WO2014049132A1 - Laser system for retinal treatment of macular degeneration - Google Patents
Laser system for retinal treatment of macular degeneration Download PDFInfo
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- WO2014049132A1 WO2014049132A1 PCT/EP2013/070230 EP2013070230W WO2014049132A1 WO 2014049132 A1 WO2014049132 A1 WO 2014049132A1 EP 2013070230 W EP2013070230 W EP 2013070230W WO 2014049132 A1 WO2014049132 A1 WO 2014049132A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/008—Methods or devices for eye surgery using laser
- A61F9/00821—Methods or devices for eye surgery using laser for coagulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/008—Methods or devices for eye surgery using laser
- A61F2009/00861—Methods or devices for eye surgery using laser adapted for treatment at a particular location
- A61F2009/00863—Retina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/008—Methods or devices for eye surgery using laser
- A61F2009/00897—Scanning mechanisms or algorithms
Definitions
- the invention relates generally to laser treatment of the retina, and more particularly to laser treatment of the retina at multiple locations for the treatm ent of macular degeneration.
- retinal conditions such as proliferative diabetic retinopathy, diabetic macular edema, and retinal venous occlusive diseases
- PRP panretinal photocoagulation
- Retinal photocoagulation procedures frequently require delivery of a large number of laser doses to the retina.
- PRP typically requires laser treatment of at least 1500 locations.
- Retinal photocoagulation is typically performed point-by-point, where each individual dose is positioned and delivered by the physician.
- laser spots range from 50-500 microns in diameter, have pulse durations of 100-200 ms and have a beam power of 200-800 mW.
- Laser wavelengths are typically green, yellow or red, although occasionally infrared radiation is used. Point by point treatment of a large number of locations tends to be a lengthy procedure, which frequently results in physician fatigue and patient discomfort.
- Various approaches for reducing retinal photocoagulation treatment time have been developed, which include forming visible aligtxtnent patterns with alignment beams, such as described in US Patent No. 7, 766,903 to Blumenkranz or using groupings of visible alignment spots and groupings of treatment spots, such as described in US Publication No. 2011/0245816 to Abe, both disclosures of which are hereby incorporated by reference in their entireties.
- the invention advantageously fills the aforementioned deficiencies by providing a retinal treatment laser system that is easy to use and allows the physician a visual indication of the order of treatment performed and the location from which the treatment started without having to see all of the spots of the target shape at once.
- a system for laser treatment of the retina of an eye of a patient including an alignment source producing an alignment beam, a treatment source producing a treatment beam and one or more scanning elements configured to direct the alignment beam and treatment beam to various positions on a retina of a patient.
- the system also includes a processor opcratively coupled to the one or more scanning elements, the processor configured to controllably shutter the alignment and treatment beams and operate the one or more scanning elements to project an alignment shape comprising a plurality of separate alignment spots onto said retina produced by the alignment beam and scanning elements, the spots of the alignment shape configured such that the alignment shape has therein continuously moving and randomly appearing spot gaps.
- the processor is also configured to deliver, responsive to an input from an operator and within a time period of about one second, at least one dose of laser energy to at least one separate treatment spot at a location which is substantially co- located with at least one of the separate alignment spots, wherein the at least one of the spot gaps provides feedback to the operator on the order of treatment performed.
- the laser treatment system is provided wherein one of the spot gaps indicates a first treatment spot and a second spot gap indicates an order of treatment performed.
- the laser treatment system wherein the treatment beam has a substantially non-visible wavelength.
- the laser treatment system further includes a retina imager configured to observe the retina, the retina imager being selected from the following group: a biomicroscope, a slit lamp, a video display, or an optical image inverter.
- the laser treatment system includes a database configured to record observations obtained from said retina imager.
- FIG. 1 is a flow diagram of a prior art method.
- FIG. 2 illustrates a block diagram of a prior art retinal laser system.
- FIG. 3a -3h show examples of suitable shapes and patterns for practicing the invention formed by prior art systems.
- FIG. 4 illustrates an embodiment of a laser retinal treatment system according to the present invention.
- FIGS. 5A-5D illustrates first a standard square pattern with all spots visible at once during an alignment step.
- FIGS. 6A-6D there is illustrated first a standard circle pattern with all spots visible at once during an alignment step.
- FIGS. 7A-7D there is illustrated first a standard triple arc pattern with all spots visible at once during an alignment step.
- FIGS. 8A-8C illustrate various images of a changing alignment pattern of a square according to the teachings herein.
- FIGS. 9A-9C illustrate various images of a changing alignment pattern of a circle according to the teachings herein.
- FIGS. 1 OA- 1 OH illustrate various images of a changing alignment pattern of a square according to the teachings herein.
- FIG. 11 illustrates a Resum e icon or image indicating resumption of a treatment regimen according to the teachings herein.
- FIG. 1 is a flow diagram of a prior art method of a retinal treatment system.
- a first step 10 of this method is projecting a visible alignment pattern, where all the spots are visible at once to an operator, having at least two separated spots onto a retina.
- step 12 of adjusting the alignment pattern is performed next by an operator (e.g. a physician or a technician).
- This adjustment can include translation of the alignment pattern relative to the retina, in order to select areas to treat and/or to ensure that critical parts of the retina (e.g., the fovea or major blood vessels) are not treated with laser radiation.
- Adjustment of the pattern can also include rotation and/or scaling of the pattern, and/or changing the size of the spots to be treated.
- Step 14 of triggering a laser subsystem is performed by an operator (e.g., by pressing a foot switch, pressing button, giving an audio command etc.).
- step 16 is automatically performed, which entails delivering at least two laser doses to locations on the retina which are aligned to some (or all) of the alignment pattern spots.
- all of the laser doses are delivered in less than about 1 second, since 1 second is a typical eye fixation time. In this manner, doses of laser energy can be delivered to visible multiple locations on the retina which are aligned with all the visible spots in the alignment pattern, responsive to a single operator action.
- the operator or doctor can stop or shut the treatment beam with the footswitch even while inside a treatment pattern (based on the preselected alignment pattern).
- the laser system and the processor is also configured to use the shutter to shut the treatment beam within the treatment pattern should any security issue with the laser beam arise.
- An upper limit to the number of locations which can be treated in a single automatic application (or session or sequence) is obtained by dividing the maximum total treatment time by the pulse duration at each treatment location. For example, for 100 ms pulses and a maximum total treatment time of 1 second, the maximum number of treatment locations is 10. We have found that 7-50 ms pulses are preferable for practicing the invention, and 7-30 ms pulses are more preferred. The corresponding range of maximum number of locations treated in 1 second for the more preferred pulse duration range is 33-100, which is enough to provide a significant reduction in total treatment time. For example, 1500 locations can be treated using only 30 automatic applications of approximately 1 second each when each application treats 50 locations with an individual pulse duration of 20 ms.
- FIG. 2 illustrates a block diagram of a prior art retinal laser system 20 suitable for performing the method of FIG. 1, as well as a retina 23 having an alignment pattern and treatment locations on it.
- system 20 Within system 20 are two subsystems, an alignment subsystem 21 and a laser subsystem 22.
- Alignment subsystem 21 provides a visible alignment pattern, with all spots being visible at once or visible in groupings, having at least two spots to retina 23.
- the alignment pattern has spots 24 arranged in a circle and a spot 26 at or near the center of the circle formed by spots 24. Alignment pattern spots are illustrated with dotted lines on FIG. 2.
