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. Despite advances in ophthamology and medical treatments in general, the recommended treatments for these exemplary common ocular disorders has remained essentially unchanged for decades.

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' 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.

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.

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.

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 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'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's life; thereby, creating a substantial hurdle to regular and effective compliance during hygienic home treatment.

Evidence suggests that medical costs associated with dry eye syndrome, often induced by ocular diseases such as blepharitis, are currently over <NUM> billion dollars each year. Many of these expenses are needlessly incurred due to the patients' 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.

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. <CIT> discloses methods and kits for treating or preventing an eye condition or for cleaning an eye area tissue. A disclosed method includes administering an isoprenoidal essential oil to eye area tissue, chafing eye area tissue with an abrasive, and removing the abrasive. A disclosed kit includes an isoprenoidal essential oil, an abrasive for chafing eye area tissue, and in instruction for use for treating an eye condition or cleansing an eye area tissue. Similar prior art instruments are disclosed by <CIT>, <CIT>, <CIT> and <CIT>.

According to the present invention, there is provided an instrument as specified in the claims
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.

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.

With reference to <FIG>, an embodiment of the device <NUM> for treating an ocular disorder, particularly with respect to eyelid margin diseases, includes a mechanical drive unit <NUM> which operably moves a swab <NUM> to facilitate removal of debris from an eye <NUM> (see <FIG>). The swab <NUM> is connected to a rigid member <NUM> having both a distal end portion <NUM> and a proximal end portion <NUM>. The swab <NUM> is affixed to the distal end portion <NUM> of the rigid member <NUM> to create an instrument <NUM>, which may be secured to the mechanical drive unit <NUM>. As shown in <FIG>, the proximal end portion <NUM> is removably secured to the mechanical drive unit <NUM> in order to transmit motion from the mechanical drive unit <NUM>, through the rigid member <NUM>, and to the swab <NUM>. It will be appreciated that any known method may be used to removably secure the instrument <NUM> to the mechanical drive unit <NUM>. Moreover, it will also be appreciated that device <NUM> is not intended to be limited to the instrument <NUM> being removably secured to the mechanical drive unit <NUM>. For instance, in another embodiment, the rigid member <NUM> may be either permanently secured or removably secured to either one of the swab <NUM> and/or the mechanical drive unit <NUM>.

In one aspect of the instrument <NUM>, the swab <NUM> includes a tip portion <NUM> and a base portion <NUM>. While the swab <NUM> may be of a size sufficient to access debris on the eye <NUM> as shown in <FIG>, and <FIG>, at least the tip portion <NUM> is of a size sufficient to access debris on the eye <NUM>. For instance, the swab <NUM> has an approximate length between <NUM> - <NUM> millimeters and an approximate width of between <NUM> - <NUM> millimeters. More particularly, the swab <NUM> has an approximate length of <NUM> millimeters and an approximate width of <NUM> millimeter. It will be appreciated that the swab <NUM> may be manufactured of any material suitable for contacting the eye <NUM> without harming the eye <NUM>. However, as shown in the embodiment of <FIG>, the swab <NUM> is a sponge. As described herein, "sponge" broadly refers to any material that is soft, porous, and resilient. Particularly, the swab <NUM> is a medical grade sponge or a surgical grade sponge capable of removing debris from on the eye <NUM> without harming the eye <NUM>. As shown in the exemplary embodiment of <FIG>, the swab <NUM> is a methyl cellulose sponge. It will be appreciated; however, that similar materials capable of removing debris from on the eye <NUM> without harming the eye <NUM> are readily apparent and may also be used.

