Patent Application
20200093638
The present invention relates generally to methods and devices for removing debris from an eye to treat an ocular disorder.
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 ophthalmology and medical treatments in general, until recently, 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 prepares 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 68 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 at home in treating ocular disorders, such eyelid margin diseases, that addresses present challenges and characteristics such as those discussed above.
An aspect of the invention is directed to a device for removing debris from an eyelid of an eye such as, for example, during the treatment of an ocular disorder. The exemplary device includes a scrubbing strip mounted to a surface of a support. The scrubbing strip is configured to access the margin of the eyelid of the eye and the support is configured to engage at least one of a finger or a mechanical eyelid scrubbing device. In an embodiment, the support is in the form of a sleeve. The device may be used by medical personnel or used at home.
Another aspect of the invention is directed a mechanical device for removing debris from an eyelid of an eye during the treatment of an ocular disorder. The mechanical device includes a rigid member that has a distal end portion and a proximal end portion. The distal end portion includes a surface having a width that is greater than a width of the shaft of the rigid member and configured to be coupled to a scrubbing strip. The mechanical device also includes a mechanical drive unit having a body. The mechanical drive unit is secured to the proximal end portion of the rigid member. The mechanical drive unit operably moves scrubbing strip relative to said body facilitating removal of the debris from the eye.
Another aspect of the invention is directed to methods of removing debris from an eye and/or treating an ocular disorder utilizing the devices disclosed herein. The disclosed devices and methods may be used in a medical setting or at home.
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
The scrubbing strip 12 has a length L1, a width W1, and a height H1, such that when the scrubbing strip 12 is mounted on the surface 14 of the support 16, the scrubbing strip 12 may access an inner eyelid margin 22 of the upper and lower eyelids 26, 28 of the eye 30 to contact and remove debris 32 from the inner eyelid margin 22 while minimizing, and preferably avoiding, contact with a surface 34 of the eyeball 36 when the upper and lower eyelids 26, 28 are in a closed position. While embodiments of the scrubbing strip 12 on embodiments intended for use on a finger 18 are illustrated as having a length L1 running coaxial with the user's finger, in alternative embodiments, the length of the scrubbing strip 12 may be rotated about 90 degrees so as to be aligned generally perpendicular to the length of the user's finger when in use. It will be appreciated that the scrubbing strip 12 may also access an outer eyelid margin 24 of the eyelids 26, 28 to contact and remove debris.
In the exemplary embodiment, the length L1 of the scrubbing strip 12 is aligned generally parallel to the length L2 of the support 16, which, during use, will be aligned with the length of the finger 18 of the user. The length L1 of the scrubbing strip 12 is greater than the width W2. In an embodiment, the length L1 of the scrubbing strip 12 is from about 0.75 cm to about 2 cm. In an alternative embodiment, the length L1 of the scrubbing strip 12 is from about 1 cm to about 1.75 cm. In a further alternative embodiment, the length L1 of the scrubbing strip 12 is about 1.5 cm.
In the exemplary embodiment, the width W1 of the scrubbing strip 12 is aligned generally perpendicular to the length L1 and generally parallel with the width W2 of the support 16. In an embodiment, the width W1 of the scrubbing strip 12 is from about 1 mm to about 2 mm. In an alternative embodiment, the width W1 of the scrubbing strip 12 is from about 1.25 mm to about 1.75 mm. In a further alternative embodiment, the width W1 of the scrubbing strip 12 is about 1.5 mm.
The height H1 of the scrubbing strip 12 is the distance that the scrubbing strip 12 projects from the surface 14 of the support 16. In an embodiment, the height H1 of the scrubbing strip 12 is from about 0.75 mm to about 1.5 mm. In an alternative embodiment, the height H1 of the scrubbing strip 12 is from about 0.9 mm to about 1.2 mm. In a further alternative embodiment, the height H1 of the scrubbing strip 12 is about 1 mm.
In the exemplary embodiment, the scrubbing strip 12 has an upper surface 50 and a lower surface. The lower surface is not shown as it is blocked from view by the support 16. The exemplary scrubbing strip 12 also has oppositely disposed side surfaces 52, 54 that are generally parallel to the length L1 of the scrubbing strip 12. The scrubbing strip 12 may also have oppositely disposed end surfaces 56, 58 that are generally parallel to the width W1 of the scrubbing strip 12. The upper surface 50 of the scrubbing strip 12 is illustrated as being generally planar, however, the upper surface 50 may also take other shapes, such as forming a convex curve between the side surfaces 52, 54, the end surfaces 56, 58, or both the side and end surfaces.
It will be appreciated that the scrubbing strip 12 may be manufactured of any material suitable for contacting parts of the eye 30 without harming the eye 30 including the inner and outer eyelid margins 22, 24 of the upper and lower eyelids 26, 28, as well as the surface 34 of the eyeball 36. However, as shown in the embodiment of
In the embodiment illustrated in
The support 16 may be composed of any material having sufficient structural integrity to support the scrubbing strip 12 and that is safe for use around the eye 30. Exemplary materials include a woven material, a knit material, non-woven/non-knit fiber based material, a polymeric material, and combinations thereof. Elastic materials may also be used in aspects of the support 16, such as for the second sheet 40. In an embodiment, the first and second sheets are formed from a non-woven/non-knit polyester material.
