Abstract:
A method and apparatus for treating ocular disorders such as blepharitis, meibomitis, and dry eye syndrome. The method includes using an electromechanical device to move a swab relative to the eye to create cyclical movement that impacts debris present at the eyelid margin and effectively removes the debris from the eye to encourage healing and prevent further digression of the health of the eye. The apparatus is an electromechanical device that includes a mechanical drive unit operatively connected to a swab to create a precise relative movement of the swab to the eye to remove debris present therein.

Description:
TECHNICAL FIELD 
       [0001]    The present invention relates generally to a method and apparatus for treating an ocular disorder, and more particularly, to treating eyelid margin disease. 
       BACKGROUND 
       [0002]    Ocular disorders such as those relating to eyelid margin disease are particularly common pathological conditions of the ocular adenexa. By way of example, these disorders include blepharitis, meibomitis, and dry eye syndrome. Despite advances in ophthamology and medical treatments in general, the recommended treatments for these exemplary common ocular disorders has remained essentially unchanged for decades. 
         [0003]    Historically, treatment of eyelid margin disease begins and ends with the patient. The patient first begins to notice symptoms including eyelid redness, flaking of skin on the eyelids, crusting and/or cysts at the eyelid margins, and a gritty sensation of the eye culminating in irritation, burning, and reduced vision. Should these symptoms remain unchanged or worsen, the patient routinely seeks the advice of an eye specialist, such as an ophthalmologist. After carefully considering the patients&#39; medical history and investigating various possible causes, the specialist may prescribe a hygienic home treatment procedure for the patient to perform regularly in conjunction with antibiotics and/or topical steroids until the disease subsides. 
         [0004]    The goal of the hygienic home treatment procedure is to remove debris, oil, and scurf that have collected along the eyelid margin during progression of the disorder. 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. 
         [0005]    Hygienic home treatment of such ocular disorders is generally a two-step process. First, the patient softens the debris and scurf by applying a warm compress, diluted baby shampoo, or a specialized liquid solution to the eyelid margin. This first step is intended to prepare the debris for removal while preventing further irritation to the eye. Second, the patient attempts to remove the debris by physically scrubbing the eyelid margin, the base of the eyelashes, and the pores of the meibomian glands. This scrubbing is routinely attempted with either a generic cotton swab, a fingertip, or a scrub pad placed over the fingertip and applied against the eye. By cleaning debris and scurf free from the base of the eyelashes and unclogging the pores of the meibomian glands, the patient may improve the overall health of the eyelid margin; thereby reducing irritation, burning, and other symptoms related to the disorder. 
         [0006]    Unfortunately for many patients, such hygienic home treatment is met with limited success due to the practical difficulties of cleaning one&#39;s own eye with an imprecise instrument such as a fingertip or cotton swab. For instance, many patients do not have the necessary dexterity to manipulate their fingertip or a cotton swab along the eyelid margin. Moreover, a shake, tremor, or poor near vision further complicate such self-treatment. Even for those capable of incorporating hygienic home treatment into their daily routine, many, if not most people, are wary of placing objects near their eyes to actively scrub along the eyelid margin. Given this anxiety, discomfort, and the inability to specifically target debris deposits, patients routinely fail to totally cleanse the margin of the eyelid, the base of the eyelashes, and the meibomian glands. While the attempted treatment may temporarily abate the patient&#39;s symptoms, subtle continuation of the disease often persists; thus permitting a low-grade inflammation to develop and, ultimately lead to chronic dry eye syndrome. Further, this treatment is typically required to be performed for the rest of the patient&#39;s life; thereby, creating a substantial hurdle to regular and effective compliance during hygienic home treatment. 
         [0007]    Evidence suggests that medical costs associated with dry eye syndrome, often induced by ocular diseases such as blepharitis, are currently over 68 billion dollars each year. Many of these expenses are needlessly incurred due to the patients&#39; failure to perform regular and effective treatments resulting in increased doctor visits, medications, and artificial tears. These expenses create a significant financial burden for insurance carriers, especially Medicare, which provides primary medical coverage for many individuals particularly prone to dry eye disease, such as the elderly. 
