Device and method for improving tracking in laser-based ophthalmic procedures
A protrusion with a larger surface area at the instrument tip addresses the challenge of bubble repulsion in laser-based ophthalmic procedures, enhancing trackability and efficiency by trapping and collapsing bubbles inward, thus improving surgical outcomes.
Patent Information
- Application Number
- JP2025504103
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-09-02
- Filing Date
- 2023-08-17
- Publication Date
- 2025-09-04
AI Technical Summary
Existing laser-based ophthalmic procedures face challenges in maintaining efficient trackability and control over laser-induced bubbles during tissue disruption, particularly at high power settings, leading to reduced cutting efficiency and material displacement.
The introduction of a protrusion with a larger distal surface area at the instrument tip to inhibit bubble migration, enhancing the instrument's ability to trap and collapse bubbles, thereby improving trackability and compliance.
The protrusion design significantly reduces bubble repulsion, enhancing the efficiency and effectiveness of laser-based procedures by ensuring that bubbles collapse inward, improving the instrument's ability to maintain contact with the treatment area.
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Figure 2025529018000001_ABST
Abstract
Description
[Technical Field]
[0001] The present disclosure relates to devices and methods for improving trackability in laser-based ophthalmic procedures. [Background technology]
[0002] Lasers are used in many different medical procedures, including many different ophthalmic procedures. For example, lasers may be used in cataract surgery, such as to fragment and / or emulsify cataractous lenses. In some procedures, a laser is first used to fragment the lens, followed by phacoemulsification of the lens with an ultrasonic handpiece to complete the fragmentation for removal. In other procedures, a laser may be used to complete the fragmentation and / or emulsification of the lens for removal without the need for separate application of ultrasonic energy. Lasers may also be used in other steps of cataract surgery, such as making corneal incisions and / or opening the lens capsule.
[0003] U.S. Patent Application Publication No. 2018 / 0360657 discloses an example of an ophthalmic laser system. This application describes the use of a laser, for example, to create a surgical incision or photodisrupt eye tissue, and for cataract surgery, such as laser-assisted cataract surgery (LACS). U.S. Patent Application Publication No. 2019 / 0201238 discloses another example of an ophthalmic laser system. This application describes the use of a laser, such as in a vitrectomy probe, to cut or break vitreous fibers. U.S. Patent Application Publication Nos. 2018 / 0360657 and 2019 / 0201238 are expressly incorporated herein by reference in their entireties.
[0004] Some laser systems emit pulses of a desired duration and repetition rate. Operating a laser in pulses can achieve desirable power and energy characteristics for a particular application.
[0005] The basic mechanism for emulsifying or disrupting the lens or other ocular tissue (e.g., in cataract surgery) is by delivering laser energy of the appropriate wavelength and pulse duration to the tip of an optical fiber (e.g., a sapphire optical fiber). The laser induces a plasma region just prior to the optical surface due to absorption of the laser energy by the surrounding material. The laser-induced plasma nucleates the formation of a bubble, which serves to disrupt its surroundings through its expansion and subsequent collapse. If the crystalline lens, cataract lens, and other ocular tissue are present in the bubble region, they can be disrupted and emulsified by the laser bubble action. [Prior art documents] [Patent documents]
[0006] [Patent Document 1] US Patent Application Publication No. 2018 / 0360657 [Patent Document 2] US Patent Application Publication No. 2019 / 0201238 Summary of the Invention
[0007] The present disclosure relates to devices and methods for improving trackability in laser-based ophthalmic procedures.
[0008] In some embodiments, the ophthalmic instrument includes a shaft having a distal end adapted to be inserted into a patient's eye toward a treatment area; an optical fiber for delivering laser energy to the treatment area, the optical fiber having a distal end adapted to be positioned facing the treatment area during use of the ophthalmic instrument; and a protrusion located at the distal end of the shaft, the protrusion having a distal surface near the distal end of the optical fiber, the distal surface adapted to be positioned facing the treatment area during use of the ophthalmic instrument.
[0009] In some embodiments, the surface area of the distal surface of the protrusion is at least two times greater than the surface area of the end face of the shaft. In some embodiments, the surface area of the distal surface of the protrusion may be at least eight times greater than the surface area of the end face of the shaft. In some embodiments, the distal surface of the protrusion has a length of 0.020 inches to 2.3 mm (0.090 inches) and a width of 0.020 inches to 1.5 mm (0.060 inches). Smaller or larger lengths and / or widths may be used.
