Intraocular cyclophotocoagulation device and method of use

Abstract

An intraocular cyclophotocoagulation device having a proximal reusable portion and a distal disposable portion. The reusable portion includes a laser treatment assembly having a laser diode and a collimating lens disposed a distal distance from the laser diode and configured to collimate light from the laser diode into a collimated laser beam and direct the collimated laser beam toward a distal end region of the proximal housing portion, and an imaging assembly. The disposable portion includes a laser guide extending through the elongate shaft, an aspheric lens disposed within the distal housing portion to receive the collimated laser beam from the proximal reusable portion and direct the collimated laser beam toward a proximal end of an optical fiber of the laser guide, an illumination light guide, and an illumination source disposed within the distal housing portion. Related devices, systems, and methods are provided.

Description

[Technical field]

[0001] This application claims the benefit of priority under 35 U.S.C. Section 119(e) to co-pending U.S. Provisional Patent Application Serial No. 63 / 264,703, filed November 30, 2021, the disclosure of which is incorporated by reference in its entirety. [Background technology]

[0002] Glaucoma is a complex disease that causes progressive vision loss through damage to the optic nerve and is the leading cause of irreversible blindness. Aqueous humor is the fluid that fills the anterior chamber in front of the iris and the posterior chamber of the eyeball behind the iris. The vitreous humor, or vitreous humor, is a gel-like substance in the posterior portion of the eyeball behind the capsular bag. Figure 1 is a diagram of the front portion of the eyeball 5 showing the lens 7, cornea 8, iris 9, ciliary body 6 with its ciliary processes 4, trabecular meshwork 10, and Schlemm's canal 12. Aqueous humor is a fluid produced by the ciliary body 6 behind the iris 9 adjacent to the lens 7. This aqueous humor flows over the lens 7 and iris 9 into a drainage system at the angle of the anterior chamber. The angle of the anterior chamber extends around the circumference of the eyeball and contains structures through which the aqueous humor drains.

[0003] A portion of the aqueous humor is absorbed through the trabecular meshwork 10 into Schlemm's canal 12, enters the collector channel, and passes through the sclera 15 into the episcleral venous circulation. The trabecular meshwork 10 extends circumferentially around the anterior chamber 16 in the angle. The trabecular meshwork 10 restricts the outflow of the aqueous humor. Schlemm's canal 12 is located beyond the trabecular meshwork 10. The two arrows in the anterior chamber 16 of FIG. 1 indicate the flow of aqueous humor from the ciliary body 6, over the lens 7, over the iris 9, through the trabecular meshwork 10, and into Schlemm's canal 12 and its collector channel.

[0004] In some cases, glaucoma is caused by obstruction to the outflow of aqueous humor, such as a hardening of the trabecular meshwork, pigment, or membrane at the angle. In other cases, the blockage occurs due to a closure of the angle between the iris and the cornea. This angle type of glaucoma is called "angle-closure glaucoma." However, the cause of the majority of glaucoma, called "open-angle glaucoma," is unknown.

[0005] Treatment of glaucoma attempts to lower intraocular pressure pharmacologically or through surgical interventions that promote the outflow of aqueous humor through the outflow pathway. Ab interno trabeculectomy is a type of glaucoma surgery that creates a new pathway for the fluid in the eye to drain out as a "controlled" leak. Traditionally, a partial thickness scleral flap is created, followed by a small hole in the anterior chamber. Aqueous humor can drain into the subconjunctival space and cause filtration bleeding. The scleral flap is elevated and a blade is used to enter the anterior chamber. During surgery, a hole is created under the scleral flap that is in fluid communication with the anterior chamber, creating an opening. The opening is partially covered by the scleral flap. Small conjunctival "bleeps" or bubbles often appear above the scleral flap near the junction of the cornea and sclera (limbus).

[0006] Minimally invasive surgery reduces intraocular pressure by enhancing the eye's natural drainage pathways while minimizing tissue damage. Minimally invasive glaucoma surgery (MIGS) uses microscopic instruments and small incisions. MIGS is an alternative to traditional glaucoma surgery and has the potential benefit of reducing patients' reliance on topical glaucoma medications. Trabeculectomy and trabeculectomy can each be performed ab interno, i.e., from inside the anterior chamber. The ab interno technique aims to reduce intraocular pressure by increasing the outflow of aqueous humor from inside the anterior chamber through a direct opening in the trabecular meshwork, so that the anterior chamber communicates directly with the outer wall of Schlemm's canal. Ab interno techniques include the TRABECTOME (MST / NeoMedix Corp.) to cut and remove the trabecular meshwork, the Kahook Dual Blade (New World Medical) for lintellectomy to remove a strip of trabecular meshwork, the gonioscopy-assisted transluminal trabeculotomy (GATT) to incise the trabecular meshwork and cannulate Schlemm's canal, and the Omni (Sight Sciences) ab interno technique for cannulation of Schlemm's canal for entorhinoplasty and trabeculotomy. Other ab interno techniques include the iStent (Glaukos), which creates a passageway in the trabecular meshwork to improve aqueous humor outflow from Schlemm's canal.

[0007] Cyclodestructive therapy is also known. Endoscopic cyclophotocoagulation uses a laser to coagulate and shrink the ciliary body, reducing aqueous humor production in the eye and lowering intraocular pressure.

[0008] Laser video endoscopes used in circulatory destructive therapy are endoscopes that are typically reused after autoclaving or other sterilization methods. Repeated sterilization tends to damage the optical elements of the endoscope over time. However, endoscope components are generally too expensive to manufacture and can't be discarded after a single use. In addition, endoscopic systems are bulky, complex, have poor resolution and visibility, and have imprecise laser light aiming, which can lead to inadvertent tissue damage.

[0009] In view of the above, there is a need for improved devices and methods relating to ophthalmic surgery for the treatment of glaucoma. Summary of the Invention

[0010] In one aspect, an intraocular cyclophotocoagulation device is described, the device including a proximal reusable portion having a proximal housing portion having a distal end region, a laser treatment assembly having a laser diode and a collimating lens disposed distally at a distance from the laser diode, the laser treatment assembly configured to collimate light from the laser diode into a collimated laser beam and direct the collimated laser beam towards the distal end region of the proximal housing portion, and an imaging assembly. The device includes a distal disposable portion having an elongated shaft extending distally from a distal end region of the distal housing portion, the distal housing portion having a proximal end region configured to reversibly couple with the distal end region of the proximal housing portion, a laser guide extending through the elongated shaft, an aspheric lens disposed within the distal housing portion to receive a collimated laser beam from the proximal reusable portion and direct the collimated laser beam toward a proximal end of an optical fiber of the laser guide, an imaging guide extending through the elongated shaft, an objective lens disposed at the distal end region of the elongated shaft and positioned to focus an image onto the distal end of the optical fiber of the imaging guide, an illumination light guide extending through the elongated shaft, and an illumination source disposed within the distal housing portion and positioned relative to the proximal end of the optical fiber of the illumination light guide.

[0011] The laser diode of the laser treatment assembly can emit at a near infrared wavelength configured to burn tissue. The collimated laser beam can remain unchanged with minimal divergence or convergence as it traverses the junction from the reusable to the disposable portion. The aspheric lens can correct spherical aberration and provide both paraxial and marginal focus to ensure that all of the light of the collimated laser beam enters the proximal end of the laser guide optical fiber. The diameter of the laser guide optical fiber can be about 200 microns and the collimated laser beam can have a focused spot of about 100 microns. The objective lens is monolithic and apertureless. The objective lens can have a frustoconical configuration with a small diameter entrance face and a largest diameter exit face, the exit face being located proximate to the entrance face near the distal end of the imaging guide optical fiber. The objective lens can have an hourglass configuration with an entrance face, an exit face and a neck between the entrance face and the exit face. The diameter of the neck can be smaller than the diameter of the entrance face and the diameter of the exit face. The focal depth of the objective lens may be 1-6 mm. The proximal end of the optical fiber of the illumination light guide may be affixed on or near the light emitting die of the illumination source. The optical fiber of the illumination light guide may be potted into a recess in the illumination source. The recess may have a curved bottom and, together with the optical adhesive in the recess, may form a focusing lens between the optical fiber of the illumination light guide and the light emitting die of the illumination source.

[0012] The device may further include an actuator that is a slider configured to increase an intensity of the emitted laser light. The slider may be disposed in the disposable portion. The elongate shaft may be curved. The device may provide a field of view of 45 to 150 degrees. The distal end region of the proximal housing portion may be tapered and sized to be received within a correspondingly shaped region in the proximal end region of the distal housing portion. The distal end region of the proximal housing portion and the proximal end region of the distal housing portion may be spring-loaded together.

[0013] The device may further include a fluid channel extending within the disposable portion. The fluid channel may extend through the elongate shaft. The fluid channel is configured to deliver a chilled liquid to the eye. The chilled liquid may be water or saline. The fluid channel is configured to deliver a therapeutic agent.

[0014] In related embodiments, an intraocular cyclophotocoagulation device is provided having a proximal reusable portion and a distal disposable portion, the reusable portion including a proximal housing portion having a distal end region, a laser treatment assembly having a laser diode and a collimating lens disposed a distal distance from the laser diode and configured to collimate light from the laser diode into a collimated laser beam and direct the collimated laser beam toward the distal end region of the proximal housing portion, and an imaging assembly. The distal disposable portion includes a distal housing portion having an elongated shaft extending distally from a distal end region of the distal housing portion, the distal housing portion having a proximal end region configured to reversibly couple with the distal end region of the proximal housing portion, a laser guide extending through the elongated shaft, an aspheric lens disposed within the distal housing portion to receive a collimated laser beam from the proximal reusable portion and direct the collimated laser beam to a proximal end of the optical fiber of the laser guide, an imaging guide extending through the elongated shaft, a monolithic objective lens without an aperture disposed at the distal end region of the elongated shaft, the objective lens positioned to focus an image on the distal end of the optical fiber of the imaging guide, and an illumination light guide extending through the elongated shaft and transmitting light from an illumination source to illuminate the interior of the eye.

[0015] The laser diode of the laser treatment assembly can emit a near infrared wavelength configured to burn tissue. The collimated laser beam can remain constant with minimal divergence or convergence as it traverses the junction from the reusable to the disposable portion. The aspheric lens can correct for spherical aberration and provide both paraxial and marginal focus such that all of the light of the collimated laser beam enters the proximal end of the laser guide optical fiber. The diameter of the laser guide optical fiber can be about 200 microns and the collimated laser beam can have a focused spot of about 100 microns. The objective lens can have a frustoconical configuration with a small diameter entrance face and a largest diameter exit face, the exit face being located proximate to the entrance face near the distal end of the imaging guide optical fiber. The objective lens can have an hourglass configuration with an entrance face, an exit face and a neck between the entrance face and the exit face. The diameter of the neck can be smaller than the diameter of the entrance face and the diameter of the exit face. The depth of focus of the objective lens can be 1-6 mm. The illumination light guide may include an optical fiber and the illumination source may include a light emitting die. A proximal end of the optical fiber of the illumination light guide may be affixed on or near the light emitting die of the illumination source. The optical fiber of the illumination light guide may be potted into a recess in the illumination source. The recess may have a curved bottom and, together with the optical adhesive in the recess, may form a focusing lens between the optical fiber of the illumination light guide and the light emitting die of the illumination source.

