Clamp for nasolacrimal sac occlusion during administration of ocular medication

The invention herein described involves a clamp placed over the bridge of the nose to apply pressure over the fossa of the nasolacrimal sac, prior to ocular medication, to seal the nasolacrimal sac, and thereby prevent drainage of medicament away from the eye.

FIELD OF THE INVENTION 
The invention relates to devices that clip or clamp to the bridge-area of 
the nose to exert pressure and thereby prevent fluid from the eyes from 
flowing away during ocular medication. 
BACKGROUND OF THE INVENTION 
Ophthalmologists have recognized that medicaments administered to the eye 
by drops drain from the eye and are absorbed into the blood stream. This 
presents a two fold problem. First, the drug absorbed from the eye to the 
blood stream can cause undesirable side-affects. Second, because the 
eyedrop medication quickly drains from the eye into the blood stream, 
contact time between the medicament and the eye is undesirably shortened, 
with the result that the medicine does not have the desired affect on the 
condition being treated. 
Ocular medications, when instilled into the eye drain away from the eye 
through the lacrimal system into the nasopharynx. This process takes 
several minutes depending upon the viscosity of the medication instilled. 
Drainage of medication away from the eye decreases contact time with the 
conjunctiva and cornea, and hence decreases ocular absorption. The 
drainage through the lacrimal system removes the drops from the eye and 
places the drops in contact with the nasal mucosa. The nasal mucosa allows 
for rapid absorption of medications into the blood stream. Certain 
medications can cause generalized side effects. Glaucoma medications, 
especially the class called beta-blockers, have been associated with 
significant morbidity, as well as, mortality from cardiovascular and 
pulmonary side effects. 
Various solutions to the problem of systemic absorption of medicaments from 
the eye into the blood stream have been proposed in the medical 
literature. 
Huang et al--American Journal of Ophthalmology, Vol. 107, February 1989 
pages 151-155 discuss several methods for maximizing contact time between 
the eye and medication. In the article they state that, 
". . . most topical ophthalmic medications with intraocular sites of action 
penetrate the eye through the cornea, conjunctiva, or sclera. The amount 
of medication absorbed is influenced by the amount of contact time between 
the medication and the ocular surfaces. Most of an eyedrop is lost to 
drainage within 15 to 30 seconds after instillation, which includes rapid 
drainage of 80% or more of the volume through the nasolacrimal system. 
Inhibition of this rapid drainage may lengthen the contact time of the 
medication with the eye and increase its absorption and efficacy. 
Inhibition of drainage through the nasolacrimal system may be achieved by 
manual occlusion with a fingertip, by placing plastic or collagen plugs 
into the puncta, or by permanently closing the puncta with cautery or 
laser. Nasolacrimal occlusion with fingertip pressure as a means of 
increasing ocular absorption of topical ocular medications has been 
proposed. Many patients, however, are unable to practice proper manual 
nasolacrimal occlusion." 
Urttic et al--Survey of Ophthalmology Vol. 37, No. 6 May--June 1993 pages 
435-456 discusses in a review article methods for minimizing the systemic 
absorption of topically administered ophthalmic drugs. One of the ways 
suggested to increase ocular absorption and minimize systemic absorption 
was punctual occlusion, to block ocular drainage of the eyedrop from the 
conjunctival sac. This method involves applying the drops and pressing the 
inner ocular corners near the bridge of the nose with the fingers for 30 
seconds to several minutes. 
Gerber et al--Survey of Ophthalmology, Vol. 35 Number 3, November--December 
1990, pages 205-218 states that: 
"Topically applied ophthalmic medications can attain sufficient serum 
levels via absorption into conjunctival, nasal, oropharyngeal and 
gastrointestinal mucosa to have systemic effects and thereby interact with 
other drugs. In fact, topical administration to the eye has been likened 
to intravenous rather than oral administration because a high percentage 
of the absorbed drug avoids hepatic first-pass metabolism; thus, drugs 
administered by this route can attain higher levels relative to dose than 
if administered orally. 
