An eyelid speculum, a kit containing the eyelid speculum, and a method of using the eyelid speculum in the diagnosis and/or treatment of a patient are provided. The eyelid speculum includes a central ring having an upper surface, a lower surface, an inner side surface, an outer side surface, a first end, and a second end. The first end and the second end are separated by a gap, and the central ring defines an opening. The eyelid speculum also includes first and second eyelid margin holders that extend outwardly from the outer side surface of the central ring at the first end and second end, respectively, where each eyelid margin holder has an upper portion and a lower portion. In addition, the eyelid speculum includes finger tabs that extend upwardly from the upper portions of the first and second eyelid margin holders.

BACKGROUND OF THE INVENTION

The traditional eyelid speculum is one of the most commonly used devices in ophthalmology. For example, recent surveys indicate that physicians in the United States use a traditional eyelid speculum at least 75% of the time when performing intravitreal injections, and the number of intravitreal injections performed yearly to treat conditions such as macular degeneration, diabetic retinopathy, and retinal vein occlusions, among other conditions, is estimated to be approximately 6 million in the United States and 22 million worldwide. One particular example of a traditional eyelid speculum is known by those in the art as the Barraquer speculum. The Barraquer speculum includes open or solid wire loops that are designed to retract the eyelids during ophthalmic surgery or minor office procedures, such as during eye injections. The purpose of an eyelid speculum is to retract the eyelids of a patient to allow for consistent exposure for surgical maneuvers, intravitreal injections, imaging procedures, and the like. The Barraquer speculum is typically formed of metal and wire and is a large device that is often intimidating to patients, with many patients finding the insertion of the Barraquer speculum to be more uncomfortable than the surgery or office procedure that follows. Moreover, the Barraquer speculum is not disposable and must be autoclaved for sterile reuse, where there is a risk that the Barraquer speculum may not be sterile if the autoclave procedure is not conducted properly. Another instrument that may be used is the Desmarres or Jaffe eyelid retractor, but, like the Barraquer speculum, it is often formed from metal, is not disposable, and must be autoclaved before reuse. Therefore, it shares many of the disadvantages of the Barraquer speculum.

As an alternative, some physicians opt to manually retract a patient's eyelids without the use of a speculum. Although many patients indicated this is more comfortable than eyelid retraction via a Barraquer speculum, manual retraction may not provide the safety to adequately expose an injection site and may not prevent contact of an instrument (e.g., a needle) with a patient's eyelashes, which puts the patient at risk for developing an infection. Further, involuntary eyelid closure during injections has been shown to lead to increased levels of needle contamination when no eyelid speculum is used

As such, a need currently exists for an eyelid speculum that is more comfortable to the patient and that is easily insertable by the physician, health care provider, or assistant. An economical, disposable eyelid speculum would also be useful.

SUMMARY OF THE INVENTION

In accordance with one exemplary embodiment of the present invention, an eyelid speculum is provided.

According to one particular embodiment of the present invention, an eyelid speculum is provided. The eyelid speculum includes a central ring having an upper surface, a lower surface, an inner side surface, an outer side surface, a first end, and a second end. The first end and the second end are separated by a gap, and the central ring defines an opening. The eyelid speculum also includes a first eyelid margin holder extending outwardly from the outer surface of the central ring at the first end and having an upper portion and a lower portion, a second eyelid margin holder extending outwardly from the outer surface of the central ring at the second end and having an upper portion and a lower portion, a first finger tab extending upwardly from the upper portion of the first eyelid margin holder, and a second finger tab extending upwardly from the upper portion of the second eyelid margin holder.

In one embodiment, an angle formed between the first end and the second end can range from about 120° to about 185°.

In another embodiment, the central ring can be c-shaped or semicircular.

In still another embodiment, the first eyelid margin-holder and the second eyelid margin holder can be c-shaped or semicircular.

In yet another embodiment, the upper portions and the lower portions of the first eyelid margin holder and the second eyelid margin holder can extend from the outer side surface of the central ring.

In an additional embodiment, the upper portions and the lower portions of the first eyelid margin holder and the second eyelid margin holder can be curved.

In one more embodiment, the upper portion and the lower portion of the first eyelid margin holder can be separated by a central portion and the upper portion and the lower portion of the second eyelid margin holder can be separated by a central portion. Further, the central portion of the first eyelid margin holder and the central portion of the second eyelid margin holder can each contact the outer side surface of the central ring.