[0016] The device may further include an actuator that is a slider configured to increase an intensity of the emitted laser light. The elongate shaft may be curved. The device may provide a field of view of 45 to 150 degrees. The distal end region of the proximal housing portion may be tapered and sized to be received within a correspondingly shaped region in the proximal end region of the distal housing portion. The distal end region of the proximal housing portion and the proximal end region of the distal housing portion may be spring-loaded together.

[0017] The device may further include a fluid channel extending within the disposable portion. The fluid channel may extend through the elongate shaft. The fluid channel is configured to deliver a chilled liquid to the eye. The chilled liquid may be water or saline. The fluid channel is configured to deliver a therapeutic agent.

[0018] In a related embodiment, an intraocular cyclophotocoagulation device is provided having a proximal reusable portion having a proximal housing portion having a distal end region, and an imaging assembly having an image sensor and a lens element. The device includes a distal disposable portion having an elongate shaft extending distally from the distal end region of the distal housing portion, the distal housing portion having a proximal end region configured to reversibly couple with the distal end region of the proximal housing portion, an imaging guide extending through the elongate shaft, an objective lens located at the distal end region of the elongate shaft distal from the distal end of the imaging guide, the objective lens positioned to image onto the distal end of the imaging guide, an illumination light guide extending through the elongate shaft, an illumination source positioned within the distal housing portion opposite the proximal end of the illumination light guide, and a laser treatment assembly. The laser treatment assembly includes a laser guide having a laser optical fiber extending through an elongated shaft having a proximal end and a distal end, a laser diode emitter disposed proximal to the proximal end of the laser optical fiber and having a base coupled to an annular casing, the casing having an inner diameter, and a ball lens supported in the annular casing and configured to direct a collimated laser beam from the emitter to the proximal end of the laser guide.

[0019] In a related aspect, a method is provided for treating glaucoma in an eye using a portable intraocular device, the method including penetrating the eye with an elongated shaft of the portable intraocular device to access the ciliary processes, delivering laser energy through the elongated shaft to the ciliary processes to effect photocoagulation, and delivering a chilled liquid to the eye during delivery of the laser energy.

[0020] The elongate shaft may be coupled to a disposable portion of the portable intraocular device, the disposable portion being releasably coupled to the reusable portion of the portable intraocular device. Providing the laser energy may include providing laser energy from an 810 nm laser diode. The laser diode may be disposed within the reusable portion and transmitted through an interface between the reusable portion and the disposable portion toward a laser guide in the disposable portion. The laser diode may be disposed within the disposable portion. Providing the laser energy may include providing the laser energy at a distance from the ciliary processes. The distance may be 1-3 mm away from the ciliary processes. The method may further include repeatedly providing the laser energy to a plurality of ciliary processes along at least 270 degrees to 360 degrees of the eye. The method may further include imaging the ciliary processes with an imaging assembly and transmitting the image to an external monitor. The imaging assembly may transmit the image wirelessly. The imaging assembly may include an image sensor and a single lens element each housed in the reusable portion. The single lens element may be a Steinheil triplet.

[0021] The disposable portion may include an illumination source having an LED coupled to an optical fiber of the illumination light guide. The LED may be a white light LED. The disposable portion may further include one or more additional LEDs. The one or more additional LEDs may emit red, near infrared, blue, green, ultraviolet, or near ultraviolet light.

[0022] The chilled liquid may be delivered through a fluid channel extending within the disposable portion. The fluid channel may extend through the elongate shaft. The chilled liquid may be water or saline. The fluid channel may be configured to deliver a therapeutic agent.

[0023] In related aspects, an intraocular cyclophotocoagulation device is provided having a proximal reusable portion and a distal disposable portion, the reusable portion including a proximal housing portion having a distal end region, a laser treatment assembly having a laser diode and configured to direct a collimated laser beam toward the distal end region of the proximal housing portion, and an imaging assembly. The distal disposable portion includes a distal housing portion having an elongated shaft extending distally from a distal end region of the distal housing portion and having a proximal end region configured to reversibly couple with the distal end region of the proximal housing portion, a laser guide extending through the elongated shaft, an aspheric lens disposed within the distal housing portion to receive a collimated laser beam from the proximal reusable portion and direct the collimated laser beam toward a proximal end of the optical fiber of the laser guide, an imaging guide extending through the elongated shaft, an aspheric lens located at the distal end region of the elongated shaft and positioned to focus an image onto the distal end of the optical fiber of the imaging guide, and an illumination light guide extending through the elongated shaft.

[0024] In a related aspect, an endoscopic intraocular treatment device is provided having a proximal reusable portion having a proximal housing portion having a distal end region and a distal disposable portion having a distal housing portion having an elongate shaft extending distally from the distal end region of the distal housing portion. The distal housing portion has a proximal end region configured to reversibly couple with the distal end region of the proximal housing portion. A frustum lens is disposed within the distal end region of the elongate shaft. The device may further include an imaging channel extending within the elongate shaft configured to transmit light from the frustum lens. The device may further include one or both of an illumination channel and a laser treatment channel extending within the elongate shaft.

[0025] In a related aspect, a method of treating glaucoma using an endoscopic device having an elongated shaft is provided that includes delivering cold water ab interno through the elongated shaft while applying laser energy through the elongated shaft to the ciliary body of the eye.

[0026] In some variations, one or more of the following may be optionally included in the above methods, apparatus, devices, and systems in any feasible combination, as described in detail in the accompanying drawings and the following description. Other features and advantages will be apparent from the description and drawings.

[0027] These and other aspects are described in detail below with reference to the following figures, in which: Figures generally are not to scale, either absolutely or relatively, and are intended as illustrative examples, and the relative placement of features and elements may be altered for clarity of illustration. [Brief description of the drawings]

[0028] [Figure 1] 1 is a diagram of the anterior portion of the eye. [Figure 2A] FIG. 1 is a block diagram showing an embodiment of a portable cyclophotocoagulation device. [Figure 2B] FIG. 2B is a block diagram illustrating the device of FIG. 2A showing additional components in the reusable portion. [Figure 2C] FIG. 11 is a block diagram showing another embodiment of a device. [Figure 3A] FIG. 1 is a schematic perspective view of a portable cyclophotocoagulation device. [Figure 3B] FIG. 3B is a schematic cross-sectional view of the device of FIG. 3A. [Figure 3C] FIG. 3B is a schematic distal end view of the distal tip portion of the device of FIG. 3A. [Figure 4A] FIG. 1 is a perspective view of an embodiment of a portable cyclophotocoagulation device. [Figure 4B] FIG. 4B is a cross-sectional view of the device of FIG. 4A taken along line BB. [Figure 4C]FIG. 1 is a perspective distal end view of the device with the disposable and reusable portions separated. [Figure 4D] FIG. 4D is a perspective proximal end view of the device of FIG. 4C. [Figure 5A] FIG. 4B is a side view of the device of FIG. 4A. [Figure 5B] 5B is a diagram showing a portion of the device of FIG. 5A. [Figure 5C] FIG. 5B is a distal end view of the probe of FIG. 5A. [Figure 6A] FIG. 1 is a schematic diagram illustrating an objective lens having an hourglass configuration for use with a cyclophotocoagulator showing a coaxial light source. [Figure 6B] FIG. 6B is a schematic diagram of the objective lens of FIG. 6A showing an off-axis light source. [Figure 7A] FIG. 13 is a schematic diagram illustrating an objective lens having a capsule-shaped configuration for use with a cyclophotocoagulator showing a coaxial light source. [Figure 7B] FIG. 7B is a schematic diagram showing the objective lens of FIG. 7A showing an off-axis light source. [Figure 7C] FIG. 7B is another schematic diagram of the objective lens of FIG. 7A. [Figure 8A] FIG. 2 is a schematic diagram showing a high numerical aperture optical fiber positioned relative to an LED illumination source. [Figure 8B] FIG. 2 is a schematic diagram showing a low numerical aperture optical fiber positioned relative to an LED illumination source. [Figure 9A] An LED illumination source and optical fiber for alignment within the disposable portion of the device. [Figure 9B] 9B is an embodiment of the LED illumination source and optical fiber of FIG. 9A positioned relative to a spherical cavity filled with optical adhesive forming a focusing lens. [Figure 9C] 9B is an embodiment of the LED illumination source and optical fiber of FIG. 9A positioned relative to a spherical ball lens. [Figure 10A] 1 shows an optical chain between disposable and reusable parts. [Figure 10B] 1 shows an optical chain in the event of axial misalignment. [Figure 11] 1 shows a laser treatment assembly housed within the disposable part. [Figure 12A] FIG. 1 is a schematic diagram of a short optical path of an imaging assembly showing a single lens element for transmitting an image of an optical fiber onto a subset of imaging pixels. [Figure 12B] FIG. 1 is a schematic diagram showing the pixel ratio of a fiber optic relay for significant oversampling. [Figure 13A] 1 shows an adjustment mechanism for changing the focus of the objective lens. [Figure 13B] 1 shows an adjustment mechanism for changing the focus of the objective lens. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] It will be appreciated that the figures are for illustrative purposes only and are not intended to be drawn to scale, and it will be understood that features of the devices described herein may not necessarily be shown in every drawing.

[0030] A fully handheld endoscopic photocoagulation (ECP) device for reducing aqueous humor production for the purpose of controlling intraocular pressure (IOP) is disclosed. More specifically, as described in more detail below, the device described herein has a reusable portion coupled to a disposable portion. The reusable portion includes elements such as an imaging unit, a therapeutic laser diode, and a microprocessor housed within a handle that has a small form factor for ergonomic use and remains outside the eye. The therapeutic laser diode irradiates at a near infrared wavelength (810 nm) and photocoagulates (e.g., burns and shrinks) the ciliary body to reduce aqueous humor production in the anterior chamber. The reusable portion reversibly couples with the disposable portion of the handle. The disposable portion includes a distal shaft sized for insertion into the eye (e.g., the anterior chamber and / or the posterior chamber between the iris and the capsular bag). The distal shaft includes channels for illumination, imaging, and laser treatment. The disposable portion also includes an illumination source. The design of the illumination source significantly reduces the overall cost and allows it to be housed in the disposable portion and discarded after a single use on one patient. Similarly, the objective lens of the imaging channel of the disposable part is cheap and easy to manufacture, thus reducing the cost of the disposable part, but does not affect the optics achieved. Furthermore, the disposable part, when connected to the reusable part, contains optics that maximize the efficiency of the transmission of collimated laser light from the treatment laser diode to the treatment channel, even if there is misalignment between the disposable and reusable parts when attached.

[0031] Use of the terms "handpiece," "handheld," or "handle" herein need not be limited to the surgeon's hand, but may include a handpiece coupled to a robotic arm or system, or other computer assisted surgical system, in which a user manipulates instrument controls using a computer console. The computer translates the user's movements and actuation of the controls to be performed on the patient by the robotic arm.

