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Implant capable of forming a differential image in an eye and methods of inserting and locating same

USPTO Application #: 20070299515
Title: Implant capable of forming a differential image in an eye and methods of inserting and locating same
Abstract: An implant capable of forming a differential image in an eye is shown. The implant comprises an elongated member having a pair of spaced ends. The elongated member is formed of a dimension to be inserted into and/or passed through a punctum opening of an eye and into the canaliculus. The implant comprises an energy obstructing material, such as for example a pigment comprising titanium dioxide, which is responsive to the application of an energy wave in the visible light range which, upon everting of an eyelid of an eye and exposing the implant to the energy wave, forms a differential image pattern showing the location of the implant in the canaliculus of the eye. (end of abstract)
Agent: Daniel J. Meaney, Jr. - Santa Barbara, CA, US
Inventor: Robert S. Herrick
USPTO Applicaton #: 20070299515 - Class: 623004100 (USPTO)
Related Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Eye Prosthesis (e.g., Lens Or Corneal Implant, Or Artificial Eye, Etc.)
The Patent Description & Claims data below is from USPTO Patent Application 20070299515.
Brief Patent Description - Full Patent Description - Patent Application Claims  monitor keywords

CROSS-REFERENCES TO RELATED APPLICATIONS

[0001] This Application claims the benefit, under Title 35, United States Code .sctn.119(e), of U.S. Provisional Patent Application Ser. No. 60/297,560 filed Jun. 11, 2001.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not Applicable

REFERENCE TO A "MICROFICHE APPENDIX" (SEE 37 CFR 1.96)

[0003] Not Applicable

BACKGROUND OF THE INVENTION

[0004] 1. Field of the Invention

[0005] The present invention relates to a an implant adapted to be utilized in the treatment of a human eye having a deficiency of tears and more specifically relates to an implant capable of forming a differential image in an eye wherein the implant includes an elongated member including a central axis and having at one end thereof a distal section which, in the preferred embodiment, is in the form of a collapsible expanded section.

[0006] The distal section may terminate in a distal tip which extends in a direction substantially parallel to the central axis. The elongated member including the distal section and collapsible expanded section are dimensioned to be inserted into and passed through a punctum opening of an eye into the canaliculus. In its broadest concept, an energy wave blocking material responsive to an energy wave, which may either be in be form of sound waves vibrating at frequencies greater than 20,000 cycles per second, e.g., ultrasound waves, or electromagnetic radiation is incorporated into the implant, which upon everting of an eyelid of an eye and exposing the implant to an appropriate energy wave, forms a differential image pattern showing the location of the implant in the eye.

[0007] In the preferred embodiment, a substantially opaque material responsive to electromagnetic radiation in the wavelength of visible light is incorporated into the implant which, upon everting of an eyelid of an eye and exposing the implant to electromagnetic radiation in the wavelength of visible light, forms a differential image pattern visually showing the location of the implant in the eye.

[0008] This invention also relates to a method for treating external eye conditions due to a deficiency of tears utilizing the implant having at one end thereof a distal section, preferably in the form of a collapsible flared section, terminating in a distal tip which extends in a direction substantially parallel to the central axis.

[0009] 2. Description of the Prior Art

[0010] It is known in the art that certain eye problems are related to the volume of tears on the surface of the eyes. Certain of these problems include dry eyes, corneal ulcer, conjunctivitis, blepharitis, contact lens problems and many other external eye diseases.

[0011] One method for treating for a deficiency of tears is disclosed in U.S. Pat. No. 4,660,546 which discloses a method for treating external human eye conditions due to a deficiency of tears which includes the step of temporarily blockading the canaliculus of the patient and observing over a preselected period of time the response of the patient's eye to the temporary blockage and to determine if any improvement in the eye condition has been achieved in response to the occlusion.

