Patent Publication Number: US-2021161375-A1

Title: Digital Colposcope for Self-Examination

Description:
TECHNICAL FIELD 
     This invention relates to colposcope devices for examining a subject&#39;s vagina and cervix. 
     BACKGROUND 
     A colposcope is a medical device used to examine a patient&#39;s vagina and cervix for detecting abnormalities such as cancerous growths or infection. Conventional colposcopes are expensive equipment that are bulky and heavy. Thus, they are not easily portable. Moreover, colposcopes are used in conjunction with a speculum to expand the vaginal canal to enable better viewing of the cervix. The speculum requires an external user for proper insertion. 
     Thus, conventional colposcope exams are performed in a clinical facility (e.g. doctor&#39;s office). There is a need for colposcopes that are lightweight, low cost, easily portable, and easy-to-use to allow for self-examination outside of a clinical facility (e.g. at home). With the appropriate technology, it is possible that a user could self-perform an examination on herself. 
     SUMMARY 
     My invention addresses this need for a device that allows self-examination of female internal genitalia, e.g. cervix and vagina. In one embodiment, my invention is a digital colposcope that could be used for self-examination. The digital colposcope comprises an elongate main body having a distal end and a proximal end. The main body could have any suitable dimension for probing into a subject&#39;s vaginal canal. In some embodiments, the main body has a length in the range of 10 to 40 cm; and in some cases, in the range of 15 to 35 cm. In some embodiments, the main body has a width in the range of 0.5 to 3.0 cm; and in some cases, in the range of 1.0 to 2.5 cm. 
     There is a digital camera module contained in the main body and has a lens cover at the distal end of the main body. The main body could also hold a wireless transmitter to send images to an external display device (e.g. a smartphone). 
     There is a self-expanding scaffold around the main body. The scaffold is designed to have a smaller compressed configuration, but self-expand in a radially outward direction when the compressive force is released. There is a stretchable protective membrane over the self-expanding scaffold. This protective membrane serves to avoid roughness or abrasion of the scaffold against the vaginal canal. 
     A slidable sheath over the protective membrane serves to radially compress the self-expanding scaffold when fully advanced to its distal position. Retraction of the slidable sheath in a proximal direction allows the scaffold to self-expand in a radially outward direction, thereby inflating the protective membrane. The slidable sheath could comprises an annular ridge at its distal end to facilitate sliding of the sheath over the protective membrane. 
     The self-expanding scaffold could have any suitable configuration or framework that acts like a spring to recover its expanded configuration when the compressing force is removed. For example, the self-expanding scaffold could be a coil or mesh. In some embodiments, the scaffold comprises a plastic material, stainless steel, or a shape memory metal such as nitinol. The digital colposcope could comprise a light source to illuminate the vaginal canal. For example, it could have LED illumination at the distal end of the main body. 
     In another embodiment, my invention is a method of performing vaginal or cervical examination using the above-described digital colposcope of my invention. The method could be performed by the subject herself (self-examination) or by another person (e.g. an assistant). The method comprises inserting (or self-inserting) the digital colposcope into the subject&#39;s vagina with the distal end of the main body pointing into the vagina. The main body of the digital colposcope is advanced into the vagina towards the cervix. Images of the vagina and cervix are acquired for analysis. The images may be transmitted to an external display device (e.g. a smartphone) via wired or wireless communication. 
     In some embodiments, the method further comprises, as the distal end of the main body approaches the cervix, retracting the slidable sheath in a proximal direction. This allows the scaffold to self-expand in a radially outward direction, thereby inflating the protective membrane to widen the vaginal canal passageway. For removal of the colposcope, the sheath could be advanced distally to downsize the expanded membrane. This could help in removal of the colposcope out of the vaginal canal. 
     In another embodiment, my invention is yet another type of digital colposcope with a display screen. This digital colposcope comprises an elongate main body having a distal end and a proximal end. The main body could have the dimensions given above. The main body could have a digital camera, lens cover, wireless transmitter, or other components described above. The digital colposcope could comprise a light source to illuminate the vaginal canal. For example, it could have LED illumination at the distal end of the main body. 
