Abstract:
An intraocular device to assist a physician for injecting into an eyeball by aligning a device to aspects of the eyeball. The device may be adapted to control the depth of an injection needle and to align the correct placement of the needle.

Description:
FIELD 
       [0001]    The invention relates to an intraocular injection guide that assists a health care professional with intraocular injections. 
       BACKGROUND 
       [0002]    Intraocular injections are necessary to treat various ocular conditions. For example certain anti-VEGF injections are used to treat very common diseases such as age related macular degeneration (AMD) and diabetic retinopathy. In this treatment, the surgeon will need to hold the eyelids open by using a speculum. The speculum pries the eyelids open to preven the eyelids from snapping back (such as blinking) especially during the critical portion of the injection, and thus prevents an infection from developing (as the lids contain a large number of bacteria). 
         [0003]    After prying open the eyelids, the surgeon then bathes the entire eye area with topical anesthetic and then with antisepetic solution. The problem with the current standard of care is that the speculum used to hold the eye open is generally considered quite painful. Many patients rate the pain of the speculum as greater than the pain of the needle penetrating the eye. This is because anesthetic drops used for the procedure numb the eyeball but are not as effective on the skin of the eyelid. Additionally, the current method leaves the eye pried open for almost a minute, drying the surface of the eye (the cornea) which leads to discomfort after the procedure and sometimes leads to a corneal abrasion (or scratch). The third disadvantage with the current method is that topical antiseptic is applied to the entire surface of the eye multiple times, which can be wasteful and cause discomfort for approximately 24 hours after the procedure. 
         [0004]    For injections, the physician will then inject by inserting the needle through the sclera such that the needle tip will be in the viterous body—the central cavity of the eye, filled with vitreous humor. The physician then depresses the needle plunger and the medicine is injected into the vitreous body. 
         [0005]    The problem that happens that given small geography to work with and that the eyelids are autonomically programmed to blink, the physician has to be very precise with the injection and work quickly to inject so that the speculum can be removed and the eyelids can return to autonomic blinking. The small geography also requires the physician to be precise in injecting the needle into the sclera at a precise location so as to avoid the lens, the iris, and the ciliary muscles. Secondly, the surgeon must visually confirm that the needle is perpendicular to the sclera at all times to avoid damaging the retina or lens (due to improper angulation). In addition, the physican must be precise in the depth of the needle penetration into the viterous body. 
         [0006]    Other devices exist that assist physicians with guiding the needle into the eye. Those devices, though, suffer from certain infirmities. First, many still require the use of a speculum to prop the eyelids open. This causes patient discomfort. Other devices are also not shaped appropriately to conform to the curvatures of the eye; that is gaps exist between the device eye surface and the eye surface itself. The means that an eyelid can close under the device, thereby pushing the device up away from the eye surface which can lead to potential contamination of the needle tip. Other devices are also not interchangeable with the various size syringes or needles. Because different medicines are used in filled syringes, the sizes of the syringe body, syringe tip, and gauge size of the needles all vary and as such, the intraocular devices in the art do not generally allow for interchangeability. 
       SUMMARY 
       [0007]    The present invention is directed to an introcular injection device that succeeds where many other devices fail. The device may include an intraocular injection device that permits the physician to grasp the device, align the device effectively with the cornea to ensure precise and replicable location, and allow interchangeability of the device with various syringes. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]    For the purpose of facilitating an understanding of the subject matter sought to be protected, there is illustrated in the accompanying drawing embodiments thereof, from an inspection of which, when considered in connection with the following description, the subject matter sought to be protected, its construction and operation, and many of its advantages should be readily understood and appreciated. 
           [0009]    Various drawings are included to show non-limiting features of embodiments of the invention. 
           [0010]      FIG. 1  is a cross sectional view of an embodiment of the invention. 
           [0011]      FIG. 2  is a view of one surface of an embodiment of the invention. 
           [0012]      FIG. 3  shows another view of a surface of an embodiment of the invention. 
           [0013]      FIG. 4  represents an alternative cross sectional view of an embodiment of the invention. 
           [0014]      FIG. 5  represents another cross sectional view of another embodiment of the invention. 
           [0015]      FIG. 6  represents another view of an embodiment of the invention.  FIG. 6  represents another cross sectional view of another embodiment of the invention. 
           [0016]      FIG. 8  demonstrates an exploded view of another embodiment of the invention. 
           [0017]      FIG. 9  represents an embodiment of the invention in operation. 