[0032] FIG. 2A is a block diagram illustrating an embodiment of a portable cyclophotocoagulation device 100 including a distal disposable portion 105 configured to releasably couple to a proximal reusable portion 110 via a coupling mechanism 101. The disposable portion 105 generally includes the components of the device configured to contact the patient, including a distal elongated probe shaft 103 configured for insertion into the eye. The distal elongated probe shaft 103 of the disposable portion 105 encloses guides, which may be fiber optic bundles or single optical fibers, including a light guide / lens 102, an image guide / lens 104, and a laser guide / lens 106. The reusable portion 110 generally includes the components of the device 100 configured to remain external to the patient, such as a laser generator and a video camera. Although the reusable portions can be resterilized and reused, the disposable portion 105 is manufactured from less expensive materials, making it economically practical to discard it after a single use.

[0033] The reusable part 110 includes one or more components that control the operation of the device 100, including one or more of the illumination assembly 120, the imaging assembly 125, the laser therapy assembly 130, and / or the optional focusing mechanism 133 and collimating lens 134. The arrangement of components between the two parts 105, 110 may be different. For example, FIG. 2B is a block diagram of an embodiment of the device 100 having the illumination source 122 of the illumination assembly 120 in the disposable part 105. FIG. 2C is a block diagram of another embodiment of the device 100 having the illumination source 122 of the illumination assembly 120 in the reusable part 110. The illumination source 122 as well as the laser therapy assembly 130, including both the laser diode 132 and the focusing lens, can be arranged in the disposable part 105 to avoid the laser light and the illumination light crossing the junction between the two housing parts. This is described in more detail below with respect to FIG. 11. Regardless of the arrangement, the coupling mechanism 101 between the disposable portion 105 and the reusable portion 110 minimizes losses in the transmission of visible and laser light between the distal end of the disposable portion 105 and the reusable portion 110. A system having three channels is described herein: laser, imaging, and illumination. It is also possible to combine two of the three channels into one channel for a total of two channels. For example, the laser guide / lens 106 and imaging guide / lens 104 could be combined into one channel, and the light guide / lens 102 could be another channel in the system.

[0034] Each component will be described in detail below.

[0035] Although described in the context of cyclophotocoagulation using 810 nm wavelength laser energy, the device 100 can be used for a variety of medical laser treatments. The device can also incorporate one or more light sources of any of a variety of wavelengths in the disposable and / or reusable portion to perform other treatments. For example, one or more LEDs or laser diodes and corresponding optical fibers can be incorporated in the disposable portion to perform photobiomodulation including red (600-700 nm), near infrared (770-1200 nm), blue, green, ultraviolet or near ultraviolet, or other colors.

[0036] Reusable parts As described above, the reusable portion 110 includes components such as the imaging assembly 125 and the laser treatment assembly 130, and is coupled to the disposable portion 105, which includes a distal shaft 103 surrounding the light guide 102, image guide 104, and laser guide 106 for placement directly within a patient's eye. The coupling between the two allows for the transmission of laser energy, for example, from the laser diode 132 of the laser treatment assembly 130 of the reusable portion 110 through the laser guide 106 of the disposable portion 105 to the eye. Similarly, image data from within the eye is transmitted to the imaging assembly 125 through the image guide 104 of the disposable portion 105 in real time during the laser treatment. The disposable portion 105 can also include an illumination source 122, which, when coupled to the durable reusable portion 110, is powered by the illumination assembly 120 and provides light through the light guide 102 to illuminate the area to be treated within the eye. The result is a fully handheld endoscopic photocoagulator device that can be manufactured in a compact and cost-effective manner without adversely affecting the optics or the treatment outcome.

[0037] Figure 3A is a schematic perspective view of device 100 including disposable and reusable portions 105, 110. Figure 3B is a schematic cross-sectional view of the device of Figure 3A showing components within device 100. Figure 3C is a schematic distal end view of the distal tip portion of the device of Figure 3A. Figures 4A-4B, 4C-4D, and 5A-5C are views of another embodiment of handheld device 100.

[0038] As best shown in FIG. 4B, the imaging assembly 125 includes an image sensor 150 and a single lens element 152 separated from the image sensor and supported by a frame or bracket. The image sensor is an imaging CCD or CMOS sensor. The imaging assembly 125 may further incorporate a glass window 154 (e.g., a sapphire window) or other optically transparent element at a distal end region of the housing portion configured to seal the housing portion and prevent the introduction of contaminants from the environment. The imaging assembly 125 is disposed within the reusable portion 110 to receive endoscopic images from the fiber optic bundle of the image guide 104 within the disposable portion 105. Upon coupling, the imaging assembly 125 of the reusable portion 110 may be focused on the proximal end of the image guide 104 within the disposable portion 105.

[0039] In conventional endoscopes, the image is transmitted through an image fiber bundle with a fixed number of individual fibers nf. The image is at the proximal end of the fiber bundle with a fiber diameter d. In conventional endoscope optics, the intention is to project the image using the largest sensor area, so the image diameter d is conventionally the same as the fiber bundle diameter. The standard solution in microscope optics is to magnify the image of the small fiber bundle end to fill the frame of the image sensor, or to project a magnified virtual image into the observation eyepiece. In this case, several relatively large and expensive optical elements are required. Due to the inverse square law, the brightness of the image decreases significantly as it is magnified to fill the large relative area of ​​the camera sensor.

[0040] The device's relay uses a 1:1 relay lens element 152 and a small portion of the total pixels available in the image sensor 150. Each fiber is relayed 1:1 to a subset of the total pixels in the image sensor 150. The pixel oversampling ratio can be at least 9:1 for image enhancement and oversampling where 9 pixels of the image sensor pixel array are covered by one fiber in the fiber bundle. The pixel oversampling ratio can be between 4:1 and 25:1, such as 4:1, 9:1, 16:1, 25:1, etc. The use of a subset depends on the pixel to bundle ratio, the size of the fiber bundle pixels and the size of the image sensor 150 pixels. The sensor pixel size is 1-3 μm. 2 , preferably about 1.2 to 1.5 μm 2 It is.

[0041] The image guide 104 includes an objective lens 127, described in more detail below, that focuses an image onto the distal end of the fiber optic bundle. The imaging fiber optic bundle includes thousands of individual optical fibers, each corresponding to a pixel of the image. The image is transmitted via the fiber optic bundle to the proximal end of the fiber optic bundle. In conventional systems, the proximal end of the fiber optic bundle is arranged to transmit the image through a series of three lenses. An image sensor of an imaging assembly located an optical path length away from the proximal end of the fiber optic bundle receives the magnified projected image. In such conventional systems, the diameter of the projected image on the sensor may be magnified twice the diameter of the fiber optic image. In the present apparatus, the proximal end of the fiber optic bundle is arranged to transmit the image through a single lens element 152 of an imaging assembly 125 having an optical path length approximately one-half the optical path length of the three lens system described above. An image sensor 150 of the imaging assembly 125 located a shorter optical path length away from the proximal end of the fiber optic bundle receives the projected image. The projected image is not magnified and is relayed 1:1 such that the diameter of the projected image on the sensor is the same as the diameter of the fiber optic image. In the device of the present invention, since the projected image on the fiber is not magnified, according to the inverse square law, the projected image is four times brighter than a conventional system using three lens systems and having twice the optical path length. Therefore, the imaging assembly 125 achieves about four times the brightness compared to a conventional microscope endoscope without compromising brightness. The numerical aperture of the imaging fiber is about 0.2 to 0.9, preferably about 0.3 to 0.5. The diameter of the imaging fiber can be about 300 to 2000 μm, preferably about 600 to 700 μm. The optical path length from the proximal end of the fiber to the position of the image sensor 152 can be about 20 to 100 mm, preferably about 30 to 40 mm. The diameter of the lens can be about 3 to 30 mm, preferably about 5 to 10 mm.

[0042] The single lens element 152 of the imaging assembly 125 can be a compound triplet lens with three lenses packed together to form the single lens element 152 configured to relay in a desired ratio. The triplet lens element 152 can correct for chromatic aberration at three wavelengths. In some implementations, the lens element 152 is a Steinheil triplet designed to relay in a 1:1 ratio. FIG. 12A is a schematic diagram of the short optical path of the imaging assembly showing a single lens element for relaying the image of the optical fiber to a subset of the imaging pixels. The single lens element 152 is located between the optical fiber bundle of the image guide 104 and the image sensor 150. The lens 152 shown is a Steinheil triplet with a relatively short optical path length L. The image I projected onto the image sensor 150 has a diameter Di equal to the diameter Df of the fiber image (i.e., 1:1 relay). The individual fibers of the fiber optic bundle of the image guide 104 are relayed 1:1 by a Steinheil lens, as described above, for example, onto 16 sensor pixels of the image sensor 150. FIG. 12B is a schematic diagram showing the pixel ratio of a fiber optic relay for significant oversampling. The schematic diagram includes a close-up cross section of the fiber optic bundle of the image guide 104, which is composed of individual fibers 1104. The image from the fibers 1104 is projected through a lens element 152 onto the image sensor 150, which is an array of pixels 1150. The width of each pixel 1150 of the sensor pixel array can be approximately 1 / 4 the width of an individual fiber 1204. Each individual fiber 1104 is relayed 1:1 by a single lens element 152 onto a subset of the sensor pixels 1150. In the example of FIG. 12B, one fiber 1104 is projected onto 16 sensor pixels 1150. This allows significant oversampling for fractal smoothing and quality improvement of the image, especially anti-aliasing. There is no loss of data due to low contrast or undersampling. The Steinheil triplet is also desirable because it can correct all five Seidel aberrations, including spherical aberration, coma, astigmatism, distortion, and Petzval curvature of field. Triplet lens element 152 can be designed to achieve a particular relay ratio, which need not be 1:1.For example, the pixel size can be made smaller (e.g., 0.5 micron pixel size) so that the image projected by the lens element 152 is smaller than in reality, or the pixel ratio is 1:0.5. The single lens element 152 can be designed to have any relay ratio, without worrying about the sensor size specifically, only the density of the sensor to achieve better brightness and better contrast with less power consumption.

