Abstract:
Tracheo-oesophageal valve cleaning apparatus comprises a fluid dispenser with a fluid reservoir and an outlet; a cleaning element mounted proximal to the outlet; and a drive mechanism including an element mounted axially within the said fluid dispenser, wherein axial movement of the element of the drive mechanism towards to the outlet causes both rotation of cleaning element and fluid to be dispensed from the outlet.

Description:
FIELD OF THE INVENTION 
       [0001]    The invention relates to cleaning apparatus; in particular to apparatus for cleaning tracheo-oesophageal valves. 
       BACKGROUND OF THE INVENTION 
       [0002]    A laryngectomy is a surgical procedure which involves the removal of a patient&#39;s voice box and other surrounding structures often for treatment of cancer of the larynx. 
         [0003]    Tracheo-oesophageal prosthetic valves are devices which allow vocal function to be restored to a patient following a laryngectomy. This type of valve is inserted into a hole between the trachea and the oesophagus. The valve blocks the flow of secretions and food materials from the oesophagus to the airway, but allows a passage of air from the airway into the throat to permit speech. 
         [0004]    These valves usually stay in place for approximately 6 months before being replaced by a doctor or nurse or other specially trained therapist. The valves can easily become contaminated with secretions and yeasts from the mouth which can cause infections. This can stop the device working altogether, necessitating the replacement of the valve. To prevent this happening, the valves must be cleaned daily by the patient. If valves are not cleaned effectively then their life span is shortened. Frequent replacement of these indwelling valves is not only inconvenient for a patient but can cause trauma to the opening in which the device is placed. These valves are also expensive and frequent replacement causes unnecessary expense. 
         [0005]    Cleaning products available currently include small brushes for insertion into the valve, and pipettes with which to flush liquid through the valve. The pipettes available on the market do not give a good seal against the valve and leakage occurs during use which is inconvenient to the user. Also, the pipettes cannot be used at the same time as using a brush. 
         [0006]    US 2002/0056219 describes a device for cleaning the inside of a gun barrel. The cleaner comprises a brush attached to a hollow rod with a handle at the opposite end. The brush is mounted so it can freely rotate when the handle is held stationary. A squeeze bottle containing cleaning fluid at the handle end can be squeezed to allow cleaning fluid to run along the hollow rod and onto the brush. 
         [0007]    Brushes and pipettes available for cleaning these valves do not give very effective cleaning. The device described in US 2002/0056219 would not be suitable for cleaning tracheo-oesophageal valves as using this type of device would require the user to manually manipulate and rotate the brush whilst squeezing the bottle to dispense fluid into the valve. 
         [0008]    The present invention offers cleaning apparatus that mitigates the above-identified problems. 
       SUMMARY OF THE INVENTION 
       [0009]    The invention provides tracheo-oesophageal valve cleaning apparatus as specified in Claim  1 . 
         [0010]    Preferred aspects of the invention are specified in the claims dependent on Claim  1 . 
         [0011]    The invention provides apparatus that offers more effective cleaning of indwelling tracheo-oesophageal valves. The apparatus of the invention provides a combined brush and fluid dispenser that dispenses an amount of fluid in a one action flush, the brush being rotated to clean the valve by the same action that forces fluid across the brush and into the valve. More effective cleaning leads to prolonged life of the valves. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    In the drawings, which illustrate preferred embodiments of the invention: 
           [0013]      FIG. 1  shows a first embodiment of a cleaning apparatus in a ‘before use’ configuration; 
           [0014]      FIG. 2  is an exploded view of the internal workings of the apparatus of  FIG. 1 ; 
           [0015]      FIG. 3  show the location of a tracheo-oesophageal valve; 
           [0016]      FIG. 4  shows the cleaning apparatus of  FIG. 1  after use; 
           [0017]      FIG. 5  shows a second embodiment of a cleaning apparatus, with a cutaway portion showing the internal workings of the apparatus; 
           [0018]      FIG. 6  shows an exploded cross-sectional view of the internal workings of the apparatus of  FIG. 5 ; 
           [0019]      FIG. 7  shows a further embodiment of a cleaning apparatus with a ring-type handle; and 
           [0020]      FIG. 8  shows an embodiment of the cleaning element of the cleaning apparatus of  FIGS. 1 and 5 . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0021]    With reference to  FIG. 1 , a first embodiment of a cleaning apparatus  1  comprises a fluid dispenser  2  with a first narrow end  7  and a second broader end  8 . A rod  3  is present within the fluid dispenser  2 . The rod  3  is connected to a shaft  4  which extends beyond the fluid dispenser  2  and out through an outlet  6 . The shaft  4  is connected to a cleaning element, which in the example is a brush  5 . 
