Patent Publication Number: US-2021186771-A1

Title: Eye treatment device and a method of using said device

Description:
This application is a 371 filing of International Patent Application PCT/DK2019/050137 filed May 3, 2019, which claims priority to PA 2018 70271 filed May 4, 2018. 
    
    
     TECHNICAL FIELD 
     The present invention relates to an eye treatment device arranged for treatment of an eye disease. 
     BACKGROUND 
     Humans may be exposed to various eye diseases, and sometimes to diseases in the eyelid region. Such diseases can, for example, be inflammation of the eyelid, eyelid infections, meibomian gland dysfunction, blepharitis, and dry eye syndrome, which among others may cause red eyes, that the skin of eyelids shells, and that debris, crusts and/or cysts are formed at the base of the eyelids. This will in turn make the eyes feel sore, burning and/or irritated, impairing the patient&#39;s vision. 
     Meibomian gland dysfunction is traditionally treated with wet compresses and lid hygiene for treating the obstructed meibomian gland, as well as with antibiotics and anti-inflammatory agents. However, such treatments are complicated and unpleasant for the patient, making it difficult to obtain the complete relief of symptoms. 
     In a similar manner the conventional treatment for blepharitis will often consist of a medical treatment combined with hygienic treatment for regular removal of debris that have accumulated along the base of the eyelashes. It is important that the accumulated debris or be removed at regular intervals, otherwise such eye disease may worsen. Such hygienic treatment often takes place by the person first softens the debris, and then in a second step mechanically removes the debris, by scrubbing the eyelashes. The softening process step may be done by applying a cloth or pad with an appropriate liquid absorbed in it to the eyelash region. Thereafter the soften debris can be removed by scrubbing with a cotton swab, a fingertip or a pad over the eye. Removal of this debris is critical to both healing the eye and preventing a resurgence of the disorder. Without proper, regular removal of accumulated debris, such ocular disorders regularly worsen despite periodic treatments. 
     However, this approach is for various reasons not optimal and therefore new ways to carry out the hygiene treatment have been proposed. Thus, in WO 2014/018651, a method and a device for treating an eye disease are suggested. Said device comprises a rotating swab connected to an electromechanical device that mechanically can remove debris from the base of the eye lashes. The disadvantage of this known device is that it only gives a solution to the second treatment step of mechanically removing the debris from the eyelid, and in order to achieve this the device have to have a very high rotational speed (e.g. above 300 rpm), and the known device therefore have to be operated at trained professionals only. Furthermore, such device cannot be used for massaging the meibomian glands. 
     SUMMARY OF THE INVENTION 
     It is therefore a first aspect of the present invention to provided a device for treatment of an eye disease, in which the two process steps of softening and scrubbing the debris, crusts and/or cysts may be done in a single process step. 
     In a further aspect is provided an eye treatment device according to the invention that can be used for massaging the meibomian glands. 
     In a further aspect is provided an eye treatment device according to the invention, by which the time consumption for treatment of the eye is reduced. 
     In a further aspect is provided an eye treatment device according to the invention, which is inexpensive to manufacture. 
     In a further aspect is provide an eye treatment device according to the invention, which is simple and easy to use, and which is suitable for home-treatment. 
     The novel and unique whereby these and other aspects are achieved according to the present invention by providing an eye treatment device arranged for removing debris from an eyelid margin, said device comprises a swab operatively connected to a housing that accommodates a drive unit, said drive unit being arranged for moving the swab relative to said housing, and wherein said device comprises heating means arranged for heating the swab. 
     The eye treatment device ensures that when a person places the heated swab at the eyelid region in contact with the debris whereby the debris will be heated and accordingly softened. As the swab is arranged to move relatively to the housing e.g. in a rotating, vibrating and/or reciprocating movement, the debris will be mechanically removed in the same process step as the softening of the debris. This means that the user in a single operation e.g. by moving the eye treatment device along or at the margin/base of the eyelid, effectively can cleanse the margin of the eyelid and the base of the eyelashes and/or massage the meibomian glands thereby mechanically open and dilate the natural orifices and ducts of the meibomian glands to remove abnormal meibum secretions. Thus, the device according to the invention may remove debris and/or massage the meibomian glands and/or provide another kind of treatment much easier, faster and in a more secure manner than using e.g. the known devices and methods. Furthermore, the time consumption for treatment of the eye is reduced, thereby providing an eye treatment device which can be used for regular, effective and hygienic home treatment. 