- Laser subsystem 22 provides doses of laser energy to at least two treatment locations on retina 23 which are substantially aligned with alignment pattern spots.
- treatment locations 25 are arranged in a circle and are substantially aligned with alignment spots 24. Treatment locations are illustrated with solid lines on FIG. 2. Perfect alignment of alignment spots to treatment locations is not required.
- FIG. 2 illustrates treatment locations 25 which are slightly smaller than alignment spots 24.
- treatment locations 25 could be larger than alignment spots 24 and/or be slightly offset from alignment spots 24.
- spot 26 can be used as a fixation spot, for example, by aligning it to a patient's fovea and requesting the patient to fixate on spot 26.
- the alignment pattern has an exclusion zone 27 within which no treatment locations are disposed.
- FIGS. 3a -3h show examples of suitable shapes and patterns for practicing the invention formed by prior art systems. These patterns include a circular pattern, elliptical pattern, donut pattern, quadrant pattern, rectangular pattern, arc pattern, line pattern (not illustrated) and annular arc pattern, respectively. Furthermore, a user-defined pattern can be created and stored for later use, and such a user-defined pattern can be used in the same way as any other pattern. A database, such as described above, can be used to store user-defined patterns. FIG. 3h illustrates an example of how such certain patterns can be used in practice. In the example of FIG.
- 3h is a retinal feature, such as the macula, or a retinal tear, or a localized region of lattice degeneration, which would not be laser treated, but which would be surrounded by laser treated regions.
- the entire treatment pattern can be applied in less than one second.
- a source module 410 is coupled by a fiber 420 to a scanner module 430.
- Source module 410 and scanner module 430 are controlled by a processor 440. Radiation emitted from seamier module 430 impinges on a retina 470 of an eye 460, and typically passes through an optional contact lens 450 on the way.
- source module 410 includes an alignment source 411 and a separate laser source 413, which is a preferred embodiment, since it increases flexibility.
- alignment source 411 can have a wavelength selected within the visible spectrum to provide improved visibility of the alignment pattern on the retina, while laser source 413 can have a wavelength selected to provide improved treatment results.
- the wavelength of laser source 413 can be at a non- visible wavelength.
- Alignment source 41 1 can be an LED (light Emitting Diode) source or a low power laser source providing less than 1 mW per alignment spot.
- Laser source 413 can be an Argon laser, Krypton laser, diode laser, fiber laser. Nd-YAG/frequcncy-doubled laser or any other pulsed or continuous wave laser suitable for retinal therapy.
- the output power of laser source 413 is from about 200 mW to about 3 W.
- a 532 nm laser is Nd-YAG (or greenlight) laser is used however in related treatments a 577nm laser can also be used.
- the pulse durations are about 10-20 ms (or can be used continuously depending on treatment) to ensure that the surrounding tissue is not damaged by high temperatures.
- the pulse duration can be an envelope of bursts of shorter pulses, or micropulses (npulsc), each of these shorter pulses being between 50 ⁇ S to 1000 ⁇ s with a 5 to 20% repetition rate.
- npulsc micropulses
- the density of power is smaller and the operator may not be able to see or detect after the treatment where he has made the spot or treatment or where the treatment ended.
- the various laser systems taught herein assist in determining where the last treatment spot is located for the operator.
- Laser source 413 can be a pulsed laser, which can be suitable for other applications, including but not limited to, selective Retinal Pigment Epithelial (RPE) treatment.
- RPE selective Retinal Pigment Epithelial
- the laser pulse duration is typically within a range of about 20 ns to 2 ⁇ s
- the laser pulse energy density is within a range of about 50 to 500 mJ/cm.sup.2.
- the short laser pulses can be applied to each treatment location in a burst.
- the repetition rate of pulses in the burst can be selected by dividing the desired number of pulses by the duration of treatment in each location. For example, delivery of 50 pulses during 30 ins is provided by a repetition rate of 1.7 kHz.
- An alignment shutter 412 and a laser shutter 414 are disposed in the beam paths of alignment source 41 1 and laser source 413 respectively. These shutters provide rapid on-off switching of the alignment and laser beams under the control of processor 440 to define the pulse duration of laser energy doses. As indicated above, we have found that 5-50 ms pulses are preferable for practicing the invention for coagulation applications, and 10-30 ms pulses are more preferred.
- Approaches for implementing shutters 412 and 414 include, but are not limited to, mechanical shutters, liquid crystal display (LCD) devices, and/or acousto-optic modulators (AGMs).
- shutters 412 and/or 414 can be omitted if sources 411 and/or 413 provide rapid on-off switching capability.
- the laser and alignment beams are combined by a turning mirror 415 and a dichroic beamsplitter 416, and then coupled into fiber 420 by coupling optics 417.
- many other arrangements of optical components are also suitable for coupling sources 411 and 413 into fiber 420, and can be used to practice the invention.
- Optical fiber 420 is preferably a highly multimode fiber (i.e., number of modes >20) at the wavelength of laser source 413 and at the wavelength of alignment source 411.
- a highly multimode optical fiber provides a smooth and nearly constant optical intensity distribution at its output, which is desirable for practicing the invention.
- Laser and alignment light emitted from fiber 420 is received by scanner module 430.
- scanner module 430 light emitted from fiber 420 is collimated by coupling optics 431 , and is then deflected by scanning elements 432 and 433.
- scanning elements 432 and 433 each provide 1-D beam deflection, so two such elements are used to provide 2-D beam deflection.
- Scanning elements 432 and 433 are preferably galvanically or piezoelectrically actuated optical elements suitable for beam deflection, such as mirrors. Of course, other deflection elements and/or actuation methods can also be used to practice the invention.
- Deflected beams 437 pass through lens 434 and optional contact lens 450 before reaching retina 470 of eye 460.
- Lens 434 and optional lens 450 in combination with refractive elements of eye 460 such as its cornea and lens, provide a selected alignment and laser beam spot size at retina 470, which is typically in a range of about 50 to 500 microns for single spot and about 100 to 500 microns for multispot treatments.
- scanning elements 432 and 433 and shutters 412 and 414 along with processor 440 are used to define an alignment pattern and a set of treatment locations on retina 470.
- scanning elements 432 and 433 are driven by processor 440 such that an alignment beam from alignment source 411 defines a pattern having spots 24 and spot 26 on retina 470.
- Shutter 412 is closed while this beam is moved from spot to spot.
- the treatment locations illustrated on FIG. 2 are then provided by opening shutter 414 when the alignment beam is aligned with one of spots 24, and closing shutter 414 while the alignment beam is moved from spot to spot, and while the alignment beam is aligned with fixation spot 26,
- An optional retina imager 436 is preferably included in a system according to the invention, to allow the physician to observe the alignment patterns and/or treatment locations on retina 470.
- retina imager 436 is optically coupled to retina 470 via a partially transmissive mirror 435.
- Partially transmissive mirror 435 is preferably highly reflective at the wavelength of laser source 413, partially reflective and partially transmissive at the wavelength of alignment source 41 1, and transmissive at wavelength(s) of any illumination source that may be present within retina imager 436.
- Other methods of coupling retina imager 436 to retina 470 while permitting deflected laser and alignment beams 437 to also reach retina 470 can also be used to practice the invention.
