Ophthalmic cutting instrument with integrated suction pump

Abstract

A device for performing ophthalmic surgery in an eye includes: a handheld portion; an elongated member extending from a distal region of the handheld portion; and a suction pump within the handheld portion. The elongated member includes a lumen and an opening near the distal region of the elongated member. The suction pump is in fluid communication with the opening of the elongated member. The suction pump includes a camshaft extending along a longitudinal axis and having a plurality of cam lobes; a conduit extending parallel to the longitudinal axis; and a plurality of cam followers driven by a cam of the camshaft to move in a plane perpendicular to the longitudinal axis to sequentially compress the conduit. Related devices, systems, and methods are provided.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority under 35 USC §119(e) to co-pending U.S. Provisional Patent Application Serial No. 62 / 849,302 filed on May 17, 2019, U.S. Provisional Patent Application Serial No. 62 / 868,688 filed on June 28, 2019, and U.S. Provisional Patent Application Serial No. 62 / 872,898 filed on July 11, 2019. The disclosures of these provisional applications are incorporated herein by reference in their entirety. Technical Field

[0003] The present technology relates generally to ophthalmic microsurgical tools and systems, and more particularly to ophthalmic cutting tools having a reusable, durable driver portion configured to be operably coupled to different disposable working portions in an interchangeable manner. Background Art

[0004] Certain types of conventional ophthalmic surgery require breaking up lens tissue and intraocular objects, such as intraocular lenses or vitreous bodies, in order to extract them from the eye. For example, lens extraction for cataract surgery is one of the most common surgical procedures, with more than 3 million operations performed each year in the United States alone. During cataract surgery, a commonly used lens extraction method is phacoemulsification, which uses ultrasonic energy to emulsify the lens, and then uses suction to remove the phacoemulsified liquid from the eye. Other methods of lens crushing and extraction can include using tools such as hooks, knives, or lasers to crush the lens into small enough fragments so that it can be extracted through an incision in the cornea in an ab interno method. The intraocular and intraocular crushing of lens tissue is important in cataract surgery to remove cataracts from an eye incision that is usually no more than 2.8-3.0 mm.

[0005] A typical phacoemulsification system includes a console in operative communication with a phacoemulsification handpiece, which provides control of the handpiece's electronics, aspiration, and irrigation. During a typical phacoemulsification procedure, a phacoemulsification tip is inserted into the anterior segment of the eye through a small incision in the cornea. The phacoemulsification tip is brought into contact with the lens of the eye so that the oscillating phacoemulsification top emulsifies the lens. The emulsified liquid is then aspirated through the lumen of the phacoemulsification tip.

[0006] A challenge associated with conventional phacoemulsification devices and other devices that use a remote vacuum source is that the aspiration line is very long and flexible, contributing to the compliance of the fluid system. Phacoemulsification machines incorporate a remote pump, typically a peristaltic pump, a venturi pump, or a combination of both, to provide fluid management during surgery. The role of the peristaltic pump is to sequentially compress the tubing segments between the plates or rollers to move a certain amount of fluid or tissue away from the surgical site. The plates or rollers are arranged so that there is at least one blocked tubing at any time. A transient pressure increase is experienced in the tubing. The peristaltic pump causes slight flow fluctuations when the rollers compress the tubing. Turbulence can cause posterior capsule bounce and iris flutter, which are undesirable movements. Long, flexible aspiration lines containing compressible materials can affect the response time at the tip when suction is turned on and off. These remote pumps are subject to post-occlusion surge.

[0007] In the context of cataract surgery, vitrectomy is used when complications occur during lens removal. For example, phacoemulsification carries the risk of penetrating the posterior lens capsule leading to inadvertent vitreous prolapse into the anterior segment of the eye. Vitrectomy is essentially a salvage procedure performed during cataract surgery. The goal of an anterior vitrectomy is to remove the vitreous from the anterior chamber, clear the vitreous from the entry incision, and allow for placement of an IOL.

[0008] The vitreous has an unpredictable flow behavior that is difficult to characterize due to its semisolid structure. The vitreous is composed primarily of water, but also of collagen fibers and hyaluronic acid. The vitreous needs to be cut before passing through the probe. Minced vitreous has a lower viscosity than intact, gelatinous vitreous. Small-sized fragments are preferred to improve aspiration and removal of the vitreous. Most commercially available anterior vitrectomies are designed for coaxial irrigation and vitrectomy. Local turbulence and vitreous volume expansion caused by hydration can be a problem for coaxial irrigation and cutting systems. Irrigation can also be performed using a two-handed approach with the vitrectomy separated from the irrigation. The vitrectomy is usually inserted through a limbal incision, but can also be inserted through a stab incision made 3 mm posterior to the limbus in the pars plana using a microvitrectomy blade. Low-level cutting (300 cuts per minute (cpm)) and aspiration can be used to remove lens fragments before starting vitreous removal. For vitreous removal, the cutting rate is set to high (500-600 cpm) with low to moderate aspiration. The high cutting speed to remove the vitreous allows a continuous flow of vitreous into the cutter. The vitrectomy cutter is placed through the capsular bag tear just below the capsular bag with the suction port facing upward toward the cornea. The vitreous is removed to a level just behind the capsular bag. Summary of the invention

[0009] According to a first aspect, a device for performing ophthalmic surgery in an eye is disclosed. The device includes a handheld portion and an elongated member extending from a distal region of the handheld portion. The elongated member includes a lumen and an opening near the distal region of the elongated member. The device includes a suction pump within the handheld portion in fluid communication with the opening of the elongated member. The suction pump includes a camshaft extending along a longitudinal axis and having a plurality of cam lobes; a conduit extending parallel to the longitudinal axis; and a plurality of cam followers driven by a cam of the camshaft to move in a plane perpendicular to the longitudinal axis to sequentially compress the conduit.

[0010] The conduit may include a proximal flow path that is divided into a pair of peripheral tubes located on either side of the cam shaft, the pair of peripheral tubes being combined on the distal side of the pumping manifold to form a distal flow path that is in fluid communication with the lumen of the elongated member. Multiple cam followers sequentially compress the pair of peripheral tubes to produce substantially non-pulsating suction. Substantially non-pulsating suction may be less than about 3 cc / minute. Substantially non-pulsating suction may be between 3 cc / minute and about 10 cc / minute. Substantially non-pulsating suction may be greater than 10 cc / minute up to about 25 cc / minute.

[0011] The elongated member may be capable of moving in a reciprocating manner relative to the handheld portion. The elongated member may be configured for lens fragmentation, phacoemulsification or anterior vitrectomy. The elongated member may have a maximum cross-sectional diameter of about 1.25 mm. The elongated member may have a maximum cross-sectional diameter of no more than about 3 mm. The elongated member may be a vitrectomy probe between 20 gauge and 27 gauge. The elongated member may be configured to slide back and forth in an outer tube that is fixedly coupled to the interior of the handheld portion. The distal tip of the elongated member may form a cutting edge. The outer tube may include an opening through the side wall. The elongated member may also include a side opening near its distal region, the side opening being configured to form two incisions in unison with the outer tube. The elongated member may include a proximal opening located in a chamber of a vacuum manifold that is fluidly connected to a suction pump.

[0012] The elongated member may be configured to oscillate at 300 cuts per minute. The elongated member may be configured to oscillate at 500-600 cuts per minute. The elongated member may be configured to oscillate up to about 5000 cuts per minute. The elongated member may be configured to oscillate up to (or reach, up to) about 7500 cuts per minute. The device may also include a gearbox configured to amplify the input from the pump to achieve the output of the elongated member configured for vitrectomy. The gearbox may be a planetary gearbox. The device may also include a drive mechanism configured to be operatively coupled to the camshaft. The drive mechanism is configured to rotate the camshaft. The device may also include a gear device to increase the input from the drive mechanism. The camshaft of the suction pump may rotate at a fixed rate to deliver a suction potential of about 15cc / minute to 30cc / minute. The input from the drive mechanism may be about 140RPM and the gear device may have a ratio of at least about 3:1, 4:1, 5:1, 6:1, up to about 30:1. The drive mechanism configured to rotate the camshaft can also drive the oscillation of the elongated member. The camshaft can be operatively engaged with a cutter assembly, which is configured to convert the rotational motion of the camshaft into a reciprocating linear motion of the elongated member. The cutter assembly can include a ramp cam and a cutter return spring. The proximal motion of the elongated member can depend on the ramp cam, and the distal motion of the elongated member can depend on the cutter return spring.

[0013] The cutter assembly may include a translating magnet disk and a rotating magnet disk. The translating magnet disk may include one or more magnets and the rotating magnet disk may include one or more magnets. When the one or more magnets of the rotating magnet disk rotate into alignment and misalignment with the one or more magnets of the translating magnet disk, the one or more magnets of the translating magnet disk and the rotating magnet disk may generate a local magnetic field. The translating magnet disk may be coupled to a cutter spline, and the cutter spline may be coupled to an elongated member so that the translating magnet disk, the cutter spline, and the elongated member all translate axially together. The translating magnet disk, the cutter spline, and the elongated member may be configured to move a distance axially bidirectionally along the longitudinal axis due to the rotation of the camshaft. The alignment of the one or more magnets of the rotating magnet disk with the one or more magnets of the translating magnet disk may cause linear motion by magnetic attraction or magnetic repulsion. The rotating magnet disk may include a plurality of magnets, which are oriented relative to each other so that the magnetic poles of the magnets alternate. The rotation of the rotating magnet disk relative to the translating magnet disk can cause the magnetic poles of the plurality of magnets to produce alternating repulsion and attraction with one or more magnets of the translating magnet disk, thereby causing the oscillation of the elongated member. The device may also include a second rotating magnet disk containing one or more magnets. The second rotating magnet disk may be located distal to the translating magnet disk. The alignment of one or more magnets of the first rotating magnet disk and the second rotating magnet disk with one or more magnets of the translating magnet disk can cause the oscillation of the cutting tube. One or more magnets of the second rotating magnet disk may have magnetic poles arranged to cause repulsion of one or more magnets of the translating magnet disk, and one or more magnets of the first rotating magnet disk have magnetic poles arranged to cause attraction. Repulsion and attraction can generate a stronger magnetic field to push the translating magnet disk to move linearly between the first rotating magnet disk and the second rotating magnet disk. The second rotating magnet disk can form a distal hard stop, and the first rotating magnet disk can form a proximal hard stop for the translating magnet disk.

[0014] The device may include a cutter switch configured to physically decouple the rotation of the camshaft from the oscillation of the elongated member. Upon activation of an input on the handheld portion, the cutter switch may control whether the elongated member oscillates. During rotation of the cutter assembly, the cutter switch may lock the oscillation of the elongated member. The discharge valve may be functionally coupled to an input (or input end, input) of the handheld portion. The discharge valve may be configured to adjust the effective flow rate of the suction pump through the lumen of the elongated member. The input (or input end, input) may be a trigger configured to be pressed. The open configuration of the discharge valve may draw away substantially all of the suction generated by the suction pump from the lumen of the elongated member. The closed configuration of the discharge valve may guide the complete suction generated by the suction pump through the lumen of the elongated member. The discharge valve may be a needle valve having a spiral drive needle that can move relative to a valve seat in a fluid channel. The open configuration of the needle valve may connect the suction pump to a flushing fluid line, resulting in minimal suction through the lumen of the elongated member. The first amount of travel of the trigger away from a stationary state activates the suction pump. The needle valve can remain open so that suction from the suction pump is not delivered through the lumen of the cutting tube. A second further travel of the trigger away from the rest state can push the needle toward the valve seat. The first travel can be greater than zero and less than about 20% of the trigger stroke. The second further travel can be at least 20% of the trigger stroke.

[0015] In a related embodiment, a kit for performing an ophthalmic procedure in an eye is provided. The kit includes a driver portion having a motor and a rotatable coupler. The kit includes a first working portion for performing a first ophthalmic procedure in an eye and configured to be operatively coupled to the rotatable coupler of the driver portion. The first working portion includes a first elongated member extending from a distal region of the first working portion. The first elongated member includes a lumen and an opening near the distal region of the first elongated member, and a piston pump within the first working portion, which is fluidically connected to the opening near the distal region of the first elongated member, the piston pump being configured to generate pulsed suction. The kit includes at least a second working portion, which is configured to be operatively coupled to the rotatable coupler of the driver portion to perform a second ophthalmic procedure in an eye. The second working portion includes a second elongated member extending from a distal region of the second working portion. The second elongated member includes a lumen and an opening near the distal region of the second elongated member. The second working portion includes a linear peristaltic pump within the second working portion that is fluidically connected to the opening of the second elongated member. The linear peristaltic pump is configured to produce a smooth flow suction.

[0016] The piston pump may include a plurality of pistons and a rotating cam assembly that can be rotated by a motor via a rotatable coupler. Rotation of the rotating cam assembly may cause the plurality of pistons to generate pulses of discontinuous negative pressure in the lumen of the first elongated member. The piston pump may be configured to generate a volumetric suction of up to about 100cc / minute. The linear peristaltic pump may include a camshaft extending along the longitudinal axis and having a plurality of cam lobes. The linear peristaltic pump may include a conduit extending parallel to the longitudinal axis and a plurality of cam followers driven by a cam of the camshaft to move in a plane perpendicular to the longitudinal axis to sequentially compress the conduit. The plurality of cam followers may sequentially compress the conduit to generate substantially non-pulsating suction. The substantially non-pulsating suction may be up to about 10cc / minute. The motor may be configured to drive the reciprocating motion of the first elongated member and the second elongated member. The first elongated member may be configured for lens fragmentation and the second elongated member may be configured for anterior vitrectomy.

[0017] In some variations, one or more of the following may be optionally included in any feasible combination of the above methods, devices, apparatuses, and systems. More details of the apparatuses, systems, devices, and methods are set forth in the accompanying drawings and the following description. Other features and advantages will be apparent from the description and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] These and other aspects will now be described in detail with reference to the following drawings. In general, the drawings are not drawn to scale, either absolutely or comparatively, but are intended to be illustrative. In addition, the relative placement of features and elements may be modified for the purpose of clarity of illustration.

[0019] Figure 1A is a block diagram of a microsurgical control system for use with a microsurgical instrument;

[0020] Figure 1B is a block diagram of an embodiment of a microsurgical instrument with an integrated aspiration pump;

[0021] Figure 1C is a block diagram of an embodiment of a microsurgical instrument including a disposable working portion having another embodiment of an integrated aspiration pump configured to be operably coupled to a reusable driver portion;

[0022] Figure 1D An embodiment of a kit comprising a microsurgical instrument in a sterile package is shown;

[0023] Figure 2A shows a perspective view of an embodiment of a microsurgical instrument;

[0024] Figure 2B Shown are separated from each other Figure 2AA perspective view of a driver and working portion of a microsurgical instrument;

[0025] Figure 2C Shows Figure 2B A partial view of the actuator portion of the device;

[0026] Figure 2D Shows Figure 2A A partial cross-sectional view of a coupling between a driver portion and a working portion of a microsurgical instrument;

[0027] Figure 3A shows a perspective view of an embodiment of a suction pump configured to be integrated within a working portion of a microsurgical instrument;

[0028] Figure 3B Shows Figure 3A A top view of a suction pump;

[0029] Figure 3C-3D Shows Figure 3A The camshaft of the suction pump;

[0030] Figures 4A-4D Shows Figure 3A An end view of a suction pump showing the left and right movement of the cam follower as the camshaft rotates;

[0031] Figure 5A An example of a suction flow rate provided by a suction pump is shown;

[0032] Figure 5B Another example of a suction flow rate provided by a suction pump is shown;

[0033] Fig. 6A and Figure 6B A perspective view and a cross-sectional view, respectively, show another embodiment of a working portion of a microsurgical instrument;

[0034] Fig. 7A shows a cross-sectional partial view of an embodiment of a microsurgical instrument for cutting and aspirating lens material from an eye;

[0035] Figure 7B-7C They are shown respectively Fig. 7A Exploded and assembled views of the cutting tube of the illustrated microsurgical instrument;

[0036] Figure 7D-7E A cam mechanism is shown, which is configured to oscillate Fig. 7A The cutting tube of the microsurgical tool embodiment shown in ;

[0037] Figures 8A-8B An exploded view of a magnetic drive is shown, which is configured to Figure 6A-6BThe cutting tube oscillates of the microsurgical tool embodiment shown in ;

[0038] Fig. 9A Shown assembled with the camshaft of the suction pump Figures 8A-8B A partial perspective view of a magnetic drive;

[0039] Fig. 9B shows the coupling to Fig. 9A a cross-sectional end view of a gearbox of a camshaft of a suction pump;

[0040] Fig. 9C A cutter switch is shown, which is configured to turn on / off the oscillation of the cutter tube;

[0041] Fig.10 An embodiment of a reusable, durable driver portion according to an embodiment is shown;

[0042] Fig.11A According to an embodiment, a Fig.10 Embodiments of the drive system of the part;

[0043] Fig. 11B According to another embodiment, a Fig.10 Embodiments of the drive system of the part;

[0044] Fig.12 A cam mechanism for cutting and suction is shown, which is configured to Fig.10 The driver portion is coupled.