In another aspect of the instrument <NUM>, the rigid member <NUM> is a plastic, cylindrical shaft including a central axis <NUM>. The shaft extends along the central axis <NUM> between the mechanical drive unit <NUM> and the swab <NUM>. The rigid member <NUM> is sufficiently rigid to effectively transmit motion from the mechanical drive unit <NUM> to the swab <NUM>. As shown in <FIG>, the swab <NUM> is permanently affixed to the distal end portion <NUM> by forming the base portion <NUM> to the rigid member <NUM> during manufacturing. However, it will be appreciated that any known method of affixing the swab <NUM> to the rigid member <NUM> may be used. In an exemplary embodiment, any material or shaft shape may be used so long as the rigid member <NUM> is rigid enough to transmit sufficient motion from the mechanical drive unit <NUM> to the swab <NUM> in order to remove debris from on the eye <NUM>.

Furthermore, the mechanical drive unit <NUM> includes a body <NUM>, an electric motor <NUM>, a chuck <NUM>, and a control switch <NUM>. As such, the device <NUM> is electromechanical in nature. In an exemplary embodiment, the electric motor <NUM>, the chuck <NUM>, and the control switch <NUM> are integrated into the body <NUM> so that the electromechanical device <NUM> is configured to be handheld as shown in <FIG>. However, the electromechanical device <NUM> is not intended to be limited to a handheld configuration, and it will be appreciated that other configurations of the device <NUM> are readily apparent.

According to the present embodiment, the electric motor <NUM> is positioned within the body <NUM>. The chuck <NUM> is operably connected to the electric motor <NUM> at a forward end portion <NUM> of the body <NUM>. The proximal end portion <NUM> of the rigid member <NUM> is removably secured to the chuck <NUM>. As described herein, the chuck <NUM> is generally any element capable of removably securing the rigid member <NUM> to the mechanical drive unit <NUM>. As such, the chuck <NUM> may be tightened or loosened to respectively secure or remove the instrument <NUM> to the chuck <NUM>. Thereby, the operable connection of the electric motor <NUM> transmits a movement <NUM> through the chuck <NUM> to the instrument <NUM>. The movement <NUM> is any motion relative to the mechanical drive unit <NUM> or, more particularly, to the body <NUM>, that creates relative motion to the debris on the eye <NUM> such that upon contacting the debris with the swab <NUM>, the debris is removed. As shown, the movement <NUM> may include, but is not limited to, a reciprocating movement 38a, a rotating movement 38b, or a vibrating movement 38c. The reciprocating movement 38a may be either along the central axis <NUM> of the rigid member <NUM> or orthogonal to the central axis <NUM> of the rigid member <NUM>. In addition, the speed of the movement <NUM> of the swab <NUM> is any speed sufficient to remove debris from on the eye <NUM>. It will be appreciated that the speed discussed herein collectively refers to both relative speed of the swab <NUM> and the frequency of the movement <NUM> of the swab <NUM>. For instance, the frequency may range from sonic frequencies to ultrasonic frequencies. Furthermore, the speed of the swab <NUM> may be variable or otherwise selectable such that an operator of the device <NUM> may select a desirable speed or a forward or reverse direction via the control switch <NUM>.

Moreover, the control switch <NUM> is operably connected to the electric motor <NUM> and an electric power source <NUM> to power the device <NUM> on and off. In an exemplary embodiment, the electric power source <NUM> is a battery power source <NUM> contained within the body <NUM>. The battery power source <NUM> may be either disposable or rechargeable. The electric power source <NUM> operably provides electrical power to the electric motor <NUM>, which the operator controls via the control switch <NUM>. It will be appreciated that any known control switch <NUM> or plurality of control switches <NUM> may be configured to power the device <NUM> on and off.

Furthermore, it will be appreciated that the device <NUM> 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 <NUM> and single-use instruments <NUM>. Some examples of such a professional mechanical drive unit <NUM> is an Algerbrush I, an Algerbrush II, or similar medical device. However, operators within the home treatment setting may desire the device <NUM> to be generally disposable and single-use.

