Patent Publication Number: US-2022233359-A1

Title: Method and apparatus for relieving headache symptoms

Description:
BACKGROUND OF THE INVENTION 
     Migraines, other severe headaches, and headaches or head discomfort in general have long plagued humans. Although some headache or migraine attacks or episodes may be relatively short and/or mild, some people suffer from debilitating migraines that are long, severe, painful, and/or frequent. Doctors, professionals, and others have worked for years to develop and identify treatments and/or remedies for migraines or other headaches, and are always seeking treatments and/or remedies that are cheaper, simpler, safer, more convenient, more accessible, or otherwise better or improved. 
     What is needed is an apparatus and/or method for treating migraines or other headaches that is more inexpensive, easier to use/apply, safer, and/or more effective. 
     BRIEF DESCRIPTION OF THE INVENTION 
     An apparatus and method for treating symptoms associated with headaches are disclosed. The apparatus, which may be referred to as a Pressure Changing Device, may comprise a bulb, tube, and ear adapter. The tube may be a substantially airtight connection between the bulb and the ear adapter, and may provide a passage for gas such as air to pass between the bulb and the ear adapter. The ear adapter may be tapered and shaped to fit an ear. 
     A method for treating symptoms associated with headaches may comprise engaging the ear adapter with an ear so create a substantially airtight connection between the ear adapter and the ear, performing a series of squeezes and releases with the bulb, and disengaging the ear adapter from the ear. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows an elevated angle view of an exemplary Pressure Changing Device. 
         FIG. 2  shows a side view of an exemplary Pressure Changing Device. 
         FIG. 3  shows an exemplary method for treating symptoms associated with headaches using an exemplary Pressure Changing Device. 
         FIG. 4  shows an exemplary side profile view of an exemplary bulb having a flat bottom. 
         FIG. 5  shows a side profile cross section view of an exemplary bulb having a flat bottom. 
         FIG. 6  shows an exemplary side profile view of an exemplary bulb having a flat bottom. 
         FIG. 7  shows a side profile cross section view of an exemplary bulb having a flat bottom. 
         FIG. 8  shows an alternative exemplary embodiment of an ear adapter. 
         FIG. 9  shows a side view of an exemplary connector for connecting tube to bulb. 
         FIG. 10  shows a side profile view of a portion of an exemplary connector for connecting tube to bulb. 
         FIG. 11  shows a side profile view of a portion of an exemplary connector for connecting tube to bulb. 
         FIG. 12  shows a side profile view of a portion of an exemplary connector for connecting tube to bulb. 
         FIG. 13  shows a side profile view of a portion of an exemplary connector for connecting tube to bulb. 
         FIG. 14  shows a side profile view of a portion of an exemplary connector for connecting tube to bulb. 
         FIG. 15  shows an exemplary method for treating symptoms associated with headaches using an exemplary Pressure Changing Device. 
         FIGS. 16 a  and 16 b    show how a connector may be inserted into bulb to create a seal. 
         FIG. 17  shows an exemplary connector for connecting tube to ear adapter. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     This Application is a continuation-in-part of U.S. application Ser. No. 15/909,362, filed on Mar. 1, 2018 and titled “Method and Apparatus for Relieving Headache Symptoms,” the first inventor of which is John Hatch, and which is incorporated herein by reference in its entirety. 
     Application Ser. No. 15/909,362 claims priority to U.S. Provisional Application No. 62/466,248, titled “Method and Apparatus for Migraine Relief,” and filed on Mar. 2, 2017, and which is incorporated herein by reference in its entirety. 
     An improved method and apparatus are disclosed for treating migraines, pressure headaches, and other headaches. 
     In one embodiment, an apparatus is configured for pumping air and/or pressure into an ear, or for sucking (e.g., a vacuum effect) air and/or pressure out of an ear. 
     For example, one embodiment of the disclosed apparatus may be a Pressure Changing Device  100  as shown in  FIGS. 1 and 2 . As shown in  FIGS. 1 and 2 , Pressure Changing Device  100  may comprise bulb  110 , hollow tube  120  and earpiece  130 . 
     Bulb  110  may be any bulb-type apparatus or device known in the art for blowing air and/or creating pressure, or for sucking air and/or relieving pressure. Such bulbs are well known in, e.g., child nose mucus sucker devices, basting tubes for kitchen use, bulbs for inflating blood pressure checking equipment, and many other fields and/or uses. In one example, bulb  110  may be the bulb distributed with a Welch Allyn Insufflation Bulb for diagnostic otoscopes (Part number: 21504; GTIN 00732094086508). This type of bulb is shown in  FIGS. 1 and 2 . 