[0045] It should be understood that the drawings are merely schematic and are not intended to be drawn to scale. It should be understood that the devices described herein may include features that are not necessarily depicted in every drawing. DETAILED DESCRIPTION

[0046] Systems, devices and methods for intraocular fragmentation and removal of the lens, vitreous and other tissues during intraocular surgery are described herein. Various systems, devices and methods are configured to perform one or more functions useful in ophthalmic surgery, including but not limited to cutting, fragmentation, emulsification, suction and / or flushing of materials present at a target location during surgery in the eye. The systems, devices and methods described herein are configured to apply a vacuum and deliver a fluid to maintain pressure balance in the eye. The systems, devices and methods for applying a vacuum and / or delivering a fluid described herein can also be configured to cut, fragment, emulsify or otherwise form smaller materials in and near a surgical site.

[0047] As used herein, "material" may include fluid (from or provided to the eye), tissue or fragments of tissue, such as lens tissue, vitreous, cells, and any other fluid or tissue or other material that may be present during surgery in the eye (e.g., cataract surgery, vitrectomy surgery, etc.).

[0048] The systems described herein may include a single reusable driver portion configured to be operatively coupled to one or more disposable working portions in an interchangeable manner. The disposable working portions may be configured for different types of ophthalmic procedures, including lens fragmentation, phacoemulsification, vitrectomy, bag polishing, aspiration, irrigation, coagulation, illumination, visualization, intraocular lens (IOL) insertion, etc. The operating parameters of the instrument may differ depending on, for example, the configuration of the disposable working portion attached to the reusable driver portion.

[0049] The various features and functions of the devices described herein may be applied to one or more of the devices described herein, even though they may not be explicitly described in combination. It should also be understood that the various features and functions of the devices described herein may be applied to conventional devices and systems known in the art and may also be used to cut, fragment, emulsify, or otherwise impact tissue at or near a surgical site, including but not limited to phacoemulsification systems, vitrectomy systems, bag polishing systems, and other tools that may be used to perform cataract surgery or vitrectomy, etc.

[0050] The apparatus described herein is configured to apply vacuum and deliver fluid to the eye, as well as cut, fragment, emulsify or otherwise form smaller materials within and near the surgical site. Ophthalmic systems are typically controlled using a foot pedal. The user can control the handpiece functions based on the position of the foot pedal. For example, when the foot pedal is not depressed, the handpiece is in an idle, stationary position where no irrigation, suction and / or cutting occurs. The user can actuate the foot pedal by depressing it downward to a first position to turn on irrigation, a second further depression of the foot pedal can add suction to the irrigation, and a third degree of depression of the foot pedal can actuate cutting. The advancement of the foot pedal to different positions provides the user with control over different surgical functions.

[0051] The apparatus described herein does not need to be controlled by a foot pedal. For example, the apparatus described herein preferably includes a finger-actuated throttle rather than a foot-actuated throttle. The functions of the apparatus described herein (i.e., flushing, suction and / or cutting functions) can be activated using an input (or input end, input) on the apparatus housing, which can be actuated with a single finger or thumb. Because the apparatus described herein does not require a foot pedal, the user can stand more comfortably and naturally (e.g., with two feet or by transferring their center of gravity from one foot to another) to perform surgery. The apparatus described herein can provide background flow or flushing / suction with or without a tip cutting action. When the finger-actuated input is actuated, the apparatus described herein can produce low-level flushing and / or suction without a cutter action. Finger control on the apparatus allows the surgeon to easily activate and finely control the system in a short time in a more convenient and easier manner than the foot pedal used in most conventional phacoemulsification / vitrectomy systems.

[0052] Instruments are sometimes referred to herein as "devices" or "tools" or "peripheral devices" or "handpieces" or "handheld units". The term "handpiece" as used herein may include a handpiece coupled to a robotic arm or a robotic system or other computer-assisted surgical system, where a user manipulates the controls of the instrument using a computer console. The computer may translate the user's movements and actuation of the controls to then be performed on the patient by the robotic arm.

[0053] The apparatus described herein can be suctioned through the cutting tube via a vacuum source (e.g., a pump) located within the housing of the apparatus. The vacuum source within the handheld portion of the device (e.g., near the distal cutting tip) minimizes the volume of the suction flow path, thereby improving control and responsiveness while reducing delays or lags. Conventional systems rely on a vacuum source in a remote control console located several feet away and connected by a long compressible tube, and there are problems of slow response and low effective vacuum applied at the treatment site. Conventional systems have long, flexible suction lines connecting the vacuum source to the handpiece. When the suction source is activated (and deactivated), compliance within the fluid system increases the time it takes for the suction to be transmitted from the suction source to the treatment site. Compliance within the fluid system can also result in frictional losses in the vacuum transmitted to the treatment site, resulting in the effective vacuum amount being different from the theoretical vacuum set at the source. For example, a remote vacuum source set to 600 mmHg may only effectively transmit 200 mmHg to the treatment site. The delays and lags in conventional phacoemulsification devices with remote vacuum sources are subject to the risk of large surge volumes after clogging, especially when the vacuum source is set at higher flow rates. The surge volume in conventional systems includes the compliant aspiration line extending between the remote vacuum source and the handpiece, which can be very large (e.g., greater than 20 mL in some cases). Users tend to set the vacuum source at a lower level to mitigate this lack of control and the risk of increased surge volume at higher flow rates. The instrument described herein has a relatively low surge volume, so there is minimal disadvantage to cycling the device open and closed. These features can allow the instrument to be activated for only a short period of time when the surgeon is ready to remove the lens tissue. This helps to remove less irrigation fluid overall, so less irrigation fluid needs to be delivered.

[0054] The apparatus described herein can apply a greater effective vacuum at the treatment site and respond to pressure changes more quickly by avoiding line losses associated with conventional systems. Even when used at a higher vacuum setting, the apparatus described herein has improved responsiveness and control. If a blockage occurs due to a lens sheet blocking the distal opening, a vacuum (e.g., up to about 500 to 600 mmHg or higher) is established. When the blockage is broken by the seal, the surge associated with the apparatus described herein is significantly improved compared to conventional apparatuses with only a remote vacuum source. For example, the surge volume of the apparatus described herein can be as low as about 100 cubic mm, 200 cubic mm, or no more than about 300 cubic mm, while the surge volume of a conventional phacoemulsification machine can be 10 times, 20 times, 50 times, or 100 times larger than this volume. The surge volume is smaller because the apparatus described herein has a relatively short suction flow path between the vacuum source and the target treatment site. The short suction flow path can also be substantially rigid or non-compliant. For example, greater than 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90% of the suction flow path of the devices described herein can be rigid, resulting in no more than 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% compliance in the suction flow path. The substantially non-compliant and short suction flow path of the devices described herein reduces potential surge volume and reduces dead space that may cause delay effects and lack of responsiveness.

[0055] The apparatus described herein includes a cutting tube that can oscillate or slide in a reciprocating manner relative to the housing. As used herein, "oscillation" or "oscillating motion" can include any periodic, repeated motion according to a pattern, and does not need to be a sinusoidal motion. The oscillating motion can include a reciprocating sliding motion that occurs in a back-and-forth manner relative to the handpiece. The oscillating motion may include repeatedly advancing and retracting the cutting tube along its longitudinal axis. Repeated advancement and retraction can occur along the longitudinal axis, but the path taken by the oscillating motion does not have to be linear. The motion path can occur nonlinearly along an elliptical path or a curved path (i.e., away from the longitudinal axis during at least a portion of the motion). The path of motion can be a rotation, orbital or torsional path around the longitudinal axis of the device, or other types of motion relative to the longitudinal axis of the device, including three-dimensional motion of the cutting tube moving forward and backward and from one side to the other. The oscillating motion includes a profile of a repetitive pattern that can be changed according to the position where the motion occurs in the oscillation cycle. As described in U.S. Publication No. 2018 / 0318133, published on November 8, 2018, the profile of the oscillating motion can be asymmetric, which is incorporated herein by reference.

[0056] The elongated component of the oscillating instrument may be referred to herein as a "shaft" or "cutter" or "cutting tube" or "elongated member" and may be configured for use with different techniques, including phacoemulsification, vitrectomy, bag polishing, or other techniques. At least a portion of the cutter may be tubular and have a lumen extending therethrough such that fluid may be delivered and / or aspirated through the lumen between a distal opening and a proximal opening of the lumen.

[0057] The oscillation of the cutter can be similar to the conventional phacoemulsification cutting tip to drill the lens tissue and aspirate it from the eye. The cutter can include an inner elongated member coaxially arranged in the outer tubular member, or the cutter can be a solid rod and does not need to include a lumen. In some embodiments, the cutter has a sharp cutting tip or bevel, which can include a needle tip. The cutter can include a sharp needle tip and can be a solid element extending through the outer tubular member and apply suction through the lumen of the outer tubular member so that fluid and tissue are sucked into the annular gap extending between the inner member and the outer member. The cutter can have an inner lumen and a distal edge configured to cut tissue. The distal edge can be sharpened, and the opening into the tube can be cut to be at an angle to the elongated axis of the cutter or perpendicular to the elongated axis of the cutter. The inner lumen of the cutter can be configured to aspirate material through it, such as eye lens material, lens fragments, vitreous body and / or fluid from the eye. Therefore, suction can be applied through the inner lumen of the cutter. However, suction may also be applied through the lumen of the tubular outer member extending over the cutter such that suction occurs through the annular space between the two to receive and / or deliver fluid to the treatment site. In this configuration, the gap between the tubular outer member and the inner member may vary, for example, from about 0.001" to about 0.100". In some embodiments, suction may be applied through the inner elongated member having a lumen and through the lumen of the outer tubular member.

[0058] The apparatus described herein integrates an oscillating cutting action with suction pumping in a handpiece. Both the oscillating motion of the cutter and the suction produced by the pump are powered by a motor in the handpiece. As will be described in more detail below, suction and cutting can be driven independently by motors, thereby decoupling these functions of the apparatus.

[0059] Figure 1A A block diagram of a system 100 is shown that is configured for use with a microsurgical instrument 200 for use by a surgeon in performing various ophthalmic surgical procedures. Figure 1B-1C A block diagram of an instrument 200 (sometimes referred to herein as a "device" or "tool" or "peripheral device" or "handpiece" or "handheld unit") according to an embodiment is shown and will be described in more detail below. The microsurgical instrument 200 can be used with Figure 1AThe system 100 shown in FIG. 1 may be used with the system 100 and may be used separately from the system 100 and used as a fully handheld stand-alone instrument.

[0060] In some embodiments, the microsurgical system 100 can include a fluid system 110 coupled to the shaft assembly 105. The shaft assembly 105 and the fluid system 110 can each be controlled by a computing unit 115 powered by a power system 120. The fluid system 110 can include an irrigation fluid source 130, an irrigation line 155 leading to the microsurgical instrument 200, and a waste line 165 leading from the microsurgical instrument 200 to a waste container 160. By coupling the irrigation line 155 of the fluid system 110 to the irrigation inlet of the instrument 200, the system 100 can provide irrigation to the microsurgical instrument 200.

[0061] Some commercially available anterior vitrectomies are not designed for coaxial irrigation and vitrectomy. Local turbulence and vitreous volume expansion caused by hydration may be a problem for coaxial irrigation and cutting systems. Therefore, in some embodiments, irrigation can be performed using a two-handed approach that separates cutting from irrigation. Therefore, irrigation line 155 can also be coupled to a different instrument configured to deliver irrigation to the treatment site.

[0062] One or more components of the system 100 may be controlled by a computing unit 115 powered by a power system 120. The computing unit 115 may include a control processor 180, a memory 190, a communication module 195, and one or more input / outputs 197. The components of the computing unit 115, such as the control processor 180, the memory 190, the communication module 195, the one or more input / outputs 197, the storage device, etc., may be interconnected via a system bus 185. The control processor 180 may be in operative communication with one or more of the shaft assembly 105, the fluid system 110, and the microsurgical instrument 200 operatively coupled to the system 100. The control processor 180 may also be in operative communication with one or more external computing devices 300. The external computing device 300 may be various, including but not limited to a desktop computer, a laptop computer, a tablet computer, a smart phone, or other device capable of transmitting and receiving user input.

[0063] The memory 190 is configured to receive and store user input data. The memory 190 can be any type of memory capable of storing data and transmitting the data to one or more other components of the system 100 (e.g., the control processor 180). The memory 190 can be one or more of flash memory, SRAM, ROM, DRAM, RAM, EPROM, dynamic storage devices, etc. The memory 190 can be configured to store one or more user-defined profiles related to the intended use of the device 200. The memory 190 can be configured to store user information, usage history, measurements taken, etc.

[0064] The communication module 195 of the computing unit 115 may be in operative communication with one or more components of the system 100, such as the control processor 180, and one or more peripheral devices, such as one or more external computing devices 300 and microsurgical instruments 200. The connection between the communication module 195 of the computing unit 115 and the external computing device 300 or microsurgical instrument 200 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 send information to the external computing device 300 and / or microsurgical instrument 200. The communication module 195 may also include a wireless communication port so that information may be fed between the computing unit 115 and the external computing device 300 and / or microsurgical instrument 200 over a wireless link, for example, to display information about the operation of the system 100 in real time on the external computing device 300 and / or to control the programming of the microsurgical instrument 200. It should be understood that, for example, if the instrument 200 is operated independently of the system 100, the external computing device 300 can communicate directly with the microsurgical instrument 200. Any of the various adjustments and programming of the system 100 can be performed using the external computing device 300. The wireless connection can use any suitable wireless system, such as Bluetooth, Wi-Fi, radio frequency, ZigBee communication protocol, infrared or cellular telephone system, and can also use encoding or authentication to verify the source of the received information. The wireless connection can also be any of a variety of dedicated wireless connection protocols.

[0065] The control processor 180 may be capable of processing instructions for execution within the system 100. Such execution instructions may implement one or more processes described herein related to using the system or a peripheral device in operative communication with the system 100. The control processor 180 may be a single-threaded processor or a multi-threaded processor. The control processor 180 may be capable of processing instructions stored on the memory 190 and / or storage device to provide an output of information about the operation of the system 100 to a user. The control processor 180 may include software that can be programmed to adjust or provide limitations on one or more aspects of the system 100 and the microsurgical instrument 200 coupled to the system 100. The software executed by the control processor 180 may provide certain aspects of the system 100 or the microsurgical instrument connected to the system 100 without any user input during use. In one embodiment, adjustments or programming may be made within the system 100 or on an external computer device 300 by the control processor 180 controlled by the software. The user may remotely program the controller 180 through an external computing device 300 that communicates with the system 100 via a wireless connection such as Bluetooth. One or more aspects of the system 100 (described in detail below) may be programmed, including the height of the irrigation source 130, the position of the valve 150 configured to control irrigation flow, and the like.

[0066] As described above, the computing unit 115 of the system 100 (or the apparatus 200) can be remotely controlled, adjusted and / or programmed, for example, via an external computing device 300. The computing unit 115 of the system 100 can also be directly controlled, adjusted and / or programmed through one or more inputs 197 on the system 100 (and one or more inputs 228 on the apparatus 200). The apparatus described herein can be used so that one or more aspects are manually controlled and / or adjusted according to manual input by a user, or programmed to control one or more aspects. The controller may include software that can be programmed to adjust or provide limitations on one or more aspects of the apparatus. The software executed by the controller can provide certain aspects of the apparatus without any user input during use. In one embodiment, adjustments or programming can be made within the apparatus or on an external computer device 300 that is in operative communication with the apparatus directly or through the system 100, by a controller controlled by software. The user can remotely program the controller through an external computing device that communicates with the apparatus through a wireless connection such as Bluetooth.

[0067] The inputs 197 of the system 100 may include one or more triggers, buttons, sliders, dials, keypads, switches, touch screens, foot pedals, or other inputs that can be retracted, pressed, squeezed, slid, tapped, or otherwise actuated to activate, modify, or otherwise cause a response of the system 100. In some embodiments, the one or more inputs 197 include a microphone configured to receive voice commands to control, adjust, and / or program one or more components of the system 100 and peripheral devices in operative communication with the system 100. The inputs 197 of the system may be separate from and in addition to the one or more inputs 228 on the microsurgical instrument 200, which will be discussed in more detail below. The system 100 (and the instrument 200) may include one or more outputs, such as a light, speaker, vibration motor, display, or other type of output, which is configured to convey information to the user through visual, audio, and / or tactile output.

[0068] Likewise, about Figure 1A , one or more of the rod assembly 105, the fluid system 110, the computing unit 115, and the microsurgical instrument 200 or other peripheral devices connected to the system 100 can be powered by the power system 120. For example, the power system 120 can provide power to the rod assembly 105 to adjust the height of the irrigation source 130 by telescopically adjusting the rod relative to the base, for example, using a motor or other power mechanism. The power system 120 can provide power to one or more valves 150 that are configured to control the flow of fluid to the irrigation line 155. The power system 120 can also provide power to any peripheral device in operative communication with the system 100, such as the microsurgical instrument 200.

[0069] Still reference Figure 1A , and as described above, the fluid system 110 may include an irrigation fluid source 130, one or more valves 150, an irrigation line 155, a waste line 165, and a waste container 160. The fluid system 110 may optionally include a pump, such as an irrigation fluid pump configured to deliver irrigation fluid from the irrigation fluid source 130. The irrigation fluid may leave the irrigation fluid source 130 and travel toward the microsurgical instrument 200 through the irrigation fluid line 155. The lines 155 and 165 may be fluidly coupled to the instrument 200 directly or through an irrigation port.