         [0022]    The brush  5  may be detachable from the tip of the shaft  4 . The shaft  4  may also be removable from the end  19  of the rod  3 . Alternatively, both the brush  5  and shaft  4  may together be detachable from the end  19  of the rod  3 . The brush  5  and shaft  4  or the brush  5  may therefore be removed and replaced as necessary, without the need to replace the cleaning apparatus  1 . 
         [0023]    The fluid dispenser  2  includes a cylindrical fluid reservoir  20 . A hollow plunger  17  fits into the cylinder  20 . A seal  9  between the plunger  17  and the cylinder  20  prevents fluid from leaking at broad end  8  of the fluid dispenser  2 . The plunger  17  mounts the seal  21  at one end thereof and a handle  10  at the other end. The rod  3  is located within plunger  17 . The end of the hollow plunger  17  mounting the handle  10  is sealed, whereas the end mounting the seal  9  includes an opening. The rod  3  is located within the plunger  17 . 
         [0024]    The fluid reservoir  20  is filled with cleaning fluid for ejection from the outlet  6 . In a preferred embodiment the cleaning fluid is a saline solution or sodium bicarbonate. The reservoir  20  may be pre-filled with cleaning fluid, and the outlet  6  may be provided with a seal to prevent leakage of fluid before use of the apparatus  1 . Alternatively, the user may fill the reservoir  20  with cleaning fluid immediately prior to use. 
         [0025]    As shown in  FIG. 2 , the rod  3  is generally cylindrical in shape and has a substantially helical groove  13  extending along its outer surface. 
         [0026]    The end  18  of the rod  3  is mounted within the plunger  17  such that it can freely rotate about its longitudinal axis. The other end  19  of the rod  3  sits in a housing formed in the dispenser  2  such that the rod  3  can freely rotate about its longitudinal axis but is constrained against movement in the direction X. The plunger  17  includes two protruding elements  15  and  16  each extending into groove  13  of the rod  3 . 
         [0027]    In use, the user inserts the brush  5  into the tracheo-oesophageal valve  12  ( FIG. 3 ). A lip  14  of larger diameter than the brush  5  may be present. The lip  14  prevents the user inserting the dispenser  2  too far into valve  12 . Inserting a brush too far into the valve could damage the valve and a replacement may be required. The user grasps the device using the handles  11  and depresses the plunger  17  using the handle  10 , applying pressure in the direction labelled X in  FIG. 1 . The movement of the rod  3  is constrained against movement in direction X as the end  19  of the rod  3  is in contact with the walls of the dispenser  2 . The protrusions  15  and  16  are forced to move along the helical groove  13  and the rod  3  is forced to rotate, thereby rotating the brush  5  inside the valve  12 . As the rod  3  rotates, the plunger  17  moves axially inside the dispenser  2  in the direction X. This axial movement of the plunger  17  forces fluid to flow out through the outlet  6 , over the brush  5 , and into the valve  12 .  FIG. 4  shows the position of the plunger  17  after use. 
         [0028]    The fluid dispenser  2  may be refilled with fluid after each use by placing the outlet  6  into an amount of fluid. Fluid is drawn up into the fluid reservoir  20  of the dispenser  2  by withdrawing the piston  17  to its original position (see  FIG. 1 ). The rod  3  is constrained against movement in direction X as it is rotatably connected with the walls of the dispenser  2 . For example the walls of the dispenser  2  may comprise a groove in which sits one or more protrusions extending radially from the rod  3 . The protrusions  15  and  16  are forced to move back along the helical groove  13 . As the plunger  17  is withdrawn, the rod  3  is forced to rotate and the reservoir  20  is re-filled with fluid. 
         [0029]      FIGS. 5 and 6  illustrate a second embodiment of the invention. Like reference numerals are used to refer to like features. 
         [0030]    With reference to  FIGS. 5 and 6 , a second embodiment of cleaning apparatus  25  comprises a fluid dispenser  26  with a first narrow end  27  and a second broader end  28 . A rod  31  is present within the fluid dispenser  26 . The rod  31  is connected to a shaft  4  which extends beyond the dispenser  26  and out through an outlet  29 . The shaft  4  is connected to a brush  5 . As in the previous embodiment, the brush  5  may be detachable from the cleaning apparatus  1 . The shaft  4  may also be removable. The brush  5  and shaft  4  together may be detachable from the cleaning apparatus  1 . 
