Vitreoretinal apparatus for illumination, fluid aspiration, and photocoagulation

Abstract

The present disclosure relates generally to small gauge instruments for surgical procedures, and more particularly to vitreoretinal instruments for retinal repair and reattachment procedures and related methods of use. Certain embodiments of the present disclosure provide a curved or articulating probe configured to provide illumination, fluid aspiration, and intraocular photocoagulation. Thus, the probe allows for aspiration of subretinal fluid that reaccumulates after initial drainage and during intraocular photocoagulation without the need to change surgical instruments or insert additional instruments into the intraocular space. Additionally, the combined functionality of the probe allows the surgeon to aspirate fluid and / or perform retinal photocoagulation while simultaneously performing scleral compression with the surgeon's other hand.

Description

Technical Field

[0001] Claim of Priority This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 230,138, entitled "VITREORETINAL INSTRUMENTS FOR ILLUMINATION, FLUID ASPIRATION, AND PHOTOCOAGULATION," filed on August 6, 2021, with inventor Steven T. Charles, and is hereby incorporated by reference in its entirety as if fully and completely set forth herein.

Background Art

[0002] In a healthy human eye, the retina is physically attached to the choroid generally circumferentially, e.g., hemispherically, via the retinal pigment epithelium ("RPE") behind the pars plana. The vitreous humor, a transparent jelly-like substance that fills the posterior segment of the eye, facilitates contact with the choroid but does not physically attach to the choroid.

[0003] A portion of the retina may develop a tear or hole and detach from the RPE. In one example, retinal detachment allows vitreous humor and sometimes aqueous humor to flow between the retina and the RPE, resulting in the accumulation of subretinal fluid. Either condition can lead to vision loss in the patient.

[0004] During surgical repair or reattachment of the retina, a surgeon may insert a vitreoretinal instrument into the posterior segment of the eye through a sclerotomy (an incision in the sclera at the pars plana). The surgeon may also insert an endoilluminator and an irrigation cannula into the eye through a similar incision and may sometimes use a suction probe instead of a vitreoretinal instrument. While observing the posterior segment with a microscope, using the endoilluminator, the surgeon can use the vitreoretinal instrument to excise and aspirate the vitreous humor and gain access to the retinal detachment or hole. During this part of the procedure, saline may be injected into the eye through the irrigation cannula to maintain appropriate intraocular pressure.

[0005] Next, the surgeon may remove fluid from under the retina and inject air, an air-gas mixture, or perfluorocarbon to repair the detached portion of the retina to its proper position and flatten the retina against the RPE or choroid. Soft-tip cannulas, forceps, or other instruments may be used for such procedures. In certain cases, liquid perfluorocarbon is injected into the posterior segment of the eye as retinal tamponade while saline is moved and removed from the posterior segment. This procedure may be called a "fluid / perfluorocarbon exchange." In certain cases, air is injected as the retinal tamponade fluid while saline is aspirated. This procedure may be called a "fluid / air exchange." In other specific cases, a mixture of air and a gas such as SF6, C3F8, or C2F6 is injected as the retinal tamponade fluid while saline is aspirated. This procedure may be called a "fluid / gas exchange." As used herein, “fluid” may include, but is not limited to, any liquid or gas suitable for intraocular use, such as saline solution with or without additives, silicone oil, liquid perfluorocarbon, air, or perfluorocarbon gas.

[0006] After performing one of the above exchanges, the surgeon may drain, for example, aspirate, the subretinal fluid present between the retina and choroid through a retinal tear or drainage retinal incision using an appropriate cannula, metal cannula, or soft-tip cannula, and then repair or reattach the retina by intraocular photocoagulation using a laser probe. For repair to be performed, the retina must be positioned relative to the RPE or choroid so that the RPE absorbs the laser energy from the laser probe. The presence of subretinal fluid between the retina and choroid can hinder the absorption of the laser during retinal repair, leading to inefficiency during such a procedure. Therefore, it is advantageous to drain the subretinal fluid from the surgical site via an aspiration probe before intraocular photocoagulation with a laser probe.

[0007] In certain cases, after the initial drainage of subretinal fluid, it may re-accumulate at the surgical site due to posterior flow, requiring additional drainage. When using conventional aspiration probes and laser probes, the aspiration probe must either be retained within the posterior segment of the eye during intraocular photocoagulation (requiring a chandelier for illumination) or re-inserted through the same or a new incision as the laser probe. However, repeated removal and insertion to switch between aspiration and laser probes can cause unnecessary trauma to the eye at the incision site or collisions with the retina or lens during instrument changes and / or delays in procedures during retinal repair. [Overview of the project] [Means for solving the problem]

[0008] According to a particular embodiment, an instrument for removing subretinal fluid from an eye is provided. The instrument comprises a handle and a cannula coupled to the handle, wherein the distal portion of the cannula has a curvature corresponding to the curvature of the retina of the eye, and the cannula further includes a lumen extending through the cannula and at least one port adjacent to the distal end of the cannula for aspirating subretinal fluid from the eye to the lumen; a first optical fiber extending through the cannula for propagating illumination light through the distal end of the cannula; and a second optical fiber extending through the cannula for propagating laser light through the distal end of the cannula.