[0070] The irrigation fluid source 130, the instrument 200, and / or the irrigation line 155 may optionally include one or more valves 150 and / or sensors configured to provide additional control of fluid flow through the irrigation line 155, which is fluidly coupled to the instrument 200 directly or through an irrigation port. The one or more valves 150 may be pinch valves or clamps configured to tightly clamp the irrigation line 155 to prevent fluid flow to the microsurgical instrument 200 or to allow all fluid to flow from the irrigation source 130 to the microsurgical instrument 200 when the valve 150 is open.

[0071] As is known in the art, the valve 150 can be opened / closed manually. The valve 150 can alternatively or additionally be actuated by an input from the computing unit 115, for example, upon actuation of the microsurgical instrument 200, which will be described in more detail below. Other valve and clamp types are contemplated herein. The instrument 200 and / or the waste line 165 (which may be referred to herein as the suction line) can optionally include one or more valves and / or sensors configured to provide additional control of the flow of fluid from the instrument 200. One or more valves 150 can be integrated in an area of ​​the telescopic pole that is suspended near the irrigation source 130 so that the valve 150 can control the flow through the irrigation line 155.

[0072] Figure 1B-1C A block diagram of an apparatus 200 (sometimes referred to herein as a "device" or "tool" or "peripheral device" or "handpiece" or "handheld unit") is shown. The apparatus 200 may include a drive mechanism 205 in operative communication with a vacuum source, such as a suction pump 245, in a housing of the apparatus 200 and in operative communication with a cutting tube 210 coupled to the housing. The cutting tube 210 is configured to be inserted into an eye to cut, aspirate material, and / or inject material into the eye, such as during cataract surgery. At least a portion of the cutting tube 210 is configured to move, such as by oscillating or reciprocatingly sliding relative to the housing, so as to remove a lens or other tissue of the eye. Each of these will be described in more detail below.

[0073] Any of a variety of microsurgical instruments 200 are contemplated herein for use with the microsurgical system 100 described above, including vitrectomy cutters, phacoemulsification or ultrasonic fragmentation handpieces, electric microscissors, fiber optic illumination instruments, coagulation handpieces, and other microsurgical instruments. In some embodiments, the instrument 200 is one or more of those described in U.S. Patent Publication No. 2018 / 0318133, published on November 8, 2018, which is incorporated herein by reference in its entirety. The operating parameters may vary depending on, for example, the specific surgery being performed, the different stages of the surgery, the surgeon's personal preference, whether the surgery is performed on the front or back of the patient's eye, etc.

[0074] The microsurgical instrument 200 may be used with Figure 1A The microsurgical instrument 200 described herein may also be used separately from the system 100 and may be a completely handheld stand-alone instrument. Figure 1B and 1C An embodiment of the instrument 200 is shown with an integrated suction pump 245 within the housing. In some embodiments, a single input (ie, drive mechanism) can drive both the cutting tube 210 and the suction pump 245. A single input or drive mechanism of the instrument 200 can independently control the cutting tube 210 and the suction pump 245.

[0075] The configuration of the suction pump 245 of the device 200 can vary. Preferably, the suction pump 245 has a small form factor so that it does not significantly affect the relative ergonomics of the handpiece. The suction pump 245 can be a piston pump, a roller pump, a peristaltic pump, a linear peristaltic pump, a vortex pump, a venturi pump, a rotary vane pump, a gear pump, a screw pump, a diaphragm pump, a centrifugal pump, a bellows mechanism, a capture pump, a positive displacement pump, a regenerative pump, a momentum transfer pump, a micropump, etc. In some embodiments, the suction pump 245 of the device 200 is such as Figure 3A-3B In other embodiments, the suction pump 245 of the apparatus 200 is a linear peristaltic pump as shown. Fig.12 The piston pump shown. The suction pump 245 of the instrument will be described in more detail below.

[0076] Figure 1C It is shown that the instrument 200 may include a disposable working part 2005, which is configured to be releasably coupled to a durable, reusable driver part 2010. Each of the working part 2005 and the driver part 2010 may include a housing portion formed by a relatively rigid, lightweight material. The working part and the driver parts 2005, 2010 may be coupled together using various mechanisms such as threads, spring locks, bayonet and similar mechanisms. The coupling mechanism may include a release button configured to disengage the two housing parts from the coupling. The coupling between the working part 2005 and the driver part 2010 may be purely mechanical or may involve mechanical and electronic coupling. For example, the working part 2005 may have an electronic input configured to be electrically coupled to a part of the driver part 2010. Alternatively, the working part 2005 may have an input configured to be mechanically coupled to and interact with the driver part 2010. The coupling between the parts 2005, 2010 will be described in more detail below.

[0077] The working portion 2005 generally includes components of the instrument 200 that are configured to come into direct contact with fluids and materials from the eye, such as the cutting tube 210 and connections for the flush line 155 and the waste line 165, etc. (not shown). Figure 1C2005). The suction pump 245 can be within the working portion 2005. The durable driver portion 2010 of the instrument 200 generally includes components of the instrument 200, such as components of the drive mechanism 205, that are configured to remain outside of the fluid path.

[0078] The instrument 200 may include a computing unit 215 including a control processor 280, a memory 290, and / or a communication module 295 that is in operative communication with one or more components of the instrument 200, such as the power system 220 and the drive mechanism 205. The components of the computing unit 215, such as the control processor 280, the memory 290, the communication module 295, and one or more input / output 228, etc., may be interconnected via a system bus 285. The computing unit 215 and the power system 220 may be contained within a durable driver portion 2010 of the instrument 200. The input 228 may be on a reusable durable driver portion 2010 or a working portion 2005. The driver portion 2010 may be resterilized and reused while the working portion 2005 is not resterilized and reused. However, it should be understood that the entire instrument 225 including the driver portion 2010 may also be disposable and made of low-cost materials, making it economically feasible for the portion 2010 to be discarded after use.

[0079] The devices described herein may be programmed to control one or more aspects. The controller may include software that can be programmed to adjust or provide limitations on one or more aspects of the device. Thus, the software run by the controller may provide certain aspects of the device without any user input during use. In one embodiment, adjustments or programming may be made within the device or on an external computer device by a controller controlled by software. The user may remotely program the controller via an external computing device that communicates with the device via a wireless connection such as Bluetooth.

[0080] As described above, the instrument 200 may include a power system 220. When the instrument 200 is operatively coupled to the system 100, power may also be provided to the drive mechanism 205 by the power system 120 of the system 100. The instrument 200 may include a cable 225 extending through the housing 226 of the durable driver portion 2010. The cable 225 may also be configured to connect the instrument 200 to a wall outlet. The drive mechanism 205 may also be powered by one or more batteries. The battery may be incorporated within the area of ​​the durable driver portion 2010, within or coupled to the area of ​​the housing, such as in a modular, removable battery pack. The battery may have different chemical compositions or characteristics. For example, the battery may include lead acid, nickel cadmium, nickel metal hydride, silver oxide, mercuric oxide, lithium ion, lithium ion polymer or other lithium chemistry. The device may also include a rechargeable battery that is recharged using a DC power port, induction, solar cell, etc. Power systems known in the art for powering medical devices used in operating rooms are also considered herein, such as spring power or any other suitable internal or external power source. In some embodiments, rather than mounting the battery pack on or in the housing, which would increase the size of the housing, the battery pack can be mounted elsewhere, such as on the arm or wrist of a user who holds the instrument 200 during surgery. A short cable connector can connect the mounted battery pack to the instrument 200 so that only the connection extends from the housing of the instrument 200 during use.

[0081] The processor 280 can process instructions for execution within the device. Such executed instructions can implement one or more processes described herein related to the use of the device. The processor 280 can be a single-threaded processor or a multi-threaded processor. The processor 280 can be capable of processing instructions stored on the memory 290 and / or storage device to provide an output of information about the operation of the device to a user.

[0082] The memory 290 may be configured to receive and store user input data. The memory 290 may be any type of memory capable of storing data and transmitting the data to one or more other components of the device (e.g., a processor). The memory 290 may be one or more of flash memory, SRAM, ROM, DRAM, RAM, EPROM, dynamic storage devices, etc. The memory 290 may be configured to store one or more user-defined profiles associated with the intended use of the device. The memory 290 may be configured to store user information, usage history, measurements taken, etc.

[0083] The connection between the communication module 295 of the apparatus 200 and the system 100 or the external computing device 300 may include a wired communication port, such as an RS22 connection, a USB, a FireWire connection, a dedicated connection, or any other suitable type of hardwired connection configured to receive and / or send information to an external computing device. The communication module 295 may also include a wireless communication port so that information can be fed between the apparatus and the external computing device through a wireless link, for example, to display information about the operation of the apparatus in real time on the external computing device 300, and / or to control the programming of the apparatus. For example, a user can program the speed curve of the motor of the apparatus on the external computing device. Any of the various adjustments and programming of the apparatus can be performed using the external computing device 300. The wireless connection can use any suitable wireless system, such as Bluetooth, Wi-Fi, radio frequency, ZigBee communication protocol, infrared or cellular phone system, and can also use coding or authentication to verify the source of the received information. The wireless connection can also be any of a variety of dedicated wireless connection protocols. The external computing device 300 with which the apparatus communicates may vary, including but not limited to a desktop computer, laptop computer, tablet computer, smart phone, or other device capable of transmitting and receiving user input.

[0084] As described above, the microsurgical instrument 200 may include one or more user inputs 228 that may be separate from the one or more inputs 197 of the system 100. The instrument 200 may be actuated using one or more user inputs 228 on the instrument itself and an input remote from the device (e.g., on the system 100 or an external computing device 300 in operative communication with the system 100), or both. The one or more inputs 228 on the instrument 200 include any of a variety of actuators, triggers, buttons, sliders, dials, keypads, switches, touch screens, foot pedals, foot switches, or other inputs that can be retracted, pressed, squeezed, slid, tapped, or otherwise actuated to activate, modify, or otherwise cause oscillation, aspiration, and / or injection of fluid through the cutting tube. In a preferred embodiment, the input 228 is a multi-way trigger that is configured to activate more than one function of the instrument 200 depending on the degree of actuation (i.e., the pressing or sliding of a finger or thumb). For example, the instrument 200 may be configured for irrigation, fluid aspiration, and cutting. One or more inputs 228 can be pushed by the user to a position that causes the drive mechanism 205 to increase one or more actions, for example, increasing the oscillation frequency of the cutting tube 210 or the suction pressure 245 of the pump (by increasing the rotation of the motor to actuate the trigger more). A finger-actuated instrument that is completely handheld without any foot pedal or other tether connected to the instrument provides the user with more portability, flexibility, and freedom of movement, and without the need to worry about catching cables or other tethers during use.

[0085] When the instrument 200 is operatively coupled to the system 100, the drive mechanism 205 may be powered by the instrument's power system 220 and / or the power system 120 of the system 100. The instrument 200 may include a cable 225 extending through the housing of the instrument 200 (see Figures 2A-2C ). The cable 225 can also be configured to connect the instrument 200 to a wall outlet. The power system 220 of the instrument 200 can include one or more batteries. The battery can be incorporated in the area of ​​the instrument housing, inside or coupled to the area of ​​the housing, such as in a modular, removable battery pack. The battery can have different chemical compositions or characteristics. For example, the battery can include lead acid, nickel cadmium, nickel metal hydride, silver oxide, mercuric oxide, lithium ion, lithium ion polymer or other lithium chemistry. The device can also include a rechargeable battery that is recharged using a DC power port, induction, solar cells, etc. Power systems known in the art for powering medical devices used in operating rooms are also considered herein, such as spring power or any other suitable internal or external power source. In some embodiments, instead of mounting the battery pack on or in the housing, which increases the size of the housing, the battery pack can be mounted elsewhere, such as on the user's arm or wrist, which holds the instrument 200 during surgery. A short cable connector can connect the mounted battery pack to the instrument 200 so that only the connection extends from the housing of the instrument 200 during use.

[0086] Figure 1C The microsurgical instrument 200 is shown to include a disposable working portion 2005 that is configured to be releasably operatively coupled to a durable, reusable driver portion 2010 (see also Figures 2A-2C ). Each of the disposable working portion 2005 and the reusable driver portion 2010 may include a housing portion formed from a relatively rigid, lightweight material. The working portion 2005 generally includes components of the instrument 200 configured to be in direct contact with fluids and materials from the eye, and the driver portion 2010 of the instrument 200 generally includes components of the instrument 200 configured to remain outside the fluid path. For example, the disposable working portion 2005 can be combined with a cutting tube 210 configured to be inserted into the eye to cut, aspirate and / or inject material into the eye and a cutter assembly 214 configured to oscillate the cutting tube 210. A suction pump 245 and connection sites for flushing lines 155 and waste lines 165, etc. (see Figure 1A) may also be part of the disposable working portion 2005. One or more components of the drive mechanism 205, the computing unit 215, and the power system 220 may be part of the reusable driver portion 2010 of the instrument 200. The input 228 may be on the reusable driver portion 2010 or the disposable working portion 2005. The reusable driver portion 2010 may be resterilized and reused, while the disposable working portion 2005 is not resterilized and reused. However, it should be understood that the entire instrument 200 including the reusable driver portion 2010 may also be disposable and made of low-cost materials, making it economically feasible for the driver portion 2010 to be discarded after use.

[0087] A single reusable driver portion 2010 can be configured to be operatively coupled to one or more disposable working portions 2005 in an interchangeable manner. The disposable working portion 2005 can be configured for different types of surgeries, including lens fragmentation, emulsification, vitrectomy, bag polishing, aspiration, irrigation, coagulation, illumination, visualization, IOL insertion, and the like. Thus, the disposable working portion 2005 can be used for any of a variety of surgeries, including vitrectomy, phacoemulsification, intraocular lens insertion, and the like. The operating parameters of the instrument can vary depending on, for example, the disposable working portion 2005 attached to the reusable driver portion 2010 and / or the specific surgery being performed, the different stages of the surgery, the surgeon's personal preference, whether the surgery is performed on the front or back of the patient's eye, and the like. The components of the working portion 2005 can vary depending on the type of surgery, and each of the different working portions 2005 can be operatively coupled and operated by a single reusable driver portion 2010 regardless of the surgery it is configured to perform. The different disposable working portions 2005 will be described in more detail below.

[0088] Figure 1C One embodiment of a working portion 2005 operatively coupled to a driver portion 2010 is shown. The working portion 2005 may be used in procedures requiring smooth flow aspiration by oscillating the cutting tube 210. Briefly, the working portion 2005 may include an aspiration pump 245 that is a linear peristaltic pump having a cam shaft 405 extending along a longitudinal axis and having a plurality of cam lobes 425 (see, e.g., Figure 3A-3B). The camshaft 405 can be driven by the drive mechanism 205 of the driver portion 2010. The cam 425 of the camshaft 405 can drive and cause the movement of a plurality of cam followers 410, which are configured to sequentially compress the conduit 415 and convert the generated suction pressure to the cutting tube 210 located in the eye. The plurality of cam followers 410 can be driven by the cam of the camshaft 405 to move in a plane substantially perpendicular to the longitudinal axis to sequentially compress the conduit 415. For example, the conduit 415 can extend spatially parallel to or along the z-axis or the center of rotation of the camshaft 405. The conduit 415 can be compressed by the cam followers 410 along an axis that is aligned approximately 90 degrees relative to the z-axis. For example, the cam followers 410 can be driven left and right along a horizontal position or an x-axis relative to the z-axis of the camshaft 405. The cam followers 410 can also be driven along a vertical position or along a y-axis relative to the z-axis of the camshaft 405. The relative angle between the cam follower 410 and the pipe 415 may also be greater or less than 90 degrees. However, the cam follower 405 does not translate axially along the side wall of the pipe 415 (ie, along the z-axis).

[0089] The single drive mechanism 205 that rotates the camshaft 405 can also drive the oscillation of the cutting tube 210, which can be a vitrectomy probe. It should be understood that the suction pump 245 can be a different type of pump (e.g., a piston pump configured to apply pulsating suction) and the cutting tube 210 can be a different type of probe (e.g., a lens crushing working tip). The camshaft 405 rotated by the drive shaft 238 from the drive mechanism 205 can engage with the cutter assembly 214, thereby causing the oscillation of the cutting tube 210. It should be understood that the cutter assembly 214 and the manner in which it engages with the camshaft 405 of the pump 245 can be different. In some embodiments, the cutter assembly 214 incorporates a cam mechanism that is configured to cause reciprocating linear motion of the cutting tube 210. The cutter assembly 214 can include a gear device to increase the rotation ratio between the rotation of the camshaft 405 and the desired number of oscillations in the cutting tube 210 as needed. Various configurations are described in more detail below.

[0090] Figure 1DAn embodiment of a kit 500 is shown, which includes a microsurgical instrument having a reusable driver portion 2010 configured to be interchangeably coupled with one or more disposable working portions 2005a, 2005b. In some embodiments, the first working portion 2005a can be configured for lens fragmentation and the second working portion 2005b can be configured for vitrectomy. The first working portion 2005a can be combined with a cutting tube configured to oscillate in an asymmetric manner and a piston pump configured to generate pulsed suction, as described in U.S. Publication No. 2018 / 0318132 published on November 8, 2018 and U.S. Publication No. 20190365567 published on December 5, 2019, both of which are incorporated herein by reference. The second working portion 2005b can incorporate a cutting tube (e.g., a cutting tube with a vitrectomy port) and a peristaltic pump configured to produce a smooth flow aspiration, which is described in more detail below. It should be understood that any of a variety of cutting tube configurations driven according to various embodiments and having any number of different pump configurations are contemplated herein. These are provided as examples.

