US 20080039807 A1
A dispensing tip apparatus for an eye drop dispenser to administer topical ophthalmic solutions is described. The apparatus integrates an ophthalmic solution-dispensing tip with an optical gauging assembly. The tip provides continuous visual feedback about it orientation and relationship to the eye. The dispensing tip when attached to any standard topical ophthalmic solution dispensing bottle or reservoir enables the user to view a target, visually align the dispenser tip, and administer an eye drop with precision. There is also a visual feedback by which the dispenser tip is prevented from gaining too close proximity and contacting the eye, thus preventing contamination of the medication and its dispenser. The visual feedback can also contain textual or graphic information that serves as a promotional advertisement.
1. An apparatus for dispensing ophthalmic solutions and drugs, the apparatus comprising:
a passageway through a dispensing tip supplying the ophthalmic solutions and drugs to a dispensing orifice in droplet form;
an optical gauging device integrated with said dispensing tip for creating axial alignment with a user's eye and setting a distance between said optical gauging device and the user's eye to position said dispensing orifice for delivering ophthalmic solutions and drugs to the user's eye;
an attachment mechanism to secure said dispensing tip to said reservoir of ophthalmic solutions and drugs; and
a closure mechanism to seal said dispensing orifice.
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17. A method of dispensing ophthalmic solutions to an eye, comprising:
providing a container having a dispensing tip at one end and a passageway from the container through the tip to a dispensing orifice, in which the container is adapted for dispensing at least one droplet from the orifice of the tip;
attaching an optical gauging dispensing tip assembly providing a hermetic seal in axial alignment to the dispensing tip of the container to create a contiguous passageway from the container through the dispensing tip, and through optical gauging dispensing tip to a dispensing orifice for dispensing at least one droplet from the orifice of the dispensing tip;
aligning the container with the optical gauging dispensing tip vertically above the eye, the dispensing orifice proximal to the eye, and along the optical axis of the eye when the user looks into a lens integral with the optical gauging dispensing tip and observing a target indicator looking for a least one concentric graphical image indicating axial alignment between the optical gauging dispensing tip and the eye;
gauging distance from the eye by moving container with optical gauging dispensing tip up and down along eyes optical axis while looking through lens on optical gauging dispensing tip and responding to graphical images indicating one of three conditions, too far from the eye to dispense a drop effectively, too close to the eye—avoid contact with the eye to avoid tip contamination, and perfect distance from the eye to deliver a drop;
dispensing the liquid from the container into the eye of the user by actuating the container to dispense a drop from the orifice of the tip while holding container with optical gauging dispensing tip along the optical axis of the eye at a distance sufficiently close to effectively dispense a drop into the eye without making contact with the eye.
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According to clinical studies a staggering 37.6% of all self-administered eye drops miss the eye. One way to improve delivery of eye drops is by providing a visual feedback means so that a person dispensing drops can position an eye drop dispenser at an optimal distance and orientation above the eye. To accomplish visual feedback, the eyedropper needs to incorporate features used in other visual range and orientation devices. One such device is a common range finder used by golfers to gauge their distance from the ball to the hole. In golf range finders, the golfer stands near their ball and looks through a lens directly at the flag on its pole. The flags are uniform at a fixed height above the ground. The closer a golfer is to the flag, the larger it appears in the range finder. The range finder has calibrated hash marks within that correspond to a given distance. The golfer by aligning the appropriate hash mark with the image of the flagpole gets distance feedback. It will be appreciated that if the flagpole were replaced by a circular target, feedback of both distance and horizontal/vertical orientation can be visualized. With some optics engineering this mechanism can be used to gauge distance and orientation between a dispensing tip and the eye.
