Abstract:
An apparatus for equalizing pressure in a middle ear includes a hand-held air source for providing a continuous flow of air at a predetermined rate and a tapered sealing nostril plug adapted to be sealed against a nostril. The tapered nostril plug has a channel there through for delivering the continuous flow of air. The channel of the tapered plug is adapted to be placed in communication with the air source through an adjustable valve assembly for selecting a pressure limit for the air in the channel of the nostril plug.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     I. Field of the Invention  
         [0002]     This invention relates generally to a portable, hand-held apparatus for equalizing pressure in the middle ear, and more particularly to a device of the type described that provides improved control over the air pressure applied by the device to a patient&#39;s Eustachian tubes during a treatment procedure.  
         [0003]     II. Discussion of the Prior Art  
         [0004]     In U.S. Pat. Nos. 5,419,762 and 5,885,242 to Arick, et al. (the contents of which are hereby incorporated by reference), there is described an apparatus for facilitating the Politzer maneuver for equalizing the pressure in the middle ear in patients suffering from Eustachian Tube Dysfunction (ETD) or Aerotitis Media. That apparatus comprises an electric-powered air source contained in a hand-held housing for providing a continuous flow of air to an exit port of the device. More particularly, a battery-powered DC motor, when energized, drives a small pump or compressor whose outlet is connected by a short length of plastic tubing contained in the housing to the device&#39;s exit port in a nozzle projecting from the housing and that is adapted to seal against one of the patient&#39;s nostrils. With the continuous flow of air into one nostril and with the other nostril pinched closed, the patient is asked to swallow. Swallowing closes the esophagus and directs air pressure to the Eustachian tube, opening it to allow any fluid to flow from the middle ear and/or to restore pressure balance to the middle ear.  
         [0005]     The Arick, et al. &#39;242 patent suggests that the applied pressure generated by the pump be limited to a lower pressure of about 1.5 psi for infants and small children and a higher pressure of about 3 psi for adults. For this purpose, a speed control circuit is coupled between the battery and the motor terminals. It has been found, however, that attempting to accurately regulate the pressure of the output air by controlling motor pump speed is less than satisfactory. Those skilled in the art recognize that the motor speed, and thus the pump&#39;s air flow rate is dependent on battery voltage and that battery voltage varies with the depletion state of the battery&#39;s charge as well as with temperature. One can understand, therefore, that the desired airflow rate, measured in liters-per-minute and in air pressure measured in pounds-per-square-inch that can be developed in a given time using the selector switch 20a in FIG. 7 of the &#39;242 patent, may be difficult to maintain.  
         [0006]     It is accordingly a principal object of the present invention to provide an improved apparatus for affecting the Politzer maneuver.  
         [0007]     Another object of the invention is to provide a hand-held, battery-operated device containing a motor-driven pump for producing a continuous flow of air at the device outlet nozzle at a plurality of selectable pressure values that are independent of battery state over the expected life of the battery.  
       SUMMARY OF THE INVENTION  
       [0008]     In its broadest sense, the present invention comprises an apparatus for equalizing pressure in the middle ear of a patient where the apparatus incorporates within a hand-held housing an electric-powered air source for providing a predetermined continuous flow of air to an exit port of the device and that has an adjustable valve assembly operatively coupled between the electrically-powered air source and the exit port for selecting a pressure limit for the air at the exit port.  
         [0009]     Without limitation, the adjustable valve assembly may comprise a valve housing having an inlet port in fluid communication with the electrically-powered air source, an outlet port in fluid communication with the device&#39;s exit port, an exhaust port leading to the ambient and a valve seat located between the exhaust port and the inlet port. A spring biased ball cooperates with the valve seat to block airflow through the exhaust port so long as the air pressure at the exit port remains below a predetermined level. Means are then provided for varying the spring-biasing force on the ball to adjust the pressure at which the ball unseats.  
         [0010]     Alternatively, the adjustable valve assembly may comprise a molded plastic manifold having an inlet port in fluid communication with the electrically-powered air source, an outlet port in fluid communication with the exit port and an exhaust port leading to the ambient where the manifold incorporates a rotatable turret carrying a plurality of check valves, where each of the check valves is adapted to open at different predetermined pressures. Rotation of the turret selectively places a selected one of the plurality of check valves in fluid circuit between the exhaust port and the inlet port. 