[0091] The distal region of the working portion 2005a can be configured to be interchangeably coupled with one or more working tips provided in the kit 500. For example, the kit 500 can include a lens removal working tip 520a and a bag polishing working tip 520b. Depending on the stage of the surgery, the lens removal working tip 520a and the bag polishing working tip 520b can be interchangeable with each other on the same disposable working portion. The kit 500 can also include a drip chamber 525 having a spike 530, which is configured to be inserted into an irrigation source such as a bottle of balanced saline solution. The drip chamber 525 can be coupled to an irrigation tube 555, which in turn can be coupled to an irrigation coupling on the instrument 200. The irrigation tube 555 can be provided with a pinch valve 558, which can be actuated by a finger to open and close the irrigation tube 555. The kit 500 may also include a waste container 560 having a waste tube 565 configured to couple an outlet from the instrument 200 to the waste container 560. All of the components in the kit 500 may be sterilely packaged together within a single sterile container 505.

[0092] Likewise, about Figures 2A-2C , which shows a reusable driver portion 2010 coupled to a disposable working portion 2005. Figure 2A The apparatus 200 is shown with two parts 2005, 2010 coupled together, and Figure 2B The device 200 is shown with the two parts 2005, 2010 separated from each other. Figure 2CA reusable driver portion 2010 of the instrument 200 is shown with a portion of the housing removed, exposing components of the drive mechanism 205. In embodiments, the drive mechanism 205 may include a motor 230 with or without a gearbox or gear head 232, a motor adapter 236, and a drive shaft 238. The drive shaft 238 may extend through the motor adapter 236 so that the drive shaft 238 may rotate freely with the motor 230.

[0093] The configuration of motor 230 can vary, including any of a variety of rotary motors, stepper motors, AC motors, DC motors, piezoelectric motors, voice coil motors, or other motors. Motor 230 can be a brushless DC motor or any type of motor or drive suitable for a rotating shaft. Motor 230 can be an electric motor combined with gear reduction via a gear head 232 or other mechanism. A harmonic drive can be combined to produce a desired output speed. In an embodiment, a harmonic drive gear reducer configured to achieve at least a 30:1 reduction is combined. In an embodiment, a gear arrangement can be combined to achieve an increase in output. For example, the input from the motor driving the pump can be increased by a gear arrangement to achieve an oscillation speed suitable for cutting (see below Figure 6A-6B In some embodiments, the gear arrangement allows a single motor to independently drive the rotation of two different shafts (see below). Fig.10 , 11A -11B).

[0094] Still reference Figures 2A-2C , the reusable driver portion 2010 can be interchangeably coupled with one or more disposable working parts 2005. The disposable working part 2005 and the reusable driver portion 2010 can be coupled together using a variety of mechanisms, such as threads, spring locks, bayonet and similar mechanisms. The coupling mechanism may include a release button 201 configured to uncouple the two housing parts. The coupling between the disposable working part 2005 and the reusable driver portion 2010 can be purely mechanical or can involve mechanical and electronic coupling. For example, the disposable working part 2005 can have an electronic input configured to be electronically coupled to a part of the reusable driver portion 2010. Alternatively, the disposable working part 2005 can have an input configured to be mechanically coupled and interact with the reusable driver portion 2010.

[0095] Likewise, about Figure 2A-2B as well as Figure 2C-2D, the bayonet motor adapter 236 can be secured to the gearbox 232 by a plurality of motor screws 202. The drive shaft 238 of the driver portion 2010 can be inserted into the proximal end of the disposable working portion 2005 so that the suction pump 245 in the disposable working portion 2005 functionally cooperates with the motor 230 of the durable driver portion 2010. The drive shaft 238 can extend distally from the adapter 236 at the distal region of the driver portion 2010. The driver portion 2010 can be inserted into the proximal end of the working portion 2005 so that the end of the drive shaft 238 cooperates with the groove 203 on the rotating camshaft coupler 204 in the working portion 2005 (see Figure 2D ). The boss 206 on the bayonet motor adapter 236 can slide through the L-shaped slot on the proximal end of the rear manifold of the working portion 2005. The driver portion 2010 can be rotated about the longitudinal axis (i.e., clockwise) relative to the working portion 2005 so that the boss 206 axially locks the drive shaft 238 into the rear manifold. The boss 206 on the bayonet motor adapter 236 can slide into the slot 203 on the camshaft coupler 204. Once rotated, the boss 206 on the bayonet motor adapter 236 can axially lock the driver portion 2010 and the working portion 2005 together. The release button 201 can be spring loaded and attached to the rear manifold of the working portion 2005.

[0096] Reference again Figure 2A-2B as well as Figure 2C-2D , the working portion 2005 can include components of the instrument 200 configured to be in direct contact with fluids and materials from the eye, while the driver portion 2010 generally includes components of the instrument 200 configured to remain outside of the fluid path, such as components configured to drive a suction pump and / or a cutting element. The drive mechanism 205 of the durable driver portion 2010 is configured to drive a suction pump 245 integrated into the handpiece of the disposable working portion 2005. The same drive mechanism 205 can also drive the cutting tube 210. The function of the instrument can depend on the components of the disposable working portion 2005 coupled to the durable driver portion 2010. The configuration of the suction pump 245 within the disposable working portion 2005 can be different because the type of cutting tube 210 coupled to the distal end of the disposable working portion 2005 can also be different (e.g., a vitrectomy probe versus a lens fragmentation probe).

[0097] The configuration of the suction pump 245 in the disposable working part 2005 can be different, including but not limited to a bellows mechanism, a diaphragm pump, a venturi pump, a capture pump, a positive displacement pump, a regeneration pump, a momentum transfer pump, a micro pump, etc.

[0098] In some embodiments, the disposable working portion 2005 may include a suction pump 245 as a piston pump. The piston pump may be configured to provide smooth continuous and / or discontinuous pulsating suction, for example, as described in U.S. Publication No. 2018 / 0318132, published on November 8, 2018, which is incorporated herein by reference. The piston pump may have a plurality of pistons driven by a piston cam, which in turn is driven by a drive mechanism 205 in a reusable driver portion 2010. Pulsating vacuum allows full vacuum to be applied through the cutting tube without the risk of anterior chamber collapse. When at the peak of the pulse, the instrument 200 may generate a high vacuum. However, since it is pulsed, the average suction flow rate may be low enough that the irrigation inflow may maintain proper anterior chamber support even at these high vacuums at the peak of the pulse. The movement of the piston in the first direction within the pump chamber generates a vacuum, so that material from the eye is sucked into the lumen of the cutting tube. The movement of the piston in the second opposite direction within the pump chamber discharges the material from the pump chamber and discharges the instrument. During lens fragmentation, higher flow pulsating suction may be useful. The disposable working part 2005 in combination with the piston pump may also include an oscillating working tip for lens fragmentation. The drive mechanism 205 of the reusable driver part 2010 may drive the piston pump and the oscillating working tip of the working part 2005.

[0099] The suction pump can be a roller, peristaltic, vortex, spiral, horseshoe, vane, gear, screw, diaphragm, centrifugal or other pump type. In some embodiments, the disposable working portion 2005 can include a suction pump 245 that is a peristaltic pump. The peristaltic pump can be configured to provide smooth continuous suction. In anterior vitrectomy, smooth continuous suction is very useful. The disposable working portion 2005 containing a peristaltic pump with a smooth flow rate can also include a vitrectomy probe having an inner shaft that oscillates within an outer shaft as described elsewhere herein. The drive mechanism 205 of the reusable drive portion 2010 can drive the peristaltic pump and vitrectomy probe of the working portion 2005.

[0100] Figure 3A-3BAn embodiment of a suction pump 245 for incorporation into the working portion 2005 is shown, which is configured to provide smooth, continuous suction through the cutting tube 210. The suction pump 245 can be a linear peristaltic pump having a symmetrical dual-chamber pumping manifold 420, a central camshaft 405 extending longitudinally through the manifold 420 along a longitudinal axis A, a plurality of cam followers 410, and a pair of peripheral conduits 415. The pumping manifold 420 can be disposed within the working portion 2005 between a proximal manifold and a distal manifold. The camshaft 405 can be coupled to a drive shaft 238 at a proximal region of the camshaft 405, for example, by a rotating camshaft coupler 204 in the working portion 2005. When the pump motor 230 rotates, the drive shaft 238 drives the camshaft 405 to rotate, thereby providing power to the suction pump 245. The camshaft 405 can also be coupled to the cutting tube 210 at a distal region of the camshaft 405, for example, by a rotating cam follower 213. The movement of the cutting tube 210 will be described in more detail below.

[0101] The two conduits 415 may be positioned on either side of the centerline C of the pumping manifold 420 (see Figure 4A ). The two conduits 415 may extend through the pumping manifold 420 in a substantially straight manner such that each conduit forms a longitudinal axis T through the pumping manifold 420 (see Figure 3B ), the longitudinal axis T being positioned parallel to the longitudinal axis A of the camshaft 405 extending through the pumping manifold 420. A first conduit 415a of the two conduits 415 can be positioned on one side of the camshaft 405, and a second conduit 415b of the two conduits 415 can be positioned on a second opposite side of the camshaft 405. The proximal flow path is divided into two flow paths connected at the proximal end to a pair of conduits 415 in the proximal manifold (not shown). The two conduits 415 can be combined into a distal manifold (not shown) at the distal side of the pumping manifold 420. The distal flow path can be in fluid communication with the lumen of the distal cutting tube 210.

[0102] Figure 3C-3D Shows Figure 3A-3B The camshaft 405 of the suction pump 245 in the embodiment of the present invention can be combined with a plurality of cam lobes 425 that work in real time to drive a plurality of cam followers 410 from side to side (or sideways) or toward and away from a pair of pipes 415, so that each pipe experiences sequential, progressive compression, thereby pushing its fluid volume along its flow path. The pair of pipes 415 can be aligned with the longitudinal axis A (rotational axis) of the camshaft 405. The lateral movement of the cam followers 410 can be perpendicular to the longitudinal axis A of the camshaft 405 and the longitudinal axis T of each of the pipes 415 (see Figure 3B) plane. For example, the conduit 415 can extend through the pumping manifold spatially parallel to or along the axis of rotation of the camshaft 405. The cam follower 410 can compress the conduit 415 along an axis that is substantially 90 degrees relative to the axis of rotation of the camshaft 405. For example, the cam follower 410 can be driven from side to side along a horizontal position or along a vertical position relative to the camshaft 405. Although the relative angle of the cam follower 410 and the conduit 415 can be greater than or less than a 90 degree angle, the cam follower 405 does not translate axially along the sidewall of the conduit 415 as occurs in a conventional peristaltic pump, which uses rollers that compress and roll along the length of the conduit to move its fluid volume along its flow path.

[0103] Each conduit 415 can be sequentially compressed by the cam follower 410 in a wave-like manner. Maximum compression closes the tube, capturing discrete volumes of fluid that are pushed along the length of the tube, resulting in a suction flow of fluid moving through the conduit 415. Conventional peristaltic pumps can involve translation of rollers or other components along the longitudinal axis of the conduit to push the fluid through the tube. As the conduit wears over time, this linear translation along the conduit can cause holes or tears in the sidewalls of the conduit. The suction pump 245 described herein need not involve translation of a compression element along the longitudinal axis (i.e., Figure 3B 415. Instead, the compression of each conduit 415 is in a plane perpendicular to the longitudinal axis T of the conduit 415. This arrangement avoids pulling or stretching of the tube and creates little or no friction on its sidewalls. In other words, the multiple cam followers do not apply forces along the axes of the two conduits and create little or no friction on the two conduits. The chamber volume remains consistent and the pump 245 has a lower risk of conduit failure or loss of pump performance that could be caused by compression translating along the length of the conduit.

[0104] like Figures 4A-4D As best shown, each of the plurality of cam followers 410 can include an internal slot 430 configured to receive their respective cam lobes 425. As the camshaft 405 rotates about its longitudinal axis A, the cam lobes 425 can travel up and down relative to and within the internal slots 430. The cam followers 410 are in turn pushed from side to side relative to the centerline C of the pumping manifold 420 by the cam lobes 425. Figure 4A One cam follower 410 is shown aligned with the centerline C. The cam lobe 425 is shown substantially aligned with the centerline C and located in the upper end region of the slot 430 of the cam follower 410. When the camshaft 405 is rotated a first degree about its axis A along arrow A, the cam follower 410 is urged away from the centerline C along axis C' in the direction of arrow R and the cam lobe 425 travels downwardly through the slot 430 ( Figure 4B ). When the cam shaft 405 is further rotated a second degree about its axis A along arrow A, the cam follower 410 is pushed back along axis C' toward the centerline C in the direction of arrow L, and the cam lobe 425 travels further downward through the slot 430 of the cam follower 410 ( Figure 4C When the camshaft 405 is further rotated a third degree about its axis A along arrow A, the cam follower 410 is pushed away from the centerline C along axis C' in the direction of L' as the cam lobe 425 travels back upward through the slot 430 of the cam follower 410 toward the upper end region of the slot 430 ( Figure 4D ).

[0105] The lateral movement of the cam followers 410 can produce offset pulses or incremental, sequential compressions of each conduit 415 so that the suction produced in the distal flow path connected to the cutting tube is smooth or substantially non-pulsating suction. The geometry of the camshaft 405 (e.g., pitch, length) and the number of cam lobes 425 and cam followers 410 can be different to achieve specific timing along the longitudinal axis T of the conduit 415. The number of cam followers 410 in the pump 245 can be different, for example, at least 2, 3, 4, 5, 6, 7, 8, 9, 10, up to about 20 cam followers 410. As the number of lobes and followers increases, the number of cam lobes 425 and cam followers 410 can more closely approximate perfectly smooth flow. For example, Figure 3B The embodiment of the suction pump 245 shown in FIG. 4 includes 10 cam lobes 425 and 10 cam followers 410. When each cam follower 410 is pushed left and right to compress the opposite pipe 415, the suction pump 245 can thereby generate a smooth sinusoidal waveform curve.

[0106] Figure 5A 4 shows how the pump 245 initially undergoes a warm-up period upon activation as the camshaft 405 begins to rotate. The cam follower 410 is pushed laterally within the pumping manifold 420 to sequentially compress the pair of conduits 415 and establish negative pressure within the flow lines of conduits 415a and 415b. The flow rate through conduit 415a can be offset from the flow rate through conduit 415b so that the target flow rate achieved through the distal flow path is substantially constant with minimal pulsating flow.

[0107] Pump 245 may include Figure 3A-3B In such an embodiment, the camshaft 405 timing may produce a curve that is more like a square curve of the off-on type (see Figure 5B). For example, an on-off square curve can provide a more consistent chamber length (i.e., the sealed volume within the tubing between the positions where the tubing is closed by the cam follower) compared to a screw-driven peristaltic pump that uses a more gradual motion to squeeze the tubing closed. Figure 3A-3B The cam lobes of the embodiment of the pump shown in follow a circular path relative to the entire device and a linear path relative to the cam follower 410. The cam follower compresses the pipes on both sides. When it moves in one direction, it compresses one pipe, and when it moves in the opposite direction, it compresses the opposite pipe. However, the cam lobes need not be driven by a spiral path with such a progressive compression. Instead, the layout of the cam lobes can be positioned radially or longitudinally relative to each other along the axis T so that the spacing between each cam lobe can produce compression on the pipe 415 to achieve the desired timing.

[0108] Again, about Figures 4A-4D , the shape of the cam follower 410 not only provides for the travel of the cam follower 410 in a lateral motion when the camshaft 405 rotates. The shape of the cam follower 410 provides for efficient compression of the pipe 415. Each cam follower 410 can incorporate a first compression area 435 on the outer surface of the cam follower 410 on a first side of the centerline C and a second compression area 435 on the outer surface of the cam follower 410 on a second opposite side of the centerline C. Each of the first and second compression areas 435, 437 can be arranged to be substantially aligned with the centerline C'. When the cam follower 410 moves along arrow R, the first compression area 435 compresses the pipe 415b ( Figure 4B When the cam follower 410 moves along the arrow L', the second compression zone 437 compresses the pipe 415a ( Figure 4D ). Each cam follower 410 may also include two displacement areas 440, 442 for each compression area 435, 437. When the pipe 415 is compressed by the compression areas 435, 437, the corresponding two displacement areas 440, 442 may receive material of the pipe 415 being compressed by the compression areas 435, 437 of the cam follower 410.

[0109] The pair of pipes 415 can extend in a straight line along the longitudinal axis T and parallel to the longitudinal axis A of the camshaft 405. The pair of pipes 415 extend substantially parallel to the axis of rotation of the camshaft 405 through the pumping manifold. Therefore, the compression on the pipes 415 occurs in a left-right motion along a horizontal plane relative to the plane of rotation of the camshaft, which can be in a plane perpendicular to the longitudinal axis A (and also perpendicular to the axis T). Therefore, this compression does not translate axially along the side wall of the pipe, thereby providing the advantage of less wear on the pipe material. In addition, the configuration of the pair of straight pipes 415 can provide additional lateral force to the cam follower 410. For example, when one pipe 415a is compressed by the cam follower 410, the opposite pipe 415b that has just been compressed by the cam follower 410 can rebound to its original shape. The elastic force can help compress the opposite pipes 415. Each pipe 415 can help cause compression of its counterpart by pushing the cam follower 410 in the opposite compression direction.