In another embodiment, the first finger tab and the second finger tab can each include a textured outer surface. Further, the textured outer surface can include a plurality of ridges.

In still another embodiment, the first eyelid margin holder can be configured for positioning around an upper eyelid and the second eyelid margin holder can be configured for positioning around a lower eyelid.

In yet another embodiment, the central ring can be free from contact with an outer surface of an eye of a patient when the eyelid speculum is used to retract an eyelid of the patient.

In an additional embodiment, the eyelid speculum can be formed from a thermoplastic polymer. Further, the thermoplastic polymer can include acrylonitrile butadiene styrene, polyethylene, polypropylene, polycarbonate, polyamide, polystyrene, polymethyl methacrylate, or a combination thereof.

In one more embodiment, the eyelid speculum can be disposable after a single use.

In another embodiment, the eyelid speculum can include an attachment, where the central ring can include a first mating component and the attachment can include a second mating component, where the central ring and the attachment can be connected by the first mating component and the second mating component.

In another particular embodiment of the present invention, a kit comprising the eyelid speculum described above and a medication delivery system is also provided. Further, the eyelid speculum and the medication delivery system can be contained within a sterilized package. In addition, the kit can also include a medication.

In still another particular embodiment of the present invention, a method for separating a first eyelid and a second eyelid from an outer surface of an eye is provided. The method can include the step of inserting the eyelid speculum into an eye of a patient, where the lower surface of the central ring is positioned adjacent yet does not contact the outer surface of the eye, where the first eyelid margin holder is positioned at an inner corner of the eye and the second eyelid margin holder is positioned at an outer corner of the eye. The method can also then include the step of rotating the eyelid speculum in a first direction by about 75° to about 115° via the first finger tab and the second finger tab by about 75° to about 115° such that the first eyelid is positioned between the upper portion and the lower portion of the first eyelid margin holder and the second eyelid is positioned between the upper portion and the lower portion of the second eyelid margin holder. Such an angle allows for a more controlled, safer, and comfortable insertion mechanism than the traditional wire speculum and may avoid the inadvertent corneal trauma sometimes associated with the metal lid holders found in traditional wire speculums.

In another embodiment, the method can also include the steps of performing a desired diagnostic or treatment procedure and removing the eyelid speculum by rotating the eyelid speculum in a second direction that is opposite the first direction by about 75° to about 115° via the first finger tab and the second finger tab such that the first eyelid margin holder is positioned at an inner corner of the eye and the second eyelid margin holder is positioned at an outer corner of the eye and lifting the eyelid speculum away from the outer surface of the eye.

DETAILED DESCRIPTION OF REPRESENTATIVE EMBODIMENTS

As used herein, the terms “about,” “approximately,” or “generally,” when used to modify a value, indicates that the value can be raised or lowered by 5% and remain within the disclosed embodiment. Further, when a plurality of ranges are provided, any combination of a minimum value and a maximum value described in the plurality of ranges are contemplated by the present invention. For example, if ranges of “from about 20% to about 80%” and “from about 30% to about 70%” are described, a range of “from about 20% to about 70%” or a range of “from about 30% to about 80%” are also contemplated by the present invention.

Generally speaking, the present invention is directed to an eyelid speculum, a kit containing the eyelid speculum, and a method of using the eyelid speculum in the diagnosis and/or treatment of a patient. The eyelid speculum includes a central ring having an upper surface, a lower surface, an inner side surface, an outer side surface, a first end, and a second end. The first end and the second end are separated by a gap, and the central ring defines an opening. The eyelid speculum also includes a first eyelid margin holder and a second eyelid margin holder that both extend outwardly from the outer surface of the central ring at the first end and second end, respectively, where each eyelid margin holder has an upper portion and a lower portion. In addition, the eyelid speculum includes finger tabs that extend upwardly from the upper portions of the first eyelid margin holder and the second eyelid margin holder.