       
    
    
     DETAILED DESCRIPTION 
       [0018]      FIG. 1  represents an outer view of the intraocular injection device  10 . The device  10  includes an injector receiving end  12  and a corneal end  14 . The device in whole or in part may be cylindrical, rectangular, or otherwise shaped. Extending from the injector receiving end  12  and the corneal end  14  is a guiding channel  13 , which is akin to a lumen connecting the two ends. The guiding channel  13  shape may be cylindrical or edged. The width or diameter of the guiding channel  13  is adapted to receive an injection device. Disposed near the corneal end  14  is an end flange  16 , which has an end flange outer surface  17  that abuts the corneo-scleral junction, a scleral surface  18 , and an end flange top surface  19 . 
         [0019]    The scleral surface  18  is curved in such a way as to sit on the eye surface and create a good fit with the eye surface. The cornea is slightly oval, having an average diameter of about 12 mm horizontally and 11 mm vertically. Accordingly, but not limited, the scleral surface  18  may have a curvature that would create an 24 mm diameter. Said another way, the scleral surface  18  may be adapted to match the curvature of the eye surface. The scleral surface  18  may be made of a material that is resilient as to conform to the eye surface irrespective of its curvature, semi-resilient for the same reason, or rigid. Exemplary materials of the device and/or flange may be made of medical device grade materials. The end flange  16  may be made uniformly with the corneal end  14  or may be separately made and affixed to the corneal end  14  thereafter. The end flange outer surface  17  may be tapered, flush edged, or otherwise shaped as to allow an eyelid that comes in contact with the end flange outer surface  17  to stop at the edge or to slide over the end flange top surface  19 . Similarly, the junction (if any) of the end flange top surface  19  and the end flange outer surface  17  may be rounded or tapered to facilitate eyelid movement over the the top surface  19 . 
         [0020]      FIGS. 2 and 3  represent a surface view of the introcular injection guide  10  by showing the scleral surface  18 . Along one side of the device  10  is a corneal edge  20 . The corneal edge  20  is concave shaped forming a rounded edge. Corneal edge  20  may also be curved in such as manner as to follow the curvature of the cornea of an eye. Disposed through the scleral surface in fluid communication with the guiding channel  13  is a needle exit  22 . Needle exit  22  is configured to allow the needle of the injector to exit the device  10  and allow for injection into the eye. Along scleral surface  18 , the needle exit  22  is configured to be closer to the corneal edge  20 . More particularly the needle exit  22  has a needle exit corneal edge  23  that is closest to the corneal edge  20 . In different embodiments, the needle exit corneal edge  23  is between 3 mm to 5 mm from the corneal edge  20  and more particularly can be at any distance therebetween. 
         [0021]      FIG. 3  also shows a view of scleral surface  18 . Corneal edge  20  may also include a corneal edge center  24  that can be the center of the corneal edge  20  curvature. Needle exit  22  also includes a needle exit opposite side  25  that is opposite to the needle exit corneal edge  23 . As such the needle exit  22  may be configured so as to have the needle exit corneal edge  23  be 3-4 mm from the corneal edge  20  with the needle exit opposite side  25  being 4-5 mm from the corneal edge  20 . In another embodiment, the needle exit corneal edge  23  may be 3 mm from the corneal edge center  24  and the needle exit opposite side  25  may be 5 mm from the corneal edge center. In this regard, the configuration may define at least one dimension for the size of the needle exit  22 . If needle exit  22  is not square or rectangular or is round or otherwise shaped, needle exit corneal edge  23  is a part of the needle exit that is closest to the corneal edge and where needle exit opposite side  25  is a part of the needle exit farther away from needle exit corneal edge  23 . In another embodiment, the scleral surface  18  may include a corneal edge opposite side  26  such that the needle exit  22  is closer to the corneal edge  20  than to the corneal edge opposite side  26 . 
         [0022]      FIG. 4  shows another view of the device  10 , in cross section. The guiding channel  13  includes a lower tapered end  30  that terminates near the corneal end  14 . The lower tapered end  30  also is in communication with the lower lumen  32  and upper lumen  33  of the guiding channel  13 . The device  10  may include one or more finger grips  34 ,  35 , which may be indented or protruding from the surface of device  10 . The lower lumen  32  within the guiding channel  13  may include a syringe blocker  36 , which may be integrally made with the lower tapered end  30  or lower lumen  32 , or may be separately made and inserted into the lower lumen. The syringe blocker  36  may be shaped to block a syringe inserted into the lumen, thereby controlling the penetration depth of a syringe and/or a needle. The syringe blocker  36  may be a bulge, protrusion, bump, or anything that may block the penetration depth of a syringe. At the end of the lower tapered end  30  may include a needle guide  38 , which is configured to ensure that a needle of an injection device can slide through the guide  38  easily and into the needle exit  22 . The needle guide  38  may also be configured so that only a certain length of the needle may exit out of the needle exit  22  and thus only a certain length of needle penetrates the eye. The needle guide  38  may work in conjunction with, or independent of, syringe blocker  26 . 
