Patent Description:
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. Eyelid margin disease usually includes a buildup of debris on the eyelid margin of the eye of an individual. The debris may include a biofilm such as secreted by bacteria, as well as scurf, mucus, oils, and other secreted fluids. Despite advances in ophthalmology and medical treatments in general, the recommended treatments for these exemplary common ocular disorders has remained essentially unchanged for decades.

Historically, treating eyelid margin disease focused on a hygienic home treatment procedure in which the patient was to scrub the eyelid margin to remove the debris that is resulting in inflammation. 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.

Hygienic home treatment of such ocular disorders is generally a two-step process. First, the patient softens the debris 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 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.

Unfortunately for many patients, such hygienic home treatment is met with limited success due to the practical difficulties of cleaning one'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, 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'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. In many cases, the debris, including biofilm and other material, is tightly attached to the lid margin by bacteria-produced glue-like proteins, such as adhesin molecules, making it virtually impossible for any type of home remedy to remove it. Further, this treatment is typically required to be performed for the rest of the patient's life; thereby, creating a substantial hurdle to regular and effective compliance during hygienic home treatment.

More recently, devices have been developed for use by medical professionals to scrub debris from the eyelid margins of affected patients. These devices typically employ a motorized scrubbing head that includes a rotary or vibrating movement. The scrubbing head is brought into contact with the eyelid margin to remove debris thereon. While these devices tend to be highly effective at removing debris from the eyelid margin and providing relief to the patient, these treatments may also results in some discomfort as the moving scrubbing head may irritate the eyelid margins of some patients. Moreover, the scrubbing head does not address debris, including a biofilm or excess bacteria, within the meibomian gland, lash follicle or lacrimal glands.

A device according to the preamble of claim <NUM> is known from the document <CIT>.

<CIT> discloses an apparatus to treat a cornea of an eye comprising an applicator shaped to contact the cornea to denervate nerves of an outer portion of the cornea to inhibit pain of an inner portion of the cornea, wherein the applicator comprises at least two electrodes spaced apart by a distance to define a treatment profile.

There is disclosed a device for electrolytically disrupting debris on an eyelid margin. The device includes an eyelid contacting portion having a surface that includes at least a first electrode and a second electrode. The device further includes a power supply electrically coupled to at least one of the first and second electrodes. The surface of the eyelid contacting portion has a shelf separating an upper portion from a lower portion with electrodes on the upper and lower portions and on upper and lower surfaces of the shelf. The eyelid contacting portion may optionally include at least one channel with electrodes.

Also disclosed but not part of the present invention is a method of electrolytically removing debris from an eyelid margin of a subject. The method includes contacting debris on an eyelid margin with a first electrode and contacting a surface of an eyelid adjacent to but spaced apart from the debris with a second electrode and supplying electrical energy to one of the first or second electrodes in an amount sufficient to disrupt the debris while not harming the underlying eyelid margin or eyelid.

Also disclosed but not part of the present invention is a device for ultrasonically disrupting debris on an eyelid margin. The device includes an eyelid contacting portion having a surface that is coupled to an ultrasonic driver. The surface of the eyelid contacting portion may optionally have a shelf separating an upper portion from a lower portion. The eyelid contacting portion may optionally include at least one channel. The eyelid contacting portion may optionally include with electrodes for applying electrical energy in addition to ultrasonic energy.

Also disclosed but not part of the present invention is a method of ultrasonically removing debris from an eyelid margin of a subject. The method includes contacting debris on an eyelid margin with an eyelid contacting portion of an instrument and supplying ultrasonic energy to one of the eyelid contacting portion in an amount sufficient to disrupt the debris while not harming the underlying eyelid margin or eyelid.

These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof.

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.

The embodiments of <FIG> and <FIG> are not in accord with the invention but are useful in understanding the invention.

