CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 61/847,009 filed July 16, 2013, which is herein incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

FIELD

[0003] Embodiments of the invention relate generally to methods and devices for cleaning a body orifice. More specifically, embodiments of the invention relate to methods and devices for cleaning the ear canal with a handheld and/or portable unit.

BACKGROUND

[0004] The Q-tip has been used by many for decades to clean the ear canal. The Q-tip has a shaft tipped with a cotton swab that a person inserts directly into the ear canal to remove ear wax buildup and/or moisture. The depth of insertion is controlled by the user, which may result in over-insertion and perforation or damage to the ear drum. The cotton swab is also not optimized for ear wax removal, and its round blunt shape can push ear wax deeper into the ear canal and lead to ear wax impaction.

[0005] Therefore, it would be desirable to provide an ear canal cleaning device that would reliably clean the ear canal while preventing or reducing (1) over-insertion and perforation or damage to the ear drum and (2) ear wax impaction.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: [0007] FIGS. 1A-1C are various views of one embodiment of an ear canal cleaning device with a disposable tip.

[0008] FIGS. 2A and 2B are perspective views of another embodiment of an ear canal cleaning device with a disposable tip.

[0009] FIG. 3 is a perspective view of yet another embodiment of an ear canal cleaning device.

[00010] FIG. 4 is a perspective view of yet another embodiment of an ear canal cleaning device. SUMMARY OF THE DISCLOSURE

[00011] The present invention relates to methods and devices for cleaning a body orifice. More specifically, embodiments of the invention relate to methods and devices for cleaning the ear canal with a handheld and/or portable unit.

[00012] In some embodiments, a handheld ear canal cleaning system is provided. The system can include a handle comprising a distal head portion having a receptacle; a disposable cleaning tip comprising a shaft having a proximal end configured to be removably inserted into the receptacle and a distal end comprising a cleaning element, the cleaning element comprising a flexible, atraumatic screw blade sized to fit within an ear canal; a motor disposed within the handle, the motor configured to rotate the receptacle; and a battery disposed within the handle, the battery configured to power the motor.

[00013] In some embodiments, the distal head portion comprises a tapered portion proximate the receptacle that is configured to fit partially within the ear canal.

[00014] In some embodiments, the system further includes a flexible shield disposed over the distal head portion, the flexible shield have a tapered portion that is configured to fit partially within the ear canal.

[00015] In some embodiments, the screw blade is tapered.

[00016] In some embodiments, the system further includes a controller programmed to operate the motor according to a predetermined routine.

[00017] In some embodiments, the predetermined routine comprises a rotational speed between about 0.25 to 5 revolutions per second.

[00018] In some embodiments, the predetermined routine comprises a rotational speed between about 0.5 to 3 revolutions per second.

[00019] In some embodiments, the disposable cleaning tip has a length that is configured to extend between about 1/3 to 2/3 of the length of the ear canal. [00020] In some embodiments, the disposable cleaning tip further comprises an absorbent material configured to absorb moisture in the ear canal.

[00021] In some embodiments, a handheld ear canal cleaning system is provided. The system can include a handle comprising a distal head portion having a receptacle; a disposable cleaning tip comprising a shaft having a proximal end configured to be removably inserted into the receptacle and a distal end comprising a cleaning element, the cleaning element comprising a plurality of flexible bristles sized to fit within an ear canal; a motor disposed within the handle, the motor configured to rotate the receptacle; and a battery disposed within the handle, the battery configured to power the motor.

[00022] In some embodiments, the distal head portion comprises a tapered portion proximate the receptacle that is configured to fit partially within the ear canal.

[00023] In some embodiments, the system further includes a flexible shield disposed over the distal head portion, the flexible shield have a tapered portion that is configured to fit partially within the ear canal.

[00024] In some embodiments, the plurality of flexible bristles are arranged in a spiral configuration.

[00025] In some embodiments, the system further includes a controller programmed to operate the motor according to a predetermined routine.

[00026] In some embodiments, the predetermined routine comprises a rotational speed between about 0.25 to 5 revolutions per second.

[00027] In some embodiments, the predetermined routine comprises a rotational speed between about 0.5 to 3 revolutions per second.

[00028] In some embodiments, the disposable cleaning tip has a length that is configured to extend between about 1/3 to 2/3 of the length of the ear canal.

