Petitioner: Haag-Streit AG
`Petitioner: Haag-Streit AG
`
`Ex. 100(cid:20)
`
`EX. 1001
`
`

`

`(12) United States Patent
`(10) Patent N0.:
`US 6,547,394 B2
`
`Doherty
`(45) Date of Patent:
`Apr. 15, 2003
`
`USOO6547394B2
`
`(54) HAND-HELD OPHTHALMIC ILLUMINATOR
`
`FOREIGN PATENT DOCUMENTS
`
`(76)
`
`Inventor: Victor J. Doherty, 32 Sterling Rd.,
`Wellesley, MA (US) 02482
`
`20001314 A1
`JP
`* cited by examiner
`
`7/2001
`
`( * ) Notice:
`
`Subject. to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`Primary Examiner—George Manuel
`
`(57)
`
`ABSTRACT
`
`.
`(21) Appl. No” 09/768’731
`(22)
`Filed:
`Jan, 24, 2001
`_
`_
`_
`Pr10r Publlcatlon Data
`US 2001/0038439 A1 Nov. 8 2001
`7
`Related US, Application Data
`
`(65)
`
`(63)
`
`Continuation—in—part of application No. 09/175,796, filed on
`00L 20, 1998, now abandoned
`A61B 3/10
`Int. Cl.7
`(51)
`..................................................
`....................................................... 351/221
`(52) us. Cl.
`58
`F' ld f S
`h
`351/205 206
`1e
`0
`earc351/221315362600321 431’ 55S
`(
`)
`’
`’
`’
`’
`References Cited
`U.S. PATENT DOCUMENTS
`
`(56)
`
`3,945,717 A
`4,964,023 A
`6,340,868 B1 *
`200 1/0007494 A1
`
`3/1976 Ryder et al.
`10/1990 Nishizawa et al.
`1/2002 Lys et al.
`................... 315/362
`7/2001 Takada
`
`The invention provides an ophthalmic illuminator, including
`a battery, an electrical resistor, an electrical switch and an
`LED. The battery is in circuit with the battery; and the
`electrical switch is in circuit with the resistor, where elec-
`trical energy flows through the circuit when the switch is in
`the closed position. The light emitting diode is in circuit with
`the switch and generates blue light energy which in turn
`causes fluorescence in a fluorescien dye administered to the
`patient’s eye when the switch is in the closed position. An
`optical element (eg, a lens or reflector) can be disposed
`between the diode and the eye to increase blue light energy
`reaching the eye. The energy can be “pulsed” such that the
`diode enerates the blue li ht at a
`redetermined fre uenc .
`g
`g
`P
`q
`y
`A user of the illuminator, e.g., a physician, can hold the
`system by hand to operate the switch (e.g., through a button).
`A magnifier coupled to the system provides a magnified
`image of the patient’s eye, if desired. Preferably, an annular
`housing integrates the LED (or a plurality of LEDs) together
`such that a button activates and generates the blue light
`energy, and a user views through the center of the housing,
`through a magnifier therein, to view the patient’s eye.
`
`20 Claims, 6 Drawing Sheets
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`US. Patent
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`Apr. 15, 2003
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`Sheet 1 0f 6
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`US 6,547,394 B2
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`FIG. 1
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`US. Patent
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`Apr. 15, 2003
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`Sheet 2 0f 6
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`US 6,547,394 B2
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`FIG. 3
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`Apr. 15, 2003
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`Sheet 3 0f 6
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`FIG. 4
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`Sheet 4 0f 6
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`FIG. 5
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`Sheet 5 0f6
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`Sheet 6 0f6
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`US 6,547,394 132
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`FIG. 7
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`US 6,547,394 B2
`
`1
`HAND-HELD OPHTHALMIC ILLUMINATOR
`
`RELATED APPLICATIONS
`
`This application is a continuation-in-part of, and claims
`priority to, commonly owned US. application Ser. No.
`09/175,796, filed on Oct. 20, 1998 now abandoned and
`hereby incorporated by reference.
`
`BACKGROUND OF THE INVENTION
`
`Ophthalmologists, optometrists and other medical doctors
`and health care professionals frequently are required to
`examine the cornea of the human eye for scrapes, abrasions,
`dirt or foreign bodies. The current technology utilizes a
`battery operated hand-held penlight illuminator in conjunc-
`tion with a solution of Sodium Fluorescein. An example of
`an existing prior art device is the Solan Blu-Slit® manufac-
`tured by Xomed Surgical Products, Inc. of Jacksonville, Fla.