Without intending to be limited by any particular theory, the present inventors have found that the particular features of the eyelid speculum of the present invention allow for the eyelid speculum to retract the eyelids and eyelashes adequately so that a health care provider can perform a desired diagnostic or treatment procedure on the eye (e.g., injections, imaging, and any other diagnostic or treatment procedures) with an unobstructed view and with minimized risk for contamination. Specifically, the eyelid speculum of the present invention is compact and sturdy yet comfortable to the patient, where the semicircular or c-shaped design of the central ring, where a gap is present between opposing ends of the ring and the central opening of the ring that allows for an unobstructed view of the portion of the eye being examined, imaged, injected, etc. In addition, the lid margin holds are curved such that they may form a c-shape or semicircular-shape, where the curved shape allows for the eyelid and eyelashes to be “scooped” into the eyelid margin holder and out of the health care provider's field of view when performing any variety of eye procedures. The shape of the eyelid margin holders also allows for the central ring to be anteriorly displaced from the outer surface of the eye (e.g., the corneal surface) so that the patient can still move his or her eye up and down and from side to side to, for instance, facilitate exposure of the injection site without the cornea contacting the eyelid speculum.

Further, the lid margin holders are spaced apart from each other by an angle θ that is defined as the angle between the first end and the second end of the central ring of the eyelid speculum, where the θ ranges from about 120° to about 185°, such as from about 125° to about 175°, such as from about 135° to about 165°. This particular angle range allows for the health care provider to accurately place the eyelid speculum for retraction of the eyelid and eyelashes, where if the angle was too small or too large, proper placement of the eyelid speculum in a location to retract both the eyelids would be challenging. Moreover, the finger tabs extending upwardly from the outer edge of the upper portion of each of the lid margin holders facilitate handling of the eyelid speculum in a safe and sterile manner. Thus, the eyelid speculum of the present invention allows for a more comfortable experience for the patient, while also allowing the health care provider to have an unobstructed view of the desired portions of the patient's eye for then conducting a diagnostic or treatment procedure.

In addition, the eyelid speculum can be formed from autoclavable and/or sterilizable materials that can also be disposable, thus eliminating the need to re-sterilize the eyelid speculum, which can increase the risk of a patient acquiring an infection. For instance, the eyelid speculum can be formed from a thermoplastic polymer. Although any suitable thermoplastic polymer can be used to form the eyelid speculum of the present invention, in one particular embodiment, the eyelid speculum and any accessories, attachments, etc. can be formed from acrylonitrile butadiene styrene, polyethylene, polypropylene, polycarbonate, polyamide, polystyrene, polymethyl methacrylate, or a combination thereof. In still other embodiments, the eyelid speculum and any accessories, attachments, etc. can be formed from any suitable biodegradable material. Moreover, it is to be understood that the eyelid speculum and any accessories, attachments, etc. can be formed via injection molding, 3D printing, thermomolding, or any other suitable method.

Various embodiments of the present invention will now be described in more detail.

Referring now toFIGS. 1-5, the particular components of the eyelid speculum100of the present invention are shown. Specifically,FIG. 1is a perspective view of the eyelid speculum100of the present invention,FIG. 2is a front view of the eyelid speculum100of the present invention,FIG. 3is a top view of the eyelid speculum100of the present invention,FIG. 4is a perspective view of another embodiment of the eyelid speculum of the present invention, andFIG. 5is a side view of the eyelid speculum of the present invention. The eyelid speculum100includes a central ring102extending in a horizontal or x-direction and having an upper surface152, a lower surface154, an inner side surface156, an outer side surface158, a first end124, and a second end126. The first end124and the second end126are separated by a gap150, and the central ring defines an opening104, where such opening104allows a health care provider to have an unobstructed view of the desired portions of a patient's eye for then conducting any number of diagnostic and/or treatment procedures. The eyelid speculum100also includes a first eyelid margin holder106and a second eyelid margin holder108that both extend outwardly from the outer side surface158of the central ring at the first end124and the second end126, respectively, where each eyelid margin holder106,108has an upper portion116and a lower portion118that are separated by a central portion160. Further, the central portion160of the first eyelid margin holder106and the central portion160of the second eyelid margin holder108each contact the outer side surface158of the central ring102. As described above, the first lid margin holder106and the second lid margin holder108are spaced apart from each other by an angle θ that is defined as the angle between the first end124and the second end126of the central ring102of the eyelid speculum100, where the8ranges from about 120° to about 185°, such as from about 125° to about 175°, such as from about 135° about 165°. Additionally, the upper portions116and the lower portions118of the first lid margin holder106and the second lid margin holder108can be curved (e.g., c-shaped or semicircular) to form a scoop-like shape to easily hold a patient's eyelids and eyelashes when the eyelid speculum100is inserted into an eye of a patient.