- Retina imager 436 can be a biomicroscope or slit lamp, slit lamp adapter or any other instrument for observing the retina.
- the physician will look into an eyepiece of retina imager 436 to observe retina 470.
- retina imager 436 will include a video display of retina 470 to make observation of retina 470 more convenient.
- retina imager 436 will typically include an optical wavelength selective filter at its input to block light having the wavelength of laser source 413 from entering retina imager 436, while permitting light having the wavelength of alignment source 411 to enter retina imager 436. Such a filter is particularly important when observations are performed directly by a physician.
- apparatus 400 is adaptable for use as a laser indirect ophthalmoscope, for use with endoscopes and for use with OR microscope adapters.
- processor 440 is configured to drive alignment source 411 and laser/treatment source 413 in such a manner as to create a novel alignment or shape targets on the patient's retina for subsequent treatment.
- FIGS. 5A-5D there is illustrated first a standard square pattern with all spots visible at once during an alignment step.
- FIG. 5A-5D there is illustrated first a standard square pattern with all spots visible at once during an alignment step.
- 5B illustrates one embodiment of a shape formed by the alignment beam having at least two spots that are continuously moving (location by location) and blinking on and off, both in a random fashion (in terms of timing and location), such that they appears as gaps or blinking spots for a constantly varying alignment configuration or shape or pattern.
- FIG. 5C there is described another embodiment of a square shape or pattern having at least two spots that are continuously moving
- FIG. 5D illustrates yet another embodiment of a square shape having at least two spots that are continuously blinking on and off, both in a random fashion in terms of timing for one and timing/location for the second spot. The effect is that they appears as gaps or blinking spots for a constantly varying shape with the further enhancement of the second "gap" or blinking spot moving in the direction in which the treatment is being performed, while the first one remains in its first position indicating where the treatment was started.
- the first blinking spot or gap indicates the first spot of the treatment and the second moving through the alignment shape indicates the order of the treatment.
- FIGS. 6A-6D there is illustrated first a standard circle pattern with all spots visible at once during an alignment step.
- FIG. 6B then illustrates one embodiment of the circle shape formed by the alignment beam having at least two spots that are continuously moving (see direction arrows, but it can be counterclockwise as well) and blinking on and off, both in a random fashion (in terms of timing and possibly location), such that they appear as gaps or blinking spots for a constantly varying shape.
- FIG. 6B illustrates one embodiment of the circle shape formed by the alignment beam having at least two spots that are continuously moving (see direction arrows, but it can be counterclockwise as well) and blinking on and off, both in a random fashion (in terms of timing and possibly location), such that they appear as gaps or blinking spots for a constantly varying shape.
- FIG. 6C illustrates another embodiment of a circle shape formed by the alignment beam having at least two spots that are continuously moving and blinking, both in a random fashion (in terms of timing and location), such thai they appear as gaps or blinking spots for a constantly varying shape with the further enhancement of the "gaps" or blinking spots moving in the direction in which the treatment is being performed.
- FIG. 6D there is illustrated yet another embodiment of a circle shape formed by the alignment beam having at least two spots that are continuously moving (in the direction of arrows) blinking on and off, both in a random fashion in terms of timing for one and timing/location for the second spot.
- the effect is that they appear as gaps or blinking spots for a constantly varying shape with the further enhancement of the second "gap" or blinking spot moving in the direction in which the treatment is being performed, while the first one remains in its first position indicating where the treatment was started.
- This is an advantage of the prior art in that the doctor/operator in the past could not see the order in which he will perform or is performing during the treatment from the alignment target/shape that he is able to see.
- the first blinking spot or gap indicates the first spot of the treatment and the second moving through, the alignment shape indicates the order of the treatment.
- FIGS. 7A-7D there is illustrated first a standard triple arc pattern with all spots visible at once during an alignment step.
- outlines and solid shapes of alignment shapes can be configured from apparatus 400, wherein treatments can be performed at the perimeter spots according to the invention.
- FIG. 7B illustrates a triple arc shape formed by the alignment beam having at least two spots that are continuously moving and blinking on and off, both in a random fashion, such that they appear as gaps or blinking spots for a constantly varying shape.
- FIG. 7B illustrates a triple arc shape formed by the alignment beam having at least two spots that are continuously moving and blinking on and off, both in a random fashion, such that they appear as gaps or blinking spots for a constantly varying shape.
- 7C illustrates a triple arc shape having at least two spots that are continuously moving and blinking, both in a random fashion (in terms of timing and location), such that they appear as gaps or blinking spots for a constantly varying shape with the further enhancement of the "gaps" or blinking spots moving in the direction in which the treatment is being performed.
- FIG. 7D there is illustrated yet another embodiment of a triple arc shape having at least two spots that are continuously moving (in the direction of the arrows, but not limited to such) blinking on and off, both in a random fashion in terms of timing for one and timing/location for the second spot.
- the effect is that they appear as gaps or blinking spots for a constantly varying shape with the further enhancement of the second "gap" or blinking spot moving in the direction in which the treatment is being performed, while the first one remains in its first position indicating where the treatment was started.
- the doctor/operator in the past could not see the order that he will perform or is performing during the treatment from the alignment target/shape that he is able to see.
- the first blinking spot or gap indicates the first spot of the treatment and the second moving through the alignment shape indicates the order of the treatment.
- FIGS. 8A-8C and 9A-9C in these other related embodiments of the invention, 2 or 3 spots move continuously and randomly throughout the alignment shape (3 x3 square or circle, respectively), thereby tracing and exhibiting ever-changing shapes in which all of the alignment spots are not visible all at one time to the operator.
- the operator understands that the treatment beam will be co-linear with spots he generally sees on the retina.
- FIGS, 8 A and 9A illustrate typical square and circle configurations formed by alignment beam where all of the spots are visible at one time.
- a center spot is fixed and blinking while the surround spots may be randomly blinking and moving.
- FIG. 8C In FIG. 8C.
- FIG. 9B illustrates a circle shape wherein one spot is on and two are blinking and are fixed or can move around the circle in either direction as illustrated in FIG. 9C.
- the aiming beam is generated by a red laser diode having a wavelength in the range of about 635 to about 650nm.
- a first spot of the pattern (drawn by the aiming beam) stays illustrated or on. This one shows the spot by which the treatment pattern will start.
- the other spots are displayed in sequence in which each of them disappears and appears again successively following the treatment pattern execution or delivery process.
- the alignment pattern changes constantly and progressively as the treatment progresses.
- the intelligent aiming beam function is also used with each type of pattern (square, circle, triple arc, etc..) and permits the user to choose where within the treatment pattern he desires to commence the treatment and the sequence that he wants follow (for example he can chose to begin by a right lower spot and/or do the sequences in the other direction ).
- FIG. 11 there is illustrated an additional function to the retinal treatment system that is reflected as an icon on the touch screen as "Resume", the Resume function which when activated allows the user to continue or resume the treatment on a previously chosen alignment and treatment pattern when the current procedure is interrupted.
- the treated spots are displayed on the screen in red.
- a canceling tab is displayed at the right-hand of a pattern display.
- the user presses the "Resume” function button until it highlights in white (about 1 second).
- the user can finish the pattern by pressing the footswitch again. He can cancel the pattern resume by pressing the canceling tab and perform or treat with a new pattern.
- the embodiment describe herein differs from prior art retinal treatment systems in that more information is provided to the physician to allow him to finish the treatment within a pattern should he be interrupted or the laser stops for any reason during treatment when he is within the selected pattern.