         [0031]    The fluid dispenser  26  includes a cylindrical fluid reservoir  30 . A hollow plunger  32  fits closely into the cylinder  30 . A circular seal  21  between the plunger  32  and the cylinder  30  seals the fluid reservoir  30 , minimising any leakage of fluid from the broad end  28  of the dispenser  26 . The plunger  32  mounts the seal  21  at one end thereof and a handle  10  at the other end. The rod  31  is located within the plunger  32 . 
         [0032]    The fluid reservoir  30  is filled with cleaning fluid for ejection from outlet  29 . In a preferred embodiment the cleaning fluid is a saline solution or a sodium bicarbonate solution. As with the previous embodiment, the reservoir  30  may be pre-filled with cleaning fluid, and the outlet  29  may be provided with a seal to prevent leakage of fluid before use of the apparatus  25 . Alternatively, the user may fill the reservoir  30  with cleaning fluid immediately prior to use. 
         [0033]    As shown in  FIG. 6 , the internal hollow of plunger  32  is substantially cylindrical in shape and has a substantially helical groove  22  extending along its inner surface. 
         [0034]    The end  33  of the rod  31  is mounted within the plunger  32  such that it can freely rotate about its longitudinal axis. The other end  34  of the rod  31  sits in a housing formed in the dispenser  26  such that the rod  31  can freely rotate about its longitudinal axis but is constrained against movement in the direction X. The rod  31  includes two protruding elements  23  and  24  each extending into the groove  22  on the internal surface of the hollow plunger  32 . 
         [0035]    In use, the user inserts the brush  5  into their tracheo-oesophageal valve  12  ( FIG. 3 ). The narrow end  27  of the dispenser  26  is tapered. The tapered end  35  prevents the user inserting the dispenser  26  too far into valve  12 . The user grasps the device using the handles  11  and depresses the plunger  10 , applying pressure in the direction labelled X in  FIG. 5 . The movement of the rod  31  is constrained against movement in direction X as it is rotatably connected with the walls of the dispenser  26 . In this embodiment the rod  31  comprises a circular groove in which sits one or more protrusions  36  and  37  extending radially from the dispenser  26 . Protrusions  36  and  37  are forced to move along this circular groove and hence movement of the rod  31  is constrained against movement in the direction X. As the plunger is depressed, the protrusions  23  and  24  are forced to move along the helical groove  22  and the rod  31  is forced to rotate, thereby rotating the brush  5  inside the valve  12 . As the rod  31  rotates, the plunger  32  moves axially inside the dispenser  26  in the direction X. This axial movement of the plunger  32  forces fluid to flow out through the outlet  29 , over the brush  5 , and into the valve  12 . 
         [0036]    As with the previous embodiment, the fluid dispenser  26  may be refilled with fluid after each use by placing the outlet  29  into an amount of fluid. Fluid is drawn up into the fluid reservoir  30  of the dispenser  26  by withdrawing the plunger  32  to its original position. The rod  31  is constrained against movement in direction X as it is rotatably connected with the walls of the dispenser  26 . As fluid is drawn up, the protrusions  23  and  24  on the rod are forced to move back along helical groove  22 . As the plunger  32  is withdrawn, the rod  31  is forced to rotate and the reservoir  30  is re-filled with fluid. There may also be a lip at the broader end  28  of the dispenser  26  to prevent the plunger being unintentionally removed from the dispenser  26  when refilling the fluid reservoir  30 . 
         [0037]    In a further embodiment of the invention, illustrated in  FIG. 7 , the plunger  32  mounts a ring handle  38 . This feature enables a user to withdraw the plunger  32  using only one finger and means the device can be operated using only one hand. 
         [0038]    In any of the aforementioned embodiments of the invention, the brush  5  may include bristles or other projections to aid cleaning of the valve. The brush  5  may include “fin-type” projections  39  such as those shown extending radially from the core  40  of the brush  5  in  FIG. 8 . The projections  39  are easier to clean and harder wearing than bristles. They are made of rubber and are simple and inexpensive to manufacture. 
         [0039]    The apparatus of the invention enables a user to efficiently clean a tracheo-oesophageal valve using a simultaneous fluid flush and rotating brush. This one step cleaning routine is much easier for a person to carry out and leads to more efficient cleaning, hence prolonging the life of the valve.