Air speculum

Abstract

A speculum (10) includes a speculum sheath (12), which is formed with: a first inner cavity (20) that is in fluid communication with a pump and a controller unit (24) for introducing pressurized air into the vagina; a second inner cavity (26) that is in fluid communication with the pump and the controller unit (24) for measuring the air pressure in the vagina; and a third inner cavity (30) in which an observation device (18) is disposed.

Description

Technical Field

[0001] The present invention relates to a vaginal speculum, and more particularly to a vaginal speculum that uses compressed air to maintain a passage through the vagina to obtain access to the cervix or other anatomical structures. Background Art

[0002] 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.

[0003] Inflatable vaginal speculums have been used to examine the vagina and cervix. However, prior art inflatable speculums require a diaphragm to seal against the vaginal wall, such as using a watertight or airtight diaphragm or plug placed at the distal end of the speculum. This seal is used to prevent fluid (water or air) from flowing out of the vagina while allowing a pressurized flow to enter the vagina. Summary of the Invention

[0004] The present invention seeks to provide a novel air speculum, as described in detail below.

[0005] The speculum of the present invention provides all the functions of prior art speculums. The speculum of the present invention can be used in many surgical procedures, such as but not limited to a comprehensive examination of the vagina and cervix, a cervical biopsy (e.g., a Pap smear), and as a working port for vaginal, cervical, and uterine surgeries.

[0006] Among the many advantages of the speculum is a significant reduction in pain caused to women and easier acceptance by women since there is no discomfort or sense of shame and the surgeon does not have to contact the female's sexual organs. The speculum enables examination and treatment of a larger area of the vagina and cervix with higher resolution. Instruments such as a hysteroscope can be used without sterilization. There is significantly improved lighting for observing and examining the vagina.

[0007] Accordingly, in a non - limiting embodiment of the present invention, there is provided a speculum comprising a speculum sheath formed with: a first lumen in fluid communication with a pump and a controller unit for introducing pressurized air into the vagina; a second lumen in fluid communication with the pump and the controller unit for measuring the air pressure in the vagina; and a third lumen in which an observation device is disposed. Brief Description of the Drawings

[0008] The present invention will be more fully understood and appreciated from the following detailed description taken in conjunction with the accompanying drawings, in which:

[0009] Figure 1A and Figure 1B is a simplified exploded view of an air speculum constructed and operated in accordance with a non - limiting embodiment of the present invention;

[0010] Figure 2A , Figure 2B and Figure 2C are simplified illustrations of a speculum sheath operating according to non - limiting embodiments of the present invention, the speculum sheath having an inner cavity for introducing pressurized air, for measuring air pressure in the vagina, for placing an observation device, and a working channel for introducing tools;

[0011] Figure 3A and Figure 3B are simplified illustrations of other possible shapes and dimensions of the inner cavity of the illumination and observation device of the speculum of the present invention;

[0012] Figure 4 is a simplified block diagram of a controller and a pump for use with a speculum according to non - limiting embodiments of the present invention; and

[0013] Figure 5 is a simplified illustration of a speculum introduced into a patient's vagina. Detailed Description

[0014] Now refer to Figure 1A and Figure 1B , which show an air speculum 10 constructed and operated according to non - limiting embodiments of the present invention.

[0015] The speculum 10 includes a speculum sheath 12, which may be disposable, and the speculum sheath is coupled to a light source 14 mounted on a handle 16. An observation device (camera) 18 is arranged to enter the speculum sheath 12.

[0016] Now refer to Figure 2A and Figure 2B to describe the structure of the speculum sheath 12. The speculum sheath 12 may be made of a medically safe flexible plastic (preferably transparent) and may be formed with a number of inner cavities. For example, a first inner cavity 20 may be in fluid communication with a pump and controller unit 24 (described in more detail with reference to Figure 4 ) via a fluid connector 22 and a pipe 23 for introducing pressurized air into the vagina. A second inner cavity 26 may be in fluid communication with the pump and controller unit 24 via a fluid connector 28 and a pipe 29 for measuring the air pressure in the vagina. A third inner cavity 30 is provided for placing the observation device 18 therein. The light source 14 may be coupled to the third inner cavity 30. The third inner cavity 30 (camera channel) may be closed at its distal end with an optically transparent lens 31 to prevent any contact of tissue or fluid with the observation device 18 and to obviate the need to disinfect the observation device 18. The sheath protects the observation device 18.

