Method and apparatus for cyclo-scanner using surface emitting lasers or LEDs
11058890 ยท 2021-07-13
Assignee
Inventors
Cpc classification
A61B3/14
HUMAN NECESSITIES
A61F9/009
HUMAN NECESSITIES
International classification
A61B3/14
HUMAN NECESSITIES
Abstract
A handheld device for delivering therapeutic light toward an eye of a patient includes a device housing that is configured to be held by a user in delivering the therapeutic light, a plurality of light sources disposed within the device housing, and an array of lenses disposed near the distal end of the device housing. Each light source is configured to independently emit a beam of therapeutic light and each lens of the array is aligned with a respective light source so that each beam of therapeutic light that is emitted from the respective light sources is focused and directed by the respective lenses of the array to target tissue of the eye in order to therapeutically treat to the target tissue.
Claims
1. A device for delivering therapeutic light toward an eye of a patient, the device comprising: a device housing having a proximal end and a distal end opposite the proximal end; a plurality of light sources disposed within the device housing, each light source being configured to independently deliver a beam of therapeutic light toward the distal end of the device housing; and an array of lenses disposed near the distal end of the device housing, each lens of the array being aligned with a respective light source of the plurality of light sources so that the beam of therapeutic light that is delivered from the respective light source is directed by the respective lens of the array to target tissue of the eye in order to therapeutically treat the target tissue; wherein the array of lenses is arranged so that the array of lenses encircles a limbus of the eye and so that each lens of the array is positioned radially outward of the limbus.
2. The device of claim 1, further comprising a control unit that is coupled with the plurality of light sources and that is configured to independently control each light source to switch each light source on and off in therapeutically treating the target tissue.
3. The device of claim 2, further comprising an infrared camera that is configured to produce an observable spot on the target tissue of the eye by reflection of the beam of therapeutic light from the target tissue, wherein the beam of therapeutic light is delivered from at least one light source of the plurality of light sources and wherein the beam of therapeutic light is delivered to target tissue of an eye at a power level of less than 1 mW.
4. The device of claim 2, wherein the control unit is configured to switch each light source on and off in a sequential manner so that the therapeutic light is delivered sequentially among a plurality of target locations.
5. The device of claim 2, wherein the control unit is configured to switch the light sources on and off so that the therapeutic light is delivered in a sweeping motion across the target tissue of the eye.
6. The device of claim 1, further comprising a contact tip having a proximal end and a distal end, the proximal end of the contact tip being detachably coupled with the distal end of the device housing and the distal end of the contact tip comprising a contact surface that is positionable on a surface of the eye.
7. The device of claim 1, wherein the plurality of light sources comprises vertical cavity surface emitting lasers (VCSELs), surface emitting LEDs, a combination thereof.
8. The device of claim 1, wherein one or more batteries are disposed within the housing such that the device is a self-contained single use disposable unit.
9. The device of claim 1, wherein the device comprises between 10 and 50 individual light sources and lenses.
10. The device of claim 9, wherein the device comprises 20 individual light sources and lenses.
11. A device for use with a plurality of light sources for providing a therapeutic treatment to an eye of a patient, the device comprising: a housing having a proximal end and a distal end; an array of lenses disposed near the distal end of the housing body, each lens of the array being aligned with a beam of therapeutic light provided by a respective light source of a plurality of light sources, each lens of the array being configured to direct the beam of therapeutic light to target tissue of the eye in order to provide the therapeutic treatment; and a control unit that is operably coupled with the plurality of light sources and that is configured to independently control each light source in order to independently deliver the therapeutic light from each light source in an automated fashion; further comprising a contact tip that houses or includes the array of lenses, the contact tip having a proximal end and a distal end, the proximal end of the contact tip being coupled with the distal end of the housing and the distal end of the contact tip being configured for positioning on a surface of the eye; and wherein the array of lenses is arranged so that when the contact tip is positioned on the eye, the therapeutic treatment is provided to the eye without requiring a repositioning of the contact tip relative to the eye.
12. The device of claim 11, wherein the plurality of light sources are disposed within the housing.
13. The device of claim 11, further comprising an infrared camera that is configured to produce an observable spot on the target tissue of the eye by reflection of the beam of therapeutic light from the target tissue, wherein the beam of therapeutic light is delivered from at least one light source of the plurality of light sources and wherein the beam of therapeutic light is delivered at a power level of less than 1 mW.
14. The device of claim 11, wherein the proximal end of the housing is coupleable with an external light source that houses the plurality of light sources.