     The inventor of the present inventing has found that when eye treatment device is arranged for heating the swab to a predefined temperature between 33° C. and 45° C., and especially advantageously embodiment is provided, in which the debris is softened to a desired degree during use but without risking that the user becomes burned. The optimal temperature depends on the desired use of the eye treatment device, but is preferably between 40° C.-43° C. However, if the eye treatment device e.g. is used for treating meibomian gland disease, the predefined temperature may alternatively be about 34° C., as said temperature has proven highly efficient in the treatment of said disease. 
     The eye treatment device preferably comprises temperature controlling means arranged to heat the temperature of the swab to the predefined temperature and/or maintain the swab at said temperature. Said heat controlling means may e.g. be a thermostat which will turn the heat on/off depending on the temperature of the swab; one of more temperature sensors; control units etc. This will also ensure that the temperature will not increase beyond an upper temperature limit, i.e. said controlling means will function as a safety switch. Such temperatures controlling means are will known in the art, and any relevant means may be included in the eye treatment device according to the invention as long as it is capable of providing and maintaining the predetermined temperature of the swab. 
     In a preferred embodiment the temperatures controlling means further comprises a temperature adjustment means arranged for individually adjusting the temperature of the swab, e.g. such that the user can increase or reduce said temperature if desired. Such temperature adjustment means may be any conventional means which ensures that the user e.g. can choose between a number of preset temperatures, such as 34° C., 37° C., 39° C. and 41° C., and/or that the user can select any desired temperature between an upper and a lower preset temperature. Irrespectively of how the heat controlling means and/or temperature adjustment means is arranged, it is preferred that the temperature of the swab cannot exceed a temperature above 45° C. and/or be lowered below 33° C., thereby ensuring e.g. that the debris is softened to a desired degree without risking that the user is burned. 
     The eye treatment device may in a preferred embodiment comprise indication means, which e.g. visually and/or aurally indicates if and when the predetermined temperature has been reached, and/or if further heating is required during operation. It is however preferred that the heat controlling means is arranged for automatically ensuring that the temperature is maintained at the selected temperature during use. 
     In one embodiment the eye treatment device further comprises an ultrasonic means, i.e. a means arranged for generating vibrations at ultrasonic frequencies e.g. from 10-40 kHz. The generated vibrations will then aid in removing the debris from the margin of the eye lid and/or massage the meibomian glands when the swab is moved along the margin/base of the eyelid. In a preferred embodiment the ultrasound is arranged for agitating a fluid which e.g. has been applied to the margin of the eye lid, thereby increasing the efficiency of the ultrasonic means. 
     The swab may in one embodiment be directly coupled to the housing, however in order to ensure that the eye treatment device can be operated without e.g. the housing abutting the chin, the swab may be coupled to the housing by means of an extension member. Said extension member may in a preferred embodiment be releasably coupled to the housing, such that the user can select an extension member having a desired length. 
     In one embodiment the swab constitutes a part that is inseparable from the extension member, which means that the both parts must be replaced when the swab is worn or too dirty to be used. This is a relatively expensive solution. Therefore, the extension member is preferably arranged such that the swab can be releasably and securely attached to the extension member. This provides a simple and very cheap solution because only a very small and cheap part needs to be replaced, when the swab is e.g. used once. 
     If the extension member is a substantially rigid rod, a swab e.g. made of sponge material can easily be held in place by frictional forces. However, the swab may e.g. comprise a first connector arranged for being releasable coupled to a second connector. Preferably both the first and second connector have a mainly cylindrical shape adapted to provide a tight fit when the second connector extend at least partly into the first connector. Such a configuration will ensure that the swab easily can be replaced after use, and that a new swab easily can be applied to the rigid rod without having to concentrate about a specific orientation of the swab. However, other configurations are also contemplated within the scope of the present invention, e.g. an embodiment, in which a swab of a spongy body simply is pressed onto the extension member. 
     In order to heat the swab, the eye treatment device according to the invention may comprises at least one heating means arranged for heating the swab to the predefined temperature. 
     The heating means may be constituted by any suitable means that can ensure that the swab is heated. In one embodiment, the heating means may be arranged immediately at the swab and be provided with electrical power through power lines drawn in the rigid rod, which in such an embodiment should be provided with a channel for accommodating the power lines. However, in an embodiment of the present invention the heating means may be arranged inside the housing and the rigid rod is made of heat conductive material. In this way, the heating means is very well protected from being destroyed and the heat from the heating means is led to the swab via the rigid rod. 
