The present invention generally relates to a hand held device utilized to irrigate and flush a canal or passage in a human body. More particularly, the present invention relates to a device to irrigate and flush debris such as cerumen, or ear wax, from the ear canal.
Many people are afflicted with ear problems that require medical treatment. A typical ear affliction includes the blockage or obstruction of the ear canal which can cause both pain to the tympanic membrane, or ear drum, as well as the loss of hearing.
A typical blockage or obstruction of the ear canal is caused by cerumen, or ear wax. However, the ear canal can also be obstructed by other debris or foreign objects.
The tympanic membrane is sensitive to sound and temperature. The tympanic membrane is also a fragile piece of anatomy that can be easily ruptured if care is not taken while examining and treating the affliction.
Numerous devices have been utilized to remove debris from the ear canal to provide access to the tympanic membrane. One device is an irrigation device which forces a liquid into the ear canal. However, utilizing a typical irrigation device includes the potential of damaging the tympanic membrane because the typical irrigation device directs the fluid inwardly, and in the general direction of the tympanic membrane. If a sufficient amount of pressure is applied to the tympanic membrane by the irrigation device, the tympanic membrane will rupture.
Further, great care must be taken to irrigate the ear canal with a liquid at about body temperature. A liquid below 85° F. and above 110° F. can cause the patient to become disorientated and lose balance due to the difference in temperature between the two ears when the ear being treated is contacted with the liquid.
A mechanical device, such as an ear curette, can also be utilized to remove the obstruction or blockage. However, the use of a mechanical device, such as an ear curette, includes the possibility of damaging the ear drum or tympanic membrane by contacting the end of the mechanical device with the tympanic membrane. For instance an ear curette could be inserted into the ear canal such that the end of the ear curette accidentally punctures the tympanic membrane.
The present invention includes an ear canal rinsing device having a main body with a cavity for storing a liquid and a temperature sensor for indicating when the liquid is within a selected temperature range that will not adversely affect the patient when the liquid contacts the tympanic membrane. A nozzle is removably attachable to the main body where the nozzle includes a distal portion adapted for insertion into the ear canal. The nozzle includes an internal nozzle lumen in fluid communication with the opening in the main body. The nozzle also includes at least one discharge port in fluid communication with the internal nozzle lumen wherein when pressure is applied to the main body a volume of the cavity decreases and liquid is forced out of the at least one discharge port such that the ear canal can be rinsed.
An ear canal rinsing device is generally illustrated in
The device 10 includes a temperature sensor 28 that is attached to the main body 12 that indicates when the temperature of the liquid is within a temperature range that will not adversely affect the patient due to a temperature difference between the tympanic membrane and the liquid. A typical selected temperature range is between about 85° F. and about 110° F.
A typical temperature sensor 28 is a liquid crystal display (LCD) having a pressure sensitive adhesive on one surface where the pressure sensitive adhesive affixes the temperature sensor 28 to an exterior surface of the main body 12. The LCD changes colors when the LCD reaches a temperature within the selected range. While a temperature sensitive LCD is contemplated, other temperature sensor could also be utilized to determine the temperature of the liquid.
The main body 12 includes a bottom wall 20 and a substantially cylindrical side wall 22 extending upwardly from the bottom wall 20. A top wall 23 extends from the side wall 22 where the top wall 23 converges to the opening 14 at the top end 16. The cavity 18 is defined by the bottom wall 20, the side wall 22 and the top wall 23. While a cylindrical configuration of the main body 12 is typical, other configurations of the main body are also contemplated.
The main body 12 also includes a lumen 24 that extends from the top end 16 to proximate the bottom wall 20 where the lumen 24 is located about a parameter of the opening 14. The lumen 24 directs the liquid out of the top end 16 of the main body 12 when opposing portions of the side walls 22 are moved toward each other typically with manual force. As opposing portions of the side wall 22 are moved toward each other, the volume of the cavity 18 is reduced and pressure is applied to the liquid which forces the liquid through the top end 16 of the main body 12.
The main body 12 includes a threaded cylindrical extension 26 which threadably engages a threaded bore 32 in the nozzle 30 to attach the spray nozzle 30 to the main body 12. A bottom portion 38 of the nozzle 30 has a substantially cylindrical outer surface which facilitates gripping of the nozzle 30 when the nozzle 30 is being connected to or disconnected from the main body 12. While a threaded connection is typical, other connecting mechanisms are also contemplated, such as but not limited to a snap connection or a friction engagement.