- the Resume function permits this resumption of treatment without injuring the patient and assuring the physician that he is not going to inadvertently rc-treat the same area.
- the Resume function is particularly useful where micropulsc ( ⁇ pulse) bursts are used in the retinal treatment due to the fact that the operator may not be able to see the location where the laser treatment has already been made or applied on the retinal tissue and now with the Resume function he can finish the treatment pattern (by starting at a non-treated spot next to a previously treated spot in the treatment pattern).
- ⁇ pulse micropulsc
- the aiming beam spot is fixed or located initially on the first point of treatment and therefore the doctor is aware of where the treatment will start.
- the doctor can choose where to start treatment on a chosen pattern. All the other aiming beam points or spots on the image (or figure) showing the pattern blink one by one, sequentially, to indicate the sequence of the actual treatment pattern. With this knowledge the doctor will know the actual treatment sequence and can stop inside this sequence if he so desires. If the doctor stops a treatment in a particular point within a selected treatment pattern, he can finish the treatment pattern using the Resume function. In a similar way, the doctor is given notice that he is at the end of the pattern as the aiming beam shows first point or spot and the sequence with which to finish the preselected pattern.
- various laser systems described above the alignment pattern is displayed on a video screen for the doctor but he only sees one target spot or fixation point on the retina. The same target point is also highlighted or blinking in the center of the alignment pattern on the video screen so that the doctor knows that once he triggers the laser beam at the target point on the retina, then the entire selected pattern will correspondingly be treated on the retina. In this manner the doctor knows where the treatment will be applied and what pattern will be used without the need for showing a visible alignment pattern on the retina.
- a contour of the figure of the pattern (such as a square, circle or arc) is formed and then it is located or highlighted as only one spot on the center of the contour.
- the contour is formed using a 50 ⁇ spot and changing the spot size and showing the center spot with a larger spot of 200 ⁇ .
- the zoom lens is not motorized, hence the contour can use similarly sized spots.
- the center spot and the contour line flash or blink (alternatively) providing the doctor with knowledge of the treatment pattern without a full alignment pattern being displayed on the retina.
- the center and edge of the treatment area are generally visible to the physician in this example.
- processor 440 is configured to provide each pattern screen a dedicated parameter icon that allows the user to rotate or to resize each of the patterns (extend/reduce the patterns; extend/reduce the radius of rounded shape patterns; etc.). To be adjusted, the icon (used to extend/reduce a pattern - extend/reduce the radius of a rounded shape pattern) is selected and then adjusted with the touch screen controller or a selector button on the system.
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Description
LASER SYSTEM FOR RETINAL TREATMENT OF MACULAR
DEGENERATION
CLAIM OF PRIORITY
[0001] This application claims priority to and the benefit of the provisional application having serial number 61/706,404 with a filing date of September 27, 2012, which is herein incorporated by reference in its entirety.
FIELD AND BACKGROUND OF THE INVENTION
[0002] The invention relates generally to laser treatment of the retina, and more particularly to laser treatment of the retina at multiple locations for the treatm ent of macular degeneration.
[0003] Several retinal conditions, such as proliferative diabetic retinopathy, diabetic macular edema, and retinal venous occlusive diseases, respond well to retinal photocoagulation treatment, with panretinal photocoagulation (PRP) being the current standard of care for proliferative diabetic retinopathy. Retinal photocoagulation procedures frequently require delivery of a large number of laser doses to the retina. For example, PRP typically requires laser treatment of at least 1500 locations. Retinal photocoagulation is typically performed point-by-point, where each individual dose is positioned and delivered by the physician. Typically, laser spots range from 50-500 microns in diameter, have pulse durations of 100-200 ms and have a beam power of 200-800 mW. Laser wavelengths are typically green, yellow or red, although occasionally infrared radiation is used. Point by point treatment of a large number of locations tends to be a lengthy procedure, which frequently results in physician fatigue and patient discomfort.
[0004] Various approaches for reducing retinal photocoagulation treatment time have been developed, which include forming visible aligtxtnent patterns with alignment beams, such as described in US Patent No. 7, 766,903 to Blumenkranz or using groupings of visible alignment spots and groupings of treatment spots, such as described in US Publication No. 2011/0245816 to Abe, both disclosures of which are hereby incorporated by reference in their entireties. However, these approaches tend to make it more difficult to see the treated area after treatment and/or provide extremely complex alignment and treatment groupings that may increase confusion for the operator in using the device and may increase in treatment time for the patient as the operator is learning to use the system. Accordingly, there is a need for simple and flexible multi-location retina treatment that is not provided by known methods.
SUMMARY OF THE INVENTION
[0005] The invention advantageously fills the aforementioned deficiencies by providing a retinal treatment laser system that is easy to use and allows the physician a visual indication of the order of treatment performed and the location from which the treatment started without having to see all of the spots of the target shape at once.
[0006] In one example embodiment, there is provided a system for laser treatment of the retina of an eye of a patient, the system including an alignment source producing an alignment beam, a treatment source producing a treatment beam and one or more scanning elements configured to direct the alignment beam and treatment beam to various positions on a retina of a patient. The system also
includes a processor opcratively coupled to the one or more scanning elements, the processor configured to controllably shutter the alignment and treatment beams and operate the one or more scanning elements to project an alignment shape comprising a plurality of separate alignment spots onto said retina produced by the alignment beam and scanning elements, the spots of the alignment shape configured such that the alignment shape has therein continuously moving and randomly appearing spot gaps. The processor is also configured to deliver, responsive to an input from an operator and within a time period of about one second, at least one dose of laser energy to at least one separate treatment spot at a location which is substantially co- located with at least one of the separate alignment spots, wherein the at least one of the spot gaps provides feedback to the operator on the order of treatment performed. In related example embodiment, the laser treatment system is provided wherein one of the spot gaps indicates a first treatment spot and a second spot gap indicates an order of treatment performed.
[0007] In another example embodiment, the laser treatment system wherein the treatment beam has a substantially non-visible wavelength. In yet another related embodiment, the laser treatment system further includes a retina imager configured to observe the retina, the retina imager being selected from the following group: a biomicroscope, a slit lamp, a video display, or an optical image inverter. In yet another related embodiment, the laser treatment system includes a database configured to record observations obtained from said retina imager.
[0008] The invention now will be described more fully hereinafter with reference to the accompany drawings, which are intended to be read in conjunction
with both this summary, the detailed description and any preferred and/or particular embodiments specifically discussed or otherwise disclosed. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of illustration only and so that this disclosure will be thorough, complete and will fully convey the full scope of the invention to those skilled in the art.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 is a flow diagram of a prior art method.
[0010] FIG. 2 illustrates a block diagram of a prior art retinal laser system.
[0011] FIG. 3a -3h show examples of suitable shapes and patterns for practicing the invention formed by prior art systems.
[0012] FIG. 4 illustrates an embodiment of a laser retinal treatment system according to the present invention.
[0013] FIGS. 5A-5D illustrates first a standard square pattern with all spots visible at once during an alignment step.
[0014] FIGS. 6A-6D, there is illustrated first a standard circle pattern with all spots visible at once during an alignment step.
[0015] FIGS. 7A-7D, there is illustrated first a standard triple arc pattern with all spots visible at once during an alignment step.