[0010] In some embodiments, the shaft is tubular. The optical fiber may be located inside the shaft. In other embodiments, the optical fiber may be located outside the shaft. The shaft may be a cannula adapted for aspiration from the treatment area.
[0011] In some embodiments, the ophthalmic instrument may include a tip disposed at the distal end of the shaft, and the protrusion is part of the tip. The tip may be transparent. The tip may comprise a polymeric material such as polycarbonate.
[0012] The ophthalmic instrument may include an irrigating sleeve. The irrigating sleeve may include a proximal hub adapted to be coupled to a housing of the ophthalmic instrument and a distal tube adapted to fit around a shaft. The distal tube of the irrigating sleeve may have a distal end, an end opening at the distal end adapted to fit around the distal end of the shaft, and at least one side opening at the distal end adjacent the end opening and adapted for irrigation fluid to flow therethrough.
[0013] In some embodiments, the protrusion may be part of the irrigation sleeve, which may comprise an elastomeric material such as silicone rubber.
[0014] The shaft may have a longitudinal axis and the protrusion may be asymmetric with respect to the longitudinal axis of the shaft. The protrusion may be angled with respect to the longitudinal axis of the shaft.
[0015] In some embodiments, a method of performing an ophthalmic surgical procedure includes inserting a distal end of an ophthalmic instrument into a patient's eye toward a treatment area, the ophthalmic instrument including a shaft, an optical fiber, and a protrusion; positioning the distal end of the ophthalmic instrument adjacent to the treatment area so that the distal end of the optical fiber faces the treatment area and so that a distal surface of the protrusion faces the treatment area; and delivering laser energy to the treatment area through the optical fiber, wherein the distal surface of the protrusion functions to inhibit bubbles formed during the procedure from migrating distally away from the distal end of the ophthalmic instrument.
[0016] Further examples and features of embodiments of the present invention will be apparent from the drawings and detailed description.
[0017] The accompanying drawings illustrate exemplary embodiments of the systems and methods disclosed herein and, together with the description, serve to explain the principles of the present disclosure. [Brief explanation of the drawings]
[0018] [Figure 1] 1 illustrates an example of an ophthalmic instrument having a laser optical fiber. [Figure 2] 2 shows an enlarged view of the distal end of the ophthalmic device of FIG. 1. [Figure 3] 1 illustrates a tip of an ophthalmic instrument according to one embodiment of the present disclosure. [Figure 4] 4 illustrates a distal end of an ophthalmic instrument having the tip of FIG. 3 according to one embodiment of the present disclosure. [Figure 5] 5 illustrates another view of the distal end of the ophthalmic device of FIG. 4. [Figure 6] 1 illustrates a distal end of an ophthalmic device according to another embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0019] The accompanying drawings can be better understood with reference to the following detailed description.
[0020] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe those and other embodiments. It will nevertheless be understood that no limitation of the scope of the claims is intended by the examples illustrated in the drawings or described herein. All changes and further modifications to the systems, devices, apparatus, or methods shown or described, and any further applications of the principles of the present disclosure, are fully contemplated as would normally occur to one skilled in the art to which the present disclosure pertains. In particular, features, components, and / or steps described with respect to one embodiment of the present disclosure may be combined with features, components, and / or steps described with respect to other embodiments of the present disclosure. For simplicity's sake, the same reference numerals may, in some cases, be used throughout the drawings to refer to the same or similar parts.
[0021] The designations "first" and "second" as used herein are not intended to denote or imply any particular location or other characteristic. Rather, when used herein, the designations "first" and "second" are used only to distinguish one component from another. The terms "mounted," "connected," "coupled," and the like mean that one component is mounted, connected, coupled, etc. to another component directly or indirectly through one or more other components, unless such direct or indirect mounting, connection, coupling, etc. is specified.