<FIG> show another embodiment of a device <NUM> for treating an ocular disorder. The device <NUM> includes an instrument <NUM> removably secured to a mechanical drive unit <NUM>. The device <NUM> provides for safe, simple, and reliable removal and replacement of disposable, single-use instruments <NUM> between treatments. Specifically, the mechanical drive unit <NUM> has a chuck <NUM> projecting from the forward end portion <NUM> of the body <NUM> and configured for unique frictional engagement with the instrument <NUM>. In this respect, the attachment between the chuck <NUM> and the instrument <NUM> discourages improper installation and inhibits the use of other, unsuitable instruments that may create unnecessary risk of damaging the eye <NUM> (see <FIG>) during use. Moreover, the instrument <NUM> and chuck <NUM> provide for simple frictional attachment via insertion and withdrawal (i.e., push-in and pull-out) of the instrument <NUM> without collars, clasps, or other mechanisms. The chuck <NUM> also effectively transmits torque to the instrument <NUM> without generating damaging stress concentrations in either the instrument <NUM> or the chuck <NUM>. The instrument <NUM> includes a rigid member <NUM> having the swab <NUM> projecting from the distal end portion <NUM> and, as such, like numbers for the device <NUM> refer to like features previously described above.

With respect to <FIG>, the rigid member <NUM> further includes a proximal end portion <NUM> sized for insertion into the chuck <NUM> and an intermediate portion <NUM> extending between the distal end portion <NUM> and the proximal end portion <NUM>. The intermediate portion <NUM> and the distal end portion <NUM> are both generally cylindrical; however, the intermediate portion <NUM> has a larger diameter than the distal end portion <NUM> and tapers toward the distal end portion <NUM>. Also, the proximal end portion <NUM> has a width that is generally as wide as the diameter of the intermediate portion <NUM>, but a depth generally less than the diameter of the intermediate portion <NUM> as shown in <FIG>. However, it will be appreciated that the relative sizes of the portions of the instrument <NUM>, such as diameters, widths, and depths, may vary in accordance with the invention described herein.

With respect to <FIG>, the proximal end portion <NUM> has a cross-sectional member profile <NUM> that inserts into an aperture <NUM> and frictionally engages a sidewall <NUM> of the chuck <NUM> for removably attaching the instrument <NUM> to the mechanical drive unit <NUM>. Thus, the proximal end portion <NUM> may be inserted into the aperture <NUM> as indicated by arrow <NUM> and withdrawn in the opposite direction to remove the instrument <NUM> from the chuck <NUM>. The frictional engagement is generally created by the proximal end portion <NUM> being sized with an interference fit within the aperture <NUM> against the sidewall <NUM>. However, the engagement is enhanced by a pair of opposing slots <NUM> extending longitudinally through the sidewall <NUM>. The slots <NUM> create resiliency within with sidewall <NUM> that further aid in frictionally engaging the proximal end portion <NUM> of the instrument <NUM>. In addition, as the aperture <NUM> receives the proximal end portion <NUM>, the slots <NUM> vent ambient air from within the aperture <NUM> to inhibit air pressure buildup that may force the instrument <NUM> from the chuck <NUM> after insertion. However, it will be appreciated that other structures may be used to create resiliency and vents. For example, the chuck <NUM> may be manufactured from a relatively resilient material, and the aperture <NUM> may include a vent of any shape through another portion of the chuck <NUM> for releasing air pressure. In an alternative embodiment, the proximal end portion <NUM> may be removably attached to the chuck <NUM> via other structures or connectors, such as a collar or clasp. In any case, the invention is not intended to be limited to the exemplary embodiments described herein.

<FIG> show an exemplary embodiment of the cross-sectional member profile <NUM> defined by the proximal end portion <NUM> that inserts into the aperture <NUM>, at least a portion of which has a cross-sectional aperture profile <NUM> for frictionally mating with the cross-sectional member profile <NUM>. The cross-sectional member profile <NUM> is generally longitudinally uniform along the proximal end portion <NUM> with a constant cross-section. However, it will be appreciated that the proximal end portion <NUM> may taper toward the chuck <NUM> or have another suitable shape for insertion into the aperture <NUM> in an alternative embodiment.

