 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. 4 g 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.
- FIGS. 4 a , 4 b, 4 c, 4 d, 4 e , 4 f and 4 h depict individual parts and steps of constructing an intravaginal monitoring device such as that of the FIG. 4 g .
- an optics assembly 429 FIG. 4 g
- a telescopic stem 411 FIG. 4 a
- FIG. 4 b 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.
- 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.
- the telescopic stem 428 can be extended and configured for rotation mechanically by a user via the end cap 433 .
- 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.
- an optics cap 435 depicted in the FIG. 4 e 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.
- 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.
- 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.
- FIGS. 5 a and 5 b are schematic diagrams illustrating a wide ranging variation in dimensions of intravaginal and cervical regions and FIG. 5 c 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.
- FIGS. 5 a , 5 b and 5 c 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.
- FIGS. 5 a - 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.
- 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.
- 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.
- radial imagers are those comprising a location with a substantial radial component, while axially directed imagers comprise a substantial axial component.
- 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.
- the a single “panoramic-like” image can be stitched and stretched together.
- 3D images and video can be constructed from the two sources of image data (i.e., from the assemblies 513 , 509 ).
- 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.
- FIGS. 5 b - c illustrate the vast differences in cervical sizes and orientations that will impact the performance of the IMD of FIG. 5 a .
- the positioning and repositioning process e.g., via guidance supported procedures
- the illustrated IMD is able to capture adequate images for such variations.
- FIGS. 6 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.
- FIG. 6 a 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.
- 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 can be extended to mate with the housing stem 614 as an alternative to mating with the stem 613 (as shown).
- 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.
- 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 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 .
- FIG. 6 b demonstrates that with a slightly wider optics cap 610 replacing the optics cap 609 of FIG. 6 a 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.
- 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 .
- a yet larger optics cap might be used, it may very well be intolerable due to comfort and insertion constraints.
- FIG. 6 c illustrates the insertion of an IMD much like that of FIG. 6 a within an entirely different vaginal channel and cervical orientation.
- a single imager assembly might be sufficient, as both of imager assemblies 627 and 631 are capable of capturing adequate images and video.
- 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. 6 a (i.e., the imager 607 ). Without such adjustment, the image and video captured by the imager assembly 627 would not span the cervical area.
- FIGS. 7 c - d are schematic diagrams illustrating a wide ranging variation in dimensions of intravaginal and cervical regions and FIGS. 7 a and 7 b 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.
- FIGS. 7 a - 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. 7 a depicts the front-end portions of the intravaginal monitoring device inserted into place to capture images of a relatively small sized cervix.
- a single imager assembly solution could be used (for example, by removing or disabling an axial imager assembly 713 .
- 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.
- 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. 7 a (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.
- FIG. 7 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.
- the relatively smaller cervix illustrated in FIG. 7 d 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.
- 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.
- FIGS. 8 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.
- 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.
- electrically powered actuators such as miniature piezo actuators
- FIG. 8 a in addition to electro-mechanical control, fully mechanical tailoring of some parts of the optical system is also shown.
- 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.
- a piezo actuator 813 controls the angle of a pivoting imager assembly 811 .
- 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.
- 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.
- 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. 8 c ). 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.
- a power button 819 is illustrated, a much more substantial user interface including a display is contemplated for some embodiments.
- a typical example of a procedure for tailoring, guiding and targeting with the IMD of FIG. 8 a 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.
- 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 .
- 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.
- FIG. 8 b 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.
- the IMD of FIG. 8 b is configured with automated telescoping and rotation.
- 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. 8 a ).
- 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 .
- 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.
- the IMD of FIG. 8B can be fully adjusted to assist in insertion guidance, zooming, panning, framing, and tracking interesting intravaginal targets.
- a user interface interacting with the IMD's of FIGS. 8 a - 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- the illustration shows a specific one of a plurality of types and sizes of optics caps, e.g., the optics cap 835 .
- 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. 8 e or glue) to at least provide partial hermetic sealing.
- 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.
- 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.
- FIGS. 9 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 FIG. 9 a closely parallels that of FIG. 8 a and thus most of the description thereof applies equally to here.
- the illustrated IMD can be fitted to adequately match a variety of females.
- 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.
- FIG. 9 b is similar to the embodiment of FIG. 8 b , and as before can share most of the aforementioned detailed description regarding FIG. 8 b .
- such details are applicable to power button 917 , housing stem 929 and much of the same adjustable optics mechanisms.
- 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.
- FIGS. 8 a - b and FIGS. 9 a - b A substantive difference between FIGS. 8 a - b and FIGS. 9 a - 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.
- FIG. 9 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.
- FIG. 9 d illustrates an inner cap 933 that is relatively harder plastic that can be used with the IMD of FIG. 9 b for example to cover and hermetically sealed the optics assembly.
- an outer cap such as the outer cap 935 of FIG. 9 c 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.
- 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).
- dimensions are nearly the same as that set forth in relation to FIGS. 8 a - e above.
- FIGS. 10 a - d are perspective diagrams illustrating further details regarding the adjustable optics assembly of FIGS. 9 a - 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.
- FIG. 10 a a standard, side-by-side arrangement of two imager assemblies 1013 and 1015 is shown.
- a stem 1017 can be rotated and elevated, and a mounting platform 1011 can be pivoted.
- FIG. 10 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 .
- FIG. 10 c 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.
- 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.
- 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.
- 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.
- 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 .
- a flange within the housing stem 1127 prevent the telescopic stem 1121 from falling out of the housing stem 1127 in the upward direction.
- 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.
- 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 .
- 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.
- 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).
- the examples could involve remotely located devices reachable via wireless cellular and/or Internet connectivity.
- 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.
- 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 .
- 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®, infrared, and WiFi.
- Repositioning of various optical systems or elements thereof can be controlled via a user interface associated with the hand-held device.
- 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.
- 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.
- 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 .
- 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.
- 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.
- 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.
- the much larger screen 1415 of the laptop computer 1417 versus that of the hand-held device 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.
- 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.
- the program application provides control signals to manipulate the electro-mechanical components within the IMD as discussed throughout this application.
- 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.
- 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.
- 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.
- processing circuitry may be implemented as a single chip processor or as a plurality of processing chips.
- 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.
- chip 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.
- 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.
- inferred coupling i.e., where one element is coupled to another element by inference
- inferred coupling includes direct and indirect coupling between two elements in the same manner as “operably coupled” and “communicatively coupled.”
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Also Published As
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US20110188716A1 (en) | 2011-08-04 |
US20110190581A1 (en) | 2011-08-04 |
US8679013B2 (en) | 2014-03-25 |
US20110190579A1 (en) | 2011-08-04 |
EA201200543A1 (ru) | 2012-11-30 |
EP2525702A4 (en) | 2014-10-29 |
MX2012003742A (es) | 2012-10-10 |
US20110190595A1 (en) | 2011-08-04 |
WO2011038310A4 (en) | 2011-06-23 |
US20130053657A1 (en) | 2013-02-28 |
EP2525702A1 (en) | 2012-11-28 |
CN103068299A (zh) | 2013-04-24 |
US8679014B2 (en) | 2014-03-25 |
US20110190580A1 (en) | 2011-08-04 |
WO2011038310A1 (en) | 2011-03-31 |
US20110190689A1 (en) | 2011-08-04 |
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