OPHTHALMIC PHOTOTHERAPY SYSTEM AND ASSOCIATED METHOD
20170225012 · 2017-08-10
Inventors
Cpc classification
A61N2005/0626
HUMAN NECESSITIES
A61B3/1241
HUMAN NECESSITIES
A61B3/14
HUMAN NECESSITIES
A61F9/0079
HUMAN NECESSITIES
A61B3/12
HUMAN NECESSITIES
International classification
A61B3/10
HUMAN NECESSITIES
A61B3/14
HUMAN NECESSITIES
Abstract
An ophthalmic phototherapy device and associated phototherapy treatment method tor promoting healing of damaged or diseased eye tissue. The ophthalmic phototherapy device includes a light emitting mechanism for transmitting light of at least one preselected wavelength to the eye tissue. The ophthalmic phototherapy method includes directing light of at least one wavelength for a selected period of time to a portion of damaged or diseased eye tissue, whereby the light transmitted to the damaged or diseased eye tissue stimulates cellular activity in the eye tissue to promote healing.
Claims
1-20. (canceled)
21. A system for treating inflammatory eye disease inside an eye of a patient, comprising: an ophthalmic imaging device; and an ophthalmic phototherapy device that includes: a first light-emitting mechanism comprising an LED or a low-power laser source, that in operation emits a first light of at least a first wavelength in a near infra-red light wavelength range, a yellow light wavelength range, or a red light wavelength range; a second light-emitting mechanism comprising an LED or a low-power laser source, that in operation emits a second light of at least a second wavelength different from the first wavelength; and a controller comprising processing circuitry that in operation controls the first and second light-emitting mechanism so as to selectively direct the first and the second light from the ophthalmic phototherapy device into the eye of the patient being treated by the ophthalmic phototherapy device for first and second preselected periods of time, respectively.
22. The system of claim 21, wherein the ophthalmic imaging device comprises an ocular coherence tomography (OCT) device.
23. The system of claim 21, wherein the ophthalmic imaging device comprises a fundus camera.
24. The system of claim 21, wherein the first wavelength is between approximately 490 nm and 810 nm.
25. The system of claim 21, wherein the second wavelength is in a near infra-red light wavelength range, a yellow light wavelength range, or a red light wavelength range, with the proviso that the first and second wavelengths are not both selected from the same wavelength range.
26. The ophthalmic phototherapy system of claim 21, wherein the processing circuitry when in operation: (a) controls when or for how long each of the first light and the second light is emitted; (b) enables emission of the first light and the second light at a preselected first brightness and a preselected second brightness, respectively; (c) controls one of a combination, a pulsed combination, and a sequence in which the first light and the second light are emitted from the light-emitting mechanisms; or (d) performs any combination of (a)-(c).
27. The ophthalmic phototherapy system of claim 21, wherein each of the first light-emitting mechanism and the second light-emitting mechanism comprises an array of a plurality of LEDs, low power laser sources, or any combination thereof.
28. The ophthalmic phototherapy system of claim 27, wherein the processing circuitry when in operation: (a) controls when or for how long each of the first light and the second light is emitted; (b) enables emission of the first light and the second light at a preselected first brightness and a preselected second brightness, respectively; (c) controls one of a combination, a pulsed combination, and a sequence in which the first light and second light are emitted from the light-emitting mechanisms; (d) selectively controls the arrays of the first and second light-emitting mechanisms to vary the wavelength of light emitted from the light-emitting mechanisms; or (e) performs any combination of (a)-(d).
29. The ophthalmic phototherapy system of claim 21, wherein the ophthalmic phototherapy device further comprises a user interface configured to permit a user to select a treatment modality comprising delivering light of at least one of a sequence, combination or pulsed format of the first and second light into the eye of the patient.
30. The ophthalmic phototherapy system of claim 21, wherein at least a portion of the ophthalmic phototherapy device may be pivoted or rotated into position to emit the first light and the second light into the eye of the patient.
31. The ophthalmic phototherapy system of claim 21, wherein the ophthalmic phototherapy device further comprises a third light-emitting mechanism comprising an LED or a low power laser source, that in operation emits a third light of at least a third wavelength, wherein the third wavelength is different from the first and second wavelengths and wherein no two of the first wavelength, the second wavelength, and the third wavelength are both selected from a near infra-red light wavelength, a yellow-light wavelength, and a red-light wavelength.
32. The ophthalmic phototherapy system of claim 31, wherein each of the first, second, and third wavelengths is selected from a near infra-red light wavelength, a yellow- light wavelength, and a red-light wavelength.
33. The ophthalmic phototherapy system of claim 32, wherein one of the first, second, and third wavelengths is between approximately 577 nm and 597 nm, and wherein at least another of the first, second, and third wavelengths is between approximately 640 nm and 700 nm.