[0009] To allow for a more detailed understanding of the above-mentioned features of this disclosure, a more specific description of this disclosure, which has been briefly summarized above, can be obtained by referring to embodiments, some of which are shown in the accompanying drawings. However, it should be noted that the accompanying drawings only illustrate exemplary embodiments and should not be considered as limiting the scope, as other equally effective embodiments may be found. [Brief explanation of the drawing]

[0010] [Figure 1]Figure 1 shows an exemplary surgical instrument according to a particular embodiment of the present disclosure. [Figure 2] Figure 2 shows a cross-sectional view of an eye into which an exemplary cannula of the surgical instrument shown in Figure 1 is inserted, according to a particular embodiment of the present disclosure. [Figure 3A] Figure 3A shows a magnified side view of the surgical instrument cannula of Figure 1, according to a particular embodiment of the present disclosure. [Figure 3B] Figure 3B shows an enlarged side cross-sectional view of the cannula of the surgical instrument shown in Figure 1, according to a particular embodiment of the present disclosure. [Figure 3C] Figure 3C shows an enlarged side cross-sectional view of the surgical instrument cannula of Figure 1, according to a particular embodiment of the present disclosure. [Figure 3D] Figure 3D shows an enlarged frontal cross-sectional view of the surgical instrument cannula of Figure 1, according to a particular embodiment of the present disclosure. [Figure 4] Figure 4 shows a schematic side cross-sectional view of the surgical instrument of Figure 1 according to a particular embodiment of the present disclosure. [Figure 5A] Figure 5A shows a different configuration of another exemplary surgical instrument according to a particular embodiment of the present disclosure. [Figure 5B] Figure 5B shows a different configuration of another exemplary surgical instrument according to a particular embodiment of the present disclosure. [Figure 5C] Figure 5C shows an enlarged side view of the cannula of the surgical instrument shown in Figures 5A-5B, according to a particular embodiment of the present disclosure. [Modes for carrying out the invention]

[0011] For the purpose of facilitating understanding, the same reference numerals are used whenever possible to indicate identical elements common to the drawings. It is assumed that elements and features of one embodiment can be usefully incorporated into other embodiments without further explanation.

[0012] In the following description, details are given as examples to facilitate understanding of what is being disclosed. However, it should be apparent to those skilled in the art that the disclosed implementations are examples and do not encompass all possible implementations. Therefore, it should be understood that references to the examples described are not intended to limit the scope of this disclosure. Any modifications and further alterations to the devices, apparatus, and methods described, as well as any further applications of the principles of this disclosure, are fully assumed to be what those skilled in the art in the field to which this disclosure relates would ordinarily conceive. In particular, features, components, and / or steps described in relation to one implementation may be combined with features, components, and / or steps described in relation to other implementations of this disclosure.

[0013] As described herein, the distal end, distal segment, or distal portion of a component refers to the end, segment, or part that is closer to the patient's body during use of that component. Conversely, the proximal end, proximal segment, or proximal portion of a component refers to the end, segment, or part that is further away from the patient's body.

[0014] Where used herein, the term "approximately" may refer to a variation of + / - 10% from the nominal value. It should be understood that such variation may be present in any of the values ​​provided herein.

[0015] This disclosure generally relates to small-gauge instruments (e.g., 23-gauge, 25-gauge, or 27-gauge) for surgical procedures, and more specifically to vitreoretinal instruments for retinal repair and reattachment procedures and related methods of use. One embodiment of this disclosure provides a curved or articulated probe configured to provide illumination, fluid aspiration, and intraocular photocoagulation. Thus, the probe allows for the aspiration of subretinal fluid that re-accumulates after initial drainage and during intraocular photocoagulation without the need to change surgical instruments or insert additional instruments into the intraocular space. Furthermore, the combined function of the probe allows the surgeon to simultaneously perform scleral compression with the surgeon's other hand while aspirating fluid and / or performing retinal intraocular photocoagulation. As a result, the use of the probe as described above allows for improved procedure efficiency and a reduced risk of damaging the patient's eye.

[0016] Figure 1 shows an exemplary surgical instrument 100 according to a particular embodiment. The surgical instrument 100 may include a flexible cannula 110. As shown in Figure 2, during an ophthalmic surgical procedure, the cannula 110 may be placed into the eye 200 through an incision 202 known as a scleral incision, via an access cannula 204, which is a separate component from the cannula 110. While present in the eye 200, the cannula 110 may be used to illuminate the intraocular space within the eye 200 via one or more optical fibers placed within the cannula 110, to aspirate material from the eye 200 through one or more suction ports placed within the cannula 110, and to propagate a laser beam for intraocular photocoagulation of tissue within the eye 200 via one or more optical fibers. In one example, during vitreoretinal surgery, the distal end 112 of the cannula 110 may be inserted posterior to the retina 210 within the eye 200 in order to illuminate the subretinal space 212, drain the subretinal fluid from there, and then seal the retina 210 by photocoagulation.