15. The device of claim 11, wherein the contact tip is removable from the distal end of the housing.
16. The device of claim 11, wherein the distal end of the contact tip is curved to correspond with a contour of eye such that the therapeutic light, directed by the array of lenses, exiting the distal end of the contact tip enters the eye at an angle that is relatively normal to the surface of the eye.
17. The device of claim 11, wherein the array of lenses is arranged so that a respective beam of therapeutic light that is delivered from each lens is disposed radially outward of a limbus of the eye, and wherein the control unit is configured to deliver the therapeutic light from each light source in a sequential manner so that therapeutic light is delivered to the target tissue of the eye around the limbus.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Further details, aspects, and embodiments of the disclosure will be described by way of example only and with reference to the drawings. In the drawings, like reference numbers are used to identify like or functionally similar elements. Elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale.
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DETAILED DESCRIPTION OF THE DISCLOSURE
(12) Conventional ophthalmic laser systems generally require a laser console and a laser probe where the laser console contains the laser source, power supply, and controller. The laser probe generally contains an optical fiber and connector for attachment to the laser console. The laser console is typically an AC powered system, placed on a surface that is at least several feet away from a patient's eye, and the laser output light from the console is typically carried by an optical fiber (i.e., waveguide) to the patient's eye where photocoagulation based treatment may take place. Such a system typically requires external AC power, a long multimode fiber to bring light to the end applicator that could be implemented with a slit lamp adapter, a scanner, or a handheld contact probe.
(13) Conventional ophthalmic laser systems also generally employ a single laser or light source. The treatment light that is provided by the single laser source is delivered to the laser probe via the optical fiber. In order to deliver the laser light to the eye tissue the ophthalmic laser system typically requires components (e.g., collimators, lenses, mirrors, and the like) that align and/or redirect the laser beam relative to the eye. Conventional systems also typically require that the laser probe be manually moved relative to the eye to reposition the laser beam at different target or treatment locations about the eye. Manually moving the laser probe over the surface of the eye may be prone to issues such as scratching the eye's surface. In addition, it is difficult to precisely control the location and/or positioning of the probe about the eye and thus, it is difficult to precisely control the delivery the laser light to the eye, which may lead to inconsistent treatment.
(14) The embodiments described herein may provide certain advantages and improvements over conventional ophthalmic laser systems. For example, the ophthalmic laser system described herein does not include a traditional laser console. Instead, the treatment probe may be configured to house the treatment light source within the probe handle. Additionally, in some embodiments, the handheld treatment probe may include a user interface, such as dials and buttons, for adjusting various parameters of the therapeutic light. With certain embodiments, the self-contained handheld treatment probe may be operated independent of an AC power source. For example, in some embodiments, the handheld treatment probe may be battery powered. Additionally, the handheld treatment probe may be disposable or may utilize replaceable distal tips. Many embodiments may be particularly designed for transscleral cyclophotocoagulation where energy is directed through selected portions of the pars plicata region to the ciliary body, structures under the scleral layers, and the overlying conjunctiva to treat a glaucomatous eye.
(15) In addition, the embodiments described herein minimize or eliminate issues associated with manually moving the laser probe about the eye by employing an array of lenses that deliver therapeutic light to a plurality of treatment locations about the eye. The array of lenses allow the therapeutic light to be delivered to the eye without requiring movement of a laser probe. Stated differently, the laser probe may be maintained stationary or in position on the eye while the array of lenses delivers the therapeutic light to multiple target or treatment positions about the eye. In some embodiments, the array of lenses may be embodied in a contact tip that is attached to a distal end of a laser probe. The contact tip may be a single use device or a multi-use device as desired. The contact tip may have a cup shaped distal end that matches the contour of the patient's eye. The array of lenses may define and enable automated cyclo-scanning of the therapeutic light using a laser or LED device. Additional features and aspects of the embodiments will be more apparent in reference to the various figures described herein below.
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(19) The treatment device body 102 also includes lens array optics 116, which is an array or ring of lenses as described herein. Each lens of the array of lenses is aligned with one of the light sources and is configured to direct a beam of therapeutic light to the target tissue. As illustrated in
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(21) The optic medium or body 202 may be made of a glass lens, a plastic lens, or of any other material employed in forming optic media. The individual lenses 204 are embedded in the single optic medium or body 202 so that each lens 202 aligns with a light source of the light source assembly 108 (see
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(23) In an exemplary embodiment, each light source 218 is a vertical cavity surface emitting lasers (VCSELs) or a surface emitting LED, or a combination thereof. A VCSEL laser emits a single mode beam that is significantly simpler to align with an individual lens than edge emitting lasers or other conventional lasers.