More particularly, the proximal end portion <NUM> has a pair of generally parallel cylindrical portions <NUM> connected by a generally linear tab portion <NUM> therebetween. As such, the proximal end portion <NUM> defines the cross-sectional member profile <NUM> as a pair of curved, opposing major arc surfaces <NUM> connected by a pair of opposing linear surfaces <NUM>. Accordingly, the generally cylindrical portions <NUM> at least partially define a groove <NUM> extending longitudinally along the proximal end portion <NUM>. According to an exemplary embodiment, the linear tab portion <NUM> and generally cylindrical portions <NUM> define a pair of opposing grooves <NUM> extending longitudinally along the proximal end portion <NUM>.

In order to receive the proximal end portion <NUM> of the instrument <NUM>, the sidewall <NUM> defines at least a portion of the aperture <NUM> with the cross-sectional aperture profile <NUM>. As such, the cross-sectional aperture profile <NUM> has similar, mating surfaces to the cross-sectional member profile <NUM>. The aperture <NUM> has a pair of generally parallel cylindrical hole portions <NUM> connected by a generally linear slot portion <NUM> therebetween. The proximal end portion <NUM> thus defines the cross-sectional aperture profile <NUM> as a pair of curved, opposing major arc surfaces <NUM> connected by a pair of opposing linear surfaces <NUM>. Accordingly, the generally cylindrical hole portions <NUM> and linear slot portion <NUM> define a pair of opposing projections <NUM> extending longitudinally along the sidewalls <NUM> within the aperture <NUM>.

As the chuck <NUM> is operatively rotated, the sidewall <NUM> transmits torque to the proximal end portion <NUM> and, in turn, rotates the instrument <NUM>. Effectively, each projection <NUM> is keyed to the respective groove <NUM> for transmitting the torque. Furthermore, the exemplary embodiment of the cross-sectional aperture profile <NUM> inhibits insertion of unsuitable instruments while continuing to effectively engage the proximal end portion <NUM> with many stress-reducing curved surfaces. However, it will be appreciated that the exemplary embodiment of the aperture <NUM> and the proximal end portion <NUM> may be other cooperating shapes providing for removable attachment. To the extent other profiles may function similarly to the embodiment described above, it will be appreciated that the exemplary embodiment of the instrument <NUM> shown in <FIG> may have ornamental characteristics, as well.

With respect to <FIG> and <FIG>, the device <NUM> is used in a method for treating ocular disorders of the eye <NUM>. While the method for treating ocular disorder will be described with respect to device <NUM>, it will be appreciated that the device <NUM> (see <FIG>) may be similarly used. For purposes of describing the environment in which this method occurs, <FIG> and <FIG> generally show a portion of a face <NUM> having a nose <NUM>, an eyebrow <NUM>, and the eye <NUM>. The eye <NUM> described herein generally includes, but is not limited to, an eyeball <NUM> including a cornea <NUM>, an upper eyelid margin <NUM>, a lower eyelid margin <NUM>, and a plurality of eyelashes <NUM>. The device <NUM> is the swab <NUM> operably connected to the mechanical drive unit <NUM> thereby creating the electromechanical device <NUM> for use in removing debris deposited on at least one of either the upper eyelid margin <NUM> or the lower eyelid margin <NUM>.

As shown in <FIG>, an instrument <NUM> is removably secured to the chuck <NUM>, after which time, the electromechanical device <NUM> may be powered on and set to a desirable speed by the operator; thereby, the operator effects movement of the swab <NUM> relative to the electromechanical device <NUM>. Such movement may include, but is not limited to, reciprocating the swab <NUM> as shown by arrows 38a, rotating the swab <NUM> as shown by arrow 38b, and/or vibrating the swab <NUM> as shown by lines 38c. The swab <NUM> is positioned near the eyeball <NUM> and along either one of the upper or lower eyelid margins <NUM>, <NUM> for treatment. In the exemplary embodiment as shown in <FIG> and <FIG>, the swab <NUM> moves with constant movement relative to the electromechanical device <NUM> while near the eyeball <NUM>. Alternatively, it may be desirable to vary the movement of the swab <NUM> relative to the electromechanical device <NUM> such that the operator has greater control of treating the ocular disorder.