     The heating means may be constituted of any suitable means, however in an embodiment of the present invention the heating means may comprise electrical heating means and an electrical source for supplying electricity to the electrical heating means. This provides a safe and reliable device for heating the swab, which ensures a uniform heating of the swab. 
     The rigid rod may be heated in different ways, either directly or indirectly, mechanically by friction or electrically. Thus, in one embodiment of the eye treatment device according to the invention the rigid rod may be an electrical resistance heating element, which is connected directly to the electrical source, preferably by means of sliding contacts that allows the rigid rod to be rotated, vibrated and/or reciprocated. In this way, a very good and uniform heating of the rigid rod can be achieved every time the device is used. 
     In another embodiment the heating means may comprise a heating element which surrounds part of the rigid rod. This provides a cheaper solution where the swab and also the rigid rod may be replaced relatively cheaply. This will be an advantage in cases where the also the extension member can be replaced e.g. due to malfunction, damage or because it becomes worn to be used again. 
     The heating means may comprise a switch to turn on and off the heating means. The switch may be controlled by a motion sensor, however, in an embodiment of the present invention the switch may be controlled manually by operating an on/off-button placed on the housing. In this way, it is ensured that the heating means is not turned on or off inadvertently. 
     The drive unit for moving the swab relative to the drive unit, i.e. rotating, vibrating and/or reciprocating the swab, may comprise any suitable means arranged for moving the swab. In a preferred embodiment the apparatus is arranged for moving, e.g. rotating the extension member, and thereby the swab. However, the swab may also be rotated independently of the extension member. Accordingly, the drive unit may comprise a mechanical arrangement, such as a spring device which is tighten each time the eye treatment device is to be used. However, in an embodiment of the present invention the drive unit for moving the extension member and/or swab relative to the drive unit may comprise an electrical motor and an electrical source for supplying electricity to the electrical motor. This provides a reliable solution that is immediately ready for use. 
     The extension member may be connected to the electrical motor of the drive unit via any appropriate means, such as a gearing. However, in an embodiment of the present invention the extension member may be connected directly to the electrical motor of the drive unit via a shaft. In this way, a good and reliable drive system for moving the swab relative to the drive unit, i.e. rotating, vibrating and/or reciprocating the swab is obtained. 
     Because the person using the eye treatment device to remove debris and various crusts from the eyelash or the eyelid typically will move the swab back and forth alone the margin of the eyelid and the base of the eyelashes, and it is preferred that the swab is able to be rotated in both directions. Accordingly, in an embodiment of the present invention the electrical motor of the drive unit may be rotatable in both directions. Hereby, the swab, regardless of the direction it is moved, may always be rotated in a direction that ensures that debris, crusts and/or cysts and the like are pushed forward in front of the swab. 
     It is furthermore preferred that the swab has a size/dimension which ensures that it easily can be moved along the margin/base of the eyelid without causing damage to the eyeball. It is furthermore preferred that said size/dimension is selected such that if the user is using the eye treatment device for self treatment, said swab will not block the users vision during use. It is accordingly preferred that the swab is relatively small with a substantially tubular shape preferably with a rounded end. Said tubular swab may have a diameter in the area between 0.2 cm and 1.0 cm, and preferably around 0.5 cm. The length of the swab may e.g. be between 0.5 and 2.0 cm. 
     The electrical source for supplying electricity to the drive unit and/or to the electrical heating means may be the power grid or a battery or both. In an embodiment of the present invention the electrical source is a battery, because the eye treatment device can thus be used independently of the access to the power grid. The battery is preferably a rechargeable battery, which may be recharged by means of the power grid, e.g. by means of power outlet, a UBS-port or the like. In this way, the battery may be charged when there is access to the power grid and otherwise the device may be used independently. 
     The drive unit comprises a switch to turn on and off the drive unit. The switch may like the switch for turning on and off the heating means be controlled by a motion sensor, however, in an embodiment of the present invention the switch may be controlled manually by operating a button. 
     It is the treatment member of the swab that is in contact with the eyelash or eyelid during the treatment of the eye, however if the swab unintentionally comes into contact with the eye ball, the swab may in a preferred embodiment be made of a cotton wadding or sponge material ensuring that this will not feel uncomfortable for a person using the eye treatment device. By sponge material is meant a material that is soft, porous and resilient. Hereby is obtained that the swab can be used without major discomfort for the person utilizing the eye treatment device and that tear liquid as well as debris, crusts and/or cysts are absorbed by the treatment member. 