         [0008]    There is a need for a method and apparatus for use in treating ocular disorders, such eyelid margin diseases, that addresses present challenges and characteristics such as those discussed above. 
       SUMMARY 
       [0009]    One exemplary embodiment of the method according to this invention comprises using a swab operably connected to an electromechanical device to treat an ocular disorder. The disorders to be treated via this method result in a build-up of a removable debris on the eye. The swab, which moves relative to the electromechanical device, contacts the portion of the eye that includes the removable debris. Thereby, the swab impacts the debris to remove the debris from the eye. Removing the debris further includes at least one of breaking the debris free of the eyelid margin, scrubbing the eyelid margin, exfoliating the eyelid margin, buffing the eyelid margin, or un-roofing the meibomian gland. 
         [0010]    In one aspect, the swab is positioned near the eyeball along the eyelid margin to target the debris with the swab. The eyelid margin is accessed with the swab without the aid of a magnification device and without lifting the eyelid margin. 
         [0011]    In another aspect, effecting movement of the swab relative to the electromechanical device includes at least one of rotating, vibrating, or reciprocating the swab. Furthermore, the movement of the swab may be set to a desirable speed. 
         [0012]    Treating the eye for the ocular disorder may include repeating the effecting movement, the contacting the portion of the eye, and impacting the debris with the swab to remove the debris after periodic intervals until the ocular disorder is sufficiently remedied. 
         [0013]    In another exemplary embodiment, a device for the removal of debris from the eye during the treatment of the ocular disorder comprises a swab having a tip portion and a base portion. The tip portion is of a sufficient size to access debris on the eye. The device also includes a rigid member and a mechanical drive unit. As such, the rigid member and the swab extend from an instrument. The rigid member has a distal end portion and a proximal end portion such that the distal end portion is affixed to the base portion of the swab and the proximal end portion is secured to the mechanical drive unit, which also includes a body. The mechanical drive unit operably moves the swab relative to the body facilitating removal of the debris from on the eye. 
         [0014]    In one aspect, the swab is a generally egg-shaped sponge having an approximate length of two millimeters and a width of one millimeter. Affixed to the sponge, the rigid member is a plastic material that is formed onto the distal end portion of the rigid member. 
         [0015]    In yet another aspect, the mechanical drive unit includes an electric motor, a chuck, and a control switch. The chuck projects from the body of the mechanical drive unit and is operably connected to the electric motor. Also, the control switch is operably coupled to the electric motor. With respect to the rigid member, the proximal end portion of the rigid member is removably secured to the chuck. In addition, the device is handheld and includes an electric power source operably coupled to the mechanical drive unit, the electric power source being a battery. 
         [0016]    Various additional objectives, advantages, and features of the invention will be appreciated from a review of the following detailed description of the illustrative embodiments taken in conjunction with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]    The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with a general description of the invention given above, and the detailed description given below serve to explain the invention. 
           [0018]      FIG. 1  is a perspective drawing of one embodiment of the device. 
           [0019]      FIG. 2A  is a drawing of the device of  FIG. 1  treating a lower eyelid margin of an eye. 
           [0020]      FIG. 2B  is a drawing of the device of  FIG. 1  treating a upper eyelid margin of an eye. 
       
    
    
     DETAILED DESCRIPTION 
       [0021]    With reference to  FIG. 1 , an embodiment of the device  10  for treating an ocular disorder, particularly with respect to eyelid margin diseases, includes a mechanical drive unit  12  which operably moves a swab  14  to facilitate removal of debris from an eye  15  (see  FIGS. 2A-2B ). The swab  14  is connected to a rigid member  16  having both a distal end portion  18  and a proximal end portion  20 . The swab  14  is affixed to the distal end portion  18  of the rigid member  16  to create an instrument  22 , which may be secured to the mechanical drive unit  12 . As shown in  FIG. 1 , the proximal end portion  20  is removably secured to the mechanical drive unit  12  in order to transmit motion from the mechanical drive unit  12 , through the rigid member  16 , and to the swab  14 . It will be appreciated that any known method may be used to removably secure the instrument  22  to the mechanical drive unit  12 . Moreover, it will also be appreciated that device  10  is not intended to be limited to the instrument  22  being removably secured to the mechanical drive unit  12 . For instance, in another embodiment, the rigid member  16  may be either permanently secured or removably secured to either one of the swab  14  and/or the mechanical drive unit  12 . 