     The digital colposcope further comprises a display panel comprising a display screen. The colposcope is configured such that the display screen faces more towards the distal direction than towards the proximal direction relative to the main body of the colposcope. The display panel could be attached to the main body in any suitable way. In some embodiments, at the proximal end of the main body, there is a connecting arm that connects the display panel to the main body. Such connecting arm could be fixed or flexible. 
     In fixed configurations, the angle between the central longitudinal axis of the main body and the plane of the display panel could be in the range of 0 to 90°; and in some cases, in the range of 30 to 75°. In flexible configurations, the range-of-motion for the display panel relative to the central longitudinal axis of the main body could be encompassed within the range of 0 to 90° (e.g. the possible range-of-motion could be 30 to 60°); and in some cases, encompassed within the range of 30 to 75°. 
     In another embodiment, my invention is a method of performing vaginal or cervical examination using the above-described digital colposcope with display screen of my invention. The method could be performed by the subject herself (self-examination) or by another person (e.g. an assistant). If used for self-examination, the colposcope could be configured such that the display screen faces towards the subject&#39;s eyes. 
     The method comprises inserting (or self-inserting) the digital colposcope into the subject&#39;s vagina with the distal end of the main body pointing into the vagina. The main body of the digital colposcope is advanced into the vagina towards the cervix. Images of the vagina and cervix are acquired for analysis. The images may be transmitted to an external display device (e.g. a smartphone) via wired or wireless communication. 
     In fixed configurations, the angle of insertion may be adjusted for better viewing of the display screen. In flexible configurations, the connecting arm may be adjusted to angle the display panel for better viewing of the display screen. 
     In some embodiments, the above-described digital colposcopes could have other sensor elements such as a urine chemistry sensor. The patient could urinate on the sensor to diagnose abnormalities that manifest in urinalysis. The digital colposcopes of my invention could provide better service and quality for home or clinical setting (e.g. hospital or doctor office). Using this digital colposcope could be used to detect abnormalities such as cancerous growths or infection. This digital colposcope could also be used to examine the cervix to assess how a pregnancy and labor is progressing. The digital colposcope could transmit the images to a screen device (e.g. smartphone) and could also assess the images for diagnosis. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a side view of an example digital colposcope of the invention. 
         FIGS. 2A and 2B  show different perspective views of the distal portion of the digital colposcope shown in  FIG. 1 . 
         FIGS. 3A-3D  show a “build-up” view of the digital colposcope shown in  FIG. 1 . 
         FIG. 4  shows a side view of the digital colposcope with a cutaway window. 
         FIGS. 5A-5C  show the operation of the digital colposcope. 
         FIGS. 6A and 6B  show an example of how the digital colposcope could be used. 
         FIG. 7  shows a perspective view of another example digital colposcope of my invention. 
         FIGS. 8A and 8B  show an example of how the digital colposcope of  FIG. 7  could be used. 
     
    
    
     DETAILED DESCRIPTION 
     To assist in understanding the invention, reference is made to the accompanying drawings to show by way of illustration specific embodiments in which the invention may be practiced. 
       FIG. 1  shows a side view of an example digital colposcope  10  of the invention. The digital colposcope  10  comprises an elongate main body  12 . To specify orientation, the distal direction is indicated by the reference label “D” and the proximal direction is indicated by the reference label “P.” At the distal end  14 , there is a lens cover  18  for the digital camera. Also behind the lens cover  18  are LED lights for illumination. A partial view of the distal end of the stretchable balloon  24  is visible underneath the slidable sheath  20  covering over the balloon  24 . The slidable sheath  20  is fully advanced to hold the spiral coil  30  in place (not seen in this view). The distal end of the sheath  20  has an annular ridge  22  to facilitate sliding of the sheath  20  over the balloon  24 . The proximal end  16  is also shown. The digital colposcope  10  uses a wireless transmitter to send images to any suitable display device, e.g. a smartphone or display monitor. 