     Additionally, a swab made e.g. of a sponge material will also be able to absorb a treatment liquid that can be used to either soften the debris and/or for providing a medical treatment. In this way, an eye disease can be treated more efficiently. Any liquid solution capable of disinfecting and/or loosening the debris to help removal of the debris may be used. A suitable treatment liquid may e.g. be physiological saline and/or a pharmaceutical composition aiming at treating the specific eye condition. 
     It is preferred that the swab has a substantial ball or cone shape, as this ensures that the eye treatment device can be controlled very accurately along the margin of the eyelid and/or the base of the eyelashes, e.g. effectively massaging the meibomian glands, i.e. the change of unintentionally touching the eye bail is reduced. 
     In order to ensure that the eye ball is not damaged if the swab unintentionally touches said eye ball during use of the eye treatment device according to the invention, it is preferred that the swab is rotated at a relatively low speed, e.g. between 50 and 150 rpm, preferably between 100 and 110 rpm. This will also ensure that the eye treatment device is suitable for home treatment, as the low rotational speed will reduce the user&#39;s anxiety to place an object close to the eye, and will accordingly increase the user&#39;s ability to specifically target debris deposits. In a preferred embodiment the eye treatment device comprises rotation control means arranged for allowing adjustment of the rotational speed during use, e.g. such that the user can increase or reduce said speed if desired. Such rotation control means may be any suitable means arranged such that the user can select between a number of preset rotational speed values, e.g. 50 rpm, 100 rpm and 150 rpm, or individually select any rotational speed between an upper and a lower pre-selected speed limit. Irrespectively of how the rotation control means is arranged, it is preferred that the swab is rotated at the relatively low speed as defined above, such that if the swab unintentionally touches the eye ball during use, said swab will not damage the eye ball. 
     The present invention also relates to a method of using the eye treatment device according to the invention, this method comprises,
         providing an eye treatment device according to the invention,   heating the swab to a temperature between 33° C. and 45° C., e.g. about 34° C. or between 40° C.-43° C.,   rotating the swab, and   move said along the margin of the eyelid and/or the base of the eyelashes.       

     In a preferred embodiment of said method, the swab is placed in contact with a treatment liquid such that said swab absorbs at least some of said liquid. 
     The eye treatment device according to the invention not only has a simple and inexpensive construction, but also has a simple and user-friendly design, making it extremely easy to operate with a single hand ensuring that the eye treatment device can be unassisted used at home. 
     The invention will be explained in greater detail below, describing only exemplary embodiments of the eye treatment device with reference to the drawing, in which 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWING FIGURES 
         FIG. 1  is a perspective top view of an eye treatment device according to the invention, 
         FIG. 2  is a side view of the eye treatment device in  FIG. 1 , 
         FIG. 3  is a schematic side view of the eye treatment device with one side of the housing removed, and 
         FIG. 4  is a drawing of the eye treatment device of  FIG. 1  treating a lower eyelid of an eye. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     In  FIGS. 1 and 2  is shown an eye treatment device  1  cleaning of eyelashes and eyelid margins in the treatment of an eye disease. The eye treatment device  1  comprises at its proximal end  2   a,  a swab  3  and a substantially rigid rod  4 . Further, the eye treatment device  1  comprises a housing  5 , which is formed to act as a handle. The housing  5  accommodates essential parts of the eye treatment device, as it will be described in further details with reference to  FIG. 3 . Further, the housing  5  comprises a lid  6  at a distal end  2   b.  The lid  6  opens into a battery section  8  in order to exchange the batteries. Further, the eye treatment device comprises a manually operated switch button  7  with which the eye treatment device may be turned on and off. 
     The eye treatment device  1  has a size which means that it fits well in the hand of the person performing the treatment of the eye. 
       FIG. 3  schematically shows the inside of the housing  5 . Thus, the eye treatment device  1  is shown to comprise the battery section  8 , to which access is achieved via the lid  6 . The batteries used are preferable rechargeable batteries. The eye treatment device  1  accommodates two rechargeable batteries of type AAA, However, the eye treatment device  1  may also be arranged for being connected to a charging station. 