[0022] The ophthalmic instruments described herein can be used in conjunction with an ophthalmic surgical console. The ophthalmic surgical console can be similar to the ophthalmic surgical console shown and described in U.S. Pat. No. 9,931,447, the entire disclosure of which is expressly incorporated herein by reference. The ophthalmic surgical console can be similar to a known and already used ophthalmic surgical console, such as the CENTURION® Vision System available from Alcon Laboratories, Inc. (Fort Worth, Texas) or the CONSTELLATION® Vision System available from Alcon Laboratories, Inc. (Fort Worth, Texas), or any other ophthalmic surgical console suitable for use with the principles described herein.
[0023] The surgical console may include one or more systems that may be used in performing an ophthalmic surgical procedure. For example, the surgical console may include a fluid system, including an irrigation system for delivering fluids to the eye and / or an aspiration system for aspirating fluids and other substances from the eye.
[0024] An exemplary surgical system according to the present disclosure may include a laser system suitable for one or more ophthalmic procedures. The laser system may include a laser that may be housed elsewhere, such as within the surgical console or within a separate console in communication with the surgical console. The laser system may have other components. For example, the laser system may include components for operating the laser, such as a power supply, a controller, a laser pump, a laser energy control element, and / or a monitor. Additionally, the laser system may include components in the optical path of the laser output, such as one or more lenses, mirrors, and / or optical fibers.
[0025] In some embodiments, the laser system may be suitable for cataract surgery. In some embodiments, the output energy of the laser system is suitable for fragmenting and / or emulsifying a cataractous lens. In some instances, the laser output is used to fragment and / or emulsify the lens sufficiently to remove the lens.
[0026] The laser may be any type of laser suitable for the desired application. The laser may output suitable electromagnetic radiation of any appropriate wavelength. For example, the laser may emit electromagnetic radiation of one or more wavelengths within the visible, infrared, and / or ultraviolet wavelengths. The laser operates or may be operated to emit a continuous beam of electromagnetic radiation. Alternatively, the laser operates or may be operated to emit a pulsed beam.
[0027] In one example, the laser operates in the infrared range. For example, the laser may output electromagnetic radiation in the mid-infrared range, e.g., a wavelength range of about 2.0 micrometers to about 4.0 micrometers. Some example wavelengths include about 2.5 micrometers to 3.5 micrometers, e.g., about 2.775 micrometers, about 2.8 micrometers, or about 3.0 micrometers. Such a laser may be suitable, for example, for lens fragmentation or emulsification in cataract surgery or other procedures.
[0028] The laser system is designed to direct the laser electromagnetic radiation from the laser to an output port. The laser system may direct the laser electromagnetic radiation from the laser to the output port through one or more optical components, such as lenses and mirrors.
[0029] An ophthalmic instrument may be optically connected to the laser system to receive the laser electromagnetic radiation from the output port. The ophthalmic instrument may be, for example, a handpiece for an ophthalmic procedure. The instrument (e.g., handpiece) may be connected to the laser system by, for example, a cable having optical fibers. The connection (e.g., cable) may be flexible and relatively long to provide flexibility for an operator to operate the handpiece at some distance from the laser system. The laser electromagnetic radiation may be transmitted from the laser system to the handpiece via the optical fibers of the connecting cable. The optical fibers of the connecting cable may be continuous through the handpiece or may be optically connected to an optical fiber within the handpiece. In either case, the handpiece may include an optical fiber that terminates distally at the distal end of the handpiece. The optical fiber carries the laser electromagnetic energy from the laser and delivers it from the distal end of the optical fiber at the distal end of the handpiece to a desired target, such as the lens or lens fragment of a patient's eye.
[0030] As described above, the ophthalmic instrument may be connected to a control console or laser system by a cable having one or more optical fibers for delivering laser energy. The ophthalmic instrument may also have one or more other connections to the console or control system. For example, the ophthalmic instrument may be connected to the control console by one or more irrigation lines for supplying irrigation fluid from the control console to the instrument and / or one or more aspiration lines for providing suction and suction through the instrument.
[0031] 1 shows an example of an ophthalmic instrument 100 having a laser optical fiber 140, for example a sapphire optical fiber. FIG. 2 shows an enlarged view of the distal end 102 of the ophthalmic instrument 100 of FIG.
[0032] Ophthalmic instrument 100 includes a housing 104 and a shaft 110, such as a cannula or other shaft, extending from a distal end of housing 104. Housing 104 may be hollow, having an interior chamber in which the internal components of instrument 100 may be housed and protected. Housing 104 may have an exterior surface that may be grasped by an operator of instrument 100, such as a surgeon.
