Abstract:
A probe for a mammalian orifice or cavity is presented. The probe includes a video probe to record video and/or images of the internal cavity area. Further, the device includes a mechanism by which fluids, tissue, or other samples can be accurately collected for later laboratory analysis. The probe further includes an electronic tissue exciter to promote physiological responses to electromagnetic stimuli. The probe also includes a dilator to expand and open an orifice or cavity to improve a range and depth of view of the tissue therein.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     The present application claims priority under 35 U.S.C. §119 to U.S. Provisional Application Ser. No. 60/650,060, filed Feb. 4, 2005, entitled CAVITY PROBE WITH EXCITER AND/OR DILATOR TIP, the disclosure of which is incorporated herein by reference. 
     
    
     BACKGROUND  
       [0002]     Examination of a mammalian orifice or cavity, such as a vagina or cervix, is presently a very arduous and/or invasive procedure. Likewise, conventional examination techniques and devices are neither accurate enough to spot anomalies in a stage early enough to be beneficial, nor configured to promote natural physiological responses by tissue in order to emphasize or highlight such anomalies. Finally, in order to get an effective examination of an orifice or cavity, conventional techniques and devices involve very long and overly costly examinations, which can deter a medical practitioner and/or patient from doing them in the first place.  
       SUMMARY  
       [0003]     This document discloses an improved cavity probe. The probe includes a video probe to record video and/or images of the internal cavity area. Further, the device includes a mechanism by which fluids, tissue, or other samples can be accurately collected for later laboratory analysis. In one embodiment, the probe includes an electronic tissue exciter to promote physiological responses to electromagnetic stimuli. In another embodiment, the probe includes a dilator to expand and open an orifice or cavity to improve a range and depth of view of the tissue therein.  
         [0004]     The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0005]     These and other aspects will now be described in detail with reference to the following drawings.  
         [0006]      FIG. 1  shows a probe with an exciter tip.  
         [0007]     FIGS.  2 A-C illustrate the exciter tip.  
         [0008]      FIG. 3  shows a probe with an exciter tip and collection device.  
         [0009]      FIGS. 4A  and B and  FIG. 5  illustrate a probe with a dilator mechanism in accordance with one embodiment.  
         [0010]      FIGS. 6-10  illustrate a probe with a dilator mechanism in accordance with another embodiment. 
     
    
       [0011]     Like reference symbols in the various drawings indicate like elements.  
       DETAILED DESCRIPTION  
       [0012]     This document describes a device that easily and comfortably spreads and holds back tissue of a cavity of a mammal, such as a cervix or vagina.  
         [0013]      FIG. 1  shows a probe  100  having a handle  102  connected to a tip  104 . The probe  100  can physically compact. The tip  104  includes a shaft  106  that is sized and configured for insertion into an orifice or cavity of a mammal. The tip  104  can include a video camera. An exciter sheath  108  is provided to the surface of the shaft  106  and/or tip  104  and is configured to electrically stimulate mammalian tissue inside the orifice or cavity. The exciter sheath  108  can be wrapped around the shaft  106  and/or tip  104 , or affixed to the shaft  106  and/or tip  104 . One example of the exciter sheath  108  is a transcutaneous electrical nerve stimulation (TENS) pad material having one or more electrodes to administer an electrical current at a particular frequency. Alternatively, the exciter sheath  108  can deliver vibration energy.  
         [0014]     The exciter sheath  108  is controlled by a tissue exciter controller  110  that sends control signals via control path  112 . The tissue exciter controller  110  may include a built-in microprocessor, or control signals may be generated externally and sent to the tissue exciter controller  110  for delivery to the exciter sheath  108 . The control path  112  may be either a physical electrical connection, or a wireless communication path. In one embodiment, the control path  112  includes a wire connected to a lower portion of the exciter sheath  108  from along a side of the handle  102  of the probe  100 . In an alternative embodiment, the tissue exciter controller  110  is built into the handle  102 , and can include a number of user-selectable control buttons or similar devices.  
         [0015]     The exciter sheath  108  electrically stimulates tissue such as muscle or other surface or subsurface tissue within the orifice or cavity, thereby generating physiological responses such as quivering or pulsating, and accentuating physiological conditions such as subsurface abnormalities. Thus, abnormalities can be brought to the surface inside of an orifice or cavity. Also, by using the probe  100  to closely monitor tissue texture, color, elasticity, etc., infection, disease, lesions, and/or other abnormalities may be detected sooner than with conventional methods, or before they are visible on the inside surface of the orifice or cavity. Accordingly, invasive sampling or examination can be avoided.  
         [0016]     FIGS.  2 A-C illustrate a probe tip  200  that is assembled for spreading and holding back tissue within a orifice or cavity of a mammal, such as a cervix.  FIG. 2A  shows a basic probe tip  200  that encloses at least one collection device  204  connected with a collector handle  206 . The collection device  204  can be tucked within molded cavities inside the tip  200  to prevent contamination of obtained tissue samples. The tip  200  may also include a video and/or photographic collection device.  
         [0017]      FIG. 2B  shows the tip  200  at least partially encompassed by a dilator  208 . The dilator  208  includes one or more slatted extensions configured for being movable from a closed position resting against the tip to an open position extending outwardly from the tip  200 . The dilator  208  can be secured to the tip at a non-extending end by a sleeve  208 , which can be slidably mounted onto or over the tip  200  and dilator non-extending end. The dilator  208  is controlled by and coupled to a dilator control handle  212 . An expandable mesh material  214  can be provided around dilator  208 , as shown in  FIG. 2C , to prevent pinching surfaces to protect tissue being examined, and to further inhibit the collection devices  204  from contacting tissue when not required.  
