Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-04-19
2001-03-06
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S093010
Reexamination Certificate
active
06196993
ABSTRACT:
TECHNICAL FIELD
This invention relates to an ophthalmic insert and method for the sustained release of medication to the eye for the treatment of eye disorders.
BACKGROUND ART
In order to treat infection, inflammation, glaucoma, and other ocular diseases, drugs are often required to be administered to the eye. A conventional method of drug delivery is by topical application to the eye's surface. The eye is uniquely suited to this surface route of drug administration because, properly constituted, drugs can penetrate through the cornea, rise to therapeutic concentration levels inside the eye, and exert their beneficial effects. In practice, eye drops currently account for more than 95% of drug delivery methods for the eye. Rarely are drugs for the eye administered orally or by injection, either because they reach the eye in too low a concentration to have the desired pharmacological effect, or because their use is complicated by significant systemic side effects.
Eye drops, though effective, are unrefined and inefficient. When an eye drop is instilled in the eye, it overfills the conjunctival sac, the pocket between the eye and the lids, causing a substantial portion of the drop to be lost due to overflow of the lid margin onto the cheek. In addition, a substantial portion of the drop remaining on the ocular surface is washed away by tears into the tear drainage system, thereby diluting the concentration of the drug. Not only is this share of the drug dose lost before it can cross the cornea, but this excess drug may be carried into the nose and throat where it is absorbed into the general circulation, sometimes leading to serious systemic side effects. The small portion of the drug in the eye drop which does penetrate the cornea results in an initial peak tissue concentration, a higher level than is required for the initial pharmacological effect. The tissue concentration then gradually decreases, such that by the time the next eye drop is due, the tissue concentration and the intended pharmacological effect may be too low.
To compound the problems described above, patients often do not use their eye drops as prescribed. Often, this poor compliance is due to an initial stinging or burning sensation caused by the eye drop. Certainly, instilling eye drops in one's own eye can be difficult, in part because of the normal reflex to protect the eye. Therefore, sometimes one or more drops miss the eye. Older patients may have additional problems instilling drops due to arthritis, unsteadiness, and decreased vision, and pediatric and psychiatric patient populations pose difficulties as well.
Attempts have been made to relieve these limitations of topical medications through systems that provide sustained drug release to the eye. Prior topical sustained release systems include gradual release formulations, either in solution or ointment form, which are applied to the eye in the same manner as eye drops but less frequently. Such formulations are disclosed, for example, in U.S. Pat. No. 3,826,258 issued to Abraham and U.S. Pat. No. 4,923,699 issued to Kaufman. Due to their method of application, however, these formulations result in many of the same problems detailed above for conventional eye drops. In the case of ointment preparations, additional problems are encountered such as a blurring effect on vision and the discomfort of the sticky sensation caused by the thick ointment base.
Alternatively, sustained release systems have been configured to be placed into the conjunctival cul-de-sac, between the lower lid and the eye. Such units typically contain a core drug-containing reservoir surrounded by a hydrophobic copolymer membrane which controls the diffusion of the drug. Examples of such devices are disclosed in U.S. Pat. No. 3,618,604 issued to Ness, U.S. Pat. No. 3,626,940 issued to Zaffaroni, U.S. Pat. No. 3,845,770 issued to Theeuwes et al., U.S. Pat. No. 3,962,414 issued to Michaels, U.S. Pat. No. 3,993,071 issued to Higuchi et al., and U.S. Pat. No. 4,014,335 issued to Arnold. However, due to their positioning, the units are uncomfortable and poor patient acceptance is again encountered.
DISCLOSURE OF INVENTION
Therefore, it is an object of the present invention to provide an ophthalmic device and method which provide sustained release of medication to the eye.
It is a further object of the present invention to provide an ophthalmic device and method that ensure controlled medication delivery to the eye over an extended period of time.
It is a still further object of the present invention to provide an ophthalmic device and method for sustained release of medication to the eye which improve patient compliance.
Accordingly, an ophthalmic insert for sustained release of medication to the eye is provided. The insert includes a body portion sized to pass through a lacrimal punctum and be positioned within a lacrimal canaliculus of an eyelid. The insert further includes a collarette connected to the body portion and sized to rest on the exterior of the lacrimal punctum, the collarette having a pore provided therein. A reservoir is contained at least partially within the body portion and in fluid communication with the pore, wherein the reservoir is designed to store and release medication through the pore and onto the eye over time in a controlled manner while the insert is positioned in the eyelid.
Correspondingly, a method is for providing sustained release of medication to the eye is provided. The method includes providing an insert having a body portion sized to pass through a lacrimal punctum and be positioned within a lacrimal canaliculus of an eyelid, a collarette connected to the body portion and sized to rest on the exterior of the lacrimal punctum and having a pore provided therein, and a reservoir contained at least partially within the body portion and in fluid communication with the pore. The method further includes positioning the insert into the lacrimal punctum and canaliculus of the eyelid. Still further, the method includes releasing medication stored in the reservoir through the pore and onto the eye over time in a controlled manner while the insert is positioned in the eyelid.
In a preferred embodiment, the insert is positioned in the upper lacrimal punctum and canaliculus, so as to minimize disruption of the normal flow of tears. In addition, the pore is preferably constructed with a specific geometry appropriate to control the rate of release of the medication onto the eye. The insert may further comprise an enlarged bulb portion connected to the body portion for securing the insert within the canaliculus. The reservoir may be partially contained within the bulb portion, and may also be in fluid communication with a reservoir extension, such as a balloon, which extends into the canaliculus to allow for additional medication volume.
The above objects and other objects, features, and advantages of the present invention are more readily understood from a review of the attached drawings and the accompanying specification and claims.
REFERENCES:
patent: 3618604 (1971-11-01), Ness
patent: 3625214 (1971-12-01), Higuchi
patent: 3626940 (1971-12-01), Zaffaroni
patent: 3630200 (1971-12-01), Higuchi
patent: 3641237 (1972-02-01), Gould et al.
patent: 3826258 (1974-07-01), Abraham
patent: 3845770 (1974-11-01), Theeuwes et al.
patent: 3949750 (1976-04-01), Freeman
patent: 3962414 (1976-06-01), Michaels
patent: 3963025 (1976-06-01), Whitaker et al.
patent: 3992071 (1976-11-01), Higuchi et al.
patent: 4014335 (1977-03-01), Arnold
patent: 4834979 (1989-05-01), Gale
patent: 4875602 (1989-10-01), Chickering et al.
patent: 4882150 (1989-11-01), Kaufman
patent: 4923699 (1990-05-01), Kaufman
patent: 4994273 (1991-02-01), Zentner et al.
patent: 5053030 (1991-10-01), Herrick et al.
patent: 5171270 (1992-12-01), Herrick et al.
patent: 5283063 (1994-02-01), Freeman
patent: 5378475 (1995-01-01), Smith et al.
patent: 5417651 (1995-05-01), Guena et al.
patent: 5417682 (1995-05-01), Wong et al.
patent: 5423777 (1995-06-01), Tajiri et al.
patent: 5723005 (1998-03-01), Herrick
pat
Cohan Bruce E.
Diamond Howard
Brooks & Kushman P.C.
Eyelab Group, LLC
Kennedy Sharon
Serke Catherine
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