It is important to remember that even where the potential for drug 
interaction exists, there are methods to reduce systemic absorption. 
Nasolacrimal occlusion, a technique in which digital pressure on the 
periphery of the nasolacrimal drainage system obstructs drainage to the 
nasopharyngeal mucosa, has been shown to significantly decrease systemic 
absorption. Eyelid closure for five minutes following drug application 
also achieves the same purpose by inhibiting nasolacrimal pump action." 
The eyelid closure method of nasolacrimal occlusion involves the steps of 
tilting the head back and gently pulling down the eyelid to form a "V" 
pocket between the eye and the lower lid; placing drops of medicine in the 
eye; closing eyes and keeping head tilted back for 30 seconds to assure 
absorption of medication into the eye. 
Methods involving the combination of punctual occlusion along with eyelid 
closure are recommended by many ophthalmologists. 
Muenzler--Geriatric Ophthalmology Vol. 2 (1), January/February 1986, pages 
19-23 in a discussion of the treatment for "dry eye" suggests another 
method of punctual occlusion using punctum plugs. Punctum plugs made of 
silicon supplied by Eagle Vision used to occlude the punctum and 
canaliculus are available to ophthalmologists. 
Collagen implants have been experimentally implanted into the canaliculus 
as temporary implants to test for various abnormalities of the eye, such 
as, redness, burning, tearing, dry eye conjunctivitis, etc. If the 
complained of condition improves with the implant, the doctor considers 
permanent closure of the canaliculus. (Ophthalmology Times, Vol. 10 No. 23 
Dec. 1, 1985). 
A review of the literature indicates that the medical profession has 
recognized a number of ways to prolong contact time between medication and 
the eye, however none of the prior art has recognized applicants' 
occlusive device or method of employing such a device to prolong contact 
time between the eye and the medicament applied to the eye. 
Prior art patents describe various clamping devices 
Carence in U.S. Pat. No. 598,467 describes a "Nostril-Protector" which is 
designed to externally close the nostrils and prevent the entrance of dust 
carried by the atmosphere from entering the nose. The Carence device has a 
spring actuated clip which grasps the central partition or cartilage 
dividing the two nostrils and thereby positions attached plates to close 
the nostrils. Thus, dust is prevented from entering the nose. 
Hackett et al in U.S. Pat. No. 186,422 discloses a spring-like device for 
use by swimmers with ear stoppers and nose pads. The ear stoppers on the 
spring frame occlude the ears, and nose pads on the spring frame seal the 
nostrils. In this way, water is prevented from entering the nose and ears. 
U.S. Pat. No. 2,274,997 to Thurman illustrates a nose plug which is 
inserted into the nose to keep water out of nasal passages during 
swimming. The device has a spring-like portion attached to laterally 
projecting integral arms which are engageable with the vomer portions of 
the nose for securing nose plugs in position to keep water out of the 
nasal passages. 
Gollubier in U.S. Pat. No. 2,620,793 depicts a U-shaped nose clip for use 
by swimmers to prevent water or foreign matter from entering the nose. The 
nose clip can be made of a single U-shaped piece of resilient wirelike 
material. The nose clip can be coated with rubber or plastic. The coating 
serves to prevent corrosion of the wirelike material. Further, the coating 
prevents the clip from scratching the skin when the clip is applied or 
removed from the nose, as well as, preventing the clip from slipping 
during vigorous swimming activity. 
In a modified embodiment, the Gollubier device has two pivotally connected 
arms. The bottom portion of the pivotally connected arms are spring 
actuated and when squeezed together open the top portion of the pivotally 
attached arms for application to the nose. Release of the bottom arms 
squeezes the top arms to seal the nasal passages. 
A clip for sealing the nostrils is taught by Claudius in U.S. Pat. No. 
2,015,617, and Browne in U.S. Pat. No. 2,488,616. The clip disclosed in 
both of these patents seals the nostrils and prevents air from entering. 