         [0023]      FIG. 4  also shows the end flange  16 , the end flange  16  has the end flange outer surface  17  and end flange top surface  19 . The end flange  16  also has a junction  40  where the flange  16  is connected to the corneal end  14 . The junction  40  can be an abrupt or defined boundary or junction or may be a more tapered or non-defined boundary. Notwithstanding, a distance may be defined by the junction  40  extending to the end flange outer surface  17 . In a non-limiting embodiment, the distance may be between 1-3 mm. The end flange  16  may be disposed around three sides of the corneal end  14 , with the fourth side being the corneal edge  20 . 
         [0024]    Also shown in  FIG. 4 , the upper lumen  33  is shown having a wider opening than the lower lumen  32 . The progressive narrowing can narrow from a wider opening 10-13 mm to a narrower width of 4-5 mm. It should be understood that these dimensions are exemplary only. 
         [0025]      FIG. 5  shows another embodiment. In this Figure, the device  10  may include a moveable syringe blocker  50  that can be height adjusted up or down the device  10  such that the depth of an inserted syringe can be controlled. Another independent feature includes a scleral positioner  52  that helps hold or secure the device to the sclera. For example, scleral positioner  52  may be rounded bumps on the scleral surface  18  that are sufficient to depress onto the sclera and assist the practitioner in aligning the device with the cornea and maintaining such position. The scleral surface  18  may include a single or a plurality of positioners  52 . The positioner  52  may be integrally made with, or made separately from, the scleral surface. In yet another embodiment (not shown), the scleral surface  18  may include indents or holes into which one or more positioners  52  may be inserted. 
         [0026]      FIG. 5  also shows another independent feature that includes an inner tube  54  that extends through the guiding channel  13 . The inner tube  54  terminates at an inner tube exit  56 , which is adapted to allow for fluid communication between the lumen of the inner tube  54  and the lower lumen  32  and/or needle guide  38 . In function, the user can pour liquid into inner tube  54  and have the contents exit into the lower lumen  32  or guide  38  and subsequently into needle exit  22 . In this embodiment, fluid entering the inner tube  54  will not generally interfere with the syringe insertion into the device. 
         [0027]      FIG. 6  demonstrates another alternate embodiment in which the device  10  is packaged with a syringe device in a kit  60 . The syringe  62  may be a prefilled syringe or may comprise an empty syringe and vial of the medicine. The kit  60  may include other parts, including but not limited to, antiseptics, anesthetics, or device inserts. Exemplary, not limiting, syringes may include medicines to treat age related macular degeneration, intraocular pressure, diabetic retinopathy, or infection. Without limitation, such medicines may include suitable agents that can be selected from, for example, small molecules, such as steroids and NSAIDs, proteins, enzymes, hormones, oligonucleotides, polynucleotides, nucleoproteins, modified DNA and RNA loaded viruses with modified capsid, polysaccharides, glycoproteins, lipoproteins, polypeptides, including drug carriers, such as pokymers, micro and nano particles. 
         [0028]    Further examples of agents useful in this invention include, without limitation, atropine, aflibercept, tropicamide, dexamethasone, dexamethasone phosphate, betamethasone, betamethasone phosphate, prednisolone, triamcinolone, triamcinolone acetonide, fluocinolone acetonide, anecortave acetate, budesonide, cyclosporine, FK-506, rapamycin, ruboxistaurin, midostaurin, flurbiprofen, suprofen, ketoprofen, diclofenac, ketorolac, nepafenac, lidocaine, neomycin, polymyxin b, bacitracin, gramicidin, gentamicin, oyxtetracycline, ciprofloxacin, ofloxacin, tobramycin, amikacin, vancomycin, cefazolin, ticarcillin, chloramphenicol, miconazole, itraconazole, trifluridine, vidarabine, ganciclovir, acyclovir, cidofovir, ara-amp, foscarnet, idoxuridine, adefovir dipivoxil, methotrexate, carboplatin, phenylephrine, epinephrine, dipivefrin, timolol, 6-hydroxydopamine, betaxolol, pilocarpine, carbachol, physostigmine, demecarium, dorzolamide, brinzolamide, latanoprost, sodium hyaluronate, insulin, verteporfin, pegaptanib, ranibizumab, bevacizumab, and other antibodies, antineoplastics, anti-VEGFs, ciliary neurotrophic factor, brain-derived neurotrophic factor, bFGF, caspase-1 inhibitors, caspase-3 inhibitors, α-Adrenoceptors agonists, NMDA antagonists, Glial cell line-derived neurotrophic factors (GDNF), pigment epithelium-derived factor (PEDF), NT-3, NT-4, NGF, IGF-2, antibiotics or antifungal drugs, anti-pain medication, anesthetics, and combinations thereof. 