[00029] In some embodiments, a disposable cleaning tip for use with a handheld ear canal cleaning device having a receptacle is provided. The tip can include a shaft with a proximal end and a distal end, the proximal end of the shaft configured to be removably inserted within the receptacle of the ear canal cleaning device; and a cleaning element disposed on the distal end of the shaft, the cleaning element comprising a flexible, atraumatic screw blade sized to fit within an ear canal.

[00030] In some embodiments, the shaft has a length that is configured to extend between about 1/3 to 2/3 of the length of the ear canal.

[00031] In some embodiments, the screw blade is tapered.

[00032] In some embodiments, the screw blade has a diameter that is greater than or equal to the diameter of an ear canal. [00033] In some embodiments, the proximal end of the shaft comprises a retaining element configured to secure the shaft within the receptacle of the cleaning device.

[00034] In some embodiments, the cleaning element further comprises an absorbent material configured to absorb moisture in the ear canal.

[00035] In some embodiments, a disposable cleaning tip for use with a handheld ear canal cleaning device having a receptacle is provided. The tip can include a shaft with a proximal end and a distal end, the proximal end of the shaft configured to be removably inserted within the receptacle of the ear canal cleaning device; and a cleaning element disposed on the distal end of the shaft, the cleaning element comprising a plurality of flexible bristles sized to fit within an ear canal.

[00036] In some embodiments, the plurality of flexible bristles are arranged in a spiral configuration.

[00037] In some embodiments, the plurality of flexible bristles have a length that tapers towards the distal end of the shaft.

[00038] In some embodiments, the cleaning element further comprises an absorbent material configured to absorb moisture in the ear canal.

[00039] In some embodiments, a disposable cleaning tip for use with a handheld ear canal cleaning device having a receptacle is provided. The tip can include a shaft with a proximal end and a distal end, the proximal end of the shaft configured to be removably inserted within the receptacle of the ear canal cleaning device; and a cleaning element disposed on the distal end of the shaft, the cleaning element comprising a plurality of mesh ribbons sized to fit within an ear canal.

[00040] In some embodiments, a method of cleaning an ear canal of a user is provided. The method can include inserting a disposable cleaning tip into a receptacle of a hand held ear canal cleaning device, the disposable cleaning tip having a shaft configured to be removably inserted into the receptacle and a cleaning element; powering a motor within the cleaning device to rotate the disposable cleaning tip; inserting the cleaning element of the disposable cleaning tip into the ear canal; and removing the cleaning element of the disposable cleaning tip from the ear canal.

[00041] In some embodiments, the disposable cleaning tip is rotated between about 0.25 to 5 revolutions per second.

[00042] In some embodiments, the method further includes abutting a shield of the ear canal cleaning device against an outer portion of the patient's ear or ear canal.

[00043] In some embodiments, the cleaning element is a screw blade.

[00044] In some embodiments, the cleaning element is a plurality of bristles.

[00045] In some embodiments, the cleaning element is a plurality of mesh ribbons. DETAILED DESCRIPTION

[00046] FIGS. 1A-1C illustrate an embodiment of an ear canal cleaning device 100 with a disposable cleaning tip 102. The ear canal cleaning device 100 can have a handle 104 and a distal head portion 106 for receiving the disposable cleaning tip 102. The handle 104 can have a power button 108 to activate a motor 110 disposed within the distal head portion 106 that functions to axially rotate the disposable cleaning tip 102. The motor 1 10 can be a small DC motor that can be powered by a common AAA or AA battery 1 12 that can fit within the handle. In some embodiments, the handle 104 can have a removable cover that allows access to the interior of the handle and allows the battery 112 to be replaced. In some embodiments, the handle 104 is sized and shaped to be grasped and manipulated by a single hand. In some embodiments, the entire device can be handheld and portable.