In addition, the eyelid speculum100includes a first finger tab110and a second finger tab112that extend upwardly in the vertical or y-direction, for instance, next to or adjacent the outer edge120and the outer edge122of the upper portions116of the first eyelid margin holder106and the second eyelid margin holder108. As shown inFIGS. 1 and 3, the first finger tab110and the second finger tab112can either be straight, or, in some embodiments (not shown), the first finger tab110and the second finger tab112can be curved (e.g., semicircular or c-shaped), where the curved-shape can correspond with the curved-shape of the outer edge120and the outer edge122of the upper portions116of the first eyelid margin holder106and the second eyelid margin holder108. Further, the outer surface114of the finger tabs110and112can be textured to enable the health care provider to easily grasp the finger tabs110and112during insertion and rotation of the eyelid speculum100. For example, the outer surface114can include a plurality of ridges162or any other suitable texturing means.

AlthoughFIGS. 1-5show one particular embodiment of the eyelid speculum100in terms of shape and size, it is to be understood that the eyelid speculum100can come in various shapes and sizes to treat newborns, infants, toddlers, young adults, adults, and even large animals (e.g., cows, horses, etc.). For instance, comparingFIG. 6A, which shows the eyelid speculum100ofFIGS. 1-5withFIG. 6B, it is appreciated by one of skill in the art that the size of the finger tabs110and112, the size of the central ring102, and the size of the first eyelid margin holder106and the second eyelid margin holder108can vary depending on the particular patient being diagnosed or treated (e.g., premature baby, infant, toddler, young adult, adult) and the particular procedure being conducted (e.g., injection, imaging, laser procedure, surgical procedure). Specifically, eyelid speculum200ofFIG. 6Bhas smaller finger tabs110and112and a thinner central ring102compared to the eyelid speculum100.

In addition, as shown inFIGS. 1, 2, and 4, the central portion120as well as the upper portion116and lower portion118of the first eyelid margin holder106and the second eyelid margin holder108can include one or more ridges164. The ridges164help to maintain the eyelid speculum100in the proper position when being used on a patient by counteracting any movement of the eyelid speculum100that might be caused by a patient squeezing or trying to close his or her eyelids, which could lead to counter rotation and misalignment of the eyelid speculum100. Without intending to be limited by any particular theory, the present inventors have found that the ridges164on the inner surfaces of the first eyelid margin holder106and the second eyelid margin holder108can prevent movement of the eyelid speculum100when aligned perpendicular to the direction of the eyelid movement.

In any event and referring toFIG. 2, the eyelid speculums100and200contemplated by the present invention can have an overall height H1in the vertical or y-direction ranging from about 0.2 inches (about 5.1 millimeters) to about 0.8 inches (about 20.3 millimeters), such as from about 0.3 inches (about 7.6 millimeters) to about 0.7 inches (about 17.8 millimeters), such as from about 0.4 inches (about 10.2 millimeters) to about 0.6 inches (about 15.2 millimeters). In addition, the distance between the upper portion116and the lower portion118of the first eyelid margin holder106and the distance between the upper portion116and the lower portion118of the second eyelid margin holder108can have a height H2in the vertical or y-direction ranging from about 0.15 inches (about 3.8 millimeters) to about 0.45 inches (about 11.4 millimeters), such as from about 0.2 inches (about 5.1 millimeters) to about 0.4 inches (about 10.2 millimeters), such as from about 0.25 inches (about 6.4 millimeters) to about 0.35 inches (about 8.9 millimeters). Moreover, the ratio of H1/H2can range from about 1.25 to about 2.5, such as from about 1.5 to about 2.25, such as from about 1.75 to about 2.