34. A method for treating inflammatory eye disease inside an eye of a patient, the method comprising: receiving an ophthalmic image of the eye of the patient that indicates the presence of inflammatory disease in the eye; providing an ophthalmic phototherapy device that includes (1) a first light-emitting device comprising an LED or a low power laser source, that in operation emits a first light of at least a first wavelength in a near infra-red light wavelength range, a yellow light wavelength range, or a red light wavelength range, (2) a second light-emitting device comprising an LED or a low power laser source, that in operation emits a second light of at least a second wavelength different from the first wavelength, and (3) a controller comprising processing circuitry that in operation controls the first and second light-emitting devices so as to selectively direct the first and second lights from the ophthalmic phototherapy device into the eye of the patient to be treated by the ophthalmic phototherapy device for first and second preselected periods of time, respectively; directing, for the first preselected period of time, the first light into the eye of the patient to expose at least a portion of an affected eye tissue inside the eye to the first light, wherein the first light has a first preselected brightness; and directing, for the second preselected period of time, the second light into the eye of the patient to expose the portion of the affected eye tissue to the second light, wherein the second light has a second preselected brightness, wherein the first wavelength of the first light is different from the second wavelength of the second light.
35. The method according to claim 34, further comprising generating the ophthalmic image prior to the receiving the ophthalmic image.
36. The method according to claim 35, wherein generating the ophthalmic image comprises performing fluorescein angiography or ocular coherence tomography on the eye.
37. The method of claim 34, wherein the second wavelength is selected from a near infra-red light wavelength, a yellow light wavelength, and a red-light wavelength.
38. The method of claim 34, wherein the first wavelength is within the range of approximately 577 to 597 nm and the second wavelength is within the range of approximately 640 nm to 700 nm.
39. The method of claim 34, wherein the first light and the second light are directed into the eye of the patient in a manner comprising at least one of sequentially or in combination or in a pulsed format.
40. The method of claim 34 further comprising, during the treatment session, exposing the portion of the eye tissue to a third light of at least a third wavelength for a third preselected period of time, the third light having a third preselected brightness, wherein the third wavelength is different from the first and second wavelengths.
41. The method of claim 34, wherein the inflammatory eye disease comprises dry age-related macular degeneration.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0015] The above-mentioned features of the invention will become more clearly understood from the following detailed description of the invention read together with the drawings in which:
[0016]
[0017]
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
DETAILED DESCRIPTION OF THE INVENTION
[0026] An ophthalmic phototherapy device is illustrated generally at 10 in the drawings. As will be discussed in detail below, the ophthalmic phototherapy device 10 produces light of a selected wavelength, or sequences or combinations of light having differing wavelengths within a particular range of wavelengths. In accordance with the ophthalmic treatment method of the present invention, the light emitted by the phototherapy device 10 is directed into the eye of a patient to promote healing of damaged or diseased eye tissue.
[0027]
[0028]
[0029] In
[0030] A further alternate embodiment of the ophthalmic phototherapy device of the present invention illustrated at 10″ in
[0031] With reference to
[0032] It will be recognized that various mechanisms could be used for pivotally securing the first arm section 28 to a supporting structure, for pivotally securing the first arm section 28 to the second arm section 34, and for pivotally securing the second arm section 34 to the bracket 40. However, as illustrated in
[0033]
[0034] Referring to
[0035] The approximate range of wavelengths desirable for ophthalmic phototherapy correspond to portions of the visible and invisible infrared spectrum ranging from blue light to near-infrared and infrared light, in other words, light having wavelengths between approximately 300 nm and 1000 nm, and preferably between 490 nm and 810 nm. However, both the general and preferred ranges are not intended to be limiting as wavelengths outside of these ranges may be helpful for certain treatment applications. The particular wavelength used varies depending on the injury or eye condition being treated. For example, light in the yellow range (approximately 577 nm to 597 nm) has been shown to switch off collagenase production by down-regulating MMP production and to switch on new collagen production. In the field of opthamology, yellow light having a wavelength of approximately 590 nm has been found to be beneficial for treating corneal trauma when directed into a traumatized cornea. Red light (approximately 640 nm to 700 nm) has been found to decrease inflammation of tissue in the eye, increase ATP production, and reset cellular activity to cause abnormal cells to exhibit more normal behavior. Further, a preselected sequence or combination of wavelengths can be advantageously used in certain conditions. For example, a sequence or combination of infrared or near-infrared light, red light, and yellow light directed into the eye at a dosage of approximately 4 joules/sq.Math.cm has been found to be beneficial for treating glaucoma. Similar dosages of sequences or combinations of infrared or near-infrared light, red light, and yellow light have been found to stimulate the cells in the trabecular meshwork to produce macrophages that then reduce the pigment cells clogging the meshwork of the eye, thereby allowing the eye to drain.