[00047] The disposable cleaning tip 102 includes a shaft 114 that is tipped on its distal end with a cleaning element 1 16. In some embodiments, the proximal end of the shaft 114 can include a retaining feature, such as a slot, tab cavity or recess, that allows the proximal end of the shaft 1 14 to be inserted into a receptacle 115 at the distal end of the distal head portion 106 and removably secured within distal head portion 106 to the drive shaft of the motor 1 10. The length of shaft 1 14 is limited so that the cleaning element 1 16 extends a predetermined distance into the ear canal. For example, in some embodiments, the shaft 1 14 and cleaning element 1 16 can extend to a depth of about one third of the length of the ear canal. In some embodiments, the cleaning tip 102 can extend to about one half or two thirds of the length of the ear canal. In some embodiments, the cleaning tip 102 can have a length that is configured to extend between about one third to about two thirds of the length of the ear canal. In general, the length of the shaft 1 14 is limited such that the cleaning tip 102 does not reach the ear drum when the cleaning tip 102 is fully inserted into the ear canal. In some embodiments, the shaft 1 14 can be rigid. In other embodiments, the shaft 1 14 can be flexible and can conform to the geometry of the ear canal. In some embodiments, the shaft 1 14 can be straight, curved, coiled, spiraled, or bent.

[00048] The distal head portion 106 can have a tapered portion 1 18 on the distal end of the distal head portion 106. The tapered portion 1 18 can be sized and shaped to fit within the proximal portion of the ear canal up to a predetermined distance. The portion of the distal head portion 106 that is proximal the tapered portion 118 can flare outwardly and have a diameter and/or a size and shape that prevents the proximal portion of the distal head portion 106 from entering the ear canal. In other words, the proximal portion of the distal head portion 106 can be configured to abut against the outer ear and thereby limit the insertion depth of the disposable cleaning tip 102. In some embodiments, the distal head portion 106 can be generally spherical or ovoid in shape.

[00049] In some embodiments, as shown in FIG. 4, the cleaning device 100 can include a shield 107 that prevents or reduces the likelihood of overinsertion of the cleaning element 1 16 into the ear canal. The shield 107 can fit over the distal head portion 106 and can be a flexible or malleable cup-like shell. The shield 107 can have a tapered portion 1 19 that can be sized and shaped to fit within the proximal portion of the ear canal up to a predetermined distance, as similarly described above for the embodiment of the distal head portion 106 shown in FIGS. 1A- 1C. The shield 107 can also have flared out portion 121 that widens to a diameter greater than the diameter of the ear canal and functions to limit insertion of the cleaning element 1 16 into the ear canal. In some embodiments, the shield 107 can have a smooth surface that can easily be washed and cleaned of debris. The shield 107 can have an opening that can be positioned over the receptacle so that the shaft disposable cleaning tip can be inserted through the shield 107 and into the receptacle.

[00050] In some embodiments, as illustrated in FIGS. 1A-1C and FIG. 3, the cleaning element 1 16 of the disposable cleaning tip 102 contains a plurality of bristles 120 that extend radially from the distal end of the shaft 1 14. In some embodiments, the bristles 120 can be arranged in a spiraling or helical row or pattern to form a screw-like blade from the bristles that can move ear wax proximally out of the ear canal when the disposable cleaning tip 102 is rotated. The length of the bristles 120 can be about one half the diameter of the ear canal. In some embodiments, the length of the bristles is between about 0.25 to 0.75 the diameter of the ear canal. In some embodiments, the bristles 120 can be flexible so that the bristles conform to the surface of the ear canal without damaging or irritating the tissues of the ear canal. In some embodiments, the bristles can be straight, looped, coiled, spiraled, helical, wavy, hooked, or barbed, or

combinations of the above. In some embodiments, the bristles can have a rounded tip. The bristles can penetrate, capture, engage, or break apart the ear wax within the ear canal.

[00051] In some embodiments, as illustrated in FIG. 4, a flexible, atraumatic screw blade 123 can be included with or in place of the bristles. The screw blade 123 can be made of a flexible plastic, silicone or rubber material that can conform to the surface of the ear canal without damaging the tissue surrounding the ear canal or the ear drum. In some embodiments, the maximum diameter of the screw blade 123 portion of the cleaning element 1 16 can be about equal to or greater than the diameter of the ear canal to ensure that the screw blade 123 completely covers the cross-sectional area of the ear canal. The flexibility and deformability of the screw blades 123 allows the use of an oversized screw blade in the ear canal. In other embodiments, the screw blade 123 may be less than the diameter of the ear canal. The diameter or width of the screw blade can taper in the distal direction so that the cleaning element 1 16 has a narrow or tapered distal tip. The screw blade can have a helical or spiral shape and function to move ear wax in proximal direction and out of the ear canal. The screw blade can also function to penetrate, capture, engage or break apart the ear wax within the ear canal.