     The size of the Welch Allyn bulb  110  shown in  FIGS. 1 and 2  is approximately 1.25 inches in diameter, with a length of approximately 2.25 inches. 
     Bulb  110  is only one solution for a source for producing air pressure or causing a vacuum result. Many machines and/or apparatuses are known in the art for creating, maintaining, and/or regulating a pressure differential between fluids such as air. For example, as may be known in the art, the tube could be connected and/or secured to a motorized air pump/vacuum which may provide air pressure or a vacuum. A motorized air pump/vacuum could be connected to and or controlled by a computer, microprocessor, electronic controller, manual on/off, increase, decrease, or other controls. For example, the pump/vacuum controller may include an interface through which a user may select a mode (either pump or vacuum or combination of both), a program (e.g., pump for three seconds, rest for three seconds, pump for three seconds, rest for three seconds; or vacuum for three seconds, rest for three seconds, vacuum for three seconds, rest for three seconds; or pump for three seconds; vacuum for three seconds; pump for three seconds; vacuum for three seconds), an air pressure or vacuum pressure, time settings, and other settings. The controller may thereby allow for customized treatments with the disclosed device. 
     As will be appreciated by one of skill in the art, many programs may be developed or devised based on length of pump or vacuum cycles, length of rest cycles, air or vacuum pressure, or any other variables associated with the disclosed apparatus. 
     In general, the disclosed apparatus may use or incorporate any device or solution known in the art, in one of many fields, that creates a pump or vacuum effect, and that may be able to regulate the strength and timing of such pump or vacuum effect. Such devices or solutions may be mechanical, manual, motorized, computer controlled, remotely controlled, battery operated, or have any other characteristics as may be known in the art. 
     An airtight tube  120  may be connected to the bulb  110 . In general, this tube will be substantially flexible. Tube  120  may be made out of many materials or combinations of materials known in the art in the medical field and in many other fields involving flexible and airtight tubing. For example, tube  120  may be made out of plastic, rubber, fabric, or any other airtight tube. In general, tube  120  will be used at relatively low pressures and at room temperature, such that the tubing materials need not be designed or selected for extreme conditions and/or environments. 
     Tube  120  may be any color. In some embodiments, transparent, or translucent, or substantially transparent or substantially translucent tubing may be beneficial as it may allow for monitoring of cleanliness and/or possible blockage of the tube. 
     In general, tube  120  may be any length. In one embodiment, tube  120  may be three to 12 inches long. In general, if tube  120  is too short it may be inconvenient to use Pressure Changing Device  100  because a caretaker or user may have to hold the Pressure Changing Device  100  very close to his or her or the patient&#39;s ear, or may be restricted in locations in which the Pressure Changing Device  100  can be held or used, or in ways in which Pressure Changing Device  100  can be oriented during use. If tube  120  is too long, it may become tangled or unwieldy for use. Also, if tube  120  is too long, or if the volume of tube  120  is too large (tube volume is a function of tube length and tube diameter), the size of bulb  110  may need to increase so that bulb  110  is large enough to generate or relieve sufficient air pressure. In general, relative to the volume of tube  120 , bulb  110  must be of a sufficient size to generate the desired air pressure or to generate the desired vacuum effect. A bulb  110  that is too small may not generate sufficient pressure or vacuum effect. A bulb  110  that is too large may be susceptible to generating too much pressure or vacuum, or a dangerous amount of pressure or vacuum. 
     In some embodiments, the length of tube  120  may be adjustable, or may be extendable by adding segments, or may be amenable to shortening by removing segments. 
     In one embodiment, the diameter of tube  120  may be 0.25 inches. In some embodiments, the diameter of tube  120  could vary over the length of tube  120 . 
     In some embodiments, the cross section of tube  120  may not be circular, but may be another shape, e.g., square, or combination of shapes, or the shape may vary along the length of tube  120 . In general, tube  120  may be any airtight apparatus with a passage for airflow. 
     The thickness of the wall of tube  120  may be constant or vary as is known in the art. 
     Tube  120  may be connected, via an airtight connection, to bulb  110 . Many devices and approaches are well-known in the art, including in the medical field, for making an airtight connection with a tube. 
     For example, as illustrated in  FIGS. 1 and 2 , tube  120  may be connected to bulb  110  using a barbed connector. In some embodiments, the barbed connector may be a part of bulb  110  (monolithic), or may be connected to bulb  110 . In other embodiments, the barbed end may be a monolithic part of tube  120 , and may fit into a female bulb adapter. Barbed connections and fittings are well known in the art in the fields of medical devices, liquid and gas plumbing, and other fields. 