A mechanical clamp-like device for shaping the nose is taught by Tanikaw in 
U.S. Pat. No. 2,757,665. 
Freeman (U.S. Pat. No. 3,949,750) and MacKeen et al (U.S. Pat. No. 
4,915,684) disclose punctum plugs for insertion into the punctual 
apertures of the eyes. Freeman's device blocks drainage of lacrimal fluid. 
The device of MacKeen et al modulates and controls the flow of lacrimal 
fluid. 
U.S. Pat. No. 580,954 to Ray discloses a device for clamping noses to 
correct nasal deformity. 
While clips per se are old, and have been placed on various parts of the 
body, including the nose, none of the prior art cited shows a clip or 
clamp applied to the bridge of the nose to exert an exact pressure over 
the fossa of the nasolacrimal sac to prevent tears from flowing and 
thereby carrying away medication topically applied to the eyes. 
SUMMARY OF THE INVENTION 
This invention has as an object the production of an efficient way of 
prolonging contact time between the eye and medication applied to the eye. 
An additional object is to produce a device which is easy to apply and 
prolongs eye contact time with the medication. 
The purpose of the current invention is to provide consistent and sustained 
occlusion of the nasolacrimal sac, with a clip over the bridge of the nose 
to achieve prolonged contact between the applied medication and the eye. 
The present invention describes a clip or clamp to go over the area of the 
bridge of the nose to exert pressure over the fossa of the nasolacrimal 
sac, thereby preventing tears from flowing away from the eye, through the 
punctae, into the "tear" or nasal lacrimal duct. The sealing of the 
nasolacrimal duct is known as nasolacrimal occlusion (NLO). This occlusion 
maximizes contact time and ocular absorption of topical medications and 
minimizes systemic side effects of topical ocular medications. 
Many designs of the clamp are possible, and in construction they can be 
made of rubber, plastic, or metal, or a combination of these. The general 
shape of the device could be a "U" shape with prominences at the position 
where the lacrimal sac is located and occlusion is to take place. The 
inside of the clamp could be tapered to fit comfortably at the bridge of 
the nose, as well as, to be better positioned for achieving good 
nasolacrimal occlusion. The outer surface of the clamp could be corrugated 
to allow for easier application and removal. In addition to a one-piece 
design, multiple-piece designs could be created with a spring at the apex 
of the "U" to allow for flexing and application of the clamp. The spring 
could be of variable or adjustable tension. An alternative design would 
allow for stick-on nose pads similar to those used for spectacles. The 
nose pads could be placed on the arms of the clip to adjust the fit of the 
clip to an individual's anatomy. Alternatively, the inside of the "U" or 
arms could be widened to provide a generalized pressure over a larger area 
at the bridge of the nose, like that of the tip of a finger. This would 
allow for occlusion with a less exact placement of the clip. An 
alternative design would have a "U" shaped clip in an outer mold, placed 
over the bridge of the nose and be filled with a rubber-like material, 
thereby producing a customized casting to fit the individual's nasal 
shape. The clip could be of a design that the patient alone could fit or 
the clip could be adjustable to allow fitting by an eye care professional 
or optician. Alternatively, the patient could be supplied with a series of 
clips and told to use the one which fits best, or the doctor could fit the 
patient with the clip which fits best. 
A most important consideration for this invention is the pressure to be 
exerted by the nasal clip. The clip has to be constructed in such a way as 
to exert enough pressure to occlude the nasopharynx and not so much 
pressure as to cut-off the blood supply and thereby produce ischemia. 
In the preferred method of use, the nasolacrimal clip or clamp is applied 
first over the bridge of the nose and then the eyedrop is applied to the 
eye. By applying the clip first and then applying the drops, advantage is 
taken of the fact that the duct is sealed prior to application of the 
drops. Since sealing of the duct takes place prior to instilling the 
eyedrops, maximum contact time between medication and eye takes place. In 
methods such as finger punctual occlusion, where the drop is applied first 
and then the finger applied to the bridge of the nose to prevent drainage, 
valuable time is lost between the application of the eye drop and the 
finger-sealing of drainage. 