[0110] The configuration of the peristaltic pump within the working portion 2005 may be different and need not be a linear peristaltic pump. For example, the peristaltic pump may be a screw design or a horseshoe peristaltic pump.

[0111] In the context of cataract surgery, vitrectomy is used when complications occur during lens removal (e.g., inadvertent prolapse of the vitreous into the anterior segment following a posterior capsule rupture). Vitrectomy is generally considered an unwelcome part of cataract surgery. The goal of anterior vitrectomy is to remove the vitreous from the anterior chamber, clear the vitreous from the entry incision, and allow for insertion of an intraocular lens. The vitreous has an unpredictable flow behavior that is difficult to characterize due to its semisolid structure. The vitreous is primarily composed of water, but also has collagen fibers and hyaluronic acid. The vitreous needs to be cut before passing through the probe. Minced vitreous has a lower viscosity than intact, gel-like vitreous. Small-sized fragments are preferred to improve aspiration and removal of the vitreous.

[0112] The cutting tube 210 and the suction pump 245 can be driven to achieve a low level of cutting (e.g., 300 cpm) and a low level of suction (e.g., less than about 3 cc / min), for example, to remove lens fragments from the eye before starting vitreous removal. The cutting tube 210 and the suction pump 245 can be driven to achieve a higher level of cutting (e.g., 500-600 cpm), and low to medium suction (e.g., 3 cc / min to about 10 cc / min) for vitreous removal and continuous flow of vitreous into the cutter. The cutting tube 210 and the suction pump 245 can be driven to achieve a high level of cutting (e.g., up to about 7,500 cpm) and high suction (e.g., greater than 10 cc / min to up to about 25 cc / min) for vitreous removal and continuous flow of vitreous into the cutter. In other embodiments, the cutting tube 210 and the aspiration pump 245 can be driven to achieve asymmetric cutting and high pulsatile aspiration (e.g., greater than 10 cc / min up to about 30 cc / min or up to about 100 cc / min), such as can be used for lens fragmentation and emulsification. The motion profile and aspiration profile can vary depending on the procedure being performed and the stage of the procedure itself.

[0113] Figure 6A-6B A disposable working portion 2005 of the microsurgical instrument 200 is shown with an integrated suction pump 245, which is a linear peristaltic suction pump 245 as described above. The disposable working portion 2005 can be configured to perform anterior vitrectomy and can be coupled with a reusable driver portion 2010 that incorporates any of the various features described herein. Thus, a single reusable driver portion 2010 can drive different working portions 2005 with different functional capabilities (e.g., lens fragmentation, vitrectomy, bag polishing, etc.).

[0114] The cutting tube 210 can have any of a variety of configurations so that it can be used for lens fragmentation, phacoemulsification, vitrectomy and other anterior segment surgeries. Typically, the cutting tube 210 has a maximum cross-sectional diameter suitable for minimizing the size of the corneal incision for minimally invasive surgery in the eye. In some embodiments, the maximum cross-sectional diameter of the cutting tube 210 is about 1.25 mm. The maximum cross-sectional diameter may be less than this diameter or may be greater than this diameter, for example, not more than about 2 mm in diameter, not more than about 3 mm in diameter, up to about 4 mm in diameter, or up to about 5 mm in diameter. The cutting tube 210 can be a No. 20, No. 23, No. 25 or No. 27 vitrectomy probe known in the art.

[0115] In some embodiments, the cutting tube 210 is a standard guillotine-shaped vitrectomy probe having an inner tubular elongated member 250 that is configured to slide reciprocally within an outer tube 252 (see Figures 7A-7C). The outer tube 252 can be a fixed tubular element coupled to a region of the working portion 2005. The outer tube 252 can be fixedly coupled within the interior of the working portion 2005 by a retainer 254. The retainer 254 can be an annular element configured to receive the outer tube 252 therethrough such that the retainer 254 is positioned around the proximal region of the outer tube 252. The elongated member 250 can also be a tubular element, but unlike the outer tube 252, it is movable so that it can oscillate within the lumen of the outer tube 252.

[0116] The distal tip of the elongated member 250 may be formed as a cutting edge 256 (see Figure 7C ). In some embodiments, the cutting edge 256 is a short, sharp bevel. The cutting edge 256 of the elongated member 250 and the opening 258 in the side wall of the outer tube 252 together form a port 260. The size of the port 260 may vary depending on the position of the elongated member 250 relative to the outer tube 252. In operation, as the elongated member 250 reciprocates within the outer tube 252, tissue may enter the cutting tube 210 through the port 260 and be cut by the cutting edge 256. The vitreous body enters the port 260 when it is aspirated through the lumen 262. As the elongated member 250 moves distally, the oscillating inner elongated member 250 may capture the lens material between the cutting edge 256 and the opening 264 to cut small pieces of the lens material aspirated into the port 260. If the elongated member 250 does not have a side opening, the port 260 may undergo a complete closure when the elongated member 250 moves distally past the side opening 264. Such closure of port 260 can lead to flow instability, fluid acceleration and retinal traction. Therefore, the elongated member 250 may also include a side opening 258 near its distal region. This configuration is described as a two-dimensional cutter, which has an increased cutting rate and better overall efficiency, while also improving the retinal traction problem. When the inner elongated member 250 oscillates in the outer tube 252, the distal shaft edge 256 can chop up the vitreous entering the port on the distal stroke. On the proximal stroke of the elongated member 250, the vitreous entering the opening 258 can also be chopped. The dual-port two-dimensional cutter can increase the amount of cutting achieved with a single forward and backward motion of the inner elongated member 250 and avoid completely closing the port 260.

[0117] Port 260 may have a width optimized for complete mincing and aspiration of ocular tissue. In some embodiments, port 260 may have an axial length of greater than 0.05" up to about 0.175". The width of port 260 may be between 0.015" and 0.06". The distal tip of outer tube 252 may be as shown. Figure 7CThe port 260 may be biased to remain in an open position to avoid snagging tissue during removal of the instrument. The cutting rate achieved may vary as known in the art, for example up to about 7,500 cuts per minute (cpm). For example, the finger trigger type input 228 of the instrument and other inputs described herein may be used to control the duty cycle of the probe.

[0118] In some embodiments, lumen 262 extends through elongate member 250 to proximal opening 266 (see Figure 7A-7B ). The proximal opening 266 is held within a chamber 268 of a vacuum manifold 270 that is in fluid communication with a distal aspiration line from the aspiration pump 245. The proximal opening 266 is held within the chamber 268 during the oscillatory motion of the elongated member 250. The aspiration pump 245 applies a vacuum within the vacuum manifold 270 to aspirate the cut tissue from the eye through the lumen 262. The cut tissue enters the lumen 262 at the port 260 and exits the lumen 262 through the proximal opening 266.

[0119] As described above, the pump 245 can include a camshaft 405 extending along the longitudinal axis of the housing. The camshaft 405 can be driven by a drive mechanism (not shown) of the driver portion 2010. The proximal region of the camshaft 405 can be coupled to the drive shaft 238, for example, via a coupler 204 in the disposable working portion 2005, and the distal end of the camshaft 405 can be operatively coupled to the cutting tube 210. Therefore, the drive mechanism 205 that drives the suction pump 245 can also drive the oscillation of the cutting tube 210. The oscillating drive mechanism can be combined with a cam assembly to convert the rotational motion of the camshaft 405 into the linear motion of the cutting tube 210.

[0120] Figures 7A-7E An embodiment of a cutter cam assembly 214 is shown that is configured to oscillate the cutting tube 210. The cutter assembly is provided as an example and may be different. In some embodiments, the cutter assembly is configured for lens fragmentation and may achieve an asymmetric motion profile as described in U.S. Patent No. 10,231,870, published on March 19, 2019. In other embodiments, the cutter assembly is configured for anterior vitrectomy. The cutter assembly 214 may include a cutter cam follower 213 that is configured to move axially along the longitudinal axis A as the cam shaft 420 rotates. Fig. 7AThe distal region of the cam shaft 405 (i.e., distal to the pumping manifold 420) is shown engaged with the cutter cam follower 213 and the cutter cam follower 213 is fixedly coupled to the proximal end of the elongated member 250. The rotational motion of the cam shaft 405 is converted into linear motion of the cutter cam follower 213, and thus, the elongated member 250. Figure 7D-7E It is shown that the cutter cam follower 213 can have a hole 272 at the proximal end, which is configured to receive the distal end of the cam shaft 405. The outer surface of the distal end of the cam shaft 405 can include a channel 274, which is configured to receive the corresponding pin element 276 of the cutter cam follower 213. When the cam shaft 405 rotates around its longitudinal axis A, the pin element 276 moves through the channel 274 around the outer surface of the cam shaft 405. The channel 274 can follow an elliptical path from the first proximal region toward the distal region and back toward the first proximal region. When the pin element 276 moves through the channel 274, the cutter cam follower 213 is pushed to move axially along the longitudinal axis A. The cutter cam follower 213 moves at least a portion of the rotation in the distal direction. The cutter cam follower 213 then moves at least another portion of the rotation in the proximal direction. Therefore, a complete rotation of the cam shaft 405 provides a reciprocating axial motion of the cutter cam follower 213 and the elongated member 250. It should be understood that other drive mechanisms are also contemplated herein to produce the oscillatory motion of the elongated member 250 that cuts the tube 210 .

[0121] In another embodiment, the cam assembly may include a bevel cam in combination with an asymmetric or symmetrical profile. The elongated member 250 of the cutting tube 210 configured to translate along the longitudinal axis of the instrument can engage with a bevel cam configured to rotate. In some embodiments, the bevel cam is combined with a simple sawtooth configuration with an asymmetric profile. In other embodiments, the bevel cam is combined with a double bevel cam with a symmetrical platform and valley. The bevel cam can be combined with a cutter return spring. The backward (proximal movement) of the elongated member 250 depends on the bevel profile, and the forward (distal movement) of the elongated member 250 can depend on the cutter return spring. When the bevel cam rotates to perform an oscillating motion, the elongated member 250 can bounce back and forth on the bevel cam.

[0122] The RPM of the motor can be increased by incorporating a gearbox. The transmission can have a ratio that increases the input by at least about 3:1, 4:1, 5:1, 6:1, up to about 30:1. For example, the transmission can be a single-stage 5:1 planetary gear transmission to increase the speed from a 140RPM input to about 700RPM. The gear ratio can be driven by the spacing of the cam profile and the ramp, thereby driving a speed of 2ms and a dwell of about 4ms. The cam can be designed to ensure that the cutting stops the elongated member 250 of the cutting tube 210 in an open position relative to the outer tube. It should be understood that the oscillating drive mechanism can be combined with other cam configurations, including eccentric cams, barrel cams, or spiral cams.

[0123] The oscillating drive mechanism does not need to be combined with a cam, but can rely on magnetic force to achieve linear movement of the slender member 250 of the cutting tube 210. The magnetic drive can rely on a push-pull magnetic array to perform linear translation of the slender member 250 of the cutting tube 210 and avoid the use of springs. The cutting tube oscillation achieved by the magnetic drive is relatively stable, and the vibration and noise are very small. Similar to the pneumatic drive system, the speed of the slender member 250 of the cutting tube 210 in the magnetic drive is force driven and does not depend on the rotation speed. An input rotation speed of 140rpm can reach a frequency of 6Hz.

[0124] Reference again Figure 6B and Figures 8A-8B, the elongated member 250 of the cutting tube 210 can be coupled to a cutter spline 1209 having a translating magnet disk 1605 at the proximal end. The cutter spline 1209 and the translating magnet disk 1605 move bidirectionally a distance in the proximal and distal directions axially along the longitudinal axis of the housing in response to the movement of the camshaft 405, while preventing rotation about the longitudinal axis. The translating magnet disk 1605 may include one or more magnets configured to interact with one or more magnets of a rotating magnet disk 1615 located proximal to the translating magnet disk 1605 to generate a local magnetic field. The rotating magnet disk 1615 is configured to rotate, for example, with the rotation of the camshaft 405 of the pump 245, preferably with a gearbox located therebetween. The one or more magnets of the rotating magnet disk 1615 rotate into alignment and misalignment with the one or more magnets of the translating magnet disk 1605. The magnetic force between the magnets of the rotating magnet disk 1615 and the magnets of the translating magnet disk 1605 causes the translating magnet disk 1605 (and therefore, the cutting tube 210) to oscillate back and forth relative to the housing. The oscillation can be achieved by magnetic attraction and / or magnetic repulsion. For example, the rotating magnet disk 1615 can have a first magnet having a positive pole positioned toward the distal end of the housing. The translating magnet disk 1605 located within the housing at a distal position of the rotating magnet disk 1615 can have a second magnet having a negative pole positioned toward the proximal end of the housing. The first magnet of the rotating magnet disk 1615 and the second magnet of the translating magnet disk 1605 can be aligned with each other when the rotating magnet disk 1625 rotates a circumferential increment around the longitudinal axis. Once aligned, the first and second magnets can be magnetically attracted to achieve linear translation of the cutter spline 1209 in the first direction. The next increment of the circumference around the longitudinal axis aligns the poles of the magnets on their respective magnet disks 1605, 1615 to repel each other, thereby achieving linear translation of the cutter spline 1209 in a second, opposite direction. As the rotating magnet disk 1615 continues to rotate relative to the translating magnet disk 1605, the magnetic forces alternate between them to achieve reciprocating linear motion. Therefore, the rotation of the rotating magnet disk 1615 relative to the translating magnet disk 1605 causes the magnetic poles of the multiple magnets of the rotating magnet disk 1615 to alternately repel and attract one or more magnets of the translating magnet disk 1605, thereby causing oscillation of the slender member 250 of the cutting tube 210.

[0125] In some embodiments, the magnetic field of the magnet disks 1605 , 1615 can be made stronger by incorporating a second rotating magnet disk 1625 . Figure 6B and Figures 8A-8BA second rotating magnet disk 1625 is shown located distally of the translation magnet disk 1605. These proximal and distal rotating magnet disks 1615, 1625 can generate a stronger magnetic field to achieve linear translation of the translation magnet disk 1605 located therebetween. The proximal and distal rotating magnet disks 1615, 1625 can be fixed relative to each other so that they rotate together. The translation magnet disk 1605 can be positioned in the space between the proximal and distal rotating magnet disks 1615, 1625. The distal rotating magnet disk 1625 can be combined with one or more magnets configured to amplify the magnetic field. For example, the magnets of the proximal magnet disk 1615 can generate an attractive magnetic field for the magnets of the translation magnet disk 1605 to push the translation magnet disk 1605 toward the proximal magnet disk 1615 in the proximal direction. The magnets of the distal magnet disk 1625 can simultaneously generate a repulsive magnetic field for the magnets of the translating magnet disk 1605 to push the translating magnet disk 1605 further toward the proximal magnet disk 1615 in the proximal direction. Therefore, the repulsive magnetic field and the attractive magnetic field work in relation to each other to achieve linear motion in the proximal direction. In order to achieve motion in the opposite (i.e., distal) direction, the magnets of the proximal rotating magnet disk 1615 can repel the magnets of the translating magnet disk 1615, while the magnets of the distal rotating magnet disk 1625 can attract the magnets of the translating magnet disk 1605, thereby generating a simultaneous distal thrust and distal pull to ensure that the translating magnet disk 1605 travels in the distal direction.

[0126] The number of magnets on each magnet disk and their relative arrangement to one another may be varied to achieve the desired oscillating motion of the elongated member 250 cutting the tube 210 . Figures 8A-8B It is shown that the translating magnet disk 1605 may include a hole 1607 sized to contain its magnets. The proximal rotating magnet disk 1615 may include a plurality of holes 1617 sized to receive its magnets, and the distal rotating magnet disk 1625 may include a hole 1627 sized to receive its magnets. The holes 1607, 1617, 1627 of each disk may be located near its periphery so that they are substantially aligned along the longitudinal axis of the housing. The distal rotating magnet disk 1625 may be combined with (or include, incorporate) a wall 1626 to form a cartridge housing sized to contain the translating magnet disk 1605 so that the translating magnet disk 1605 can slide back and forth a certain distance within the wall 1626 of the cartridge housing. The proximal-facing surface of the distal rotating magnet disk 1625 may form a hard stop for the translating magnet disk 1605 on the distal end. The distally facing surface of the proximal rotating magnet disk 1615 can form a hard stop on the proximal end for the translating magnet disk 1605. In embodiments having only one rotating magnet disk 1615, a separate distal hard stop feature can be formed in the housing to limit distal movement of the cutter splines 1209.

[0127] Oscillation can be achieved by combining a rotating disk with multiple magnets positioned around the circumference of the disk in an alternating manner so that a single disk has magnets with alternating reversed magnetic poles. The mating ring can include identical magnets. When the opposite poles of the magnets are aligned, a magnetic attraction is generated, pushing the mating ring toward the rotating disk. When the same poles of the magnets are aligned, a repulsive magnetic force is generated, pushing the mating ring away from the rotating disk. Each increment around the circumference of the disk aligns the magnets, thereby generating an attractive or repulsive magnetic field between the matching ring and the rotating disk. With each rotation increment, different forces are generated between the two. The speed at which the cutting tube oscillates depends on the rotation speed of the rotating disk. The disk can be combined with a permanent magnet or an electromagnet. The electromagnet can be controlled to program the leading and trailing edges of the magnetic force. In some embodiments, the disks can be angled relative to each other so as to orient the magnetic field on the translating ring to encounter a sharp increase in the electromagnetic force relative to its opposite ring during extension, thereby changing sharply, and gradually decreasing during retraction to achieve asymmetry in the motion of the cutting tube. The magnets on the disk can have an offset of about 10 degrees relative to each other, rather than being flush with each other. The rotating ring may encounter a steeper magnetic gradient density at the leading edge of the forward stroke, but the trailing edge may taper more slowly than the leading edge. The gradient for each rotation increment may be much higher in the leading edge.