     In other embodiments, tube  120  may be glued to bulb  110 , or welded to bulb  110 , or heat welded to bulb  110 , or monolithically manufactured as part of bulb  110 , or secured with a threaded connection, or secured and/or attached in any other manner known in the art. 
     At the opposite end of tube  120 , i.e., opposite the end to which bulb  110  is secured or located, is ear adapter  130 . 
     In general, ear adapter  130  may be connected to tube  120  in the same manner as bulb  110  is connected to tube  120 , e.g., using a barbed connection, or monolithically, or with any other tubing connection well known in the art as described herein relative to bulb  120 . 
     In one embodiment, ear adapter  130  may be connected to tube  120  using a barbed connector that is part of tube  120 . 
     In some embodiments, ear adapter  130  may be designed to be easily removable and/or replaceable, which may be important for cleanliness and/or sanitation reasons. 
       FIGS. 1 and 2  illustrate an exemplary ear adapter  130  connected and/or secured to the end of tube  120 .  FIGS. 1-2  illustrate a Welch Allyn diagnostic otoscope (Part number: 21504, GTIN 00732094086508), which is one exemplary embodiment. 
     In a preferred embodiment, ear adapter  130  is configured and/or designed to create an airtight seal with the ear for the purpose of pumping pressure into, or vacuuming pressure out of, the ear. In some embodiments, ear adapter  130  may be referred to as an earbud. 
     Ear adapter  130  has a canal or passageway through which air may travel from the tube, into and through the ear adapter, and into the ear, or be vacuumed out of the ear. 
     Ear adapter  130  may be manufactured out of plastic, foam, rubber, a combination and/or hybrid of such, of the material used in the Welch Allyn diagnostic otoscope (Part number: 21504, GTIN 00732094086508), or any other material, or combination or materials, known in the art. 
     In one embodiment, as shown in  FIGS. 1-2 , ear adapter  130  may be tapered to adapt to different sizes of ears and different variations of ear shapes and/or formations of ears. As shown in  FIGS. 1 and 2 , ear adapter  130  may have more than one tier. In some embodiments, one or more tiers of ear adapter  130  may be removed, e.g., cut off or sliced off, to adapt and/or customize an ear adapter to different patients and/or ear sizes, formations, or configurations. 
     Ear adapter  130  may be any color. 
     In general, ear adapter  130  may be any ear piece, disposable or non-disposable, known in many fields in the art for fitting in a human ear. Fields include medical, head phones for music and sounds, ear plugs, and other fields dealing with ears. 
     Ear adapter  130  may be manufactured in multiple sizes or configurations for human ears and configurations of varying sizes. 
     Ear adapter  130  may be designed to be configured for different sizes and configurations, e.g., with breakaway or removable parts or segments. 
     As shown in exemplary method  300  in  FIG. 3 , Pressure Changing Device  100  may be used or applied to treat or otherwise relieve headaches or symptoms associated with headaches. At step  310  ear adapter  130  may applied to the ear by inserting ear adapter  130  sufficiently to create an airtight seal between ear adapter  130  and the ear. At step  320 , ear adapter  130  may be secured in place by manually holding it in place, or by using another device, e.g., a headband, to secure ear adapter  130  to the ear and to facilitate the air tight seal. In general, ear adapter  130  may remain in place in the ear without holding it manually or using another apparatus or device to hold ear adapter  130  in place. At step  330 , with ear adapter  130  inserted into the ear, the user, or a different operator (e.g., a doctor or a parent), may perform a sequence or pattern of squeezing and releasing bulb  110 , or by using another pressure/vacuum generating device attached to the end of tube  120 . For example, the operator may squeeze bulb  110  to generate pressure, or may release bulb  110  to generate a vacuum effect. In general, the operator may operate Pressure Changing Device  100  apparatus manually, or by entering a program, or by selecting a program, or in any other manner described herein, according to any of the programs or approaches described herein. At step  340 , when the pattern of squeezing and releasing has been completed, the user may disengage ear adapter  130  from the ear. 
     Many variations on application of Pressure Changing Device  100  may be applied depending on symptoms, diagnoses, patient characteristics, patient preferences, or any other factors known in the art. For example, in one embodiment, after inserting Pressure Changing Device  100  into a user&#39;s or patient&#39;s ear in a manner that creates an airtight seal, or a substantially airtight seal, bulb  110  may be repeatedly compressed, followed by removal of Pressure Changing Device  100  from the ear. In one example, bulb  110  may be compressed 20 times and then removed from the ear. This pattern may be repeated cyclically. For example, bulb  110  may be compressed 20 times and then removed from the ear for 20 minutes, and this may be repeated for multiple, e.g., five, iterations. 