The lower surface of the scrubbing strip 12 may be attached to the outer surface 14 of the support 16 with an adhesive that is safe for use on devices that come in contact with the eye 30. It is anticipated that the scrubbing strip 12 may be attached to the outer surface 14 of the support 16 with other techniques, such as stitching.
As illustrated in
With reference to
The rigid member 108 includes a shaft 116 and a central axis 118. The shaft 116 extends along the central axis 118 between the proximal end portion 112, which is coupled to the mechanical drive unit 102 and the distal end portion 110 having a scrubbing strip 104 coupled thereto. The rigid member 108 is sufficiently rigid to effectively transmit motion from the mechanical drive unit 102, to the distal end portion 110 and thereby, the scrubbing strip 104. In an embodiment, the rigid member 108 is made from a plastic material, however, other sufficient rigid materials may also be used.
In the exemplary embodiments shown in
In the exemplary embodiment, the width W3 of the distal end portion 110 of the rigid member 108 is at least as long as the length L5 of the scrubbing strip 104. Preferably, the width W3 of the distal end portion 110 is equal or slightly greater than (i.e., not more than about 20% greater, and preferably, not more than 10% greater than) the length L5 of the scrubbing strip. Accordingly, in an embodiment, the width W3 of the distal end portion 110 of the rigid member 108 is from about 0.75 cm to about 2.4 cm. In an alternative embodiment, the width W3 of the distal end portion 110 of the rigid member 108 is from about 0.75 cm to about 2.2 cm. In another alternative embodiment, the width W3 of the distal end portion 110 of the rigid member 108 is from about 1 cm to about 2 cm. In another alternative embodiment, the width W3 of the distal end portion 110 of the rigid member 108 is from about 1.5 cm to about 1.8 cm.
In the exemplary embodiment, the length L3 of the distal end portion 110, as measured between the distal edge 173 and the proximal edge 174 of the distal end portion 110, is greater than the width W5 of the scrubbing strip 104. In an embodiment, the length L3 of the distal end portion 110 is at least two times greater than the width W5 of the scrubbing strip. In an alternative embodiment, the length L3 of the distal end portion 110 is at least three times greater than the width W5 of the scrubbing strip. In an embodiment, the length L3 of the distal end portion 110 is from about 2 mm to about 20 mm. In another embodiment, the length L3 of the distal end portion 110 is from about 5 mm to about 15 mm. In another embodiment, the length L3 of the distal end portion 110 is from about 6 mm to about 10 mm.
The mechanical drive unit 102 includes a body 124, an electric motor 126, a chuck 128, and a control switch 130. As such, the device 100 is electromechanical in nature. In an exemplary embodiment, the electric motor 126, the chuck 128, and the control switch 130 are integrated into the body 124 so that the mechanical eye wipe device 100 is configured to be handheld as shown in
According to the present embodiment, the electric motor 126 is positioned within the body 124. The chuck 128 is operably connected to the electric motor 126 at a forward end portion 134 of the body 124. The proximal end portion 112 of the rigid member 108 is removably secured to the chuck 128. As described herein, the chuck 128 is generally any element capable of securing the rigid member 108 to the mechanical drive unit 102. In embodiments utilizing a removable rigid member, the chuck 128 may be tightened or loosened to respectively secure or remove the removable rigid member to the chuck 128. Through the chuck 128, the operable connection of the electric motor 126 transmits a movement to the rigid member 108. The movement is any motion relative to the mechanical drive unit 102 or, more particularly, to the body 124, that creates relative motion to the debris 140 on the eye such that upon contacting the debris 140 with the scrubbing strip 104, the debris 140 is removed. The mechanical drive unit 102 creates relative motion M in the distal end portion 110 of the rigid member 108 that is in the same general direction as the length L5 of the scrubbing strip 104 coupled to the distal end portion. In embodiments in which the scrubbing strip 104 is coupled to the distal end portion 110 with the length L5 of the scrubbing strip 104 extending in a direction generally perpendicular to the central axis 118 of the shaft 116, the mechanical drive unit 102 creates a side to side movement M that is generally perpendicular to the central axis 118 of the shaft 116. This alternative embodiment is not illustrated herein. In alternative embodiments in which the scrubbing strip 104 may be coupled to the distal end portion 110 with the length L4 extending in a direction generally parallel to the central axis 118 of the shaft 116, the mechanical drive unit creates an in and out movement that is generally parallel to the central axis 118 of the shaft 116. Thus, the movement may be a vibrating movement either orthogonal to the central axis 118 of the rigid member 108 or along the central axis 118 of the rigid member 108. In addition, the speed of the movement of the scrubbing strip 104 is any speed sufficient to remove debris 140 from on the eye 142. It will be appreciated that the speed discussed herein collectively refers to both relative speed of the scrubbing strip 104 and the frequency of the movement of the scrubbing strip 104. For instance, the frequency may range from sonic frequencies to ultrasonic frequencies. Furthermore, the speed of the scrubbing strip 104 may be variable or otherwise selectable such that an operator of the device 100 may select a desirable speed via the control switch 130.
