Patent Publication Number: US-2023157924-A1

Title: Meibomian Gland Roller System with Eye Pads

Description:
CROSS-REFERENCES TO PRIORITY AND RELATED APPLICATIONS 
     This application is a continuation-in-part of U.S. patent application Ser. No. 17/461,796, filed Aug. 30, 2021, entitled “Meibomian Gland Roller,” which in turn is a continuation of U.S. patent application Ser. No. 15/143,348, filed on Apr. 29, 2016 (now U.S. Pat. No. 11,103,417 issued Aug. 31, 2021), entitled “Meibomian Gland Roller,” which claims the benefit of U.S. Provisional Application 62/155,174, filed on Apr. 30, 2015, entitled “MG Roller.” 
     The entire disclosures of applications/patents recited above are hereby incorporated by reference, as if set forth in full in this document, for all purposes. 
    
    
     FIELD 
     The present disclosure generally relates to methods and apparatus for treatment of dry eyes and, more specifically, to meibomian gland treatment including the use of eye pads. 
     BACKGROUND 
     The meibomian glands (or tarsal glands) are a type of sebaceous gland inside the substance of the eyelids responsible for the supply of meibum, an oily substance that prevents evaporation of the eye&#39;s tear film. Meibum prevents tear spillage onto the cheek, trapping tears between the oiled edge and the eyeball, and makes the closed eyelids airtight. Dysfunctional meibomian glands often cause dry eyes, one of the more common eye conditions. Inflammation of the meibomian glands causes the glands to be obstructed by thick waxy secretions. Besides leading to dry eyes, the obstructions can result in other medical problems. Treatment can include expression of the gland by a professional. In some cases, antibiotics or steroids are prescribed. 
     SUMMARY 
     A roller includes a cylinder, an axle about which the cylinder can rotate, a handle, and arms. The cylinder and axle include a heating element, and the cylinder is configured to roll over and apply pressure to the eyelid of a user. The handle includes a power source and the axle is held to the handle by the arms and power is supplied by the arms from the power source to the heating element. An eye pad might be included to be placed over the user&#39;s eyelid prior to application of the roller. 
     A method includes warming the cylinder of a roller, where the roller has a handle and arms by which the cylinder is attached to the handle. A user applies pressure to an eyelid of the user by the warmed cylinder and rolls the warmed roller across the user&#39;s eyelid to express the meibomian glands. 
     This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive presentation of features, details, utilities, and advantages of methods and apparatus, as defined in the claims, is provided in the following written description of various embodiments of the disclosure and illustrated in the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various embodiments in accordance with the present disclosure will be described with reference to the drawings, in which: 
         FIG.  1    illustrates an embodiment of a meibomian gland roller. 
         FIG.  2    shows an example of an eye pad. 
         FIG.  3    includes some of the internal detail for the roller structure. 
         FIG.  4    is a side view of an embodiment of a meibomian gland roller. 
         FIG.  5    is a schematic diagram of some electrical elements for an exemplary embodiment of the roller. 
         FIG.  6    shows an example of a charging well for the roller system. 
         FIG.  7    is a schematic for some elements that can be in the base. 
         FIG.  8    is a flow to illustrate use of the meibomian gland roller. 
     
    
    
     DETAILED DESCRIPTION 
     In the following description, various embodiments will be described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the embodiments. However, it will also be apparent to one skilled in the art that the embodiments may be practiced without the specific details. Furthermore, well-known features may be omitted or simplified in order not to obscure the embodiment being described. 
     The Meibomian Gland Roller described here is a practical way to self-administer the treatment for one of the leading causes of dry eyes, namely, tear film oil deficiency. This roller combines an effective and safe method to use mechanical rolling pressure combined with heat for meibomian gland drainage. The roller can be distributed as a kit that is a complete package to melt, effectively and safely milk, and wash away the common hardened contents of a dysfunctional meibomian gland. 
     The device is designed with an externally applied roller that can be applied to a closed eye that can be safely used by the consumer on their own eyelids without the need for a clinician inserting anything into the eye. Additionally, this roller can have an embedded sensor in the roller to control and maintain the temperature at the range of 42 to 45 degrees Celsius. Since eye shape and size vary from person to person, the roller head width will be designed to be about ⅓ of the width of the average adult person&#39;s eyelid size, on the order of 1-2 cm, for example. With this size roller, the device can be used on the eyelid of different size adult eyes, as well as the pediatric population. 