[0012] If an improvement in eye condition is noted, an implant is placed within the canaliculus of the eye of the patient. A temporary blockading of the canaliculus is performed by placing a dissolvable, removable element, which may be in the form of a collagen material or other dissolvable material such as, for example, catgut, in the canaliculus. Unless removed shortly after insertion, the dissolvable implant is typically absorbed by the body in approximately a two-week period.

[0013] A determination is first made if the canaliculus blockage results in an improvement in the eye condition or other conditions caused by related nasal congestion warranting permanent blockage of the canaliculus, for example, the patient will respond to a partial 60% to 80% retention of constant tears.

[0014] If permanent blockage of the canaliculus is warranted, U.S. Pat. No. 4,660,546 discloses that the permanent blocking of the canaliculus is performed by utilizing a permanent implant. U.S. Pat. No. 4,660,546 discloses that the permanent implant is fabricated of a non-absorbable or non-dissolvable material and is in the form of a cylindrically shaped central body having a tapered end or an end of reduced diameter to facilitate the implantation of the implant into and for removal of the implant from the canaliculus. Both the temporary collagen implant or other dissolvable material and the permanent implant disclosed in U.S. Pat. No. 4,660,546 are in the form of a cylindrically shaped central member having a predetermined diameter which may terminate at one end in a tapered end and which reduces in diameter as it slopes away from the central member to form a tapered tip to facilitate insertion of the implant through the punctum, and into the canaliculus.

[0015] U.S. Pat. No. 4,461,295 discloses another treatment method which is a method for laser punctal occlusion. It is known in the art that punctal occlusion has been proven to be an effective way of treating patients with conditions such as sinusitis, hay fever, middle eye infection (chronic), post nasal drip, front headache and other such conditions.

[0016] The treatment method disclosed by U.S. Pat. No. 4,461,295 includes the use of a temporary suture to stitch the tear drainage canals of the eyes closed to determine if a greater tear volume on the surface of the eyes would improve certain eye problems. This diagnostic procedure has become known in the art as the Herrick Stitch Test. The Herrick Stitch Test is performed by anesthetizing the local area around the lower or upper punctum of the eye. A stitch is carefully placed to occlude the punctum by an eye surgeon utilizing magnification of the eye.

[0017] After a preselected period of time using the Herrick Stitch Test, the eye surgeon determines if the eye condition has improved, if so, then the eye surgeon permanently closes the punctum by using an ARGON laser. The punctum may be reopened at a later time if excess tearing is experienced. The reopening of the punctum can be performed by surgical and laser techniques, all as disclosed in U.S. Pat. No. 4,461,295.

[0018] It is also known in the art to utilize other plugs and or techniques for occluding the punctum. One plug device which is known in the art is referred to as a punctum plug which is described in an article by Jerre M. Freeman, MD, entitled "The Punctum Plug: Evaluation of a New Treatment for the Dry Eye" which appeared in the publication of the transcripts of the America Academy of Ophthalmology and Optometry, pages OP-874 through OP-879 (hereinafter referred to as the "Freeman Reference"). In addition, the same punctum plug is disclosed and described in U.S. Pat. No. 3,949,750.

[0019] The punctum plug disclosed in the Freeman Reference and in U.S. Pat. No. 3,949,750 is a plug that is adapted to be inserted into one or more of the upper and/or lower punctal openings of the eye to block or occlude the punctum. The punctum plug of Freeman is a rod-like plug formed with an oversized rigid or solid tip or barb portion that dilates and blockingly projects into the that portion of the canaliculus located adjacent the punctum opening.

[0020] The punctum plug has a smaller neck or waist portion around which the punctum sphincter ring or fibrous tissue defining the punctum opening tightens. The punctum plug has relatively large, smooth head portion that rests on top of the punctal opening and is intended to prevent the plug from passing down into the canaliculus. The smooth head portion is designed to be domed shaped to permit the head to rest in the lacrimal lake and against the conjunctiva and cornea, sometimes with irritation. The head portion functions to prevent the punctum plug from passing or migrating further into the canaliculus. The punctum plug of Freeman is subject to being inadvertently removed from the eye by the patient.

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Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor

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