         [0022]    In one aspect of the instrument  22 , the swab  14  includes a tip portion  24  and a base portion  26 . While the swab  14  may be of a size sufficient to access debris on the eye  15  as shown in  FIGS. 1-2B , at least the tip portion  24  is of a size sufficient to access debris on the eye  15 . For instance, the swab  14  has an approximate length between 1.0-3.0 millimeters and an approximate width of between 0.5-1.5 millimeters. More particularly, the swab  14  has an approximate length of 2 millimeters and an approximate width of 1 millimeter. It will be appreciated that the swab  14  may be manufactured of any material suitable for contacting the eye  15  without harming the eye  15 . However, as shown in the embodiment of  FIG. 1 , the swab  14  is a sponge. As described herein, “sponge” broadly refers to any material that is soft, porous, and resilient. Particularly, the swab  14  is a medical grade sponge or a surgical grade sponge capable of removing debris from on the eye  15  without harming the eye  15 . As shown in the exemplary embodiment of  FIGS. 1-2B , the swab  14  is a methyl cellulose sponge. It will be appreciated; however, that similar materials capable of removing debris from on the eye  15  without harming the eye  15  are readily apparent and may also be used. 
         [0023]    In another aspect of the instrument  22 , the rigid member  16  is a plastic, cylindrical shaft including a central axis  27 . The shaft extends along the central axis  27  between the mechanical drive unit  12  and the swab  14 . The rigid member  16  is sufficiently rigid to effectively transmit motion from the mechanical drive unit  12  to the swab  14 . As shown in  FIG. 1 , the swab  14  is permanently affixed to the distal end portion  18  by forming the base portion  26  to the rigid member  16  during manufacturing. However, it will be appreciated that any known method of affixing the swab  14  to the rigid member  16  may be used. In an exemplary embodiment, any material or shaft shape may be used so long as the rigid member  16  is rigid enough to transmit sufficient motion from the mechanical drive unit  12  to the swab  14  in order to remove debris from on the eye  15 . 
         [0024]    Furthermore, the mechanical drive unit  12  includes a body  28 , an electric motor  30 , a chuck  32 , and a control switch  34 . As such, the device  10  is electromechanical in nature. In an exemplary embodiment, the electric motor  30 , the chuck  32 , and the control switch  34  are integrated into the body  28  so that the electromechanical device  10  is configured to be handheld as shown in  FIG. 1 . However, the electromechanical device  10  is not intended to be limited to a handheld configuration, and it will be appreciated that other configurations of the device  10  are readily apparent. 
         [0025]    According to the present embodiment, the electric motor  30  is positioned within the body  28 . The chuck  32  is operably connected to the electric motor  30  at a forward end portion  36  of the body  28 . The proximal end portion  20  of the rigid member  16  is removably secured to the chuck  32 . As described herein, the chuck  32  is generally any element capable of removably securing the rigid member  16  to the mechanical drive unit  12 . As such, the chuck  32  may be tightened or loosened to respectively secure or remove the instrument  22  to the chuck  32 . Thereby, the operable connection of the electric motor  30  transmits a movement  38  through the chuck  32  to the instrument  22 . The movement  38  is any motion relative to the mechanical drive unit  12  or, more particularly, to the body  28 , that creates relative motion to the debris on the eye  15  such that upon contacting the debris with the swab  14 , the debris is removed. As shown, the movement  38  may include, but is not limited to, a reciprocating movement  38   a,  a rotating movement  38   b,  or a vibrating movement  38   c.  The reciprocating movement  38   a  may be either along the central axis  27  of the rigid member  16  or orthogonal to the central axis  27  of the rigid member  16 . In addition, the speed of the movement  28  of the swab  14  is any speed sufficient to remove debris from on the eye  15 . It will be appreciated that the speed discussed herein collectively refers to both relative speed of the swab  14  and the frequency of the movement  38  of the swab  14 . For instance, the frequency may range from sonic frequencies to ultrasonic frequencies. Furthermore, the speed of the swab  14  may be variable or otherwise selectable such that an operator of the device  10  may select a desirable speed or a forward or reverse direction via the control switch  34 . 
