Invented by Harold D. Mansfield
The Harold D. Mansfield invention works as followsA handheld application designed to deliver a liquid drop ophthalmic medication into the human eye.” The basic structure includes a finger grip and a drop retention section that is connected with the grip section by an extension. The device is constructed from an elastomeric substance that allows for a safe transfer of liquid drops into the eye. The device is designed to hold a drop from a container. Surface tension creates adherence. While maintaining a clear view through an eyeglasses, the user can administer the drop without tilting the head. The drop is applied from the peripheral vision. Contact with the eye relieves surface tension and allows the drop to safely enter the eye. “The same applicator can have two drop retainer sections with different structures on either side.
Background for Drop transfer and eye drop applicator
The invention is a device for manually applying eye drops to humans, and more specifically, an annual eye drop applicator, as well as a method of inserting a liquid drop into the eye.
Eye droppers have been used for many years to relieve various eye conditions. Some eye ailments can be treated by applying topical medications. For example, bacterial conjunctivitis, a/k/a/ ?pink eye? Antibacterial solutions can be used to treat bacterial conjunctivitis (as opposed the viral form). Keratoconjunctivitis Sicca (also known as “chronic dry eye”) can be treated with antibacterial solutions. Artificial tears can help to alleviate the symptoms of keratoconjunctivitis sicca. Artificial tears and other solutions can treat a variety of eye irritations.
In these cases, it is important to get some solution into the lower sac conjunctival, which is the space between the sclera (the white part of the eye) and the lower lid. The solutions are inexpensive, so wasting drops on the cheek is not a big deal.
Glaucoma is a much more serious condition. This condition manifests itself in the most common form as an accumulation of pressure between the retina and lens. Untreated, the optic nervous can be damaged and lead to blindness. The treatment usually involves applying one or more eye drops containing one or several medications. The cost of wasted eye drops can be significant in this situation. Prescriptions are written based on the assumption that one drop is used per application. Wastage can lead to prescriptions being renewed prematurely. Insurance coverage is a concern. “Lastly, many glaucoma medications have side effects, and an accidental overdose, although usually limited by the conjunctival sac capacity, is not desired.
Over-the-counter solutions are used as needed to relieve a condition perceived by the consumer. Many times, successful drop application provides immediate relief. The drops are not felt in the case of glaucoma. To prevent further vision loss, the drops must be used twice or more every day.
Over the years, we have developed a preferred method for administering medicated drops to patients. In the past, eyedroppers were sold separately in bottles. Now they are integrated into the plastic bottle. These small, pliable hand-held containers have cone-shaped nozzles with varying inner diameters. Drops are released by inverting and squeezing the container. The size of the drops depends on the solution and the bottle tilt angle.
How to insert eye drops? The NIH Clinical Center offers typical advice to patients: “Wash your hands to prevent eye infection, hold the bottle with one hand (the left for right-handed individuals), lie down or tilt the head back to make the eye look up, use the index fingers of the other hand and pull the lower lid down to create a pocket and then squeeze the bottle so that a few drops fall onto the eye.
While this may seem simple, it can be difficult for many patients to perform consistently. The blink reflex is common in most people, making it hard to keep an eye open while viewing close objects. Glaucoma is more common in older people. They may have poor manual dexterity, making it difficult to squeeze a drop that is the right size. Some people have difficulty aiming the bottle to ensure that the drop falls in the eye and not on the cheek or eyelid. Studies have shown that noncompliance to prescribed treatments is a major obstacle to effective management of glaucoma.
For example, Winfield et al. In 1990, Winfield et al. (1990) conducted a study on the causes of noncompliance. They also reviewed the findings from earlier teams between 1982 and 1986 (see footnote). Missed doses, difficulty placing drops in the eyes, large variations in drop sizes from commercial droppers and difficulties in aiming are all problems. In 1985, several aids were available that were aimed at aiming. The study included patients (9-92 years old) who were taking drops to treat glaucoma (32%) post-surgically (25%), dry eye (10%) irritation (10%) and balance. The drops were administered using a dispenser bottle that was aimed directly at the eye. The majority of 57% reported some difficulty. Poor aim was the main problem, followed by difficulty in squeezing and blinking. The authors suggested a bottle-holding device with a stabilizer around the eye socket.
Although this was not a study of compliance, the problems were evident even earlier. Fraunfelder (1996) used radioactive technetium to determine the best way to apply topical medications. He says that most commercial eyedroppers are too big, producing 50-75 uL of drops. This is because they cause a blinking reflex which removes the majority. According to what the conjunctival pouch can hold after a blink, a 13 uL drop size is recommended.
Salyani et al. “Methods for improving patient compliance with topical use prescribed glaucoma medications are sorely required,” (2005). The researchers evaluated the patient’s use of an eye drop guide consisting of a plastic funnel inverted that fits over a bottle. It was difficult to clean and not worth the effort, according to experienced users. Newsom (2008) states in his How to Put In Eye Drops advice that “many people find it difficult to take drops.” but shows two drop aids. Xalease appears to be a combination bottle squeezer/eye socket alignment guide.
The problem has not been solved. In a study on bottle force requirements by Connor & Severn, (2011) they summarize previous studies and state: “Non-compliance is common in glaucoma, ocular hypotension, and ophthalmic hypertension.” At least 50% of patients have difficulty self-administration. Two of the most frequent reported difficulties are aiming and squeezing bottles. They say that the insidiousness of disease progression, and the need for long-term treatment are important issues. The ease of topical application is paramount in these conditions.
It is obvious that there has been an urgent need to improve on the eyedropper for a long time.
Some patents also address similar problems. The following are thumbnail sketches that use the inventor’s language as much as is possible, in an approximate order of date. These patents, even if they are not similar art, provide an historical perspective. Searching is not foolproof, and other relevant patents may have been overlooked or not found.
U.S. Pat. No. No. The patent, entitled?Medical Insert Instrument?, was issued to Adams on July 19, 1977. The invention is a swab that can be used to place and remove plastic inserts which deliver time-released medication into the eye.
U.S. Pat. No. No. 3. 1990 (Division U.S. Patent. No. 4,838,851, Jun. The patent, entitled ‘Applicator and Packaging Thereof?, was filed on June 13, 1989. Composed of a handle and a tip that is designed to be used for cleaning an eyelid.
U.S. Pat. No. No. The apparatus consists of a hollow, compressible body that is connected to a nozzle around 900. The nozzle discharge is designed to produce a predetermined liquid drop when the body’s pressed. The advantages include not having the head tilted back, and being able use one hand to squeeze the body while holding the lower eyelid.
U.S. Pat. No. 5,516,008 to Rabenau et al. On May 14, 1996, the ‘Medication Dispensing container,’ was filed. The squeeze bottle is replaced by a small storage cavity with a flexible wall that can be squeezed. The discharge nozzle is positioned at a right angle with the cavity housing. “Sterilization and plastic manufacturing can cause rough edges that are eye hazards.
U.S. Pat. No. Gueret for No. 30 1999, entitled “Capillary Dosing Unit with Terminal Slit” This patent is not related to applying dermopharmaceuticals on the nail, eyelids or any other part of the scalp or face. The flexible applicator is a hand-held device with a cylindrical end that has a slit on the diameter. This slit acts as a reservoir for capillary fluid after it’s been dipped into a solution. The amount of capillary fluid to be used depends on the volume, since any excess can simply be wiped away inside a dispenser.
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