     The rolling action of this instrument, combined with the rolling head increases its effectiveness in emptying inspissated meibomian glands. The roller tip allows the patient to safely start the application of the pressure at the bottom of the glands and effectively roll open the clogged-up oil glands, analogous to squeezing out the contents of a tooth paste tube. The washable roller keeps the head clean for long term use. The removable roller head allows for a multi-user application. 
     A preheated, eye-shaped, soft eye pad can be used to prepare the eyelids by softening the meibomian gland contents and making it easier for the roller to have a more effective action to induce mechanical extraction of the gland content. As discussed below, a charging well structure can include a well for heating an eye-shaped pad. This allows for eye pads to be heated without use of a microwave to heat the eye pad, which makes it safer as well as more convenient to use. It is safer because no microwaves are used to heat up the eye pad before its application so close to the eye. It can be more convenient since it can be used at any location simply by plugging it into an electric outlet or using the rechargeable battery. The eye pad can be designed to maintain the temperature between 42 and 45 degrees Celsius for 3 to 5 minutes or longer. 
     In some configurations and treatment processes, the eye pad is applied to the user&#39;s eyelid and is in place while the roller is applied. In some embodiments, the eye pad comprises a soft gel component, wherein the eye pad comprises an outer surface material enclosing a soft gel. The eye pad could be flat and thin, such as a single or a few layers of fabric or similar thicknesses, or might enclose a gel or silicone capable of absorbing and releasing heat. The eye pad could comprise a gel, silicone, fabric, plastic, or other appropriate material that can provide for the desired heat conduction. An adhesive material can be applied to the eye pad to allow the eye pad to adhere to the user&#39;s face around the user&#39;s eyelids. In some embodiments, the eye pad is eye-shaped whereas in other embodiments, it has another shape. 
     In some embodiments, treatment involves pre-heating the eye pad, but in other embodiments the eye pad is not pre-heated prior to application. Some variations of the eye pad could include pressure sensors and/or temperature sensors. 
     In one set of exemplary embodiments, the components of a roller system can include a heatable roller, having a roller cylinder and handle, an eye pad, a charging base with a well for charging the roller, and a heating well for the eye pad. 
       FIG.  1    is a schematic element of the roller and eye pad. The roller includes a handle  15 , arms  13 , and a roller cylinder  11  supported on an axle (not visible in  FIG.  1   ) held by the arms. The arms  13  hold the axle for the roller cylinder and attach to the handle  15 , providing electric connections between the handle  15  and the axle and cylinder. The roller cylinder is the part that touches the eyelid. In a first exemplary embodiment, the roller cylinder is of a metal substance and attached to a chargeable handle to keep the roller at the temperature that corresponds to the melting point of the meibum and that is a safe temperature for the skin, such as 42 to 45 degrees Celsius, during application period. Electric power supplied can be supplied to a heating element in the roller by a battery in the handle to maintain this temperature range. The roller materials are preferably washable and comfortable against the skin. The roller can be packaged with additional rollers for future replacement. Also, replacement roller heads can optionally be bought or supplied. 
     The roller cylinder can include the heating element and a temperature sensor to detect the temperature of the roller. Depending on the embodiment, the heating element can be part of the axle, part of the roller cylinder, or part of the surface of the roller cylinder or just below the surface of the roller cylinder. The temperature sensor, which, depending on the embodiment, is optional, can be located just below the surface of the roller cylinder or part of the axle, for example. The roller cylinder width will be designed to be about ⅓ of the width of the average adult person&#39;s eyelid size, on the order of 1-2 cm, for example. 
     The roller cylinder  11  can be made from metal with an appropriate thermal conductivity, silicone cast resin, or other materials, such as one or more of Teflon(tm) material, acrylic, bitumen, cellulose acetate, molded material, sheet material, granite, dry leather, limestone, polycarbonate, polymethylmethacrylate, porcelain, polyvinylchloride (PVC), quartz mineral, silicone cast resin, or vinyl ester, or similar materials. 
     A chargeable handle  15  for the roller can include a rechargeable battery, indicator light, and a switch that is controlled through a control button, as well as a connector to a well for charging the rechargeable battery. Alternately, wireless charging can be used. 
