Abstract:
The present invention relates to a single-use disposable eyelid speculum and scleral depressor. The eyelid speculum comprises an elongated curved arm formed from an elastic single piece element. The elongated curved arm terminates in integrally formed spoons, each spoon being configured to engage an eyelid. The eyelid speculum and scleral depressor may be provided as a kit in either separate or combined packing in a sterilized condition. The kit is intended to be disposable after a single use.

Description:
FIELD OF THE INVENTION 
     The present invention relates generally to eye examination devices and more specifically to eyelid speculum used to hold a patient&#39;s eyelids open, and to a disposable kit including a speculum for eye examination. 
     BACKGROUND OF THE INVENTION 
     Various devices have been used in the past for the purpose of holding a patient&#39;s eyelid open to allow access to an eyeball for examination, treatment and ocular surgery. Such procedures are performed on human and animal patients of all ages and all sizes regularly. However, tools for such examinations are typically designed for use in adult human eyes. 
     Examination of infant eyes is very important in a number of situations. For example, examination for retinopathy prematurity (ROP) is an important clinical task for pediatric ophthalmologists, certain general ophthalmologists and retina specialists. Timely ROP examinations are essential in reducing the incidence of blindness in premature infants. ROP examinations are typically initially performed at the crib or incubator in the neonatal intensive care unit (NICU) with additional exams performed in an out-patient clinic or office. The ROP examination involves the use of an indirect ophthalmoscope, an eyelid speculum and a scleral depressor. It has been estimated that 300,000 ROP examinations are performed in NICU&#39;s in the United States every year. 
     Examination tools known in the art suffer from at least two deficiencies when used for infants. First, they are typically steel instruments which are heavy and not well-sized to an infant&#39;s eye. Not only are these devices cumbersome to use, but also the appearance may be frightening to family or staff attending the infant. Secondly, the devices currently used are relatively expensive; hence, they are intended for multiple uses. Autoclave sterilization is the only adequate method of cleaning the instruments between use. Instrument cleaning methods other than sterilization, such as alcohol swabs and chlorhexidine gluconate, have been shown to be inadequate for eradicating all microorganisms. Without resterilization, a risk of nosocomial eye infection exists. Substantial cost is incurred in having a sufficient number of instruments available and in reprocessing instruments for reuse. 
     Further, lack of availability of instruments at hospitals is not uncommon and, hence, it is not unusual for ophthalmologists to transport non-sterile instruments from their offices and use them for multiple examinations without benefit of sterilization. 
     Thus, there is a need for a lightweight speculum and scleral depressor for use in examining infant eyes which are practically and economically single-use devices. 
     SUMMARY OF THE INVENTION 
     The present invention includes a single-use disposable eyelid speculum and a scleral depressor. The eye speculum and scleral depressor are intended to be presented to the user in sterile packaging and to be disposed of after a single use. This reduces the risk of nosocomial eye infection. Additionally, the eyelid speculum and scleral depressor are constructed of lightweight material which improves performance. The combination of materials used and design results in a speculum that applies a constant, predictable, uniform force to the eyelids, is conveniently sized to accommodate various ages and sizes of patients and has a less onerous appearance. 
     The eyelid speculum of the invention has an elongated curved arm formed from an elastic, single piece element. The elongated curved arm is curved such that the two ends of the arm are in a generally parallel and opposing position. Integrally formed spoons are formed as a portion of the ends of the elongated curved arm. Each of the spoons has a curvature adapted to the shape of the eyelid. 
     The eyelid scleral depressor of the invention has an elongated handle portion with at least one end of the handle terminating in stem portion. The stem portion terminates in a tip which is configured for touching an eyeball. 
     The speculum and scleral depressor may be provided as a kit in either separate or combined packaging in a sterilized condition. The kit is intended to be disposable after a single-use. 
     A method for examining a patient&#39;s eye using the eyelid speculum and scleral depressor is provided. The method for examining a patient&#39;s eye comprises of the steps of positioning the eyelid speculum proximate to the patient&#39;s eye, engaging each of the upper and lower eyelids of the patient&#39;s eye with each of the spoons of the eyelid speculum, applying the scleral depressor to the surface of the eyeball portion of the patient&#39;s eye and manipulating the eyeball by applying pressure to the sclera of the eyeball. 
    
    
     BRIEF DESCRIPTION OF THE FIGURES 
     FIG. 1 shows an embodiment of an eyelid speculum; 
     FIG. 2 shows a perspective view of an eyelid speculum; 
     FIG. 3 shows one embodiment of a scleral depressor; and 
     FIG. 4 shows the scleral depressor of FIG. 4 as it appears rotated 90° from the portion shown in FIG.  3 . 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The present invention includes a single-use eyelid speculum and scleral depressor which may be sized for convenient use in eye examinations or medical procedures for human and/or animal patients of any age including infant patients. The eyelid speculum and scleral depressor of the invention may be packaged in sterile packaging to provide a single-use, sterile eye examination kit. 