[0033] Shaft 110 may be tubular, e.g., a hollow tube such as a cannula, having an opening 114 at its distal end 112 that can be used for suction. For example, by applying suction through a suction channel from the proximal end of a suction luer at the proximal end of housing 104, fluid and / or tissue, such as a lens or other tissue fragments, can be aspirated through opening 114 at distal end 112 of shaft 110.
[0034] As shown, the optical fiber 140 may be located inside the shaft 110. In other embodiments, the optical fiber 140 may be located outside the shaft 110. The optical fiber tip 142 may be flush with (in the same plane as) the end face 116 of the shaft 110. In other embodiments, the optical fiber tip 142 may extend beyond the end face 116 of the shaft 110, or the end face 116 of the shaft 110 may extend beyond the optical fiber tip 142. The optical fiber tip 142 need not be inside the suction port 114, but only need be close enough to facilitate suction of material affected by laser action.
[0035] The ophthalmic instrument 100 may also include an irrigation sleeve 120. The irrigation sleeve 120 may function to direct irrigation fluid, such as saline, to the distal end 102 of the instrument 100. The housing 104 may have an irrigation supply line through which irrigation fluid can be introduced. The irrigation sleeve 120 may be coupled directly to the housing 104 or may be coupled to the housing 104 via another portion of the ophthalmic instrument 100. In one example, the housing 104 may have external threads at its distal end and the irrigation sleeve 120 may have internal threads at its proximal end, thereby allowing the irrigation sleeve 120 to be attached to the housing 104. As seen in FIG. 1 , the irrigation sleeve 120 generally has a proximal hub 126 having a relatively large diameter for coupling to the housing 104 and a distal tube 128 in the form of a thin tube having a relatively small diameter for fitting around the shaft 110 in a size small enough to be inserted through an incision in the eye.
[0036] In the illustrated example, the irrigation sleeve 120 is disposed around the shaft 110 to provide a fluid passageway or channel from its attachment point to the housing 104 through the space between the irrigation sleeve 120 and the shaft 110. The irrigation sleeve 120 may have an end opening 123 at its distal end 122 through which the distal end 112 of the shaft 110 extends, and one or more side openings 124 at its distal end 122 adjacent the end opening 123. At the end openings 123, the irrigation sleeve 120 fits snugly around the shaft 110. When irrigation fluid is introduced through a supply line in the housing 104, the irrigation fluid passes through the channel in the irrigation sleeve 120 and exits the side openings 124 at the distal end 122 of the irrigation sleeve 120.
[0037] As an example, the distal tube 128 of the irrigating sleeve 120 may have an outer diameter in the range of 0.76 mm (0.030 inches) to 2.0 mm (0.080 inches) to fit through the incision in the eye, and an inner diameter in the range of 0.51 mm (0.020 inches) to 1.8 mm (0.070 inches) to accommodate the shaft 110. The end opening 123 at the distal end 122 of the irrigating sleeve 120, through which the distal end 112 of the shaft 110 protrudes, may be a circular opening having a diameter in the range of 0.25 mm (0.010 inches) to 1.7 mm (0.065 inches), which is equal to or slightly smaller than the outer diameter of the distal end 112 of the shaft 110 and can form a snug fit around the distal end 112 of the shaft 110. The example dimensions and dimension ranges represent possible embodiments, and other embodiments with different dimensions may be used.
[0038] The irrigating sleeve 120 may be made of an elastomeric material, such as flexible silicone rubber. Alternatively, the irrigating sleeve 120 may be made of other materials, such as polyurethane, ethylene propylene, neoprene, or other suitable materials. The elastomeric material for the irrigating sleeve 120 allows for some flexibility and facilitates a snug fit between the irrigating sleeve 120 and the shaft 110 in the area of the end opening 123. The elastomeric material of the irrigating sleeve 120 also facilitates a seal or snug fit between the irrigating sleeve 120 and adjacent ocular tissue at the incision site, such as the cornea or sclera, which may help minimize leakage from the eye between the ocular tissue and the irrigating sleeve 120.