[00052] In some embodiments, the cleaning element 1 16 can further include or alternatively include a plurality of mesh ribbons. In some embodiments, the cleaning element can include an absorbent material, such as cotton, for drying the ear. In some embodiments, the cleaning element can be similar to a Q-tip in shape, material and function, as illustrated in FIGS. 2A and

2B, and can include a rounded cotton swab or another absorbent material.

[00053] In some embodiments, the distal end of cleaning element 1 16, whether made of bristles or one or more screw threads or another feature, can be wedge shaped, conically shaped, frustoconically shaped, tapered, round, or ovoid. Embodiments of the cleaning element 1 16 that present a more narrow or tapered distal end may avoid or reduce pushing wax further into the ear canal as compared to a blunt end. Therefore, a wedge shaped or conically shaped or tapered distal end may reduce wax impaction relative to the round end presented by a Q-tip. The narrow or tapered distal end can more easily pierce the ear wax as the cleaning element 116 is advanced, and can, with the use of a screw blade feature as described herein, be rotated to removed the ear wax from the ear canal.

[00054] In some embodiments, the ear canal cleaning device 100 can have a controller 122 that is designed or preprogrammed to execute a predetermined cleaning routine when the power button 108 is pushed or actuated. In some embodiments, the controller 122 can include a processor and memory for storing instructions, that when executed by the processor, execute the cleaning routine. In other embodiments, the instructions can be implemented into an ASIC. In some embodiments, the cleaning routine can comprise a rotation speed and a rotation duration. For example, the rotation speed of the disposable cleaning tip 102 can be between about 0.25 to 5, or 0.5 to 3 revolutions per second. In some embodiments, the duration can be between about 5 to 60 seconds, or between about 15 to 45 seconds, or about 10, 20, 30, 40, 50, or 60 seconds. In some embodiments, the cleaning routine can further comprises one or more cycles, where the rotation speed and rotation duration can be varied between cycles.

[00055] In other embodiments, the device 100 may be user controlled and can operate while switched into an "on" configuration. For example, the device 100 may be switched into an "on" configuration by pressing a button or switch. In some embodiments, the device 100 may return to an "off configuration" when the user stops pressing down the "on" button. In other embodiments, separate "on" and "off buttons or a rocker switch with an "on" and "off configuration can be used to switch the device 100 between "on" and "of states. In some embodiments, the device 100 rotates the cleaning tip 102 at a speed between 0.25 to 5 revolutions per second, or between about 0.5 to 3 revolutions per second.

[00056] In some embodiments, the device 100 can have a rotatable dial or two buttons for controlling the speed of rotation of the cleaning element 1 16. For example, the on/off button can be replaced with a dial to allow variable speed control.

[00057] To use the device 100 to clean an ear canal, the user, if needed, inserts a clean disposable cleaning tip 102 into the distal head portion 106 so that the disposable cleaning tip

102 is in mechanical communication with the drive shaft of the motor 1 10. The user can select the type of cleaning element 1 16 and the size of the disposable cleaning tip 102 depending on the desired application. The user can grab the device 100 with a single hand and insert the disposable cleaning tip 102 into the ear canal. The user advances the disposable cleaning tip 102 into the ear canal until the outer ear abuts against the distal head portion 106 or shield 107. The user can then push the power button 108 to activate the preprogrammed and/or predetermined cleaning routine or simply to power the device on. Once the cleaning routine is finished, the user can withdraw the disposable cleaning tip 102 from the ear canal, remove the disposable cleaning tip 102 from the distal head portion 106, and dispose the disposable cleaning tip 102.

[00058] The term "about" and "approximately" and the like can mean within 10, 20, or 30 percent.

[00059] It is understood that this disclosure, in many respects, is only illustrative of the numerous alternative device embodiments of the present invention. Changes may be made in the details, particularly in matters of shape, size, material and arrangement of various device components without exceeding the scope of the various embodiments of the invention. Those skilled in the art will appreciate that the exemplary embodiments and descriptions thereof are merely illustrative of the invention as a whole. While several principles of the invention are made clear in the exemplary embodiments described above, those skilled in the art will appreciate that modifications of the structure, arrangement, proportions, elements, materials and methods of use, may be utilized in the practice of the invention, and otherwise, which are particularly adapted to specific environments and operative requirements without departing from the scope of the invention. In addition, while certain features and elements have been described in connection with particular embodiments, those skilled in the art will appreciate that those features and elements can be combined with the other embodiments disclosed herein.