[0017] Referring again to Figure 1, the surgical instrument 100 may also include a handle 120 having a proximal end 122 and a distal end 124. In some embodiments, the handle 120 is a handpiece having an outer surface configured to be grasped by a user, e.g., a surgeon. Thus, the handle 120 may be given an ergonomic contour to fit substantially to the user's hand. In some embodiments, the outer surface may be textured or have one or more gripping features 126 formed thereon, e.g., one or more grooves and / or ridges. The handle 120 may be made from any material commonly used in such instruments and suitable for ophthalmic surgery. For example, the handle 120 may be made of lightweight aluminum, a metal alloy, a polymer or other suitable material. In some embodiments, the handle 120 may be sterilized and used for two or more surgical procedures, or it may be a single-use device.

[0018] The handle 120 further includes a number of ports 128 (e.g., three ports 128a-c shown in Figure 1) at its proximal end 122 for connecting to a number of tubes 130 (e.g., three tubes 130a-c shown in Figure 1). In the example in Figure 1, port 128a provides a fluid connection between the handle 120 and the internal lumen of the cannula 110 (described below) and the tube 130a, and the tube 130a may be an extrusion tube for fluidly coupling a surgical instrument 100 to a vacuum source 132 of the surgical console for, for example, aspirating subretinal fluid from the eye 200. In one embodiment, port 128a includes a Luer lock connector for coupling the handle 120 to the tube 130a. Port 128b provides a connection for the tube 130b. The tube 130b may be an optical fiber cable for coupling optical fibers in the handle 120 and the cannula 110 to an illumination light source 134 of the surgical console for propagating illumination light to the eye 200. Port 128c provides a connection to 130c, which may be an optical fiber cable for coupling the optical fibers in the handle 120 and cannula 110 to the laser light source 136 of the surgical console in order to propagate the laser light to the eye 200. While using the surgical instrument 100, the user can activate one of the vacuum source 132, illumination source 134, and laser light source 136 via one or more toggles (e.g., buttons, switches, etc.) on the handle 120, the surgical console communicating with the surgical instrument 100, or a foot pedal communicating with the surgical console and / or the surgical instrument 100.

[0019] In the example of FIG. 1, note that the illumination light source 134 and the laser light source 136 are shown as separate light sources that can be coupled to separate optical fibers (e.g., one optical fiber for propagating illumination light and another optical fiber for propagating laser light) respectively. In such an embodiment, each optical fiber can be housed within a separate optical fiber cable, such as tubes 130b and 130c. However, in other embodiments, a single light source and a single optical fiber can be used to generate and propagate both illumination light and laser light, which further requires only a single optical fiber cable, such as tube 130b or tube 130c.

[0020] The cannula 110 extends axially from the distal end 124 of the handle 120 and can be directly or indirectly coupled to the handle 120 within the internal chamber of the handle 120. Generally, the cannula 110 is formed of a flexible or elastic material, such as a superelastic alloy or a shape memory alloy, that can still have sufficient rigidity to facilitate manipulation of eye tissue during a surgical procedure. Examples of suitable superelastic alloys include nickel titanium (i.e., Nitinol (Nickel Titanium Naval Ordinance Laboratory)) and spring steel. However, other flexible metals are also contemplated. In one embodiment, the cannula 110 includes a proximal straight portion 114 and a distal curved portion 116. Referring to FIG. 2, when the curved portion 116 is disposed within or otherwise passes through the access cannula 204, the curved portion 116 is made of a superelastic material and thus bends or straightens to allow its passage through the access cannula 204.

[0021] FIG. 3A shows an enlarged side view of the cannula 110, and FIG. 3B shows a stylized cross-sectional side view of the cannula 110. As shown, the cannula 110 is generally an elongated tubular member including a straight portion 114 and a curved portion 116. The longitudinal axis M shown in FIG. 3B extends axially within the cannula 110 and includes a first portion 340 passing through the straight portion 114 and a second portion 342 passing through the curved portion 116. In some embodiments, the cannula 110 has an axial length A of about 15 millimeters (mm) to about 45 mm (e.g., along the axis M), although in some embodiments it may have a longer or shorter axial length A. In further embodiments, due to the curvature of the curved portion 116, the cannula 110 has a linear length L shorter than the axial length A, e.g., a linear length L of about 15 mm to about 30 mm, although in some embodiments it may have a longer or shorter linear length L.

[0022] The cannula 110 may generally have an outer diameter D less than about 20 gauge, e.g., an outer diameter D of less than about 23 gauge, 25 gauge, 27 gauge or 29 gauge. In some embodiments, as shown in FIGS. 3A - 3B, the cannula 110 may have a constant or uniform outer diameter D along the axis M, and in other embodiments, the cannula 110 may have a non-uniform outer diameter D along the axis M. For example, in some embodiments, the cannula 110 may have a tapered outer diameter D along the axis M, with the outer diameter D decreasing distally along the axis M. In other embodiments, the cannula 110 is segmented along the axis M, and different segments of the cannula 110 may have different outer diameters D. For example, a more distal segment of the cannula 110 may have a smaller diameter D than a more proximal segment of the cannula 110.