With reference to <FIG>, these depict devices <NUM>, 10a for electrolytically disrupting debris <NUM>, that includes, but is not limited to, includes at least one of a biofilm, bacteria, scurf, keratinization, dead cells, and secreted fluids, along the upper eyelid margin <NUM>, the lower eyelid margin <NUM>, or both the upper and lower eyelid margins <NUM>, <NUM> of an eye <NUM> of a subject. With reference to <FIG>, <FIG>, <FIG>, and <FIG> embodiments of the devices include electrodes <NUM>, 20a, 20b, 20c, <NUM>, 22a, 22b, 22c, <NUM>, 24a, <NUM>, 26a on an eyelid contacting portion <NUM> to contact the one or both of the upper eyelid <NUM> and the lower eyelid <NUM> of a subject to apply low voltage and low current electrical energy to the eyelids <NUM>, <NUM>. The electrical energy passes, illustrated as arrows with dashed lines, from one or more anode electrodes through the eyelid(s) and debris on the eyelid margin to one or more cathode electrodes. The electrical energy passing through the debris <NUM> disrupts the debris <NUM> and allows for disrupted debris to be easily removed, such as with a wash solution (<FIG> and <FIG>) or by wiping with a tissue or towel. In some embodiments, the device includes nozzles (<FIG>) for applying the wash solution to the eyelid margin to remove the disrupted debris.

In an embodiment of the invention, the voltage of the electrical energy applied to disrupt the debris <NUM> is in the range from about <NUM> V to about <NUM> V. In another embodiment, the voltage applied to disrupt the debris <NUM> is in the range from about <NUM> V to about <NUM> V. In another embodiment, the voltage applied to disrupt the debris <NUM> is in the range from about <NUM> V to about <NUM> V. In another embodiment, the voltage applied to disrupt the debris <NUM> is in the range from about <NUM> V to about <NUM> V. In another embodiment, the voltage applied to disrupt the debris <NUM> is in the range from about <NUM> V to about <NUM> V. In another embodiment, the voltage applied to disrupt the debris <NUM> is in the range from about <NUM> V to about <NUM> V. In another embodiment, the voltage applied to disrupt the debris <NUM> is in the range from about <NUM> V to about <NUM> V. In another embodiment, the voltage applied to disrupt the debris <NUM> is in the range from about <NUM> V to about <NUM> V. In another embodiment, the voltage applied to disrupt the debris <NUM> is in the range from about <NUM> V to about <NUM> V. In another embodiment, the voltage applied to disrupt the debris <NUM> is in the range from about <NUM> V to about <NUM> V. In another embodiment, the voltage applied to disrupt the debris <NUM> is in the range from about <NUM> V to about <NUM> V. In another embodiment, the voltage applied to disrupt the debris <NUM> is in the range from about <NUM> V to about <NUM> V.

In an embodiment of the invention, the current applied to disrupt the debris <NUM> is less than about <NUM> milliamps. In another embodiment of the invention, the current applied to disrupt the debris <NUM> is in a range from about <NUM> milliamps to about <NUM> milliamps. In another embodiment of the invention, the current applied to disrupt the debris <NUM> is in a range from about <NUM> milliamps to about <NUM> milliamps. In another embodiment of the invention, the current applied to disrupt the debris <NUM> is in a range from about <NUM> microamp to about <NUM> milliamps.

With reference to <FIG>, <FIG>, <FIG>, and <NUM> embodiments of the device <NUM>, 10a, 10b include a power supply <NUM> to supply electrical energy to the electrodes <NUM>, <NUM>, <NUM>, <NUM>. Embodiments of the device <NUM>, 10a, 10b may also include hardware, software, or any combination thereof that may be used to control the electrical energy being supplied to the electrodes. The hardware, such as a controller <NUM>, may include software and be electrically coupled to the power supply <NUM> and the electrodes <NUM>, <NUM>, <NUM>, <NUM>. Embodiments of the device <NUM>, 10a, 10b may also include instructions supplied by a machine-readable medium, which may be read and executed by one or more processors. A machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computing device). For example, a machine-readable medium may include read only memory (ROM); random access memory (RAM); magnetic disk storage media; optical storage media; flash memory devices; electrical optical, acoustical or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.), and others. Further software routines and instructions may be described herein as performing certain actions. However, it should be appreciated that such descriptions are merely for convenience and that such actions in fact result from computing devices, processors, controllers <NUM>, or other devices executing the software, routines, instructions, etc..