`The penlight illuminator typically uses conventional batter-
`ies as a power source and an incandescent or halogen light
`bulb. A cobalt blue filter attached over the lamp filters the
`white light emitted by the bulb to produce a blue beam. This
`blue beam is used to illuminate the patient’s eye after
`application of the Sodium Fluorescein dye.
`The fluorescein dye, which is typically impregnated in
`sterile paper, is administered by the physician in the follow-
`ing manner. The patient’s upper eyelid is retracted and the
`sodium fluorescein impregnated paper applicator is made to
`contact the bulbar conjunctiva of the eye at the temporal
`side. The applicator is removed and the eyelid is opened and
`closed several times to allow diffusion of the dye over the
`entire conjunctival area and cornea.
`The fluorescein dye tends to accumulate in epithelial
`defects of the cornea and illumination of the eye will cause
`the defect to fluoresce vividly. By using blue filtered light to
`illuminate the eye of the patient, which has been dyed with
`fluorescein,
`this fluorescence is most observable. The
`amount of fluorescence observable is proportional to the
`accumulation of the fluorescein or the magnitude of the
`defect. However, the magnitude of the fluorescence is also
`proportional to both the intensity and spectral purity of the
`light
`illuminating the patient’s eye.
`In other words, a
`brighter and more spectrally pure beam will show more
`detail and thus is more desirable to the physician.
`
`SUMMARY OF THE INVENTION
`
`The subject of this invention is a device which is used to
`illuminate a patient’s eye that has been administered with a
`fluorescent dye for the purpose of examining the eye for
`epithelial defects. The invention in its simplest form utilizes
`four components: a battery, an electrical resistor, an electri-
`cal switch and a blue light emitting diode.
`
`BRIEF DESCRIPTION OF THE INVENTION
`
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`FIG. 1 depicts an electrical schematic of an ophthalmic
`illuminator utilizing a blue LED source, according to the
`invention.
`
`FIG. 2 shows an alternative ophthalmic illuminator of the
`invention.
`
`60
`
`FIG. 3 shows a perspective view of a hand held eye
`illuminator constructed according to the invention.
`FIG. 4 shows a perspective view of another hand held eye
`illuminator constructed according to the invention.
`FIG. 5 shows a perspective interior view of the illumina-
`tor of FIG. 4.
`
`65
`
`2
`FIG. 6 shows a perspective view of another hand held eye
`illuminator constructed according to the invention.
`FIG. 7 shows a perspective interior view of the illumina-
`tor of FIG. 6.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`In schematic 10 of FIG. 1, when the switch 12 is closed
`electrical energy from the battery 14 flows through the
`circuit 10 and causes the blue LED 16 to produce blue light
`18. The resistor 20 is used to limit the current that is applied
`to the LED 16 as per the manufacturer specifications which
`is typically 20 to 30 milli-amps. Certain LED’s have an
`internal resistor 20 built into the LED package, as known in
`the art. Battery 14 voltage is typically four to twelve volts
`DC. The blue LED’s are for example manufactured by both
`CREE and NICHIA and typically produce illumination on
`the order of 0.50 candle or more at a wavelength of 450
`nano-meters with a typical bandpass of 50 nm. These LED’s
`typically are comprised of Gallium Nitride on a Silicon
`Carbide substrate (NICHIA) or just Silicon Carbide
`(CREE). In one embodiment of the invention, resistor 20 is
`not required; rather, battery 14 serves as the resistor for
`circuit 10.
`
`The ophthalmic illuminator as depicted in FIG. 1 is
`superior to the current
`incandescent
`technology for the
`following reasons: first, the blue LED 16 emits more illu-
`mination in the desired blue spectrum (425 to 475 NM) than
`the filtered incandescent lamp which results in more fluo-
`rescence of the fluorescein dyed eye 22 and thus has better
`sensitivity; second, the blue LED 18 uses less power than a
`blue optically filtered incandescent or halogen bulb so that
`the battery power source 14 should last significantly longer;
`third, the invention is simpler to the prior art technology in
`that there is no need for a blue bandpass optical filter.
`There are a number of enhancements that can be made to
`
`the basic invention as shown in FIG. 1. First, a lens 24 may
`be added close to the LED 18 between the LED 18 and the
`
`patient’s eye 22 to maximize the light collection efficiency
`of the system. A reflector could be added separately or used
`in conjunction with a lens for the same purpose. Second, the
`electrical circuit 10 could be modified with a pulse means 13
`to cause the blue LED 16 to operate in a pulsed mode instead
`of continuous mode. This would enable higher peak current
`to be applied to the blue LED 16 to produce the appearance
`of an even brighter beam and hence more fluorescence
`sensitivity to the physician. Third, a simple magnifier tens
`could be added to the device 10 to provide a magnified view
`of the patient’s eye 22 to the physician or user (see FIG. 2).