     In an exemplary embodiment of the invention, the invention has three components: an eyelid speculum, a scleral depressor, and a packaging portion which can maintain the eyelid speculum and scleral depressor in a sterilized condition until time of use. 
     FIGS. 1-2 show an exemplary embodiment of an eyelid speculum device  10  of the present invention used to hold a patient&#39;s upper or lower eyelids open to allow access to an eyeball for examination, treatment, ocular surgery or the like. The eyelid speculum device  10  has an elongated curved arm  12 , having two arm ends  30 ,  31 . A curvature  20  of the elongated curved arm  12  at a position between the arm ends  30 ,  31  permits the arm end  30  to be aligned in opposing position with respect to arm end  31  as shown in FIG.  1 . The elongated curved arm  12  has grasping portions  22 ,  23 . In some embodiments, the grasping portions  22 ,  23  simply designate a position oppositely positioned on either side of the elongated curved arm  12  between each of the ends  31 ,  32  and the curvature  20 , as shown in FIG.  1 . As one skilled in the art will appreciate, the grasping portions  22 ,  23  may be designed to facilitate grasping. For example, the grasping portions  22 ,  23  may have integrally formed texturing, indentations enlarged portion, or a molded curvature and the like. These are representative examples of designs that facilitate grasping which are provided for illustrative purposes. As one skilled in the art will recognize, a number of alternatives for facilitating grasping compatible with the design or function of the speculum may be employed. Additionally, the elongated curved arm  12  has an outer surface  16  and an inner surface  14 . Optionally, the elongated curved arm may be contoured to fit the contour of a patient&#39;s face. For example, referring to FIG. 1 in some exemplary embodiments the region of the curvature  20  will curse upward or downward with respect to the plane parallel to the surface shown in FIG. 1 of the Speculum  10 . As FIG. 1 shows, the speculum is flexible, and applying pressure, preferably at the grasping portions  22 ,  23  permits adjustment of the distance between the two arm ends  30 , 31 . 
     Each of the arm ends  30 ,  31  each terminate in an integrally formed spoons  32 ,  33 . Spoon  32  is shown in a perspective view in FIG.  2 . Each of spoons  32 ,  33  has a spoon-cupped surface  34 ,  35  an spoon outer surface  36 , a spoon edge  38  and a spoon curvature  40 . The integrally formed spoons  32 ,  33  are oriented such that the spoon-cupped surface  34 ,  35  are directed outward, i.e., in the direction of the elongated arm  12  outer surface  16 . Thus, when the eyelid speculum  10  is positioned over an eyeball, the spoon-cupped surfaces  34 ,  35  are oriented toward the eyelids and away from the cornea. Optionally, the outer surface  36  of the spoons  32 ,  33  may be contoured to fit against the patient&#39;s eyeball. 
     To use the eyelid speculum  10  to perform an examination, the examiner positions his fingers on the grasping portions  22 ,  23  of the eyelid speculum  10  and gently applies pressure to the eyelid speculum  10  at the grasping portion  22 ,  23 . This squeezes the ends  30 ,  31  of the eyelid speculum  10  closer together. The eyelid speculum  10  is then positioned nearer the patient&#39;s eyeball with the spoons  32 ,  33  generally aligned with the upper and lower eyelids and the pressure applied to the eyelid speculum  10  is gently decreased. This allows the elongated arm  30  to return to its original position and the spoon-cupped surfaces  34 ,  35  of the spoons  32 ,  33  to engage the upper and lower eyelids, respectively. To remove the eyelid speculum  10 , pressure is again applied to the grasping portions  22 ,  23  and the ends  31 ,  31  move closer together, disengaging the spoons cupped surfaces  34 ,  35  from the upper and lower eyelids. 
     A suitable material for constructing an eyelid speculum  10  should be resilient, have a modulus of elasticity that allows for bending of the arm  12  without permanent deformation and causes the elongated curved arm  12  to return to its original position after the grasping portions  22 ,  23  are released. Further, it is desirable that the material be lightweight, sterilizable without deterioration, and non-reflective. It is further desirable that the material be disposable after a single use. In an exemplary embodiment, the eyelid speculum  10  is constructed from a polymeric material. In certain embodiments it is desirable to use a moldable polymeric material for ease of manufacturing and production of the device at a cost economically reasonable for a singe-use device. The combination of material selection and curvature  20  of the curved elongated arm  12  is such that, when the device is positioned in the patient&#39;s eye, the spoon-cupped surfaces  34 ,  35  exert a force to hold the upper and lower eyelids open. In an exemplary embodiment suitable for use with prematurely born infants it is desirable that the spoon-cupped surfaces  34 ,  35  exert a force, of about 90-150 grams against the eyelids when properly positioned. The force exerted may be adjusted in other embodiments to accommodate the requirements of a specific category of patient. 