[0016] FIGS. 8A-8C illustrate various images of a changing alignment pattern of a square according to the teachings herein.
[0017] FIGS. 9A-9C illustrate various images of a changing alignment pattern of a circle according to the teachings herein.
[0018] FIGS . 1 OA- 1 OH illustrate various images of a changing alignment pattern of a square according to the teachings herein.
[0019] FIG. 11 illustrates a Resum e icon or image indicating resumption of a treatment regimen according to the teachings herein.
BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0020] Referring now more specifically to FIGs.1-4, FIG. 1 is a flow diagram of a prior art method of a retinal treatment system. A first step 10 of this method is projecting a visible alignment pattern, where all the spots are visible at once to an operator, having at least two separated spots onto a retina. In most cases, step 12 of adjusting the alignment pattern is performed next by an operator (e.g. a physician or a technician). This adjustment can include translation of the alignment pattern relative to the retina, in order to select areas to treat and/or to ensure that critical parts of the retina (e.g., the fovea or major blood vessels) are not treated with laser radiation. Adjustment of the pattern can also include rotation and/or scaling of the pattern, and/or changing the size of the spots to be treated. Step 14 of triggering a laser subsystem is performed by an operator (e.g., by pressing a foot switch, pressing button, giving an audio command etc.). After step 14, step 16 is automatically performed, which entails delivering at least two laser doses to locations on the retina which are aligned to some (or all) of the alignment pattern spots. Preferably, all of the laser doses are delivered in less than about 1 second, since 1 second is a typical eye fixation time. In this manner, doses of laser energy can be delivered to visible multiple locations on the retina which are aligned with all the visible spots in the alignment pattern, responsive to a single operator action. In this example embodiment, the operator or doctor can stop or shut the treatment beam
with the footswitch even while inside a treatment pattern (based on the preselected alignment pattern). In addition, the laser system and the processor is also configured to use the shutter to shut the treatment beam within the treatment pattern should any security issue with the laser beam arise.
[0021] An upper limit to the number of locations which can be treated in a single automatic application (or session or sequence) is obtained by dividing the maximum total treatment time by the pulse duration at each treatment location. For example, for 100 ms pulses and a maximum total treatment time of 1 second, the maximum number of treatment locations is 10. We have found that 7-50 ms pulses are preferable for practicing the invention, and 7-30 ms pulses are more preferred. The corresponding range of maximum number of locations treated in 1 second for the more preferred pulse duration range is 33-100, which is enough to provide a significant reduction in total treatment time. For example, 1500 locations can be treated using only 30 automatic applications of approximately 1 second each when each application treats 50 locations with an individual pulse duration of 20 ms.
[0022] FIG. 2 illustrates a block diagram of a prior art retinal laser system 20 suitable for performing the method of FIG. 1, as well as a retina 23 having an alignment pattern and treatment locations on it. Within system 20 are two subsystems, an alignment subsystem 21 and a laser subsystem 22. Alignment subsystem 21 provides a visible alignment pattern, with all spots being visible at once or visible in groupings, having at least two spots to retina 23. In the example of FIG. 2, the alignment pattern has spots 24 arranged in a circle and a spot 26 at or near the center of the circle formed by spots 24. Alignment pattern spots are
illustrated with dotted lines on FIG. 2. Laser subsystem 22 provides doses of laser energy to at least two treatment locations on retina 23 which are substantially aligned with alignment pattern spots. In the example of FIG. 2, treatment locations 25 are arranged in a circle and are substantially aligned with alignment spots 24. Treatment locations are illustrated with solid lines on FIG. 2. Perfect alignment of alignment spots to treatment locations is not required. For example, FIG. 2 illustrates treatment locations 25 which are slightly smaller than alignment spots 24. Alternatively, treatment locations 25 could be larger than alignment spots 24 and/or be slightly offset from alignment spots 24. There is no treatment location corresponding to spot 26. Therefore, spot 26 can be used as a fixation spot, for example, by aligning it to a patient's fovea and requesting the patient to fixate on spot 26. The alignment pattern has an exclusion zone 27 within which no treatment locations are disposed.
[0023] FIGS. 3a -3h show examples of suitable shapes and patterns for practicing the invention formed by prior art systems. These patterns include a circular pattern, elliptical pattern, donut pattern, quadrant pattern, rectangular pattern, arc pattern, line pattern (not illustrated) and annular arc pattern, respectively. Furthermore, a user-defined pattern can be created and stored for later use, and such a user-defined pattern can be used in the same way as any other pattern. A database, such as described above, can be used to store user-defined patterns. FIG. 3h illustrates an example of how such certain patterns can be used in practice. In the example of FIG. 3h, is a retinal feature, such as the macula, or a retinal tear, or a localized region of lattice degeneration, which would not be laser treated, but which would be surrounded by laser treated regions. In the case of smaller regions to be
treated with a relatively limited number of total spots, typically less than 100, the entire treatment pattern can be applied in less than one second.
[0024] Referring now to FIG, 4, there is illustrated an apparatus 400 of an embodiment of the present invention. A source module 410 is coupled by a fiber 420 to a scanner module 430. Source module 410 and scanner module 430 are controlled by a processor 440. Radiation emitted from seamier module 430 impinges on a retina 470 of an eye 460, and typically passes through an optional contact lens 450 on the way. In the example of FIG. 4, source module 410 includes an alignment source 411 and a separate laser source 413, which is a preferred embodiment, since it increases flexibility. For example, alignment source 411 can have a wavelength selected within the visible spectrum to provide improved visibility of the alignment pattern on the retina, while laser source 413 can have a wavelength selected to provide improved treatment results. In fact, the wavelength of laser source 413 can be at a non- visible wavelength. Alignment source 41 1 can be an LED (light Emitting Diode) source or a low power laser source providing less than 1 mW per alignment spot. Laser source 413 can be an Argon laser, Krypton laser, diode laser, fiber laser. Nd-YAG/frequcncy-doubled laser or any other pulsed or continuous wave laser suitable for retinal therapy. Typically, the output power of laser source 413 is from about 200 mW to about 3 W. In this example embodiment, a 532 nm laser is Nd-YAG (or greenlight) laser is used however in related treatments a 577nm laser can also be used. The pulse durations are about 10-20 ms (or can be used continuously depending on treatment) to ensure that the surrounding tissue is not damaged by high temperatures. In one example embodiment, the pulse duration can be an envelope of bursts of shorter pulses, or micropulses (npulsc), each of these
shorter pulses being between 50μS to 1000μs with a 5 to 20% repetition rate. Where the micropulse bursts are used in a treatment, the density of power is smaller and the operator may not be able to see or detect after the treatment where he has made the spot or treatment or where the treatment ended. The various laser systems taught herein assist in determining where the last treatment spot is located for the operator.
[0025] Laser source 413 can be a pulsed laser, which can be suitable for other applications, including but not limited to, selective Retinal Pigment Epithelial (RPE) treatment. In this case the laser pulse duration is typically within a range of about 20 ns to 2μs, and the laser pulse energy density is within a range of about 50 to 500 mJ/cm.sup.2. The short laser pulses can be applied to each treatment location in a burst. The repetition rate of pulses in the burst can be selected by dividing the desired number of pulses by the duration of treatment in each location. For example, delivery of 50 pulses during 30 ins is provided by a repetition rate of 1.7 kHz.