         [0018]      FIG. 3  illustrates the tip  200  coupled to a handle  220 . As shown in  FIG. 4A , in operation the tip  200  is inserted into an orifice or cavity with the dilator  208  in the closed position. Once inserted, when the tip  200  is retracted, the slatted extensions of the dilator  208  begin to spread outward toward the open position, encased by the elastic mesh  214 , and spreading and holding back tissue for an expanded opening from the top of the tip  200 . The opened dilator  208  can be held in place by the dilator control handle  212 . As shown in  FIG. 4B , the sampling device  204  can extended to collect sample tissue or fluids from the expanded orifice or cavity, and then retracted into the tip  200  to protect against contamination or damage.  
         [0019]     The expansion of the dilator  208  can be calibrated or limited such that when adequate pressure is reached to comfortably hold back tissue, the dilator  208  material will start bending to maintain that pressure, while not overextending the tissue&#39;s expansion limits. Thus, discomfort by the mammal can be minimized. As shown in  FIG. 5 , the dilator  208  can be closed when the tip  200  is pushed back into the dilator  208 , and can be locked back into the closed position once the tip  200  is completely within the dilator  208 . Then, the entire probe can be safely and comfortably removed from the orifice or cavity, and the collected sample can be removed from the shielded collection device  204  for transport and analysis.  
         [0020]      FIGS. 6A  and B show a probe tip  300  and an alternative embodiment of a dilator. In  FIG. 6A , the probe tip  300  includes a collection device  303  for collecting samples of tissue or other items within an orifice or cavity of a mammal. The collection device  303  can tucked into a molded cavity within a shaft of the tip  300 , and extended and retracted, or otherwise controlled, by a handle. In  FIG. 6B , the probe tip  300  includes a dilator  302  provided to and at least partially circumscribing the tip  300 . In an embodiment, the dilator  302  is made of an expandable latex or rubber-based material, in a form of a balloon, and is enfolded around the top  301  of the tip  300 . The dilator  302  is connected to a conduit  304 .  FIG. 6C  shows a top-down cross sectional view of the top  301 , which can be a lens or other soft-shaped end.  
         [0021]      FIGS. 7A  and B each illustrate side and top views of an operation of a probe  310  having a handle  312  and the tip  300  as described with reference to  FIGS. 6A  and B. In a closed position, the dilator  302  is deflated and fitted closely to the tip  300  to allow easy insertion and/or removal to and from the mammalian orifice or cavity. The conduit  304  is connected to a pressure source  306 . Air, fluid or other pressure-providing fluid is injected into the dilator  301  from the pressure source  306  via the fluidic conduit  304 . In an exemplary embodiment, the pressure source  306  is a manually-operated squeezable bulb connected to the handle  312  that stores a fluid, and when squeezed sends the fluid to the dilator  302  to inflate it.  
         [0022]     As shown in  FIG. 7B , when the dilator  302  is inflated to an open position, the dilator  302  expands the mammalian orifice or cavity to push back tissue therein, and create a larger opening for the probe  310 . Accordingly, a larger surface area of the orifice or cavity is in view of the top  301  of the probe  310 , and a camera provided to the top will have a wider angle of view.  
         [0023]     In one exemplary embodiment, a dilator in the open position can be slidably detached from the rest of the probe  310 , as illustrated in  FIGS. 8A  and B.  FIG. 8A  illustrates the probe  310  being pulled back outwardly from the orifice or cavity, to increase the focal length of a field of view from a camera in the tip  300  or in general from the top of the tip  300 , and the dilator  302  remains in place and stationary in the open position inside the orifice or cavity.  
         [0024]     As shown in  FIG. 8B , the probe  310  can be controlled and operated in various ways with the dilator  302  still connected to the conduit  304  and in the open position, but detached from tip  300  of the probe  310 . In the configuration shown, the collection device  303  can be extended from the tip  300  to explore and gather tissue within the orifice or cavity. Once collection is done, the collection device  303  can be retracted back into the tip  300  and/or the handle  312  of the probe  310  to protect collected samples, shield the collection device  303  from damage, or the like.  
         [0025]      FIGS. 9A  and B show further operation of the probe  310 , illustrating several removal techniques of the probe  310  from the orifice or cavity. As shown in  FIG. 9A , the dilator  302  is returned to the closed position, i.e. deflated and against the tip  300 , such that the tip  200  of the probe  310  can be safely and comfortably removed from the orifice or cavity. Alternative, as shown in  FIG. 9B , the dilator  302  can be kept in the open position, i.e. inflated, and then detached entirely or at least partially from the probe  310 , so that the probe  310  can be removed from the expanded orifice or cavity.  
         [0026]      FIG. 10  illustrates a removal technique of the dilator  302  from the orifice or cavity apart from the probe  310 . The dilator  302  is deflated by removing fluidic pressure from the dilator  302  back through the conduit  304 . In one exemplary embodiment, the conduit  304  can include a clamp to close off the conduit and/or dilator  302  to maintain the dilator in a pressurized, inflated open position. The clamp can be opened to reopen the conduit  304  and/or dilator  302  to release the pressure in the dilator  302 . Once the pressure is released and the dilator is substantially back to the closed, deflated position, the dilator  302  may be removed from the orifice or cavity. In an exemplary embodiment, the dilator  302  can be moved and controlled by a person pulling on the conduit  304  to move the dilator  302 .  
         [0027]     Although a few embodiments have been described in detail above, other modifications are possible. Other embodiments may be within the scope of the following claims.