In an embodiment, the device <NUM>, 10a, 10b may include a user interface <NUM> that includes an input system and a display system. The input system allows the user to adjust the operation of the device <NUM>, 10a, 10b and, in some embodiments, interact with the controller <NUM> to control the device <NUM>, 10a. For example, the user interface <NUM> may allow the user to activate the supply of electrical energy to the electrodes <NUM>, <NUM>, <NUM>, <NUM>, to increase or decrease the electrical energy being supplied to the electrodes <NUM>, <NUM>, <NUM>, <NUM>, increase or decrease the duration of treatment, activate a pump controlling the flow of wash solution from a reservoir <NUM> to nozzles <NUM> (<FIG>), activate a pump controlling the flow of waste fluid from irrigation ports <NUM> to a waste fluid receptacle such as a waste fluid reservoir <NUM> or sink (<FIG>), and combinations thereof. The input system may include at least one of a button <NUM>, a dial, a trigger <NUM>, a switch, a touch screen and other input devices as are known in the electrical arts. The display system conveys information to the user with respect to the status of the device. In an embodiment, the display may include one or more lights <NUM> such as light emitting diodes, an LCD display <NUM> (<FIG>), gauges, or other types of displays as are known in the art. For example, the device <NUM>, 10b may include one or more lights <NUM> to indicate the powered on status of the device <NUM>, 10b, indicate the level of energy remaining in the power supply, such as in a battery, or if the electrodes are making sufficient contact with the skin of the subject undergoing treatment.

As illustrated in <FIG>, the controller <NUM>, power supply <NUM>, user interface (e.g., lights <NUM>, buttons, <NUM>, and triggers <NUM>) may be contained in a housing <NUM>, 55a shaped in the form of a handle from which the eyelid contacting portion <NUM>, 30a, 30b, 30c projects. It will be appreciated that the controller, power supply, user interface, and other components may be in one or more housings and the one or more housings need not be in the form of a handle. For example, in the embodiment illustrated in <FIG>, the housing with one or more components may be a base unit <NUM> that can be located some distance away from the subject but that is also electrically coupled to the eyelid contacting portion by a flexible member, such as an electric cable. The base unit <NUM> may optionally be fluidly coupled to the eyelid contacting portion by one or more flexible tubes to allow for the delivery of wash fluid, the removal of waste fluid, and combinations thereof for eyelid contacting portion having such functionality.

With reference to <FIG>, an embodiment of the device <NUM> for treating an ocular disorder, particularly with respect to eyelid margin diseases, includes an eye contacting portion <NUM> with a surface <NUM> that includes a first electrode <NUM> and a second electrode <NUM>. The surface <NUM> of the eye contacting portion <NUM> may be curved to generally correspond to the external curvature of the eye and in particular, the curvature of the upper and lower eyelids <NUM>, <NUM> so that the first electrode <NUM> may make contact across the outer surface of the upper eyelid <NUM> and the second electrode <NUM> may make contact with the outer surface of lower eyelid <NUM> when the eyelids <NUM>, <NUM> are in a closed position. Each of the first and second electrodes <NUM>, <NUM> has a width W that generally corresponds to the width of the each of the upper and lower eyelids <NUM>, <NUM>. In an embodiment, each of the first and second electrodes <NUM>, <NUM> has a width W that ranges from <NUM> to about <NUM>. One of the first electrode or second electrodes <NUM>, <NUM> functions as a cathode and the other of the first electrode or second electrodes <NUM>, <NUM> functions as an anode. The first and second electrodes <NUM>, <NUM> are electrically coupled to a circuit <NUM> that includes a power supply <NUM> (<FIG>).