(24) The use of a VCSELs or surfacing emitting LED provides several advantages over edge emitting lasers that are used in conventional devices. For example, VCSELs emit a symmetric, circular beam that is typically contained in an angle of approximately 15 degrees. Such a beam can be easily collimated onto a circular spot with lower cost lenses. In contrast, edge emitting laser diodes emit a far field beam that is not symmetric and requires the use of special collimators, diodes, and various other components for shaping and aligning the beam with optic fibers and/or other components. Such collimation is difficult to control since the focal length of the fast axis and slow axis require different lens designs. The ophthalmic treatment device 100 of the instant application does not require the use of any optical fibers and thus, the system may be entirely free of optical fibers and the components that are associated therewith.
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(26) Although the individual light sources 218 are described as being individually controlled to emit a beam of therapeutic light, it should be realized that in other embodiments, multiple individual light sources 218 may be simultaneously controlled or switched on to simultaneously deliver multiple beams of therapeutic light.
(27) The array of light sources 218 is mounted on a device that is placed a distance from the eye. The array of light sources 218 is typically disposed within the housing 106, but may be positioned elsewhere as required or desired. The number of individual light sources 218 is typically similar to the number of target sites to be treated. In an exemplary embodiment 20 individual light sources are employed. Likewise, the number of individual lenses 204 is similar to the number of individual light sources 218, which in the exemplary embodiment is 20 individual lenses.
(28) The control unit 110 is operably coupled with the individual light sources 218 to individually control and power on the light sources 218 in a desired manner. For example, the control unit 110 may power on the light sources 218 so that a treatment beam of light travels around the eye in a clockwise or counterclockwise direction 217. In this manner, the light source assembly 108 and lens array optics 116 may be employed in delivering a desired therapeutic treatment, such as cyclophotocoagulation. The control unit 110 may likewise be programmed to deliver other treatment patterns or procedures.
(29) As described herein, the lens array optics 116 may be part of the contact tip 104, which may be a single-use or multi-use component. The contact tip 104 may have a cup shaped arrangement that is configured to be directly pressed against the treated eye. The contact tip 104 may be designed with a usage recording device that may include one or more of the following devices: an RFID, a memory chip, a special mechanical attachment mechanism (locking, keys, etc.), and/or an electronic reader attached to the laser/LED source. A distal end 124 of the contact tip 104 is positioned against the sclera 2 of the eye 1 and the ophthalmic treatment device 100 may be held parallel to the visual axis 10 of the eye 1. The ophthalmic treatment device 100 is then able to apply energy to a plurality of spaced apart fixed locations via the light source assembly 108 and lens array optics 116 as described above.
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(32) As briefly described above, the control unit 110 is operably coupled with and configured to independently control the individual light sources 218 by switching each light source on or off in an automated fashion. The control unit 110 may switch each light source 218 on and off in a sequential manner so that therapeutic light is delivered sequentially among a plurality of target locations in a clockwise or counterclockwise manner around the limbus as shown in
(33) In certain embodiments, the light source assembly 108 and control unit 110 may be configured to deliver light energy in a pulsed or continuous wave emission mode. Careful selection of the laser energy pulse on and off times can avoid undesired thermal damage to a target by allowing the target to cool during the off time of the laser before the next pulse of energy is delivered during the on time. The duty cycle may be selected so that cumulative thermal buildup, caused by insufficient cooling during the off time may be avoided. Thus, damage may be reduced to a minimum level sufficient to trigger a biological response needed for lowering of intraocular pressure (IOP).
(34) In typical embodiments, a semiconductor laser diode or a semiconductor laser diode pumped laser (e.g., DPSS green/yellow laser) is used as the light source for ophthalmic therapy. Such lasers have defined peak lasing wavelengths such as 532 nm, 577 nm or 810 nm, and have defined spectral line width such as +/3 nm, and have defined threshold current such as 700 mA for an 810 nm laser diode, and have defined electrical impedances that allow the lasers to be electrically or optically modulated at any repetition rate (such as 1 kHz or higher), with pulse width at any value (such as 1 ns or higher), for an extended period of time (such as 1 ms or longer).