[0043] 4A-4B and 4C-4D, the laser treatment assembly 130 can include a laser diode 132 with collimating optics. In some embodiments, the laser treatment assembly 130 is disposed within the reusable portion 110 (see FIG. 4B). The laser diode 132 is disposed proximate to a focusing mechanism 133 incorporating a collimating lens 134 and a light tube 131 (see FIG. 4B). The collimating lens 134, which can be a high numerical aperture collimating lens, can be disposed at a collimating distance away from the laser diode 132 to narrow the beam width of the laser diode 132. The high numerical aperture collimating lens 134 can be disposed proximate to the laser diode 132. The focusing mechanism 133 can be a threaded element that adjusts the position of the collimating lens 134 and the light tube 131 relative to the laser diode 132 during manufacturing and assembly to ensure proper alignment of the parts. Within the collimating stage of the optical chain of the laser treatment assembly 130, the diameter of the resulting beam is smaller than the mating window and clear opening of the collimating lens 134. Preferably, the beam width is about 1 / 2 or less the diameter of the clear opening of the collimating lens 134. Collimation allows for lateral variations in the emission point of the laser diode 132 and is set to optimize the beam width based on the Z-axis position of the laser diode 132. The laser beam emitted from the laser diode 132 passes through the collimating lens 134 and the light tube 131 to an optical window 137 located near the distal end region of the reusable part 110. The collimated beam crosses the junction substantially intact, with minimal divergence or convergence occurring between the junction and the window 137. The optical window 137 can be a sapphire window located within the distal end region of the housing 112 of the reusable part 110 and seals the housing part from contaminants. The material of the sapphire window 137 does not affect the beam path, provided the windows are well aligned. The beam is directed from the distal end of the reusable portion 110 to the proximal end of the disposable portion 105. The disposable portion 105 incorporates focusing optics, described in more detail below, that ensure that marginal rays of the collimated laser beam are directed into the optical fiber of the laser guide 106, even if the beam is misaligned.

[0044] The collimating lens 134 may have a numerical aperture of about 0.3 to 0.8, preferably about 0.5 to 0.7. The collimating lens 134 may have a diameter of about 2 to 10 mm, preferably about 3 to 6 mm. The collimating lens 134 may have a focal length of about 1 to 4 mm, preferably about 2 to 3 mm.

[0045] The laser treatment assembly 130 may also be disposed within the disposable portion 105, as will be described in more detail below with respect to FIG.

[0046] The reusable part 110 may incorporate one or more cooling features 118 configured to cool internal components disposed within the housing 112. Depending on the overall power of the laser incorporated in the device 100, the cooling feature 118 may include a heat sink 119 (see FIG. 3B or FIG. 4B) for providing conductive cooling, an active cooling fan 126 (see FIG. 3B), a heat pipe, or a fluid heat exchanger.

[0047] The reusable portion 110 of the device can include a microprocessor / controller 136 on a PCB board 135 that is powered by a power system. The PCB board 135 translates user input to actively control one or more of the imaging assembly 125, the laser therapy assembly 130, and active cooling elements, such as the active cooling fan 126.

[0048] The PCB board 135 may include a communication assembly configured to operatively communicate with one or more peripheral devices, such as an external computing device 140 having a video monitor. The connection may include a wired communication port, such as an RS22 connection, a USB, a Firewire connection, a proprietary connection, or any other suitable type of hardwired connection configured to receive and / or transmit information to an external computing device or ablation device. The communication assembly may also include a wireless communication port so that information may be provided between the device and the external computing device 140 and / or via a wireless link to the device, for example, to display information regarding the operation and / or control programming of the device 100 on the external computing device 140 in real time. It should be appreciated that an external computing device 140, such as a console or a portable device such as a tablet, may communicate directly with the device 100. The external computing device 140 may be used to perform various adjustments and programming of the device. The wireless connection may use any suitable wireless system, such as Bluetooth, Wi-Fi, radio frequency, ZigBee communication protocol, infrared, or a cellular telephone system, and may employ coding or authentication to verify the origin of the received information. The wireless connection may be any of a variety of proprietary wireless connection protocols.

[0049] The external computing device 140 can be a video monitor and / or computing device 140 for use in real time during a procedure. The imaging guide 104 can relay images to an imaging assembly 125 in the reusable part 110 that interfaces with a video camera at its proximal end in the disposable part 105 via a cable 145 to transmit video data to a monitor. The reusable part 110 can include a video transmitter, which can be a wireless transmitter. The video transmission can carry control, status, and / or user information. The external computing device 140 can include recording and image processing software so that computer enhancements (e.g., image size, contrast, color balance, orientation) can be performed in real time before the image is displayed on the monitor. In some embodiments, the PCB can incorporate an acceleration sensor so that the video projected to the user shows an "up" orientation, as the image data is automatically adjusted for orientation in real time.

[0050] Power can be provided to the reusable portion 110 of the device 100, such as through a cable 145 extending from a proximal end of the reusable portion 110. The cable 145 can also be configured to connect the device 100 to an electrical outlet. The device 100 can also be powered by one or more batteries. The batteries can be incorporated within an area of ​​the durable portion 110, either internally or coupled to an area of ​​the housing, such as in a modular, removable battery pack. The batteries can have different chemical compositions and characteristics. For example, the batteries can include lead acid, nickel cadmium, nickel metal hydride, silver oxide, mercury oxide, lithium ion, lithium ion polymer, or other lithium chemistries. The device can also include rechargeable batteries, either using a DC power port, induction, solar cells, or the like. Power systems known in the art for powering medical equipment for use in an operating room, such as spring power, or other suitable internal or external power sources, are also contemplated herein.

[0051] The device 100 can incorporate automatic power modulation capabilities by implementing clinical decision support algorithms. A machine learning or machine vision framework for laser-based eye treatment can be incorporated. The machine learning framework can use any suitable segmentation, feature extraction, image recognition, or image processing algorithm. Examples include deep learning models such as convolutional neural networks, the U-NET system for image segmentation, the MASK-R convolutional neural network for image segmentation, the RANSAC algorithm for change and outlier detection, the Bag-Of-Features algorithm for assigning and detecting feature vectors in an image, autoencoders for feature detection, and many other regression and classification algorithms. The framework can implement image recognition and processing algorithms that allow for analysis of image data acquired during treatment. The laser energy applied by the devices described herein is designed to damage tissue, but too much laser energy applied during eye treatment can cause undesirable damage. The imaging assembly can communicate information to a control algorithm that automatically adjusts power to the laser treatment assembly to prevent undesirable types of tissue damage while allowing the desired tissue damage for disease treatment.

[0052] The machine learning image detection algorithm can identify one or more ciliary bodies from the image communicated from the imaging assembly. The algorithm can be a trained deep neural network or convolutional network, or similar. The algorithm can segment the image and detect patterns associated with the ciliary processes with a high probability. A second algorithm (e.g., a "feature extraction algorithm") can characterize the shape and size of each ciliary process in the image. The feature extraction algorithm can use any number of machine vision and machine learning techniques to orient and characterize the shape (e.g., ratio, aspect ratio, size and shape relative to adjacent ciliary processes, pixel counting, etc.). When laser power is applied to the ciliary processes in the field of view, the machine vision can continuously monitor the image for changes in shape, size, aspect ratio, or other relevant features and automatically and very quickly reduce the power at the appropriate moment (e.g., after sufficient contraction and before the ciliary processes are excessively damaged) to prevent undesired laser treatment effects. This algorithm allows the physician to adjust the laser power applied to the ciliary tissue to the appropriate level to achieve the desired treatment outcome.

[0053] Disposable part 3A-3C, 4A-4B, 4C-4D, the disposable portion 105 includes a distal shaft 103 designed for insertion into the anterior chamber, posterior chamber, and / or vitreous chamber of the eye. The shaft 103 is preferably 18-gauge, 19-gauge, or 20-gauge for use in the anterior and posterior chambers, although other sizes are contemplated. For example, larger gauges (23-, 25-) can be used for retinal indications and intravitreal use. The shaft 103 can be straight, as shown in FIG. 3A, or curved, as shown in FIG. 4A. The curvature of the shaft 103 can allow for a larger field of view (FOV) for some indications. The FOV can be 45-150 degrees, preferably about 130-140 degrees.

[0054] The shaft 103 encloses channels therethrough, including an illumination channel or light guide 102, an imaging channel or image guide 104, and a laser treatment channel or laser guide 106 for placement directly within a patient's eye. The channels can include one or more optical fibers or fiber optic bundles extending from the distal end of the shaft 103 to a proximal end region of the disposable portion 105. Each optical fiber or fiber optic bundle can include a central core surrounded by a cladding material. The image guide 104 can include an objective lens 127 at the distal end of the shaft 103 and fiber optic bundles that stores information of the transmitted optical image (e.g., a coherent bundle). The proximal end of the image guide 104 interfaces with an imaging assembly 125 of the reusable portion 110. The light guide 102 can include fiber optic bundles that can be incoherent in that they do not maintain relative position. The laser treatment guide 106 may be a single small diameter optical fiber designed to deliver laser photocoagulation radiation (typically 810 nm infrared) from a laser source in the reusable portion 110 to the distal treatment end of the shaft 103. Shorter wavelength laser sources may also be used (e.g., green 532 nm, yellow 577 nm).

[0055] A channel in the shaft 103 of the disposable portion 105 is configured to reversibly interface with a corresponding assembly in the reusable portion 110. The disposable portion 105 and the durable portion 110 can each include housing portions 112a, 112b arranged to couple to one another using a coupling mechanism 101. The housing portions 112a, 112b can be formed of a relatively rigid, lightweight material, preferably plastic, but can also be made of metal. The coupling mechanism 101 can be different, such as a bayonet, threads, snap lock, etc.

[0056] 5A-5B show an embodiment of a coupling mechanism 101 incorporating a release button 114 on a distal end 121 of the reusable part housing 112b configured to engage a corresponding slot 116 on the proximal end 123 of the disposable part housing 105 housing 112a. The distal end 121 of the durable part housing 112b is sized and shaped to be received within the proximal end 123 of the disposable part housing 112a. The proximal end 123 of the disposable part housing 112a can surround the distal end 121 of the durable part housing 112b such that the taper of the distal end 121 is wedged with a correspondingly shaped region within the proximal end 123 of the disposable part housing 112a. The release button 114 on the distal end 121 can be inserted and engaged into a corresponding slot 116 on the proximal end 123 of the disposable portion housing 112a, and the taper on the distal end 121 of the reusable portion housing 112b which secures the coupling can be spring loaded to provide a snug wedge-like fit between the two portions 105, 110, helping to achieve optimal attachment and alignment of the components within the two portions 105, 110.

[0057] The coupling mechanism 101 between the two housing parts 112a, 112b can be mechanical as well as electronic. For example, the electronic coupling ensures that if the disposable part 105 includes an illumination source 122 (e.g., a white light LED), it properly interfaces with the electronics (e.g., LED driver) of the durable part 110 that powers the illumination source 122 located in the reusable part 110. The coupling mechanism 101 ensures that the imaging assembly 125 of the reusable part 110 is aligned and optically connected with the image guide 104 of the disposable part 105, and that the laser treatment assembly 130 of the reusable part 110 is aligned and optically connected with the laser guide 106 of the disposable part 105, as described below.

[0058] As described above, the image guide 104 can include a fiber optic bundle having a proximal end and a distal end, the distal end being disposed near the objective lens 127 at the distal end of the shaft 103 (see FIG. 5C). The objective lens 127 is designed to focus the distal end of the imaging fiber optic bundle to capture high resolution tissue images and transmit them to the proximal end. The field of view (FOV) of the objective lens 127 is significantly enlarged compared to surgical microscopes, which are designed to be placed inside the eye and therefore have a limited FOV. The objective lens 127 can have a manually or automatically adjustable depth of focus between 0.75-40 mm, or 1-30 mm, preferably 1-6 mm.