In an exemplary embodiment, the operator preferably targets the debris present on the eye <NUM> with the swab <NUM> of the electromechanical device <NUM>. The debris may be targeted by visually inspecting the eye <NUM> with or without the aid of a magnification device. Once the debris is targeted, the swab <NUM> contacts the portion of the eye <NUM> 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 <NUM>, <NUM> or the plurality of eyelashes <NUM>. Thereby, upon contacting the portion of the eye <NUM> with the debris, the swab <NUM> impacts the debris to remove the debris from the eye <NUM>. Furthermore, a liquid solution configured to loosen the debris may be absorbed within the swab <NUM> to further aid in removing the debris from the eye <NUM> and/or minimizing irritation to the eye <NUM>. 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.

The electromechanical device <NUM> operably drives the swab <NUM> to break the debris free from either of the upper or lower eyelid margins <NUM>, <NUM>. 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 <NUM>. Such treatment may include scrubbing, exfoliating, or buffing the eyelid margin or un-roofing a meibomian gland <NUM> with the swab <NUM>.

In another aspect, the cornea <NUM> of the eye <NUM> is directed away from the position of the swab <NUM> to minimize contacting the swab <NUM> to the cornea <NUM> during treatment. As shown in <FIG>, while treating the lower eyelid margin <NUM>, the eyeball <NUM> directs the cornea <NUM> upward, thereby bringing the cornea <NUM> closer to the upper eyelid margin <NUM> than the lower eyelid margin <NUM>. However, as shown in <FIG>, while treating the upper eyelid margin <NUM>, the eyeball <NUM> directs the cornea <NUM> downward, thereby being closer to the lower eyelid margin <NUM> than the upper eyelid margin <NUM>.

As shown in <FIG>, accessing the portion of the eye <NUM> with the debris, such as the upper or lower eyelid margins <NUM>, <NUM>, may be accomplished without further moving or lifting other portions of the eye <NUM>. However, as shown in <FIG>, if accessing the portion of the eye <NUM> with the debris is difficult, the operator may use a hand <NUM>, or similar gripping device, to move or lift a portion of the eye <NUM>, such as lifting the upper or lower eyelid margin <NUM>, <NUM> from against the eyeball <NUM>, to improve access to the debris. Such lifting may be particularly beneficial for improving access to the meibomian gland <NUM>. It will be appreciated that, in order to improve access to the debris, any portion of the eye <NUM> may be moved or lifted regardless of which eyelid margins <NUM>, <NUM> are being treated. <FIG> and <FIG> are merely exemplary embodiments showing both non-assisted access and assisted access of the swab <NUM> to the eye <NUM> respectively.

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 <NUM>. 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. Periodic intervals are treatments with the electromechanical device <NUM> once every month. It will be appreciated that any periodic interval of repeating the method of treating the ocular disorder with the electromechanical device <NUM> may be so used.

Alternatively, in the case of home treatment by the patient, the patient may treat his or her own ocular disorder with the electromechanical device <NUM> 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 <NUM> 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 <NUM> 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 <NUM>.

Claim 1:
An instrument (<NUM>; <NUM>) for the removal of a debris from an eye during the treatment of an ocular disorder, the instrument comprising:
a swab (<NUM>), the swab having a tip portion (<NUM>) and a base portion (<NUM>), the tip portion being sized to provide access to the debris on an eyelid margin of the eye; and
a rigid member (<NUM>), the rigid member having a distal end portion (<NUM>) and a proximal end portion (<NUM>, <NUM>), the distal end portion (<NUM>) being affixed to the base portion (<NUM>) of the swab;
characterized in that the proximal end portion of the rigid member has a connected pair of generally parallel cylindrical portions (<NUM>);
the generally parallel cylindrical portions (<NUM>) are connected by a generally linear tab portion (<NUM>); and
the linear tab portion and generally cylindrical portions define a pair of opposing grooves extending longitudinally along the proximal end portion.