[0039] In operation of the device, an operator inserts the distal end 102 of the ophthalmic instrument 100 through an appropriate incision in a patient's eye and positions the distal end 102 of the ophthalmic instrument 100 at a desired location, for example, adjacent to the patient's cataractous lens. The distal end 112 of the shaft 110 is directed toward the treatment area, with the tip 142 at the distal end of the optical fiber 140 positioned facing the treatment area. Irrigation fluid, such as saline, can be supplied from the control console through the irrigation supply line and the irrigation sleeve 120 to flow out the side opening 124 and into the target area. The laser can be activated to emit laser energy from the tip 142 of the optical fiber 140 (i.e., the distal end of the optical fiber 140), which can fragment and emulsify desired tissue, such as a cataractous lens. At the same time, the pump module can be used to apply suction through shaft 110, thereby drawing fluid and tissue and / or lens fragments separated by the action of the laser through opening 114.
[0040] Figure 3 shows a tip 150 of an ophthalmic device 100 according to one embodiment of the present disclosure. Figure 4 shows a distal end 102 of an ophthalmic device 100 having the tip 150 of Figure 3. Figure 5 shows another view of the distal end 102 of the ophthalmic device 100 of Figure 4.
[0041] The tip 150 has a cylindrical hub 152 and a protrusion 154. As seen in FIGS. 4 and 5 , the cylindrical hub 152 is adapted to fit over and fit over the distal end 112 of the shaft 110. In this illustrated example, the tip 150 has a central bore that provides an entrance to the channel in the shaft 110 for suction. In this illustrated example, the optical fiber 140 is located inside the shaft 110 and inside the central bore of the tip 150. In another example, the tip 150 also has a central bore that provides an entrance to the channel in the shaft 110 for suction, but the optical fiber 140 is located outside the shaft 110, with the optical fiber 140 being located either inside or outside the central bore of the tip 150. In some embodiments, placing the optical fiber 140 outside the shaft 110 may help reduce clogging of the suction channel by offsetting the laser action from the suction channel.
[0042] 4 and 5, by having tip 150 as part of instrument 100, protrusion 154 is located at distal end 112 of shaft 110 and distal end 102 of instrument 100. Protrusion 154 has a distal surface 160 near distal tip 142 of optical fiber 140. Distal surface 160 faces the area into which fiber optic tip 142 is directed. When instrument 100 is in use with fiber optic tip 142 facing the treatment area, distal surface 160 also faces the treatment area.
[0043] The protrusions 154 having distal surfaces 160 provide a significantly larger surface area facing the treatment area than would otherwise face the treatment area. For example, in the illustrated instrument 100, without the protrusions 154, the end face 116 of the shaft 110 (see FIG. 2) would be the only surface facing the treatment area, other than the tips 142 of the optical fibers 140 themselves. The protrusions 154 provide a significantly larger surface area facing the treatment area compared to the end face 116 of the shaft 110.
[0044] In one example, end face 116 has an outer diameter of 0.62 mm (0.0243 inches), an inner diameter of 0.47 mm (0.0187 inches), and a surface area of 0.128 square mm (0.000198 square inches). In one example of protrusion 154, the surface area of distal surface 160 facing the treatment area is 1.06 square mm (0.00164 square inches). Thus, in this example, the surface area of distal surface 160 of protrusion 154 is more than eight times greater than the surface area of end face 116 of shaft 110.
[0045] In other examples, the surface area of the distal surface 160 of the protrusion 154 may be at least two times greater than the surface area of the end face 116 of the shaft 110, or at least four times greater than the surface area of the end face 116 of the shaft 110, or at least six times greater than the surface area of the end face 116 of the shaft 110. The distal surface 160 of the protrusion 154 may have a length of 0.020 inches to 2.3 mm (0.090 inches) and a width of 0.020 inches to 1.5 mm (0.060 inches). Smaller or larger lengths and / or widths may also be used. In one example, the distal surface 160 of the protrusion 154 has a length of approximately 0.050 inches and a width of approximately 0.020 inches. The distal surface 160 of the protrusion 154 may be wholly or partially recessed or curved, thereby presenting a concave surface facing the treatment area that better conforms to the shape of the bubble induced by laser action.