Referring to
As the nozzle 30 is threadably secured to the main body 12 through the threaded engagement of the threaded bore 32 and the threaded cylindrical extension 26, the extension 34 is forced into the lumen 24 such that when the nozzle 30 is secured to the main body 12, the outer surface 36 of the extension 34 forms a seal with the lumen 24. The seal prevents liquid from leaking out of the device 10 through the threaded engagement of the nozzle 30 with the main body 12. Leakage through the threaded engagement would detrimentally decrease the pressure of the liquid delivered to the ear canal as well as potentially spraying the care giver or the patient with unwanted liquid.
Referring to
Referring to
While a row of three discharge ports is contemplated one or more discharge ports that direct liquid away from the tympanic membrane are also contemplated. Offsetting the top discharge ports such that the top discharge ports do not form a row is also contemplated.
The bottom row of discharge ports 52 includes three evenly spaced ports around the circumference of the top portion 44 that are positioned at about a 45° angle from the central axis 60 of the nozzle 30. The discharge ports 52 are angled to direct liquid to contact the canal wall in a direction toward the tympanic membrane but not contacting the tympanic membrane. The angle of the bottom row of discharge ports can range from about 30° to about 60° or any degree within the range provided that the liquid discharged from the top row of discharge ports 50 does not substantially contact the tympanic membrane. However due to the distance of the bottom row of discharge ports 52 from the tympanic membrane and the pressure of the liquid, the tympanic membrane will not be adversely affected by the ear canal rinse.
While a row of three discharge ports is contemplated, one or more discharge ports that discharge liquid toward the tympanic membrane are also contemplated. Offsetting the bottom discharge ports such that the bottom discharge ports do not form a row is also contemplated.
The bottom row of discharge ports 52 are offset from the top row of discharge ports 50 such that the entire circumference of the ear canal is rinsed instead of only a portion of the ear canal. The angle of the discharge ports 50, 52 is best illustrated in
The top and bottom discharge ports 50 and 52 have diameters that are typically within the range of 0.024 inches and 0.030 inches. However, ports having diameters smaller than 0.024 inches and larger than 0.030 inches are also contemplated provided a sufficient amount of liquid is discharged at a sufficient pressure to effectively rinse the ear canal of the obstruction.
By directing about half of the liquid to contact the canal wall in a direction toward the tympanic membrane, without actually contacting the tympanic membrane with a substantial amount of liquid, and about half of the liquid away from the tympanic membrane, a more effective rinse is created when compared to a nozzle that only directs a liquid in one direction. While not being bound to any theory, it is believed that the cerumen may be loosed from the canal wall by a liquid flush in one direction and is dislodged from the ear canal wall by a liquid flush in the opposite direction.
While two rows of discharge ports are typical, one or more rows of discharge ports are contemplated. Also while three ports per row of discharge ports are typical, two or more ports per row are contemplated. Also a randomized pattern of discharge ports is also contemplated.
The nozzle 30 includes a top portion 54 that is inserted into the ear canal. The top portion 54 extends from a shoulder 37 that connects the top portion 54 to the bottom portion 38. The top portion 54 is of a length that will not contact the tympanic membrane of a person with a typical distance from the entrance to the ear canal to the tympanic membrane. The top portion 56 has a rounded end 58 that prevents damage to the tympanic membrane in the unlikely event that the rounded end 58 contacts the tympanic membrane.
The nozzle 30 also includes a plurality of chamfers 62 that are connected to an outer perimeter of the shoulder 37 and the top portion 56 below the top end 58. The chamfers 62 engage the entrance to the ear canal which also prevents excessive insertion of the top portion 56 into the ear canal. The chamfers 62 are spaced apart which prevents a seal from being formed between the nozzle 30 and the ear canal. A seal at the entrance to the ear canal is undesirable because when a seal is formed and liquid is forced into the ear canal, pressure will be placed upon the tympanic membrane which could cause pain at a minimum, and potentially rupture the tympanic membrane.
The chamfers 62 also provide openings 64 through which the liquid and debris such as cerumen can be drained from the ear canal. While six evenly spaced chamfers are typical, three or more chamfers are also contemplated.
Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.
The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/086,903 which was filed on Aug. 7, 2008, the contents of which are incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61086903 | Aug 2008 | US |