[0026] An alignment shutter 412 and a laser shutter 414 are disposed in the beam paths of alignment source 41 1 and laser source 413 respectively. These shutters provide rapid on-off switching of the alignment and laser beams under the control of processor 440 to define the pulse duration of laser energy doses. As indicated above, we have found that 5-50 ms pulses are preferable for practicing the invention for coagulation applications, and 10-30 ms pulses are more preferred. Approaches for implementing shutters 412 and 414 include, but are not limited to, mechanical shutters, liquid crystal display (LCD) devices, and/or acousto-optic modulators (AGMs). Alternatively, shutters 412 and/or 414 can be omitted if sources 411 and/or 413 provide rapid on-off switching capability. In the example of
FIG. 4, the laser and alignment beams are combined by a turning mirror 415 and a dichroic beamsplitter 416, and then coupled into fiber 420 by coupling optics 417. Of course, many other arrangements of optical components are also suitable for coupling sources 411 and 413 into fiber 420, and can be used to practice the invention,
[0027] Optical fiber 420 is preferably a highly multimode fiber (i.e., number of modes >20) at the wavelength of laser source 413 and at the wavelength of alignment source 411. A highly multimode optical fiber provides a smooth and nearly constant optical intensity distribution at its output, which is desirable for practicing the invention.
[0028] Laser and alignment light emitted from fiber 420 is received by scanner module 430. Within scanner module 430, light emitted from fiber 420 is collimated by coupling optics 431 , and is then deflected by scanning elements 432 and 433. In the example of FIG. 4, scanning elements 432 and 433 each provide 1-D beam deflection, so two such elements are used to provide 2-D beam deflection. Scanning elements 432 and 433 are preferably galvanically or piezoelectrically actuated optical elements suitable for beam deflection, such as mirrors. Of course, other deflection elements and/or actuation methods can also be used to practice the invention. Deflected beams 437 pass through lens 434 and optional contact lens 450 before reaching retina 470 of eye 460. Lens 434 and optional lens 450, in combination with refractive elements of eye 460 such as its cornea and lens, provide a selected alignment and laser beam spot size at retina 470, which is typically in a
range of about 50 to 500 microns for single spot and about 100 to 500 microns for multispot treatments.
[0029] In operation of the embodiment of FIG. 4, scanning elements 432 and 433 and shutters 412 and 414 along with processor 440 (and associated software) are used to define an alignment pattern and a set of treatment locations on retina 470. For example, to create the alignment pattern illustrated on FIG. 2, scanning elements 432 and 433 are driven by processor 440 such that an alignment beam from alignment source 411 defines a pattern having spots 24 and spot 26 on retina 470. Shutter 412 is closed while this beam is moved from spot to spot. The treatment locations illustrated on FIG. 2 are then provided by opening shutter 414 when the alignment beam is aligned with one of spots 24, and closing shutter 414 while the alignment beam is moved from spot to spot, and while the alignment beam is aligned with fixation spot 26,
[0030] An optional retina imager 436 is preferably included in a system according to the invention, to allow the physician to observe the alignment patterns and/or treatment locations on retina 470. In the example of FIG. 4, retina imager 436 is optically coupled to retina 470 via a partially transmissive mirror 435. Partially transmissive mirror 435 is preferably highly reflective at the wavelength of laser source 413, partially reflective and partially transmissive at the wavelength of alignment source 41 1, and transmissive at wavelength(s) of any illumination source that may be present within retina imager 436. Other methods of coupling retina imager 436 to retina 470 while permitting deflected laser and alignment beams 437 to also reach retina 470 can also be used to practice the invention.
[0031] Retina imager 436 can be a biomicroscope or slit lamp, slit lamp adapter or any other instrument for observing the retina. In some cases, the physician will look into an eyepiece of retina imager 436 to observe retina 470. In other cases, retina imager 436 will include a video display of retina 470 to make observation of retina 470 more convenient. In the preferred embodiment where alignment source 411 and laser source 413 have different wavelengths, retina imager 436 will typically include an optical wavelength selective filter at its input to block light having the wavelength of laser source 413 from entering retina imager 436, while permitting light having the wavelength of alignment source 411 to enter retina imager 436. Such a filter is particularly important when observations are performed directly by a physician.
[0032] Many optical elements of the embodiment of FIG. 4 belong to both the alignment subsystem (21 on FIG. 2) and to the laser subsystem (22 on FIG. 2). This commonality between the two subsystems provides co-alignment of the laser and alignment beams. In particular, fiber 420 and scanning elements 432 and 433 arc common to both subsystems. This greatly simplifies the embodiment of FIG. 4 compared to an embodiment where both sources are not coupled into the same fiber, or where deflection of the alignment and laser beams is performed with two separate scanners. The flexibility of the embodiment of FIG. 4 results mainly from having two sources 41 1 and 413 with two independent shutters 412 and 414 respectively. The embodiment of FIG. 4 illustrates a preferred way of aligning the laser treatment locations to the alignment spots, namely coupling both alignment source 411 and laser source 413 into the same optical fiber 420. Other methods of co-aligning alignment subsystem 21 and laser subsystem 22 can also be used to practice the
invention. In related embodiment, apparatus 400 is adaptable for use as a laser indirect ophthalmoscope, for use with endoscopes and for use with OR microscope adapters.
[0033] Referring now more specifically to FIGS. 5-8, the following figures describe various embodiments of improved methods of conducting retinal treatment with apparatus 400 through programming of processor 440. In general, processor 440 is configured to drive alignment source 411 and laser/treatment source 413 in such a manner as to create a novel alignment or shape targets on the patient's retina for subsequent treatment. With respect to FIGS. 5A-5D, there is illustrated first a standard square pattern with all spots visible at once during an alignment step. FIG. 5B illustrates one embodiment of a shape formed by the alignment beam having at least two spots that are continuously moving (location by location) and blinking on and off, both in a random fashion (in terms of timing and location), such that they appears as gaps or blinking spots for a constantly varying alignment configuration or shape or pattern.
[0034] Referring now to FIG. 5C. there is described another embodiment of a square shape or pattern having at least two spots that are continuously moving
(location to location) and blinking, both in a random fashion (in terms of timing and location), such that they appear as gaps or blinking spots for a constantly varying shape with the further enhancement of the "gaps" or blinking spots moving in the direction in which the treatment is being performed. FIG. 5D illustrates yet another embodiment of a square shape having at least two spots that are continuously blinking on and off, both in a random fashion in terms of timing for one and
timing/location for the second spot. The effect is that they appears as gaps or blinking spots for a constantly varying shape with the further enhancement of the second "gap" or blinking spot moving in the direction in which the treatment is being performed, while the first one remains in its first position indicating where the treatment was started. This is an advantage over the prior art in that the doctor/operator in the past could never see the order that he will perform or is performing during the treatment from the alignment target/shape that he is able to see. In FIG. 5D, the first blinking spot or gap indicates the first spot of the treatment and the second moving through the alignment shape indicates the order of the treatment.
[0035] Referring now to FIGS. 6A-6D, there is illustrated first a standard circle pattern with all spots visible at once during an alignment step. FIG. 6B then illustrates one embodiment of the circle shape formed by the alignment beam having at least two spots that are continuously moving (see direction arrows, but it can be counterclockwise as well) and blinking on and off, both in a random fashion (in terms of timing and possibly location), such that they appear as gaps or blinking spots for a constantly varying shape. FIG. 6C illustrates another embodiment of a circle shape formed by the alignment beam having at least two spots that are continuously moving and blinking, both in a random fashion (in terms of timing and location), such thai they appear as gaps or blinking spots for a constantly varying shape with the further enhancement of the "gaps" or blinking spots moving in the direction in which the treatment is being performed.