       FIG.  2    illustrates and example of an eye pad  17 , which in this example is more or less eye-shaped. In some configurations and treatment processes, the eye pad is applied to the user&#39;s eyelid and is in place while the roller is applied. 
     In some embodiments, the eye pad comprises a soft gel component. The eye pad could be flat and thin, such as a single or a few layers of fabric or similar thicknesses, or might enclose a gel or silicone capable of absorbing and releasing heat. The eye pad could comprise a gel, silicone, fabric, plastic, or other appropriate material that can provide for the desired heat conduction. An adhesive material can be applied to the eye pad to allow the eye pad to adhere to the user&#39;s face around the user&#39;s eyelids. In some embodiments, the eye pad is eye-shaped whereas in other embodiments, it has another shape. For example, the eye pad might be an eye-shaped soft gel eye pad. The eye pad could be a heated eye pad. 
     In some embodiments, treatment involves pre-heating the eye pad, but in other embodiments the eye pad is not pre-heated prior to application. Some variations of the eye pad could include pressure sensors and/or temperature sensors. An eye pad temperature sensor and/or an eye pad pressure sensor could be embedded within the eye pad and possibly able to communicate signals to a device or app for monitoring, displaying, and/or alerting the user to certain alarm or other conditions. 
       FIG.  3    illustrates an alternative example of an eye treatment roller, with some of the detail internal to both the roller  11  and handle  15  shown inside. The battery is shown at  37 , where the wiring then runs through the arms  13  to the axle  19 . Here the heating coil  35  is shown to be within the axle  19  and a temperature sensor circuit  33  is in the roller. A control button is represented on the handle at  31 . 
     When the control button  31  is pressed, the switch can connect the rechargeable battery  37  to the heating element  35  and the temperature sensor  33  in the roller cylinder, and to the indicator light in the handle, to supply power to these three devices. When the roller is heated to the desired temperature, this is sensed by the temperature sensor, which can send a signal to the indicator light in the handle and to the charging base to so indicate. When the control button  31  is pressed again, the switch toggles and turns off the connection between the rechargeable battery and the heating element, the temperature sensor in the roller, and the indicator light in the handle. 
       FIG.  4    is a side view corresponding to  FIG.  1   . 
       FIG.  5    is a schematic diagram of some electrical elements for an exemplary embodiment of the roller. The heating coil  35  and temperature sensor  33  are connected through the wiring in the arms to the handle&#39;s control circuitry  43 . Depending on the embodiment, the rechargeable battery  37  can be charged through a connector or by way of an induction coil  41  for wireless charging. A LED  45  is included for an indicator light on the handle. 
       FIG.  6    is a view for one embodiment of a charging base  61  with a roller well  63  and a heating well  65  for heating the eye pad, where an additional well can be included for an extra eye pad. The charging well  63  can include a socket for charging the handle, or an induction coil  73  for wireless charging. A cord  71  for connection to a power source. The charging well might receive a second end of the handle that is opposite a length of the handle from the first end. The charging base can also include a built-in rechargeable battery. In this way, it can be used by simply plugging the cord  71  into an electric outlet, as well as using its rechargeable battery to operate it where there is no electricity available. The charging well can be equipped with an on-off switch (not shown) and an indicator light to signal when the arm and the eye pad are at the right temperature to be used. 
     The eye pad well  65  can heat the eye pad to the appropriate temperature. This allows the eye pad to be heated without use of a microwave oven, for example, as some people prefer not to heat using a microwave oven or it is not nearby to where the device is used. A flexible soft gel eye-shaped pad enclosing gel can be heated to 42-45 degrees Celsius before it is applied to the eyelids. A pair of indicator lights  67  and  69  can indicate the charge state or temperature for the handle and the temperature for eye pad. 
       FIG.  7    is a schematic for some elements that can be in the base  61 . A base controller  75  can be connected the lights  67  and  69  and induction coil  73 , as well as a heating coil  81  for the eye pad. The cord  71  is connected to the power converter  77  that supplies power to the base, and an on-off switch is represented at  79 . 