     Another exemplary embodiment or application may comprise the following steps: (1) deflate bulb  110 , (2) insert bulb  110  into ear, (3) release bulb  110  and hold in the ear for 20 seconds, (4) pull bulb  110  out of ear, (5) wait five seconds, and (6) repeat steps (1)-(5) up to five times. Steps (1)-(6) may be performed on each ear, once every three hours, up to eight times per day. 
     In one alternative embodiment, as shown in  FIGS. 4-7 , the bulb may have a flat bottom.  FIG. 4  shows a side view of an exemplary bulb  210  with a flat bottom  215 .  FIG. 4  additionally shows exemplary dimensions for an exemplary bulb  210  with a flat bottom  215 . In general, the plane of flat bottom  215  is perpendicular to the length of bulb  210 . The diameter of flat bottom  215  may be approximately 22.12 mm. The diameter of flat bottom  215  may have many different lengths. The length of the diameter of flat bottom  215  may vary, and may depend on the size and dimensions of bulb  210 , the desired finger engagement location on bulb  210 , the desired air/fluid displacement properties of bulb  210 , usability and convenience of a user to grip and engage bulb  210  with his/her fingers, and any other factor that may affect usability or aesthetics of bulb  210 . 
       FIG. 5  shows a cross section of bulb  210 . As shown in  FIG. 5 , flat bottom  215  may comprise a recessed crater  217  surrounded by a ridge  216 . Although a flat bottom, on which bulb  210  may stand by itself, may be configured in many ways, using a ridge and crater system avoids instability that may result from imperfections in a completely flat bottom. 
     A flat bottom has several advantages. One advantage is that a flat bottom allows a device  200  (similar to device  100 —but with a flat bottom) to stand upright, with the bulb on the bottom and the ear adapter pointing upward. Standing upright prevents device  200  from rolling, keeps the ear adapter from coming in contact with potential dirty surfaces, and allows for easy pickup by a user. 
     Additionally, adding a flat bottom allows for an easy way to alter the volume of the bulb. For example, by varying the location of the flat bottom along the length of the bulb, the volume of the bulb may be altered without changing the shape, curvature, or other dimensions of the bulb. 
       FIGS. 6 and 7  show a side view and a cross section of bulb  210  having slightly different dimensions from the dimensions in  FIGS. 4 and 5 . 
       FIG. 8  shows an alternative exemplary embodiment of an ear adapter  330 .  FIG. 8  shows dimensions for ear adapter  330  in millimeters. Ear adapter  330  may be used just as ear adapter  130  is used and shown in  FIGS. 1 and 2 . The ear adapter dimensions shown in  FIG. 8  are large enough to fit human ears and to create an improved seal between the interior of device  100  and a human ear. Ear adapter  330  may have similar qualities, characteristics, and may comprise similar or the same materials, as ear adapter  130  as disclosed herein. 
       FIGS. 9-14  show various views of an exemplary connector for connecting tube  120  to bulb  110  or bulb  210 . In one embodiment, as shown in  FIGS. 5 and 7 , bulb  210  may include interior flange/lip  217 , which is dimensioned to complement tip  235  and flange  237  in connector  230 . 
       FIGS. 16 a  and 16 b    show how a connector may be inserted into bulb to create a seal. In one embodiment, flange in connector and lip in bulb may be designed with tolerances so that, at a specific pressure, the seal fails, thereby providing a safety feature to prevent a user from using excessive air/fluid pressure. For example, the tolerances of connector and bulb may be adjusted so that the seal fails at a desired pressure. This may be accomplished by adjusting dimensions. Modest trial and error may be required. 
     As shown in exemplary method  500  in  FIG. 13 , Pressure Changing Device  100  may be used or applied to treat or otherwise relieve headaches or symptoms associated with headaches. At step  510 , the bulb is depressed. At step  520 , the ear adapter is placed in a user&#39;s ear to engage the ear and ear canal. At step  530 , the bulb may be released, thereby creating a vacuum effect. 
       FIG. 17  shows an exemplary connector for connecting tube  120  to ear adapter  130 . 
     It should be understood that the usage scenarios, patterns, and applications described herein are exemplary, and may be modified or altered for a variety of reasons, and remain within the scope of the disclosure herein. For example, the rate of inflation/deflation, frequency of inflation/deflation, rest periods between inflation/deflation, vigor/strength of inflation/deflation, and other characteristics of use of the disclosed apparatus may be varied for particular applications, desired outcomes, or circumstances.