       FIGS. 2A and 2B  show different perspective views of the distal portion of the digital colposcope  10 . Over the main body  12 , there is a spiral coil  30 , which is in a compressed configuration, but ready to self-expand outwardly in a radial direction. The protective balloon  24  is shown in truncated, cutaway view to show how it covers over spiral coil  30 . The sheath  20  covers over the protective balloon  24  and the spiral coil  30  to restrain the radial self-expansion of the spiral coil  30 . Here, the sheath  20  is retracted slightly, but for better visual clarity, the protective balloon  24  and the spiral coil  30  are shown in their unexpanded configuration. In actual use, the retraction of sheath  20  would allow the spiral coil  30  to expand, along with the protective balloon  24 . 
       FIGS. 3A-3D  show a “build-up” view of the digital colposcope  10 , i.e. showing the device in a series of layers.  FIG. 3A  shows the elongate main body  12  of the digital colposcope  10  with the distal end  14  and the proximal end  16 . The main body  12  houses the various electronic components for operation of the digital colposcope  10 . For example, it may house the digital camera module, battery power supply, LED illumination, wireless communication (e.g. Bluetooth transmitter), user controls (e.g. buttons, switches, etc.) and so on. This view shows the digital camera module  34 , wireless transmitter  36 , and LED lights  38 . Some of the electronic and mechanical components that could be used in the main body  12  are described in patent publications US 2019/0150725 (Ramanujam et al.) and WO 2019/070998 (Duke University), which are incorporated by reference herein. At the distal end tip of the main body  12  is the lens cover  18  for the digital camera and LED illumination lights. 
       FIG. 3B  shows the spiral coil  30  extending over the main body  12 . The spiral coil  30  is in a radially compressed configuration that is capable of self-expanding to a larger diameter. The spiral coil  30  may be made of any suitable material, such as stainless steel or plastic.  FIG. 3C  shows the protective balloon  24  covering over the spiral coil  30 . The function of the protective balloon  24  is to reduce abrasion against the vaginal mucosa.  FIG. 3D  shows the slidable sheath  20  covering over the protective balloon  24 . The function of the sheath  20  is to restrain the radial self-expansion of the spiral coil  30 . The slidable sheath  20  can be retracted proximally or advanced distally to control the expansion of the balloon  24  and coil  30 .  FIG. 4  shows a side view of the digital colposcope  10  with a cutaway window  40  to expose the underlying layer structures. In the cutaway window  40 , the overlapping layers of the slidable sheath  20 , the balloon  24 , the spiral coil  30 , and main body  12  are all visible. 
       FIGS. 5A-5C  show the operation of the digital colposcope  10 . In  FIG. 5A , the digital colposcope  10  is provided in a compact configuration with the slidable sheath  20  fully advanced to its distal position. In  FIG. 5B , the sheath  20  is retracted in the proximal direction. This exposes a portion of the protective balloon  24  and releases the spiral coil  30 , allowing it to unwind and expand outward against the balloon  24 .  FIG. 5C  shows a see-through view of the spiral coil  30  with its distal segment unwound to inflate the balloon  24 . 
       FIGS. 6A and 6B  show an example of how the digital colposcope  10  could be used. The relevant anatomy here is the uterus  74 , the cervix  72 , and the vaginal canal  70 . Initial insertion of a vaginal speculum is optional, but not necessary. As seen in  FIG. 6A , the user self-inserts the colposcope  10  into her vaginal canal  70  with the distal end pointing in. The user views the camera images on a mobile smartphone  44 , which receives the images via wireless transmission from the colposcope  10 . Alternatively, the colposcope  10  may be connected to the smartphone via a cord for image data transmission, e.g. a USB port. The user continues to advance the colposcope  10  through the vaginal canal  70  towards cervix  72 . Because the contours of the vaginal canal  70  may not allow adequate visualization of the passageway, the user retracts the sheath  20  in a proximal direction. 