For years, the primary method of medically treating disorders of the eye has been via topical administration of various medications and other chemical compounds useful in combating a host of ophthalmic ailments. In fact, studies show that when measuring concentrations of these compounds at the desired target site (whether it be in the tear film, intracorneal, or intraocular), topical delivery equals or exceeds those concentrations obtained by systemic routes (oral or intravenous), and has far fewer systemic untoward signs and symptoms (side effects). Thus, it is no wonder that most remedies and medications are delivered via the topical route. Historically, this has been achieved via ointments, suspensions, solutions, contact lenses, collagen shields, and palpebral inserts. Far and away, the most common mode of delivery has been via topical suspensions and solutions. Typically, dispensers have fairly standard sizes and shapes (although there is some slight variation), and there is a reproducible standard drop size that is governed by the dropper (dispenser) tip. As simple as topical delivery may seem to achieve, there are various difficulties and shortcomings with current topical dispensing units (vials and bottles), many of which have not been previously or adequately addressed and solved.
The most common problem that the typical patient experiences when attempting to use an eye drop is the inability to introduce a drop into the eye, or simply missing the eye. There are several reasons for this. First, the normal bottle tip is not clearly visible as it approaches a normal emmetropic, hyperopic, or even myopic eye. This immediately leads to the probability that the first drop will become the “test drop”, landing on the cheek, forehead, or eyelashes, leading to waste and frustration. Second, there is a natural aversion to closely approaching objects, causing the eye to wander or drift, and look everywhere but at the dispenser tip. Again, this leads to the possibility that a drop will miss. Finally, most users are not taught how to use eye drops. They are simply given the bottle and instructed to “place one drop in the eye”.
The next important issue is one of waste. When a typical eye drop is introduced into the eye, the average inferior cul-de-sac only holds one-quarter to one-half of a standard drop. The remainder is either washed out down the cheek, or drained by the lachrymal system. Large strides in preventing waste were made when a dispenser tip was developed that delivered smaller drop sizes, thus eliminating a portion of waste. However, this advantage is negated if it takes several drops to gain access to the ocular surface. This issue is critical when evaluating cost to the patient and the healthcare system. The cost problem for the patient is obvious: the more drops they use, the greater the amount of money spent. With respect to the healthcare system as a whole, cutting costs are of paramount importance. In fact, many Health Maintenance Organizations (HMO's) will not let their members get refills on their ophthalmic medications more than once a month. The rationale behind this is simple. If the bottle has “x” number of drops in it, it should last “y” number of days. If the patient is not proficient with a high success ratio, then the drops will run out before the specified time allowed. This, in turn, leads to the patient either being without their valuable medications, or having to pay for the medications themselves.
Finally, there is the problem of contamination of the dispenser tip, and cross-contamination between patients. Since the tip is not clearly visible upon the approach to the ocular surface, it oftentimes will inadvertently come in contact with the eye or lid structures. This will lead to an inoculation of the tip with ocular flora, and be a potential source for spreading infection. Although sharing medications in general, especially eye drops, is always discouraged, many different people, whether friends or family members, often find the ease and convenience of sharing overwhelmingly tempting. Again, this can lead to cross-contamination and, in turn, the spread of infection.
Most of the current problems of efficiently dispensing ophthalmic drugs stem from user error. Therefore, it is the goal of this device to create a “user friendly” ophthalmic drug dispenser.
This invention seeks to create an integrated dispensing tip and optical gauging means for administering topical ophthalmic drug preparations, which enables the patient to direct an eye drop into the eye with the ease and accuracy, previously only attained by a proficient few. In addition, this particular device may serve to prevent cross-contamination, and ultimately save both the patient and the healthcare system money typically lost to waste.