A specific embodiment of this invention involves a nasolacrimal clamp for 
placement over the bridge of the nose to apply pressure over the fossa of 
the nasolacrimal sac, prior to ocular medication. The clamp has two arms 
having inner surfaces for fitting over the bridge of the nose, with each 
of said arms of the clamp supplying a predetermined pressure to the 
nasolacrimal sac, to occlude drainage of medicament, without occluding the 
blood supply and causing ischemia. The clamp can be resilient and arcuate 
in form. The predetermined pressure supplied by the two arms can be 
created on the two inner surfaces of the clamps by the resiliency of the 
material from which the clamp is made. Alternatively, the predetermined 
pressure supplied by the two arms can be created on the inner surfaces of 
the arms by a spring. 
In a specific embodiment the clamp has on the inner surface of each arm 
attached adjustable pads, such that the pads when adjusted on the inner 
surface of the arms apply pressure at the exact point over the fossa of 
the nasolacrimal sac. 
In a unique embodiment of this invention the clamp is attached to 
eyeglasses designed to accept eyedrop medication applied to the eye. 
A special embodiment of this invention envisions embedding the clamp in a 
flexible molded positioning device which has been molded to fit the shape 
of the bridge of the nose and with the clamp in such a position in the 
molded device to positively seal the nasolacrimal sac and thereby prevent 
drainage of medicament. By the use of the flexible molded positioning 
device with the nose clamp embedded therein, the clamp will be accurately 
placed over the fossa, and the exact amount of pressure can be built into 
the clamp to assure the effective sealing of the fossa of the nasolacrimal 
sac without causing ischemia. 
The inventors expect to dispense the clamp of this invention with 
medications applied to the eye; and specifically in a package containing 
eyedrops. In the most preferred embodiment, the package will be a 
dispensing package containing a container of eyedrops and an eyedropper. 
The clip could be supplied in a sterile wrapper put into the package along 
with the eyedrops. This method of dispensing would involve a kit or 
package containing the eyedrop medicament along with the clip. Directions 
for use could be inserted in the package as a package insert. 
In specific use, the disclosed invention involves a specific improved 
method for applying medication to the eye, comprising applying a clamp to 
the bridge of the nose to apply a predetermined pressure over the area of 
the fossa of the nasolacrimal sac to occlude drainage of medicament from 
the eye, and then administering medication to the eye. Specifically that 
medication can be applied in the form of an eyedrop.

GENERAL DESCRIPTION OF THE PREFERRED EMBODIMENTS 
With reference to FIGS. 1 and 2 eyedrops 10 are applied to eyes 11 (FIG. 1) 
and then placement of the finger 12 to the bridge of the nose 13 (FIG. 2) 
to occlude the nasolacrimal system 14 as done by the prior art. As set 
forth above this system was inefficient. 
In FIGS. 3 and 4 the clamp 15 placed over the bridge of the nose 13 
occludes the nasolacrimal system (not shown) (FIG. 3) allowing eyedrops 10 
to be applied FIG. 4 with maximum contact time between medication and the 
eye 11. 
Several embodiments envisioned by this invention are exemplified in the 
drawings (FIGS. 5-16). 
A clamp or clip 15 for applying generalized pressure over the fossa of the 
nasolacrimal sac (FIG. 5) can be molded of rubber or plastic; or can be 
made of spring metal covered by rubber or plastic. 
The clamp can be a one-piece molded clamp 15 (FIG. 6), with projections 16 
on the inside surface 17 of the two legs 18 of the clamp for applying 
pressure to the nasal lacrimal duct. 