`The fixed magnification of this lens would typically be
`chosen to between 1.5x and 15x. Typically the magnifica-
`tions are between 2x and 10x. Avariable focal length zoom
`lens could also be substituted as the simple magnifier to
`provide a range of magnification for the physician user.
`The invention described here can be manufactured as a
`
`stand-alone hand held device or incorporated into other
`ophthalmic diagnostic instruments such as a table-top or
`hand held slit lamp.
`FIG. 2 shows an alternative system 100 of an ophthalmic
`illuminator constructed according to the invention. FIG. 2
`also shows the patient’s eye 102 illuminated by blue light
`104 generated by the diode 106. The light 104 is preferably
`coupled to the eye 102 through an optical lens (or reflector,
`known in the art) 108 to increase the blue light energy at the
`eye 102.
`System 100 preferably integrates to a common housing
`110 such that a user can hold the system 100 during,
`
`

`

`US 6,547,394 B2
`
`3
`treatment of the eye 102. Although not shown, the circuit of
`FIG. 1 can reside within the housing 110; and a button 112
`can be used to operate the switch 12 (FIG. 1) which in turn
`causes the generation of light 104. The button 112 is for
`example operated by a physician’s finger.
`System 100 can also include a magnifier 114 coupled to
`the housing 110 such that the physician’s eye 116 can view
`the patient’s eye 102 with increased magnifier. A zoom lens
`(known in the art can replace the magnifier 114 such that
`selective control of that magnification is achieved.
`FIG. 3 shows a hand held illuminator 200 constructed
`
`according to the invention. Illuminator 200 has an annular
`housing 202 that contains circuitry such as schematic 10 of
`FIG. 1. Abutton 204 is arranged with housing 202 such that
`a user may press to generate light energy 206 to illuminate
`a patient’s eye 208. Button 204 for example functions as
`switch 12, FIG. 1. A user of illuminator 200 may then peer
`through aperture 210, along path 212, to conveniently view
`patient eye 208. Aperture 210 may optionally include a
`magnifying lens, or zoom lens, according to preferred
`embodiments of the invention. Sources for generating
`energy 206 include a LED such as LED 16, FIG. 1. Sources
`may be integrated with housing 202 in various ways as
`illustrated below. In accord with the invention, energy 206
`delivered from sources (e.g., LEDs) may be considered a
`transmit channel while path 212 may be considered a receive
`channel. In one embodiment of the invention, the energy is
`blue light that creates green fluorescence from the eye; and
`thus a lens in aperture 210 is preferably coated with a green
`filter thin film coating to filter light along the receive
`channel.
`FIG. 4 shows a hand held illuminator 214 constructed
`
`according to the invention. Illuminator 214 has an annular
`housing 216 that contains circuitry such as schematic 10 of
`FIG. 1. Abutton 218 is arranged with housing 216 such that
`a user may press to generate light energy 221 to illuminate
`a patient’s eye 217, as above. Button 218 for example
`functions as switch 12, FIG. 1. Illuminator 214 further has
`an optical magnifier in the form of a lens 219 for a user to
`peer through to conveniently view patient eye 217. A LED
`220 integrates with housing 216 to generate light energy
`218. LED 220 may optionally include a focusing lens,
`though one is not required.
`FIG. 5 shows an interior portion 222 of illuminator 214.
`Specifically, interior portion 222 shows further features of
`button 218 and LED 220, each connected in circuit
`to
`internal battery 224. Battery 224 for example operates as in
`battery 14, FIG. 1, to power LED 220. Element 216a forms
`the back of housing 216.
`FIG. 6 shows a hand held illuminator 230 constructed
`
`according to the invention. Illuminator 230 has an annular
`housing 232 that contains circuitry such as schematic 10 of
`FIG. 1. Abutton 234 is arranged with housing 232 such that
`a user may press to generate light energy 235 to illuminate
`a patient’s eye 236. Button 234 for example functions as
`switch 12, FIG. 1. Though not required, illuminator 230
`further has an optical magnifier in the form of a lens 237 for
`a user to peer through to conveniently view patient eye 236.