[0036] The duration of the phototherapy treatments varies depending on the particular eye condition being treated. Beneficial tissue response can be obtained from dosages of less than 4 joules/sq.Math.cm, such that the duration of treatment can be relatively short. Exposure times of less than one minute can be beneficial, with exposure times in excess of 10 minutes being contemplated. For example, to achieve approximate dosages of less than 4 joules/sq.Math.cm, treatment duration could vary between under a minute to approximately 10 minutes, depending upon the output power and intensity of the light source utilized. Further, although phototherapy treatments of less than 0.1 joules/sq.Math.cm, and having durations of 40 seconds or less, have been shown to be beneficial, longer treatments may be desirable to provide additional benefit, or to allow for larger dosages of light energy per unit area of cellular tissue. Of course, it will be understood by one skilled in the art that beneficial tissue response can be obtained from dosages of light energy greater than 4 joules/sq.Math.cm, and such dosages may be used without departing from the spirit and scope of the present invention.
[0037]
[0038] In a dosage selection step 80, a suitable dosage of light is selected for use in the method 76 for the selected wavelength. In the illustrated embodiment, selection of the dosage 80 includes selection of amount of light energy 82 to be delivered over a selected period of time 84 at a selected intensity 86. However, it will be understood that other factors, such as for example the topical area of cellular tissue to be treated, diffusion of the light to be applied, and other such factors, may be selected during the selection of dosage 80 without departing from the spirit and scope of the present invention. A light source is provided which is capable of generating a beam of light having the characteristics selected during the dosage selection step 80. At a treatment phase 74, the light source is used to generate a beam of light 88 having the characteristics selected during the dosage selection step 80. In the illustrated embodiment, a beam of light is generated 88 having the energy, duration, and intensity characteristics selected in the dosage selection step 80. Of course, it will be understood that the particular characteristics of the generated beam of light depend upon the specific factors selected during the dosage selection step 80. At a direction step 90, the beam of light 88 is directed to a portion of eye tissue to be treated. Upon exposure of cells in the eye tissue to the beam of light 88, at least a portion of the cells at e stimulated to undergo at least one desired cellular activity corresponding to the selected wavelength. In this way, cellular activity useful in promotion of healing of the eye tissue is stimulated.
[0039] In another embodiment, illustrated in
[0040] In a damage phase 62, a medical procedure for correcting vision problems is performed, thereby damaging a portion of eye tissue. The medical procedure of the illustrated embodiment uses laser surgery of the epithelium and stroma portions of the cornea of the eye, a laser-assisted in situ keratomileusis procedure commonly referred to as LASIK eye surgery as an example. The LASIK procedure involves the step 64 of cutting a flap in the epithelium of the cornea of an eye while leaving the eye tissue at one end of the flap uncut. It will be appreciated by those familiar with LASIK that a knife, referred to as a microkeratome, or a laser, such as the IntraLase™ femtosecond (1054 nm) laser, can be used to cut the flap 64. In a folding step 66, the uncut tissue serves as a hinge that allows the flap to be folded back to reveal the stroma, or middle section of the cornea. A reshaping step 68 uses pulses from a computer controlled excimer laser to vaporize a portion of the stroma and reshape the cornea. The LASIK procedure ends with a flap replacement step 70 in which the flap of epithelium tissue is replaced 70.
[0041] To this extent, in the illustrated embodiment, the damage phase 62 includes performing LASIK eye surgery on an eye. However, while the embodiment of the method in
[0042] Following the damage phase 62, a treatment dosage selection step 80 is performed. As discussed above, selection of the treatment dosage 80 includes selection of an amount of light energy to be delivered over a selected period of time at a selected intensity. In a treatment step 74, light of a selected wavelength is directed into the cornea of the patient's eye in accordance with the selected treatment dosage 80 for photobiomodulating the damaged eye tissue to promote healing and suppress inflammation.
[0043] Whereas numerous wavelengths are beneficial during the optional initial step 72, the yellow range of wavelengths (approximately 577 nm to 597 nm) is particularly beneficial for treatment 74 of the eye tissue after laser eve surgery. Thus, in one embodiment, the light directed into the patient's eye 72 subsequent to replacement of the epithelial flap 70 is preselected to exhibit a wavelength in the yellow spectrum, having a range of approximately 577 nm and 597 nm. In another embodiment, the light directed into the patient's eye 72 subsequent to replacement of the epithelial flap 70 is preselected to exhibit a wavelength between the range of approximately 577 nm and 1000 nm. In more discreet embodiments, the light directed into the patient's eye 72 following laser surgery 62 is preselected to exhibit multiple wavelengths in the yellow light spectrum, having ranges of between approximately 577 nm to 597 nm, and the red and near-infrared spectrum, having ranges between approximately 640 nm to 1000 nm.