[0128] The oscillating drive mechanism, whether using a cam assembly or a magnetic drive to convert rotary motion into axial motion, can be combined with a gear device to increase the output from the rotation of the camshaft 405. The suction pump 245 generally requires a slower rotation speed for driving suction than the rotation speed required for the oscillation of the elongated member 250 of the cutting tube 210. For example, in vitrectomy, it may be necessary to achieve up to 5000 cuts per minute and achieve a vacuum capacity of 650mmHg or 25cc / minute volume. The instrument can be combined with a small transmission or gear train to achieve the desired oscillation speed. The gear train can be positioned between the camshaft 405 and the elongated member 250 of the cutting tube 210, and in some embodiments, can be configured to engage and disengage the elongated member 250 of the cutting tube 210, acting as a clutch mechanism in the oscillation of the elongated member 250. The gear train can achieve a fixed ratio between the cutting tube oscillation speed and the suction pump rotation speed.

[0129] The camshaft 405 of the suction pump 245 can rotate at a fixed rate to deliver a suction potential of about 15-30cc / minute. However, a gear device can be used to increase the rotation to increase the input from the motor to the output of the desired cutting rate. For example, the above-mentioned double bevel cam can include a single-stage 5:1 planetary gear drive to increase the rotation speed from 140 input RPM to about 700RPM. This ratio can be driven by the spacing of the cam profile and the bevel angle, thereby driving a cutting speed of 2ms and a pause of about 4ms. The rotation input of the camshaft 405 can be increased to reach up to about 5000CPM. Depending on the input speed and the desired output, the gear device can be in any of various ratios. For higher input speeds, a gear box may not be included. A higher gear box transmission ratio can also reduce the number of magnets combined in the magnetic drive. The gear device can also be used as a transmission element to open / close the cutting of the elongated member 250.

[0130] In an embodiment, the magnetic drive mechanism may include a planetary gearbox 1232 to amplify the input from the drive motor for the pump 245 to achieve the desired output (ie, 5000 CPM) of the elongated member 250 cutting the tube 210 . Figures 9A-9B Gearbox 1232 is shown. Gearbox 1232 can include a planet carrier 1242 configured to rotate around a central axis A. Planet carrier 1242 can be fixed to and driven by camshaft 405, which in turn is driven by a motor drive shaft in a driver portion (not shown). Planet carrier 1242 can be coupled to a plurality of planet gears 1239. Planet carrier 1242 and planet gears 1239 are located within a ring gear 1241. Planet gears 1239 mesh with internal threads on ring gear 1241 surrounding planet gears 1239, and mesh with sun gears 1244 positioned inside planet gears 1239. Ring gear 1241 causes each planet gear 1239 to rotate around their own central axis A' as they rotate around the central axis A of planet carrier 1242 together with planet carrier 1242. Rotation of planet gears 1239 causes internal sun gear 1244 to rotate around central axis A.

[0131] As discussed in more detail above, rotation of the internal sun gear 1244 drives oscillation of the elongated member 250 cutting the tube 210 . Figure 6A-6B The sun gear 1244 in the illustrated embodiment is positioned on the proximal side of the proximal rotating magnet disk 1615, which, as described above, causes reciprocating motion of the translating magnet disk 1605 on the cutter splines 1209 and, therefore, the cutting tube 210.

[0132] The gear ratio between the rotation of the camshaft 405 and the rotation of the sun gear 1244 can vary. The gear ratio can be about 5:1 or 6:1, although the ratio can vary.

[0133] The proximal rotating magnet disk 1615 may include a central rod 1628 that is sized and positioned to mate with a corresponding central hole 1608 in the translating magnet disk 1605. The coupling between the rod 1628 and the hole 1608 may be sealed by one or more O-rings (see Figure 6B ). The internal sun gear 1244 extending from the proximal end of the rotating magnet disk 1615 may additionally incorporate a rod having one or more O-rings to seal the fluid path extending from the opening of the cutting tube 210 to the suction pump 245.

[0134] Although physically coupled, the pump and oscillation can be functionally decoupled. The working portion 2005 can incorporate a cutter switch 1632 on a portion of the housing. When the trigger 228 is pressed, the cutter switch 1632 can control whether the cutting tube 210 is activated. The cutter switch 1632 can lock the oscillation mechanism so that no oscillation occurs when the trigger 228 is activated. The user can control whether the instrument is cutting during suction or not. Fig. 9C As best shown, the cutter switch 1632 can be a generally annular disk having an external grip feature 1634 and a central hole 1636. The grip feature 1634 is configured to extend outside the housing of the working portion 2005 so that a user can engage and actuate the cutter switch 1632. In one embodiment, the cutter switch 1632 is configured to rotate about the longitudinal axis of the instrument to select between oscillating the cutting tube and not oscillating the cutting tube. However, it should be understood that the actuation of the switch 1632 can be different. The cutter spline 1209 can extend through the central hole 1636 of the cutter switch 1632. The cutter spline 1209 can include a ramp feature 1638 at its base, which has a shape corresponding to the ramp feature 1639 surrounding the central hole 1636 of the cutter switch 1632. When the cutter switch 1632 is rotated about the longitudinal axis in a first direction, the ramp feature 1639 of the center hole 1636 and the ramp feature 1638 at the base of the cutter spline 1209 are disengaged, allowing the cutter spline 1209 to translate axially relative to the hole 1636. When the cutter switch 1632 is rotated about the longitudinal axis in a second, opposite direction, the ramp feature 1639 of the center hole 1636 engages with the ramp feature 1638 at the base of the cutter spline 1209. The ramp features 1638, 1639 cause the cutter spline 1209 to translate axially in the distal direction relative to the hole 1636. The engagement of the ramp features with each other secures the cutter spline 1209 to the cutter switch 1632 and prevents it from axially translating relative to the hole 1638, effectively shutting off the oscillation even as the magnetic drive continues to rotate.

[0135] As discussed elsewhere herein, one or more user inputs (e.g., a multi-way trigger 228) can be used to turn the motor on / off. The effective suction delivered through the tube 210 can depend on trigger actuation (e.g., pressing with a finger or thumb). For example, the first 20% of the trigger stroke can turn on the motor. The first 0-10% of the trigger stroke can be a dead time. After the first 10% to about 20% of the trigger stroke, the motor can be turned on to establish a vacuum. After 20% of the trigger stroke, the valve can be opened to control the suction achieved. The vacuum can depend on the trigger position, for example, from 0–100%. The cutting mode can be selected with a cutter switch 1632 or other selector. The cutting rate achieved by vitrectomy is preferably about 5000 CPM, which is constant during use. A constant cutting rate can be activated after 20% of the trigger stroke.

[0136] The suction pump can be run in reverse to reverse the flow of fluid from the cutting tube 210. Tissue may be caught accidentally or blocked during surgery. Reverse operation of the suction pump can cause fluid to flow back from the tube 210 and release these tissues and / or help clear blockages. Running the suction pump forward to generate vacuum or reverse operation to clear fluid from the tip can be associated with the position of the trigger 228. For example, during surgery, the trigger 228 can be pressed to open the suction pump and allow vacuum to be established in the instrument. When released, the trigger 228 can return to its neutral position and suction is closed. The user can then manually clean the tube 210 by pushing the trigger 228 upward away from the neutral position, thereby causing the suction pump to reverse and push the fluid through the tube 210 and push out from the distal opening. The instrument can be coupled to an irrigation source so that the suction pump running in reverse delivers irrigation fluid from the irrigation source to the outside of the tube 210.

[0137] The instrument can allow for at least two modes of operation, including (1) suction only and (2) suction plus cutting. The term "suction only" is used in the context of whether or not cutting is also being performed. It should be understood that "suction only" can be performed simultaneously with the delivery of irrigation fluid. As described above, the instrument can also be operated in an irrigation delivery only mode. The suction delivered through the cutting tube 210 can be controlled by a bypass valve or vent valve 1640 (see Figure 6B) control. In some embodiments, the exhaust valve 1640 may be positioned distal to the suction pump 245 and proximal to the cutter assembly. The exhaust valve 1640 can be used to adjust the effective flow rate of the suction pump 245 through the lumen of the cutting tube 210. The motor driving the pump can operate at a fixed speed, causing the suction pump 245 to operate at a fixed speed. The exhaust valve 1640 allows the user to adjust the effective suction when the trigger 228 is actuated. The exhaust valve 1640 can basically suck the suction generated by the suction pump away from the lumen of the elongated member. When the exhaust valve 1640 is open, the vacuum pump 245 is connected (i.e., bypassed) to the irrigation fluid, so there is very little or no suction delivered through the cutting tube 210. When the valve 1640 is closed, the bypass is closed and the vacuum pump 245 is directly connected to the cutting tube 210. When the exhaust valve 1640 is fully closed, the complete suction is directed through the lumen of the cutting tube 210.

[0138] The exhaust valve 1640 can be coupled to the actuation of the trigger 228 so that the movement of the trigger 228 controls the position of the valve 1640. The coaxial irrigation can be routed through the exhaust valve 1640 to minimize compliance to mitigate surges in the vacuum. For example, when the instrument is in a static state (i.e., the trigger 228 is not actuated), the exhaust valve 1640 can be opened to the atmosphere (or irrigation fluid), thereby drawing suction through the cutting tube 210. The first amount of travel of the trigger 228 out of the static state can activate the motor 230, which in turn drives the suction pump 245. The exhaust valve 1640 can remain open so that suction is not delivered through the cutting tube 210 even if the motor is running at full speed. Further travel of the trigger 228 can begin to close the exhaust valve 1640 to slowly increase the suction delivered through the cutting tube 210. The more the trigger 228 is actuated, the more suction is delivered through the cutting tube 210 until the exhaust valve 1640 reaches a fully closed position. The valve 1640 can allow flow control of the suction from near zero to 100% (650 mmHg). In some embodiments, the trigger travel from 0 to 20% can be a dead band for starting the motor 230 and suction, so that valve movement does not begin until the trigger 228 reaches at least 20% of the initial movement from the rest position. The relationship between the trigger movement and the suction percentage can be linear or nearly linear.

[0139] The configuration of the exhaust valve 1640 can vary. In some embodiments, the exhaust valve 1640 can be a needle valve or a butterfly valve (i.e., inline or rotary). The motion of the trigger can be scaled down to the motion of the valve 1640. Mechanical scaling of the trigger motion can incorporate a spiral cam, rack and pinion cam, or connecting rod driven motion. Figure 6BAs shown, the orientation can be in line with the longitudinal axis of the device, or can be vertical, vertical or horizontal. In some embodiments, the exhaust valve 1640 can be a needle valve having an axially aligned spiral cam driven needle that moves relative to the valve seat in the fluid channel. The pitch and angle of the valve seat can be designed to achieve the desired scaling relative to the trigger movement. As the trigger moves away from the static position, the needle is pushed further toward the valve seat, thereby gradually closing the valve. The valve 1640 can also be a rotationally driven flat valve, which provides a shorter length and a smaller angle on the valve seat. The flat valve can be aligned with the trigger axis to drive directly from a pivot such as the trigger. In another embodiment, the valve 1640 can be a vertical needle rack pinion valve. The trigger 228 can move the rack along the longitudinal axis of the device. The rack can engage the pinion to push the fluid seal up and down relative to the valve seat in the fluid channel. The scaling of the trigger movement can be combined with lower friction.

[0140] Other Implementations

[0141] The drive for the suction pump need not be coupled to the cutting tube motion. The drive mechanism 205 can be configured to allow a user to drive suction through the suction pump 245 independently of cutting through the cutting tube 210 in a seamless manner, for example, depending on the degree of actuation of the trigger 228. For example, the reusable drive portion 2010 of the instrument can include a clutch or gear train that is configured to decouple the rotation of the suction pump 245 from the oscillation of the cutting tube.

[0142] Fig.10 A reusable driver portion 2010 is shown for use with the instrument 200. A portion of the housing is removed, exposing components of the drive mechanism 205. In an embodiment, the drive mechanism 205 can include a motor 230 with or without a gearbox or gear head 232, a gear train 234 located between the gear head 232 and a motor adapter 236, and a concentric motor drive including an inner drive shaft 238 extending through an outer drive shaft 240. Each of the inner drive shaft 238 and the outer drive shaft 240 can extend through the motor adapter 236 and be attached to a gear head drive shaft 243 of the gear head 232. There can be a gap between the motor adapter 236 and the shafts 238, 240 so that the shafts rotate freely with the motor 230. Since there are concentric drive shafts 238, 240 that each drive the cutting tube 210 or the suction pump 245, the drive of the cutting tube 210 and the suction pump 245 can be decoupled.

[0143] Fig.10Gear train 234 is shown located between gear head 232 and motor adapter 236. In an embodiment, gear train 234 is a differential. A standard differential allows a motor to drive two shafts at different RPMs. A standard differential has a ring gear connected to at least one star gear. The star gear can move along two rotational axes - one along the axis of the ring gear and the other around its own rotational axis. The two side gears and the star gear mesh together. Power from the motor flows to the ring gear, the star gear, and the two side gears, causing the two shafts to rotate. The ring gear, the star gear, and the side gears can all rotate as a single solid unit, causing the two shafts to rotate at the same RPM. The star gear can also rotate around its own axis, resulting in a combined rotation - a rotation around the ring gear axis and a rotation around the star gear's own axis. The side gears meshing with the star gear will cause the shafts to move at different RPMs. A standard differential relies on turning the power flow direction 90 degrees to each shaft. In the present system, the differential gear train 234 does not divert the power flow away from the axis A of the motor drive shaft, but rather maintains the power flow of the motor 230 along the axis A of the motor drive shaft.

[0144] Fig.11AAn embodiment of a differential gear train 234 of the drive mechanism 205 of the instrument 200 is shown. A gear carrier 242 is fixed to and driven by a gear head drive shaft 243, such that the gear head 232 drives the gear head drive shaft 243, which in turn drives the gear carrier 242 to rotate about the longitudinal axis A of the entire assembly. The gear carrier 242 rotates with the gear head 232 and the gear head drive shaft 243. The gear carrier 242 can be coupled to two opposing pinion gears 246, which are configured to rotate about two axes. When the gear carrier 242 rotates, the pinion gears 246 can rotate about the longitudinal axis A of the entire assembly. The pinion gears 246 can also rotate about their own axis A'. The two pinion gears 246 mesh with a first side gear 248 at the proximal end, which is arranged concentrically with the gear carrier 242. The two pinion gears 246 mesh with a second side gear 257 at the distal end. The inner drive shaft 238 can be fixedly connected to the first side gear 248 so that there is no relative movement between them. The inner drive shaft 238 rotates with the first side gear 248. The inner drive shaft 238 extends concentrically through the outer drive shaft 240. The outer drive shaft 240 can be fixedly connected to the second side gear 257 so that the second side gear 257 rotates the outer concentric drive shaft 240. Power from the motor 230 drives the gear head 232, which in turn drives the gear head drive shaft 243, which in turn drives the gear carrier 242, which provides power to the differential gear train 234. Power from the gear carrier 242 drives the pinion 246, which drives one or both of the side gears 248, 257. The differential gear train 234 of the drive mechanism 205 does not direct power from the gear head drive shaft 243, for example, at a right angle relative to the axis A, as occurs in a standard automotive differential. Instead, inner drive shaft 238 extends concentrically through outer drive shaft 240 and is secured to and driven by side gears 248. The differential drive gears may be incorporated within the driver portion of the instrument or within the disposable portion of the instrument.

[0145] The drive mechanism 205 may additionally include a second motor 259 that controls the speed of the outer concentric drive shaft 240. The second motor 259 may be a small, very low-power motor. The second motor 259 may include a rotary encoder. The first motor 230 and the gear head drive shaft 243 may provide all the power for the drive system of the device, and the second motor 259 may differentially distribute the power between the concentric drive shafts 238 and 240. The configuration of the second motor 259 may be different. In some embodiments, the second motor 259 is a flat motor. A flat motor is an example of a low RPM, high torque motor that can directly drive the drive shaft to rotate. In an embodiment, the second motor 259 may be a flat motor with a central hole, the inner diameter of which is configured to receive the concentric drive shafts 238 and 240 passing therethrough. The second motor 259 may include a first ring portion concentrically positioned within the inner diameter of the outer second ring portion of the motor 259. The inner first portion of the motor 259 may rotate relative to the outer second portion of the motor 259. The inner first portion of the motor 259 can rotate while the outer second portion of the motor 259 can be stationary, for example, an area attached to the housing or a motor bracket. The second motor 259 can have an aspect ratio that is much flatter than conventional motors that are typically cylindrical. The flat aspect ratio allows the second motor 259 to be positioned in a small space. Preferably, the second motor 259 has a relatively high torque to distribute power between the two drive shafts 238, 240. The second motor 259 is also preferably low RPM so that it can directly control the rotation of the shaft without gear reduction. The inner first portion of the second motor 259 can directly drive the outer drive shaft.