`A plurality of LEDs 238 integrate with housing 232 to
`generate light energy 235. Each of LEDs 238 may optionally
`include a focusing lens, though one is not required. Although
`three LEDs 238 are shown, more or fewer LEDs can be used
`without departing from the scope of the invention.
`FIG. 7 shows an interior portion 240 of illuminator 230.
`Specifically, interior portion 240 shows further features of
`button 234 and LEDs 238, each connected in circuit to
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`internal battery 242. Battery 242 for example operates as in
`battery 14, FIG. 1, to power LEDs 238. Element 232a forms
`the back of housing 232.
`In addition to the advantages apparent in the foregoing
`description,
`the invention may have application in other
`fields outside of ophthalmology. For example, in the field of
`dermatology, an illuminator of the invention may be used to
`illuminate skin, along the transmit channel, and to view the
`skin along the receive channel.
`In view of the foregoing,
`What is claimed is:
`
`1. An ophthalmic illuminator, comprising:
`a battery;
`an electrical resistor in circuit with the battery;
`an electrical switch in circuit with the resistor;
`at least one light emitting diode, in circuit with the switch,
`for generating blue light energy in response to activa-
`tion of the switch; and
`a fiuorescein dye administered to a patent’s eye, the dye
`being responsive to the energy to fluoresce.
`2. An illuminator of claim 1, further comprising an optical
`element disposed between the diode and the eye to increase
`blue. light energy reaching the eye.
`3. An illuminator of claim 2, wherein the element is one
`of a lens or a powered reflector.
`4. An illuminator of claim 1, further comprising electron-
`ics for cyclically energizing the diode, wherein the diode
`generates the blue light at a predetermined frequency in
`order to increase the illumination appearance of the energy.
`5. An illuminator of claim 1, further comprising a housing
`for integrating the battery, switch, resistor and diode into an
`integral package, the diode being positioned to generate blue
`light energy away from the package, and further comprising
`a magnifier lens coupled to the housing for providing a
`magnified image of the patient’s eye to a user of the
`illuminator.
`
`6. An illuminator of claim 5, wherein the magnifier lens
`has a magnification between about 1.5x and 15x.
`7. An illuminator of claim 1, further comprising a housing
`for integrating the battery, switch, resistor and diode into an
`integral package, the diode being positioned to generate blue
`light energy away from the package, and further comprising
`a zoom lens coupled to the housing for providing a selective
`magnified image of the patient’s eye to a user of the
`illuminator.
`
`8. An illuminator of claim 1, wherein the dye comprises
`Sodium Fluorescein.
`
`9. An illuminator of claim 1, wherein the diode comprises
`Gallium nitride.
`10. An illuminator of claim 1, wherein the diode com-
`prises Silicon Carbide.
`11. An illuminator of claim 1, further comprising a
`substantially annular housing constructed and arranged with
`a button for operating the switch, a user of the illuminator
`viewing through an aperture in the housing to view the
`patient’s eye.
`12. An illuminator of claim 11, further comprising a
`magnifying lens constructed and arranged with the aperture,
`for magnifying the patient’s eye for the user.
`13. An illuminator of claim 11, further comprising a
`plurality of light emitting diodes, each diode responsive to
`activation by the button to generate the blue light.
`14. An illuminator of claim 1,
`further comprising a
`focusing lens constructed and arranged with at least one of
`the diodes to focus the blue light energy onto the patient’s
`eye.
`
`

`

`US 6,547,394 B2
`
`5
`15. A method for illuminating a patient’s eye for oph-
`thalmic examination, comprising the steps of: administering
`a fluorescein dye to the patent’s eye, illuminating the eye
`with blue light energy generated from one or more light
`emitting diodes, the dye being responsive to the blue light
`energy to fluoresce, and Viewing the patient’s eye, and
`Viewing the eye while the dye fluoresces.
`16. A method of claim 15, wherein the step of adminis-
`tering a fluorescein dye comprises administering Sodium
`Fluorescein to the eye.
`17. Amethod of claim 15, wherein the step of illuminating
`the eye comprises pressing a button on an annular-shaped
`
`6
`housing, and wherein the step of Viewing the patient’s eye
`comprises Viewing through a center of the housing.
`18. Amethod of claim 15, wherein the step of illuminating
`comprises generating light from a plurality of light emitting
`diodes.
`
`19. A method of claim 15, wherein the step of Viewing
`comprises Viewing through a magnifying lens coupled with
`a housing that supports the diodes.
`20. A method of claim 15, further comprising the step of
`10 focusing the blue light energy onto the patient’s eye.
`*
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