With reference to <FIG>, during use, electrical energy (arrows with broken lines) flows from the first electrode <NUM> through the upper eyelid <NUM> and the upper eyelid margin <NUM> to the debris <NUM>. The electrical energy then passes through and disrupts the debris <NUM> before passing through the lower eyelid margin <NUM> and lower eyelid <NUM> to the second electrode <NUM>. One of ordinary skill in the art will appreciate that the electrical energy could flow in the opposite direction from the second electrode <NUM> to the first electrode <NUM> if the second electrode <NUM> is the anode and the first electrode is the cathode.

In an embodiment, an electrolyte solution may be added to the eye, such as between the upper and lower eyelid margins <NUM>, <NUM>, to improve the disruption of debris <NUM> by the electrical energy.

<FIG>, <FIG> illustrate embodiment of the eye contacting portion 30a of the device <NUM>. <NUM>, in accordance with the present invention. The surface 54a of the eye contacting portion 30a is separated into an upper portion <NUM> and a lower portion <NUM> by a shelf <NUM>. The shelf <NUM> has an upper shelf surface <NUM> and a lower shelf surface <NUM>. The upper portion <NUM> includes a first electrode 20a and the upper shelf surface <NUM> adjacent the upper portion <NUM> includes a second electrode 22a. One of the first or second electrodes 20a, 22a will be an anode and the other of the first or second electrodes 20a, 22a will be a cathode. Similarly, the lower portion <NUM> includes a third electrode <NUM> and the lower shelf surface <NUM> includes a fourth electrode <NUM>. One of the third or fourth electrodes <NUM>, <NUM> will be an anode and the other of the third or fourth electrodes <NUM>, <NUM> will be a cathode. The first, second, third, and fourth electrodes 20a, 22a, <NUM>, <NUM> are electrically coupled to a circuit that includes a power supply.

During use, the second electrode 22a on the upper shelf surface <NUM> contacts the upper eyelid margin <NUM> of the upper eyelid <NUM> and may be curved to generally correspond with the curvature of the upper eyelid margin <NUM>. The second electrode 22a will also contact debris <NUM> along the upper eyelid margin <NUM> of the upper eyelid <NUM>. Similarly, the fourth electrode <NUM> on the lower shelf surface <NUM> contacts the lower eyelid margin <NUM> of the lower eyelid <NUM> and may be curved to generally correspond with the curvature of the lower eyelid margin <NUM>. As with the previous embodiment, the first and third electrodes 20a <NUM> each have a width that corresponds generally with the widths of the respective upper and lower eyelids <NUM>, <NUM>. Similarly, the second and fourth electrodes 22a, <NUM> on the upper and lower shelf surfaces <NUM>, <NUM> each have a length and a width that generally corresponds with the length and width of the respective upper and lower eyelid margins <NUM>, <NUM> for the upper and lower eyelids <NUM>. In an embodiment, the widths of each of the first, second, third, and fourth electrodes 20a, 22a, <NUM>, <NUM> may range between about <NUM> and about <NUM>. In an embodiment, the lengths of the second and fourth electrodes may range between about <NUM> and <NUM>, or between about <NUM> and about <NUM>.

In the embodiment illustrated in <FIG>, the second and fourth electrodes <NUM>, <NUM> on the upper and lower shelf surfaces <NUM>, <NUM>, respectively, are anodes and the first and third electrodes 20a, <NUM> on the upper and lower portions <NUM>, <NUM> of surface 54a are cathodes, when the device utilizes a direct current power source. Electrical current flows from the anodes through debris <NUM> on or near the upper and lower eyelid margins <NUM>, <NUM> to disrupt the debris <NUM>. The electrical current then travels through the upper and lower eyelids <NUM>, <NUM> to the cathode to complete the circuit. The power supply, which may be a battery or other source of electricity, provides electrical energy to the anodes. It will be appreciated that the polarity of the electrodes may be reversed. It will also be appreciated that an alternating current power source, which will obviate the anode cathode designation of the electrodes.