[0146] The first motor 230 provides power to the inner shaft 238 and the outer shaft 240 through a transmission system between the inner shaft 238 and the outer shaft 240. The second motor 259 allows the user to select the RPM of the outer shaft 240 and the inner shaft 238. In order to run both shafts at the same speed, the second motor 259 rotates at the same RPM and direction of rotation as the gearbox drive shaft 243.

[0147] A control processor 280 including software may be on a PCB 255 within the housing 226. The software is programmed or capable of being programmed to control the RPM of the output from the gear head drive shaft 243 and the RPM of the outer concentric shaft 240 through the second motor 259 and the encoder. Thus, the software indirectly controls the output of the inner concentric drive shaft 238 by specifying the RPM of the gear head drive shaft 243 and the outer concentric shaft 240. In doing so, the RPM of the outer and inner concentric drive shafts 238, 240 may be specified independently.

[0148] It should be understood that the configuration of the gear train 234 of the drive mechanism 205 may be different. In some embodiments, the gear train 234 of the drive mechanism 205 configured to independently drive two shafts is a planetary gear train. Fig. 11B An embodiment of a planetary gear train 234 is shown. Fig.11A As with the described embodiment, the drive mechanism 205 can drive the pump independently of the cutting tube via concentric, coaxial drive shafts 238, 240. Fig. 11B The gear train 234 of the drive mechanism shown in the figure can allow at least two operating modes, including (1) suction only and (2) suction plus cutting. The gear carrier 242 is fixed to and driven by the gear head drive shaft 243, so that the gear head 232 drives the gear head drive shaft 243, which in turn drives the gear carrier 242 to rotate around the longitudinal axis A of the entire assembly. The gear carrier 242 rotates with the gear head drive shaft 243. The gear carrier 242 can be coupled to a plurality of planetary gears 239. When the gear carrier 242 rotates, the planetary gears 239 can rotate around the longitudinal axis A of the entire assembly. The planetary gears 239 can also rotate around their own axis A'. The planetary gears 239 are meshed with a ring gear 241 surrounding the planetary gears 239 and with a sun gear 244 positioned within the planetary gears 239, so that the planetary gears 239 travel around the sun gear 244. The inner drive shaft 238 may be fixedly connected to the sun gear 244 so that there is no relative motion between the sun gear 244 and the inner drive shaft 238. The inner drive shaft 238 rotates with the sun gear 244. The inner drive shaft 238 extends concentrically through the outer drive shaft 240. The outer drive shaft 240 may be fixedly connected to a gear carrier 242, which is fixedly connected to a gear head drive shaft 243. Power from the motor 230 drives the gear head 232, which in turn drives the gear head drive shaft 243, which in turn drives the gear carrier 242, which provides power to the gear train 234. The gear head drive shaft 243 directly drives the outer drive shaft 240.

[0149] In the first mode, Fig. 11B The gear train 234 shown in the figure allows the pump to operate but does not activate the cutting oscillating motion of the cutting tube. Therefore, the first mode can be an inhalation / aspiration "I / A" mode. Only the sun gear 244 and therefore the inner drive shaft 238 of the cutting tube remain stationary while the rest of the gear train 234 rotates. Friction in the disposable cutter system keeps the sun gear 244 stationary. In the second mode, Fig. 11B The gear train 234 shown in FIG. 2 can also allow activation of cutting in addition to suction / suction via the pump. The sun gear 244 rotates while the ring gear 241 remains stationary. Fig. 11BUnlike the differential gear train described above, the planetary gear train does not need to include a second motor to drive the outer drive shaft 240, thereby providing a more compact and lower cost system. For example, the ring gear 241 can be prevented from rotating by a user input (e.g., a finger throttle on the instrument). Depressing the finger throttle can cause the component to manually contact an area of ​​the ring gear 241, thereby acting as an interruption to stop its rotation. Preventing the rotation of the ring gear 241 forces the input power from the gear head drive shaft 243 to be transferred from the ring gear 241 to the sun gear 244. When this occurs, the cutting tube is powered to begin oscillating due to the rotation of the inner drive shaft 238 in addition to the outer drive shaft 240 that is already rotating. The slower the ring gear 241, the more power is directed to the sun gear 244 and the inner drive shaft 238.

[0150] As described above, the gear train 234 allows the cutting and suction to be driven independently. Fig.10 and 11A -11B shows the inner concentric drive shaft 238 extending through the outer concentric drive shaft 240, which in turn extends through the second motor 259. The inner drive shaft 238 can extend further distal to the outer drive shaft 240, and the inner drive shaft 238 and the outer drive shaft 240 extend beyond the distal end of the housing 226 of the driver portion 2010. The combination of the inner drive shaft 238 and the outer drive shaft 240 extending beyond the housing 226 of the driver portion 2010 forms a concentric motor coupler 263, which is configured to engage with corresponding features within the working portion 2005. The coupler 263 drives the suction pump 245 and the cutting tube 210 of the working portion 2005. In some embodiments, the inner drive shaft 238 provides power for cutting by oscillation of the cutting tube 210, and the outer drive shaft 240 drives suction through the cutting tube 210 by activation of the suction pump 245.

[0151] The inner drive shaft 238 can be coupled to a cutter cam 212 configured to convert the rotational motion of the drive shaft 238 into linear motion of the cutting tube 210. The outer drive shaft 240 can be coupled to a piston cam 249 configured to convert the rotational motion of the outer drive shaft 240 into linear motion of a piston 247 of a suction pump 245 to power suction through the cutting tube. The coupler 263 of the driver portion 2010 can be inserted into the proximal end of the working portion 2005 so that the shafts 238, 240 cooperate with their respective cams.

[0152] As described above, the suction pump 245 of the device 200 may be a piston pump and may incorporate any of a variety of mechanisms configured to generate negative pressure within the lumen of the elongated member (see Fig.12). In some embodiments, the suction pump 245 is a piston pump having a plurality of pistons 247 driven by a piston cam 249, which is in turn driven by the drive mechanism 205. The suction pump 245 is configured to provide smooth continuous and / or discontinuous pulsating suction, for example, as described in U.S. Publication No. 2018 / 0318133, published on November 8, 2018, which is incorporated herein by reference. The pulsating vacuum allows a full vacuum to be applied through the cutting tube 210 without the risk of anterior chamber collapse. The instrument 200 can generate a high vacuum when at the peak of the pulse. However, because it is pulsed, the average suction flow rate can be low enough that the irrigation inflow can maintain proper anterior chamber support even at these high vacuums at the peak of the pulse. The movement of the piston 247 in the first direction within the pumping chamber creates a vacuum so that material from the eye is drawn into the lumen of the cutting tube 210. The movement of the piston 247 in the second opposite direction within the pumping chamber discharges material from the pump chamber and the instrument 200.

[0153] The piston 247 can be moved by the piston cam 249 (see Fig.12 ) move in their respective pumping chambers. Fig.12 The cam surface 219 is shown configured to provide a reciprocating linear motion of the piston 247. The piston cam 249 is positioned proximally of the piston 247 so that the cam surface 219 pushes the piston 247 distally toward the distal end of their respective pumping chambers when the piston cam 249 rotates. The geometry of the cam surface 219 can be designed to provide different motion curves of the piston 247 in their respective piston chambers, and thereby produce different vacuum distributions (i.e., smooth continuous, continuous with negative pressure spikes, or discontinuous pulsed negative pressure). The cam surface 219 can be elliptical, eccentric, oval, or snail-shaped. During the first portion of the rotation of the cam 249, the proximal piston head 253b slides along the inclined portion of the cam surface 219, and the piston 247 moves distally along the longitudinal axis A of the instrument 200. During the second portion of the rotation of the cam 249, the proximal piston head 253b slides over the cam surface 219 that terminates at the protrusion. When the piston head 253b drops from the protrusion, the distal force of the cam 249 on the piston 247 is released. Due to the second slope of the cam surface 219, the piston 247 can also move proximally, allowing the piston 247 to retract slowly in their pump chamber.

[0154] The spring 251 around the central portion of the piston 247 is biased to push the proximal piston head 253b toward the proximal region of the piston chamber in the proximal direction. When the piston 247 is pushed by the cam surface 219 in the distal direction, the spring 251 is compressed. When the piston cam 249 rotates further, the force pointing to the distal side of the proximal piston head 253 is removed (that is, due to the protrusion or due to the second inclined surface) and the spring 251 pushes the piston 247 backward, thereby generating a vacuum in the corresponding pumping chamber. The complete rotation of the piston cam 249 therefore allows each piston 247 to move axially continuously. For pulsating vacuum, the piston head 253b slides along the cam surface 219 and extends in the distal direction at a first rate, and the piston head 253b falls from the cam surface 219 and retracts in the proximal direction at a second rate much faster than the first rate. For more continuous flow, the piston head 253b slides more smoothly and in an overlapping manner along the inclined surface of the cam surface 219.

[0155] Fig.12 A cam mechanism for cutting tube 210 and a cam mechanism for suction pump 245 are shown. The cam mechanism for cutting tube 210 may include a cutter cam 212 located distally of cam follower 213. The cam mechanism for suction pump 245 may include a piston cam 249. Piston cam 249 may include a generally cylindrical body defining a hole 261. The hole 261 may extend from a proximal receptacle 218 in piston cam 249 toward a cam surface 219 at a distal end of piston cam 249. The cam surface 219 at a distal end of piston cam 249 may engage a proximal piston head 253 of piston 247. Proximal receptacle 218 is located within a proximal region of working portion 2005.

[0156] The shafts 238, 240 may be coupled within the working portion 2005 by their outer surface geometry. Fig.10 As best shown, each of the shafts 238, 240 can terminate in a hexagonal head. The working portion 2005 can incorporate features having complementary geometry that is configured to mate with the hexagonal heads of the shafts 238, 240. Fig.12It is shown that the cutter cam 212 and the cam follower 213 can be located in the hole 261 of the piston cam 249. The thin wall tube 221 can be located in the hole 261 between the piston cam 249 and the cutter cam 212. The tube 221 can include a proximal receptacle 222 coaxially arranged in the hole 261, so that the receptacle 222 of the tube 221 is just located distal to the receptacle 218 of the piston cam 249. The proximal receptacle 218 of the piston cam 249 can have a geometry that is complementary to the geometry of the outer drive shaft 240 of the motor coupler 263. For example, the outer drive shaft 240 can include a hexagonal head and the proximal receptacle 218 of the piston cam 249 can engage with the geometry of the hexagonal head so that the piston cam 249 rotates with the outer drive shaft 240. Similarly, the proximal receptacle 222 of the tube 221 has a geometry that is complementary to the geometry of the inner drive shaft 238 of the motor coupler 263. Inner drive shaft 238 may include a hex head and engage with proximal receptacle 222 of tube 221 such that tube 221 rotates with inner drive shaft 238 .

[0157] Cutter cam 212 and cam follower 213 are configured to rotate independently of piston cam 249. Tube 221 may be connected to cutter cam 212 but not to piston cam 249, such that piston cam 249 and cutter cam 212 are configured to rotate independently of each other via their respective couplings to the drive shaft.

[0158] Still about Fig.12 , the cutter cam 212 can include teeth 211 on its proximally facing surface that are configured to engage corresponding teeth on the distally facing surface of the proximal cam follower 213. As the cutter cam 212 rotates, the teeth 211 slide along the teeth of the proximal cam follower 213. The cam follower 213, the cutter spline 209, and the cutting tube 210 are pushed rearward or in the proximal direction P until the teeth 211 of the distal cutter cam 212 reach a step on the cam follower 213 (at Fig.12 209 and cam follower 213. At this point, the force of spring 216 pushes cutting tube 210, cutter spline 209 and cam follower 213 forward or in the distal direction D. A cutter pad 217 may be incorporated to provide cushioning when cutter spline 209 rebounds toward the distal position. Cutter pad 217 can reduce the noise generated by instrument 200 during operation by cushioning cutter spline 209 when the cutter rebounds forward. As cutter cam 212 and cam follower 213 rotate, cutting tube 210 oscillates back and forth.

[0159] The cutting tube 210 can be connected to a cam follower 213. The cam follower 213 can have a cam surface at its distal end that engages with the cutter cam 212. The proximal end of the cam follower 213 can be connected to a spring 216, which pushes the cam follower 213 distally. When the cutter cam 212 rotates, the cam surface moves the cam follower 213 proximally, thereby further compressing the spring 216. The cam follower 213 can fall forward (i.e., distally) from the step at a certain point in the rotation. At this time, the spring 216 quickly pushes the cam follower 213 forward until the cam surface engages again. Through such a mechanism, the cutting tube 210 can be retracted with a retraction speed curve that depends at least in part on the rotation speed of the cutter cam 212. The rotation speed of the cutter cam 212 can be controlled so that the maximum tip retraction speed remains below the critical "cavitation threshold speed", otherwise it will cause eye cavitation. The cutting tube 210 can then be extended at an extension speed profile that depends at least in part on the force of the spring 216 and the mass of the cutting tube assembly. In this way, the average retraction speed can be slow, i.e., below the cavitation threshold speed, but the average extension speed can be fast, i.e., close to or above the average retraction speed of a typical phacoemulsification tip. Thus, the benefits of a mechanical jackhammer can be achieved while completely avoiding the deleterious effects of cavitation.

[0160] When in use, the drive mechanism 205 can retract the cutting tube 210 in the proximal direction with a retraction speed curve and advance the cutting tube 210 in the distal direction with an extension speed curve. The retraction speed curve can be different from the extension speed curve. In addition, the motion curve of the cutting tube 210 can be coordinated with the vacuum distribution. For example, when a vacuum pulse is applied by the cutting tube 210, the cutting tube 210 can be simultaneously launched in the distal direction D. In the case where the cutting tube 210 is described as moving in the forward and distal directions relative to the treatment site, the vibration of the cutting tube 210 is also considered. The cutting tube 210 can vibrate in a manner similar to a conventional phacoemulsification machine. Therefore, the cutting tube 210 can vibrate while applying a vacuum pulse, and at a certain stage or after the vacuum pulse, the vibration and vacuum can be turned off so that the system is stationary before the vibration-vacuum sequence is started again. The coordination between the movement and / or vibration of the cutting tube 210 and the vacuum applied through the cutting tube 210 is described in U.S. Publication No. 2018 / 0318133, published on November 8, 2018, which is incorporated herein by reference.

[0161] As described above, the device may include a multi-way trigger 228, such as a finger-actuated throttle or trigger. The input provided by the user through the finger throttle can inform the software of the desired speed of each drive axis based on the throttle position mapping program. For example, the trigger 228 of the instrument 200 can be actuated to move a first amount. One or more sensors can assess that the travel of the input 228 is greater than 0%, but less than a specific amount of the total travel that the input can travel, such as between about 0% and about 5%. A signal can be sent to the computing unit 115 of the system 100, causing the computing unit 115 to communicate with the fluid system 110 to open the valve 150 of the irrigation system. When the valve 150 is opened, irrigation fluid from the irrigation source 130 can flow to the microsurgical instrument 200 through the irrigation line 155. This places the system 100 in an initial irrigation-only stage, wherein the line 155 is filled with irrigation fluid and the microsurgical instrument 200 is able to deliver the irrigation fluid to the treatment site. The input 228 of the instrument 200 can be actuated to move a second amount. One or more sensors may assess that the stroke of the input is greater than 5%, but less than a second amount of the total stroke, for example between about 6% and about 20%. Low-level suction via pump 245 may begin to draw fluid from microsurgical instrument 200 through waste line 165. Valve 150 of the irrigation system may remain open so that irrigation fluid from irrigation source 130 continues to be delivered to the eye, preferably so that the volume of fluid entering the eye is substantially equal to the volume of fluid leaving the eye. This places microsurgical instrument 200 in an irrigation plus suction phase. Background I / A flow alone may have a low flow rate, for example, about 2cc / minute to about 20cc / minute at a 20% finger trigger position. Input 228 of instrument 200 may be actuated to move a third amount. One or more sensors may assess that the stroke of the input is greater than 20% up to about 100%. The vacuum within the handpiece of microsurgical instrument 200 by suction pump 245 may be increased. Valve 150 may remain open so that the irrigation supply continues. Once the trigger position reaches a threshold value (i.e., 20% travel), the mechanical oscillation of the cutting phase begins and further increases to a higher frequency as the trigger is further depressed. Once the procedure is completed, the user can then adjust the trigger 228 of the microsurgical instrument 200 back down to 0%, at which point the vacuum through the suction pump 245 stops. The valve 150 can be closed some time after the pump is deactivated (e.g., about 2 seconds), thereby suspending the flushing toward the microsurgical instrument 200.

[0162] As described elsewhere herein, an input can activate one or more components of the system such that the pumping and cutting characteristics can gradually increase with further actuation of the input, such as, for example, an accelerator pedal. Generally, the greater the input, the greater the aspiration vacuum applied. Irrigation delivery can be passive and deliver fluid on demand. As fluid leaves the eye, it can be replaced by substantially equal volumes at substantially equal rates. An irrigation source can be maintained above the eye so that hydrostatic pressure maintains a positive pressure in the anterior chamber. The fluid path is substantially sealed so that when fluid is aspirated, the irrigation fluid immediately replaces it.