Moreover, the control switch 130 is operably connected to the electric motor 126 and an electric power source 146 to power the device 100 on and off. In an exemplary embodiment, the electric power source 146 is a battery power source contained within the body 124. The battery power source may be either disposable or rechargeable. The electric power source 146 operably provides electrical power to the electric motor 126, which the operator controls via the control switch 130. It will be appreciated that any known control switch or plurality of control switches may be configured to power the device 100 on and off.
Furthermore, it will be appreciated that the device 100 may be manufactured from various materials suited to specific environments of use. For instance, operators may desire a durable, reusable mechanical drive unit 102 with permanently attached rigid members 108 but with single use scrubbing strips 104 shown in
The scrubbing strip 104 for use on the mechanical eye wipe device 100 is similar to the scrubbing strip 12 utilized with the eye wipe device 10 described herein with respect to the embodiment illustrated in
In particular the scrubbing strip 104 has a length L5, a width W5, and a height H5, such that when the scrubbing strip 104 is mounted on the surface 151 of support 150 (
The length L5 is greater than the width W4. In an embodiment, the length L5 of the scrubbing strip 104 is from about 0.75 cm to about 2 cm. In an alternative embodiment, the length L5 of the scrubbing strip 104 is from about 1 cm to about 1.75 cm. In a further alternative embodiment, the length L5 of the scrubbing strip 104 is about 1.5 cm.
The width W5 of the scrubbing strip 104 is aligned generally perpendicular to the length L5 and generally parallel to the length L6 the surface 151 of the support 150. In an embodiment, the width W5 of the scrubbing strip 104 is from about 1 mm to about 2 mm. In an alternative embodiment, the width W5 of the scrubbing strip 104 is from about 1.25 mm to about 1.75 mm. In a further alternative embodiment, the width W5 of the scrubbing strip 104 is about 1.5 mm.
The height H5 of the scrubbing strip 104 is the distance that the scrubbing strip 104 projects from the surface 151 of the support 150 (
The scrubbing strip 104 has an upper surface 164 and a lower surface, which is not shown as it is block from view by the support 150 (
It will be appreciated that the scrubbing strip 104 may be manufactured of any material suitable for contacting parts of the eye 142 without harming the eye 142 including the inner and outer eyelid margins 152, 153 of the upper and lower eyelids 154, 156 as well as the surface 158 of the eyeball 159. As shown in the embodiment of
In the exemplary embodiment illustrated in
As illustrated in the exemplary embodiment shown in
The support 150 may be composed of any material having sufficient structural integrity to support the scrubbing strip 104 and that is safe for use around the eye 142. Exemplary materials include a woven material, a knit material, non-woven/non-knit fiber based material, a polymeric material and combinations thereof. Elastic materials may also be used in aspects of the support 150, such as for the second sheet 176. In an embodiment, the first and second sheets are formed from a non-woven/non-knit polyester material.
The lower surface of the scrubbing strip 104 may be attached to the outer surface 151 of the support 150 with an adhesive that is safe for use on devices that come in contact with the eye. The scrubbing strip 104 may be attached to the outer surface 151 of the support 150 with other techniques, such as stitching.
As illustrated in
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. For example, while embodiments of the scrubbing strip on embodiments intended for use on a finger are illustrated as having a length running coaxial with the length of the user's finger, in alternative embodiments, the length of the scrubbing strip may be rotated about 90 degrees so as to be aligned generally perpendicular to the length of the user's finger when in use. Likewise, while embodiments of the scrubbing strip intended for use with a mechanical device are illustrate as running perpendicular to the central axis of the rigid member shaft, in alternative embodiments, the length of the scrubbing strip may be rotated about 90 degrees so as to be aligned generally parallel to the central axis. In this alternative embodiment, the device will move the scrubbing strip generally parallel to the central axis of the rigid member. Furthermore, embodiments of the scrubbing strip 12 on embodiments intended for use on a finger 18 are illustrated as having a length L1 extending only partially along the length L2 of the support 16, i.e., the scrubbing strip 12 does not extend along its length L2 all the way to either the closed end 46 or the end with the opening 44 of the support 16. However, it is anticipated that the scrubbing strip 12 could extend all the way to, or nearly all the way to the closed end 46, the end with the opening 44, or both the closed end 46 and end with the opening 44 of the support 16. 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.
This application is a Divisional of U.S. patent application Ser. No. 14/889,707, filed Nov. 6, 2015 (pending), which claims priority to International Patent Application No. PCT/US2015/013790, filed Jan. 30, 2015, the disclosures of which are incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14889707 | Nov 2015 | US |
| Child | 16689459 | US |