<FIG>, <FIG> illustrate an alternative embodiment of the eye contacting portion 30b of the device <NUM>. In the alternative embodiment, the eye contacting portion 30b is separated into an upper channel <NUM> and a lower channel <NUM>.

The upper channel <NUM> is defined by an upper outer sidewall <NUM> and an opposite upper inner sidewall <NUM>. The upper outer sidewall <NUM> is joined to the upper inner sidewall <NUM> by an upper base wall <NUM>. The upper base wall <NUM> includes a first electrode 20b. One of the upper outer and upper inner sidewalls <NUM>, <NUM> includes a second electrode 22b. In an embodiment, both of the upper outer and upper inner sidewalls <NUM>, <NUM> include an electrode, with one of the upper sidewalls including the second electrode 22b and the other upper sidewall including a third electrode 24a. One of the first and second electrodes 20b, 22b will be an anode and the other of the first or second electrodes 20b, 22b will be a cathode. In embodiments with a third electrode 24a, the third electrode 24a will have the same polarity as the second electrode 22b. In other words, if the second electrode 22b is a cathode, the third electrode 24a will also be a cathode.

The lower channel <NUM> is defined by a lower outer sidewall <NUM> and an opposite lower inner sidewall <NUM>. The lower outer sidewall <NUM> is joined to the lower inner sidewall <NUM> by a lower base wall <NUM>. The lower base wall <NUM> includes a first electrode 20c. One of the lower outer and lower inner sidewalls <NUM>, <NUM> includes a second electrode 22c. In an embodiment, both of the lower outer and lower inner sidewalls <NUM>, <NUM> include an electrode, with one of the lower sidewalls including the second electrode 22c and the other lower sidewall including a third electrode 24b. One of the first and second electrodes 20c, 22c will be an anode and the other of the first or second electrodes 20c, 22c will be a cathode. In embodiments with a third electrode 24b, the third electrode 24b will have the same polarity as the second electrode 22c. In other words, if the second electrode 22c is a cathode, the third electrode 24b will also be a cathode.

During use, the upper eyelid <NUM> of a subject is inserted into the upper channel <NUM> and the lower eyelid <NUM> of the subject is inserted into the lower channel <NUM>. The inner surfaces <NUM>, <NUM> of the respective upper and lower eyelids <NUM>, <NUM> will contact electrodes located on the respective upper and lower inner sidewalls <NUM>, <NUM>. The outer surfaces <NUM>, <NUM> of the respective upper and lower eyelids <NUM>, <NUM> of the subject will contact electrodes that may be located on the respective upper and lower outer sidewalls <NUM>, <NUM>. The upper and lower eyelid margins <NUM>, <NUM> of the respective upper and lower eyelids <NUM>, <NUM>, as well as debris <NUM> on the eyelid margins <NUM>, <NUM> will contact the electrodes on the upper and lower base walls <NUM>, <NUM>. Electrical current will flow from the anodes through the debris and eyelid to the cathodes.

Alternative embodiments, such as illustrated in <FIG>, may include one or more nozzles <NUM> in the upper and lower channels <NUM>, <NUM> to spray a wash solution <NUM>, such as a balanced salt solution, across the upper and lower eyelid margins <NUM>, <NUM> to assist with removing disrupted debris along the upper and lower eyelid margins <NUM>, <NUM>. In an embodiment, the nozzles <NUM> are positioned in the upper and lower inner sidewalls <NUM>, 74a, <NUM>, 82a to spray wash solution <NUM> away from the eyeball <NUM> to wash disrupted debris away. The nozzles <NUM> will be in fluid communication with a wash solution reservoir <NUM> (<FIG> and <FIG>). The wash solution <NUM> may be pushed through the nozzles <NUM> with a pump <NUM>. The pump <NUM> may be operated by the controller <NUM>. In the alternative, the wash solution may be gravity fed to the nozzles <NUM> (<FIG>).