(35) The light source in the embodiments could be a single mode laser, a multimode laser, or a broad spectrum LED such as a visible spectrum LED for different colors (e.g., green, yellow, or red). The pulse energy, pulse width and pulse repetition rate (aka duty cycle) can be adjusted to provide optimum treatment effect such as demonstrated by the MicroPulse laser treatment parameters.
(36) Electronics 110 may further include a feedback control implemented in hardware to control the light source assembly 108 power that is faster than the response of a software control loop. The hardware optical power feedback control is preferably implemented with a commercially available laser driver chip that has built-in automatic power control feature that uses photodetector input that correlates with laser output to directly control the bias current of the laser diode to achieve constant power level. This typically results in fast real time power control when compared with a software feedback loop.
(37) In some embodiments, batteries 112 can be an alkaline battery, lead-acid battery, lithium-ion battery, or any other rechargeable or disposable battery. The treatment device body 102 may include a battery receptacle for receiving the battery 112 and the housing 106 may include a removable cover for battery 112 replacement when needed. The use of a battery 112 to power a therapeutic light source assembly 108 housed in the same housing 106 may allow for more convenient treatments as the ophthalmic treatment device 100 may not need to be tethered to a separate laser console. The lack of tethering to a laser console may also allow for a greater freedom of motion with the ophthalmic treatment device 100 and better targeting of tissues. Additionally, the battery powered ophthalmic treatment device 100 may allow for the use of the ophthalmic treatment device 100 in rural or secluded areas where electricity is not available. Additionally, the ophthalmic treatment device 100 housing the light source assembly 108 and the power source 112 may potentially reduce manufacturing costs which may allow for greater availability of ophthalmic treatment device 100 in emerging markets.
(38) User interface 114 may comprise one or more mechanical dials, buttons, or switches that may be used to adjust parameters of the therapeutic light source with or without a touchscreen or a dedicated electronic display. When a non-touch-screen user interface is employed, a simple mechanical display using digits to indicate laser settings may be used. Additionally or alternatively, treatment parameters may be communicated to the probe via radio frequency, such as Bluetooth.
(39) The user interface 114 may also comprise an infrared camera that is used to observe the 810 nm infrared laser beam at a standby power level such as less than 1 mW (eye safe) when the beam spot incident on the eye tissue is reflected back to the infrared camera and is observable to the laser operator. The observed low power laser spot can be used as the aiming beam, similar to that which is usually implemented with a different wavelength (e.g., 650 nm red laser diode), but in this embodiment the aiming beam is produced by the same treatment beam at an eye-safe level (i.e., <1 mW). This aiming beam would represent the true beam spot for the treatment laser beam, which is more precise than an auxiliary aiming beam from a separate laser diode that is not always coaxially aligned with the treatment beam.
(40) In some embodiments, the housing 106 may optionally include an illumination light source. The illumination light source may be configured to direct white light into the eye to illuminate the ciliary process, as described in U.S. Patent Publication 2015/0305938, incorporated by reference herein in its entirety. The illuminated tissue may help a clinician align of the probe 100 with the tissue during therapeutic light delivery.
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(42) The contact tip 104 includes a proximal end 122 and a distal applicator end 124 opposite the proximal end 122. The contact tip 104 also typically houses or includes the lens array optics 116. Specifically, the lens array is often integrally formed with or otherwise attached to the contact tip 104. The contact tip 104 may be designed to produce a certain spot size of the therapeutic light on the target tissue. The spot size of the therapeutic light may be adjusted by selecting a different contact tip 104 to use for the treatment procedure. The lens array is typically arranged in a ring shape pattern within the contact tip 104 so that the array of lenses encircles the limbus of the eye and so that each lens of the array is positioned radially outward of the limbus.
(43) The proximal end 122 of the contact tip 104 is configured to mechanically couple with the distal end 120 of the housing 106 of using one or more engagement features. For example,
(44) Since the distal end 124 of the contact tip 104 is typically positioned against the eye, a contact surface 196 of the distal end 124 is typically contoured to match the contour of the eye. For example, the contact surface 196 may be concave with a curvature configured to match the curvature of the sclera. The concave configuration of the contact surface 196 may render the contact surface essentially cup shaped with a configuration that corresponds to an average eye geometry. The contoured configuration of the contact surface 196 may also ensure that the beam of therapeutic light is delivered at an angle that is normal to the surface of the eye. The contact tip 104 may also be keyed to ensure a proper alignment of the contact tip 104 and housing 106. The keyed configuration of the contact tip 104 may help ensure that the lens array is properly aligned with the light source array so that each beam of therapeutic light properly aligns with, and is focused by, a corresponding lens. The keyed contact tips 104 may also facilitate in replacement of the tip with the lens array and light source array axially aligned.