[0163] Table 1

[0164]

[0165] Table 1 shows an example of a multi-stage trigger and throttling to implement different functions of an instrument 200 having two drive shafts. In throttle position 0, the trigger travels 0%, the motor 230 (and the second motor 259, if present) do not rotate and the suction, irrigation and cutting functions are all off. The RPM of the motor 230, the inner drive shaft 238 and the outer drive shaft 240 are all zero and the BSS pinch valve 150 is fully closed. For example, in throttle position 1, the trigger travels greater than 0% to an upper threshold, such as 5%. The motors 230, 259 are still not rotating, but the pinch valve 150 is open to start the irrigation flow. This position provides the instrument 200 with only irrigation functions. The pinch valve 150 remains open at every throttle position except 0. In throttle position 2, the trigger travels greater than the upper threshold of position 1, such as greater than 5% to the upper threshold of position 2, such as 20% travel. Both the motor 230 and the second motor 259 begin to rotate. The motor 230 and the second motor 259 rotate at the same speed as the gear head drive shaft 243. As a result, the inner drive shaft 238 (the shaft coupled to the cutter cam 212) does not move. The instrument 200 provides irrigation (due to the valve 150 remaining open) and suction (due to the movement of the piston cam 249) in I / A mode. The speed increases with further compression of the finger throttle, thereby increasing the suction rate. In preparation for entering throttle position 3, the motor 230 RPM drops to a low level (e.g., about 10%) so that the suction drops to a low background flow level (e.g., 2-4cc / minute). The RPM of the outer shaft 240 matches the RPM of the gear head drive shaft 243, so that the RPM of the inner drive shaft 238 remains at zero. This low background flow can help to attract tissue to the distal end of the cutting tube 210, thereby improving cutting by aspirating lens fragments into contact with the cutting tube 210 before cutting occurs. This transition will not be noticed by the user. At throttle position 3, the trigger travel reaches and exceeds the upper threshold of position 2 (e.g., 20%) and the motor 230 begins to increase RPM. The motor 230 increases RPM throughout throttle position 3. The second motor 259 slows down relative to the rotational speed of the gear head drive shaft 243. This starts the rotation of the inner drive shaft 238. The inner drive shaft 238 rotates the cutter cam 212, which converts the rotational motion into linear motion of the cutting tube 210. The cut is then made. As the finger throttle is further depressed (e.g., the throttle travels greater than the upper threshold of position 2, toward 100%), the cutter speed and the suction rate increase in unison.

[0166] In an alternative embodiment, the inner drive shaft 238 is coupled to the piston cam 249 and the outer drive shaft 240 is coupled to the cutter cam 212. In finger throttle position 2, the motor 230 may begin to rotate while the motor 259 remains stationary. In finger throttle position 3, the motor 230 continues to rotate and the second motor 259 begins to slowly rotate, thereby increasing the rotation of the inner drive shaft 238 and initiating the cutting motion of the cutting tube 210. As the finger throttle is further depressed beyond position 3, the speed of the cutting motion increases.

[0167] The gear train 234 can be configured so that it does not need to be combined with two motors 230, 259 to achieve independent actuation of the two drive shafts 238, 240. For example, the gear train 234 can be as described with respect to Fig. 11B The planetary gear train 234 is described. The inner drive shaft 238 (the shaft coupled to the cutter cam 212) does not move until the throttle position 3 is reached. The throttle position 3 can cause the RPM of the motor 230 to increase and interrupt (i.e., delay) the rotation speed of the ring gear 241. Any deceleration of the ring gear 241 will cause the rotation of the sun gear 244, thereby starting the rotation of the inner drive shaft 238. The inner drive shaft 238 can rotate the cutter cam 212, which converts the rotational motion into linear motion for cutting the tube 210.

[0168] One or more aspects of the microsurgical instrument 200 may be programmable by the user. For example, the user may program one or more aspects of the drive mechanism 205, such as the speed of the suction pump 245, the oscillation speed of the cutting tube 210, a maximum speed limit, disabling / enabling various modes (i.e., pulse mode or burst mode vacuum), adjusting mode parameters (i.e., on time versus off time during pulse mode), and various other controllable parameters of the instrument 200 as described elsewhere herein. The user may also program the microsurgical instrument 200 using an external computing device 300 that communicates directly with the instrument 200 rather than through the instrument 200 or the system 100. The instrument 200 and / or the system 100 may also be programmed to provide limitations on specific actions when the input 228 is actuated. For example, the drive mechanism 205 of the instrument 200 may be programmed to have a minimum and / or maximum speed when the input 228 is actuated, or in the case of fluid infusion and aspiration, the instrument 200 may be programmed to have a minimum and / or maximum fluid pressure when the input 228 is actuated. Thus, the instrument 200 described herein may be programmed using inputs that are adjustable by the user as well as pre-programmed instructions that affect one or more aspects of the instrument 200 when the input 228 is actuated.

[0169] The control processor can be programmed by input on the device itself or remotely programmed, such as by an external computing device 300 having an input. The control processor can operate according to program instructions stored in the memory. Any of a variety of adjustable functions of the instrument can be programmed in this manner, including but not limited to the travel distance of the cutting tube 210, the oscillation frequency of the cutting tube 210, the extension speed curve, the retraction speed curve, or any other aspect of the motion profile of the cutting tube 210. One of the multiple aspects of the suction pump (e.g., the pump 145 of the system 100 and the suction pump 245 of the instrument 200) can also be programmed by the user to control the vacuum applied at the distal region of the cutting tube 210, including but not limited to the suction flow rate, the minimum vacuum pressure, the maximum vacuum pressure, the vacuum pulse frequency, or any other aspect of the vacuum distribution.

[0170] Aspects of the subject matter described herein can be implemented in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and / or combinations thereof. These various implementations can include implementations in one or more computer programs that are executable and / or interpretable on a programmable system that includes at least one programmable processor that can be either special or general purpose and 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.

[0171] These computer programs (also referred to as programs, software, software applications or code) include machine instructions for a programmable processor and may be implemented in high-level procedural and / or object-oriented programming languages ​​and / or in assembly / machine language. As used herein, the term "machine-readable medium" refers to any computer program product, device and / or device (e.g., disk, optical disk, memory, programmable logic device (PLD)) for providing machine instructions and / or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal. The term "machine-readable signal" refers to any signal for providing machine instructions and / or data to a programmable processor.

[0172] In various embodiments, the description is made with reference to the accompanying drawings. However, some embodiments may be practiced without one or more of these specific details or in combination with other known methods and configurations. In the specification, many specific details, such as specific configurations, dimensions, and processes, are set forth to provide a thorough understanding of the embodiments. In other cases, well-known processes and manufacturing techniques are not described in particular detail so as not to make the description unnecessarily unclear. Throughout the specification, references to "one embodiment", "an embodiment", "an implementation", "an implementation", etc. refer to the specific features, structures, configurations, or characteristics described being included in at least one embodiment or implementation. Therefore, the phrases "one embodiment", "an embodiment", "an implementation", "an implementation", etc. appearing in various places throughout this specification do not necessarily refer to the same embodiment or implementation. In addition, in one or more embodiments, specific features, structures, configurations, or characteristics may be combined in any suitable manner.

[0173] Relative terms are used throughout the specification to 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 to the first direction. However, these terms are provided to establish a relative frame of reference and are not intended to limit use or orientation to the specific configurations described in the various embodiments.

[0174] Although this specification contains many details, these details should not be interpreted as limitations on the scope of the claimed protection or the scope that can be claimed, but rather as descriptions of specific features of specific embodiments. Certain features described in this specification in the context of separate embodiments may also be implemented in combination in a single embodiment. On the contrary, the various features described in the context of a single embodiment may also be implemented in multiple embodiments or in any suitable sub-combination, respectively. Moreover, although the features may be described above as working in certain combinations and even initially claimed as such, in some cases, one or more features in the claimed combination may be deleted from the combination, and the claimed combination may be for a sub-combination or a variant of a sub-combination. Similarly, although operations are depicted in a particular order in the drawings, this should not be understood as requiring such operations to be performed in the particular order shown or in a continuous order, or performing all the operations shown to obtain the desired results. Only some examples and implementations are disclosed. Variations, modifications and enhancements may be made to the described examples and implementations and other implementations based on what is disclosed.

[0175] In the above description and claims, phrases such as "at least one ..." or "one or more of ..." may appear, followed by a list of combinations of elements or features. The term "and / or" may also appear in a list of two or more elements or features. Unless implicit or significantly contradictory to the context in which it is used, the phrase is intended to represent any element or feature listed individually, or to represent any quoted element or feature combined with any other quoted element or feature. For example, the phrases "at least one of A and B", "one or more of A and B", "A and / or B" represent "alone A, alone B or A and B together" respectively. Similar explanations are also intended to be used for lists containing three or more items. For example, the phrases "at least one of A, B and C", "one or more of A, B and C", "A, B and / or C" are intended to represent "alone A, alone B, alone C, A and B together, A and C together, B and C together, or A and B and C together".

[0176] Use of the term "based on" above and in the claims is intended to mean "based, at least in part, on," thereby also allowing for non-recited features or elements.

Claims

1. An apparatus for performing ophthalmic surgery in an eye, the apparatus comprising: Handheld part; an elongated member extending from a distal region of the handheld portion, the elongated member including a lumen and an opening proximate the distal region of the elongated member; and a suction pump located within the handheld portion and in fluid communication with the opening of the elongated member, wherein the suction pump comprises: a camshaft extending along a longitudinal axis and having a plurality of cam lobes; a conduit extending parallel to said longitudinal axis; and a plurality of cam followers driven by the cam of the camshaft to move in a plane perpendicular to the longitudinal axis to sequentially compress the pipe, Wherein a drive mechanism configured to rotate the cam shaft also drives oscillation of the elongated member.

2. The device according to claim 1, wherein: The conduit includes a proximal flow path that splits into a pair of peripheral tubes on either side of the cam shaft that combine distally of a pumping manifold to form a distal flow path in fluid communication with the lumen of the elongated member.

3. The device according to claim 2, wherein: The plurality of cam followers sequentially compress the pair of peripheral tubes to produce non-pulsating suction.

4. The device according to claim 3, wherein: The non-pulsating suction is less than 3cc / minute.

5. The device according to claim 3, wherein: The non-pulsating suction is between 3cc / minute and 10cc / minute.

6. The device according to claim 3, wherein: The non-pulsating suction is between 10cc / minute and 25cc / minute.

7. A device according to any one of the preceding claims, wherein: The elongated member is movable in a reciprocating manner relative to the handheld portion.

8. The device according to any one of claims 1 to 6, wherein: The elongated member is configured for lens fragmentation, phacoemulsification, or anterior vitrectomy.

9. The device according to any one of claims 1 to 6, wherein: The elongate member has a maximum cross-sectional diameter of 1.25 mm.

10. The device according to any one of claims 1 to 6, wherein: The elongate member has a maximum cross-sectional diameter not exceeding 3 mm.

11. The device according to any one of claims 1 to 6, wherein: The elongated member is a vitrectomy probe between 20 and 27 gauge.

12. The device according to any one of claims 1 to 6, wherein: The elongated member is configured to slide reciprocally within an outer tube that is fixedly coupled within an interior of the handheld portion.

13. The device according to claim 12, wherein: The distal tip of the elongated member forms a cutting edge.

14. The device according to claim 13, wherein: The outer tube includes an opening through a side wall.

15. The device according to claim 14, wherein: The elongated member further includes a side opening proximate a distal region thereof, the side opening being configured to form two cutouts in conformity with the outer tube.

16. The device according to any one of claims 1 to 6, wherein: The elongated member includes a proximal opening within a chamber of a vacuum manifold in fluid communication with the aspiration pump.

17. The device according to any one of claims 1 to 6, wherein: The elongate member is configured to oscillate at 300 cuts per minute.

18. The device according to any one of claims 1 to 6, wherein: The elongate member is configured to oscillate at 500-600 cuts per minute.

19. The device according to any one of claims 1 to 6, wherein: The elongate member is configured to oscillate up to 5000 cuts per minute.

20. The device according to any one of claims 1 to 6, wherein: The elongate member is configured to oscillate up to 7500 cuts per minute.

21. The device of any one of claims 1-6, further comprising a gearbox configured to amplify input from the pump to achieve an output of the elongated member configured for vitrectomy.

22. The device according to claim 21, wherein The gearbox is a planetary gearbox.

23. The device of any one of claims 1-6, further comprising a drive mechanism configured to be operatively coupled to the camshaft, wherein: The drive mechanism is configured to rotate the camshaft.

24. The apparatus of claim 23 further comprising a gear arrangement to enhance input from the drive mechanism.

25. The device according to claim 24, wherein The camshaft of the suction pump rotates at a fixed rate to deliver a suction potential of 15 cc / min to 30 cc / min.

26. The device according to claim 24, wherein: The input from the drive mechanism is approximately 140 RPM and the gear arrangement has a ratio of 3:1, 4:1, 5:1, 6:1 or 30:

1.

27. The device according to claim 1, wherein: The cam shaft is operatively engaged with a cutter assembly configured to convert rotational motion of the cam shaft into reciprocating linear motion of the elongated member.

28. The device according to claim 27, wherein The cutter assembly includes a ramp cam and a cutter return spring.

29. The device according to claim 28, wherein Proximal movement of the elongated member is dependent upon the ramp cam, and distal movement of the elongated member is dependent upon the cutter return spring.

30. The device according to claim 27, wherein: The cutter assembly includes a translating magnet disk and a rotating magnet disk.

31. The device according to claim 30, wherein: The translating magnet disk comprises one or more magnets, and wherein the rotating magnet disk comprises one or more magnets.

32. The device according to claim 31, wherein The one or more magnets of the rotating magnet disk and the one or more magnets of the translating magnet disk generate a localized magnetic field as the one or more magnets of the rotating magnet disk rotate into and out of alignment with the one or more magnets of the translating magnet disk.

33. The device according to claim 32, wherein: The translating magnet disk is coupled to the cutter spline and the cutter spline is coupled to the elongated member such that the translating magnet disk, the cutter spline and the elongated member all translate axially together.

34. The device according to claim 33, wherein The translating magnet disk, cutter splines, and elongated member are configured to bi-directionally move axially a distance along the longitudinal axis as a result of rotation of the camshaft.

35. The device according to claim 31, wherein Alignment of the one or more magnets of the rotating magnet disk with the one or more magnets of the translating magnet disk induces linear motion through magnetic attraction or magnetic repulsion.

36. The device according to claim 31, wherein The rotating magnet disk includes a plurality of magnets oriented relative to each other such that the magnetic poles alternate.

37. The device according to claim 31, wherein Rotation of the rotating magnet disk relative to the translating magnet disk causes the poles of the plurality of magnets to alternately repel and attract the one or more magnets of the translating magnet disk, thereby inducing oscillation of the elongated member.

38. The apparatus of claim 31 further comprising a second rotating magnet disk, the second rotating magnet disk comprising one or more magnets, wherein The second rotating magnet disk is located distally from the translating magnet disk.

39. The device according to claim 38, wherein Alignment of the one or more magnets of the first and second rotating magnet disks with the one or more magnets of the translating magnet disk causes oscillation of the elongated member.

40. The device according to claim 39, wherein The one or more magnets of the second rotating magnet disk have magnetic poles arranged to cause repulsion of the one or more magnets of the translating magnet disk, and the one or more magnets of the first rotating magnet disk have magnetic poles arranged to cause attraction, and the repulsion and attraction generate a magnetic field to push the translating magnet disk to move linearly between the first rotating magnet disk and the second rotating magnet disk.

41. The device according to claim 40, wherein The second rotating magnet disk forms a distal hard stop and the first rotating magnet disk forms a proximal hard stop for the translating magnet disk.

42. The device of any one of claims 1-6, further comprising a cutter switch configured to physically decouple rotation of the cam shaft from oscillation of the elongated member.

43. The device according to claim 42, wherein: Upon activation of an input on the hand-held portion, the cutter switch controls whether the elongated member oscillates.

44. The device according to claim 42, wherein: The cam shaft is operatively engaged with a cutter assembly, and the cutter switch locks oscillation of the elongated member during rotation of the cutter assembly.

45. The device of any one of claims 1-6, further comprising a bleed valve functionally coupled to an input of the handheld portion, the bleed valve being configured to regulate an effective flow rate of the suction pump through the lumen of the elongated member.

46. ​​The device according to claim 45, wherein The input is a trigger configured to be pressed.

47. The device according to claim 46, wherein The open configuration of the exhaust valve draws all of the suction generated by the suction pump away from the lumen of the elongate member.

48. The apparatus of claim 46, wherein: The closed configuration of the exhaust valve directs complete suction generated by the suction pump through the lumen of the elongate member.

49. The apparatus of claim 46, wherein: The vent valve is a needle valve having a screw-actuated needle movable relative to a valve seat in a fluid passage.

50. The apparatus of claim 49, wherein the open configuration of the needle valve connects the aspiration pump to an irrigation fluid line, resulting in minimal aspiration through the lumen of the elongate member.

51. The apparatus of claim 50, wherein: A first amount of travel of the trigger away from a resting state activates the aspiration pump, wherein the needle valve remains open such that aspiration from the aspiration pump is not delivered through the lumen of the elongated member.

52. The apparatus of claim 51, wherein: A second further travel of the trigger away from the resting state pushes the needle toward the valve seat.

53. The apparatus of claim 51, wherein: The first travel amount is greater than zero and less than 20% of the trigger travel.

54. The apparatus of claim 52, wherein: The second further travel amount is at least 20% of the trigger travel.

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