Alternative embodiments, such as illustrated in <FIG>, may also include one or more irrigation ports <NUM> in the upper and lower channels in the upper and lower channels <NUM>, <NUM> to remove wash solution <NUM> and debris from the channels and to decreases the overflow of wash fluid and debris into the eye and onto the face of the subject. The irrigation ports <NUM> may be in fluid communication with a waste fluid receptacle such as a waste fluid reservoir <NUM> or sink (<FIG>). The drained wash solution <NUM> may be drawn into the irrigation ports <NUM> by a pump, such as vacuum pump <NUM>. The pump, such as vacuum pump <NUM>, may be operated by the controller <NUM>.

<FIG> and <FIG> illustrate an alternative embodiment of the device that includes upper and lower channels 68a, 70a similar to the upper and lower channels <NUM>, <NUM> in the embodiment illustrated in <FIG>, <FIG>. As best illustrated in <FIG>, the upper and lower outer sidewalls 72a, 80a in this alternative embodiment may move relative to the upper and lower base walls 76a, 84a and upper and lower inner sidewalls 74a, 82a. This movement allows the upper and lower channels 68a, 70a to open to ease insertion of the upper and lower eyelids <NUM>, <NUM> into the respective upper and lower channels 68a, 70a. After the upper and lower eyelids <NUM>, <NUM> are inserted into the respective upper and lower channels 68a, 70a, the upper and lower outer sidewalls 72a, 80a may be move toward the upper and lower inner sidewalls 74a, 82a, such as the through a trigger <NUM> coupled to a mechanism for moving the upper and lower outer sidewalls 72a, 80a until the sufficient contact is made with the electrodes in the upper and lower channels 68a, 70a. The electrodes and nozzles <NUM> may be activated to remove debris <NUM> as discussed above with respect to the embodiment disclosed in <FIG>, <FIG>.

While the embodiments illustrated in <FIG> are shown as having upper and lower channels <NUM>, 68a, <NUM>, 70a, it will be appreciated that embodiments of the device <NUM> and 10a may be made with a single channel to allow for treatment of one eyelid at a time.

<FIG> illustrates an alternative embodiment of the eyelid contacting portion 30d of the device 10b. 10b, according to the present invention. In this embodiment, upper and lower inner side walls 74b and 82b are separated by shelf having upper and lower base walls 76b and 84b. The eyelid connecting portion 30d is configured to be positioned such that the upper and lower inner side walls 74b and 82b are placed between the inner surface of the eyelid and the outer surface of the eyeball. An electrode 20b, such as an anode, is positioned on the upper base wall 76b and another electrode 20c, such as another anode, is position on the lower base wall 84b. In an embodiment, the electrodes 20b, 20c on the upper and lower base walls 76b, 84b are generally of the same polarity, i.e., either both anodes or both cathodes. During use, the eyelid contacting portion 30d is positioned such that the margin of the eyelid of the upper eyelid, as well as debris thereon, contacts the electrode 20b on the upper base wall 76b and the margin of the eyelid of the lower eyelid, as well as debris thereon, contacts the electrode 20c on the lower base wall.

The electrodes 20b, 20c on the eyelid contacting portion 30d are electrically coupled to a base unit <NUM> by a flexible member, such as an electric cable. In the exemplary embodiment, the flexible member projects from the shelf such that, during use, the flexible member projects between the upper and lower eyelids of the subject.