[0044] In another embodiment, illustrated in
[0045] Upon diagnosis 94 of dry ARMD in a patient's eye, a treatment dosage selection step 80′ is performed as shown in
[0046] It will be understood that the exact intensity, energy, and duration of light which must be generated 88′ and directed 90′ at the patient's eye in order to deliver the selected dosage to the patient's retinal eye tissue is dependent, among other factors, upon the amount of, and transparency or opaqueness of, any matter imposed between the ophthalmic phototherapy device 10 and the retinal tissue to be treated. For example, in certain embodiments in which the patient's eyelid is to remain closed during treatment 74′, light that is generated 88′ and directed 90′ toward the patient's eye is of much higher intensity and energy than that which is needed to accomplish the selected dosage. Thus, it is understood that the light will first pass through the closed eyelid of the patient before reaching the patient's retinal eye tissue, whereupon only a portion of the generated 88′ and directed 90′ light will reach the patient's retinal eye tissue, thereby accomplishing delivery of the selected dosage to the retinal eye tissue. In other embodiments, the patient's eyelid is to remain open during treatment 74′. In these embodiments, light that is generated 88′ and directed 90′ toward the patient's eye is of only slightly higher intensity and energy than that which is needed to accomplish the selected dosage. Thus, it is understood that the light will pass through the relatively transparent cornea, lens, and vitreous humor of the eye without losing much of its intensity and energy, whereupon most of the generated 88′ and directed 90′ light will reach the patient's retinal eye tissue, thereby accomplishing delivery of the selected dosage to the retinal eye tissue.
[0047] Numerous selectable dosages of light phototherapy have been found to be beneficial in the treatment 74′ of dry ARMD. In one embodiment, the selected treatment dosage comprises a plurality of different light beams applied in sequence to the patient's retinal tissue. For example, In the embodiment illustrated in
[0048] Following the application 112 of the continuous beam to the patient's retina, a pulsing beam of light is generated 114. The generated pulsing beam, in several embodiments, exhibits multiple wavelengths in the red and/or near-infrared spectrum, and exhibits a pulse rate, or duty cycle, in which the beam is turned on and off at predetermined intervals. In several embodiments, the duty cycle of the pulsing beam, that is, the ratio of duration that the pulsing beam is “on” versus the duration that it is “off,” is between approximately 30% “on” and 70% “off,” and approximately 70% “on” and 30% “off.” For example, in one embodiment, a pulsing beam is generated 114 exhibiting at least a first wavelength between approximately 580 nm to 680 nm, and preferably approximately 670 nm, as well as at least a second wavelength between approximately 850 nm to 950 nm. In this embodiment, the pulsing beam exhibits a duty cycle of approximately 250 milliseconds on and 150 milliseconds off. The generated pulsing beam is directed 116 to the retinal tissue of the patient's eye through the patient's closed eyelid for approximately 35 to 45 seconds, or approximately 100 cycles, to achieve an initial applied dose of approximately 0.11 joules/sq.Math.cm. to the patient's eyelid, with the effective dose reaching the patient's retinal tissue through the closed eyelid and other interposed eye tissue being approximately 0.01 joules/sq.Math.cm.
[0049] It will be understood that, while the above-discussed dosage of light phototherapy has been found to be beneficial in the promotion of healing in retinal tissue demonstrating dry ARMD, it is in no way the intention of the applicant to limit the scope of the present general inventive concept to the above-discussed ranges of wavelengths and/or duty cycles. For example, in certain embodiments, a dosage is selected 80′ and applied in the treatment step 74′ in which the pulsing beam exhibits a duty cycle of approximately 50% “on” and 50% “off.” In certain embodiments, the various wavelengths of the pulsing beam may include two or more wavelengths in the red spectrum and/or two or more wavelengths in the near-infrared spectrum. Furthermore, in certain embodiments, multiple ophthalmic phototherapy devices 10 may be provided to produce the various wavelengths of light comprising a given selected dosage, such that each discreet wavelength emanates from a separate ophthalmic phototherapy device, rather than a Light phototherapy dosage comprising a plurality of collimated wavelengths emanating from a single ophthalmic phototherapy device 10. Moreover, as discussed above, the specific energy and/or intensity of light used in the treatment step 74′ may be adjusted to accommodate either an open or closed eyelid of a patient, and it is not the intention of the applicant to limit the scope of the present general inventive concept to methods which necessarily require opening or closure of the patients eyelid for treatment
[0050] In light of the above, it will be recognized that the ophthalmic phototherapy devices 10, 10′, and 10″ are particularly well suited for administering phototherapy to the eye of a patient. It will be noted that use of the ophthalmic phototherapy device 10″, with its articulated support arm 24 (see
[0051] While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of applicant's general inventive concept.