[0023] The curved portion 116 of the cannula 110 is positioned distal to the straight portion 114 and is defined by an outer curved surface 304 and an inner curved surface 306. In some embodiments, the curved portion 116 or at least the inner curved surface 306 has a radius of curvature similar to that of the retina of the patient's eye, for example, the retina 210 in Figure 2. For example, as shown in Figure 3B, the longitudinal axis M of the cannula 110 or the inner curved surface 306 may have a curvature defined by a radius 344 that coincides with or corresponds to the radius of curvature of the retina 210. As further shown in Figure 3B, the curved portion 116 may be curved to define an angle α between portions 340 and 342 of the axis M. In some embodiments, the angle α is in the range of about 90° to about 180°, for example, about 110° to about 160°, for example, about 120° to about 150°, for example, about 120° to about 140°.

[0024] The curved portion 116 further includes one or more suction ports 302 arranged along its outer curved surface 304, one or more of which can be fluidly coupled to, for example, a vacuum source 132 via an internal lumen 330. The lumen 330 functions as a suction channel through the cannula 110 to the internal chamber of the handle 120 and to the tube 130a shown in Figure 1. Thus, when the vacuum source 132 is activated, for example, ophthalmic material in the eye 200 can be aspirated through the suction ports 302 to the lumen 330 of the cannula 110 and through the tube 130a. By arranging the suction ports 302 along the outer curved surface 304, the risk of retinal entrapment during subretinal fluid drainage using the surgical instrument 100 is reduced. This is because, for example, if inserted through a retinal tear, the retina is located close to the inner curved surface 306 and opposite to the outer curved surface 304. In general, the suction port 302 may have any suitable form for, for example, aspirating subretinal fluid, and may be arranged in any suitable arrangement along the outer curved surface 304. For example, the suction port 302 may be arranged in one or more longitudinal rows along the curved surface 304, as shown in Figures 3A to 3C. Due to the curvature of the curved portion 116, the suction port 302 may be offset angularly and laterally from the straight portion 114 of the cannula 110.

[0025] As described above, the surgical instrument 100 is configured to propagate and deliver both illumination light and laser light to the eye 200 via one or more optical fibers placed within the cannula 110. Figures 3C to 3D show an example of a cannula 110 within the assembled surgical instrument 100, which has two optical fibers placed within it, each optical fiber configured to propagate either illumination light or laser light. Although the examples in Figures 3C to 3D are described as having two optical fibers, it should be noted that in some embodiments, a single optical fiber configured to propagate both illumination light and laser light may also be used.

[0026] Figure 3C shows a stylized longitudinal section of a cannula 110 in which a first optical fiber 310 and a second optical fiber 320 are housed. As shown, the cannula 110 includes a lumen 330. In addition to providing an aspiration channel for ophthalmic material, such as subretinal fluid, the lumen 330 also provides a conduit for the first and second optical fibers 310, 320 to extend through the cannula 110 to the distal end 112. The distal end 112 of the cannula 110 further includes a protective window 350, which provides an optically clear or transparent barrier through which laser light and / or illumination light can pass during surgical procedures. Thus, the window 350 includes an optically clear or transparent material such as sapphire, fused silica, or other glass or ceramic material having a high transition temperature. In certain embodiments, the transparent material has refractive power, and in certain other embodiments, the transparent material does not have refractive power. Refractive power (also called refractive power, focusing power, or converging power) is the degree to which a lens, mirror, or other optical system focuses or diverges light. Therefore, the window 350 itself may be a lens such as a spherical lens or an aspherical lens having a concave or convex surface.

[0027] The first optical fiber 310 is designed to act as an optical waveguide, propagating illumination light 312 generated by an illumination light source 134 (e.g., a light engine) through the distal end 112 of the cannula 110 to illuminate a surgical site in the intraocular space, such as a site or retinal tear or detachment. In some embodiments, the first optical fiber 310 is an optical nanofiber having a diameter of less than about 30 μm (micrometers), for example, about 20 μm to about 30 μm. In such embodiments, the reduction in the overall cross-sectional footprint (i.e., occupied area) of the first optical fiber 310 increases the amount of unoccupied cross-sectional area within the lumen 330, thereby providing a wider fluid channel and improving the flow of aspirated ophthalmic material through the lumen 330. Furthermore, the optical nanofiber may have reduced stiffness compared to larger, more conventional optical fibers, thus allowing for relatively greater flexibility (e.g., bending over a wider angular range) of the cannula 110.

[0028] As shown in Figure 3C, the first optical fiber 310 may further include a microlens 316 positioned at its end 314 for generating a diverging broad-spectrum illumination beam. Thus, the microlens 316 may be a spherical lens (e.g., a ball lens) or an aspherical lens (e.g., a bullet lens) having a concave or convex surface. In one embodiment, the end 314 abuts against the window 350 in the lumen 330, while in other embodiments, as shown in Figure 3C, the end 314 is positioned at a distance from the window 350.