(45) In some embodiments, the contact tip 104 includes a computer readable media. The computer readable media may be an optical barcode (e.g., 2D barcode), embedded chip (e.g., RFID, NFC, direct read memory chip), and the like. The computer readable media may be read by a corresponding sensor associated with the treatment device body 102. In some embodiments, the computer readable media may be a security feature that protects the treatment device body 102 from being used with unauthorized replacement contact tips 104. Optionally, the computer readable media may carry treatment parameter information associated with the contact tip 104. For example, a contact tip 104 may be coupled with the treatment device body 102 and a sensor of the treatment device body may read the computer readable media to determine which treatment parameters are associated with the type of contact tip 104 that is attached thereto. Thereafter, the control unit 110 of the treatment device body 102 may be configured to automatically adjust parameters of the light source assembly 108 for the particular treatment.
(46) As described above, an infrared camera can optionally be included in the user interface 114 to observe the laser treatment beam at an eye safe level (i.e., <1 mW). In such embodiments, the beam spot may be used to guide the treatment laser beam when it is fired at higher power levels.
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(48) At block 404, the contact tip is aligned relative to the eye so that the beam of therapeutic light from each respective light source is deliverable to target tissue of the eye to be treated. At block 406, the control unit is activated in order to deliver the beam of therapeutic light from each respective light source in an automated fashion and to direct, via each lens of the array, the beam of therapeutic light from each respective light source to the target tissue to therapeutically treat the target tissue.
(49) In one embodiment, delivering the beam of therapeutic light from each respective light source in the automated fashion comprises independently delivering the beam of therapeutic light from each light source in a sequential manner so that therapeutic light is delivered to the target tissue of the eye in a clockwise or counterclockwise manner. In such an embodiment, the therapeutic light may be delivered in a circular pattern around a limbus of the eye. The beam of therapeutic light from each respective light source may be delivered in a series of pulses with each pulse of therapeutic light being sufficient to induce therapeutic healing of the target tissue without damaging the tissue. In another embodiment, delivering the beam of therapeutic light from each respective light source in the automated fashion may include delivering the beam of therapeutic light from each light source in a manner so that therapeutic light is delivered to the target tissue in a sweeping manner.
(50) One or more computing devices may be adapted to provide desired functionality by accessing software instructions rendered in a computer-readable form. When software is used, any suitable programming, scripting, or other type of language or combinations of languages may be used to implement the teachings contained herein. However, software need not be used exclusively, or at all. For example, some embodiments of the methods and systems set forth herein may also be implemented by hard-wired logic or other circuitry, including but not limited to application-specific circuits. Combinations of computer-executed software and hard-wired logic or other circuitry may be suitable as well.
(51) Embodiments of the methods disclosed herein may be executed by one or more suitable computing devices. Such system(s) may comprise one or more computing devices adapted to perform one or more embodiments of the methods disclosed herein. As noted above, such devices may access one or more computer-readable media that embody computer-readable instructions which, when executed by at least one computer, cause the at least one computer to implement one or more embodiments of the methods of the present subject matter. Additionally or alternatively, the computing device(s) may comprise circuitry that renders the device(s) operative to implement one or more of the methods of the present subject matter.
(52) Any suitable computer-readable medium or media may be used to implement or practice the presently-disclosed subject matter, including but not limited to, diskettes, drives, and other magnetic-based storage media, optical storage media, including disks (e.g., CD-ROMS, DVD-ROMS, variants thereof, etc.), flash, RAM, ROM, and other memory devices, and the like.
(53) The subject matter of the present invention is described here with specificity, but the claimed subject matter may be embodied in other ways, may include different elements or steps, and may be used in conjunction with other existing or future technologies.
(54) This description should not be interpreted as implying any particular order or arrangement among or between various steps or elements except when the order of individual steps or arrangement of elements is explicitly described. Different arrangements of the components depicted in the drawings or described above, as well as components and steps not shown or described are possible. Similarly, some features and sub-combinations are useful and may be employed without reference to other features and sub-combinations. Embodiments of the invention have been described for illustrative and not restrictive purposes, and alternative embodiments will become apparent to readers of this patent. Accordingly, the present invention is not limited to the embodiments described above or depicted in the drawings, and various embodiments and modifications may be made without departing from the scope of the claims below.