[0059] The majority of microendoscopic objective lenses (e.g., those used for working distances of 1-6 mm) incorporate an opaque disk with a central aperture to increase the depth of focus (DOF). The increase in DOF is primarily a result of the paraxial rays being focused through the pinhole effect. Non-paraaxial and peripheral rays are blocked by the opaque material of the disk. This disk is difficult to manufacture in that an aperture must be placed in the optical path through a tedious and expensive process. Typically, a doublet is formed by sandwiching an opaque disk between two glass elements and bonding the two together. The aperture in the disk is usually in the sub-millimeter diameter range, small at about 0.15 mm in diameter relative to the working distance. The diameter of the entire lens is often about 0.5 mm or less, reaching the limit of what can be manufactured.

[0060] An endoscopic device described herein for intraocular treatment may have a proximal reusable portion having a proximal housing portion with a distal end region and a distal disposable portion having a distal housing portion with an elongated shaft extending distally from the distal end region of the distal housing portion. The distal housing portion has a proximal end region configured to reversibly couple with the distal end region of the proximal housing portion. A frustum lens may be disposed in the distal end region of the elongated shaft that functions as an objective lens for imaging. The device may further include an imaging channel extending within the elongated shaft configured to transmit light from the frustum lens. The device may further include one or both of an illumination channel and a laser treatment channel extending within the elongated shaft.

[0061] The image guide 104 of the devices described herein can incorporate an objective lens 127 that has an apertureless configuration and is manufactured as a single piece. FIGS. 6A-6B and 7A-7C are schematic diagrams illustrating an objective lens 127 that is manufactured as a monolithic component and has an apertureless configuration. The objective lens 127 in FIGS. 6A-6B has an hourglass configuration, and the objective lens 127 in FIGS. 7A-7B has a frustoconical configuration. The hourglass configuration of the objective lens 127 places a small diameter neck 128 in the optical path, propagating only paraxial rays. The neck 128 is sized similarly to the opaque disk aperture of a conventional objective lens (e.g., about 0.10 mm to 0.15 mm). The entrance surface 124, located distal to the neck 128, can be aspheric, spherical, or other optimized lens shape. The exit surface 129, located proximal to the neck 128, can be convex or planar. The walls of the entrance face 124 of the lens 127 approaching the neck 128 are shaped such that total internal reflection (TIR) ​​is induced on rays from the light source 10 that are not axially aligned with the neck 128 (see FIG. 6B). TIR reflects these rays out of the entrance face 124, preventing non-paraxial and marginal rays from passing through the neck 128. The diameter of the neck 128 determines the extent of non-paraxial light transmission. Because there is no need for an opaque disk aperture or a disk sandwiched between glass pieces, the monolithic design is easy to manufacture by machining, diamond turning, injection molding, or similar techniques. The objective lens 127 relies on TIR to reject non-paraxial and marginal rays from the optical path.

[0062] 7A-7C, the cone-shaped configuration of the objective lens 127 has a small diameter entrance face 124 and an increasing diameter body moving proximate to a maximum diameter exit face 129. The entrance face 124 can be a flat, convex or concave, aspheric, spherical or other optimized shaped lens. The entrance face 124 is located distal to the exit face 129 such that the exit face 129 of the objective lens 127 is located near the distal end of the imaging optical fiber and the entrance face 124 is located away from the optical fiber towards the target. The outer surface 138 of the lens 127 can be opaque and / or roughened. The opaque outer surface 138 can be due to an outer surface coating, an outer surface diffuse texture, or a second shot of opaque polymer that forms the contour of the lens 127, for example a cylindrical contour or other shape suitable for fitting within the system. The exit face 129 may define the maximum diameter of the lens 127 and may be flat, convex or concave, aspheric, spherical or any other optimized shape of the lens. The small diameter of the entrance face 124 relative to the working distance of the lens 127 allows only paraxial rays to propagate to the exit face 129, greatly improving depth of field performance. The monolithic design is easy and inexpensive to manufacture and does not require any apertures in the optical path.

[0063] Methods for creating surface opacity for lenses 127 having an hourglass shape can include EDM surface texturing, while methods for creating surface opacity for lenses 127 having a cone shape can be by applying a black high solids ink. Mechanical surface roughening, EDM surface texturing, black coating with paint, ink, high solids epoxy, etc., or a second shot injection with an opaque material are all contemplated herein.

[0064] The clear opening of the entrance face 124 of the objective lens 127 having an hourglass shape can be about 300-1000 μm, preferably about 500-700 μm. The diameter of the neck 128 can be about 120-500 μm, preferably about 100-300 μm. The clear opening of the exit face 129 of the objective lens 127 can be about 300-2000 μm, preferably about 500-700 μm. The refractive index of the material can be about 1.45-1.7, preferably about 1.65-1.68. The cone half angle of the objective lens 127 can be about 20°-40°, preferably about 20°-25°. The parameters of the objective lens having a truncated cone shape can be similar. The clear opening of the entrance face 124 of the objective lens 127 having a frustoconical shape can be about 120-1000 μm, preferably about 100-300 μm. The clear opening of the exit face 129 of the objective lens 127 can be about 300-5000 μm, preferably about 500-700 μm. The refractive index of the material can be about 1.4-1.7, preferably about 1.65-1.68. The half cone angle of the objective lens 127 can be about 20°-80°, preferably about 40°-50°.

[0065] The shaft 103 may also include a light guide 102 disposed relative to an illumination source 122. Conventional endoscope scopes include an illumination source in a remote console. In the device described herein, the light source 122 may be in the reusable portion 110, preferably in the disposable portion 105, to provide wide-field illumination in the eye. The light source 122, when coupled with the durable reusable portion 110, is powered by the illumination assembly 120 and provides illumination light through the light guide 102 to illuminate the area to be treated in the eye. The light source 122 may be an LED, and the light guide 102 is an optical fiber 141. Efficiently coupling the luminous output of an LED to an optical fiber is difficult and costly. The light emitted from the LED die is highly divergent, typically with a Gaussian intensity profile, with a viewing angle of, for example, 120 degrees or more (i.e., light at off-axis angles with less than 50% light intensity). This widely divergent output makes it difficult to collimate and / or focus the light, and therefore to inject the light power into an optical fiber for endoscopic illumination. Traditionally, multiple lenses, including exotic and expensive cone and parabolic lenses, are used to achieve this injection with relatively low efficiency.

[0066] The light source 122 and optical fiber 141 of the device disclosed herein are coupled in an efficient and cost-effective manner so that they can be incorporated into the disposable portion 105 of the device 100. Various parameters are considered in determining the optimal potting configuration of the optical fiber 141 and the light source 122, including the numerical aperture NA of the optical fiber 141, which corresponds to the accepted input angle, the minimum practical distance Df between the optical fiber 141 and the emitter die 144 of the light source 122, the diameter Do of the optical fiber core, the size of the light emitting die 144 of the light source 122, and the refractive index of the optical adhesive and / or potting compound used to attach the fiber 141 on or near the light emitting die 144 (see Figures 8A-8B). In some embodiments, the disposable portion incorporates multiple colored LEDs (e.g., white, blue, green, far infrared, near infrared, ultraviolet, etc.). Multiple light sources with different frequencies can be attached on or near the fiber, respectively. Various LEDs can be incorporated into the shaft without changing the OD of the entire shaft. FIG. 8A is a schematic diagram showing a high numerical aperture optical fiber 141 positioned relative to an LED illumination source 122. FIG. 8B is a schematic diagram showing a low numerical aperture optical fiber 141 positioned relative to an LED illumination source 122. A fiber with a higher numerical aperture has a larger acceptance angle and collects more light generated by the light source 122. The optical fiber 141 is ideally located directly above the die 144, so that the distance Df between them is zero. However, other components of the light source 122 (e.g., electrical leads, reflector cup, support structure, etc.) prevent this type of positioning. The minimum distance Df is defined as the repeatable distance that can be achieved without damaging the light source 122. The size of the fiber core relative to the dimensions of the LED emitter die 144 determines the theoretical maximum efficiency. The smaller the emitter die 144, the higher the injection efficiency for a given fiber numerical aperture, diameter, and distance from the die 144.

[0067] The numerical aperture of the optical fiber 141 relative to the light guide 102 can be about 0.1-0.6, or about 0.15-0.5, preferably about 0.5. The dimensions of the LED emitter die 144 can be about 200-1000 μm, about 200-500 μm, preferably about 100-300 μm. The distance Df between the fiber 141 and the die 144 can be about 0-500 μm, about 50-400 μm, preferably about 100-200 μm. The diameter Do of the optical fiber core can be about 10-1000 μm, 25-500 μm, preferably about 100-300 μm. The refractive index of the potting compound can be about 1.4-1.7, preferably about 1.60-1.65.

[0068] The optical fiber 141 can be potted into the shaft or recess 142 of the light source 122, for example, as created in a surface mount LED or through hole LED (see FIG. 9A). The recess 142 can be spherical and filled with an optical adhesive that creates a focusing lens (see FIG. 9B). The recess 142 can incorporate a spherical optical lens 143 used for focusing, placed directly in front of the die 144 that separates the die 144 from the optical fiber 141 (see FIG. 9C). By matching the diameter and material index of refraction of the lens 143 to the parameters mentioned above, the widely diverging light from the emitter can be focused onto the end of the optical fiber 141, increasing the transmission efficiency. FIG. 9A shows a flat bottom recess 142, and FIG. 9B shows a shaped bottom recess 142. In the case of a flat bottom recess 142, the flat polished end of the optical fiber 141 is fitted into the bottom of the recess 142 using an optical adhesive. This creates a transparent joint between the LED lens material and the optical fiber 141. The shape of the bottom of the recess 142 can be designed to create a refractive surface in the light path that helps focus the light emitted from the die 144 onto the fiber 141. The shape of the bottom of the recess 142 can be a simple spherical shape, an aspheric shape, or an optimized optical surface. An adhesive / potting compound can be used that has a higher RI than the lens material on the die 144. When the optical adhesive is placed in the recess 142, it can fill the curved bottom of the recess 142 and create a focusing lens. The optical fiber 141 can have a similar outer diameter as the top of the recess 142 so that when the optical fiber 141 is potted, it is not inserted past the point where the curved surface of the recess 142 begins. The higher the RI of the optical adhesive lens, the more light it focuses onto the optical fiber 141.

[0069] The disposable portion may incorporate a light guide 102, an image guide 104, and a laser guide 106. Each guide may incorporate a single optical fiber or a fiber optic bundle. When the term "optical fiber" or "optical fiber" is used herein, both single optical fibers and fiber optic bundles are contemplated. For example, when one optical fiber is described as being potted within the light source recess 122, multiple optical fibers or fiber optic bundles may be potted.

