Patent Publication Number: US-2022218192-A1

Title: Air speculum

Description:
FIELD OF THE INVENTION 
     The present invention relates to vaginal speculums and particularly to a vaginal speculum that uses pressurized air to maintain a passageway through the vagina, such as to gain access to the cervix or other anatomy. 
     BACKGROUND OF THE INVENTION 
     Vaginal speculums provide access to the vagina and cervix for physical examinations and for introducing surgical instruments, such as for collecting tissue samples or for introducing medications. 
     Inflatable vaginal speculums have been used to examine the vagina and cervix. However, prior art inflatable speculums require sealing the septum against the vaginal walls, such as with a watertight or airtight septum or plug placed at the distal end of the speculum. The seal is meant to prevent flow of fluid (water or air) from the vagina and at the same time permit pressurized flow into the vagina. 
     SUMMARY OF THE INVENTION 
     The present invention seeks to provide a novel air speculum, as described in detail below. 
     The inventive speculum provides all the functionality of prior art speculums. The speculum of the invention can be used for many procedures, such as but not limited to, vaginal and cervical general inspection, cervical biopsies (e.g., Pap smears), and as working port for vaginal, cervical and uterine surgical procedures. 
     Among the many benefits of the speculum are significant reduction in pain to the woman and better acceptance by women, since there is no discomfort or shame and the physician does not have to contact the intimate organs of the woman. The speculum enables examining and treating a greater area of the vaginal canal and cervix with higher resolution. Instruments such as hysteroscopes can be used without sterilization. There is significantly improved illumination to view and examine the vagina. 
     There is thus provided in accordance with a non-limiting embodiment of the present invention a speculum including a speculum sheath formed with a first lumen which is in fluid communication with a pump and controller unit for introducing pressurized air into a vagina, a second lumen in fluid communication with the pump and controller unit for measuring air pressure in the vagina, and a third lumen in which is disposed a viewing device. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which: 
         FIGS. 1A and 1B  are simplified exploded and pictorial illustrations of an air speculum, constructed and operative in accordance with a non-limiting embodiment of the present invention; 
         FIGS. 2A, 2B and 2C  are simplified pictorial illustrations of a speculum sheath with lumens for introducing pressurized air, for measuring air pressure in the vagina, for placing a viewing device and a work channel for introducing tools, operative in accordance with a non-limiting embodiment of the present invention; 
         FIGS. 3A and 3B  are simplified pictorial illustrations of other possible shapes and sizes for illumination and viewing device lumens of the speculum of the invention; 
         FIG. 4  is a simplified block diagram of a controller and pump for use with the speculum, in accordance with a non-limiting embodiment of the present invention; and 
         FIG. 5  is a simplified illustration of the speculum introduced in the vagina of a patient. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
     Reference is now made to  FIGS. 1A and 1B , which illustrate an air speculum  10 , constructed and operative in accordance with a non-limiting embodiment of the present invention. 
     Speculum  10  includes a speculum sheath  12 , which may be disposable, which couples with a light source  14 , mounted on a handle  16 . A viewing device (camera)  18  is arranged to pass into speculum sheath  12 . 
     The structure of speculum sheath  12  is now described with reference to  FIGS. 2A and 2B . The speculum sheath  12  may be made of a medically-safe flexible plastic (preferably transparent) and may be formed with several lumens. For example, a first lumen  20  may be in fluid communication via a fluid connector  22  and tubing  23  with a pump and controller unit  24  (described more in detail with reference to  FIG. 4 ), for introducing pressurized air into the vagina. A second lumen  26  may be in fluid communication via a fluid connector  28  and tubing  29  with pump and controller unit  24 , for measuring air pressure in the vagina. A third lumen  30  is provided for placing therein viewing device  18 . The light source  14  may be coupled to third lumen  30 . The third lumen  30  (camera channel) may be closed at its distal end with an optically clear lens  31  to prevent any contact of tissues or fluids with viewing device  18  and avoid the need to sterilize viewing device  18 . The sheath protects the viewing device  18 . 
     The viewing device  18  may be, without limitation, a small diameter tube camera (1.6 mm) with a very wide lens (120°), good resolution and USB connection. The light source  14  may be one or more LEDs located on the handle  16 . With light guides (e.g., optical fibers), the light is directed to the distal end of the device to illuminate the vaginal channel. With a wide lens and appropriate lighting, the user sees a well-illuminated picture of the vagina channel, and may move the device back and forth for viewing desired areas. 
     Optionally, as seen in  FIGS. 2B and 2C , a fourth lumen  32  (work channel) may be provided for introducing a Pap smear brush  33  ( FIG. 2B ) or a tool  34  ( FIG. 2C ), such as but not limited to, biopsy tools, cutting incision tools, drug delivery tools and many other tools and devices. 
     The sizes, shapes and profiles of the air speculum and its lumens may be determined by different factors, such as but not limited to, a structure that minimizes or eliminates pain when inserting and using the device, and a structure that seals the entrance to the vagina as much as possible for efficient inflation and pressure measurement. 
     For example, as seen in  FIGS. 3A and 3B , the speculum sheath  12  may be oval to better seal against the labia minora and/or labia majora of the vagina, or may have other possible shapes and sizes for accommodating other illumination and viewing device lumens and sealing structure against the female anatomy. The viewing device  18  may be central with more than one such light source  14  (such as three light sources  14 ) around the viewing device  18 . 
     The device may be, without limitation, approximately 6 mm in diameter. The first lumen  20  may be used to inflate the vaginal canal up to 20 mmHg, without limitation. The inflation fluid may be air, CO 2  or nitrogen, for example. The second lumen  26  may be used to sense the real-time pressure in the vaginal tunnel to avoid pressure drops. 
     Reference is now made to  FIG. 4 , which is a simplified block diagram of the pump and controller unit  24 . Unit  24  may include, without limitation, a pump  40 , which may be switched on and off by a switch  41 , which may be foot-controlled. Pump  40  is coupled to a fluid inlet  39  and outputs pressurized fluid to a flow meter  43 , via a pressure relief safety valve  46  for safety. The pressurized fluid flows from the flow meter  43  to the tubing  23  (connected to first lumen  20  as shown above in  FIG. 2A ), such as via a proportional flow control valve  44 . As mentioned above, tubing  29  is used for measuring air pressure in the vagina. Tubing  29  may be coupled to a pressure sensor  45 , which is coupled to flow meter  43 . This provides feedback control for regulating the pressurized fluid supplied to the vagina. 
       FIG. 5  is a simplified illustration of the speculum  10  introduced in the vagina of a patient. 
     In use, the speculum provides continuous flow control with no need for any vaginal plug. The pressure in the vaginal canal is continuously monitored and any drop in pressure can be compensated by pumping more air. Feasibility tests have shown that with no plug or seal, the speculum can maintain a pressure of approximately 15 mm/Hg in the vagina. Feasibility tests used ˜18 mmHg to inflate the vagina and the pressure relief came into operation at 20 mmHg. To keep the vagina inflated, there was no need for a high flow rate.