Further, the eyelid speculums100and200can have an overall width W1in the horizontal or x-direction ranging from about 0.5 inches (about 12.7 millimeters) to about 1.75 inches (about 44.5 millimeters), such as from about 0.75 inches (about 19.1 millimeters) to about 1.5 inches (38.1 millimeters), such as from about 1 inch (about 25.4 millimeters) to about 1.25 inches (about 31.8 millimeters). In addition, the opening104defined by the central ring102can have a width W2in the horizontal or x-axis can range from about 0.25 inches (about 6.4 millimeters) to about 0.75 inches (about 19.1 millimeters), such as from about 0.35 inches (about 8.9 millimeters) to about 0.65 inches (about 16.5 millimeters), such as from about 0.45 inches (about 11.4 millimeters) to about 0.55 inches (about 14.0 millimeters). Additionally, the ratio of W1/W2can range from about 1.5 to about 3, such as from about 1.75 to about 2.75, such as from about 2 to about 2.5.

Moreover, and referring toFIG. 5, the width W3of the eyelid margin holders106and108can range from about 0.1 inches (about 2.5 millimeters) to about 0.4 inches (about 10.2 millimeters), such as from about 0.15 inches (about 3.8 millimeters) to about 0.35 inches (about 8.9 millimeters), such as from about 0.2 inches (about 5.1 millimeters) to about 0.3 inches (about 7.6 millimeters). Further, the width W4of the finger tabs110and112can range from about 0.075 inches (about 1.9 millimeters) to about 0.3 inches (about 7.6 millimeters), such as from about 0.1 inches (about 2.5 millimeters) to about 0.25 inches (about 6.4 millimeters), such as from about 0.15 inches (about 3.8 millimeters) to about 0.2 inches (about 5.1 millimeters). In addition, the ratio of W3/W4can range from about 1.1 to about 1.5, such as from about 1.2 to about 1.45, such as from about 1.3 to about 1.4.

Without intending to be limited by any particular theory, the present inventors have found that utilizing the particular height and width dimensions and ratios described balances the comfort of the patient with the ability of the health care provider to easily insert the eyelid speculums contemplated by the present invention.

Turning now toFIGS. 7A-7C, the present invention also contemplates that the eyelid speculum100can include one or more attachments300that can be positioned on the central ring102of the eyelid speculum100. For instance, the central ring102can include a first mating component304and the attachment300can includes a second mating component302, wherein central ring102and the attachment300can be connected to one another by the first mating304component and the second mating component302. The first mating component304can be in the form of an indentation, socket, etc., while the second mating component302can be in the form of a protrusion, ball, etc. and vice versa. In any event, any suitable attachment mechanisms can be used to join the eyelid speculum100to the attachment300, and when connected, the outer surface308of the attachment300can be positioned adjacent the outer side surface158of the central ring102, and the first edge310and the second edge312of the attachment can be positioned between the first end124and the second end126of the central ring102. Meanwhile, the attachment300can have a curved shape such that the inner surface306of the attachment300can be defined by upper portion314and lower portion316of the attachment. The attachment300can be used in conjunction with the eyelid speculum100during certain procedures such as anterior chamber paracentesis, where the health care provider can press on the attachment300with a finger, such as at its upper portion316, to indirectly press on the eye, stabilize the eye globe during insertion of a needle into the anterior chamber, and help express fluid into a needle inserted in the anterior chamber between the cornea and iris. Thus, the present invention is directed to not only the eyelid speculum100described above, but also various accessories such as the attachment300discussed above, or any other accessory that can be attached to the eyelid speculum100to assist a health care provider in performing a diagnostic or treatment procedure. For instance, accessories such as attachment300can be used not only for anterior chamber paracentesis, but can also be used during removal of corneal foreign bodies, surgical lens placement, imaging, vitrectomy viewing, etc. For example, and referring toFIGS. 11 and 12, the eyelid speculum100can be used for placement of a surgical lens318, where the surgical lens318can be placed within the opening104and can be designed so that the perimeter of the surgical lens318has the same curvature as the central ring102.

Referring now toFIGS. 8A-9, one method400for using the eyelid speculum100of the present invention to retract the eyelids of a patient is described in more detail. Generally, the method400for separating a first eyelid140(e.g., the upper eyelid) and a second eyelid142(e.g., lower eyelid) as well as the eyelashes144of a patient128from an outer surface138(e.g., the corneal surface covering the pupil132and iris136of an eye130and continuous with the sclera134) of the eye130includes obtaining an eyelid speculum in step402, and then inserting the eyelid speculum into an eye of a patient in step404, where the lower surface154of the central ring102of the eyelid speculum100is positioned adjacent yet does not contact the outer surface138of the eye130, wherein the first eyelid margin holder106is positioned at an inner corner146of the eye130and the second eyelid margin holder108is positioned at an outer corner148of the eye130. Such initial positioning is shown inFIG. 8Afor a left eye130of a patient128, although it is to be understood that similar positioning would be used for the right eye.