[0036] Referring now to FIG. 6D. there is illustrated yet another embodiment of a circle shape formed by the alignment beam having at least two spots that are continuously moving (in the direction of arrows) blinking on and off, both in a random fashion in terms of timing for one and timing/location for the second spot. The effect is that they appear as gaps or blinking spots for a constantly varying shape with the further enhancement of the second "gap" or blinking spot moving in the direction in which the treatment is being performed, while the first one remains in its first position indicating where the treatment was started. This is an advantage of the prior art in that the doctor/operator in the past could not see the order in which he will perform or is performing during the treatment from the alignment target/shape that he is able to see. In FIG. 6D, the first blinking spot or gap indicates the first spot of the treatment and the second moving through, the alignment shape indicates the order of the treatment.
[0037] With respect to FIGS. 7A-7D, there is illustrated first a standard triple arc pattern with all spots visible at once during an alignment step. In one example embodiment, (not illustrated) outlines and solid shapes of alignment shapes can be configured from apparatus 400, wherein treatments can be performed at the perimeter spots according to the invention. In an example embodiment. FIG. 7B illustrates a triple arc shape formed by the alignment beam having at least two spots that are continuously moving and blinking on and off, both in a random fashion, such that they appear as gaps or blinking spots for a constantly varying shape. In a related embodiment, FIG. 7C illustrates a triple arc shape having at least two spots that are continuously moving and blinking, both in a random fashion (in terms of timing and location), such that they appear as gaps or blinking spots for a constantly
varying shape with the further enhancement of the "gaps" or blinking spots moving in the direction in which the treatment is being performed.
[0038] Referring now to FIG. 7D, there is illustrated yet another embodiment of a triple arc shape having at least two spots that are continuously moving (in the direction of the arrows, but not limited to such) blinking on and off, both in a random fashion in terms of timing for one and timing/location for the second spot. The effect is that they appear as gaps or blinking spots for a constantly varying shape with the further enhancement of the second "gap" or blinking spot moving in the direction in which the treatment is being performed, while the first one remains in its first position indicating where the treatment was started. This is another advantage of the prior art in that the doctor/operator in the past could not see the order that he will perform or is performing during the treatment from the alignment target/shape that he is able to see. In FIG. 7D, the first blinking spot or gap indicates the first spot of the treatment and the second moving through the alignment shape indicates the order of the treatment.
[0039] Referring now to FIGS. 8A-8C and 9A-9C, in these other related embodiments of the invention, 2 or 3 spots move continuously and randomly throughout the alignment shape (3 x3 square or circle, respectively), thereby tracing and exhibiting ever-changing shapes in which all of the alignment spots are not visible all at one time to the operator. The operator understands that the treatment beam will be co-linear with spots he generally sees on the retina. FIGS, 8 A and 9A illustrate typical square and circle configurations formed by alignment beam where all of the spots are visible at one time. In FIG. 8B, a center spot is fixed and
blinking while the surround spots may be randomly blinking and moving. In FIG. 8C. a blinking spot is moving from location to location and can move about the outside to outline the square shape. FIG. 9B illustrates a circle shape wherein one spot is on and two are blinking and are fixed or can move around the circle in either direction as illustrated in FIG. 9C.
[0040] Referring now to FIGS. 1 OA- 1 OH, there is illustrated an intelligent function of the aiming beam according to the teachings herein. In this example embodiment, the aiming beam is generated by a red laser diode having a wavelength in the range of about 635 to about 650nm. In particular, starting at FIG. 10A a first spot of the pattern (drawn by the aiming beam) stays illustrated or on. This one shows the spot by which the treatment pattern will start. The other spots are displayed in sequence in which each of them disappears and appears again successively following the treatment pattern execution or delivery process. In this example embodiment, the alignment pattern changes constantly and progressively as the treatment progresses. For the physician or operator, they are provided with an advanced notice of how the treatment will proceed before the treatment is actually actuated or given to the patient, thereby allowing for adjustments before the laser treatment is delivered. In related embodiments, the intelligent aiming beam function is also used with each type of pattern (square, circle, triple arc, etc..) and permits the user to choose where within the treatment pattern he desires to commence the treatment and the sequence that he wants follow (for example he can chose to begin by a right lower spot and/or do the sequences in the other direction ).
[0041] Referring now to FIG. 11 , there is illustrated an additional function to the retinal treatment system that is reflected as an icon on the touch screen as "Resume", the Resume function which when activated allows the user to continue or resume the treatment on a previously chosen alignment and treatment pattern when the current procedure is interrupted. The treated spots are displayed on the screen in red. A canceling tab is displayed at the right-hand of a pattern display. In order to activate, the user presses the "Resume" function button until it highlights in white (about 1 second). For actual use, after the release of the footswitch, the user can finish the pattern by pressing the footswitch again. He can cancel the pattern resume by pressing the canceling tab and perform or treat with a new pattern. The embodiment describe herein differs from prior art retinal treatment systems in that more information is provided to the physician to allow him to finish the treatment within a pattern should he be interrupted or the laser stops for any reason during treatment when he is within the selected pattern. The Resume function permits this resumption of treatment without injuring the patient and assuring the physician that he is not going to inadvertently rc-treat the same area. The Resume function is particularly useful where micropulsc (^pulse) bursts are used in the retinal treatment due to the fact that the operator may not be able to see the location where the laser treatment has already been made or applied on the retinal tissue and now with the Resume function he can finish the treatment pattern (by starting at a non-treated spot next to a previously treated spot in the treatment pattern).
[0042] Referring again to FIGs. 10 and 1 1 , the aiming beam spot is fixed or located initially on the first point of treatment and therefore the doctor is aware of where the treatment will start. In one example embodiment, the doctor can choose
where to start treatment on a chosen pattern. All the other aiming beam points or spots on the image (or figure) showing the pattern blink one by one, sequentially, to indicate the sequence of the actual treatment pattern. With this knowledge the doctor will know the actual treatment sequence and can stop inside this sequence if he so desires. If the doctor stops a treatment in a particular point within a selected treatment pattern, he can finish the treatment pattern using the Resume function. In a similar way, the doctor is given notice that he is at the end of the pattern as the aiming beam shows first point or spot and the sequence with which to finish the preselected pattern.
[0043] In yet another related embodiment, various laser systems described above the alignment pattern is displayed on a video screen for the doctor but he only sees one target spot or fixation point on the retina. The same target point is also highlighted or blinking in the center of the alignment pattern on the video screen so that the doctor knows that once he triggers the laser beam at the target point on the retina, then the entire selected pattern will correspondingly be treated on the retina. In this manner the doctor knows where the treatment will be applied and what pattern will be used without the need for showing a visible alignment pattern on the retina. In a related embodiment, a contour of the figure of the pattern (such as a square, circle or arc) is formed and then it is located or highlighted as only one spot on the center of the contour. In this example, the contour is formed using a 50μηι spot and changing the spot size and showing the center spot with a larger spot of 200 μηι. On other lasers, the zoom lens is not motorized, hence the contour can use similarly sized spots. Alternatively, the center spot and the contour line flash or blink (alternatively) providing the doctor with knowledge of the treatment pattern
without a full alignment pattern being displayed on the retina. The center and edge of the treatment area are generally visible to the physician in this example. These approaches can be used in related applications where diagnosis tools are used to display figures, shapes and patterns that are larger than those generated by normal ophthalmologic lasers and where the zoom on the lens can be changed as well as the spot size.