         [0026]    Moreover, the control switch  34  is operably connected to the electric motor  30  and an electric power source  42  to power the device  10  on and off. In an exemplary embodiment, the electric power source  42  is a battery power source  42  contained within the body  28 . The battery power source  42  may be either disposable or rechargeable. The electric power source  42  operably provides electrical power to the electric motor  30 , which the operator controls via the control switch  34 . It will be appreciated that any known control switch  34  or plurality of control switches  34  may be configured to power the device  10  on and off. 
         [0027]    Furthermore, it will be appreciated that the device  10  may be manufactured from various materials suited to specific environments of use. For instance, operators within the professional clinic setting may desire a durable, reusable mechanical drive unit  12  and single-use instruments  22 . Some examples of such a professional mechanical drive unit  12  is an Algerbrush I, an Algerbrush II, or similar medical device. However, operators within the home treatment setting may desire the device  10  to be generally disposable and single-use. 
         [0028]    With respect to  FIGS. 2A and 2B , the device  10  is used in a method for treating ocular disorders of the eye  15 . For purposes of describing the environment in which this method occurs,  FIGS. 2A and 2B  generally show a portion of a face  50  having a nose  52 , an eyebrow  54 , and the eye  15 . The eye  15  described herein generally includes, but is not limited to, an eyeball  56  including a cornea  58 , an upper eyelid margin  60 , a lower eyelid margin  62 , and a plurality of eyelashes  64 . In the exemplary embodiment, the device  10  is the swab  14  operably connected to the mechanical drive unit  12  thereby creating the electromechanical device  10  for use in removing debris deposited on at least one of either the upper eyelid margin  60  or the lower eyelid margin  62 . 
         [0029]    As shown in  FIG. 1 , the electromechanical device  10  is powered on and may be set to a desirable speed by the operator; thereby, the operator effects movement of the swab  14  relative to the electromechanical device  10 . Such movement may include, but is not limited to, reciprocating the swab  14  as shown by arrows  38   a,  rotating the swab  14  as shown by arrow  38   b,  and/or vibrating the swab  14  as shown by lines  38   c.  The swab  14  is positioned near the eyeball  56  and along either one of the upper or lower eyelid margins  60 ,  62  for treatment. In the exemplary embodiment as shown in  FIGS. 2A and 2B , the swab  14  moves with constant movement relative to the electromechanical device  10  while near the eyeball  56 . Alternatively, it may be desirable to vary the movement of the swab  14  relative to the electromechanical device  10  such that the operator has greater control of treating the ocular disorder. 
         [0030]    In an exemplary embodiment, the operator preferably targets the debris present on the eye  15  with the swab  14  of the electromechanical device  10 . The debris may be targeted by visually inspecting the eye  15  with or without the aid of a magnification device. Once the debris is targeted, the swab  14  contacts the portion of the eye  15  that includes the debris. For purposes of treating the ocular disorder, the debris may be removably attached on either the upper and lower eyelid margins  60 ,  62  or the plurality of eyelashes  64 . Thereby, upon contacting the portion of the eye  15  with the debris, the swab  14  impacts the debris to remove the debris from the eye  15 . Furthermore, a liquid solution configured to loosen the debris may be absorbed within the swab  14  to further aid in removing the debris from the eye  15  and/or minimizing irritation to the eye  15 . It will be appreciated that any liquid solution sufficiently capable of loosening the debris to further aid in removing the debris may be so used. 