[0029] In one embodiment, the illumination source 134 may be used to continuously or pulsely supply illumination light 312 to the first optical fiber 310, and the illumination light 312 may then be propagated by the first optical fiber 310 through the distal end 112 of the cannula 110 in one of various ways. The illumination source 134 may be any suitable type of light source, such as a light-emitting diode (LED) based light source or a superluminescent diode (SLED) based light source. However, other types of light sources such as xenon or halogen based light sources, UV (ultraviolet) light sources, white light sources, etc., are also conceivable. As described above, the illumination source 134 may be part of an illumination module in a surgical console or may be a separate, independent light engine.

[0030] Similar to the first optical fiber 310, the second optical fiber 320 is designed to act as an optical waveguide, propagating laser light 322 generated by a laser light source 136 (e.g., a laser engine) through the distal end 112 of the cannula 110, allowing retinal tissue in the eye 200 (labeled 210 in Figure 2) to be repaired by intraocular photocoagulation. In one embodiment, the end 324 of the second optical fiber 320 abuts against the window 350 in the lumen 330, while in another embodiment, as shown in Figure 3C, the end 314 is spaced away from the window 350. In one embodiment, the second optical fiber 320 may be an optical nanofiber with a diameter of less than about 30 μm, for example, about 20 μm to about 30 μm. As described above, in such embodiments, the reduction in the overall cross-sectional area of ​​the optical fiber 320 may facilitate a wider fluid channel within the cannula 110, potentially improving the flow of aspirated ocular material through the lumen 330. Furthermore, compared to larger conventional optical fibers, the reduced rigidity of nanofibers may allow for relatively greater flexibility in the cannula 110.

[0031] The properties of the laser light 322 propagated through the second optical fiber 320 are such that the laser light 322 coagulates the retinal tissue in the path of the laser light 322 by thermal energy, and then this retinal tissue heals and seals the retina 210. The cauterization is performed by the laser light 322, heating the tissue to a temperature above 50°C but below 100°C. At this point, the proteins in the tissue are denatured and platelets begin to coagulate. Thus, the laser light source 136 may include any suitable type of ophthalmic laser light source for generating photocoagulation laser light capable of treating retinal tissue (for example, to perform retinal reattachment surgery). For example, the laser light source 136 may be configured to generate laser light having wavelengths from about 440 nm to about 830 nm, such as a blue-green laser light source (e.g., 488 nm), a green laser light source (e.g., 514 nm), a high-power green diode laser light source, or a red laser light source (e.g., 647 nm). In one embodiment, the laser light source 136 is an Nd:YAG laser light source (e.g., 532 nm) or a frequency-doubling CW Nd:YAG laser light source (e.g., 1064 nm). In one embodiment, the laser light source 136 generates laser light 322 having a pulse rate in the range of about 1 kilohertz (kHz) to about 500 kHz, which can effectively provide heating of the retina, although other pulse rate ranges are also intended. In one embodiment, the laser light source 136 generates continuous wave laser light 322. For example, the laser light source 136 may generate continuous wave laser light 322 at low power.

[0032] Figure 3D shows a front cross-sectional view of a cannula 110 containing a first optical fiber 310 and a second optical fiber 320, according to a particular embodiment of the present disclosure. As shown, the first optical fiber 310 and the second optical fiber 320 are positioned side by side along the longitudinal portion of the inner side wall 352 of the cannula 110, opposite the suction port 302 (e.g., coupled). The optical fibers 310, 320 may be bonded or joined to the inner side wall 352 by any suitable adhesive or bonding mechanism. For example, in one embodiment, the optical fibers 310, 320 may be bonded to the inner side wall 352 by an epoxy or acrylic adhesive. However, other suitable adhesives or binders are also intended. By coupling both optical fibers 310 and 320 to the inner side wall 352 on the opposite side of the suction port 302, it may be possible to improve the flow of ophthalmic material drawn through the suction port 302 and lumen 330 by reducing the amount of flow path obstruction in the central part of the lumen 330 and / or near the suction port 302.

[0033] Figure 4 shows a schematic side cross-sectional view of a surgical instrument 400 according to a particular embodiment of the present disclosure. More specifically, Figure 4 shows an exemplary arrangement of optical fibers placed within and coupled to the surgical instrument 400, representing a particular embodiment described herein that uses optical nanofibers, for example, optical fibers having a diameter of about 30 μm or less, within a cannula 110.

[0034] As shown in Figure 4, the surgical instrument 400 includes an optical nanofiber 410 extending into the cannula 110. The optical nanofiber 410 represents the first optical fiber 310 and / or the second optical fiber 320 in Figures 3C-3D, where the optical fiber 310 and / or optical fiber 320 are optical nanofibers. Although only one optical nanofiber 410 is shown, it should be noted that this arrangement can be applied to both the first optical fiber 310 and the second optical fiber 320. As described above, the use of the optical nanofiber 410 increases the unoccupied cross-sectional area within the lumen 330 in order to improve the aspiration of ocular material by the surgical instrument 400. However, conventional surgical consoles and / or illumination or laser sources may only conform to standard 84-inch long optical fibers with larger diameters, for example, about 120 μm. Therefore, in order to enable the compatibility of the surgical instrument 400 with conventional surgical consoles and / or illumination and laser light sources, the optical nanofibers 410 may be optically coupled to the surgical console and / or illumination or laser light source via one or more additional optical fibers joined (i.e., coupled) in series.