     As shown in  FIG. 6B , this exposes the protective balloon  24  and releases the spiral coil, allowing it to expand outward against the balloon  24 . Inflation of balloon  24  in this manner widens the passageway to facilitate visualization of the cervix  72 . Video or still images of the cervix  72  may be taken and recorded. Clinical assessment of the images could be performed automatically by artificial intelligence software, review by a clinician, or combination thereof (e.g. computer-assisted diagnosis). The artificial intelligence software may reside on the colposcope  10 , on a remote device (e.g. a smartphone app), or a combination thereof. 
       FIG. 7  shows a perspective view of another example digital colposcope  50  of the invention. The digital colposcope  50  comprises an elongate main body  52  with a distal end  56 . To specify orientation, the distal direction is indicated by the reference label “D” and the proximal direction is indicated by the reference label “P.” At the distal end  56 , there is a lens cover  54  for the digital camera and LED illumination. At the proximal end, there is a display panel  58  having a display screen  60  to display images acquired from the digital camera. The colposcope  50  is configured such that display screen  60  faces towards the distal direction, i.e. towards the self-examining user. The display panel  58  is connected to the main body  52  by a flexible connector arm  62 , which allows the display panel  58  to be adjusted for better viewing by the user. The display screen  60  may have a touchscreen interface. 
       FIGS. 8A and 8B  show an example of how the digital colposcope  50  could be used. Initial insertion of a speculum is optional, but not necessary. As shown in  FIG. 8A , the user  78  self-inserts the colposcope  50  into her vaginal canal  70  with the distal end pointing in. The user  78  views images from the digital camera of the colposcope  50  on the display screen  60  of the panel  58 . Because the display screen  60  is facing towards the user  78 , this facilitates easier viewing by the user  78 . The user  78  continues to advance the colposcope  50  through the vaginal canal  70  towards cervix  72 . Video or still images of the cervix  72  may be taken and recorded. Clinical assessment of the images may be performed automatically by artificial intelligence, review by a clinician, or combination thereof (e.g. computer-assisted diagnosis). Clinical assessment of the images could be performed automatically by artificial intelligence software residing on the colposcope  50 , on a remote device (e.g. a smartphone app), or a combination thereof. 
       FIG. 8B  shows how to measure the angle between the display panel  58  and the main body  52 . The main body  52  has a central longitudinal axis  80 . This intersects with the crossing axis  82  of display panel  58  (on the imaginary plane upon which the display panel  58  resides). The angle  84  between axis  80  and axis  82  is considered the angle between the display panel  58  and the main body  52 . This also applies in the alternate scenario where the connector arm  62  between display panel  58  and main body  52  is fixed. 
     In addition to the descriptions given above, the digital colposcope of the present invention could have any of various different sizes and shapes. The digital colposcope could be used for examining the internal or external genitalia of males or females. The digital colposcope could also detect or identify abnormalities and transmit the results (e.g. images or descriptive text) to a display screen in real-time. The digital colposcope could also have a sensor for urine analysis, which could be implemented by urinating on the sensor, wiping the sensor (e.g. with bathroom tissue), or inserting the sensor into the urinary tract. Again, the digital colposcope could also detect or identify abnormalities in the urine sample and transmit the results (e.g. images or descriptive text) to a display screen in real-time. In males, this could also be used in the relevant anatomy of male subjects, such as anus or penis. 
     The foregoing description and examples have been set forth merely to illustrate the invention and are not intended to be limiting. Each of the disclosed aspects and embodiments of the invention may be considered individually or in combination with other aspects, embodiments, and variations of the invention. In addition, unless otherwise specified, the steps of the methods of the invention are not confined to any particular order of performance. Modifications of the disclosed embodiments incorporating the spirit and substance of the invention may occur to persons skilled in the art, and such modifications are within the scope of the invention. 
     Any use of the word “or” herein is intended to be inclusive and is equivalent to the expression “and/or,” unless the context clearly dictates otherwise. As such, for example, the expression “A or B” means A, or B, or both A and B. Similarly, for example, the expression “A, B, or C” means A, or B, or C, or any combination thereof.