[0017] The observation device 18 can be, but is not limited to, a small-diameter tube camera (1.6 mm) with a large wide-angle lens (120°), good resolution, and a USB connection. The light source 14 can be one or more LEDs located on the handle 16. Using an optical waveguide (such as an optical fiber), light is guided to the distal end of the device to illuminate the vaginal canal. With the wide-angle lens and appropriate illumination, the user sees a well-illuminated picture of the vaginal canal and can move the device back and forth to observe the desired area.

[0018] Optionally, as Figure 2B and Figure 2C shown, a fourth lumen 32 (working channel) can be provided for introducing a cervical smear brush 33 ( Figure 2B ) or a tool 34 ( Figure 2C ), such as, but not limited to, a biopsy tool, a cutting incision tool, a drug delivery tool, and many other tools and devices.

[0019] The size, shape, and contour of the air speculum and its lumen can 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 vaginal entrance as tightly as possible for effective inflation and pressure measurement.

[0020] For example, as Figure 3A and Figure 3B seen, the speculum sheath 12 can be oval to better seal against the labia minora and / or labia majora of the vagina, or can have other possible shapes and sizes to accommodate other illumination and observation device lumens and to seal the structure against the female anatomy. The observation device 18 can be located in the center, with more than one such light source 14 (such as three light sources 14) around the observation device 18.

[0021] The diameter of the device can be, but is not limited to, about 6 mm. The first lumen 20 can be used to inflate the vaginal cavity up to 20 mmHg, without limitation. The inflation fluid can be, for example, air, CO2, or nitrogen. The second lumen 26 can be used to sense the real-time pressure in the vaginal canal to avoid pressure drop.

[0022] Now refer to Figure 4 , Figure 4 which is a simplified block diagram of the pump and controller unit 24. The unit 24 can include, but is not limited to, a pump 40, which can be switched on and off by a switch 41 that can be foot-controlled. The pump 40 is connected to the fluid inlet 39 and outputs pressurized fluid to the flow meter 43 via a pressure relief safety valve 46 for safety. The pressurized fluid flows from the flow meter 43 to the pipeline 23 (as described above in Figure 2AAs shown therein, the conduit is connected to the first lumen 20). As described above, conduit 29 is for measuring the air pressure in the vagina. Conduit 29 may be coupled to a pressure sensor 45, which is coupled to a flow meter 43. This provides feedback control for regulating the pressurized fluid supplied to the vagina.

[0023] Figure 5 is a simplified illustration of a speculum 10 introduced into a patient's vagina.

[0024] In use, the speculum provides continuous flow control without the need for any vaginal plug. The pressure in the vaginal cavity is continuously monitored and any pressure drop can be compensated for by pumping in more air. Feasibility tests have shown that the speculum can maintain a pressure of approximately 15 mmHg in the vagina without a plug or seal. The feasibility tests used 18 mmHg to inflate the vagina and the pressure release started operating at 20 mmHg. To maintain vaginal inflation, a high flow rate is not required.

Claims

1. A speculum (10), the speculum comprising: A pump and controller unit (24); An observation device (18); And A speculum sheath (12), the speculum sheath being formed with: a first inner cavity (20) that is in fluid communication with the pump and controller unit (24) for introducing pressurized fluid into the vagina; a second inner cavity (26) that is in fluid communication with the pump and controller unit (24) for measuring the fluid pressure in the vagina; and a third inner cavity (30) in which the observation device (18) is disposed.

2. The speculum (10) according to claim 1, the speculum further comprising a light source (14) coupled to the speculum sheath (12).

3. The speculum (10) according to claim 1, wherein, The pump and controller unit (24) includes a pump (40), a flow meter (43), and a pressure relief safety valve (46).

4. The speculum (10) according to claim 1, wherein, The pump and controller unit (24) includes a pressure sensor (45) coupled to the pump (40) and the second inner cavity (26), wherein the pump and controller unit (24) uses feedback from the pressure sensor (45) to control the pump (40) to supply the pressurized fluid.

5. The speculum (10) according to claim 1, the speculum comprising a fourth inner cavity (32) for introducing a tool through the fourth inner cavity (32).

6. The speculum (10) according to claim 1, wherein, The speculum sheath (12) is elliptical.

7. The speculum (10) according to claim 1, wherein, A plurality of light sources (14) are placed around the observation device (18).

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