[0035] In the arrangement shown in Figure 4, the optical nanofiber 410 is proximal to the tapered optical fiber 420 at a junction 440 in the lumen 421 of the handle 120, and the tapered optical fiber 420 is proximal to the delivery fiber 430 at a junction 442 in the lumen 421. The tapered optical fiber 420 generally has a tapered (e.g., non-constant) diameter that increases proximal to allow optical coupling between the optical nanofiber 410 and the delivery fiber 430, which may be a standard-sized optical fiber. Thus, the tapered optical fiber 420 includes a smaller distal end 422 configured to couple with the proximal end 414 of the optical nanofiber 410 and a larger proximal end 424 configured to couple with the distal end 432 of the delivery fiber 430. The delivery fiber 430 is at least partially located within the tube 130. The tube 130 may be an optical fiber cable extending into the port 128 of the handle 120 to physically connect the surgical instrument 400 to a surgical console and / or an illumination source or laser source such as an illumination source 134 or a laser source 136.

[0036] In one embodiment, the optical nanofiber 410 and the tapered optical fiber 420 and / or the tapered optical fiber 420 and the delivery fiber 430 are butt-joined at joints 440, 442 by fusion splicing or mechanical connection. For example, in one embodiment, the optical nanofiber 410 and the tapered optical fiber 420 and / or the tapered optical fiber 420 and the delivery fiber 430 are mechanically connected at joints 440, 442 using epoxy or a mechanical clamping mechanism. In a further embodiment, a connector such as a linear mating sleeve or a tapered / biconical mating sleeve is used to butt-join the optical nanofiber 410 and the tapered optical fiber 420 at joint 440 and / or the tapered optical fiber 420 and the delivery fiber 430 at joint 442.

[0037] In one embodiment, the optical nanofiber 410 has an numerical aperture (NA) of about 0.66, a critical angle of about 41.3°, and a firing cone angle of 82.6°. In other specific embodiments, the optical nanofiber 410 has an numerical aperture (NA) of about 0.86, a critical angle of about 59.32°, and a firing cone angle of 118.6°. To optimize the coupling efficiency between the optical nanofiber 410 and the tapered optical fiber 420 and / or between the tapered optical fiber 420 and the delivery fiber 430, which may otherwise be adversely affected as a result of variations in core diameter, NA, refractive index profile, etc., the tapered optical fiber 420 can be selected based on the optical properties of the optical nanofiber 410, and the delivery fiber 430 can be selected based on the optical properties of the tapered optical fiber 420. For example, based on the above-mentioned properties of the optical nanofiber 410 (e.g., NA, critical angle, firing cone angle, etc.), the selected delivery fiber 430 may have a low NA and a large diameter.

[0038] In one embodiment, the tapered optical fiber 420 and / or delivery fiber 430 are given by the following formula: A*Ω(proximal end of thin fiber) = A*Ω (distal end of a thick fiber) It can be selected based on the following criteria.

[0039] Here, "A" is the cross-sectional area of ​​the corresponding fiber end, and "Ω" is the solid angle of the optical cone of the corresponding fiber end. Therefore, for example, to optimize the coupling efficiency between the optical nanofiber 410 and the tapered optical fiber 420, the A*Ω product of the optical nanofiber 410 can be matched to the A*Ω product of the distal end 422 of the tapered optical fiber 420. In one embodiment, selecting the tapered optical fiber 420 and subsequently the delivery fiber 430 based on the optical properties of the optical nanofiber 410 may provide the additional benefit of eliminating coupling loss from the cannula 110 and / or handle 120, which could otherwise result in increased undesirable thermoformation.

[0040] Figures 5A and 5B schematically illustrate different configurations of another exemplary surgical instrument 500 according to a particular embodiment of the present disclosure, and Figure 5C shows an enlarged side view of the cannula 510 of the surgical instrument 500. The surgical instrument 500 is substantially similar to the surgical instruments 100 and 400 described above, but includes a cannula 510 with an articulated distal tip 516. Thus, in addition to the advantages provided by the combined functions of illumination, suction, and intraocular photocoagulation, the surgical instrument 500 further provides some degree of controllable articulation in one or more selected directions.

[0041] As shown in the figure, in addition to the articulated distal tip 516, the cannula 510 includes a proximal portion 514 that extends axially from the distal end 124 of the handle 120 and can be directly or indirectly coupled to the handle 120. The proximal portion 514 may generally have an outer diameter D1 of less than about 20 gauge, for example, less than about 23 gauge, 25 gauge, 27 gauge, or 29 gauge (shown in Figure 5C). In some embodiments, the proximal portion 514 is formed of a rigid and biocompatible material such as stainless steel or other suitable rigid metal alloy. In contrast, the distal tip 516 is formed of a flexible or elastic material such as a superelastic alloy or shape memory alloy, which may still have sufficient rigidity to facilitate manipulation of ocular tissue during surgical procedures. Examples of suitable superelastic alloys include nitinol and spring steel. However, other flexible metals are also intended for the distal tip 516. In one embodiment, the distal tip 516 has an outer diameter D2 that is substantially the same as or smaller than the outer diameter D1 of the proximal tip 514. For example, in one embodiment, the distal tip 516 has an outer diameter D2 of about 20 gauge, 23 gauge, 25 gauge, 27 gauge, or less than 29 gauge.