[0044] In a related embodiment, processor 440 is configured to provide each pattern screen a dedicated parameter icon that allows the user to rotate or to resize each of the patterns (extend/reduce the patterns; extend/reduce the radius of rounded shape patterns; etc.). To be adjusted, the icon (used to extend/reduce a pattern - extend/reduce the radius of a rounded shape pattern) is selected and then adjusted with the touch screen controller or a selector button on the system.
[0045] While the invention has been described above in terms of various specific embodiments, it is to be understood that the invention is not limited to these disclosed embodiments. Upon reading the teachings of this disclosure many modifications and other embodiments of the invention will come to mind and those skilled in the art to which this invention pertains, and which are intended to be and are covered by both this disclosure and the appended claims, it is indeed intended that the scope of the invention should be determined by proper interpretation as understood by those of skill in the art relying upon the disclosure in this specification and the attached drawings. The various embodiments of the describe device can also be used on the wall as well.
Claims
1 , A system for laser treatment of the retina of an eye of a patient, the system comprising: an alignment source producing an alignment beam; a treatment source producing a treatment beam; one or more scanning elements configured to direct the alignment beam and treatment beam to various positions on a retina of a patient; and a processor operatively coupled to the one or more scanning elements, the processor configured to controllably shutter the alignment and treatment beams and operate the one or more scanning elements to: project an alignment shape comprising a phirality of separate alignment spots onto said retina produced by the alignment beam and scanning elements, the spots of the alignment shape configured such that the alignment shape has therein continuously moving and randomly appearing spot gaps; and deliver, responsive to an input from an operator and within a time period of about one second, at least one dose of laser energy to at least one separate treatment spot at a location which is substantially co-located with at least one of the separate alignment spots, wherein the at least one of the spot gaps provides feedback to the operator on the order of treatment performed.
2. The system of claim 1, wherein one of the spot gaps indicates a first treatment spot and a second spot gap indicates an order of treatment performed.
3. The system of claim 1, wherein the treatment beam has a substantially non- visible wavelength.
4. The system of claim 1, further comprising a multimode optical fiber configured to guide the alignment beam and treatment beam to the one or more scanning elements.
5. The system of claim 1, further comprising a retina imager configured to observe the retina.
6. The system of claim 5, wherein the retina imager comprises a biomicroscope, a slit lamp, a video display, or an optical image inverter.
7. The system of claim 5, further comprising a database configured to record observations obtained from said retina imager.
8. The system of claim 1, wherein the alignment shape is initially selected from the group consisting of a quadrant pattern, a circular pattern, an elliptical pattern, a donut pattern, a rectangular pattern, an arc pattern, an annular arc pattern, a line pattern and a user-defined pattern.
9. The system of claim 1 wherein the processor of the laser treatment system is configured to provide a laser treatment resumption function to a user within a selected treatment pattern.
10. The system of claim 9 wherein the laser treatment resumption function visually indicates to a user on an alignment pattern a spot location from which the treatment will resume.
11. The system of claim 9 wherein the laser treatment resumption function visually indicates to a user on an alignment pattern the spots on the alignment pattern that have been treated.
12. The system of claim 9 wherein the laser treatment resumption function visually indicates to a user of a micropulse procedure spots on the retina tissue that have been treated.
13. The system of claim 1 wherein the processor is adapted to adjust the size of the alignment shape.
14. The system of claim 1 wherein the processor is adapted to adjust the alignment shape such that a center spot and a contour of the alignment shape alternatively flash on a retina.
15. The system of claim 1 wherein the processor is adapted to display the alignment shape on a visual display for the operator and wherein the processor is further adapted to display a spot on a retina corresponding to a center spot on the displayed alignment shape.
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| US201261706404P | 2012-09-27 | 2012-09-27 | |
| US61/706,404 | 2012-09-27 |
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| WO2014049132A1 true WO2014049132A1 (en) | 2014-04-03 |
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|---|---|---|---|
| PCT/EP2013/070230 Ceased WO2014049132A1 (en) | 2012-09-27 | 2013-09-27 | Laser system for retinal treatment of macular degeneration |
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| JP2018171395A (en) * | 2017-03-31 | 2018-11-08 | 株式会社ニデック | Ophthalmic laser treatment apparatus |
| CN109414346A (en) * | 2016-04-08 | 2019-03-01 | 卡尔蔡司医疗技术股份公司 | Method for minimally invasive, cell-selective laser therapy at the eye |
| DE102018205179A1 (en) | 2018-04-06 | 2019-10-10 | Carl Zeiss Meditec Ag | Device and method for previewing a spot pattern to be applied for a laser therapy on the eye |
| CN112601499A (en) * | 2018-08-31 | 2021-04-02 | 艾瑞黛克斯公司 | Method and system for laser treatment of large-spot retina |
| EP4299043A1 (en) * | 2022-06-28 | 2024-01-03 | NORLASE ApS | Apparatus for ophthalmic treatment |
| US12376994B2 (en) | 2018-03-22 | 2025-08-05 | Norlase Aps | Body mounted laser indirect ophthalmoscope (LIO) system |
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| WO2015170947A1 (en) * | 2014-05-09 | 2015-11-12 | (주)루트로닉 | Ophthalmic treatment device |
| US10470843B2 (en) | 2014-12-05 | 2019-11-12 | Convergent Dental, Inc. | Systems and methods for alignment of a laser beam |
| US9980789B2 (en) | 2014-12-05 | 2018-05-29 | Convergent Dental, Inc. | System and methods for alignment of a laser beam |
| CN109414346A (en) * | 2016-04-08 | 2019-03-01 | 卡尔蔡司医疗技术股份公司 | Method for minimally invasive, cell-selective laser therapy at the eye |
| CN109414346B (en) * | 2016-04-08 | 2021-05-28 | 卡尔蔡司医疗技术股份公司 | Laser system for minimally invasive, cell-selective laser therapy in the eye |
| JP2018171395A (en) * | 2017-03-31 | 2018-11-08 | 株式会社ニデック | Ophthalmic laser treatment apparatus |
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| WO2019193077A1 (en) | 2018-04-06 | 2019-10-10 | Carl Zeiss Meditec Ag | Device and method for the pre-display of a spot pattern to be applied for a laser treatment of the eye |
| DE102018205179A1 (en) | 2018-04-06 | 2019-10-10 | Carl Zeiss Meditec Ag | Device and method for previewing a spot pattern to be applied for a laser therapy on the eye |
| US11951042B2 (en) | 2018-04-06 | 2024-04-09 | Carl Zeiss Meditec Ag | Device and method for the pre-display of a spot pattern to be applied for a laser treatment of the eye |
| CN112601499A (en) * | 2018-08-31 | 2021-04-02 | 艾瑞黛克斯公司 | Method and system for laser treatment of large-spot retina |
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| EP4299043A1 (en) * | 2022-06-28 | 2024-01-03 | NORLASE ApS | Apparatus for ophthalmic treatment |
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