     
    
     DESCRIPTION OF THE DRAWINGS  
       [0011]     The foregoing features, objects and advantages of the invention will become apparent to those skilled in the art from the following detailed description of a preferred embodiment, especially when considered in conjunction with the accompanying drawings in which like numerals in the several views refer to corresponding parts.  
         [0012]      FIG. 1  is a schematic diagram showing the arrangement of the components used in the present invention;  
         [0013]      FIG. 2  is an isometric view of the housing comprising the hand-held device;  
         [0014]      FIG. 3  is an exploded view of an adjustable valve assembly usable in the combination of  FIG. 1 ; and  
         [0015]      FIG. 4  is an alternative design for an adjustable valve assembly usable in implementing the present invention. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0016]     Referring to the schematic diagram of  FIG. 1 , the improved apparatus for equalizing pressure in a patient&#39;s middle ear is seen to comprise a battery  10  that is connected through a single pole, single throw switch  12  to a small DC motor  14  of an electrically-powered air source, shown enclosed by the broken line box  16 . The motor shaft  18  drives a compressor pump  20  for continuously producing air, under pressure, to the input of an adjustable valve assembly  22  by way of a tubing connection  24 . The valve  22  has an outlet port  26  connected by tubing  28  to a nose piece  30 . The adjustable valve  22  also has an exhaust port  32  leading to the ambient.  
         [0017]     The valve  22  remains closed so long as the inlet air pressure from the compressor  20  is below a preset value. The valve remains closed, blocking the exhaust port while allowing air flow from the inlet  24  through the outlet  26  leading to the nose piece  30 . However, when the pressure at the inlet port of the valve  22  reaches the preset valve, the valve opens, preventing any further increase in the pressure of the air reaching the nose piece  30 .  
         [0018]      FIG. 2  is a cross-sectional view showing how the components of  FIG. 1  may be placed within a hand-held housing. The housing itself is identified by numeral  34  and is preferably formed from a suitable plastic and it includes a top  36 , a base  38  and four mutually perpendicular sidewalls, only three of which are seen in  FIG. 2  including a front wall  40 , a rear wall  42  and a left side wall  44 . The conically-shaped nozzle  30  projects upwardly from the top surface  36 . It may be permanently affixed to the top surface  36  or, preferably is removable and replaceable. The nozzle  30  includes a central  46  leading to an exit port  48  proximate its apex. It has also proved expedient to incorporate a duck-bill valve  49  in the nozzle which opens with air flow from the valve  22  but that serves to block expiratory flow carrying mucous back through the nozzle.  
         [0019]     The electrical on/off switch  12  is shown as being located within the housing  34  but with an actuating member  50  projecting through the front wall  40  of the housing so as to be assessable to the user.  
         [0020]     The power source (battery)  10  is suitably supported within the housing and provision is made so that the housing can be opened to gain access to the battery  10  for replacement purposes.  
         [0021]     Also contained within the housing  34  is the motor-driven compressor  16  that includes a miniature DC motor  14  connected in driving relation to a compressor pump  20 . The motor  14  and pump  20  is preferably an A-Series, Iron-Core Air Pump available from Sensidyne, Inc. capable of delivering from about 0.1 to about 3.5 l/min at a pressure of up to 10 psig. The combination motor and pump occupies only 3.4 cubic in. and weighs approximately 2.9 oz. The pump  20 , itself, is a diaphragm pump. While the Sensidyne Micro Air Pump is well suited to the present application, other commercially available DC motor driven pumps are commercially available from other suppliers and limitation to the Sensidyne A-Series motor-driven pump is not intended.  
         [0022]     The adjustable valve assembly  22  is supported by the base  38  of the housing and it has a valve inlet  52  connected by plastic tubing  54  to the outlet of the pump  20 . The valve outlet  56  is connected by flexible plastic tubing  58  to the bore  46  of the nose piece  30 .  
         [0023]     For clarity in the drawings, the electrical wires connecting the battery  10 , the switch  12  and the motor  14  in series are not shown.  