More specifically, this invention relates to a dropper tip with an integrated lens and target system which, when coupled with or integral to any standard topical ophthalmic drug dispensing bottle, enables the user to view the target, align the dispenser tip, and administer an eye drop with precision not attained before. To achieve this precision, the target and lens system is calibrated to align the dispensing tip with the optical axis of the eye at a specified distance from the eye. The resulting geometric relationship between the dispensing tip and the eye insures that a dispensed drop will enter the eye. Prior art such as U.S. Pat. No. 5,558,653 “Targeted eye drop dispenser” which uses visual feedback to align an ophthalmic drug dispenser simply helps place the nozzle along the axis of the eye at an arbitrary distance selected at random by the user. This is only effective if the axis of the eye and the path a dispensed drop falls are the same. The axis and path are only identical when the eye is rotated 90 degrees with respect to the horizon, which can only be easily achieved lying down. Most users dispense eye drops while standing or sitting with the eye rotated about 50 degrees back and will miss often with those types of implementations.
A similar mechanism is described in U.S. Pat. No. 5,932,206 “Ophthalmic Drug Dispensing System” issued Aug. 3, 1999. The devices disclosed in U.S. Pat. No. 5,932,206 couple a discreet optical gauging mechanism to an eye drop dispenser. By combining the dispensing tip and optical gauging features into a single compact tip the device becomes more compact, portable, cheaper, and easier to manufacture.
To dispense drugs efficiently with this invention, the user would use a dropper bottle outfitted with the new calibrated tip or would press fit the calibrated tip over the existing tip, tilt his/her head back, position the lens proximal to the eye where drug dispense is desired, align a target with his/her eye until a specified image appears thereby gauging distance, orientation and concentricity with the axis of the eye, then dispense a drop directly into the eye. Since the success rate of delivering a single drop in the desired location, i.e. the eye, will exceed 99%, the amount of waste can be reduced dramatically. At the same time, a visual mechanism by which the dispenser tip is prevented from gaining too close proximity and contacting the eye is provided, thus preventing contamination of the medication and its dispenser.
It is therefore one aspect of the present invention to provide visual feedback from a calibrated optical gauging system embedded in a dropper tip to properly align an ophthalmic drug dispenser to dispense drugs into an eye with a high rate of accuracy.
It is another aspect of the present invention to provide visual feedback from a calibrated optical gauging system embedded in a dropper tip when the ophthalmic drug dispenser becomes too close to the users eye to prevent eye contact and subsequent contamination.
It is another aspect of the present invention to provide a calibrated tip for an eye drop bottle that can be integrated with a bottle of eye drops and is compatible with existing pharmaceutical filling and packaging equipment.
It is another aspect of the present invention to provide a calibrated optical gauging system embedded in a dropper tip as an accessory for aftermarket attachment to any bottle of eye drops.
It is another aspect of the present invention to provide materials compatible with sterilization techniques employed in the pharmaceutical industry.
It is another aspect of this invention to provide promotional advertising to users each time they dispense an eye drop.
It is another aspect of the present invention to provide a means to regulate drop flow and volume.
It is another aspect of the present invention to provide a means to prevent bottles with larger volumes of eye drops from dispensing a drop prior to actuation.
The present invention will become more fully understood from the detailed description given herein below and the accompanying drawings which are given by way of illustration only, and thus are not limitive of the present invention, and wherein:
The lens assembly 3 of optical gauging dispensing tip assembly 1 focuses the optical target 4 and has an aperture with a circular field of view. Using the optical target 4 with two concentric rings, inner ring green and outer ring red, the user gets two distinct graphical feedbacks. As the lens assembly 3 approaches the eye, the green ring becomes visible when the eye's axis is vertical and the lens assembly is the optimal distance above the eye to dispense. As the optical gauging dispensing tip assembly 1 becomes too close, the red ring becomes visible, instructing the patient to move the lens assembly further away to avoid contact with the eye.
It will thus be seen that the objects set forth above, and those made apparent from the preceding descriptions, are effectively attained and since certain changes may be made in the above construction without departing from the spirit and scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings, shall be interpreted as illustrative and not in a limiting sense.
It is also to be understood that the following claims are intended to cover all generic and specific features of the invention herein described and all statements of scope of the invention, which as a matter of language, might be said to fall therebetween.