     Further, the eye treatment device  1  comprises a drive unit  9  in form of an electrical motor  9  for rotating the swab  3 , and heating means  10  for heating the swab  3 . The rigid rod  4  of the swab  2  is connected to the electrical motor  9  via a shaft  11  and is thereby rotatable by the electrical motor  9 . Furthermore, the rigid rod  4  of the swab  2  is mounted and journalled in a bearing  17  arranged close to the end of the housing  5  comprising the swab  2 . The eye treatment device  1  may also include means for vibrating and/or reciprocating the swab  2 , however such means is not shown in  FIG. 3 . 
     The rigid rod  4  is made of any heat conductive material, such as any metal as iron or steel. The heating means  10  comprises an electrical heating element and a temperature controlling means arranged to heat the temperature of the rigid rod  4  and the swab  3  to the predefined temperature of e.g. between 40 to 43° C. and maintain the swab at said temperature. 
     In an alternative not shown embodiment, the rigid rod  4  of the swab  2  may be an electrical resistance heating element. Because the rigid rod  4  is to be rotated, the electrical contacts that supply the rigid rod  4  in such an embodiment must be formed by suitable slide contacts. 
     In the shown embodiment the switch button  7  is adapted to turn on and off both the electrical motor  9  and the heating means  10 . In alternative embodiments the electrical motor  9  and the heating means  10  are turned on and off by means of separate switches, hence making it possible to use the eye treatment device with only one of these turned on. 
     In the same way the electrical source for both the electrical motor  9  and the heating means  10  is the batteries in battery section  8 . 
     The switch button  7  is arranged in such a way that the electrical motor  9  may be rotated in both rotational directions. 
     As shown in  FIGS. 1 to 3  the treatment member  3  consists of a cone of sponge. In the shown embodiment the treatment member  3  of the swab  4  is replaceable as the treatment member  3  quite simple may be twisted on and off the rigid rod  4 . Hereby it is easy and also cheap to replace the treatment member  3 , when it is worn or too dirty to be used. 
     The treatment member  3  of the swab  2  is selected to consist of a cone of sponge in order to be able to absorb a treatment liquid that may be applied to the swab prior to use. In this way, the eye disease can be treated more efficiently and the person with eye disease can be cured faster. 
     In  FIG. 4  is shown how the eye treatment device  1  according to the invention is used for treating a lower eyelid  12  of an eye  13  for an eye disease. The user activates the eye treatment device by pressing the button  7 , whereby the swab is heated and begins to rotate. When the swab is heated to the predetermined temperature of e.g. between 40 to 43° C., in a short heating period of e.g. 30 second, the user can easily move or slide the eye treatment device  1  from one side of the eye  13  to the other side in such a way the swab  3  slides over the lower eyelid  12  while simultaneously rotating and heating up and pushing away debris and various crusts from the eyelid  12 . In this way the debris are heated to and thus softened, and as the swab simultaneously rotates the debris are removed in the same process step. If electrical motor  9  is rotating at a speed of about 108 rpm, which means that the swab  2  is rotating at the same speed. 
     The eye  13  also comprises an upper eyelid  14  and a plurality of eyelashes  15 , which parts of the eye may be treated in the same way as the lower eyelid  12 . 
     By adding a disinfecting liquid, such as a saline solution, to the treatment member  3 , the softening and loosening process of the debris, crusts and/or cysts etc. is facilitated. This as due to the heating of the swab  2 , the disinfecting liquid is also heated, which greatly promotes the softening and loosening process of the debris, crusts and/or cysts and thus also the cleaning process of the eye  13 . 
     The eye also comprises an eyeball  16 , which should not be touched during the treatment of the eye because it will feel uncomfortable to the person with eye disease. Because the treatment member  3  consists of a cone, it is easy to avoid that the treatment member  3  comes into contact with the eyeball  16 . 
     In this way, by using the eye treatment device according to the invention two process steps of softening and scrubbing the debris, crusts and/or cysts may be done in a single process step. 
     The device according to the invention has a simple and inexpensive design, and can therefore be used equally well for both privately and in medical or hospital facilities where the known eye treatment devices are too troublesome and complicated to use. The device may be used for treating various eye diseases e.g. meibomian gland dysfunction, blepharitis, and dry eye syndrome, however, the device may be equally well used for a simple hygienic treatment of the eye-regions. 
     Modifications and combinations of the above principles and designs are foreseen within the scope of the present invention.