This embodiment also utilizes another electrode 22d that is separate from the eyelid contacting portion 30d. Generally speaking, this electrode will have an opposite polarity from the polarity of the electrodes 20b, 20c on the eyelid contacting portion 30d. In an embodiment, the electrodes 20b, 20c on the eyelid contacting portion 30d are anodes and the electrode 22d is a cathode. In another embodiment, the electrodes 20b, 20c on the eyelid contacting portion 30d are cathodes and the electrode 22d is an anode. The electrode 22d may include an electrolyte, such as an electrolytic gel, an adhesive, or an electrolytic adhesive to improve contact with the skin. Electrodes as are known in the art may be utilized for this purpose. The electrode 22d is electrically coupled to the base <NUM> with an electric cable. During use, the electrode 22d is position adjacent the eye being treated with the eyelid contacting portion 30d. In an embodiment, the electrode 22d is position between <NUM> inch and <NUM> inches from margin of the lower eyelid. In an embodiment, the electrode is position below the eye being treated. In another embodiment, the electrode 22d is position lateral to the eye being treated. In another embodiment, the electrode 22d is position above the eye being treated.

In an embodiment, the eyelid contacting portion includes one or more wash fluid nozzles <NUM>. In an embodiment, the wash nozzles are located along the upper and lower inner side walls 74b and 82b on the surface that faces the inner surface of the eyelid such that washing fluid expelled from the nozzles <NUM> will wash away debris disrupted by the electrodes 20b, 20c. The wash fluid nozzles <NUM> are fluidly coupled to a reservoir of washing fluid by a flexible tube. In an embodiment, the flexible tube connects to a luer lock that projects from the shelf of the eyelid connecting portion. In an embodiment, the wash fluid reservoir is positioned at a height that is greater than the treatment height of the patient so that washing fluid is gravity fed to the fluid from the nozzles <NUM>. It will be appreciated that a pump could be used to pump the washing fluid from a reservoir to the nozzles.

It will be appreciated that the electrodes may be made from materials as are known in the art for transmitting electrical energy to the surfaces of the skin. For example, the electrodes can be made of a number of materials, such as metals, carbon graphite electrodes, and electrically conducting rubber sheets. Exemplary metals include gold, silver, and other biologically tolerated metals and alloys thereof.

In embodiments of the invention, the eyelid contacting portions <NUM>, 30a, 30b, 30c, 30d may be removable from the housing such that the eyelid contacting portions may be disposed of after a single use or, if reused, sterilized between uses. As such, an embodiment of the invention is directed to removable eyelid contacting portions that are configured to be reversibly coupled to a housing. Such removable eyelid contacting portions may have an electrical coupling, such a male or female electrical contact that mates with a corresponding electrical contact on the housing. The removable eyelid contacting portions may also have a contacting surface having a shape that mates with a correspondingly shaped contacting surface on the housing.

Embodiments of the invention utilize only electrical energy to disrupt debris without utilizing other forms of energy to result in debris disruption. As described above, alternative embodiments may utilize electrical energy to disrupt debris in combination with a wash fluid to assist with debris disruption, to remove debris, or both to disrupt and remove debris.

Another embodiment of the invention may include an ultrasonic driver <NUM> coupled to the eyelid contacting portion to induce ultrasonic movement of an eyelid contacting portion (<FIG> and <FIG>). Embodiments of the invention will utilize the ultrasonic driver <NUM> in combination with electrical energy applied through electrodes to disrupt debris. Accordingly, these devices will include electrodes, as described above as well as an ultrasonic driver. Other embodiments of the invention will utilize only the ultrasonic driver <NUM> to induce ultrasonic movement of the eyelid contacting portion to disrupt debris without applying electrical energy to the eye through electrodes to disrupt debris. Accordingly, these embodiments of the device will have an ultrasonic driver but will lack electrodes.

The embodiments utilizing an ultrasonic driver <NUM> may optionally utilize a wash fluid delivered through nozzles <NUM> to assist with disrupting, removing, or both disrupting and removing debris. Accordingly, embodiments of the device utilizing a wash fluid will include nozzles, a reservoir, and pump, as previously described. These embodiments may also optionally utilize irrigation ports <NUM> to remove fluids, such as waste fluid and debris, during use. Accordingly, embodiments of the device may include irrigation ports <NUM> coupled to a pump, such as a vacuum pump. The waste fluid may optionally be pumped to a reservoir or to a waste receptacle, such as a sink.