[0070] The laser guide 106 may include a single optical fiber extending through the shaft 103 such that the distal end of the guide 106 is located at the distal end of the shaft 103 for intraocular treatment (see FIG. 5C). Upon coupling, the proximal laser guide 106 of the disposable part 105 is aligned with the laser treatment assembly 130 of the reusable part 110. The laser treatment assembly 130 includes collimated optics directed at the proximal end of the optical fiber of the laser guide 106. FIGS. 10A-10B are schematic diagrams illustrating an optical chain for launching the laser beam 15 from the reusable part 110 to the optical fiber 147 of the laser guide 106 of the disposable part 105. The disposable part 105 may incorporate optics configured to focus the laser beam 15 from the light tube 131 and inject laser energy into the optical fiber 147 of the laser guide 106 of the disposable part 105. The reversible mating of the two parts, the disposable part 105 and the reusable part 110, can lead to imprecise optical alignment between the laser beam from the light tube 131 of the reusable part 110 and the laser beam from the laser guide 106 of the disposable part 105. A high degree of axial alignment between the two components cannot always be guaranteed. An optical chain incorporating optics can be included in the disposable part 105 to prevent inefficient injection of laser energy into the optical fiber 147 of the laser guide 106 in case of misalignment during mating of the two components of the device. For example, a bushing 146 located in the proximal end region of the disposable part 105 can glue an aspheric lens 149 between the proximal end of the fiber-matched numerical aperture optical fiber 147 and the collimated beam of the laser passing through the window 137 in the distal end of the reusable part 110 (see also FIG. 4B). The optical fiber 147 can be approximately twice as large as the focused spot size to allow for misalignment. For example, the diameter of fiber 147 may be approximately 200 microns and the focused spot size of the beam may be approximately 100 microns. Aspheric lens 149 creates a very small spot size from the collimated beam 15 to "inject" the laser energy into the optical fiber 147.The condenser lens 149 can have a numerical aperture of about 0.1 to 0.5, preferably about 0.2 to 0.3. The condenser lens 149 can have a focal length of about 5 to 20 mm, about 4 to 12 mm, preferably about 7 to 9 mm. The condenser lens 149 can have a lens diameter of about 3 to 20 mm, preferably about 4 to 5 mm. The condenser lens 149 can have an asphericity optimized for a single focal diameter of 3 to 8 mm, for example about 3 to 6 mm. The numerical aperture of the laser optical fiber can be about 0.1 to 0.7, preferably about 0.2 to 0.3. The laser optical fiber can have a core diameter of about 10 to 1000 μm, preferably about 100 to 300 μm.

[0071] FIG. 10A shows an optical chain with a high axial alignment tolerance between the laser beam 15 and the optical fiber 147. FIG. 10B shows an optical chain with a small axial alignment deviation between the two. The collimated beam 15 from the reusable part 110 is focused by an aspheric focusing lens 149 in the disposable part 105. The focusing lens 149 is located a focal distance Df away from the proximal end of the optical fiber 147. The beam 15 from the laser assembly hits the lens 149 at the clear aperture area of ​​the focusing lens 149, so that even if marginal rays of the collimated laser beam 15 hit the edge of the clear aperture of the focusing lens 149, the beam 15 will be focused at the end of the optical fiber 147. The tolerance for alignment deviation is a function of the collimated beam width Wb relative to the clear aperture of the aspheric lens 149D. The smaller the beam width Wb relative to the clear aperture, the greater the alignment deviation of the optical path. FIG. 10B shows a high numerical aperture collimating lens 134 in the reusable part 110 of the device, located close to the laser diode 132 at a collimating distance Dc, resulting in a smaller beam width Wb (compared to a collimating lens with a longer focal length), and with a misalignment M. The closer the collimating lens 134 is located to the laser diode emitter 132, the shorter the distance for the beam to diverge before hitting the collimating lens 134. A collimating lens 134 with a high numerical aperture and a short focal length is required because of the short distance from the lens to the emitter. The distance can be on the order of 2-3 cm. The small collimated beam width Wb allows the entire beam to enter the collecting lens 149 in the disposable part 105, even with an axial misalignment. A properly designed aspheric collecting lens 149 corrects for spherical aberration and provides a perfect focus for both paraxial and marginal rays so that all light enters the optical fiber end 147.

[0072] 2A-2C, 4B, and 10A-10B each show a laser treatment assembly 130 having a laser diode emitter 132 located within the reusable portion 110. Light is directed across the junction between the housing portions 112a, 112b to an aspheric lens 149 within the disposable portion 105 to direct the laser energy for treatment at the distal end of the shaft 103. The laser treatment assembly 130 may be disposed entirely within the disposable portion 105. FIG. 11 shows an example of a laser treatment assembly 130 disposed entirely within the disposable portion. The laser treatment assembly 130 may include a laser diode 132 and a ball lens 156 located between the laser diode emitter 132 and the optical fiber 147. The laser diode emitter 132 (e.g., 808 nm) includes a base 160 coupled to an annular casing 161 having an inner diameter that defines an opening 165 extending through the casing. Glass window 162 is mounted within casing 161 which forms a recess 163 at an end of casing 161. Recess 163 is located on the opposite side of glass window 162 from base 160 of laser diode emitter 132. Ball lens 156 fits within recess 163 in casing 161 and may be held in a predetermined position relative to casing 161 by housing 158 which surrounds casing 161 and ball lens 156. Ball lens 156 is held in the appropriate position within recess 163.

[0073] The ball lens 156 can have a diameter, refractive index, and material selected with consideration given to the divergence characteristics of the particular laser diode emitter 132. The ball lens 156 can be designed to have an outer diameter sized to only partially fit within the recess 163 such that the annular casing 161 supports the ball lens 156. The size of the recess 163 can be slightly smaller than the outer diameter of the ball lens 156 such that the ball lens 156 is supported by the inner diameter of the recess 163 of the laser diode emitter 132. For example, the laser diode emitter 132 of the laser treatment assembly 130 can be approximately 5 mm in diameter and incorporate a recess 163 that is approximately 1 mm in diameter. The ball lens 156 can be approximately 1.5 mm in diameter such that the ball lens 156 fits partially within the recess 163 but remains substantially outside of the recess 163 such that the majority of the ball lens 156 is located outside of the recess 163.

[0074] The laser diode emitter 132 emits light in a rapidly diverging ellipsoid having an emission point 164. A ball lens 156 resting in a recess 163 of the casing 161 of the laser diode emitter 132 focuses the laser light onto the proximal end of the optical fiber 147. The optical fiber 147 can be attached to the ball lens 156, such as by adhesive, or can be suspended a small distance away from the ball lens 156, such as by a fiber ferrule 159. The optical fiber 147 can be held by the fiber ferrule 159 so that it is positioned normal to the optical path. The distance between the optical fiber 147 and the ball lens 156 can be adjusted to set the optimum focus. The optical fiber 147 can be aligned with the brightest image transmitted through the lens 156. This allows the reusable part 110 to incorporate only the imaging assembly 125, while the illumination assembly 120 and the laser treatment assembly 130 are placed in the disposable part 105 and do not need to be autoclaved. Integrating the laser treatment assembly 130 completely within the disposable portion 105 means the beam does not have to cross the junction between the reusable portion 110 and the disposable portion 105, solving alignment issues. The laser treatment assembly 130 has fewer parts and is less expensive. One adjustment (ferrule-in-shaft position) gives perfect focus, making it easier to set focus in production.

[0075] The fiber 147 may have a numerical aperture of about 0.1-0.6, preferably about 0.20-0.25. The diameter of the recess may be about 800-2000 microns, preferably about 1000-1700 microns. The diameter of the ball lens 156 may be about 1000-3000 microns, preferably about 1500-2500 microns, larger than the diameter of the recess. The refractive index of the ball lens may be about 1.45-2.0, preferably about 1.75-1.80. The distance between the ball lens 156 and the optical fiber 147 may be 0-10 mm, preferably about 250-400 microns. The material of any lens described herein may be modified, not just the ball lens. Examples of lens materials include any optical material, including BK7, fused silica, magnesium fluoride, zirconia, sapphire, ruby, etc., or optical polymers. Sapphire in particular is a suitable material for any of the lenses described herein due to its ability to withstand being heated to high temperatures without melting and cooling again, and it has a very high refractive index, which allows it to bend light very well.

[0076] The power level of the 810 nm laser to achieve whitening and shrinkage of the ciliary body tissue of the eye can be between 100-300 mW, typically about 250 mW at the treatment site. Conventional systems may have lasers that use a maximum power of about 1.0-2.0 W recorded at the console, but there is power loss within the eye due to low efficiency (e.g., about 50% loss to about 500 mW). The efficiency in the transmission of laser energy between the reusable and disposable portions of the devices described herein is very high (e.g., about 25% loss) such that the required power of the laser is reduced.

[0077] The disposable portion 105 can be connected via a fluid port (not shown) to a fluid channel, such as a tube from an IV bag, to supply fluid to the distal shaft during use. The supply of fluid can be passive gravity-assisted or pump-assisted as known in the art. The supplied fluid can be an irrigation fluid, such as saline. The fluid can be chilled to aid in cooling during a procedure using a laser. The tube supplying the fluid to the shaft 103 can be positioned relative to the shaft 103, such as with an irrigation sleeve surrounding at least a portion of the shaft 103. Even if an irrigation sleeve is present, the maximum cross-sectional diameter of the shaft 103 is preferably suitable for minimally invasive procedures within the eye to minimize the incision size. The maximum cross-sectional diameter of the probe is preferably about 1.25 mm. The maximum cross-sectional diameter can be less than this diameter or greater than this diameter, for example, about 2 mm or less in diameter, about 3 mm or less in diameter, about 4 mm or less in diameter, or about 5 mm or less in diameter. The fluid can be transported through a tube adjacent to the shaft as described above, or through the interior of the shaft 103. For example, the shaft 103 can incorporate microfluidic channels in addition to the light guide. The fluids carried by the tubes or channels can vary depending on the needs of the procedure being performed. For example, glaucoma can be treated using an endoscopic device by delivering cold water ab interno through the elongated shaft while applying laser energy through the elongated shaft to the ciliary body of the eye. The fluid can be an irrigation fluid such as saline, a cooling cold liquid such as water or saline, a liquid to reduce inflammation, an anti-inflammatory therapeutic preparation, an antibiotic preparation, or other therapeutic preparation clinically relevant to the procedure being performed. In ophthalmic procedures such as glaucoma treatment, vitreous surgery, cataract surgery, macular surgery, and the like, various dyes, drugs, and fluids are administered. The fluids can include therapeutic dyes such as trypan blue, indocyanine green (ICG), lissamine green, rose bengal, triamcinolone acetonide, brilliant blue G / acid blue, light green SF, bromophenol blue, patent blue, Chicago blue, E68, fluorescein, and the like.