         [0031]    The electromechanical device  10  operably drives the swab  14  to break the debris free from either of the upper or lower eyelid margins  60 ,  62 . Further treatment may be performed to enhance the effects of the debris removal by helping to improve healing and reducing further infection of the eye  15 . Such treatment may include scrubbing, exfoliating, or buffing the eyelid margin or un-roofing a meibomian gland  66  with the swab  14 . 
         [0032]    In another aspect, the cornea  58  of the eye  15  is directed away from the position of the swab  14  to minimize contacting the swab  14  to the cornea  58  during treatment. As shown in  FIG. 2A , while treating the lower eyelid margin  62 , the eyeball  56  directs the cornea  58  upward, thereby bringing the cornea  58  closer to the upper eyelid margin  60  than the lower eyelid margin  62 . However, as shown in  FIG. 2B , while treating the upper eyelid margin  60 , the eyeball  56  directs the cornea  58  downward, thereby being closer to the lower eyelid margin  62  than the upper eyelid margin  60 . 
         [0033]    As shown in  FIG. 2A , accessing the portion of the eye  15  with the debris, such as the upper or lower eyelid margins  60 ,  62 , may be accomplished without further moving or lifting other portions of the eye  15 . However, as shown in  FIG. 2B , if accessing the portion of the eye  15  with the debris is difficult, the operator may use a hand  68 , or similar gripping device, to move or lift a portion of the eye  15 , such as lifting the upper or lower eyelid margin  60 ,  62  from against the eyeball  56 , to improve access to the debris. Such lifting may be particularly beneficial for improving access to the meibomian gland  66 . It will be appreciated that, in order to improve access to the debris, any portion of the eye  15  may be moved or lifted regardless of which eyelid margins  60 ,  62  are being treated.  FIGS. 2A and 2B  are merely exemplary embodiments showing both non-assisted access and assisted access of the swab  14  to the eye  15  respectively. 
         [0034]    Furthermore, the method of treating the ocular disorder may be repeated as directed by a physician or patient in order to sufficiently remedy the disorder. For instance, in the case of physician directed treatment, the physician may direct the patient to visit the physician in periodic intervals for treating the ocular disorder with the electromechanical device  10 . More specifically, the physician directs the patient to visit the physician in periodic monthly or weekly intervals so that the physician may treat the patient. In the exemplary embodiment, periodic intervals are treatments with the electromechanical device  10  once every month. It will be appreciated that any periodic interval of repeating the method of treating the ocular disorder with the electromechanical device  10  may be so used. 
         [0035]    Alternatively, in the case of home treatment by the patient, the patient may treat his or her own ocular disorder with the electromechanical device  10  in periodic intervals. However, according to the exemplary embodiment, the physician repeats the method of treating the ocular disorder in periodic intervals with the electromechanical device  10  and the patient also treats the ocular disorder in between physician treatments using traditional treatments. This method of treating the ocular disorder with the electromechanical device  10  in treatments occurring in periodic intervals achieves superior removal of the debris compared to traditional treatments, because the periodic intervals act as reminders to the patient. Thus, the patient is less likely to forget to treat the ocular disorders once symptoms begin to subside, which may result in a resurgence of the disorder. However, the traditional treatments, despite being less effective, may be performed regularly by the patient to further treat the ocular disorder in conjunction with physician treatments with the electromechanical device  10 . 
         [0036]    In any case, the physician or patient treats the ocular disorder until the ocular disorder is sufficiently healed and thereafter to prevent a recurrence of the disorder. It will be appreciated that sufficiently healed refers to the dissipation of inflammation and/or discomfort related to the debris within the eye  15  at which time the treatments by the physician may decrease in frequency, but may continue in periodic intervals during home treatment by the patient. In the event that the inflammation, discomfort, or debris worsens, the method of treating the ocular disorder may resume as the physician or patient desires. However, the treatment may be required in periodic intervals throughout the remainder of the patient&#39;s life. 
         [0037]    While the present invention has been illustrated by the description of one or more embodiments thereof, and while the embodiments have been described in considerable detail, they are not intended to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and method and illustrative examples shown and described. Accordingly, departures may be from such details without departing from the scope or spirit of the general inventive concept.