[0042] The distal tip 516 can be articulated in a manner controllable in a selected direction by applying tension to a control mechanism fixed within the cannula 510. In one embodiment, the control mechanism includes a pull wire or similar device extending into the distal tip 516 and the proximal tip 514, which can be controlled by applying tension to it via a toggle 528 such as a button, pinion, slide pin, lever, etc., on the handle 120. In one embodiment, the distal tip 516 can be articulated between a straight position 560 shown in Figure 5A and a curved position 562 shown in Figure 5B. In one embodiment, when the distal tip 516 is in the curved position 562, the distal tip 516 may match or have a similar radius of curvature to the retina of the patient's eye, for example, the retina 210 in Figure 2. Therefore, when positioned in a curved position 562, the distal tip 516 can be inserted through a tear in the retina, e.g., retina 210, and access the subretinal space, e.g., subretinal space 212. Here, the curvature of the distal tip 516 substantially matches the curvature of the retina to improve subretinal fluid aspiration while reducing retinal impaction. Such embodiments offer advantages over straight and rigid vitreoretinal instruments, which limit such vitreoretinal instruments to the position of a retinal tear or tear boundary, as access to the subretinal space without retinal impaction may be difficult.

[0043] Similar to the curved portion 116 of the cannula 110, the distal tip 516 includes one or more suction ports 502 (shown in Figure 5C) located within its wall, which may be fluidly coupled to a vacuum source, e.g., vacuum source 132, via the internal lumen of the cannula 510. The internal lumen of the cannula 510 functions as a suction channel through the cannula 510 to the internal chamber of the handle 120 and, for example, the tube 130a. In one embodiment, when the distal tip 516 is in the curved position 562, the suction ports 502 are formed along a surface 504 that forms the outer curved surface of the distal tip 516. Positioning the suction ports 502 along the surface 504 reduces the risk of retinal impaction during subretinal fluid drainage using the surgical instrument 500, because, when inserted through a retinal tear in the curved position 562, for example, the retina is located close to the surface 506 and opposite to the surface 504. Similar to the surgical instrument 100, the suction port 502 may have any suitable form for, for example, aspirating subretinal fluid, and may be arranged in any suitable arrangement along the surface 504. For example, the suction port 502 may be arranged in one or more longitudinal rows along the surface 504, as shown in Figure 5C. When the distal tip 516 is in the curved position 562, the suction port 502 may be offset angularly and laterally from the proximal portion 514 of the cannula 510.

[0044] In addition to providing suction, the surgical instrument 500 is also configured to propagate and deliver both illumination light and laser light to an eye, for example, an eye 200, via one or more optical fibers positioned within the cannula 510. Thus, as described with reference to surgical instruments 100 and 400, the surgical instrument 500 may have the same or substantially similar arrangement of one or more optical fibers within it, and therefore, for brevity, corresponding details are omitted. For example, the surgical instrument 500 may include two optical fibers positioned within it, each optical fiber configured to propagate either illumination light or laser light, or the surgical instrument 500 may include a single optical fiber, the single optical fiber configured to propagate both illumination light and laser light. To allow the propagation of illumination light and / or laser light from the distal tip 516, the distal tip 516 may include a protective window 550 at its distal end 512, the protective window 550 providing an optically clear or transparent barrier through which the laser light and / or illumination light can pass during surgical procedures. Similar to the window 350, the window 550 may include an optically clear or transparent material such as sapphire, fused silica, or other glass or ceramic materials having a high transition temperature. In some embodiments, the transparent material may have refractive power, and in certain other embodiments, the transparent material may not have refractive power. Thus, the window 550 itself may be a lens such as a spherical or aspherical lens having a concave or convex surface.

[0045] As described above, embodiments of the present disclosure provide a curved or articulated probe configured to provide illumination, fluid aspiration, and intraocular photocoagulation. Thus, the probe enables aspiration of subretinal fluid that re-accumulates during intraocular photocoagulation and after initial drainage by moving backward, without the need to change surgical instruments multiple times or insert additional instruments into the intraocular space. Furthermore, the combined function of the probe allows the surgeon to perform scleral compression with the surgeon's other hand while simultaneously aspirating fluid and / or performing retinal intraocular photocoagulation. As a result, the use of the probe as described above enables improved procedure efficiency and a reduced risk of damaging the patient's eye.

[0046] Exemplary Embodiments Embodiment 1: An instrument for removing subretinal fluid from an eye, comprising: a handle; an articulated cannula coupled to the handle, the articulated cannula being configurable between a linear and a curved configuration, the articulated cannula including a lumen extending through the cannula and at least one port adjacent to the distal end of the cannula, the port being for aspirating subretinal fluid from the eye to the lumen; a first optical fiber extending through the articulated cannula, the first optical fiber being for propagating illumination light through the distal end of the cannula; and a second optical fiber extending through the articulated cannula, the second optical fiber being for propagating laser light through the distal end of the cannula.