         [0029]      FIG. 7  demonstrates an alternate embodiment of the device  10 . In this embodiment, there is an outer housing  70  that can be integrally made with or separately made from the end flange  16 . The outer housing  70  may include one or more of the features shown in any other embodiment. The outer housing  70  also includes an outer housing inner surface  72  and a housing lumen  73 . This embodiment demonstrates an insertable insert  74  into the lumen  73 . The insert  74  has an insert outer wall  76  that is disposed to face the outer housing inner wall  72  at one or more points along the inner wall  72 . The insert outer wall  76  is adapated to fit into the outer housing  70 . Within the insert  74  near its insert bottom  75  may include a syringe stopper  77  and an insert needle guide  78 . The insert needle guide  78  is adapted to be aligned with the needle exit  22  of the end flange  16 . The syringe stopper  77  is adapted to control the depth of the needle penetration into the eye. In this regard, different inserts  74  can be used in the same outer housing  70  and upon use, the inserts  74  can be swapped out. Furthermore, with different size syringes, different inserts  74  can be used wherein the insert chosen controls the depth of the needle into the eyeball. 
         [0030]      FIG. 8  demonstrates the alternate embodiment of  FIG. 7  in an exploded view, showing the insert  74  insertable into, but not inserted into, the outer housing  70 . Though  FIGS. 7 and 8  demonstrate that the outer housing inner wall  72  and insert outer wall  76  are angled, they need not be so. Either wall may be straight or angled. Similarly, insert inner wall  80  may be straight or angled. 
         [0031]      FIG. 9  demonstrates the device  10  in use by looking “down” the device from the injector receiving end  12  along the length of the device  10  to the corneal end  14 . The user places the device  10  onto the surface of the eye. The user aligns corneal edge  20  along the boundary of the cornea. The user can hold the device  10  so that the user&#39;s fingers are holding the device along the same sides as end flange outer surface  17 , with in certain embodiments, holding the device  10  using finger grips  35 . 
         [0032]    In this  FIG. 9 , as the device  10  is placed on the eye and corneal edge  20 , the user can insert the syringe into the device  10  and, depending on the type of syringe blocker used, can then guide the syringe needle into the various needle guides and into the needle exit for injection into the eye. Because of the positioning of the needle exit  22 , the syringe needle will inject the eye at a proper and controlled location. In addition, the syringe blockers, when used, can control the depth of the injection into the eye. Also, as the device  10  is placed on the eye, the eyelids are permitted to move (because no speculum is needed to pry the eyelids open during the injection), the eyelids will contact the end flange outer surface  17  and are permitted to ride over the end flange surface  19 . In this regard, even if the eyelids do close, which makes the procedure and comfortable to both the user and the patient, the eyelids are out of the way of the injection site. 
         [0033]    When the device  10  is properly placed, the user then can deposit some antiseptic into the device, which ultimately will exit the needle exti  22  and cleanse the area to be injected. In this regard, by using the device  10 , only a certain area of the eye needs to be cleansed whereas with other devices, the entire eye will be cleansed. The user then can insert the syringe into the device  10  and depending on the form or feature of the syringe stopper, the user then can inject the eye, thereby maintaining proper location and depth of the injection. 
         [0034]    As used herein, the term “device equivalent” means any subsequent device that is approvable by a governmental health regulatory agency wherein that device is deemed equivalent to this device  10 , under health regulatory regulations. For example, but not limited to, under current U.S. FDA guidelines, a later device may be deemed substantially equivalent to this device  10  as a so-called 510(k) clearance. If for example the device  10  is deemed to be a predicate device, then a subsequent device is a substantial equivalent if in in comparison to a predicate, the subsequent device: (A)(i) has the same intended use as the predicate; and (ii) has the same technological characteristics as the predicate; or (B)(i) has the same intended use as the predicate; and (ii) has different technological characteristics and the information submitted to FDA; and (a) does not raise new questions of safety and effectiveness; and (b) demonstrates that the device is at least as safe and effective as the legally marketed device. 
         [0035]    The manner set forth in the foregoing description and accompanying drawings and examples, is offered by way of illustration only and not as a limitation. More particular embodiments have been shown and described, and it will be apparent to those skilled in the art that changes and modifications may be made without departing from the broader aspects of the disclosure. The actual scope of the protection sought is intended to be defined in the following claims when viewed in their proper prospective based on the prior art.