     The roller can also be used with sweeping applicators, which can be included in a kit with the roller and base, or obtained separately. The sweeping applicators can be individually foil-wrapped double ended sweepers with a presoaked gauze tip. The tips can be presoaked with a mild detergent and anti-bacterial solution. 
     In a typical application of the roller system, the charging base would be plugged in (or already plugged in), turned on, and the eye pad heated up to the right temperature. The indictor light can turn from red to green on the charging base, indicating that the desired temperature has been reached in the eye pad. The eye pad can then be applied on a closed eye for, say, two to three minutes, then removed from the eye, and placed back in the well to reheat it for the second eye. Alternatively, the eye pad could remain on the eyelid during treatment. 
     The roller can then be removed from the charging well, the indicator light on the handle having turned from red to green to indicate that the roller cylinder is in the proper temperature range. The user can then hold the handle firmly by hand, while in front of a mirror, and place the roller cylinder at the base of the lower eyelid and gently press on the eyelid and roll up towards the lashes. This motion can be repeated two to three times at each section of the lower eyelid until the user has covered the whole eyelid. The roller can then be applied to the upper eyelid, repeating the same steps as on the lower eyelid, except with a downward motion from the top of the upper eyelid towards the lashes. (The lower and upper eyelids can be done in either order.) The process is then repeated for the second eye. The user can then wash away the extruded meibomian gland debris with the presoaked sweeping applicators and wash the face with lukewarm water. 
       FIG.  8    is a flowchart illustrating an example use of the meibomian gland roller. At  101 , a gel eye pad is heated, applied to the user&#39;s eyelid at  103 , and then removed at  105 . At  109 , the cylinder of the roller is used to apply pressure to the user&#39;s eyelid, having previously been heated at  107 . The user can then roll the cylinder across the user&#39;s eyelid at  111  to express the meibomian glands of the eyelid. At  113 , the extruded meibomian gland debris is washed away with the sweeping applicators. 
     In an alternate set of embodiments, the heated roller can interface with a smartphone or similar device for power, communication, or both. For example, a smartphone application might be used to control and/or monitor its use and the frequency of use. Additionally, in some embodiments the handle could be connected to the smartphone to receive power. 
     The apparatus and techniques described above allow for the long term, regular maintenance of meibomian gland function by users themselves. Under previous arrangements, maintenance would involve going to a professional eye care practice for a patient to go through expensive meibomian gland drainage procedures. In between these procedures, which can be expensive, patients would rely upon maintenance procedures that can lack ease of use and that are of uncertain effectivity. In contrast, the procedures presented here are designed for ease of usage and effectiveness, allowing for a regular maintenance of the glands for an effective treatment regime. 
     Conjunctive language, such as phrases of the form “at least one of A, B, and C,” or “at least one of A, B and C,” unless specifically stated otherwise or otherwise clearly contradicted by context, is otherwise understood with the context as used in general to present that an item, term, etc., may be either A or B or C, or any nonempty subset of the set of A and B and C. For instance, in the illustrative example of a set having three members, the conjunctive phrases “at least one of A, B, and C” and “at least one of A, B and C” refer to any of the following sets: {A}, {B}, {C}, {A, B}, {A, C}, {B, C}, {A, B, C}. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of A, at least one of B and at least one of C each to be present. 
     The use of examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate embodiments of the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention. In the foregoing specification, embodiments of the invention have been described with reference to numerous specific details that may vary from implementation to implementation. The sole and exclusive indicator of the scope of the invention, and what is intended by the applicants to be the scope of the invention, is the literal and equivalent scope of the set of claims that issue from this application, in the specific form in which such claims issue, including any subsequent correction. Further embodiments can be envisioned to one of ordinary skill in the art after reading this disclosure. In other embodiments, combinations or sub-combinations of the above-disclosed invention can be advantageously made. The example arrangements of components are shown for purposes of illustration and combinations, additions, re-arrangements, and the like are contemplated in alternative embodiments of the present invention. Thus, while the invention has been described with respect to exemplary embodiments, one skilled in the art will recognize that numerous modifications are possible. 
     For example, the processes described herein may be implemented using hardware components, software components, and/or any combination thereof. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense. It will, however, be evident that various modifications and changes may be made thereunto without departing from the broader spirit and scope of the invention as set forth in the claims and that the invention is intended to cover all modifications and equivalents within the scope of the following claims.