Surgery – Means for introducing or removing material from body for... – Treating material applied to or removed from external...
Reexamination Certificate
1999-03-16
2003-10-14
Lo, Weilun (Department: 3761)
Surgery
Means for introducing or removing material from body for...
Treating material applied to or removed from external...
C222S420000
Reexamination Certificate
active
06632202
ABSTRACT:
FIELD OF INVENTION
This invention relates to eye dropper bottles for dispensing liquids. More particularly, this invention relates to bottles for instilling medicinal liquids into a person's eye while the head is tilted back and the bottle is held against the bridge of the nose in a near horizontal orientation. This invention also is used for instilling drops into an eye by tilting the head back and holding the bottle in a near horizontal orientation with the dropper tip above and over an eye.
BACKGROUND OF THE INVENTION
The instillation of medicinal eye drops tends to be difficult and annoying for many individuals. Generally, a person tilts their head back and looks up. Simultaneously, the dropper bottle is elevated above the eye and held in an inverted position while the walls are squeezed, causing the drop to fall toward the eye. If the lower eyelid is retracted down at the same time, the drop will more easily find its target.
Often, however, the drop misses the eye altogether and falls on the face, where it has no therapeutic value and may even be irritating to the skin. Or, several drops might be released if there is a momentary delay in the first drop and a second one is squeezed from the bottle, causing an overdose and waste of medicine.
There are several factors that often complicate the conventional way of instilling eye drops. First, it is difficult for some individuals, especially the elderly, to elevate their shoulder high enough to place the eye dropper in an ideal position above the eye. Secondly, limitation of motion of the hand or the wrist makes it difficult to turn the bottle in a substantially inverted position. Thirdly, some individuals, as they grow older, find that their hands and head are no longer steady, thus posing the problem of not being able to maintain proper alignment while the drops are being instilled. It is interesting that many patients, even without these limitations, confess that they are never sure where the drop will fall, even though they use drops on regular, daily basis.
It is important to note that dozens of new medications to treat various ocular conditions are discovered and produced every year. There has been tremendous advances in the treatment of ocular diseases, especially in the field of glaucoma. Hundreds of millions of bottles of eye drops are produced each year for this condition alone. Yet, in spite of all the advances in the medications themselves, little or no progress over the past 40 years or more has been made in the way the drops are delivered to the patient.
Billions of dollars are spent annually just to treat glaucoma. It would be interesting to know what percentage of those billions of dollars are wasted because of the present delivery system for these medications. Presently, insurance companies, health maintenance organizations, governmental agencies and especially patients are concerned about the cost of treating various medical conditions. It is essential that the delivery system for ocular medications be reexamined and improved.
There are some individuals who are unable to administer their own drops and either rely on a spouse or a caregiver to instill them. Often the caregiver finds it difficult to get the patient to open their eyes widely while the drops are being instilled. When the hand of the assistant comes before the eye holding the bottle vertically and obscuring the vision, there is a very strong protective reflex to close the eyelids. This makes it difficult to instill the drops with any accuracy and often the drop misses the eye and runs down the cheek. At that point one doesn't know if a drop or a portion of a drop did indeed get into the eye.
The vast majority of individuals administer their own drops and it is imperative to devise a better delivery system for the benefit of these individuals. It is important that the condition for which the drops are taken is adequately treated and that waste is kept to an absolute minimum.
Some attempts have been made over the years to improve the way drops are instilled into the eye. The prior art shows such devices as eye cups that screw onto the threads of a standard eye dropper bottle. Two such prior art eye dropper bottles are described in the patents to Spector (U.S. Pat. No. 5,030,214) and to Bauer (U.S. Pat. No. 5,007,905). However, the bulkiness of these devices, problems with maintaining sterility, and the tremendous variation in bottle sizes, all keep these devices from being widely used. Also, prior art shows attempts have been made to place various devices, such as an angled spout, on the end of an eye dropper bottle to better direct the drop into the eye. One such prior art eye dropper bottle is described in the patent to Menchel et al. (U.S. Pat. No. 5,069,675). Again, it has not solved the delivery system problems that exist.
Today's standard eye dropper bottles are designed in such a way that for all the liquid of the bottle to be used, the bottle must be virtually turned upside down. This is especially true as the volume of liquid decreases in the bottle. This is necessary because the slope of the internal surface of the reservoir of the bottle is flat except for the upper end of the bottle where the slope abruptly changes and turns toward the outlet. The angle that is formed is nearly 90 degrees. It is essential for all the liquid in the reservoir to flow toward the tip so it can be released from the bottle. However, with today's standard eye bottles, a large portion of the liquid remains in the reservoir when the bottle is held in a horizontal position.
A standard 15 ml. (milliliters) eye bottle, without a tip and held in a perfectly horizontal position, will retain 35% of the liquid in the bottle. In other words, 65% of the liquid in the bottle will run out spontaneously, but the remaining 35% of the liquid will not flow out the bottle opening because of the slope of the internal surface of the upper end of the reservoir.
One of the standard 5 ml. dropper bottles on the market today, holding approximately 140 drops, has been observed to retain 50 drops in the bottle when the upper end of the bottle is held down at a 10 degree angle. This same bottle retains 20 drops when that angle is increased to 40 degrees. In fact, the bottle must be held down almost 80 degrees to have virtually all the liquid flow out of the bottle.
Not only do the currently produced bottles need to be held in a markedly down position to empty the bottle, but the bottle needs to be held down to avoid the drop from adhering to the surface of the tip, where it refuses to fall. This adherence of the drop to the tip of the bottle is caused by molecular adhesion or surface tension. The force of molecular adhesion acting upon the drop can be greater than the force of gravity. If a drop adheres to the tip, the patient will squeeze out a second drop which will either fall or further migrate down the surface of the tip. In those circumstances often the drop will fall from the threaded portion of the neck of the bottle. When this occurs the drop usually misses the target altogether. One can readily see where considerable waste can occur.
Not only is an improved bottle needed, but an improved dropper tip to complement such a bottle is mandatory.
(A dropper tip to complement the present invention has been designed that makes drop instillation more accurate, consistent and simultaneously prevents drops from adhering to the stem of the dropper tip. A patent for such a newly designed dropper tip has been filed with the U.S. Patent and Trademark Office; Titled, “Precision Release Tip For Medicinal Liquid Dropper”; Inventor, James Hagele; PTO Application Number, 09/156,216; Filing Date, Sep. 18, 1998; Preliminary Class, 222.)
SUMMARY OF THE INVENTION
The present invention addresses the problems associated with placing drops into an eye in a consistent and precise manner with minimum waste. A bottle has been designed in which the internal surface of the walls of the reservoir maintains a constant slope between the base and the upper end of the reservoir. The constant s
Lo Weilun
Truong Linh
LandOfFree
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