     The eyelid speculum device  10  should be dimensioned such that, when in use, the spoon-cupped surfaces  34 ,  35  retract the upper or lower eyelids to expose the entirety of the cornea and preferably about a millimeter of sclera on either side of the cornea. Preferably, in this position of use the internal aspects of the two spoons are parallel to each other, thereby creating a symmetrical spreading of the eyelids with an even distribution of force to the eyelids. Sizing of the spoon  32 ,  33  is important as, for example, a spoon which is too wide for the patient may not open the eyelids wide enough without causing tissue damage. As one skilled in the art will appreciate, dimensioning can be conveniently varied to accommodate various sizes and ages of human an/or animal patients. For example, in one embodiment intended for use with young human infants, the spoons may be spaced from each other by about 12 millimeters when in the in-use position, the spoon-cupped surfaces have a depth of about 5 millimeters from spoon edge  38  to spoon curvature  40 , and a length of each spoon along the inner edge of about 6 millimeters. Suitable dimensions for other embodiments may be determined by one skilled in the art from known and well-documented information regarding the size and anatomical characteristics for human and animal ocular regions. 
     The invention may also include in an exemplary embodiment a scleral depressor. An embodiment of the scleral depressor  50  is shown in FIGS. 3-4. As shown in FIGS. 3-4, the scleral depressor  50  has an elongated handle portion  52 , two bent stem portions  54 ,  55  and two tips  56 ,  57 . The tips  56 ,  57  may optionally be enlarged with respect to the portions  54 ,  55  stems and also optionally may be curved or shaped to facilitate their use in touching an eyeball. In other embodiments the scleral depressor may have only a single bent stem portion and a single tip or optionally have a straight stem portion. 
     A grasping portion  58  is located on the handle portion  52  of the scleral depressor  50  at a point between the bent stem portions  54 ,  55 . The grasping portion  58  may be simply a position on the elongated handle portion  52 . Optionally, the grasping portion  58  may be configured to facilitate grasping. As one skilled in the art will recognize, there are many configurations and/or methods to facilitate grasping and any compatible method known to one skilled in the art may be employed. Representative examples of configurations for facilitating grasping include integral texturing or configurations having flattened, enlarged, indented or contoured shapes at the grasping position. 
     Degree of tilt of the bent stem portions  54 ,  55  and the shape of the tips  56 ,  57  may be varied to accommodate conveniently putting the scleral depressor  50  in a position of use touching an eyeball. Additionally, the scleral depressor  50  may be sized with different dimensions to facilitate use of the scleral depressor  50  with different sizes and ages of human and animal patients. A typical scleral depressor used for an infant, for example, may have a total length of about 100 to 150 millimeters with tips  56 ,  57  about 4 to 6 mm across. For convenience in examination it may be desirable in some embodiments that the tips  56 ,  57  be of different sizes and/or contours. 
     It is desirable that the scleral depressor be made of a rigid material that is lightweight, sterilizable without deterioration, and non-reflective. Further, it is desirable that the scleral depressor be formed from material that is practically and economically disposable after a single use. Rigid polymeric materials are one example of a suitable material. 
     Although the eyelid speculum  10  and the scleral depressor  50  may be used independently, typically, the scleral depressor  50  will be used in conjunction with eyelid speculum  10 . When using the speculum and scleral depressor for examining a patient&#39;s eye, the eyelid speculum is first positioned proximate to the patient&#39;s eyeball and is positioned to engage the patient&#39;s upper and lower eyelids as described above. When the eyelid speculum  10  is in place, the scleral depressor is then touched to the surface of the eyeball and the eyeball is manipulated by applying pressure to the scleral depressor. The eyelid speculum  10  may be used alone or in conjunction with the scleral depressor for eye examinations, eye treatments, eye surgery and the like. 
     In an exemplary embodiment of the invention, the eyelid speculum  10  and scleral depressor  50  are provided as a kit wherein the eyelid speculum  10  and scleral depressor  50  are in a sterilized condition and packaged to maintain the sterile condition until immediately prior to use. Methods of sterilizing equipment for medical uses, either prior to or subsequent to packaging, and maintaining the equipment in a packaged sterilized state until ultimate end use are well-known in the art. Any of the known methods compatible with the physical features and characteristics of the eyelid speculum  10  and scleral depressor  50  may be used. In some exemplary embodiments, the eyelid speculum  10  and scleral depressor  50  are packaged together in a single package. In other embodiments the scleral depressor  50  and eyelid speculum  10  are packaged in a single package with separate compartments for each of the scleral depressor  50  eyelid and eyelid speculum  10 . Independent packaging of the eyelid speculum  10  and scleral depressor  50  may be equally convenient and is used in other embodiments in the invention. 
     Those persons skilled in the art will appreciate that the present invention is susceptible to a broad utility and application. Many embodiments and adaptations of the present invention other than those herein described, as well as many variations, modifications will be apparent from or reasonably suggested by the present invention and the foregoing description thereof, without departing from the substance or scope of the present invention. Accordingly, while the present invention has been described herein in detail in exemplary embodiments, it is to be understood that this disclosure is only illustrative and exemplary of the present invention and is made merely for purposes of providing a full and enabling disclosure of the invention. The foregoing is not intended or to be construed to limit the present invention or otherwise to exclude any such other embodiments, adaptations, variations, modifications, the present invention being limited only by the claims appended hereto and the equivalents thereof.