[0078] The disposable portion 105 and / or the reusable portion 110 can include a basic user interface 115 including actuators such as buttons, wheels, switches, sliders, dials, switches, pedals, and other actuators configured to operate one or more aspects of the device 100. The embodiment shown in Figures 4A-4B, 4C-4D, and 5A-5B includes an actuator 115 on the disposable portion 105, configured to provide a multi-directional trigger of the device 100, such as using a Hall sensor or other mechanism. The actuator 115 can be moved by a user from a home position, where all functions of the device 100 are off, to at least a first position to turn on a function of the device 100, such as a treatment laser. Further movement of the actuator 115 from the home position can increase the intensity of the laser output. Although the actuator 115 is shown as a slider, the actuator 115 can also be a trigger configured to be depressed several times to increase the intensity. The actuator 115 can move between set positions to achieve a preprogrammed intensity position, or can move along a variety of infinite positions between home and full intensity. The device 100 can have different actuators 115 for powering one or more other functions of the device 100, such as actuators for turning on one or both of the illumination source 122 and the imaging assembly 125. As another example, the device 100 can have actuators for controlling different wavelengths of LEDs, such as one actuator 115 for white light LEDs for visible light observation, another actuator 115 for near-UV fluorescence observation, and another actuator 115 for photobiomodulation LEDs (e.g., 808 nm LED light). In further embodiments, the device 100 can incorporate a remote control box that frees up space on the handle to control various functions. Alternatively, the illumination source 122 and the imaging assembly 125 can be powered on when the device 100 is connected to a power source.

[0079] It is not necessary to include a mechanism for changing the optical focus of the imaging assembly 125. The device may include a focus mechanism that allows manual or automatic focusing of the depth of field (e.g., 1-30 mm). The depth of focus may be adjusted by moving the fiber bundle 104 relative to the objective lens 127 or by moving the lens 127 relative to the fiber bundle 104. The device 100 may incorporate a separate actuator 115 for changing the position of one or both of the fiber optic bundle 104 and the objective lens 127. The movement achieved by the actuator may be approximately 200-250 microns. The movement may be achieved using a micro-piezo actuator or other linear actuator. Figures 13A-13B show an example of a system configured to change the distance between the objective lens 127 and the fiber optic bundle 104. The probe shaft 103 may incorporate an outer sleeve 170 having a proximal end and a distal end. The distal end of the sleeve 170 can be coupled to the objective lens 127 such that the sleeve 170 remains on the outside of the shaft 103 and the lens 127 coupled to the sleeve 170 is located on the inside of the shaft 103. The proximal end of the sleeve 170 can be coupled to a linear actuator, such as a piezo actuator, configured to move the sleeve 170 to change the focal length of the objective lens 127. FIG. 13A shows the sleeve 170 retracted to a proximal position such that the objective lens 127 is located near the distal end of the fiber optic bundle 104 (not visible in FIG. 13A). FIG. 13B shows the sleeve 170 in a distal position extended such that the objective lens 127 is away from the distal end of the fiber optic bundle 104. The sleeve 170 can be completely tubular or only partially tubular as shown. FIGS. 13A-B show a pair of straps configured to encircle the shaft 103.

[0080] The device may also incorporate user feedback or outputs 117, such as visual, audio, and / or tactile outputs. The outputs 117 may include one or more of a light, a display, a speaker, a vibration motor, or other types of outputs configured to communicate information to the user by visual, audio, and / or tactile output. As an example, the disposable portion 105 may include a light (e.g., an LED) that illuminates a light pipe that is visible from outside the housing 112a. The LED may blink when the device 100 is powered on but before the laser is activated. Once the laser is activated, the LED may remain steadily lit to inform the user that the laser is on. Various colors may be used for the LED. For example, rather than changing from a blinking to a steady light, the LED may change from a green light to a red light to inform the user that the laser is active. The location of the outputs 117 may vary depending on the placement of the housing 112, but are positioned so that they are easily observed by the user during use. It should also be understood that one or more of the inputs and outputs may be located on the disposable portion, the reusable portion 110, or both.

[0081] How to use As an example of a method of use, the eye can be penetrated in a limbal or pars plana approach to access the ciliary processes. Access to the ciliary processes can be achieved from an anterior approach in phakic, pseudophakic, and aphakic eyes. A limbal approach is preferred when photocoagulation is combined with cataract surgery and intraocular lens implantation. Alternatively, a scleral tunnel incision can be used during cataract surgery to provide access for the device. A pars plana approach can also be used in patients with pseudocataracts to allow better visualization of the ciliary processes. Anterior vitreous surgery may be performed when using this method.

[0082] A clear corneal incision or puncture instrument may be used to create the incision (e.g., 1.5-2.2 mm long), and an ophthalmic viscoelastic may be used to deepen the sulcus. The disposable probe connected to the reusable part can be connected via a cable to a video monitor that provides real-time imaging and power. The video footage can be connected to the monitor via a wireless connection. Laser energy is administered to blanch the ciliary processes and produce visible tissue shrinkage. Photocoagulation can be performed at a distance away from the ciliary processes, e.g., about 1.0 mm to 3.0 mm from the ciliary processes, preferably about 2 mm. Slow, continuous "painting" can be performed along each ciliary process at least about 270 degrees and up to about 360 degrees (from one incision with a curved endoscopic probe, or from two incisions).

[0083] There are various ways to approach the ciliary process and various techniques can be employed depending on the condition of the lens and the type and severity of the disease being treated. Endoscopic photocoagulation (ECP) approaches and surgical techniques can be varied including: limbal / clear cornea, pars plana, over-the-bag, through-the-bag, anterior approach in phakic eyes, aphakic eyes, pseudophakic eyes, ECP plus for refractory glaucoma, endoscopic cycloplasty (ECPL), intrasirioplasty for plateau iris syndrome, ICE technique (MIGS implant combined with cataract surgery and ECP), cataract, ECP, ECP for keratoprosthesis glaucoma treatment, uveitis glaucoma hypotony symptoms, pseudoexfoliation glaucoma, ECP for annular dialysis hiatus, etc.

[0084] The endoscopic devices described herein allow imaging, illumination, and laser illumination when anterior or posterior conditions prevent posterior vision. Treatable conditions can include opaque corneas, opaque anterior chambers, small pupils, opaque lenses, broken lens implants, gas in the vitreous, etc. The endoscopic devices described herein allow for viewing of anatomical or pathological structures not visible with a surgical microscope, including the posterior iris, ciliary body, pars plana, peripheral retina, intraocular foreign bodies, dislocated lens implants, and angles for gonadotomy.

[0085] The endoscopic devices described herein assist in unique surgical procedures such as vitreous inclusion during sclerotomy, cryptic intraocular hemorrhage or infection, subretinal placement of infusion cannulas, sclerotomy-induced retinal detachment, submicroscopic vitreous, and formation of posterior vitreous separation during macular hole surgery. The endoscopic devices described herein allow for endoscopic monitoring of vitreous surgery, membrane resection, block peeling, fluid exchange with air, liquid, or silicone oil, internal drainage of subretinal fluid, retinotomy / retinal resection, lensectomy, and retinal detachment-laser endoscopic repair. Disease-specific applications discussed herein include the surgical management of diabetic retinopathy and its complications, retinal detachment, proliferative vitreous retinopathy, dislocated cataract, dislocated lens implant, neovascular glaucoma, endophthalmitis, intraocular foreign body, hypotony, and choroidal hemorrhage.

[0086] The endoscopic devices described herein need not be limited to use in the eye. For example, the endoscopic devices can be used in ENT sinus surgery, for example to shrink polyps. The length of the probe shaft can vary depending on the intended use. In sinus surgery to treat polyps or chronic sinusitis, the probe shaft can be increased depending on which sinus (e.g., maxillary sinus) is being treated.

[0087] The system may include a control unit, a power supply, a microprocessor computer, etc. Aspects of the subject matter described herein may be implemented in digital electronic circuitry, integrated circuits, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and / or combinations thereof. These various implementations may include implementations in one or more computer programs executable and / or interpretable on a programmable system including at least one programmable processor, which may be special purpose or general purpose, coupled to receive signals, data, and instructions from a storage system, at least one input device, and at least one output device, and to transmit signals, data, and instructions to the storage system, at least one input device, and at least one output device.

[0088] These computer programs (also referred to as programs, software, software applications, or code) contain machine instructions for a programmable processor and may be implemented in high-level procedural and / or object-oriented programming languages, and / or assembly / machine languages. As used herein, the term "machine-readable medium" refers to any computer program product, apparatus, and / or device used to provide machine instructions and / or data to a programmable processor (e.g., magnetic disks, optical disks, memory, programmable logic devices (PLDs)), including a machine-readable medium that receives machine instructions as a machine-readable signal. The term "machine-readable signal" refers to any signal used to provide machine instructions and / or data to a programmable processor.

[0089] Various embodiments are described with reference to the drawings. However, a particular embodiment may be implemented without one or more of these specific details or in combination with other known methods and configurations. In this specification, numerous specific details, such as specific configurations, dimensions, steps, etc., are defined in order to fully understand the embodiments. In other instances, well-known processes and manufacturing techniques are not described in detail in order not to unnecessarily obscure the description. References throughout this specification to "one embodiment," "an embodiment," "one embodiment," "an embodiment," and the like mean that a particular feature, structure, configuration, or characteristic described is included in at least one embodiment or embodiment. Thus, although the expressions "one embodiment," "an embodiment," "one embodiment," "an embodiment," and the like appear in various places throughout this specification, they do not necessarily refer to the same embodiment or embodiment. Furthermore, particular features, structures, configurations, or characteristics may be combined in any suitable manner in one or more embodiments.

[0090] The use of relative terms herein may indicate relative positions or directions. For example, "distal" may indicate a first direction away from a reference point. Similarly, "proximal" may indicate a position in a second direction opposite the first direction. The reference point used herein may be the operator, such that the terms "proximal" and "distal" are relative to the operator using the device. A region of the device closer to the operator may be described herein as "proximal" and a region of the device further from the operator may be described herein as "distal". Similarly, the terms "proximal" and "distal" may also be used herein to refer to a patient's anatomical location as viewed from the operator, or as viewed from the entry point of the system, or along an insertion path from the entry point of the system. Thus, a location that is proximal may refer to a location within the patient that is closer to the entry point of the device along the insertion path toward the target, and a location that is distal may refer to a location within the patient that is farther from the entry point of the device along the insertion path toward the target location. However, such terms are provided to establish a relative frame of reference and are not intended to limit the use or orientation of the devices to the specific configurations described in the various embodiments.

[0091] As used herein, the term "about" refers to a range of values ​​including the specified value that would be considered reasonably similar to the specified value by one of ordinary skill in the art. In embodiments, "about" refers to within a range of standard deviation using measurements generally accepted in the art. In embodiments, "about" refers to a range of up to ±10% of the specified value. In embodiments, "about" includes the specified value.

[0092] Although many specifics are described herein, these should not be construed as limiting the scope of what is or can be claimed, but rather as describing the unique features of certain embodiments. Certain features described herein in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in a particular combination, and may even be initially claimed as such, one or more features from the claimed combination may in some cases be excluded from the combination, and the claimed combination may be directed to a subcombination or subcombination variation. Similarly, although operations are depicted in the figures in a particular order, this should not be understood as requiring such operations to be performed in the particular order depicted, or in the sequential order, or to perform all of the depicted operations, to achieve the desired results. Only some examples and examples have been disclosed. Variations, modifications, and enhancements to the described examples and embodiments, as well as other embodiments, may be made based on the disclosed content.