         [0024]     Referring next to  FIG. 3 , there is shown the make-up of one type of pressure adjustable valve that can serve as the valve  22 . It includes a tubular air flow passage  60  leading from the valve inlet  52  to its outlet  56 . The tubular flow passage  60  is integrally molded with a valve housing  62  that includes a central bore  64  leading to a frusto-conically shaped valve seat  66  located between the bore  64  and a counterbore  68  leading to the passage  60 . A transversely extending bore  70  is formed through the wall of the valve housing  62 .  
         [0025]     Contained within the bore  64  is a ball valve member  72  that is urged against the seat  66  by a spring  74 . An adjusting nut  76  is internally threaded so as to mate with the external threads on the valve housing  62 . By rotating adjusting nut  76  to the right, the biasing force of the spring  74  on the ball  72  is increased, thus requiring a higher air pressure in the passage  60  to unseat the ball. Turning the adjustment nut  76  to the left when viewed as in  FIG. 3  decreases the spring biasing force on the ball  72 , thus lessening the amount of air pressure in the passageway  60  needed to unseat the ball and allow air flow out through the bore  70 .  
         [0026]     The adjustable valve assembly  22  is mounted in the housing  34  of  FIG. 2  such that the adjustment nut  76  is exposed and assessable to allow its rotation.  
         [0027]     Assuming that the pump  20  is capable of delivering air at a pressure of 10 psig and the valve is adjusted such that a pressure of 3 psig will unseat the ball  72 , the excess pressure will then be relieved through the port  70  in the valve housing  62 . If desired, a suitable detent can be placed between the adjusting nut  76  and the valve housing  62  to establish plural predetermined pressure settings for the adjustable valve assembly  22 . Without limitation, the detent may permit selection of, say, 1.5 psi, 2.5 psi, 5 psi and 10 psi. It has been found than the incorporation of the adjustable valve  22  in the hand-held device yields a more precise control of the air pressure at the exit port  48  that is achievable using a speed control circuit for regulating the speed of the motor  14  driving the pump  20 .  
         [0028]      FIG. 4  illustrates an alternative construction of an adjustable valve assembly that can be used as a valve  22  in the hand-held device used for equalizing pressure in the middle ear of a patient. It is seen to comprise a molded plastic valve body  78  having a cylindrical cavity for receiving a rotatable turret  80  therein. Integrally molded with the housing member  78  are a plurality of exhaust ports  82 ,  84  and  86 . Disposed in each of the exhaust ports is a check valve, each designed to open at a different predetermined pressure. For example, the check valve (not shown) inserted within the exhaust port  82  may be designed to open at 1.5 psi, the check valve contained within the exhaust port  84  to open at 2½ psi and the check valve within the exhaust port  86  designed to open at 5 psi.  
         [0029]     Also integrally molded with the housing  78  is a flow passage comprising a tube  88 . The outlet of the pump  20  connects by tubing  54  to the valve inlet  52 . The valve outlet  56  is coupled by tubing  58  to the bore  46  in the nozzle  30 . The turret  80  includes an L-shaped passageway  89  with one leg of the L in fluid communication with the interior of the tube  88  and the other leg of the L exiting the turret  80  at a location that sequentially aligns with the exhaust ports  82 ,  84  and  86  as the turret  80  is rotated.  
         [0030]     In operation, with the turret set so that the L-shaped passage has its one leg aligned with the exhaust port  82 , it may take a pressure of 1.5 psi to open the check valve in the exhaust port  82 . In a similar manner, when the turret  80  is rotated so that the one leg of the L-shaped bore aligns with the exhaust port  84 , the check valve contained therein will only open when the pressure in tube  88  equals or exceeds 2.5 psi. Assuming that the check valve associated with the exhaust port  86  requires 5 psi to actuate it, a user may select 5 psi as the desired pressure for application through the nose piece  30  by rotating the turret  80  until the one leg of the L-shaped bore formed in the turret aligns with the exhaust port  86 . Again, the adjustable valve assembly of  FIG. 4  is disposed in the hand held housing  34  so that the rotatable turret  80  is accessible through the base  38  of the housing  34 .  
         [0031]     This invention has been described herein in considerable detail in order to comply with the patent statutes and to provide those skilled in the art with the information needed to apply the novel principles and to construct and use such specialized components as are required. However, it is to be understood that the invention can be carried out by specifically different equipment and devices, and that various modifications, both as to the equipment and operating procedures, can be accomplished without departing from the scope of the invention itself.