[0047] Embodiment 2: The cannula is the instrument of Embodiment 1, formed from a material containing a superelastic alloy.

[0048] Embodiment 3: The apparatus of Embodiment 2, wherein the superelastic alloy is nitinol.

[0049] Embodiment 4: The apparatus of Embodiment 1, wherein the proximal end of the handle includes a Luer lock type connector for connecting to an extrusion tube for aspirating subretinal fluid.

[0050] Embodiment 5: The apparatus of Embodiment 4, wherein the lumen is in fluid communication with a vacuum source via an extrusion tube.

[0051] Embodiment 6: The apparatus of Embodiment 1, wherein the first and second optical fibers are nanofibers having a diameter of approximately 30 microns or less.

[0052] Embodiment 7: The apparatus of Embodiment 6, wherein a first optical fiber is joined to a third optical fiber located within a handle, and the third optical fiber has a tapered diameter from its proximal end to its distal end.

[0053] Embodiment 8: The apparatus of Embodiment 7, wherein the third optical fiber is joined to a fourth optical fiber that is at least partially located within the handle.

[0054] Embodiment 9: The apparatus of Embodiment 6, wherein the first optical fiber includes a microlens at the distal end of the first optical fiber for generating a divergent beam of illumination light.

[0055] Embodiment 10: The apparatus of Embodiment 1, wherein the first optical fiber is optically coupled to a light-emitting diode (LED) illumination source.

[0056] Embodiment 11: The apparatus of Embodiment 1, wherein the first optical fiber is optically coupled to a superluminescent diode (LED) illumination source.

[0057] Embodiment 12: The apparatus of Embodiment 1, wherein the second optical fiber is optically coupled to a narrowband or broadband laser source.

[0058] Embodiment 13: The apparatus of Embodiment 12 above, wherein the laser source is a supercontinuum laser source.

[0059] Embodiment 14: The apparatus of Embodiment 1, further comprising an optically clear or transparent window positioned within the distal end of a cannula, the window further comprising an optically clear or transparent window that facilitates the propagation of illumination light and laser light through the distal end of the cannula.

[0060] Embodiment 15: The apparatus of Embodiment 1, wherein the first and second optical fibers are coupled to the inner side wall of a lumen facing at least one port.

[0061] The subject matter disclosed above is intended to be illustrative and not restrictive, and the attached claims are intended to cover all such modifications, improvements and other embodiments that constitute the true intent and scope of this disclosure. To the maximum extent permitted by law, the scope of this disclosure shall be determined by the broadest permissible interpretation of the following claims and their equivalents, and shall not be limited or restricted by the detailed description above.

Claims

1. An instrument for removing subretinal fluid from the eye, The handlebars and A cannula coupled to the handle, wherein the distal portion of the cannula has a curvature corresponding to the curvature of the retina of the eye, and the cannula is A lumen extending through the aforementioned cannula, and At least one port adjacent to the distal end of the cannula for aspirating subretinal fluid from the eye to the lumen, Furthermore, a cannula, A first optical fiber extending through the cannula, for propagating illumination light through the distal end of the cannula, A second optical fiber extending through the cannula, for propagating laser light through the distal end of the cannula, It is equipped with, The first optical fiber is joined to a third optical fiber located within the handle, and the third optical fiber has a tapered diameter from its proximal end to its distal end.

2. The apparatus according to claim 1, wherein the cannula is formed from a material containing a superelastic alloy.

3. The apparatus according to claim 2, wherein the superelastic alloy is nitinol.

4. The apparatus according to claim 1, wherein the proximal end of the handle includes a Luer lock type connector for connecting the handle to an extrusion tube for aspirating the subretinal fluid.

5. The apparatus according to claim 4, wherein the lumen is in fluid communication with a vacuum source via the extrusion tube.

6. The apparatus according to claim 1, wherein the first optical fiber and the second optical fiber are nanofibers having a diameter of about 30 microns or less.

7. The apparatus according to claim 1, wherein the third optical fiber is joined to a fourth optical fiber that is at least partially located within the handle.

8. The apparatus according to claim 6, wherein the first optical fiber includes a microlens at the distal end of the first optical fiber for generating a divergent beam of illumination light.

9. The apparatus according to claim 1, wherein the first optical fiber is optically coupled to a light-emitting diode (LED) illumination source.

10. The apparatus according to claim 1, wherein the first optical fiber is optically coupled to a superluminescent diode (LED) illumination source.

11. The apparatus according to claim 1, wherein the second optical fiber is optically coupled to a narrowband or broadband laser source.

12. The apparatus according to claim 11, wherein the laser source is a supercontinuum laser source.

13. The apparatus according to claim 1, further comprising an optically clear or transparent window disposed within the distal end of the cannula, which facilitates the propagation of illumination light and laser light through the distal end of the cannula.

14. The apparatus according to claim 1, wherein the first optical fiber and the second optical fiber are coupled to the inner side wall of the lumen facing the at least one port.

Images