[0046] The protrusion 154, having its distal surface 160 presenting a surface area facing the area to be treated by the laser, helps to inhibit the migration of laser-formed bubbles away from the fiber optic tip 142. Without the surface area of the protrusion, in certain circumstances, the action of the laser and the dynamic behavior of the bubble could cause the laser-formed bubble to migrate away from the distal end of the instrument, which could reduce the efficiency of the laser action or otherwise adversely affect the performance of the instrument.
[0047] This challenge is best understood by the behavior of a bubble nucleated at the tip of a laser fiber without an adjacent surface, such as the distal surface 160 of the protrusion 154, as the bubble undergoes its life cycle from nucleation to collapse. As described above, emulsification or disruption of the lens or other ocular tissue (e.g., in cataract surgery) can be achieved by delivering laser energy of an appropriate wavelength and pulse duration (e.g., short laser pulses) to the tip of an optical fiber. When the fiber is immersed in a medium that can readily absorb the laser energy, a plasma zone is generated at the fiber tip. The vaporized material begins to expand into a bubble.
[0048] In its life cycle, the bubble begins to expand immediately after delivery of laser energy. The bubble continues to expand until it reaches a maximum diameter. The maximum bubble size depends on the amount of energy delivered to the tip of the fiber. In one example, the bubble can grow to envelop the delivery fiber. As the bubble expands, it can displace fluid.
[0049] In a typical bubble life cycle, after reaching its maximum diameter, the bubble begins to collapse. As the bubble collapses, the presence of the optical fiber can cause the bubble walls near the optical fiber to collapse at a faster rate than the front of the bubble (opposite the fiber). Typically, once the bubble walls reach the tip of the optical fiber, the bubble moves away from the optical fiber but continues to collapse.
[0050] At this point, the separated bubble is typically asymmetrical because the separated wall penetrates the bubble. The bubble center is no longer in front of the fiber where the bubble nucleated. In continuing the life cycle of a bubble formed by a system without adjacent surfaces, such as distal surface 160 of protrusion 154, the bubble gains forward momentum or a repulsive force away from the fiber.
[0051] In the continuation of a typical bubble life cycle, the bubble will soon collapse again completely, creating extremely high pressures and temperatures, causing another rebound or another bubble expansion. In a typical bubble formation (without an adjacent surface, such as distal surface 160 of protrusion 154), the bubble may move or rebound significantly away from its original location. A second bubble may also collapse and rebound again before the energy is completely dissipated by the surrounding medium. The completed bubble may move substantially away from the location of nucleation.
[0052] A potential problem is that along with the destructive (tissue cutting / ablative) effects of the laser energy and bubble dynamics, a repulsion effect can occur, which can impair the efficiency of the system. The repulsion generated by the system tends to push away the material the operator is working with. When using this method to emulsify cataractous lenses, the cutting action is typically combined with an irrigation and aspiration system. In laser systems with very low laser repetition rates (e.g., 50 Hz or less) or when there are pauses in the laser firing, aspiration can help reduce the repulsion issue. When higher laser power or material cutting rates are desired, aspiration rates (e.g., rates up to 40 cc / min) may not be sufficient to control the repulsion effect of the laser. Higher material cutting rates can range from 1500 Hz (repetition rate) or even higher.
[0053] Thus, without the protrusions and associated surface area facing the treatment area (e.g., protrusions 154 with distal surface 160), the system may have good holding power at high vacuum levels or low power settings, but at higher laser power settings, the laser action and bubble dynamics may cause the generated bubbles to repel, thus significantly reducing cutting force or emulsification efficiency as the target tissue or material moves away from the distal end of the instrument tip rather than being crushed and sucked into the cannula.
[0054] Using a protrusion (e.g., protrusion 154) with a large surface area (e.g., the surface area of distal surface 160) facing the treatment region helps to suppress the distal migration of bubble action from fiber optic tip 142. At the very least, it reduces the repulsive effect of the laser-induced bubble dynamics. In some embodiments, it can reverse the effect so that repulsion becomes attractive. In cataract surgery terms, using a protrusion with its surface area facing the treatment region improves trackability.
[0055] Protrusions with their surfaces facing the treatment area improve compliance because collapsing bubbles tend to collapse toward their surfaces. If a bubble (e.g., approximately equal to or larger than the largest bubble) nucleates near a solid boundary, upon collapse, the bubble tends to collapse within the boundary.