With reference to <FIG> and <FIG>, the ultrasonic driver <NUM> may be contained in a housing <NUM>, 55a from which an eyelid contacting portion <NUM>, 30a, 30a, 30b, 30c projects. The ultrasonic driver <NUM> is physically coupled, such as through a shaft, to the eyelid contacting portion such that ultrasonic energy from the ultrasonic driver <NUM> is transferred to the eyelid contacting portion. An exemplary ultrasonic driver is a piezoelectric driver. The piezoelectric driver may cause the eyelid contacting portion to oscillate as a frequency that ranges between about <NUM> to about <NUM>. In the embodiments illustrated in <FIG> and <FIG>, the ultrasonic driver <NUM> is provided in addition to the electrodes. However, it will be appreciated that the device may include ultrasonic driver without electrodes for delivering electrical energy to the eyelid.

During use, the eyelid contacting portion is brought into contact with the external portion of the upper eyelid, the external portion of the lower eyelid, the upper eyelid margin between the external surface of the upper eyelid and the internal surface of the upper eyelid, the lower eyelid margin between the external surface of the lower eyelid and the internal surface of the lower eyelid, the internal surface of the upper eyelid, the internal surface of the lower eyelid or combinations thereof. It is further appreciated that the eyelid contacting portion simultaneously contacts the relevant portion of the eyelid as described in the previous sentence across at least fifty percent of the width of the eyelid. In another embodiment, the eyelid contacting portion contacting portion contacts the relevant portion of the eyelid across at least seventy five percent of the width of the eyelid. In another embodiment, the eyelid contacting portion contacting portion contacts the relevant portion of the eyelid across at least ninety percent of the width of the eyelid. The width of the eyelid being defined as the portion of either the upper or lower eyelid that extends between the medial commissure and the lateral commissure. The ultrasonic driver <NUM> is activated and ultrasonic energy is applied to the at least one of the eyelid surfaces as well as to debris located thereon by the eyelid contacting portion.

In an embodiment, ultrasonic energy is applied without the application of any other form of energy to disrupt debris. In another embodiment, the ultrasonic energy is applied in combination with another form of energy to disrupt debris. For example, ultrasonic energy may be applied in combination with electrical energy to disrupt debris. In an embodiment, the ultrasonic energy may be applied at the same time as the other form of energy, such as electrical energy. In another embodiment, the ultrasonic energy and the other form of energy, such as electrical energy, are not applied at the same time. For example, ultrasonic energy and the other form of energy, such as electrical energy, may be applied in an alternating manner, or one of these forms of energy may be applied first and the other form of energy may be applied second. This alternating pattern may be repeated. In an embodiment, the other form of energy, such as electrical energy, is applied first and the ultrasonic energy is applied second. In another embodiment, the ultrasonic energy is applied first and the other form of energy, such as electrical energy, is applied second. The ultrasonic energy is applied for a duration and at a frequency sufficient to disrupt debris on the eyelid, and in particular debris on the eyelid margin.

Claim 1:
An eyelid contacting portion configured to be coupled to a device housing for removing debris from an eyelid margin, the eyelid contacting portion comprising:
an eye contacting portion (<NUM>) having a first surface (<NUM>) curved to correspond to a curvature of upper and lower eyelids of an eye, the eye contacting portion (<NUM>) characterised by having:
a shelf (<NUM>) on the first surface (<NUM>) that separates the first surface to form an upper portion (<NUM>) and a lower portion (<NUM>);
a first electrode (<NUM>, <NUM>, <NUM>, <NUM>) on the upper portion; and
a second electrode (<NUM>, <NUM>, <NUM>, <NUM>) on the lower portion and spaced apart from the first electrode, wherein at least one of the first and second electrodes (<NUM>, <NUM>, <NUM>, <NUM>) are electrically coupled to an electrical contact configured to mate with another electrical contact on the device housing.