[0093] In the above description and in the claims, phrases such as "at least one" or "one or more" may be followed by a connectable list of elements or features. The term "and / or" may appear in a list of more than one element or feature. Such phrases are intended to mean any of the listed elements or features individually, or any of the listed elements or features in combination with any of the other listed elements or features, unless otherwise implicitly or explicitly contradicted by the context in which it is used. For example, the phrases "at least one of A and B," "one or more of A and B," and "A and / or B" are each intended to mean "A alone, B alone, or both A and B." A similar interpretation is intended for lists containing more than two items. For example, the phrases "at least one of A, B, C," "one or more of A, B, C," and "A, B and / or C" are each intended to mean "A alone, B alone, C alone, both A and B, both A and C, both B and C, or all of A, B, and C."

[0094] Use of the term "based on" above and in the claims is intended to mean "based at least in part on" and in that sense also allows for unrecited features or elements.

[0095] The systems disclosed herein may be packaged together in a single package, the completed package may be sterilized using a sterilization method such as ethylene oxide or radiation, labeled and boxed, and instructions for use may be provided on the box or via an internet link printed on the label.

[0096] All methods described herein can be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context. Any examples provided herein, or the use of exemplary language (e.g., "for example"), are intended merely to better illustrate the invention and are not intended to limit the scope of any claims. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0097] Groupings of alternative elements, embodiments, or implementations disclosed herein are not to be construed as limitations. Each group member may be referenced and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in or deleted from a group for reasons of convenience and / or patentability. When such inclusions or deletions are made, the specification is deemed to include the modified group and will satisfy the description of all Markush groups used in the appended claims.

[0098] P embodiment P. Embodiment 1. An intraocular-portable cyclophotocoagulation device having a reusable handle body including a light source, an imaging unit, a laser diode, a wireless video transmitter, and a disposable endoscope distal tip including focal length adjustment and a sheath, a light guide / lens, a laser guide / lens, and an image guide / lens.

[0099] P embodiment 2. A device of P embodiment 1, in which single, multiple or grouped lumens contained within the distal tip and shaft provide visible light to and from a designated treatment area and are intended to be single use and disposable.

[0100] P embodiment 3. The device of P embodiment 1, wherein the distal shaft has an image transmitting lumen with a field of view of at least between 45 degrees and 150 degrees.

[0101] P embodiment 4. The apparatus of P embodiment 1, wherein the focus mechanism of the reusable portion has manual focus adjustment from 1 to 30 mm depth of field.

[0102] P embodiment 5. The device of P embodiment 1, wherein the focus mechanism of the reusable portion has an automatic focus adjustment function for a depth of field of 1 to 30 mm.

[0103] P embodiment 6. A device of P embodiment 1, wherein the distal shaft has a single, multiple single, or grouped lumens for delivering 810 nm wavelength light from a laser diode to a predetermined treatment site and is intended for one-time disposable use.

[0104] P embodiment 7. The device of P embodiment 1, wherein the distal tip is attached to a reusable hand-held portion of the device to minimize loss.

[0105] P embodiment 8. The device of P embodiment 1, wherein the reusable handle body houses the control electronics and illumination source and is intended to be reusable.

[0106] P embodiment 9. The device of P embodiment 1, wherein the reusable handle body can wirelessly transmit video and data to a screen, computer, or other portable device.

[0107] P embodiment 10. The device of P embodiment 1, wherein the reusable handle body includes an LED transmitter that includes white, blue or green visible light for the purpose of photobiomodulation.

Claims

1. An intraocular cyclophotocoagulation device, a proximal reusable portion and a distal disposable portion; the proximal reusable portion a proximal housing portion having a distal end region; a laser treatment assembly including a laser diode and a collimating lens positioned a distance distal to the laser diode and configured to collimate light from the laser diode into a collimated laser beam and direct the collimated laser beam toward the distal end region of the proximal housing portion; an imaging assembly; and the distal disposable portion a distal housing portion having an elongate shaft extending distally from a distal end region thereof, the distal housing portion having a proximal end region configured to reversibly couple with the distal end region of the proximal housing portion; a laser guide extending through the elongate shaft, and an aspheric lens disposed within the distal housing portion to receive the collimated laser beam from the proximal reusable portion and direct the collimated laser beam toward a proximal end of an optical fiber of the laser guide; an imaging guide extending through the elongate shaft; and an objective lens located at the distal end region of the elongate shaft and configured to focus an image onto the distal end of an optical fiber of the imaging guide; an illumination light guide extending through the elongate shaft; and an illumination source disposed within the distal housing portion and positioned opposite a proximal end of an optical fiber of the illumination light guide; having Device.

2. 10. The apparatus of claim 1, wherein the laser diode of the laser treatment assembly is configured to deliver near-infrared wavelengths configured to burn and shrink tissue.

3. 10. The device of claim 1, wherein the collimated laser beam remains unchanged with minimal divergence or convergence upon crossing the junction from the reusable portion to the disposable portion.

4. 10. The apparatus of claim 1, wherein the aspheric lens corrects for spherical aberration and provides focal points for both paraxial and marginal rays of the collimated laser beam such that all of the light is incident on the proximal end of the optical fiber of the laser guide.

5. 10. The apparatus of claim 1, wherein the optical fiber of the laser guide has a diameter of 200 microns and the collimated laser beam has a focused spot of 100 microns.

6. The apparatus of claim 1 , wherein the objective lens is monolithic and does not have an aperture.

7. the objective lens has a frustoconical configuration with a small diameter entrance face and a largest diameter exit face; The device of claim 1 , wherein the exit face is located proximal to the entrance face near a distal end of the optical fiber of the imaging guide.

8. the objective lens has an hourglass configuration having an entrance face, an exit face, and a neck located between the entrance face and the exit face; The device of claim 1 , wherein the neck has a diameter smaller than the diameter of the inlet face or the diameter of the outlet face.

9. The apparatus of claim 1 , wherein the objective lens has a depth of focus between 1 and 6 mm.

10. The apparatus of claim 1 , wherein a proximal end of the optical fiber of the illumination light guide is attached to or near a light emitting die of the illumination source.

11. The apparatus of claim 10 , wherein the optical fiber of the illumination light guide is potted into a recess in the illumination source.

12. 12. The apparatus of claim 11, wherein the recess has a curved bottom and, together with an optical adhesive in the recess, forms a focusing lens between the optical fiber of the illumination light guide and the light emitting die of the illumination source.

13. The apparatus of claim 1 , further comprising an actuator that is a slider configured to increase the intensity of the emitted laser light.

14. The device of claim 13 , wherein the slider is disposed on the disposable portion.

15. The device of claim 1 , wherein the elongate shaft is curved.

16. 16. The device of claim 15, providing a field of view of between 45 and 150 degrees.

17. The device of claim 1 , wherein the distal end region of the proximal housing portion is tapered and sized to be received within a correspondingly shaped region of the proximal end region of the distal housing portion.

18. 18. The device of claim 17, wherein the distal end region of the proximal housing portion and the proximal end region of the distal housing portion are coupled under a spring load.

19. The device of claim 1 , further comprising a fluid channel extending within the disposable portion.

20. 20. The device of claim 19, wherein the fluid channel extends through the elongate shaft.

21. 20. The device of claim 19, wherein the fluid channel is configured to supply a chilled liquid to the eye.

22. 22. The apparatus of claim 21, wherein the cooled liquid is water or salt water.

23. 20. The device of claim 19, wherein the fluid channel is configured to deliver a therapeutic agent.

24. An intraocular cyclophotocoagulation device, a proximal reusable portion and a distal disposable portion; the proximal reusable portion a proximal housing portion having a distal end region; a laser treatment assembly including a laser diode and a collimating lens positioned a distance distal to the laser diode and configured to collimate light from the laser diode into a collimated laser beam and direct the collimated laser beam toward the distal end region of the proximal housing portion; an imaging assembly; and the distal disposable portion a distal housing portion having an elongate shaft extending distally from a distal end region thereof, the distal housing portion having a proximal end region configured to reversibly couple with the distal end region of the proximal housing portion; a laser guide extending through the elongate shaft; and an aspheric lens disposed within the distal housing portion to receive the collimated laser beam from the proximal reusable portion and direct the collimated laser beam toward the proximal end of the optical fiber of the laser guide. an imaging guide extending through the elongate shaft; and a monolithic apertureless objective lens located at a distal end region of the elongate shaft, the objective lens positioned to focus an image onto a distal end of an optical fiber of the imaging guide; an illumination light guide extending through the elongate shaft for transmitting light from an illumination source for illuminating the interior of the eye; An apparatus having:

25. An intraocular cyclophotocoagulation device, a proximal reusable portion and a distal disposable portion; the proximal reusable portion a proximal housing portion having a distal end region; an imaging assembly having an image sensor and a lens element; and the distal disposable portion a distal housing portion having an elongate shaft extending distally from a distal end region thereof, the distal housing portion having a proximal end region configured to reversibly couple with the distal end region of the proximal housing portion; an imaging guide extending through the elongate shaft; and an objective lens located at a distal end region of the elongate shaft distal to a distal end of the imaging guide, the objective lens positioned to focus an image at the distal end of the imaging guide; an illumination light guide extending through the elongate shaft; and an illumination source disposed within the distal housing portion and positioned opposite a proximal end of the illumination light guide; a laser treatment assembly; and The laser treatment assembly includes: a laser guide having a laser optical fiber extending through the elongate shaft having a proximal end and a distal end; a laser diode emitter located proximal to the proximal end of the laser optical fiber, the laser diode emitter having a base coupled to an annular casing, the casing having an inner diameter; a ball lens supported on the annular casing, the ball lens configured to direct a collimated laser beam from the emitter toward the proximal end of the laser guide. Device.

26. An intraocular cyclophotocoagulation device, a proximal reusable portion and a distal disposable portion; the proximal reusable portion a proximal housing portion having a distal end region; a laser treatment assembly having a laser diode and configured to direct a collimated laser beam toward the distal end region of the proximal housing portion; an imaging assembly; and the distal disposable portion a distal housing portion having an elongate shaft extending distally from a distal end region thereof, the distal housing portion having a proximal end region configured to reversibly couple with the distal end region of the proximal housing portion; a laser guide extending through the elongate shaft, and an aspheric lens disposed within the distal housing portion to receive the collimated laser beam from the proximal reusable portion and direct the collimated laser beam toward a proximal end of an optical fiber of the laser guide; an imaging guide extending through the elongate shaft; and an objective lens disposed in a distal end region of the elongate shaft and positioned to focus an image onto a distal end of an optical fiber of the imaging guide; an illumination light guide extending through the elongated shaft; An apparatus having:

27. 1. An endoscopic device for intraocular treatment, the device comprising: a proximal reusable portion having a proximal housing portion having a distal end region; a distal disposable portion having a distal housing portion with an elongate shaft extending distally from a distal end region of the distal housing portion, the distal housing portion having a proximal end region configured to reversibly mate with the distal end region of the proximal housing portion; a frustoconical lens disposed within the distal end region of the elongate shaft; An apparatus having:

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