With reference to FIGS. 7 and 8, the clamp 15 has adjustable stick-on pads 
19. The adjustment of the pads 19 on the legs of the clamp 18 will allow 
the patient or doctor to adjust the placement of the pads 19 to fit 
exactly over fossa of the nasolacrimal sac thus assuring maximum occlusion 
once the clamp is applied. 
The projections or stick-on pads 19 can be hollow and air-filled, or hollow 
and filled with a gel. Alternatively, the pads could be made of soft 
rubber or soft plastic. The consistency of the stick-on pads 19 should be 
such as to make application of the clamp 15 as comfortable as possible for 
the patient, bearing in mind the need for proper occlusion. Comfort of 
application is particularly important because of the desire to ensure that 
the patient employ the clamp 15 religiously. 
In FIGS. 9-12 the nasolacrimal clamp 15 is tong-like 20. The two legs of 
the clamp 18 (FIGS. 9-10) are held together by a spring 21 which provides 
pressure when the clamp 15 is applied to the fossa of the nasolacrimal 
sac. FIGS. 11-12 depict the tong-like clamps 15 made of flexible metal or 
plastic, etc. In this latter embodiment pressure is applied through the 
flexibility of the material 22, such as plastic, rather than a spring 
action 21 (FIGS. 9-10). Pressure grips 23 (FIGS. 9-12) at the top of the 
clamp 15 aid in opening the legs of the clamp 18 for placement of the 
clamp on the bridge of the nose. 
The clamp 15 can be attached to eyeglasses 24 (FIG. 13). A special type of 
eyeglass 24 (known in the art) with holes 25 in the lenses 26 allows 
eyedrop medication to be applied to the eye through the holes 25. This 
eyeglass 24 is used to attach clamp 15. The clamp 15 is applied to the 
bridge of the nose prior to administering the medicament to the eye 
through the hole 25 in the eyeglasses. 
With reference to FIG. 14 the nasolacrimal clamp 15 is seated in a flexible 
molded positioning device 27. The flexible molded positioning device 27 
containing the clamp 15 is molded to substantially exactly fit the clamp 
over the bridge of the nose 13 and the fossa of the nasolacrimal sac. The 
straight dashed lines in FIG. 14 show the direction the clamp 15 will take 
to the bridge of the nose to seal the nasolacrimal sac and thereby occlude 
drainage of medicament. 
More specificaly, with reference to FIG. 15, in a sectional view taken 
along lines 1-15 of FIG. 14, a dovetail joint 29 is integral with the 
clamp 15 and is embedded in the flexible molded positioning device 27. 
This dovetail joint 29 is designed to more effectively secure the clamp 15 
in the flexible molded positioning device 27. 
With reference to FIG. 16, the invention envisions the clamp 15 being 
packaged 30 along with the eye drop 10 for dispensing to a patient. 
The nasolacrimal occlusion clamp and method of this invention have many 
advantages over the prior art devices and methods: 
1. The device of this invention is superior to manual occlusion because, 
once the clamp is applied to the bridge of the nose both eyes can be 
medicated without the need for applying pressure with the fingers. Thus 
with the clamp in place before applying medication to the eye, contact 
time between medication and eye is maximized. 
2. The clamp of this invention when used to seal drainage has the advantage 
over the use of plastic or collagen plugs placed into the puncta, because 
the clamp can be applied easily by the lay person; and does not require 
the use of a doctor or skilled technician for application. 
3. It is quite evident, that the clamp, in its convenience of use, is 
superior to closing the puncta with cautery or laser. These latter methods 
require surgery. These processes may not be reversible. 
4. The clamping method herein disclosed offers advantage over the eyelid 
closure method because a more positive and complete occlusion is possible. 
Clearly, the clamp herein disclosed presents important advantages over the 
prior art methods and devices; and offers a significant benefit for the 
patient receiving eyedrop medication. 
Obviously, many modifications may be made without departing from the basic 
spirit of the present invention. Accordingly, it will be appreciated by 
those skilled in the art that within the scope of the appended claims, the 
invention may be practiced other than has been specifically described 
herein.