Next, in step406, a health care provider can rotate the eyelid speculum100by about 75° to about 115° of a 360° circle, such as from about 80° to about 110°, such as from about 85° to about 105° via the finger tabs110and112so that the upper eyelid140as well as at least a portion of the patient's eyelashes144extending from the upper eyelid140are positioned between the upper portion116and lower portion118of the first eyelid margin holder106and so that the lower eyelid142as well as at least a portion of the patient's eyelashes144extending from the lower eyelid142are positioned between the upper portion116and lower portion118of the second eyelid margin holder108, as shown inFIG. 8B. When placing the eyelid speculum100in the left eye, the eyelid speculum100can be rotated in the counterclockwise direction, and when placing the eyelid speculum in the right eye, the eyelid speculum100can be rotated in the clockwise direction. However, it is also to be understood that when placing the eyelid speculum100in the left eye, the eyelid speculum100can be rotated in the clockwise direction, and when placing the eyelid speculum in the right eye, the eyelid speculum100can be rotated in the counterclockwise direction, and the direction of rotation can depend upon the anatomical location of the eye that the healthcare provider needs access to for performing a specific diagnostic or treatment procedure.

Additionally, after inserting the eyelid speculum100into the eye130of the patient128as shown inFIGS. 8A and 8B, the patient128is still able to move his or her eye130in the medial M or lateral L direction as shown inFIG. 8Csince the central ring102is free from contact with the outer surface138of the eye130. This feature of the eyelid speculum100allows for a more comfortable experience for the patient128and also provides more options for the healthcare provider in performing any diagnostic or treatment procedures since the patient128is able to move his or her eye130, as shown in step408.

Next, after the desired diagnostic or treatment procedure has been performed, the eyelid speculum100can be removed in step410by rotating the eyelid speculum100by about 75° to about 115° of a 360° circle, such as from about 80° to about 110°, such as from about 85° to about 105° via the finger tabs110and112in a direction opposite from the direction of rotation of insertion in step404such that the first eyelid margin holder106is positioned at an inner corner146of the eye130and the second eyelid margin holder108is positioned at an outer corner148of the eye130and lifting the eyelid speculum100away from the outer surface138of the eye130. For instance, if the eyelid speculum100was inserted by rotating the eyelid speculum100in the counterclockwise direction, then removal of the eyelid speculum100would involve rotating the eyelid speculum100in the clockwise direction. Meanwhile, if the eyelid speculum100was inserted by rotating the eyelid speculum100in the clockwise direction, then removal of the eyelid speculum100would involve rotating the eyelid speculum100in the counterclockwise direction. After removal, the eyelid speculum100can be disposed of or recycled since it can be economically fabricated from a thermoplastic polymer for one-time or single use. Such a method400as described inFIG. 9is simple and efficient for the healthcare provider and safe for the patient and avoids the use of the bulky, metal conventional eyelid speculums known in the art.

Referring now toFIG. 10, the eyelid speculum100of the present invention can be a part of a kit500that can be provided to the healthcare provider in a sterile package502depending on the diagnostic or treatment procedure to be performed. For instance, the package502can include the eyelid speculum100and a medication delivery system504such as a needle/syringe508, dropper, etc. and medication506. In addition, it is to be understood that in place of or in addition to the medication delivery system504, the kit500can also include one or more medical instruments510, cotton swabs512, and other supplies such as but not limited to measuring devices, disinfecting solutions (i.e., betadine), and/or any other medical supply that the healthcare provider would typically need to perform the desired diagnostic or treatment procedure. Further, as shown, the eyelid speculum100can be positioned within a recess514for easy access by the health care provider and to ensure the health care provider removes the eyelid speculum100from the package502in the proper orientation.

Further, it is to be understood that the eyelid speculum100is contemplated for use in humans as well as other animals, including, but not limited to canines, felines, bovines, and equines.