[0056] This phenomenon can be understood by considering the mass flux of a bubble near such a solid boundary as it begins to collapse. As the bubble begins to collapse, fluid mass from the surrounding medium moves in to fill the void, but due to the presence of the adjacent solid boundary, this "filling" is not symmetric. Mass cannot flow in from this location because the solid boundary acts as a restriction. Therefore, the net effect is to cause the bubble to collapse toward the solid boundary, thereby minimizing repulsion and potentially creating fluid flow toward the solid boundary.
[0057] By using protrusions (e.g., protrusions 154) with a large surface area facing the treatment area (e.g., the surface area of distal surface 160), the dynamic behavior of the bubbles is transformed such that bubble migration away from the instrument is inhibited or reduced. In some embodiments, the bubbles collapse within the cannula, minimizing or even completely negating rebound.
[0058] So, in summary, the repulsive effect of laser action and subsequent bubble collapse can be greatly reduced by providing an appendage to the distal end of the instrument or modifying it to create a surface to "trap" the bubbles. This surface serves to trap the bubbles and implode them inwards, or to exert a force on the bubbles towards the instrument, thereby minimizing repulsion.
[0059] The shape of the protrusions and their distal surface can control how the bubble collapses. In one example, the tip 150 with the protrusions 154 is a plastic part that is added to the shaft 110, for example, a metal cannula. The protrusions can also be formed from the shaft or cannula itself. The shape of the protrusions can have different configurations depending on performance requirements. The surface shape can be modified to create different bubble collapse shapes.
[0060] The tip 150, including the hub 152 and the protrusion 154, may be transparent to facilitate visualization through the material by an operator. The tip may comprise a polymeric material. By way of example, the tip may comprise polycarbonate.
[0061] The protrusions 154 and distal surface 160 may be asymmetric about the longitudinal axis 118 of the shaft 110. This may allow for a cutting or scraping action on one side of the instrument 100.
[0062] The protrusions 154 may be angled relative to the longitudinal axis 118 of the shaft 110, i.e., not perpendicular thereto, which may help to facilitate insertion of the distal end 102 of the instrument 100 into the eye. That is, the operator may tilt the instrument 100 at a first angle to manipulate the protrusions 154 through the incision in the eye, and then tilt the instrument 100 at a second angle to manipulate the shaft 110 through the incision in the eye.
[0063] FIG. 6 illustrates the distal end of an ophthalmic instrument 200 according to another embodiment of the present disclosure. The ophthalmic instrument 200 may be similar to the ophthalmic instrument 100, except that instead of a tip 150, the irrigating sleeve 220 incorporates a protrusion 254 having a distal surface 260. Thus, the protrusion 254 is part of the irrigating sleeve 220. The distal surface 260 functions similarly to the distal surface 160. In this illustrated example, the irrigating sleeve 220 has a central bore that provides an entrance to the channel in the shaft 110 for aspiration. In this illustrated example, the optical fiber 140 is located inside the shaft 110 and within the central bore of the irrigating sleeve 220. In another example, the irrigating sleeve 220 also has a central bore that provides an entrance to the channel in the shaft 110 for aspiration, but the optical fiber 140 is disposed outside the shaft 110, with the optical fiber 140 located either inside or outside the central bore of the irrigating sleeve 220.
[0064] The irrigation sleeves 160, 260, including the protrusions 154, 254, may be transparent to facilitate visualization through the material by the operator. The protrusions 154, 254 may be formed of the same material as the irrigation sleeves 160, 260 or a different material, for example, a polymeric material such as polycarbonate or an elastomeric material such as silicone rubber.
[0065] Like protrusion 154, protrusion 254 and distal surface 260 may be asymmetric about longitudinal axis 118 of shaft 110, which may allow for a cutting or scraping action on one side of instrument 200. Protrusion 254 may also be angled, i.e., not perpendicular, to longitudinal axis 118 of shaft 110 to facilitate insertion of the distal end of instrument 200 into the eye, as described above.
[0066] In a method of performing an ophthalmic surgical procedure, an operator inserts the distal end of the ophthalmic instrument 100, 200 into a patient's eye toward a treatment area. The operator positions the distal end of the ophthalmic instrument 100, 200 adjacent to the treatment area with the distal end of the optical fiber facing the treatment area and with the distal surfaces 160, 260 of the protrusions 154, 254 facing the treatment area. The operator delivers laser energy to the treatment area through the optical fiber. The distal surfaces 160, 260 of the protrusions function to inhibit bubbles formed during the procedure from migrating distally away from the distal end of the ophthalmic instrument 100, 200.
[0067] As will be appreciated by those skilled in the art, the systems and methods disclosed herein have advantages over conventional systems and methods. For example, the systems and methods described herein can improve trackability and laser action, improving the ease, time, efficiency, accuracy, outcomes, and / or cost of a procedure.
[0068] Those skilled in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the specific exemplary embodiments described above. While exemplary embodiments have been shown and described, a wide range of modifications, variations, and substitutions to the foregoing disclosure are contemplated. It is understood that such variations can be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and consistently with the present disclosure.
Claims
1. 1. An ophthalmic instrument comprising: a shaft having a distal end adapted to be inserted into a patient's eye and toward a treatment area; an optical fiber for delivering laser energy to the treatment area, the optical fiber having a distal end adapted to be positioned facing the treatment area during use of the ophthalmic device; a protrusion located at the distal end of the shaft, the protrusion having a distal surface proximate the distal end of the optical fiber, the distal surface adapted to be positioned facing the treatment area during use of the ophthalmic device; 1. An ophthalmic instrument, comprising:
2. The ophthalmic device of claim 1 , wherein the shaft has an end face at a distal end thereof, and the surface area of the distal surface of the protrusion is at least two times greater than the surface area of the end face of the shaft.
3. The ophthalmic device of claim 2 , wherein the surface area of the distal surface of the protrusion is at least eight times greater than the surface area of the end face of the shaft.
4. 10. The ophthalmic device of claim 1, wherein the distal surface of the protrusion has a length between 0.020 inches and 0.090 inches and a width between 0.020 inches and 0.060 inches.
5. The ophthalmic device of claim 1 , wherein the shaft is tubular, the tubular shaft adapted for suction from the treatment area.
6. The ophthalmic device of claim 5 , wherein the optical fiber is located within the tubular shaft.
7. The ophthalmic device of claim 5 , wherein the optical fiber is disposed externally of the tubular shaft.
8. The ophthalmic device of claim 1 , including a tip disposed at the distal end of the shaft, the protrusion being a part of the tip.
9. The ophthalmic device of claim 8 , wherein the tip is transparent.
10. The ophthalmic device of claim 9 , wherein the tip comprises a polymeric material.
11. The ophthalmic device of claim 10 , wherein the tip comprises polycarbonate.
12. The ophthalmic device of claim 1 , comprising an irrigation sleeve.
13. 13. The ophthalmic device of claim 12, wherein the irrigation sleeve includes a proximal hub adapted to be coupled to a housing of the ophthalmic device and a distal tube adapted to fit around the shaft.
14. 14. The ophthalmic device of claim 13, wherein the distal tube of the irrigation sleeve has a distal end, an end opening at the distal end adapted to fit around the distal end of the shaft, and at least one side opening at the distal end adjacent the end opening adapted for irrigation fluid to flow therethrough.
15. The ophthalmic device of claim 12 , wherein the protrusion is part of the irrigation sleeve.
16. The ophthalmic device of claim 15 , wherein the irrigation sleeve comprises an elastomeric material.
17. The ophthalmic device of claim 16 , wherein the irrigation sleeve comprises silicone rubber.
18. The ophthalmic device of claim 1 , wherein the shaft has a longitudinal axis and the protrusions are asymmetrical about the longitudinal axis of the shaft.
19. The ophthalmic device of claim 1 , wherein the shaft has a longitudinal axis and the protrusion is angled relative to the longitudinal axis of the shaft.
20. 1. A method of performing an ophthalmic surgical procedure, comprising: inserting a distal end of an ophthalmic instrument into a patient's eye toward a treatment area, the ophthalmic instrument including a shaft, an optical fiber, and a protrusion; positioning the distal end of the ophthalmic device adjacent to the treatment area such that the distal end of the optical fiber faces the treatment area and such that a distal surface of the protrusion faces the treatment area; delivering laser energy to the treatment area through the optical fiber; Including, the distal surface of the protrusion inhibits bubbles formed during a procedure from migrating distally away from the distal end of the ophthalmic instrument. method.
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